ACTUATION MECHANISM AND METHOD

BACKGROUND

|0OOI ] Embodiments relate to medical devices and methods. More particularly, embodiments relate to stereotactic table mounted or hand-held single insertion, multiple sample soil tissue excisional biopsy and coring devices and corresponding methods for retrieving multiple soft tissue biopsy- samples using a single insertion.

SUMMARY

[0002} Embodiments are drawn to medical devices and methods that are used for core biopsy procedures. According to one embodiment, a biopsy coring/delivery device, als referred to herein as an excisional device, may be configured to retrieve multiple samples of normal and/or abnormal appearing tissues during a single insertion through the skin (percutaneous procedure). Embodiments ma comprise structures and fenctioiiainy for different phases of a multi-phase biopsy procedure, which may be performed, by hand or through attachment to a stereotactic table or Magnetic Resonance imaging (MRI) stage. For example, embodiments may comprise a pre-treafoiem of the area and/or of the abnormal tissue, or the delivery of tracer materials for tracking the potential spread or flow patterns of abnormal tissues (such as cancerous tissues) through die process of metastasis. Embodiments may also comprise an intra-proeedure delivery of medications ^' that may anesthetize tissues at the site, or that may deli ver other therapeutic agents such as, for example, pro-coagul nts. Embodhnents may also be configured for the delivery of post-procedure materials such as medications, implantable materials for cosmetic purposes- marking elements and othe implantable elements for later imaging reference, or other purposes. Embodiments may also be configured for imaging of the surrounding tissaes during pre-operative, intraoperative, and/or post-operative phase of the device's clinical use. Embodiments may als be configured to allow for ablation of tissue daring pre-, intra-, and/or post-operative phases. Embodiments of the biopsy device, along with associated related subcomponents described herein, may be configured to retrieve solid, contiguous and/or fragmented tissues as well as liquid and semi-solid tissues for analysis,, diagnosis and treatme t Embodiments may he portable, disposable or reusable and ma be electrically,, mechanically and/or manually powered and operated.

BRIEF DESCRIPTION OF THE DRAWINGS

{0003] Fig, 1 is a perspective view of a. core biopsy device according to one embodiment;

{β0$ Fig. 2 is a perspective view of a movable, rotatable seoopida-shaped outer sheath with a movable, rotatable cutting element and transport helix attached, according to one embodiment;

[0005] Fig, 3 is a side view of air outer sheath and articulated beak and helical element, according to one embodiment;

{0006] Fig. 4 is a side view of an outer sheath and rotating inner beak and helical element,, according to one embodiment;

{0007] Fig. 5 is an overhead view of a beak element with living hinge closing against a scoopula-shaped outer sheath, according to one embodiment;

|00ί)8] Fig , 6 is a side vie w of an outer sheath and inner cutting elemen and helical element, according to one embodiment;

{0009] Fig. 7 is a side view of an outer sheath and cutting element, according to on embodime t;

[0010] Fig. 8 is a side view of anothe embodiment of an articulated beak and attachment mechanism, according to one embodiment;

[0011] Fig. 9 is a side view of the working elements of Fig, 8, in open beak configuration^ according to one embodiment;

{00123 Fig, 1.0 is a side view of the rotating inner cutting element and outer rotatable scoopola-shaped element; according to one embodiment;

^• {0013] Fig, 11 is a side view of another ^■ embodiment of an outer sheath and inner cutting element; ^" |00Ϊ4{ Fig, 12 is a top iew of an ©titer sheath and cutting element aligned at ts distal tip, according to one embodimen ; fOOlSj Fig, 13 is m end on perspective view of at* outer sheath and inner cutting element in over center open configuration, according to one embodiment;

[00.161 Fig. 14 A is an end -on perspective view of an outer sheath and inner cutting element in rotated position, according to one embodiment;

[0017J. Fig. J.4B is an end on perspective view of an outer sheath and inner cutting element in further rotated position, according to one embodiment;

[0018] Fig, I SA is a perspective view of a split-tube single beak assembly in retracted position against an oute sheath with seoopi a, according to one embodiment;

100191 Fig. I SB is a perspective view of a split-tube single beak assembly extending part way out of an outer sheath, witli the beak open over center, according to one embodiment;

|0O2O) Fig. J SC is perspective view of split-tube single beak assembly in fully extended position at the end of the scoopula of an outer sheath for part off of a ^' tissue specimen and for other purposes, according to one embodiment;

[002 jj Fig. 16 A shows details of a work element according to one embodiment; f 002 1 Fig. 168 sho w details of a work element and outer sheath of an excisioual device according to one embodiment;

|0023j Fig 17 A shows an element of an excisional device according to one embodiment"

[ ^' 00241 Fig, 17B shows a detail of an element of an excisiona! deviee _s according to one embodiment;

1 025j Fig. 18 shows a proximal sheath comprisin a plurality of elongated slots disposed in a spiral pattern around a longitudinal axis, according to one embodiment;

|0026j Fig. 1 shows details of a proximal sheath, beak actuation elements and inner helical element of an excisional device according to one embodi ment; |ί*ίί27] -Fig. 20 shows an onter difierentially rotating or rotataMe pxti& sheath, which may ^" imctkm as a true owter sheath inchwimg an op n but nan- scoopula shaped extremity or as a distal sheath of m exeislonal device ^' ccording to embodiments;

| 028| Fig. 21 a view of a twin beak work assembl of an exctsionaJ device with the distal sheatb and outer sheath removed, according to one embodiment;

[ ^■ 0029] Fig. 22 is a view of a single beak work assembly of an exeisionai device with the outer sheath, dista sheath and proximal sheath removed, according to one embodiment;

|003θ] Fig. 23 shows a top -view of a -mechanical arrangement for cutting element

.rotation, and actuation, according to one embodiment;

|$Mi3i] Fig . 24 is an illustration of a cam aid cam follower arrangement, according to one embodiment;

10032] Fig. 25 is a side vie w of a cutting element actuation mec an sm, according to one embodiment;

10833] Fig. 26 A is a side view of the internal and external features of a biopsy device according to one embodiment;

| >034| Fig. :26B is a f ront end-on view o f the shape of a ^' biopsy device, according to one embodiment;

f0035] Fig. 26C is a perspectiv view of a transfer m gazine, according to one embodiment;

f 0036} Fig. 26t> is a cross sectional view of a transfer magazine according to one embodiment, taken along line A A' of Fig, 26C;

f§037] Fig, 26E is a perspective view of a hinged, clamshell e di ent of a transfer magazine, according to one embodiment;

J0O38! Fig. 27 A is a first view of a stereotactic table adapter for a biopsy device, according to one embodiment.

|0039} Fig. 27B is a second view of a stereotactic adapter for a biopsy device, according to one embodiment [0040] Fig, 27C is a side view of an adapter p tforn¾ suitable for a stereotactic: table stage, and on which an excisional device may be coupled, according to one embo iment. fl04!J Fig, 2SA is a perspective exploded view' of a capstan assembly, according to one embodiment.

100421 Fig. 2 SB is a top view of a capstan assembly, according to one embodiment

{00 31 Fig. 28C is a top view of a capsta assembly in a first configuration, according to one embodiment

[0044} Fig. 28D is a top view of a capstan assembly in a second configuration, according to one embodiment

[0045] Fig. 29A shows structure of an element of a exeisionai device according to one embodiment.

[0046] Fig. 296 shows structere of an additional element of an excisional device according to one embodiment.

[0047] Fig. 29C snows still more strtjcaire of an element of an exCisional device according to one embodiment

[0048] Fig, 29D shows further structure of an exeisionai device according to one embodiment.

[0049] Fig, 30A shows a monolithic beak assembly of an excisions! device according to one embodiment

[0050] Fig. 30B shows a detail of a proximal end of a monolithic beak assembly of an exeisionai device according to one embodiment.

[0051] Fig, 31 snows the distal end of a proximal sheath of an exeisionai device according to one embodiment.

|0052| Fig. 32 shows an assembly comprising the monolithic beak assembly and the proximal sheath of an exeisionai device according to one embodiment.

[0053] Fig. 33 shows the distal end of a distal sheath of an exeisionai device, accordin to one embodiment Fig. 34 shows a» assembly comprising a monolithic beak assembly, a proximal sheath and ; : distal she th., aceordiug to one embodiment.

Fig, 35 shows the distal portion of an e cisiona! device according to one

Fig, 36 is a flowchart of a method ^■ according to one embodiment

10057J Fig. 37 is a flowchart of a method: of posi tioning a biopsy device, according to one embodiment,

00581 Fig. 38 is a flowchart of another method according to one embodiment

Fig. is a view of distal portion of an excisions! device according to one embodiment

Fig, 0 is a view of a distal portion, of an. exelsional device according to one embodiment

Fig. 4] is a flowchart of a method according to one embodiment,

DETAILED DESCRIPTION ff 0S2] Reference will now be made in detail to the construction and operation of embodiments- -illustrated in the accompanying drawings. The following-: description is only exemplary of the embodiments described and shown herein. The embodiments, merelbre, are not limited to these implementations, b t ma be realized by other implementations.

|0063| Core biopsy procedures have evolved from simple core needle biopsies comprising aspiration of fluids using, a simple syringe and needle t devices having the capability to extract solid; tissues for histopathologkal analysis. This more recent capability has proved to be a far more power&l way to diagnose diseases and. abnormal tissue entities, some of which are extremely Me threatening, and others, which may be more benign bat nevertheless mast be ^• definitively distinguished from the more dangerous types of abnormalities, including precancerous lesions, in-situ cancers, invasive cancers, and other space occupying lesions such as cystic lesions, serious infections and others. As core biopsy procedures have evolved into far more diagnostic-ally powerml tools, they have displaced many sf the more invasive open, surgical procedures which, however, continue t be performed for diagnostic purposes based on the advantages of retrieving a sufficient volume of tissue wi th, the preserved architecture that is m important in. the diagnosis and treatment algorithm used by clinicians in addressing these abnormalities and diseases. One of the basic seeds during a biopsy procedure is to accurately correlate tissue diagnoses with imaging diagnoses. in order to successfully accomplish ibis, it is important to know that the retrieved tissue actuall and accurately represents the imaged abnormality. This i an aspect where many coring biopsy devices fall short. It i for this reason that open surgical diagnostic procedures and. other invasive procedures continue to be performed. Other clinicall significant limitations of core biopsy procedures include the manner in which the abnormal tissue is separated from the host organ, the manner in which the tissue is retrieved and handled during the procedure by the coring biopsy device, and the amount of biopsy artifact/damage imparted to the tissue specimens b the coring procedure and device, it is well known that the larger the caliber of the retrieved tissue samples, the better the correlation with the imaging abnormality, and thus the easier and more accurate., definitive and helpful the diagnosis. However, in order to retrieve larger caliber specimens, -most biops devices have large outer diameters, leading to increased complications, pain and other adverse effects, due principally to the greater trauma associated with the larger bore devices. Moving these larger bore device through the tissues is much more difficult, particularly without the help of an active mechanism to aid in smoother and more gradual advancement of the biopsy device. Additionally, the larger the caliber of the biopsy device, the more difficult it becomes to precisely visualize the biopsy device in relation to- the target abaor aiity, especially for small lesions (OH the order of about ½■ cm to less than % em). Despite these limitations, more than 4-5 million diagnostic core biopsies are performed each year around the world in the breast alone, with as many as 2 million diagnostic breast biopsies being performed each year in the US. There is little doubt tha many invasive, open surgical diagnostic biopsies should be replaced by improved core biopsy procedures.

{0064} Reference will now be made in detail to the construction and operation of embodiments illustrated in the accompanying drawings. Fig. 1 shows a biopsy ojr ₅ more generally, an excisi onal device 10 according to embodiments. The excisional biopsy device 10 may comprise a. tubular coring and transport- assembly 11 thai may* according to one embodiment* have a distal end defining a seooputa shape. The distal end may have a shape that differs from the seoopula shape and that differs from that shown in the figures. The seoopula forms part o an outer sheath, (also called "outer tube," or "non-rotating outer sheath," or "differentially rotating outer sheath," or ''!manualiy rotating outer : he3th ^ί, }: of appropri ate dimensions to ret ve a sing le or multiple core samples of tissue (not shown) that Is are sufficient to provide the desired clinical diagnostic or therapeutic result The scoopula may be made of materials, or include coatings, tha may enhance penetration arid/or hentostasis, and may also he configured to include external features that enhance penetration and/or stabilization withi the tissue, for example, spirally-disposed ridges ^• and ox grooves, as well as features such as axial slits to enhance visibility under guidance modalities such a$ ultrasound. Such an appropriate dimension may e, for example _* about 4 inches in length, in addition to a forward excursion of the tubu lar coring and transport assembly 11 during the coring phase. It is to be understood, -However, thai, the foregoing dimensions and any dimensions referred to herein are exemplary in nature only. Those of skill in this art will recognize that other dimensions and/or configurations may he implemented, depending upon the application, and that the fi ul r coring and transport assembly 1 and its subparts, as well as oilier elements of the device, could be of any length or dimension, all of which are considered within the scope of this disclosure. Furthermore, any discussion of dimensions or ranges of dimensions or physical or dynamic aspects such as flow rates or ranges of motion or time factors outlined herein are exemplary in nature only and should not be considered to be limiting. The outer sheath ma be removable such that, according to one embodiment, such outer sheath may be fully detached from the biopsy device 10 and thus be temporarily placed, or left in place in the body to enable delivery through its lumen of substances or othe devices during preoperative, biopsy., and/or postoperative phases,

|i06S| O e embodiment of the biopsy devi ce ! ©, as shown in the figures , may be configured for hand-held operation and may comprise an ergonomically comfortable and secure handle 12 at its proximal end from which the tubular coring and transport assembly 1 1 extends so that the biops device 10 ma be easily i ected with one han while the other baud is free to hold a guiding probe such as an ultrasound transducer. However, it is to be understood that embodiments may readily be configured to fit onto any number of guiding devices such as a stereotactic table imaging stage or equipment associated with other guidance modalities such as Magnetic Resonance imaging (MR!) (not shown). As shown, one embodiment of the biopsy device 10 may comprise one or more sharp, rotating or non-rotating cutting elements 13 (herein, alternativel and- collectively referred to as "cutting element," "work element, "beak," "beak assembly, ^* * articulable beak ^* or "beak element" or '%eak; elements ^* -) projecting forward from tie distal free end of the removable tubular coring and transport : assembly 1.1. According to one embodiment, the (one or BOOTS) cutting element 13 may travel distaijy up to the end of a distal scoopula for the purposes of forward penetration, coring and/or parti ng off of the cots sample in a combtaed forward cutting and side cuttin motion in reference to the scoop ilia. Such a scoopula itself may be composed of one or more elements, suc as a series of small forward projections,, which in the aggregate have the form. ^' of a scoopula. There may also be more than one scoopula extending from the tubular coring and transport assembly, and these may be of differ n shapes to each other.. The tubular coring and transport assembl 11 may comprise a plurality of components, which plurality may be configured to transmit rotational movement and opening/closing actions to the rotating or non-rotating cutting beak elements 13. It is to be understood that the ''tubular" description of the coring and transport assembly 11 expressly encompasses any cross sectional shape ami size, of an length and may in addition be flex ible, as for example, to na vigate through vascular spaces or around sensitive structures within soft tissues. It is further to be understood that th term non-rotating also includes other cutting actions such as axla!!y aligned, fore and aft movements of cutter elements, which may be powered or manually actuated. Such actions may consist of slow ^' "jack-hammering" movements alone or in combination, with rotation, or may include high frequenc motions such as ultrasonic vibrations. Cutting may also be carried out alone or in combination with these motions and/or rotation (rotation including continuous in one direction, cyclic reversing or in oscillation) by energizing cutting surfaces with modalities or combinations of modalities such as laser, radio-frequency, microwave, beat and cheniicafarnong others, Emhodiruents include tailoring of excursion Of fore and a ft and/or rotational movements such that they may be configured to preferentially cut core specific tissues. For example, shorter freque tly repetitious excursions could preferentially sever hard tissue leaving soft tissue intact, while longer excursions that exceed certain soft tissue elastic limits could bias cuttin to ards more effective soft tissue severing. The components and features of the tubular corin and transport assembly 11 may also be con figured to transfer the core samplers) back proxitnaily along the internal length of a inner lumen defined ^' within the tubular coring and transport assembly 1 to the handl 12 and to thetmnsrer compartment or maga ine 27,

ίίό&} According to one embodiment thereof, the biopsy device 10 may comprise a handle 12, which handle 12 may comprise and/or be coupled to mechanical components (not shown in this figure) configured to drive the distal tubular coring and transport assembly 11 to enable t to discharge its: coring, ttarrsport, part-oil and delivery functions. As shown, one ■embodiment nay com rise a dista!ly-disposed beak element 13 that may. comprise one or more sharp cutting tip blades configured, together with a distal seoopula ortion of an. outer sheath, to penetrate tissue to the target site of the■intended biopsy, core the target biological tissue and part- off or cut off the core sample (not shown) at the end of the seoopnla or beyond, or at any desired point along the length of the seoopula of the outer sheath. The ability of the present biopsy device to repeatedly core and retrieve multiple samples (not shown) durin a single insertion and then, accumulate the cored samples in a transfe magazine 27 means that with a single penetration through the skin of- for example, a human breast, the operator can sample multiple areas without causing additional trauma that would otherwise be associated by repeatedly removing the biopsy device 10 each time a sample is taken, and reintroducing the biopsy device 10 back into the patient to take additional core samples. The handle 12 may also comprise and/or be coupled ^' t (internal or external) mechanical components ^' (not shown) and features for vacuum-assisted fluid e vacuation as well as components -configured for the delivery of materials such as, for example, a variety of medications, tracer materials, implantable elements, marker elements and diagnostic and therapeutic devices. The tubular coring and transport, assembly 11 , according to one embodiment, may be configured such as to create the smallest possible caliber (e.g., outside diameter) of coring rube (tubular coring and transport assembly 1.1) with, a range of (for example) about i poiuhel6 gauge to about 8 gauge diameter, while providing a sufficientl large diameter of core sample obtained to be clinically useful. The tubular coring and transport assembly 1 1 may also be constructed of flexible materials and be of a sufficient length to reach target sites distant from the skin surface without the need for an open surgical procedure to enable the distal end (that end thereof that is furthest from the handle .1.2) of the biopsy device 10 to reach the targeted she. In the embodiment of Fig, 1, the distal tubular coring and transport assembly 1 3. of the biopsy device 10 may extend distaliy from the handle 1,2 and. be configured to provide a distance sufficient to create a core of sufficient length for diagnosis and/or treatment purposes. As is described below, this distance of forward or distal projection ma be sel ecti vely changed at will, thanks to structure configured for that purpose, which may be built into or otherwise coupled to the present biopsy device 10.

f¾067J Embodiments of the present biopsy device 10 may be used by right and/or left handed persons and in .multiple positions and orientations, so that in areas of limited access, the resent biopsy device may still be easily positioned tm idea! orientation to perform a biopsy procedure under real-time or oiher image guidance modality. The entire device may be configured to be disposable or m y be configured to be reusable in whole or in part Embodiments of the present biopsy device 10 may be electrically powered by oae or more batteries aad or external power sources through a simple electrical coupling to connect to an external power su ply conveniently placed, for example, in the handle -or proximal end of the present biopsy device as sh wn at element 637 , The entire device may also be internally or externally manually powered, mechanically po wered or be powered by means such as compressed air, gas or pressurized fluid. Powering the excisional device entirely mechanically may be advantageous in areas in which the electric grid is absent, unavailable, or unreliable, in Fig. I, the biopsy device 10 is shown in a pre- coring configuration with the scoopula-shaped distal end thereo open and i a configuration in which it partially projects forward from the proximal handle- 12 from its resting position with a portion of the beak element 13 extending slightly distally in closed configuratio along the first part of its forward excursion. In this view, the biopsy device 10 is show with various illustrative switches to activate and/or physically move various internal components (not shown).

[§0681 Otoe embodiment is method of carrying out a breast biopsy. Such a method ma comprise imaging the tissue of the or gan (the breast, in this example) of interest and identifying the target lesion(s) or tissue to be removed or biopsied. The skin may then be cleaned esing sterile techniques, the patient may he draped and anesthetics may be delivered,: in the case wherein the present biopsy device is configured for stereotactic operation, the present, biopsy device may be mounted to the stage of a stereotactic table. The stage is used to fix the positio of the biopsy instrument, which may be electronically registered and tendered on a screen. The generated electronic dat ay be used to position the device within the patient under computer assistance. The ^■ ■ coordinates of the target lesion from th initial images may be recorded I» y and 2 axes. Thereafter, once the biopsy device is attached, those dimensions are automatically keyed into the system and %, y and z axes are then calculated to aim the biopsy device (manually entered into the adjusting wheels of th stage) and the stage is cocked for firing or, according to embodiments, the internal firing mechanism of the device 10 is used in place of or in addition to the stereotactic table stage firing mechanism. Once the biopsy device is in place (after firing), a new set of images are taken with X-ray and the new target coordinates (i changed) are entered. If the biopsy device appears well placed, biopsies are generally taken abpu* the clock face", according to one embodiment. Herein, "about the clock face ⁵ * generally means in. 6-12 space positions around the clock face (i,e,, 6 to 12 samples over a 360 degree sweep around the initial biopsy penetration axis). If short samples (shorter than, the length of the scooptda, for instance) are desired, th operator may manually part off the core sample at an length along the forward ^• movement of the cutting elements and continue to core forward or reset the coring assembly at its most rear-ward position. for further full length or short coring procedures. Once all core samples are taken* the device may then be backed out with the stage controls (manually) and a postprocedure set of X-ray images may he taken to determine whether the target was partially or fully remo ved . Next* a photographic record ^' may be take of the samples in the transfer magazine and/or a post procedure set of X -ray images m ay be taken of the removed samples to determine whether markers of the lesio (micro-calcifications in this instance) are- present in the retrieved samples. Lastly _* a post procedure clip or marker may be placed in the biopsy site area to mark the location of the biopsy to enable a later precise identification of the location of the biopsy and the wound may be dressed and bandaged.

[0869] hs more detail and according to one embodiment, once the present biopsy device has been fixed to ^' the stereotactic table stage, the distal tip of the biopsy device m¾y be introduced through a nick/incision i the patienf s skin. The present biopsy device may then be maneuvered into the desired position, using one of the penetration modes of the device. Once the distal end of the device is in close proximity to and al igned with the target lesion, a -further penetration mode of the present biopsy device may be activated, either with the stereotactic table's ow firing mechanism or the- depth controllable firing mechanism built into the present biopsy device or both, accordin to embodiments. Such embodiments may specif that only the outer sheath and incorporated seoopu!a are actually tired through the lesion or the entire tubular coring and transport assembly may be fired fo ward together with the outer sheath and scoopula. i one embodiment, the scooputa may be fired to a specified distance less than its full travel capabilities. It. should he noted that the scoopuSa and any other elements, for example, a- guide, ma be fired, independently of any other element in any of these- penetration modes, or in otherwise maneuverin the device,, the seoopu!a- shape disial end of the outer sheath, of the biopsy device may be placed in proximit to or throug the target lesion. Alternatively, the removable outer sheath may be similarly placed by itself through a. nic in the patient's ski to a position in. proximit to or through the target lesion, with or without a jig or fixture or holding device to fix i to the stereotactic table stage or manuall , at which point an optional delivery stage May then be initiated, to deliver, for exam le, the contents of a preloaded cartridge comprising, for example, tracer elements such a visible dyes, echo-enhancing materials and/or radioacti ve tracer elements. After or instead of such an optional delivery stage, the device 10 may be connected to the previous!) ¹ placed removable outer sheath in order io deliver biologkaily-active substances such as Medications (such as epinephrine, for example) or anesthetics. It should be noted that such biol ogically-active substances may also be delivered, at any stage of the biopsy procedure , either directly through the open beaks, through the l i ving hinges of the closed beaks or vi a a reverse flo from the flush system built into the device _* After or instead of such an optional injection stage, the distal beak or beaks or work element 13 may then be opened and advanced along the scooputa- shaped distal portion of the outer sheath and may be caused to rotate to facilitate penetration through the tissue and coring. The rotation and advancement of the distal beak or beaks 13 may be caused to stop just at or near the forward edge of the scoopula leaving, according to one embodiment no or substantially no dead space at the distal-niost tip of the present biopsy device that would otherwise be unavailable for sample acquisition, lite coring may then continue as ^• normally · encountered in stereotactic procedures, i.e., around the clock face but also laterally i an direction with the present device, and in either an aiitomatic or semiautomatic mode. During One or more of the corings, record stage may be acti vated to halt the corin stage just after the specimen has been paited-off in order to enable the practitioner to record image(s) of the shaft o scoojpula of the biops device in place in the lesion, and to record and document thai core samples in the transfer magazine 2? (particularl those of d rlerent cliosen lengths obtained serially during the procedure) were acquired precisely and sequentially from the previously-imaged, lesions. Following the acquisition of a sufficient number of core samples and following the herein aforementioned documentation stage, the cor sample acquisition site may be firmly correlated with the image abnormality location,

flO70j Another embodimen is another method of carrying out a biopsy. Such a method ma comprise imaging the tissue of the organ (the breast, in this example) of interest and identifying the target lesion(s) or tissue to be removed or biopsied. The skin may then be cleaned using sterile techniques, the patient may be draped and anesthetics may be deli vered, hi the case wherein the present biopsy device is configured to enable independent -forward firing of the outer sheath or seoopnla, the device may he infedneed through the skin, nick in the ^ re-fte' ⁵ loaded position mi mo ed i rwij with or without rotation to the nearest edge of an imaged lesion. At that point, the operator would release the scoopuia to fire forward under the force of a spring or compressed gas, such as a CO2 cartridge for example, or manually., or by any other mechanical means, including pressurized fluids for example, or by electromechanical means. Once fired, the scoopuia would enter the lesion center with little if ny residual shift: in tire lesion position, even if the lesion were to be of a firm nature (as in a beni gn fiteadenoma or a malignant carcinoma for example) and even if situate within very elastic fatty/fibrous tissue such, as exists in the majori ty of otherwise normal breast organs. Once across the target lesion and approximately centered, the scoopuia ma be re-miaged for verification iloses and to precisely correlate the biopsy device position with respect to imaged abnormality. Additionally, the device may then be easily manipulated for fme-itsntog purposes if desired. Also, were me scoopuia to be fired to a position close to a nearb vulnerable structure (whether tissue or radiology backing plate or other), the operator may then be able to advance carefully the last few millimeters to the most optimal location. After these maneuvers and verifications have been completed, the target is now feed by virtue of title pinning stabilization effect of the scoopui component. This enables the operato to then, proceed with a number ^' of options. First, the operator may elect to deliver substances in a more pinpoint locatio using the scoopuia as a reference as well as a delivery pathway. For example, a radiation source could be introduced through the central !rnften, antibiotics and/or local anesthetic medications as well as coagulants- and/or ^' vasoconstrictors may be introduced. Likewise tracer elements to trace the pathway to sentinel node drainage may be introduced at this stage of tire procedure such that sufficient ti ted passes, while the rest of the biopsy procedure is completed to enable detection, in the sentinel node toward the end of or after the biopsy portion of the procedure has been completed. Another option is to simpl proceed with multi-sample biops while taking cores "about the clock face" as previously described. Following sampling to completion, other options may follow such as halting the coring beaks in open and proximal position while leaving the scoopuia disiaily placed, such mat post-procedure elements may then be introduced via the distatiy placed (across the lesion that had been completely sampled or removed) scoo nia _s precisely in the place of the biops a pling. These elements could include implants such a cosmetic filler/delivery substances as well as other post-procedure devices that .may be introduced via the central himen/scoopula path ay, such as an. electron beam reflector, a fiber-optic scope, an ultrasound transducer, a cryotherapy element such a an "ice-bali-on-a-stick" probe (as described ^' in m re detail in the following aragraph: , a laser or radiofreqneney tissue ablating device or even m optica! signal ac uisition and processing device to capture rnieroroeter- resoiutioft, three-dimensional images. Upon completion of any of these options, the seoopula may be detached and left in place for oilier purposes or may optionally be removed together with the parent device and then the rocedure terminated in the usua, way with control of any bleeding, closure of the skin nick and the usual postprocedure dressingCs).

|0O7J J An embodiment of a biops device additionally includes an. independently movable or fixed _. guiding .-element such as a stiff or floppy wire that may lead the way throug a natural surface plane or lumen -of a hollow body such as a duct, lymphatic space, blood vessel or other natural space or potential space. Such a guiding element could be pre-placed and then elements of a biopsy device advanced over the guiding element Alternatively, a guiding element may be fired forward in the same maimer as the scoopala described above, or it may simply be fixed near or at a forward (distal) position of elements of the biopsy device. Further still, a guiding element could be coaxial with, in tandem with or adjacent to the long axis of elements of the biopsy device . The guiding element could additionally , be a completely separate entity that ma be pre- placed by m operator skilled in imaging and targeting and feed-in place near or within the target tissue. After placement and fixation an operator may then proceed b advancing the biopsy instrument over the previously precisely placed and anchored guiding element.

[0G72J Embodiments of the biopsy device, along with related subcomponents and features, may also be configured for imaging of the surrounding tissue during pre-operative, intraoperative, and/or post-operative phases of the device clinical use. One embodiment for imaging integration may be implemented by insertion of a transducer or associated optical com en s for ultrasound imaging, direct visual imaging, or Optical Coherence Tomography (OCT), through the lumen of the biopsy device which may be carried out at any one or multiples of the aforementioned phases. The transducer may be comprised of a single: element a phased array, or a stacked array and may be fixed or move is. rotation or translation relative to the scoopnla and may move with a beak(s). Embodiments of the biopsy device might incorporate imaging transducers in parts of distal biopsy device subassemblies such as the distal portion of the outer sheath or scoopnla or as part of the beak. Embodiments of the biopsy device could also use a lumen for free-space coupling of laser or broad spectrum ligh into and/or out of the tissue and may use tlie living hinge or a reflective component attached thereto to direct or steer the electromagnetic radiation. The internal surfaces of tile tubes or seoopula may also act as reflectors or directors tor the light beam. Embodiments of the biops de ice may also be configured to allow for ablation of tissue during fire-operative, intra-operative, and/or post-operative phases. Ablation may be accomplished through one or more combinations of ^' hyperfljermic ablation (such as radiofrequeacy, .microwave, laser, and ultrasound) and/or eryoahlation techniques. The ablation sub-assembly may attain access through the central lumen of the biopsy de vice , m ay be an integral part, of the biopsy device, ot may connect to ot be inserted through a portion of the biopsy device that is left in the body providing appropriate access to the tissue site. One embodiment may use radio frequency ablation techniques where parts of the seoopula or beaks are energized. The relative rotation and or placement of the distal components of the biopsy -device may serve to selectively direct and/or focus the energy. The sub-assemblies to accomplish this ma be an integral pari of the biopsy device or may be insetted through the lumen of the biopsy device. These sub-assemblies may be configured to interact with elements of the distal seoopula to raise them into position needed for their function and these interactions may also enable them to perform a part of the biopsy procedure itself, such as forming a surface against which part-off may b accomplished . They may also accomplish cori ng and/or part off by themselves (through flexing, rotation or other actions as described for beak elements, or by being energized) or in combination with surfaces of the seoopula or with other elements Introduced along the seoopula including physical elements and/or beams or other form of energy such as electromagnetic sources., heat sources and others, according to embodiments. Another embodiment may use microwave radiation ablation and may incorporate antennae elements into the beak, outer tube or seoopula or ma incorporate antennae elements i a sub-assembly that conk! be inserted through the centra! lumen o m close proximity to the axial length of the tubular coring and transport assembly 1.1. (j ust underneath or al ongside, for example) of the biopsy device when, desired The location of the antennae ma be vari ed along the axial length of the open seoopula and may also be rotated, relati ve to the seoopula resulting in selectively directing the microwave energy. Furthermore, electromagnetic reflectors could be built into the seoopula or other members and stacked or phased, arrays of antennae ma be employed to farther direct or dynamically tune the radiation pattern. Auoiher embodiment may also use electron-beam ablatio an may incorporate a beam guide tube that may be inserted throngh-a lumen in the biopsy device t deliver the electron beam to selective locations in the tissue surrounding the device. Another embodiment may use laser ablation and may deliver a»d direct the laser beam through an optical fiber or through a free-space coupled beam . The beam or fiber may be directed by a reflective surface on or attached to the internal angle of the living binge and / or a reflective surface of the scoopuia. This may allow the bean to be directed in a pattern optimal for the desired ablation. The laser ablation sub-assembly may use the central hi eii to deliver the light to the distal portion of the biopsy dev ice or may attach to an integral optical delivery system. Another embodiment of the biopsy device may include a probe that provides cryosurgical ablation of tissue surrounding a cold probe that ma be inserted through- or be integral fo the biopsy device. The cold probe may repeatedly warm and rapidly cool die surrounding tissue resulting hi ablatioa. The probe may be positioned relative to the scoopuia such that the rotatable scoopuia provides a heat sink selectively shielding tissue from ablation.

100731 Upon completion of the biopsy procedure and, if desired, prior to remo val of the device, specimen ultrasound or a radiograph may be carried out upon the specimens collected within the transfer magazine 27, which magazine may be specifically configured for echo- and radio- lueency as well as compatibility with MR! and/or other imaging technologies. The removable transfer ma azine 27 may then be placed into receptacle that may be preloaded with preservative and sealed, if desired, a replacement transfer magazine 27 may then he loaded int the biops device to continue the biops procedure. Alternati vely, with the biops device 10 in p lace, an adapter configured for the deli very of materials to the biopsy site ma be substituted for the transfer magazine 27 at an time. Alternatively with the biopsy device 10 in place, the tissue transfer magazine 27 m y be -removed and replaced with an injectio cartridge that may be pre-loaded with post-biopsy elements such as medications, cosmetic implants, brachytherapy elements such as radio-active seeds, and or-a porous element loaded with a bio logical ly active substance and/or other .maferiais. Alternatively still, the biops device TO may be withdrawn- from the removable eater sheath, which oiiter sheath may then be used tor delivery of post-procedure materials to the target site while other components of the biopsy device may be packaged appropriatel and delivered to an appropriate laboratory for pathology/cytology analysis. The outer sheath of the biopsy device may then be completely removed from the site and the wound dressed vising the customar standard of care procedures, if so attached to biopsy device 10 via an aspiration/material delivery port 639, hqtud aspirate storage vessel ma be removed from biops device 10 at any time and cappe securel for transport to as appropriate laboratory for cellular a»d subcellular analysis.. An liksiraiive placement of an aspiration/material delivery port 63 da biopsy device JO is shown in Fig. 1 herein _*

(0074] Fig, 1 also shows illustrative placement of various external, controls, including a depth stop adjustment mechanism 630, a .forward firing trigger and lever 631 , a drive train earner bolt 63:2, a manual pan-off lever 633, and a cam clutch button 634, as well as other features such as a power switch/indicator 635, a DC power plug 637.. a flush port 638 and an aspiration/material deliver port 639, which will be discussed in more detail in further figures. Hie placement of these exteniai controls is Illustrative in nature and embodiments may contain some or all of these controls in the locations shown in Fig. 1 or other locations,

f0075 it is to be under tood that the above descriptions are but exemplary

^• ¾$thibd0lofie^ id^i.¾ifte-o ^ia-ore: of the steps described above may be omitted., while other steps may be added thereto to any of these embodiments, depending on the target site within the body, which is not limited to the breast. Other operator method embodiments and device 10 embodiments are supported, as well. The order of some of the steps may additionally e changed, according to the desired procedure.

|0O76| Fig. 2 shows 8 distal end of a coring and transport assembl 11 of Pig. 1, with a configuration of a manually rotatable outer sheath 512, having a distal tip in the form of an edge-sharpened trough or seooptila. As shown, tire coring and transport assembly 1.1 may comprise a rotating and longitttdinally movable (eg., selectably movable .in the distal and proximal directions-) articulable beak {or work element) 13, which may, in one embodiment be actuated by an internal helix 472, Although a single beak is shown and described this figure and some of the following figures, it is to be understood that more than one beak may be used in embodiments, and for that reason, whether only one beak, double beaks or multiple beaks are described herein, .all such embodiments are considered to be within the scope of this disclosure. If more than one beak is present, their individual shapes may be asymmetric to each .other or have differing features. As described above, upon entry of the coring and transport assembl 1 i to the target site within die body a procedural option may be chosen where only the sedo ula-shaped distal portion, of the outer sheath may be exposed, and the work element may fee held in place at the proximal opening of the scoopuia. As the devic Is advanced, the sharpened troitgh-like scoopu!a may be made to cut its way forward in the distal direction, with, little disturbance to the target lesion. Indeed, as th scooprik-shaped distal portion of the outer sheath presents a .nimfemssed. cross section (as compared, for example, to the cross-sectional profile presented by a tube), di ssection of the tissue path to the lesion occurs with reduced distally-direeted foree and little disturbance- to the surrotmding tissue and to the target lesion. This is a significant feature of the device 10. according to embodiments because with, a mini ise cross-section, suc -a scoopula ma be made to cross the lesion (or tissue immediately adjacent thereto) with minimal disturbance to or displacement of the lesion and. may also be moved laterally for precise positioning, as previously discussed herein,. As cor ing has not yet occurred, the scoopuia-shaped distal portion of the outer sheath enables the device 1.0 to be advanced to or past the target lesion with a reduced chance of transporting potentially malignant, ceils or material through die lesion to otherwise healthy tissue. A further advantage of optionally advancing only the trough shaped scoopula is that it. minimizes both physical and visual distortion of th image, enabling a guidance modality to identify structure nearl as easily as before anything was introduced across the lesion, enabling positive correlation between the imaged -tissue and later pathology findings, it is to be understood that; according to embodiments, the phrase '-scoopula-shaped distal portion of the outer sheath" is intended to encompass a distal portio of the outer sheath that is shaped so as to present an ope portion or a iess-than full cross-section, as compared to more proxiraally-disposed portion(s) of the outer sheath 512,

|βίϊ77| The sides or edges of the distal soopuSa a be sharpened, may be parallel to the long axis, or may be of varying profile with respect to the long axis. For example, the sklewails of the scoopula may be .gradually rising from its distal to proximal portions, enabling pre-seve mg of th tissue prior to engagement of the beak or beaks work element. Some or all of the edges of the scoopula, including the "roof ^! or proximal arch of the eo pukj may be sharpened, serrated or otherwise configured in order to optirni¾e coring and^or slabi&ing actions as well as to permit a variety of pathways for aiding core sample transport, such as fluid flush and vacuum, in one embodiment, a beak or beaks work element by itself may sever tissue without the need to contact any surface of the scoopula, simply by nature of the shearing action and b virtue of exceeding the elastic limit of the tissue as tissue is f ced over the edges of the scoopula, With a distal scobpuia acting as a stabilizer and being anchored through the lesion, the work element (single beak, ultiple beaks etc) may then be made to move axially in a distal direction and, accordin to one embodiment, unde rotation. This effectively combines a forward cuttin mechanism, with reference to a single rotating beak (or .multiple beaks) acting against the slies or edges of the scoepuh _j as such a beak or beaks moves forward with a scissors-like action against the side of ^" the scoopuia, and a side catting mechanism from the point of perspective of the scoopuia. as the sharpened sides of the beak or beaks bear against the sides or edges of the scoopuia, according to embodiments. In one embodiment, a beak or beaks work element by itself may sever tissue without ^' the need to contact any surface of the .scoopuia, simply by nature of the shearing action and by virtue of exceeding the elastic limit of the tissue as tissue is forced over the edges of the scoopuia. f ig. 2 -shows the coring beak disposed distally almost all the way forward to its part-off point and rotated slightl as it would be seen, as a snapshot of its continuous forward travel whil e rotating, coring, and then eventually partin off as it reaches the end of the scoopuia. The coring beak may then be configured to part-off die cored sample by closing down against the inside diameter of the scoopuia _* Upon finishing its coring cycle, the work element may be configured to withdraw under rotation or not back to its initial position (according t one embodiment, adjacen to the proximal opening of the scoopuia), thereby transferring the parted- off sample proximaliy to an internal transport, mechanism and continuing to a transfer magazine 27 (not shown). In the- embodiment illustrated in Fig, 2, such internal transport may be carried out by a rotating helix or helices 472 disposed in the central lumen of the de vice. It should be rioted that th centrally-disposed helix 47 shown in Fig. 2 is but one possible mechanism to rotate the beak elements) 13 and to transport par-ted-off cored samples in the proximal direction, and embodiments are not to be limited thereby.

fMTSJ Significantly, if the perator allows full forward travel of the work eSement(s 1 % there will be no or substantially no distal ti dead s ace* i.e., the device will sample (e.g..,. core) nil the way to or substantially to the distal-most tip of the scoopuia within or past the lesion., as originally placed. This tack of dead space allows optimal placement of the exeisional device 0 in relation to physical structures such as the chest wall, radiology backing imaging plates or other structures associated with either the bod or the supporting device _. , such as a stereotactic table. If the device is used with a stereotactic table, either the device itself, in one embodiment, or the outer sheath, in one embodiment, may then, be rotated, "around, the clock" such that the open portion of the scoopuia faces the next desired clock face positio and coring may begin again, repeating as ofte as desired, selectively f¾il Of partially, it should, also be noted that, because th distal end and edges of the scoopuia may he very sharp, according to one emb di ent, lateral

portion of the outer sheath 512 may also be useful next: to sensitive structures in general and In cardiovascular applications is particular. It should, be noted that the scoopula and i t coixesponding work element may be of any length necessary to .match a particular tissue,, target lesion, and/or site, according to embodiments. In this figure, the beak of the work element 13 is shown opened over center, and as it rotates it is thus forced to close down, slightly against the edges of the scoopula and parallel with the long axis of the helix, which supplie either some or all of the rotating force, according to one embodiment, in this view, it can easily be envisioned thai much or all of the rotating force may also be supplied to the beak, by an extended collar to which the beak may be attached, in. one embodiment, by a living hinge 458, as will be described later i more detail in other figures. According to one embodiment, an internal helix 472 may be configured to provide the axial force that is necessary to open and close the beak(s) against me scoopula for tissue part- off and retrieval and transport.

|0O80j According to one embodiment, a helical element 472 and first articulable beak element 13 (or first and. second articulable beaks in a double beak configuration, according to embodiments described herein below) may be configured to rotate at a -rotation rate of between, for example, 0 to about 10,000 rpm. For example, a rotation rate of between about 3 ,000 and 7,000 ^' rpm may be- selected for parts of procedure. According to one embodiment, a dither or slight jittering of the articulable beak elements may h implemented in place of or imposed on to of the rotation _* One implementation calls for a rotation rate of about 5,000 rpm (phis or minus about 20%) during at least one phase of the tissue coring and excision process. According t one embodiment, a helical element 472 may define a single-coil configuration. According to embodiments, the helical element or elements may be provided with structure configured to increase its- column strength and torque and to decrease the torsional deformation thereof. For example, such a first helical element 472 may comprise a two or three (or more) coil, structures. Collectively, these coils may decrease the tendency of a helical element 472 to compress, may increase the torq e that it may apply against the tissue through trie first or first and second articulable beaks and may increase its resistance to deformation as it is rotated. Such configuration may also spread the torqu load to multiple points of attachment with the first ^' and/or first and second or mul tiple articulable beaks,

[0081] Fig. 4 illustrates the same components of Fig. 3. but in a different snapshot

^• of time, corresponding to- a later period where the beak -element 13 is -shown rotating to core the tissue and nearmg its final part-off point by action of a single beak closing, in ^· $»$ . embodim nt _* against the end of the scoopula., which in tilts embodiment acts as a second, uen- or differentially rotating beak in relation to the single beak 13 shown in this view. Differential rotation as used herein implies and encompasses different rotation speeds in both the same and opposite directions between individual elements.

|0082j Fig. 5 illustrates the same components of Figs. 2-4, but in this case, the operator has chosen to manually part-off the sample before the beak element 13 has reached th distal end of the scoopula portio of an outer sheath 512, an operation made possible by the drive ^• mechanism of one embodiment of this device, as is described below in later figures. The beak element 13 in such an embodiment ma also comprise a living hinge 458. According to one embodiment, a living hinge 458 may comprise an H-shaped series of stress-relieving kerfs and relieving features at the ends of the kerf cuts, allowing the beak element to close against any portion of the scoopula. ^' These stress-relieving kerfs may reduce the stress induced in the living hinge 458 to a non-inclusive range, for example of 10 to 360 ksi (kips per square inch). These elements of a living hinge 458 may -also, according to embodiments, serve- as conduits for. medications (anesthetics and epinephrine, for example) and other liquids, such as saline flushes. Such conduits enable such fluids to flow through the centra! hinie of the device 10 for delivery to the distal end thereof even if the beak{s) may be closed during such an inim-opemtive procedure.

|B083J Fig, 6 is a side view of the com onents of Figs, 2-5, In this Mhtsitation, a more typical part-off point i show-n with the toward edges of a trough-shaped scoopula beak and the active beak perfectly or near- erfectly opposed, eliminating all or substantially all dead space at th distal end of the device. One beak attachment tab is shown interacting with the distal end of a helical element 472,

|§0 | Fig, 7 shows a view of a variant of e distal end of the device, according to one embodiment, that comprises an extended collar on a single beak assembly 13 revealed where the outer tubular element 5 2 is cut away to reveal the attachment point of the extended collar wit a helical Inner tubular element 4·7¾· as shown ; Fig, 6. This variant provides greater stability in the trough-shaped scoopul sections of travel of the inner coring, cutting, transport and part-off active portion of the device and enables high-speed spinning of the active beak element daring coring, while protecting the tissue sample from being exposed to high speed helical motion until it has the opporiiuhty to move along the helical portion, a la!ly after being fully parted off from the host tissue. Details of active beak .attachment are not shown i n this ill ustration.

10085] Fig, 8 show details of a single distal active beak 13 attachment to elements of a split collar using torsion bar 13 A and bands 13B to aeconmiodate the transfer of forces needed ^• to open, close, and stabilize the acti ve beak element 13 _P according to one embodiment. By relative axial movement of the lower half 13D to the upper half 13C of the split collar extension of the beak 1 , the bands 13B move proxinially causing the beak 13 to close, as shown later n Fig. 11. In such TO embodiment, such attachmenis may. simplify the attachment and bending reqiurernents of the active ^' be fc(s) such that they may not interfere with sample acquisitio and transfer to transport components of the coring and transport assembly 11 of the device, according to this embodimen Such split collar extension may be configured to have a straight longitudinal split, i one embodiment, or a curved split wit respect to the long axis of the device, in other embodiments.. Such a curved: split wit h r espect to the long axis of the de vice will impart: twisting of the beak or beaks as they close down, which May aid in part off, particularly if the twist is in the opposite direction of the beak assembly rotation. Not shown, in this view is the outer sheath 512. | i*S6| Fig, 9 shows the same configuration as in Fig. 8 ab«ve ₅ but m. a snapshot position showing a scissors-like spring-jaws action of a beak against th scoopuia portion of the outer sheat 512, which is shown in this view. Such spring-jaws action is enabled by opening the single beak, in this illustration, more than it would be if the _. back of the beak 13 remained parallel with the extended collar to which it is attached, or effectively over center.: In this view, the torsion bar 13 A attached to the proximal end of the beak and tlie distal end of the upper half 13C of the split, collar to which the beak; is attached is shown being flexed in. a twistin motion to provide a force against which the beak opens. Such a configuration of being open over center causes the beak edges to come i very close proximity with the edges of the scoopuia of the outer sheath 512 with every revolution. In this case, the spring action is provided proxiraaliy by a helical element and transmitted forward via the tower collar half 13D of the split collar, which is attached to the bands I3B (similar in action to beak opening and closing tendon, elements 468 disclosed in further figures below). The activ beak element 13 (active in that it moves from an over center open positio to a parallel open position) is forced to conform to the trough dimensions of the scoopuia each time it comes around in its rotation. Resisting this conformation is the axial force of a helical element acting through a lower collar half 13D and a torsion bar 1.3A. This results in a powerful shearing acti on of the acti ve beak against the edges of the scoopuia (in this illustration - an inactive r fixed structure). It may also enable a slightly larger sample to be acquired and forced into the collar section. Additionally, the conformation of an active beak relative to a trough section with each rotational cycle of the active beak creates a slight repeated back and forth motion of a lower collar half 13D compared with. an. tipper collar half 13C and thus an axial oscillation action, between lower and upper halves of an extended collar section, which may tend to move the severed ti ssue specimen axiaily in a proximal direction. If inner elements such as scales etched or ground into the inner diameter of a split collar are added to such an embodiment to take advantage of the axial tissue specimen movement gained by this repeated back and forth, action, a ratcheting .mechanism to aid delivery of tissue to a transport section of the device may be created. Other inner wall treatments such as rifling, among such treatments, may a so be added to aid in the transport of the cored and paried-off tissue samples in the proximal direction.

J08S7| ig. 1:0, further to the points above, show an active beak nearly completing its fo ced compliance with the inner diameter of a trough-shaped, scoopuia of an outer sheadi. element during a, snapshot in. time of its rotation/forward movement, it sho ld be noted that sharp edges of an mtef sheath scoopuk 512 as sbiiwh may be beveled either externally or intetmliy, according to .era odxrae-a s. Fig, 11 shows the same components of Figs. 9 and 1.0, hot OW showing an active single beak in close apposition with the forward edges of the seoopnla section of an outer sheath 512. This illustration shows another embodiment of the shape of the edges of a trough or scoQpuia section, which particularl if enabled to be oscillating, may aid in coring and thus facilttate the distal advancement of an entire distal portion of the biopsy device at the initial stages of the procedure. The edges of the scoopula may also he asymmetrical at any point relative to any other point, according to embodiments.

fwOSSj Fig. 12 shows the same components as are shown in Figs. 9, 10 and i 1 , but from a top view perspecti ve, This view shows a torsion bar 13 A m close proximity to the proximal portion or base of an active beak 13 with respect to the tipper half 13C of an extended collar portion of an active beak assembly, according to one embodiment Various methods of attachment, of a torsion bar to the base of a beak 13 may be envisioned, and are not specifically described herein.

|0089| Fig. 13 shows the- embodiment of fig, 2, viewed facing the distal end. Fig,

1.3 shows an exaggerated beak opening for illustrative purposes. Couplings are shown mechanically linki ng a helical element 472 and the prox ima l portion of a mo veab le beak 13. Other couplin arrangements that couple a tivhnlar coring: and transport assembly (pr ₅ simply, the proximal end of the device) ar possible and fall wit a the scope of this disclosure-. Again, sharpened be vels of an outer sheath 512 and a beak 13 may be internal or external or opposite to one another,

|0O O Fig. 1 A sh ws the configuration of a tubular transport and coring assembly

I t of Fig. , showing forced, compliance cycling of an active beak element 13 with the inside diameter of the scoopula portion of a outer sheath 512, according to one embodiment. this case, the beak was opened over center, as ai Fig. 13, and as roiation occurs, the beak must move back to a fully opened, but not o ver center positi on, eventually as a Straight extension of a helical element 472, until it moves past the opposite edge of outer sheath 512's scoopnla and then can again, ope slightly over center. f#091f Fig, 14B shows the ^' features- f co nents -of Fig. 14A, according to one embodiment, but now showing nearly completed forced compliance of an active beak element 13 -alignment with the inside diameter of the scoopnla portion of an outer sheath 51.2. IM 21 Fig, 15A. is a perspective view of a split-tube single beak assembly 13 In retracte position against an outer sheath 512 that terminates in a seoopu¼ Shown in this view is a living hinge 458, which attaches a distal beak to an upper half 13C (Fig. ISB) of a split tube aid which allows the beak 13 to close dow against the inside diameter of a seoopu!a 512 of an outer sheath, as will be shown and described in later figures. Element 458 may be considered to be similar in function to the torsion bar 13. A described relative to the previous Fig. 8 above. The ac tio of li ving hinge 458 provides positive attachment to both the distal tip of a beak assembl y 13 as well as the upper half 13C of a split tube. The spl it tube may be similar in nature to a split collar upper half 13C and lower half 130 previously described, albeit longer than a split collar. The split tube may be of s ch a length as to be coupled directl to its own rotational and axial drive -mechanism withiu a handle 12 of the biopsy device, to allow beak actuation and rotation. In the position shown in this figure, the beak 13 may not be rotating at all , in order to facilitate the forward penetration of the exeisioiia! device to a target tissue site withiu the body, as previously described above, according to embodiments. 6093] Pig: l.SB is a perspective view of a spirt-tube single beak assembly extending partly out of an outer sheath, with a beak open over-center arid, selectively under rotation about longitudinal axis 14 o not. According to one embodiment, the beak(s) 13 may also be configured to move substantially parallel to this longitudinal axis 1 , as the beak(s) 13 move from a retracted position to a pattingK>ff position in which the distal tip of beak 13 extends substantially to the distal tip of outer sheath 512, to thereby achieve substantially zero dead space. The over- center action of the beak is due to an attachment of two beak opening and closin tendons 468 formed with a beak .-(one on either side) and the lower half of a split†ube ₅ shown as element 13D in this view.- The upper half of a spli tube 1.3C may be attached to the proximal end of a Jiving hinge 458. Relative axial movement between an upper half 13C d lower half HO of tire split: tube actuates a beak 13 to open and close. Such axial movement may be limited, in embodiments, by a T-shaped or otherwise shaped tab that may be formed as part of a lower tube half 13D sliding within a travel limitin slot 467 in an upper half 13C of split tube, accordin to one embodiment or opposite In other embodiments, as well as being o any shape. Sev eral of these tabs and slots may be arranged along the length of a split tube, and th split tube, beak., l iving hinge and tendons may be ferned of a single tube tha may be, for example laser cut Additionally* the slot(s} 46? may be filled with flexible substance, such as silicone,: that may also be provided with, a small hole that will open and close as a T-shaped tab moves axial ly in the slot. According to embodiments, this may allow flush fluids drawn between, an. oute sheath 512 and a split tube to selectively pass nto die central lumen of a split tube to aid m tissue specimen transport. It should also be noted that according to one embodiment, a single axially split tube may have more than one beak., configured with a .movable beak attached to die upper half DC of a split tube wi th a living hinge and tendons, as described above, and fixed beak as a distal extension of the lower half 13D of the split tube, ie„ distal to the attachment points of the proximal ends of the tendons as an extension of the knver half 13D, Such a fixed beak in. the So wer half .13D may be thought of as a short scoopnla mimicking that of the outer sheath 512, but shorter., and in fact reaching distai!y only .to the point where the .movable beak would close down against it In such an embodiment, the beak assemb ly would be capable of both coring and parting off a tissue spec imen beyond the end of the outer ^■ sheath 512 scoopula, if desired. This embodiment is not illustrated, but may be easil envisioned by imagining that the split tube beak assembly of Fig. 15B had an extended fixed beak as part of the lower half 13D of the split tube. Under rotation, ei ther a split tube single beak embodiment or a split tube doubl e beak embodiment will part off a tissue specimen if the movable beak moves to at least the longitudinal axi 1 of Fig, 15B.

|§094] Fig, 15B also shows that at least the outer sheath 512 may be rotated, as suggested at 16. n so doing, the sharpened edge of the open scoopula- shaped distal portion of the outer sheath.512 cuts through an arc of tissue. According to one embodimen t and as shown hi Fig . 15B, the arc of tissue along 16 may be oriented substantially normal to the long axis 17 of the tissue specimen 18, That is, according to one embodiment, the open scoopula-shaped distal portio of the outer sheath 512 may be rotated about its longitudinal axis (e.g., 14 in Fig, 158), which is normal to the long axis I ? of the tissue specimen 18. As also shown in Fig, 1 SB, the specimen 18 may (but need not) be shaped like a shori segment of a tube, with tapered ¾i ! and distal ends. After obtaining first tissue specimen, further tissue specimens may be cut from the tissue then facing the open scoopula-shaped distal portion of the just-rotated outer sheath 51.2, which lacing tissue may be radially separated from the tissue from which the previous, pre-rotation specimen was cut. After rotating the open scoopula-shaped distal portion of the outer sheath. 512, a radially- directed force may be imparte on the biops device, to cause tissue to prolapse into the scoopula- shaped distal portion or to increase the amount of tissue that prolapses therein,: This may increase the qualit of the tissue specimen, depending upom for example, the type and arehkectute of the tissue being cut

|109;S| Figure 15C is a perspective view of a pllt-tobe single beak assembly in. full extended position at the end of the seoopnla of an outer sheath, which position is suitable for part-off of a tissue specimen and tor other pur oses, including penenation to a target tissue site or fepositioning to a second target site, according to embodiments. The elements of a li ving hinge 458, the distal tip of a beak assembly 13, an outer sheath 512, the upper half 13C of a split tube of such a B.KMolithie beak assembly, and a slot 467 with its distance. M tt n ^' g tab may be seen, in this view.

fM96 Tijxnijig now to further e bodiments .an in greater detail, the discussion that follows will focus on general features of as entir device 1.0 for purposes of illustrating its enabling mechanisms, which ma comprise a distal end consisting of an outer sheath, an inner or distal sheath, a proximal sheath, work elemen or elements and such features as first, second and third helical elements, i any combination, as well as other elements such as suggested by Fig. I or previous .figures and as detailed further below. The description below begins at the distal end and continues to the proximal end of the device 10, and embodiments ^' may include any or all of these elements, according to individual, enibodloienis.

flO j Fig, .16.4 shows details of a work element and Fig. B shows work element in relation to an outer sheat 512 ending in a seoopula shape of -ao excisionaf device aceordlag to one tmibodinieni As shown, a first or, according to some embodiments, a first and second (or more) articulable beaks 13 may comprise one or more slots 461 defined therein to form a living hinge or hinges 458, For example slots 461 may have lengths ranging iton-inclusively from 0.050 inches to 0.500 inches. The separation between adjacent slots 461 may also be in the range o 0.005 inches to 0.050 inches or up to 2/3 of the distal tube internal diameter. The thickness of living hinge 458 ma be different in thickness than that of the surrounding material and may be in the range of 0.001 inches to 0:015 inches. The range of motion of the living hinges 458 may be ftem 5 degrees t 75 degrees with respect to the longi udinal axis of the outer sheath. 512. Living hinges 458 could be fabricated from currently existing alloys such as a stainless steel, for example, 304, 31 or 0* In different tempers or work hardened states* nickel titanium alloys, maraglng steel, composite materials such as made from fibers, for example, carbon fiber, and/or .future high ductility alloys. Additionally, wedge-shaped (for example) cutouts 466, which may be left joked at the base of the wedge adjacent to. slots 461, maybe provided to define the articulable beaks of a work element 13, to Improve the articulation thereof and to provide for a great range of motion. Accordin to embodiments, each of a first arid second articulable beak tips 452, 454 may define or ma be coupled to a first tendon 468 coupled to one side of the first articulable beak and a second tendon 470 coupled to the other side of the first articulable beak. Alternatively, a single tendon .may b defined or multiple tendons may be defined Additionally, these tendons may be defined at different relative angles to each other to impose an unequal or asymmetrical force to the sides of the distal end of an articulable beak tip 452 or 454, i embodiments. These first and second tendons 468, 70 may be configured to selectively apply proximaliy-directed force and a distally-directed force to the distal portion of an articulable beak to cause the first and second articulable beak tips 452, 454 to assume their closed and progressively open configurations,, respectively, or in the case of a single beak configuration, to open or close at some {which may be eser-seiectable) point along a scoopula of an outer sheath (as shown in Fig, 1.6B). Indeed, pulling on the first and second tendons 468, 470 by proximal force acting on an actuating element 469 tends to close the first and second articulable beak tips 452, 45 (i.e., draw the respective distal tips closer to the longitudinal axis and closer to one another) and pushing on the first and second tendons 468, 470 tends to open the first and second articulable beak tips 452, 454 (i.e., draw the respective distal tips away from the longitudinal axis and away from one another ). Tendons 468, 470 may be fabricated using the same engineering principles* concepts and material considerations as for the living hinge 458» Geometr of the tendons ma be designed to ensure the ail closure stress levels be kept in the 10 ksl to 360 ksi range. The width arid height of the tendon element ma have non-square and/or non-constant cross sections, as elliptical for example, in the range of 0,000$ inch to 0.015 inch on a side. The lengths of the tendon flexures could be in the range of 0.025 inches to 0.500 inches,

1§098J Fig, 16B shows a work element { shown as cutting elements 13 in the embodiment of Fig. 1} comprising, in one embodiment, twin articulable beaks 516 and 518 (numbered, differently is this illustration to indicate that the entire beak ot beaks may be comprised of many features already outlined in Fig. 16 A) and outer sheath 512 of an excisional device according to one enibodinieut. As shown therein;, an excisional device, according: to one embodiment, may comprise an outer sheat 51:2 defining a longitudinal, axis whose distal end, as shown, may comprise a seoopul (seen rom the to down and shortened in this view, not necessarily to scale), trough or otherJeadmg edge s a e, According to one. embodiment, the distal edge or edges of such seoopula, trough or other distal feature may he sharpened at least partially around its circumference- and side edges as desired. A work element may be configured to at least partially fit within an. outer sheath 512 and may he configured t be withdrawn in the proximal direction into an outer sheath 532 and extend out in the distal direction at or near the end of the distal free end of a seoopula while lying within ts curvature _* The work element, according to one embodiment, ma comprise a single beak (518, although 516 conid be chosen as well since the ^• work element rotates and such a single beak m act against the seoopula portion of the outer sheath 512 as shown m Figs, 2-15 above), A beak 518 or 5.16 may be configured, including: by Its shape, according to one embodiment to close against the in side diameter of a seoopula at any point along its length, as shown in previous figures, as well a the distal-most edge of the seoopula, which shape may be similar to beak(s}. The beakf s) may be configured to rotate within an outer sheath 512 about the longitudinal axis thereof As shown i Fig, 16B and other figures, a first and/or first and second articulable beaks 516, 538 may define respective first and second curved distal surfaces configured to cut tissue. The work element may he further configured to be advanced distally such that at least a first and second curved distal surfaces of a beak or first and second articulable beaks 516, 518 are at least, partially disposed outside of a distal outer sheath (not shown in Fig. I6B). As particularly- shown la Fig, B, a portion of both of the first and second curved surfaces of a single beak or of the first and second articulable beaks 516, 518 may be configured to rotate at- least partially outside of an outer sheath 512- wim the remaining portions ^' thereof configured to rotate within an outer sheath 512.

fw099j Indeed,, in tfns embodiment, a substantial portion of a first and second

.articulable beaks 516, 518 may be configured to- rotate within an outer sheath 512, This configuration radially supports a first and second articulable beaks 516, 518, and prevents them from over-extending or otherwise undesirably deforming when cutting through tough tissue. According to one embodiment, a shearing or scissors action may be imparted, as the distal tips of a first and second articulable beaks 516, 518 rotate inside the extremity of an outer sheath 512 and act with their sharpened edges against: die side edges of an outer differentially or non-rotating sheath 512 as previousl described _* According to one embodiment, the shearing or scissors action, occurs between the distal portions of a first a d/or second articulable beaks 51 , 518 against edges of a seoopula portion of an outer sheath 512. However, the first and second articulable beaks 516,

i00 The distal f ee end of an outer sheath 512 may be shaped as desired and may comprise., as shown in Fig. l$ _i a. seoopula (or a. trowel- or trough-like, for example) shape. This distal edge may be shar ened _^ to aid in the penetration into and coring of tissue. Vacuum slots may he provided -within an outer sheath, as shown at 520. Should a vacuum he drawn within the lumen of an outer sheath 5.12, surrounding tissue may be drawn thereto, thereby assisting in stabil izing the distal end of the exeisional device during the specimen cutting procedure. Vacuum slots 520 may also serve to collect liquids and f e cells fro the surrounding tissue or to deliver liquids to the surrounding tissue. They may also serve as an opening at the dis tal end of the device so that as vaeunr is applied Internally at the prcmlrnal end. of an outer sheath 512 as n aid in tra sporting tissu specimens pro imally, a corresponding vacuum is not built u behind (distall to) the tissue ^ecimens. Avoidance of vacuum buildup distal, to the tissue specimens may facilitate tissue transport ^' in. the proximal direction as well as prevent tissue specimens from acting as plugs in the work element Slots may also be provided in. the trough of a scoopula itself as an. aid to imagin devices to sharpen visibility of a scoopula in relation to siuTounding tissues.

fulill j The shape of the sharp cutting elements beak (or work) assembly 1.3, such as the embodiment . thereof shown in Figs. 1 and MA and 16B, for example, provides substantial support for all movements required of the cutting beaks daring rotation, opening/closing and axial motions not sho n _* ti ing the nomerselature of Fig. I in particular,, this mbodin½iit enables the sharp cutting elements of beak assembly 13 to be made exireniely thin, which fulfills a requirement that for an gi v en outer i¾dial dimension of a tabular coring and transport assembly (including the cutting beak assembly) 1 1 (see also Fig. 1 ), the caliber of the core sample retrieved from the patient will be as large as possible. The shape(s) of the sharp cutting elements of beak assembly 13 specified for use in coring and part-off according to embodiments enable the biopsy device 10 to core & foil diameter, and in fact larger than full diameter with respect to the dimensions of th coring and transport assembly 1.1 _:S f which slightly larger caliber (e.g.,, diameter) ma be desirable in order to compress, "stuff', or pack in as muc tissue sample into the tubular coring and transport assem ly .11 as possible, which may prove advantageous from several standpoints (including diagnostic, clinical standpoints) or provide more sample (not shown) for analysis,

fw|ft2j According to one embodiment and as described herein, a work element 13 of Fig, ,1 , including articulable .beak(s 516 and 518, or 516 or 518 alone of Fig, J6TL ma be configured for rotation within an outer non- or differentially-rotating outer sheath(s), such as 512 of Fig, 1 B, oreo er, the articula le beafc(s), according to one enibodinient _:! may comprise a surface having substantially the same curvature as me body portion of the work elemen 13. The body portion of the work element may be that portion thereof that is proximal- to the articulable beak or beaks, According to one embodiment, the articulable head ^' s) may be generally described as- being r com r sing - one ^' - or more hyperbolic segments of one o more sections of a hollow cylinder, such as a hypo tube. Variations including complex curves may be incorporated into the shape of articulable beak(s) to optimize function in different sections of, for example, the edges of the articulable beaks. Moreover, first: and second articulable beaks, according to embodiments, may have slightly different shapes from one another. The angle .formed by the distal portion of first and second articulable beaks or between a single articulable beak and a scoopula may be, for example:, from about 5 to 75 degrees. According to one eumodhiient, the angle m y he between about 10 and: 30 degrees. According to another embodiment the angle formed by tire distal portion of first and second articulable beaks or first beak and a seoopula may be about I S degrees.

| 1O3] Note that, according to one embodiment, the entire work element, inchidiiig a first or first and second articulable beaks .16 ^' and 518 of beak assembly 13 along with first and second tendons, beak actuation mechanisms such as 469, l i ving hinges 458 (as best shown i Figs. 15.C and 16A) connecting a single or first and second articulable beaks to th body portion of the -work element, travel hmiter slruetures and, as described below, a first helical, element may ail together comprise a single monolithic structure formed of a same material thai may be (e.g., laser-) cut from, for example, a single solid hypo tube. That is, these structures- .may be formed together of a same pi ece of unbroken homogeneou s material whether a single split tube i s selected or whether a non-split tube is .selected* according to embodiments. Such a monolithic structure may be considered to be a monolithic work assembly, and may take the form of a monolithic beak assembly, which is but one embodiment thereof.

(01041 Continuing to describe add itional el ments- of a tubular transport and coring assembly Π of Fie. t, accordi is to ^■■ embodiments. Flas. 17A and 17B show an intermediate., proximal sheath 540 of an exeisiaual dev ce 10,: according to one embodiment, ithou showing any additional non- or difiere ially-rotating distal and outer sheaths. According to one embodiment, a proximal sheath 540 may be configured to fit over at least a. portion of a work element 13 (as shown later i Fig. 21.) and abut collar 542, which collar may be nothing more th an internal shoulder within a distal sheath 590, .such as shoulder 593 in Fig. 20 below. According to one embodiment, a proximal sheath 540 may be configured to resiiienil bias a first and second articulable beak 518 or beaks 516 and SIS, if twin (or multiple) beaks are used, in the open position. According t one embodiment, a proximal sheath 540 ma he slid over the proximal portion of a work element 13 and then further advanced over the work element 13 until the distal end of the proximal sheath 540 abuts agains a, collar .542: (or shoulder 593 of Fig, 20), Therefore, as will be described below relative to Fig. 21 , selectively acting upon (e. g.., exerting a proximaily- directed or distafly-directed. force on) the proximal portion 548 of a proxi mal sheath 540 causes a first and second articulable beak 516, 51 S to open and close. If only one beak is present, that beak may b configured to open and close against, for example, an otherwise immobile seoopula* shaped portion of an outer sheath 12, as previously described above. According to one embodiment, a roximal sheath 540. m y itself he enclosed by art outer non~ or diifereniiaih/ rotating distal, sheath: 590, which efFeetiveiy captures the distal portion.546 of a proximal sheath against an outer sheath 512, as shown in Figs. 20 an 21. further on. Thus, a proximal sheath may act in concert wit a distal sheath 590, as shown i Fig. 20, over at least a portion of the work element Ϊ 3 to cause a first and second articulable beaks 5.16, 518 to open and close. According to one embodiment, the ^■ proximal sheath 540 may be either free Soaring or driven in rotation, and may be noa- or differential i rotating, with respect to any outer sheaths as described tether on. According to another embodiment furthe detailed below,, collar 542,. which is primarily shown for illustrative purposes, may be eliminated and a beak actuating portion 469, as shown in Fig, 16, and a body portion 428, as shown m Fig. 19, of the working element 13 may ^' be directly attached to a proximal sheath 540 at the distal and proximal ends of a helical portio 544 of the proximal sheath, in such an embodiment, the work element 13 may be attached, to a proximal end of such a second helical element 544 to rotate the work element 13, including a first and second articulable beaks. In this -m nner, a proximal sheath 540 may be configured to entrain the work element 13 in rotation as well as to open and close articulable beaks. In such an embodiment,, a first helical element 472. such as previously show in Figs, 2-6, may be decoupled from the work element. 13, thereby enabling a first helical element 472 to be driven at a rotational speed that is independent of the rotation speed of a connected proximal sheath 541) and a first r a first a d secoad articulable beaks 518 or 516, 518, as is shown and discussed in greater detail below. According to one embodiment, to bias a first and second articulable beaks 516, 518 in the ope position, at least partially within an outer sheath 512, according to one embodiment, proximal sheath 540 may comprise such a second helical element 544. In this manner, according to one embodiment, not only .may the present biopsy device comprise a first or a first and second helical elements, but such helical elements may be eo-axiali arranged within the device, one over the other. According to one embodiment, at least a portion of a second helical element may fit over a first helical element within the biopsy device to effectively define a stracture comprising a coil-within-a-coil, as shown in Fig. 19,

(0!05] Accordin t one embodiment;, a proximal sheath 540 ma comprise a proximal region 548 and a distal region 546 comprising a second helical element 544. The proximal region 548 may be generally co-extensive with at least a portion of a first helical element 472, if included in such embodiment, of the work element and may comprise stracture configured to aid in the proximal transport of a severed tissue specimen, indeed, after being severed from surrounding tissue, the cored specimen will be urged i the proximal directio within the body portion of the work demerit ί 3 and eventually engage such a rotating first helical element, if used, or engage a flush conduit that aids tissue transport. A first helical element, if present according to embodime ts, may assist In the transport of the cored specimen to, e.g., a tissue collection transfer magazine 27 coupled t the present biopsy device. Surface features may be provided on the inner lumen of a proximal sheath 540 which, however configured, m y aid in the transport of cored specimen by providin some measure : of friction between the cored specimen and a rotating first helical elemen t 472, if used, to enable the cored spec ime to move i a proximal direction through the device. According to one embodiment and as shown in Figs. 1 and 21 further on, when a proximal sheath 540 is fitted over the work element 13, tissue entrained by a first helical element,, illustrated by 582 of Figs, 19 and 22, will als be drawn against the inner lumen of a proximal sheath 540. According to embodiments, a flush and a vacuum ma be drawn within at least a proximal sheath.540, In this manner, cored tissue specimen(s) may be drawn through the coils of a first helical element, if present, to come into intimate contact with the (e.g., patterned or slotted) surface of a proximal sheath's inner lumen. Alternatively, in other ^* embodiments, only the flush fluid and vacuum, acting in concert but with out a first helical element, may suffice to ensure tissue specimen transport to a transfer magazine. The flush, may be provided with, flow rates ranging from 0 to 100 cubic centimeters per minute. The vacuum may be provided with a pressure range from atmospheric to ^' 0:001 Tort and may have flow rates rangin from 0 to 200 cubic centime ters per minute,

ffl j As shown in Fig. 17A, and according to one embodiment, a proximal sheath

540 may define one or more elongated slots 552 therein. Fig. IB shows a proximal sheath 540 comprising a plurality of elongated slots 552 disposed in a spiral pattern a ound a longitudinal axis and serving as a helical element, according t one embodiment Such slots 552 may allow fluid communication with the interior lumen of a proximal sheath 540. In other words, a slot or slots 552 may go all of the way through the wail thickness of a proximal sheath 540. For example, when vacuum is drawn within a proximal sheath, cored tissue specimens being transported, by first rotatin helical element 582, if used, may be drawn to slots 552, and partially invaginated dierein, providin s me resistance to the cored tissue specimen, thereby preventing them from, simply rotating in place within a first helical element without moving. Slots 552 may also serve as conduits for flushing liqui s used to aid teansporS:: m concert with aspiratio applied from a vacuum source within or external to the device 10. According to one embodiment slots 552 may be seriall disposed end-to-end substantially parallel to the longitudinal axis of a proximal sheath 540, as shown iti Fig. 17 A, may he offset relative to one another, or may be disposed in a spiral pattern, whether non-overlapping o overlapping, as shown in Fig, I S,, thus effectively acting as a elongated co-axially disposed third helical element of similar or different pitch than a second helical element similar to that discussed -under Fi , 17B above _*

|0I O7| Fig, 18 shows one embodiment where a proximal sheath 540 includes slots

552, as previously shown in Fig. 17 A, hi an overlapping spiral pattern, which slots 552 ma effectivel ina tion as a third helical element co-axially disposed relative to first helical element 582 and second helical element 544. The slots 552, according to one embodiment, may he configured to provide Resistance to the cored tissue specimen to enable a first helical element to transport the tissue specimen in the proximal direction. It is recalled that a first helical element ma foe decoupled from the work element. 13 (including the first and second articulable beaks), and that a proximal sheath S40 ma he mechanically coupled to tendon, actuating elements 469 (and, also, to a first or first and second articulable beaks) to provide both rotational force and beak opening and closin actuation, as described relative to Figs., 1.9 and 21. in such. an. ernbodirrseni, therefore, the relati ve speeds of rotation of a first or first and second articulable beaks and a first helical element may be driven independeeti and differentially tuned to optimize both tissue coring and tissue specimen axial transport in proximal direction (e.g. to transfer magazine 27 of a device 10).

i I OS Fig , 1 shows details of a proximal sheath, beak actuatio elements and a inner first helical element, according to embodiments, it is to he noted that the figures herein are not t scale and the relati ve dimensions of the constituent elements of the biopsy device 10 may vary front figure to figure. Accordin to one embodiment,, the working end (e.g., substantially all structures distal to the handle 12) of the biopsy device -10 may be essentially composed or formed of two or more separate elements that, are disposed substantially concentrically or co-axially relative to one another. This results m a .mechanically robust working end of the excisional device that is economical to manufacture and to assemble . As shown in the exploded view of Fig. 19, one embodiment comprises a work element thai comprises 8 body portion 428 and tendon actuating elements 469 (only one of which is shown in this view), and may be terminated by a fif stand/or second articulable beaks (not shown in this view), A first helical .element 582 may be formed of the same material as the work element 13, According to one embodiment, the work ement 13 (i.e., a body portion 428, a tendon actuation element 469 and a first or first and second ^■ articulable beaks) and a first helical element may be cot of f rmed from a single piece of material, such as a hyp tube. For example, the hypo tube may be suitably (e.g., laser) cut to form the bod portion 428, the tendon actuation elements 4( 9, the first and second articulable beaks as well as a first helical element 582, A first helical element 582 may then be .mechanically decoupled from the work element 13 by cutting the two structures apart These two structures are, therefore, labeled (la) and (lb) in Fig. 19, to suggest thai they may have been originall formed of a single piece of material. Thai a first helical element is mechanically decoupled from the work element 13 enables the rotation of a first helical element 582 to be independent of the rotation of the work element 13, For example, a first helical element 582 may rotate at a comparatively slower rate flmn the rate of rotation of the work element 3, as transport of a severed tissue specime may not retpire the same rate of rotation as may be advisable for the work element 13. According to further embodiments, a first helical element 582 may be deleted, leaving an expansion chamber in its place, relative to die central lumen inside a proximal sheath. 540 (not shown in this figure}, since the diameter of a proximal sheath 540 is greater than the diameter of the beak assembly 1.3 to which it may be fixed, thus providing an expansion chamber pto imal. to the roximal end of the beak assembly 13. In such embodiment, a prox imal sheat could extend proximaliy to a transfer magazine 27 at a vacuum tight junction, full 1 The second of the three main separate elements of the working end of the biops device,, in one embodiment, is aproximal. sheath 584, as shown at (2) in Fig. 19, A proximal sheath 584 ma comprise, near its distal end, a second helical element 585 (similar to 544 of Fig, .18). As shown in Fig, 1 , a second helical element 585 may be dispose concentrically over a portion of & first helical element 582. Accordin to one embodiment, a proximal sheath 584 may comprise one or more proximal locations 586 and one or more distal locations 587. The proximal and distal locations 586, 587 ma define, for example, indentations., obrounds or through holes and may indicate the position of, for example, spot welds (or other artacint!eni modalities) that are configured to mechanicall couple a proximal sheath 584 with the work element of the biopsy device. When assembled, a proximal sheat 584 may be concentrically disposed over a Irst helical element 582, if present in such embodiment, nd ^' advanced such that the one or more proximal locations 586 on a proximal sheath 584 are aligned with corresponding one or more proximal attachment locations 588, if preseot, o the work ^■ element 13 and such that one or more distal location 587 on a proximal sheath 584 is aligned with corresponding one or more distal attachment location 58 on a tendon actuating element 469. The corresponding locations 586, 588 and 587, 589 roa then be attached to one another- For example^ one or more proximal locations 586 on the proximal sheath 584 ma b spot-welded to corresponding on Or more proximal attachment locations 588 on the work. element 13 and one or more distal locatio 587 o the proximal sheath 584 may be spot -welded to corresponding one or more distal attachment location 539 on a tendon actuating elements 469.

|0! I t] It is t be noted that locations 5S6 _S 587, 588 and 589 are only shown in the figures as illustrative, and exemplar only, as there are many ways of mechanically coupling or attaching a proximal sheath 584 to the work element 13, as those of skill may recognize. According to one embo iment, a proximal sheath 584 may he attached uch that movement of a second helical element 585 (e.g,, extension and compression) correspondingly actuates a first beak (and, if present _* a second articulable beak) between a first (e.g., open) configuration and a second (e.g., closed) configuration. Indeed, a proximal sheath 584 may be mechanicall coupled to the work element of the biopsy device such that, for example, a proximal portion thereof (e,g. , at o in the vicinit of proximal locations 586) is attached to a body portion 428 of the work element 13 and suc that a distal portion thereof (e.g., at or in the vicinity of distal location 587) may be attached to a tendon actiiating elements 469. In this manner, compression and extension of the second helical -element 585 may cause a. relative displacement of a tend n ^■ actuation, elements 469. and a body portion 428 (i.e.. one may mow while the other is immobile or substantially so _¾ or both may move relative to one another), thereby causing the actuation of a first or first and second articulable eaks,

[012] Fig. 20 shows a son-, differentially, o same-speed rotating distal sheath

590, (which ma also serve as an outer sheath 512, wherein scoopida of such structure ma extend from about 1 millimeter to more than 200 millimeters , according to embodiments) which may or ma not, according to .embodiments, extend over a first or first and second articulable beaks. It should be noted^that diflerential rotation may also imply not only a difference in relative speeds between two elements, such as a proximal nd distal sheath, but also ihat th direction of rotation may be different* according to embodiments. Such opposite rotation serves to increase the relat ve concentric rotational speed between die two elements, while allowing simplification of the ^■ corresponding drive mechanisms, which may thus not have to he rotated at the high speeds necessary to achieve a certain relative speed differential between two snob elements-. Th third ( labeled as 3 in thi s figure as its prox imal end is of greater diameter than 1 and 2 of Fig. 19) of the three or four coring and transport assembly 11 elements, according to certain embodiments, is a. distal sheath 590 which may be configured to fit over the work element 13 as shown in Fig. 19 composing a body portion 428, a tendon, actuating element 469 and at least a portion of first or first and second articulable beaks, A distal sheath 590 may also be configured to sl ide and fit over a proximal .sheath 584 that is mechanicall coupled to the work element 13. When the distal sheath 590 is combined wi h a: proximal sheath 584 and work element 13, it may be referred to as an inner assembly, which .may be fitted into an outer sheath, A distal sheath 590, according to one embodiment, may comprise a distal portion 592 (shown extended, to the tips of the beaks within, but which may be shortened all the way to just distal of shoulder 593) having a first diameter, and a proximal portion 594 having second diameter. The second diameter may be larger than the first diameter. To accommodate the differences in diameters of the first and second portions 592, 594, a distal sheath may comprise a shoulder 593 comprising a s rface that transitions between the distal and proximal portions 592, 594 of differing diameters and against which the distal portion of a second helical element 585 of Fig, 19 may act, in one embodiment, furthermore, a distal sheath such as shown in thi s figure exte ded nearl to die tips of the beaks or only partway along the beak assembly 13 may be configured to core forward along the length of the scoopula of an outer sheath, such as 5.12 of Fig, 16B, while lying in the trough of the scoopula, which may be useful in ensuring that any tissue encountered woul not slide away from the scoopula by combining a forward cutting and side cutting mechanism s previously discussed herein. The scoopula side cuts as it is rotated about the clock face in sampling or is moved laterally to a new target tissue site, and the beak or beaks forward cut as they core within the trough of the scoopula . Furthermore, s the beaks act against the sides the scoopula, there exists a. scissors action between the edge o f the scoopula and the beak or beak edges combine forward and side cutting by combined application of their individual cutting surfaces. According to embodiments, not only a distal sheath, but a proximal sheath and an outer sheaths as well may ha e shoulders similar to shoulder element 593 of Fig, 20, Such first and second diameter portions of each of these sheaths may be incorporated to accommodate each other in configuration, but also t establish a further expanded expansion chamber portion of a: proximal sheat 584 proximal to its attachme t to a .monolithic beak assembly 13. Such an expansion chamber, which may be even greater than the inner diameter expansion that is simpl due to a proximal sheath's greater inside diameter than that of a monolithic beak assembly 1.3* may similarly serve to allow tissue sample expansion once clear of the corin and severing beak(s}.. which may farther aid tissue transport with or without a first helical element, and in. the presence of active or passive flush .fluids and/or aspiration as primary or secondary transport aids. Such an expansion chamber may reduce inner wall friction between the tissue sampl -and the inner lumen of the device .10, as well as providing space for flus fluids, either passive or acti ve in motion, as will be shown in a further illustration below, to aid tissue transport to a transfer magazine 27 of the device, as shown in. PigJ ,

[0.1.13] ^' Fig. 21 is a view of a two-beak assembly with both a distal sheath 590 and the outer sheath 512 removed, according to embodiments. Fig..2.1. shows: components of the work element. 13 (comprising, e. g., a body portion 428, one of a tendon actuation elements 469 and a first and second articulable beaks 602, 604} mechanically coupled to a proximal sheath 584. To show interior sntictiires, a distal sheath 590 is omitted in this view. As -suggested at 586, 588 and at 587, 589, a proximal sheath 584 may be spot- welded to the work element 13 in such a manner as to enable differential motio of a body portion 42S of the work element 13 relative to tendon actuating elements 469 thereof when a second helical element 585 compresses and extends, which differentia! motion actuates e.g>, opens and closes) a fi st and second articulable beaks 602, 604. Significantly,, the attachment, of a proximal sheath 584 to both a body portion 428 and to a tendon actuating elements 469 of the work element 13 results in substantially equal torque being imposed on the constituent element of the work element thereby maintaining the structural integrity of the work element as it is spun up to speed (by rotating a proximal sheath 584 in this embodiment) and as a first and second articulable beaks 602, 60 cut through variably dense, fibrous and vascularized tissues.

$0,114} Fig.22 is a view of a configuration of a short monolithic (to distinguish over ^• the split tube- long monolithic single beak configuration of Fig. 15C _t for example) single-beak 604 assembly, according to enihodlments. Pig. 22 shows a body portion 428, a tendon actti doR element 469 and a. first articulable beak 604 of die work element 13 tog-ether with a first helical element 582. A proximal sheath 584, a distal sheath 590 and an outer sheath 512 are -not visible in this view. As shown, a first helical element may be co-axial!y disposed felative to a body portion 428 of the work element 13 and i»ay e of the same or substantially the same diameter. As noted above, the two may be formed of or cut from a single piece of material such as, for example, a stainless steel hypo tube. According to another embodiment, a first helical member may be of a different diameter than a bod portion 42 S. However., such an embodiment may require corresponding changes to the diameters of a .proximal sheath 584 and the proximal portion 594 of a distal sheath 590 and a change to a shoulder 593, if present In one embodiment, such a single beak 604 may act against the side and forward edges of an outer sheath 512 (not. shown in this figure) as illustrated- b Figs. 2-15, according to embodiments. For ex mple, a single beak 604 ma act against a scoopuia-shaped distal end portion of an outer sheath as previously described ,

[0115 j Based upon the principles of distal work element (beaks) operations from the previous descriptions associated with Figs,. 16-22, it may be seem that, accord ng to embodiments, a rotating proximal sheath 58 may serve to both rotate single or multiple beaks as well as provide the mechanism for opening and closing a beak or beaks by being itself moved axialiy disfally such that its distal end pushes up against a non- or differentially or same speed rotating distal sheatli 590, or a rotating proximal sheath 584 may serve- to rotate a single or multiple beaks of the work element 13 being attached to a proximal portion of a monolithic wo k element while an identically rotating distal sheath 590 may be attached to a beak tendon actuation elements 69, whereby the relative axial movement of proximal and distal .sheaths allows far beak actuation. These structures ma be ituther enclosed, by a BOB- or differentially rotating ot rotaiahie and removable outer sheath 51 tha may terminate, according to one embodiment, in a trough or scoopula shape, all of which for this device 10 are referred to as the tubular coring and transport, assembly .1 1 in Fig. L In the inner ksmen of this coring and transport assembly 1 I, a first helical element 582 may be provided to transport cored and severed specimen in the proximal direction, which ma be further aided or replaced by liquid flush induced into the central. lumen at the distal end or along the length of the assembl 11 aad/or a vacuum aspiration introduced at the proximal end of device 0; If provided, a first helical element 582 may rotate at a. different speed than that of a proximal sheath 584 and the beak element(s) 13. With diese principles tn mind, me following set of %ure:§ addresses the tnechanical means of providing such actions -to the distal end of device 10 of Fig. 1, according to embodiments, it .may also be seen, that the mechanical arrangements described herein are not the onl arrangements that ma accomplish some or ail of these desired actions on the tubular coring and traasport assembly 1 „ and other arrangements that may be envisioned by a person skilled in the art are considered within the scope of this invention..

[0.116j fig. 23 shows a top view of a mechanical arrangement: for tubular coring and transport assembly 11 rotation and actuation, according to one embodiment. In this view, a outer sheaA 512 is not . shown for ease of illustration, bet" is shown in Fig. 26A, which illustrates the entire device 10, according to one embodiment. From the left or distal side, a proximal end of a distal sheath 590 passes through a- front seal, which in this view is at the distal end of a housing of device 10. A. distal sheath 590 is free to move against an internal spring., axiaily forward and back. According to one embodiment, the iota? distance of sach novetneat m be about equal to a maximum sample ttssae length (not to scale, all relative distances such as Xmm ₅ Ymm and corresponding Dx and Dy (D for distance) are shown for illustrative purposes only). A its proximal end, a distal sheath 590 nwy he embedded into a tube socket/seal 603, which is itsel coup led, to th e forward wall of a distal sheath: carder 6 6^ wh ich may be configured to slide back and forth within a slide 605 a maximum distance defined by a carrier sto 604, both of which are formed in the outer housing of device 10 in this embodiment. Continuing to the right of the illustration, a proximal sheat 584, contained within a distal sheath 590 a«d rotating indepemientiy thereof, in this embodiment, may be seen passing through thrust bearing 60 A. in the forward wall of a proximal sheath carrier 609, A proximal sheath carrier 609 may be configured to slide axially inside a distal sheath carrier on slide 608, which is furnished with its own spring to effectively allow a return force to separate the two (distal and. proximal) carriers if they are pushed together, which causes : p oxi al sheath 584 to move backward or ^" forward, respeetiveiy, i relation to a distal sheath 590. Recalling that it is the differential axial movement between a distal sheath 590 and a proximal sheath 584 that ac tivates beak opening and closing, it may be seen. that, in such embodiment, such axial movement may be accomplished by the action of the two carriers in relation to one another. The total distance travelled by a proximal sheath carrier 609 therefore relates to the axial distance travelled between proximal and distai sheaths to open or close the beak or beaks 13 at the distal end of device 10 according to embodiments. i 17} A proxinmi sheat 584 is also free to move ax l rathe distal and proximal directions- under rotation as a result of a thrust bearing 609 A described abo ve. A proximal sheath 584 continues prcixirnally in this illustration through a vacuum seal 612 at forward bulkhead of vacuum chamber 61 1, which serves to capture any stray fcids that may not have been aspirated through the central, lumen of the whole tubular coring arid transport assembly 11 a d through a transfer magazine 27. Rotational force for a proximal sheath 584 is provided b its gear 614 (which may, according to embodiments, be extended to also rotate a distal sheath 590 at the same speed if they rotate together as described in Fig. 22 above), i this illustration, which is driven by a proximal sheath pinion gear 613, A first helical element 582 may also be ee in this figure, which first helical element 582, if present, may be driven at a different rotational speed than that of a proximal sheath by its own gear 616 and pinion gear 615, which may also drive a flush pump or vacuum system of the device (not shown , i such is provided, a first helical; element may terminate within a transfer magazine 27 in which tissue samples may be deposited serially.

[91 IS Fig. 23 also shows that, according to one embodiment* distal and proximal sheath, earners ma terminate proximaiiy by vertical, side wails of any shape, md upon which a rotating dual c m: gear 620, witli individual cams swch as a distal sheath cam 618 mid a proximal sheath cam 61.9, act upon the vertical side walls of the two carriers. The inner side wall s a d cam 619 correspond to the proximal sheath carrier 609 and the outer side walls and cam 618 correspond to the distal sheat carrier 606, it may be envisioned, depending on the side profile of each cam, as well as the side profiles of the two vertical side walls, that many different fine-timed configurations may actuate the same r .differential movement, acceleration and timing of differeutiai movement of the two carriers relative to each other, and thus to the combine and coordinated action of the distal work element of device 10 _» according to enibodiments. For instance, the beginning of the rotatio of twin gear cams 620 with their individual, cams 618 and 6Ϊ9 may actuate the carriers equally, corresponding to distal-directed movement of distal and proximal sheaths, thus coring tissue with the beaks open and rotating. Upo reaching a certain axial distance, cam 19 may continue forward, closing the beaks and keeping them closed while both distal and proximal sheaths retreat p oxiraaliy carrying the tissue sample backwards and delivering it to a transport mechanism for e ventual deliver) ¹ to a transfer magazine 27. I n such a embodiment, gentle traction would be applied to the tissue sample take at th end of die part off stage of the biopsy device 1.0's action for that sample,, further ensuring a positive part-off from surr sfidiflg tissue,. Many different cam caiBi lower (vertical rear walls of the. carriers) configurations or shapes may be envisioned to provide forward and backward axial movement combined with differential acceleration of the individual sheaths to allow the device H) to accomplish it desired operations at different pre-, intra-, and post-operative stages of penetration, coring, part-off, retrieva!. and stotage of sequential samples, as well as material collection from, or delivery' to the target site as described previously, for instance, a dimple in die center vertical sectio of a vertical rear wall of an inner carrier would result in a double closing of the heals after a short time interval, which may result in forther aiding positive part off of the tissue sample. he vertical walls of each carrier ma be asymmetrical to each other or in their upper or lower sections, dependin on the mechanical effect desired. The cams themselves may be asymmetrical ^' k their individual side shapes which, combined with special shapes imparted to the vertical rear walls of the carriers, may enable or result in extremel fine tun ng of the carrier axial movements at any desired point in time, defined by the revolut onary speed and instantaneous radial angle during revelation of twin cam gears at any ti me. The twin cam gears of this embodiment may be powered by a worm gear 621 , which may allow for movement of the two carriers to be frozen in position at any desired stage. The worm gear 621 may itself be driven by a pinion gear 623 movable on it pilot shaft 624 operating through a simple chito - mechanism 622. It should also be noted that at any time, carrier 609 and carrier 606 may be manually squeezed, together through a simple mechanical linkage (not shown), which may cause the beaks to close and part off or remain closed at an operator's choice. It should also be noted that rotation and axial movement axe independent of one another with such atr arrangement, and thus may be controlled with different actuation mechanisms to allow the device 10 to accomplish ail of its intended functions. Again, this illustration, is only one of many different mechanical arrangements that ma be envisioned by one of skill in the art, all of which are considered to be within the scope of this disclosure., and that may be se lected to enable the de vice to accomplish any or all of the following actions considered, characteristic of device 10, according to embodiments;

* Penetration to the target tissue site or withdrawal f om the site:

o Beak(s} closed and withdrawn _. , no rotation- scoopul in pre- firing or extended mode; o Beakfsj closed ami extended, m rotation, seoopnla in pre-iiring or extended mode;

o Beak(s) closed and withdraws, with rotation, scoe ola in pre-firlng or extended mode;

o Beak(s) closed and extended, with rotation, scoopala in pre-fiiing or extended mode', o Beak s) ope , either withdrawn, or extended, no rotation, seoopiria in pre- firing or extended mode;

o Beak(s) open, eithe withdrawn or extended, with rotation, seoopula In pre- firin or extended mode;

« Semi-automatic tissue sampling (gear cams stop after one rotation);

* Automatic tissue sampling (gear cams continue to rotate until interrupted);

• Short core sampling rising the manual part off fimctio described above); and

♦ Continuous core sampling of air sample length, terminating in. m n l part oft

^' [011 ] Fig, 24 is an illustration of principl es of a different arrangement of a earn gea and cam f¾I lower attange en , according to embo i ents. This figure specifically looks at the time-based action of geared cam 620 (shown as the central circle i n this figure) but configured with two pins surrounded by bashings that act in a similar manner to cams 61 S and 619 from Fig, 23, and are thus labeled as such in this figure. In this embodiment, the geared cam wheel 62 is assumed to rotate in a clockwise direction, wit pin 618 (analogous in function to cam 61.8 of Fig. 23) being a short pin. that acts only on the inside proximal sheath carrier's vertical rear wall, and pin 61 (analogous in function to cam 619 of fig. 23), which is a longer pin that is capable at times of effectively acting on both the proximal sheath carrier 609 and the distal sheath carrier 606 vertical rear walls ^■ simultaneously. The arc distance betwee the two pins on the Inner surface of the gear cam wheel shown by the two angles *V\ using the analogy from Fig.23, determines which of the two pins is acting on which carrier at any given point in time, either together or in a lead- la relationship depending on the revolutionary position In time of the gear wheel as it rotates. For purposes of illustration, the larger arcs scribed in this figure correspond to the vertical rear wail surface of the distal sheath, carrier 60 , and the smaller scribed arcs correspond to tile vertical rear wall of the - proximal sheath carrier ^' 609, The pins 618 and.6T9 are shown with their bushings only at the start of the cycle, for purposes of illustration., arid are shown as dots at various other locations ^' which correspond to their movement at various time intervals with gear cam wheel 620, The gear cam wheel 620 is shown to the tight ofthe figure, with the arcs of the carriers extending to tire left to correspond with the independent carrier movement outlined in the previous Fig. 23. It can be seen that the longer pin 61 is a shorter radial distance from the center of the gear cam wheel 620 than the short pin 18, which pin 618 acts only on the proximal sheath carrier 609, The short pin. 618 is also lagging the long pin 619 in revolutionary time, which implies- thai it conies into play only at a certain point in the clockwise movement o the gear cam wheel 620. Recalling that if th proximal sheath is pressed farther distal ly than the distal sheath carrier at any time (even manually b the operator) wit suc an embodiroeni, tire beak(s) will tend to close, following die principles outlined in previous figures, that at a certain point in time (at approximately the 8 o'clock position i this figure) the short pin will begin to act independently on. the proximal sheath carrier and extend it differentially farther distally than the distal sheath carrier, closing the beak(s) and keepin them closed until that point in time (at approximately the 2 o'clock position in this illustration) when the eak(s) will again, open in. anticipation of another forward excursion of both- proximal, and distal sheaths for coring and sampling.

[0120] For purposes of illustration, ft is assumed that the rest position ofthe two carriers is when the long pin 61 is in the 3 o'clock position (beak{s) are open (labeled as "A ^* ' or zero time in terms of rotation time), both distal and. proximal sheath are at their c losest proximal point to the housing of biopsy device 10). The figure includes a small microswite-h 632 with a pointer on the gearwheel* whose hinetio could he to stop/restart gear wheel 620 revolution when the long pin 619 is In its starling 3 o ^' clock position, which action may correspond to the differcnce between .semi-automatic (one revolution and microswitch stops revolution until re-enabled) and folly automatic (rnicroswiteh disabled altogether and thus rotation and sampling continues until operator interruption of the process) sampling action of the device 10, accordin to embodiments. The total excursion time of the distal end o the device 10 (coring forward, part off, sample retrieval and transfer to the transport mechanism, retur to starting position) occurs in a single revolution of the gear cam 620, and the individual actions of the pins on the individual sheath carriers 606 and 609 are as described herein. Such total sample (excursion) time may vary from as little as about 2 seconds to as long as ahoat 12 seconds, depending on embodiments, with, a nominally ^' designated time of 4 seconds, in one embodiment If the ^' total time for rotation is ssumed to be about 4 seconds, then rotational position ^A" corresponds to zero, position '¾ corresponds -to one second elapsed time, position "( to . ^' that interval when- the short pin takes over and the beak(s) begin to close , position to two seconds elapsed time (and wherein the beak(s) have closed completely as the short pin 61$ reaches that position), position 1- to three seconds elapsed time and the return to position A corresponds to four seconds total rotation time, assuming constant speed of gear cam wheel 620, which may also be variable., according to embodiments.. With the long pin at the 3 o'clock position, it is acting on the vertical rear wall edges of both carriers simultaneously, which continues to be the case until the long pin ^' 619 has reached approximately the 9 o'clock position, at which time the short pin 61 lagging behind at a calculated, arc distance a and fruitier radially than the long pin, will start to engage only the inner proximal sheath carrier vertical rear walk condoning its forward traver-s at die moment when the distal sheath carrier has ceased its maximum forward or distal movement.

[0121] The result is that the beak(s) will close, and remain closed until the long pin reaches approximately the 1 o ^* clock position, thus withdrawing the sample under either continuing proximal sheath rotation or not, as desired and according to embodiments (since rotation action of the -proximal sheath, which rotates the beafc(s) and forward/rearward excursion, of the carriers are independent of one another _* as illustrated in Fig, 23). As the long pin 619 reaches the 3 o 'clock position, the beak(s) are fully open and ready tor corin forward again and parting off and transferring another sample to the transport mechanism and ultimately to transfer magazine 27. Of note is that according to.. em odiments, sampling cycle time is a function of the time of one revolution of the gear cam. wheel 620, and that the timing .for beak actuation is a function, of the placement o short pin 618 in relation t lon pin 19. The arched (in one emlx>diment) configuration of the carrier vertical rear walls is only one configuration, but different profile shapes of each vertical rear wall will tend to accelerate or decelerate the actions of the pins on those surfaces, and many different vertical rear wall profile shapes are possible, depending on embodiments. Additionally, the profile shapes of the vertical fear walls of the carriers may differ from top to bottom to impose time-based factors on. the action (axial, movement, with implied beak actions associated, with such excursions of the tw carriers, is relation to one another) of each, individual carrier 60 or 609, according to embodiments. Finally, in this illustrated embodiment. axial disiattce liorixo!itaSiy between the short pin 618 and long pin 619 eoirespoods to die axial relative distance (and, therefore, time) necessary f r travel of the proximal sheath carrier 60 compared to the distal sheath carrier 606 m order to accomplish beakts) closure (or apeni«g, bot shown as "b" in this figure and as shown and discussed in Figs. 19, 21 and 22 above.) Total excursion, distance of the distal end of device 10 is shown as ^* ¾" in this figure, and is a fimetiors of the placement of pins 618 and 639 and the diameter of the gear cam wheel 620, i one embodiment. Such total excursion distance may be of any lengt desired, according to embodiments, and for one embodiment, such distance is nomiaally 1 inch or 2.54 centimeters, corresponding to maximum automatic sample length. Again, it should be noted that samples of any length maybe- obtained by the operator with device 10; as will ^' be discussed further below.

[0122] Fig. 25 is a side view of a culling element actuation mechanism consisting of twin inner and outer sheath carriers, -such as 606 and 609 of Fig. 23, according to embodiments. From the preceding Figs, 23 and 24, it may be seen that rotation of gear cam wheel 620 will slide both carriers axia!ly distall and proximaliy, in differential movement to each other, as previousl described. Also shown in. this figure is the distal, sheath 590 with its external return spring, a distal sheath socket and optional flnsh port .603, the proximal sheath 584, the proximal sheath thrust bearing 60 A, the gear earn wheel 620 with, its short bushed pin 618 and its long bushed pin 619, the gear cam wheel raicroswiieh 63 and the maximum forward travel proximal sheath carrier micros witch 633, In the embodiment shown In this figure, the vertical rear alls of each earner 606 and 609 are profile shaped as hemi-cirea!ar in form, and of nearly the same size, although other embodiments may alter the shapes of either carrier rear vertical wall to be of an shape desired, which will affect the action of the two carriers" axial movements, according to embodiments and as described under Fig. 24,, The rear walls ay have special, features, such as elliptical shapes in their upper or lower halves, dimples, wavy shapes or any other shape desired, and one skilled in the art will recognize that such profile features will act with the pins of the gear cam wheel to accelerate or decelerate the individual axial movements of the two carriers, in relation, to each other, all such designs and corresponding movements of which are considered to be within the scope of this invention.. Further, the profile shape of each of the two carriers may differ from eac h other, and the rear walls may be lowered in relation to the long horizontal ax is of each of the carriers, resulting in a cantilevered action on the: earners as imparted b the gear earn wheel 620. This may be especially u i|?ortafit for embodiments of device 1.0 specifically designed fo stereotactic table use, whe e keeping the corin and transport assembly I I of Figs. 1 and 26 as near as possible t the tipper en of the device as possible may be of benefit in allowing a 'Viown the barrel" view of the device in action, as well as for imaging mechanisms where such a benefit has use in being placed as closely as possible to the long axis of die working end (distal end) of the biopsy device, according to embodiments.

|0123} Fig. 26A is a side view of internal and external features and elements of a biopsy device 1 Q, and Figure 26B is a front end-on view of a shape of a biops device 10, according to embodiments. In this figure, the eekanisro of a distal sheath carrier 606 and a proximal sheadi carrier 609 with their elements of Figs. 23, 2 and 25 are shown i near scale size, according to embodiments, and are themselves carried by and slide a iai! withi drive mechanism carrier 640. An outer sheath 512 may be field to the forward bulkhead of drive mechanism carrie 640 in a manner similar to the way that distal sheath 590 is socketed to ^■ distal sheath carrier 606 _s but is also easily removable from the device 10 by the operator if desired prior to, during or at the end of a procedure, thus being placed or left in situ for the purposes of pre or post-procedure cavity ( target tissue site) access for such purposes as the Introduction of markers, medicatiotiS'-ot llei'tnatenais as. well as drainage or as m introducer for additional devices. If it is placed p.re-procedurally,. it may be placed over locating wire and serve itself as a locating tube for device 10 or other devices. It may also have external features t support an extendable locating wire or other structure designed t improve visibilit of the tip of the device, immobilize a target tissue or measure its extent, among other functions. A outer sheath 512 may be easily coupled to handle 12 or housing of device 10 by a Luer lock system, for instance and in one embodiment, which would allow .for easy assembly and dis~assembly, as well as tor the connection of additional devices for fluid or solid delivery systems, drainage systems and other devices. Other elements also shown in various previotts: figures herein include a tubular coring and transport assembly J 1. _» a non- or differentially rotating or rotatahle outer sheath 512, a work element with its beak(s) 13, a distal sheath 590, a proximal sheath 584, a distal slieath canier 606, a proximal sheath carrier 609, a proximal sheath thrust bearing 60 Λ, a distal sheath socket/flush port 603. a proximal sheath pulle 614 (analogous to gear 614 of Fig, 23 _s as will also apply to other pulleys in this figure, which correspond to various gears of Fig. 23), a first hel ical: element pulley 616, a vacuum chamber 6J 1 , a first helical element or txansport helix: 582, if present according to embodiments, trausfor magazine 27, & flush por 638,. an aspiratirm/fnater delivery port 639, a power s itcli indicator 635, a D C adapter port 637 , a DC moto 636, a transport he Si x, inion pulle 615, a proximal sheath pinion pulley and clutch. mechanism, (magnetic ox otherwise) 613, a worm gear clutch pinion pulley 623, a worm gear clutch 622, worm gear clutch (gear c m wheel clinch) button 634, a worm gear pinion 621, a gear earn wheel 620, a drive mechanism earner common driveline 6 1 , a return spring 642, a forward tiring mechanism, trigger nd leve 631 , and depth stop adjustment ^' mechanism 630. It should be noted that, according to embodiments, many other substitutions for any or all of the elements noted herein that accomplish the same function or f nctions may be devised by one skilled in tire art, and all such substitutions are considered within the scope of this disclosure. Th drive mechaiiism carrier may be used to slide nearly all of the internal drive components illustrated in this figure forward against a stop at the distal end of the handle 12 of device 10. which may correspond: to an internal forward firing mechanism for placement of an outer sheath and sc opula portion of an outer sheath 512 in. proximity to or through a lesion, as desired by the operator, and as described for such a procedure in Fig. 1 above. Alternatively, only the outer sheath itself may be forward fired without carrying the internal drive mechanism with it according to embodiments. This outer sheath may be manually, or in other embodiments, automatically rotated to various "o'clock" positions b the operator through a simple manual or driven wheel or ratchet mechanism attached to an outer sheath 512 (not shown), it should be noted that according to embodiments, rotation of a proximal sheath, a. first helical element, if present, and a distal sheath (if rotated) are independent of the distal and proximal axial movement of the tubular coring and transport assembly 1 1 , and becau se of that feature,, aceording to embodiments, tlie operator may select various ftmetions of the device .1 at an time, as described previously under Fig. 23 above. f0!24| Fig. 26B is an end on view of a biopsy device 10, according to one emhodiment. Various other end profile shapes are possible,. - nd are considered: within the scope of this disclosure. Of particular note with this view and this embodiment, the device lO's tubular coring and transport assembl 1 1 is located near the very top of the device, which may th us allow a better viewpoint for both the operator and the imaging devices used with device 10.

[0125] Fig. 26C shows transfer magazine 27, according to one embodiment. Fig.

26D is a eross-sectiona! view of a transfer magazine 27 of Fig. 26C, taken along cross-sectional line AA% and Fig. 26E shows a view of an internal collection tube that .may be split open as shown therein. Considering now Figs, 26C, 26D and 26E collectively, a transfer magazine 2? may coMain an internal elongated tube 422 (as shown in Fig, 2 E) configured to receive cored and severed tissue specimens. In particular, a transfer ma azine 2? may be configured to receive and (e.g,, temporarily) store cored tissue specimens or samples., and to preserve the order in which the samples were acquired. Specifically, a transfer magazine 27, according to one embodinaeat, may be configured to store a serial train of tissue samples, from a first sample at one end of the serial train of samples to the last sample acquired at the opposite end of the serial train of samples. For example, the first sample taken may be urged within an elongated tube 422 to be closest to the distal end of a transfer magazine, wherein proximal and distal quali fiers are defined relati ve to the biopsy device. As shown in Fig. 2SA, the distal end 406 of a transfer m azine 2? is closest to the beak assembly 13 and die proximal end 404 of transfer magazine 27 may form one of th proximal- most structures of the present biopsy device.

[0126J A transfer magazine 27 may address various clinical needs by enabling the operator of the present biops de vice to inspect the core samples more closely , and in some cases tactileiy, without destroying th record-keeping function of transfer magazine 27, A transfer magazine 27 is referred to as such, as the storage of the cored and severed tissue samples may fee short iemt Since transfer magazines 27, according to embodiments, m y be configured to b removabl and/or replaceable at any tirue(s) during the procedure, the present biopsy device enables a variety of procedural methods to be carried out, which methods would not be possible, or at least would be impractical, withoirt the structures disclosed herein. Fo example, usin the present biopsy device, a clinician may segregate the contents of one transfer magazine 27 from the contents of another, additional transfer magazine 27. The operator of the present biopsy device may als have the abilit to interrupt eoring/fransport storag with, another function of biopsy device, all the while^ at the operator's discretion, keeping the present biops device' tubular coring and transport assembly 11 in place, or ^' alternatively elements of such assembly 11 , such as a removable outer sheath 5 ! 2, thus minimizing trauma associated with repeated removal and insertion of the present biopsy de vice .

f 01.27] According to embodiments, a transfer magazine 27 may comprise a single or multiple piece assembly which may include a tube or tubes 422 extending forward inside the device all the way di tally to monoli thic beak assembly 13. in place of a first helical element 582, or alternatively may extend only to the proximal end of either a proximal sheath 584 as shown in Fig. 26A or to the proximal end of a split tube Song .monolithic beak assembly such, as shown in Fig. i SB, sad may also contain slots a ranged to allow for flush s stems to direct fluids in such a manner as to akl transport of the tissue s ecimen and also collect body fluids for subsequent analysis, in such embodiments, flush fluids and aspiration by vacuum, would enable continuous transport of specimens from the distal end of the device to the main body of transfer magazine 27, and a transfer magazine 27 may either he separated from its distal transpor tube, if present, according to embodiments, or removed from the device with its integral transport tube. Such a System would maintain vacuum integrity within suc simple mechanisms from the distal end of the device to its most proximal end.

[01281 An elongated tube 422, according to one embodiment, may also comprise a central track or inner transfer magazine track, such as shown in Fig, 26B below, configured to receive the serial tissue specimen, and, according to embodiments, m ^' be fitted with a Luer-lock type fitting for easy attachment to the device. Vacuum may be provided via an axial vacuum port, for instance in the expanded region of Fig. 26 at the distal end of the magazine, which may allow fo only one vacuum connection to be required by the device, according to embodiments. At regular intervals (on the order of the length o tissue samples acquired by th excisional device:, for example) along the length of an inne transfer magazine track, the present transfer magazine 27 may defin vacuum holes through which a vacuum, may fee drawn between the outer tube 402 and the inner tube 422, whic receives the samples in serial order. According to embodiments, these vaciruni holes may be lined with a filter element, such as sterile filter paper or other filter media, to catch and filter ceils and other materials from any fluids that accompany a tissue sample to the transfer magazine. This vacuum, optionally along with flush, may urge the cored and severed tissue specimen i the proximal direction., towards the proximal end 404 of transfer ma azi e 27.- Having reached the proximal end of the interior track, the cored and- severed: tissue specimen may come to rest and may , according to one embodiment, block or occlude one or more vacuum holes disposed along the length of an elongated inner tube 422. I this manner, no farther vacuum will be draw through such blocked vacuu hole(s). This blocke vacuum hole or holes, however, keeps the just-obtained tissue specimen in place (at the proximal-most availabte slot along the interior track of the magazine 27) while allowing more distaily-disposed vacuum: holes to continue to draw the vacuum therethrough and to continue to urge later-obtained samples to the next-distal position within the magazine. According to one embodiment, when, the last vacuum: hole disposed along die length of die e longated uifee 422 has bee blocked by an obtained sample. a transfer magazine 27 ma be considered to be full A full transfer magazine 27 .may then be withdrawn from the biops device, A new transfer magazine 27 may then be provided and inserted into the biopsy device to continue the procedure, if desired. Note that a transfer magazine 27 may fee withdrawn from and replaced back into, the biopsy device, without interrupting the procedure and without ithdra ing the work element 13 from the tissue. Moreover, withdrawing a transfer magazine 27 allows access to th interior lumen of the beak assembly, which in turn allows any number of imaging materials of devices, cosmetic materials or dierapetincally-beriefici l substances to be delivered, or fluids and/or cells to be evacuated from, the target site,

[01291 Once magazine 27 is withdrawn from the biopsy device, a magazine capping and sealing element 408 may be coupled to the distal end of the magazine 27. A capping and sealing element 408 may be configured to sea! the collected samples, cells and any fluids collected fro the outside, to enable ready transport, imaging, direct visual observation or even tactile manipulation, A capping and sealin element 408 may comprise a fluid release element 410: A fluid release element 410 may comprise, for example, an ampule of fluid surroynded and sealed within a soft covering of _> .for example, rubber or viny l. The soft covering ma be squeezed between the user's fingers to crush the ampule of fluid, which flui may then fee released t permeate the interior of a transfe magazine 27, For example, the fluid released may comprise a preservative configured to preserve the tissue architecture and prevent degradation of the collected tissue samples. Other fluids (e.g.., stains) May be added thereto or used in place of the preservative.

[0130} According to one embodiment shown in Fig _* 26B, a transfer magazine 27 inner track, as described in the previous paragraph, may comprise a clam-Shell structure. Indeed, a transfer magazine 27 inner track ma comprise a (living, for example) hinge 414 so as to enable the transfer magazine 27 to be opened along its longitudinal axis and its contents directly viewed by the user or pathologist. In such an opened state, a transfer magazine enables an one or all of the samples to e withdrawn from a transfer magazine 27 for close examination and, if desired, replaced therein, without disturbing the sequential order in which die samples were stored. According to embodiments, a transfer magazine 27 may comprise visible markings and/or radio opaque markings 412, to assist the user in determining the order in which the samples were obtained. Such markings may, for example, comprise numbers or identifying features appearing on the elongated tube 422. For example, the number "1 " may be visible in the proximal-most position of a sample with a transfer magazine, followed by " " for the location of the next Specimen, an m on. It i then easy to ^' correlate the specimen with tlie locatio from which the specime was taken. For example, if 12 specimens were taken "around the clock", th first specimen will correspond to the 12:00 o'clock position and the 7* sequentially disposed specimen within a transfer magazine 27 will correspond to the 6:0§ o'clock location with the body. Alternatively or additionally _* visible markings 412 ma consist of metric o imperial ruled markings for ease of sample length measurement, and may also be radio-opaque or embossed with individual transfer magazine mtrabers to distinguish multiple magazines from each, other. Par or all of a transfer magazine 27 ma comprise or be formed of transparent material, so as to enable direct visualization y the user of the obtained specimen, A transfer ma zine 27, according to embodiments, may be lucent to other imaging .modalities, such as MM, for example. The vacuum holes disposed along die length of the elongated tube 422 are visible in this view at 416. I an embodiment, features may be included within a transfer magazine 27, for example on. outer tube 402, thai could be configured to magnify and/or illuminate the acquired specimens. Fin-like extensions 4.18 may be provided, to enable an. opened transfer magazine 27 to lie in a stable manner against a flat surface. Such fins may be asymmetric relative to each other to aid in. stabil ity of the device when placed upon an unstable or irregular surface. A transfer magazine may be provided with snap or interference fittings 420 to enable a magazine 27 to he manually opened and dosed and reopened _' 'xeclosed.

[0131 } ^' According to one embodiment _^ a tissue biops method may comprise performing coring / biopsy / transport cycles as described above. Thereafter, removin a transfer magazine and/or proceeding to marking and/or ^' treatment phases may complete the procedure. A transfer magazine may then be removed and, if desired, placed ^' under -ftay, magnetic resonance imaging and/or ultrasound transducer or high-resolution, digital camera- if a transfer magazine is made of tmnspareni mat ial. Th core ti sue Specimens may then e -hinged/recorded. The magazine may then be placed in a delivery receptacle, sealed and delivered to a lab for further analysis, making note of core lengths and -correlating with imaging record(s) in-sttu and ex-vivo. Upon removal of transfer magazine 27 fro the present biopsy device, the collected cores may then be visually inspected through the transparent walls of a magazine. The magazine may then be split open to .manually handle and analyze the tissue specimens as desired as well as to collect an .fluids- or ceils for cytologic analysis. The magazine may then be closed again, with the specimen, therein.. ί 32} A transfer rnag. azine 2? may then be re laced with additional empty transfer magazine(s) as needed, to complete the biopsy procedure. Alternatively,, other, cartridges / magazines may be fitted to the present biopsy device to deliver medications, markers and/or tracer elements, _, therapeutic -agents, or therapeutic and or cosmetic implants to the biopsy site. Still other devices for imaging or therapeutic purposes ma also be placed into the device In place of a transfer magazine, as desired and according to embodiments. The procedure may then/be terminated, or continued, such as would be the case should the practitioner desire to biopsy /cote other nearby areas as deemed clinically useful.

[01331 As shown, a device 10 with a outer sheath 512 with a scalpel-like distal end may be gently placed in proximity to or through a lesion, or may be forward-fired through the lesio using the internal mechanism of device 10, according to embodiments. Clinically and procedurally, the -ability of a biopsy device to advance gently towards a target lesion provides several advantages, indeed, when a biopsy device does not advance gently toward a target lesion or does not smoothly core through dense target tissue, the operator may be led to exert excessive force onto the biopsy device, thereb potentially forcing- the biopsy device into and even through adjacent structures. There have been instances of biops device components being broken off, requiring surgical removal thereof from the biopsy site when excessive torce was needed in attempts to obtain core samples from tissues such as dense breast tissue. The present method of introducing a sharpened scalpel-like scoopula, with the withdrawn and closed beaMs) configured in a penetration mode according to one embodiment herein and provided for with a specific cycle stage in th biops device 10 of Fig. t, enables a operator to gently and smoothly approach a target lesion without requiring excessive manual axially-directed force to be exerted o th present biopsy device, by the operator or by the stereotacti c table itself, if used, ft is to be noted thai when excessive feree must be exerted to advance conventional coring: devices through dense tissue, the resultant image provided by guidance modalities may be significantly distorted by the effects of the applied force onto the conventional coring device and transferred to the surrounding tissue, which may cause the resultant image to be less distinct or blurred, which, in turn, makes the biopsy procedure less accurate and much more difficult technically. This excessi ve force may also damage tissue, resulting in loss of tissue architecture and production of the aforementioned biopsy artifact. It is m important -goal of ail core biopsy procedures to irmly establish that the core sample is taken: from the highly specific image area, notwithstanding the constraints imposed by th small dimensions of the target tissue. Such small dimensions, therefore, require clear views of sharp margins to attain the kind of accuracy desired.

|1I34| Flush and liquid/solid materials delivery meeharnsms may be irieor or ted into the biops device I Q, accordiag to embodiments, to aid in tissue specimen transport to t e transfer ma axine 27, Such mechan sms may consist of the distal tube socket. / flush port 603 of Fig. 23, which may deliver Hus fluids to the distal end of the device between the distal and proximal sheaths,, or. similarly with another ^' analogous port between the distal sheat and outer sheath 512, with- flush fluids being connected t th device through port 638 of Fig. .26 A _* for example. Flush fluids and other materials may also be delivered to the tissue site through the central lumen of the device, with he&fcfs) closed (as described for liquids under Fig, 5 above through the living hinge slots) or open,, using the aspiration port 639 shown i ; Fig, 26 A or through a transfer magaz ne 27 of Fig. 1 above, according to embodimen s.. Flush fluids may also be delivered to the distal tip through ports in the collar 593 of the distal sheath sho n in Fig. 20 above. As previousl described, fluids, solids and other materials may be delivered to the tissue site through the central l umen of the device and various slots and echanisms such as the open beafc(:s) may be used in conjunction with . flush iuids to gather and transport cells and liquids from the tissue she for later cytologic*! analysis.

135j Fig. 27 A is a first view of a stereotactic: table adapter for a biopsy device, accordin to one embodiment Fig. 27B is second view of a stereotactic adapter for a biopsy device, according to one embodiment, in Figs, 27 A and 2711, reference 270 denotes some type of generic interventional device. Reference numeral 278 represents the distal end of the excisions! device, whereas numeral 277 represents the proximal end of the generic de vice 270. For example, 277 may represent a source of vacuum. The distal tip of 278 may be provided, for example, with a monolithic beak assembly, a described and shown herein. The excisional device 270 may rest upon stereotactic platform 276, which may be coupled to th stereotactic table stage. According to one emb diment, aft exeisionai device according to one embodiment o most an excisiona! device may be coupled to the stereotactic platform 276 through one or more capstan assemblies 272, 274, One or more of the capstan assemblies 272, 27 (or windlass assemblies, by virtue of their horizontal axes), may be provided to enable the user to change the orientation or angle of attack of the excisional device 270 relative to the platform 276 and thus relative to the stereotactic table stage as well. The capstan assemblies 272, 274 may be, according io one embodiment, secured to both fee excisiona! device 270 and to the platform 276. That depending upon the orientation of the constituent elements hereof, the capstan assemblies 272, 274 may enab le one or both ends of the excisiona! device 270 to be moved along the x- plane (e.g., up aid/or over a device penetration axis along z). lit so doing, the proximal end of the excisiona! device may be raised and or moved off-cente relat e to the platform 276, by manipulating the capstan assembl 272. Similarly, the distal end of the excisiona! device may be raised and/or moved off-center relative to the platform 276 by manipulating the distal capstan assembly 274, Both, the proximal and the distal ends of the excisiona! device 270 ma be raised or moved off center, either i the same or different manners. This enables flexibility and ¾e-graineti control of the orientation of the excisiona! device 270 independently to the orientation of the stereotactk table stage, or in contraction with it, as small adjustments in the orientation of the proximal end of the device have a correspondingly larger effect at the distal end (i.e., working end) of the device 270. In turn, tins ^• ma -enable the user to exert great control of th location within the body from which the samples are cored and severed (or ablated, dissected, etc., depending upo the nature of the excisiona! device 270).

|« 36| During operation, the user may adjust the orientation of the device 270 by turning a actuator such as ship's heel 271 of the capstan assembly 272 in either of the directions indicated at 273 and/or by turning ship's wheel 279 of capstan assembly 274 in either of the directions- indicated at 275. The capstan assembl 272 may be operated. Using other forms of actuators. Moreover, such an actuator need not be operated by rotation, as ts the ship's wheel 279 shown and described herein, as those of skill i this art may realize. By turning the ship's wheel 2Ί9 i this manner, the user may selectively move the proximal end of the device and or the distal end thereof up and off-center (relative to its I ni tial centered position shown, in Figs,. 27 A and. B _* pl37j Fig, 27C s a side cutaway view of a platform, suitable for a. stereotactic table stage, on which an excisiona! device 270 may be coupled according to one embodiment. As showu, the p!alfomi, similar rs feficttou t element. 27 of Figs. 2?A and 27B may comprise an upper adapter plate 360 and a lower adapter plate 358. The lower adapter plate 358 may be coupled, at 36 , to the stereotactic table stage 364. The lower adapter plate 358, therefore, may he held immobile with respect to the stereotacti table stage 364. T!ie upper adapter plate 36 may be movably coupled to the fixed lower adapter plate 358 through, for example, two or more pivot arms 357. Therefore, the upper plate 360, to which, the excisiona! device 270 is fixed, may move relative to the lower adapter plate 35¾. _: As sho s:, each end of the upper adapter plate 360 (and thus the exciskraai device 270) ma move somewhat .Independently of the other d of the -upper adapter plate.

| 0! 3S| As shown in Fig. 27C, each of the upper and lower adapter plates comprise descending extensions with the lower adapter plate 358 comprising the inner descending extensions and the upper adapter plate 360 comprisin the outer descending extensions that are generally parallel to the descending extensions of the lower adapter plate 358. Accord ng to one embodiment the capstan assemblies 272, 274 of Fip. 27 A. and 27C ma be fitted in the space between the descending extensions of the upper adapter plate 360 and the descending extensions of the lower adapter plate 358. According to one embodiment, the capstan assemblies 272, .274 may be fitted over respective central pins of the lower plate 358 such that the ship's wheels 271. 279 ate coupled to the descending extensions of th lower adapter plate 358. According to one embodiment, and as is described further relative to Figs. 28A-0, rotation of the ship wheel 271. 279 thus moves the upper plate 360 (and thus the excisionai device coupled thereto) through its Ml range of motion as the fixed central pi .355 of the lower plate .358 is acted upon by an outer wheel of the capsta assembl 271, 279. In such so embo iment* the ship wheels 271,279 are placed well below the biopsy device 27 ^' G, and thus such a system of upper and lower adapter plates may be fitted to and osed with any existing stereotactic biopsy device since this embodiment merely fits between and mates to both a biopsy device 270 and a stereotactic table stage 364, as well as with the biopsy device of the present disclosure.

Ϊ§ 39| The stereotactic devices commonly encountered today take a series of biopsy samples starting with an initial sample, with subsequent samples being taken by manually rotating the outer sheath of the distal end of such devices hi a. manner so as to sample "around the clock." The capstan assemblies 272, 274 allow for additional movement of any stereotactic biopsy device in a greater range of motion, than is currently available through the use of the stereotactic table stage controls for x _; y and z placement of e: de vice. Of note als is that the proximal and distal capstan assemblies 272, 274 may not only be rotated in synchronism, with one another but also may he rotated differentially relative to one another* such that angles can be obtained hi addition to displacement. Such movement may he accomplished by manual manipulation but may also be directed by software executing within a stereotactic biopsy device controller. The abilit to rotate the two capstans 272, 274 independently or i synehronieity enables an. interventional radiologist to gala access to otherwise difficult anatornkal locations without .repositioning the breast, for e m e _* In effect, the addition of one or more ca st n assemblies 272, 274 acid polar coordinate orientation capability to an. otherwise■Cartesian-restricted machine., and vice versa.

{0.1 0] Fi s, 28A thtoiigh :28D show one emb di newt of a capstan, assembly, such as shown at 272 and 274 in Figs, 27A-C. As shown in Fig. 28A, a capstan, assembly 272 may comprise a ship's wheel 271 fitted with extending prehensile features 372 around the ■circumference thereof to enable the user to easily turn the ship's wheel 273 about a central pin of the lower adapter plate 358 of Fig, 27C, for example,, which Is configured to fit within central well 370, to ena l the ship's wheel 271 to rotate thereabout- The ship's wheel 271 may comprise a wheel guide extension 374, disposed between the central well 370 and the outer circumference and substantially parallel to the wheel central well 370, A notched inner washer 375 may fit over the wheel wel l 370, such that the wheel guide extension 374 fits within the notch of the inner notched wheel 375. A spiral path element 376 ma then be disposed over the wheel guide extension 374 such that the wheel guide extension 374 fits within the spiral pathwa 377 disposed withio the spiral guide element 376, as shown in the top view of Fig. 2SB,

| 41 J As shown in Fig. -2-8C when the ship's wheel 271 is rotated relative to the spiral guide element 376, the wheel guide extensio 374 travels within the spiral pathway 377 defined within the spiral path element 376, which may be coupled to the upper adapter place 360 of Fig. 27C fo example, i so doing, the spiral guide element. 376 is shifted away from the substantially centered configuration shown in fig. 28C to the more eccentrically-disposed configuration, shown in Fig. 2 D _f That is, when the wheel guide extension 374 is disposed within the spiral pathway 377 closest to the central well 370. the spiral path element 376 is substantially centered on. the ship's wheel 370, as shown in Fig. 2SC, In this configuration, the upper adapter plate 360 is in first, initial configuration. As the ship's wheel 271 is turned and as the wheel guide extension: 37 travels withm the spiral pathwa 377, the spiral path element 3 6 deviates more and more from its initial centered position to an eccentric position relative to the wheef well 370, as shown at Fig. 28B. At its outermost position within spiral pathway 377, the wheel guide extension 374 forces th spiral path element 376 some distance in the x~y plane (see Fig. 27A), to thereby force the uppe adapter plate 360 to correspondingly move the same amount along the x-~ y plane. The amount of eccentricity of the -spiral path element (and thus movement of the upper plate 360 relative to the lower plate 358) m y be readily adjusted by the aser b fine-tonfeg the taming of the ship's wheel 271, as well as by simultaneously numipolating either or both capstan, assemblies with the stereotactic table stage x, y,.z controls as described above in paragraph 62.

| 142| Turning now back to embodiments of the present excislonai device, it is to be noted that, herein, the phrase "he-Heat element" ami the terms "helix" or "helices" are intended to -encompass a broad spectrum of structures., indeed, the structures shown herein are but possible implementations of a helical element, helix- o helices. According to other embodiments, "helical element", 'liefix' of "hel ces ^' ' arid equivalent expression rimy be implemented as tubes having one or more slot-shaped openings or fenestrations along. at least a. portion of the length thereof Such fenestrations may be substantially parallel to the longitudinal axis of the tube or ma be disposed, for example, in spiral configuration. The fenestrations may be continuous along at least a portion of the length of the tube or maybe discontinuous, such, as to result in a plurality of such parallel or spirally wound fenestrations. The fenestrations may be very wide such that the resultant structure- ^· resembles a spring, or more narrow, such that the resuliing structure more closely resembles a tube having narrow,, slot-shaped openings therein, Th eontiuuous or diseoutinuous fenestrations ma he caused to assume other configurations along at least a ^■ portion, of the t bes in which they are formed. For example, the fenestrations may be caused to form a zigzag pattern such as "NNNN...".. "ΛΛΛΛΛΓ or "WW..." or a cross-shaped, pattern, such as ^' "ΧΧΧΧΧ' Significantly, he terms "helical element", "helix" or "helices" should be understood to cover a spectrum of structures, from spring-like structure s shown in Figs. 2-14, to tubes having selected slot-shaped openings, examples of which- are shown i Figs. 17A.-22,

| 43| Figs. 29A-29D show structure- of another embodiment of an excisionai device according to one embodiment. As shown, the structure referenced by numeral 280 of Fig. 29 A may replace the first helical -element described above and may discbarge, together with the proximal sheath shown at 284 in f ig, 29B, the tissue transport &»etiot ity. That is, the helical element 280, which ma rotate independently of the work elemeni(s), urges the cored, and severed specimen from the distal portion tiiereof to the transfer ^' magazine 27. As shown, the helical element 280 may be formed of a hollow tube in which one or more slot-shaped openings or fenestrations 282 may be defined. Such fenestrations 282 may be continuous or discontinuous, non-overlapping or overlapping. In the implementation shown in Fig. 29 A, a plurality of fenestrations 282 (which may foe laser-cat from the tube fo ing the proximal sheath), ar disposed In a generally spiral configuration. Other configurations are ossi le.

f§J44J Fig, 2 B shows one embodiment of a proximal sheath 284 of ail excisional device accord mg to one embodiment The proximal sheath may discharge a dual ftmctlon of actuating the tewdon actuating element 469 (if conf ure as in. Fig, .19) through differential motion thereof with the body portion 428 (Fig. 1.9), as well as working In concert with the helical element 280 to transport the cored and severed tissue samples proximally toward the storage or transfer magazine 27. The proximal sheat 2:84 may be conpled to the body portion 428 and to die actuation element 46 of the work element as shown, for example, in Figs, 21 arid 22, As shown In Fig. _; 29B, the proximal sheath 284 may comprise one or more slot-shaped (for example) fenestrations 286. in the implementation of Fig. 29B, the fenestrations are narro slots that are- disposed I a spiral pattern,: These slots may be continuous or discontinuous overlapping or non- overlapping, of uniform or non-uniform width. Fenestrations, slots or openings of different shapes are expressly encompassed herein. As shown in Fig, 2 B, the fenestrations 2S6 may be spirally- wound around die tube, andthe direction of the resulting spiral pattern may be the sam as that of the helical element 280. However., when the proximal sheath 284 s fitted over at least a portion of the .helical element 280, die respective spiral (or other) fenestrati n patterns may b crossed such that the fenestration pattern in the helical element 2.80 cross the fenestration pattern in the proximal sheath 284 or not, depending on the relativ e axial position between these two helical, elements at any given time, as shown. In Fig. 29

i 45} According to one embodiment, effective tissue transport may be achieved when the fight balance is achieved between the resistance to tissue advancement as between the helical element 280 and inner wall of the proximal sheath 284. In order to promote the longitudinal (axial) movement of the cored and severed tissoe sample within the helical element, stopping or greatly reducing the rotation of the sample may be beneficial. As noted above, the proximal sheath 284, according to one embodiment , is fitted over at least a portion of the helical element 280, as shown end-on in Fig, 29D, Fig, 29D shows the annular space 288 formed between the outer wall of the helical element 280 and die inner wall of the proximal sheath 284. According to one embodiment a flush ma be incorporated in the annular space 288, or between the outer sheath (which may actually take the form of either a distal sheath 590 or an outer sheath 512 previously referred to in other figures, but referred to collectively as 590, according to embodiments and as shown in this figure for simplicity) and inner sheaths, to litrther facilitate tissue transport. Moreover,: a vacuum ma be drawn within at least the helical element, which raayftuther facilitate tissue transport. This enables the user to collect any fluids to enhance cleanliness during the procedure, to help, with visimiizatioa and to collect cells for cytology.. Moreover, according to one embodime _* such a flush, pathway enables the delivery o£, for example, biologically active substances ^' and/or markets. It should be noted that, according to embodiments, an inner helical element 280 ma .not be present, while other embodiments^ such as those using a split tube long monolithic beak assembly, such as previously described in Figs. ISA, 15B and ISC above, may only have two concentric tubes, which ma be considered, to be an outer sheath, and the inner long beak assembly.

I 0.146} Coupled with flash and vacuum, the fenestrations defined in the proximal sheath 284 and in the helical element 280 may enable a helical jumping'' feature and to create a reservoir of fluids surrounding the tissue, which may enable a swirling wave action to interact -with, the cored and severed tissue samples to gently push them in the proximal direction. The fenestrations in both the helical element 280 and the proslmal sheath 284, as examples of Such fenestrations or features, lessen the .respective wall surface areas of these structures and thus decrease the surface friction experienced by the cored and severed tissue sample, both of which (wall surface area and friction) impede transport. Such structures als exhibit a favorable "sealing" effect surrounding the tissues, particularly where irregular tissues might, based on thei own surface architecture, engender vacuum leaks. Indeed, the gentle urging of the cored and severed tissue samples preserves the underlying tissue architecture and delivers ¾· clinically-useful sample (e.g,, one whose tissue architecture has ot been unaeeeptahly damaged during its transport to the transfer magazine 27.

f 147j One embodiment;, as discussed above and shown relative to Figs. 29A-P, replaces the discrete, spring-like helical element with a tube 280 having one or mote slot-shaped fenestrations defined therein. Replacing a discrete helical element with the variant shown in Fig, 2 A. eliminates a separate structure that otherwise would have been required to both transmit torque and provide differential forces in a longitudinal direction for beak actuation. Moreover, eliminating .a spring-like helical .member . i favor of unitary tube in which slot-shaped (for example) fenestrations may be present reduces the parts count and eases manufacturing of the device 10, The structure of Fig. 29D comprising, the proxima! sheath 284 fitted over at least a ψ ϋτύύα. ofthe helical element 286 provides simplicity, robustness, increased actuation recision, a decreased torque .drain, and less disr ptions in the architecture of the transported tissue sample . fit 48] Accordin to one embodiment a thin outer sheath 590 may be disposed over at least a portion of the proximal sheath 284. The thin outer sheath 590, according to one embodiment, may be configured to be non~or manu lly rotating. According to one embodiment, the outer sheath 590 (shown in Fig. 29D) may be formed of or comprise, for example, polyimide. f®l49j According to another emb diment, and as shown in Fig, 20 _: , the nan* ot: difierentialty rotatin distal sheath (not shown in this Fig, 29D speci ically) may be configured t fit over the work element as shown i Pig. 19 comprising the body portion 428, the tendon actuating element 469 and at least a portion of the first or first and (if present) articulable beaks > The outer sheath 590 ma he configured to slide and fit over both the distal and the proximal sheat 584 that is mechanically coupled to the work element. In such an embodiment, the inner or first helical element ma be deleted entirely; but the helical slots previously shown in element 280 of Fig. 28 A may be incorporated into such distal sheath. The outer sheath 590, according to embodiments may cover the distal sheath to prevent, or lessen tissue wind-up during rotation. The outer sheath 590 ma also create an annular space for flush to travel forward to its distai end, depositing fl ush, ane heties* aiAieoaguiants* vasoconstrictors and the like to the very distal end of the work element; that is, to the beak or beaks and/or to the scoopula-shaped distal end of the device. The outer sheath 590 ma function to protect the beak(s) of the work element durin opening thereof, to prevent the beafc(s) from experiencing too great strangulation forces, as the beak(s) ofthe work element may be caused to move slightly proximally daring beak opening, such that the beaks open (for the most part) under the shelter provided by the outer sheath 590, The thin (e,g, _? polyraiide or thin hypotube) outer sheath also protects the tendons and the living hinge areas of the work element, as weli as the distal portions ofthe beak o beaks by removing some of the rotational resistance. Moreover, such outer sheath 590 may also provide cover and protection tor at least part of the distal sheath and proximal sheat 284 that does not flex inward with the living hinge and work elements, such that these do not snag tissues during forward excursion within tissue. Lastly, a polyimide or other material outer sheat 590 may have a naturally or coated iubrlciou surface that is highly impervious to chemicals that the excisionaf device is likely to ^' encounter and can readily be sterilized. i SO] Fi s. MA and 30B slow another embodiment of a work element according to one embodiment. Specifically , the work element 13 in. Fig,. 3GA Is similar ^' to that shown in Figs. 21 and 22 {although two beaks are shown in Fig. 30A). Attention is drawn to the proximal end of the work element 13. Therein, the body portion 428 of the work- element 13 may be meclmrilcal!y coupled to the tendon actuating element 469 at the proximal end of the work element. Note dial the tendon actuating element 469, from the embodiment of Figs. 21 and 22, is already coupled to the body portion 428 through the tendons 468, 70, toward the distal end of the work element 13. That is, the entire work element 1 may be formed of a single homogeneous material ··· such as from a single hollow tube that is (for example) laser-cot to form the structures shown in Figs _* 30A and 30B. Two beaks are shown. It is to be understood, however, thai such need not ^' be the ease, as the work element 13 may comprise multiple beaks or a single beak that acts against a non- moveable part such as a fixed trough-shaped or scoopula-shaped distal portion of an outer sheath, such as element 512 from Figs. I SA and 1 B above. fOlSl j According to one embodiment, as - shown i Figs, 30A and 3GB, the proximal, end of the tendon actuating element 46 may be mechameali coupled to the proxirnai portion of the body portion 428. Such mechanical coupling: may be configured to maintain th teiKiott actuating element centered on the cutout in the body portion formed to accommodate the tendon actuating -element 469 and/or to provide additional biasing force In the .-distal direction, as well as to aid in manaikciuiing, Que embodiment comprises resilient member 42? having one end thereof coupled to the tendon actuating element 469 and another end thereof coupled to th proximal portion of the work element 13 , Such a resilient member 427 may be configured to bias the beak or beaks of the work element 13 in the open configuration., such that sufficiently great proximaily-directe force applied to the tendon actuating element 469 tends to close die eak or beaks . Conversely, release of snob proximal ly-dlrecied force causes the. resilient membe 42? to release the energy stored during the ^' extension thereof and return to its un-extended state, thereby exerting a distaliy-directed force on the tendon actuating member 469, which causes the beak or beaks to return to its or their default open configuration.

[0151] Also shown in Fig. 30B, attachment holes 29.2 A and 292B may be provided on the body portion 428 and on the tendon actuating element 469, respectively. Such attachment boles 292 may, according to one embodiment, indicate the location of, for example, spot welds, as detailed below. ft! 53} -Fig. 31 SHOWS a distal portion of a proximal sheath according to one embodiment The proximal sheath 300, as shown in Fig. 31 may comprise a number of fenestrations or slots 304 that tun through the wall of the proximal sheath 300,, from an outer surface to the interior lumen thereof. The distal portion of the proximal sheath 30© may be configured to- .tit over aad a tach to the proximal end of the monolithic beak, assembly 13 of Figs. 30A and 30B. During assembly- of the present excisional device and as shown in Fig. 32, the attachment holes 308A and 308B of the proximal sheath 300 may be lined up wit the attachment holes 292 A and 292 B, respec tively, of the monolithic beak: assembly 13 and the proximal sheat 300 attached to the monolithic beak assembly 33 at attachment points 292A. 308A and 2-92B.. 3088. According to one implementation, the attachment point 308A of the proximal sheath 30 may be spot-welded to the attachment point 292 A of the tendon actuating member 469 of the monolithic beak assembly 1.3. Although not shown in these figures, coTOspoiidmg ^' attachment points ma be provided on the hidden side of the device. Similarly, the attachment point 308B of the proximal sheath 300 may be spot-welde to the attachment point 292B of t e body portion 428 of the monolithic beak assembly 13. As also shown in Fig. 31, the distal portion of the proximal sheath 300 may define a resilient or spring portion, as shown at reference numeral 306.

ff)f 54 Fig, 33 shows the distal portion of a distal sheath 320, according to one embodiment. The distal sheath 320 may be configured to fit over the proximal sheath 300 and the attachment point 326 of the distal sheath 320 attached to . tac ment point 310 on the proximal sheath 300, as shown in Figs. 32 and 34. For example, the attachment porat 326 of the distal sheath 322 may be spot-welded to attachment point 310 on the proximal sheath 300, as suggested in Fig. 34, The distal sheat 320 is transparency illustrated i Fig. 34, to show underlying detail It is to be un derstood that spot-welding is ho one method of attaching die constituent components of the present exdsional device to one another. Other attachment technologies may also be used, as appropriate. Once the distal sheath 320 is spot welded in place, it will rotate in synchroiiicity with the beak assembly 1.3 and proximal sheath 300, but will be able to move axially relative to proximal sheath 300, Such axial movement between the distal and proximal sheaths will positively pen and/or close the beak or beaks of monolithic beak assembly 13* as previously discussed.

015S| Fig. 35 shows one embodiment of tile present exeisional device, in a still further intermediate state of assembly. In Fig, 35, an outer sheath 330 has been fitted over the assembly comprising the monolithic beak assembly 13, the proximal sheath 300 and the distal sheath: 320, and for purposes of illustration, without the seoopula shaped exirem y that would be formed in the continuation of the outer sheath, in order to show the beaks 13 easily. For example, the outer sheath 330 ma -comprise: polyimide or may comprise or be formed of stainless steel. The outer sheath 330 may be configured, to be manually rotating, non-rotating, or at least differentially rotating with respect to the- assembly -comprising me monolithic beak assembly 13 _s the proximal sheath 300 and the distal sheath 320. That is, while the assembly comprising the assembly monolithic beak assembly 1:3, the proximal sheath 300 and the- distal sheath 320 may rotate at relatively high rates of speed (in the thousands of revolutions per minute, for example), the outer sheath 330 ma be held stationary or rotated as needed, either manually or otherwise actuated by any mechanical means.. For example, the user may rotate the outer sheath 330 few tens of degrees at a time, as and when the procedure requires, for example in sampling around the clock as previously described. The outer- sheath 330 may extend distal ly to the beaks of the monolithic beak assembly 13, may expose a greater proportion of the monolithic beak assembly 13 or may cover a significant portion of the beaks. According to one embodiment, one "side" of the outer sheath 330 may form a trough or seoopula shape and extend at least slightl beyond th distal-most tip of the beak or beaks of the monolithic beak assembly i 3, ndeed , the embodiment show and described rel tive to Figs, 29.A through 33 may comprise a single beak or two or more beaks,

10156} According to one embodiment, the outer sheath 330 may be dimensioned so as to allow an annular space to exist between the outer surface of the distal sheath, the distal portion of the monoKrhic beak assembl 13 along with the distal sheath 320 arid, the inner wall of the outer sheath 330, This annular space allows for flush to be introduced at selected stages i the procedure. The flush may provide lubrication for the rotation of the assembly comprising the assembly monolithic beak assembly 1 _S the proximal, sheath 300 and the distal sheath 320 and may facilitate the rotation and thus the transport of the cored and severed tissue specimen in the distal ^• direction. According to one embodiment, when the beak or beaks of the monolithic beak assembly is or are in the open configuration, the fenestrations or slots 304 (Fig, 31) defined in the proximal sheath 300 are not lined up with th fenestrations or slots 324 (Fig, 33) defined in the distal sheath 320. However, according to one embodiment, when the beak or beaks are actuated,, and the beaks are closing, are closed or are substantially closed, the fonestrauons or slots 324 defined in the distal sheath 320 become or are lifted up or substantially lined up with corresponding one or ones of the fenestrations or slots 304 defined tn the proximal sheath 300. in this slate, if there is flas in the annular space between the outer surface of the distal sheath 320 and the inner wall of the outer sheath 330. this flush will eater the interior lumen of me device (where die cored and severed tissue specimens are collected and ar transported). Moreover, as the flush may have been entrained into rotation in the -aforementioned annular space as the assembly comprising die monolithic beak assembly 13. the proximal sheath 300 and the distal sheath 320 rotates, the rotatin flush may enter this interior lumen- with some force and may exert that forc on any cored and severed tissue specimen therein. This flush ma act as a lubricant as well, to the specimen contained in the inner lumen of the device. According to one embodiment, a vacuum may be drawn within the interior lumen of the device. According to one embodiment, the force imparted on the cored and severed tissue specimen, together wit the force imparted on such specimen by the flush enterin this interior lumen, draws and transports the cored and severed tissue specimen in the proximal direction, for eventual transport to the transfer magazine 27, for example.

J0157) Transport may he aided by die shoulder shown at 332 in Fig. 35. Indeed, this shoulder encompasses the location define by the proximal end of the monolithic beak assembl 13 and the distal end of the proximal sheath 300, As the diameter of the proximal sheath 300 is somewhat greater than that of the proximal end of the monolithic beak assembly 13, the interior lumen of the proximal sheath 300 is correspondingly greater than the interior lumen of the monolithic beak -assembly 13. As the cored and severed tissue specimen enter the interio lumen of the monolithie beak assembly 13 , they may he some what compressed . Such compression may be somewhat relieved as the tissue specimens transition from the lumen of the monolithic beak assembly 13 to the lumen of somewhat greater diameter of the proximal sheath 300, at shoulder 332. This decompression of the tissue specimen in the lumen of the proximal sheath 300 may, together with the flush and the vacuum, also facilitate tissue transport. The shoulder at 332 could expand the inner lumen diameter in the range of 0.001 inch to 0.100 inch additional over the original lumen internal diameter or double die lumen internal diameter, whichever is greater. As previously mentioned, shoulder features ma he incorporated into the proximal sheath, distal sheath and outer sheath to augmen such, tissue xpansion/nansport action.

|0t58] Fig. 36 is flowchart of a method ccording to one embodiment As show therein, block Β36Ί calls for providing a device. According t one embodiment, the provided device may comprise an outer sheath and an inner assembly configured to be received -{at least partially) mtkm the outer sheath. The oute sheath ma define a diameter, a longitudinal axis, a proximal portion ami ma comprise a fixed, distal scoop or trough-shaped open portion _* The inner assembly may define a proximal portion, a distal portion and a body portion between the proximal and distal portions. According to one embodiment, the distal portion may comprise an articulable beak element configured to cote th ough and cut tissue. Block B362 _s as shown, calls for insetting the fixed distal scoop-shaped open portion of the biopsy device into tissue through an incision, with the articul ble beak eter eni(s) in a closed configuration relative to the fixed distal scoop- shaped open portion. As shown at B3 3, if not already open, the articulable beak, element may be opened relative to the fixed distal scoop-shaped open portion and a step of coring through the tissue may be carried out. According to oae embodiment, the articulable beak element may be rotatin during all or part of the coring. The ^■ articulable beak element may then be dosed and the cored tissue may be parted-off against the fixed distal scoop-shaped open portion, as shown at B364. The articulable beak element may be rotating during the parting-off. As previously described, the parted-off cored tissue may then be transported- i» the proximal direction within the inner assembly .

[0.159] Fig. 37 is a flowchart of method of positioning a biopsy device, according to one enibodimePt. As shown therein, Block B3?3 call fo coupling: biopsy device to a Stereotactic biopsy device assembly comprising at least one capstan assembly, One embodiment of a suitable capstan is shown i Figs. 27AC and Figs, 28A-D. The stereotactic biops device assembly may be configured to couple to a Stage f a stereotactic table. According to one embodiment, the stereotactic biopsy device assembly may comprise a first portion configured to fixedly couple to the stage and a second portion movaMy coupled to the firs portion. A first capstan assembly may be configured to couple to the second portion of the platform and to the biops device. Block B372 calls for the biopsy device to enter the tissue along the z~axi j ^■ whereupon a tissue sample may be obtained, as shown at B373. The capstan assembly may then be operated, as shown at B37 . For example, a ship's wheel (or other type of actuator) of the capstan, assembly may be turned or otherwise actuated either manually or by machine using either Cartesian or polar coordinates, within the degrees of freedom allowed by the capstan assembly. The capsta assembly may be operated entirely mannally, controlled by the user using his or her best ciimcal judgment and skill, optionally u der direct visualization. The position of the biopsy device i the x~y plane within the tissue may then be changed (changing die angle of attack f the biops device) as- the capstan assembly or assemblies is/are operated, as shown at B37S. For ■exam le,, capstan assemblies: may be used to identically or ditleienti i!y raise or lower the distal and/or proximal ^' ends of the biopsy device nd to move the biops t a position that is off-center relative to its initial position. The. biopsy device may also be rotated in conjunction, with the Movement imparted thereto by the capstan assembly or assemblies coupled thereto.

{ ^' 0160] Fig. 38 is a flowchart, of another tnethod according to One embodiment. As shown in Fig. 38, Block B381 calls for inserting a biopsy device through art incision in tissue. According to one embodiment, the inserted biopsy device may comprise an outer element comprising an open scoop wia-shaped distal portion having a sharpened edge, and an inner assembly configured to fit at least partially within the outer element and comprising a tissue coring and parting off assembly. As shown at B3S2, the biopsy device may then be advanced within the tissue to the intended biops site- 8383 calls for coring and parting off the tissue to cut a first tissue specimen front the biops site. At least the outer element may be rotated as shown at B384, while the sharpened edge of the open seoopnla-shaped distal portion cuts through an arc of tissue. According to one embodiment, the arc of tissue ma y be oriented substantially normal to the long axis of the tissue specimen. That is, according to one embodiment, the open $c¾opu!a-shaped distal portion may be rotated about its longitudinal ax s (e.g., 14 in Fig. 15B), which is norma! t the long axis of the tissue specimen (shaped like, according t one embodiment, short segments of a ni ^' pe, w it tapered proximal an d distal ends}. After rotating, one or more further tissue specimens ma be cut .from the tissue lacing the open scoopula-shaped distal portion., which lacing tissue may be radially separated from t e tissue from which the previous, pte-rotation specimen was cut.

|0ί 61 According to one embodiment, the inserting in Block B3S 1 may be carried out with, the tissue coring and part-off assembly comprising at least one articulated beak element. Coring and parting of , rotating and generating steps may be repeated as desired to generate tissue specimens at least partially "around the clock"; that is, at least partially about 360 degrees of rotation. The tis sue may be caused to prolapse or to prolapse further into the open scoopula-shaped. distal portion after the rotatin step of Block B384. Such may be carried out by, for example, imposing an axially-directed movement on the biopsy device before or after the rotating step. The cut specinien(s) may then be transported within the biopsy device away from the biopsy site. Advancing the biops device within the tissue in Block B3S2 may cause the sharpened edge of the open scoopula-shaped distal portion to dissect tissue along an insertion path. According to one embodiment, as the coring and part~otF assembly is advanced such that the distal tip thereof feces the distal tip f the open scoopnta-shaped distal portion, the coring and parting off of the tissue may be carried out with substantially :¾ero dead space at the distal tip of the biopsy device. Conversely, the tissue coring and parting off assembly may be, retracted away from the distal tip. and -sharpened edge of the ope scoopiila-shaped distal portion during the advancing and/or rotating steps or for such purposes as patting oft. a specimen thai is less than the full length of the scoopitla, as well as other purposes. Such advancing, retracting and rotating steps may be carried out stereotactieaiby Of ma be controlled- or carried, out manuall by the nser of the biopsy device. The sharpened edge of tie open scooptila-shaped distal portion may be configured to cut at an angle that is substantially normal (i.e., substantially perpendicular) to a long axis of the specimens .(generally tapered tube-shaped pieces of tissue) cut and collected by the biopsy device.

1( 16:2} As shown in the figures and as noted above, the proximal sheath 300, according to one embodiment, .may be attached to the body portion 428 as well as to- the tendon actuating portion 469 of the monolithic beak assembly 13. m turn, the distal sheath 320 may be attached to the proximal sheath 300 at attachment point 326. in this manner, rotation of the distal sheath, will e train the monolithic beak assembly and the proximal sheath 300 in .rotation also or vice versa, depending on the driving taechanism of such embodiments. Therefore, according to one embodiment, the rotation for tisane specimen transport is the same as the .rotation for specimen collection using the monolithic beak assembly. Moreover, since the interior lumen of the proximal sheath 300 may be relati vely smooth and as the interior lum thereof may be farther lubricated with flush entering the lumen through aligned fenestrations 304, 324 in the proximal sheath 300 and the distal sheath 320, the tissue specimen may be transported substantially intact (e.g., with the tissue architecture undamaged or not damaged to such degree as to hinder examination), to the transfer magazine 27 or to the proximal end of the interior lumen.

[01631 AceoMuigt one embodiment, as attachment points 326 of the distal sheath

320 are attached t corresponding attachment points 310 on proximal sheath 300, which are attached to the tendon actuating members 469, a distally-directed force applied to the proximal sheath 300 acts to close the beak or beaks of the monolithic beak assembly 13, This is because the tendon actuating members 469 are acted upon by the axial!y stationary distal sheath 320, while the bod portion of the inonolithic beak assembly 13 is held by the proximal sheath 302, at attachment points 30SB, 292B and moved axially forward, causing the beaks to close down via their living hinges. The spring or resilient portions 427 on the monolithic beak, assembly 1 , the spring o resilient portion of the proximal sheath 302 act. in concert to bias the beak or beaks in the open configuration such that* when the distally-direeied forc imparted on. the proximal sheath 300 is released, the beak or beaks of the monolithic beak assembly 13 return to their default open eontigoration. It should be noted that holding the proximal sheath stationary axiaily while exerting a proximal force on the distal sheath will produce an identical beak open/closing mechanism, and may be selected to match with a driving mechanism that will accommodate such action, as ma be envisioned by one skilled in the art

|0164J According to one embodiment,, the beak may be configured for actuation and cycling between a closed configuration (for penetration and part-off] and an open configuration (for coring and capturing tissue sample) while rotating. Such cycling between closed and open beak configurations ma he accomplished, according to one enihodinient, usin a push-pull mechanism that originates in a driving assembly far proximal to the beak structures themselves. Such a push-pull mechanism, between a proximal driver and the movable structures of the beak assembly including movement of living backbone hinge elements relative to living hinge tendon/keystone elements of the beaks,, may comprise relatively rigid structures that can transmit small movements precisely, relying on column strength structural integrity combined with reiaiively inelastic tension structures to transmit these direct, linear forces over the length between the distal beaks and the proximal driver mechanism. f ill 65] Such a driving mechanism ma be appropriate for instruments that can rely on relatively short and rigid members between the handle (driver) and the working end. However, in the event the application requires a reiaiively long flexible catheter between the driver (pro teat handle end) and the working (distal) end, use of such a simple proximal push-pull motion that must be transmitted in a linear manner along potentially tortuous pathway may present challenges. In fact, it has been determined that there are* several factors that render a linear motion mode of force transmissio alon the length of a flexible catheter undesirable, in. certain applieationSv as a wa to transmit the precise forces needed to actuate the beak mechanisms to cycle between folly open and closed configurations. This is because the distal motions may he as small as several thousandths of an inch, particularly when the catheter is forced into, around and past curves needed to gain access to a treatment site. As a result, it has been found to be advantageous to generate the push-pull forces needed to actuate the beaks locally; that is, as near the actual living-hinge backbone ar living tendon members as possible, using feces ma are less affected by flexing the catheter over or through which these forces are transmitted.

f §1.66] One embodiment of sue h a distal !y-originated beak actuation mechanism is described herein. Significantly;, one embodiment utilizes a ^■ mechanism that allows significant flexing of the catheter that contacts the driver and the workin distal, end while providing forces that mm be converted to small, precise, repeatable linear -push-pull forces locally - that is, at the distal end very near to keystone and backbone, living _, hinge and tendon elements; In so doing, such tel st ve motion causes the distal, beak to cycle between open and closed confi dura ions. This cycling between open and closed beak configurations raay be carried oat while also -enabling powered rotation of the beak elements for penetration (closed beak), coring (open beak.), and part- off' ranspoit (closed beak) operating modes, it is -also desirable to permit an open core transmission section between the distal beak elements and the storage chamber^ which may be disposed proximal to the driving mechanism. Embodiments shown herein and detailed below fulfil! these requirements, f0l67j Fig. 39 shows a twin-beak device, comprising a double beak eoring/part-oif assembly in relationship with a sheath 3902 comprising a distal scoop-shaped open portion 3903 (seoopula), according t one embodiment, fig. 39 shows an inner element comprising an articulable distal assembly 3904. in Fig. 39, the articulable distal assembly 3904 comprises two articulable -memb rs (beaks) 3906, 3908. In Fig. 40. the articulable distal beak assembly 3904 comprises a single articulable member 3910. i the embodiments of Figs. 39 and 40, the articulable beak assembly 3904 is disposed in the imtermost position within a middle tabular element 3 1.2. In Fig. 39, the two beaks 3906, 3908 are shown in distal position where they are about to be cl osed to part-off ti ssue (not shown) through whi ch they have cored white rotating and traveling m a proximal to distal direction in the seoopula, in their wide open configuration. The mechanism and method, according to embodiments, for openin the twin beaks 3906, 3908 and keeping tiierti ope -throughout the if proximal to distal excursion ma y compris e ro tating the tubular element 3912 (which is outer with respect to the inner element (that terminates distally with the articulable distal assembly 3904) and/or helical element, and inner relative to the non- or ■differentially rotating sheath 3902 and distal scoop-shaped open portion 3903) in a counterclockwise (for example) direction, together with and after holding back the rotation of the inner element only a matter of degrees such that its helical/fesilient element 3914 (seen through c rr esponding a«d eo-axia!ly-disposed helical/resilient element 3916 in the tubular elem nt 3 12), is driven back proximaliy, after which the inner element and the tubular element 3$ 1 niay rotate together until the desired closed configuration is achieved. In. this example, the living backbone (hinge) elerae»t(s) of the articulable distal assembly 3904 is of one . integral structure with its he ical/fesilient component 391 ("threaded" section, nesting m s milar, component in the ffiiddie tubular/helical "threaded" section) and has limited travel ability that Comprises both rotation relative to the middle tubular/helical structure 3916 of the tabular element 3912 and longitudinal (linear, along the long axis of the excisional devke) movement Because the keystone element of the inner element is constrained such that it may only move i a circular slot In the middle tobnlar helical/resilient structure 3916 of the tubular element 391 , which is at a finer pitch (shown here as 90 degrees to the long axis), the articulable distal members) (beak(s)) 3906, 3908, 3910 of the articulable distal assembly 3904 are necessarily open wide based on the relative linear motions imposed on keystone (attached to living tendons) and living backbone (hinge). Upon reaching the part-off .region, (or at any time part-off or oilier reason to close the beak elements is des ired) the inner-most mbe/hei ix/res lient portion 3914 of the inner element is made to '¾aich up" while rotating, to the middle nibuiar helicaL/resilient element 3916, thus causing the threaded elements of each of the tubular/helical.' 'resilient components that are threaded with each other, to return to the resting or "closed" configuration and force a linear motion, again based on the fact that the keystone element is constrained to only move at a finer pitch (In this case approximately 90 degrees to the long axis of the roughly tabular elements) than those of the threaded, elements to fully close the articulable distal assembly 3904..

f¾M8j Figure 40 shows an embodiment in which the inner element comprises an articulable distal assembly 390 comprising a single articulable member (beak) 3 10 configured to operate based on similar principles and modes of operation as were di scussed above relative -to Fig, 39, in which the articulable distal assembl 3904 of the inner element comprised two (e.g... a first and a second) articulable members (beaks), in the depletion of Fig. 40, the single articulable member (beak) 3 10 is alread at a. point where it is desirable to have it close down against the inner surface of the scoop-shaped open portion 3903 of the sheath 3902 for purposes of parting- off a cored specimen or for presenting a tapered profile to ease penetratio within tissue to a target of for other purposes such as to deliver a substance or element to a site without allowing ingress of tissue during the approach, to a target. |ϋίό9| In this case, th rotating iialer tubular/helical resilient 3914 structure ^' will

^' have been made to "catch up" (briefly accelerated in rotation) with respect to the also rotating middle tubuiar helicai/resilimt structure 3916, thereby closing the art culable distal assembly 3904 (in this case comprising single articulable member or beak 3910) down against the scoop-shaped Open portion 3903 of the sheath 3902, At that point rotation may be completely halted for beak retraction and transport "of cored speeirnen(s) and the entire sequence repeated as ofte as desired.

10170] One embodiment, therefore, is a e&cisional device that may comprise a sheath 3902; a tubular element 3912 configured for rotation with the sheath 3902 and an inner element configured for rotation and disposed at least partially within the tubular element 3912. The inner element may comprise an articulable distal assembly 3904 configured to cor® through tissue in an open configuration and part-off cored tissue in a closed configuration. According to one -embodiment, differentia! rotation of the inner element (that comprises the distaily-disposed articulable assembly 3904) with respect to the tubular element 3912 causes the articulable distal assembly 3904 to selectively assume the open and closed configurations,

(01.71 J According to one embodiment, the sheath 3902 may comprise a distal scoop-shaped open portion, shown at 3903 in Figs. 39 sad 40. Rotating the inner element comparatively faster than the tubular elemen may cause the. -articulable distal assembl 3904 t assume the closed configuration.. Conversely, rotating the inner element comparativel slower than the tubular elemen 3 1.2 may causes the articulable distal assembly 3904 to assume the open configuration. In. one embodiment* the articulable distal assembly 3904 may comprise a single articulable member 3 10 that may be configured to bear against the sheath 3902 when the articulable distal assembly 3904 is in the closed configuration, in another embodiment, the articulable distal assembly 3904 ma comprise a first, articulable member 3906 and a second articulable member 3908. The first and second articulable members 3906, 3908 may be configured to ear against each other when the articul ble distal assembly 3 04 is i the closed configuration. As noted above, the amount of the ^■ differential rotation of the inner element with respect to the tubular element 3912 is limited. Indeed, the artic lable distal assembly 3904 may be mechanically coupled to the tubular element 3912 so .as to allow a limited amount of differential rotation of the tabular element- 3 12 relative to the inne element. This limited amount of differential rotation of the tabular element relative to the inner element, however, is sufficient for the articulable distal assembly 3904 to selectively assume the open and closed configurations. The- inner element may lie configured to comprise a first resilient portion 3914 and the tabular element 3912 may b configured to comprise a second resilient portion 3916 that may be mechanically ^■ coupled (or at least constrained in its relative movement with respect) to the first resilient portio 3914. Operationally, -differential rotation of the inner element with respect to the tubular element may comprise the inner element lagging in rotation relative to the tabular -element and/or the inner element leading in rotation relative to the tabular element. 0172] Fig, 41 is a flowchart of a method according to one embodiment As show tirerein, block; B4l I calls for providing a device eoHtprisJng a sheath, a tubular element configured for rotation within the sheath, and an inner element comprising an articulable distal assembly configured for rotation and disposed -at least: partially within the tubular element Block B4.1.2 calis- for coring through tissue with the articulable distal assembly in an open configuration. In block 8413, the cored tissue may he parted off with the articulable distal assembly in a closed, configuration- Lastly, 8414 calls for differentially rotating the inner element with respect to the tubular element to selectively control the articulable distal assembly to assume the open (block B 12) and the closed: -configuration, (block B4.13),

|0173| Significantly, the coring and transport mechanisms and methods described and sho n, herein are configured to apply traction while coring, as- the bea¾s) either close against the seoopala. If one beak is used, or against each other if dual beaks are used and are then withdrawn to its or their resting position within the proximal edge of the scoopu!a opening, carrying the tissue specimen with it or them.. That is, coring, cutting, parting-off, traction and transport may be, according to one embodiment, carried out simultaneously. I so doing, as traction is a plied during a cutting event, the cutting event is not only rendered more efficient, hut ma be the only way to successfully cut certain tissue types. This traction, according to one embodiment, is facilitated by the continuous interaction of the helical elements), the tubular coring and transport assembly, and the flush and aspiration, depending on embodiments, which all or separately act together to provide gentle continuous traction beginnin immediately upon die tissue entering the lumen of the tubular coring and transport assembly 11 of Fig. 1 and continuing during part-off of the tissue specimen- According to one embodiment, the ratio between the twisting and pulling actions may he carefull controlled by, for example, control of rotation versus crank or cam speed, or other axial control mechanism. According to one embodiment, when the beak assembly is open wider than the Inner lumen of the tubular coring and transport assembly, tissue is drawn in by at least the syffece tfeatajent(s) ₅ channels, and helical elements past the sharp beak assembly and into ^' the interior lumen of the tubular coring and transport assembly. This may be, according to one embodiment, augmented with either flush or vacuum or both. However, it is to be noted that the transport mechanisms and functionality described herein is more effective limn vacuum alone, as vacuum predominantly acts locally at the proximal surface of a specimen, indeed, the transport mechanisms described and shown herein {e.g., surfac treatments, rifling, vacuum slot , helical elementCs), and the selective rotation of these) m y be configured to act along the entire length of the sidewalls of the tissue specimen, which may be useful in transporting certain tissue types. Vacuum,, according to one embodiment,, may well augment such tractio and transport but need not be the primary modality by which tissue specimen are drawn ptoxirna! y or materials are pushed distaily to the target lesion site. According to one embodiment, vacuum may be used for extracting cells, bod fluids and flush fluids, and to prevent the ^■ inadvertent injection of outside air, which may obscure an ultrasound image or transfer other unwanted elements into the body ,

|0:I74| The present biopsy devic may be farmed! .f or comprise one or more biocoiBpatible materials such as, for example, stainless steel or other biocompatible alloys, and may be made of, comprise or be coated with polymers,, suc as polyimide, ami'or biopolymer materials as needed to optimize funciion(s). For example, the catting elements (such as the constituent elements of the beak assembly 13) may comprise or be made of hardened alloys and may be additionally coated -with slippery material or materials to thereby optimize passage through Irving tissues of a variety of consistencies and frictions. Some of the components may be purposely st.r¾ce-¾reated'di¾rentia with respect to adjacent components, as detailed herein in reference to the transporting tubular and storage co nponents, The various gears or pulleys may be made o an suitable, commercially available materials such, as nylons, polymers such as mo!dabie plastics, and others., if used, the motor powering the various powered functions of the present biopsy device may be a commercially available electric DC motor. The handle of the present biopsy device may likewise be made of or comprise inexpensi ve, injection-molded plastic or other suitable rigid, easil hand held strong and light-weight material. The handle may be configured in such a way as to make it. easily adaptable to one of any number of existing guiding platforms, such as stereotactic table stages,. The materials used in- the present biopsy device may also be carefully selected from a er omagnetic standpoint such that the present biopsy device maintains compatibility with RI equipment that is conrnio y used for biopsy procedures. The- vacuum/delivery assembly components may comprise commercially available vacuum pinups, syringes and tubing for cotineciiag to the present biopsy device, along with readily available reed valves for switching between suction and emptying of materials such as fluids, whic may be suctioned by the vacuum components. The fluids collected by the embodiments of the present biopsy device in this manner may then be ejected into an additional external, yet portable, liquid storage vessel connected to the tubing of the- present biopsy device* for di scarding or lot safe keeping for laborator cellular analysis.

[9175] The power source may comprise an external commercially available AC to

DC transformer approved for medic l device use and plugged into the provided socket In the present biopsy device, or may comprise an enclosed battery of any suitable and commercially available -power source. The battery may fee of the one-time use disposable (and optionally recyclable) variety, or may be of the rechargeable variety. Additionally, other power sources, for example, mechanical linkages or compressed air motors, ma be used.

f 0176j The cutting beak -assembly of embodiments of the biops devices may be used, without alteration of thei shape, attachment or any other .modification, to penetrate tissue an approach to a target lesion. The cutting beak asse bly ma then be used to open and core the tissue specimen, and to t reafter part-off the specime at the end of the coring stage. The beak assembly ma also be nsed to hel augment transport of the collected, specimen. Having Such multiple functions integrated in a single device saves valuable cross-sectional area, which in turn creates a device that has a minimal outer diameter while, providing the maximum diameter core S8mp Maximizing the diameter of the core sample is believed to be significant from a clinical standpoint, since it has been demonstrated in multiple peer-reviewed journals that larger diameter core specimens yield more accurate diagnoses. The clinical desire for large diameter core samples, however, must be balanced against the trauma associated with larger caliber devices. Embodiments optimize the ratio so that the clinician can have the best of both worlds.

[0177] Advantageously, according to one embodiment, an internal helical transport system may be eonfiguredto augment the coring functio of the forward cutting beaks. The helical, transport coring elements may be configured to appl gentle, predictable traction, on the cored specimen, during and after coring, which permits pairing the ideal speed of longitudinal excursion of f he coring elements of t present biopsy device with the idea! speed of rotational movement of the same decreets, ^" in this manner, the architecture of the collected specimen is less likely to ^' be disrupted during transport, ^' It has been shown in peer-reviewed scientific articles that presetting tissue architecture (i.e., preserving the architecture of the tissue as it was in vivo) to the extent possible leads to a easier and more accurate diagnosis. The present vacuum delrv ery mechanism may be configured to enable the force of vacuum to be exerted directly to the coring transport components, such that coring and transport of the specimen is handled as delicately, yet as surely, as possible and comprises noo-signifieantly dimension nereasi«g components such as progressively sized fenestration features within collection magazine areas, if the present biopsy device were to rely solely on vacuum for tissue transport, then vacuum artifact, which is a known and described phenomenon associated with -conventional biopsy devices, might be present to a greater degree than is present (if at all) in -embodiments, described herein. On the other hand were embodiments of the present biopsy device to rely solely art a physical pushing or pulling -mechanism to retrieve cut specimen .samples- crush, artifact might he mor promineni than is otherwise present when embodiments of the present biopsy device and methods are used.

[0178] The internal surface treatments of an outer tube and hollow, helical inner component, when acting in conceit, move materials in a variety of phase stales along longitudinally without the need for complex components that would otherwise contribute substantially to the outer calibe dimensions of the present biopsy device . Embodiments comprise a hollow helical transport mechanism that may be both strong and flexible, which continues t function even when distorted by bending. Conventional biopsy device typically cease to function properly if distorted even, slightly.. As such, the present biopsy device may be configured to define a curve along its longitudinal mis and would still .function, properly, -with minimal modifications.

l79j Advantageously, a biopsy and coring device, according to embodiments, comprises features configured to perform medical core biopsy procedures or for shaping (such as for vascular applications) or harvesting tissue for other uses. These features comprise structures configured for penetration, coring, part-off, transport and storage of core specimens for medical purposes such as diagnosis and treatment of a variety of diseases and. abnormalities, integral and detachable components may be provided and configured to aspirate fluids for cellular analysis as we ^' ll as deliver agents at various selectable stages of the procedure. The present biopsy device may be .selectable, for automatic - and/or semi-automatic function:, may be used with or wi thout image guidance, and may fee comp tible with a variety of g idance ^' imagin m^ n nt suc a ultrasound, magnetic resonance imaging and X-ray imaging. The present biops device may be configured ^' to be disposable and/or recyclable, highly portable, and delivered for use i sterile packaging, typical of medical devices ^' having contact with internal body structures. The present biops device may be configured to be minima l invasive. As embodied herein, the presen biops device comprises several features that may be therapeutic in nature, to be utilized at various stages along the diagnosis/treatment pathway.

(OJ.80J While certain embodiments of the disclosure have been described, these embodiments have been presented by way of example only, and are not intended to limit the scope of the disclosure.. Indeed, the novel methods, devices and systems described herein may be embodied in a variety of other forms and other applications. For instance, the monolithic beak structures with living hinges, tendon actuation mechanisms and attached actuating sheaths and other mechanisms described herein may find use on a different scale for such applications, suc as robotic arm manipulation and collection systems, so that such a robotic arm would be capable of picking up an object or material, If desired, As another exam le _* the cam and cam follower configurations described in Figs, 23-26 V ma find applications such as for interna! combustion ^• engine- valve configurations, wherein an overhead cam of a special shape acts on a valve stem or extension of a valve stem for instance a domed or other shape. Following the discussion outlined in these last referenced figures, it niay be seen that the valves on an internal combustion engine may be extremely finely tuned with respect to dynamics such as initial or staged acceleration/deceleration during opening and closing of the valves. All such other applications makin use of the principles disclosed herein for this device and that could be env sioned by one skilled in the art are there-fore considered to be within the scope of thi s disclosure, ^' Fasr hersiore* various omissions, substitutions and changes in the form of the methods and systems described herein may be made without departing from the spirit of the disclosure. The accompanying claims and their equivalents are intended to cover such fortns or modifications as would fall within the scope and spirit of the disclosure. For example, those skilled in the art. will appreciate that in various embodiments, the actual physical and logical structures and dimensions thereof may differ from those shown in the figures. Depending on the embodiment, certain steps described in the example above may be removed, others ma be added. Also, the fe tures and attributes of the specific embodinients disclosed abov ma be combined m difiereM ways to form additional em odiments, all of which fall within tfci scope of the present disclosure. Although the present .disclosure provides certait) preferred embodiments and applications, other embodiments thai are apparent to those of ordinary skill in the art, including embodiments which do not provide all of the features and advantages set forth herein, are also within tire scope of this disclosur ; Accordingly, the scope of the present disclosure is intended to he defined only by reference to the appended claims.