DEVICES FOR ASSEMBLING STRANDS COMPRISING RADIOACTIVE SEEDS

DEVICES FORASSEMBLING STRANDS COMPRISING RADIOACTIVE SEEDS

[0001] This application claims benefit of priority of U S patent application filed on June 29, 2007 and accorded number 11/771,741 of which is entirely incorporated herein by reference

[0002] The present invention is directed generally to medical devices and methods Moie particularly, the present invention is directed to cartridges, assemblies, and methods for dispensing items for strands comprising at least one of radioactive seeds, non-radioactive spacers, and connectors, for brachytherapy as well as methods for assembling the strands,

[0003] Cancel patients in need of brachytherapy require certain treatment regimens, i e , a discrete number of radiological seeds arranged in a defined configuration, For example, different numbers of seeds may be required depending on, e g , the size of the patient, the nature of the tissue in which the seeds are to be implanted, and the type of cancer being treated In the past, very little (if any) flexibility was provided in assembling strands of brachytherapy seeds That is, a certain number of seeds were provided to the health care provider in a standard configuration regardless of the needs of the patient The devices and methods disclosed herein are suitable for treating a number of different types of cancer, especially tissue tumors For example, the devices and methods can be used to assemble strands for insertion into the prostate gland to treat prostate cancer or the breast to treat breast cancer [0004] With the advent of specialized brachytherapy, the need has arisen foi cartridges, assemblies, and methods for dispensing items for strands of radioactive seeds, connectors and, optionally, non-radioactive spacers in accordance with defined, specialized treatment plans It may also be desired to provide such cartridges, assemblies, and methods with added functionality Such added functionality may include methods for detecting an empty cartridge and preventing actuating of the empty cartridge, and with the ability to dispense such items without

ciushing 01 otherwise deforming them Such added functionality may also include providing such devices and methods with manual methods foi detecting assembly enois to ensuie an appropriately assembled device Such devices and methods could provide for a more efficient brachytherapy ptoceduie, at least because the procedure could be performed in leal-time

[0005] In various aspects, the present disclosure is directed to a device for assembling a stiand of radioactive seeds, The device may include a catiiage portion configuied to receive a plurality of cartridges, a selector slidable in a diiection perpendicular to the longitudinal axis of the device, and a track configured to receive a plurality of ^' biachytherapy elements. The selector may be operable to select one of the caitiidges An actuator may be configured to eject a seed, connector or, optionally, a spacer from the selected cartridge to the track, and a combiner may be slidable relative to the carriage poition and operable to combine a plurality of seeds and connectors into a single stiand

[0006] In some aspects, a device for assembling a strand of radioactive seeds may include a selector assembly operable to select at least one of a radioactive seed, a non-radioactive connector, and a non-radioactive spacer, a track configuied to receive a plurality of seeds, connectois, and spacers, an actuator ¹ configured to eject either a seed, connector, or ¹ a spacer from the selector assembly to said track, and a combiner configured to combine a plurality of seeds, connectois and spacers into a single stiand

[0007] According to various aspects, a system fbi assembling a stiand of radioactive seeds may include a housing having a pluiality of receptacles for a plurality of the carti idges described above Each of the cartridges may be associated with one of the receptacles At least one of the cartridges may contain radioactive seeds, and at least one of the caitiidges may contain non-radioactive spaceis, and at least one of the cartridges may contain non-iadioactive connectois The track may be configuied to receive a plurality of the radioactive seeds, non-iadioactive connectors, and non-

radioactive spacers, and an actuatoi may be configured to eject either a seed, a connectoi, oi a spacer from the selected cartridge to the track [0008] In other aspects, the present disclosure is directed to certain particular aspects of the caitridge described above A cartridge comprising a housing configured to contain a plurality of like items and a track inside the housing according to the invention is described herein The track extends in a first direction, and a plungei may be slidable along the track in the first direction and configured to urge the items toward a first end of the housing The cartridge may include a gate attached to the housing The gate may be movable between a first positron preventing the items from being removed from the housing and a second position allowing one (oi more) of the items to be removed from the housing The gate may be configured to remove the one item(s) from being urged by the plunger ¹

[0009] According to some aspects of the disclosure, a dispensing assembly may comprise the aforementioned cartridge and a rotatable camming member comprising a surface associated with a cam follower The camming member may be configured to cyclically move the gate from the first position to the second position and allow the gate to move from the second position to the fust position

Brief Description of the Drawings

[0010] F oi the purposes of illustrating the various aspects of the invention, there are shown in the drawings forms that are presently preferred, it being understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown

[0011] FIG 1 is a perspective view of an exemplary assembling device in accordance with various aspects of the disclosure

[0012] TIG. 2 is a side view of an exemplary part removal assembly and caitridge of the assembling device of FIG 1 ,

[0013] FIG 3 is a magnified view of region A of FIG 2

[0014] FIG 4 is a perspective view of the part removal assembly of FIG 2

[0015] ϊIG 5 A is a side view of an exemplaiy compiession mechanism of the assembling device of FIG 1

[0016] PIG 5B is a partially cut-away end view taken fiom line A-A of the exemplaiy compiession mechanism of the assembling device of FIG 5A

[0017] FIG 6 is a cut-away bottom view of the compiession mechanism of FIG 5

[0018] FIG 7 is a top view of an exemplaiy carriage assembly of the assembling device of FIG, 1

[0019] FIG 8 is a side view of the exemplary caπiage assembly of the assembling device of FIG 7

[0020] FIG 9 is a side view of an exemplaiy cartridge in accoidance with vaiious aspects of the disclosure.

[0021] FIG 10 is a side view of the cartridge of FIG 9 in a different configuration

[0022] FIG 11 is a front view of the cartridge of FIG 9

[002,5] FIG 12 is a peispective view of the cartridge of FIG 9

Detailed Desciiption

[0024] Accoiding to various embodiments, the devices disclosed herein aie used to assemble strands of biachytherapy elements such as, for example, radioactive seeds, non-radioactive spacers, and non-radioactive connectors. Radioactive seeds comprising, e g , Pd ¹⁰³ and I ¹²⁵ , are well-known and commercially available For example, I ¹²⁵ seeds suitable for brachytheiapy are obtainable from Bard Brachytherapy in Carol Stream, IL Non-radioactive spacers are typically appioximate the size and shape of radioactive seeds They can be constructed of a variety of different materials such as, for example, aluminum, polypropylene, and bioabsoibable materials In accordance with certain embodiments, non-iadio active spacers are optionally included in strand assembly Non-radioactive connectors are configured to join any combination of seeds and optional spacers in end-to-end configurations to form a stiand, which in turn is configured foi insertion into a biachytherapy needle for delivery to a tumor, such as a tumor ¹ in a prostate gland or a

breast. Suitable connectors include those disclosed in U S. Patent No. 6,010,446 to Petei Giimm, and those disclosed in U. S 6,969,344 to Drobnik et al (the disclosuies of which are each incorporated by reference herein in their ¹ entirety). [0025] An exemplary embodiment of a cartridge and device for assembling strands of brachytheiapy elements is illustrated in FIGS 1-12 [0026] According to one exemplary aspect of the disclosure, FlG. 1 shows that a device 100 for assembling a strand of radioactive elements may include a housing 101 Housing 101 may include, for example, a carriage portion 102 having a plurality of receptacles 104 configured to receive a corresponding plurality of cartridges 106 Each cartridge 106 may contain one of radioactive seeds, nonradioactive connectors, and non-radioactive spacers (not shown in FIG. 1), and each receptacle may have a different shape to ensure that the cartridges inserted into the respective receptacles each contain the appropriate biachytherapy element. For example, grooves 105 and 105A ate complementary to corresponding projections on the cartridges, so that one of five cartridges will fit in only one of five receptacles. [0027] FIG 1 shows that carriage portion 102 may further include a selector 103 comprising a handle portion 108, siidable in a direction perpendicular to the longitudinal axis of housing 101 Selector 103 may be operable to select one of the cartridges from which biachytherapy elements - e g , radioactive seeds, nonradioactive connectors, or' nonradioactive spacers, may be ejected. The brachytherapy elements may be ejected by an actuatoi to a track 112 configured to leceive a plurality of biachytherapy elements It should be noted that the element numbeis of FIG. 1 are used in some instances in the description that follows The elements shown in FIG. 1 are intended by these uses [0028] FIG. 2 shows a side view of an exemplary part removal assembly and cartridge of the assembling device of FIG, 1 , FIG. 2 shows cartridge 206 Cartridge 206 may include a housing 208 configured to contain a plurality of like items and a track inside the housing 208 The track extends in a first direction (as indicated in

FIG. 2). A plungei 1104 may be slidable along the track in the first direction and configuied to υige the items toward a fust end of the housing 208. Plungei ¹ 1104 may be protected by housing 208 of caitiidge 206,, According to some aspects, cartridge 206 may be transparent, translucent, or opaque. Cartridge 206 further comprises a member 210 that indicates the number of brachy therapy elements remaining in the cartridge. Member 210 can comprise graduated markings on the exterior ¹ thereof corresponding to the number ¹ of brachytherapy elements remaining in the caitiidge.

[0029] FIG 3 shows a magnified view of region A of FIG 2. f he cartridge may include a gate 302 attached to the housing The gate may be movable, fbi example, pivotally, between a first position preventing the items from being removed from housing 304 and a second position allowing one (oi more) of the items to be removed from housing 304. Gate 302 may be configured to remove the one item from being urged by the plunger, In some aspects, gate 302 may be pivotal about an axis substantially perpendicular to the first direction (See, FIGs 9 and 10) [00.30] Cartridge gate slot 306 may be adapted to allow a blade to pass therethrough in order ¹ to remove an individual part from the cartridge

[00.31] FIG. 4 is a perspective view of the part removal assembly of FIG 2, FIG., 4 shows an actuator ¹ that may comprise a blade removal assembly 400 with a thin blade 402 that removes individual parts from cartridge 206 (shown in FIG 2) Assembly 400 may include a rotatable camming member 404 that is configured to cyclically iuge a cam follower extending from the gate of each cartridge (see, e g , 310 in FIG.

3)

[0032] The camming member 404 /cam follower assembly (the blade 402 may be considered associated with the cam follower because it depends on the movement of the cam: see below for more detail about blade 402) may cause a gate associated with a selected cartridge to move between a first, closed position and a second, open position, In moving from the fust position to the second position, the gate may

remove a single pait fiom a plurality of paits out of the path of the plunger (see FIG 2 for "fϊtst direction" of the plungei) FIG 4 also shows a caitiidge caniage motion locking track 406 that locks the motion of the cartridge caniage [0033] The plurality of parts may be integrally connected with the caitiidge, and, when the gate ieturns to its pievious position, the gate may sever such connection of the single part. The gate may further include a slot (see caitiidge gate slot 306 in FIG 3) for holding the removed part such that the part is no longer being urged by the plunge: The slot may extend through the gate in a direction substantially perpendicular to the first direction

[00.34] The blade removal assembly may further include a pusher 402, for example, a thin blade, associated with the cam follower and configured to remove the single part from slot 306 in the selected cartridge The part may be either a seed or a spacei depending on which cartridge is selected Plunger 1104 may be structured and arranged to prevent operation of the actuator ¹ when no parts remain in a caitiidge, thus providing an indication of an empty caitiidge and functioning as a lockout mechanism to prevent a blank dispensing

[0035] Device 100 may fuithei include a combiner housing 109 (see FIG 1) slidable relative to carriage portion 102 Combiner housing 109 may comprise a compression handle 110 operable to combine, via an attached stylet (not shown), a plurality of seeds, connectors and optional spacers in tiack 112 into a single strand [0036] FIG 5A shows a slidable handle 510 FIG 5B shows a side view taken fiom line A-A in FIG 5A FIG 5B shows structural support member 502, magnetic material 504 (behind a plastic cover) and handle connection 506 that connects handle 510 to be able to release the internal mechanics of the combiner housing 109 [0037] FIG 6 shows a cut-away bottom view of the compression mechanism of FIGs 5 A and 5B The compression force of combiner housing 109 may be delivered by decoupling magnets, including permanent - i e , fixed with respect to the movement of handle 510 - magnet 612 and magnetic material 614, so as to prevent

application of excessive foice to the brachytheiapy elements during compiession, which could iesult in mptuiing those elements Alternatively, a mechanical fiiction force may be used The combiner may also be operable to urge the combined stiand into a needle via a needle adaptoi (see element 114 in PIG 1) associated with track 1 12 shown in FIG 1 Needle adaptoi 114 may extend fiom to the exteiioi of the device, and may be complementary to the hub of a brachytheiapy needle [0038] The device may include a stylet 616 associated with the combiner The combiner may be configured to urge the stiand into a needle (not shown) via the stylet 616 Stylet 616 may be pushed along linear guide i ail 618 Stylet 616 may be pievented from buckling by stylet buckling support 620 [0039] The device may include a lockout mechanism configured to pi event opeiation of the actuator when a selected cartridge is empty This feature may be in addition to, or as an alternative to, a visual indicatoi associated with each cartridge [0040] In operation, a user may place up to five cartridges - one into each of the five receptacles (see FIG 1, elements 104) - in the carnage portion 102 of device 100 One cartridge can include ladioactive seeds, the second can include non-iadioactive spacers, and three cartridges can include non-radioactive connectors of various lengths and configurations Carriage portion 102 may then be moved by sliding carriage handle 108 in a direction perpendicular to the longitudinal dimension of the device Carriage portion 102 may be moved so as to align a selected one of the five cartridges with a removal assembly 116 Device 100 may have an indicator to aid with such alignment

[0041] By pressing release button 118 on device 100, an actuator, for example, a blade removal assembly (see, FIGs , 2-4), interacts with gate 302 of the selected cartridge and prepares one part (e g , a radioactive seed, non-radioactive connector, or non-radioactive spacei) foi removal from cartridge 102 In one exemplary embodiment, such preparation may comprise shearing a single part from a plurality of interconnected parts The actuator may then remove the part from the selected

cartridge and advance it into tack 112 of device 100 This alignment and lemoval procedure may be repeated until the opeiatoi has positioned all of the parts for a desiied strand into the track

[0042] FIG 7 shows a top view of an exemplary carriage assembly of the assembling device of FIG 1 Release button 718 which may include a magnetic clutch 720 structured and arranged to disengage when a cartridge is emptied in order to alert the operator and prevent the final strand from being misassembled Gate button 722 and handle 724 aie also shown in FIG 7

[0043] FIG 8 shows a side view of the exemplary carriage assembly 800 of the assembling device in FIG 7 taken from line B-B Carriage assembly 800 includes an inserted brachytherapy element cartridge 802, handle 810, release button 818, gate button 822, motion transfer gearing 824 and part removal assembly 826

Motion transfer gearing 824 acts to transform actuation of 818 into cyclical motion of part removal assembly 826 The cyclical motion of assembly 826 removes an individual pait from the gate and places it in track 112

[0044] Once all of the seeds and spacers are positioned in track 112 as desired, the operator may slide combiner 110 toward track 112 to form the seeds and spacers into a strand For example, the combiner may include a compression handle which is attached to a stylet, (see element 510 in FIG 5) and applied force compresses the stylet into the brachytherapy elements to form a strand This compression occurs when stylet (see 616 in FIG 6) is engaged

[0045] A needle (not shown) may be attached to needle adaptor 114. Gate button

1 19 (FIG. 1) may then be held in the downward position and handle 510 slid toward track 112 to move the strand into the needle

[0046] At any point during operation, the operator may inspect a cartridge 106 by simply removing the cartridge 106 from its receptacle 104 in the carriage portion 102 Upon removal from receptacle 104, the cartridge gate (see, element 302 in FIG 3) keeps the contents of the cartridge safely contained

[0047] FIG 9 shows a side view of gate 902 in a closed position

[0048] FIG 10 shows a side view of gate 1002 in an open position

[0049] FIG 11 shows a fiont view of a caitiidge 1102 When a cartridge is empty, a plungei 1104 in caitiidge 1102 may advance down into the caitiidge gate, causing the caitiidge gate to be immobilized If the ielease button is pressed when the actuatoi is aligned with an empty caitiidge, the immobilized gate pievents the actuatoi from opeiating This positive stop, oi lockout, pievents the opeiator fiom proceeding even if the opeiatoi doesn't notice the visual indicatoi on the cartridge

As a i e suit, the device is pi evented fiom assembling an incorrect stiand configuiation

[0050] FIG 12 shows a peispective view of a caitiidge 1202 according to the invention

[0051] Although the invention herein has been described with iefeience to particular embodiments, it is to be understood that these embodiments are merely illustrative of the piinciples and applications of the present invention It is therefoie to be understood that numeious modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing fiom the spirit and scope of the piesent invention as defined by the appended claims