TECHNOLOGICAL FIELD

The disclosed subject matter relates to a surgical instrument assembly and system for reducing and removing tissue masses from a body during minimally invasive procedures, such as laparoscopic surgery.

BACKGROUND ART

References considered to be relevant as background to the presently disclosed subject matter are listed below:

- US6,152,932

- US8,152,820

Acknowledgement of the above references herein is not to be inferred as meaning that these are in any way relevant to the patentability of the presently disclosed subject matter.

BACKGROUND

Several surgical procedures require removing a tissue mass or an organ from the body of a patient. Among such procedures are hysterectomy, splenectomy, nephrectomy, etc.

Hysterectomy is a gynecological procedure in which a woman's uterus is being detached and removed from her body. Hysterectomy is typically performed in cases of severe endometriosis, presence of fibroids, cancer, cervical dysplasia, uterine prolapse and more. With the advent of minimally invasive surgery such as laparoscopic surgery large tissue masses such as the uterus are removed through small incisions, decreasing post operative pain and hospitalization time.

Several types of hysterectomy are performed fully or partially laparoscopically and these include Total Laparoscopic Hysterectomy (TLH) where the uterus and cervix are removed through few small incisions made in the abdomen; Laparoscopic Supracervical Hysterectomy (LSH) where the uterus is removed, but the cervix is left intact. In both cases the uterus is removed through one of the small incisions using an instrument called a morcellator. Another approach is a Total Vaginal Hysterectomy (TVH) where the uterus and\or cervix are removed through the vagina.

In laparoscopic hysterectomies for example, the uterus is removed using instruments inserted through small tubes into the abdomen, resulting in few small incisions in the abdomen. A laparoscopic approach offers surgeons better visualization of affected structures (e.g. by using an endoscope) than either vaginal or abdominal hysterectomy.

Splenectomy is a procedure in which the spleen is removed from the body of a patient and there is a tendency to perform this procedure in as less invasive as possible manner.

Nephrectomy is a procedure in which part or a complete kidney is being removed from a patient's body.

Other tissue masses are also removed from the body using minimally invasive procedures, such as in the cases of tumor.

GENERAL DESCRIPTION

The disclosed subject matter is directed to a device and method for extracting a tissue mass from a cavity within a body of a patient. The device and method allow a continuous extraction of the tissue mass. In addition, the device and method of the disclosed subject matter allow staging of the extracted tissue for reconstruction purposes.

The term "fundus" as used herein refers to a portion of the tissue mass opposite the entrance port (e.g. natural opening or incision) of the device.

The device and method of the disclosed subject matter are configured for isolation of the tissue from the surrounding tissues or organs and for continuous, relatively fast extraction of the tissue from the operative site and the patient's body. In addition, the device and method of the disclosed subject matter are configured for allowing the operator to visualize the targeted tissue and to establish the previous location of the extracted mass when the mass is outside the operation site. In accordance with one aspect of the disclosed subject matter, a device for isolating, fixing and extracting a tissue from a target site is provided. The device comprising:

a central elongated, hollow shank coupled to activation and controlling handle at its proximal end;

an elongated manipulation member having a proximal end and a distal end defining at least one hollow passageway therebetween and extending within the hollow shank and concentrically from a distal end of the shank;

a continuous, flexible tubular encapsulating sleeve having a leading end and a lagging end, the encapsulating sleeve extending through said hollow passageway and configured for deployment through the distal end of said manipulation member;

wherein the, the encapsulating sleeve is adapted to continuously advance through said passageway.

In accordance with another aspect of the disclosed subject matter, a de-bulking device is provided. The device comprising an elongated tubular housing having a distal end and a proximal end defining a longitudinal passage therebetween and a longitudinal de-bulking member rotatably extending within the housing, wherein the de-bulking member is a longitudinal element fully received within the housing, comprising a de- bulking portion and wherein the housing is provided with at least one longitudinally extending opening extending from the edge of the distal end and towards the proximal end thereof, such that the length of the opening substantially conforms to the length of the de-bulking portion.

In accordance with another aspect of the disclosed subject matter there is provided a method for isolating, fixing and extracting a tissue mass from a target site. The method comprises:

providing a device for isolating, fixing and extracting a tissue from a target site; introducing the manipulation member into the target site and through the tissue mass;

activating the device to discharge and deploy the encapsulating sleeve through a distal end of the manipulation member; the sleeve being configured to continuously extend through the manipulation member, said sleeve having a proximal end configured to extend outside the target site and a distal, leading edge configured for folding over to advance over an outer periphery of said tissue mass, to surround said tissue mass; withdrawing the leading edge of said sleeve from the target site;

activating the de-bulking assembly to de-bulk the tissue, while continuously pulling the leading edge of the sleeve in a proximal direction and pushing the sleeve through the manipulation member in a distal direction.

Any one or more of the following configurations, designs and embodiments can be associated with the device, the de-bulking device and/or the method subject of the presently disclosed subject matter, individually or in various combinations thereof: the manipulation member and the shank are concentrically disposed for reciprocal movement therebetween, allowing additional elements to be disposed therebetween;

the distal end of the manipulation member is further provided with a cutting element configured for cutting through a tissue allowing the manipulation member to advance therethrough until reaching the desired location;

the cutting element is a retractable element;

the cutting element is a detachable part;

the encapsulating sleeve is a flexible yet resilient, substantially cylindrical continuous sheath open at both ends and configured for enclosing and isolating a target tissue;

the encapsulating sleeve is impermeable and/or transparent;

a de-bulking assembly, the assembly having an elongated, hollow tubular shaft having at least one longitudinally extending de-bulking member, and configured to extend through the shank and over the manipulation member;

the de-bulking assembly further comprising an outer cover tube configured for covering the at least one de-bulking member, the outer tube being provided with at least one longitudinal opening thereon, exposing the de-bulking member; the manipulation member is configured as a de-bulking assembly, comprising on its outer periphery de-bulking member surrounded by an outer cover tube configured with tissue feeding window;

the de-bulking assembly further comprises an imaging element attached to the outer cover tube of the de-bulking assembly;

the encapsulating sleeve is configured to fold over and encapsulate the tissue at the target site; the leading end of the encapsulating sleeve is configured to be engaged with an outer trochar shaft or cannula to facilitate the folding over and the pulling over the target tissue;

a distal end of the shank is configured with sleeve engaging elements to engage the leading end of the encapsulating sleeve;

the distal end of the shank is provided with a funnel like structure configured for receiving the leading end of the encapsulation member configured to direct it toward the engaging elements;

the encapsulating sleeve is further fitted with a circumferentially extending inflatable balloon on its leading end;

the encapsulating sleeve is further fitted with structural longitudinally extending wires and/or circumferentially extending wires;

the wires are integrally formed with the sleeve;

the sleeve comprises inflatable channels configured for inflation;

the leading end of the encapsulating sleeve comprises a pull string;

a cage like basket deployable to surround the target tissue;

the distal end of the manipulation member is fitted with an inflatable balloon, configured for inflation;

the proximal end of the manipulation member is provided with indicia, visible to an operator and wherein such indicia corresponding to the defined lengths of the target tissue;

the de-bulking member is a hollow tubular member terminating in an annular distal end portion and an annular proximal end portion comprising at least one longitudinal blade extending longitudinally between the annular distal end portion and the proximal end portion;

further provided with an aspiration mechanism receivable through the shank, a circumferential pressure is applied over the tissue mass through the encapsulating sleeve;

the circumferential pressure is applied by tightening the sleeve around the tissue mass;

the circumferential pressure is exerted over the tissue by tightening the sleeve around it such that the distal edge of the sleeve is pulled at a rate higher than the rate in which it extends through the manipulating member; the circumferential pressure is exerted over the tissue by rotating or twisting the sleeve;

a cage-like basket is deployed to surround the target tissue mass prior to the deployment of the encapsulating sleeve;

the cage like basket comprises at least two arms fitted with a circumferentially extending inflatable balloon at their leading edge;

the balloon, when inflated, maintains a relatively constant diameter larger than the diameter of the tissue it is intended to cage;

the balloon is deflatable so as to bring together the leading edge of the arms and to engage the leading edge of the deployed encapsulation sleeve; and after engaging the leading edge of the sleeve, the balloon of the cage like basket is configured to be re-inflated and to pull the leading edge of the sleeve in a proximal direction towards the shank.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to better understand the subject matter that is disclosed herein and to exemplify how it may be carried out in practice, embodiments will now be described, by way of non-limiting examples only, with reference to the accompanying drawings, in which:

Fig. 1 is a schematic illustration of a side view of the operative portion of the device in accordance with an example of the disclosed subject matter, in an assembled configuration, with cut away portions illustrating various elements of the device;

Fig. 2A is a perspective side view of a schematic illustration of a device in accordance with an example of the disclosed subject matter, being inserted into a tissue mass;

Fig. 2B is a perspective side view of the device of Fig. 2A, cutting through the fundus of the tissue mass;

Fig. 2C is a perspective side view of the device of Fig. 2A, in an initial deployment stage of the encapsulating sleeve with the tissue mass shown transparent to allow visualization of the device portions in operation; Fig. 2D is a perspective side view of the device of Fig. 2A, in a fully deployed stage with the de-bulking device being inserted therethrough;

Figs. 2E and 2F illustrate the device of Fig. 2A in a cross section and in a perspective view, respectively, with the device in a fully operational position in accordance with an example of the disclosed subject matter;

Figs. 2G to 21 illustrate in a perspective view, sequentially, the stages of extraction of the device from the target site;

Figs. 3A and 3B illustrate a distal portion of a de-bulking assembly in a perspective side view and a sectioned view, respectively, in accordance with an example of the disclosed subject matter;

Figs. 4 and 5 are a perspective side view of a de-bulking assembly in accordance with another example of the disclosed subject matter;

Fig. 6 is a perspective side view of a de-bulking device in accordance with an example of the disclosed subject matter;

Fig. 7 is a perspective side view of a de-bulking device in accordance with yet an example of the disclosed subject matter;

Figs. 8A to 81 are a side perspective view of sequential steps of a device in operation, in accordance with an example of the disclosed subject matter, with Fig. 8 A illustrating an initial insertion of the manipulation member into the target mass and Fig. 81 illustrating the de-bulking stage of the tissue mass;

Figs. 9A to 9C are a perspective side view of an encapsulation assisting device, in accordance with one example of the disclosed subject matter in various stages of deployment; and

Figs. 10A to IOC are a perspective side view of an encapsulation assisting device, in accordance with another example of the disclosed subject matter in various stages of deployment.

DETAILED DESCRIPTION OF EMBODIMENTS

While in the disclosed subject matter reference is made to hysterectomy, it will be appreciated that the disclosed subject matter can apply to other procedures and for removal of other tissue masses, full organs, tumors, glands etc. from human patients or in a veterinary use. Before referring in detail to the drawings illustrating the disclosed subject matter in accordance with some of its examples, the following are the steps typically taken during the laparoscopic or laparoscopy assisted hysterectomy procedure and which are brought to ease the understanding of the disclosed subject matter.

Typical procedure entails disconnecting the uterus from its surroundings, including disconnecting it from three main types of connections: ligaments, blood vessels and continuous tissue (e.g. connection of the cervix to vagina); and extracting or removing the uterus from the body of the patient. During the extraction procedure, to facilitate the removal of the uterus through the laparoscopic port, a morcellator is used to cut through the tissue to reduce its total size. Once the uterus is disconnected, morcellator is introduced into the abdominal\pelvic cavity of the patient and is activated. During the operation of the morcellator the tissue is brought into a close proximity of the morcellator blade to facilitate morcellation and extraction/aspiration of the tissue therethrough and removal of the tissue from the body. Reaching a relatively small volume of the remaining tissue, the small mass is extracted from the operative site and procedure is completed.

The presently disclosed subject matter is directed to a device configured for isolation of the tissue from the surrounding tissues or organs and for extraction of the tissue from the operative site and the patient's body. In addition, the device and method of the disclosed subject matter are configured for allowing the operator to visualize the targeted tissue and may be configured to establish the previous location of the extracted mass when the mass is outside the operation site, e.g. for staging of the tissue removal, e.g. performed for purposes of reconstructability.

Turning now to Fig. 1, a device for reducing and removing a tissue mass in accordance with the presently disclosed subject matter is generally designated 10. The device comprises a central shank 12 coupled to activation and controlling handle (not seen) at its proximal end PI, a folded encapsulating sleeve 14 and a manipulation member 16. The shank part 12 is an elongated tubular member configured to receive and pass therethrough the manipulation member 16 which in turn is configured to receive and allow the encapsulating sleeve 14 to extend therethrough along the longitudinal axis x of the device 10. At its proximal end PI the shank 12 is connected to a handle that can be held by a surgeon or other medical personnel operating the device. The manipulation member 16 is a hollow, elongated tubular member, in this example having a circular cross section. It will be appreciated that other geometrical shapes can be used such as to have an elliptical cross section, rectangular, square etc. As can be appreciated the external diameter d of the manipulation member 16 is relatively smaller than the inner diameter D of the shank. The manipulation member and the shank are concentrically disposed for reciprocal movement therebetween, allowing additional elements to be disposed therebetween as will be explained herein.

The manipulation member 16 is configured with at least one working channel extending along its length. The manipulation member is of a length sufficient to extend through the target tissue or organ (as best seen, e.g. in Fig. 2A). At least one channel of the manipulation member is configured at its distal end (P2) (the end farthest from the shank) with an opening for dispensing therethrough the encapsulating sleeve 14 (best seen in Fig. 2C). The distal end is further provided with a cutting element 18 configured to cut through a tissue allowing the manipulation member to advance therethrough until reaching the desired location, typically the enveloping layer of the target tissue. As seen in Figs. 2A-2H, in hysterectomy procedure, the manipulation member 16 advances through the uterus cavity U, cutting through any tissue that might be present on its walls, e.g. fibroids, and up to the fundus of the uterus F, where the cutting element cuts therethrough exposing the distal end of the manipulation member 16 (seen in Fig. 2B) and allowing the encapsulation sheath to be continuously discharged therethrough (e.g. seen in Fig. 2C). The cutting element 18 can be a permanent fixture of the manipulating member at its distal end 19, which can be for example retractable upon completion of the incision. It can also be a detachable part thereof (not shown).

The device of the disclosed subject matter is further configured with a de- bulking assembly generally designated 20. In accordance with the illustrated example, the de-bulking assembly 20 comprises a tubular hollow shaft 22 which is advanced through the central shank and over the manipulation member. The de-bulking assembly comprises a window-like opening 24 at a distal portion thereof. This opening is provided to allow operation of a de-bulking mechanism, such as a rotatable blade 26, when inserted through the shank 12 into the uterus cavity U during the tissue processing and extraction procedure, i.e. the extraction of the target tissue in small pieces from the operation site. In accordance with an example of the disclosed subject matter illustrated in Fig. 4, the manipulation member generally designated 40 can be configured as a de-bulking assembly, comprising on its outer periphery de-bulking member such as blades 44 or electrosurgical mechanism (not shown) surrounded by an outer, cover tube 46 configured with tissue feeding window 48. The length of the de-bulking member, or its blades, can range from 10mm to 200mm or more, and can be of length substantially corresponding to the length of the target tissue mass.

To allow imaging of the target tissue and of the de-bulking procedure the de- bulking assembly in accordance with an example of the disclosed subject matter can further comprise an imaging element (not shown), such as an ultrasonic scanner/sensor, attached to the outer tube of the de-bulking assembly.

The encapsulating sleeve 14 is a flexible yet resilient, substantially cylindrical continuous sheath open at both ends and configured for enclosing and isolating a target tissue. The dimensions, shape, size, in diameter and/or length, of the sheath can vary in accordance with the procedure to be performed, i.e. the tissue to be enclosed and removed. The encapsulating sleeve is impermeable, transparent, and can for example be made from a polyurethane. The material chosen can be elastic or non elastic.

The encapsulating sleeve is flexible so that it can be folded and inserted into the body cavity through a working channel in the manipulating member 16 as seen in Fig. 1 and Fig. 2C. As will be further disclosed in more detail, in operation the flexible sheath is introduced through the working channel of the manipulating member 16, advanced therein through the target tissue (e.g. seen in Fig. 2B), and when reaching the outermost edge F of the target tissue, the sheath is allowed to extend outside the channel. From this stage the encapsulating sleeve 14 is folded over forming a distal folded end 17 (as best seen in Fig. 2E) and is continuously discharged through the manipulating member 16 to begin surrounding the target tissue as the sheath is pushed through the working channel in the direction of arrow T and extends over the tissue (e.g. by pulling it towards the proximal end of the manipulating member) to surround and encapsulate the target tissue. It is understood that the target tissue mass has already been surgically detached from the surrounding tissue at its operation site. It will be appreciated that an outer trochar shaft or cannula can be used to facilitate the folding over and the pulling of the encapsulating sleeve over the target tissue (not shown). Once the target tissue is surrounded, the leading end L of the encapsulating sleeve is pulled out of the insertion point in the direction of arrow A (e.g. vagina or the incision through which the device was introduced) to prevent escape of the diseased tissue (e.g. malignant cells) into the surrounding target tissue area (e.g. seen in Figs. 2D and 2E).

In accordance with an example of the disclosed subject matter, the distal end of the shank can be configured with clasping or hooking elements to engage the leading edge of the encapsulating sleeve and pull it outwards in the proximal direction of the shank (not shown). To ease the engagement process, the distal end of the shank can be provided with a funnel like structure, receiving the lead edge of the encapsulation member essentially directing it toward the engaging elements (not shown). Such a funnel structure can be an integral part of the shank or a detachable attachable structure introduced and used at the initial stage of the encapsulation.

In accordance with the example of the disclosed subject matter illustrated in 2C, the encapsulating sleeve 14 is further fitted with a circumferentially extending inflatable balloon 30 on its leading edge. The balloon is configured for inflation during the enclosing, encapsulating stage. The inflation is performed by the user at the desired stage and in a chosen speed. This provides for a substantially smooth, round and soft edge and assists in avoiding damages to tissues in the vicinity of the target tissue. The sheath 14 in accordance with the embodiment is further lined with structural longitudinally extending wires 33 and circumferentially extending wires 35 (best seen in Fig. 2D) to impart the sheath with strength and resilience as well as shape, as will be discussed. The wires form a cage like structure around the tissue, supporting the sheath thereon and isolating the tissue from the surrounding. It will be appreciated that the sheath may comprise only longitudinally or circumferentially extending wires or be devoid of any such wires. The wires are flexible enough to allow manipulation of the sheath prior to insertion and during the operation of the device. The wires can be separate members or can be interconnected to form a structured frame. The wires can be made of any bio-medically compatible material such as surgical steel, aluminum, and\or set of shape memory alloy wires and\or of thin plastic rods and\or any other material that can add the desired flexibility and elasticity to the encapsulating sleeve. The wires can be provided along the entire length of the sheath or a portion thereof.

In accordance with another example (not shown), the sheath is configured with longitudinal passages along at least a portion of its length configured for receiving therethrough wires to impart the encapsulating sleeve with a cage like structure. As shown in the example illustrated, e.g. in Fig. 2C and Fig. 8 the encapsulating sleeve is formed with air passage ducts/channels extending longitudinally and circumferentially forming a cage like structure, dimensioned to surround the target tissue. These channels are provided over a proximal portion of the sheath forming the encapsulating sleeve 14 at a length sufficient to surround the target tissue. In operation, these channels are inflated and thus the structure is erected, advancing from the distal most end of the manipulation member 16 and the target tissue towards the proximal end thereof, until it reaches the shank 12. At this stage the edges of the leading end of the encapsulation member are engaged, the structure is deflated and the encapsulation member substantially extends around the target tissue. It will be appreciated that the encapsulation member can be provided with both the inflatable channels over a portion thereof and a continuous wire structure along a substantial length of the sheath forming the encapsulation member. This will facilitate formation of a cage like structure at the advanced stages and following the extraction of the leading end of the sheath configured with the inflatable channels.

To guide the enclosure within the body, its leading end L can be fitted with a pull string which in operation is manipulatable by the user. According to another example, the enclosure can be manipulable by instruments inserted through a separate trochar or cannula.

The device may be used laparoscopically or in the instance of hysterectomy it can also be used through the vagina. For laparoscopic use, the device can be fitted with a pressure-seal at the shaft (not shown) for maintaining and regulating the pneumoperitoneum pressure (the pressure of gas inside the abdominal\pelvic cavity) in the desired level throughout the procedure, for purposes of visualization or any other purpose. It will be appreciated that various elements can be inserted through the shaft to maintain, increase or provide for an internal pressure of gas inside a cavity of the body of a patient.

The tissue mass can be cut/de-bulked mechanically or electrosurgically or a combination thereof. Mechanical morcellator as the term is used herein refers to cutting/de-bulking of tissue using, for example, sharp end-effectors such as rotating blades. Electrosurgical and ultrasonic morcellators refer to morcellator using energy to morcellate tissue. One example of the morcellator in accordance with the disclosed subject matter is illustrated in Figs. 1 and 3A-3B. The morcellator 20 in accordance with the disclosed subject matter comprises a tubular housing 22 and a longitudinal de- bulking member 26 extending within the housing. The housing is generally an elongated tubular body having a distal end and a proximal end defining a longitudinal passage 25 therebetween. The housing is provided with a two diametrically opposed longitudinally extending, rectangular openings 24 extending from the edge of the distal end and towards the proximal end thereof. It will be appreciated that more or less than two windows can be provided on the housing, depending on the area of the de-bulking member in need of exposure.

The de-bulking member is a longitudinal element fully received within the housing, comprising a de-bulking portion 26. The length of the opening 24 in the housing substantially conforms to the length of the de-bulking portion 26 of the de- bulking member extending within the housing and the opening will be referred to hereafter as the tissue receiving window. In accordance with the example illustrated in Fig. 3A, the de-bulking member 26 is a hollow tube terminating in an annular distal end portion 27 and an annular proximal end portion (not seen) comprising a pair of longitudinal blades extending longitudinally between the annular distal end portion and the proximal end portion. It will be appreciated that the de-bulking member can comprise one or more de-bulking portions extending thereon, either longitudinally or circumferentially. For example, the de-bulking member can comprise along its length, more than one, non continuous blades, or alternatively, the de-bulking portion can comprise two pairs of blades, etc.

The de-bulking member 26 is rotatable within the housing allowing the blades to de-bulk a tissue when brought into a close proximity thereto. In accordance with this example the blades have cutting edges on both sides thereof (best seen in Fig. 3B). Using this configuration the de-bulking member 26 can be used to cut through the tissue either when rotated in a clockwise direction or the counterclockwise direction. This allows use of the same de-bulking member for removal of larger amounts of tissue and for a longer duration. For example, the de-bulking member can be first used by rotating the blades in one direction and as the cutting action becomes more difficult as the blades lose their sharpness, i.e. become blunt, the direction of rotation can be switched and the counter edge of the same blade can be used. In accordance with another example, the de-bulking member can be imparted with a reciprocal rotational movement. Due to the hollow structure of the de-bulking member, the cut tissue is pushed through the passageway and is either progressed therethrough under pressure or is aspired therethrough, e.g. by applying a suction device to pull the cut tissue from within the member and outside the operating site.

According to the example illustrated in Fig. 4 the de-bulking member 46 can be in a form of a spiral blade 44 extending along a tubular shaft 40. According to yet an example seen in Figs. 5 and 7, the de-bulking member 50, 60 is a bi-polar diathermia device. According to an alternative example, a monopolar device can be configured. According to this example, the wires 55, 65, are coupled to an energy source and are provided on the shaft 52, 62, extending along its length and received within the housing 53, 63, accessible only through the tissue receiving windows 54, 64. The shaft 52, 62 is configured to rotate, thus rotating the wires, allowing these to de-bulk the tissue at contact therewith. According to another example, the de-bulking can be performed using a laser device or an ultrasonic device fitted over the de-bulking assembly (not shown).

In accordance with the disclosed subject matter the manipulating member can be configured to hold an integrated camera system for control and observation of the operation. Alternatively, a separate trochar or an endoscope can be provided for observing the operation.

Another example of the disclosed subject matter is illustrated in Figs. 9A to 9C and 10A to IOC. In accordance with these examples of the disclosed subject matter a cage-like basket (200, 201-202, 205, 300, 301, 302, 303) is deployed to surround the target tissue mass prior to the deployment of the encapsulating sleeve. Such a basket is provided to prevent unintentional damage to the surrounding tissue, e.g. by puncturing the tissue while performing the deployment cut of the fundus. The device 200 for tissue extraction in Fig. 9 is similar to the previously described device with the addition of the deployable basket cage (201, 201, 205). Such a cage is deployed through the proximal end of the shank and is progressed towards the distal end of the tissue mass. The cage comprises three or more wire arms 201, 202, 301, 302 (only two are seen in the illustrations) with a circumferentially extending inflatable balloon 205, 305, provided at their leading edge. The balloon, when inflated, maintains a relatively constant diameter larger than the diameter of the tissue it is intended to cage. When the fundus is reached, the balloon is deflated, the leading edge of the arms 201, 202, 301, 302 are thus brought together and are configured to engage the leading edge L of the deployed encapsulation member 214. Having engaged the encapsulation member, the circumferential balloon 205 is re-inflated, enlarging its diameter and pulling the sleeves leading edge in a proximal direction (i.e. rearwards), the sleeve thus follows the balloon and the retracted cage, forming the encapsulation frame surrounding the tissue. As the leading edge of the encapsulation member approaches the shank, it is pulled therethrough and from hereon onwards, the operation will be the same as in the previous example, which is described more fully hereinafter.

The device of Fig. 10 is similar to that previously disclosed and similar elements will be designated using same numerals, upped by 300. One difference between the device 300 and that described with reference to device 10, is in the encapsulating sleeve 314 being devoid of inflatable ducts. Another difference is in the protective basket that is deployed through the shank 312 around the tissue and encapsulating the tissue such that a space is left therebetween. The cage will remain to surround the tissue mass for as long as the extraction process is performed. The cage is similar in structure to cage 203, however in this example the wire arms are provided with a cover sheath 307. The distal end of the protective basket, as is shown in Fig. IOC, includes an internal layer (shown by a thick arrow). This layer is designed to connect to the encapsulating sleeve, using a closing loop mechanism. In this example, the operator encapsulates the entire length of the uterus by the protective basket prior to penetrating the fundus. After the leading edge balloon 301 is deflated and the protective basket becomes hermetically closed, then the manipulator member penetrates through the fundus. After penetrating the fundus, the inner layer 314 can be closed around the manipulator member, connecting to the encapsulating sleeve. From this point on the process is similar - balloon inflation and pulling of the protective basket proximally, consequently pulling the encapsulating sleeve out of the body. This enables safe penetration of the fundus.

It will be appreciated that other solutions for protection of the surrounding tissue can be used. For example, the leading edge of the manipulation member can comprise an inflatable balloon, configured for inflation when released from the outermost layer of the target tissue mass, e.g. after cutting through the fundus. The inflation of the balloon will provide an indication to the operator that the fundus has been cut through. Hereinafter, with the balloon inflated, the manipulation member can be slowly advanced into the cavity surrounding the target tissue, utilizing the balloon as a protective measure, preventing unintentional damage, such as tear in tissues, while still advancing to provide for example for a larger encapsulation, in case the target tissue is of irregular shape. Alternatively, the manipulation member can be provided with indicia on its proximal end, visible to the operator, such indicia corresponding to the typical, or pre- calculated lengths of the target tissue mass, e.g. the length of the uterus. The operator, noting that the manipulating element has entered a distance known to be the length of the target tissue, will arrest the member and will commence the deployment of the encapsulation device.

In operation, the shank 12 is inserted through an opening towards the proximal end of target tissue (e.g. through an incision or a vagina and towards the cervix). Having reached the target site, the manipulation member 16 is introduced into the target tissue mass and is pushed therethrough in a longitudinal direction, substantially parallel to the longitudinal axis of the target tissue, cutting its way through the tissue until reaching the most distal and farthest point of the specimen relative to the entry point (e.g. fundus) (seen in Fig. 2A-2B, Fig. 8 A, Fig. 9 A). At this stage the distal, cutting edge of the manipulation member cuts through the fundus and essentially extends through the target tissue mass. The tubular sheath forming the encapsulating sleeve is then deployed.

Upon deployment the sheath is folded over itself and is now in an inverted position to the sheath extending within the manipulation member, continuously pushed therethrough. The folding over can be imparted for example by shape memory alloy wires extending through/lining the encapsulating sleeve. Parallel to the pushing of sheath and substantially at the same rate the inverted leading edge is pulled towards the shank 12 so as to be pulled outside the insertion site thereof. This stage continues until the leading edge is withdrawn from the target site. In the examples of Fig. 2 and 8, the encapsulating sleeve is configured with an inflatable structure including a circumferentially extending balloon at its leading edge L. As fluid (gas or liquid) is propelled through the inflation channels, the sheath is pulled towards the shank, surrounding the tissue mass and isolating it from the surrounding tissues and organs.

To withdraw the leading edge of the encapsulating sleeve, the leading edge is engaged through, e.g. the shank and, the inflated channels are deflated and the sheath can be easily pulled out. Having encapsulated the target tissue mass, the de-bulking assembly 20 is introduced over the manipulation member (Fig. 2D). To bring the tissue in contact with the tissue feeding window of the de-bulking assembly, pressure is exerted circumferentially over the tissue. In accordance with the disclosed subject matter, by pulling the encapsulating sleeve at a rate higher than the rate of pushing it through the manipulation member, the diameter of the encapsulating sleeve diminishes and thus pressure will be exerted circumferentially by the encapsulating sleeve around the tissue mass. Additionally, shear forces are applied on the mass by relative motion of the encapsulating sleeve from the fundus proximally. The shear forces translates tissue proximally and towards the proximal end of the de-bulking component. In addition, the circumferential pressure feeds tissue to the de-bulking component. These two processes facilitate the processing of the internal tissue of the specimen, aiming to core/de-bulk it. It will be appreciated that the pressure difference can be obtained by other means. For example, a pressure within the capsule can be substantially decreased, e.g. by applying vacuum.. In accordance with yet another example, the distal edge of the sleeve (i.e. the portion pulled out of the target site) can be rotated to twist over so as to decrease the diameter of the sleeve surrounding the tissue mass.

As the tissue mass is continuously pressed towards the de-bulking assembly for as long as the relative rates mentioned above are maintained, the tissue feeding windows are in full contact with the tissue, thus continuously de-bulking the tissue. The tissue specimens are further continuously pushed through the passageway extending between the de-bulking member and the outer surface of the manipulation member. To facilitate faster removal of the cut tissue, aspiration mechanism can be employed or a higher pressure can be exerted externally over the tissue mass by the surrounding portion of the encapsulation member. As the process is continuous (due to the push/pull pressure ratio and the ease of manipulation, e.g. if needed the sheath can be pushed or pulled faster to manipulate the tissue towards the tissue feeding window of the de- bulking assembly), the extraction of the tissue mass is also continuous. As such, the extracted tissue, pushed through the device and accumulated outside can be used for reconstructing the de-bulked tissue, as the stage of extraction of each layer of tissue mass is known.

As the tissue mass is reduced in volume, its outer diameter decreases (best seen comparatively and sequentially in Figs. 2F-2I), the de-bulking assembly can be withdrawn and the encapsulating sleeve will now be pulled, while the proximal end thereof will be maintained static, thus the remaining tissue mass will be pushed through the shank and outside the entry port (Fig. 2F-Fig. 21). Alternatively, as the outer diameter decreases and reaches the diameter close to the diameter of the incision port, the device is removed in its entirety, with the encapsulating sleeve still extending over the manipulation member and the remaining tissue mass entrapped therebetween.

Figs. 8A-8I, illustrate operation of the device in accordance with the disclosed subject matter in sequence, with Fig. 8A illustrating the manipulation member of the device progressing through the tissue and Figs. 8B-8F illustrating the deployment of the encapsulating sleeve and the stages of its progressing towards the shank of the device. The device is similar in its structure and function to the previously described device 10, with the difference seen in the funnel like structure F deployable at the distal end of the shank and extending therethrough. As discussed above, this structure is configured to facilitate engagement of the shank to the encapsulating sleeve to withdraw it outside the target site and facilitate manipulation thereof, e.g. pulling to exert pressure on the encapsulated tissue mass. The engagement can be facilitated by use of pull strings to pull the leading edge of the encapsulating sleeve towards the funnel. Additional difference is in the presence of an imaging sensor IM (ultrasonic sensor) over the housing 122 of the de-bulking assembly 120 (seen in Fig. 8H). With the structure and function being substantially the same as in previous example, the device is designated 100 and its element will bare same numbering upped by 100. As in the previous example, reconstruction of the tissue mass is possible using the device and the described procedure, however, the degree of certainty is raised as the imaging device allows more precise staging of the extracted mass. This device allows staging and reconstruction of the tissue removed.