AU719809B2 - Surgical apparatus - Google Patents

Description

WO 97/09922 PCT/AU96/00574 SURGICAL APPARATUS THIS INVENTION relates to surgical apparatus for removal of bodily tissue.

This invention has particular application to surgical collection and removal of body parts in endoscopy and laparoscopy, and the invention is hereinafter described with reference to this application. However, apparatus in accordance with the present invention may find other uses such as in veterinary medicine and autopsy procedures.

Surgical techniques such as laparoscopy and endoscopy are now routinely performed in lieu of open cavity surgery, resulting in reduced trauma, shorter hospital stays and better surgical outcomes.

Laparoscopic surgery involves making relatively small incisions through which a laparoscope may be inserted.

Generally, a passage for the laparoscopic instruments and accessories is provided by insertion of a tubular trocar. The trocars employed are typically of 5 to 18 mm internal diameter.

One or more trocar incisions may be used for laparoscope viewing, surgical instruments and for expanding the body cavity with a suitable gas, typically CO 2 The sites may also be used for introducing irrigation tubes into the body cavity.

Such surgery has been used for removing growths, tumours and body organs. The removal of large pieces of tissue with this surgical technique is difficult since the organs and the like are too large to be withdrawn through conventional trocar sheaths, or even through the trocar incision with the sheath removed.

It is not desirable to cut the organ or the like into small enough pieces within the body cavity and then withdraw the pieces because of the danger that tissue debris will be left in the cavity which can lead to the development of septic conditions and other complications. Also, cutting the organ or the like WO 97/09922 PCT/AU96/00574 2 into pieces within the body cavity is time consuming and lengthens the time taken to complete the surgical procedure.

Earlier proposals have suggested a method for morsellating the organ or the like within the cavity by placing the organ or the like within the cavity by placing the organ into a bag within the cavity and inserting a cutter into the bag to cut the organ into smaller pieces so that the bag and its contents may be removed through the trocar sheath or the incision.

Patent specification PCT/US94/09487 discloses a system for removing an organ from a body cavity. The system includes an elongate, expandable, tubular member with an impervious lining. An opening is provided in the tubular member to allow the organ to be inserted into the tubular member and within the interior of the impervious lining. Tissue cutting or tearing means extends through the device. When the tissue removal device is advanced through an exit trocar the organ is comminuted within the body cavity while the device passes through the exit trocar. This device requires at least two trocar incisions and sheaths.

United States Patent specification 5215521 discloses a laparoscopy organ retrieval apparatus including an organ entrapment envelope which is introduced into the body cavity through a laparoscopy port. When the organ is placed into the cavity the neck of the envelope is left slightly open to allow the insertion of a morsellator. The morsellator includes a suction port and a drive shaft with a cutting head.

The source of vacuum at the head assists in allowing cutting contact with the organ and removal of tissue pieces.

With both of these earlier proposals there remains a danger that the envelope or the impervious lining and tubular member may be damaged while cutting of the organ into pieces. Tissue pieces may then be inadvertently left in the body cavity.

In many instances it is desirable that pathology or cytology be conducted on the organ or tissue removed from the patient. To conduct such tests it is desirable to use large pieces of tissue, or at least ensure that the tissue is viable for testing. The tissue pieces which result from the use of the devices and methods of patent specifications PCT/US94/09487 and US Patent 5215521 are too small or disrupted, and may be unsuitable for conducting meaningful pathology, histology or cytology.

It is an object of the present invention to provide a surgical apparatus for removal of bodily tissue which reduces at least one of the foregoing disadvantages referred. Other objects and advantages will hereinafter become apparent.

With the foregoing and other objects in view, this invention in one aspect resides in surgical apparatus for removal of bodily tissue from within a body cavity, the apparatus including: a flexible body member having a cavity 0o00 :°.:adapted to receive a tissue to be removed; a plurality of flexible cutting elements located in said cavity, the cutting elements being adapted to provide a cutting process to morcellate the tissue, and cutting element operating S 20 means extending out of said cavity.

The flexible body member may be of a material substantially impervious to fluids such as blood and other bodily fluids, gastrointestinal gases or body S• cavity inflation gases. For example, the flexible body member may comprise a plastics material, a proofed ripstop fabric-such as polyamide, latex or of any other suitable material.

The flexible body member may take the form of a bag or pouch into which an organ or body tissue may be placed for removal from the patient during surgery.

For laparoscopic use, the flexible body member may be adapted to be R 30 inserted into patient through a lumen or WO 97/09922 PCT/AU96/00574 4 through the incision. To this end, the apparatus may be adapted to be collapsed into elongate form for insertion into the patient. The apparatus may also be provided with extraction means such as a drawing cord or the like which may remain outside of the patient during the procedure. When used with a larger diameter, short trocar, the flexible body member may also be adapted to be removed from the patient therethrough, the morsellisation allowing distribution of the tissue parts within the cavity to permit egress.

An opening may be provided which serves as a collection port for the tissue and an operating port through which the cutting element operating means may pass. Alternatively, the body member may be provided with separate ports. Where the body member is selected to take the form of an elongate envelope of flexible material, the collection and operating opening is preferably at one end of the envelope.

The opening may be of enlarged diameter relative to the remainder of the envelope. The enlarged opening may be adapted to be gripped by a surgical assistant during the morsellation process. The enlarged opening may include a portion folded over the outside of the body member the improve the hold obtainable. The opening may be selectively closed by closure means.

The opening may be provided with an end portion reinforced with a cord, draw string or flexible wire loop or otherwise formed into portions which may easily be grasped.

In order to reduce the likelihood of the loss of tissue from the body member, the body member may be adapted to be partially externalised during the cutting process. To this end the opening polon may be adapted to pass into the trocar for cutting or the trocar removed enabling the opening portion to exit the incision. The opening portion and incision may be provided with guide means adapted to protect the tissue WO 97/09922 PCT/AU96/00574 surrounding the incision from damage from the cutting means when the trocar is removed.

The cutting elements may be selected from blades, garotting or sawing wires, diathermy implements or the like, including means for water cutting. Thewire or blade embodiments may be selected to cut through a particular tissue type or a broad range of tissue types. The presence or absence of staples, clips or stones may influence material and construction choice.

Preferably, the cutting elements are selected to be radiotranslucent.

The cutting elements may be associated with the interior surface of the cavity in such a way as to conform therewith for insertion into the patient and subsequent capture of the organ or tissue. T h e cutting elements may form a cage within the cavity such that an organ or body tissue therewithin may be cut into a plurality of controlled-size pieces.

Wire or blade cutting elements may be releasably secured to an interior wall of the cavity by any suitable means such as frangible bonding.

Alternatively, the cutting elements may be secured in position on the cavity wall by a frangible inner membrane, whereby shear release forces are avoided and the cutting members may move freely. The frangible inner membrane may be provided with perforations or other weakening at the preferred rupture points of the frangible membrane. The frangible membrane may extend continuously over the inner surface of the cavity, or may be selectively applied thereto.

As a further alternative, the cutting members may be retained on the inner surface of the cavity by conforming recesses provided thereon.

Wire sawing or garotting cutting elements may consist of single filaments or multiple filaments would or woven into a plurality of strands, cords or wires.

It is preferred that the cutting elements comprise WO 97/09922 PCT/AU96/00574 6 woven wire strands. Whether blade or wire, the cutting means may comprise a plurality of cutting elements secured by one or more ends to the operating means located outside of the cavity. For example, the cutting means may comprise a selected number of cutting strands extending between two graspable operating portions adjacent the opening in the cavity.

The multiple cutting members may be substantially uniformly spaced in the cavity. It has been found advantageous that adjacent pairs of wires cross in the distal end of the cavity.

Alternatively, the cutting member may comprise a single strand making multiple turns through the cavity between the graspable operating portions.

The cutting element operating means may take any form consistent with the selection of cutting elements and the requirement that operating means be operable substantially outside of the cavity. For example, for wire or flexible blade cutting members, the operating means may comprise one or more handles adapted to engage the cutting members and be hand operable to pass the cutting members through the tissue to be cut.

Where the cutting members have a terminal end fixed to the body member, a single handle may be used. Where the cutting members have both termini free of the body member, there may be provided a pair of handles.

The handles may be operated by a pulling action to effect slicing of the tissue or by a sawing action in the case of the two handled embodiment where the cutting members are so adapted. Alternatively the operating means may comprise ultrasonic or other high frequency vibrating means adapted to impart vibration to the cutting members whereby gentle tension on the cutting members may effect cutting of the tissue. In a yet further applications, handles may be adapted to the to deliver diathermic or water cutting to appropriate cutting means.

The handles may be secured to the cufftting members by any suitable means dictated largely be the selection of cutting members. The handle and cutting members may be provided with complementary releasable engagement means. For example, the ends of the cutting members may be provided with an integrally formed or fabricated lug adapted to engage a lug recess in the handle. In this embodiment, the cutting members may be lined up with the direction of pull of the handle by means of a slot. Alternatively the handle may include a hook like portion adapted to engage a corresponding loop on the cutting member. If desired, the hook like portion may be associated with retaining means adapted to releasably lock the hook like portion to the loop to avoid inadvertant disengagement during the cutting operation.

The surgical apparatus in accordance with the present invention may be supplied in and introduced by applicator means. The applicator means may comprise a sterile package.

Accordingly, in a further aspect this invention resides in an applicator applicator assembly including: a housing having a delivery outlet and adapted to contain a surgical apparatus; the surgical apparatus including a flexible a.

body member having a cavity adapted to receive a tissue to be removed, a plurality of flexible cutting elements located in said cavity, the cutting elements *being adapted to provide a cutting process to morcellate the tissue, and o° cutting element operating means extending out of said cavity; and a plunger S: co-operable with said housing and adapted to deliver said surgical apparatus to said delivery outlet.

25 The surgical apparatus is preferably selected to be collapsible into the housing. The housing may be adapted to pass through a trocar into a patient or alternatively may be adapted to be used directly through an incision.

The abovedescribed surgical apparatus may be contained in the housing complete with the operating means. However in the interests of maintaining the narrowest possible deployable package, it is preferred that the surgical apparatus comprise the body member WO 97/09922 PCT/AU96/00574 8 and cutting member assembly, with the operating means being releasably attached thereto after deployment.

The opening portion of the body member is preferably configured whereby the opening may be linearized under opening bias in the housing, whereby after deployment the opening opens for tissue capture.

The plunger may be attached to the body member whereby the surgical apparatus may be manipulated thereby after deployment. For example, the plunger may be affixed to the opening portion and become the means whereby the opening may be manipulated to accept the tissue. The plunger may be adapted to enable the housing to pass over the end of the plunger remote from the body member, whereby the manipulation can occur without the impediment of the housing.

The housing and plunger may be adapted to facilitate deployment of the surgical apparatus by means such as lubrication therebetween, or by mechanical means. An example of mechanical assistance means may include the provision of cooperating screw portions on the plunger and the housing, compelling a twisting action on the surgical apparatus, thus urging the surgical apparatus into a tightly compressed form and thereby permitting freer passage out of the outlet.

the plunger may include a bifurcated end compressed against an opening bias in the housing whereby clearance of the bifurcated end from the housing results in the bifurcation springing open, which action may be utilized to assist in opening the cavity for tissue capture.

The invention is hereinafter described with reference to embodiments the subject of the accompanying drawings wherein: FIG. 1 is an elevational view of the surgical device according to an embodiment of the invention; FIG. 2 shows an exploded view of the surgical WO 97/09922 PCT/AU96/00574 9 device according to an embodiment of the invention; FIG. 3 shows an assembled view of the applicator of FIG. 2; FIG. 4 shows diagrammatically how the applicator of FIG.s 2 and 3 is positioned during surgery; FIG. 5 is a perspective view of a guide which may be used during surgery employing the surgical device of the invention; FIG. 6 is a side view of alternative apparatus in accordance with the present invention, and FIG. 7 is an exploded view of the apparatus of FIG. 6.

FIG. 1 shows an embodiment of a surgical device according to an embodiment of the invention. The device 10 includes an envelop 11 which is in the form of a sheath having a base or end wall 12, a body portion 12 and a flared end portion 14 terminating in an opening 15 spaced from end wall 12. Cutting elements 16, 17, 18, 19 and 20 extend along an inner wall of the envelope along one side, over the base and along a side opposite the one side of the inner wall.

If the body portion 13 is substantially cylindrical when the envelope is in its relaxed state, then the cutting elements may be circumferentially spaced over the inner wall of the envelope. Ends of the cutting elements terminate in two user graspable ends or eyelets 21 (only one of which is visible in this view).

The cutting elements may be loosely bonded to the inside face of the envelope by a sheet of plastic material bonded to the inner face at locations 22 between the cutting elements.

FIG. 2 shows an exploded view of an applicator consisting of a plunger 31, a barrel 32, and an outer tubular elongate handle 33.

The plunger has enforcing strands 34 at one end for reinforcing the opening 15 at one end of the WO 97/09922 PCT/AU96/00574 envelop 11 and for securing the envelope to the end of the plunger 31. The plunger 31 has a stem 34A and an operating knob 35 at an end of the stem spaced from the end to which the envelope is secured.

The barrel 32 has a rib 36 at one end to limit the degree to which it can be received within the handle 33. At an end opposite the rib 36 the barrel has longitudinally extending slots 37 into which strands 34 may extend to assist in the normal retention of the envelope within the barrel.

Tubular handle 33 has formations 38 at one end to allow the applicator to be grasped by the surgeon.

These formations provide a grip portion on the handle.

FIG. 4 shows how the applicator 30 may be used in surgery. The handle 33 may be inserted into a body cavity 40 either directly through an incision in a wall 41 leading to a cavity or through a trocar lumen. Once the free end of the tubular handle locates in the cavity 40 the plunger may be depressed to cause the barrel to move into the handle to the extent allowed by rib 36. This partially ejects the envelope 11 from the applicator. Complete depression of the plunger allows the envelope to open to allow a body part 42 to be captured by the envelope. Once this occurs, the envelope may be partially drawn through the wall 41 to render the opening in the envelope accessible so that the surgical procedure may be continued.

Usually a trocar will be employed in the surgical procedure and the envelope is partially withdrawn from the cavity and partially through the trocar to render the open end of the envelope accessible.

The surgeon now either directly grasps eyelets 21 or employs hooked tools for this purpose and imparts a sawing action to the cutting elements to cause them to cut through the body part and cut the body parts into segments. The number of segments produced in this way is directly dependant on the number of cutting WO 97/09922 PCT/AU96/00574 11 elements. The cutting elements, which form a cage like structure around the body part may then be completely withdrawn from the envelope and some of the segments produced by the sawing action will also be withdrawn from the envelope when this is done. The remaining segments are small enough to either be removed from the envelope by a suitable surgical tool such as forceps or the envelope may now be completely withdrawn from the body cavity and the surgery completed.

If the applicator is not used to introduce the envelope into the body cavity through a trocar lumen or the trocar is removed before the sawing action is commenced, it may be preferable to employ a guide like that shown in FIG. 5 during the sawing or cutting action to protect tissue surrounding the incision from damage being imparted by the cutting elements.

The guide 43 has an apertured body 44 with a disc and a tubular portion 46 extending from the underside of the disc and through the incision in the body wall. Handles 47, 48 allow the guide to be grasped. The eyelets and cutting elements pass through the guide. The tubular portion protects the patient from the cutting elements during the sawing action.

The surgical device allows body tissue and parts to be cut into portions small enough to be withdrawn through a trocar lumen yet allows these portions to remain large enough for pathological tests to be readily conducted on the tissue removed from the patient. Unlike the device of specification PCT/AU94/09487, the device of the present invention only requires a single incision. Of course additional incisions for other purposes still need to be made.

In the embodiment illustrated in FIGS. 6 and 7 there is provided surgical apparatus comprising a body member 50 of impervious sheet material adapted to be bonded at 51 to form a bag-like assembly. Laminated to the face of the body member 50 is a frangible layer 52 WO 97/09922 PCT/AU96/00574 12 being preferentially bonded at zones 53 to provide elongate pockets 54. A plurality of cutting wires are disposed in pairs between opposed termini 56, the respective pairs crossing over at 57 to provide for even morsellisation. The frangible membrane 52 is further sealed at 60 to capture the termini 56 for packaging.

The outer end portions 61 and body member 50 are configured to provide an enlarged opening 62 in the assembled bag of figure 6, the form of the end portions 61 being such that a gripping portion 63 is provided in the assembly. The termini are provided with loops 64 adapted to engage a cutting handle.

It will be appreciated that the above examples are illustrative only of the present invention and that modifications and alterations can be made thereto without departing from the inventive concept as defined in the claims appended hereto.

Claims (32)

1. Surgical apparatus for removal of bodily tissue from within a body cavity, the apparatus including: a flexible body member having a cavity adapted to receive a tissue to be removed; a plurality of flexible cutting elements located in said cavity, the cutting elements being adapted to provide a cufftting process to morcellate the tissue, and cutting element operating means extending out of said cavity.

2. Surgical apparatus according to Claim 1, wherein said flexible body member takes the form of a bag or pouch into which an organ or body tissue may be placed for removal from the patient during surgery.

3. Surgical apparatus according to Claim 2, wherein said flexible body 15 member is adapted to be inserted into patient through a lumen or incision.

4. Surgical apparatus according to Claim 3, wherein said body member is provided with extraction means. Surgical apparatus according to any one of the preceding Claims, wherein said body member is provided with a single opening portion for use as a collection port for the tissue and as an operating port through which the cutting element operating means may pass.

6. Surgical apparatus according to Claim 5, wherein said opening portion is of enlarged diameter relative to the remainder of the body member.

7. Surgical apparatus according to Claim 6, wherein said opening portion is adapted to be externalised of the patient during the cutting process.

8. Surgical apparatus according to Claim 7, wherein said opening portion and 'incision are protected by guide means adapted to protect the tissue surrounding the incision from damage from the cutting means. 14

9. Surgical apparatus in accordance with any one of the preceding Claims, wherein said cutting elements are selected from blades, garrotting or sawing wires or diathermy implements.

10. Surgical apparatus in accordance with Claim 9, wherein said cutting elements are associated with the interior surface of the cavity in such a way as to conform therewith for insertion into the patient and subsequent capture of the tissue.

11. Surgical apparatus according to Claim 10, wherein said cutting elements are releasably secured to an interior wall of the cavity.

12. Surgical apparatus according to Claim 11, wherein said cutting elements are secured in position on the cavity wall by a frangible inner membrane. *13. Surgical apparatus according to Claim 12, wherein said cutting 15 elements comprise woven wire strands secured by one or more ends to the 9*t° operating means located outside of the cavity.

14. Surgical apparatus according to Claim 13, wherein said wire strands are secured in pairs, adjacent strands crossing over in the distal end of the cavity. 20 15. Surgical apparatus in accordance with any one of the preceding Claims, wherein said cutting elements comprise wires and said operating means comprises a handle adapted to engage terminal ends of said wires.

16. Surgical apparatus according to Claim 15, wherein said handles are secured to the cutting members by complementary releasable engagement means.

17. Surgical apparatus in accordance with any one of the preceding claims in combination with an applicator means.

18. An applicator assembly including a housing having a delivery outlet, a plunger and a surgical apparatus of any one of Claims 1 to 17, the housing being adapted to contain the surgical apparatus, the plunger co-operable with said housing and adapted to deliver said surgical apparatus to said delivery outlet.

19. An applicator assembly according to Claim 18, wherein said surgical apparatus is selected to be collapsible into the housing. An applicator assembly according to Claim 19, wherein the housing is adapted to pass through a lumen or incision into a patient.

21. An applicator assembly including a housing having a delivery outlet and a surgical apparatus, the housing being adapted to contain the surgical apparatus; the surgical apparatus including a flexible body member having a cavity adapted to receive a tissue to be removed, a plurality of flexible cutting elements located in said cavity, the cutting elements being adapted to provide a cutting process to morcellate the tissue, and cutting element operating means extending out of said .cavity; and plunger co-operable with said housing and adapted to deliver said surgical apparatus to said delivery outlet. 0 1 *.0

22. An applicator assembly according to Claim 21, wherein said flexible body member takes the form of a bag or pouch into which an organ or body tissue may be placed for removal from the patient during surgery. 0 0 0

23. An applicator assembly according to Claim 21 or Claim 22, wherein said .0body member is provided with a single opening portion for use as a collection port for the tissue and as an operating port through which the cutting element operating 25 means may pass. l 06000:

24. An applicator assembly according to Claim 23, wherein said opening portion is of enlarged diameter relative to the remainder of the body member. An applicator assembly according to Claim 23 or Claim 24, wherein said opening portion is adapted to be externalised of the patient during the cutting process. 16

26. An applicator assembly according to any one of claims 21 to wherein said cutting elements are selected from blades, garrotting or sawing wires or diathermy implements.

27. An applicator assembly according to Claim 26, wherein said cutting elements are associated with the interior surface of the cavity in such a way as to conform therewith for insertion into the patient and subsequent capture of the tissue.

28. An applicator assembly according to Claim 27, wherein said cutting elements are releasably secured to an interior wall of the cavity.

29. An applicator assembly according to Claim 28, wherein said cutting elements are secured in position on the cavity wall by a frangible inner membrane.

30. An applicator assembly according to Claim 29, wherein said cutting 15 elements comprise woven wire strands secured by one or more ends to the operating means located outside of the cavity. wI

31. An applicator assembly according to Claim 30, wherein said wire strands are secured in pairs, adjacent strands crossing over in the distal end S Sl Sa of the cavity. 6 6a S• S.

32. An applicator assembly according to any one of claims 21 to 31, wherein said cutting elements comprise wires and said operating means S:°i comprises a handle adapted to engage terminal ends of said wires.

33. An applicator assembly according to Claim 30, wherein said handles are secured to the cutting members by complementary releasable engagement means.

34. An applicator assembly according to any one of claims 21 to 33, wherein the opening portion of the body member is configured such that the opening portion may be collapsed against an opening bias to be within the housing, whereby after deployment the opening opens for tissue capture. 17 An applicator assembly according to any one of claims 21 to 33, wherein said plunger is attached to the body member whereby the surgical apparatus may be manipulated thereby after deployment.

36. An applicator assembly according to Claim 35, wherein said plunger is adapted to enable the housing to pass over the end of the plunger remote from the body member, whereby the manipulation can occur without impediment of the housing.

37. An applicator assembly according to Claim 36, wherein said housing and plunger are provided with respective cooperating screw portions on the plunger and the housing, compelling a twisting action on the surgical apparatus.

38. Surgical apparatus substantially as hereinbefore defined with reference to the accompanying drawings. fot 15 39. An applicator assembly substantially as hereinbefore defined with reference to the accompanying drawings. o Dated this 1st day of December 1999 CUT SAFE PTY LTD By their Patent Attorneys 20 COLLISON CO. *ooo