AU5012801A - Mesh with spreader and fixation in laparoscopic hernia repair - Google Patents

Description

P/00/011 28/5/91 Regulation 3.2

AUSTRALIA

Patents Act 1990

ORIGINAL

COMPLETE SPECIFICATION STANDARD PATENT Name of Applicant: Actual Inventor Address for service is: Bose Nominees Pty Ltd Ganendra Coomer Bose WRAY ASSOCIATES 239 Adelaide Terrace Perth, WA 6000 Attorney code: WR Invention Title: Mesh with Spreader and Fixation in Laparoscopic Hernia Repair Details of Associated Provisional Application No(s): PQ8000 filed on 2 June 2000 PQ9488 filed on 17 August 2000 The following statement is a full description of this invention, including the best method of performing it known to me:- -2- MESH WITH SPREADER AND FIXATION IN LAPAROSCOPIC HERNIA

REPAIR

The present invention relates to a prosthetic device(s) for use in the surgical repair of hernias and more particularly to a method for repairing medical afflictions such as hernias using the prosthetic device.

Background art Hernia repairs are one of the most commonly performed operations in western society. In the United States alone an estimated 600,000 to 700,000 hernia repairs are performed each year. Unfortunately, hernia repairs are also one of the more commonly repeated surgeries. Repairs are commonly needed where the initial repair does not reinforce the hernia or the repair breaks down because of additional strain in the locality of the hernia.

Many different medical devices have been put forward over the last century as possible solutions to this problem. All have sought to provide different methods of hernia repair.

One way in which hernia repairs have been improved upon is making a tension free repair through the use of mesh or other material to reinforce the site in which hernias occur. A variety of different mesh materials have been put forward for this possible use, with MarlexTM and ProleneTM meshes being the most popular and commonly used in these types of operations.

Generally, the mesh is fashioned in the form of a patch that is placed over the Shernia to provide reinforcement and support. Such patches are usually constructed as a single sheet and are held in place via staples, tacking device, or tissue glue sutures. The main problem with this form of prosthetic repair is that sutures are difficult to apply via laparoscopic surgery and there is a great likelihood that the repair will break due to failure to make the repair anatomical i.e.

the mesh not providing protection in the potential weakness areas. To overcome these problems various alternative prosthetic mesh patches have been proposed which are located either in part or in whole within the hernia.

-3- A further problem with the use of mesh alone to repair the hernia is encountered in positioning the mesh in place. The mesh has a tendency to bulk up instead of forming a single layer. There are further difficulties experienced in inserting the mesh to the desired area through the ports and delivery of the mesh via the transverse delivery tube.

In light of these problems there exists a need for an improved prosthetic for use in hernia repair, which is capable of ameliorating some or all of the disadvantages associated with the prior art. The present invention seeks to provide such a prosthetic together with a method for its use.

Throughout this specification, unless the context requires otherwise, the word "comprise", or variations such as "comprises" or "comprising" will be understood to imply the inclusion of a stated integer or group of integers, but not the exclusion of any other integer or group of integers including method steps.

Description of Invention The present invention resides in a prosthesis for repairing or reconstructing a *.*tissue or muscle wall defect, comprising: a material suitable for reconstructing the tissue or muscle wall defect, which is of sufficient size to at least cover the defect and which is adapted to releasably engage a material spreader, and (ii) at least a material spreader which is capable of being removed or released from the material when located in situ in a patient.

The spreader employed in the present invention should be capable of spreading the prosthetic material when located in situ in a patient and should be capable of being released or separated from the material following insertion. A wide variety of spreaders may be used in the present invention. For example, the spreader may comprise one or more inflatable members (eg a tube or bag) engaged to the prosthetic material about its periphery or in such a manner that permits effective spreading of the material when it is inflated. Inflation of the inflatable member(s) may be achieved by any suitable means. Preferably, inflation is achieved by the use of a pump such as a hand pump that is connected to the member(s). In such an example, the hand pump preferably also has a release valve providing the user -4with a means for deflating the member(s) when the material has been correctly positioned. Once deflated or at least partially deflated the inflatable member(s) may be removed or separated from the prosthetic material. Alternatively the inflatable member may be left in situ if the member is prepared from a material that is biodegradable when located in a patient.

In an alternate form, the spreader(s) may consist of a substantially flexible or deformable material that is capable of retaining a memory such that when it is placed in close proximity to the tissue or muscle wall defect it is capable of expanding or stretching the prosthetic material sufficiently to at least cover the defect. Most preferably, it expands the material sufficiently to also cover the tissue surrounding the defect.

For ease of delivery, preferably, the spreader(s) is composed of a substantially flexible or deformable material that is capable of being compressed into an implanting condition such that it is capable of fitting within a surgical tube and can be expanded upon deployment when brought into spatial proximity with the tissue or muscle wall defect which it is used to repair.

In a highly preferred embodiment of the invention, the spreader(s) is made from a biologically compatible implantable material. For example, it may be formed from any metallic or non-metallic material capable of expanding the prosthetic material.

If, for example, the spreader is made of a metal or metal-like material, it may be made of stainless steel or nickel-titanium alloy. Alternatively, the spreader may be made of a non-metallic material such as a heavy gauge fishing line or molded plastic or biodegradable suture material or like materials. When such material is used in the invention the material should be adapted to ensure delivery of the mesh and spreader to the site of repair and be capable of easy removal of the spreader from the site of repair if needed. Moreover, the spreader material should be capable of flexibility, enabling the mesh to conform to the shape of the hernia.

The spreader may be releasably engaged with the material by any means that is capable of temporarily holding the spreader and the material together during delivery of the material to the tissue or muscle wall defect. By way of example, the spreader may be attached to the periphery or other sections of the material by means such as clips, pockets, hems or sutures. The points of attachment need only be sufficient to hold the spreader in position until its removal is required. The location of the spreader on the material and the points of its attachment to the material should preferably be such as to allow the material to be folded for laparoscopic insertion, unfolded at the site of repair and then allow easy removal of the spreader after the material has been positioned.

In one preferred form of the invention the spreader is releasably engaged with the material through the use of one or more hems located at or near the periphery of the prosthetic material. For example, if the material generally has a number of sides or is of a circular or oval shape at least two of sides that are generally opposite each other may possess hems that extend either part or all of the way along the material periphery to form a housing for the spreader. The spreader is preferably located in part within each of the hems in such a manner that permits the spreader to expand the material when located in situ and which allows removal of the spreader. Once located in place the spreader may then be separated from the material by pulling it out of each hem.

In an alternate example the spreader may consist of a flexible elongate member that is generally bent in a U-shape comprising two ends that are spatially separated from each other and which are adapted to engage in a releasable manner the prosthetic material. One example of such a flexible material might be heavy gauge fishing line. Located at the each end of the flexible member is at least one orifice through which a suture may pass. In use the flexible member l may be releasable engaged to the material by tacking the suture to the material about each end of the flexible member. Additional tacking stitches may then be made around the material and the flexible member to hold the flexible member °*oo and the material together. Preferably only one additional stitch is provided to hold the flexible member and the material together. In use, after the spreader has expanded the material in situ a surgeon may separate the spreader and the material by simply cutting the suture(s) that hold the material and the flexible member together.

In a further example of the manner in which the spreader may be releasably engaged to the mesh, the mesh may have a tube like structure associated with it, -6which is formed on or near the periphery of part of the mesh structure. It will be appreciated that the relative location of the tube is not particularly important provided it is capable of housing a spreader which is capable of at least partially spreading the mesh when place in situ. Desirably the tube: is adapted to receive the spreader, has apertures in its surface which permit the passage of fluid from the inside of the tube to the outside of the tube and is made of mesh material or absorbable material. Most preferably the tube will have a sufficient number of aperture to allow release of any fluid inside the tube, but the number of apertures will not be so great that any fluid forced into the tube when the mesh is located in situ will not be able to flow to the end of the tube before being expelled from the tube.

Where the Mesh is provided with a tube like arrangement of the type discussed in the previous paragraph the spreader may, for example, be elastic material like

NITINOL

T M or stainless steel wire (eg guide wire material) or even stiff nylon material or any other like suitable material. Once the material and the spreader are located in situ the spreader should be separated from the mesh. Once separated tissue glue may be introduced into the tube in a manner which leads to *•the passage of glue through the tube and which forces the glue out of the tube enabling it to bind to closely associated tissue.

material used in the invention is preferably prepared from a biologically compatible implantable material such as a knitted polypropylene monofilament mesh fabric, such as ProleneTM mesh. Other biologically compatible soft tissue reconstruction or repair material, having openings for ingrowth are contemplated within the scope of the invention are, without limitation, MarlexTM, DacronTM, Teflon T M (expanded PTFE) and Merselene T M Although a single layer knitted monofilament mesh fabric is preferred, the porous prosthetic repair material may alternatively be formed of multi-filament yarns in a woven or braided arrangement.

When such material is used in the invention the material should be adapted to ensure porosity for tissue ingrowth. Moreover the material should be capable of some flexibility, enabling it to conform to the shape of the hernia.

-7- The exact size, shape and thickness of the material should be determined by the surgeon depending upon the particular repair being performed and the age and size of the patient. The exact size and shape of the removable spreader may be determined by the size and shape of the material used during the repair.

Desirably the material and its spreader are of such a size that the material covers muscle tissue in the general locality in which there is a propensity for tissue or muscle damage to form.

In a particularly preferred form of the invention the material and removable spreader from which the prosthesis is formed needs to account for irregularities in the shape of a defect. Thus the material and the removable spreader should be capable of adapting to the slender configuration that approximates the shape of the defect. Moreover the material and the spreader should preferably be compressible into varying shapes and sizes allowing a single or at most a nominal range of sizes to be indicated for the repair of most commonly occurring inguinal defects and soft tissue reconstruction, after which time the spreader may be removed, leaving the material in position except when the spreader is of absorbable suture material.

In use, the prosthetic material, together with the removable spreader, are brought in to close proximity to a tissue or muscle wall defect, such as a hernia in the internal ring depending on the type of hernia being treated. This may be achieved by any means known in the art. For example it may be achieve by simply deforming the shape of the spreader in such a way that permits its delivery and •passage to the tissue or muscle wall defect though an orifice created in the patient. Desirably the spreader is delivered through a laparoscopic tube or a tube of like design that is adapted for insertion into a patient. Delivery of the spreader thought the use of such a tube may be achieved by pulling it through the laparoscopic tube by attaching at least a suture to the prosthetic and by passing a length of suture line along the length of the laparoscopic tube. By simply locating the end of the laparoscopic tube in the patient near the defect a surgeon can pull a suture line through the laparoscopic tube to deliver the prosthetic to the locality requiring surgical repair. Alternatively this can be done by pushing the prosthetic through a laparoscopic tube by use of a plunger attached to the spreader and -8mesh. When located in situ the prosthetic is extracted from the laparoscopic tube, which preferably allows it to expand. The spreader may then be removed from the prosthetic material. After removal of the spreader, the material preferably may not necessarily require any further fixation when used in extraperitoneal space.

In an embodiment of the invention the prosthetic material and the releasably engaged spreader may be compressed and housed within a delivery vehicle which is adapted to deliver the material and spreader to the defect. Preferably the delivery vehicle is a tube like member that has a diameter which is capable of traversing a laparoscopic tube, but which is wide enough to house the material with its spreader. Where the material and spreader are housed within such a delivery vehicle, preferably the spreader activates to expand the material as it is removed from the vehicle. Alternatively, where the spreader is an inflatable member the vehicle and or inflatable member may be connected to an inflation and or deflation means, which is adapted to expand the prosthetic material upon release from the vehicle. In addition to housing the material and spreader the delivery vehicle may contain one or more members which are adapted to either pull or push the vehicle through a suitable laparoscopic tube.

o. Once delivered to the tissue or muscle wall defect the spreader should be capable of expanding the material when released from its deformed state. Thus, when pulled or pushed from a laparoscopic tube the material and spreader should be Secapable of automatically expanding the material.

ooo Once located in close proximity to the defect the remainder of the material may be flattened out over the tissue surrounding the defect. The material may then be fastened where appropriate and the spreader may be carefully removed, leaving **the material in position.

The present invention is further described by the following non-limiting Figures o oe and Examples. In the drawings: Figure 1 illustrates generally a prosthetic in accordance with the present invention.

Figure 2 illustrates a prosthetic housed within a delivery vehicle.

-9- Figure 3 illustrates a spreader consisting of a flexible elongate member bent in a U-shape.

Figure 4 illustrates a prosthetic containing a spreader with orifices.

Best Method of Performing the Invention Further features of the present invention are more fully described in the following Examples. It is to be understood, however, that this detailed description is included solely for the purposes of exemplifying the invention, and should not be understood in any way as a restriction on the broad description as set out above.

Example 1 Figure 1 illustrates a prosthetic 2 (shown generally) prepared according to the invention, containing a prosthetic material member 4, and a spreader member 6.

In this example, prosthetic material member 4 and the spreader 6 are releasably engaged by means of a hem 8 sewn around a portion of the periphery 10 of the material. Alternatively the borders of mesh can be curled up by heat for accommodating the spreader. Located within the hem 8 is the spreader 6 :It can be seen from the Figure 1 that the hem 8 does not completely pass around the periphery 10 of the prosthetic material member 4. A portion 12 of the spreader 6 is exposed (ie it is not covered by a hem). As illustrated the exposed portion of spreader 6 should be of sufficient size to allow it to be grasped by a grasping means. Further, the gap 14 in the hem where the spreader is exposed .°*-*should be of sufficient size to provide for withdrawal as well as introduction of the ee66 spreader from the hem when located in situ.

::Figure 2 illustrates a preferred means for delivery of the prosthetic. In this embodiment the prosthetic 20 including the spreader and the prosthetic material member are deformed in shape and are inserted into a delivery vessel 22 that is of sufficient shape and size to fit within a laparoscopic tube 24.

In use, the vessel 22 may be delivered to the tissue or muscle wall defect by passage through a laparoscopic tube 24. Where necessary, the delivery vessel 22 and or prosthetic may possess a means adapted for pulling the vessel through the laparoscopic tube. For example, the prosthetic or vessel may be adapted with a tab 26 to which is attached a suture or cotton like material 28 that is capable of being grasped to pull the vessel and or prosthetic material member 20into close proximity to the tissue or muscle wall defect.

Once in close proximity to the tissue or muscle wall defect the prosthetic material member 20 may be separated from the delivery vessel 22 and the delivery vessel 22 may be removed from the site of operation. The prosthetic material member and the spreader 20 may be separated from the delivery vessel 22 by the same suture or cotton like material 28 that was used to pull the delivery vessel through the laparoscopic tube. Alternately the prosthetic material member and the spreader may be pulled from the laparoscopic tube by using laparoscopic graspers that are capable of pulling the prosthetic from the tube.

Removal of the delivery vessel may be achieved using any means known in the art for example by attaching a piece of string or cotton like material to the vessel and then using that to pull the vessel back through the laparoscopic tube.

Alternatively the vessel may possess one or more means to hold it within the end or tip of the laparoscopic tube. Upon release from the delivery vessel the spreader expands the prosthetic material to cover the tissue or muscle wall defect.

In an example of the invention the spreader can be a flexible deflated tube made of Bio-Compatible and or Bio-Degradable material being attached to the part or whole of the periphery of the mesh material. After introduction into the body cavity the mesh can be inflated with air and or gas pressure making it automatically become stiffer. This will act as a spreader and will unfold the mesh .oo.

*providing a barrier over the body wall defect.

*o":Figure 3 illustrates a spreader member 6 that is bent in a U shape comprising two *ends 36 and 37 that are spatially separated from each other and which are adapted to engage in a releasable manner the prosthetic material. Located at each end of the spreader member 6 are orifices 34 and 35 through which a suture may pass.

-11- Figure 4 illustrates a prosthetic 2 prepared according to the invention, containing a prosthetic material member 4 and a spreader member 6. The spreader member 6 is bent in a U shape comprising two ends that are spatially separated from each other and which are adapted to engage in a releasable manner the prosthetic material member 4. Orifices 30 and 31 in the prosthetic material are provided through which the ends 36 and 37 of spreader member 6 initially passes through.

The ends 36 and 37 of spreader member 6 then passes under the prosthetic material member 4 to emerge and pass through orifices 32 and 33 in the prosthetic material. The spreader member 6 is then releasably engaged to the prosthetic material member 4 by tacking the suture to the material about each end 36 and 37 of the flexible member.

Example 2 According to the method of the invention a patient was anaesthetised and markings made on the anterior superior iliac spine, the pubic tubercle, the inguinal ligament, and the proposed sites of a number of ports.

A subumbilical incision was made to reach the posterior rectus sheath. A blunt O. dissection was then performed; first with a finger, then a 10mm blunt obturator was pushed down the midline and a blunt dissection was carried out in the extraperitoneal space up to pubic bone. A balloon made of a finger stall cut off from size 8 gloves which was tied onto a size 16 Foley's Catheter, was then inserted into the extraperitoneal space and inflated according to the size of the 6 patient. This typically required from 20 pumps to 35 pumps. The balloon was kept in position for 2-3 minutes then deflated and removed. A Hassons Cannula :.oo was then fixed into the extraperitoneal space and a 30-degree telescope was passed into the dissected space.

Two ports were then positioned, one 10 to 12 mm midway between the umbilicus and the pubic bone and another port 5 mm away from the midline, at the suprapubic, on the opposite side of the hernia. A further blunt dissection determined the type of hernia.

-12- In the event that there was an indirect sac present, the sac was removed by dissection from the spermatic cord, reduced and pushed back towards the abdomen. If the indirect sac was large, it was necessary to remove part of the distal sac by dissection and leave the remainder with the spermatic cord.

A straight needle of 3/0 monocryl suture was passed through the internal ring percutaneously, grabbed by a grasper and pulled out through the 10 to 12 mm port. This suture was then passed through the folded junctional area of the specially designed mesh. The suture was then tied to a separate tiny piece of mesh. That is, when the other end of the suture is pulled, the junctional area of the mesh is pulled into the internal ring area. Prior to passing this suture through, the mesh was cut into specially designed shape from 15/15 cm prolene mesh, folded at the junctional area and the area then tied by a separate suture.

An elasticised spreader was positioned along the perimeter of the mesh, and held in place by pockets made on the superior and inferior borders of the mesh. The suture positioned through the internal ring was passed through the mesh as previously described. The medial curved end of the mesh was grasped along with the spreader and pushed into the 10 to 12 mm port until the medial end of the mesh popped out of the port towards the symphyis pubis. A second grasper, positioned out of the suprapubic port, grasped this end of the mesh (with the stiffener) whilst the first grasper released the mesh and was removed.

The medial end of the mesh while being held at the pubic bone and the port containing the mesh is gradually pushed laterally towards the internal ring. The mesh automatically spread out over the repair site as it comes out of the port.

The outer end of the suture near the groin is pulled with the aid of an assistant until the junctional area of the mesh was pulled out of the port and positioned at the internal ring. When the suture is pulled from the junctional area of the mesh forms a cone like shape and acts as a plug at the internal ring.

The mesh may, on occasions, require to be spread out slightly with the graspers.

However, once it was verified that the mesh adequately covered the direct weakness and the internal ring, the spreader was removed by grasping near the -13medial curved portion, carefully avoiding the mesh. As the stiffener was removed by pulling, the 10 mm port was pushed toward the mesh, thus aiding in the removal of the spreader. At the same time, another grasper steadied the mesh in position once the stiffener has been totally removed.

One or two graspers held the mesh in position whilst the gas was let out and the peritoneum was allowed to come into contact with the anterior abdominal wall.

Finally, the graspers were removed from the peritoneum and a long needle or a Verhees needle was pushed from the suprapubic port used to the exit point of the suture subcutaneously and the end of the suture grasped. The needle with the suture was pulled out and then the suture was left in that position and cut short.

Finally all wounds were sutured. Alternatively the mesh can have two sutures attached, one at the junctional area another near the medial end. Either one or both sutures can be housed in the pockets made on the borders of the mesh in a way that the end of the suture pointing out of the pocket. The sutures can be unfolded or stretched out by pulling on the free end. And if necessary the pockets can be on different sides of the mesh thus allowing the easy pull out of the suture without getting entangled. If the upper pocket is on Side A then the lower pocket will be on Side B.

It should be understood that the foregoing description of the invention including the principles, preferred embodiments and Examples cited above are illustrative of *.l.*the invention and should not be regarded as being restrictive on its scope.

Variations and modifications may be made to the invention by others without departing from the spirit of that which is described as the invention and it is oleo expressly intended that all such variations and changes which fall within this ambit are embraced thereby.

Claims (25)

1. A prosthesis for repairing or reconstructing a tissue or muscle wall defect, comprising: a material suitable for reconstructing the tissue or muscle wall defect, which is of sufficient size to at least cover the defect and which is adapted to releasably engage a material spreader, and (ii) at least a material spreader which is capable of being removed or released from the material when located in situ in a patient.

2. A prosthesis according to claim 1 wherein the spreader comprises one or more inflatable members engaged to the prosthetic material in such a manner that permits effective spreading of the material when it is inflated.

3. A prosthesis according to claim 1 or 2 wherein the spreader consists of a substantially flexible or deformable material that is capable of retaining a memory such that when it is placed in close proximity to the tissue or muscle wall defect it is capable of expanding or stretching the prosthetic material sufficiently to at least cover the defect.

4. A prosthesis according to claim 3 wherein the spreader expands the material sufficiently to also cover the tissue surrounding the defect. A prosthesis according to any one of the preceding claims wherein the spreader is composed of a substantially flexible or deformable material that is o **,capable of being compressed into an implanting condition such that it is capable of fitting within a surgical tube and can be expanded upon deployment when brought into spatial proximity with the tissue or muscle wall defect which it is used to repair.

6. A prosthesis according to any one of the preceding claims wherein the spreader is biologically compatible implantable material.

7. A prosthesis of claim 6 wherein the spreader is formed from any metallic or non-metallic material capable of expanding the prosthetic material.

8. A prosthesis according to claim 7 wherein the spreader is made of stainless steel or nickel-titanium alloy.

9. A prosthesis according to claim 7 wherein the spreader is selected from the group consisting of heavy gauge fishing line, molded plastic, biodegradable suture material or like materials. prosthesis according to any one of the preceding claims wherein the spreader is releasably engaged with the material through the use of one or more hems located at or near the periphery of the prosthetic material.

11.A prosthesis according to any one of the preceding claims wherein the spreader is located in part within each of the hems in such a manner that permits the spreader to expand the material when located in situ and which allows removal of the spreader.

12.A prosthesis according to any one of the preceding claims wherein the spreader consists of a flexible elongate member that is generally bent in a U- .•.-.shape comprising two ends that are spatially separated from each other and :.:":which are adapted to engage in a releasable manner the prosthetic material.

13.A prosthesis according to claim 12 wherein located at each end of the flexible oooo member is at least one orifice through which a suture may pass.

14.A prosthesis according to any one of the preceding claims wherein the mesh lol* may have a tube like structure associated with it, which is formed on or near ~the periphery of part of the mesh structure. OO prosthesis according to claim 14 wherein the tube: is adapted to receive the spreader, has apertures in its surface which permit the passage of fluid from the inside of the tube to the outside of the tube and is made of mesh material or absorbable material. -16-

16.A prosthesis according to claim 15 wherein the tube will have a sufficient number of aperture to allow release of any fluid inside the tube, but the number of apertures will not be so great that any fluid forced into the tube when the mesh is located in situ will not be able to flow to the end of the tube before being expelled from the tube.

17.A prosthesis according to any one of claims 14 to 16 wherein the spreader is made from material selected from the group consisting of NITINOL T M stainless steel wire and stiff nylon material.

18.A prosthesis according to any one of the preceding claims wherein the material used in the invention is prepared from a biologically compatible implantable material.

19.A prosthesis according to claim 18 wherein the material is prepared from a knitted polypropylene monofilament mesh fabric.

20.A prosthesis according to claim 18 wherein the porous prosthetic repair material is formed of multi-filament yarns in a woven or braided arrangement.

21.A prosthesis according to any one of the preceding claims where in the material and its spreader are of such a size that the material covers muscle tissue in the general locality in which there is a propensity for tissue or muscle damage to form.

22.A prosthesis according to any one of the preceding claims wherein the :•:material and removable spreader from which the prosthesis is formed needs to S- account for irregularities in the shape of a defect.

23.A prosthesis according to any one of the preceding claims wherein the prosthetic material and the releasably engaged spreader may be compressed and housed within a delivery vehicle which is adapted to delivery the material and spreader to the defect. -17-

24.A prosthesis according to claim 23 wherein the delivery vehicle is a tube like member. method of delivering the prosthesis in close proximity to the defect comprising the following steps: delivery of the prosthetic to the site of defect through a tube member (ii) extracting the prosthetic from the tube member; and (iii) removing the spreader from the prosthetic material.

26.A method according to claim 25 wherein the prosthesis is a prosthesis according to any one of claims 1 to 24.

27.A method according to claim 25 or 26 wherein the tube member is a laparoscopic tube.

28.A prosthesis according to claim substantially as described in Example 1. 28.A prosthesis according to claim 1 substantially as described in Example 1 DATED this FIFTH day of JUNE 2001 BOSE NOMINEES PTY LTD Wray Associates *0 0 Perth, Western Australia

29.Patent Attorneys for the Applicant III! Patent Attorneys for the Applicant