AU756106B2 - Laparoscopic hernia repair - Google Patents

Description

WO 99/56664 PCT/AU99/00329 LAPAROSCOPIC HERNIA REPAIR Field of the Invention The present invention relates to a prosthetic device 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 by 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 hernia to provide reinforcement and support. Such patches are usually constructed as a single sheet and are held in place via staples, tacking device, or 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 ie 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. In one example, the patch is formed as a rolled up sheet of surgical plastic mesh WO 99/56664 PCT/AU99/00329 -2that is maintained in a rolled up form by two bands. Longitudinal slits are formed in one of the ends of the rolled up mesh to form multiple flared out flaps to which a sheet of plastic surgical mesh is secured. The rolled up part of the patch is then inserted through the internal ring and the sheet is fixed in position with a tacking device.

While there are many different types of hernia repair patches that are available on the market, most are somewhat complicated and difficult to implant via laparoscopic surgery. Furthermore, most patches rely on fastening means such as a tacking device or staples to hold them in place.

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 the Invention The present invention resides in a biologically compatible prosthesis for repairing or reconstructing a tissue or muscle wall defect, comprising: a first member, a second member, and a holding member wherein: the first and second members overlap in part to form a double layer of porous prosthetic repair material; the first member and the second member are engaged to each other via the holding member(s), in the region of overlap; and the holding member(s) is capable of being used for the purposes of (i) drawing at least a portion of the first and or second members through the tissue or muscle wall defect and (ii) fastening the prosthesis to the tissue under repair.

WO 99/56664 PCT/AU99/00329 -3- As used herein the members in the prosthetic includes any material that is substantially flexible, is of a single layer in the locality where the members overlap and of a substantially single layer in the remaining regions. A material that is of a substantially single layer includes materials where about 50%, 60%, 70%, 85%, 90%, 95% 99% or most preferably 100% of the member is of a single layer of material which material is when laid flat. Thus, the material may contain one or more ribs to provide additional support to the member when located in situ in a patient. In use, the material should be able to conform to the contours of muscle or tissue when positioned in situ. Most preferably the material exists in a flat state ex situ but due to its flexible properties is capable of being compressed.

As used herein "tissue or muscle wall defect" includes any separation in the tissue or muscle that has lead to a interstice, hole or gap being formed in that tissue such as that which would be formed from a hernia or the like.

While the present invention is described in such a way that the first member, and the second may each be separate unconnected members of the prosthetic, a person of ordinary skill in the field will appreciate that these members may also be connected together without departing from the spirit of the invention.

In a preferred embodiment of the invention the first and second members are joined via a bridging means formed of essentially the same material from which the members are constructed. The bridging means is preferably located in the general region where the members overlap when in use. Most preferably the bridging means engages the members in the same place where the holding means attaches to the members.

Thus, in one embodiment the invention consists in a biologically compatible prosthesis for repairing or reconstructing a tissue or muscle wall defect, comprising: a first member, a second member, a bridging member and a holding member wherein: the first and second members are joined by the bridging member; the first member, bridging member and the second member are folded on top of each other forming an overlap in that region; WO 99/56664 PCT/AU99/00329 -4the first member, bridging member and the second member are engaged to each other via the holding member(s), in the region of overlap; and the holding member(s) is capable of being used for the purposes of (i) drawing at least a portion of the first and or second members and the bridging member partially through the tissue or muscle wall defect and (ii) fastening the prosthesis to the tissue under repair.

In a particularly preferred form of the invention the first member and the second member are connected via a bridging member which provides an attachment point for the holding member. In use, the second member is folded over the first member. The second member is then folded back over the bridging member, therein forming three layers in the locality of the bridging member and two layers in the remaining locality where the first and second members overlap. The holding member can then be attached to the first member, the second member and the bridging member in the locality where each of these members over lap.

This may be achieved where the holding member is a suture cord by sewing the suture cord through each of the first member, the second member and the bridging member and then fastening it at the point of connection.

Generally, the first and second members may be of any shape or dimension.

Preferably, they are shaped such that in use, when a portion of the first and second members are drawn though the tissue or muscle wall defect the members overlap, in the region of the defect while at the same time covering the surrounding tissue without forming a substantial distortion to the layer of the member like that which might be formed from wrinkles or creases or crumpling of the members. Most preferably the members are of such a size and shape that they cover a substantial portion of the tissue in the general locality of the defect, and of a construction which allows them to conform to the contours of the tissue without crumpling in a way that leads to creases or a folding of the members.

It will be appreciated that the holding member(s) may be made from any material that is capable of securing the first and second members in place. In a preferred form of the invention the holding member is made of cord engaged (eg by sewing or tying) to the overlap between the first and second members. Most preferably, the cord is adapted to receive a needle capable of penetrating a patient's tissue.

WO 99/56664 PCT/AU99/00329 The cord may be for example suture cord or any other cord that is suitable for use in a patient.

In use, the holding member preferably passes through either the tissue or muscle wall defect or the internal ring where it may either engage the tissue in a fastening manner or pass back through the tissue in which the hernia is formed at a distance away from the hernia which equates to the size of either the first or second member. The holding member is then attached to the member, therein fastening the prosthetic in place. Any means for attaching the holding member to the member may be used. Most preferably the holding member is tied to the member.

While the present invention may be made with a single holding member, it will be appreciated that a plurality of holding members may be used in the invention.

Where a plurality of holding members are provided each member should be capable of passing through either the tissue or muscle wall defect or the internal ring and then back through the tissue in which the tissue or muscle wall defect is formed at a distance, away from the tissue or muscle wall defect, which equates to the size of either the first or second member to which it would attach.

In an alternative embodiment of the invention the first or second member may engage at least a securing means. In one form of this embodiment the securing member is adapted to pass through the tissue which the members cover and in which there is a tissue or muscle wall defect. The securing means and the holding member may then be connected (eg by tying or through any other means) therein holding the prosthetic in place.

In another form of this embodiment, the securing means may be a glue or glue like substance that is capable of binding or engaging the members with the tissue under repair. For example, the glue or glue like substance may be a fibrin based glue like tissel glue.

In a further embodiment there may be provided one or more engaging means attached to the first and or second member, which are capable of engaging the WO 99/56664 PCT/AU99/00329 -6first or second members to assist in defining the relative shape of the members when located in situ.

Preferably, the prosthetic is composed of a substantially porous prosthetic repair material that is capable of being compressed into an implanting condition such that it fits within a surgical tube and can be expanded upon deployment when brought into spacial proximity with the tissue or muscle wall defect which it is used to repair. In a particularly preferred form of the embodiment the porous prosthetic repair material may contain one or more ribs which serve to return the members to their shape when deployed into position.

While the first member and second member may be of any shape, they are each preferably cut to minimise folding or creasing when implanted in situ. In a highly preferred form of the invention, the first member is generally heart shaped while the second member is generally diamond shaped. When constructed in this manner, the heart shaped first member preferably overlaps with the diamond shaped second member at the top of the heart. Most preferably the second member is connected to the first member at the recess in the top of the heart.

The exact size and shape of the mesh material may be determined by the surgeon depending upon the particular repair being performed and the age and size of the patient. Desirably, the members are of such a size that they cover muscle tissue in the general locality in which there is a propensity for hernias to form.

In a particularly preferred form of the invention the mesh from which the prosthesis is formed needs to account for irregularities in the shape of the rupture. Thus the mesh should be capable of adapting to the slender configuration that approximates the shape of the defect. Moreover the mesh 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 The biologically compatible implantable prosthesis is preferable formed of knitted polypropylene monofilament mesh fabric, such as ProleneTM mesh or monocril WO 99/56664 PCT/AU99/00329 -7mesh. 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, TeflonTM (expanded PTFE) and MerseleneTM. Although a single layer knitted monofilament mesh fabric is preferred, the porus 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 in-growth. Moreover the material should be capable of some flexibility, enabling it to conform to the shape of the hernia.

In a further embodiment, the invention consists in a method of repairing or reconstructing a tissue or muscle wall defect, comprising the steps of: covering the tissue or muscle wall defect with a prosthesis as described above in such a manner that the region where the first and second members overlap is capable of protruding into over part or all tissue or muscle wall defect; drawing the holding member through either the tissue or muscle wall defect in such a manner that a portion of the overlapped first and second members are drawn through the tissue or muscle wall defect; and passing the holding member back through the tissue under repair in such a manner that the holding means engages either the first or second member and the tissue that is under repair.

Most preferably the invention is used for hernia repair operations. In such instances that the method of the invention is performed by an operator drawing the holding member through either the hernia or the internal ring depending on the type of hernia being treated. After the holding member has passed through the hernia a small portion of the first member and second member is also pulled through the hernia therein forming a plug. The remainder of the prosthetic is then flattened out over the tissue surrounding the area thus covering the direct hernia present or preventing future direct hernias from occurring. The holding means is then passed back through the surrounding muscle tissue so that it can be fastened to either the first member or the second member.

WO 99/56664 PCT/AU99/00329 -8- Best Mode of Performing the Invention The present invention is further described by the following non-limiting Figures and Examples. In the drawings: Figure 1 illustrates a prosthetic prepared according to the preferred form of the invention.

Figure 2 illustrates a prosthetic prepared according to the preferred form of the invention and the means by which it is inserted in place.

Figure 3 illustrates a prosthetic located in situ in a patient.

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

The following describes how the present invention and a method for using the invention in hernia repair operations. It should be understood by those of ordinary skill that the present invention may be used ot repair any hole, gap or interstice in tissue Figure 1 illustrates a prosthetic 2 (shown generally) prepared according to the preferred form of the invention, containing a first member 4, a second member 6 and a bridging member 8. In this example the bridging member 8 is provided as the connection between the first and second members and is attached within the recess at the top of the heart shaped arrangement of the first member 4 and to the bottom of the diamond shaped arrangement of the second member 6. Use of a bridging member 8 ensures that the first and second members remain together.

In use, the bridging member also provides a further (third) layer of structural support in the connection region 10 which is where the holding member (not shown) attaches. In the illustrated example the bridging member is shown as being postioned equidistant between the two sides of the first member. A person of ordinary skill in the field will appreciate that the bridging member need not be located in such a precise position but may be directed further towards one side of the first and second members as compared to the other side of those members.

WO 99/56664 PCT/AU99/00329 WO 99/6664 CT/AU-/093- -9- As can be seen from figure 1 the first member 4 is substantially greater in size compared to the second member 6 and is cut in a grotesque heart shape. The first member 4 is adapted in this way to cover tissue surrounding the hernia or if the prosthetic is placed through the internal ring, the hernia itself.

In use, the first and second members are folded over each other in the manner illustrated by the arrow 12 in the diagram. First, the bridging member and the first member are folded over the second member. Second, the first member is folded back over the bridging member (ie. away from the second member) therein forming three layers of material in the general locality of the bridging member, ie.

in the connection region 10. Further, when folded in this manner the upper portion 16 of the heart shaped first member and the bottom portion 18 of the diamond shaped second member overlap (not shown) therein forming a double layer of material in the overlap area 14. Such an overlap provides the prosthetic with an additional level of strength in this region.

Figure 2 illustrates the manner by which the prosthetic is applied to tissue to cover a hernia. The figure shows the flat abdominal muscles 21, the iliacus muscle 23, the psoas muscle 25, the iliac vessels 27, the vas 29. As can be seen from the diagram the holding means 20 passes through the internal ring 26. The holding means is then used to pull the prosthetic against the tissue and hernia 22 to be covered. Once the prosthetic has been layed out to cover the treatment zone 24 a small amount of the first and second members is then pulled through the internal ring therein forming a plug within the internal ring. The holding means is then passed back through the tissue covered by the prosthetic and attached to the first member. In each instance the connection of the holding member to the connection region and the first member is made via knots made using the holding member.

Figure 3 illustrates the prosthetic applied to tissue requiring treatment. From this illustration it can be seen that the prosthetic is applied to the treatment zone covering the hernia. Drawing numbers are according to figures 1 and 2.

According to the method of the invention a patient is anaesthetised and markings are made on the abdomen, anterior super iliac, spine, the pubic tubercle, the WO 99/56664 PCT/AU99/00329 inguinal ligament, and the femoral vessels. Markings are also made for the port sites. A 1cm incision was made below the umbilicus enabling the anterior rectus sheath to be opened. The rectus muscle was then pushed away to one side exposing the posterior sheath. A blunt 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 patient. This typically required from 20 pumps to pumps. The balloon was kept in position for 2-3 minutes then deflated and removed. A Hassons Cannula was then fixed into the extraperitoneal space and a 30-degree telescope was passed into the dissected space.

One 10-12mm port midway between the umbilicus and the pubic bone on the midline and another 5mm port just above the pubic bone lateral to the midline of the side of the hernia were then put in place. Further blunt dissections were made with graspers and the spermatic cord was dissected out. If an indirect sac is present it should be reduced (if necessary) and pushed upwards. If it is big, a part of the sac may be cut off leaving the remaining portion along with the spermatic cord in the Inguinal canal.

Once this has been achieved a 3(0) monocril suture on a straight needle was pushed from outside through the internal ring and grasped and pulled out with a grasper through the 10-12mm port. The first suture was then attached to the mesh near the bridging member.

Once the first suture has been connected to the mesh a second suture of monocril was passed from outside the patient about 5-8cm above the pubic tubercle near the mid line, through an I.V. cannula or through a Verhees Needle in the extra epritoneal space. The suture was pulled out from the extraperitoneal space through the 10-12 mm port. The first suture was kept taught by an assistant while a grasper was used to pick up the second suture thus preventing a loop being formed. Formation of a loop can prevent the present invention from unfolding properly. The second suture was then tied to the mesh towards the WO 99/56664 PCT/AU99/00329 -11medial end of the upper border, approximately 8-10cm away from the-previous suture, depending upon the size of the patient.

The mesh of the invention was then grasped with a non-toothed grasper over the first suture at the folded area and then pushed inside the 10-12 mm port and gradually pushed towards the Internal Ring along with the port. As mesh comes out of the port the first suture should be pulled simultaneously by.the assistant gently. As the mesh is pulled out of the port, the port also can also be gently pulled back towards the abdominal wall at the same time the second suture can be gradually pulled by the assistant. This facilitates the mesh to unfold easily.

Following this, the mesh should be flattened out in all directions.

After verifying that the mesh had covered the weakness area properly and the Indirect Sac was positioned proximal to the mesh, one grasper was left pushing the mesh against the anterior abdominal wall while gas in the peritoneum space mesh remains pressed flat against the abdominal wall. This process should be monitored via laparoscopic telescope. Once the gas has been released the grasper can be removed.

Finally a long needle or a Verhees needle without the obturator was pushed from Sthe medial suture point to the lateral suture point subcutaneously. The lateral suture was then threaded inside the needle, and the needle was pulled out bringing the lateral suture to the medial suture subcutaneously. The sutures were then loosely tied and cut. The knot was then pushed inside the subcutaneous layer. Following this all the wounds were sutured.

It should be understood that the foregoing description of the invention including the principles, preferred embodiments and Examples cited above are illustrative of 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 expressly intended that all such variations and changes which fall within this ambit are embraced thereby.

r AS' roughout the specification, unless the context requires otherwise, the word mprise" or variations such as "comprises" or "comprising", will be understood to ply the inclusion of a stated integer or group of integers but not the exclusion of any other integer or group of integers.

Claims (6)

1. A biologically compatible prosthetic for repairing or reconstructing a tissue or muscle wall defect, comprising: a first member, a second member, and a holding member wherein: the first and second members overlap in part to form a double layer of porous prosthetic repair material; the first member and the second member are engaged to each other via the holding member(s), in the region of overlap; and the holding member(s) is capable of being used for the purposes of (i) drawing at least a portion of the first and or second members through the tissue or muscle wall defect and (ii) fastening the prosthetic to the tissue under repair.

2. A prosthetic according to claim 1 wherein the first and second members are joined via a bridging member.

3. A biologically compatible prosthetic for repairing or reconstructing a tissue or muscle wall defect, comprising: a first member, a second member, a bridging member and a holding member wherein: the first and second members are joined by the bridging member; the first member, bridging member and the second member are folded on top of each other forming an overlap in that region; the first member, bridging member and the second member are engaged to each other via the holding member(s), in the region of overlap; and the holding member(s) is capable of being used for the purposes of (i) drawing at least a portion of the first and or second members and the bridging member partially through the tissue or muscle wall defect and (ii) fastening the prosthetic to the tissue under repair.

4. The prosthetic according to claims 1 or 2 wherein there is engaged to either of the members a securing means that is adapted to engage the holding means to secure the prosthesis to the tissue under repair. WO 99/56664 PCT/AU99/00329

13- The prosthetic according to claims lor 2 wherein the members comprise substantially porous prosthetic repair material. 6. The prosthetic according to claim 5 wherein the substantially porous prosthetic repair material is adapted to be compressed so that it fits into an implanting condition such that it fits within a surgical tube and is capable of expanding either by itself or with assistance upon deployment. 7. The prosthetic according to claim 1 wherein the first member and second member are each cut to minimise folding or creasing when implanted in situ. 8. The prosthetic according to claim 7 wherein the first member is generally heart shaped 9. The prosthetic according to claim 7 wherein the second member is generally diamond shaped. The prosthetic according to claim 7 wherein the first member is generally heart shaped and the second member is generally diamond shaped. 11.The prosthetic according to claim 1 wherein the first member and the second member overlap at the depression at the top of the heart. 12.A method of repairing or reconstructing a tissue or muscle wall defect, comprising the steps of: covering the tissue or muscle wall defect with the prosthetic as claimed in any one of the preceding claims in such a manner that the region where the first and second members overlap covers crosses over part or all tissue or muscle wall defect; drawing the holding member through either the tissue or muscle wall defect in such a manner that a portion of the overlapped first and second members is drawn through the tissue or muscle wall defect; and passing the holding member back through the tissue under repair in such a manner that the holding means engages either the first or second member and the tissue that is under repair. WO 99/56664 PCT/AU99/00329 -14- 13.A method according to claim 12 wherein the invention is used to repair hernia of either a direct or indirect nature.

14.A biologically compatible prosthetic according to claim 1 substantially as herein before described with reference to the example. method according to claim 12 substantially as herein before described with reference to the example. **o