Hernia mesh patches

Surgically implantable mesh patches for the repair of inguinal and other abdominal wall hernias, which are intended for permanent placement within a patient's body space, have been provided and used previously as set forth, for example, in the following US patents:

In 1954, Benjamin F. Pease, Jr., in his patent US 2,671,444 illustrated and described his non-metallic mesh surgical insert for hernia repair, comprising a sheet of relatively fine uniform, open mesh work of a durable, permanently pliable, nontoxic radiation permeable resinous material, which was compatible with body tissues and fluids, and inert chemically with respect thereto. All the joints of the mesh work were preferably unitary, in consequence of which the surgeon could trim the sheet of open mesh work to any desired size and shape, without any danger of it unravelling. The cut edge provided an adequate strong portion for suturing the mesh work to the patient's body tissues at any convenient location. The mesh work itself promoted the ready growth therethrough of the patient's own repair tissue. The mesh work insert was adapted to remain permanently in the patient's body, facilitating the body's own efforts to repair the hernia, and minimizing the chance of reoccurrence, without the danger of future difficulties because of irritation, corrosion, or the like.

In 1962, Francis C. Usher in his patent US 3,054,406, illustrated and described his improved surgical mesh which was intended to be held in place by sutures. His surgical mesh was made of a polyethylene thread, free of water leachable irritant impurities and having a tensile strength of at least 50,000 p.s.i., and a weight from 100 to 500 denier. The threads of this improved surgical mesh were spaced at intervals in the range of 5 to 50 mils. These threads were unattached to each other at their points of crossing. This improved surgical mesh was physiologically inert even in the presence of any possible infection.

In 1982, Francis C. Usher in his patent US 4,347,847 continued describing and illustrating his improvements in providing surgical mesh and the method of the use thereof in hernia repair. In his method of repairing hernias and other defects of the abdominal and chest wall, he placed a tubular surgical mesh over the defect in its flattened form to provide continuous border edges. The tubular surgical mesh was of a size sufficient to bridge the defect, and to position the continuous border edges thereof on tissue adjacent the opposite sides of the defect, free of selvage edges. He then sutured through the mesh adjacent the continuous border edges of the tissue. The surgical mesh was comprised of monofilament threads which were free of water leachable irritant impurities and were physiologically inert, even in the presence of infection. The monofilament threads had a tensile strength sufficient, when doubled, to withstand wound tension. The threads of the mesh had a diameter in the range of 5 to 15 mils. The mesh was formed having 10 to 20 stitches per inch, and during the formation of continuous tubular shape was created. The threads were unattached to each other at their points of crossing. The threads were made of a polypropylene monofilament.

In 1992, Mark A. Eberbach in his patent US 5,116,357 illustrated and described his hernia plug and introducer apparatus. Mr. Eberbach provided, via a laparoscopic system, a plug and patch assembly comprising a cylindrical plug of flexible material, positionable in an opening in the abdominal wall to be repaired, with the plug being in contact with the opening. The plug had a distal end and a proximal end. Then there was a patch of an inextensible and flexible mesh material to be positioned over weakened portions of the abdominal wall adjacent to the opening. A central extended portion of the patch was coupled to the proximal end of the cylindrical plug, with the periphery of the patch being remote from the plug, and constituting a flange. Then a resilient small cross-sectional diameter adjustable loop of ribbon material, constructed of surgically antiseptic material, was used to keep the patch extended in the intended location thereof, both over and beyond the weakened portions of the abdominal wall. A surgeon using conventional laparoscopic techniques finally positioned the patch, after the initial placement of this loop of ribbon material.

Also in 1992, Mark A. Eberbach in his patent US 5,122,155 illustrated and described another of his hernia repair apparatus and method of use. His laparoscopic repair of abdominal hernias by a surgeon, through patching of a weakened portion of the abdominal part to be repaired, comprised the steps of: "providing a patch formed of flexible, inextensible material and positionable in a plane adjacent to the weakened portions of the abdominal part to be repaired, the patch having an elongated passageway located in the plane of the patch adjacent to the majority of the periphery of the patch, the passageway having an opening at one end thereof, providing an elongated interior ribbon having a distal end positioned through the opening of the passageway and slidable within the passageway, the ribbon being sufficiently rigid whereby it may be remotely pushed into the passageway, providing an elongated intermediate cylindrical plunger having an interior slidably receiving the ribbon, the plunger having a distal end coupled to the patch and a proximal end to be manipulated by the surgeon, providing an elongated exterior cylindrical sheath having an interior slidably receiving the plunger, the ribbon and the patch, the sheath having a distal end adjacent to the patch and a proximal end to be manipulated by the surgeon, the sheath being of a length to extend from exterior of a patient through a laparoscopic port into a surgical cavity which includes the part to be repaired, positioning the patch and distal ends of the ribbon, plunger and sheath into a patient adjacent to the area to be repaired, advancing the patch and plunger from the sheath, advancing the ribbon into the passageway of the patch to expand the patch, coupling the patch to the area to be repaired, withdrawing the ribbon from the patch, separating the patch from the plunger, and withdrawing the ribbon, plunger and sheath from the patient".

Also in 1992, Alfredo Fernandez illustrated and described in US-A-5,147,374 his prosthetic mesh patch for laparoscopic hernia repair. His mesh patch, which was inserted through the opening in the patient to be repaired, was a rolled up sheath of surgical plastic mesh maintained in a rolled up form by attaching at least two bands around it. Then he made multiple longitudinal cuts in the first end of this rolled up mesh to form multiple flared out flaps. The flaps were then stitched to a planar sheet of plastic surgical mesh. The overall patch was then inserted into the patient's opening, by using a second end of the rolled up sheet of surgical plastic. In this way, the rolled portion of the patch entered the patient's opening, and the flaps and the planar sheet of plastic surgical mesh were displayed out over an entrance to the patient's opening. Thereafter, the planar sheet of plastic surgical mesh was stapled to adjacent tissue of the patient to retain the patch in position.

In 1993, Arnold S. Seid in his patent US 5,254,133 illustrated and described his surgical implantation device and related method of use to seal an enlarged, generally circular opening in the wall of one of the patient's body cavities. He provided a surgical implantation device having a generally planar first portion and a second portion which were interconnected by a connecting segment. He then inserted and located one end of a surgical tube through the patient's wall opening and adjacent a first side of the wall. The he forced the first portion of the surgical implantation device out of the surgical tube adjacent the first side of the wall, and allowed this first portion to automatically assume a planar shape. Thereafter he forced the connecting segment of the surgical implantation device out of the surgical tube to be within the wall opening. Subsequently, he forced the second planar portion of the surgical implantation device out of the surgical tube adjacent a second side of the wall, and allowed this second portion to automatically assume a planar shape. Then he passed a suture through the first portion, the connecting segment, and the second portion of the surgical implantation device, and tied off the suture to attach these three portions together. Finally, he withdrew the surgical tube from the patient. Resilient members were respectively attached to either the first of the second portions, which were initially flexible enough to be folded into the surgical tube. Thereafter, when they were cleared from the surgical tube, they unfolded into a planar orientation with their respective first or second portions.

These inventors in illustrating and describing their patches and their ways of using their patches, led the way of creating tension free surgical repairs of hernias using synthetic mesh materials to bridge and to patch hernia defects. These repairs resulted in both a decrease in the recurrence rate as well as a decrease in the amount of a patient's post operative discomfort. Patient's undergoing these more advanced procedures were able and are able to resume their normal activities sooner. As realised, some of these earlier inventions are somewhat complicated or are complicated. Several use some type of a plug or a locating member to fit within the hernia defect itself. Also many of these earlier inventions were designed specifically for use in laparoscopic repair of hernias. Moreover, many of the prior inventions required their suturing to the patient's body tissue. Although these medical advances are acknowledged for their usefulness and success, there remained a need or needs for more improvements in the surgical repair of hernias.

A hernia mesh patch for use in the sutureless surgical repair of a patient's inguinal, or other abdominal wall hernias, is available for relatively low cost and simplified surgical permanent placement within a patient's body space. This hernia mesh patch has top and bottom layers of an inert, synthetic mesh, preferably polypropylene mesh, sewn to each other at approximately one centimetre from their outer edges. The top layer has a transverse cut or slip opening into the interior pocket or pouch volume of this patch. Then to serve a spring function, an implantable inert monofilament fibre, arranged in an oval, ovoid, loop or ring configuration, having a circumference slightly greater than the circumference of the interior pocket volume of this patch, is inserted into this pocket to keep the hernia mesh patch expanded under tension in a planar configuration.

Then without the need for general anaesthesia, nor expensive laparoscopic instrumentation, a surgeon, when repairing an inguinal hernia, makes a small incision in the patient, approximately three centimetres long, arranged obliquely, approximately two to three centimetres above the internal ring location of the inguinal hernia. Through this small incision, using the muscle splitting technique, the surgeon performs a dissection deep into the patient's preperitoneal space, creating a pocket in this space into which this hernia mesh patch is to be inserted.

Thereafter, the surgeon, using his or her fingers, readily folds and compacts this hernia mesh patch and directs it through the incision and into the patient's preperitoneal space, where it unfolds and expands into its planar configuration, creating a trampoline effect. Then the surgeon, using just one of his or her fingers, placed partially through a slit in the top layer of mesh and into the pocket or pouch between the top and bottom layers of this hernia mesh patch, conveniently and accurately moves the hernia mesh patch to cover the defect in the patient's thick reinforcing lining of his or her abdominal cavity. Thereafter the surgeon withdraws his or her fingers and then secures the incision with stitches.

The patient's post-operative discomfort can be decreased, and risk of any recurrence is likewise decreased. The patient's body, soon after surgery, can react to the mesh of the hernia mesh patch, and in a short time, the mesh can become stuck, thereby keeping the hernia mesh patch in place. Thereafter, the patient's scar tissue grows into the mesh over a period of time, between thirty and sixty days, to permanently fix the hernia mesh patch in its intended position over the repaired area, where the hernia was located.

The hernia mesh patches may be made in several sizes. Four standard sizes accommodate ninety percent of the inguinal and abdominal wall hernias. With respect to repairing inguinal hernias, the most appropriate size is eight by ten centimetres.

The diameter of the monofilament fibre, which is preferably made from nylon, polypropylene, or polyester, and arranged to subsequently serve as a spring, may be adjusted in size in respect to the selected size of the hernia mesh patch to be used. A larger diameter fibre can be used in the spring of a larger diameter mesh patch to make the hernia mesh patch stiffer. While allowing for the sufficient stiffness to ensure the hernia mesh patch will open to its predetermined overall dimensions, there must be adequate flexibility to allow this hernia mesh patch to conform to the patient's uneven body contours and surfaces, and initially to allow for the folding and compacting of the hernia mesh patch for its insertion through the small entrance incision. In respect to all sizes of these hernia mesh patches, the presence of the monofilament fibre spring also allows for the use of a smaller diameter mesh fibre, which might otherwise be necessary to provide the necessary stiffness in a patch not having such a fibre spring.

In respect to large hernia mesh patches, the spring may include the winding of two or more monofilament fibres. Also large hernia mesh patches may be initially kept from sliding by using a limited number of anchoring stitches. They are placed without creating tension, without significantly increasing a patient's post-operative discomfort, and without contributing to the strength of the overall surgical repair of the patient's hernia.

Regarding the one centimetre, initially free outer edges of the respective top and bottom layers of the mesh material, they are slit in radial cuts to create scalloped or fringed edges. The bottom layer flat scalloped edges serve to fill uneven voids in the patient's tissue surface, which helps to minimize any risk of the patient's tissue slipping over this patch and allowing the hernia to recur. The top scalloped edges may be folded back and sewn along the monofilament fibre spring, leaving some portions of their folded over scalloped edges free to subsequently resist the migration of this hernia mesh patch, after it has been inserted into the limited sized preperitoneal pocket or pouch developed by the surgeon under the patient's hernia defect. The hernia mesh patch held in its intended shape by the fibre spring completely fills enough of this pocket to completely extend over and beyond the patient's hernia defect. After its initial insertion, and thereafter, the patient's hernia mesh patch is held in position by the hydrostatic pressures created between the two tissue layers of fascia above the patch and the peritoneum below the patch.

In respective designs of these hernia patches, small holes are cut through both layers of the mesh inside the fibre ring, to increase friction and to minimize the sliding or migration of the hernia mesh patch, after it is positioned. Also in some designs, spaces spikes are attached to the fibre spring, or are integrally formed with the fibre spring to serve as anchors, by entering the patient's tissue. Also in some designs of these hernia mesh patches to be used in a location where the patient's peritoneum has been destroyed, one layer of this patient's hernia patch is made of a material, such as "Gortex" material, which is less prone to adhere to a bowel or other intra-abdominal organ.

In respect to all the hernia mesh patches, they have their simplicity of design and method of insertion. They adequately underlay a hernia defect by a minimum of two centimetres around the circumference of the hernia defect, with sufficient rigidity and with sufficient friction to eliminate or minimize sliding or migration.

When these hernia mesh patches are used, the repair of inguinal and other abdominal wall hernias are repaired through a smaller wound or incision, with less tension, less post-operative discomfort, shorter operating time, and at a potential lower cost to the patient.

Embodiments of the invention will now be described, by way of example only, and with reference to the accompanying drawings, in which: <ul id="ul0001" list-style="none"><li>Figure 1 is a schematic partial front view of a patient's body indicating, in respect to the surgical repair of an inguinal hernia, where a three centimetre incision is made obliquely approximately two to three centimetres above the location described as the internal ring of the hernia, in reference to the location of an inguinal hernia;</li><li>Figure 2 is a schematic partial diagrammatic cross-sectional view of a patient's abdominal wall layers showing an inguinal or other abdominal wall hernia, and where the surgically implantable hernia repair mesh patch has been correctly positioned in the preperitoneal created space;</li><li>Figure 3 is a top view of a preferred embodiment of the surgically implantable hernia repair mesh patch, having anchoring or friction holes cut through both layers of the mesh, which after the surgical insertion of the surgically implantable hernia repair mesh patch, serve to minimize any risk of the mesh migrating or moving once positioned by a surgeon;</li><li>Figure 4 is similar to Figure 3 showing how a surgeons finger is inserted through a slit, which is made by cutting through only the top layer of the two layers of mesh used in this surgical hernia patch, whereby a surgeons finger, so inserted between these layers of mesh, then directs the movement of this surgical hernia patch through the incision and on to the location of the inguinal hernia;</li><li>Figure 5 is an exploded view of the surgically implantable hernia repair mesh patch shown in Figures 2, 3 and 4, to show the two layers of the mesh, preferably cut from polypropylene mesh material, and also to show a resilient monofilament ring, which when located between the layers of mesh, becomes a resilient spring ring keeping the surgical hernia patch fully expanded;</li><li>Figure 6 is a transverse cross sectional view of the centre of the preferred surgically implantable hernia repair mesh patch, illustrated in Figures 2, 3, 4 and 5, with the top and bottom layers shown slightly separated for illustrative purpose, and showing how some of the bottom mesh materials extending free of the peripheral stitching are split, forming tab portions of mesh, and showing how some of the top mesh materials are first folded back and then sewn in place by the fold, while allowing the remaining split portions to remain free before use, and later both these top and bottom free split tab portions, during and after surgery, help in minimizing or eliminating any risk of the mesh migrating or moving once positioned by a surgeon;</li><li>Figure 7 is a top view of another resilient monofilament ring, which becomes the located spring ring, showing how spaced anchoring monofilament spikes are secured to this ring or are made integral with this ring;</li><li>Figure 8 is a top view of another embodiment of the surgically implantable hernia repair mesh patch, which has the resilient monofilament ring, illustrated in Figure 7, placed between the layers of mesh thereof, and the spaced anchoring monofilament spikes are extending diagonally upwardly, and they are located, where there are respective anchoring or friction holes, made through both layers of the mesh, and the top layer has the slit to accommodate a surgeons finger; and</li><li>Figure 9 is a partial top view of another embodiment illustrating a circular surgically implantable hernia repair mesh patch having the resilient monofilament spring ring with spikes, spaced anchoring holes, and irregular cut edges of both the top and bottom layers of mesh, where they extend beyond the stitching, and also a slit for receiving a finger of a surgeon.</li></ul>

The hernia mesh patches 10, illustrated in the drawings, are surgically permanently implantable within a patient's body space 12 to adequately cover, correct, and repair any inguinal or other abdominal wall hernias 14. The surgeon has the objective of making a sutureless repair, by first cutting an approximately three centimetre incision 16, obliquely positioned approximately two to three centimetres above the location described as the internal ring 18, where an inguinal hernia 14 has occurred, as shown in Figure 1. then the surgeon working through this incision 16, and using a muscle splitting technique, dissects deeply into the patient's preperitoneal space 20, entering slightly superior and posterior to the patient's hernia defect 14. The surgeon then creates a pocket 22 in the patient's preperitoneal space 20, into which the hernia mesh patch 10 is inserted, as shown in Figure 2.

The surgeon in dissecting deeply into the patient's peritoneal space 20, as indicated in Figure 2, will have used a sharp instrument to make the incision or wound 16 through the patient's skin 24, the subcutaneous fatty tissues 26, and the external oblique fascia 28, which has been cut parallel with its fibres a short distance. Then the surgeon has incised the transversalis fascia 32, creating an entrance into the preperitoneal space 20, above the peritoneum 34 at a location above the hernia 14. In so doing, the surgeon has identified and freed up the hernia sac and has created the pocket 22 in the preperitoneal space 20. This space 20 underlies the area referred to as Hesselbach's triangle, in reference to both indirect and direct hernias. The surgeons placement of this hernia mesh patch 10, using this method, protects the entire inguinal floor, and therefore not only will it repair or correct a single small hernia, but will also protect against future hernias through other potentially weakened areas. In a similar way, a hernia mesh patch 10, sandwiched between a hernia 14, i.e. defect 14, and the inner lining 34, is used to underlay a femoral canal area, not shown, through which femoral hernias occasionally occur. Wherever used, the hernia mesh patch 10, in its respective embodiments, serves as the basis for tension free surgical repair of a hernia, as it is used to patch and to bridge the hernia 14, i.e. the defect 14. The hernia mesh patch 10 is made, so after completing this preparation, the surgeon using his or her fingers, can fold and compact the hernia mesh patch 10 and insert it down through the incision 16 into preperitoneal space 20. Thereafter, using his or her finger, the surgeon expands, moves and directs, the hernia mesh patch 10 into position in the pocket 20 within the preperitoneal space 20 to bridge the hernia 14, or defect 14.

An embodiment 40 of these hernia mesh patches 10, is illustrated in Figures 2 to 6 which is particularly designed for the repair of an inguinal hernia 10. This embodiment 40 is composed of two similarly sized and shaped pieces 42,44 of an inert synthetic mesh material 46, which preferably is a polypropylene material. This mesh material 46 is formed from monofilament material which is resistant to infection, and which has been used safely in many hernia operations, in previous ways and in previous embodiments. Preferably, the two similarly sized and shaped pieces of mesh material 42,44 are made in respective circle, loop, ovoid, or oval shapes. One 42 of these pieces 42,44 is referred to as the first or top layer 42 of the synthetic mesh material 46 and the other one 44 of these pieces 42,44 is referred to as the second or bottom layer 44 of the synthetic mesh material 46. These two layers 42,44 are sewn to each other approximately one centimetre in from their outer edges 48,50 using a thread 51 of inert synthetic material. The outer one centimetre of mesh material 52 of the bottom mesh material piece or layer 44 is left free to serve as an apron 54 to fill uneven voids in the patient's tissue. The outer one centimetre of mesh material 52 of the top mesh material piece or layer 42 is folded back and sewn adjacent the fold 56, while leaving free the remaining portions of this outer one centimetre of mesh material 52 of this top mesh layer 42. Thereafter, this free portion 57, when the hernia mesh patch 10 has been placed in the preperitoneal space, serves to frictionally keep this patch 10 in its hernia 14 repair position. Also inside of the fold 56, like size holes 59, aligned one above the other, are cut respectively in the top and bottom mesh layers 42,44. The presence of these holes 59 helps initially to frictionally keep the hernia mesh patch 10 in place. Thereafter the patient's scar tissues grow in and around these holes 59 to continue to keep the hernia mesh patch in position. The outer one centimetre of mesh materials 52 are both cut or slit 58, radially or diagonally creating scalloped or fringed edges 60 on respective flap, or tab portions 62, of both the outer one centimetre of mesh materials 52, of the top and bottom mesh layers 42,44.

Also the top mesh material, or top layer piece 42, is cut or slit 66 transversely at the centre 68 thereof, creating a finger access 66 into the interior space 70, or pouch 70, between the top and bottom layers 42,44 of the synthetic mesh material 46. Through this slit 66, a ring-like arrangement 72 of a continuous, inert, implantable, monofilament fibre 74, when squeezed temporarily to narrow it and to elongate it, is inserted into the interior space 70 or pouch 70. Then it is released, and allowed to expand, serving a spring function and therefore it is called a spring 72, while it is compressibly held in this interior space 70 or pouch 70 of the hernia mesh patch 10, thereby keeping this patch 10 fully extended in a planar arrangement, as shown in Figures 2, 3 and 4. This spring 72 is made of a synthetic material, such as nylon, polypropylene, or polyester. In each embodiment, this monofilament loop, ring or spring 72 has a circumference which is slightly larger than the circumference of the interior space 70, or pocket 70, or pouch 70, which is formed between the top and bottom layers 42,44 of the synthetic mesh material 46.

Another embodiment, i.e. a second embodiment 78, is illustrated in Figures 7 and 8 wherein the ring or spring 80 has spaced monofilament spikes 82 secured to the ring 80, or made integrally with it. They are directed on an angle to extend above this embodiment 78 of a hernia mesh patch 10, to enter the patient's body tissue. In this way the continuing accurate location of this hernia mesh patch 10 is ensured. The outer one centimetre of mesh material 52, as shown in Figure 8, is not cut nor slit.

Another embodiment, i.e. a third embodiment 86, is illustrated in Figure 9 wherein a portion of it is shown, indicating its similarity to the second embodiment 78, illustrated in Figures 7 and 8. However, the outer one centimetre of mesh materials 52 are cut to create scalloped or fringed circumferential edges 88, above and below, which also serve to frictionally hold the hernia mesh patch 10 in place, along with the spikes 82 on the loop, ring or spring 80.

These hernia mesh patches 10 in their various embodiments are made in several sizes. Generally four standard sizes accommodate ninety percent of the inguinal and abdominal wall hernias. Inguinal hernias are generally repaired by using a hernia mesh patch 10, which is eight centimetres wide and 10 centimetres long.

At the conclusion of the surgeons use of both sharp and blunt instruments to create the pocket 22 in the preperitoneal space 20, he or she selects the type and size embodiment of the hernia mesh patch 10 best suited to be used in the repair of the patient's defect or hernia 14. The selected embodiment 40, 78, 86 or another one, not shown, of the hernia mesh patch 10, is folded and further compacted, as may be necessary, by the surgeon using his or her fingers, so the selected patch 10 may be conveniently inserted through the wound or incision 16 and down into the preperitoneal space 20. In this space 20, the hernia mesh patch 10 is freed and allowed to expand under the force of the loop, ring or spring 74. Thereafter the surgeon using his or her finger, continues any further expansion of this patch 10, which might be necessary. Then his or her finger is inserted through the cut or slit 66 in the centre 68 of the top mesh layer 42, and the hernia mesh patch 10 through the preperitoneal space to the pocket 22. After the withdrawal of his or her finger, the surgeon completes the repair surgery by closing the wound or incision with stitches, in respect to this repair of an inguinal hernia, using the remote incision 16, as illustrated in Figure 1.

In the repair of other hernias, and especially those that are large, a direct incision is made, and after the placement of a large hernia mesh patch 10, the surgeon may use limited sutures to keep the larger hernia mesh patch 10 in place. Generally, most of the embodiments of this hernia mesh patch 10 are positioned, and so remain, without the use of limited sutures.

In respect to the utilization of all of the embodiments of these hernia mesh patches 10, they have their simplicity of manufacturing design and of their surgical method of insertion. All these patches 10 adequately underlay a hernia 14 or defect 14, with a minimum of two centimetres of a surrounding underlay about the circumference of the hernia 14. The do so, with sufficient rigidity and with sufficient friction, to eliminate or minimize sliding or migration. When these hernia mesh patches 10 are used by a surgeon, the repair of a patient's inguinal hernia 14, or of another abdominal wall hernia 14, is repaired through a smaller wound or incision 16, with less surgical tension, less post-operative patient discomfort, shorter operation time, and at a potential lower cost to the patient.