KR102169777B1 - Single plane tissue repair patch having a locating structure - Google Patents

Abstract

A tissue repair patch is disclosed having a base member 610 having an opening 620 therethrough, and a closure member (not shown) associated with the opening. The positioning structure 670 is mounted on the periphery of the bottom surface of the base member. In a preferred embodiment, the base member comprises a mesh and can be used in open surgical procedures for hernia repair and other repairs of body wall defects.

Description

Single plane tissue repair patch with positioning structure {SINGLE PLANE TISSUE REPAIR PATCH HAVING A LOCATING STRUCTURE}

Reference of related application

This application is a continuation in part of the pending publicly assigned U.S. Patent Application No. 13/443,347, filed April 10, 2012, which is incorporated by reference.

The technical field to which the present invention pertains is an implantable surgical tissue repair patch, more specifically an implantable surgical mesh hernia patch for use in a hernia repair procedure.

Hernia repair is a relatively simple surgical procedure, the ultimate purpose of which is to restore the mechanical integrity of the abdominal wall by repairing a muscle wall defect protruding through the peritoneum and possibly the section of the underlying viscera. There are various types of hernias, including abdominal wall hernia, umbilical hernia, incision hernia, sports hernia, femoral hernia, and inguinal hernia, each of which has its own specific surgical repair procedure. Most hernias are believed to be due to weakness within a section of tissue of the abdominal wall.

Precipitating events, such as unusual movements or lifting of extremely heavy weights, cause the points of weakness within the abdominal wall tissue to become overly stressed, resulting in tissue separation or rupture, and the peritoneum and underlying tissue through the separated or ruptured tissue section. It can cause protrusion of the intestines, such as sections of the intestines. These weaknesses can be attributed to several factors. The weakness in the abdominal wall may be congenital or may be associated with a previous incision or trocar wound from a surgical procedure. Other factors may include trauma, genetic predisposition, and aging.

Although commonly used conventional surgical procedures for correcting or repairing various types of hernias are somewhat specific, they have something in common with respect to mechanical repairs. Typically, protrusion of the peritoneum through a muscle or abdominal wall defect results in a hernia sack containing the underlying and protruding viscera. The hernia sac is dissected and the intestines are pushed back into the abdominal cavity. Subsequently, a tissue reinforcement or repair implant, such as a mesh patch device, is typically implanted and fixed at the site of the abdominal wall defect. Autologous tissue grows rapidly into the mesh implant, providing the patient with a firm and strong restoration. In certain patient symptoms, it may be desirable to suture or otherwise close the defect without an implant, but this is typically much less desirable for optimal results.

One common type of hernia is an abdominal wall hernia. This type of hernia typically occurs in the abdominal wall and can be caused by a previous incision or perforation, or by an area of a tissue weakness that has been stressed. Depending on the patient's individual characteristics and the nature of the hernia, there are several repair procedures that can be employed by surgeons to treat such hernias. In one technique, an onlay mesh is implanted on the posterior surface of the anterior fascia of the abdominal wall. Another technique provides an inlay mesh, where a prosthetic material is sutured to the abdominal wall and acts as a "bridge" to close the abdominal defect. Placing a prosthetic mesh posteriorly to the rectus muscle of the abdominal wall is known as the Reeves Stoppa or retromuscular technique. In this technique, a mesh implant is placed under the muscles of the abdominal wall, but above the peritoneum. Implantation of the mesh into an intraperitoneal location can be done through an open or laparoscopic approach. The mesh is inserted into the patient's abdominal cavity through an open anterior incision or through a trocar and positioned to cover the defect. The surgeon then fixes the mesh implant to the abdominal wall using conventional mechanical fixation or using a suture disposed through the full thickness of the abdominal wall. There are a variety of such mechanical fixation devices, such as tacking instruments, that can be used in laparoscopic or open surgery. Intraperitoneal placement of the mesh via an open approach may be a required repair technique when the layers of the abdominal wall are weakened and a laparoscopic approach is not required. The placement of the mesh through this technique poses several unique challenges including poor visibility during mesh handling and fixing, poor handling, and insufficient ergonomics of currently available products. Mesh repair patch implants designed for intraperitoneal placement typically function as tissue separation components to separate the intestines from the prosthetic abdominal wall restoration layer, thereby preventing or substantially inhibiting the formation of post-operative adhesions. Need treatment or layer of. The addition of such a layer can increase the complexity of wound healing due to the presence and mass of the additional layer.

While hernia repair patch implants exist for open abdominal wall hernia repair, there are known drawbacks associated with their use. The drawbacks include difficulty in handling the mesh, poor visibility during mesh handling, implantation and fixation, poor utility and ergonomics when using laparoscopic instruments, and the use of double or multiple layers of mesh. Commercially available mesh repair patch implants for such applications typically have at least a double layer of mesh or fabric with pockets or skirts to provide attachment to the parietal wall through a top layer or skirt. It can also be appreciated that multilayer meshes tend to be more expensive and complex to introduce and manufacture more foreign body mass than single layer mesh implants. Another drawback associated with hernia repair patch implants is the periphery of the patch so that the surgeon can attach the patch to the tissue by installing a tack or other fastener to properly secure the implant to the tissue in an appropriate manner. It is the convenience of positioning.

Thus, novel tissue repair implants, such as abdominal wall hernia repair patch implants, that can be used in open surgical procedures and can be fixed to tissue using single or multiple crown techniques without requiring mesh fixation or adhesion layers. There is a need in the art for There is also a need for a tissue repair implant that facilitates positioning of the periphery of such an implant by the surgeon.

US Patent Application Publication No. US2010/0292712 (2010.11.18) US Patent Application Publication No. US2011/0079627 (2011.04.07) US Patent Application Publication No. US2011/0307077 (2011.12.15)

Thus, a novel tissue repair patch is disclosed. The tissue repair patch has a base member that is substantially flat or planar. The base member is preferably a mesh. There is an opening located in the base member, and there is a closing member associated with the opening. The base member has a top side and a bottom side, and an outer periphery and a periphery edge. A locating structure is mounted on the bottom surface of the base member adjacent to or on the periphery of the base member. The positioning structure is preferably an engagement ring member. Optionally, the positioning structure has a flange member extending downward. The patch can have a polymeric layer on at least a portion of at least one side of the base member. It is preferred that the side of the mesh facing the intestine has a polymer layer covering substantially all of that side. The tissue repair patch of the present invention is particularly useful for open hernia repair procedures, such as abdominal wall hernia repair, and is also useful for other types of body wall tissue repair.

Another aspect of the present invention is a method of repairing a body wall defect, such as a hernia defect, in an open surgical procedure using the tissue repair patch implant described above.

These and other aspects and advantages of the present invention will become more apparent from the following description and accompanying drawings.

1 is a plan view of an embodiment of a single planar tissue repair mesh patch of the present invention, the patch having a base member having an opening, and a closed patch member mounted on the top surface of the base member over the opening.
Figure 2 is an exploded perspective view of the repair mesh patch of Figure 1;
FIG. 3 is a view showing a surgical tacking instrument with an elongated shaft inserted below the flap member and through an opening in the base member of the repair patch of FIG. 1, wherein the instrument shaft is at the bottom of the base member. Shown as approached.
FIG. 4 is a plan view of a tissue repair patch of the present invention similar to the repair patch shown in FIG. 1 but having rectangular occlusive patch members connected along opposite minor sides, the closure patch member orienting the patch during implantation. Shown as including a directional guide for use by a surgeon in sikime.
5 is an exploded perspective view illustrating two halves of another embodiment of the tissue repair patch of the present invention, the two halves joined to form a repair mesh patch having a closure flap.
FIG. 6 is a plan view of a tissue repair patch of the present invention made by joining the two halves shown in FIG. 5 with the flaps in a rest position.
7 is a perspective view of the tissue repair patch of FIG. 6 with the flaps in a rest position.
FIG. 8 is a perspective view of the tissue repair patch of FIG. 7 showing both flaps in the up position, which do not cover an opening in the base member, thereby providing access through the base member.
9 illustrates the tissue repair patch of FIG. 8 in which the curved shaft of the surgical tacking instrument is partially inserted through the opening of the base member.
Figure 10 is a plan view of another embodiment of the tissue repair patch of the present invention, the mesh patch is shown to have an opening, wherein the surgical suture and the surgical needle (continuous mattress suture configuration) Mounted around the opening.
Figure 11 illustrates the tissue repair patch of Figure 10, wherein the opening is closed by applying tension to the suture after the patch is attached to the patient's body wall over the hernia defect.
12 is an exploded perspective view of another preferred embodiment of the tissue repair patch of the present invention, the patch shown having an upper closure flap and a lower closure flap mounted around an opening in the base member.
FIG. 13 is a plan view of the tissue repair mesh of FIG. 13, showing closure flaps mounted around an opening in the base member, with one closure flap adjacent to the bottom surface of the base member and one closure flap being the top surface of the base member Adjacent to and flaps in rest position.
14 is a plan view of a preferred embodiment of the tissue repair patch of the present invention, the patch shown as having a pair of closure flap members.
FIG. 14A is a cross-sectional view of the repair patch of FIG. 12 along View Line 14a-14a.
14B is a partially enlarged view of the cross section of FIG. 12A, illustrating flaps positioned around an opening in the base member of the patch.
15 is an exploded perspective view of two base member halves of the tissue repair patch of FIG. 14 with both halves extending from the base member section.
16 is a perspective view of a tissue repair patch made by joining the two halves shown in FIG. 15 together, with one closure flap positioned below the base member and one closure flap positioned above the base member.
FIG. 17 is a perspective view of the tissue repair mesh patch of FIG. 16 with both closure flaps in the up position so that the opening in the base member is accessible between the flaps.
FIG. 18 is a perspective view of the mesh repair patch of FIG. 17, with the distal end of the curved long shaft of the surgical tacking instrument through an opening in the base member at a location below the patch to secure the mesh repair patch to tissue. Illustrative of partially inserted.
FIG. 19 is a perspective view of the tissue repair patch of FIG. 18, with both flaps selectively sutured together in an upwardly extending position to close an opening in the base member after the patch is attached to the tissue.
Figure 20 is a side cross-sectional view of the tissue repair patch of Figure 16 inserted into the patient's abdominal cavity and positioned adjacent to the patient's peritoneum, wherein the curved shaft of the surgical tacking device is through an access opening such as a hernia defect in the patient's body wall. And inserted through an opening in the base member of the repair patch so that the distal end of the shaft is shown in a position under the patch to grasp a section of the base member of the patch to the body wall.
21 is a perspective view of the mesh repair patch of FIG. 17, illustrating that the distal end of the straight long shaft of the surgical tacking instrument is partially inserted through the opening of the base member at a predetermined position to fix the tissue repair patch to the tissue. box.
FIG. 22 is a side view of the tissue repair patch of FIG. 21 inserted into the patient's abdominal cavity and positioned adjacent the patient's peritoneum, with the distal section of the straight shaft of the surgical tacking instrument through the access opening in the patient's body wall and of the repair patch. Inserted through an opening in the base member, the distal end of the shaft is shown in a position under the patch to tackle a section of the base member of the patch to the body wall.
FIG. 23 illustrates a hernia repair procedure, wherein a surgeon secures the tissue repair patch of FIG. 17 in a position over the hernia defect using a surgical tacking instrument having a curved long shaft, the distal section of the shaft The tissue patch is inserted through an access opening in the patient's body wall and through an opening in the tissue repair patch to secure the tissue patch to the peritoneum, the abdomen above the distal end of the shaft of the instrument to place the tag at the desired location on the patch Shown as promoting.
Fig. 24 is a side cross-sectional view illustrating a preferred embodiment of the tissue repair patch of the present invention in a position above the hernia defect adjacent to the patient's peritoneum, wherein the curved long shaft of the surgical tacking instrument is a section of the base member of the patch. To attach to the peritoneum through an access opening in the patient's body wall and through an opening in the patch, the patient's visceral organs are shown positioned adjacent to the base of the patch and the peritoneum, and the closure flap upwards through the opening in the body wall. Shown as extending to.
25 is an exploded perspective view of an alternative embodiment of the mesh tissue repair patch of the present invention, the base member shown as having an opening in the base member surrounded by a closure ring, and a closure patch having a mating closure ring. Also shown.
Fig. 26 is a perspective view of the tissue repair patch of Fig. 25, showing that the patch is fixed to the base member.
FIG. 27 is a peritoneal view of the bottom of a preferred embodiment of a tissue repair patch of the present invention secured to the peritoneum using a double row surgical tag referred to as a double crown technique. Illustratively, the opening in the base member is shown closed, both flaps are positioned upwards away from the top surface of the base member, and the flaps are fixed to close the opening in the base member.
28 is a perspective view of an alternative embodiment of a mesh tissue repair patch of the present invention, shown as having a slit in the base member to provide a central opening.
FIG. 29 is a perspective view of the patch of FIG. 28 having a surgical suture mounted around the slit in a shoelace type configuration to close the opening in the slit.
Fig. 30 is a perspective view of the tissue repair patch of Fig. 29 after the end of the suture is tensioned after the patch is fixed to the patient's body wall, thereby closing the opening and the slit.
31 is a cross-sectional view of a tissue repair patch of the present invention having a positioning structure located on the bottom of the member of the base on the periphery. The tissue repair patch is shown positioned adjacent to the body wall below the hernia defect. Surgical tacking instrument shown, with its distal end of its shaft positioned proximate the visceral side of the body wall, the shaft tip abutting the positioning structure and in a position to launch a tag through the base member into the body wall. being. The positioning structure is in the form of a ring.
Fig. 32 is a perspective view of the tissue repair patch of Fig. 31 viewed from a direction below the patch.
FIG. 33 is a perspective view of the tissue repair patch of FIG. 31, showing the repair patch and the bottom of the tissue repair structure.
Fig. 34 is a partially enlarged side view of the repair patch of Fig. 31 showing the tip of the tacking tool shaft adjacent the positioning structure.
35 is a cross-sectional view of an embodiment of a tissue repair patch of the present invention having a positioning structure, the structure shown as having a textured surface. The patch is in a position to be attached to repair a body wall defect using a surgical tacking device.
FIG. 36 is a partially enlarged view of the patch of FIG. 36, showing the tip of the shaft of the surgical tacking instrument in engagement with the textured surface of the positioning structure.
37 is a cross-sectional view of an embodiment of the tissue repair patch of the present invention having a locating structure, the structure shown having a downwardly extending flange member formed from the periphery of the base member. The patch is in a position to be attached to repair a body wall defect using a surgical tacking device.
FIG. 38 is a partially enlarged view of the patch of FIG. 36, showing the tip of the shaft of the surgical tacking instrument in engagement with a downwardly extending flange member of the positioning structure.
39 is a partially enlarged cross-sectional view of a tissue repair patch, wherein the positioning structure is a downwardly extending flange member mounted at the periphery of the base member.
Fig. 40 is a partially enlarged cross-sectional view of a tissue repair patch, wherein the positioning structure is a ring member having a flange member extending downwardly, and the ring member is mounted on the periphery of the top surface of the base member.
41 is a partially enlarged cross-sectional view of a tissue repair patch, wherein the positioning structure is a ring member having a flange member extending downwardly, and the ring member is mounted on the periphery of the bottom surface of the base member.

The novel tissue repair patch or device of the present invention is particularly useful for open abdominal wall or incisional hernia repair surgical procedures. The tissue repair patch device consists of a base member having an opening. The base member has a closure member or device associated with the opening for securing the opening after implantation. The repair patch device of the present invention has utility in other conventional tissue repair procedures including inguinal hernia repair procedures, trocar puncture wounds, trocar incision hernias, and the like.

Tissue repair implants and surgical instruments for applying a tack to secure the tissue repair implant are disclosed in the following co-pending pending patent applications, which are incorporated by reference: US patent application Ser. No. 12/464,151; 12/464,165; 12/464,177; No. 12/464,143; 12/944,651; And 12/815,275.

The tissue repair patch of the present invention can be made from any conventional biocompatible material. The patch and its components are preferably made from conventional biocompatible polymers, which may be non-absorbable or bioabsorbable. The term “bioresorbable” is defined to have its conventional meaning, and includes both biodegradable and bioresorbable. Examples of such non-absorbent polymers include polypropylene, polyester, nylon, ultra high molecular weight polyethylene, and the like, and combinations thereof. Examples of suitable bioabsorbable polymers include polylactide (PLA), polyglycolide (PGA), polydioxanone (PDO, PDS), copolymer of PGA/trimethylene carbonate (TMC), PLA/TMC. Copolymers and the like are included. If desired, a combination of a biocompatible non-absorbable polymer and a bioabsorbable polymer may be used to construct the tissue repair implant patch device of the present invention.

While it is preferred to use a surgical mesh to construct the hernia repair patch of the present invention, other conventional woven or nonwoven surgical repair fabrics or thermoformed implants may also be used. In addition, tissue repair patches may be made from other conventional implantable materials, such as polytetrafluoroethylene (PTFE), such as ePTFE films and laminates. The patch may consist of a composite of a polymer film and a mesh and/or fabric.

Meshes useful in the hernia repair patch apparatus of the present invention will be manufactured in a conventional manner using conventional manufacturing equipment and methods including knitting, weaving, nonwoven techniques, and the like. The mesh will typically have a pore size sufficient to effectively provide tissue ingrowth; For example, the mesh may have a pore size ranging from about 0.3 mm to about 5 mm, and other conventional size ranges. Examples of commercially available non-absorbable and bioabsorbable polymer meshes that can be used to construct the hernia repair patch of the present invention are available from Ethicon, Inc., Route 22 West, Somerville, NJ 08876, USA. , ETHICON PHYSIOMESH™ and ETHICON PROCEED™ surgical mesh.

When constructing the novel tissue repair patch of the present invention from surgical fabrics other than mesh, the fabric has a pore size sufficient to effectively provide tissue ingrowth, for example having a typical size of about 0.3 mm to about 3 mm. Will have open pores. By "open pores" is meant an opening extending from one side of the fabric to the opposite side and providing a path through the fabric. The fabric restoration member may be constructed from monofilament, multifilament, or combinations thereof. Examples of commercially available non-mesh fabrics that can be used to make the hernia repair patches of the present invention include textile fabrics, textiles and tapes for surgical applications. Other fabrics or materials include perforated condensed ePTFE films and nonwoven fabrics having a pore size of 1 millimeter or more. Non-mesh fabrics can be constructed from conventional biocompatible materials.

The fabric or mesh may include, in addition to long-term stable polymers, resorbable polymers (ie, bioabsorbable or biodegradable). Polymers that are resorbable and long-term stable preferably comprise monofilaments and/or multifilaments. The terms "resorbable polymer" and "bioabsorbable polymer" are used interchangeably herein. The term “bioabsorbable” is defined to have its conventional meaning. Although not preferred, the fabric or mesh tissue repair member can be made from a bioabsorbable polymer or bioabsorbable polymers without any long-term stable polymer.

The tissue repair patch of the present invention may also include a polymer film. The film may be attached to the top surface, the bottom surface, or both, and may also cover a peripheral edge of the repair patch device or extend beyond the peripheral edge of the repair patch device. The films used to make the tissue repair patch implant devices of the present invention will have a thickness sufficient to effectively prevent adhesions from forming or otherwise function as a tissue barrier or tissue separation structure or membrane. For example, the thickness may typically range from about 1 μm to about 500 μm, and preferably from about 5 μm to about 50 μm, although this will depend on the individual properties of the selected polymer film. Films suitable for use with the repair patch of the present invention include both bioabsorbable and non-absorbable films. The films are preferably polymer based and can be made from a variety of conventional biocompatible polymers including bioabsorbable and non-absorbable polymers. Non-resorbable or very slow resorbable materials include polyalkenes (e.g. polypropylene or polyethylene), fluorinated polyolefins (e.g. polytetrafluoroethylene or polyvinylidene fluoride), polyamides, poly Urethane, polyisoprene, polystyrene, polysilicon, polycarbonate, polyarylether ketone (PEEK), polymethacrylic acid ester, polyacrylic acid ester, aromatic polyester, polyimide, as well as mixtures and/or copolymers of these substances Consolidation is included. Synthetic bioabsorbable polymeric materials such as polyhydroxy acids (e.g., polylactide, polyglycolide, polyhydroxybutyrate, polyhydroxyvalerate), polycaprolactone, polydioxanone, synthetic and Natural oligoamino acids and polyamino acids, polyphosphazenes, polyanhydrides, polyorthoesters, polyphosphates, polyphosphonates, polyalcohols, polysaccharides, and polyethers are also useful. However, naturally occurring materials such as collagen, gelatin, or naturally derived materials such as bioabsorbable omega 3 fatty acid crosslinked gel films or oxygenated regenerated cellulose (ORC) may also be used.

The film used in the tissue repair patch device of the present invention may cover the entire outer surface of the hernia patch member or a portion thereof. In some cases, it is beneficial to have a film overlapping the edges and/or perimeters of the repair patch. The repair patch of the present invention may also have an adhesion barrier layer attached to one or both sides. The adhesion barrier will typically consist of conventional biocompatible polymeric materials including, but not limited to, absorbent and non-absorbable polymers. Examples of conventional non-absorbent polymeric materials useful for adhesion barriers include expanded polytetrafluoroethylene, polytetrafluoroethylene, silicone, and the like. Examples of conventional absorbent polymeric materials useful for adhesion barriers include oxidized regenerated cellulose, polyglycapron 25 (copolymer of glycolide and epsilon-caprolactone), and the like.

It is particularly preferred that the tissue repair patch of the present invention has a mesh structure, and the embodiments illustrated in the drawings have such a mesh structure. The tissue repair implant of the present invention has special utility for hernia repair procedures, but can also be used for other tissue repair surgical procedures.

Referring now to Figures 1-3, a tissue repair patch 10 of the present invention is shown. The patch 10 has a mesh structure. The repair patch 10 is shown having a substantially flat or planar base member 20 and a closure patch member 30. The base member 20 is exemplified as having a substantially elliptical shape or configuration, but may have other configurations including a square, a rectangle, a circle, a polygon, or a combination thereof. The base member 20 is shown to have an upper surface 22, a lower surface 24, and a perimeter 26. A slot 40 with an opening 42 bounded by opposite sides 44 and opposite ends 43 extends through the base member 20. The closure patch member 30 is shown to be a substantially flat or planar member having a substantially elliptical configuration. The closure patch member 30 is shown having a top surface 32, a bottom surface 34, and a perimeter 35. The closure patch member 30 is shown having opposed curved ends 37 and opposed sides 38. The patch member 30 is formed of the base member 20 through the connections 39 along the ends 37 such that the bottom surface 34 of the closing patch 30 is adjacent to the top surface 22 of the base member 20. It is mounted on the top surface. The closure patch employs any conventional attachment method to create the connection 39, including, but not limited to, stitching, welding, tacking, riveting, stapling, gluing, and the like. It is mounted using. The closure patch 30 is mounted on the base member 20 to cover the slot 40 and the opening 42. An opening 48 adjacent to the side 38 provides an access passageway for the surgical instrument to and through the opening 42 of the slot 40. A partial schematic diagram of a surgical tacking instrument 60 that can be used to tack the base member 20 of the patch 10 to tissue is shown in FIG. 3. The instrument 60 has a proximal handle 62 and an elongated shaft 70 extending in a distal direction with a distal end 78. The distal section 76 of the shaft 70 extends through the opening 48, under the bottom surface 34 of the closure flap 30, and through the opening 42 of the slot 40, whereby it extends through the base member ( 20) is shown to be located under the bottom surface 24. The distal end 78 is a bottom surface 24 such that a surgical tag can be fired to secure the patch to tissue adjacent the top surface 22 of the base member 20 and the top surface 32 of the closure patch member 30. It is shown to be positioned proximate to the periphery 26 of the base member 20 adjacent to. The repair patch 10 is fixed around its perimeter 26 to the tissue with the fixation points arranged, for example every about 1 to 2 cm, i.e. the fixation devices or tacks are about 1 cm Separated by a distance of 2 cm. In many embodiments of the tissue or hernia repair patch of the present invention, it is desirable to have a slot in the base member to provide an opening through the base member, but the opening may be slit, round, oval, rectangular, polygonal, etc. Other types of openings with various geometric configurations may be used, including combinations of and the like. Although not preferred, it is possible to form the tissue repair patch of the present invention such that the base member and/or the closure member is curved or otherwise in more than one plane.

Once the tissue repair patch 10 of the present invention is implanted and secured to the tissue by tacking or other conventional methods (e.g., stapling, suturing, etc.), the shaft section 76 of the surgical attachment instrument 60 is slotted. It is removed from the body through 40. The closure patch member 30 prevents the underlying tissue or viscera from moving through the slot 40 and opening 42.

An alternative embodiment of a tissue repair patch 10 is shown in FIG. 4. The patch 10 is shown as having a similarly shaped base member 20, but the closure member 50 has opposing smaller end sides 56 and opposing larger sides 57. Is shown to have a substantially rectangular shape. The closing member 50 has a top surface 52 and a bottom surface 54 adjacent to the top surface 22 of the base member 20. The patch member 50 is mounted to the base member 20 over the slot 40 by means of connections 59 along the smaller sides 56. The connection can be created as described above. An opening 48 under the sides 57 provides access to the slot 40 and opening 42. As shown in FIG. 4, the tissue repair patch 10 is shown with a direction indicator 80 included on or within the closure member 50. Indicator 50 may traditionally be sewn, molded or formed, printed, dyed or laminated within or on member 50. The indicator 80 is shown as having a central section 81, which has opposed transverse sections 82 extending therefrom. The longitudinal sections 85 and 87 extend longitudinally in an opposite manner. Section 87 is shown as being thicker than section 85. Indicator 80 allows the surgeon to determine the position of the patch relative to the patient after insertion by aligning the respective axes of the tissue repair patch 10 with respect to the patient and the incision, so that the use of a tacking instrument or for attachment Allows a more precise fixation, using a sealing material. Such a direction indicator may be used with other embodiments of the tissue repair patch of the present invention.

Referring now to Figures 5-9, an alternative embodiment of the tissue repair patch 100 of the present invention is shown. The patch 100 is shown as having a substantially flat or planar base member 110 formed from a substantially flat or planar base section 120, 140. The base member 110 has a bottom surface 112, an upper surface 114, and a peripheral portion 116. The base section 120 is shown having a straight side 122 with an end 124. The base section 120 is also shown as having a curved side 126 having an end 128 connected to an end 124. A closing flap member 130 having a hinged side 132 and a free end 134 separated from the side 122 by a slot 136 extends from the straight side 122. Slot 136 has a closed end 137 and an open end 138. The closing flap member 130 is shown to have a generally rectangular configuration, but may have other geometric configurations including circular, elliptical, polygonal, and the like, combinations thereof, and the like. The base section 140 is shown having a straight side 142 with an end 144. The base section 140 is also shown as having a curved side 146 with an end 148 connected to an end 144. A closure flap member 150 having a hinged side 152 and a free end 154 separated from the side 142 by a slot 156 extends from the straight side 142. Slot 156 has a closed end 157 and an open end 158. The closing flap member 150 is shown to have a generally rectangular configuration, but may have other geometric configurations including circular, elliptical, polygonal, and the like, combinations thereof, and the like. The base member 110 and tissue repair patch 100 are formed from the base sections 120 and 140 by connecting the base sections along straight sides 122 and 142 along a seam 118. This can be done in any conventional manner, including stitching, welding, tacking, stapling, gluing, etc., and combinations and equivalents thereof. It can be seen that only the straight sides 122 and 142 are connected on both sides of the closing flip members 130 and 150. Closing flap members 130, 150, the hinged side 132 of the closure flap 130 is received in the slot 156 of the flap member 150, and the hinged side 152 of the closure flap 140 is closed. They are mounted together to be received within the slot 136 of the member 130. This is bounded by the inner portions of the straight sides 122, 142 of the base sections 120, 142, respectively, and also on the hinged sides 132, 152 of the flap members 130, 150, respectively. A slit 160 in the base member 110 is created, having a through opening 165 bounded by it.

In the rest position as shown in FIG. 6, the flap member 130 is located on the top surface 145 of the base section 140 of the base member 110, while the flap member 150 is positioned at the base section 120. It is located on the upper surface 125 of. In this resting configuration, the slit 160 and the opening 165 are covered. The tissue repair patch 100 is shown in the ready position in FIG. 8, wherein the closure flap members 130 and 150 are in an upright position exposing the slit 160 and the opening, so that the fixing mechanism is the opening 165 Can be inserted through. A tacking mechanism 170 is illustrated in FIG. 9 along with the tissue repair patch 100 of the present invention. The tacking mechanism 170 is shown having a proximal handle 172 and an actuation trigger 174. A curved shaft 180 having a distal section 182 and a distal end 184 extends from the distal end 176 of the handle 170. The distal section 182 is inserted through the slit 160 and the opening 165 between the upwardly extending flaps 130 and 150 to secure the base member to the tissue using a surgical tag. Is shown to be movable around the bottom surface 112 of the base member 110. Once the tag is placed through the base member 110 of the patch 100 to secure the patch 100 to the tissue, the tacking mechanism 170 can be removed from the slit 160, and two flap members 130 , 150 may be engaged with each other by folding or rotating the flap members downwardly onto the upper surface 114 of the base member 110. One or both of the flap members may optionally be bonded or attached to the base member 110 using a variety of conventional closure methods including adhesives, sutures, surgical fasteners, and the like.

An alternative embodiment 400 of a single planar tissue repair patch of the present invention is shown in FIGS. 10 and 11. The repair patch 400 has a base member 410 having a top surface 412 and a bottom surface 414. The patch has a periphery 416. A slit 420 having an opening 424 bounded by sides 422 is positioned within the base member 410. The slit 420 has an end 428. Surgical suture material 430 with surgical needle 436 mounted at end 432, 434 and end 432 and optionally, but not shown, at end 434 is around slit 420. Installed. The suture material 430 is mounted around the opening 424 in a conventional mattress suture material (continuous) configuration. As shown in FIG. 11, the opening 424 is closed by tensioning the suture ends 432, 434, allowing the sides 422 to be accessed. If desired, suture needle 436 may be used to engage tissue with suture material 430. Referring to Figures 28 and 29, a modification of the suture mounting is illustrated. The restoration patch 450 is similar to the restoration patch 400, but a rectangular shaped base member having opposite larger sides 454 and opposite smaller sides 456 connected by rounded corners 457 ( 451). The base member 451 has a bottom surface 458 and an upper surface 459, and an outer peripheral portion 452. The base member 451 has a centrally located slit 460 with an opening 464 bounded by sides 462. The slit 460 has an end 468. Surgical suture 470 having ends 472 and 474 is mounted around slit 460. The suture material 470 is mounted in a "shoelace" type configuration. The suture 470 is shown to be mounted to the slit 460 by engaging opposite sides 462 of the slit 460 around the opening 464. The suture 470 is shown having ends 472 and 474 positioned adjacent to each other along one end 468 of the slit 460. Slit 460 is secured after placement of patch 450 by closing opening 464 by pulling ends 472 and 474. The suture 460 may optionally have a surgical needle mounted to one or both of the ends 472 and 474. The base members 410 and 451 can have any suitable geometry.

A preferred embodiment of the tissue repair patch 200 of the present invention is shown in FIGS. 12 and 13. The patch 200 is shown as having a substantially flat or planar base member 210 having a top surface 212, a bottom surface 214 and a perimeter 216. The base member 210 is shown to have an elliptical shape, but may have other geometric shapes, including rectangular, circular, square, polygonal, combinations thereof, and the like. A slot 220 having an opening 222 therethrough is located in the base member 210. The slot 220 is bounded by opposite sides 224 and 225 and curved ends 226. The patch 200 is shown having an upper closing flap 230 and a lower closing flap 240. The top closure flap 230 is shown to have a substantially rectangular shape, but it may have other geometric configurations including circular, elliptical, rectangular, polygonal, and the like. The flap 230 is shown to have a top surface 231 and a bottom surface 232. The flap 230 also has opposing sides 235 and 236 that are connected by opposing end sides 237. The flap 230 is sewn to create a seam 239, by connecting the flap 230 along the side 235 in a conventional manner such as gluing, stapling, welding, riveting, etc. It is mounted on the upper surface 212 of the base member 210 adjacent to 224. In this way, the flap 230 has its bottom surface 232 facing the top surface 212 of the base member 210 and is positioned to cover the slot 220 and the opening 222 in the rest position. The closing flap can be rotated upward about the seam 239 to uncover the slot 220 and the opening 222. Another closure flap 240 is mounted on the bottom surface 214 of the base member 210. The flap 240 is shown to have a top surface 241 and a bottom surface 242. The flap 240 also has opposite sides 245 and 246 connected by opposite end sides 247. The flap 240 is stitched to create a seam 249, by connecting the flap 240 along the side 245 in a conventional manner such as gluing, stapling, welding, riveting, etc. It is mounted on the bottom surface 214 of the base member 210 adjacent to 225. In this way, the flap 240 has its top surface 241 facing the bottom surface 214 of the base member 210 and is positioned to cover the slot 220 and the opening 222 in the rest position. The closing flap can be rotated downward about the seam 249 to uncover the slot 220 and the opening 222. The flap 240 can also be rotated upward about the seam 249 through the slot 220 and opening 222.

Referring now to FIGS. 14, 14A, 14B, and 15-17, a preferred tissue repair patch 250 of the present invention is shown. The patch 250 is similar to the patch 200, but is constructed in a different manner from two separate base section members. Patch 250 is shown having a substantially flat or planar base member 260 formed from substantially flat or planar base sections 270 and 280. The base member 260 has a bottom surface 264, an upper surface 262 and a peripheral portion 266. The base section 270 is shown as having a straight side 272 with an end 274. The base section 270 is also shown having a side 276 with a curved end 278 connected to the end 274. A closing flap member 290 having a hinged side 292 and a free side 294 extends from the straight side 272. The closure flap member 290 is shown to have a generally rectangular configuration, but may have other geometric configurations including circular, elliptical, rectangular, polygonal, and the like. The base section 280 is shown as having a straight side 282 having an end 284. The base section 280 is also shown as having a side 286 having a curved end 288 connected to an end 284. A closing flap member 300 having a hinged side 302 and a free side 304 extends from the straight side 282. The closure flap member 300 is shown to have a generally rectangular configuration, but may have other geometric configurations including circular, elliptical, rectangular, polygonal, and the like. The base member 260 and the hernia closure patch 250 are formed from the base sections 270 and 280 by connecting the base sections along the straight sides 272 and 282 along the seam 268. This can be done in any conventional manner, including stitching, welding, tacking, stapling, gluing, etc., and combinations and equivalents thereof. It can be seen that the straight sides 272 and 282 are connected on both sides of the closure flap members 290 and 300, thereby creating a slit 310 having an opening 315 between the members 290 and 300. Slit 310 is bounded by hinged sides 292 and 302 of closure flap members 290 and 300 and has opposite ends 312. When assembling the patch 250 and the base member 260, the closing flap 290 is inserted through the opening 315 in the slit 310. In the rest position as shown in FIGS. 12 and 16, the flap member 300 is located on the top surface of the base section 270 of the base member 260, while the flap member 290 is the base section 280. It is located on the bottom of In the resting state, the closing flaps 290 and 300 cover the slit 310 and the opening 315, respectively. It will be appreciated that either closing flap can be rotated through the slit 310 and the opening 315, but the patch 250 as illustrated is rotated through the slit and the bottom surface 264 of the base member 260 Shows a closure flap member 290 positioned adjacent to. In addition, the slit 310 may have other geometrical configurations and shapes including slots and the like.

Referring now to FIGS. 17 to 22, the repair patch 250 is shown in a ready position for fixation to tissue in a tissue repair procedure such as a hernia repair procedure. As shown in FIG. 17, the patch is disposed in the ready position by rotating the flap 300 upwardly toward the away from the upper surface 262 of the base member 260. The flap 290 is also shown rotating upward through the slit 310 and opening 315. By rotating the closure flaps 290 and 300 in this manner, the slit 310 and opening 315 are uncovered, providing access to a surgical instrument such as a tacking instrument or a surgeon's finger. A surgical tacking instrument 320 is shown in FIG. 18 along with the tissue repair patch 250 of the present invention. The tacking mechanism 320 is shown having a proximal handle 322 and an actuation trigger 324. A curved shaft 330 having a distal section 332 and a distal end 334 extends from a distal end 326 of the handle 322. The distal end section 332 is inserted through the slit 310 and the opening 315 between the upwardly extending closure flaps 290 and 300 to secure the base member 260 to the tissue using a surgical tag. It is shown that the distal end 334 can be moved around the bottom surface 264 of the base member 260. A hernia patch 250 is shown implanted into the patient in FIG. 20. A cross section of the body wall 370 with the surgically created opening 372 is shown. Body wall 370 is shown to have an inner peritoneal layer 374, then an upper fascia layer 375, then a muscle layer 376, a fat layer 377, and finally a normal skin layer 378. . The top surface 262 of the base member 260 is shown to be mounted adjacent to the peritoneal layer 334, with the closure flap members 290 and 300 extending outward through the opening 332. The shaft 330 of the tacking instrument 320 is shown inserted through the surgical opening 332, through the slit 310 and opening 315, and into a body cavity underlying the patient. The distal end section 332 and the distal end 334 are shown positioned adjacent to the bottom surface 264 of the base member 260 to attach a section of the base member 260 to the peritoneal layer 374. . Referring to Figure 19, the patch 250 is flap members 290, 300 selectively by a surgical suture 380 having ends 381, 382, respectively, their bottom surfaces 302, 292. It is shown in a fixed state along the way. A surgical needle 388 is attached to the suture end 281. The sealed flap members close the opening 315 in the slit 310. Alternatively, the flap members may be joined or secured together to close the slit 310 by conventional adhesives, surgical fasteners, or the like. The flap members 290 and 300 can alternatively be used in their resting position during implantation. The shaft of the tacking mechanism will be inserted under flap 300 through slit 310 and opening 315 without rotating the flaps upward. After fixation, the flaps can remain in the rest position without further fixation of the flaps. The flap 290 will prevent tissue or viscera from moving into the slot 310 and opening 315; Any pressure on the flap 290 will cause it to seal against the bottom surface 264 of the base member 260, closing the slit 310.

A surgical tacking instrument 340 having a straight shaft 350 that can be used to secure the tissue repair patch of the present invention is shown in FIGS. 21 and 22. The instrument 340 has a proximal handle 342 with an actuation trigger 344. A straight shaft 350 having a distal section 352 and a distal end 354 extends from the distal end 346 of the handle 340. The distal end section 352 is inserted through the slit 310 and the opening 315 between the upwardly extending closure flaps 290 and 300 to secure the base member 260 to the tissue using a surgical tag. The distal end 354 is shown as being movable around the bottom surface 264 of the base member 260. Tissue repair patch 250 is shown implanted into the patient in FIG. 22. A cross section of the body wall 370 with the surgically created opening 372 is shown. Body wall 370 is shown to have an inner peritoneal layer 374, then an upper fascia layer 375, then a muscle layer 376, a fat layer 377, and finally a normal skin layer 378. . The top surface 262 of the base member 260 is shown to be mounted adjacent to the peritoneal layer 374, with the closure flap members 290 and 300 extending outward through the opening 332. The shaft 350 of the tacking instrument 350 is shown inserted through the surgical opening 372, through the slit 310 and opening 315, and into the body cavity underlying the patient. The distal end section 352 and the distal end 354 are shown positioned adjacent the bottom surface 264 of the base member 260 to attach the section of the base member 260 to the peritoneal layer 374 .

23 and 24 illustrate implantation of the tissue repair patch 250 of the present invention into a patient during a surgical procedure to repair a hernia defect. The surgeon is shown holding the handle 322 of the surgical tacking instrument 320 with one hand while engaging the trigger 324. The instrument has a curved shaft 330, the proximal section 332 of the shaft 330 through the opening 372 of the body wall 370, and the slit 315 and opening 350 of the hernia repair patch 250. ). The repair patch 250 is implanted in the body cavity of the patient so that the upper surface 262 of the base member 260 is adjacent to the peritoneal layer 374. Closing flaps 290 and 300 are rotated upward to expose the slits 310 and openings 315 and extend out through the openings 372 of the body wall 370, so that they partially extend over the skin layer 378. Has been. The patient's viscera 379 is shown adjacent to the bottom surface 264 of the base member 260. The shaft 330 of the tacking instrument 320 is shown inserted through the surgical opening 372, through the slit 310 and opening 315, and into the body cavity underlying the patient. The distal end section 332 and the distal end 334 are shown positioned adjacent to the bottom surface 264 of the base member 260 to attach a section of the base member 260 to the peritoneal layer 374. . The surgeon's other hand is shown to be actuating the trigger 324 to facilitate the patient's body wall 370 over the distal end 334 to position the tack prior to delivering the tack. Referring to FIG. 26, after implantation of the patch 250 and fixing using the tag 380, the bottom surface 264 of the base member 260 is a tag 382 to fix the patch 250 to the peritoneal layer 374. , 384) can have two concentric (concentric) crowns.

Another embodiment of the tissue repair patch of the present invention is shown in FIGS. 25 and 26. The repair patch 500 is shown as having a substantially flat base member 510 having a top surface 512 and a bottom surface 514. The base member 510 is shown as having a circular opening 520 bounded by a perimeter 522. The closing ring 530 is shown mounted around the perimeter 522 of the circular opening 520. The patch 500 also has a closed patch 540 having a top surface 542 and a bottom surface 544. A mating closure ring 548 is mounted on the bottom 544 of the patch 540. Mating closure ring 548 is removably engageable with closure ring 530. When used in a surgical procedure, the surgeon exposes the opening 520 by removing the closure patch 540 from the base member 510. The base member 510 is then implanted into the patient's body cavity such that the upper surface 512 of the base member 510 is adjacent to the inner layer of the body cavity, such as the peritoneum. The surgeon then inserts the distal section of the shaft of an attachment instrument, such as a surgical tacker, through the opening 520 into the body cavity below the bottom surface 514 of the base member 510. After the base member 510 is fixed to the inner layer of tissue and the shaft of the fixation instrument is removed, the surgeon applies the closure patch 540 to the base member 510 so that the mating closure ring 548 and the closure ring 530 engage. It is mounted on the upper surface 512 of.

Referring to Figures 31 to 41, a further embodiment of the tissue defect patch 600 of the present invention is illustrated. 31-34, the tissue repair patch 600 is shown as having a base member 610 having a top surface 612 and a bottom surface 614. The patch has a perimeter 616 and a perimeter edge 618. A centrally located slot or slit 620 having an opening 624 bounded by sides 622 is located within the base member 610. The slit 620 has an end 628. If desired, the slit or slot 620 may be positioned such that it is offset from the center. The base member 610 is illustrated as having a substantially elliptical shape or configuration, but may have other configurations including a square, a rectangle, a circle, a polygon, and the like, combinations thereof, and the like. It is preferred that the base member 610 is substantially flat, but it may be shaped, for example curved, and the like. The positioning structure 650 is mounted on the bottom surface 614 of the base member 610. Structure 650 is shown to be a ring-like structure having a top surface 652 and a bottom surface 654. As illustrated, the top surface is substantially flat and the top surface has a rounded configuration, so that the cross section is D-shaped. However, it will be appreciated that the cross-section of the positioning structure may have a variety of cross-sectional shapes including, but not limited to, circular, elliptical, square, rectangular, polygonal, straight cross-section and curved cross-section, combinations thereof, and the like. The structure 650 will have a shape generally conforming to the periphery of the base member 610, for example circular, elliptical, rectangular, square, polygonal, curved side, straight side, and combinations thereof. The structure 650 has an outer edge 655, an inner edge 656 and a central opening 657, but if desired, the central opening 657 can be removed, although not preferred. While the positioning structure 650 can be made from biocompatible polymers and bioabsorbable polymers as described above herein, it is particularly preferred to make the structure 650 from a bioabsorbable polymer. The structure 650 can be manufactured using conventional manufacturing processes including injection molding, machining, three-dimensional ink jet printing, solution casting, extrusion, composite lamination, and the like. Positioning structure 650 is a variety of conventional, including gluing, welding, stitching, fastening using mechanical fasteners, co-molding, the use of a high temperature platen or press, thermoforming, etc. Can be attached to the base member 610 in a manner. In one embodiment described below, the structure 650 may be molded or formed into the base member 610.

Referring now to FIG. 33, the tissue repair patch 600 is shown to be implanted in the patient under the hernia defect 700 in the body wall 710. The surgically created opening 715 is included in the body wall 710 above the hernia defect 700. The bottom surface 614 of the base member 610 is shown facing the patient's viscera, while the top surface 612 of the base member 610 is adjacent to the inner surface 712 of the body wall 710. The device 600 is fixed to the body wall 700 in a conventional manner by surgical fasteners such as surgical tags or the like. The tag or fastener inserts the distal section 815 of the shaft 810 of the surgical tacking instrument 800 into the opening 640 and utilizes the distal tip 818 of the distal section 815 of the shaft 810. Therefore, it is applied by determining the position of the peripheral portion 616 of the base member 610. The perimeter 616 is conveniently and accurately positioned by the surgeon moving the distal end section 815 of the shaft 810 such that the tip 818 contacts or proximate the positioning structure 650. Subsequently, by moving and manipulating the tip 818 around the positioning structure 650, a tack or other fixing or fastening device is provided through the base member 610 into the body wall 710 and the periphery 616 of the base member 610 Fired around the whole. The positioning structure 650 helps the surgeon locate and position the perimeter 616 of the base member 610 for proper placement of a tag or other fastening or fastening device. The opening 624 in the slit or slot 620 is secured and closed using a suitable closure member as described above herein, such as a suture.

Referring now to FIGS. 35 and 36, an embodiment of a tissue repair patch device 600 of the present invention having a positioning structure 650 having a textured top surface 660 is shown. The device 600 is shown mounted adjacent to the bottom of the body wall 710 under the hernia defect 700. Structure 650 is shown having a textured bottom surface 660. As shown, surface 660 has a plurality of pointed ridges 662 extending upward from surface 660 and having a base 664 and peaks 667. Ridge 662 is shown as having a rectangular cross section. Ridges can also be round and have other geometric cross-sections including square, rectangular, oval, semicircular, and the like. Although not shown, the textured surface may be textured by grooves or other indentations, or by a combination of grooves or indents and protrusions. The distal tip 818 of the distal section 815 of the shaft 810 of the tacking or fixation mechanism 800 is a textured surface at a location for firing the tack through the base member 610 and into the body wall 710. 660).

An embodiment of a tissue repair patch device 600 of the present invention having a positioning structure 650 with a downwardly extending flange configuration is shown in FIGS. 37-41. First, referring to FIGS. 37, 38, and 39, the tissue repair patch device 600 is a flange member 670 extending downward manufactured by molding or otherwise forming a portion of the peripheral portion 616 of the base member 610. It is shown as having a positioning structure 650 in the form of. Flange member 670 is shown having a lower end edge 672, an inner side 674, an outer side 676 and an upper end 678. The flange member has a curved cross section, but may have other configurations and cross sections, including straight and angled. The device 600 when installed adjacent to the patient's body wall 710 on the inner surface 712 as shown, the tip 818 is close to or in contact with the inner surface 674 of the flange member 670. To be secured by manipulating the distal tip 818 of the distal section 815 of the shaft 810 of the instrument 800. As shown in FIG. 39, the positioning structure 650 may be made of a separate flange member 680 having an upper end 682, a lower end 684, an inner side 686 and an outer side 688. The upper end 612 of the flange member 680 is mounted on the peripheral edge 616 or the peripheral edge 618 of the base member 610 in a conventional manner, for example, by gluing, welding, stitching, fastening, cavity forming, etc. Can be. A device 600 having a flange member 680 is shown to be implanted and used in a patient to repair a tissue defect as described above.

Another embodiment of a tissue repair member 600 having a positioning structure 650 with a flange structure extending downward is shown in FIGS. 40 and 41. Structure 690 is shown as consisting of a ring or peripheral element 691 and a flange section 695 extending downward. Perimeter element 691 is shown having a top surface 692, a bottom surface 693 and an outer surface 694. The downwardly extending flange section 695 has an upper end 696, a lower end 697, an inner side 698, and an outer side 699. The structure 690 may be mounted such that the bottom surface 693 of the peripheral element is on the top surface 612 of the base member 614 adjacent to or on the peripheral portion 616 and the peripheral edge 618 is covered, or The structure 690 can be mounted such that the top surface 692 of the perimeter element 691 is on the bottom surface 614 of the base member 614 adjacent to or on the perimeter 616. Device 600 with structure 690 is shown to be implanted and used in a patient to repair tissue defects as described above.

The repair patch of the present invention may optionally contain or be coated with a sufficiently effective amount of an active agent, for example a therapeutic agent. Substances suitable as active agents may be naturally occurring or synthesized, for example, antibiotics, antimicrobial agents, antibacterial agents, antiseptic, chemotherapeutic agents, cytostatic agents, metastasis inhibitors, Antidiabetic agents, antifungal agents, gynaecological agents, urological agents, antiallergic agents, sex hormones, sex hormone inhibitors, haemostatic, hormones, peptide hormones, antidepressants, vitamins, e.g. vitamins C, antihistamines, naked DNA, plasmid DNA, cationic DNA complexes, RNA, cell constituents, vaccines, and cells naturally occurring in the body, or genetically modified cells, but Conventional formulations are not limited thereto.

In one embodiment, the active agent is gentamicin or an antibiotic of the ZEVTERA™ (ceftobiprole medocaril) brand (available from Basilea Pharmaceutica Ltd., Basel, Switzerland). It may be an antibiotic including an agent such as. In one embodiment, the implant is a broadband antimicrobial agent used against different bacteria and yeast (even in the presence of body fluids), e.g. octenidine, octenidine dihydrochloride (Schulke & Meyer, Norderstadt, Germany). (Available as an active ingredient Octenisept® disinfectant from Schulke & Mayr), polyhexamethylene biguanide (PHMB) (Lavasept® from Braun, Switzerland) ), triclosan, copper (Cu), silver (Ag), nano silver, gold (Au), selenium (Se), gallium (Ga), taurolidine, N-chlorotaurine, alcohol System disinfectants, such as Listerine® mouthwash, Na-lauryl-L-arginine ethyl ether (LAE), myristicamidopropyl dimethylamine (MAPD, SCHERCODINE™) M), oleamidopropyl dimethylamine (OAPD, available as active ingredient of schercodin™ O), and stearamidopropyl dimethylamine (SAPD, activity of schercodin™ S (Available as an ingredient). In one embodiment, the agent may be octenidine dihydrochloride (hereinafter referred to as octenidine) and/or PHMB.

While it is desirable to have a single centrally located opening in the hernia repair patch device of the present invention, the opening and associated closure member may be offset from the center. Additionally, more than one opening and closing member may be used in the hernia repair device of the present invention.

The following examples illustrate the principles and practice of the present invention, but are not limited thereto.

Example 1

A patient suffering from an abdominal wall or incision hernia is prepared for an open hernia repair procedure in the following manner. The skin area around the hernia is wiped with a conventional antibacterial solution such as betadine. The patient is subjected to conventional general anesthesia in a conventional manner by induction and inhalation. The surgeon then initiates the surgical procedure by making an incision in the skin and subcutaneous tissue overlying the hernia. In the case of a planned intraperitoneal mesh placement, the hernia sac is opened. The edges of the healthy fascia around the defect are examined and any attachments of the viscera to the abdominal wall are divided to create free space for fixation of the mesh.

At this point in the procedure, the surgeon then prepares the mesh tissue repair hernia patch of the present invention, which mesh tissue repair hernia patch has a locating structure, the closure flap, and the top surface of the mesh adjacent to the peritoneum around the defect. And a base member for insertion into the abdominal cavity and through the abdominal wall defect so that the bottom of the mesh device faces downward toward the intestines of the patient. A stay suture can be placed through the mesh into the abdominal tissue as desired, i.e. at the four compass points of the mesh (north, south, east, west). The flaps are rotated upward after placement, exposing an opening in the base member of the mesh. The mesh is secured using conventional surgical tacker instruments or other fastening means. The tacker is inserted through the opening so that the distal end of the tacker is between the mesh and the viscera, and the surgeon positions the periphery of the repair patch by engaging the positioning structure with the tip of the shaft of the tacker instrument. The periphery of the mesh is then secured using a plurality of tacks in a crown configuration. The tacker is removed and the opening in the mesh is closed by folding the flaps as appropriate for the present invention. The flaps can optionally be secured using adhesives, sutures, rivets, or other closure means, or can be returned to their rest position without securing to each other. Hernia defects can be largely closed if desired. The skin incision is closed using an appropriate suture or closure technique, the incision is properly bandaged, and the patient is moved to a recovery room.

The novel hernia repair device of the present invention has a number of advantages. The novel repair patch device provides a single layer mesh repair device that can be attached via tacking in an open intraperitoneal hernia repair procedure. The repair patch device has additional advantages, including less foreign matter (ie, lower mass of foreign matter) and the ability to implant a single layer tissue repair mesh in open procedures. The tissue repair device of the present invention, preferably made from mesh, potentially speeds up the rate of tissue integration, provides less area for biofilm formation, can have lower manufacturing costs, and has improved ergonomics. It is easier to package, sterilize, and use.

While the present invention has been shown and described with respect to detailed embodiments of the present invention, it will be understood by those skilled in the art that various changes in form and detail thereof may be made without departing from the spirit and scope of the claimed invention. .

Claims (42)

As a tissue repair patch,
A substantially flat base member having a top side, and a bottom side, and a periphery;
A locating structure positioned adjacent to the periphery of the base member, on the bottom surface;
An opening, the opening positioned within the base member such that a pocket is accessible through the opening; And
A closure member associated with the opening
Containing, tissue repair patch. The tissue repair patch of claim 1, further comprising a polymer layer on at least one side of the base member. The tissue repair patch of claim 1 further comprising an adhesion barrier on at least one side of the base member. The tissue repair patch of claim 1, wherein the base member comprises a mesh. The tissue repair patch of claim 1, wherein the base member comprises a fabric. 6. The tissue repair patch of claim 5, wherein the fabric is woven. 6. The tissue repair patch of claim 5, wherein the fabric is nonwoven. The tissue repair patch of claim 1, wherein the base member comprises an expanded polymeric film. The tissue repair patch of claim 1, wherein the base member comprises a biocompatible non-degradable polymer. The tissue repair patch of claim 1, wherein the base member comprises a bioabsorbable polymer. 10. The tissue repair patch of claim 9, wherein the non-degradable polymer is selected from the group consisting of polypropylene, polyester, nylon, and ultra high molecular weight polyethylene. The method of claim 10, wherein the bioabsorbable polymer is polylactide, polyglycolide, polydioxanone, polycaprolactone, copolymers of glycolide and trimethylene carbonate, and lactide and trimethylene carbonate. Tissue repair patch selected from the group consisting of copolymers of, and copolymers and blends thereof. The tissue repair patch of claim 1, wherein the base member comprises a biocompatible non-degradable polymer and a bioabsorbable polymer. The tissue repair patch of claim 1, wherein the opening is a slit. The tissue repair patch of claim 1, wherein the opening is circular. The tissue repair patch of claim 1, wherein the opening is in the shape of a slot. The tissue repair patch of claim 1, wherein the closure member comprises opposing closure flap members hingedly mounted around the opening. The tissue repair patch of claim 1, wherein the closure member comprises a patch having an outer periphery, and a section of the periphery is mounted around the opening and to the top surface of the base member. The tissue repair patch of claim 1, wherein the closure member comprises a surgical suture mounted around the opening. The method of claim 1, wherein the closure member comprises a patch having an engagement member extending from the bottom surface, together with a top surface and a bottom surface, wherein the base member is mounted around the opening and on the top surface. A tissue repair patch having a mating engagement member such that the closure patch engages and disengages from the base member. The tissue repair patch of claim 1, wherein the opening includes a slit having opposite sides, and the closure member includes a surgical suture threaded around the slit adjacent the sides. 18. The tissue repair patch of claim 17, wherein the flaps have free end sections separated from the base member by slots such that each closure flap member is able to engage within the slot of an opposite flap member. The tissue repair patch of claim 1, wherein the opening is centrally located. The tissue repair patch of claim 1 comprising at least two openings and closure members. 3. The tissue repair patch of claim 2, wherein the polymeric layer comprises a non-absorbable polymer. 3. The tissue repair patch of claim 2, wherein the polymeric layer comprises a bioabsorbable polymer. 26. The tissue repair patch of claim 25, wherein the polymer is selected from the group consisting of silicone, PTFE, polyester, and polypropylene. The method of claim 26, wherein the bioabsorbable polymer is selected from the group consisting of oxidized regenerated cellulose, polydioxanone, polyglycapron 25 (copolymer of glycolide and epsilon-caprolactone), and combinations thereof. , Tissue repair patch. 3. The tissue repair patch of claim 2, wherein the polymeric layer is an adhesion barrier. The polymer according to claim 3, wherein the adhesion barrier is selected from the group consisting of oxidized regenerated cellulose, polydioxanone, polyglycapron 25 (copolymer of glycolide and epsilon-caprolactone), and combinations thereof. Containing, tissue repair patch. 4. The tissue repair patch of claim 3, wherein the adhesion barrier comprises a polymer selected from the group consisting of silicone, PTFE, and ePTFE. The tissue repair patch of claim 1, wherein the positioning structure further comprises a downwardly extending flange member. The tissue repair patch of claim 1, wherein the positioning structure is an engagement ring member. The tissue repair patch of claim 1, wherein the positioning structure further comprises a textured surface. The tissue repair patch of claim 1, wherein the locating structure comprises a bioabsorbable polymer. The method of claim 35, wherein the bioabsorbable polymer is oxidized regenerated cellulose, polydioxanone, polyglycapron 25 (copolymer of glycolide and epsilon-caprolactone), polylactide, polyglycolide, and A tissue repair patch selected from the group consisting of copolymers and combinations. The tissue repair patch of claim 1, wherein the positioning structure is formed into the periphery of the base member. 38. The tissue repair patch of claim 37, wherein the positioning structure is a downwardly extending flange member. 34. The tissue repair patch of claim 33, wherein the ring member has a D-shaped cross section. delete delete delete

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