RU2689030C2 - Single-plane implant for tissue plasty, having structure of arrangement - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: disclosed is an implant for tissue plating having base member (610) with through hole (620) and a closing element (not shown) connected to the opening. Arrangement structure (670) is located on the lower side of the base element.

EFFECT: in the preferred embodiment, the base element comprises a suture and can be used in open surgical interventions for hernia repair and other types of body wall defects.

42 cl, 41 dwg

Description

Links to related inventions

This is a partial continuation of the simultaneously pending US patent application belonging to the same holder with serial number 13/443347, submitted on April 10, 2012, which is incorporated by reference.

Technical Application Area

The field of technology to which the present invention belongs is implantable surgical implants for tissue plastics, in particular, implantable surgical mesh implants for use in hernia repair procedures.

BACKGROUND OF INVENTION

Hernia repair is a relatively simple surgical procedure, the ultimate goal of which is to restore the mechanical integrity of the abdominal wall using plasty of a muscle wall defect into which the peritoneum and, possibly, part of the underlying organs are protruding. There are different types of hernia, including abdominal hernia, umbilical hernia, postoperative hernia, sports hernia, femoral hernia and inguinal hernia, and each of them applies a special procedure of surgical plastics. It is believed that most hernias are caused by the weakness of parts of the tissue of the abdominal wall.

Provocative factors, such as unusual movements or lifting of extremely heavy objects, can lead to excessive stress on weak points in the tissues of the abdominal wall, which leads to separation or tearing of the tissues and protrusion of the peritoneum and underlying organs, such as the intestines, through separated or torn pieces of cloth. This weakness can be caused by many factors. Abdominal wall weakness may be congenital or may be associated with stitches left after surgery or trocar openings. Other factors may include injury, genetic predisposition or age.

Despite the fact that each of the commonly used traditional surgical interventions for the correction or plastic surgery of various types of hernia has its own characteristics, they are all similar in terms of mechanical plastics. As a rule, the protrusion of the peritoneum through the muscles or a defect in the wall of the abdominal cavity forms a hernial sac that contains the underlying and protruding internal organs. The hernial sac is cut and the internal organs are pressed back into the abdominal cavity. Further, as a rule, the implant is implanted, which strengthens or restores the tissue, for example a mesh implant, and fixes it in the place of the defect of the abdominal wall. Autologous tissue quickly grows into a mesh implant, providing the patient with a reliable and sustainable recovery. In some cases, it is desirable for patients to stitch up or otherwise close the defect without an implant, although this is usually much less desirable for an optimal outcome.

One of the common types of hernia is a hernia of the abdominal wall. This type of hernia usually occurs in the wall of the abdominal cavity and can be caused by incisions or punctures in the past or by the load that a weak tissue section is subjected to. Depending on the individual characteristics of the patient and the nature of the hernia, there are several types of plastics that the surgeon can use to treat such hernias. In one technique, an overlay mesh is implanted on the dorsal surface of the anterior fascia of the muscles of the abdominal wall. Another technique involves a grid insert, with the prosthetic material being attached to the wall of the abdominal cavity and playing the role of a “bridge” to close the defect in the abdominal cavity. The location of the prosthetic mesh behind the rectus abdominis is known as the Reeves Stopp technique, or axillary technique. In this technique, a mesh implant is placed under the muscle of the abdominal wall, but above the peritoneum. Implantation of the mesh into the intraperitoneal space is carried out by an open or laparoscopic approach. The mesh is introduced into the abdominal cavity of the patient through an open front incision or through a trocar and covers the defect. Next, the surgeon fixes the mesh implant to the wall of the abdominal cavity by traditional mechanical fixation or sutures overlaid through the entire thickness of the abdominal wall. There are a large number of devices for such mechanical fixation that can be used in laparoscopic or open surgery, such as herniosteplers. Intraperitoneal placement of the mesh through open access may be the desired technique of plastics, when the layers of the abdominal wall are weakened and the laparoscopic approach is undesirable. The arrangement of the grid by this method creates some peculiar difficulties, including poor visibility of the grid during handling and during fixation, poor handling and insufficient ergonomics of the currently existing products. Plastic mesh implants designed for intraperitoneal placement usually require additional treatment or an additional layer in order to function as a tissue dividing component and separate the peritoneum from the prosthetic layer for the abdominal plastic, thus preventing or essentially slowing the formation of postoperative adhesions. Adding this layer can complicate wound healing due to the presence of an extra layer and its mass.

Although there are implants for open plastics of the hernia of the abdominal wall, there are well-known disadvantages associated with their use. Such disadvantages include the difficulty of handling the mesh, poor visibility when handling the mesh, during its implantation and fixation, lack of practicality and ergonomics in the use of a laparoscopic instrument and the use of two or more layers of the mesh. Commercially available mesh implants for a given application usually have at least two layers of mesh or fabric with pockets or skirts to ensure fixation to the parietal wall through the upper layer or skirt. You should also take into account that the mesh with many layers represent a foreign body with a larger mass and, as a rule, more expensive and difficult to manufacture than a single-layer mesh implant. Another disadvantage associated with implants for hernia repair is the simplicity of placing the peripheral part of the implant, so that the surgeon can fix the implant on the tissue by installing clips or other fixatives to properly fix the implants on the tissue in a satisfactory manner.

Accordingly, there is a need in the art for new tissue implants, such as implants for abdominal wall hernia, that can be used in open surgical procedures and that do not require a mesh layer for attaching and fixing and can be attached to the tissue using one technique. or many crowns. There is also a need for plastic tissue implants that make it more convenient for the surgeon to place the peripheral parts of such implants.

STATEMENT OF THE INVENTION

Accordingly, new tissue implants are being opened. Plastic tissue implants have a substantially flat or two-dimensional base element. The base element is preferably a mesh. In the base element there is a hole and a closing element associated with the hole. The base element has an upper side, a lower side, an outer periphery and an outer edge. The placement structure is located on the underside of the base element, adjacent to or located on top of the peripheral part of the base element. Preferably, the placement structure is a connecting annular element. The placement structure is not necessarily a downward flange element. The implant may have a polymer layer on at least a portion of at least one side of the base member. Preferably, the side of the mesh that faces the internal organs has a polymer layer that covers substantially the entire side. Implants for plastics tissue, representing the subject in accordance with the present invention, especially applicable for procedures open plastic hernia, such as plastic hernia of the abdominal wall, as well as useful for other types of plastic tissue wall of the body.

Another aspect in accordance with the present invention is the method of plasty of a defect in the body wall, such as a hernial defect, with open surgery using the above-mentioned implants for tissue plastics.

These and other aspects and advantages in accordance with the present invention will become more understandable after studying the following description and the accompanying drawings.

Brief Description of the Drawings

In FIG. 1 is a plan view of an embodiment of the invented single-plane implant for plastics of a tissue; the implant has a base element with a hole and a closing element mounted on the upper side of the base above the hole.

In FIG. 2 is a perspective view with a spatial separation of the components of the mesh implant shown in FIG. one.

In FIG. 3 shows a surgical gerniostepler with an elongated shaft that is partially inserted under the valve element and through the hole of the base element of the implant shown in FIG. one; the tool shaft has access to the underside of the base member.

In FIG. 4 is a plan view of an implant for plastics in accordance with the present invention, similar to the implant shown in FIG. 1, but having a rectangular closing implant element connected along its opposite smaller sides; The implant closure element has a directional guide to help the surgeon correctly orient the implant during surgery.

In FIG. 5 is an exploded perspective view illustrating the two halves of one embodiment of a plastic graft in accordance with the present invention; the two halves are connected so that they form a mesh implant with folding flaps.

In FIG. 6 is a plan view of an implant for plastics in accordance with the present invention, obtained by joining the two halves shown in FIG. five; valves are in the initial position.

In FIG. 7 is a perspective view of the plastic graft shown in FIG. 6, the valves are in the initial position.

In FIG. 8 is a perspective view of the plastic graft shown in FIG. 7, in which both valves are shown upward and open the bottom of the base member, thus providing access through the base member.

In FIG. 9 shows an implant for plastic tissue, shown in FIG. 8, with the curved stem of the surgical herniostepler partially inserted through the hole of the base element.

In FIG. 10 shows another embodiment of an invented plastic graft in which a mesh implant has a hole with a surgical suture and a surgical needle, mounted around the hole in a continuous mattress suture configuration.

In FIG. 11 shows an implant for plastic tissue, shown in FIG. 10, in which the hole is closed by tensioning the thread after fixing the implant to the parietal wall over the hernial defect.

In FIG. 12 is an exploded perspective view of another embodiment of the inventive plastic implant according to the present invention; the implant has an upper flap and a lower flap mounted near the opening in the base member.

In FIG. 13 is a plan view of a mesh implant for plastic repair of a tissue shown in FIG. 13, showing flap valves mounted around the opening of the base member, one flap valve adjacent to the bottom side of the base member, and another flap valve adjacent to the upper side of the base member, and the valves are in the rest position.

In FIG. 14 is a plan view of a preferred embodiment of the plastic graft of the present invention, in which the implant has a pair of flap valves.

In FIG. 14a is a cross-sectional view of the implant shown in FIG. 12, along line 14a-14a.

In FIG. 14b is an enlarged partial view of the cross-section shown in FIG. 12a, showing the valves mounted around the orifice of the implant base member.

In FIG. 15 presents a perspective view with a spatial separation of the components of the two halves of the base element of the implant for plastic tissue, shown in FIG. 14; Both halves have a flap valve extending from the base element sections.

In FIG. 16 is a perspective view of a plastic graft by joining together the two halves shown in FIG. 15; one valve is located below the base element, and the other valve is located above the base element.

In FIG. 17 presents a perspective view of a mesh implant for plastic tissue shown in FIG. 16, both valves are shown upward in such a way that the base member can be accessed between the valves.

In FIG. 18 is a perspective view of the mesh implant shown in FIG. 17, which depicts a distal end of a curved, elongated shaft of a surgical herniostepler, partially inserted through the opening of the base member to a position below the implant for attaching the mesh implant to the tissue.

In FIG. 19 is a perspective view of the plastic graft shown in FIG. 18, in which the two valves are not necessarily sewn in the forward position to close the opening of the base member after fixing the implant to the tissue.

In FIG. 20 is a cross-sectional side view of an implant for plastics of tissues from FIG. 16, which is placed in the abdominal cavity of the patient and is located next to the peritoneum of the patient; The curved stem of the surgical herniostepler is inserted through the access hole, such as a hernial defect in the patient's body wall, and through the hole in the implant base member so that the distal end of the stem is in a position below the implant, to attach the implant base member with a clip to the body wall.

In FIG. 21 is a perspective view of the mesh implant shown in FIG. 17, which depicts the distal end of a straight elongated shaft of a surgical herniostepler, partially inserted through the hole of the base element in position for attaching the implant for plastic tissue to tissue.

In FIG. 22 is a side view of the plastic graft shown in FIG. 21, which is placed in the abdominal cavity of the patient and is located near the patient's peritoneum; The distal part of the direct rod of the surgical herniostepler is inserted through the hole in the patient's body wall and through the hole of the implant base element so that the distal end of the rod is in a position below the implant to fasten the implant base element with a clip to the body wall.

In FIG. 23 depicts the procedure for plastic hernia, where the surgeon secures the implant for plastic tissue, shown in FIG. 17, in position above a hernia defect with the help of a surgical herniostepler having a curved elongated shaft; the distal part of the rod is inserted through the access hole in the patient's body wall and through the hole in the implant for plastics of tissues in order to fix the implant on the peritoneum; the surgeon's hands palpate the abdomen over the distal end of the tool shaft to place the clip in the desired position on the implant.

In FIG. 24 is a side cross-sectional view of a preferred embodiment of an implant for plastics of tissues in accordance with the present invention in place over a hernia defect adjacent to a patient’s peritoneum; the curved elongated shaft of the surgical herniostepler was installed through the access hole in the patient's body wall and through the hole in the implant to attach the section of the implant base element to the peritoneum; The internal organs of the patient are located near the lower side of the implant and peritoneum, and the closing valves are directed upwards through an opening in the body wall.

In FIG. 25 is an exploded perspective view of an alternative embodiment of a mesh implant for plastics in accordance with the present invention; the base element has an opening surrounded by a closing ring; the closing element is also shown with a mating closing ring.

In FIG. 26 is a perspective view of the plastic graft shown in FIG. 25, in which the closing element is depicted attached to the base element.

In FIG. 27 shows a peritoneal underside of a preferred embodiment of a plastic graft in accordance with the present invention, attached to the peritoneum with a double row of surgical clips, which is called a double crown technique; the hole in the base element is closed, both valves are directed upwards from the top of the base element; valves are fixed to close the hole in the base element.

In FIG. 28 is a perspective view of an alternative preferred embodiment of a mesh implant for tissue plastics in accordance with the present invention; the implant has a gap in the base element, providing a central hole.

In FIG. 29 is a perspective view of the implant shown in FIG. 28, with a surgical suture of the “shoelace” type laid over the slot to close the opening of the slot.

In FIG. 30 is a perspective view of the plastic graft shown in FIG. 29, after tensioning the ends of the thread, thus closing the hole and the slit after attaching the implant to the wall of the patient's body.

In FIG. 31 is a cross-sectional view of an implementation of an implant for plastics in accordance with the present invention, having an accommodation structure located on the underside of the base member at the periphery. The implant for plastics is shown located close to the body wall, below the hernial defect. Surgical herniostepler is shown with the distal end of its shaft located proximally to the inner side of the body wall with the tip of the stem near the placement structure and in the position for releasing clips through the base element into the body wall. The placement structure is ring shaped.

In FIG. 32 is a perspective view of the plastic graft shown in FIG. 31, bottom-up view from a position below the implant.

In FIG. 33 is a perspective view of the plastic graft shown in FIG. 31, showing the underside of the implant and the structure for plastics.

FIG. 34 is a partial enlarged side view of the implant of FIG. 31, showing the tip of the herniostepler shaft next to the placement structure.

In FIG. 35 is a cross-sectional view of an embodiment of a plastic implant according to the present invention, having an arrangement structure; It can be seen that the structure has a textured surface. The implant is in the position of readiness for fixation to correct the defect in the body wall using a surgical instrument.

FIG. 36 is a partial enlarged view of the implant of FIG. 36, showing the tip of the surgical hernia-steeper rod, grasping the textured surface of the placement structure.

In FIG. 37 is a cross-sectional view of an embodiment of a plastic implant according to the present invention, having an arrangement structure; it is seen that the structure has a downwardly protruding flange element formed from the periphery of the base element. The implant is in the position of readiness for fixation to correct the defect in the body wall using a surgical instrument.

FIG. 38 is a partial enlarged view of the implant of FIG. 36, showing the tip of the surgical hernia-steeple rod, grasping a downward flange element of the placement structure.

FIG. 39 is a partial enlarged cross-sectional view of the plastic implant, where the placement structure is a downward flange element located at the periphery of the base element.

FIG. 40 is a partial enlarged cross-sectional view of the plastic implant, where the placement structure is an annular element with a down flange element; the annular element is located on the top of the base element.

FIG. 41 is a partial enlarged cross-sectional view of the plastic implant, where the placement structure is an annular element with a downward flange element; the annular element is located at the bottom of the base element.

DETAILED DESCRIPTION OF THE INVENTION

New implants or devices for tissue plastics in accordance with the present invention are particularly useful in open surgical interventions for abdominal hernias or postoperative hernias. Implants for plastic tissue consist of a base element with a hole. The base element has a closing element or device associated with the hole and serving to close the hole after implantation. Implants for plastic grafting in accordance with the present invention can be used in other traditional procedures of surgical plastics, including procedures for plastic inguinal hernia, trocar stab wounds, trocar postoperative hernias, etc.

Implants for tissue repair and surgical instruments for stitching to fix implants for tissue repair are disclosed in the following patent applications belonging to the same holder, which are simultaneously considered patent applications, the contents of which are incorporated herein by reference: No. 12/464,151; 12/464 165; 12/464 177; 12/464 143; 12/944 651 and 12/815 275.

Implants for plastic tissue in accordance with the present invention can be made from any conventional biocompatible material. Implants and their components are preferably made from standard biocompatible polymers, which can be non-absorbable or bioresorbable. The term “bioabsorbable” is defined as having its standard meaning and includes the terms “biodegradable” and “self-absorbable”. Examples of such non-absorbable polymers include polypropylene, polyester, nylon, ultrahigh molecular weight polyethylene, etc., as well as combinations thereof. Examples of suitable bioabsorbable polymers include polylactides (PLA), polyglycolides (PGA), polydioxanones (PDO, PDS), PGA / trimethylene carbonate copolymers (TMK), PLA / TMC copolymers, etc. Combinations of biocompatible nonabsorbable polymers and bioabsorbable polymers can be used with the present invention.

Although it is preferable to use surgical nets to create hernia grafts in accordance with the present invention, other traditional woven and non-woven materials for surgical plastics or thermally formed implants can also be used. In addition, implants for plastic tissue can be made from traditional implantable materials, such as PTFE (polytetrafluoroethylene), for example, from films and multilayer materials of porous PTFE. Implants may consist of composites of polymer films and nets and / or fabrics.

Grids suitable for implants for hernia repair in accordance with the present invention can be manufactured in conventional manner using traditional manufacturing equipment and standard methods, including knitting, weaving, non-woven techniques, etc. The mesh hole size is usually sufficient to effectively ensure tissue ingrowth; for example, sizes can be from about 0.3 to about 5 mm, and other normal size ranges are possible. Examples of commercially available non-absorbable and bioabsorbable polymeric meshes that can be used to manufacture hernia grafts of the present invention include surgical meshes ETHICON PHYSIOMESH ™ and ETHICON PROCEED ™, supplied by Ethicon, Inc., Route 22 West, Somerville, NJ 08876.

When creating new implants for plastics of tissue in accordance with the present invention from surgical tissues other than nets, the tissues should have open pores of a size sufficient for effective germination of tissues, for example, with a typical size from about 0.3 to about 3 mm. By "open pores" they mean holes that pass from one side of the web to the opposite side and form a through passage through the web. Fabric elements for plastics can be made of single-strand fibers, multi-strand fibers, or combinations thereof. Examples of commercially available non-woven fabrics that can be used to manufacture hernia implants in accordance with the present invention include woven materials, textiles and tapes for surgical use. Other webs or materials include perforated condensed porous PTFE films and nonwoven materials with a pore size of at least one millimeter. Non-mesh fabrics can be made from traditional biocompatible materials.

The fabric or mesh may contain, along with a long-lasting polymer, an absorbable polymer (i.e., bioabsorbable or biodegradable). Absorbable polymer and long-term stable polymer preferably contain monofilament and / or multifilament yarn. The terms "resorbable polymers" and "bioabsorbable polymers" are used interchangeably herein. The term "bioabsorbable" has the usual meaning. Although this is not preferred, a fabric or mesh element for plastic tissue can be made from a bioabsorbable polymer or bioabsorbable polymers without the use of long-lasting stable polymers.

Implants for plastic tissue in accordance with the present invention may also include polymer films. The film may be attached to the upper surface, the lower surface, or both surfaces and may also cover the peripheral edges of the plastic implants or extend beyond the periphery of the plastic implants. The films used to make plastic implants in accordance with the present invention have a thickness sufficient to effectively prevent adhesions, or otherwise function as a tissue barrier, or structure, or membrane for tissue separation. For example, the thickness may typically vary from about 1 μm to about 500 μm, and preferably from about 5 μm to about 50 μm, but this depends on the individual characteristics of the selected polymer film. Films suitable for use with plastic implants in accordance with the present invention include both bioabsorbable and nonabsorbable films. The films preferably have a polymer base and can be made from a variety of traditional biocompatible polymers, including bioabsorbable and nonabsorbable polymers. Nonabsorbable or very slowly resorbable substances include polyalkenes (eg polypropylene or polyethylene), fluorinated polyolefins (eg polytetrafluoroethylene or polyvinylidene fluoride), polyamides, polyurethanes, polyisoprenes, polystyrenes, polysilicones, polycarbonates, poliarilefirketony (PAEK), esters of polymethacrylic acid esters polyacrylic acid, aromatic polyesters, polyimides, as well as mixtures and / or copolymers of these substances. You can also use synthetic bioabsorbables, such as polyhydroxy acids, for example, polylactic acid However, you can also use materials of natural origin, such as collagen, gelatin, or materials derived from natural, such as films based on cross-linked gels from omega-3 bioabsorbable fatty acids or oxidized regenerated cellulose (ORC).

Films used for implants for plastic tissue in accordance with the present invention, can cover the outer surface of the implant element for plastic hernia in whole or in part. In some cases, it is preferable that the film overlaps the boundaries and / or periphery of the plastic implants. Implants for plastic tissue in accordance with the present invention may also have a anti-adhesive barrier layer attached on one or both sides. Anti-adhesive barrier usually consists of traditional biocompatible polymeric materials, including absorbable and non-absorbable polymers, but not limited to them. Examples of conventional non-absorbable polymeric materials suitable for the manufacture of anti-adhesive barriers include porous polytetrafluoroethylene, polytetrafluoroethylene, silicone, etc. Examples of traditional absorbable polymeric materials suitable for the production of anti-adhesive barriers include oxidized regenerated cellulose, polyleflectron 25 and epsilon-caprolactone), etc.

It is particularly preferable that the plastic implants of the tissue of the present invention have a mesh construction, and the embodiments shown in the Figures have such a mesh construction. Implants for plastic surgery in accordance with the present invention are particularly convenient for carrying out hernia repair procedures, but can also be used in other plastic surgical procedures.

In FIG. 1-3 shows an implant for plastic tissue 10 in accordance with the present invention. The implant 10 has a mesh structure. It can be seen that the implant for plastics 10 has a substantially flat or two-dimensional element of the base 20 and a covering element of the implant 30. The element of the base 20 is shown to have a substantially oval shape or configuration, but may also have other configurations, including square, rectangular, circular, polygonal and etc., their combinations, etc. It can be seen that the base element 20 has the upper side 22, the lower side 24 and the periphery 26. Through the base element 20 passes a slot 40 with a hole 42, limited by opposite sides 44 and opposite mi ends 43. It is seen that the closing element 30 of the implant is a substantially flat or two-dimensional element with a substantially oval configuration. It can be seen that the implant closing element 30 has an upper side 32, a lower side 34 and a periphery 35. It can be seen that the implant closing element 30 has opposite curved ends 37 and opposite sides 38. The closing element 30 is mounted on the upper element of the base 20 by means of connections 39 along the ends 37 so that the lower side 34 of the closing element 30 is adjacent to the upper side 22 of the base element 20. The closing element is installed using any traditional method of fi ation, including sewing, welding, installing staples, rivets, clamps, bonding and so on. d., and so on. n., but not limited thereto. The closing element 30 is mounted on the element of the base 20 to close the slit 40 and the hole 42. The holes 48 adjacent to the sides 38 provide access paths for surgical instruments to the hole 42 and the slits 40 and through them. A partial diagram of the surgical herniostepler 60, which can be used to fasten the base element 20 of the implant 10 to the tissue, is shown in FIG. 3. The tool 60 has a proximal handle 62 and a distal elongated rod 70 with a distal end 78. It can be seen that the distal 76 of the rod 70 passes through the hole 48, under the bottom 34 of the flap valve 30, and through the hole 42 of the slit 40 so that is located under the bottom side 24 of the base element 20. It can be seen that the distal end 78 is located proximal to the periphery 26 of the base element 20 adjacent to the bottom side 24, so that surgical clips can be installed for attaching the implant that to the tissue adjacent to the upper side 22 of the base element 20 and the upper side 32 of the closing element of the implant 30. The plastic implant 10 is fixed around the perimeter 26 to the fabric with fixation points, for example, approximately every 1-2 cm, i.e. fixing devices or paper clips approximately 1 cm to 2 cm apart. Although in many embodiments of implanting tissue or hernia, it is desirable to have a slot in the base element to create a through hole in the base element, the hole can t is a slit or other type of hole of different geometric configurations, including round, oval, rectangular, polygonal, etc., their combinations, etc. Although it is not preferable, it is possible to form implants for plastic tissue in accordance with the present invention such that the base element and / or the closing element will be curved or otherwise located in more than one plane.

After implanting and attaching the plastic graft of the tissue 10 according to the present invention to the tissue by installing clips or using other traditional methods (for example, stapling, stapling, etc.), part of the stem 76 of the surgical herniostepler 60 is removed from slot 40. The closure element of the implant 30 prevents the underlying tissue or internal organs from sliding through the slot 40 and the opening 42.

An alternative implementation of the implant for plastic tissue 10 is shown in FIG. 4. It can be seen that the implant 10 has a similar shape of the base element 20, however, it can be seen that the covering element 50 has a substantially rectangular shape with smaller opposite ends of the sides 56 and large opposite ends of the sides 57. The closing element 50 has an upper side 52 and a lower side 54 adjacent to the top side 22 of the base element 20. The implant element 50 is mounted on the base element 20 on top of the slit 40 by connections 59 along the smaller sides 56. The connections can be made as described above. Holes 48 under the sides 57 provide access to the slit 40 and the hole 42. As can be seen in FIG. 4, the implant for plastic tissue 10 has a direction indicator 80, which is on or in the covering element 50. The indicator 50 may be traditionally sewn, cast or formed, printed, painted or laminated in or on the element 50. It can be seen that the indicator 80 has a central part 81, from which the opposite transverse parts 82 continue. In the longitudinal direction, the longitudinal parts 85 and 87 continue in opposite directions. It can be seen that part 87 is thicker than part 85. The pointer 80 allows the surgeon to determine the location Implant voltage relative to the patient after administration by aligning the corresponding implant tissue plasty axes 10 relative to the patient and the incision, and get a more accurate fix by using either securing gerniostepler or surgical sutures. Such directional signs can be used with other embodiments of a plastic graft in accordance with the present invention.

In FIG. 5-9, another embodiment of a plastics tissue implant 100 according to the present invention is shown. It can be seen that the implant 100 has a substantially flat or two-dimensional base element 110 formed from substantially flat or two-dimensional portions of the base 120 and 140. The base member 110 has a lower side 112, an upper side 114, and a periphery 116. It can be seen that the base part 120 has straight side 122 with ends 124. It is also clear that part of base 120 has a curved side 126 with ends 128 that connect to ends 124. From the straight side 122 there is a flap valve element 130, which has a folding side 132 and a free end 134, separated from one hundred pony 122 with slot 136. Slot 136 has a closed end 137 and an open end 138. It can be seen that the element of the flap valve 130 has a substantially rectangular configuration, but may have other geometric configurations, including round, oval, polygonal, etc. combinations thereof, etc. It can be seen that the base part 140 has a straight side 142 with the ends 144. It is also clear that the base portion 140 has a curved side 146 with the ends 148, which are connected to the ends 144. The flap valve element extends from the straight side 142 150 having a folding side at 152 and the free end 154, separated from the side 142 by the slot 156. The slot 156 has a closed end 157 and an open end 158. It can be seen that the flap valve element 150 has a substantially rectangular configuration, but may have other geometrical configurations, including a circular one, oval, polygonal, etc., their combinations, etc. The base element 110 and the plastic graft implant 100 are formed from the base parts 120 and 140 by connecting the base parts along the straight sides 122 and 142 along the seams 118. This can be done with any traditional way including sewing, welding, installing clips, staples, gluing, etc., as well as combinations of the above or similar methods. It can be seen that only the straight sides 122 and 142 are connected on both sides of the elements of the flap valve 130 and 150. The elements of the flap valve 130 and 150 are mounted together so that the flap side 132 of the flap valve 130 is in slot 156 of the valve element 150, and the flap side 152 of the flap valve 140 was located in the slot 136 of the closing member 130. This creates a slot 160 in the base member 110 having an opening 165 limited to the internal parts of the straight sides 122 and 142 of the base sections 120 and 142,

respectively, as well as limited flanges 132 and 152 flange elements 130 and 150, respectively. In the initial position, as shown in FIG. 6, the flap valve element 130 is located above the upper side 145 of the base part 140 of the base element 110, while the flap valve element 150 is located above the upper side 125 of the base part 120. In this initial configuration, the slot 160 and the hole 165 are covered. In FIG. 8 shows an implant for plastics of a tissue 100 in the ready position, with elements of a flap valve 130 and 150 in a vertical position opening the slit 160 and an opening so that a fixation tool can be inserted through the opening 165. In FIG. 9 shows a herniostepler 170 with a plastic graft implant 100 in accordance with the present invention. It can be seen that the herniostepler 170 has a proximal handle 172 and an activating trigger 174. From the distal end 176 of the handle 170, the curved rod 180 continues with the distal part 182 and the distal end 184. It can be seen that the distal part 182 is inserted through the slit 160 and the hole 165 between upwards valves 130 and 150 so that the distal end 184 can be moved along the underside 112 of the base member 110 to secure the base member to the tissue with surgical clips. After installing the staples through the base element 110 of the implant 100 to secure the implant 100 onto the herniostepler fabric 170, it can be removed from the slot 160, and the two flap valves 130 and 150 can be engaged by folding or turning the flap valve elements down onto the upper side 114 of the base element 110. One or Both flaps can optionally be fixed or fixed to the base member 110 using various standard fastening methods, including adhesives, surgical threads, surgical clamps, etc.

In FIG. 10 and 11 show another embodiment 400 of a single plane implant for plastic grafting of a tissue in accordance with the present invention. The plastic implant 400 has a base element 410 with an upper side 412 and a lower side 414. The implant has a periphery 416. The base element 410 has a slit 420 with a hole 424 bounded by the sides 422. The slit 420 has ends 428. There is a surgical suture around the slit 420 430 with the ends 432 and 434 and a surgical needle 436 mounted at the end of the 432, and optionally, although not shown, at the end 434. The thread 430 is installed around the opening 424 in the traditional configuration of a mattress suture (continuous). As shown in FIG. 11, the hole 424 is closed by tensioning the ends of the thread 432 and 434, which brings the sides 422 closer together. If necessary, a surgical needle 436 can be used to hook the fabric with the thread 430. In FIG. 28 and 29 show another way of installing the thread. The plastic implant 450 is similar to the plastic 400 implant, but has a base element 451 of a rectangular shape with large opposite sides 454 and smaller opposite sides 456 connected by rounded corners 457. The base element 451 has a bottom side 458 and an upper side 459, as well as the outer periphery 452 The base element 451 has a central slit 460 with a hole 464, limited by sides 462. The slit 460 has ends 468. There is a surgical suture thread 470 with ends 472 and 474 around the slit 460 guration "shoelace shoelace." It can be seen that the thread 470 is mounted on the slit 460 by gripping the opposite sides 462 of the slit 460 around the hole 464. ends 472 and 474, thereby closing the opening 464. On the thread 460, surgical needles may optionally be mounted at one or both ends 472 and 474. The base elements 410 and 451 may have any suitable geometrical configuration.

In FIG. 12 and 13 illustrate a preferred embodiment of a plastic graft implant 200 in accordance with the present invention. It is seen that the implant 200 has a substantially flat or two-dimensional element of the base 210, which has a top 212, a bottom 214 and a periphery 216. It is seen that the element of the base 210 has an oval shape, but also may have other geometric shapes, including rectangular, round, square , polygonal, their combinations, etc. In the base element 210 there is a slot 220 with a through hole 222. The slot 220 is bounded by opposite sides 224 and 225 and curved ends 226. It can be seen that the implant 200 has an upper flap valve 230 and a lower flap valve 24 0. It can be seen that the top flap valve 230 has a substantially rectangular shape, although it may have other geometric configurations, including round, oval, rectangular, polygonal, etc., etc. It can be seen that the valve 230 has an upper side 231 and a lower side 232. The valve 230 also has opposite sides 235 and 236 connected by opposite end sides 237. The valve 230 is mounted on the upper side 212 of the base element 210, adjacent to the side 224 of the slot 220 by connecting the valve 230 along its side 235 such as sewing, gluing, installing staples, welding, installing rivets, etc., to create a seam 239. Thus, the valve 230 has its lower side 232 facing the upper side 212 of the base element 210 and is positioned so that The initial position is to cover the slot 220 and the hole 222. The flap valve can be turned upwards around the seam 239 to open the slot 220 and the hole 222. On the lower side 214 of the base element 210, another flap valve 240 is installed. 242. Valve 240 also has t opposite sides 245 and 246, connected by opposite end sides 247. Valve 240 is mounted on the bottom side 214 of base element 210 adjacent to side 225 of slot 220 by connecting valve 240 along side 245 in the traditional way, such as sewing, gluing, installing staples, welding, installation of rivets, etc., to create a seam 249. Thus, the upper side 241 of valve 240 faces the bottom side 214 of the base element 210, and the valve itself is positioned so that in the initial position to cover the slot 220 and hole 222. From The tail valve can be turned up around seam 249 to open slot 220 and hole 222. Valve 240 can also be turned up around seam 249 through slot 220 and hole 222.

FIG. 14, 14a, 14b and 15-17 illustrate the preferred implant for plastics of the tissue 250 of the present invention. The implant 250 is similar to the implant 200, but is made in a different way from two separate parts of the base elements. It can be seen that the implant 250 has a substantially flat or two-dimensional base element 260 formed from substantially flat or two-dimensional portions of the base 270 and 280. The base member 260 has a lower side 264, an upper side 262, and a periphery 266. It can be seen that the base part 270 has straight side 272 with ends 274. It is also seen that part of the base 270 has a side 276 with curved ends 278, which are connected to the ends 274. From the straight side 272, the flap valve 290 element continues, having a flap side 292 and a free side 294. ale The flap valve 290 has a substantially rectangular configuration, but may also have other geometric configurations, including round, oval, rectangular, polygonal, etc., etc. It can be seen that the base part 280 has a straight side 282 with ends 284. It is also seen that part of the base 280 has a side 286 with curved ends 288, which are connected to the ends 284. From the straight side 282 there is a flap valve element 300, which has a flap side 302 and a free side 304. It can be seen that the flap valve element 300 has essentially It has a rectangular configuration, but may also have other geometric configurations, including oval, rectangular, polygonal, etc., etc. The base element 260 and the implant for closing the hernia 250 are formed from the base parts 270 and 280 by connecting the base parts along straight sides 272 and 282 along seams 268. This can be done by any traditional method, including sewing, welding, installing clips, staples, gluing, etc., as well as combinations of the above or similar methods. It can be seen that the straight sides 272 and 282 are connected on both sides of the flap valve elements 290 and 300, thereby creating a gap 310 between the elements 290 and 300 with an opening 315. The slot 310 is bounded by the flap sides 292 and 302 of the flap valve elements 290 and 300 and has opposite ends 312. When assembling the implant 250 and the base member 260, the flap valve 290 is inserted through the opening 315 in the slit 310. In the initial position, as shown in FIG. 12 and 16, the valve element 300 is on the upper side of the base part 270 of the base element 260, and the valve element 290 is on the lower side of the base part 280. In the initial position, each valve element 290 and 300 covers the slit 310 and the orifice 315. It should be understood that any of the flap valves can be turned through the slit 310 and the opening 315, although, as shown, the element of the flap valve 290 of the implant 250 is turned through the slit and is located adjacent to the underside 264 of the base element 260. In addition, the slit 310 can have other geometric config radios and shapes including a slot, and so on. d.

In FIG. 17-22, an implant 250 is shown in the ready position for attachment to a tissue during a plastic procedure of a tissue, such as a hernia repair procedure. As shown in FIG. 17, the implant was positioned in the ready position by turning the valve 300 up from the upper side 262 of the base element 260. It is also seen that the valve 290 is turned up through the slit 310 and the opening 315. After the flip valves 290 and 300 are turned, thus the slit 310 and the opening 315 turn out open to provide access to a surgical instrument, such as a herniostepler, or surgeon's fingers. Surgical gerniostepler 320 is shown in FIG. 18 along with a plastic graft implant 250 of the present invention. It can be seen that the herniostepler 320 has a proximal handle 322 and an activating trigger 324. From the distal end 326 of the handle 322, a curved rod 330 with a distal part 332 and a distal end 334 extends. upward flaps 290 and 300 so that the distal end 334 can be moved along the underside 264 of the base member 260 to secure the base member 260 to the tissue with surgical clips. In FIG. 20 shows an implant for a hernia plasty 250 implanted into a patient. A cross section of the body wall 370 with a surgical opening 372 is shown. It can be seen that the body wall 370 has an inner peritoneal layer 374, then an upper fascia layer 375, then a muscle layer 376, a fat layer 377 and an upper dermal layer 378. It can be seen as the upper side 262 of the base member 260 is mounted adjacent to the peritoneal layer 334, with the flap members 290 and 300 extending in and out of the opening 332 and through. It can be seen as the core 330 of the herniostepler 320 is inserted through the surgical opening 332, through the slit 310 and the opening 315 into the lower abdomen of the patient. It can be seen that, as part of the distal end 332 and distal end 334, are positioned adjacent to the underside 264 of the base member 260 for securing a portion of the base member 260 on the peritoneal layer 374. In FIG. 19 shows the implant 250, the valve members 290 and 300 of which are optionally fixed along their lower sides 302 and 292, respectively, with a surgical suture thread 380 with ends 381 and 382. The surgical needle 388 is attached to the end of the thread 281. The stitched valve elements cover the opening 315 in the slit 310 In addition, the valves can be connected or fastened together to close the gap 310 with conventional adhesives, surgical clips, etc. Valves 290 and 300 can alternatively be applied in their original position during implantation. The core of the herniostepler is inserted under the valve 300 through the slit 310 and the opening 315, without turning the valves up. After fixing, the valves can be left in their original position without additional fixing of the valves. The valve 290 does not allow the tissue or internal organs to move to the slot 310 and the hole 315; any pressure on the valve 290 will result in it being tightly pressed against the bottom side 264 of the base element 260, closing the slit 310.

FIG. 21 and 22 illustrate a surgical herniostepler 340 with a straight shaft 350 that can be used to attach an implant for plastic grafting in accordance with the present invention. The tool 340 has a proximal handle 342 with an activating trigger 344. From the distal end 346 of the handle 340, a straight rod 350 extends with a distal portion 352 and a distal end 354. 290 and 300 so that the distal end 354 can be moved along the underside 264 of the base member 260 to secure the base member 260 to the tissue with surgical clips. In FIG. 22 shows an implant for plasty 250 implanted in a patient. A cross section of the body wall 370 with a surgical opening 372 is shown. It can be seen that the body wall 370 has an inner peritoneal layer 374, then an upper fascia layer 375, then a muscle layer 376, a fat layer 377 and an upper dermal layer 378. 262 of the base member 260 is mounted adjacent to the peritoneal layer 374, with the flap members 290 and 300 extending in and out of the opening 332 and through. It can be seen that the core 350 of the herniostepler 350 is inserted through the surgical opening 372, through the slit 310 and the opening 315 into the lower abdomen of the patient. It can be seen that, as part of the distal end 352 and the distal end 354, are positioned adjacent to the underside 264 of the base member 260 for securing a portion of the base member 260 on the peritoneal layer 374.

FIG. 23 and FIG. 24 illustrates the implantation of a plastic graft implant 250 in accordance with the present invention to a patient during surgery of a hernial defect plasty. You can see the surgeon holding the handle 322 of the surgical herniostepler 320, activating the trigger 324 with one hand. The tool has a bent rod 330, and the proximal part 332 of the rod 330 is inserted through the opening 372 of the body wall 370 and through the hernia repair 250. The implant 250 is implanted in the abdominal cavity of the patient so that the upper side 262 of the base element 260 is adjacent to the peritoneal layer 374. The flap valves 290 and 300 are turned upward to open the slit 310 and the hole 315 and pass through the hole 372 of the body 370 in such a way as to partially pass over the dermal layer 378. It is seen that the internal organs of the patient 379 are adjacent to the lower side 264 of the base element 260. It can be seen how the core 330 of the herniostepler 320 is inserted through the surgical hole 372, through the slit 310 and the hole 315 into the lower abdomen of the patient. It can be seen as part of the distal end 332 and the distal end 334 are arranged adjacent to the underside 264 of the base element 260 to secure a portion of the base element 260 on the peritoneal layer 374. It can be seen how the surgeon’s other hand probes the patient’s body wall 370 above the distal end 334 to determine the location clips before installing it by activating the trigger 324. As shown in FIG. 26, after implantation of the implant 250 and its fastening with clips 380 on the underside 264 of the base element 260, there may be two concentric crowns of the clips 382 and 384 for attaching the implant 250 to the peritoneal layer 374.

In FIG. 25 and 26 show another embodiment of a plastic graft in accordance with the present invention. It can be seen that the implant 500 has a substantially flat base element 510 with an upper side 512 and a lower side 514. It can be seen that the base element 510 has a circular hole 520 limited by the periphery 522. It is seen that a closing ring 530 is located above the peripheral 522 of the circular hole 520. The implant 500 also has a closing element 540 with an upper side 542 and a lower side 544. On the lower side 544 of the closing element 540 there is a mating closing ring 548. The mating closing ring 548 is removably engaged with the closing ring string 530. When used in surgical procedures, the surgeon removes the covering element 540 from the base element 510, thus opening the hole 520. Then the base element 510 is implanted into the patient's body wall so that the upper side 512 of the base element 510 is adjacent to the inner layer of the abdominal cavity such as the peritoneum. The surgeon then inserts the distal part of the attachment rod, such as a herniostepler, through the hole 520 into the abdominal cavity under the bottom 514 of the base element 510. After attaching the base element 510 to the inner tissue layer and after removing the core of the attachment tool, the surgeon places the closing element 540 on the upper part 512 of the base element 510 so that the mating closing ring 548 and the closing ring 530 are connected.

In FIG. Figures 31-41 illustrate an additional embodiment of an implant for plastics tissue 600 in accordance with the present invention. As can be seen in FIG. 31-34, the plastic implant 600 has a base element 610 with an upper side 612 and a lower side 614. The implant has a peripheral portion 616 and a peripheral edge 618. The base element 610 has a central slot or a slit 620 with a hole 624 bounded by sides 622 The slot 620 has ends 628. If desired, the slot or slot 620 can be positioned so that it is offset from the center. The base element 610 is shown to be essentially oval in shape or configuration, but may also have other configurations, including square, rectangular, circular, polygonal, etc., combinations thereof, etc. Although it is preferable that the base element 610 is essentially flat , it can be formed, for example, curved. The placement structure 650 is located on the bottom side 614 of the base element 610. It can be seen that the structure 650 is annular with the top surface 652 and the bottom surface 654. As shown in the illustration, the top surface is essentially flat and the top surface has a rounded configuration such The cross section is D-shaped. However, it is obvious that the cross section of the placement structure may have various transverse shapes, including, but not limited to, round, oval, square, rectangular, polygonal, straight sections and curved sections, combinations of the above, etc. The structure 650 will have a shape that generally corresponds to the periphery of the base element 610, for example, round, oval, rectangular, square, polygonal, with curved sides, straight sides and combinations of the above. Structure 650 has an outer edge 655, an inner edge 656, and a central hole 657, although, if desired, although not preferable, the central hole 657 can be eliminated. The placement structures 650 can be made from biocompatible polymers and bioabsorbable polymers, as described herein above, but it is particularly preferable to make the structures 650 from bioabsorbable polymers. Structures 650 can be manufactured using conventional manufacturing processes, including injection molding, mechanical processing, 3-D printing, solution casting, extrusion, composite lamination, and the like. Layout structures 650 can be connected to base elements 610 using a variety of conventional methods, including gluing, welding, stitching, fixing with mechanical locks, casting, using heating plates or presses, thermomorphing, etc. In one embodiment, as described below, the structures 650 may be fused or formed as part of a base member 610.

According to FIG. 33, a plastics tissue implant 600 is implanted in a patient below a hernia defect 700 in the body wall 710. A surgical opening 715 is located in the body wall 710 above the hernia defect 700. It can be seen that the lower side 614 of the base element 610 adjoins the internal organs of the patient, and the upper side 612 of the base member 610 abuts against the inner side 712 of the wall of the body 710. The device 600 is fixed to the wall of the body 700 in a conventional manner using surgical fixatives such as surgical clips and the like. Clips or latches are used by inserting the distal section 815 of the stem 810 of the surgical herniostepler 800 into the hole 640 and placing the periphery 616 of the base element 610 using the distal tip 818 of the distal section 815 of the stem 810. The periphery 616 is conveniently and gently placed by the surgeon who moves the distal end section 815 of the stem 810 in such a way that the tip 818 contacts or is positioned proximally to the placement structure 650. Then brackets or other fasteners or fixing devices are released through the element Considerations 610 around the entire periphery of the body wall 710,616 base member 610 by moving and manipulating tip 818 around the placing structure 650. The placement of the structure 650 assists the surgeon in locating and placing the periphery of base member 616 610 for the correct placement of clips or locking devices. The hole 624 in the slot or slot 620 is secured and closed with a corresponding closing element as described in the document, for example, with a seam.

In FIG. 35 and 36, an embodiment of a tissue repair device 600 of the present invention is seen having an accommodation structure 650 with a textured upper surface 660. A device 600 is seen positioned near the lower side of the body wall 710 under a hernia defect 700. The structure 650 is visible having a lower textured surface 660 As shown, the surface 660 has a plurality of pointed ridges 662 protruding upward from the surface 660 and having bases 664 and tips 667. It is seen that the ridges 662 are rectangular in cross section. Combs can also be rounded and have other geometric cross-sectional shapes, including square, rectangular, oval, semi-circular, etc. Although not shown, the textured surface may be textured by gutters or other depressions, or a combination of gutters or depressions and protrusions. The distal tip 818 of the distal section 815 of the core 810 of the herniostepler or locking tool 800 is visible, located in contact with the textured surface 660 in the position for releasing clips through the base element 610 into the body wall 710.

In FIG. 37-41, an embodiment of a tissue repair apparatus 600 of the present invention having an accommodation structure 650 with a downward flange structure is seen. As can be seen in FIG. 37, 38, and 39, the tissue recovery device 600 has an arrangement structure 650 in the form of a flange element 670 protruding downwards, which is made by casting or otherwise forming part of the periphery 616 of the base element 610. It can be seen that the flange element 670 has a lower side 672, side 674, outer side 676 and upper 678. The flange member has a curved cross section, but may have other configurations and cross sections, including straight and angled. The device 600, being placed adjacent to the wall of the patient’s body 710 on the inner surface 712, is shown fixed by manipulating the distal tip 818 of the distal section 815 of the rod 810 of the tool 800 so that the tip 818 is located proximally or touches the inside 674 of the flange element 670. As can be seen FIG. 39, placement structure 650 may consist of a separate flange element 680 having an upper portion 682, a lower portion 684, an inner side 686, and an outer side 688. The upper portion 612 of the flange element 680 may be placed on the periphery 616 or on the peripheral edge 618 of the base element 610 in the usual way, such as glue, welding, stitching, fixing, casting, etc. It can be seen how the device 600, having a flange element 680, is applied and implanted into a patient to correct a tissue defect, as previously described above.

In FIG. 40 and 41, one more embodiment of the repair element of the fabric 600 is seen, having a structure 650 with a downward flange structure. It is seen that structure 690 consists of a ring or a peripheral element 691 and a downward flange section 695. It can be seen that the peripheral element 691 has an upper side 692, a lower side 693, and an outer side 694. the inner side 698 and the outer side 699. The structure 690 may be located so that the lower side 693 of the peripheral element is on the upper side 612 of the base element 614 near or on the periphery 616 and the peripheral edge 618 is covered laid so that the upper side 692 of the peripheral member 691 is on the bottom side 614 of the base member 614 near or at the periphery 616. It can be seen that the device 600 having the structure 690 is used and implanted into a patient to correct the tissue defect as previously described above.

Implants in accordance with the present invention may optionally contain a sufficient effective amount of the active substance, such as a therapeutic substance, or be covered with it. Substances allowed for use as active substances include traditional substances that may be synthetic or of natural origin and may, without limitation, include, for example, antibiotics, antimicrobial agents, antibacterial drugs, antiseptics, chemotherapeutic drugs, cytostatics, metastatic inhibitors , antidiabetic agents, antifungal agents, gynecological drugs, urological drugs, antiallergic drugs, sex hormones, sex hormone synthesis inhibitors, hemostatic agents, hormones, peptide hormones, antidepressants, vitamins such as vitamin C, antihistamines, deproteinized DNA, plasmid DNA, cationic DNA complexes, RNA, cellular components, vaccines and cells present in the body in vivo , or genetically modified cells.

In one embodiment, the active substances may be antibiotics, including substances such as gentamicin or an antibiotic marketed under the trademark ZEVTERA ™ (ceftobiprol medocaryl) (manufactured by Basilea Pharmaceutica Ltd., Basel, Switzerland). In one embodiment, the implant may include broad-spectrum antimicrobial agents used against various bacteria and yeasts (even in the presence of body fluids), such as octenidine, octenidine dihydrochloride (included as an active component in Octenisept® disinfectant Mayr, Norderstedt, Germany), polyhexamethylene biguanide (PHMB) (included as an active ingredient in Lavasept® from Braun, Switzerland), triclosan, copper (Cu), silver (Ag), nano-silver, gold (Au), selenium (Se), gallium (Ga), taurolidine, N-chlortaurin, alcohol-based antiseptics, such as Listerine® mouthrinse, N- ethyl ester alpha-lauryl-L-arginine (LAE), myristamidopropyl dimethylamine (MAPD, included as an active component in SCHERCODINE ™ M), oleamidopropyl dimethylamine (OAPD, included as an active component in SCHERCODINE ™ O) and stearamidopropyldimethylamine as an active ingredient in the preparation SCHERCODINE ™ S). In one embodiment, the active substance may be octenidine dihydrochloride (hereinafter referred to as octenidine) and / or PHMB.

Although it is preferable that the implants for a hernia repair in accordance with the present invention have one opening in the center, the opening and the closing element associated with it can be offset from the center. In addition, in the implants for hernia repair in accordance with the present invention, more than one opening and a closing member can be used.

The following examples illustrate the principles and methods of implementation in accordance with the present invention, although not limited to them.

Example 1

A patient with an abdominal or postoperative hernia is prepared for the procedure of an open hernia repair as follows. The skin surrounding the hernia is cleaned with a standard antimicrobial solution, such as betadine. The patient is given standard general anesthesia in a standard way by induction and inhalation. The surgeon then begins the surgery by making a skin incision and subcutaneous tissue that covers the hernia. In the case of planned intraperitoneal placement of the mesh, the hernia sac is opened. The edges of the healthy fascia around the defect are examined and any joints of the internal organs with the abdominal wall are divided to create free space for fixing the mesh.

At this stage of the procedure, the surgeon prepares a mesh implant for the hernia repair of the present invention, having a placement structure and flap valves and a base element for insertion through a defect in the abdominal wall into the abdominal cavity so that the upper side of the wall is adjacent to the peritoneum that surrounds the defect and the lower side The mesh implant was facing down to the patient’s internal organs. Fixing stitches can be applied through the net to the abdominal tissue as needed, for example, on four sides of the net (North, South, East, West). After positioning, the valves turn upward to open a hole in the base element of the mesh. The mesh is fixed with traditional surgical herniostepler or other fixation methods. The herniostepler is inserted through the opening so that the distal end of the herniostepler is located between the mesh and the internal organs, and the surgeon places the peripheral part of the implant, capturing the structure of the placement with the tip of the herniostepler shaft. Then the perimeter of the grid is fixed with a variety of clips in the configuration of the crown. Herniostepler is removed and the mesh opening is closed, wrapping the closing valves appropriately for the present invention. Valves can optionally be fixed with an adhesive, thread, rivets, or other methods of fixation, or can be returned to their original position without attaching to each other. If desired, the hernial defect can be initially closed. The skin incision is closed using appropriate stitching or closure techniques, and the incision is properly ligated, and the patient is transferred to the postoperative ward.

New implants for hernia repair in accordance with the present invention have numerous advantages. New implants for plastic hernia include a single-layer tissue implant, which can be fixed with clips during the procedure of open plastic intraperitoneal hernia. Plastic implants have additional advantages, including a smaller amount of foreign material (i.e., a smaller mass of foreign material) and the ability to implant a single-layer plastic mesh for tissue with open surgery. Implants for plastic tissue in accordance with the present invention, preferably made of mesh, can potentially increase the rate of tissue accretion, provide a smaller area for biofilm formation, have a lower production cost, they are easier to pack, sterilize and use with improved ergonomics.

Although the present invention is shown and described in relation to the detailed embodiments thereof, it will be understood by those skilled in the art that various changes in its form and details are possible without departing from the spirit and scope of the claimed invention.

Claims (54)

1. Implant for plastic tissue containing: a substantially flat base member having an upper side and a lower side, and a periphery; the placement structure for searching and locating the periphery of the base element in the patient’s body; a hole located on the specified element of the base; and closing element associated with the specified hole. 2. The implant for plastic tissue according to claim 1, further comprising a polymer layer on at least one side of the base element. 3. The implant for plastic tissue according to claim 1, further comprising an anti-adhesive barrier on at least one side of the base member. 4. The implant according to claim 1, characterized in that the base element contains a grid. 5. The implant according to p. 1, characterized in that the base element contains the canvas. 6. The implant according to claim 5, characterized in that the web is woven. 7. The implant according to p. 5, characterized in that the fabric is non-woven. 8. Implant according to claim 1, characterized in that the base element contains a porous polymer film. 9. Implant according to claim 1, characterized in that the base element contains a biocompatible non-absorbable polymer. 10. Implant according to claim 1, characterized in that the base element contains a bioabsorbable polymer. 11. The implant according to claim 7, characterized in that the non-absorbable polymer is selected from the group consisting of polypropylene, polyester, nylon and ultra-high molecular weight polyethylene. 12. The implant according to claim 10, characterized in that the bioresorbable polymer is selected from the group consisting of polylactides, polyglycolides, polydioxanones, polycaprolactones, copolymers of glycolides and trimethylene carbonate and copolymers of lactides and trimethylene carbonate, and their copolymers and mixtures. 13. The implant according to claim 1, characterized in that the base element contains a non-absorbable polymer and a bioabsorbable polymer. 14. The implant under item 1, characterized in that the hole is a slit. 15. The implant according to claim 1, characterized in that the hole has a round shape. 16. The implant according to claim 1, characterized in that the hole has the shape of a groove. 17. The implant for plastics tissue under item 1, characterized in that the closing element contains opposite elements of a flap valve, installed with the possibility of hinged rotation around the hole. 18. The implant for plastic tissue under item 1, characterized in that the covering element contains an implant having an outer periphery, with a portion of the periphery mounted on the upper side of the base element around the hole. 19. Implant for plastics tissue under item 1, characterized in that the closing element contains a surgical thread, installed around the hole. 20. Implant for plastic tissue under item 1, characterized in that the covering element contains an implant having an upper side and a lower side with a coupling element extending from the lower side, and moreover, the base element has a mating coupling element mounted on the upper side around the hole so that the closing element can be hooked on the base element and detached from it. 21. Implant for plastics tissue under item 1, characterized in that the hole contains a slit having opposite sides, and the closing element contains a surgical thread, stitched around the slit adjacent to the sides. 22. The implant for plastic tissue under item 17, characterized in that the valves have parts with free ends, separated from the base element by slots so that each element of the flap valve can be hooked into the slot of the opposite element of the flap valve. 23. The implant under item 1, characterized in that the hole is located in the center. 24. An implant according to claim 1, comprising at least two openings and a closure member. 25. The implant according to p. 2, characterized in that the polymer film contains a non-absorbable polymer. 26. Implant according to claim 2, characterized in that the polymer film contains a bioabsorbable polymer. 27. An implant according to claim 25, wherein the polymer is selected from the group consisting of silicone, polytetrafluoroethylene (PTFE), polyester and polypropylene. 28. An implant according to claim 26, wherein the bioabsorbable polymer is selected from the group consisting of oxidized regenerated cellulose, polydioxanone, polyglekapron 25 (a copolymer of glycolide and epsilon-caprolactone), and combinations thereof. 29. The implant according to claim 2, characterized in that the polymer film is an anti-adhesive barrier. 30. The implant according to claim 3, wherein the anti-adhesive barrier comprises a polymer selected from the group consisting of oxidized regenerated cellulose, polydioxanone, polyglecapron 25 (a copolymer of glycolide and epsilon-caprolactone), and combinations thereof. 31. The implant according to p. 3, characterized in that the anti-adhesive barrier contains a polymer selected from the group consisting of silicone, PTFE and porous PTFE. 32. The implant according to claim 1, wherein the placement structure further comprises a flange element protruding downward. 33. The implant according to claim 1, wherein the placement structure is a connecting annular element. 34. The implant according to claim 1, wherein the placement structure further comprises a textured surface. 35. The implant according to claim 1, wherein the placement structure comprises a bioabsorbable polymer. 36. The implant according to p. 35, wherein the bioabsorbable polymer is selected from the group consisting of oxidized regenerated cellulose, polydioxanone, polyglekaprona 25 (a copolymer of glycolide and epsilon-caprolactone), polylactide, polyglycolide and copolymers, and combinations thereof. 37. The implant according to claim 1, where the placement structure is formed on the periphery of the base element. 38. The implant according to claim 37, where the placement structure is a downward flange member. 39. An implant according to claim 33, wherein the annular element has a D-shaped cross section. 40. A method for performing plastic repair of a body wall defect, comprising the steps of: A. the introduction of the implant for plastic tissue in the inner layer of the body wall, having a tissue defect, and the implant contains: a substantially flat base member having an upper side and a lower side, and a periphery; the placement structure for searching and locating the periphery of the base element in the patient’s body; a hole located in the specified element of the base; and a closure member associated with said opening; B. the location of the implant around the defect so that the upper side of the base element is located adjacent to the inner layer of the body wall; C. introducing the end of the instrument for surgical fixation through the opening to access the lower side of the base element to the structure of placement and fixing the base element to the inner layer of the body wall; and D. manipulation of the element closure to close the hole. 41. A method according to claim 40, wherein the implant for plastics tissue further comprises a polymer layer on at least one side of the specified element of the base. 42. The method of claim 40, wherein the tissue defect is a hernia.

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