RU2519638C2 - Multipurpose endoprosthesis for abdominoplasty (versions) - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: group of inventions refers to surgery and may be used for abdominoplasty. An endoprosthesis comprises two layers made from spatially cross-linked polymer by methacrylate oligomer photopolymerisation, one of which has a smooth surface for contact to visceral tissues, and the other one is perforated; between these two layers, there is a polypropylene mesh; the three layers are bond by a photopolymerised glue to form splices uniformly distributed in the entire area of the endoprosthesis. The other endoprosthesis of the group of inventions comprises a layer representing a polypropylene mesh and a layer made from the spatially cross-linked polymer by methacrylate oligomer photopolymerisation one surface of which is smooth and used for contact to visceral tissues, and the other surface contains mushroom or hook-shaped flanges providing the bond to the polypropylene mesh.

EFFECT: endoprosthesis reduces a risk of developing adhesion with visceral tissues.

4 cl, 5 dwg

Description

The invention relates to medicine, namely to surgery, is intended for abdominoplasty in the presence of hernias or any other diseases and injuries accompanied by a deficiency of soft tissues of the abdominal wall.

Known endoprosthesis [1, 2], containing a xenopericardial plate. Biological material (xenopericardium) has certain disadvantages:

1. Allergic and immunological reactions of the patient to biological material.

2. The difficulties of preserving the material and the long time required to carefully remove the preservative solution;

3. The difficulty of manufacturing plates of large size;

4. The need for research for the presence of infections that can be transmitted through transplantation material, which not only increases the cost of the material and increases the manufacturing time of the endoprosthesis, but also complicates its use in emergency situations;

5. Unpredictable behavior in conditions of infection;

6. The moral and ethical aspect of the use of biological transplantation material;

7. The endoprosthesis is of limited use, namely its implantation is not recommended in case of accidental or planned opening of the gastrointestinal tract or any other infection of the surgical area, as it can lead to purulent-inflammatory complications from the wound and rejection of the endoprosthesis, since the biological material is breeding ground for microorganisms.

One of the modern methods of reconstruction of the abdominal wall is abdominoplasty using a multilayer endoprosthesis, which is placed in the abdominal cavity and fixed to the abdominal wall from the side of the peritoneum. The specified endoprosthesis has several layers with various surface properties that are bonded to each other. During implantation, one side of the endoprosthesis is adjacent to the tissues that should grow together with the surface of the prosthesis, and the other is in contact with visceral tissues, which fusion should be minimized.

Multilayer endoprostheses are known [3, 4, 5], one of the layers of which is a polypropylene mesh, and the other is made of resorbable material. Polypropylene mesh has excellent strength, durability and has the structure necessary for tissue ingrowth. The absorbable layer that separates the polypropylene mesh from the visceral tissues is designed to reduce the likelihood of fusion with the visceral peritoneum. However, these endoprostheses also have certain disadvantages:

1. The absorbable layer reduces the severity and degree of adhesions, but does not exclude it.

2. Biodegradation of the absorbable layer in the postoperative period can cause a tissue reaction, which is not possible to predict.

3. High risk of infection of the absorbable layer

Known endoprosthesis according to the application RU 2010124471, made of a spatially cross-linked polymer by photopolymerization of methacrylic oligomers and consisting of central and peripheral parts. The peripheral part is made in the form of monolithic strips, and the central part forms a monolithic system consisting of a film and a grid interconnected, and one surface of the film is smooth and is intended for contact with abdominal organs. Polypropylene thread passes through the monolithic strips and the central part, which strengthens the structure. This endoprosthesis has certain disadvantages that limit its use:

1. The endoprosthesis is intended exclusively for seamless plastic surgery, since the material from which the central and peripheral parts are made is easily erupted during hemming.

2. The endoprosthesis is not modeled for the size of the defect.

3. Compared with a polypropylene mesh, it has lower strength, which does not allow its use for abdominoplasty using the inlay method in conditions of deficiency of its own tissues.

A well-known surgical mesh (endoprosthesis) intended for the treatment and prevention of hernias and known under the trademark PROCEED ™ (manufactured by ETHICON Inc., USA, website: www.hemiasolutions.com) was selected as the prototype.

The composition of the endoprosthesis includes braided material from oxidized regenerated cellulose and a soft, non-absorbable polypropylene mesh encapsulated by polydioxanone. The part of the endoprosthesis, which is a polypropylene mesh, is designed to grow soft tissues into it, and the part made of oxidized regenerated cellulose serves as an absorbable layer that physically separates the polypropylene mesh from visceral tissues during wound healing to minimize the likelihood of fusion with the mesh. Polydioxanone provides adhesion to a layer of oxidized regenerated cellulose.

The prototype provides a high strengthening effect, but has certain disadvantages. The absorbable layer of the endoprosthesis, which separates the polypropylene mesh from the abdominal organs, reduces the severity and degree of adhesions, but does not exclude it. Also, the absorbable layer during the resorption process can cause a tissue reaction. The disadvantage is that this endoprosthesis has limited use, and it is not recommended to implant it in case of accidental or planned opening of the lumen of the gastrointestinal tract or in the infected area, as this can cause infection of the endoprosthesis itself, since its absorbable layer (oxidized regenerated cellulose ) favors the colonization of microorganisms, which in the postoperative period can lead to purulent-inflammatory processes [6].

The objective of the invention is to increase the effectiveness of treatment by creating a universal endoprosthesis for any type of abdominoplasty, durable, made of biocompatible biostable material, completely eliminating the adhesion process with visceral tissues and having unlimited application in herniology.

In the first embodiment, the task is solved in that the universal endoprosthesis for abdominal grafting contains a layer representing a polypropylene mesh and two layers made of a spatially crosslinked polymer by the method of photopolymerization of methacrylic oligomers. One of the polymer layers has a smooth surface designed for contact with visceral tissues, and the other polymer layer is perforated. A polypropylene mesh is contained between these polymer layers, the adhesion of the three layers provides bonding places with photopolymerizable glue, which are uniformly distributed over the entire area of the endoprosthesis.

According to the second option, the task is solved in that the universal endoprosthesis for abdominal plasty contains a layer representing a polypropylene mesh and a layer made of a spatially cross-linked polymer by photopolymerization of methacrylic oligomers, one surface of which is smooth and designed to contact visceral tissues, and the other surface contains mushroom-shaped or hook-shaped protrusions providing adhesion to the polypropylene mesh.

A distinctive feature of the method of forming layers from a spatially cross-linked polymer by the method of photopolymerization of methacrylic oligomers is that the product formation process eliminates any mechanical effect on the layers. Any mechanical effect on the polymer is known to provoke the formation of free radicals, which subsequently lead to polymer degradation and undesirable toxic reactions. The roughness of the layer intended for contact with visceral tissues is from 10 to 50 nanometers, which excludes the germination of tissues adjacent to this layer during the operation of the endoprosthesis. Achieving such smoothness when processing material is a technologically challenging task worldwide. In the case of the claimed product, this degree of roughness of the material is easily achieved directly in the production process. The polypropylene mesh provides the claimed endoprosthesis with the excellent strength required for abdominoplasty using the inlay method. Polypropylene and the specified spatially cross-linked polymer are hydrophobic and do not contain nutrient media for microorganisms, which minimizes the likelihood of bacterial colonization, significantly reduces the risk of implant infection and allows the use of an endoprosthesis in case of accidental or planned opening of the lumen of the gastrointestinal tract, as well as in patients with colostomy and ileostomy.

For the manufacture of polymer layers, a photosensitive composition based on methacrylic oligomers is used, from which a spatially cross-linked polymer is obtained during photopolymerization. For the manufacture, including the use of photosensitive compositions according to patents RU 2309781, RU 2129880, RU 2198661, RU 2275884, RU 2288494. In each case, when using the material according to one of these patents, a spatially crosslinked polymer with necessary physical and mechanical properties, namely, they obtained elastic biologically inert material. The photosensitive compositions according to the indicated patents differ in the quantitative and qualitative ratio of the oligomers and monomers of the methacrylic series, 2,2-dimethoxy-2-phenylacetophenone is used as a photoinitiator, 2,4-ditretbutylchloroquinone is used as an inhibitor.

The invention is illustrated by the following graphic material:

Figure 1 - view of the universal endoprosthesis for abdominal plastics according to the first embodiment from the side adjacent to the tissues that should grow.

The top of the endoprosthesis contains a perforated polymer layer (1), under it is a layer in the form of a polypropylene mesh (2), under which there is a third polymer layer intended for contact with visceral tissues. The adhesion of the three layers provides gluing places (3) with photopolymerizable glue, which are uniformly distributed over the entire area of the endoprosthesis.

Figure 2 is a cross-sectional profile of a universal endoprosthesis according to the first embodiment.

The endoprosthesis according to the first embodiment contains two polymer layers (1) and (4), while layer (4) has a smooth surface (5) intended for contact with visceral tissues, and layer (1) is perforated and a polypropylene mesh is contained between these layers (2). The adhesion of the three layers provides gluing places (3) with photopolymerizable glue, which are uniformly distributed over the entire area of the endoprosthesis. During implantation, the side (6) of the endoprosthesis is adjacent to the tissues that are supposed to grow.

Figure 3 is a view of a universal endoprosthesis for abdominal plasty according to the second embodiment from the side adjacent to the tissues that are supposed to grow.

On top, the endoprosthesis according to the second embodiment contains a layer in the form of a polypropylene mesh (7), under which there is a smooth polymer layer intended for contact with visceral tissues. The adhesion of the layers is ensured by mushroom-shaped or hook-shaped protrusions (8) on the polymer lower layer, which are uniformly distributed over the entire area of the endoprosthesis.

Figure 4 is a cross-sectional profile of a universal endoprosthesis for abdominal plastics according to the second embodiment, where the adhesion of the layers is provided by mushroom-shaped protrusions.

A universal endoprosthesis for abdominal plastic surgery contains two layers, one of which is a polypropylene mesh (7), and the other layer (9) is made of a spatially cross-linked polymer by photopolymerization of methacrylic oligomers. One surface (12) of the polymer layer is smooth and is intended for contact with visceral tissues, and the other surface contains mushroom-shaped protrusions (10) that provide adhesion to the polypropylene mesh. During implantation, the side (11) of the endoprosthesis is adjacent to the tissues that are supposed to grow.

Figure 5 is a sectional view of the profile of a universal endoprosthesis for abdominal plastics according to the second embodiment, where the adhesion of the layers is provided by hook-shaped protrusions.

A universal endoprosthesis for abdominal plastic surgery contains two layers, one of which is a polypropylene mesh (7), and the other layer (9) is made of a spatially cross-linked polymer by photopolymerization of methacrylic oligomers. One surface (12) of the polymer layer is smooth and is intended for contact with visceral tissues, and the other surface contains hook-shaped protrusions (12) that provide adhesion to the polypropylene mesh. During implantation, the side (11) of the endoprosthesis is adjacent to the tissues that are supposed to grow.

The claimed universal endoprosthesis of abdominal plasty according to the first and second option has been successfully implemented in practice, which is confirmed by the following clinical examples.

Example 1: Patient T., 67 years old, was admitted to the coloproctology department with complaints of hernial protrusion of the gigantic anterior abdominal wall, shortness of breath with little physical exertion. History 6 years ago - extirpation of the rectum for cancer, sigmoidostomy in the left ileal region. The postoperative period was difficult, there was a total suppuration of the median wound. After the wound healed, a hernial protrusion, gradually increasing in size, began to appear on the anterior abdominal wall. She did not seek medical help until the hernia reached gigantic proportions, shortness of breath appeared, pain when torso and walking. The patient is obese, type 2 diabetes, skin folds are macerated, with an unpleasant odor. The entire anterior abdominal wall is represented by a giant hernial protrusion located both in the midline and in the lateral abdomen, including the left iliac region, where the sigmostoma is located. This creates difficulties in caring for a colostomy and maceration of the skin with fecal fragments. When examining data for recurrence of a tumor of the colon was not obtained. After preoperative preparation, including skin toilet, sugar correction, antibiotic prophylaxis, the patient is operated on. The scar-modified hernial sac is excised, the contents - loops of the small intestine - are immersed in the abdominal cavity, the commissures of the peritoneum are divided. Abdominoplasty with local tissues was impossible, because due to a large hernial defect, it would inevitably lead to severe respiratory failure. Plastic surgery with a polypropylene mesh was risky, since it was not possible to isolate the mesh from intestinal loops. Intraperitoneal plastic mesh with an infection-resistant coating of resorbable material increased the risk of purulent-septic complications due to the proximity to the surgical wound of the colostomy and macerated skin areas.

Performed abdominoplasty with the claimed universal prosthesis for abdominoplasty according to the first embodiment is fixed intraperitoneally. The postoperative period was uneventful, the patient was discharged for outpatient treatment 16 days after surgery in a satisfactory condition.

Example 2: Patient K., 63 years old, was admitted to the coloproctology department of the Nizhny Novgorod Regional Clinical Hospital with complaints of a large hernial protrusion in the area of the postoperative scar in the left iliac region. A history of 2 operations. The first operation was performed for a sigmoid colon tumor complicated by acute intestinal obstruction. A resection of the sigmoid colon was performed according to the Hartmann type with the removal of a single-barrel sigmoid in the left ileal region. Then, after 6 months, the abdominal closure of the sigmoid was performed, and the sigmorectal anastomosis was applied. This operation was complicated by suppuration of the surgical wound; it healed within 2 months by secondary intention. A year later, in the area of the postoperative scar located in the left iliac region, a painful, irreducible hernia appeared, which rapidly increased in size. On examination, ulceration and maceration of the skin over a hernial protrusion were observed. Concomitant diseases - bronchial asthma and type 2 diabetes.

Under anesthesia, hernia repair was performed, the contents - loops of the small intestine - were immersed in the abdominal cavity, an intraperitoneal abdominoplasty was undertaken with the claimed universal prosthesis according to the second option, fixed so that its smooth surface was in contact with the intestinal loops, and the polypropylene layer was turned towards the abdominal wall. Fixation of the endoprosthesis on the periphery was carried out using nodal polypropylene sutures, capturing both layers of the prosthesis, and in the center by a continuous suture with a thread with a long resorption period drawn through the edges of the hernial portal and the polypropylene layer of the endoprosthesis. The absence of delamination of the mesh used was provided by hook-shaped protrusions that securely fix both layers in contact with each other. This made it possible to avoid leaving poorly drained cavities, which was an additional prevention of the formation of seroma and hematoma.

The postoperative period was uneventful, the patient was discharged with recovery 14 days after surgery.

Literature:

1. Patent RU 2421162 "METHOD OF PROSTHETIC PLASTIC OF MEDIUM VENTRAL HERNIA WITH RECONSTRUCTION OF THE WHITE LINE OF THE ABDOMEN"

2. Patent RU 2400160 "METHOD FOR PROSTHETIC HERNIOPLASTY OF MEDIUM VENTRAL HERNIA"

3. Patent RU 2143868 "ALLOTRANSPLANT FOR PLASTIC HERNIUM DOORS"

4. Patent RU 74290 "PROSTHESIS FOR HERNIOPLASTY OF POSTOPERATIVE VENTRAL HERNIA"

5. Patent EP 1306061 ABSORBABLE MESH IMPLANT

6. Instructions for the use of the PROCEED ™ surgical mesh (Appendix 1) (http://www.herniasolutions.com/sites/default/files/pdf/3 89659R09_04.16.10_0.pdf)

Claims (4)

1. A universal endoprosthesis for abdominal plastics, containing a layer representing a polypropylene mesh, characterized in that the endoprosthesis additionally contains two layers made of a spatially crosslinked polymer by photopolymerization of methacrylic oligomers, one of which has a smooth surface designed for contact with visceral fabrics and the other is perforated, a polypropylene mesh is contained between these layers, the adhesion of the three layers provides bonding places for photopolymerizing adhesive disposed uniformly over the entire area of the endoprosthesis. 2. An endoprosthesis according to claim 1, wherein the surface intended for contact with visceral tissues has a roughness of 10 to 50 nanometers. 3. An endoprosthesis for abdominal plastics, containing a layer representing a polypropylene mesh, characterized in that the endoprosthesis contains a layer made of a spatially cross-linked polymer by photopolymerization of methacrylic oligomers, one surface of which is smooth and designed to contact visceral tissues, and the other surface contains mushroom-shaped or hook-shaped protrusions providing adhesion to a polypropylene mesh. 4. The endoprosthesis according to paragraph 3, wherein the surface intended for contact with visceral tissues has a roughness of 10 to 50 nanometers.

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