CN115569242B - Anti-adhesion abdominal wall hernia composite patch and preparation method thereof - Google Patents
Anti-adhesion abdominal wall hernia composite patch and preparation method thereof Download PDFInfo
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- CN115569242B CN115569242B CN202211236895.XA CN202211236895A CN115569242B CN 115569242 B CN115569242 B CN 115569242B CN 202211236895 A CN202211236895 A CN 202211236895A CN 115569242 B CN115569242 B CN 115569242B
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/005—Ingredients of undetermined constitution or reaction products thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/042—Polysaccharides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
Landscapes
- Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Heart & Thoracic Surgery (AREA)
- Public Health (AREA)
- Vascular Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Surgery (AREA)
- Epidemiology (AREA)
- Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Materials For Medical Uses (AREA)
Abstract
The invention relates to the technical field of medical materials, in particular to an anti-adhesion abdominal wall hernia composite patch, and a preparation method and application thereof. An anti-adhesion abdominal wall hernia composite patch comprising from bottom to top: a support layer, an adhesive layer and an anti-blocking layer; the supporting layer is a dermis matrix; the anti-adhesion layer is a biological film. The hernia patch provided by the invention has the advantages that the hernia patch is not easy to adhere to abdominal viscera after being implanted into a body, so that infection recurrence is avoided. According to the invention, the thermal compression crosslinking treatment is carried out on the composite patch, so that the degradation time of the composite patch is prolonged, and the tensile strength of the composite patch is enhanced.
Description
Technical Field
The invention relates to the technical field of medical materials, in particular to an anti-adhesion abdominal wall hernia composite patch, and a preparation method and application thereof.
Background
Hernias are very common surgical diseases, when the abdominal wall of a human body has weak places due to congenital or acquired factors, organs grow from the abdominal cavity to the outside of the abdominal wall along the weak places, and a bump is formed locally, so that hernia is formed, which is also called as small intestine qi-flowing. The types of hernias can be divided according to the location, such as hernias protruding from the umbilical region, such as umbilical hernias, masses formed from the groin, such as inguinal hernias, and also femoral hernias, leukotrichia hernias, incisional hernias. Once hernia is formed, the hernia can not self-heal, and the hernia is difficult to recover due to severe or inflammatory swelling, so that dangerous situations such as intestinal obstruction, intestinal necrosis and the like are caused, and the hernia must be treated through surgery.
The current method for treating hernia is to perform hernia repair, including direct suturing and implantation patch repair, and the clinical requirements for the hernia patch are as follows: (1) has good cell compatibility; (2) good tensile properties; (3) can be cut at will to form the required shape; (4) anti-infective; (5) has certain anti-adhesion performance.
The common hernia repair patch materials mainly comprise artificial synthetic materials and natural biological materials, such as polypropylene/polyester/polytetrafluoroethylene/polyvinylidene fluoride and other artificial synthetic non-degradable materials, polylactic acid, polyvinyl alcohol, polycaprolactone and other artificial synthetic degradable materials; natural biological materials such as animal origin and allogenic materials. Although the artificial synthetic patch is low in price, the artificial synthetic patch has a plurality of irreparable defects, such as high recurrence rate of the absorbable synthetic patch after degradation, reduced tissue compatibility of the non-absorbable patch along with the extension of in-vivo time, easy intestinal fistula occurrence caused by rough surface, and the like; the natural biological patch is a dermal matrix of human or animal origin, and can remove immunogenic substances by treatment, retain a natural three-dimensional scaffold structure, induce fibrous cells to grow in after being implanted into a human body, secrete collagen, promote the healing of wound surfaces and defect parts, repair defects, and solve the defects of the artificial synthetic patch in terms of degradation and biocompatibility. However, biological patches also have some drawbacks due to their own nature. For example, dermal matrix has a certain supporting effect, but the anti-adhesion effect is general.
Disclosure of Invention
The present invention aims to solve at least one of the above technical problems.
The invention provides an anti-adhesion abdominal wall hernia composite patch which at least can solve the problem that the existing dermal matrix patch is not ideal in anti-adhesion effect.
An anti-adhesion abdominal wall hernia composite patch comprising, from bottom to top: a support layer (bottom layer), an adhesive layer (middle layer) and an anti-blocking layer (upper layer); the supporting layer is a dermis matrix; the anti-adhesion layer is a biological film.
In some embodiments, the dermal matrix of the support layer is one of a porcine, bovine, ovine, and other animal-and human-derived dermal matrix.
In some embodiments, the humanized dermal matrix is a decellularized allogeneic dermal matrix that has been subjected to a specific chemical treatment. In some embodiments, the humanized dermal matrix is prepared according to the methods described in CN 108261565A (summary and examples).
In some embodiments, the binder layer is one or more (composition or formulation) of sodium hyaluronate, polysaccharide, gelatin, collagen.
In some embodiments, every 100cm 2 The quality of the adhesive layer on the supporting layer is 0.05g-0.1g, and the biological film after freeze-drying cannot be perfectly attached to the dermal matrix when the quality of the adhesive is higher or lower.
In some embodiments, the biological membrane of the upper anti-adhesion layer is made of one or more of human or animal amniotic membrane, basement membrane, pericardium, peritoneum, pleura, or visceral submucosa.
In some embodiments, the anti-adhesion abdominal wall hernia composite patch consists of, from bottom to top, the support layer (bottom layer), the adhesive layer (middle layer), and the anti-adhesion layer (upper layer).
In some embodiments, the rough surface (a surface) of the supporting layer faces downwards, and the smooth surface (B surface) of the supporting layer is coated with an adhesive to form the adhesive layer.
In some embodiments, the rough side (a side) of the anti-blocking layer faces downward, i.e., is connected to the adhesive layer; the smooth surface (B surface) of the anti-adhesion layer faces upwards.
On the other hand, the invention also provides a preparation method of the anti-adhesion abdominal wall hernia composite patch, which comprises the following steps:
(1) Providing a dermal matrix (as a support layer);
in a specific operation, the rough surface (A surface) of the dermal matrix faces downwards, and the smooth surface (B surface) faces upwards;
(2) Applying an adhesive to the smooth surface (B-surface) of the dermal matrix (support layer) to form an adhesive layer;
(3) Providing a biofilm (as an anti-blocking layer);
(4) Spreading the rough surface (A surface) of the biological film on the adhesive layer, namely a smooth surface (B surface) of the dermis matrix coated with the adhesive;
(5) Freeze drying;
(6) Hot pressing and compounding; specifically, a hot press can be used for hot-pressing the compounded sample at a certain temperature and strength.
In the above method for producing an anti-adhesion abdominal hernia composite patch, as a preferred embodiment, the hernia patch produced in the method described in CN 108261565A (summary and examples) is used as a dermal matrix (rough surface (a surface) facing downward and smooth surface (B surface) facing upward) in the above step (1) before lyophilization.
In some embodiments of the invention, the method of preparing the dermal matrix comprises the steps of:
step one, throwing a variant skin raw material into an enzyme solution, soaking and oscillating to obtain a semi-finished product A; the enzyme is phospholipase, or the enzyme is phospholipase and protease;
taking out the semi-finished product A, soaking the semi-finished product A in normal saline, and carrying out oscillation treatment to obtain a semi-finished product B;
step three, putting the semi-finished product B into a surfactant solution, and performing ultrasonic soaking treatment to obtain a semi-finished product C;
soaking the semi-finished product C in normal saline, and carrying out oscillation treatment to obtain a semi-finished product D;
step five, putting the semi-finished product D into a container containing DNA hydrolase solution, and carrying out oscillation treatment to obtain a semi-finished product E;
step six, soaking the semi-finished product E in normal saline, and carrying out oscillation treatment to obtain a semi-finished product F;
step seven, taking out the semi-finished product F, putting the semi-finished product F into a container containing a cross-linking agent solution, and soaking the semi-finished product F for 24 to 36 hours to obtain a semi-finished product G;
step eight, soaking the semi-finished product G in normal saline, and carrying out oscillation treatment to obtain a semi-finished product H;
step nine, cleaning and soaking the semi-finished product H by using water for injection to obtain a finished product I (acellular allogenic dermal matrix), namely the dermal matrix.
In some embodiments of the invention, the dermal matrix is prepared as follows:
adding the allogenic dermis raw material into a solution of phospholipase with concentration of 0.2g/L and trypsin with concentration of 0.1g/L, wherein the pH value of the enzyme solution is 7.0, the temperature is 37 ℃, and the enzyme solution is replaced once after shaking for 2 hours at 100rpm, and the process is repeated once to obtain a semi-finished product A; phospholipase A1, phospholipase A2, phospholipase C and phospholipase D are mixed according to the mass ratio of 1:1:1:1;
taking out the semi-finished product A, soaking in physiological saline, oscillating for 3 times, wherein each time of oscillation lasts for 2 hours, the oscillating speed is 80rpm, and the temperature is 2 ℃, so as to obtain a semi-finished product B;
putting the semi-finished product B into a TritonX-100 solution containing 0.2g/L, carrying out ultrasonic treatment for 5 minutes at 50KHz and 220W, soaking for 3 hours, and repeating the process for 3 times to obtain a semi-finished product C;
taking out the semi-finished product C, soaking in physiological saline, oscillating for 3 times, wherein each time of oscillation is carried out for 2 hours at the temperature of 2 ℃ and the oscillating speed of 80rpm, so as to obtain a semi-finished product D;
putting the semi-finished product D into a DNA hydrolase solution with the concentration of 5g/L, pH of 7.0, carrying out oscillation treatment for 4 hours at the temperature of 37 ℃ and the oscillation rotation speed of 20rpm to obtain a semi-finished product E;
soaking the semi-finished product E in physiological saline, oscillating for 3 times, wherein each time of oscillation is carried out for 2 hours, the temperature is 2 ℃, and the oscillating speed is 80rpm, so as to obtain a semi-finished product F;
taking out the semi-finished product F, putting the semi-finished product F into a cross-linking agent solution, and soaking the semi-finished product F for 30 hours at the temperature of 5 ℃ to obtain a semi-finished product G;
the cross-linking agent solution contains N-hydroxysuccinimide, 1- (3-dimethylaminopropyl) -3-ethylcarbodiimide and a phosphate buffer solution, wherein the concentration of the 1- (3-dimethylaminopropyl) -3-ethylcarbodiimide is 5g/L, the molar ratio of the N-hydroxysuccinimide to the 1- (3-dimethylaminopropyl) -3-ethylcarbodiimide is 1:5, and the pH value of the cross-linking agent solution is adjusted to 5.5 by using the phosphate buffer solution;
soaking the semi-finished product G in normal saline, oscillating for 3 times, wherein each time of oscillation is carried out for 2 hours, the temperature is 2 ℃, and the oscillating speed is 80rpm, so as to obtain a semi-finished product H;
soaking the semi-finished product H in physiological saline, oscillating for 3 times, wherein each time of oscillation is carried out for 2 hours, the temperature is 2 ℃, and the oscillating speed is 80rpm, so as to obtain a finished product I (acellular allogeneic dermal matrix), namely the dermal matrix.
In the above method for preparing an anti-adhesion abdominal wall hernia composite patch, as a preferred embodiment, in the step (2), the concentration of the binder is 0.1wt% to 5wt% (the solvent may be water generally). Preferably, the area ratio of the binder to the smooth surface (B surface) of the dermal matrix is (1-10) ml/100 cm 2 。
In the above method for preparing an anti-adhesion abdominal wall hernia composite patch, as a preferred embodiment, in the step (3), the preparation of the biofilm includes the steps of:
s1: placing the biomembrane treated by hydrogen peroxide and ethanol into purified water for three times, placing the biomembrane in glutaraldehyde solution, placing the biomembrane in a shaking table, setting the rotation speed of the shaking table to be 100r/min, and performing crosslinking treatment; wherein,
preferably, the concentration of hydrogen peroxide is 5wt% to 15wt%.
Preferably, the ethanol concentration is 75%.
Preferably, the glutaraldehyde concentration is 0.0% -0.5%.
Preferably, the shaking table time is 0.1-30h.
S2: placing the crosslinked biological film in purified water, and placing in an ultrasonic cleaning machine for cleaning at a cleaning frequency of 40KHz for 4-8 times for 10min each time to obtain the biological film.
In the above method for preparing an anti-adhesion abdominal wall hernia composite patch, in step (5), the composite patch semi-finished product is pre-frozen before the freeze-drying, and then the freeze-drying is performed. The pre-freezing can lead the sample to have better molding effect after the freeze drying is finished, and the freeze drying is more sufficient.
Preferably, the pre-frozen temperature is-45 to-10 ℃ (e.g., -40, -30, -20 ℃) for a period of 1-3 hours (e.g., 1h,2h,3 h). Then heating to-5- -30deg.C, vacuum-pumping and sublimating for drying for 10-20h, vacuum degree is 0-30pa, heating to room temperature, and continuously drying for 4-10h. In the above method for preparing an anti-adhesion abdominal wall hernia composite patch, as another preferred embodiment, in the step (5), the semi-finished product of the composite patch is pumped down in a freeze dryer; preferably, the vacuum degree is 0-30pa, the temperature is 20-35 ℃ and the time is 12-48h.
In the above preparation method of the anti-adhesion abdominal wall hernia composite patch, as a preferred embodiment, in the step (6), the composite sample is hot-pressed at a suitable temperature of 20-140 ℃, a pressure of 200kg-1000kg, and a time of 1-10min.
The invention also comprises the anti-adhesion abdominal wall hernia composite patch prepared by the method.
The invention also comprises application of the anti-adhesion abdominal wall hernia composite patch in preparation of an anti-adhesion abdominal wall hernia composite patch material or operation.
The hernia patch provided by the invention has the advantages that the hernia patch is not easy to adhere to abdominal viscera after being implanted into a body, so that infection recurrence is avoided.
According to the invention, the thermal compression crosslinking treatment is carried out on the composite patch, so that the degradation time of the composite patch is prolonged, and the tensile strength of the composite patch is enhanced.
Drawings
FIG. 1 shows the contact angles of the anti-adhesion abdominal wall hernia composite patches prepared in examples 1-4 and comparative example 1.
Detailed Description
The following examples are illustrative of the invention and are not intended to limit the scope of the invention. The specific techniques or conditions are not identified in the examples and are described in the literature in this field or are carried out in accordance with the product specifications. The reagents or equipment used were conventional products available for purchase by regular vendors without the manufacturer's attention.
Example 1
1. A pre-lyophilization sample of hernia patch (i.e., finished product I) was prepared as dermal matrix according to the method described in example 1 of CN 108261565A.
2. A0.1 wt% sodium hyaluronate solution was prepared and uniformly applied to the smooth surface (B surface) of the dermal matrix to form an adhesive layer.
3. Preparing amniotic membrane as anti-adhesion layer
3.1 spreading fresh amniotic membrane, and manually scraping the fresh amniotic membrane against the growth direction of the chorionic membrane on the surface of the amniotic membrane by using a smooth sheet-shaped stainless steel scraper to obtain the amniotic membrane without chorion;
3.2, immersing the amniotic membrane after the chorion is scraped in a 5wt% hydrogen peroxide solution for 4 hours;
3.3, placing the amnion soaked by hydrogen peroxide in purified water for three times for continuous cleaning, and then placing the amnion in 75% ethanol for soaking for 2 hours;
3.4, placing the amnion treated by hydrogen peroxide and ethanol into purified water for three times, placing the amnion into glutaraldehyde solution with the concentration of 0.1%, placing the amnion into a shaking table, setting the rotation speed of the shaking table to be 100r/min and the time to be 5h, and performing crosslinking treatment;
3.5, placing the crosslinked amnion into purified water, and placing the water in an ultrasonic cleaner for cleaning, wherein the cleaning frequency is 40KHz, the cleaning time is 10min each time for 4 times;
4. paving the rough surface (A surface) of the amnion after the cleaning treatment on the adhesive layer, namely arranging the rough surface (B surface) of the dermal matrix coated with sodium hyaluronate;
5. and (3) freeze drying: pre-freezing the semi-finished product obtained in the step 4 at the pre-freezing temperature of minus 30 ℃ for 1h. Then heating to-5 ℃, vacuumizing, sublimating and drying for 15h, wherein the vacuum degree is 0pa, heating to room temperature, and continuously drying for 7h.
Example 2
1. A pre-lyophilization sample of hernia patch (i.e., finished product I) was prepared as dermal matrix according to the method described in example 1 of CN 108261565A.
2. A0.1 wt% sodium hyaluronate solution was prepared and uniformly applied to the smooth surface (B surface) of the dermal matrix to form an adhesive layer.
3. Preparing amniotic membrane as anti-adhesion layer
3.1 spreading fresh amniotic membrane, and manually scraping the fresh amniotic membrane against the growth direction of the chorionic membrane on the surface of the amniotic membrane by using a smooth sheet-shaped stainless steel scraper to obtain the amniotic membrane without chorion;
3.2, immersing the amniotic membrane after the chorion is scraped in a 5wt% hydrogen peroxide solution for 4 hours;
3.3, placing the amnion soaked by hydrogen peroxide in purified water for three times for continuous cleaning, and then placing the amnion in 75% ethanol for soaking for 2 hours;
3.4, placing the amnion treated by hydrogen peroxide and ethanol into purified water for three times, placing the amnion into glutaraldehyde solution with the concentration of 0.1%, placing the amnion into a shaking table, setting the rotation speed of the shaking table to be 100r/min and the time to be 5h, and performing crosslinking treatment;
3.5, placing the crosslinked amnion into purified water, and placing the water in an ultrasonic cleaner for cleaning, wherein the cleaning frequency is 40KHz, the cleaning time is 10min each time for 4 times;
4. placing the A surface of the amnion after the cleaning treatment on the B surface of the dermal matrix coated with sodium hyaluronate;
5. and (3) freeze drying: pre-freezing the semi-finished product obtained in the step four for 1h at the pre-freezing temperature of minus 30 ℃. Then heating to-5 ℃, vacuumizing, sublimating and drying for 15h, wherein the vacuum degree is 0pa, heating to room temperature, and continuously drying for 7h.
6. And (3) hot pressing and compounding: placing the semi-finished product biological film surface after freeze drying into a mold with patterns with the leather surface facing upwards, carrying out hot-pressing compounding, setting the hot-pressing temperature to be 75 ℃ and the pressure to be 500kg, demoulding after hot-pressing for 1min, and cooling to room temperature to obtain the anti-adhesion abdominal wall hernia composite patch.
Example 3
1. A pre-lyophilization sample of hernia patch (i.e., finished product I) was prepared as dermal matrix according to the method described in example 1 of CN 108261565A.
2. A0.1 wt% sodium hyaluronate solution was prepared and uniformly applied to the sliding surface (B surface) of the dermal matrix to form an adhesive layer.
3. Preparing amniotic membrane as anti-adhesion layer
3.1 spreading fresh amniotic membrane, and manually scraping the fresh amniotic membrane against the growth direction of the chorionic membrane on the surface of the amniotic membrane by using a smooth sheet-shaped stainless steel scraper to obtain the amniotic membrane without chorion;
3.2, immersing the amniotic membrane after the chorion is scraped in a 5wt% hydrogen peroxide solution for 4 hours;
3.3, placing the amnion soaked by hydrogen peroxide in purified water for three times for continuous cleaning, and then placing the amnion in 75% ethanol for soaking for 2 hours;
3.4, placing the amnion treated by hydrogen peroxide and ethanol into purified water for three times, placing the amnion into glutaraldehyde solution with the concentration of 0.1%, placing the amnion into a shaking table, setting the rotation speed of the shaking table to be 100r/min and the time to be 5h, and performing crosslinking treatment;
3.5, placing the crosslinked amnion into purified water, and placing the water in an ultrasonic cleaner for cleaning, wherein the cleaning frequency is 40KHz, the cleaning time is 10min each time for 4 times;
4. placing the A surface of the amnion after the cleaning treatment on the B surface of the dermal matrix coated with sodium hyaluronate;
5. and (3) freeze drying: pre-freezing the semi-finished product obtained in the step four for 1h at the pre-freezing temperature of minus 30 ℃. Then heating to-5 ℃, vacuumizing, sublimating and drying for 15h, wherein the vacuum degree is 0pa, heating to room temperature, and continuously drying for 7h.
6. And (3) hot pressing and compounding: placing the semi-finished product biological film surface after freeze drying into a mold with patterns with the leather surface facing upwards, carrying out hot-pressing compounding, setting the hot-pressing temperature to be 75 ℃ and the pressure to be 500kg, demoulding after hot-pressing for 3min, and cooling to room temperature to obtain the anti-adhesion abdominal wall hernia composite patch.
Example 4
1. A pre-lyophilization sample of hernia patch (i.e., finished product I) was prepared as dermal matrix according to the method described in example 1 of CN 108261565A.
2. A0.1 wt% sodium hyaluronate solution was prepared and uniformly applied to the sliding surface (B surface) of the dermal matrix to form an adhesive layer.
3. Preparing amniotic membrane as anti-adhesion layer
3.1 spreading fresh amniotic membrane, and manually scraping the fresh amniotic membrane against the growth direction of the chorionic membrane on the surface of the amniotic membrane by using a smooth sheet-shaped stainless steel scraper to obtain the amniotic membrane without chorion;
3.2, immersing the amniotic membrane after the chorion is scraped in a 5wt% hydrogen peroxide solution for 4 hours;
3.3, placing the amnion soaked by hydrogen peroxide in purified water for three times for continuous cleaning, and then placing the amnion in 75% ethanol for soaking for 2 hours;
3.4, placing the amnion treated by hydrogen peroxide and ethanol into purified water for three times, placing the amnion into glutaraldehyde solution with the concentration of 0.1%, placing the amnion into a shaking table, setting the rotation speed of the shaking table to be 100r/min and the time to be 5h, and performing crosslinking treatment;
3.5, placing the crosslinked amnion into purified water, and placing the water in an ultrasonic cleaner for cleaning, wherein the cleaning frequency is 40KHz, the cleaning time is 10min each time for 4 times;
4. placing the A surface of the amnion after the cleaning treatment on the B surface of the dermal matrix coated with sodium hyaluronate;
5. and (3) freeze drying: pre-freezing the semi-finished product obtained in the step four for 1h at the pre-freezing temperature of minus 30 ℃. Then heating to-5 ℃, vacuumizing, sublimating and drying for 15h, wherein the vacuum degree is 0pa, heating to room temperature, and continuously drying for 7h.
6. And (3) hot pressing and compounding: placing the semi-finished product biological film surface after freeze drying into a mold with patterns with the leather surface facing upwards, carrying out hot-pressing compounding, setting the hot-pressing temperature to be 75 ℃ and the pressure to be 500kg, demoulding after hot-pressing for 7min, and cooling to room temperature to obtain the anti-adhesion abdominal wall hernia composite patch.
Example 5
1. A pre-lyophilization sample of hernia patch (i.e., finished product I) was prepared as dermal matrix according to the method described in example 1 of CN 108261565A.
2. A0.1 wt% sodium hyaluronate solution was prepared and uniformly applied to the sliding surface (B surface) of the dermal matrix to form an adhesive layer.
3. Preparing amniotic membrane as anti-adhesion layer
3.1 spreading fresh amniotic membrane, and manually scraping the fresh amniotic membrane against the growth direction of the chorionic membrane on the surface of the amniotic membrane by using a smooth sheet-shaped stainless steel scraper to obtain the amniotic membrane without chorion;
3.2, immersing the amniotic membrane after the chorion is scraped in a 5wt% hydrogen peroxide solution for 4 hours;
3.3, placing the amnion soaked by hydrogen peroxide in purified water for three times for continuous cleaning, and then placing the amnion in 75% ethanol for soaking for 2 hours;
3.4, placing the amnion treated by hydrogen peroxide and ethanol into purified water for three times, placing the amnion into glutaraldehyde solution with the concentration of 0.1%, placing the amnion into a shaking table, setting the rotation speed of the shaking table to be 100r/min and the time to be 5h, and performing crosslinking treatment;
3.5, placing the crosslinked amnion into purified water, and placing the water in an ultrasonic cleaner for cleaning, wherein the cleaning frequency is 40KHz, the cleaning time is 10min each time for 4 times;
4. placing the A surface of the amnion after the cleaning treatment on the B surface of the dermal matrix coated with sodium hyaluronate;
5. and (3) freeze drying: the vacuum degree was 0pa, the temperature was 25℃and the time was 24 hours.
Example 6
1. A pre-lyophilization sample of hernia patch (i.e., finished product I) was prepared as dermal matrix according to the method described in example 1 of CN 108261565A.
2. A0.1 wt% sodium hyaluronate solution was prepared and uniformly applied to the sliding surface (B surface) of the dermal matrix to form an adhesive layer.
3. Preparing amniotic membrane as anti-adhesion layer
3.1 spreading fresh amniotic membrane, and manually scraping the fresh amniotic membrane against the growth direction of the chorionic membrane on the surface of the amniotic membrane by using a smooth sheet-shaped stainless steel scraper to obtain the amniotic membrane without chorion;
3.2, immersing the amniotic membrane after the chorion is scraped in a 5wt% hydrogen peroxide solution for 4 hours;
3.3, placing the amnion soaked by hydrogen peroxide in purified water for three times for continuous cleaning, and then placing the amnion in 75% ethanol for soaking for 2 hours;
3.4, placing the amnion treated by hydrogen peroxide and ethanol into purified water for three times, placing the amnion into glutaraldehyde solution with the concentration of 0.1%, placing the amnion into a shaking table, setting the rotation speed of the shaking table to be 100r/min and the time to be 5h, and performing crosslinking treatment;
3.5, placing the crosslinked amnion into purified water, and placing the water in an ultrasonic cleaner for cleaning, wherein the cleaning frequency is 40KHz, the cleaning time is 10min each time for 4 times;
4. placing the A surface of the amnion after the cleaning treatment on the B surface of the dermal matrix coated with sodium hyaluronate;
5. and (3) freeze drying: the vacuum degree was 0pa, the temperature was 25℃and the time was 24 hours.
6. And (3) hot pressing and compounding: placing the semi-finished product biological film surface after freeze drying into a mold with patterns with the leather surface facing upwards, carrying out hot-pressing compounding, setting the hot-pressing temperature to be 75 ℃ and the pressure to be 500kg, demoulding after hot-pressing for 1min, and cooling to room temperature to obtain the anti-adhesion abdominal wall hernia composite patch.
Comparative example 1
1. A pre-lyophilization sample of the hernia patch (i.e., finished product I) was prepared according to the method described in example 1 of CN 108261565A.
2. And (3) freeze drying: pre-freezing the semi-finished product obtained in the step four for 1h at the pre-freezing temperature of minus 30 ℃. Then heating to-5 ℃, vacuumizing, sublimating and drying for 15 hours, wherein the vacuum degree is 0pa, heating to room temperature, and continuously drying for 7 hours to obtain the product.
To verify the rehydration stability and anti-adhesion effect of the above anti-adhesion abdominal wall hernia composite patches, the anti-adhesion abdominal wall hernia composite patches of examples 1-6 and comparative example 1 were subjected to rehydration stability, contact angle, tensile strength, cell compatibility, and in vivo animal adhesion test.
The anti-adhesion abdominal wall hernia composite patches prepared in examples 1-4 were placed in normal saline, and soaked for 24 hours, wherein delamination occurred at the corners after 2 hours in example 1 (example 1 was not subjected to hot pressing treatment, freeze-dried and placed in water, the adhesive was hydrated and the corners delaminated), and neither of examples 2-4 was delaminated, which fully demonstrates the feasibility of the composite process of the present invention.
The anti-blocking effect and biosafety of examples and comparative example 1 were verified using a contact angle tester (Dataphysics, germany), tensile tester (CTM 2000) and animal test.
(1) Contact angle test: distilled water droplets were dropped on the smooth surfaces of examples 1 to 4 and comparative example 1, and the angle at which the droplets were brought into contact with the material surface was recorded.
Compared with comparative example 1, the contact angles of examples 1-4 are all obviously improved, the hydrophobicity is improved, and the anti-adhesion effect is improved. The results are shown in FIG. 1.
(2) Tensile strength test: the anti-adhesion abdominal hernia composite patches obtained in examples 1 to 6 and comparative example 1 were molded into dumbbell shapes, and the tensile strength of the materials was measured at a speed of 100mm/min on a tensile machine (reference: showy, tang Guoqing, but time, et al. Study of procyanidine crosslinked decellularized pig dermal matrix [ J ]. Leather science and engineering, 2012,22 (5): 15-19.)
The tensile strength results are shown in Table 1 below.
TABLE 1
(3) Cell compatibility test:
the cell proliferation rates of the groups were examined by MTS method after 1 day, 3 days and 5 days of culture, and thus cytotoxicity was judged, by co-culturing the mouse fibroblasts L929 transferred to the third generation with the anti-adhesion abdominal wall hernia composite patches (10 mm. Times.10 mm) prepared in examples 2 to 4 and comparative example 1, respectively, and the cell proliferation conditions of the groups are shown in Table 1. According to the regulations of the national food and drug administration, when the cell proliferation rate is more than or equal to 80%, the cytotoxicity is less than or equal to 1, and the requirement of implantation safety is met. The cell proliferation rate of each of examples 2 to 4 was not less than 80%, which is not different from that of comparative example 1. The results are shown in Table 2 below.
TABLE 2
(4) Animal test: 20 New Zealand white rabbits are selected, and the average of the two rabbits is divided into 4 groups of 5 rabbits. A20 mm x 20mm incision was made in the abdomen of New Zealand white rabbits, and the patches prepared in examples 1-5 above were respectively implanted, sized 40mm x 40mm, and the patches were fixed and the wound was sutured. The anti-blocking performance (blocking area and blocking incidence) was evaluated 3 months after the operation, and the anti-blocking effect of each of examples and comparative example 1 is shown in table 3 below.
TABLE 3 Table 3
As shown in Table 3, the adhesion occurred in 5 New Zealand rabbits and the incision was severe when the pure dermal matrix patch was implanted, whereas the adhesion prevention composite patches prepared in examples 2 to 4 were implanted with little adhesion reaction.
The experiment proves that the anti-adhesion abdominal wall hernia composite patch prepared by the invention has excellent anti-adhesion effect and reliable safety.
CN 108261565A is incorporated herein in its entirety, or by reference herein.
While the invention has been described in detail in the foregoing general description and with reference to specific embodiments thereof, it will be apparent to one skilled in the art that modifications and improvements can be made thereto. Accordingly, such modifications or improvements may be made without departing from the spirit of the invention and are intended to be within the scope of the invention as claimed.
Claims (5)
1. An anti-adhesion abdominal wall hernia composite patch comprising, from bottom to top: a support layer, an adhesive layer and an anti-blocking layer; the supporting layer is a dermis matrix; the anti-adhesion layer is a biological film;
the dermis matrix of the supporting layer is one of pig, cattle, sheep and human dermis matrix;
the adhesive layer is one or more of sodium hyaluronate, gelatin and collagen; every 100cm 2 The mass of the adhesive layer on the supporting layer is 0.05g-0.1g;
the biomembrane of the anti-adhesion layer is prepared from one or more of human or animal amniotic membrane, pericardium, peritoneum, pleura or visceral submucosa;
the rough surface of the supporting layer faces downwards, and the smooth surface of the supporting layer is coated with an adhesive to form the adhesive layer; the rough surface of the anti-adhesion layer faces downwards, namely is connected with the adhesive layer; the smooth surface of the anti-adhesion layer faces upwards;
the preparation method of the anti-adhesion abdominal wall hernia composite patch comprises the following steps:
(1) Providing a dermal matrix as a support layer;
(2) Coating an adhesive on the smooth surface of the supporting layer to form an adhesive layer;
(3) Providing a biofilm as an anti-blocking layer;
(4) Spreading the roughened surface of the biofilm on the adhesive layer;
(5) Freeze drying;
(6) Hot pressing and compounding; the temperature of the hot-pressing compounding is 75-140 ℃, the pressure is 200kg-1000kg, and the time is 1-10min.
2. A method of preparing an anti-adhesion abdominal wall hernia composite patch in accordance with claim 1, comprising:
(1) Providing a dermal matrix as a support layer;
(2) Coating an adhesive on the smooth surface of the supporting layer to form an adhesive layer;
(3) Providing a biofilm as an anti-blocking layer;
(4) Spreading the roughened surface of the biofilm on the adhesive layer;
(5) Freeze drying;
(6) Hot pressing and compounding; the temperature of the hot-pressing compounding is 75-140 ℃, the pressure is 200kg-1000kg, and the time is 1-10min.
3. The method of preparing an anti-adhesion abdominal wall hernia composite patch according to claim 2, wherein in step (2), the concentration of the binder is 0.1wt% to 5wt%; and/or the number of the groups of groups,
the area ratio of the binder to the smooth surface of the dermal matrix is (1-10) ml/100 cm 2 。
4. An anti-adhesion abdominal wall hernia composite patch prepared by the method of claim 3.
5. Use of an anti-adhesion abdominal wall hernia composite patch according to any one of claims 1 or 4 for the preparation of an anti-adhesion abdominal wall hernia composite patch material.
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN201664349U (en) * | 2009-06-30 | 2010-12-08 | 中国人民解放军第二军医大学 | Novel composite hernia and body wall repairing piece |
| US20120239063A1 (en) * | 2009-11-29 | 2012-09-20 | Jeongsam Lee | Mesh patch for use in laparoscopic hernia surgery |
| CN108261565A (en) * | 2018-02-08 | 2018-07-10 | 北京桀亚莱福生物技术有限责任公司 | A kind of hernia sticking patch, preparation method and its application in hernia repairing |
| US20200253707A1 (en) * | 2016-04-26 | 2020-08-13 | Tela Bio, Inc. | Hernia repair grafts having anti-adhesion barriers |
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Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN201664349U (en) * | 2009-06-30 | 2010-12-08 | 中国人民解放军第二军医大学 | Novel composite hernia and body wall repairing piece |
| US20120239063A1 (en) * | 2009-11-29 | 2012-09-20 | Jeongsam Lee | Mesh patch for use in laparoscopic hernia surgery |
| US20200253707A1 (en) * | 2016-04-26 | 2020-08-13 | Tela Bio, Inc. | Hernia repair grafts having anti-adhesion barriers |
| CN108261565A (en) * | 2018-02-08 | 2018-07-10 | 北京桀亚莱福生物技术有限责任公司 | A kind of hernia sticking patch, preparation method and its application in hernia repairing |
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