CN111821521A - Preparation method of hernia repair patch containing polyvinylidene fluoride - Google Patents
Preparation method of hernia repair patch containing polyvinylidene fluoride Download PDFInfo
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- CN111821521A CN111821521A CN202010795309.XA CN202010795309A CN111821521A CN 111821521 A CN111821521 A CN 111821521A CN 202010795309 A CN202010795309 A CN 202010795309A CN 111821521 A CN111821521 A CN 111821521A
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- hernia repair
- repair patch
- polyvinylidene fluoride
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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
- A61L31/04—Macromolecular materials
- A61L31/048—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
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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
- A61L31/08—Materials for coatings
- A61L31/10—Macromolecular materials
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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
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/146—Porous materials, e.g. foams or sponges
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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
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/148—Materials at least partially resorbable by the body
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- Heart & Thoracic Surgery (AREA)
- Surgery (AREA)
- Vascular Medicine (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Dispersion Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Materials For Medical Uses (AREA)
- Prostheses (AREA)
Abstract
The invention relates to a preparation method of a hernia repair patch containing polyvinylidene fluoride, belonging to the technical field of medical instruments. The preparation method of the hernia repair patch containing polyvinylidene fluoride comprises the following steps: (1) feeding a monofilament containing polyvinylidene fluoride into a looping system, and carrying out regular yarn laying movement by a yarn guide needle to form a mesh sheet in a mesh braided fabric form; (2) stretching the mesh sheet obtained in the step (1) by using a stretching frame, and performing high-temperature heat setting on the mesh knitted fabric in a pre-stretched state in an inert gas atmosphere at a high temperature of 135-150 ℃ for 10-30 min; and then carrying out quenching treatment on the mesh, placing the mesh in a heating furnace for secondary heat setting at the temperature of 60-90 ℃ for 0.5-4 hours, and cutting to obtain the hernia repair patch. The preparation method can avoid aging and yellowing of the PVDF, greatly improve the dimensional stability of the PVDF and prolong the service life of the PVDF.
Description
Technical Field
The invention relates to the technical field of medical appliances, in particular to a preparation method of a hernia repair patch containing polyvinylidene fluoride.
Background
PVDF is a nonabsorbable fluoropolymer. PVDF sutures are widely used in cardiac and orthopedic surgery. In the field of hernia repair, PVDF is a novel material, but shows superiority in both in vivo and in vitro experiments. The tensile force and surface characteristics are similar to those of polypropylene and polyester patches, but the patch is more excellent in hydrolysis resistance, degradation resistance and hardening resistance. Studies have shown that PVDF has greater tissue integrity in mouse models than polypropylene and has a lighter inflammatory response process than a lightweight macroporous polypropylene patch, thereby regularly limiting the deposition of body tissue glia to the patch area without forming scar tissue surrounding the entire patch. Based on the structural characteristics of PVDF, the heat aging type of PVDF is lateral group removal, and after the PVDF removes hydrogen fluoride, a chromophoric group with a conjugated double bond structure is formed, so that the apparent color becomes dark, and the mechanical property is reduced. Therefore, the adoption of proper heat setting mode has important significance for maintaining the performance of the material, but the heat setting process in the prior art has room for improvement. In addition, the PVDF hernia repair patch material is easy to generate the phenomenon of boundary warping after being placed for a period of time, the operation difficulty of a doctor during operation is increased, and meanwhile, the boundary has the risk of thread slipping.
Disclosure of Invention
In order to solve the above technical problems in the prior art, the present invention provides a method for preparing a hernia repair patch comprising polyvinylidene fluoride.
The preparation method of the hernia repair patch containing polyvinylidene fluoride comprises the following steps:
(1) knitting
Installing a guide bar device comprising a front guide bar and a rear guide bar, winding and withdrawing a monofilament containing polyvinylidene fluoride from a warp beam, entering a looping system according to a certain warp let-off amount, and carrying out regular yarn laying motion by a yarn guide needle according to a variable chain warp satin weave yarn laying number to form a mesh sheet in a mesh knitting fabric form;
(2) heat setting
Carrying out stretching and finishing on the mesh sheet obtained in the step (1) by using a stretching and finishing frame, putting the stretching and finishing frame into an oven, arranging the mesh braided fabric in an inert gas atmosphere under the condition that the pretension is 10-20N, and carrying out high-temperature heat setting at the high temperature of 135-150 ℃ for 10-30 min; and then carrying out quenching treatment on the mesh, then placing the mesh in a heating furnace for secondary heat setting at the temperature of 60-90 ℃ for 0.5-4 hours, and cutting to obtain the hernia repair patch.
The preparation method further comprises the step (3) of carrying out overlocking treatment on the edge of the hernia repair patch. The border locking treatment can be carried out by weaving monofilaments to form a border, and a solution of an absorbable material can be dipped in the border of the hernia repair patch, wherein the absorbable solution is a glycolide-caprolactone solution or a lactide-caprolactone solution, and the border width is 1-3mm, so that the phenomenon of slight warping of the border or possible border line separation caused by long-term placement can be prevented.
Among them, the quenching treatment is preferably water cooling or forced air cooling. In order to obtain special properties, the surface of the polyvinylidene fluoride monofilament may be provided with a coating.
Wherein, the temperature of the secondary heat setting is preferably 70-80 ℃, and the time is preferably 1-3 hours.
The hernia repair patch is of a standard type, the front guide bar is made of polyvinylidene fluoride monofilament, and the rear guide bar is made of monofilament capable of absorbing biological materials or polyvinylidene fluoride monofilament. The standard type porosity is 50% -70%, and the gram weight is 80-110 g/cm2。
The hernia repair patch is light in weight, wherein the warp flat tissues and the variable warp flat tissues are combined together in the light in weight, a large mesh is formed at the positions of the warp flat backing yarns, and the variable warp flat backing yarns are used for closing the mesh. Further, one or more monofilaments with a distinct marking color are used in the warp knit chain weave to provide a mark for the surgeon during the procedure. The lightweight porosity is 70-90%, and the gram weight is 50-70 g/cm2。
Compared with the prior art, the preparation method of the hernia repair patch containing polyvinylidene fluoride has the following beneficial effects:
the hernia repair patch disclosed by the invention avoids aging and yellowing of PVDF (polyvinylidene fluoride) through a special heat setting mode (firstly carrying out high-temperature heat setting in a preset tension and inert atmosphere, and then carrying out secondary heat setting), greatly improves the dimensional stability of the hernia repair patch, and prolongs the service life of the PVDF hernia repair patch. The PVDF hernia repair patch can be matched with other absorbable membrane materials for use or used independently.
Drawings
Fig. 1 is a PVDF standard patch weave layout.
Fig. 2 is a PVDF light weight patch roadmap.
Fig. 3 is an SEM image of a PVDF standard hernia repair patch.
Fig. 4 is an SEM image of a PVDF lightweight hernia repair patch.
Fig. 5 is a DSC curve of a PVDF hernia repair patch.
Fig. 6 is an energy spectrum of the PVDF hernia repair patch which is not shaped by nitrogen atmosphere heat.
Figure 7 is an energy spectrum of a PVDF hernia repair patch heat set by a nitrogen atmosphere.
Detailed Description
The method for preparing the hernia repair patch containing polyvinylidene fluoride according to the present invention will be further described with reference to the following specific examples to help those skilled in the art to have a more complete, accurate and thorough understanding of the technical solution of the present invention.
The invention firstly adopts two different weaving modes to prepare the standard type and light weight type hernia repair patch containing PVDF, wherein the light weight type adopts a partial-warp large mesh weave structure, and the standard type is a satin weave structure so as to meet different clinical requirements. The weaving method of the hernia repair patch comprises the steps of installing a guide bar, winding and withdrawing a monofilament from a warp beam, entering a looping system according to a certain warp let-off amount, and making a mesh fabric with regular yarn laying motion by a yarn guide needle according to the changed chain warp satin weave yarn laying number. The edge of the hernia repair patch can be processed by overlocking, so that the phenomenon of slight warping of the edge or possible edge separation caused by long-time placement is prevented. The aging degree of the material of the patch in the process of setting by pulling is reduced, and the service life of the hernia repair patch can be obviously prolonged. The PVDF-containing hernia repair patch is formed by weaving polyvinylidene fluoride (which can be coated) fibers or polyvinylidene fluoride + absorbable biomaterial fibers (such as polyglycolide lactide, polyglycolide caprolactone and the like).
The light weight type combines the warp flat structure and the change warp flat structure to form a larger mesh at the position of the warp flat backing yarns, the change warp flat backing yarns are used for closing the mesh, and one or more monofilaments with obvious marking colors can be used in the warp knitting chain structure for carrying out backing yarn movement so as to provide marks for doctors during operation. The standard type is to weave PVDF monofilament on the front guide bar and other types (such as absorbable biomaterial) monofilament on the back guide bar to form a composite patch containing more than two monofilaments, or the front guide bar and the back guide bar are both PVDF monofilament, so as to obtain a patch only composed of PVDF. The hernia repair patch is straightened by adopting a needle type straightening frame, the shaping temperature is 135-150 ℃ during high-temperature shaping, and the high-temperature shaping is carried out in the atmosphere of inert gas (such as nitrogen and the like). And (3) taking the heat-set hernia repair patch out of the setting temperature, and treating the patch by adopting a rapid cooling mode, such as a water cooling mode, an air cooling mode and the like. And then carrying out secondary heat setting in a furnace, wherein the returning temperature is 60-90 ℃, and the returning time is 0.5-4 hours.
The edge of the hernia repair patch can be locked in a special mode or not, the edge locking mode can be that a single filament is woven into a boundary with a proper width, and a solution of an absorbable material with a proper width can be dipped in the boundary of the hernia repair patch. Wherein the absorbable solution can be glycolide-caprolactone solution, lactide-caprolactone, etc., and the width of the boundary is 1-3 mm.
The lightweight porosity of the hernia repair patch obtained by the invention is 70-90%, and the standard porosity is 50-70%. The lightweight gram weight of the hernia repair patch is 50-70 g/cm2The standard gram weight is 80-110 g/cm2。
After the drawing and shaping, carrying out high-temperature shaping on the drawing and shaping frame with the meshes, and then cooling by adopting a quick cooling mode, wherein the purpose of quick cooling is to quickly crystallize the material so that the performance of the material is more stable; and then, returning to the furnace at a certain temperature for secondary heat setting to release the internal stress generated in the process of drawing and finishing. The heat setting mode of the invention greatly reduces the amplitude of the dimensional change of the material in the later period. Figure 4 shows a PVDF hernia repair patch DSC curve indicating that the temperature range for high temperature heat setting is preferably between 135 deg.c and 150 deg.c. As can be seen from a comparison of fig. 5 and 6, the heat setting method of the present invention also significantly retards the aging and oxidation of the hernia repair patch. The hernia repair patch is also subjected to overlocking to obtain the hernia repair patch with ageing resistance, boundary warping resistance and stable performance.
Example 1
According to the route chart shown in fig. 1, the front guide bar is a PVDF monofilament, the rear guide bar is a glycolide-lactide monofilament, the mesh shown in fig. 3 is woven, the obtained mesh is pulled and adjusted by a pulling and adjusting frame with a preset tension of 20N, the pulling and adjusting frame is placed in an oven, the mesh is heat-set for 20 minutes at 135 ℃ in a nitrogen atmosphere, the patch is rapidly cooled by air cooling, then the patch is placed in the oven with a temperature of 90 ℃, the patch is heat-set for 2 hours for the second time, the patch is naturally cooled after being taken out, and after the patch is cut to obtain a required size, the performance of the patch is confirmed, and the results are shown in table 1.
TABLE 1
Example 2
According to the routing diagram shown in fig. 2, a monofilament with a marked color is used for carrying out lapping movement in a warp knitting chain structure, a mesh sheet with a mark line in the middle is woven, the mesh sheet is in a mesh type as shown in fig. 4, the obtained mesh sheet is subjected to stretching and setting by a stretching and setting frame with a preset tension of 16N, the stretching and setting frame is placed into an oven, the mesh sheet is subjected to heat setting for 15 minutes at 140 ℃ under a nitrogen atmosphere, the water cooling is adopted to rapidly cool the mesh sheet, the mesh sheet is placed into the oven with the temperature of 80 ℃, the secondary heat setting is carried out for 2 hours, the mesh sheet is taken out and naturally cooled, after the required size is obtained through cutting, the performance of the mesh sheet is confirmed, and the result.
TABLE 2
Example 3
According to the routing diagram shown in fig. 2, a monofilament with a marked color is used in a warp knitting chain tissue for carrying out lapping movement, a mesh-type mesh sheet with a marked line in the middle is woven, the mesh sheet is pulled and integrated by a pulling and integrating frame, the tension of 10N is preset, the pulling and integrating frame is placed in an oven, the mesh sheet is subjected to heat setting at 130 ℃ for 30 minutes under the atmosphere of N2, the patch sheet is rapidly cooled by air cooling, then the patch sheet is placed in the oven at 80 ℃, the secondary heat setting is carried out for 2 hours, the patch sheet is taken out and naturally cooled, after the patch sheet is cut to obtain the required size, four sides of the patch sheet are dipped in a glycolide-caprolactone solution with the width of 2mm, and after standing and volatilization, the performance of the patch sheet is confirmed, and the results are shown in table 3.
TABLE 3
The heat setting method adopted by the invention can ensure that the hernia repair patch containing PVDF has more stable performance and longer service life, PVDF has stronger tissue integration than polypropylene, and compared with a polypropylene patch with light weight and large pores, the hernia repair patch has a lighter inflammatory reaction process, so that the deposition of body tissue colloid is regularly limited in the range of the patch, and scar tissues wrapping the whole patch are not formed. The shrinkage rate of a product obtained by using the polyvinylidene fluoride hernia repair patch is measured after the product is placed for 10 days, and for a standard type patch, the transverse shrinkage rate is less than or equal to 0.6 percent, and the longitudinal shrinkage rate is less than or equal to 0.9 percent; for the lightweight patch, the transverse shrinkage is less than or equal to 0.6%, and the longitudinal shrinkage is less than or equal to 0.2%. The comparative example shows that, if high-temperature heat setting is carried out only once, or heat setting is carried out in an air atmosphere or without applying the pretension in the range of the invention, the transverse shrinkage rate is not less than 1.9 percent and the longitudinal shrinkage rate is not less than 2.1 percent for the standard patch; the light-weight patch is not less than 1.2%, and the longitudinal shrinkage rate is not less than 1.9%.
The hernia repair patch avoids aging and yellowing of PVDF (polyvinylidene fluoride) through a special heat setting mode, greatly prolongs the service life of the PVDF hernia repair patch, and shows excellent size stability. The patch may be used in conjunction with other absorbable film materials or alone.
For those skilled in the art, the specific embodiments are only exemplary descriptions of the present invention, and it is obvious that the specific implementation of the present invention is not limited by the above-mentioned manner, and various insubstantial modifications made by the technical solution of the present invention are within the protection scope of the present invention.
Claims (10)
1. A method for preparing a hernia repair patch comprising polyvinylidene fluoride, comprising the steps of:
(1) knitting
Installing a guide bar device comprising a front guide bar and a rear guide bar, winding and withdrawing a monofilament containing polyvinylidene fluoride from a warp beam, entering a looping system according to a certain warp let-off amount, and carrying out regular yarn laying motion by a yarn guide needle according to a variable chain warp satin weave yarn laying number to form a mesh sheet in a mesh knitting fabric form;
(2) heat setting
Carrying out stretching and finishing on the mesh sheet obtained in the step (1) by using a stretching and finishing frame, putting the stretching and finishing frame into an oven, arranging the mesh braided fabric in an inert gas atmosphere under the condition that the pretension is 10-20N, and carrying out high-temperature heat setting at the high temperature of 135-150 ℃ for 10-30 min; and then carrying out quenching treatment on the mesh, then placing the mesh in a heating furnace for secondary heat setting at the temperature of 60-90 ℃ for 0.5-4 hours, and cutting to obtain the hernia repair patch.
2. The method for preparing a hernia repair patch comprising polyvinylidene fluoride according to claim 1, wherein: the preparation method further comprises the step (3) of carrying out overlocking treatment on the edge of the hernia repair patch.
3. The method for preparing a hernia repair patch comprising polyvinylidene fluoride according to claim 1, wherein: the quenching treatment adopts water cooling or forced air cooling.
4. The method for preparing a hernia repair patch comprising polyvinylidene fluoride according to claim 1, wherein: the surface of the polyvinylidene fluoride monofilament has a coating.
5. The method for preparing a hernia repair patch comprising polyvinylidene fluoride according to claim 1, wherein: the overlock processing adopts monofilaments to weave into boundaries.
6. The method for preparing a hernia repair patch comprising polyvinylidene fluoride according to claim 1, wherein: the serging treatment refers to dipping a solution of an absorbable material on the boundary of the hernia repair patch, drying the solution to form the boundary, wherein the absorbable solution is a glycolide-caprolactone solution or a lactide-caprolactone solution.
7. The method for preparing a hernia repair patch comprising polyvinylidene fluoride according to claim 6, wherein: the width of the border is 1-3 mm.
8. The method for preparing a hernia repair patch comprising polyvinylidene fluoride according to claim 1, wherein: the hernia repair patch is light in weight, the porosity of the light in weight is 70% -90%, and the gram weight is 50-70 g/cm2(ii) a The lightweight warp knit combines a warp flat knit with a varying warp flat knit to form a larger mesh at the warp flat spacer, the varying warp flat spacer serving to close the mesh.
9. The method for preparing a hernia repair patch comprising polyvinylidene fluoride according to claim 8, wherein: in the warp knitting chain structure, one or several monofilaments with obvious mark colors are used for carrying out yarn laying movement.
10. The method for preparing a hernia repair patch comprising polyvinylidene fluoride according to claim 8, wherein: the hernia repair patch is of a standard type, the porosity is 50% -70%, and the gram weight is 80-110 g/cm2(ii) a The front guide bar adopts polyvinylidene fluoride monofilament, and the back guide bar adopts monofilament capable of absorbing biological material or polyvinylidene fluoride monofilament。
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| US4876774A (en) * | 1982-09-30 | 1989-10-31 | Allied-Signal Inc. | Method for preparing heat set fabrics |
| JP2005194461A (en) * | 2004-01-09 | 2005-07-21 | Kuraray Co Ltd | Fluorinated vinylidene resin porous film and method for producing the same |
| JP2010088552A (en) * | 2008-10-06 | 2010-04-22 | Maxell Seiki Kk | Method of manufacturing thin cap, the thin cap, and dirt prevention cover provided with lens cap |
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| CN111821521B (en) | 2022-05-20 |
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