CN113262075A - Partially absorbable hernia repair patch and preparation method thereof - Google Patents

Partially absorbable hernia repair patch and preparation method thereof Download PDF

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Publication number
CN113262075A
CN113262075A CN202010094131.6A CN202010094131A CN113262075A CN 113262075 A CN113262075 A CN 113262075A CN 202010094131 A CN202010094131 A CN 202010094131A CN 113262075 A CN113262075 A CN 113262075A
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China
Prior art keywords
hernia repair
repair patch
absorbable
monofilaments
medical
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Chinese (zh)
Inventor
隋纹龙
盛励斌
李重标
迟少萍
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Shanghai Xinhua Ruisi Medical Science & Technology Co ltd
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Shanghai Xinhua Ruisi Medical Science & Technology Co ltd
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    • 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
    • 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
    • A61F2002/0068—Implantable repair or support meshes, e.g. hernia meshes having a special mesh pattern
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
    • 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
    • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001—Designing or manufacturing processes

Abstract

The invention discloses a partially absorbable hernia repair patch, which has a structure of a four-comb-shaped variable warp plain satin tissue structure formed by compositely weaving medical non-absorbable synthetic monofilaments and medical absorbable synthetic monofilaments; the hernia repair patch is a mesh braided fabric, and meshes on the surface of the hernia repair patch are hexagonal meshes; the aperture of the hernia repair patch is 3.5mm-5mm, the gram weight of the hernia repair patch before degradation is 50-75g/m2, and the gram weight of the absorbable material after complete degradation is 16-30g/m 2. In addition, the invention also discloses a preparation method of the partially absorbable hernia repair patch. The partially absorbable hernia repair patch has good operation performance and is convenient to place on an affected part. The degradable material implanted into a human body is completely absorbed and then becomes the hexagonal mesh light-weight net sheet with firm form, which is beneficial to the rapid growth of fibroblast, greatly reduces the probability of the occurrence of complications such as foreign body sensation and effusion of a patient, can be processed into a flat sheet or a three-dimensional net sheet required by clinical practice, and has good application prospect.

Description

Partially absorbable hernia repair patch and preparation method thereof
Technical Field
The invention relates to a hernia repair patch, in particular to a novel partially absorbable hernia repair patch and a preparation method thereof.
Background
Hernia refers to the functional disorder of some organs caused by the fact that some tissues or organs of some parts of the human body leave the original position and enter another part through some defects, gaps and weak points of the human body. The existing tension-free repair operation applying the hernia repair patch has the advantages of small wound, light postoperative pain, quick recovery, shorter learning curve of operation and low recurrence rate, and is a main operation mode for treating hernia.
The lightweight patch can reduce the incidence of postoperative complications and local inflammatory reaction and connective tissue formation, thereby reducing chronic pain of the abdominal wall, foreign body sensation and abdominal wall constraint sensation of the patch, greatly improving the comfort of patients and being a hotspot developed at present. And because the material of many light-duty patch products on the market is too soft at present, make the doctor's operation place the patch degree of difficulty increase, operating time prolongs greatly, has increased the risk of infecting in the patient's operation process. There is a great need to develop new lightweight patches that are more convenient for the physician to operate on the basis of ensuring patient comfort.
Chinese patent application CN201210238415 discloses a partially absorbed hernia repair patch, which is a double-layer mesh formed by compounding a bottom mesh sheet made of an absorbable material and a petal mesh sheet made of a non-absorbable material, and has no innovation in the core preparation technology of the mesh sheet, namely, the weaving technology (including the weaving structure).
Chinese patent application CN201510410262 discloses a method for producing a partially absorbable fiber membrane hernia repair patch, which is a patch with an absorbable membrane layer formed by compounding a non-absorbable (polypropylene) mesh sheet and an absorbable material, wherein the absorbable membrane layer can play a role in reducing organ adhesion, and the product can only be used for repairing hernia in an abdominal cavity, but cannot solve the problems of unsmooth placement of the patch, strong foreign body sensation of patients and the like in the most clinical extraabdominal hernia repair surgery.
In 2 patents of the applicant filed in 2014, CN 201410341099-a light hernia repair patch and a weaving method thereof, and CN 201410341431-a large-hole light hernia repair patch and a weaving method thereof, the prior patent products pay more attention to large mesh and light weight, so as to reduce the foreign body sensation of a patient and improve the comfort of the patient without paying more attention to the operation convenience of doctors, and during laparoscopic surgery, due to the increased operation complexity, the used products are required to be placed to a defect part better and faster. However, the following defects still exist in the two patents of CN201410341099 and CN 201410341431: the patch is difficult to place by the doctor in the operation, the operation time is greatly prolonged, and the risk of infection in the operation process of the patient is increased.
Therefore, there is a great need in the art to develop a new hernia repair patch to solve the above technical problems of difficulty in placing a patch by a doctor in an operation, greatly prolonged operation time, and increased risk of infection in a patient during the operation.
Disclosure of Invention
The invention aims to solve the technical problem of providing a partially absorbable hernia repair patch which is formed by compounding and weaving non-absorbable materials and has a four-comb-shaped variable warp plain satin weave structure. The patch has good rigidity before being implanted into a human body, is convenient for a doctor to place, can be degraded along with an absorbable material after being implanted into the human body, is a light mesh with a firm original hexagonal mesh shape, is beneficial to the rapid growth of fibroblasts, greatly reduces the probability of the occurrence of complications such as foreign body sensation and effusion of a patient, can be processed into a plain film or a three-dimensional mesh required in clinical practice, and can solve the current clinical pain point. In addition, the invention also provides a preparation method of the partially absorbable hernia repair patch.
In order to solve the technical problems, the invention provides a partially absorbable hernia repair patch, which has a structure of a four-comb-shaped variable satin weave structure formed by composite weaving of a medical non-absorbable synthetic monofilament and a medical absorbable synthetic monofilament, and is a mesh braided fabric, wherein meshes on the surface of the hernia repair patch are hexagonal meshes; the aperture of the hernia repair patch is 3.5mm-5mm, and the gram weight before degradation is 50-75g/m2The gram weight of the absorbable material after complete degradation is 16-30g/m2。
As a preferred technical scheme, the four-bar variable warp plain satin weave structure is a mesh structure formed by wrapping medical absorbable synthetic monofilaments with medical non-absorbable synthetic monofilaments, wherein the four bar variable warp plain satin weave structures are formed by enabling four bar bars to be threaded one by one and empty, enabling the first two bars of the medical absorbable synthetic monofilaments to be lined with symmetrically variable warp plain satin lapping yarns, and enabling the second two bars of the medical absorbable synthetic monofilaments to be lined with correspondingly variable weft lapping yarns; the variable warp flat satin refers to a weave formed by alternately cycling and lapping the warp flat and the chain warp satin, and each weave cycle has 10 courses.
Preferably, the 10 courses of the first two combs are formed by alternating 6 warp flat weave courses and 4 pillar weave courses.
As a preferred technical scheme, the transverse mesh density of the hernia repair patch is as follows: 5-12/inch, longitudinal mesh density: 5-10 pieces/inch.
As a preferable technical solution, the medical non-absorbable synthetic monofilament includes polypropylene monofilament, polyester monofilament, etc., and the medical absorbable synthetic monofilament includes polyglycolide monofilament, glycolide-caprolactone copolymer monofilament, polyhydroxyalkanoate monofilament, etc.
As an optimized technical scheme, the diameter range of the medical non-absorbable synthetic monofilament and the medical absorbable synthetic monofilament is 0.08-0.15 mm, the breaking strength is 3.2-7.5 g/d, and the breaking elongation is 10% -50%.
According to the preferable technical scheme, the thickness of the hernia repair patch is 0.7-0.8 mm.
As a preferable technical scheme, the hernia repair patch is processed into a flat sheet form with a rectangular shape, an oval shape and an irregular shape, or a three-dimensional structure designed according to a specific formula.
The basic physical indexes of the partially absorbable hernia repair patch are as follows:
pore diameter: 3.5mm-5mm, gram weight: 50-75g/m2。
Thickness: 0.7-0.8 mm
Transverse mesh density: 5-12/inch, longitudinal mesh density: 5-10 pieces/inch.
The mechanical properties of the partially absorbable hernia repair patch are as follows:
transverse breaking strength: 150-210N; elongation at break in the transverse direction: 50% -75%;
longitudinal breaking strength: 300-460N; elongation at break in the machine direction: 15% -30%;
burst strength: 220 to 260 Kpa;
stitching strength: 20-40N;
the production process of the partially absorbable hernia repair patch comprises the following steps: monofilament, warping, weaving, shaping and post-treatment.
In addition, the invention also provides a preparation method of the partially absorbable hernia repair patch, which comprises the following steps:
four guide bars are arranged on a warp knitting machine, medical synthetic monofilaments (medical non-absorbable synthetic monofilaments and medical absorbable synthetic monofilaments) are unwound from a warp beam and enter a looping system according to a certain warp let-off amount, the four guide bars are threaded and empty, the front two bars carry out symmetrical variable warp plain satin yarn laying motion, the rear two bars carry out correspondingly variable weft insertion yarn laying motion, and a hexagonal mesh braided fabric is formed.
A shaping process: the sizing is to heat the chemical fiber fabric to a required temperature under a certain tension by utilizing the thermoplasticity of the chemical fiber, heat the fabric for a period of time at the temperature, and then rapidly cool the fabric to keep the size and the shape of the fabric stable. Setting temperature: above the glass transition temperature of the selected material, below its crystal melting temperature; setting time: 10-25 min.
Compared with the prior art, the invention has the beneficial effects that:
(1) the invention adopts a four-comb-changing warp-flat satin tissue structure, can completely meet the requirement of sufficient mechanical strength required by physiology, has good operation performance, is convenient for a doctor to place a patch on an affected part, and becomes a hexagonal mesh light-weight patch with firm form and stable meshes after being implanted with a human degradable material and completely absorbed, is beneficial to the rapid growth of fibroblasts, and greatly reduces the probability of the occurrence of complications such as foreign body sensation, effusion and the like of a patient.
(2) The four-comb variable warp plain satin weave structure has wide raw material variety, and the patch prepared from different raw materials can meet the requirements of different operation types.
(3) The mesh braided fabric provided by the invention adopts a four-comb variable warp plain weave, can be processed into a rectangular, round, oval or other irregular-shaped plain sheet form, can also be prepared into a stereo patch, and has a good application prospect.
(4) The preparation process is relatively simple and is convenient for industrial production in clean workshops.
The applicant filed 2 patents in 2014, CN 201410341099-a light hernia repair patch and a weaving method thereof, and CN 201410341431-a large-hole light hernia repair patch and a weaving method thereof, compared with the two patents, the invention mainly has the following differences and advantages in terms of product composition:
(1) the material composition is of different kinds: the patch product of the former two patents has only one material component, and the material components of the patch product of the present patent have two types, one is an absorbable material, and the other is a non-absorbable material;
(2) the weave structure is different: the two patent products are in a two-comb structure, the patent product is in a four-comb structure, and the yarn laying track of each comb in the four-comb structure is different from that of the previous comb, so that a hexagonal mesh composite woven mesh with a stable structure is formed;
(3) the product performance has the advantages that: compared with the prior two patent products, the composite knitted mesh has higher weight and thickness, thereby having better rigidity, being convenient for placing outside the abdominal cavity when a doctor performs an operation, and bringing greater convenience especially during an endoscopic operation. Because the absorbable material is contained, the absorbable material can be gradually degraded and absorbed by the human body along with the prolonging of the time of being implanted into the body, and finally only the non-absorbable net piece with stable shape is remained in the body, so that the amount of the non-absorbable material remained in the body is less than that of the previous two light products while the sufficient mechanical strength is maintained, the foreign body sensation of a patient can be relieved, and the comfort level is improved.
Drawings
Fig. 1 is a movement diagram of two front combs of the partially absorbable hernia repair patch of the present invention with symmetrically changed warp plain inlay yarn sports inlay yarns, wherein each group of 10 courses of the circulating inlay yarns is composed of 6 warp plain weave courses and 4 chaining weave courses which are alternately changed.
Fig. 2 is a motion diagram of the back two combs of the partially absorbable hernia repair patch of the present invention with varying weft insertion with 10 courses of weft insertion for each loop weave, and the trajectory of the weft insertion is shown in fig. 2.
Fig. 3 is a schematic structural view of a partially absorbable hernia repair patch in accordance with the present invention.
Detailed Description
The present invention will be described in further detail with reference to the accompanying drawings and examples.
The structure of the partially absorbable hernia repair patch is a variable satin mesh structure formed by weaving medical non-absorbable synthetic monofilaments and medical absorbable synthetic monofilaments in a composite manner; the hernia repair patch is a mesh braided fabric which is of a four-comb variable warp plain satin weave structure, and meshes on the surface of the hernia repair patch are hexagonal meshes (see fig. 3); the aperture of the hernia repair patch is 3.5mm-5mm, and the gram weight before degradation is 50-75g/m2The gram weight of the absorbable material after complete degradation is 16-30g/m2 。
1. The invention adopts four-bar changing warp flat satin weave, namely four bar weaves are all one through and one hollow, the front two bars do symmetrical changing warp flat satin yarn laying motion, the rear two bars do corresponding changing weft insertion yarn laying motion, and figures 1 and 2 are four-bar yarn laying motion diagrams shown in the invention. The variable warp flat satin refers to a weave formed by alternately cycling and lapping the warp flat and the chain warp satin, and each weave cycle has 10 courses. The 10 courses of the first two combs shown in FIG. 1 are formed by alternating 6 warp flat weave courses and 4 pillar weave courses.
2. The yarns used by the front two combs of lapping yarns shown in figure 1 are non-absorbable monofilaments, and the yarns used by the back two combs of lapping yarns shown in figure 2 are absorbable monofilaments. The medical non-absorbable synthetic monofilament comprises polypropylene monofilaments and polyester monofilaments, and the medical absorbable synthetic monofilament comprises polyglycolide-lactide monofilaments, glycolide-caprolactone copolymer monofilaments and polyhydroxyalkanoate monofilaments.
The transverse mesh density of the hernia repair patch is as follows: 5-12/inch, longitudinal mesh density: 5-10 pieces/inch.
The diameter ranges of the medical non-absorbable synthetic monofilament and the medical absorbable synthetic monofilament are as follows: 0.08-0.15 mm, the breaking strength is 3.2-7.5 g/d, and the elongation at break is 10% -50%.
The thickness of the hernia repair patch is 0.7-0.8 mm.
The hernia repair patch can be processed into a flat sheet form in a rectangular shape, a circular shape, an oval shape or other irregular shapes, or a three-dimensional structure designed according to a specific formula.
The invention will be further illustrated with reference to the following specific examples. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. Further, it should be understood that various changes or modifications of the present invention may be made by those skilled in the art after reading the teaching of the present invention, and such equivalents may fall within the scope of the present invention as defined in the appended claims.
Example 1
As shown in fig. 1 and 2, embodiments of the present invention relate to a novel partially absorbable hernia repair patch and a method for preparing the same.
The production process of the partially absorbable hernia repair patch comprises the following steps: monofilament, warping, weaving, shaping and post-treatment.
1. Selection of raw materials of partially absorbable hernia repair patch
In this example, medical polypropylene monofilament is selected as a raw material, and the properties thereof are shown in table 1.
TABLE 1 Material selection and Properties
Figure 865521DEST_PATH_IMAGE001
2. Warping process of medical synthetic monofilament for partially absorbable hernia repair patch
Warping refers to uniformly winding monofilaments on a warp beam with a certain tension according to the number and length of monofilaments required by a weaving process, and using the monofilaments by a warp knitting machine. Warping is classified into beam warping, sectional warping and sectional warping. In this embodiment, sectional warping is adopted, i.e. the required whole monofilament raw material is divided into several sectional beams wound into narrow widths, and then the sectional beams are assembled into beams on a warp knitting machine.
3. Weaving technological parameters of partially absorbable hernia repair patch
The part of the absorbable hernia repair patch is woven by a warp knitting process in the textile technology, the weave structure is a variable satin weave, the motion trail of the adopted weave lapping yarn in the embodiment is shown in figures 1 and 2, and the specific machine processing process is shown in table 2.
TABLE 2 Process parameters on machine
Figure 907295DEST_PATH_IMAGE002
4. Heat setting technological parameter of partially absorbable hernia repair patch
Heat setting is to heat a chemical fiber fabric to a desired temperature under a certain tension by using the thermoplasticity of the chemical fiber, heat the fabric for a period of time at the temperature, and then rapidly cool the fabric to keep the size and shape of the fabric stable. The heating temperature is generally the glass transition temperature TgAbove and below the crystal melting temperature Tm. The process parameters for the patch heat-setting in this example are shown in table 3.
TABLE 3 Heat-setting Process parameters and basic Properties after setting
Figure 749349DEST_PATH_IMAGE003
5. Post-treatment
After the shaping is finished, the hernia patch product is cut into a flat sheet or a three-dimensional structure according to the specific application of the hernia patch product, and then the hernia patch product is cleaned, dried, packaged and sterilized to obtain the final hernia patch product.
6. The mechanical property of the partially absorbable hernia repair patch of the invention
1) According to the method specified in GB/T39233.2, the transverse breaking strength of the absorbable hernia repair patch is 156N, and the transverse breaking elongation is 58%; the longitudinal breaking strength is 361N, and the longitudinal breaking elongation is 21%;
2) according to the method specified in GB/T7742.1-2005, the bursting strength of the absorbable hernia repair patch is 238 Kpa;
3) suture strength test method: the size of the sample is 50mm multiplied by 50mm, and 5 pieces of the sample are longitudinally arranged; the method comprises the steps of selecting a high-strength suture line to penetrate through a position 6mm away from the edge of a sample, clamping the suture line on an upper clamping head, vertically clamping the bottom of the sample on a lower clamping head, clamping the distance of the clamping distance to be 100mm, stretching at the speed of 100mm/min, testing the suture strength of the sample and averaging. The patch was measured to have a transverse seam strength of 36N and a longitudinal seam strength of 32N.
7. The invention is compared with the performance of the market products
The comparative data of the partially absorbable hernia repair patch of the present embodiment and the commercially available strongly super-ordinary partially absorbable products are shown in the following table.
Table 4 comparison of the performance of the partially absorbable hernia repair patch of this embodiment with that of the partially absorbable hernia repair patch on the market
Figure 269192DEST_PATH_IMAGE004
It can be seen from the comparison of data in table 4 that the hernia repair patch is partially absorbable in this embodiment, and the hexagonal mesh structure with a stable form, the weight and thickness of the product before degradation are both higher than the Qiangsheng superpure, which indicates that the rigidity of this product is better than the Qiangsheng superpure, which is more convenient for the doctor to operate and place, and the aperture of the product after degradation is larger, and the weight is lighter, which indicates that the hernia repair patch is partially absorbable in this embodiment, and compared with the hernia repair patch partially absorbable in the market, the hernia repair patch has advantages in the aspects of doctor's convenience in operation, patient's comfort enhancement, and the like.
Example 2
1. Selection of raw materials of partially absorbable hernia repair patch
In this example, medical polypropylene monofilament is selected as a raw material, and the properties thereof are shown in table 5.
TABLE 5 Material selection and Properties
Figure 411460DEST_PATH_IMAGE005
2. Warping process of medical synthetic monofilament for partially absorbable hernia repair patch
In this embodiment, sectional warping is adopted, i.e. the required whole monofilament raw material is divided into several sectional beams wound into narrow widths, and then the sectional beams are assembled into beams on a warp knitting machine.
3. Weaving technological parameters of partially absorbable hernia repair patch
The part of the absorbable hernia repair patch is woven by a warp knitting process in the textile technology, the weave structure is a variable satin weave, the motion trail of the adopted weave lapping yarn in the embodiment is shown in figures 1 and 2, and the specific machine processing process is shown in table 6.
TABLE 6 Process parameters of operating machine
Figure 84188DEST_PATH_IMAGE006
4. Heat setting technological parameter of partially absorbable hernia repair patch
The process parameters for the patch heat-setting in this example are shown in table 7.
TABLE 7 Heat-setting Process parameters and basic Properties after setting
Figure 679118DEST_PATH_IMAGE007
5. Post-treatment
After the shaping is finished, the hernia patch product is cut into a flat sheet or a three-dimensional structure according to the specific application of the hernia patch product, and then the hernia patch product is cleaned, dried, packaged and sterilized to obtain the final hernia patch product.
6. The mechanical property of the partially absorbable hernia repair patch of the invention
1) According to the method specified in GB/T39233.2, the transverse breaking strength of the absorbable hernia repair patch is 152N, and the transverse breaking elongation is 75%; the longitudinal breaking strength is 300N, and the longitudinal breaking elongation is 28%;
2) according to the method specified in GB/T7742.1-2005, the bursting strength of the absorbable hernia repair patch is 220 Kpa;
3) suture strength test method: the size of the sample is 50mm multiplied by 50mm, and 5 pieces of the sample are longitudinally arranged; the method comprises the steps of selecting a high-strength suture line to penetrate through a position 6mm away from the edge of a sample, clamping the suture line on an upper clamping head, vertically clamping the bottom of the sample on a lower clamping head, clamping the distance of the clamping distance to be 100mm, stretching at the speed of 100mm/min, testing the suture strength of the sample and averaging. The patch was measured to have a transverse seam strength of 23N and a longitudinal seam strength of 20N.
Example 3
1. Selection of raw materials of partially absorbable hernia repair patch
In this example, medical polypropylene monofilaments are selected as raw materials, and the properties thereof are shown in table 8.
TABLE 8 Material selection and Properties
Figure 2652DEST_PATH_IMAGE008
2. Warping process of medical synthetic monofilament for partially absorbable hernia repair patch
In this embodiment, sectional warping is adopted, i.e. the required whole monofilament raw material is divided into several sectional beams wound into narrow widths, and then the sectional beams are assembled into beams on a warp knitting machine.
3. Weaving technological parameters of partially absorbable hernia repair patch
The part of the absorbable hernia repair patch is woven by a warp knitting process in the textile technology, the weave structure is a variable satin weave, the motion trail of the adopted weave lapping yarn in the embodiment is shown in figures 1 and 2, and the specific machine processing process is shown in table 9.
TABLE 9 Process parameters on machine
Figure 733847DEST_PATH_IMAGE009
4. Heat setting technological parameter of partially absorbable hernia repair patch
The process parameters for the patch heat-setting in this example are shown in table 10.
TABLE 10 Heat-setting Process parameters and basic Properties after setting
Figure 851845DEST_PATH_IMAGE010
5. Post-treatment
After the shaping is finished, the hernia patch product is cut into a flat sheet or a three-dimensional structure according to the specific application of the hernia patch product, and then the hernia patch product is cleaned, dried, packaged and sterilized to obtain the final hernia patch product.
6. The mechanical property of the partially absorbable hernia repair patch of the invention
1) According to the method specified in GB/T39233.2, the transverse breaking strength of the absorbable hernia repair patch is 210N, and the transverse breaking elongation is 50%; the longitudinal breaking strength is 457N, and the longitudinal breaking elongation is 15%;
2) according to the method specified in GB/T7742.1-2005, the bursting strength of the absorbable hernia repair patch is measured to be 260 Kpa;
3) suture strength test method: the size of the sample is 50mm multiplied by 50mm, and 5 pieces of the sample are longitudinally arranged; the method comprises the steps of selecting a high-strength suture line to penetrate through a position 6mm away from the edge of a sample, clamping the suture line on an upper clamping head, vertically clamping the bottom of the sample on a lower clamping head, clamping the distance of the clamping distance to be 100mm, stretching at the speed of 100mm/min, testing the suture strength of the sample and averaging. The patch was measured to have a transverse seam strength of 40N and a longitudinal seam strength of 34N.

Claims (10)

1. The partially absorbable hernia repair patch is characterized in that: the hernia repair patch is in a four-comb-shaped variable warp plain satin tissue structure formed by compositely weaving medical non-absorbable synthetic monofilaments and medical absorbable synthetic monofilaments; the hernia repair patch is a mesh braided fabric, and meshes on the surface of the hernia repair patch are hexagonal meshes; the aperture of the hernia repair patch is 3.5mm-5mm, and the gram weight before degradation is 50-75g/m2The gram weight of the absorbable material after complete degradation is 16-30g/m2 。
2. The partially absorbable hernia repair patch according to claim 1, wherein: the four-bar variable warp flat satin weave structure is a mesh structure formed by wrapping medical absorbable synthetic monofilaments with the medical absorbable synthetic monofilaments, wherein the four bar variable warp flat satin weave structure is formed by enabling four bar bars to be threaded through one hole and empty, enabling the first two bars lined with the medical absorbable synthetic monofilaments to be symmetrically variable warp flat satin lapping yarns, and enabling the second two bars lined with the medical absorbable synthetic monofilaments to be correspondingly variable weft lapping yarns; the variable warp flat satin refers to a weave formed by alternately cycling and lapping the warp flat and the chain warp satin, and each weave cycle has 10 courses.
3. The partially absorbable hernia repair patch according to claim 2, wherein: the 10 courses of the first two combs are formed by alternating 6 warp flat weave courses and 4 chaining weave courses.
4. The partially absorbable hernia repair patch according to claim 1, wherein: the transverse mesh density of the hernia repair patch is as follows: 5-12/inch, longitudinal mesh density: 5-10 pieces/inch.
5. The partially absorbable hernia repair patch according to claim 1 or 3, wherein: the medical non-absorbable synthetic monofilament comprises polypropylene monofilaments and polyester monofilaments, and the medical absorbable synthetic monofilament comprises polyglycolide-lactide monofilaments, glycolide-caprolactone copolymer monofilaments and polyhydroxyalkanoate monofilaments.
6. The partially absorbable hernia repair patch according to claim 1 or 3, wherein: the diameter ranges of the medical non-absorbable synthetic monofilament and the medical absorbable synthetic monofilament are as follows: 0.08-0.15 mm, the breaking strength is 3.2-7.5 g/d, and the elongation at break is 10% -50%.
7. The partially absorbable hernia repair patch according to claim 1, wherein: the thickness of the hernia repair patch is 0.7-0.8 mm.
8. The partially absorbable hernia repair patch according to claim 1, wherein: the hernia repair patch is processed into a flat sheet form or a three-dimensional structure designed according to a specific operation formula.
9. The partially absorbable hernia repair patch according to claim 1, wherein: the transverse breaking strength of the hernia repair patch is 150-210N; the transverse elongation at break is 50% -75%; the longitudinal breaking strength is 300-460N; the longitudinal elongation at break is 15% -30%; the bursting strength is 220-260 Kpa; the stitching strength is 20-40N.
10. The method of preparing a partially absorbable hernia repair patch according to any one of claims 1-9, wherein: the method comprises the following steps: on a warp knitting machine, four guide bars are used for guiding yarns, medical non-absorbable synthetic monofilaments and medical absorbable synthetic monofilaments are unwound from a warp beam and enter a looping system according to a certain warp let-off amount, the four guide bars are all threaded and empty, the front two bars carry out symmetrical variable warp flat satin lapping yarn movement, the rear two bars carry out correspondingly variable weft lapping yarn movement, and part of the absorbable mesh braided fabric is braided according to lapping yarn numbers.
CN202010094131.6A 2020-02-15 2020-02-15 Partially absorbable hernia repair patch and preparation method thereof Pending CN113262075A (en)

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CN202010094131.6A CN113262075A (en) 2020-02-15 2020-02-15 Partially absorbable hernia repair patch and preparation method thereof

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Application Number Priority Date Filing Date Title
CN202010094131.6A CN113262075A (en) 2020-02-15 2020-02-15 Partially absorbable hernia repair patch and preparation method thereof

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CN113262075A true CN113262075A (en) 2021-08-17

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