CN213190318U - Absorbable tissue repair mesh - Google Patents
Absorbable tissue repair mesh Download PDFInfo
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- CN213190318U CN213190318U CN202020330411.8U CN202020330411U CN213190318U CN 213190318 U CN213190318 U CN 213190318U CN 202020330411 U CN202020330411 U CN 202020330411U CN 213190318 U CN213190318 U CN 213190318U
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Abstract
The utility model discloses a net piece is repaired to absorbable tissue, it includes: more than one upper surface layer, more than one middle layer and more than one lower surface layer; the upper surface layer and the lower surface layer are respectively made of a fabric unit A, the middle layer is made of a fabric unit B, and the fabric unit A and the fabric unit B are woven by monofilament yarns or multifilament yarns of absorbable materials; the average pore diameter of the fabric unit A is larger than that of the fabric unit B, wherein the average pore diameter of the fabric unit A is 20-500 mu m, and the average pore diameter of the fabric unit B is 5-20 mu m; therefore, the wound surface of the fragile tissue after operation can be strengthened to bear the pulling pressure of suturing or inosculating, the blood and the liquid at the suturing position or the needle eye position or the nail eye position of the wound surface are prevented from seeping, and the healing of the local wound surface is promoted.
Description
Technical Field
The utility model relates to an implant class medical instrument technical field, concretely relates to but a absorbability tissue repair net piece that is used for postoperative fragile tissue organ surface of a wound to strengthen repairing, reduces the body fluid seepage and promotes tissue healing.
Background
Irreversible lesions or accidental injuries of parenchymal organ tissues in the abdominal cavity of a human body (such as lung, liver, gastrointestinal tract, spleen, pancreas, gall bladder, kidney and the like) are often treated by surgical operations. Patients with emphysema, for example, often have to have surgical removal of the bulla; such as peritonitis patients, often by surgical removal of the inflamed diseased gastrointestinal site; in other general surgery operations, lesions of liver, spleen, kidney and other organs are often removed.
Because the visceral organs have thin membranes and fragile tissues and sometimes have inflammation, the strengthening and anti-leakage treatment of the wound surfaces or the stump parts of the tissues are troublesome due to the anatomical physiological and pathological characteristics. If the wound surface of the fragile tissue is directly sutured or anastomosed, the pressure applied to the small surface area of the tissue during suturing or anastomosing is large due to the small surface stress area of the suture or the anastomotic nail. The suture or staple may cut into the damaged tissue, causing further damage to the delicate tissue. Meanwhile, the risks of blood seepage, liquid seepage, infection and the like still exist at the suture position, the needle eye position or the nail eye position of the wound surface, the medical cost is increased, and the recovery of patients is influenced.
SUMMERY OF THE UTILITY MODEL
The utility model provides a solve above-mentioned problem, provide a absorbable tissue repair net piece, can strengthen the fragile tissue surface of a wound of postoperative and endure to sew up or anastomotic pulling pressure, prevent the department of sewing up or needle eye department or nail eye department infiltration blood, the infiltration liquid of surface of a wound, promote local surface of a wound healing.
In order to achieve the above object, the utility model adopts the following technical scheme:
an absorbable tissue repair mesh, comprising: more than one upper surface layer, more than one middle layer and more than one lower surface layer; the upper surface layer and the lower surface layer are respectively made of fabric units A, the middle layer is made of fabric units B, and the fabric units A and the fabric units B are respectively woven by monofilament yarns or multifilament yarns of absorbable materials; and the average pore diameter of the fabric unit A is larger than that of the fabric unit B, wherein the average pore diameter of the fabric unit A is 20-500 mu m, and the average pore diameter of the fabric unit B is 5-20 mu m.
Preferably, the average pore diameter of the fabric unit A is 50-200 μm, and the average pore diameter of the fabric unit B is 15-20 μm.
Preferably, the upper surface layer and the lower surface layer are respectively one layer, and the middle layer is 1-10 layers, preferably 1-5 layers; the thickness of each layer of fabric unit A and each layer of fabric unit B is 0.05-0.15 mm, and preferably 0.1 mm.
Preferably, the absorbable material adopts: more than one synthetic polymer material, and/or more than one polysaccharide polymer material, and/or more than one protein natural polymer material; wherein the synthetic polymer material comprises: polyglycolic acid, polylactide-glycolide copolymer, polycaprolactone, poly (p-dioxanone), glycolide-epsilon-caprolactone copolymer and lactide-epsilon-caprolactone copolymer; the polysaccharide polymer material comprises: chitosan and derivatives thereof, pectic acid and derivatives thereof; the protein natural high molecular material comprises: gelatin, collagen, fibrin, and blends or copolymers of two or more thereof.
Preferably, the absorbable material adopts polyglycolic acid, and the weight-average molecular weight of the polyglycolic acid is 30000-1000000; preferably, the weight average molecular weight of the polyglycolic acid is 30000-400000.
Preferably, the monofilament diameter of the multifilament yarn is 5-50 μm, preferably 15-20 μm; the average breaking strength is 3 to 6.0 cN/dtex.
Preferably, the two adjacent fabric units are connected by needling or welded by ultrasonic waves, and the weaving method of the fabric units adopts weft knitting or warp knitting, preferably weft knitting.
Preferably, the mesh has an apparent density of 5g/m2～300g/m2Preferably, the apparent density is 25g/m2～200g/m2。
The utility model has the advantages that:
(1) the tissue repair mesh sheet of the utility model consists of an upper surface layer, a lower surface layer and a middle layer which are all multilayer sheet structures woven by absorbable materials, can strengthen the tension force of the postoperative fragile tissue wound surface to resist sewing or inosculation, and prevent the blood and the seepage at the sewing position or the needle eye position or the nail eye position of the wound surface; moreover, the absorbable tissue repair mesh can maintain a good mechanical supporting effect for a period of time in the early stage of implantation, the strength of the repair mesh is gradually reduced along with the healing of the tissue, the repair mesh gradually absorbs water and degrades to be absorbed by metabolism of a human body, and the healing of a local wound surface is promoted;
(2) existing tissue repair methods, in order to increase strength, typically employ a combination of non-absorbable and absorbable materials, the non-absorbable materials serving to provide support; each layer of the utility model is made of absorbable material, and the average aperture of the fabric unit of the upper and lower surface layers is larger than that of the fabric unit of the middle layer, so that the middle layer not only can provide support and improve strength, but also can prevent body fluid leakage, thereby promoting cells to accelerate tissue recovery;
(3) the average pore diameter of the fabric unit A is 20-500 mu m, the average pore diameter of the fabric unit B is 5-20 mu m, and the design of the pore size can prevent free cells in body fluid, blood and the like from passing through, is favorable for conveying nutrition and oxygen, and is favorable for the growth, proliferation and differentiation of cells to form tissues;
(4) the upper surface layer and the lower surface layer are respectively one layer, and the middle layer is 1-10 layers, preferably 1-5 layers; the thickness of each layer of fabric unit A and each layer of fabric unit B is 0.05-0.15 mm, and the thickness is just the penetration thickness of cells, so that the aims of preventing body fluid leakage, promoting cell proliferation and tissue regeneration can be better fulfilled;
(5) the absorbable material of the present invention is preferably polyglycolic acid, which has good biocompatibility, is suitable for cell adhesion and propagation, and has been approved by the U.S. federal health and food administration (FDA); on the other hand, polyglycolic acid is completely degraded in vivo, and its degradation product is CO2And H2O, finally discharged out of the body by urine and respiration; on the other hand, the complete absorption time of the polyglycolic acid is 60-90 days, and the molecular weight, the molecular weight distribution and the crystallinity can be conveniently regulated and controlled, so that the degradation rate and the strength retention rate of the product are matched with the repair time of the implanted part;
(6) the weight average molecular weight of the polyglycolic acid of the utility model is preferably 30000-400000, and the strength of the prepared absorbable tissue repair mesh is insufficient because the weight average molecular weight is lower than 30000, so that the good tissue strengthening effect can not be achieved; when the weight average molecular weight exceeds 400000, the degradation rate in vivo becomes slow, and a foreign substance reaction may occur;
(7) the tissue repairing mesh sheet of the utility model adopts needling connection or ultrasonic welding, and the permeability and porosity of the fabric are not affected;
(8) the apparent density of the net sheet is 5g/m2～300g/m2Thereby ensuring the strength of the mesh and the adhesion between the mesh and the tissue.
Drawings
The accompanying drawings, which are described herein, serve to provide a further understanding of the invention and constitute a part of this specification, and the exemplary embodiments and descriptions thereof are provided for explaining the invention without unduly limiting it. In the drawings:
FIG. 1 is a schematic view of the absorbable tissue repair mesh of the present invention;
FIG. 2 is a schematic structural view of fabric units A and B of the present invention;
fig. 3 is an SEM image of a fabric unit a of the present invention;
fig. 4 is an SEM image of a fiber prepared using example 1 of the present invention;
FIG. 5 is a water drop angle measurement of an absorbable tissue repair mesh prepared in example 1 of the present invention;
fig. 6 is a water drop angle measurement of the absorbable tissue repair mesh prepared in example 2 of the present invention.
Detailed Description
In order to make the technical problem, technical solution and advantageous effects to be solved by the present invention clearer and more obvious, the following description is made in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the invention.
The structure of the absorbable tissue repair mesh comprises the following components:
as shown in fig. 1 to 4, the absorbable tissue repair mesh of the present invention comprises: more than one upper surface layer 1, more than one middle layer 2 and more than one lower surface layer 3; the upper surface layer 1 and the lower surface layer 2 are respectively made of a fabric unit A, the middle layer 2 is made of a fabric unit B, and the fabric unit A and the fabric unit B are woven by monofilament yarns or multifilament yarns of absorbable materials; and the average pore size of the fabric unit a is larger than the average pore size of the fabric unit B.
Important factors affecting cell and tissue regeneration are, in addition to the material, the porosity and average pore size of the patch mesh. In the embodiment, the average pore diameter of the fabric unit A is 20-500 μm, preferably 50-200 μm; the average pore diameter of the fabric unit B is 5-20 μm, preferably 15-20 μm. Thereby forming: the upper and lower surface layers are of multi-layer sheet fabric structure with large aperture and the middle layer is of small aperture, so as to achieve the purposes of preventing body fluid leakage and promoting cell proliferation and tissue regeneration.
The tissue repairing mesh is of a multi-layer sheet structure, preferably, the upper surface layer 1 and the lower surface layer 3 are respectively one layer, and the middle layer 2 is 1-10 layers, preferably 1-5 layers; alternatively, the upper surface layer 1 and the lower surface layer 3 may be two or more layers, respectively. The thickness of each layer of fabric unit A and each layer of fabric unit B is 0.05-0.15 mm, and preferably 0.1 mm. This thickness matches the osmotic thickness of the cells; the thickness of the fabric unit is measured by a YG141 type digital fabric thickness meter.
The conventional absorbable materials are mainly as follows:
(1) animal-derived materials:
the animal-derived material is prepared by treating an animal tissue matrix through deimmunization, antigenicity reduction and the like, and has the hidden dangers of potential immunogenicity or virus infection and the like, so the animal-derived material has certain limitations in clinical application.
(2) Artificially synthesized absorbable polymer material:
the repairing sheet made of synthetic absorbable polymer material is represented by Neoveil and Vicryl net (Polyglactin 910).
Neoviel is an absorbable soft non-woven product made of polyglycolic acid with a 202 # green colorant. The addition of colorants complicates the ingredients; the attachment of the non-woven fabric structure which is arranged disorderly and the tissue wound surface needs to be improved; the product is expensive; the biological protein glue can play a good role in preventing leakage only by being matched with the biological protein glue, and the application and popularization of the product are limited.
The Vicryl net is woven by using a glycolic acid and L-lactic acid copolymer with a molar ratio of 90/10, and the surface of the Vicryl net is covered with a 2-10% coating layer of a mixture of amorphous polylactic acid 370 and calcium stearate. The Vicryl mesh is not flexible due to the coating; the price is high; the degradation period is longer, the complete absorption time is more than 15 weeks, and the time is not matched with the repair time of the fragile tissue part.
The utility model discloses in, the absorbable material adopts: more than one synthetic polymer material, and/or more than one polysaccharide polymer material, and/or more than one protein natural polymer material; that is, the absorbable material of the present invention may be any one or a combination of two or more of synthetic polymer materials, polysaccharide polymer materials, and protein natural polymer materials; the synthetic polymer material may further contain one or more kinds, the polysaccharide polymer material may further contain one or more kinds, and the protein-based natural polymer material may further contain one or more kinds. Wherein the synthetic polymer material comprises: polyglycolic acid, polylactide-glycolide copolymer, polycaprolactone, poly (p-dioxanone), glycolide-epsilon-caprolactone copolymer and lactide-epsilon-caprolactone copolymer; the polysaccharide polymer material comprises: chitosan and derivatives thereof, pectic acid and derivatives thereof; the protein natural high molecular material comprises: gelatin, collagen, fibrin, and blends or copolymers of two or more thereof.
In a preferred embodiment, the absorbable material adopts polyglycolic acid, and the weight average molecular weight of the polyglycolic acid is 30000-1000000; preferably, the weight average molecular weight of the polyglycolic acid is 30000-400000.
In this embodiment, the absorbable material is preferably woven by multifilament yarn, so that the absorbable material has better flexibility; the monofilament diameter of the multifilament yarn is 5-50 μm, preferably 15-20 μm; the average breaking strength is 3 to 6.0 cN/dtex. The mesh sheet has an apparent density (gram weight) of 5g/m2～300g/m2Preferably, the apparent density is 25g/m2～200g/m2. Wherein the diameter of the fiber monofilament is measured by an electron scanning microscope; the average breaking strength is measured by an XQ-1A fiber strength and elongation instrument.
In this embodiment, the two adjacent fabric units are connected by needling, ultrasonic welding, or heat sealing or gluing.
In the embodiment, the fabric unit a and the fabric unit B are both knitted fabrics, and the knitting method of the fabric unit adopts weft knitting or warp knitting, preferably weft knitting, so that the fabric can show good extensibility. The structural schematic diagram of the fabric units a and B is shown in fig. 2. The scanning electron microscope of the fabric unit a is shown in fig. 3.
Secondly, a preparation method of the absorbable tissue repair mesh sheet comprises the following steps:
the preparation method comprises the following steps:
s1, preparing materials: slicing the absorbable material, and carrying out pre-crystallization treatment and vacuum drying treatment;
s2, spinning of as-spun yarns: carrying out melt spinning on the dried absorbable material to obtain nascent yarn;
s3, preparing fiber yarns: stretching and heat-setting the nascent yarn to obtain fiber yarn of an absorbable material;
s4, preparing a fabric unit A and a fabric unit B: adjusting weaving parameters, and weaving the fiber yarns into the fabric unit A and the fabric unit B;
s5, preparing the absorbable tissue repairing mesh: and superposing more than one layer of fabric units B according to a preset thickness to form a middle layer, superposing an upper surface layer on the upper surface of the middle layer, superposing a lower surface layer on the lower surface of the middle layer, and connecting the layers to form the absorbable tissue repairing mesh sheet with a multilayer sheet structure.
In this embodiment, the preparation method specifically includes the following steps:
s1, preparing materials: pre-crystallizing the absorbable material slices in a vacuum drying oven at 50-70 ℃ for 2-4 h, and then drying in vacuum to enable the water content of the slices to be lower than 100 ppm; in this embodiment, polyglycolic acid (PGA resin) is used as the absorbable material;
s2, spinning of as-spun yarns: putting the dried absorbable material into a bin of a spinning machine, carrying out melt spinning on the absorbable material through a spinning plate by the spinning machine, and winding a bobbin to obtain nascent yarn of the absorbable material;
s3, preparing fiber yarns: stretching and heat-setting the nascent yarn on the bobbin to obtain fiber yarn of the absorbable material;
s4, preparing a fabric unit A and a fabric unit B: adjusting weaving parameters, and weaving the fiber yarns into the fabric unit A and the fabric unit B by a weft knitting method;
s5, preparing the absorbable tissue repairing mesh: and superposing more than one layer of fabric units B according to a preset thickness to form a middle layer, superposing an upper surface layer on the upper surface of the middle layer, superposing a lower surface layer on the lower surface of the middle layer, and then preparing the absorbable tissue repairing mesh sheet with a multilayer sheet structure by needling connection or ultrasonic welding.
Finally, the absorbable tissue repairing mesh prepared in the step S5 can be cut into proper sizes according to clinical requirements, and the absorbable tissue repairing mesh is filled into a super-strong paper bag and then is filled into an aluminum foil bag after a specific disinfection mode to obtain a final product. The specific disinfection mode can be ethylene oxide disinfection, gamma ray disinfection, ultraviolet disinfection or other disinfection modes, and ethylene oxide disinfection is preferred.
In step S1, the temperature of vacuum drying is 100 ℃ and the time is 12 hours; in step S2, the diameter and number of the spinneret are used to define the diameter and number of the multifilament fibers, the diameter of the spinneret is 0.3mm, and the number of the spinneret is 16; in the step S2, in the melt spinning condition, the temperature of a spinning area is 230-240 ℃, and the spinning speed is 200-250 m/min; in the step S3, the value range of the heat setting temperature in the stretching heat setting condition is 100 to 130 ℃, preferably 110 to 120 ℃; the value range of the heat setting time is 1-3 h, preferably 1.5 h; the stretching ratio ranges from 2.0 times to 10.0 times, preferably from 5 times to 6 times.
In step S5, the ultrasonic welding is preferably spot welding, where the two fabric surfaces are rubbed with each other to increase the temperature at the spot welding point to form fusion between the molecular layers, and after the ultrasonic stops acting, the pressure is allowed to continue for a preset time (for example, several seconds) to solidify and form the welding point, so that the multiple layers of fabrics are joined together.
Ultrasonic waves, when applied to the absorbable material, produce high frequency vibrations of several tens of thousands of times per second, which reach a certain amplitude, transmitting ultrasonic energy to the weld zone through the upper weldment, and thus producing a local high temperature due to the large acoustic resistance at the interface of the two welds. And because the absorbable material has poor heat conductivity, heat is concentrated on the welding area, so that the two contact surfaces are rapidly melted. Under the action of pressure, the contact surfaces are fused into a whole, so that the purpose of welding is achieved.
The following will describe the preparation process of the patch sheet in detail by taking polyglycolic acid (PGA resin) as an example of the absorbable material, and taking several specific examples as follows:
the first embodiment is as follows:
(1) PGA fiber yarn preparation
Pre-crystallizing PGA resin slices with weight average molecular weight of 400000 in a vacuum drying oven at 60 deg.C for 3h, and vacuum drying at 100 deg.C for 12h to make water content of the slices lower than 100 ppm; the dried PGA resin was rapidly charged into a hopper of a spinning machine and melt-spun. The temperature of the spinning area is 230-240 ℃, and the spinning speed is 250 m/min; the aperture of the spinning plate is 0.3mm, the number of holes is 16, and the spinning plate is wound by a bobbin to obtain nascent yarn; and (3) carrying out drawing and heat setting on the as-spun yarns on the bobbin, wherein the drawing and heat setting temperature is 115 ℃, the drawing and heat setting time is 1.5h, and the drawing multiple of the drawing and heat setting is 6 times, and each bundle of 16 PGA fiber yarns is obtained after drawing and heat setting. The monofilament fiber in the yarn had a diameter of 15 μm and an average breaking strength of 6.0 cN/dtex. The SEM image of the fiber prepared in this example is shown in FIG. 4, from which it can be measured that the diameter of the monofilament fiber is about 15 μm.
(2) Absorbable tissue repair mesh preparation
Adjusting proper weaving parameters, and weaving the PGA fiber yarns into a fabric unit A with the average pore diameter of 50-200 mu m and the thickness of 0.1mm and a fabric unit B with the average pore diameter of 15-20 mu m and the thickness of 0.1mm by a weft knitting method; 1 layer of fabric unit B is used as a middle layer, surface layers are respectively superposed on the upper surface and the lower surface of the middle layer, and then the absorbable tissue repair mesh sheet with a 3-layer lamellar structure is manufactured by a needling method; cutting the prepared absorbable tissue repairing mesh into 100 x 50mm size according to clinical requirements, filling into a super-fiber strong paper bag, sterilizing by ethylene oxide, and filling into an aluminum foil bag to obtain the product.
The surface properties characteristic of this example were measured by a contact angle measuring SDC-200 meter, and the drop angle was about 105 ° with a leakage effect. The water drop angle measurement of the absorbable tissue repair mesh prepared according to the embodiment of the present invention is shown in fig. 5.
Example two:
(1) PGA fiber yarn preparation
The preparation process of reference example one.
(2) Absorbable tissue repair mesh preparation
Adjusting proper weaving parameters, and weaving the PGA fiber yarns into a fabric unit A with the average pore diameter of 50-200 mu m and the thickness of 0.1mm and a fabric unit B with the average pore diameter of 15-20 mu m and the thickness of 0.1mm by a weft knitting method; superposing 3 layers of the fabric units B as a middle layer, superposing surface layers on the upper surface and the lower surface of the middle layer respectively, and preparing the absorbable tissue repair mesh sheet with a 5-layer lamellar structure by a needling method; cutting the prepared absorbable tissue repairing mesh into 100 x 50mm size according to clinical requirements, filling into a super-fiber strong paper bag, sterilizing by ethylene oxide, and filling into an aluminum foil bag to obtain the product.
The surface properties specific to this example were tested with a contact angle measuring SDC-200 instrument, and the drop angle was about 115 ° with a leakage effect. The water drop angle measurement of the absorbable tissue repair mesh prepared according to the embodiment of the present invention is shown in fig. 6.
Example three:
(1) PGA fiber yarn preparation
Pre-crystallizing PGA resin slices with weight average molecular weight of 400000 in a vacuum drying oven at 60 deg.C for 3h, and vacuum drying at 100 deg.C for 12h to make water content of the slices lower than 100 ppm; the dried PGA resin was rapidly charged into a hopper of a spinning machine and melt-spun. The temperature of the spinning area is 230-240 ℃, and the spinning speed is 250 m/min; the aperture of the spinning plate is 0.3mm, the number of holes is 16, and the spinning plate is wound by a bobbin to obtain nascent yarn; and (3) carrying out drawing and heat setting on the as-spun yarns on the bobbin, wherein the drawing and heat setting temperature is 115 ℃, the drawing and heat setting time is 1.5 hours, and the drawing multiple of the drawing and heat setting is 4.5 times, and each bundle of 16 PGA fiber yarns is obtained after drawing and heat setting. The monofilament fibers in the yarn had a diameter of 18 μm and an average breaking strength of 5.5 cN/dtex.
(2) Absorbable tissue repair mesh preparation
Adjusting proper weaving parameters, and weaving the PGA fiber yarns into a fabric unit A with the average pore diameter of 50-200 mu m and the thickness of 0.1mm and a fabric unit B with the average pore diameter of 15-20 mu m and the thickness of 0.1mm by a weft knitting method; taking 1 layer of fabric unit B as a middle layer, respectively superposing surface layers on the upper surface and the lower surface of the middle layer, and preparing the absorbable tissue repair mesh sheet with a 2-layer lamellar structure by a needling method; cutting the prepared absorbable tissue repairing mesh into 100 x 50mm size according to clinical requirements, filling into a super-fiber strong paper bag, sterilizing by ethylene oxide, and filling into an aluminum foil bag to obtain the product.
The tissue and organ in the abdominal cavity have a remarkable characteristic: the healing period is short (generally about 12 weeks) and long-term reinforcement is not needed. The utility model discloses a repair degradation cycle and the tissue growth cycle phase-match of net piece, consequently, the utility model discloses a absorbable tissue repair net piece can maintain the good mechanics supporting role of a period in the early stage of implanting, and along with the tissue healing, the intensity of repairing the net piece descends gradually, and the degradation that gradually absorbs water is absorbed by human metabolism, still can provide the good environment of cell and tissue growth, promotes the healing.
And, absorbable tissue repair net piece, its distinctive microcosmic structure not only has sufficient mechanical strength and pliability, is favorable to the cell to grow into moreover, can prevent body fluid, the free cell of blood again and leak, prevents the seepage, promotes tissue regeneration. Meanwhile, the specially designed surface layer and the specially designed middle layer structure can prevent leakage and promote cell proliferation and tissue regeneration.
In summary, the absorbable tissue repair mesh of the present invention has good biocompatibility, excellent tensile strength and flexibility, and exhibits a good tissue reinforcement effect when connected to damaged or weakened organ tissues; moreover, the degradation rate and the strength retention rate of the absorbable tissue repair mesh of the utility model are matched with the time required by the regeneration and repair of the implanted part; furthermore, the utility model discloses a absorbable tissue repair net piece has good microcosmic structure, and the great hole of superficial layer just is favorable to the cell to grow into, and the less hole in intermediate level can prevent that free cell in body fluid, blood etc. from leaking, prevents that the seepage can effectively promote cell regeneration simultaneously.
The specific test procedure for the above properties is as follows:
porosity (P)
Porosity (P) test method: the porosity of the absorbable tissue repair mesh was tested by solvent filling. The specific determination method is as follows: the absolute ethanol solution was poured into a 100mL container, and the absorbable tissue repair mesh (weight m) dried to constant weight was weighed1) Soaking in ethanol. Weighing the total weight m of the repairing net containing ethanol and absorbable tissue and the beaker2Then taking out the absorbable tissue repairing mesh containing ethanol inside, and weighing the total weight of the beaker and the residual ethanol as m3And testing for 3 times, and taking an average value.
The calculation formula is as follows:
wherein: (m)2-m3-m1) The mass of ethanol contained in the pores in the sample to be detected;
(m2-m3) Is the total mass of the sample to be tested containing ethanol.
(II) tensile breaking Strength (f)
The tensile breaking strength (f) was measured by the following method: the absorbable tissue repair mesh was tested for tensile breaking strength (f) by a tensile machine.
Cutting the absorbable tissue repairing mesh into a sample to be measured of 40mm multiplied by 10mm, and measuring the thickness (T) of the sample to be measured by using a thickness meter; the two ends of the long side of the sample were clamped by a universal material testing machine, and the clamping lengths of the two sides were each 10 mm. The sample is pulled at a tensile rate of 300 + -50 mm/min, the maximum tensile breaking strength (F) at break of the sample is recorded, the test is performed 3 times in parallel, and the average value is taken.
The calculation formula is as follows:
wherein F isBreaking strength, wherein T is the thickness of the sample to be detected, and B is the width of the sample to be detected.
(III) apparent Density (. rho.)
The method for measuring the apparent density (. rho.) was: weighing the weight of the sample to be measured by a balance with more than one micrometer of precision, measuring the size of the sample to be measured by a steel ruler, further calculating the area of the sample to be measured, carrying out parallel test for 3 times, and taking an average value.
The calculation formula is as follows:
wherein rho is the apparent density of the sample to be detected, m is the weight of the sample to be detected, and S is the area of the sample to be detected.
The properties of the absorbable tissue repair mesh prepared in the above examples are shown in table 1.
| Test items | Example one | Example two | EXAMPLE III |
| Porosity (%) | 92.3 | 87.2 | 89.7 |
| Apparent density (g/m)2) | 50.7 | 82.4 | 65.0 |
| Tensile Strength (MPa) | 3.5 | 6.5 | 5.2 |
In this document, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising an … …" does not exclude the presence of other identical elements in a process, method, article, or apparatus that comprises the element.
While the above description shows and describes the preferred embodiments of the present invention, it is to be understood that the invention is not limited to the forms disclosed herein, but is not intended to be exhaustive or to exclude other embodiments and may be used in various other combinations, modifications, and environments and is capable of changes within the scope of the invention as expressed in the above teachings or as determined by the knowledge of the relevant art. But that modifications and variations may be effected by those skilled in the art without departing from the spirit and scope of the invention, which is to be limited only by the claims appended hereto.
Claims (12)
1. An absorbable tissue repair mesh, comprising: more than one upper surface layer, more than one middle layer and more than one lower surface layer; the upper surface layer and the lower surface layer are respectively made of a fabric unit A, the middle layer is made of a fabric unit B, and the fabric unit A and the fabric unit B are woven by monofilament yarns or multifilament yarns of absorbable materials; and the average pore diameter of the fabric unit A is larger than that of the fabric unit B, wherein the average pore diameter of the fabric unit A is 20-500 mu m, and the average pore diameter of the fabric unit B is 5-20 mu m.
2. The absorbable tissue repair mesh of claim 1, wherein: the average pore diameter of the fabric unit A is 50-200 mu m, and the average pore diameter of the fabric unit B is 15-20 mu m.
3. The absorbable tissue repair mesh of claim 1, wherein: the upper surface layer and the lower surface layer are respectively one layer, and the middle layer is 1-10 layers; the thickness of each layer of fabric unit A and the thickness of each layer of fabric unit B are both 0.05-0.15 mm.
4. The absorbable tissue repair mesh of claim 3, wherein: the intermediate layer is 1-5 layers; each layer of fabric element a and each layer of fabric element B is 0.1mm thick.
5. The absorbable tissue repair mesh of claim 1, wherein: the absorbable material adopts the following components: synthetic polymer material, polysaccharide polymer material, or protein natural polymer material.
6. The absorbable tissue repair mesh of claim 1, wherein: the absorbable material is polyglycolic acid, and the weight average molecular weight of the polyglycolic acid is 30000-1000000.
7. The absorbable tissue repair mesh of claim 6, wherein: the weight average molecular weight of the polyglycolic acid is 30000-400000.
8. The absorbable tissue repair mesh of claim 1, wherein: the monofilament diameter of the multifilament yarn is 5-50 μm; the average breaking strength is 3 to 6.0 cN/dtex.
9. The absorbable tissue repair mesh of claim 8, wherein: the monofilament diameter of the multifilament yarn is 15-20 μm.
10. The absorbable tissue repair mesh of claim 1, wherein: the two adjacent fabric units are connected by needling or welded by ultrasonic waves, and the weaving method of the fabric units adopts weft knitting or warp knitting.
11. The absorbable tissue repair mesh of claim 1, wherein: the apparent density of the mesh sheet is 5g/m2～300g/m2。
12. The absorbable tissue repair mesh of claim 11, wherein: the apparent density of the mesh sheet is 25g/m2～200g/m2。
Priority Applications (1)
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