CN216724875U - Artificial patch - Google Patents

Abstract

The utility model provides an artificial patch. The patch base material of the artificial patch is coated with the biocompatible anti-leakage coating, the coating material of the anti-leakage coating can penetrate into the pores of the patch base material, the anti-leakage performance of the artificial patch is greatly improved, and the patch base material is coated with the coating material, so that the edge of the patch is not easy to fall off when the patch is cut, the stitching is facilitated, the bleeding can be reduced in the using process, and the probability of inflammation is reduced. In addition, the anti-leakage coating applied to the patch is biocompatible and will facilitate endothelialization of cells and rapid tissue ingrowth relative to an uncoated patch.

Description

Artificial patch

Technical Field

The utility model relates to the technical field of medical supplies, in particular to an artificial patch.

Background

The heart patch is a medical consumable commonly used in surgeries such as congenital heart disease and is mainly used for repair surgeries of diseases such as ventricular septal defect, atrial septal defect and ventricular wall repair of the heart. The vascular patch is mainly used for repairing angioma of aorta and carotid and vascular fistula caused by vascular stenosis and other reasons. The artificial patch used in the above-mentioned method, whether it is a heart patch or a blood vessel patch, is arbitrarily cut in shape and can be used as a surgical suture mat after cutting. Therefore, the artificial patch needs to have the characteristics of leakage resistance, easy cutting and sewing and the like. However, the artificial patches on the market generally have the problems of large blood seepage and easy falling-off of the parts after patch cutting. The patch is easy to leak, and will easily cause hemolysis, bacterial or fungal infection; and after the patch is cut, yarns on the edge part are easy to shed, and the generated flocculent substances are easy to cause inflammation.

In recent years, in order to improve the leakage resistance of artificial patches, patches having a multilayered composite structure formed by forming a blood blocking layer by an electrospinning technique and then performing post-treatment have been proposed, but the process is complicated. The field also provides a knitted polyester surgical repair material which is formed by weaving polyester yarns, adopts a weft-knitted double-faced rib structure, can keep good strength and uniform air permeability, and is beneficial to tissue ingrowth; but after shearing, the terylene base material is easy to fall off. And further interweave dacron substrate and dacron silk each other and form knitting structure, can play the reinforcing effect, solved the dacron patch and easily dropped the phenomenon of dacron substrate after the shearing, but this dacron patch anti-permeability is poor, easily takes place the oozing in the use. In addition, the field also provides a composite heart or blood vessel patch, the patch structure is divided into three layers, and a fabric reinforcing layer, an elastic layer and a blood blocking layer are sequentially arranged from outside to inside, the composite patch has good permeability resistance and thrombus resistance, the defect that the existing artificial patch is easy to leak blood is overcome, but the process of the three-layer composite structure is complicated.

Therefore, there is a need to develop an artificial patch which has a simple process, good anti-permeability and is not easy to fall off after being cut.

SUMMERY OF THE UTILITY MODEL

The utility model aims to provide an artificial patch and a forming method thereof, and aims to solve the problems that the conventional artificial patch is complex in process, poor in anti-permeability and easy to fall off after being cut.

In order to solve the technical problem, the utility model provides an artificial patch, which comprises a patch base material formed by weaving yarns and a biocompatible anti-leakage coating coated on the patch base material.

Optionally, the anti-leakage coating is a protein coating. Wherein, the protein coating comprises the following components: one or more of silk fibroin, collagen, albumin and gelatin.

Optionally, the patch substrate is a woven or knitted fabric. Wherein, the patch substrate of the woven fabric and the fabric weave can adopt one of plain weave, satin weave and twill weave. And a patch substrate of a knitted fabric, wherein the fabric weave can adopt one of single-warp flat, double-warp flat, warp flat velvet and warp satin weave.

Optionally, the thickness of the yarn is 20D to 100D. And, the composition of the yarn may include: one or more of polyethylene terephthalate, polytetrafluoroethylene, polyethylene and silk.

Optionally, the thickness of the artificial patch is 0.50 mm-0.70 mm.

Optionally, the artificial patch is a cardiac patch or a vascular patch.

In the artificial patch provided by the utility model,weaving by using a weaving technology to form a patch base material, and coating a biocompatible anti-leakage coating on the patch base material. The coating material of the anti-seepage coating can permeate into pores of the patch base material, so that the anti-seepage performance of the artificial patch is greatly improved, and zero seepage of the artificial patch is favorably realized (for example, the seepage value of the artificial patch can be reduced to 0-0.5 ml/min-cm)²). In addition, because the patch base material is coated, the edge of the patch is not easy to be loosened and is beneficial to sewing when being cut under the coating of the coating material, and the bleeding can be reduced and the probability of inflammation can be reduced in the using process. In addition, the anti-leakage coating coated on the patch provided by the utility model has biocompatibility, and is more beneficial to endothelialization of cells and rapid growth of tissues compared with the uncoated patch.

Namely, the artificial patch provided by the utility model can realize the effect of zero leakage or nearly zero leakage of the artificial patch through a simple process, can obviously reduce the blood leakage after sewing, is not easy to loose at the edge fabric after being cut, and is beneficial to reducing the probability of inflammation.

Drawings

Fig. 1 is a schematic view of a vascular patch.

Fig. 2 is a schematic diagram of an artificial patch in an embodiment of the utility model.

Fig. 3 is a schematic view of a braid formed by weaving.

Fig. 4 is a schematic view of a weft knitted fabric formed by knitting.

Fig. 5 is a schematic view of a warp knit fabric formed by knitting.

Fig. 6 is a schematic flow chart of a method for preparing an artificial patch according to an embodiment of the present invention.

Detailed Description

The core idea of the utility model is to provide an artificial patch, which comprises a patch base material and a biocompatible anti-leakage coating coated on the patch base material. The artificial patch may be used, for example, in a cardiac patch, but may also be applied in a vascular patch (such as that shown in fig. 1).

As shown in fig. 2, this embodiment provides an artificial patch, wherein a biocompatible leakage-proof coating 200 is coated on a patch substrate 100. And, the coating material of the anti-leakage coating 200 can also penetrate into the pores of the patch substrate 100 to achieve the effect of zero leakage or near zero leakage of the artificial patch (for example, the water seepage value of the artificial patch after coating can be from 500 to 2500ml/min cm.)²The concentration is reduced to 0 to 0.5ml/min cm²) When the composition is applied to an operation, the phenomenon of blood seepage can be obviously reduced. And under the coating of the coating substance, the edge of the artificial patch is not easy to be loosened and sutured when being cut, and the occurrence of bleeding and inflammation can be obviously reduced in the using process.

The anti-leakage coating can be a protein coating, so that the creeping attachment of tissue cells is facilitated, the tissue can grow in conveniently, and the anti-leakage coating can be degraded gradually in the self-environment to reduce the weight of the patch, so that the foreign body sensation is reduced. In particular embodiments, the protein coating may include: one or more of silk fibroin, collagen, albumin and gelatin. The protein coating is a coating substance composed of amino acids, and the source of the amino acids can be extracted from animal tissue.

Further, the patch substrate can be woven by using biocompatible yarns. The composition of the yarn may include: one or more of polyethylene terephthalate (PET), Polytetrafluoroethylene (PTFE), Polyethylene (PE) and silk. And the yarn used has, for example, a thickness (denier) of 20D to 100D and a multifilament number of, for example, 1f to 72 f. By adopting thinner yarns, the thickness of the patch base material formed by weaving is smaller (for example, the thickness after the fabric is off-machine can be less than or equal to 0.5mm), the foreign body feeling after implantation is reduced, and the thinner yarns are more beneficial to the knitting process when the knitting mode is adopted for weaving.

Further, the patch substrate may be formed by weaving or knitting using a yarn. The weaving is a weaving method (for example, refer to fig. 3) in which a group of warp yarns and a group of weft yarns which are vertical to each other are criss-cross on a weaving machine according to a certain rule, and the fabric formed by weaving has the characteristics of stiff and smooth cloth cover, high breaking strength and stiff hand feeling. And, knitting is a knitted fabric in which yarns are bent into loops by a knitting needle and then the yarns are interlooped and connected with each other. The method can be divided into two categories of weft knitting (for example, refer to fig. 4) and warp knitting (for example, refer to fig. 5) according to the knitting method; wherein, the weft-knitted fabric is easy to reversely fall off (such as common handmade sweaters, woolen trousers, hats and the like in life); the warp knitted fabric is one or several groups of parallel yarns which are simultaneously knitted into loops (such as mosquito nets, lace and the like), and has the characteristics of good transverse elasticity and extensibility, stable longitudinal dimension, soft texture, small detachability, good air permeability and the like. Therefore, both knitted and woven fabrics are suitable for preparing artificial patches.

Specifically, when the patch base material is woven in a weaving mode, the fabric weave of the patch base material can adopt one of plain weave, satin weave and twill weave, wherein the warp density and the weft density of the patch base material formed by weaving can be both 100-150 pieces/inch. Alternatively, in the case of knitting the patch base material forming the warp knit fabric by knitting, the weave structure may be one of a single warp flat, a double warp flat, a warp pile flat and a warp satin weave, and the draw density of the knit fabric may be set to 20 to 70 courses/cm, more specifically, 34 to 60 courses/cm, for example.

With continued reference to fig. 2, in the present embodiment, the patch substrate 100 is woven in a weaving manner as shown in fig. 3, for example, that is, the patch substrate 100 in the present embodiment is woven by a weaving method in which a set of warp yarns and a set of weft yarns perpendicular to each other are woven in a weaving machine in a regular criss-cross manner. It should be appreciated that in other embodiments, the patch substrate may be woven in a manner such as the weaving illustrated in fig. 4 or 5.

Further, in the partial cross-sectional view shown in fig. 2, it is specifically a cross-sectional view along a direction corresponding to the AA' direction in the patch substrate 100, i.e., a cross-sectional view along the weaving direction of the yarn 110 (e.g., warp or weft), and thus the cross-section of the patch substrate illustrated in the partial cross-sectional view of fig. 2 corresponds specifically to the cross-section of the yarn 110 (e.g., warp or weft). And, the coating substance of the leakage-preventing coating 200 permeates into the pores between the adjacent yarns 110.

In addition, for the patch base material formed by weaving, the lower thickness of the fabric is 0.2 mm-0.4 mm, and the porosity is 2% -5%. The patch base material formed by the knitting mode has the lower thickness of the fabric of 0.25 mm-0.50 mm, the porosity of 30% -40%, the transverse density of the fabric of 17-25 longitudinal rows/cm and the longitudinal density of 20-70 transverse rows/cm.

And the coating times on the patch base material can be correspondingly adjusted according to specific conditions, so long as the coated artificial patch has a small enough leakage value. For example, for woven patch substrates, the number of coatings can be reduced, for example; for a knitted patch substrate, the number of coatings may be increased. This is, of course, merely an example, and in the actual production process, the number of coating times can also be adapted to the viscosity of the coating solution.

Specifically, the patch substrate may be sequentially coated 2-6 times to form the leakage-proof coating. In one embodiment, the anti-leakage coated artificial patch has a thickness of, for example, 0.50mm to 0.70mm, a porosity of less than 1% (e.g., about 0.5% to 1%), and a water permeability of 0 to 0.5ml/min cm 2.

An embodiment of the present invention further provides a method for preparing an artificial patch, which can be specifically described with reference to fig. 6, and the method for preparing the artificial patch includes the following steps.

Step S1, providing a yarn.

The composition of the yarn may include: one or more of polyethylene terephthalate (PET), Polytetrafluoroethylene (PTFE), Polyethylene (PE) and silk. The thickness of the yarn used may be 20D to 100D, and the number of multifilaments may be 1 to 72 f.

Step S2, weaving to form a patch substrate.

Specifically, the weaving mode can be adopted for weaving, the fabric weave can adopt one of plain weave, satin weave and twill weave, the warp density of the fabric is 100-150 pieces/inch for example, and the weft density is 100-150 pieces/inch for example. Or, the yarn can be woven by a high-grade warp knitting machine with the machine number of 30-36, and the yarn is warped to be made into a pan head before being woven so as to be used by the warp knitting machine.

In step S3, the patch substrate is cleaned (e.g., ultrasonic cleaning) to remove stains from the fabric. In a specific embodiment, the cleaning agent used for cleaning may include triton and sodium carbonate, and the ratio of the two substances is, for example, 1: 1-1: 3, and the cleaning temperature is 80-90 ℃, and the cleaning time is 30-60 min.

Step S4, after cleaning the patch substrate, further comprising: and carrying out heat setting treatment on the patch base material to stabilize the shape. Specifically, the heat setting mode of the patch base material can adopt dry heat setting or wet heat setting; wherein the dry heat setting temperature is, for example, 90-120 ℃, and the time is, for example, 10-30 min; and the temperature of the wet heat setting is, for example, 90-120 ℃, and the time is, for example, 10-30 min.

After the patch base material is subjected to the shaping treatment, the coating treatment can be carried out. Optionally, the water permeability value of the woven body is detected before the coating treatment, and the water permeability value of the woven body is about 500-2500 ml/min cm²。

Step S5, coating treatment to coat a leakage-proof coating on the patch substrate.

Specifically, the coating treatment comprises: a coating solution of a viscosity, for example, in the range of 100mpa.s to 150mpa.s, is provided and the patch substrate is vacuum dip coated at least once (e.g., 2 to 6 coats of the patch substrate may be applied). Wherein, each vacuum dip coating process comprises the following steps: and immersing the yarns into the coating solution, and then taking out and drying for 20-30 minutes.

The coating is dipped in the vacuum environment, so that the coating can be easily infiltrated into the pores of the patch substrate, and the effect of zero leakage of the artificial patch can be realized. And the viscosity of the coating solution and the coating times of the patch base material can be correspondingly set according to the penetration condition of the patch base material before coating. For example, in the case where the amount of leakage from the patch base material before coating is large, the number of times of coating can be increased, and the like; otherwise, the number of coating times can be reduced. Or, when the porosity of the patch substrate before coating is larger, the viscosity of the coating solution can be increased; conversely, the viscosity of the coating solution may be reduced. It should also be appreciated that the coating times and the viscosity of the coating solution as described above may be adjusted in a matched manner, for example, the coating times and the viscosity of the coating solution may be adjusted alternatively, or both the coating times and the viscosity of the coating solution may be adjusted by a small amount, and the like.

In addition, the number of coating times can be adjusted accordingly according to the viscosity of the coating solution. For example, for coating solutions with greater viscosity, the number of coatings can be reduced; conversely, for less viscous coating solutions, the number of coatings can be increased.

In particular embodiments, the coating solution may comprise one or more of silk fibroin, collagen, albumin, and gelatin. In addition, the coating solution may further include glycerin as an ingredient to perform plasticizing and softening functions.

Further, the preparation method further comprises the following steps: and step S6, performing crosslinking treatment to make the anti-leakage coating crosslinked and fixed on the patch substrate. The crosslinking treatment may include: formaldehyde fumigation, glutaraldehyde fumigation, dry heat crosslinking, moist heat crosslinking, ultraviolet crosslinking, and EDC-NHS crosslinking. Wherein EDC-NHS is prepared by crosslinking collagen with 1-ethyl-3- (3-dimethylaminopropyl) -carbodiimide (EDC) and N-hydroxysuccinimide (NHS) crosslinking agent.

In order to more clearly illustrate the artificial patch provided by the present invention, several specific examples are listed below for further explanation.

Example one

In the preparation method provided in this embodiment, a knitting manner is adopted to weave a patch substrate.

In step S1, the yarn (warp yarn) is made of polyethylene terephthalate (PET), and the yarn type is 20D/14 f. Furthermore, 600 warps are warped to be made into a pan head with the length of 100m, and the pan head is ready to be woven.

In step S2, the fabric is knitted by a warp knitting machine with a machine number of 36 to form a patch base material, the fabric structure may be double warp flat, and the draw density is set to 60 courses/cm. The thickness of the fabric after it has been run off the machine is, for example, 0.25 mm.

In step S3, the patch substrate is subjected to ultrasonic cleaning to remove stains on the fabric, the cleaning agent is triton and sodium carbonate, and the ratio of the two substances is 1: 1, the cleaning temperature is 80 ℃, and the ultrasonic cleaning time is 30 min.

In step S4, the patch base material is subjected to wet heat setting treatment to stabilize the form. The temperature for wet heat setting is 90 deg.C, and the time is 30 min.

At this time, the patch substrate was tested to have a water penetration value of about 2500ml/min cm²。

In step S5, a coating solution with a viscosity of 150mpa.s is prepared, specifically a collagen/glycerol solution. And carrying out vacuum dipping coating on the patch base material, and then taking out and drying for 20-30 minutes. The dipping-drying process was repeated 4 times under vacuum.

In step S6, a cross-linking treatment is performed, specifically, the artificial patch after the coating treatment is cross-linked at 110 ℃ for 16 hours. After crosslinking, the artificial patch was measured to have a thickness of 0.50 mm.

So far, the water seepage value of the artificial patch from the front of coating to the back of coating can be 2500ml/min cm²The solution is dropped to 0.3ml/min cm²。

Example two

The preparation method of the artificial patch provided in this example is as follows.

In step S1, the yarn (warp) is made of Polytetrafluoroethylene (PTFE) and the type of the yarn is 100D/48 f. Furthermore, 600 warps are warped to be made into a pan head with the length of 100m, and the pan head is ready to be woven.

In step S2, knitting is performed using a warp knitting machine with a gauge 30 to form a patch base material, the fabric texture is flat using warp pile, and the draw density is set to 20 courses/cm.

In step S3, the patch substrate is subjected to ultrasonic cleaning to remove stains on the fabric, the cleaning agent is triton and sodium carbonate, and the ratio of the two substances is 1: 2, the cleaning temperature is 90 ℃, and the ultrasonic cleaning time is 60 min.

In step S4, the patch base material is subjected to dry heat setting treatment to stabilize the form. The dry heat setting temperature is 120 deg.C, and the time is 10 min.

At this point, the patch substrate was tested to have a water penetration value of about 1800ml/min cm 2.

In step S5, a coating solution having a viscosity of 120mpa.s is prepared, which is specifically a gelatin/glycerin solution. And carrying out vacuum impregnation coating on the patch base material, and then taking out and drying for 20-30 minutes. The dipping-drying process was repeated 5 times under vacuum.

In step S6, a cross-linking treatment is performed, specifically, glutaraldehyde fumigation cross-linking is performed on the artificial patch subjected to the coating treatment for 2 hours. After crosslinking, the artificial patch was measured to have a thickness of 0.70 mm.

In this embodiment, the water permeability of the artificial patch from before coating to after coating can be 1800ml/min cm²The solution is dropped to 0.5ml/min cm²。

EXAMPLE III

In this embodiment, a patch base material with a relatively small permeation amount is formed by weaving.

In step S1, the yarns (warp and weft) are made of Polytetrafluoroethylene (PTFE) and the type of the yarns is 60D/24 f. In this embodiment, the yarn includes warp and weft yarns, both of which are made of Polytetrafluoroethylene (PTFE), and 600 warp yarns are warped to make a 100-meter bobbin, and the weft yarns are wound into a pirn.

In step S2, the fabric is woven on a high-precision loom, and the weave is woven, for example, with a satin weave using five-warp three-fly. The warp density was set to 150 threads/inch and the weft density was set to 100 threads/inch.

In step S3, the patch substrate is subjected to ultrasonic cleaning to remove stains on the fabric, the cleaning agent is triton and sodium carbonate, and the ratio of the two substances is 1: 2, the cleaning temperature is 90 ℃, and the ultrasonic cleaning time is 60 min.

In step S4, the patch base material is subjected to dry heat setting treatment to stabilize the form. The dry heat setting temperature is 120 deg.C, and the time is 10 min.

The patch substrate was tested for water penetration of about 700ml/min cm2 prior to coating.

In step S5, a coating solution having a viscosity of 130mpa.s is prepared, and the coating solution is specifically an albumin/glycerol solution. And carrying out vacuum dipping coating on the patch base material, and then taking out and drying for 20-30 minutes. The dipping-drying process was repeated 3 times under vacuum.

In step S6, a cross-linking treatment is performed, specifically EDC-NHS cross-linking is performed on the artificial patch that has been subjected to the coating treatment for 3 hours. After crosslinking, the artificial patch was measured to have a thickness of 0.50 mm.

In the embodiment, the water permeability value of the artificial patch from before coating to after coating can be from 700ml/min cm²The solution is dropped to 0.5ml/min cm²。

Example four

In the preparation method provided in this embodiment, the patch substrate is woven in a weaving manner.

In step S1, the yarns (warp and weft) were made of Polytetrafluoroethylene (PTFE) and the yarn type was 40D/12 f. In this embodiment, the yarn includes warp and weft yarns, both of which are made of Polytetrafluoroethylene (PTFE), and 600 warp yarns are warped to make a 100-meter bobbin, and the weft yarns are wound into a pirn.

In step S2, the fabric is woven on a high-precision loom with a 1-over-1-under plain weave, a warp density of 120 pieces/inch, and a weft density of 120 pieces/inch.

In step S3, the patch substrate is subjected to ultrasonic cleaning to remove stains on the fabric, the cleaning agent is triton and sodium carbonate, and the ratio of the two substances is 1: 2, the cleaning temperature is 90 ℃, and the ultrasonic cleaning time is 60 min.

In step S4, the patch base material is subjected to dry heat setting treatment to stabilize the form. The dry heat setting temperature is 120 deg.C, and the time is 10 min. The water seepage value of the shaped patch base material is 500ml/min cm 2.

The patch substrate was tested for water penetration of about 500ml/min cm2 prior to coating.

In step S5, a coating solution with a viscosity of 100mpa.s is prepared, and the coating solution is specifically a silk fibroin/glycerol solution. And carrying out vacuum dipping coating on the patch base material, and then taking out and drying for 20-30 minutes. The dipping-drying process was repeated 5 times under vacuum.

In step S6, a cross-linking treatment is performed, specifically, ultraviolet cross-linking is performed on the artificial patch subjected to the coating treatment for 4 hours. After crosslinking, the artificial patch was measured to have a thickness of 0.30 mm.

In this embodiment, the water permeability of the artificial patch can be from 500ml/min cm before coating to 500ml/min cm after coating²Down to a value close to or even equal to 0ml/min cm²。

The embodiments in the present description are described in a progressive manner, each embodiment focuses on differences from other embodiments, and the same and similar parts among the embodiments are referred to each other. Moreover, the above description is only for the purpose of describing the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention, and any variations and modifications made by those skilled in the art based on the above disclosure are within the scope of the appended claims.

Furthermore, the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. The defined terms are complementary to the technical, scientific, or ordinary meaning of the defined terms as commonly understood and accepted in the relevant context.

Claims (10)

1. The artificial patch is characterized by comprising a patch base material formed by weaving yarns and a biocompatible anti-leakage coating coated on the patch base material.

2. The artificial patch of claim 1, wherein the leakage-resistant coating is a protein-based coating.

3. An artificial patch according to claim 2, wherein the proteinaceous coating comprises: one of silk fibroin, collagen, albumin and gelatin.

4. An artificial patch according to claim 1, wherein the yarn has a denier in the range of 20D to 100D.

5. A patch according to claim 1, wherein said patch substrate is a woven or knitted fabric.

6. The artificial patch of claim 5, wherein the woven fabric has a base material and a weave selected from the group consisting of plain, satin, and twill.

7. An artificial patch according to claim 5, wherein the knitted fabric patch substrate has a weave pattern selected from the group consisting of single warp flat, double warp flat, warp pile flat and warp satin weave.

8. An artificial patch according to claim 1, wherein the yarn has a composition comprising: one of polyethylene terephthalate, polytetrafluoroethylene, polyethylene and silk.

9. The artificial patch according to claim 1, wherein the artificial patch has a thickness of 0.50mm to 0.70 mm.

10. An artificial patch according to any of claims 1-9, wherein the artificial patch is a cardiac patch or a vascular patch.

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