CN114469219A - An absorbable/biodegradable surgical implant and method of manufacture - Google Patents

Abstract

The invention provides an absorbable/biodegradable implant for surgical operation and a manufacturing method thereof, belonging to the technical field of medical textile instruments. The absorbable/biodegradable surgical implant is a composite structure, in particular consisting of a first fibrous braided core and a shell braided from a second fibrous; the first fiber is nonabsorbable/biodegradable material, and is selected from one or more of polyester, polypropylene, polytetrafluoroethylene, polybutylene ester and ultrahigh molecular weight polyethylene; the second fiber is absorbable/biodegradable material, and is selected from one or more of polylactic acid, polyglycolide-lactide polymer, polycaprolactone, polydioxanone and polyhydroxyalkyl polyester. The shell can avoid the phenomenon of stress concentration and reduce the shearing and tearing of the tissue; after the shell is absorbed or biodegraded, the tissue also gradually heals, at which point the required tensile strength is reduced, no stress concentration occurs, and the core can still provide sufficient strength to remain stable.

Description

An absorbable/biodegradable surgical implant and method of manufacture

technical field

The invention relates to the technical field of medical textiles and instruments, in particular to an absorbable/biodegradable surgical implant and a manufacturing method.

Background technique

As a surgical implant, orthopedic suture is a common medical consumable widely used in wound suture, tissue ligation, joint and implant fixation, and soft tissue repair. Compared with ordinary surgical sutures, orthopedic sutures have higher performance requirements. The ideal orthopaedic suture should achieve the best mechanical properties, maneuverability and biological properties, including high tensile strength, easy to distinguish and knot in appearance, and small tissue scissors after implantation. Cut and foreign body reaction, etc. At present, almost all products related to orthopedic surgical sutures used clinically in my country rely on imports, which not only causes high operating costs for patients, but also this technological monopoly is not conducive to the development of my country's related medical device industry.

First of all, regarding the selection of raw materials, with the advancement of the chemical and material industries, different types of absorbable and non-absorbable synthetic raw materials have been developed, and various new types of sutures have been produced, but each material has certain weaknesses. It is also committed to the development of sutures that integrate the advantages of various raw materials. It is usually achieved by methods such as multi-component spinning, mixed weaving and surface coating, which often require high time and economic costs to develop, and the final product effect is difficult to maintain stable.

At present, the common structure of orthopedic suture is braided wire, and most of them have a circular cross-section. Due to the small contact area between the shape and the tissue, stress concentration is likely to occur after implantation, resulting in tissue cutting or tearing. Relatively speaking, flat-shaped sutures can reduce the phenomenon of stress concentration, but larger nodules are likely to be formed at the knots of the flat-shaped sutures, which are prone to more intense discomfort after surgery.

SUMMARY OF THE INVENTION

Aiming at the defects existing in the prior art, the present invention provides an absorbable/biodegradable surgical implant and a manufacturing method, so as to solve the problem of stress concentration after the implant is implanted into human/animal organs and tissues, Alleviate the contradiction between high tensile strength and degradable and absorbable properties, that is, to achieve both high tensile strength and reduction of stress concentration after the surgical implant is stressed, and has a positive effect on tissue repair. certain promotion.

The present invention is achieved through the following technical solutions:

In one aspect, an absorbable/biodegradable surgical implant is provided, the absorbable/biodegradable surgical implant is a composite structure, in particular a core woven from a first fibrous material and a A second fibrous braided shell consists of the shell wire connecting the core and wrapping around the outside of the core;

Wherein, the first fiber is a non-absorbable/biodegradable material selected from polyester (PET), polypropylene (PP), polytetrafluoroethylene (PTFE), polybutene ester (PB) and ultra-high One or several components in molecular weight polyethylene (UHMWPE);

The second fiber is an absorbable/biodegradable material selected from the group consisting of polylactic acid (PLA), polyglycolide-lactide polymer (PGLA), polycaprolactone (PCL), polyparadioxy One or more of cyclohexanone (PDS) and polyhydroxyalkyl polyester (PHA).

In one or more embodiments, the absorbable/biodegradable surgical implant is in the form of a braided suture.

In one or more embodiments, the core braided from the first fibrous material is a circular braid construction.

In one or more embodiments, the cross-sectional diameter of the circular braid construction is in the range of 0.250mm-0.850mm.

In one or more embodiments, the shell woven from the second fibrous material is of a flat braid construction.

In one or more embodiments, the cross-sectional width of the flat braided construction is in the range of 1.0mm-5.0mm.

In one or more embodiments, the first fibrous material and the second fibrous material are composed of monofilaments or multifilaments.

In one or more implementation cases, the diameter of the monofilament ranges from 0.05mm to 0.2mm, and the thickness of the multifilament ranges from 20D to 600D.

In one or more implementation cases, the colors of the monofilament and the multifilament are set to a variety of different colors, which play a role of identification and are convenient for doctors to distinguish during surgery.

In another aspect, there is provided a method for manufacturing the above-mentioned absorbable/biodegradable surgical implant, the method comprising: on the same knitting machine, first weaving a first fibrous material into a core, and then weaving a second fibrous material into a core. The fiber is connected to the core and woven into the shell, and the shell wire is connected to the core and wrapped around the outside of the core; the braiding length of the core and the braiding length of the shell can be adjusted arbitrarily, and the braiding of the shell The length is less than the braided length of the core.

Compared with the prior art, the present invention has at least the following beneficial effects:

1. The absorbable/biodegradable surgical implant provided by the present invention is woven by using a combination of different raw materials, and the ratio of raw materials can be selected according to the use environment of the implant to adjust the degradation cycle of the suture in the body.

2. The present invention uses absorbable/biodegradable material to knit the shell of the flat knitted fabric, non-absorbable/biodegradable material to knit the core of the circular knitted fabric, the initial stage of implant use, the flat knitted fabric It can avoid stress concentration and reduce the occurrence of tissue shearing and tearing; after the absorbable/biodegradable shell is absorbed or biodegraded, the tissue is gradually healed, and the required tensile strength is reduced. Stress concentrations can occur and the core of the circular braid construction can still provide enough strength to remain stable.

3. For the implant of the composite structure provided by the present invention, after the operation, as the tissue of the human body or animal body grows and heals, the absorbable/biodegradable shell gradually degrades, providing more space for cell growth, which is conducive to promoting the operation. post repair.

4. The manufacturing method of the absorbable/biodegradable surgical implant provided by the present invention is simple and convenient, a composite structure implant can be completed on a medical braiding machine, and the process adjustment is convenient, and the thickness and length of the product can be adjusted. Strong adjustment.

Of course, any product implementing the present invention does not necessarily need to achieve all the above-mentioned technical effects at the same time.

Description of drawings

The accompanying drawings are used to provide a further understanding of the present invention, and constitute a part of the specification, and together with the following specific embodiments, are used to explain the present invention, but do not constitute a limitation to the present invention. In the attached image:

Fig. 1 is the enlarged structural schematic diagram of the implant of the composite structure in the embodiment of the present invention;

FIG. 2 is a schematic diagram of an enlarged cross-sectional structure of a core in an implant according to an embodiment of the present invention;

FIG. 3 is an enlarged cross-sectional structural schematic diagram of the implant composite structure in the embodiment of the present invention;

4-7 are schematic diagrams showing the enlarged structure of the implant surface pattern in the embodiment of the present invention, wherein black and white respectively represent yarns of different colors;

FIG. 8 is a schematic diagram of the use of the implant for suturing human tissue in an embodiment of the present invention.

Reference number:

1001, the second fibrous braided shell, 1002, the connecting line of the shell and the core, 1003, the first fibrous braided core; 3001, the cross section of the connecting line between the shell and the core, 3002, the yarn cross section of the shell, 3003, Yarn cross section of core; 8001, Human/animal body tissue, 8002, Suture with composite structure in contact with tissue, 8003, Core in circular braid construction, 8004, Knot formed by core.

Detailed ways

The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

Unless otherwise specified otherwise, the sources of raw materials used in the examples of the present invention can be purchased through commercially available methods.

First, the following explanations are made to the terms involved in the present invention:

Surgical Implants: Implantable medical devices are implantable items that are placed in a body cavity created by a surgical procedure or physiologically present.

The surgical implant involved in the present invention can be realized in the form of a hernia repair mesh, a surgical suture, and the like. In the following embodiments, the surgical implant is realized in the form of a surgical suture, so as to clearly and completely describe the technical solution provided by the present invention.

The core involved in the present invention refers to the central part of the surgical implant, which can be understood as a middle inner layer structure, which is generally realized as a circular braid structure, with stable structure and high tensile strength.

The shell involved in the present invention refers to the peripheral part of the surgical implant, which can be understood as a structure that does not completely wrap the core, and is generally realized as a flat braided structure, which increases the contact area with human/animal body tissue, and further Avoid stress concentrations and reduce tissue shearing and tearing.

In addition, it should be noted that the second fiber is an absorbable/biodegradable material, and the degradation cycle of the selected specific material in the human/animal body is known. For example, the strength of the PLA suture can be maintained after implantation. 12 weeks; PDS can be kept for 20 weeks; if two raw materials, PLA and PDS, each account for 50%, the degradation cycle is about 16 weeks. The degradation cycle can be based on the degradation cycle of known materials in the body, and the ratio of raw materials can be set to meet the actual needs.

FIG. 1 exemplarily shows an absorbable/biodegradable surgical implant provided by the present invention, embodied as a braided suture, the braided suture is a composite structure, and is specifically composed of a first fibrous material A braided core 1003 and a second fibrous braided shell 1001 are formed. The sheath wire connects the core and wraps around the outside of the core. In the figure, 1002 is the connecting wire between the "shell" and the "core".

In this embodiment, the first fibrous material is a non-absorbable/biodegradable material selected from ultra-high molecular weight polyethylene (UHMWPE); of course, the tensile strength of the reference material can also be selected from One or more of polyester (PET), polypropylene (PP), polytetrafluoroethylene (PTFE) and polybutene ester (PB).

In this embodiment, the second fibrous material is an absorbable/biodegradable material selected from polyglycolide-lactide polymer (PGLA). The cycle of biodegradation can also be selected from one or more of polylactic acid (PLA), polycaprolactone (PCL), polydioxanone (PDS) and polyhydroxyalkyl polyester (PHA). kind.

FIG. 2 exemplarily shows a schematic enlarged cross-sectional structure of the core woven by the first fibrous material. It can be seen that the core of the first fibrous knitting is realized as a circular woven fabric configuration, and the cross section of the circular woven fabric configuration The diameter range is 0.250mm-0.850mm, which is 0.507mm in this embodiment; the first fiber is composed of monofilament or composite filament, which is realized as multifilament in this embodiment; the thickness of the yarn ranges from 20D to 600D; further, this embodiment The first fiber in the example uses 8 strands of ultra-high molecular weight polyethylene (UHMWPE) multifilaments with a thickness of 200D, of which 1 strand is a white multifilament, and 7 strands are blue multifilaments. Different colors play the role of identification. , which is convenient for doctors to distinguish during surgery.

Figure 3 exemplarily shows a schematic enlarged cross-sectional structure of the implant composite structure, from the section 3001 of the connecting line between the "shell" and the "core" in the figure, the yarn section 3002 of the "shell", and the "core" 3003 of the yarn section, it can be seen that the shell of the second fibrous braid is realized as a flat braid structure, and the cross-sectional width of the flat braid structure is in the range of 1.0mm-5.0mm. In this embodiment, it is realized as 1.5mm; the second fiber is composed of monofilament or composite fiber, which is realized as monofilament in this embodiment, and the diameter of the monofilament ranges from 0.05mm to 0.2mm; specifically, the second fiber in this embodiment adopts 9 strands of diameter It is a 0.15 mm polyglycolide-lactide polymer (PGLA) monofilament.

Figures 4-7 exemplarily show the enlarged structure diagram of the implant surface pattern, in which the black and white colors represent yarns of different colors, and in this embodiment, blue and white ultra-high molecular weight polymer Ethylene (UHMWPE) multifilament.

The absorbable/biodegradable surgical implant in the embodiment of the present invention is realized in the form of a braided suture, and the specific manufacturing process includes:

The first fibrous material is first woven into the core on the same braiding machine, and optionally, 8 strands of ultra-high molecular weight polyethylene (UHMWPE) multifilament with a thickness of 200D are woven into the core of a circular braid configuration; the second The fibrous material continues the core and is woven into a shell of a flat braided construction, the shell wires are connected to the core and wrapped around the outside of the core, optionally, 9 strands of polyglycolide- The monofilament of lactide polymer (PGLA) continues the braided core and continues to be braided into a shell, and the "shell" wire is connected to the "core" and wrapped around the outside of the "core". Optionally, the braiding length of the core and the braiding length of the shell can be arbitrarily adjusted by the braiding time, and the braiding length of the shell is smaller than the braiding length of the core.

In the embodiment of the present invention, the knitting pitch can be adjusted according to the known knitting technology, so as to adjust the tightness of the knitted surgical suture; type, etc. In the embodiment of the present invention, the absorbable/biodegradable surgical implant, namely the braided suture, wherein, according to the Chinese pharmaceutical industry standard YY0167-2020 "Non-absorbable Surgical Suture", the breaking strength test method, The core knotted tensile breaking strength of the obtained circular braided fabric was 163.89N; the overall tensile breaking strength of the flat braided shell and the circular braided core, that is, the composite structure of the suture, was 238.54N, All meet the requirements of the suture strength standard.

In the embodiment of the present invention, the overall length of the absorbable/biodegradable suture of the woven composite structure is 1200 mm, and the length of the flat section portion is 400 mm.

FIG. 8 exemplarily shows that the absorbable/biodegradable suture of the composite structure provided by the embodiment of the present invention is applied to the repair of human/animal body tissue, and the suture 8002 with the composite structure in contact with the tissue passes through the human/animal body. At the injury site of the animal body tissue 8001, the suture is pulled, and the core 8003 of the circular braid construction is realized as a knot 8004 formed by the "core" during or after surgery. It can be seen that the flat braid construction can avoid stress concentration and reduce the occurrence of tissue shearing and tearing, while the core of the circular braid construction has a narrower line width than the braided suture of the composite structure. , easy to tie the knot, and the "knot" formed is smaller.

To sum up, the absorbable/biodegradable surgical implant provided by the embodiment of the present invention is woven by using a combination of different raw materials, and the ratio of raw materials can be selected according to the use environment of the implant, so as to adjust the suture in the The degradation cycle in the body. In the embodiment of the present invention, absorbable/biodegradable material is used to knit the shell of the flat knitted fabric, and the non-absorbable/biodegradable material is used to knit the core of the circular knitted fabric. In the initial stage of implant use, the flat knitted fabric The structure avoids stress concentrations and reduces tissue shearing and tearing; and after the absorbable/biodegradable shell is absorbed or biodegraded, the tissue gradually heals, and the required tensile strength is reduced. Stress concentrations do not occur and the core of the circular braid construction still provides enough strength to remain stable. For the implant of the composite structure provided by the embodiment of the present invention, after the operation, as the tissue of the human body or animal body grows and heals, the absorbable/biodegradable shell is gradually degraded, providing more space for cell growth, which is conducive to promoting the operation post repair. The absorbable/biodegradable surgical implant provided by the embodiment of the present invention has a simple and convenient manufacturing method, a composite structure implant can be completed on a medical braiding machine, the process adjustment is convenient, and the product thickness and length are uniform. Can be adjusted according to needs.

The foregoing descriptions of specific exemplary embodiments of the present invention have been presented for purposes of illustration and description. These descriptions are not intended to limit the invention to the precise form disclosed, and obviously many changes and variations are possible in light of the above teachings. The exemplary embodiments were chosen and described for the purpose of explaining certain principles of the invention and their practical applications, to thereby enable others skilled in the art to make and utilize various exemplary embodiments and various different aspects of the invention. Choose and change. It is intended that the scope of the present invention be limited by the claims and their equivalents.

Claims (10)

1. An absorbable/biodegradable surgical implant, characterized in that the absorbable/biodegradable surgical implant is a composite structure, specifically a core woven by a first fibrous material and a shell consisting of a second fibrous braid, the shell wire connecting the core and wrapping the outside of the core; Wherein, the first fiber is a non-absorbable/biodegradable material selected from one or more of polyester, polypropylene, polytetrafluoroethylene, polybutene ester and ultra-high molecular weight polyethylene; The second cellulosic material is an absorbable/biodegradable material selected from the group consisting of polylactic acid, polyglycolide-lactide polymer, polycaprolactone, polydioxanone and polyhydroxyalkyl poly One or more of the esters. 2. The absorbable/biodegradable surgical implant of claim 1, wherein the absorbable/biodegradable surgical implant is in the form of a braided suture. 3. The absorbable/biodegradable surgical implant of claim 1, wherein the core woven from the first fibrous material is a circular braid construction. 4. The absorbable/biodegradable surgical implant of claim 3, wherein the circular braid construction has a cross-sectional diameter ranging from 0.250 mm to 0.850 mm. 5. The absorbable/biodegradable surgical implant of claim 1, wherein the shell woven from the second fibrous material is of a flat braid construction. 6. The absorbable/biodegradable surgical implant of claim 5, wherein the flat braid construction has a cross-sectional width in the range of 1.0 mm to 5.0 mm. 7. The absorbable/biodegradable surgical implant of claim 1, wherein the first fibrous material and the second fibrous material are composed of monofilaments or multifilaments. 8. The absorbable/biodegradable surgical implant according to claim 7, wherein the diameter of the monofilament is in the range of 0.05mm-0.2mm, and the thickness of the multifilament is in the range of 20D-600D . 9 . The absorbable/biodegradable surgical implant according to claim 7 , wherein the color of the monofilament or multifilament is set to a plurality of different colors to play a role of identification. 10 . 10. A method for manufacturing an absorbable/biodegradable surgical implant according to any one of claims 1 to 9, wherein the method comprises: on the same knitting machine, first The first fibrous material is woven into a core, and then the second fibrous material is connected to the core and woven into the shell, and the shell wire is connected to the core and wrapped around the outside of the core; the braiding length of the core is the same as that of the core. The braiding length of the shell can be adjusted arbitrarily, and the braiding length of the shell is smaller than that of the core.

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