CN107335097B

CN107335097B - Composite soft tissue repair material with improved operation hand feeling

Info

Publication number: CN107335097B
Application number: CN201710456663.8A
Authority: CN
Inventors: 张剑; 谢亚运; 周海洋; 胡志前; 程文悦
Original assignee: Shanghai Zhuoruan Medical Technologies Co ltd; Zhuoruan Medical Technology Suzhou Co ltd; Second Military Medical University SMMU
Current assignee: Shanghai Zhuoruan Medical Technologies Co ltd; Zhuoruan Medical Technology Suzhou Co ltd; Second Military Medical University SMMU
Priority date: 2017-06-16
Filing date: 2017-06-16
Publication date: 2020-09-15
Anticipated expiration: 2037-06-16
Also published as: CN107335097A

Abstract

The invention relates to a composite soft tissue repair material with improved operation hand feeling, which comprises a three-dimensional reticular structure membrane biological material and a synthetic material, and is fixed into a whole by cross weaving and/or bundling and sewing through a weaving method. The synthetic material provided by the invention can obviously improve the mechanical strength and flexibility of the hydrated three-dimensional reticular structure membrane biomaterial, and has the advantages of strong material integrity, difficulty in layering, uniform mechanical strength, good biocompatibility and good application prospect.

Description

Composite soft tissue repair material with improved operation hand feeling

Technical Field

The invention belongs to the field of soft tissue repair, and particularly relates to a composite soft tissue repair material with improved operation hand feeling.

Background

Biomaterials include synthetic biomaterials, extracellular matrices, and the like. After the biological material with the three-dimensional reticular structure is implanted into a body, the normal configuration of tissues can be maintained, a bracket is provided for cell regeneration, the growth of cells or collagen of a host is stimulated and induced, and the tissue defect is repaired; meanwhile, the medicine does not contain cellular components causing immune reaction, thus avoiding rejection reaction, being completely absorbed and utilized by organisms and playing a role through body remodeling.

However, the biological material has the problems of softness after hydration, difficult attachment and difficult suture fixation. And the degradation period is short, the balance between the degradation of the implant material and the remodeling of the new tissue cannot be maintained, and long-term elasticity loss or bulging is easy to cause, particularly when a bridging method is applied to repair huge abdominal wall defects.

Disclosure of Invention

The invention aims to solve the technical problem of providing a composite soft tissue repair material with improved operation hand feeling, the synthetic material related to the material can obviously improve the mechanical strength and flexibility of the hydrated three-dimensional reticular structure membrane biomaterial, and the material has strong integrity, is not easy to delaminate, has uniform mechanical strength and good biocompatibility, and has good application prospect.

The composite soft tissue repair material with improved operation hand feeling comprises a three-dimensional reticular structure membrane biological material and a synthetic material, and is fixed into a whole by cross weaving and/or bundling and sewing.

The three-dimensional reticular structure membrane biomaterial is one or more of extracellular matrix, collagen, fibrin, chitosan, chondroitin sulfate, hyaluronic acid, gelatin, P4HB and fibroin.

The extracellular matrix is human or mammal cavity organ submucosa, dermis, pericardium, basement membrane, peritoneum, pleura or amnion with cells and cell components removed, and the material crosslinking degree is 0-100%.

The synthetic material is fiber, thread, ring, film or mesh prepared from polyethylene, polypropylene, polytetrafluoroethylene, polydioxanone, polylactic acid, polyglycolic acid or polyethylene terephthalate.

The ring, the film or the mesh is used as a middle layer or a surface layer of the composite single-layer or multi-layer three-dimensional reticular structure membrane biological material.

The shape of the ring is one or more of a circle, a square, a triangle and a polygon.

The film has through holes to improve the integrity of the material.

The weaving method is characterized in that the synthetic material alternately penetrates through the splicing seams of the three-dimensional reticular membrane biological material up and down without penetrating through a single material; the binding and sewing method is that the synthetic material penetrates through the multi-layer three-dimensional net structure membrane biological material from top to bottom and integrally sews the multi-layer membrane biological material in a mode of at least stabilizing the unidirectional mechanics of the material; both methods may be used simultaneously or independently.

The method of fastening into a whole further comprises using an adhesive or pressure to enhance the integrity of the material.

Compared with the pure three-dimensional net-shaped structure membrane biological material, the integral bending length of the invention is improved by at least 200-300%.

Advantageous effects

The synthetic material can obviously improve the mechanical strength and flexibility of a three-dimensional net-shaped structure biological material such as an extracellular matrix after hydration, obviously improve the operation hand feeling of the material after hydration, and is easy to sew and fix and easy to be attached to a defect surface; the material has strong integrity, is not easy to delaminate when in use or after hydration, can realize the effect of uniform mechanical strength in all directions by uniformly distributing the synthetic material in the composite tissue repair material, can bear multidirectional tension after implantation, and has wider application range.

Drawings

FIG. 1 is a schematic structural view of the composite soft tissue repair material with improved handling in example 1; wherein, 1 is SIS, 2 is polydioxanone suture;

FIG. 2 is a schematic structural view of the composite soft tissue repair material with improved handling in example 2;

FIG. 3 is a schematic structural view of the composite soft tissue repair material with improved handling feeling in example 3; wherein, 1 is a polyethylene terephthalate ring, and 2 is SIS.

Detailed Description

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

Cutting a membrane-shaped porcine small intestinal submucosa extracellular matrix (SIS) into a rectangular appearance of 5 multiplied by 15cm, flatly laying 4 SISs in the axial direction along the edge of a splint in a parallel mode to a required area, keeping the SISs in the axial direction parallel, and paying attention to the fact that the two SISs are placed in a seamless mode as far as possible without overlapping to form a first layer of SIS; fixing one end along the ring direction, taking a proper length of polydioxanone suture, forming stable cross lamination with the first layer of SIS in an up-down alternating mode with the single SIS, taking the 2 nd suture after the suture is fixed, alternately placing the 2 nd suture and the first layer of SIS up and down, simultaneously staggering the 1 st suture up and down, and waiting for subsequent lamination. According to the figure 1, 8 layers of single units are repeatedly overlapped by staggering 90 degrees to form a plurality of layers of units, and the units are compounded into a complete soft tissue repair material by-200 mm Hg, namely the compound soft tissue repair material with improved operation hand feeling.

Example 2

SIS is spliced and combined into a multilayer material with 8 layers and 20 multiplied by 15cm, a polydioxanone suture line with a proper length is taken to circularly sew the multilayer material (figure 2), and the polydioxanone suture line is compounded into a complete soft tissue repair material with-250 mm Hg, namely the composite soft tissue repair material with improved operation hand feeling.

Example 3

The SIS is spliced into sheets with larger areas according to the mode of interlayer dislocation, and the sheets are tiled into four layers, are bonded into a whole by medical adhesives, are used as an upper surface layer and a lower surface layer, and are used as an intermediate layer by polyethylene terephthalate circular rings. The upper and lower surface layers and the ring were placed in order (fig. 3). The medical adhesive is used for adhesion, and the materials are pressed into a whole by-200 mm Hg, namely the composite soft tissue repair material with improved hand feeling is operated.

The tensile force of the sample was measured using an electronic detector. The bending length (mm) of the sample was measured by the slope method according to GB/T18318.1-2009, and the results were as follows:

	breaking force (N/cm)	Bending length (mm)
			Example 1	74.2	33.6
Example 2	70.8	32.0
			Example 3	58.3	27.2
Simple 8-layer SIS	49.5	12.0

Claims

1. A composite soft tissue repair material with improved operation hand feeling is characterized in that: the three-dimensional reticular structure membrane biological material and the fiber, the thread or the annular synthetic material are fixed into a whole by the weaving method, and the weaving method is that the synthetic material alternately penetrates through the splicing seam of the three-dimensional reticular structure membrane biological material from top to bottom without penetrating through a single material.

2. The composite soft tissue repair material with improved handling feel of claim 1, wherein: the three-dimensional reticular structure membrane biomaterial is one or more of extracellular matrix, collagen, fibrin, chitosan, chondroitin sulfate, hyaluronic acid, gelatin, P4HB and fibroin.

3. The composite soft tissue repair material with improved handling feel of claim 2, wherein: the extracellular matrix is human or mammal cavity organ submucosa, dermis, pericardium, basement membrane, peritoneum, pleura or amnion which is removed with cells and cell components.

4. The composite soft tissue repair material with improved handling feel of claim 1, wherein: the synthetic material is polyethylene, polypropylene, polytetrafluoroethylene, polydioxanone, polylactic acid, polyglycolic acid or polyethylene terephthalate.

5. The composite soft tissue repair material with improved handling feel of claim 1, wherein: the ring is used as the middle layer or the surface layer of the composite single-layer or multi-layer three-dimensional reticular structure membrane biological material.

6. The composite soft tissue repair material with improved handling feel of claim 1, wherein: the shape of the ring is one or more of a circle, a square, a triangle and a polygon.

7. The composite soft tissue repair material with improved handling feel of claim 1, wherein: the method of fastening as a whole further comprises the use of adhesives or pressure.