CN110559481A

CN110559481A - Surgical implant material for mechanical repair of pelvic floor muscles of gynecology

Info

Publication number: CN110559481A
Application number: CN201911063858.1A
Authority: CN
Inventors: 赖琛; 奚廷斐; 盛立远
Original assignee: PKU-HKUST SHENZHEN-HONGKONG INSTITUTION
Current assignee: PKU-HKUST SHENZHEN-HONGKONG INSTITUTION
Priority date: 2019-11-04
Filing date: 2019-11-04
Publication date: 2019-12-13

Abstract

the invention provides a surgical implant material for mechanical repair of pelvic floor muscles of gynecology, which comprises a reticular bacterial cellulose substrate material containing a collagen compound, wherein the porosity of the material is 30 ~ 60%, the pore diameter is 1 ~ 2mm, the endotoxin content is not higher than 0.25EU/ml, and the atomic percentage of nitrogen in the material is 5 ~ 15%.

Description

Surgical implant material for mechanical repair of pelvic floor muscles of gynecology

Technical Field

the invention relates to a medical surgical material, in particular to a surgical implant material for mechanical repair of pelvic floor muscles in gynecology.

background

however, as women age, pelvic floor muscles gradually relax, and pelvic organs descend and enter the vaginal wall when the fascia and ligaments do not bear the respective weights, resulting in female pelvic floor dysfunctional diseases such as urinary incontinence, uterine prolapse, etc., with a rise in the disease rate of about 40 ~ 60% in middle ~ aged and elderly women, surgical implantation of the respective materials is the only effective treatment.

To overcome the drawbacks of the polypropylene surgical implant materials, it has also been proposed to use bacterial cellulose in mesh sheets for gynecological pelvic floor patches, as disclosed in patent application 201410089918.8. However, when the mesh sheet is used for being implanted into a human body such as a vagina, the mesh sheet is very easy to fold and curl along with movement, so that surrounding tissues cannot grow into the mesh sheet, severe inflammatory reaction is caused, and the operation fails; and when the bacterial cellulose is used for gynecological pelvic floor patches, the tissue growth time is slow due to poor compatibility with pelvic floor tissues, so that the recovery period after the operation is too long.

Disclosure of Invention

the invention provides a surgical implant material with good tissue compatibility for the mechanical repair of pelvic floor muscles in gynecology. The invention is realized by the following scheme.

A surgical implantation material for mechanical restoration of gynecological pelvic floor muscles comprises a reticular bacterial cellulose substrate material containing a collagen compound, wherein the porosity of the material is 30 ~ 60%, the pore diameter is 1 ~ 2mm, the endotoxin content is not higher than 0.25EU/ml, and the atomic percentage of nitrogen in the material is 5 ~ 15%.

the surface root mean square roughness of the material is 40 ~ 50 nm, and the material has the characteristics of better softness, smoothness, conformability and the like.

the material has the breaking strength of 15 ~ 28Mpa and the sewing strength of 8 ~ 12N, and has better applicability.

the preparation method of the surgical implant material for the mechanical repair of the pelvic floor muscles of the gynecology department can adopt the following steps:

firstly, punching holes on a bacterial cellulose material by adopting a laser cutting machine processing mode to obtain a reticular bacterial cellulose substrate material with the porosity of 30 ~ 60% and the hole diameter of 1 ~ 2 mm;

secondly, placing the reticular base material in a sodium hydroxide aqueous solution at 50 ~ 90 ℃ for mixing treatment for more than 10 hours, separating and purifying by a dialysis method at room temperature by using water as a solvent until the conductivity of the separated sodium hydroxide aqueous solution is lower than 1 mu S/cm, stopping dialysis, removing water from the separated and purified reticular base material until the water content is 18 ~ 30%, sealing, and irradiating the sealed reticular base material for 30 ~ 60 seconds by using gamma rays with the dosage of 20 ~ 50kGy, wherein the content of endotoxin is not higher than 0.25 EU/ml;

thirdly, the reticular bacterial cellulose substrate material treated in the second step is placed into a solution of a collagen compound with a certain concentration, is dried at normal temperature after standing for more than 24 hours, and is placed into an aqueous solution of an aldehyde compound with a mass percentage concentration of 0.5 ~ 10 percent and is placed into an aqueous solution of an aldehyde compound with a mass percentage concentration of 30 ~ 50 percent^oCsoaking for 50 ~ 70 minutes, and then soaking the material in 100 ~ 120 parts of the solution^oCand reacting for 10 ~ 20 seconds to prepare the surgical implant material for the mechanical repair of the pelvic floor muscles of the gynecology.

the steps in the above preparation process are not limited, for example, the second step of removing endotoxin can be performed by soaking in sodium hydroxide solution at high temperature.

Compared with the prior art, the surgical implant material for the mechanical repair of the pelvic floor muscles of the gynecology department, which is prepared by the invention, has the advantages that the collagen is crosslinked on the surface of the bacterial cellulose and in the fiber gaps, so that the biocompatibility of the material is good, the material is well fused with the tissues of the back wall of the vagina, the material still basically has the characteristics of softness, smoothness, close fit and the like of the bacterial cellulose substrate, the damage of the surrounding tissues caused by friction can be reduced, and the bleeding and inflammatory reaction are reduced; the strength properties of the material are sufficient to meet the application requirements.

Detailed Description

Example 1

The surgical implant material for the mechanical repair of the pelvic floor muscles of the gynecology department is prepared according to the following steps,

The second step is that: placing the reticular base material in 0.1 mol/L sodium hydroxide aqueous solution at 90 ℃ for mixing treatment for 60 hours, wherein the mass ratio of the reticular base material to the NaOH solution is 1: 90; separating and purifying by dialysis method at room temperature with water as solvent until the conductivity of the separated sodium hydroxide aqueous solution is lower than 1 μ S/cm, removing water from the separated and purified reticular substrate material to water content of 18%, sealing, and irradiating with 30kGy gamma ray for 50S to obtain endotoxin content of 0.25 EU/ml;

The third step: placing the reticular bacterial cellulose substrate material treated in the second step into a solution of a collagen compound with the mass concentration of 10%, standing for 24 hours, and drying at normal temperature; then putting the substrate material into glutaraldehyde 37 with the mass percentage concentration of 2%^oCIs soaked in the aqueous solution of (2) for 70 minutes, and then the soaked material is soaked in 115^oAnd C, reacting for 10 seconds to prepare the surgical implant material for the mechanical repair of the pelvic floor muscles of the gynecology department.

the material prepared by the method has the porosity of 30 ~ 60% and the pore diameter of 1 ~ 2mm, the content of endotoxin is 0.25EU/ml by a turbidity method, the atomic percent of nitrogen in the material is 5.57% by detection, the surface root mean square surface roughness of the material is 47.8 nm by an atomic force microscope, the breaking strength is 15 ~ 28Mpa by a mechanical property test, and the sewing strength is 8 ~ 12N.

Example 2

Substantially the same procedure as in example 1 was followed, with the following differences:

1. In the second step, the endotoxin of the reticular base material is removed to a content lower than 0.25EU/ml by adopting a sodium hydroxide solution high-temperature soaking method.

2. In the third step, the concentration of the collagen compound is 5 percent, the collagen compound is kept stand for 48 hours, the collagen compound is soaked in aqueous solution of glutaraldehyde with the mass percentage concentration of 10 percent for 50 minutes, and the soaked material is placed in a place of 120 percent^oAnd C, reacting for 20 seconds.

the material prepared by the method has the porosity of 30 ~ 60% and the pore diameter of 1 ~ 2mm, the content of endotoxin is 0.23EU/ml by a turbidity method, the atomic percent of nitrogen in the material is 14.87% by detection, the surface root mean square surface roughness of the material is 40.5 nm by an atomic force microscope detection, the fracture strength is 15 ~ 28Mpa by a mechanical property test, and the sewing strength is 8 ~ 12N.

Claims

1. the surgical implant material for mechanical restoration of gynecological pelvic floor muscles is characterized in that a reticular bacterial cellulose substrate material contains a collagen compound, the porosity of the material is 30 ~ 60%, the pore diameter is 1 ~ 2mm, the endotoxin content is not higher than 0.25EU/ml, and the atomic percentage of nitrogen in the material is 5 ~ 15%.

2. the surgical implant material for the mechanical restoration of the gynecological pelvic floor muscles according to claim 1, wherein the surface roughness of the material is 40 ~ 50 nm in root mean square.

3. the surgical implant material for the mechanical restoration of the gynecological pelvic floor muscles according to claim 1 or 2, wherein the fracture strength of the material is 15 ~ 28Mpa, and the suture strength is 8 ~ 12N.