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Pelvic floor biological patch and preparation method thereof

A biological patch, pelvic floor technology, applied in the direction of tissue regeneration, medical science, prosthesis, etc., can solve the problems of incomplete regeneration, loss of fold structure, etc., to reduce the amount of material implantation, improve mechanical properties, The effect of ensuring biosafety

Active Publication Date: 2019-07-12
BEIJING DATSING BIO TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, because most of the biological patches are derived from biofilms (such as small intestinal submucosa, bladder submucosa, and pericardium), these biofilms are mostly fascia tissues or membranous materials, so after a series of treatments such as decellularization, they are still intact. The patch made of membranous material is relatively flat. Although it can gradually metabolize and promote the regeneration of surrounding defect tissue after implantation in the body, because the patch is usually implanted around the vaginal wall in a relatively flat state, it guides the surrounding tissue to gradually recover. Attaches to the patch and regenerates a smooth tissue along the patch, so that the inner wall of the vagina loses its original wrinkled structure after the patch is implanted
Incomplete regeneration of original tissue

Method used

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  • Pelvic floor biological patch and preparation method thereof
  • Pelvic floor biological patch and preparation method thereof
  • Pelvic floor biological patch and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Embodiment 1 pelvic floor biological patch and its preparation

[0031] The porcine small intestinal submucosa acellular matrix material was prepared, and four layers of porcine small intestinal submucosa acellular matrix material were cross-compacted and dried to form a 10cm×10cm sheet material.

[0032] Make a through hole with a diameter of 0.4cm on the sheet material (S≈0.125cm 2 ), guaranteed every 1cm 2 Evenly punch two round holes with a diameter of 0.4cm. The perforated area accounts for 25% of the total area. A cross-shaped strip with a width of 1 cm and running through the entire patch is reserved at the center point of the sheet material, and no holes are punched on the cross-shaped strip.

[0033] Wet the two sheets of above-mentioned perforated materials with physiological saline, and stagger the perforated parts by a certain distance, so that the two layers of materials do not form through holes. The material was compacted with clamps and freeze-dried,...

Embodiment 2

[0035] Embodiment 2 pelvic floor biological patch and its preparation

[0036] The porcine small intestinal submucosa acellular matrix material was prepared, and two layers of porcine small intestinal submucosa acellular matrix material were cross-compacted and dried to prepare a sheet material with a diameter of 12 cm.

[0037] Make a parallelogram hole on the sheet material, the length of the bottom side of the hole is 0.5cm, and the height is 0.1cm (S≈0.05cm 2 ), guaranteed per cm 2 Punch 10 holes evenly. The perforated area accounts for 50% of the total area.

[0038]Use 0.1% sodium hyaluronate solution to wet the two pieces of the above-mentioned punched material, and stagger the punched parts by a certain distance, so that the two layers of materials do not form through holes. The material was compacted with clamps and freeze-dried, sterilized by Co60 radiation, and packaged for preservation. After testing, the tensile strength of the perforated part of the material ...

Embodiment 3

[0039] Embodiment 3 pelvic floor biological patch and its preparation

[0040] To prepare porcine small intestinal submucosa acellular matrix material, 10 layers of porcine small intestinal submucosa acellular matrix material were cross-compacted and dried, and prepared into a trapezoidal sheet material with an upper base of 9 cm, a lower base of 13 cm, and a height of 12 cm.

[0041] The bottom edge of the parallelogram hole on the sheet material is 2cm, and the height is 0.5cm (S≈1cm 2 ), guaranteed per cm 2 Punch 0.8 holes evenly. The perforated area accounts for 40% of the total area. A cross-shaped strip with a width of 3 cm and running through the entire patch is reserved at the center point of the sheet material, and no holes are punched on the cross-shaped strip. The samples were sterilized by ethylene oxide and used after 21 days of dialysis.

[0042] After testing, the tensile strength of the hole in the material is 23N / cm. The material was attached to the upper...

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Abstract

The invention provides a biological patch for pelvic floor, and a preparation method of the biological patch. The biological patch for the pelvic floor is prepared by compounding and punching a biodegradable natural acellular matrix material with low immunogenicity and good biocompatibility; after being implanted into a body, the material is gradually degraded; by means of technologies of compounding and punching, the absolute amount of an implant and the risk of immune are reduced while the mechanical support in the body is guaranteed; furthermore, the compliance between the implant material and soft tissues of the pelvic floor is improved; therefore, the regeneration and repair of the tissues of the pelvic floor are promoted, and the aim of treating POP is achieved by reinforcing soft tissue fascia.

Description

technical field [0001] The invention relates to the field of medical biological materials, in particular to a pelvic floor biological patch and a preparation method thereof. Background technique [0002] Female pelvic floor dysfunction (PFD) mainly manifests as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). It is reported that 50% of multiparous women have pelvic floor dysfunction to varying degrees. With the development of society and economy, the trend of population aging and the improvement of people's requirements for health and quality of life, the incidence of pelvic dysfunction is increasing year by year, and it has become a gynecological problem that seriously affects the health and quality of life of middle-aged and elderly women. Patients with pelvic floor dysfunction have varying degrees of weak connective tissue or changes in anatomical structures. Surgery is the main method for treating more serious pelvic floor dysfunction. The surgical meth...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61L27/36
CPCA61L27/3633A61L27/365A61L27/3687A61L27/3691A61L27/3695A61L2430/02
Inventor 宋岩峰王凤玫牛睿赵小龙李湘杰李次会
Owner BEIJING DATSING BIO TECH
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