A kind of injection preparation and injection method for treating female stress urinary incontinence

An injection preparation and pressure-sensitive technology, which is applied in the field of injection preparations and injections for the treatment of female stress urinary incontinence, can solve the problems of long-term curative effect not as good as surgical treatment, long-term curative effect reduction, foreign body formation, etc., to relieve female stress Sexual urinary incontinence, no side effects, and the effect of returning to normal life

Active Publication Date: 2021-03-16
CHENGDU QINGKE BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Injection therapy has the characteristics of simple operation, non-invasive safety and repeatable operation, but the shortcoming is that the long-term curative effect is not as good as surgical treatment. The injection filling materials include polytetrafluoroethylene, collagen, silicone polymers, resin composites, and hydroxyapatite. Calcium stone and polyacrylamide hydrogel, etc., compared with surgical treatment, the recurrence rate after filler injection treatment is higher. Although the short-term effect is better, as time goes on, the injection material degrades, and its long-term effect is significantly reduced. There are risks of complications such as sterile abscess, granuloma foreign body formation, and immune rejection

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] An injection preparation for treating female stress urinary incontinence includes mesenchymal stem cells and fillers; the volume ratio of mesenchymal stem cells to fillers is 1:1; the mesenchymal stem cells are derived from umbilical cord placenta donated by healthy puerperas (24 hours after birth), prepared and expanded on a GMP-compliant cell preparation platform until the 3rd to 5th passages were frozen and stored for later use, and passed the quality inspection;

[0020] The filler is mainly sodium hyaluronate with a molecular weight of 1.5 million, which is prepared with normal saline at a concentration of 1% for use;

[0021] Take 1*10 umbilical cord mesenchymal stem cells each time 7 / ml, a total of 3ml, take physiological saline to prepare 3ml of medical grade sodium hyaluronate (molecular weight: 1.5 million) with a concentration of 1%, and mix them together.

[0022] When in use, inject the needle from the vaginal anterior wall mucosa at a distance of 1.5cm f...

Embodiment 2

[0025] An injection preparation for treating female stress urinary incontinence includes mesenchymal stem cells and fillers; the volume ratio of mesenchymal stem cells to fillers is 1:2; the mesenchymal stem cells are derived from autologous endometrium and meet The GMP standard cell preparation platform is prepared and expanded until the 3rd-5th passage is frozen and stored for later use, and the quality inspection is qualified; the culture adopts starvation therapy, and the inoculation density is 1*10 5 / ml, when the growth density reaches about 75%, wash and replace serum-free and phenol-red-free DMEM culture medium, collect the supernatant after 24 hours, and measure its growth factors with the enzyme labeling method as shown in the following table:

[0026] Table 1 Determination of growth factors secreted by umbilical cord-derived mesenchymal stem cells (pg / ml)

[0027] VEGF bFGF TGF PDGF Generation 3 1# 215 42 119 7020 3rd generation 2# 52...

Embodiment 3

[0033] An injection preparation for the treatment of female stress urinary incontinence includes mesenchymal stem cells and fillers; the volume ratio of mesenchymal stem cells to fillers is 1:3; The cell preparation platform was prepared, expanded and cultured until the 3rd to 5th passages were frozen and stored for later use, and the quality inspection was qualified;

[0034] The filler is mainly sodium hyaluronate with a molecular weight of 2 million, which is prepared with normal saline at a concentration of 1% for later use;

[0035] Take 1*10 umbilical cord mesenchymal stem cells each time 7 / ml, a total of 2ml, take physiological saline to prepare 2ml of medical grade sodium hyaluronate (molecular weight: 2 million) with a concentration of 1%, and mix them together.

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Abstract

The invention relates to an injection preparation for treating female stress urinary incontinence. The injection preparation is prepared from a mesenchymal stem cell and a filler with the volume ratio being 1:1 to 1:3. An injection method comprises the steps of inserting a needle for injecting at an anterior vaginal wall mucosa part, which is 1.5cm away from an opening end of a vagina; after a needle head enters gaps of connective tissues at an anterior vaginal wall and a mid-urethral rear wall, adopting a needle inserting point as a center, pushing 0.5 to 1ml of injection preparation into an upper point part, a lower point part, a left point part and a right point part by adopting 0.5cm as a radius, and pushing and withdrawing until a semi-enclosed circumvolution is formed around the mid-urethral rear wall. The mesenchymal stem cell and the filler in the injection preparation in a short time jointly play a role in filling, the symptom of female stress urinary incontinence is relieved, meanwhile, the mesenchymal stem cell stimulates local tissue repair and angiogenesis in a microenvironment through secreting growth factors and cell factors, and a contraction function of urethral sphincter is improved, so that the problem of female stress urinary incontinence is fundamentally solved.

Description

technical field [0001] The invention specifically relates to an injection preparation and an injection method for treating female stress urinary incontinence. Background technique [0002] Stress urinary incontinence (SUI) is a common disease of middle-aged and elderly women. The incidence rate in Europe and the United States is 10-23%, and it is about 18.9% in China. The causes of female stress urinary incontinence are: 1. Women after the age of 40 Epithelial cells begin to shrink as ovarian function begins to decline and estrogen decreases; 2. Muscle damage during pregnancy and childbirth; 3. Congenital dysplasia factors; symptoms manifest as urine when abdominal pressure increases (coughing, sneezing, laughing, weight-bearing, etc.) The involuntary overflow has brought great troubles to the daily life of middle-aged and elderly women, resulting in a significant decline in the quality of life. [0003] At present, the treatment methods for female stress urinary incontinen...

Claims

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Application Information

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Patent Type & AuthorityPatents(China)
IPC IPC(8): A61L27/38A61L27/20A61L27/54
CPCA61L27/20A61L27/3834A61L27/3882A61L27/54A61L2300/412A61L2400/06C08L5/08
Inventor陈静娴张宗蓉海泉高雪华赵峻
OwnerCHENGDU QINGKE BIOTECH