Method for tightening vagina by using biological bridle

Abstract

The invention discloses a method for tightening a vagina by using a biological band, which comprises the following steps: S1, preparing the biological band which is made of decellularized allogeneic dermis and mainly comprises elastin, fibronectin, hyaluronic acid, I-type collagen, III-type collagen, IV-type collagen and VII-type collagen; s2, the biological bridle is in a strip shape of a 3D structure, the specification of the biological bridle is 1 * 15 cm, and in the using process, the biological bridle is cut into different lengths according to using requirements. The problems that in a traditional vaginal contraction operation, part of vaginal mucosa or muscular layer needs to be cut off through an incision, and suturing and tightening are conducted, so that tissue damage is large, postoperative pain is obvious, the recovery period is long, mucosa nerve damage, sexual sensitivity reduction, scar formation and the like are likely to occur after operation, and the vaginal function and life quality are affected are solved.

Description

Technical Field

[0001] The present invention relates to the field of medical technology, and in particular to a method for tightening the vagina using a biological band. Background Art

[0002] The method of using a biological band to tighten the vagina is a type of medical device use. The purpose of traditional anterior and posterior vaginal wall repair surgery is to fold and suture the vaginal muscles and the bladder surface fascia or vaginal side wall tissue to restore the protruding bladder and vagina to their normal positions. The surgical method usually separates the vaginal mucosa, cuts off the excess vaginal mucosa, and then sutures layer by layer. The protrusion of the anterior and posterior vaginal walls is a clinical manifestation of tissue displacement caused by relaxation of the pelvic floor muscles.

[0003] There is also a tightening method that uses non-biological material implants. Non-biological materials are polypropylene plastic patches and slings. These materials are fixed behind the pubic bone and through the obturator foramen. Due to the damage caused by too many blind operations, corresponding complications occur, and the mucosal erosion and exposure of the implanted materials are particularly obvious in the long term. The vaginal wall hardens and it is expensive. The therapeutic principle of non-biological material implantation is to stimulate tissue and produce scars, while the modified biological band only produces scars where needed.

[0004] The 3D bio-band modifies the muscle structure around the vagina, folding and gathering these muscles to achieve a vaginal tightening effect. The long-term effect is not achieved through the thread or band, but through the adhesion and fusion of muscle tissue. The 3D bio-band folds and gathers the corpus spongiosum, superficial transverse perineal muscles, and levator ani muscles, providing a certain amount of filling.

[0005] Traditional vaginal tightening surgery requires removing part of the vaginal mucosa or muscle layer through an incision and suturing and tightening it, which causes severe tissue damage, significant postoperative pain, and a long recovery period. In addition, problems such as mucosal nerve damage, decreased sexual sensitivity, and scar formation are prone to occur after the operation, affecting vaginal function and quality of life. Summary of the Invention

[0006] The purpose of the present invention is to provide a method for tightening the vagina using a biological band, which solves the problem that traditional vaginal tightening surgery requires removing part of the vaginal mucosa or muscle layer through incision and suturing and tightening, resulting in severe tissue damage, obvious postoperative pain, and a long recovery period. In addition, the postoperative mucosal nerve damage, decreased sexual sensitivity, scar formation and other problems are prone to occur, affecting vaginal function and quality of life.

[0007] To achieve the above-mentioned object, the present invention provides the following technical solution: a method for tightening the vagina using a biological band, comprising the following steps:

[0008] S1. Prepare the bio-band. The material of the bio-band is acellular allogeneic dermis, the main components of which are elastin, fibronectin, hyaluronic acid, type I collagen, type III collagen, type IV collagen, and type VII collagen.

[0009] S2. The biobelt is a 3D strip with a size of 1×15 cm. During use, it can be cut into different lengths according to the needs.

[0010] S3. The surface of the biobelt is porous, and cells attach and new tissues grow into the pores of the biobelt;

[0011] S4. The bio-band is a natural cell scaffold that induces autologous cell proliferation and generates new connective tissue and blood vessels. After being sutured into human tissue, the bio-band gradually degrades and is replaced by autologous tissue, eventually fusing with the surrounding tissue.

[0012] S5. Perform surgery on the patient using the prepared biological band.

[0013] As a preferred method of tightening the vagina using a biological band according to the present invention, the surgery is autologous mucosal mid-urethral plication.

[0014] As a preferred method of tightening the vagina using a biological band according to the present invention, the autologous mucosal midurethral plication procedure comprises the following steps:

[0015] S1. Under general anesthesia, the patient is placed in the lithotomy position and the vagina is filled with water to form a water cushion to support the vaginal wall.

[0016] S2. Make a longitudinal incision of the vaginal mucosa along the vaginal wall 1 cm above the external urethral opening, with a length of 1-3 cm.

[0017] S3. Bluntly dissect the vaginal tissue from the submucosal side to the sides until the inferior margin of the pubic bone is exposed, forming a mucosal flap that matches the width of the mid-urethra.

[0018] S4. Lift the mucosal flap upward to cover the upper area of ​​the mid-urethra.

[0019] S5. Use an absorbable bio-band to fix and suture the edge of the mucosal flap to the vaginal tissue around the urethra to form a support structure for the mid-urethra.

[0020] As a preferred method of tightening the vagina using a biological band of the present invention, when preparing the biological band, dermal tissue from a healthy donor is selected as a base material, and the dermal tissue is preliminarily cleaned to remove blood, fat and epidermal layer.

[0021] As a preferred method of tightening the vagina using a biological band of the present invention, the cell components in the substrate are removed by chemical treatment or physical treatment to retain the extracellular matrix, wherein the chemical treatment is the use of detergents or enzymatic hydrolysis, and the physical treatment is ultrasonic treatment or mechanical stirring to assist decellularization, ensuring that the cell residual rate is less than 0.1%.

[0022] As a preferred method of tightening the vagina using a biological band of the present invention, the decellularized dermal tissue is processed into a 3D strip structure by freeze drying, microfluidic bubble technology or mold forming, and the strip has a size of 1×15 cm and a porosity in the range of 50–500 μm.

[0023] As a preferred method of tightening the vagina using a bio-band according to the present invention, the 3D band is cross-linked to enhance its mechanical strength and simulate the mechanical properties of human tissue.

[0024] As a preferred method of tightening the vagina using a bio-band according to the present invention, bioactive factors are loaded into the porous structure.

[0025] As a preferred method of tightening the vagina using a bio-band according to the present invention, the bioactive factors are loaded into the porous structure by electrospinning technology, wherein the electrospinning voltage is 10-30 kV and the receiving distance is 10-20 cm.

[0026] As a preferred method of the present invention for tightening the vagina using a bio-band, the bio-band is sterilized by gamma ray sterilization or ethylene oxide sterilization, the degradation performance, biocompatibility and sterility of the sterilized material are verified, and the performance of the bio-band is evaluated through cytotoxicity tests, mechanical property tests and in vitro degradation experiments.

[0027] Compared with the prior art, the present invention has the following beneficial effects:

[0028] 1. The present invention uses a biological band to tighten the vagina, which can regenerate its functions and reverse vaginal aging. It uses its good mechanical properties to re-adhere damaged muscles and other tissues, restore the normal structure and function of the perineum, reverse vaginal aging, regenerate tissue, and delay aging. The 3D biological band is a natural cell scaffold. After implantation, a large number of cells will grow on the cell scaffold to form new connective tissue and blood vessels, delaying vaginal aging, tissue filling, and preventing vaginal aging. The 3D biological band can stimulate the vaginal mucosa to produce a large amount of type III collagen, which can prevent vaginal aging caused by vaginal mucosal atrophy, thinning or disappearance of the mucosa.

[0029] 2. Due to its excellent mechanical properties and unique material properties, the 3D bio-band of this invention restores the tissues of the anterior and posterior vaginal walls to their normal anatomical position, tightening and securing them. The entire process requires no incision, separation, cutting, or damage to the vaginal mucosal tissue, thus preserving the integrity of the vaginal mucosa to the greatest extent possible, thereby protecting its function.

[0030] 3. The 3D bio-band of this invention achieves tissue replacement, structural reconstruction, and anatomical restoration. It repositions the bladder neck and proximal urethra, combines with manipulation of the anterior vaginal wall, alters the muscle structure around the urethra, and increases pressure on the muscles around the urethra to counteract pressure from the abdominal cavity or bladder, achieving the therapeutic purpose of treating stress urinary incontinence. It primarily supports and supports the mid-urethra. It is precisely positioned and does not require fixation. Its mechanical and filling properties increase the support of the anterior vaginal wall; its anti-aging properties provide a certain degree of protection for the anterior vaginal wall, ensuring that the entire operation lasts longer. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 It is a schematic diagram of the process of the present invention. DETAILED DESCRIPTION

[0032] See also Figure 1 , a method for tightening the vagina using a bio-band, comprising the following steps:

[0033] S1. Prepare the bio-band. The material of the bio-band is acellular allogeneic dermis, the main components of which are elastin, fibronectin, hyaluronic acid, type I collagen, type III collagen, type IV collagen, and type VII collagen.

[0034] S2. The biobelt is a 3D strip with a size of 1×15 cm. During use, it can be cut into different lengths according to the needs.

[0035] S3. The surface of the biobelt is porous, and cells attach and new tissues grow into the pores of the biobelt;

[0036] S4. The bio-band is a natural cell scaffold that induces autologous cell proliferation and generates new connective tissue and blood vessels. After being sutured into human tissue, the bio-band gradually degrades and is replaced by autologous tissue, eventually fusing with the surrounding tissue.

[0037] S5. Perform surgery on the patient using the prepared biological band.

[0038] Furthermore, the surgery is an autologous mucosal mid-urethral plication.

[0039] Furthermore, the autologous mucosal midurethral plication procedure includes the following steps:

[0040] S1. Under general anesthesia, the patient is placed in the lithotomy position and the vagina is filled with water to form a water cushion to support the vaginal wall.

[0041] S2. Make a longitudinal incision of the vaginal mucosa along the vaginal wall 1 cm above the external urethral opening, with a length of 1-3 cm.

[0042] S3. Bluntly dissect the vaginal tissue from the submucosal side to the sides until the inferior margin of the pubic bone is exposed, forming a mucosal flap that matches the width of the mid-urethra.

[0043] S4. Lift the mucosal flap upward to cover the upper area of ​​the mid-urethra.

[0044] S5. Use an absorbable bio-band to fix and suture the edge of the mucosal flap to the vaginal tissue around the urethra to form a support structure for the mid-urethra.

[0045] Furthermore, when preparing the bio-band, the dermal tissue of a healthy donor is selected as the base material, and the dermal tissue is initially cleaned to remove blood, fat and epidermal layer.

[0046] Furthermore, the cell components in the substrate are removed by chemical treatment or physical treatment, while retaining the extracellular matrix. The chemical treatment is the use of detergents or enzymatic hydrolysis, and the physical treatment is ultrasonic treatment or mechanical stirring to assist decellularization, ensuring that the cell residual rate is less than 0.1%.

[0047] Furthermore, the decellularized dermal tissue was processed into a 3D strip structure by freeze-drying, microfluidic bubble technology or mold molding. The strip size was 1×15 cm and had a porosity range of 50–500 μm.

[0048] Furthermore, the 3D strips were cross-linked to enhance mechanical strength and simulate the mechanical properties of human tissue.

[0049] Furthermore, bioactive factors are loaded into the porous structure.

[0050] Furthermore, the bioactive factors were loaded into the porous structure by electrospinning technology, with an electrospinning voltage of 10–30 kV and a receiving distance of 10–20 cm.

[0051] Furthermore, the bio-band was sterilized by gamma ray sterilization or ethylene oxide sterilization to verify the degradation performance, biocompatibility and sterility of the sterilized material, and the performance of the bio-band was evaluated through cytotoxicity tests, mechanical property tests and in vitro degradation experiments.

[0052] The above are only preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A method for tightening the vagina using a bio-band, characterized in that: The following steps are involved: S1. Prepare the bio-band. The material of the bio-band is acellular allogeneic dermis, the main components of which are elastin, fibronectin, hyaluronic acid, type I collagen, type III collagen, type IV collagen, and type VII collagen. S2. The biobelt is a 3D strip with a size of 1×15 cm. During use, it can be cut into different lengths according to the needs. S3. The surface of the biobelt is porous, and cells attach and new tissues grow into the pores of the biobelt; S4. The bio-band is a natural cell scaffold that induces autologous cell proliferation and generates new connective tissue and blood vessels. After being sutured into human tissue, the bio-band gradually degrades and is replaced by autologous tissue, eventually fusing with the surrounding tissue. S5. Perform surgery on the patient using the prepared biological band.

2. The method for tightening the vagina using a bio-band according to claim 1, characterized in that: The surgery was an autologous mucosal mid-urethral plication.

3. The method for tightening the vagina using a bio-band according to claim 2, characterized in that: Autologous mucosal midurethral plication involves the following steps: S1. Under general anesthesia, the patient is placed in the lithotomy position and the vagina is filled with water to form a water cushion to support the vaginal wall. S2. Make a longitudinal incision of the vaginal mucosa along the vaginal wall 1 cm above the external urethral opening, with a length of 1-3 cm. S3. Bluntly dissect the vaginal tissue from the submucosal side to the sides until the inferior margin of the pubic bone is exposed, forming a mucosal flap that matches the width of the mid-urethra. S4. Lift the mucosal flap upward to cover the upper area of ​​the mid-urethra. S5. Use an absorbable bio-band to fix and suture the edge of the mucosal flap to the vaginal tissue around the urethra to form a support structure for the mid-urethra.

4. The method for tightening the vagina using a bio-band according to claim 3, characterized in that: When preparing the bio-band, the dermal tissue of a healthy donor is selected as the base material, and the dermal tissue is initially cleaned to remove blood, fat and epidermal layer.

5. The method for tightening the vagina using a bio-band according to claim 4, characterized in that: The cell components in the substrate are removed by chemical treatment or physical treatment, while the extracellular matrix is ​​retained. Chemical treatment includes the use of detergents or enzymatic hydrolysis, and physical treatment includes ultrasonic treatment or mechanical stirring to assist decellularization, ensuring that the cell residual rate is less than 0.1%.

6. The method for tightening the vagina using a bio-band according to claim 5, characterized in that: The decellularized dermal tissue is processed into a 3D strip structure by freeze drying, microfluidic bubble technology or mold forming. The strip has a size of 1×15 cm and a porosity in the range of 50–500 μm.

7. The method for tightening the vagina using a bio-band according to claim 6, characterized in that: The 3D strips were cross-linked to enhance mechanical strength and mimic the mechanical properties of human tissue.

8. The method for tightening the vagina using a bio-band according to claim 7, characterized in that: Loading bioactive factors in the porous structure.

9. The method for tightening the vagina using a bio-band according to claim 8, characterized in that: The bioactive factors were loaded into the porous structure by electrospinning technology with a voltage of 10–30 kV and a receiving distance of 10–20 cm.

10. The method for tightening the vagina using a bio-band according to claim 9, characterized in that: The bio-bands were sterilized by gamma ray sterilization or ethylene oxide sterilization to verify the degradation performance, biocompatibility and sterility of the sterilized materials. The performance of the bio-bands was evaluated through cytotoxicity tests, mechanical property tests and in vitro degradation experiments.

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