CN112006809A - Suspension band for treating stress urinary incontinence - Google Patents

Abstract

The invention discloses a suspension band for treating stress urinary incontinence, which comprises a rigid arch part, a flexible arch part and a connecting sleeve, wherein the rigid arch part and the flexible arch part are detachably connected through the connecting sleeve, an open clamping groove is formed in the inner cavity of the connecting sleeve, a flexible sheet is integrally formed at the tail end of the rigid arch part, a first spring is connected between the flexible sheets, the flexible sheet is clamped in the clamping groove, and a sealing gasket is arranged at the clamping position of the flexible sheet and the connecting sleeve. The invention relates to the technical field of medical instruments, and provides a suspension band for treating stress urinary incontinence, which is an improvement on the prior art and provides a medical instrument device for relieving female urinary incontinence.

Description

A sling for the treatment of stress urinary incontinence

technical field

The invention relates to the technical field of medical devices, in particular to a sling for treating stress urinary incontinence.

Background technique

Stress urinary incontinence (SUI) is a common disease that mostly occurs in women. Stress urinary incontinence is defined by the International Continence Society (ICS) as a sudden increase in abdominal pressure resulting in an involuntary outflow of urine that is not caused by systolic pressure of the detrusor or the tonic pressure of the bladder wall on the urine . It is characterized by no enuresis under normal conditions, but urine automatically flows out when the abdominal pressure suddenly increases. Although it is not a life-threatening disease, it seriously affects the quality of life and physical and mental health of patients. Therefore, active prevention and treatment of urinary incontinence is the top priority to protect women's health.

Von Giordano first developed the sling for the treatment of stress urinary incontinence in 1907, and his surgical techniques and sling materials have been modified several times since then. The sling can be performed with native fascia (rectus abdominis, lateral fascia, ligamentum teres) or synthetic silicone straps. A sling is inserted under the bladder neck through a lower abdominal incision, and the slings on both sides are sutured to the iliopubic ligament to form a small tension. The bladder-urethral junction supports the urethra and partially compresses the urethra. The cure rate is about 80% to 90%. In addition to the treatment of bladder neck hypermobility anatomical stress urinary incontinence, sling is also effective for internal urethral sphincter disorder stress urinary incontinence and mixed urinary incontinence combined with urge incontinence. It is also effective for multiple urinary incontinence surgeries. Failed cases also have a higher cure rate. In recent years, the medical synthetic sling has developed rapidly. Vaginal tension-free midurethral sling is currently the most widely used surgical method for stress urinary incontinence in the world. Especially for elderly and frail patients, the surgical safety is increased.

The existing sling has poor stability, is easy to fall off after long-term use, and is accompanied by some complications.

SUMMARY OF THE INVENTION

(1) Technical problems solved

In view of the deficiencies of the prior art, the present invention provides a sling for treating stress urinary incontinence, which solves the problems of poor stability and easy falling off of the existing sling.

(2) Technical solutions

In order to achieve the above purpose, the present invention provides the following technical solutions: a sling for the treatment of stress urinary incontinence, comprising a rigid arch, a flexible arch and a connecting sleeve, the rigid arch and the flexible arch are connected by Set of detachable connections.

The inner cavity of the connecting sleeve is provided with an open card slot, the end of the rigid arch is integrally formed with a flexible sheet, a first spring is connected between the flexible sheets, and the flexible sheet is snapped to the card In the groove, a sealing washer is arranged at the clamping joint between the flexible sheet and the connecting sleeve.

A connecting belt is fixedly connected between the connecting sleeves, a flexible sleeve is arranged between the connecting belts, a silicone sheet is arranged in the inner cavity of the flexible sleeve, and both sides of the silicone sheet are connected with a second spring, so One end of the second spring away from the silicone sheet is connected with the connecting strip on the corresponding side.

The flexible arch piece is a hollow structure, and the hollow structure is provided with an electrode sheet.

Preferably, the electrode sheet is signal-connected to an external controller.

Preferably, the rigid arch has a circular arc shape, and the flexible arch has an arc shape.

Preferably, the end of the flexible sheet is in the shape of a hook to prevent falling off.

Preferably, the rigid arch is used to support the vaginal back wall and the vaginal front wall, and the flexible arch is used to buffer the rigid structure against the vaginal wall, which can reduce the pressure of the rigid structure on the vagina.

Preferably, the rigid arch member can be made of titanium alloy, and the flexible member can be made of flexible metal material.

(3) Beneficial effects

The present invention provides a sling for treating stress urinary incontinence. Has the following beneficial effects:

The sling for treating stress urinary incontinence, the present invention is an improvement on the prior art, and provides a medical device for reducing female urinary incontinence, which is small in size and adapts to the shape of the vagina Strong, stable, will not cause sliding and falling off, and the large contact area will not cause local necrosis of tissue, no complications, and good patient compliance; the device of the present invention can be a combination of a rigid structure and a flexible structure, or Can be a separate rigid structure. The rigid structure is mainly used to support the posterior vaginal wall and the anterior vaginal wall, and generate pressure on the bladder trigone and upper urethra to relieve or relieve female urinary incontinence. The flexible structure is mainly used to cushion the vaginal wall of the rigid structure, which can reduce the pressure of the rigid structure on the vagina and avoid tissue necrosis; due to the existence of the flexible structure, it can be well used for different patient vagina sizes, and will not or rarely cause sliding and falling off after implantation. .

Description of drawings

Fig. 1 is the structural representation of the present invention;

2 is a sectional view of the connecting sleeve structure of the present invention;

3 is a sectional view of the flexible arch structure of the present invention;

FIG. 4 is a cross-sectional view of the flexible sleeve structure of the present invention.

In the figure: 1. Rigid arch; 2. Flexible arch; 3. Connecting sleeve; 4. Slot; 5. Flexible sheet; 6. First spring; 7. Sealing washer; 8. Connecting belt; 9. Flexible sleeve ; 10, silica gel sheet; 11, second spring; 12, electrode sheet.

Detailed ways

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

As shown in Figure 1, the present invention provides a technical solution: a sling for treating stress urinary incontinence, comprising a rigid arch 1, a flexible arch 2 and a connecting sleeve 3, the rigid arch 1 and the flexible arch The connecting sleeve 3 is detachably connected. The rigid arch 1 is used to support the posterior vaginal wall and the anterior vaginal wall. The flexible arch 2 is used to buffer the rigid structure against the vaginal wall, which can reduce the pressure of the rigid structure on the vagina. The rigid arch 1 is round. The arc shape, the flexible arch piece 2 is an arc shape, the rigid arch piece 1 can be made of titanium alloy, and the flexible piece 2 can be made of flexible metal material.

As shown in FIG. 2 , the inner cavity of the connecting sleeve 3 is provided with an open slot 4, and the end of the rigid arch 1 is integrally formed with a flexible sheet 5. The end of the flexible sheet 5 is in the shape of a hook, which is used to prevent falling off and is flexible. A first spring 6 is connected between the sheets 5 , the flexible sheet 5 is clamped into the slot 4 , and a sealing washer 7 is provided at the clamping position between the flexible sheet 5 and the connection sleeve 4 .

As shown in FIG. 4 , a connecting belt 8 is fixedly connected between the connecting sleeves 3 , a flexible sleeve 9 is arranged between the connecting belts 8 , a silicone sheet 10 is arranged in the inner cavity of the flexible sleeve 9 , and both sides of the silicone sheet 10 are connected with The second spring 11, one end of the second spring 11 away from the silicone sheet 10 is connected to the connecting strip 8 on the corresponding side.

As shown in FIG. 3 , the flexible arch 2 is a hollow structure, and the hollow structure has a built-in electrode sheet 12 , and the electrode sheet 12 is signal-connected to an external controller.

When in use, the rigid arch 1 is mainly used to support the posterior vaginal wall and the anterior vaginal wall, and generate pressure on the trigone of the bladder and the upper part of the urethra to relieve or relieve female urinary incontinence. The flexible arch 2 is mainly used to buffer the vaginal wall of the rigid arch 1, which can reduce the pressure of the rigid arch 1 on the vagina and avoid tissue necrosis; due to the existence of the flexible arch 2, it can be well used for different vaginal sizes of patients, and will not be affected after implantation. Will or rarely cause slippage and shedding.

By arranging the detachable connecting sleeve 3, it is convenient to replace the rigid arch 1, by arranging the hook-shaped flexible sheet 5, the rigid arch 1 can be prevented from falling off, and by arranging the flexible sleeve 9 and the second spring 11, the suspending belt can be improved. The flexible shape can be used to shock the bladder muscle (within a safe voltage) by setting the electrode sheet 12 to promote normal varicose muscles.

2. The main key technical problems solved

(1) The technical route and method adopted

The present invention is an improvement on the prior art, and provides a medical device for relieving female urinary incontinence, which is small in size, has strong adaptability to the shape of the vagina, has good stability, and does not cause sliding and falling off. , and the large contact area will not cause local necrosis of tissue, no complications, and good patient compliance.

(2) The effect achieved

Treat urinary incontinence.

4. Clinical evaluation criteria:

Efficacy evaluation: The urinary catheter was removed 48h after operation. All patients underwent urodynamic examination after operation, and whether there was bladder outlet obstruction was evaluated according to the results of pressure-urinary flow rate. The patients were followed up for 1 year after operation.

Criteria for cure: The patient can keep the urethra dry even under activities that induce increased abdominal pressure such as coughing; if there is still leakage of urine, the operation is considered a failure.

5. Overall design (including probability analysis of success and failure):

Successful analysis:

Preclinical stage: The cycle is about 2 years

Process research stage: It is expected to cost about 300,000 yuan in half a year to one year.

Preclinical research stage: material selection, workshop design, equipment manufacturing, etc., clinical trial approval, 1 year to 1.5 years, cost about 1.1 million

Clinical stage: the cycle is about 2 to 2.5 years

Clinical research stage: at least 40 clinical trials are required, (it is not excluded that the number of cases may be increased at the request of CFDA), and the total cost of each operation is estimated at 50,000 yuan (need to negotiate with clinicians and patients, which may be reduced or even reduced) A lot), the current conservative estimate is about 2 million.

Analysis of possible failures:

This product is the second original innovative product of the listed product, and there is no similar finished product for reference, and its approval process is bound to be stricter.

6. Risk and benefit analysis of clinical trials:

Products in clinical trials can be taken out of the body at any time, and the insertion and removal will not cause damage to the human body, so there is no risk.

7. The duration of the clinical trial and the reasons for its determination:

This project is a Class III medical device. The clinical sample size is determined according to the expected sensitivity and specificity of product testing. The clinical sample size needs to be statistically significant, which is estimated to be less than 100 cases, and the initial period is 18 months.

8. The number of clinical trial cases for each disease and the reasons for their determination:

Collect samples for urinary incontinence indications for clinical trials of the product. Subject determines:

1. Inclusion criteria: The included cases are recommended to have clinical diagnosis results, and patient-related information can be shared.

(1) Age > 18 years old, gender is not limited;

(2) The collected samples need to have the complete medical records of the subjects and the clinical research record form (CaseReport Form, CRF);

(3) Confirmed as stress urinary incontinence with reference to the diagnostic criteria for urinary incontinence formulated by my country or WHO;

(4) Urinary incontinence patients are people with basically normal vital signs;

(5) The control group was healthy people without urinary incontinence or other major diseases.

2. Exclusion criteria:

(1) Failure to preserve samples as required;

(2) Patients without complete medical record information and CRF form;

(3) Patients before and after the relevant treatment in the rescue stage;

3. Rejection standard:

Patients who do not meet the inclusion criteria of this program. The reasons for the excluded cases should be explained, and the CRF table should be kept for future reference, but not included in the statistical analysis of efficacy.

4. Falling off standard:

(1) Serious adverse events, complications and special physiological changes occur, and it is not advisable to continue receiving

subject.

(2) Those who withdraw by themselves during the experiment.

(3) Cases who withdrew from the trial due to various other reasons, were lost to follow-up or died.

(4) The information is incomplete, which affects the judgment of effectiveness and safety.

9. Select the scope of objects, the number of objects to be selected and the reasons for selection, and the settings of the control group if necessary:

Collect samples for urinary incontinence indications for clinical trials of the product. The clinical sample size is tentatively set at 100 cases.

10. Prediction of side effects and measures to be taken:

Products in clinical trials can be taken out of the body at any time, and the insertion and removal will not cause damage to the human body, so there is no risk.

11. Evaluation method and statistical processing method of clinical performance:

Evaluation method: Adverse events were closely observed and evaluated during the test. For clinically occurring adverse reactions, follow-up was required until symptoms disappeared and recorded.

Statistical analysis: For the statistical analysis of the efficacy of the trial, the data set that conforms to the protocol, that is, the data of all subjects that meet the requirements of the trial protocol, is used for statistical analysis.

To sum up, the sling for the treatment of stress urinary incontinence has a small size, strong adaptability to the shape of the vagina, good stability, will not cause sliding and falling off, and will not cause local necrosis of tissue due to a large contact area, and has no complications. Symptoms occur, and patient compliance is good.

It should be noted that, in this document, relational terms such as first and second are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any relationship between these entities or operations. any such actual relationship or sequence exists. Moreover, the terms "comprising", "comprising" or any other variation thereof are intended to encompass a non-exclusive inclusion such that a process, method, article or device that includes a list of elements includes not only those elements, but also includes not explicitly listed or other elements inherent to such a process, method, article or apparatus.

Although embodiments of the present invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, and substitutions can be made in these embodiments without departing from the principle and spirit of the invention and modifications, the scope of the present invention is defined by the appended claims and their equivalents.

Claims (6)

1. A sling for use in the treatment of stress urinary incontinence, comprising: the device comprises a rigid arch part (1), a flexible arch part (2) and a connecting sleeve (3), wherein the rigid arch part (1) is detachably connected with the flexible arch part through the connecting sleeve (3);

an open clamping groove (4) is formed in the inner cavity of the connecting sleeve (3), flexible sheets (5) are integrally formed at the tail end of the rigid arch piece (1), a first spring (6) is connected between the flexible sheets (5), the flexible sheets (5) are clamped into the clamping groove (4), and a sealing gasket (7) is arranged at the clamping position of the flexible sheets (5) and the connecting sleeve (4);

connecting belts (8) are fixedly connected between the connecting sleeves (3), flexible sleeves (9) are arranged between the connecting belts (8), a silicon sheet (10) is arranged in an inner cavity of each flexible sleeve (9), second springs (11) are connected to two sides of each silicon sheet (10), and one ends, far away from the silicon sheets (10), of the second springs (11) are connected with the connecting belts (8) on the corresponding sides;

the flexible arch piece (2) is of a hollow structure, and an electrode plate (12) is arranged in the hollow structure.

2. A sling for use in the treatment of stress urinary incontinence as claimed in claim 1, wherein: the electrode plate (12) is in signal connection with an external controller.

3. A sling for use in the treatment of stress urinary incontinence as claimed in claim 1, wherein: the rigid arch part (1) is arc-shaped, and the flexible arch part (2) is arc-shaped.

4. A sling for use in the treatment of stress urinary incontinence as claimed in claim 1, wherein: the tail end of the flexible sheet (5) is in a hook shape and used for preventing falling off.

5. A sling for use in the treatment of stress urinary incontinence as claimed in claim 1, wherein: the rigid arch part (1) is used for supporting the posterior wall and the anterior wall of the vagina, and the flexible arch part (2) is used for buffering the rigid structure against the vaginal wall, so that the pressure of the rigid structure against the vagina can be reduced.

6. A sling for use in the treatment of stress urinary incontinence as claimed in claim 1, wherein: the rigid arch part (1) can be made of titanium alloy, and the flexible part (2) can be made of flexible metal material.

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