WO2019205608A1

WO2019205608A1 - Sling for treating urinary incontinence and preparation method therefor

Info

Publication number: WO2019205608A1
Application number: PCT/CN2018/116859
Authority: WO
Inventors: 李根云; 李建民; 顾奇巍; 韦建宇
Original assignee: 苏州优迈医疗器械有限公司
Priority date: 2018-04-24
Filing date: 2018-11-22
Publication date: 2019-10-31
Also published as: CN108652785A

Abstract

A sling for treating urinary incontinence, having a long rectangular shape. The sling comprises both ends distributed in a length direction and both side edges distributed in a width direction. Each side edge is provided with a damping portion and a smooth portion. The smooth portion is an intact fiber for eliminating sharp broken fibers and maintaining curved in the shape of natural woven. The sling having a special edge is obtained by being opened at a vein at a specific position of the sling and being torn in a specific direction. The damping portion is a molten ball formed by means of heat treatment, and the diameter of the molten ball is greater than that of the fiber. The sling completely maintains the intact fiber having a woven mesh characteristic, and improves the retention capacity on both ends of the sling, so that the tension of the sling is effectively maintained.

Description

Sling for treating urinary incontinence and preparation method thereof

Technical field

The invention belongs to the technical field of surgical instruments and manufacturing methods, and particularly relates to a sling for treating urinary incontinence and a manufacturing method thereof.

Background technique

Female urinary incontinence is a common disease in women. According to global statistics, the prevalence rate is close to 50%, and about half of them are Stress Urinary Incontinence (SUI). Stress urinary incontinence means that when the bladder pressure is greater than the maximum urethral pressure, in the absence of contraction of the bladder detrusor, the urine also involuntarily overflows from the external urethra, especially when the abdominal pressure suddenly increases, such as: laughing, sneezing, Coughing occurs at the same time. Postmenopausal populations are more susceptible to morbidity. Most of the causes of the disease are due to birth injury during childbirth, estrogen levels after menopause, and soft tissue relaxation at the pelvic floor. SUI began to be considered one of the top five diseases affecting human health in the mid-1990s and is known as "social cancer." Especially in China, with the further aging of the population, SUI has received more and more attention. A recent investigation on the incidence of urinary incontinence in Beijing alone found that 23%-45% of females had varying degrees of urinary incontinence, and about 7% had significant symptoms of urinary incontinence, of which about 50% were stress urinary incontinence. A group of foreigners reported 37.7% of women with urinary incontinence over 60 years of age. To this end, the search for effective methods for treating SUI has urgent and significant clinical significance.

In order to treat urinary incontinence, U.S. Patent No. 6,080,845, Japanese Patent Publication No. JP-A-1998-155897, and Korean Patent Publication No. KR2003-34218, etc., disclose the insertion of an elastic insert into the vagina or injection into a soft tissue around the urethra or ureter. Techniques for hydrogel particles (polymer: polymer). In recent years, with the advancement of science and technology and the deep understanding of the principle of urinary incontinence, a variety of minimally invasive methods have been applied, that is, the best therapeutic effect is obtained by taking the surgical operation and technical methods that minimize the damage to the patient. At present, one treatment for stress urinary incontinence is tension-free suspension in the middle of the transvaginal urethra, that is, a 2 cm incision is made in the anterior wall of the vagina, and a suspender placed at the bottom of the middle part of the urethra is inserted into the soft tissue of the body through a puncture device. In the gap, the pelvic floor soft tissue is enhanced to support the urethra. Thus, when the abdominal pressure is increased, the extent of the downward movement of the urethra is limited by the implanted sling, and the ureter is compressed and closed, so that the patient's leakage phenomenon is controlled.

In the existing sling implant surgery for treating SUI, the slings used are mostly polypropylene woven meshes having a specific length, width and thickness, for example, woven slings having a thickness of 1 mm, a width of about 1 cm, and a length of about 40 cm. However, since the sling is usually made by using scissors, laser or other contact cutting tools and methods, the filaments at the edge of the sling are often rough and sharp, and the direct use may cause irritation or damage to the soft tissue experienced. Even more, even doctors who perform surgery will be cut and cut. Even if the surgical procedure successfully implants the sling, it is difficult to avoid the irritation of the vaginal tract and the surrounding tissue on both sides of the sling, and once the body bends and squeezes the sling in the daily life, the side will inevitably cause the surrounding tissue to be produced. Pain stimulates and affects comfort.

In order to improve and minimize this stimuli, researchers have invented a method of heat treating the middle section of the sling to eliminate sharp cuts on both sides of the middle of the sling. However, this conventional preparation method still has certain defects. For example, the heat treatment range is limited, only the middle section of the sling eliminates the sharp cut edge, although the remaining position of the sling still retains the sharp cut edge. Although the sharp cut edge can facilitate the growth strength of the sling after the tissue growth and coating, it is difficult to avoid the movement of the limb to the sharp The pain and long-term repeated irritation caused by the trimming. Moreover, the heat treatment of the method adopts laser cutting or fire source melting, and although the sharp trimming is eliminated, the soft tissue of the implanted site is still greatly stimulated, and excessive scar tissue is easily generated. Not only may affect the use of the sling, it is more likely to affect the quality of life of the patient.

Summary of the invention

In view of the above-described drawbacks of the existing sling structure and the preparation method, the object of the present invention is to propose a sling for treating urinary incontinence and a preparation method thereof.

The technical solution of the first object of the present invention is to provide a sling for treating urinary incontinence, which has a long rectangular shape, characterized in that the sling includes both ends distributed along the length and distributed along the width. Both sides, and each side is provided with a damper portion and a compliant portion, which is a complete fiber yarn which eliminates the sharp broken wire and maintains the natural braided shape.

Further, either side is provided with two sections of damping portions near the first end and the second end, the compliant portions being located between the two sections of the damping portions of the corresponding sides and having a length greater than 3 cm.

Further, the compliant portion has a length of 4 cm and is symmetrical toward the center with respect to the length of the sling.

Further, the compliant portion has a length of 6 cm and is symmetrical toward the center with respect to the length of the sling.

Still further, the sling is provided with a positioning mark line that is opposite to the color of the sling in the middle of the length.

Further, the damper portion is a heat-molded molten ball, and the diameter of the molten ball is larger than the diameter of the fiber.

The technical solution for achieving the above second object of the present invention is a method for preparing a sling for treating urinary incontinence, comprising the steps of: providing a woven mesh having a larger than the desired sling size; and weaving according to the width dimension of the sling The edge of the net cuts an opening along the direction of the knitting direction of the machine, and the opening is opened along an interlaced vein parallel to the length direction; the two lobes formed by the opening are torn apart perpendicularly to the plane of the woven mesh to form a compliant portion on both sides Sling; the sling is cut according to the length dimension of the sling, and heat-treated at both ends of the sling and the sides near the ends to form a fused spherical damper portion, retaining the soft portion of the middle portion.

Further, the heat treatment is to gradually approach the sling with a non-direct contact heat source, so that the fiber filaments at the edge of the sling are heated and melted to form a hemisphere having a diameter larger than the diameter of the fiber filament to form a new sling edge, that is, a damper portion.

Further, the method further includes the step of: encapsulating the jacket film on the sling surface of the compliant portion and the damper portion, and the covering strength of the package sleeve satisfies the sling in the sleeve film by the external force without sliding.

The sling and the preparation method thereof of the invention have outstanding substantive features and remarkable advancement compared with the sling used in the conventional surgical operation: the sling completely retains the complete fiber filament of the woven mesh characteristic, eliminating the sling The sharp broken wire at the edge of the cut eliminates any stimulation to the surrounding tissue after the operation, and improves the retention ability at both ends of the sling, so that the sling tension is effectively maintained.

DRAWINGS

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a partial schematic view showing the sling of the present invention for treating urinary incontinence.

detailed description

The embodiments of the present invention will be further described in detail with reference to the accompanying drawings, in which the claims

The designer of the present invention has carried out in-depth research on the traditional sling structure and the various deficiencies in the treatment of stress urinary incontinence, and summarized the root causes of post-operative discomfort symptoms, and explored the idea from the original woven mesh structure of the sling to explore. The sling edge shape and the processing acquisition method propose a new design and a feasible method to solve the sling implantation process and no longer stimulate the surrounding tissue and provide reliable tension retention.

Firstly, from the external structure, the sling for treating urinary incontinence has a long rectangular shape, that is, a rectangular sheet whose length is much larger than the width. The conventional specifications are described in the background art, and of course, it can be freely selected and lengthened according to the operation needs. Customization of widening or subtle corners of its corners. As far as the innovative features of the sling 1 of the present design are concerned, it comprises two ends distributed along the length direction and two

sides

11 and 12 distributed along the width direction, wherein the two ends include the first end A and the second end B without distinction . And each side is provided with a damper portion 13 facing outward and a compliant portion 14. In particular, the compliant portion 14 is a complete fiber filament that eliminates sharp broken wires and maintains a natural braided shape. That is, the handle on the side of the sling is very smooth, completely eliminating the tingling sensation brought by the sharp edges of the existing slings. Such a sleek side allows the sling to avoid any painful irritation from the sling after the surgical implantation of the urinary incontinence, even if the limb moves frequently, the surrounding tissue of the urethral bottom side will be protected from any sling.

In addition to the above outlined aspects, the more detailed features of the sling include: either side is provided with two sections of damper 13 adjacent the first end A and the second end B, and the compliant portion 14 is located at two sides of the corresponding side The dampers 13 are between each other and have a length greater than 3 cm. In a preferred embodiment, the compliant portion has a length of 4 cm and is symmetrical toward the center with respect to the length of the sling. The term "middle length" as used herein refers to a crease formed by the length of the sling to the opposite side, whereby the compliant portion is positioned in the middle of the length of the sling. Depending on the needs of different surgical procedures, the length of the compliant portion may also be 6 cm, and the compliant portion is also symmetrical toward the center with respect to the length of the sling. In order to facilitate the tension adjustment after the sling implantation in the outer casing operation, the sling 1 is provided with a positioning mark line 15 which is opposite to the sling color jump in the middle of the length, and the positioning mark line 15 can be diffused with good biocompatibility and non-toxic components. The pigment is printed, and the width can be about 1mm.

The damper portion 13 is a molten ball formed by heat treatment at the end of the fiber, and the diameter of the molten ball is larger than the diameter of the fiber. The design of the molten sphere is intended to enhance the fusion strength of the sling after implantation with the surrounding tissue, thereby ensuring that the sling can pull the urethra stably for a long period of time and avoid recurrence in the short term after stress urinary incontinence. The molten spheres formed at the ends of the fibers may also be formed by a combination of a plurality of filaments.

Of course, as a medical product and a surgical implant sling, the sling is further covered with a protective cover film during use/implantation.

The sling designed by the present invention needs to be formed by a special manufacturing method, which is described in detail below. The preparation method of the sling for treating urinary incontinence comprises the following steps: 1. providing a woven mesh having a larger than the required sling size; 2. cutting a guiding opening along the woven running direction of the woven mesh edge according to the width dimension of the sling The opening is opened along an interlaced vein parallel to the length direction; 3. The two lobes formed by the opening are torn apart in a direction perpendicular to the plane of the woven mesh to form a sling having a compliant portion on both sides; The length of the sling is taken from the sling, and heat-treated at both ends of the sling and the sides near the ends to form a fused spherical damper portion, retaining the soft portion of the middle portion.

As a detailed description, the woven mesh used therein is a tension woven mesh commonly used in medical applications. For the position selection of the cut opening, as described in step 2, there is a specific direction and positioning, and only the opening in the machine weaving direction at the interlaced vein can be torn in the manner described in step 3. If the position of the opening is deviated from the interlaced vein, then step 3 will be futile and the desired sling will not be obtained. Moreover, the depth of the opening need not be too large, usually 5mm-1cm. Moreover, in the above step 3, the sling with the compliant side is obtained by the tearing method, and the tearing direction is also specifically limited, and cannot be torn to the both sides in the plane of the woven net itself, which is futile and fruitless. The tearing method described with reference to step 3 is easier to handle, and the desired sling with a compliant portion can be obtained.

Further, as a molding process of the damper portion, the heat treatment of the present invention is where a non-direct contact heat source is gradually brought close to the sling to form a damper portion. Different from the previous laser or open flame, it is easy to cause the blackening of the sling edge or the material change, and the so-called non-sharp edge of the forming is actually uneven, which is not conducive to the application of surgery. In the present invention, the non-direct contact heat source is gradually approached and heat-transferred, so that the complete fiber filament of the compliant portion is deformed and agglomerated, so that the damper portion formed has the advantages of uniformity of the molten ball, feel and appearance.

The temporary protection required for suspender transportation and surgical implantation, the method for preparing the sling further comprises the steps of: encapsulating the protective cover film on the sling surface of the compliant portion and the damper portion, and the coating strength of the sling film Satisfy the sling in the cover film by the external force without loss of sliding.

In summary, the summary features and embodiments of the sling for the urinary incontinence of the present invention and the method for preparing the same are more prominent than the conventional slings used in such surgical operations, and the slings have outstanding substantive features and remarkable advancement: the sling is complete. The whole fiber yarn retaining the characteristics of the woven mesh eliminates the sharp broken wire at the edge of the sling cutting, eliminates any stimulation to the surrounding tissue after the operation, and improves the retention ability at both ends of the sling, so that the sling tension is effectively maintained. More importantly, the sling obtained by the preparation method of the invention avoids the generation of woven mesh debris and the slings by avoiding the use of the cutting process, and completely avoids the subsequent infection caused by the debris after implantation. The possibility of disease.

Claims

A sling for treating urinary incontinence, having a long rectangular shape, characterized in that: the sling includes both ends distributed along the length direction and two sides distributed along the width direction, and each side is provided with a damper portion And a compliant portion, the compliant portion being a complete fiber filament that eliminates a sharp broken wire and maintains a natural braided shape.
The sling for treating urinary incontinence according to claim 1, wherein: either side is provided with two dampers near the first end and the second end, and the compliant portion is located at two dampers of the corresponding side. Between and more than 3cm in length.
A harness for treating urinary incontinence according to claim 2, wherein said compliant portion has a length of 4 cm and is symmetrical toward the center with respect to the length of the sling.
A harness for treating urinary incontinence according to claim 2, wherein said compliant portion has a length of 6 cm and is symmetrical toward the center with respect to the length of the sling.
A sling for treating urinary incontinence according to claim 3 or 4, wherein the sling is provided with a positioning mark line which is opposite to the color of the sling in the middle of the length.
A harness for treating urinary incontinence according to claim 1, wherein said damper portion is a heat-molded molten ball, and the diameter of the molten ball is larger than the diameter of the fiber.
A method for preparing a sling for treating urinary incontinence, comprising the steps of:

Providing a woven mesh having a web size greater than the desired sling size;

Cutting an opening in the direction of the machine weaving along the width of the woven mesh according to the width dimension of the sling, the opening being opened along an interlaced vein parallel to the length direction;

The two lobes formed by the opening are torn apart in a direction perpendicular to the plane of the woven mesh to form a sling having a compliant portion on both sides;

The slings are cut according to the length dimension of the slings, and heat-treated at both ends of the slings and the sides near the ends to form a fused spherical damper portion, retaining the soft portion of the middle portion.
The method of preparing a sling for treating urinary incontinence according to claim 7, wherein the heat treatment is performed by using a non-direct contact heat source to gradually form a damper portion adjacent to the sling.
The method for preparing a harness for treating urinary incontinence according to claim 7, further comprising the steps of: encapsulating the sleeve on the surface of the sling of the compliant portion and the damper portion, and the covering strength of the sleeve satisfies the sling in the sleeve film It is subject to non-destructive sliding by external forces.