Human body-implantable device for treating urinary incontinence comprising composite material

Abstract

The present invention relates to a human body-implantable structure for urethral compression and a composition for treating urinary incontinence comprising same. The structure of the present invention does not require a separate removal procedure due to the biocompatibility and biodegradability of a central main body implanted in the human body, can be replaced with autologous tissue without adhesion problems to thereby continuously compress the urethra, and has excellent durability without structural deformation even during thermal shrinkage of a shrinkable tube surrounding a connection portion between lifting threads, due to the heat resistance of a side mesh that connects the lifting threads and the central main body. In addition, the mesh included in the structure of the present invention is manufactured by weaving polymer yarns such that the course direction alternates front-to-back, thereby generating uniform resistance in all directions when inserted into the human body, which enables the structure to be smoothly inserted and be seated without curling in one direction.

Description

Human implantable device for treating urinary incontinence comprising composite materials

[0001] The present invention relates to a human insertion structure for urethral compression, which is composed of a composite polymer and has excellent biocompatibility and heat resistance, and a method for treating urinary incontinence using the same.

[0002]

[0003] Urinary incontinence is the involuntary leakage of urine. It is most common in middle-aged and older women, those with neurological disorders, and the elderly. Urinary incontinence is more common in women than in men, affecting 40% of Korean women. While it can occur at any age, its incidence tends to increase with age.

[0004] Urinary incontinence is broadly classified into stress incontinence, which occurs when force is applied to the abdomen due to weakened urethral sphincter muscles; urge incontinence, which is caused by involuntary contraction of the bladder due to excessively frequent and uncontrollable urination; overflow incontinence, which occurs when urine overflows due to bladder dysfunction when the bladder can no longer store urine; and reflex incontinence, which occurs when the bladder pressure reflex center is hypersensitive due to spinal cord injury or other causes, and the bladder reflexively contracts when there is only a small amount of urine in the bladder.

[0005] Currently known therapeutic approaches to treat urinary incontinence include non-surgical methods such as medication, pelvic muscle exercises, and sling insertion, as well as surgical treatments. Among these, sling insertion is particularly useful for women with stress urinary incontinence. It involves inserting a sling into the bladder neck or beneath the urethra to maintain the urethra within the abdominal cavity or artificially compress the urethra to increase resistance. Existing slings for urinary incontinence treatment are primarily made of non-absorbable polymers such as polypropylene, which can lead to adhesions and related complications, as well as the need for follow-up surgery for removal after treatment. In addition, there is a thread connecting the urethral compression area and the elevator, but if the thread breaks during the procedure, it cannot be restored and a new sling must be reinserted. In addition, it is difficult to remove the sling with the broken thread, and even if the urethral compression is smoothly performed at the desired location after the procedure, if the end of the sling is not finished well, there is a problem that it can damage the surrounding body tissues. Therefore, there is a need for improvement in the sling insertion technique that has been used in the past.

[0006]

[0007] Numerous papers and patents are referenced and cited throughout this specification. The disclosures of these cited papers and patents are incorporated herein by reference in their entirety to provide a clearer understanding of the state of the art and the scope of the present invention.

[0008]

[0009] The present inventors have made extensive research efforts to develop an efficient human implantable structure that controls urinary incontinence symptoms by applying appropriate pressure to the urethra, with not only excellent tissue engineering properties but also high heat resistance and mechanical strength. As a result, the central body in the form of a band that performs urethral compression is composed of a biocompatible polymer mesh, and the side mesh that connects the lifting thread and the central body is composed of a heat-resistant polymer, thereby eliminating the need for a separate removal procedure for the urethral compression part that remains in the human body after the procedure, and the connecting part of the lifting thread can be used as a composite material human implant with excellent durability that maintains its structure even when exposed to high temperatures.

[0010] Accordingly, the purpose of the present invention is to provide a human insertion structure for urethral compression and a composition for treating urinary incontinence including the same.

[0011] Other objects and advantages of the present invention will become more apparent from the detailed description, claims and drawings below.

[0012]

[0013] According to one aspect of the present invention, the present invention provides a human insert structure for urethral compression, comprising:

[0014] (a) a band-shaped mesh extending in the longitudinal direction and containing a biocompatible polymer;

[0015] (b) a side mesh connected to both ends of the band-shaped mesh and including a heat-resistant polymer;

[0016] (c) a giant thread connected to the side mesh to guide the band-shaped mesh and insert and fix it into the body; and

[0017] (d) A shrink tube wrapping the connection between the side mesh and the giant room.

[0018] The present inventors have made extensive research efforts to develop an efficient human insertion structure with excellent tissue engineering properties, high heat resistance, and high mechanical strength, as a structure that controls urinary incontinence symptoms, especially stress incontinence caused by weakening of the urethral sphincter, by applying appropriate pressure to the urethra. As a result, the central body in the form of a band that performs urethral compression is composed of a biocompatible polymer mesh, and the side mesh that connects the lifting thread and the main body is composed of a heat-resistant polymer, thereby eliminating the need for a separate removal procedure for the urethral compression part remaining in the human body after the procedure, and the connecting part of the lifting thread can be used as a composite material human insert with excellent durability that does not undergo structural deformation even when exposed to high temperatures, such as during the heat shrinkage process of a shrink tube, thereby completing the present invention.

[0019] As used herein, the term "human implantable construct" means a physical support that is artificially delivered into the human body of a recipient and is settled and fixed for a certain period of time for the purpose of supplementing and / or maintaining the functional integrity of cells, tissues or organs of the human recipient.

[0020] As used herein, the term "urethral compression" refers to artificially increasing urethral resistance by applying physical pressure to the urethra to improve urinary incontinence caused by urethral sphincter dysfunction. When the structure of the present invention is inserted into the urethra, a band-shaped mesh (100) corresponding to the aforementioned configuration (a) is positioned at the center of the urethra, thereby compressing the urethra and inducing restoration of continence.

[0021] In this specification, the term “band” refers to a structure in the shape of a strip extending in the left-right direction, also called a sling.

[0022] The term “polymer” as used herein refers to a synthetic or natural polymer compound in which monomers of the same or different types are continuously bonded. Accordingly, polymers include homopolymers (polymers polymerized from one type of monomer) and copolymers prepared by polymerizing at least two different types of monomers, while copolymers include copolymers (polymers prepared from two different types of monomers) and polymers prepared from more than two different types of monomers.

[0023] In this specification, the term “biocompatibility” means a property of not causing short-term or long-term side effects when administered into a living body and coming into contact with cells, tissues or body fluids of an organ, and specifically, it includes tissue compatibility and blood compatibility that do not cause necrosis of tissue or coagulation of blood when coming into contact with living tissue or blood, as well as biodegradability that disappears after a certain period of time after administration to a living body.

[0024] The term “biodegradability” used herein refers to a property of being naturally decomposed when exposed to a physiological solution of pH 6-8, and specifically refers to a property of being decomposed over time by body fluids, decomposing enzymes, or microorganisms in a living body. Any synthetic or natural polymer can be applied as a biodegradable polymer as long as it has the above-described biodegradability, and examples thereof include, but are not limited to, PCL (polycaprolactone), PLLA (poly(L-lactic acid)), PLCL (poly(L-Lactide-co-ε-caprolactone)), PVL (poly(valerolactone)), PHB (polyhydroxybutyrate), PHV (polyhydroxyvalerate), collagen, gelatin, chitosan, hyaluronic acid, or a combination thereof.

[0025] According to the present invention, the band-shaped mesh (100) corresponding to the aforementioned configuration (a) of the present invention is made of a biocompatible polymer, so that after insertion into the human body, it provides a therapeutic effect (urethral compression) for a certain period of time and then does not require a second surgery to remove it, and can be safely implanted without causing side effects such as damage or necrosis of surrounding tissues while remaining in the human body.

[0026] In this specification, the term “thermal resistance” means a property in which the material is not denatured even when exposed to a high temperature environment and in which all physical properties at room temperature are not significantly deteriorated. According to the present invention, the side mesh (200) of the above-described configuration (b) of the present invention, unlike the central body mesh (100) of the configuration (a), is made of a heat-resistant polymer and thus has high heat resistance and tensile strength. Accordingly, the structure of the present invention, unlike the single-material sling for urinary incontinence treatment that has been commonly used so far, provides a urethral compression part that remains inserted into the human body for a certain period of time to perform urethral compression, and a connection part with a lifting thread for guiding the urethral compression part to the lesioned area, and the side mesh does not need to be biodegradable because it comes into contact with a shrink tube and is removed after the procedure, thereby attempting to maximize its efficiency by manufacturing it using different materials suited to its respective purposes.

[0027] According to a specific embodiment of the present invention, the heat-resistant polymer that can be used in the present invention includes, but is not limited to, various natural and synthetic polymers known in the art to have heat resistance, for example, PGA (poly(glycolic acid)), PLGA (poly(lactic-co-glycolic acid)), PBS (poly(butylene succinate), PE (poly(ethylene)), polyester, PP (poly(propylene), PET (polyethylene terephthalate), PEO (poly(ethylene oxide)), PDO (poly(dioxanone)), PLA (poly(lactic acid)), PVC (poly(vinyl chloride)), PVA (poly(vinyl alcohol), PMA (poly(methacrylate), PEI (poly(ether imide), PMMA (poly(methyl methacrylate), PC (poly(carbonate)), PA (poly(amide)), PS (poly(styrene)), PEG (poly(ethylene glycol)), PU (polyurethane), Nylon-6 (Nylon-6) or a combination thereof. It can be used without restrictions.

[0028] According to the present invention, the biocompatible mesh (e.g., PCL mesh) constituting the central mesh and the heat-resistant side mesh (e.g., PGA) connected to both ends thereof are made of different materials, so that their boundaries can be easily identified with the naked eye. Therefore, the central mesh can be accurately positioned in the center of the urethra to be compressed by simply adjusting the exposed length of both ends so that the length to the boundary exposed outside the body of the subject after insertion is the same.

[0029] As used herein, the term "shrink tube" (400) refers to a tube that wraps around the connection between the elastic thread and the side mesh to reinforce the connection so that the elastic thread and the side mesh do not break easily, and to prevent sharp connections that could cause injury when inserted into human tissue from being exposed, thereby allowing smooth insertion into the human body. According to a specific embodiment of the present invention, the heat-resistant shrink tube shrinks by thermal stimulation.

[0030] According to a specific embodiment of the present invention, the structure of the present invention may additionally include a covering vinyl (500) that wraps the central body mesh (100) and the side mesh (200). In this case, the shrink tube of the present invention described above wraps the covering vinyl (Fig. 3), thereby preventing the sharp ends of the covering vinyl (the portion where the side mesh, the lifting thread, and the covering vinyl come into contact) from damaging human tissue when inserted into the human body.

[0031] The structure of the present invention is installed by passing through the pelvic obturator from outside the labia majora through the urethra by grasping the lifting thread (300) that guides the medical staff to move in and out of the body, and installing the central body mesh (100), which is the urethral compression part, below the urethra (Fig. 1b), and then the remaining parts (the lifting thread, the covering vinyl, and the shrink tube) except for the central body mesh (100) made of a biocompatible material are removed.

[0032]

[0033] According to a specific embodiment of the present invention, the band-shaped mesh is manufactured by weaving biocompatible polymer yarn.

[0034] As used herein, the term "weaving" refers to the process of forming a flat fabric by repeatedly intersecting yarns, which are the raw material of the mesh, in the warp (vertical) and weft (horizontal) directions. The method of producing a mesh-shaped woven fabric using biocompatible polymer yarns, specifically PCL yarns, can be accomplished by various processes known in the art, for example, by applying PCL yarns to weaving equipment.

[0035] According to a more specific embodiment of the present invention, the weaving of the polymer yarn is produced by weaving the same number of times in the direction of the stitches in the front and back directions.

[0036] More specifically, the weave of the polymer yarn can be manufactured by weaving the direction of the stitches forward three times and backward three times (3 x 3), or by weaving the direction of the stitches forward twice and backward twice (2 x 2), and most specifically, the weave of the polymer yarn can be manufactured by weaving the direction of the stitches forward once and backward once (1 x 1).

[0037] As shown in the examples described below, among the various weaving patterns, the 1 x 1 pattern, which crosses the direction of the nose once in the front and back, was confirmed to have the highest tensile strength and the thinnest mesh while generating resistance in an even direction when inserted into the human body, so that the structure can smoothly enter and settle without being rolled in one direction.

[0038] According to a specific embodiment of the present invention, the polymer yarn has a diameter of 0.1 to 0.3 mm, more specifically, a diameter of 0.12 to 0.25 mm, even more specifically, a diameter of 0.13 to 0.18 mm, and most specifically, a diameter of about 0.15 mm.

[0039] According to a specific embodiment of the present invention, the side mesh is manufactured by weaving heat-resistant polymer yarn.

[0040] According to the present invention, the side mesh of the configuration (b) in the form of a mesh, similar to the main body mesh of the configuration (a) described above, can also be manufactured by weaving a heat-resistant polymer as a yarn. The weaving process for manufacturing the side mesh can also be performed in the same manner as the process for manufacturing the biodegradable main body mesh. For example, the weaving of the heat-resistant polymer yarn is manufactured by weaving by repeating the direction of the stitches forward and backward the same number of times. More specifically, the weaving of the heat-resistant polymer yarn can be manufactured by weaving by repeating the direction of the stitches forward three times and backward three times (3 x 3), or by weaving by repeating the direction of the stitches forward twice and backward twice (2 x 2), and most specifically, the weaving of the heat-resistant polymer yarn can be manufactured by weaving by repeating the direction of the stitches forward and backward once each (1 x 1).

[0041] According to a specific embodiment of the present invention, the heat-resistant polymer yarn has a diameter of 0.1 to 0.3 mm, more specifically, a diameter of 0.12 to 0.25 mm, even more specifically, a diameter of 0.13 to 0.18 mm, and most specifically, a diameter of about 0.15 mm.

[0042]

[0043] According to another aspect of the present invention, the present invention provides a human insert structure for urethral compression, which includes a band-shaped mesh that extends in the longitudinal direction of the left and right sides and is manufactured by weaving polymer yarns.

[0044] According to a specific embodiment of the present invention, the weaving of the polymer yarn is performed by weaving the yarn by crossing it back and forth in the same number of times.

[0045] More specifically, the weave of the polymer yarn can be manufactured by weaving the direction of the stitches forward three times and backward three times (3 x 3), or by weaving the direction of the stitches forward twice and backward twice (2 x 2), and most specifically, the weave of the polymer yarn can be manufactured by weaving the direction of the stitches forward once and backward once (1 x 1).

[0046] According to a specific embodiment of the present invention, the polymer yarn has a diameter of 0.1 to 0.3 mm, more specifically, a diameter of 0.12 to 0.25 mm, even more specifically, a diameter of 0.13 to 0.18 mm, and most specifically, a diameter of about 0.15 mm.

[0047] According to another aspect of the present invention, the present invention provides a composition for treating urinary incontinence comprising the human insert structure of the present invention described above.

[0048] According to another aspect of the present invention, the present invention provides a method for treating urinary incontinence, comprising the step of inserting the human insert structure of the present invention described above into a subject.

[0049] The term “treatment” as used herein means (a) suppressing the development of a disease, condition, or symptom; (b) alleviating the disease, condition, or symptom; or (c) eliminating the disease, condition, or symptom. The human insert structure for urethral compression of the present invention effectively restores continence in urinary incontinence, particularly stress urinary incontinence caused by weakened urethral sphincter, thereby suppressing the development of symptoms caused by urinary incontinence, eliminating them, or alleviating them. Therefore, the composition of the present invention may be a composition for treating urinary incontinence on its own, or may be used together with other pharmacological ingredients having therapeutic activity for urinary incontinence (e.g., trospium, tolterodine, fesoterodine, solifenacin, oxybutynin, propiverine, flavoxate, etc.) and applied as an auxiliary treatment for urinary incontinence. Accordingly, the term “treatment” as used herein includes the meaning of “assistant treatment.”

[0050]

[0051] The features and advantages of the present invention are summarized as follows:

[0052] (a) The present invention provides a human insertion structure for urethral compression and a composition for treating urinary incontinence comprising the same.

[0053] (b) The structure of the present invention does not require a separate removal procedure due to the biocompatibility and biodegradability of the central body inserted into the human body, and can continuously perform pressure on the urethra by being replaced with autologous tissue without adhesion problems, and has excellent durability in that the structure is not deformed even when the shrink tube wrapping the connection part of the lifting thread is heat-shrinked due to the heat resistance of the side mesh connecting the lifting thread and the central body.

[0054] (c) The mesh included in the structure of the present invention is manufactured by weaving polymer yarns so that the direction of the nose is crossed and repeated back and forth, so that when inserted into the human body, resistance is generated in an even direction, so that the structure can smoothly enter and settle without being rolled in one direction.

[0055]

[0056] FIG. 1 is a diagram illustrating the configuration of a human body insertion structure for urethral compression of the present invention (FIG. 1a) and the form in which the structure is inserted into a human body to perform urethral compression (FIG. 1b).

[0057] FIG. 2 is a schematic diagram (FIG. 2a) of a woven body mesh or side mesh manufactured by weaving biocompatible polymer yarn or heat-resistant polymer yarn within a structure of the present invention, a scanning electron microscope (SEM) photograph (FIG. 2b, magnification x 20), a result comparing the tensile strength of PLC mesh according to weaving method (FIG. 2c), and a result comparing the thickness of PLC mesh according to weaving method (FIG. 2d) are drawings showing the same.

[0058] FIG. 3 is a drawing showing a side mesh and a connecting part of a giant room in a structure of the present invention wrapped with a shrink tube.

[0059] FIG. 4 is a drawing showing the results of comparing the tensile strength of various heat-resistant polymers that are raw materials for the side mesh and the upper thread in the structure of the present invention, and is a result of comparing the tensile strength (FIG. 4a) when PGA, nylon, and polypropylene are used as the upper thread, and the tensile strength (FIG. 4b) when PGA, polypropylene, polyethylene, rayon, and nylon are used as the side mesh in a state where the side mesh and the upper thread are connected.

[0060] Figure 5 is a drawing showing the results of evaluating cell adhesion by weaving pattern, including a schematic diagram showing an outline of the experimental procedure (Figure 5a), a confocal microscope image showing the degree of cell adhesion by each weaving pattern (Figure 5b), and an OD (optical density) value (Figure 5c), respectively.

[0061]

[0062] Hereinafter, the present invention will be described in more detail through examples. These examples are intended solely to illustrate the present invention more specifically, and it will be apparent to those skilled in the art that the scope of the present invention is not limited by these examples, in accordance with the gist of the present invention.

[0063]

[0064] Example

[0065] Fabrication of a composite material urethral compression implantable structure

[0066] Unlike conventional incontinence treatment bands made of a non-absorbent single material such as polypropylene, the inventors of the present invention attempted to manufacture a composite material structure in which the central body (100) that is inserted into the human body and performs urethral compression is made of a biocompatible polymer such as polycaprolactone (PCL), and the side meshes (200) on both sides are made of a heat-resistant polymer such as poly(glycolic acid) (PGA) that does not deform even when the shrink tube (400) is heat-shrinked.

[0067] In summary, a rectangular knitted fabric measuring 40 cm in length and 2 cm in width was designed using knitting design software (M1PLUS, Stoll, Germany) to produce a band in the shape of a belt extending in the longitudinal direction. Since the thickness and mesh shape of the knitted fabric change for each design pattern, woven fabrics with various patterns (1 x 1, 2 x 2, 3 x 3, front stitch, back stitch) were additionally produced. The biocompatible material in the center and the heat-resistant material at both ends were arranged according to the characteristics and purpose of each material, so that it was designed to have the shape as in Fig. 1a. The completed design file was input into a knitting machine (CMS330, Stoll), and PCL and PGA yarns were installed in the machine to produce a human insertion structure for urethral compression of the present invention. For cleaning for human insertion, it was washed twice with 70% EtOH for 3 minutes each and twice with distilled water for 3 minutes each in an ultrasonic cleaner. Afterwards, it was dried in a hot air dryer (30℃) for 2 hours for drying. After the drying was completed, a process of assembling a vinyl cover (polyester) and a shrink tube (polyolefin) to prevent damage to human tissues was performed on the structure. First, the vinyl cover was applied to the structure, and a 3 cm shrink tube was applied to the end of the vinyl cover through the two lifting threads. To induce shrinkage of the shrink tube applied to the structure, heat was applied to all parts of the shrink tube with a 110℃ heat gun for 20 seconds to complete the shrinkage process. In order to package the structure assembled through the above process, the structure was applied to a plastic case and a silver pouch. The packaging process was completed by heating the silver pouch contact part for 0.6 seconds and cooling it for 3 seconds through a packaging machine.

[0068] The shrink tube (400) prevents the structure of the present invention covered with the covering vinyl (500) from becoming thicker and prevents the sharp end of the covering vinyl (500) from causing injury when inserted into human tissue, while allowing it to be inserted smoothly into the human body (Fig. 3). However, since the shrink shape is completed by applying heat, the connection between the side mesh (200) and the lifting thread (300) wrapped by the shrink tube (400) is directly exposed to heat. Accordingly, the present invention prevents deformation due to heat by manufacturing the side mesh (200) and the lifting thread (300), which are removed after insertion into the human body, using PGA, a heat-resistant polymer.

[0069]

[0070] Measurement of thickness by weave pattern

[0071] The main body (100) of the present invention was manufactured by applying biocompatible PCL yarn to a weaving equipment and weaving it into a mesh shape, which is faster and less expensive than 3D printer technology. The inventors of the present invention woven the mesh so that the direction of the nose was the same, or the direction of the nose was crossed and repeated the same number of times (1 x 1, 2 x 2, 3 x 3) in the front and back directions (Figs. 2a and 2b) and compared the characteristics of the results. In the case of a mesh woven in the same direction in the front or back direction, a rolling phenomenon occurred when inserted into the human body, and a cross structure in which the same direction was repeated 2 and 3 times (2 x 2 and 3 x 3) also caused a phenomenon of wrinkles or rolling due to the friction of the contact surface generated when inserted into the human body, but in the case of a mesh (1 x 1) woven by crossing and repeating the direction of the nose once each in the front and back directions, no rolling phenomenon occurred at all and the mesh was inserted most smoothly.

[0072] In addition, when the 1 x 1 pattern was applied, the thinnest mesh was formed, which was most suitable for insertion into the human body (Fig. 2d).

[0073]

[0074] Measurement of tensile strength by weaving pattern

[0075] In the case of the main body mesh (100) that plays a main role in supporting the urethra among the components of the band for urinary incontinence treatment, tensile strength is important for efficient urethral compression and support. Therefore, the tensile strength of the mesh for each weaving pattern was measured under a grip length of 40 mm and a speed of 100 mm / min, and as a result, the tensile strengths of 1 x 1 (17.37 kgf) and 2 x 2 (17.94 kgf) were the best (Fig. 2c).

[0076]

[0077] Measurement of tensile strength of side mesh and giant yarn

[0078] The side mesh (200) and the lifting yarn (300) of the incontinence treatment band are in direct contact with the shrink tube, so heat-resistant yarn was applied. The lifting yarn (300) directly connected to the side mesh (200) is used by the user by hanging it on a lifting machine, and requires strength to withstand being pulled with the lifting machine. Accordingly, in order to search for a polymer yarn with the best tensile strength among the heat-resistant yarns used for the lifting yarn (300), the tensile strength was measured under a grip length of 40 mm and a speed of 100 mm / min. As a result of the measurement among PGA, nylon, and PP, it was confirmed that PGA (4.672 kgf) had the best tensile strength (Fig. 4a). In addition, in order to measure the tensile strength when the main body (100) and the side mesh (200) and the lifting thread (300) are connected, polypropylene, polyethylene, rayon, and nylon were used as side mesh raw materials, respectively, and the lower surface of the main body (100) and the end of the lifting thread (300) were gripped and the tensile strength was measured under a grip length of 100 mm and a speed of 100 mm / min. As a result, it was confirmed that the tensile strength (10.15 kgf) was the best when PGA was applied as the side mesh among various applicable heat-resistant polymers (Fig. 4b).

[0079]

[0080] Measurement of cell adhesion by weaving pattern

[0081] In order to select the most advantageous weaving pattern for tissue regeneration when the human insertion structure for urethral compression of the present invention is inserted into the human body after skin incision, the cell adhesion ability according to the weaving pattern of the mesh was evaluated. Mesh specimens for each design pattern in a square shape measuring 1 cm x 1 cm were placed in a 24-well tissue culture plate (TCP, Corning, USA). Human dermal fibroblasts (ATCC, USA) were cultured, and 500,000 fibroblasts (passage number 15) were seeded on each specimen so that they could adhere well, and cultured for approximately 20 minutes. After that, 1 ml of a medium containing 10 v / v % FBS (Fetal bovine serum, Gibco, USA) and 1 v / v % antibiotics (Gibco, USA) mixed with DMEM (Dulbecco's Modified Eagle Medium, low glucose, Gibco, USA) was added to each specimen, and cultured at 37°C and 5% CO2. To confirm the degree of fibroblast attachment to the mesh specimens for each design pattern, 1 day after the start of culture, the fibroblasts attached to each mesh specimen were fixed with 4% PFA (paraformaldehyde), stained using Actin Cytoskeleton and Focal Adhesion Staining Kit (Merck, Germany), and observed with a confocal microscope (LSM700, Zeiss, Germany) (Fig. 5a). 3 and 7 days after the start of culture, the degree of attachment and proliferation of the fibroblasts attached to the mesh specimens and the fibroblasts cultured on the bottom of the tissue culture plate through the mesh specimens was confirmed using CCK-8 (Cell Counting Kit-8, DOJINDO Laboratories, Japan). The cell viability was confirmed by measuring the absorbance using a spectrophotometer (VERSA max microplate reader, Morecular Devices, USA).As a result, among the meshes with various design patterns, the 1 x 1 pattern, which is the thinnest and flattest to support the urethra over a wide range, was confirmed to have the best adhesion to fibroblasts compared to other design conditions (Fig. 5b, Fig. 5c). In the remaining design conditions, the meshes of the 1 x 1 pattern group, which maintain a flat, curved shape by forming a curved shape, seem to have obtained the results by providing sufficient space for cells to attach and proliferate. Accordingly, it was confirmed that the 1 x 1 pattern mesh, which has the lowest risk of damage to other tissues when inserted into the human body due to its thin thickness and the best cell adhesion, is the optimal shape that can be applied to a human implantable structure for the treatment of urinary incontinence.

[0082]

[0083] While specific aspects of the present invention have been described in detail above, it should be apparent to those skilled in the art that these specific descriptions are merely preferred embodiments and do not limit the scope of the present invention. Therefore, the substantial scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A human insertable structure for urethral compression, including: (a) a band-shaped mesh extending in the longitudinal direction and containing a biocompatible polymer; (b) a side mesh connected to both ends of the band-shaped mesh and including a heat-resistant polymer; (c) a giant thread connected to the side mesh to guide the band-shaped mesh and insert and fix it into the body; and (d) A shrink tube wrapping the connection between the side mesh and the giant room.

2. A structure according to claim 1, characterized in that the biocompatible polymer is at least one polymer selected from the group consisting of polycaprolactone (PCL), poly(L-lactic acid) (PLLA), poly(L-Lactide-co-ε-caprolactone) (PLCL), poly(valerolactone) (PVL), polyhydroxybutyrate (PHB), polyhydroxyvalerate (PHV), collagen, gelatin, chitosan, and hyaluronic acid.

3. A structure according to claim 1, wherein the heat-resistant polymer is at least one polymer selected from the group consisting of PGA (poly(glycolic acid)), PLGA (poly(lactic-co-glycolic acid)), PBS (poly(butylene succinate), PE (poly(ethylene)), polyester, PP (poly(propylene), PET (polyethylene terephthalate), PEO (poly(ethylene oxide)), PDO (poly(dioxanone)), PLA (poly(lactic acid)), PVC (poly(vinyl chloride)), PVA (poly(vinyl alcohol), PMA (poly(methacrylate), PEI (poly(ether imide), PMMA (poly(methyl methacrylate), PC (poly(carbonate)), PA (poly(amide)), PS (poly(styrene)), PEG (poly(ethylene glycol)), PU (polyurethane), and Nylon-6.

4. A structure according to claim 1, characterized in that the heat-shrinkable tube shrinks by thermal stimulation.

5. A structure according to claim 1, characterized in that the band-shaped mesh is manufactured by weaving a biocompatible polymer yarn.

6. A structure characterized in that in the fifth paragraph, the weaving of the polymer yarn is performed by weaving the direction of the stitches by crossing them back and forth an equal number of times.

7. A structure characterized in that in the 6th paragraph, the weaving of the polymer yarn is performed by weaving by crossing the direction of the yarns back and forth once each.

8. A structure according to claim 5, characterized in that the polymer yarn has a diameter of 0.1 to 0.3 mm.

9. A structure according to claim 1, characterized in that the side mesh is manufactured by weaving heat-resistant polymer yarn.

10. A human insert structure for urethral compression, comprising a band-shaped mesh that extends in the longitudinal direction of the left and right sides and is manufactured by weaving polymer yarns.

11. A structure characterized in that in the 10th paragraph, the weaving of the polymer yarn is performed by weaving the direction of the stitches by crossing them back and forth an equal number of times.

12. A structure characterized in that in the 11th paragraph, the weaving of the polymer yarn is performed by weaving by crossing the direction of the yarns back and forth once each.

13. A structure according to claim 12, characterized in that the polymer yarn has a diameter of 0.1 to 0.3 mm.

14. A composition for treating urinary incontinence comprising a human insert structure according to any one of claims 1 to 13.

Images