Novel implantable device for treating urinary incontinence in human body

Abstract

The present invention relates to an insertable structure for urethral compression in the human body, and a urinary incontinence treatment composition including same. The present invention enables accurate application of a desired amount of pressure to the urethra only by a simple procedure of adjusting, with the naked eye, the lengths of central thickness adjustable labels which are located at both ends of a belt shaped band and externally exposed from the body, the band being inserted into the body in order to apply an appropriate stepwise pressure to the urethra according to the alleviation of urinary incontinence symptoms. Accordingly, the structure of the present invention enables the pressure applied to the urethra to be varied according to a change in a symptom only with a single insertion into the body, and due to the high biocompatibility and biodegradability thereof, requires no separate removal procedure and is replaced by autologous tissue without adhesion issues, thereby continuously applying pressure to the urethra.

Description

A novel human implantable device for treating urinary incontinence

[0001] The present invention relates to a human insertion structure for urethral compression 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 treatments such as medication, pelvic muscle exercises, and sling insertion, as well as surgical treatments. Among these, sling insertion is a surgical procedure that inserts a sling into the bladder neck or under the urethra to maintain the urethra within the abdominal cavity or artificially compress the urethra to increase resistance, particularly in the case of stress urinary incontinence in women. However, although this sling insertion procedure is simple, it is difficult to properly adjust the position of the sling to ensure that pressure is applied precisely to the urethra. Furthermore, it is difficult to adjust the compression intensity according to the degree of urethral sphincter dysfunction. Therefore, improvements to the existing sling insertion technique are needed.

[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 conducted extensive research efforts to develop a human implantable structure capable of effectively controlling urinary incontinence symptoms by applying graduated pressure to the urethra. As a result, they discovered that urinary incontinence can be effectively treated through a simple procedure in which multiple urethral compression sections of different thicknesses are positioned at the center of a belt-shaped band, and two corresponding central thickness-adjusting labels are positioned equidistantly from each compression section in opposite ends, thereby adjusting the length of each pair of labels exposed outside the body to be the same. This allows the urethral compression sections of a desired thickness to apply appropriate pressure according to the severity of the symptom.

[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]

[0012] Other objects and advantages of the present invention will become more apparent from the detailed description, claims and drawings below.

[0013]

[0014] According to one aspect of the present invention, the present invention provides a human insert structure for urethral compression, comprising:

[0015] (a) A band in the shape of a belt extending in the left and right longitudinal directions;

[0016] (b) a urethral support member comprising a plurality of compression members having different thicknesses and located at the center of the band; and

[0017] (c) A plurality of center thickness adjustment labels, each corresponding to one of the plurality of compression parts, having the same spacing distance from the corresponding compression part and formed in the direction of both ends of the band.

[0018] The present inventors have made extensive research efforts to develop a human insertable structure that can effectively control urinary incontinence, particularly stress incontinence caused by weakening of the urethral sphincter, by applying progressive pressure to the urethra. As a result, the present invention was completed by discovering that a plurality of urethral compression parts, each with a different thickness, are positioned at the center of a band having a belt shape, and two corresponding central thickness-adjusting labels are positioned at the same distance from each compression part in the direction of both ends, thereby adjusting the length of each pair of labels exposed outside the body so that the urethral compression parts of a desired thickness apply an appropriate pressure according to the severity of the symptom, thereby effectively restoring defecation continence.

[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 originating and / or maintaining the functional integrity of cells, tissues or organs of the human recipient.

[0020] 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.

[0021] The term “center thickness adjustment label” as used herein refers to a pair of labels positioned at the same distance on the left and right from a corresponding compression portion formed within the urethral support portion located at the center of the band of the present invention, which labels serve as indicators for determining whether the corresponding compression portion of a specific thickness is located at the exact center of the human body, i.e., the urethra. The number of center thickness adjustment labels corresponds to the number of compression portions within the urethral support portion. For example, when compression portions having three different thicknesses are included in the urethral support portion, three pairs of center thickness adjustment labels corresponding to each of these are included at both ends of the band. Accordingly, not only medical staff but also patients themselves can adjust the length of the corresponding pair of center thickness adjustment labels exposed outside the body to be the same so that the compression portion of a specific thickness is located in the urethra in order to apply a desired degree of urethral compression.

[0022] According to a specific embodiment of the present invention, the structure further comprises two anchors coupled to opposite ends of the band to secure the band to the body of the subject.

[0023] According to a specific embodiment of the present invention, the central thickness adjustment label indicates information about the thickness of a corresponding compression part, so that when the structure is inserted into a subject, when the central thickness adjustment labels at both ends have the same length exposed outside the body of the subject, information about the thickness of the compression part that compresses the urethra is provided.

[0024] More specifically, information about the thickness of the corresponding compression portion indicated on the center thickness adjustment label is indicated by one or more selected from the group consisting of letters, numbers, symbols and colors.

[0025] If the compression part thickness information indicated on the center thickness adjustment label is in the form of letters, numbers or symbols, it may be written so that the relative compression level (thickness) of the corresponding compression part can be intuitively felt, such as “upper, middle, lower”, “level 1, level 2, level 3” or “A, B, C”, or it may be indicated in a set color that corresponds 1:1 to the thickness of the corresponding compression part. In this case, if it is desired to apply a specific size of urethral compression that is predetermined to correspond to the color green, the left and right center thickness adjustment labels indicated in green can be adjusted on both sides of the band so that the length exposed outside the body becomes the same.

[0026] According to a specific embodiment of the present invention, a calibrator may be displayed on the band from the center toward both ends for easy measurement of the length of the center thickness adjustment label exposed outside the body.

[0027]

[0028] According to a specific aspect of the present invention, the human insertion structure for urethral compression of the present invention is a dual-structure scaffold comprising:

[0029] (a) a support containing a first polymer having biocompatibility; and

[0030] (b) A second polymer mesh bonded to the surface of the support and having biocompatibility.

[0031] As used herein, the term "scaffold" refers to a tissue engineering structure that continuously provides appropriate physical compression or support to the urethra to promote restoration of the biological function of the urethral tissue. Specifically, the structure of the present invention may be a multi-layer structure in which at least two different biocompatible polymers are laminated.

[0032] 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 in which one type of monomer is polymerized) 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.

[0033] 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.

[0034] 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 able to be decomposed over time by body fluids, decomposing enzymes, or microorganisms in a living body. Any synthetic or natural polymer can be applied as long as it has the above-described biodegradability, and examples thereof include, but are not limited to, collagen, gelatin, chitosan, hyaluronic acid, poly(valerolactone), poly(hydroxybutyrate), poly(hydroxyvalerate) collagen, gelatin, chitosan, hyaluronic acid, and combinations thereof.

[0035] According to a specific embodiment of the present invention, the first polymer is collagen.

[0036] When the biocompatible first polymer of the present invention is collagen, the support containing the first polymer may be a collagen sponge.

[0037] The term "sponge" as used herein refers to a spongy porous material composed of a three-dimensional network of polymers linked by ionic or covalent bonds and using water as a dispersion medium. The collagen sponge of the present invention may be used without limitation as long as it has a spongy structure with cavities or voids in the collagen. For example, it may be manufactured by freeze-drying a collagen solution or dispersion, or various commercially available ready-made collagen sponges may be purchased and used.

[0038] According to a specific embodiment of the present invention, the second polymer is selected from the group consisting of polycaprolactone (PCL), poly(L-lactic acid) (PLLA), poly(glycolic acid) (PGA), poly(lactic-co-glycolic acid) (PLGA), poly(L-Lactide-co-ε-caprolactone) (PLCL), and combinations thereof. More specifically, the second polymer is PCL.

[0039] The method of bonding the second polymer mesh of the present invention to a support containing the first polymer may be performed by solidifying the second polymer mesh by impregnating the raw material of the first polymer (e.g., collagen solution) with the second polymer mesh, or by fabricating a support containing the first polymer (e.g., collagen sponge) and then embossing the second polymer, e.g., PCL, in a mesh shape on the surface thereof, thereby producing a collagen sponge-PCL mesh bond. The term “embossing” as used herein refers to a process of bonding a PCL polymer to the surface of the collagen sponge so that a mesh shape is engraved in a protruding form on the surface of the sponge. The embossing may be performed, for example, by using a 3D printer to output the second polymer in a mesh shape on the surface of the support containing the first polymer.

[0040]

[0041] According to a specific aspect of the present invention, the band included in the human insert structure for urethral compression of the present invention includes a second polymer mesh having biocompatibility; and the urethral support includes a first polymer having biocompatibility.

[0042] Since the first and second polymers used in the present invention have already been described above, their description is omitted to avoid excessive duplication.

[0043] According to the present invention, the band of the present invention may be formed of a second polymer mesh, for example, a PCL mesh, and the compression member within the urethral support member may be formed of a first polymer, for example, a collagen sponge. In this case, the compression member may be a collagen sponge of different thicknesses to provide various pressures.

[0044] According to the present invention, the adhesion problem that occurs in existing bands for treating urinary incontinence made of non-absorbable materials such as polypropylene can be solved by bonding a urethral support made of a first polymer having biocompatibility to a band made of a second polymer mesh having biocompatibility, and the collagen of the urethral support can be replaced with autologous tissue, so that the replaced tissue can continuously provide support to the urethra.

[0045]

[0046] 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.

[0047] 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.

[0048] 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.”

[0049]

[0050] The features and advantages of the present invention are summarized as follows:

[0051] (a) The present invention provides a human insertion structure for urethral compression and a composition for treating urinary incontinence comprising the same.

[0052] (b) The present invention can accurately apply a desired amount of pressure to the urethra by a simple procedure of visually adjusting the length of the central thickness adjustment label located at both ends of a belt-shaped band inserted into the body to apply an appropriate stepwise pressure to the urethra according to the alleviation of urinary incontinence symptoms.

[0053] (c) Accordingly, the structure of the present invention can vary the pressure applied to the urethra according to the change in symptoms with just one insertion into the human body, and due to its high biocompatibility and biodegradability, no separate removal procedure is required, and it can be replaced with autologous tissue without adhesion problems and continuously apply pressure to the urethra.

[0054]

[0055] Fig. 1 is a drawing showing the external appearance (Fig. 1a), a schematic diagram (Fig. 1b) of a human insertion structure for compressing the urethra of the present invention, and a position adjustment process (Fig. 1c) for compressing the urethra with a compression part of a desired thickness during human insertion. As seen in Fig. 1b, each central thickness adjustment label (A', B', C') is positioned at the same left and right distance (a, b, c) from the compression part (A, B, C) within each corresponding urethral support part.

[0056] FIG. 2 is a drawing showing the external appearance (FIG. 2a) and the three-dimensional structure (FIG. 2b) of the human insertion structure for urethral compression of the present invention having a dual-structure scaffold structure composed of a collagen sponge and a biodegradable mesh.

[0057] FIG. 3 is a schematic diagram (FIG. 3a) and a three-dimensional structure (FIG. 3b) of a human insert structure for urethral compression of the present invention, in which a urethral support member made of a collagen sponge is joined to a band made of a biodegradable mesh.

[0058]

[0059] 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.

[0060]

[0061] Example

[0062] Example 1: Fabrication of a human implantable structure for urethral compression

[0063] In order to manufacture a human insert structure for urethral compression, a rectangular knitted fabric measuring 40 cm in length and 2 cm in width was designed using knitting design software (M1PLUS, Stoll, Germany). In addition, a plying process (2-ply yarn for middle thickness, 3-ply yarn for thickest thickness) was performed to design compression sections of various thicknesses and a center thickness adjustment label within each urethral support section. The completed design file was input into a knitting machine (CMS330, Stoll, Germany), and PCL yarn was installed in the machine to manufacture a human insert structure for urethral compression of the present invention.

[0064]

[0065] Example 2: Fabrication of a cylindrical human implantable structure for urethral compression with a material for tissue regeneration inserted therein.

[0066] In order to manufacture a cylindrical human insert structure for urethral compression with a collagen sheet inserted, which is a material for tissue regeneration, a cylindrical knitted fabric measuring 40 cm in length and 2 cm in width was designed using knitting design software (M1PLUS, Stoll, Germany). In addition, a plying process (2-ply yarn for medium thickness and 3-ply yarn for thickest thickness) was performed to design a compression section of various thicknesses and a thickness-adjustable label located in the center. The completed design file was input into the knitting machine (CMS330, Stoll), and PCL yarn was installed in the machine to manufacture a cylindrical human insert structure for urethral compression. After that, a collagen sheet measuring 35 cm in length and 1.5 cm in width was inserted into the cylinder to complete the manufacture of a cylindrical human insert structure for urethral compression with a material for tissue regeneration inserted.

[0067]

[0068] Example 3: Fabrication of a human insert structure for urethral compression with a collagen sheet applied to the urethral compression area.

[0069] In order to produce a band in the shape of a belt extending in the longitudinal direction, a rectangular knitted fabric measuring 40 cm in length and 2 cm in width was designed using knitting design software (M1PLUS, Stoll, Germany). In order to design compression sections of various thicknesses and a thickness adjustment label for the center section within each urethral support section, a plying process (2-ply yarn for the middle thickness and 3-ply yarn for the thickest thickness) was additionally performed. In order to produce an additional structure for inserting a tissue regeneration material, an additional plying process was performed to design a shape as shown in Fig. 3b. The completed design file was input into the knitting equipment (CMS330, Stoll), and PCL yarn was installed in the equipment to produce a human insertion structure for urethral compression. Then, a collagen sheet measuring 9 cm in length and 1.5 cm in width was inserted into the tissue regeneration material insertion section, completing the production of a human insertion structure for urethral compression with a collagen sheet, a tissue regeneration material.

[0070]

[0071] 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 in the shape of a belt extending in the longitudinal direction; (b) a urethral support member comprising a plurality of compression members having different thicknesses and located at the center of the band; and (c) A plurality of center thickness adjustment labels, each corresponding to one of the plurality of compression parts, having the same spacing distance from the corresponding compression part and formed in the direction of both ends of the band.

2. A structure according to claim 1, characterized in that the structure additionally includes two anchors that are connected to both ends of the band to secure the band to the body of the object.

3. In the first paragraph, the central thickness adjustment label indicates information about the thickness of a corresponding compression part, so that when the structure is inserted into a subject, the central thickness adjustment labels at both ends have the same length exposed outside the body of the subject, and the structure provides information about the thickness of the compression part that compresses the urethra.

4. A structure characterized in that, in the third paragraph, information on the thickness of the corresponding compression part indicated on the center thickness adjustment label is indicated through at least one selected from the group consisting of letters, numbers, symbols, and colors.

5. In the first paragraph, the human insertion structure for urethral compression is characterized in that it is a double-structured scaffold including: (a) a support containing a first polymer having biocompatibility; and (b) A second polymer mesh bonded to the surface of the support and having biocompatibility.

6. A method according to claim 5, characterized in that the first polymer is collagen.

7. A structure according to claim 5, characterized in that the second polymer is selected from the group consisting of polycaprolactone (PCL), poly(L-lactic acid) (PLLA), poly(glycolic acid) (PGA), poly(lactic-co-glycolic acid) (PLGA), poly(L-Lactide-co-ε-caprolactone) (PLCL), and combinations thereof.

8. A structure characterized in that in the first paragraph, the band comprises a second polymer mesh having biocompatibility; and the urethral support comprises a first polymer having biocompatibility.

9. A structure according to claim 8, characterized in that the second polymer is selected from the group consisting of polycaprolactone (PCL), poly(L-lactic acid) (PLLA), poly(glycolic acid) (PGA), poly(lactic-co-glycolic acid) (PLGA), poly(L-Lactide-co-ε-caprolactone) (PLCL), and combinations thereof.

10. A structure according to claim 8, characterized in that the first polymer is collagen.

11. A composition for treating urinary incontinence comprising a human insert structure according to any one of claims 1 to 10.

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