Light irradiation device for strengthening urethral muscle, and method for using same

Abstract

The present invention relates to a light irradiation device for strengthening urethral muscles and a method for using same. The light irradiation device according to the present invention minimizes damage to urethral mucosal tissue and transmits light to a target surrounding muscle layer by using a balloon structure and a movable and rotatable light-emitting unit, thereby increasing lost muscle density and strengthening the urethral muscles.

Description

Light irradiation device for strengthening urethral muscles and method of using the same

[0001] The present invention relates to a light irradiation device for strengthening urethral muscles and a method of using the same, and more particularly, to a light irradiation device capable of strengthening urethral muscles by irradiating light into a target urethra and a method of using the same.

[0002] Urinary incontinence is a condition characterized by the involuntary loss of urine. While not life-threatening, it is significantly associated with psychological stress in daily life. Due to weakened pelvic muscles caused by pregnancy and childbirth, the prevalence of urinary incontinence in women ages 45 to 50 is as high as 35-40%. Globally, women account for 75-80% of all urinary incontinence cases. Furthermore, due to age-related muscle weakness and loss, the number of patients with urinary incontinence is rapidly increasing both domestically and internationally in an aging society.

[0003] Urinary incontinence is classified into stress urinary incontinence, urge urinary incontinence, overflow urinary incontinence, and functional urinary incontinence. Stress urinary incontinence accounts for 80-90% of all urinary incontinence types, and symptoms of urine leakage occur when abdominal pressure increases during daily activities such as sneezing, exercise, and laughing. Stress urinary incontinence is caused by muscle damage and weakening of the external urethral sphincter, which cannot close the urethra.

[0004] Treatment for stress urinary incontinence can be divided into pharmacological, non-surgical, and surgical options. Pharmacological treatments include smooth muscle relaxants and antidepressants, but these can lead to psychological problems such as anxiety and insomnia, and in severe cases, urinary incontinence and cardiovascular disease. Non-surgical treatments include pelvic floor muscle exercises, vaginal cones, and electrical stimulation, as well as physical therapy and behavioral therapy. These treatments are typically used in the early stages. These non-surgical treatments require regular exercise, and patients often complain of fatigue due to their minimal effectiveness and repeated treatments.

[0005] The most widely used surgical treatment is the sling procedure. Sling surgery involves placing a tape, a structural supportive structure, within the abdominal cavity to support the urethra. This procedure has been performed for decades. However, due to biocompatibility issues with the tape, it carries a high risk of recurrence, complications, and mortality.

[0006] Minimally invasive approaches to treating female stress urinary incontinence include research using radiofrequency and laser therapy. Radiofrequency therapy involves inserting a radiofrequency probe into the urethral mucosa and heating it, but it carries the risk of postoperative pain and increased risk of urinary tract infection. To mitigate these side effects, research and treatments using laser therapy to induce new collagen growth in the vaginal mucosa are on the rise. However, existing laser treatments are highly ablative and carry the risk of causing injury or burns to the mucosal tissue due to the high temperature. Furthermore, due to a lack of safety evidence, the FDA has issued a warning against the inappropriate use of laser therapy for vaginal rejuvenation.

[0007] While thermal therapy is effective in treating stress urinary incontinence, existing treatment studies have shown a risk of gynecological diseases, such as mucosal burns and vaginal bleeding, due to the heat generated by laser irradiation. Therefore, further improvements are needed to ensure the safety of phototherapy.

[0008] As related prior literature, reference may be made to Patent Application No. 10-2010-0063594 (July 1, 2010) and No. 10-2014-7005989 (August 2, 2012).

[0009] Accordingly, the present invention has been devised to solve the above-described problems, and the purpose of the present invention is to provide a light irradiation device and a method of using the same, which can strengthen urethral muscles by minimizing damage to urethral mucosal tissue and transmitting light to the target surrounding muscle layer, thereby increasing the lost muscle density.

[0010] First, to summarize the features of the present invention, a light irradiation device according to one aspect of the present invention for achieving the above object comprises: a distal balloon and a proximal balloon provided on one side of a tubular body to be inserted into the urethra; a control unit coupled to the other side of the tubular body to be positioned outside the urethra; a distal balloon channel formed between the control unit and the inner side of the distal balloon in the lumen of the tubular body; a urine discharge channel and a bladder washing channel formed between the control unit and the end of the one side in the lumen of the tubular body; a proximal balloon channel and a light transmission channel formed between the control unit and the inner side of the proximal balloon in the lumen of the tubular body; And it includes a light emitting unit provided at the end of an optical fiber extended from the control unit through the light transmission channel, and the control unit controls the expansion and contraction of the distal balloon and the proximal balloon through the distal balloon channel and the proximal balloon channel, controls the discharge of urine through the urine discharge channel and the washing of the bladder through the bladder washing channel, and can control the light irradiation of the light emitting unit.

[0011] The light irradiation device further includes a pressure measuring channel formed between the control unit and the one end in the inner lumen of the tubular body; a bladder pressure sensor electrically connected to the control unit through the pressure measuring channel and installed on the one end of the outer wall of the tubular body; a urethral pressure sensor electrically connected to the control unit through the pressure measuring channel and installed on the outer wall of the tubular body between the distal balloon and the proximal balloon; and an external sphincter pressure sensor electrically connected to the control unit through the pressure measuring channel and installed on the outer wall of the proximal balloon, wherein the control unit can be configured to measure and monitor the pressure of the bladder, the pressure of the urethra, or the pressure of the external sphincter.

[0012] The above external sphincter pressure sensor can be placed at the upper end of the proximal balloon.

[0013] The above control unit is configured to determine whether there is fluid flow in the urethra and bladder by injecting saline solution through the pressure measurement channel, and may be configured to measure and monitor the pressure of the bladder, the pressure of the urethra, or the pressure of the external sphincter when injecting the saline solution.

[0014] The above control unit can control the saline solution injected through the bladder washing channel during bladder washing to be discharged through the urine discharge channel.

[0015] The above control unit can control the saline solution injected through the pressure measurement channel to be discharged through the urine discharge channel.

[0016] The above light emitting unit has an output power of 100 mW to 50 W and can irradiate light with a wavelength between visible light and near-infrared light, including a laser.

[0017] The above light emitting unit may be configured to irradiate light at a predetermined length along the tubular body, and to irradiate light at an angle of 360 degrees, 180 degrees, or 45 degrees in the circumferential direction centered on the tubular body.

[0018] The size of the above proximal balloon is 9 to 20 Fr in width and 1 to 4 cm in height, and according to the user's operation, the control unit can be configured to control the operation of the motor connected to the optical fiber so that the light emitting unit moves between the upper and lower ends of the above proximal balloon along the light transmission channel.

[0019] The above light emitting unit may be configured to irradiate light at a predetermined length along the tubular body, irradiate light at an angle of 360 degrees or less in a circumferential direction centered on the tubular body, and the control unit may control the operation of a motor connected to the optical fiber according to a user's operation so that the light emitting unit rotates.

[0020] According to the user's operation, the control unit is configured to control the operation of a motor connected to the optical fiber to rotate the light emitting unit and move along the light transmission channel, and the control unit can be configured to transmit light for image acquisition to the light emitting unit through the optical fiber and detect scattered light received through the light emitting unit to acquire an optical coherence tomography image or a 2-3D ultrasound image.

[0021] A temperature sensor may be included inside the proximal balloon, the temperature sensor may be electrically connected to the control unit, and the control unit may be configured to supply and circulate a fluid maintained at a predetermined temperature to the proximal balloon through the proximal balloon channel based on the temperature detected by the temperature sensor.

[0022] The above-described balloon may include a temperature sensor on the outside, the temperature sensor being electrically connected to the control unit, and the control unit being configured to control the output power of a light source that transmits light to the light-emitting unit based on the temperature detected by the temperature sensor.

[0023] The above proximal balloon may be transparent, or at least one portion of the inner or outer upper portion, lower portion, or a portion between the upper and lower portions may be coated with a material to reduce light intensity.

[0024] The above-mentioned proximal balloon may have a shape when inflated, such as an elongated hexagon, an elongated cylinder, or a shape in which at least one of the upper end and the lower end of the hexagonal cylinder or the cylinder is tapered, or a hemispherical shape in which the upper end has a larger diameter than the body of the hexagonal cylinder or the cylinder.

[0025] According to the light irradiation device of the present invention, urethral muscle strengthening is possible by minimizing damage to urethral mucosal tissue and delivering light stimulation to the targeted muscle layer. That is, by using a balloon structure, an irregularly shaped urethral mucosa can be expanded into a uniform surface that is easy to irradiate with light, and pressure damage to the urethral mucosa caused by the inflated balloon can be prevented through mucosal pressure measurement and feedback. In addition, a fluid circulation system is used to circulate low-temperature liquid within the balloon, thereby providing a water-cooling effect on the contacting tissue, thereby minimizing thermal damage to the mucosa that may be caused by light irradiation. In addition, by using a motion controller to control the position and rotation of the light-emitting unit, light irradiation can be selectively applied to the targeted mucosal area.

[0026] The accompanying drawings, which are included as part of the detailed description to aid understanding of the present invention, provide examples of the present invention and, together with the detailed description, explain the technical idea of ​​the present invention.

[0027] FIG. 1 is a schematic cross-sectional view of a light irradiation device according to one embodiment of the present invention.

[0028] Figure 2 is an example of the distal balloon and proximal balloon of the present invention being inserted into the bladder neck and urethra.

[0029] Fig. 3a is a longitudinal cross-sectional view of the AL portion of Fig. 1.

[0030] Figure 3b is a cross-sectional view of the A1-A2 portion of Figure 1.

[0031] Figure 4a is a longitudinal cross-sectional view of the BL portion of Figure 1.

[0032] Fig. 4b is a cross-sectional view of the B1-B2 portion of Fig. 1.

[0033] Fig. 5 shows the channels of the joint portion of the tubular body and the control unit of Fig. 1.

[0034] Figures 6a to 6c show various embodiments of the light emitting unit of the present invention.

[0035] Fig. 7a shows the movement of the light emitting part within the proximal balloon of the present invention, and Fig. 7b shows the control of the motor drive for this.

[0036] Fig. 8a shows the rotation of the light emitting part within the proximal balloon of the present invention, and Fig. 8b shows the control of the motor drive for this.

[0037] FIG. 9 is a drawing for explaining the configuration of a control unit for determining fluid flow through a pressure measurement channel of the present invention and measuring and monitoring the pressure of the bladder, the pressure of the urethra, or the pressure of the external sphincter.

[0038] Fig. 10 is a drawing for explaining the configuration of a control unit for obtaining an image through a light-emitting unit of the present invention.

[0039] FIG. 11 is a drawing for explaining the configuration of a control unit for preventing degeneration and thermal damage to urethral tissue through temperature measurement and fluid circulation of the urethra through the proximal balloon channel of the present invention.

[0040] Figure 12 is a schematic diagram of the state of the urethra before and after insertion of the proximal balloon of the present invention into the urethra during inflation.

[0041] Figures 13a to 13c are drawings for explaining the light intensity control of the proximal balloon of the present invention.

[0042] Figures 14a to 14c are drawings for explaining various shapes of the proximal balloon of the present invention.

[0043] Figure 15 is a block diagram showing the relationship between each channel and sensors, light emitting unit, and control unit configured in the tubular body of the light irradiation device of the present invention.

[0044] Figure 16 is a flow chart of a light irradiation method for treating the external urethral sphincter using the light irradiation device of the present invention.

[0045] Figure 17 shows data on the internal and external temperatures of a tubular body in a light irradiation experiment on pig urethral tissue using the light irradiation device of the present invention.

[0046] Figures 18a and 18b are microscopic images of the control group and the treatment group for urethral muscle thickness in a light irradiation experiment on pig urethral tissue using the light irradiation device of the present invention, and Figure 18c is a graph showing the comparison results.

[0047] Figure 19 is a graph showing the results of a comparison between the control group and the treatment group regarding the thickness of the urethral mucosa layer in a light irradiation experiment on pig urethral tissue using the light irradiation device of the present invention.

[0048] Hereinafter, the present invention will be described in detail with reference to the attached drawings. In this case, the same components are indicated by the same reference numerals in each drawing, where possible. In addition, detailed descriptions of functions and / or configurations already known will be omitted. The content disclosed below focuses on parts necessary for understanding the operation according to various embodiments, and descriptions of elements that may obscure the gist of the description will be omitted. In addition, some components in the drawings may be exaggerated, omitted, or schematically illustrated. The size of each component does not entirely reflect the actual size, and therefore, the contents described herein are not limited by the relative sizes or spacing of components drawn in each drawing.

[0049] In describing embodiments of the present invention, if a detailed description of a known technology related to the present invention is judged to unnecessarily obscure the gist of the present invention, the detailed description will be omitted. In addition, the terms described below are terms defined in consideration of their functions in the present invention, and this may vary depending on the intention or custom of the user or operator. Therefore, the definitions should be made based on the contents throughout this specification. The terminology used in the detailed description is only for the purpose of describing embodiments of the present invention and should never be limited. Unless clearly used otherwise, the singular form includes the plural form. In this description, expressions such as "comprises" or "having" are intended to indicate certain features, numbers, steps, operations, elements, parts or combinations thereof, and should not be construed to exclude the presence or possibility of one or more other features, numbers, steps, operations, elements, parts or combinations thereof other than those described.

[0050] Additionally, although terms such as first, second, etc. may be used to describe various components, the components are not limited by the terms, and the terms are used only for the purpose of distinguishing one component from another.

[0051] FIG. 1 is a schematic cross-sectional view of a light irradiation device (100) according to one embodiment of the present invention.

[0052] Figure 2 is an example in which the distal balloon (110) and the proximal balloon (120) of the present invention are inserted into the bladder neck and urethra.

[0053] Referring to FIGS. 1 and 2, a light irradiation device (100) according to one embodiment of the present invention is a device for irradiating light to strengthen urethral muscles, and may include a distal balloon (110) and a proximal balloon (120) coupled to one side of a tubular body (10) in the form of a catheter for insertion into the urethra, and a control unit (130) coupled to the other side of the tubular body (10) so as to be positioned outside the urethra (outside the body). The proximal balloon (120) may be positioned in the urethra, and the distal balloon (110) may be positioned in the bladder neck (bladder neck).

[0054] The control unit (130) may be equipped with a bladder washing unit (127), a urine discharge unit (128), a balloon control unit (129), a fluid management unit (131), a pressure measurement unit (132), an optical fiber movement unit (133), an optical fiber rotation unit (134), an image acquisition unit (135), and a diagnosis unit (136), as described in FIG. 15.

[0055] The control unit (130) performs overall control over the components of the light irradiation device (100) and may include devices, units, etc. necessary for controlling the operation of the components of the light irradiation device (100). Furthermore, the control unit (130) may include hardware such as a display device, a semiconductor processor, and a semiconductor memory. The components of the control unit (130) may also be operated in combination with software as needed. The detailed configuration and operation of the control unit (130) will be described later.

[0056] Fig. 3a is a longitudinal cross-sectional view of the AL portion of Fig. 1.

[0057] Figure 3b is a cross-sectional view of portion A1-A2 of Figure 1.

[0058] Fig. 4a is a longitudinal cross-sectional view of the BL portion of Fig. 1.

[0059] Figure 4b is a cross-sectional view of portion B1-B2 of Figure 1.

[0060] Fig. 5 shows the channels of the joint portion of the tubular body (10) and the control unit (130) of Fig. 1.

[0061] Referring to FIGS. 3A to 5, the inside of the tubular body (10) includes a distal balloon channel (1), a urine discharge channel (2), a bladder washing channel (3), a proximal balloon channel (4), a pressure measurement channel (5), and a light transmission channel (6), which are connected and coupled to a control unit (130) depending on the location. In addition, the tubular body (10) connected and coupled to the control unit (130) may further include an additional channel for accommodating a wire for electrically connecting a pressure sensor (121) or a temperature sensor (not shown) provided on the outside of the proximal balloon (120).

[0062] The tubular body (10) may be made of a material such as silicone or latex. The tubular body (10) may have a total length of 10 to 50 cm from the channels (bundles) (1 to 6) that start at the same location when connected to the control unit (130) to the opposite end, depending on the design purpose or need. The diameter of the tubular body (10) may be implemented in various specifications between 2 and 10 mm. In addition, the distance between the lower end of the distal balloon (110) and the upper end of the proximal balloon (120) may be implemented in various sizes between 0.5 and 5 cm.

[0063] The distal balloon channel (1) is formed between the control unit (130) and the inner side of the distal balloon (110) in the inner lumen of the tubular body (10).

[0064] The urine discharge channel (2) and the bladder washing channel (3) are formed between the control unit (130) and the one end of the tubular body (10) in the lumen of the tubular body (10). The urine discharge channel (2) and the bladder washing channel (3) pass through the distal balloon (110). The control unit (130) can control the saline solution (or distilled water) injected through the bladder washing channel (3) during bladder washing to be discharged through the urine discharge channel (2) as described below. By injecting the saline solution (or distilled water) at 35 to 37°C through the bladder washing unit (127) and the urine discharge unit (128) of the control unit (130), urine removal and washing in the bladder can be performed to minimize infection.

[0065] The proximal balloon channel (4) and the light transmission channel (6) are formed between the control unit (130) and the inner side of the proximal balloon (120) in the lumen of the tubular body (10). The proximal balloon channel (4) and the light transmission channel (6) do not extend outside the proximal balloon (120) toward the distal balloon (110).

[0066] A pressure measurement channel (5) is formed between the control unit (130) and the end portion on one side of the inner lumen of the tubular body (10). The control unit (130) can control saline solution (or distilled water) injected through the pressure measurement channel (5) to be discharged through the urine discharge channel (2).

[0067] In particular, the light irradiation device (100) of the present invention can control the expansion and contraction of the distal balloon (110) and the proximal balloon (120) through the distal balloon channel (1) and the proximal balloon channel (4), respectively, under the control of the control unit (130), and can control the discharge of urine through the urine discharge channel (2) and the washing of the bladder through the bladder washing channel (3). In addition, the light irradiation device (100) can control the light irradiation of the light emitting unit (122) provided at the end of the optical fiber (11) extended from the control unit (130) to the light transmission channel (6) through the light transmission channel (6) under the control of the control unit (130).

[0068] Furthermore, the light irradiation device (100) of the present invention is configured to measure and monitor the pressure of the bladder, and for this purpose may include a bladder pressure sensor (111). The bladder pressure sensor (111) is electrically connected to the control unit (130) through the pressure measurement channel (5), and may be installed at the outer wall end of one side of the tubular body (10) above the distal balloon (110), as shown in FIG. 1.

[0069] In addition, the light irradiation device (100) of the present invention is configured to measure and monitor the pressure of the urethra, and for this purpose, may include a urethral pressure sensor (112). The urethral pressure sensor (112) is electrically connected to the control unit (130) through the pressure measurement channel (5), and, as shown in FIG. 1, may be installed on the outer wall of the tubular body (10) between the distal balloon (110) and the proximal balloon (120).

[0070] In addition, the light irradiation device (100) of the present invention is configured to measure and monitor the pressure of the external sphincter, and for this purpose, may include an external sphincter pressure sensor (121). The external sphincter pressure sensor (121) is electrically connected to the control unit (130) along the tubular body (10) through the pressure measurement channel (5) or another additional channel (not shown), and may be installed on the outer wall of the proximal balloon (120), as shown in FIG. 1. The external sphincter pressure sensor (121) is preferably arranged at the upper end of the proximal balloon (120), particularly above the middle of the proximal balloon (120).

[0071] The light irradiation device (100) of the present invention minimizes damage to the urethral mucosal tissue and transmits light stimulation to the target muscle layer, thereby enabling strengthening of the urethral muscles. That is, by using the balloon (110, 120) structure, the irregularly shaped urethral mucosa can be expanded into a uniform surface that is easy to irradiate with light, and pressure damage to the urethral mucosa caused by the inflated balloon (110, 120) can be prevented through mucosal pressure measurement and feedback. In addition, by using a fluid circulation system (see FIG. 11) to circulate a low-temperature liquid inside the balloon, a water-cooling effect is provided on the contacting tissue, thereby minimizing thermal damage to the mucosa that may be caused by light irradiation. In addition, by using the motion control (see FIG. 8b) of the control unit (130), the position and rotation of the light-emitting unit (122) can be controlled, so that light irradiation can be selectively applied to the target mucosal area.

[0072] In order to explain the light irradiation device (100) of the present invention in more detail, reference will be made to FIGS. 6a to 19b.

[0073] Figures 6a to 6c show various embodiments of the light emitting unit (122) of the present invention.

[0074] As shown in FIGS. 6A to 6C, the light emitting portion (122) may be configured to irradiate light at a predetermined length along the tubular body (10), and to irradiate light at an angle of 360 degrees (full direction) (FIG. 6A), 180 degrees (FIG. 6B), or 45 degrees (FIG. 6C) in the circumferential direction centered on the tubular body (10). In addition, the light emitting portion (122) may be configured to irradiate light at various other angles as needed. For example, the length of the light emitting portion (122) may be appropriately designed to be less than 20 cm, since the length of the urethra is approximately 15 to 20 cm.

[0075] The light emitting unit (122) is connected to the optical fiber of the control unit (130) and has an optical fiber (11) end formed in various shapes, such as a lens shape, to receive and irradiate light from various light sources, such as a high-frequency light source and an LED (Light Emitting Diode) of the control unit (130). The light emitting unit (122) is configured to irradiate light at an angle of 360 degrees (full direction) (Fig. 6a), 180 degrees (Fig. 6b), or 45 degrees (Fig. 6c) in the circumferential direction centered on the tubular body (10), thereby distributing light in various cross-sectional shapes, such as a circle, a semicircle, and a quarter circle (fan shape).

[0076] The light emitting unit (122) is connected to the optical fiber (11) from the control unit (130), and has an output power of 100 mW to 50 W according to the thickness or length of the external urethral sphincter according to the control of the control unit (130), and can irradiate light with a wavelength between visible light and near infrared (e.g., 500 to 20,000 μm), including laser. As described above, the light emitting unit (122) is configured to partially irradiate light according to the characteristics of the external urethral sphincter, and rotates the optical fiber (11) connected to the light emitting unit (122) (e.g., 10 to 20 degrees / second) according to the control of the motor (not shown) of the control unit (130), thereby rotating the light emitting unit (122) in the circumferential direction (e.g., 10 to 20 o / sec). It is preferable that the outer surface of the light emitting part (122) be covered with a material that does not interfere with the direction of light transmission, such as glass or acrylic.

[0077] Fig. 7a shows the movement of the light emitting part (122) within the proximal balloon (120) of the present invention, and Fig. 7b shows the control of the motor drive for this.

[0078] Referring to FIGS. 7A and 7B, the light emitting unit (122) can be configured to move between the upper and lower ends of the proximal balloon (120) along the light transmission channel (6) (e.g., 4 cm, etc.). The size of the proximal balloon (120) can be 9 to 20 Fr (1 Fr = 3.3 mm) in the horizontal (lateral direction) and 1 to 4 cm in the vertical (longitudinal) direction. In addition, the size of the distal balloon (110) can be 4 to 30 Fr (1 Fr = 3.3 mm) in the horizontal and vertical diameters, respectively. According to the user's operation, the optical fiber moving unit (133) of the control unit (130) can control the operation of the motor (131) connected to the optical fiber (11) to control the light emitting unit (122) to move between the upper and lower ends of the proximal balloon (120) along the light transmission channel (6). It can be configured to apply light irradiation to the entire or a specific part of the target external urethral sphincter by moving the light emitting part (122) up and down.

[0079] Fig. 8a shows the rotation of the light emitting part (122) within the proximal balloon (120) of the present invention, and Fig. 8b shows the control of the motor drive for this.

[0080] Referring to FIGS. 8a and 8b, the light emitting unit (122) irradiates light at a predetermined length along the tubular body (10), and irradiates light at an angle of 360 degrees or less in the circumferential direction centered on the tubular body (10) (see FIGS. 6a, 6b, and 6c), and the optical fiber rotation unit (134) of the control unit (130) can be configured to control the operation of the motor (M) connected to the optical fiber (11) according to the user's operation so that the light emitting unit (122) rotates 0 to 360 degrees.

[0081] FIG. 9 is a drawing for explaining the configuration of the pressure measuring unit (132) of the control unit (130) for determining the fluid flow through the pressure measuring channel (5) of the present invention and measuring and monitoring the pressure of the bladder, the pressure of the urethra, or the pressure of the external sphincter.

[0082] Referring to FIG. 9, the pressure measuring unit (132) of the control unit (130) is configured to determine whether there is fluid flow in the urethra and bladder by injecting saline solution (or distilled water) through the pressure measuring channel (5), and may be configured to measure and monitor the pressure of the bladder, the pressure of the urethra, or the pressure of the external sphincter when the saline solution is injected. This is to monitor whether the pressures have an appropriate pressure according to the fluid flow. The saline solution is not limited thereto, and a sterilized liquid such as distilled water may be used.

[0083] At this time, in order to measure the pressure of the bladder, the bladder pressure sensor (111) is electrically connected to the control unit (130) through the pressure measurement channel (5), and can be installed at the outer wall end of one side of the tubular body (10) above the distal balloon (110), as shown in FIG. 1.

[0084] In addition, in order to measure the pressure of the urethra, the urethral pressure sensor (112) is electrically connected to the control unit (130) through the pressure measurement channel (5), and can be installed on the outer wall of the tubular body (10) between the distal balloon (110) and the proximal balloon (120), as shown in FIG. 1.

[0085] In addition, in order to measure the pressure of the external sphincter, the external sphincter pressure sensor (121) is electrically connected to the control unit (130) through the pressure measurement channel (5), and can be installed on the outer wall of the proximal balloon (120) as shown in Fig. 1. For example, in particular, the external sphincter pressure sensors (121) can be arranged in multiples, such as 4 to 10, at predetermined intervals (e.g., 10-90 degree intervals) along the circumferential direction depending on the area, length, thickness, etc. of the external sphincter.

[0086] As shown in FIG. 9, the pressure measurement unit (132) of the control unit (130) may include a converter (911) that amplifies an electrical signal from a bladder pressure sensor (111) and converts it into a digital signal, a converter (912) that amplifies an electrical signal from a urethral pressure sensor (112) and converts it into a digital signal, and a converter (913) that amplifies an electrical signal from an external sphincter pressure sensor (121) and converts it into a digital signal.

[0087] The pressure measuring unit (132) of the control unit (130) includes a pressure measuring device (915) for checking signals of the transducers (911, 912, 913) according to the injection of the saline solution. The pressure measuring device (915) collects and stores signals of the transducers (911, 912, 913) and signals regarding the injection of the saline solution, and can display the trend of these pressures in the form of text or a graphical graph through the display device (915) to monitor whether the pressure of the bladder, the pressure of the urethra, or the pressure of the external sphincter has an appropriate value.

[0088] Accordingly, it is possible to check whether the urethra is functionally restored before and after phototherapy.

[0089] FIG. 10 is a drawing for explaining the configuration of the image acquisition unit (135) of the control unit (130) for acquiring an image through the light-emitting unit (122) of the present invention.

[0090] Referring to FIG. 10, the image acquisition unit (135) of the control unit (130) includes a linear manual stage (1010), and the linear manual stage (1010) can be configured to control the operation of a motor (M) connected to an optical fiber (11) according to a user's operation to rotate the light emitting unit (122) (see FIG. 8b) and move in the longitudinal direction along the light transmission channel (6) (see FIG. 7b).

[0091] In addition, the image acquisition unit (135) of the control unit (130) can be configured to transmit light for image acquisition to the light emitting unit (122) through an optical fiber (11) and detect scattered light received through the light emitting unit (122) to acquire an optical coherence tomography (OCT) image or a 2-3D ultrasound image.

[0092] To this end, the image acquisition unit (135) of the control unit (130) includes an optical coupler (1020) for splitting the light from the light emitting diode (1030) into the light for image acquisition, and the light emitting unit (122) may include a receiving means (not shown) for receiving the scattered light or ultrasonic signal in response to the light for image acquisition and transmitting it to the optical coupler (1020). The scattered light or ultrasonic signal transmitted to the optical coupler (1020) is processed and amplified through a photodetector (1040) and converted into a digital signal in an analog-to-digital converter (1050). The diagnostic unit (136) can process and analyze the digital signal to obtain optical coherence tomography (OCT) images or 2-3D ultrasound images (data), and display these optical coherence tomography (OCT) images or 2-3D ultrasound images through a display device (915), thereby assisting the practitioner in checking the patient's urethral condition, such as tissue degeneration, thickness, and properties, and making necessary diagnoses.

[0093] Fig. 11 is a drawing for explaining the configuration of a control unit (130) for preventing degeneration and thermal damage to urethral tissue through temperature measurement and fluid circulation of the urethra through the proximal balloon channel (4) of the present invention.

[0094] Referring to FIG. 11, a temperature sensor (125) is included inside the proximal balloon (120), and the temperature sensor (125) is electrically connected to the fluid management unit (131) of the control unit (130) along the tubular body (10) through the proximal balloon channel (4) or another additional channel (not shown).

[0095] The fluid management unit (131) of the control unit (130) may be configured to supply and circulate a fluid maintained at a predetermined (cooling) temperature to the proximal balloon (120) through the proximal balloon channel (4) based on the temperature detected by a temperature sensor (125) such as a thermocouple, a liquid thermometer, or an FBG (Fiber Bragg Grating) sensor. The fluid may include any solution within a substance that does not affect the measurement of the temperature within the proximal balloon channel (4) and the light irradiation of the light emitting unit (122), excluding an organic solvent, and may be a liquid maintained at 4 to 10°C.

[0096] The fluid management unit (131) of the control unit (130) may include a temperature detector (1110) that processes an electrical signal from a temperature sensor (125) to detect temperature, and a fluid circulation pump (1120) for supplying and circulating (e.g., circulation speed 0.5 to 1.0 ml / sec) the fluid supplied from the solution supply tank (1140). In a state where a 3-way stopcock (1131) connects a syringe (1130) and a solution supply tank (1140), the fluid may be supplied to the solution supply tank (1140) through the syringe (1130), and in a state where the 3-way stopcock (1131) connects the solution supply tank (1140) and the fluid circulation pump (1120), the fluid may be supplied from the solution supply tank (1140) to the fluid circulation pump (1120). The fluid in the solution supply tank (1140) can be configured to be maintained at 4 to 10 °C.

[0097] Additionally, a temperature sensor (not shown), such as a thermocouple, a liquid thermometer, or an FBG sensor, may be further provided on the outside of the proximal balloon (120), for example, at one or more of the top, middle, and bottom, to measure the temperature of the urethral mucosa. The temperature sensor (not shown) is electrically connected to the light control unit (not shown) of the control unit (130) along the tubular body (10) through the proximal balloon channel (4) or another additional channel (not shown). The light control unit (not shown) of the control unit (130) may be configured to control the output power of a light source that transmits light to the light emitting unit (122) so that the detection temperature becomes lower than a threshold temperature (e.g., 50°C) based on the detection temperature based on the temperature sensor (not shown). This is to prevent thermal denaturation of the urethral mucosa when it reaches about 60°C.

[0098] Figure 12 is a schematic diagram of the state of the urethra before and after insertion of the proximal balloon (120) of the present invention into the urethra during inflation.

[0099] Referring to Fig. 12, when a fluid maintained at a predetermined (cooling) temperature is supplied to the proximal balloon (120) through the proximal balloon channel (4) according to the operation of the fluid management unit (131) of the control unit (130) of Fig. 11 to expand it, the mucosal layer of the urethra is spread and expanded along the surface of the expanded proximal balloon (120) as shown on the right. The supply of fluid to the proximal balloon (120) can be controlled within the range of 15 to 50 ml depending on the condition of the urethra. Normally, the shape of the mucosal side of the urethral tissue is not circular, but during treatment, the expansion of the proximal balloon (120) allows the mucosal layer to be spread to a uniform thickness and shape. By expanding the proximal balloon (120), uniform light transmission to the external sphincter of the urethra is enabled, and by injecting a 4 to 10°C fluid into the proximal balloon (120), high heat energy can be transmitted to the muscle layer without thermal damage to the urethral mucosal layer and submucosal layer.

[0100] The balloon control unit (129) of the control unit (130) can also be implemented similarly to the fluid management unit (131) of FIG. 11, and as shown in FIG. 12, when a fluid maintained at a predetermined (cooling) temperature is supplied to the distal balloon (110) through the distal balloon channel (1) according to the operation of the balloon control unit (129) of the control unit (130) to expand it, the bladder inlet can be spread and expanded along the surface of the expanded distal balloon (110). The supply of fluid to the distal balloon (110) can be controlled within a range of 1 to 5 ml depending on the state of the urethra.

[0101] That is, the balloon control unit (129) of the control unit (130) may be configured to supply and circulate a fluid maintained at a predetermined (cooling) temperature to the distal balloon (110) through the distal balloon channel (1) based on the temperature detected by the temperature sensor (not shown) in the distal balloon (110). The balloon control unit (129) of the control unit (130) may include a temperature sensor (not shown) that processes an electrical signal from the temperature sensor to detect the temperature, and a fluid circulation pump (not shown) for supplying and circulating the fluid supplied from a solution supply tank (not shown). The balloon control unit (129) of the control unit (130) may be equipped with a three-way cock (not shown), a syringe (not shown), and a solution supply tank (not shown) similar to FIG. 11.

[0102] Figures 13a to 13c are drawings for explaining the light intensity control of the proximal balloon (120) of the present invention.

[0103] Referring to Fig. 13a, the proximal balloon (120) may be made of a transparent material such as silicone. The distal balloon (110) and the proximal balloon (120) may be made of an elastic material such as PET (Polyethylene Terephthalate), Pebax, or Polyethylene. The distal balloon (110) and the proximal balloon (120) may be coated on the entire surface with an optical glass material (such as N-BK7 or B270). In particular, the proximal balloon (120) may be implemented to have a high light transmittance of 90% or more.

[0104] Referring to Fig. 13b, the upper portion (129-1) and a portion of the lower portion (129-2) on the inner or outer side of the proximal balloon (120) may be further coated with a material (e.g., a metal such as gold, a polymer, a biocompatible material, etc.) to reduce light intensity. The portion may be implemented in various ways, such as in the shape of a band spaced at a predetermined interval, in the shape of a coating surface spaced at a predetermined angle in the circumferential direction, or in a combination thereof (the same applies hereinafter).

[0105] Referring to Fig. 13c, the proximal balloon (120) may be further coated with a material to reduce light intensity, either at the upper end (129-1) or the lower end (129-2) on the inner or outer side, or between the upper and lower ends (129-3). Various embodiments are possible, such as a band shape spaced apart at a predetermined interval, a coating surface spaced apart at a predetermined angle in the circumferential direction, or a combination thereof.

[0106] That is, by combining the above embodiments, the proximal balloon (120) may have at least one portion among the upper portion (129-1), the lower portion (129-2), and a portion between the upper portion and the lower portion (129-3) on the inner or outer side coated with a material for reducing light intensity.

[0107] In this way, the range of light irradiation reaching the external sphincter of the urethra located on the outside is controlled by the coating structure of the proximal balloon (120), and by coating the front surface of the proximal balloon (120), the degree of freedom in controlling the light intensity according to the thickness of the external sphincter can be increased.

[0108] Figures 14a to 14c are drawings for explaining various shapes of the proximal balloon (120) of the present invention.

[0109] Referring to Fig. 14a, the proximal balloon (120) may have an elongated hexagonal shape when inflated, and at least one of the upper and lower portions may have a tapered shape.

[0110] Referring to Fig. 14b, the proximal balloon (120) may have a shape of an elongated cylinder when inflated, and at least one of the upper and lower portions may have a tapered shape. In other words, the shape of the longitudinal cross-section may be an ellipse.

[0111] Referring to Fig. 14c, the proximal balloon (120) may have a hexagonal cylindrical body when inflated, and a hemispherical upper portion with a larger diameter than the body. The lower portion on the opposite side may have a tapered shape. This structure is the same even when the body is cylindrical. In other words, the longitudinal cross-section may have a hemispherical shape.

[0112] FIG. 15 is a block diagram showing the relationship between each channel (1 to 6) configured in the tubular body (10) of the light irradiation device (100) of the present invention, the sensors (111, 112, 121), the light emitting unit (122), and the control unit (130).

[0113] Referring to FIG. 15, as described above, the control unit (130) may be equipped with a bladder washing unit (127), a urine discharge unit (128), a balloon control unit (129), a fluid management unit (131), a pressure measurement unit (132), an optical fiber movement unit (133), an optical fiber rotation unit (134), an image acquisition unit (135), and a diagnosis unit (136). In addition, the control unit (130) may additionally be configured with necessary units such as a light control unit (not shown).

[0114] The tubular body (10) is connected to the control unit (130) through the distal balloon channel (1), the urine discharge channel (2), the bladder washing channel (3), the proximal balloon channel (4), the pressure measurement channel (5), and the light transmission channel (6).

[0115] The light irradiation device (100) includes a distal balloon (110) and a proximal balloon (120) coupled to one side of a tubular body (10) in the form of a catheter for insertion into the urethra, and the proximal balloon (120) can be configured to be seated in the urethra and the distal balloon (110) to be seated in the bladder neck.

[0116] The light emitting unit (122) is connected to the control unit (130) by an optical fiber (11) through a light transmission channel (6) and is placed inside the proximal balloon (120). A temperature sensor (125) is further placed inside the proximal balloon (120).

[0117] The urine discharge channel (2) and the bladder washing channel (3) are formed between the control unit (130) and the one end of the tubular body (10) in the lumen of the tubular body (10). The urine discharge channel (2) and the bladder washing channel (3) pass through the distal balloon (110).

[0118] In addition, a bladder pressure sensor (111), a urethral pressure sensor (112), and an external sphincter pressure sensor (121) are connected to the control unit (130) through a pressure measurement channel (5).

[0119] Figure 16 is a flow chart of a light irradiation method for treating the external urethral sphincter using the light irradiation device (100) of the present invention.

[0120] Referring to Figure 16, after a medical professional, such as a doctor or practitioner, checks various vital signs of a patient, the distal side of the tubular body (10) of the light irradiation device (100) is slowly inserted through the urethra (S110).

[0121] Next, by injecting a solution such as a fluid into the distal balloon (110) to expand it in order to fix the inserted light irradiation device (100), the proximal balloon (120) can be placed in the urethra, and the distal balloon (110) can be placed in the bladder neck (bladder neck) (S120).

[0122] Next, to minimize infection, a saline solution of 35 to 37°C is injected through the bladder washing unit (127) and the urine discharge unit (128) to remove urine from the bladder and discharge the washing solution out of the body to wash it (S130).

[0123] Next, liquid is injected into the proximal balloon (120) to expand it (S140).

[0124] Next, depending on the thickness or position of the external urethral sphincter within the proximal balloon (120), the optical fiber (11) is moved and rotated to the target location for shooting, such as the entire or part of the external urethral sphincter, according to the light-emitting angle of the light-emitting unit (122) (S150), and an optical coherence tomography (OCT) image or a 2-3D ultrasound image is acquired by the image acquisition unit (135) (S160).

[0125] Next, the light emitting unit (122) is positioned to correspond to the location of the external sphincter of the urethra, which is the target tissue for treatment, through the control unit (130), and the light emitting unit (122) is moved and rotated so that light is irradiated to the corresponding target treatment location of the external sphincter of the urethra confirmed through the image acquisition unit (135) (S170).

[0126] Next, the pressure measuring unit (132) is operated together with the pressure sensor (111, 112, 121) to measure the corresponding pressures before light irradiation (S180).

[0127] Next, before the light irradiation, the fluid management unit (131) is operated to operate the fluid circulation pump to circulate the fluid to maintain the internal temperature of the proximal balloon (120) at 4 to 10°C (S190), and the temperature is measured and monitored (S200).

[0128] Next, light irradiation is performed on the target tissue, the external urethral sphincter, by the light emitting unit (122), and the fluid is circulated by the fluid management unit (131) to maintain the water cooling effect during the light irradiation (S210). The light control unit (not shown) of the control unit (130) can be configured to control the output power of the light source that transmits light to the light emitting unit (122) so that the detection temperature becomes lower than the critical temperature (e.g., 50°C) based on the detection temperature based on the temperature sensor (not shown) outside the proximal balloon channel (4). This is to prevent thermal denaturation, which begins to occur when the urethral mucosa layer reaches about 60°C.

[0129] Next, the pressure measurement unit (132) is operated together with the pressure sensor (111, 112, 121) to measure the pressure change after the light irradiation treatment (S210) to determine whether treatment has been performed, and when the appropriate treatment is completed, the liquid in the proximal balloon (120) is discharged to the outside through the proximal balloon channel (4), and the light irradiation device (100) is removed from the body (S220).

[0130] Figure 17 shows data on the internal and external temperatures of a tubular body (10) in a light irradiation experiment on pig urethral tissue using a light irradiation device (100) of the present invention.

[0131] Referring to FIG. 17, it was confirmed that the temperature inside the urethra (Inner) measured by the temperature sensor (125) inside the proximal balloon (120) of the FBG (Fiber Bragg Grating) sensor and the temperature outside the urethra (Outer) measured by the IR (infra red) sensor were measured at a higher temperature outside than the temperature inside the urethra during light irradiation using the light irradiation device (100).

[0132] Here, a 4-10°C solution was injected into the proximal balloon (120) before light irradiation and circulated to maintain a pressure of 1-5 atmospheres (atm). Since the external temperature (maximum temperature 34.5°C) was measured to be higher than the internal temperature of the urethra (maximum temperature 33.3°C) during light irradiation, it was confirmed that there was a water cooling effect by the solution.

[0133] Figures 18a and 18b are microscopic photographs of the control group and the treatment group for the thickness of the urethra muscle in a light irradiation experiment on pig urethra tissue using the light irradiation device (100) of the present invention, and Figure 18c is a graph showing the comparison results.

[0134] Referring to FIGS. 18a to 18c, the thickness of the external urethral sphincter of the control group that did not receive laser treatment was 2 to 2.6 mm, and the thickness of the group that received laser treatment using the light irradiation device (100) of the present invention (laser treatment group) was 2.6 to 4.0 mm. Accordingly, it was confirmed that the thickness of the urethral muscle was effectively increased after the laser irradiation treatment. This can be supported by the fact that the p-value indicating no statistically significant difference (NS) in the hypothesis of statistical testing was less than 0.05 (there was a difference).

[0135] Figure 19 is a graph showing the results of a comparison between the control group and the treatment group regarding the thickness of the urethral mucosa layer in a light irradiation experiment on pig urethral tissue using the light irradiation device (100) of the present invention.

[0136] Referring to Figure 19, when the thickness of the urethral mucosa was measured, the control group showed 14-40 μm, and the laser treatment group showed 17-38 μm. This clearly demonstrates that there was little change in the thickness of the urethral mucosa, indicating that thermal damage to the mucosa did not occur before and after laser treatment. This can be supported by the result of the p-value of 0.8, which indicates no statistically significant difference (NS) in the hypothesis of statistical testing.

[0137] As described above, according to the light irradiation device (100) of the present invention, urethral muscle strengthening is possible by minimizing damage to urethral mucosal tissue and delivering light stimulation to the target muscle layer. That is, by using a balloon structure, an irregularly shaped urethral mucosa can be expanded into a uniform surface that is easy to irradiate with light, and pressure damage to the urethral mucosa caused by the inflated balloon can be prevented through mucosal pressure measurement and feedback. In addition, by using a fluid circulation system to circulate a low-temperature liquid within the balloon, a water-cooling effect is provided to the contacting tissue, thereby minimizing thermal damage to the mucosa that may be caused by light irradiation. In addition, by using a motion controller to control the position and rotation of the light-emitting unit, light irradiation can be selectively applied to the target mucosal area.

[0138] As described above, the present invention has been described with specific details such as specific components and limited examples and drawings, but these are provided only to help a more general understanding of the present invention, and the present invention is not limited to the above-described examples, and those with ordinary skill in the art to which the present invention pertains may make various modifications and variations without departing from the essential characteristics of the present invention. Therefore, the spirit of the present invention should not be limited to the described examples, and all technical ideas that are equivalent or equivalent to the claims described below as well as the claims should be interpreted as being included in the scope of the rights of the present invention.

Claims

1. A distal balloon and a proximal balloon provided on one side of the tubular body to be inserted into the urethra; A control unit coupled to the other side of the tubular body so as to be positioned outside the urethra; A distal balloon channel formed between the control portion and the inner side of the distal balloon in the inner lumen of the tubular body; A urine discharge channel and a bladder washing channel formed between the control unit and the one end portion in the lumen of the tubular body; A proximal balloon channel and a light transmission channel formed between the control unit and the inner side of the proximal balloon in the lumen of the tubular body; and It includes a light emitting unit provided at the end of an optical fiber extended from the control unit through the light transmission channel, The above control unit controls the expansion and contraction of the distal balloon and the proximal balloon through the distal balloon channel and the proximal balloon channel, controls the discharge of urine through the urine discharge channel and the washing of the bladder through the bladder washing channel, and controls the light irradiation of the light emitting unit, a light irradiation device.

2. In paragraph 1, A pressure measuring channel formed between the control unit and the one end portion in the inner lumen of the tubular body; A bladder pressure sensor electrically connected to the control unit through the pressure measuring channel and installed on an outer wall end of one side of the tubular body; A urethral pressure sensor electrically connected to the control unit through the pressure measuring channel and installed on the outer wall of the tubular body between the distal balloon and the proximal balloon; and It further includes an external sphincter pressure sensor electrically connected to the control unit through the pressure measuring channel and installed on the outer wall of the proximal balloon. The above control unit is a light irradiation device configured to measure and monitor the pressure of the bladder, the pressure of the urethra, or the pressure of the external sphincter.

3. In paragraph 2, The above external sphincter pressure sensor is a light irradiation device placed at the upper end of the above proximal balloon.

4. In paragraph 2, The above control unit is configured to determine whether there is fluid flow in the urethra and bladder by injecting saline solution through the pressure measuring channel, and is a light irradiation device configured to measure and monitor the pressure of the bladder, the pressure of the urethra, or the pressure of the external sphincter when the saline solution is injected.

5. In paragraph 1, The above control unit is a light irradiation device that controls saline solution injected through the bladder washing channel during bladder washing to be discharged through the urine discharge channel.

6. In paragraph 4, A light irradiation device in which the control unit controls the saline solution injected through the pressure measuring channel to be discharged through the urine discharge channel.

7. In paragraph 1, The above light emitting unit is a light irradiation device that irradiates light with a wavelength between visible light and near-infrared light, including a laser, and has an output power of 100 mW to 50 W.

8. In paragraph 1, The above light emitting unit is a light emitting device configured to irradiate light at a predetermined length along the tubular body, and to irradiate light at an angle of 360 degrees, 180 degrees, or 45 degrees in the circumferential direction centered on the tubular body.

9. In paragraph 1, The size of the above proximal balloon is 9 to 20 Fr in width and 1 to 4 cm in length, and the control unit controls the operation of the motor connected to the optical fiber according to the user's operation so that the light emitting unit moves between the upper and lower ends of the above proximal balloon along the light transmission channel.

10. In paragraph 1, The above light emitting part irradiates light at a predetermined length along the tubular body, and irradiates light at an angle of less than 360 degrees in the circumferential direction centered on the tubular body. A light irradiation device configured such that the control unit controls the operation of a motor connected to the optical fiber according to a user's operation so that the light emitting unit rotates.

11. In paragraph 1, According to the user's operation, the control unit controls the operation of the motor connected to the optical fiber to rotate the light emitting unit and move along the light transmission channel. A light irradiation device configured to transmit light for image acquisition to the light emitting unit through the optical fiber and detect scattered light received through the light emitting unit to acquire an optical coherence tomography image or a 2-3D ultrasound image.

12. In paragraph 1, A temperature sensor is included inside the above-mentioned proximal balloon, and the temperature sensor is electrically connected to the control unit. A light irradiation device, wherein the control unit is configured to supply and circulate a fluid maintained at a predetermined temperature to the proximal balloon through the proximal balloon channel based on the temperature detected by the temperature sensor.

13. In paragraph 1, A temperature sensor is included on the outside of the above-mentioned proximal balloon, and the temperature sensor is electrically connected to the above-mentioned control unit, A light irradiation device, wherein the control unit is configured to control the output power of a light source that transmits light to the light emitting unit based on the temperature detected by the temperature sensor.

14. In paragraph 1, The above-mentioned proximal balloon is a light irradiating device in which at least one of the upper part, lower part, or a portion between the upper and lower parts of the inner or outer side is coated with a material for reducing light intensity.

15. In paragraph 1, The above-mentioned proximal balloon is a light irradiating device whose shape when inflated is an elongated hexagon, an elongated cylinder, or a shape in which at least one of the upper and lower ends of the hexagonal cylinder or the cylinder is tapered, or a hemispherical shape in which the upper end has a larger diameter than the body of the hexagonal cylinder or the cylinder.

Images