Apparatus and method for treating tissue

Abstract

A treatment device is disclosed. The treatment device comprises a cover sized to be inserted into the anal sphincter region and connected to a handpiece, at least one optical fiber configured to partially emit a laser beam such that the laser beam is oriented perpendicular to at least one axis of the optical fiber, a laser light source coupled to the at least one optical fiber, a thermometer connected to the cover, and a controller configured to control the laser light source based on a temperature measurement value received from the thermometer.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to U.S. Provisional Patent Application No. 63 / 349,594, entitled "SYSTEMS AND METHODS FOR TREATING TISSUES WITH LASER ENERGY", filed on June 7, 2022, the entire contents of which are incorporated herein by reference.

[0002] The present invention generally relates to laser - based medical treatment devices. More particularly, the present invention relates to laser - based medical treatment devices for treating tissues.

Background Art

[0003] The gastrointestinal (GI) tract, also called the alimentary canal, is a muscular, hollow, continuous tubular organ that begins at the mouth and ends at the anus and is responsible for digesting and absorbing ingested food and liquids. Circular rings of smooth muscle called sphincters surround parts of the GI tract. The anal canal has two circular muscles called the internal anal sphincter (IAS) and the external anal sphincter (EAS). The IAS and EAS control the outflow of gas and feces from the anus. The IAS is a thin white muscle that surrounds the anal canal. The internal sphincter has a resting tone so that small amounts of liquid and gas do not accidentally leak out during rest and sleep. The IAS is surrounded by the EAS, which is a large, thick, red voluntary muscle. The EAS is used to voluntarily delay defecation. The EAS muscle is voluntary, and the IAS muscle is involuntary.

Summary of the Invention

Problems to be Solved by the Invention

[0004] The internal anal sphincter (IAS) is part of the circular smooth muscle layer of the anal canal and is typically about 5 mm thick and about 35 mm long. It accounts for approximately 65% of the involuntary resting tone. The external anal sphincter (EAS) is usually 4 - 30 mm thick and accounts for about 25% of the resting tone. Normally, these muscles work in coordination to control the outflow of gas and feces through the anus from the anal canal. The anal sphincter may weaken with childbirth or aging.

[0005] Weakening or damage to the IAS or EAS muscles within the anal canal can cause sphincter dysfunction or a decrease in anal sphincter tone, potentially resulting in leakage of gas, liquid stool, or solid stool, and causing extreme embarrassment. Consequently, feces may descend through the anal canal without warning, stimulating a sudden defecation urge, resulting in fecal incontinence, also known as bowel incontinence. Thus, the ability to control defecation is lost, and excrement (stool) unexpectedly leaks from the anal canal. Fecal incontinence varies from occasional leakage of stool when passing gas to a complete inability to control defecation. The loss of dignity associated with the loss of control of bodily functions can lead to confusion, embarrassment, frustration, and depression. People with fecal incontinence generally try to hide the problem or avoid social interactions.

[0006] In certain surgical systems, high-frequency energy is applied to tissues at various tissue levels to create multiple tissue degenerations. However, patients who have received high-frequency treatment for fecal incontinence complain of severe pain due to the electrodes piercing the rectal tissue and have few long-term benefits. Furthermore, high-frequency treatment is applied to a small area, and it is necessary to manually move the handpiece repeatedly within the anal and rectal anatomical structures and within the anal canal. Additionally, this type of movement, which involves rotational and insertion / removal movements, can be unpleasant for patients in a clinical setting. The typical treatment temperature is between 85 and 95 degrees Celsius, while the typical rectal temperature of an adult can vary between 36 and 38 degrees Celsius. To eliminate the need for electrodes that pierce the tissue, it may be advantageous to preheat the anal canal and control the temperature of the tissue around the anal canal to be close to the treatment temperature. Preheating may make it possible to increase the depth of non-invasive high-frequency treatment without the need for electrodes that pierce the tissue.

[0007] In other surgical systems, laser energy is directly applied to tissue to create denaturation. Laser therapy has been used for decades to rejuvenate the vaginal canal. So-called vaginal therapy can increase the thickness of the vaginal wall and restore tissue moisture. This can reduce vaginal dryness, vaginal atrophy, and mild involuntary urinary leakage. Laser therapy is painless, but the application of laser energy mainly heats the surface of the tissue and is sufficient to treat the thin IAS but insufficient to treat the thick EAS surrounding the IAS. Since the penetration depth of laser energy is limited, lasers are not very suitable for the treatment of fecal incontinence. The typical treatment temperature is 85-95 degrees Celsius, while the typical rectal temperature of an adult can vary between 36-38 degrees Celsius. During laser energy treatment, much of the laser energy dissipates into the surrounding tissue, which is much cooler than the tissue being treated. This energy loss occurs in an uncontrollable manner and limits the depth of laser treatment. By preheating the rectal tissue to a temperature slightly lower than the treatment temperature, the depth of laser treatment can be increased in a more controlled manner with minimal laser energy. Therefore, it would be advantageous to provide a system that controls the temperature of rectal tissue before applying laser energy. A temperature probe mounted on a handheld device can provide feedback to a temperature controller, and the temperature controller can apply heating and cooling to control the temperature of the anal canal to a desired preheating temperature, such as 45°C. Additionally, the laser energy can be applied radially or semi-radially, reducing the number of energy treatment sessions and shortening the overall treatment time.

[0008] Furthermore, a more stationary handpiece is used in laser therapy, and when withdrawn from the anal canal, all areas of the rectal wall are covered by a radial laser, thus shortening the treatment time and eliminating the need for rotational or insertion / withdrawal movements. The application of laser energy is assisted by adhering to a treatment protocol so that the tissue is not heated beyond the scope of treatment and tissue damage or burns do not occur. The application of laser energy can further be assisted by monitoring specific tissue and / or device parameters so that the tissue is not heated beyond the scope of treatment and tissue damage or burns do not occur.

[0009] Ultrasound therapy is a treatment that has been used by physical therapists or occupational therapists for many years to relieve pain and promote tissue healing. Although ultrasound therapy can penetrate deeper into tissues, there are many contraindications to ultrasound, such as in pregnant women, treatments near the spine, infectious diseases, and ischemia. An ultrasound beam with a focused ultrasound energy can be precisely and accurately applied to deep tissues such as the EAS without damaging the surrounding bone or tissue. The focused ultrasound energy can also provide beneficial nerve stimulation within and near the anal canal. By preheating the tissue of the anal canal and controlling the temperature to be close to the treatment temperature, the ultrasound energy will dissipate more slowly by the surrounding tissue, so that the focused ultrasound can be applied more precisely and accurately.

[0010] Preheating the tissue before treatment has many advantages. Preheating can increase the temperature at the treatment depth, thereby providing a controlled temperature before treatment, enhancing the accuracy and precision of the treatment, and reducing the dissipation of treatment energy to the surrounding tissue. However, there are limits to the application of thermal energy, such as burns. At a temperature of 45 degrees Celsius, it takes 3 hours for tissue damage to occur, but at 50 degrees Celsius, tissue damage occurs after 4 minutes, at 55 degrees Celsius, tissue damage occurs after only 30 seconds, and at 60 degrees Celsius, tissue damage may occur after 5 seconds. Therefore, in order to protect the tissue from damage, it would be advantageous to preheat for a limited time under control immediately before treatment and then cool. Therefore, a temperature control system that provides both heating and cooling is ideal. Furthermore, a temperature control system that can quickly perform both the application of heating energy and the absorption of thermal energy is also advantageous. For example, a system that can raise the rectal temperature from approximately 37 degrees Celsius to 50 degrees Celsius in about 2 minutes before applying laser energy and then lower the rectal temperature to 45 degrees Celsius or even 37 degrees Celsius. There are several ways to apply such heating and cooling. Preheating can also be achieved through the application of laser energy that is converted into thermal energy. Preheating can also be achieved through the use of ultrasonic energy that is converted into thermal energy. Preheating can also be achieved through the use of high-frequency energy that is converted into thermal energy. The tissue can also be preheated by a resistance heating device, an induction heating device, or an infrared heating device. Heated air, water, or other fluids can also be passed through the anal canal to preheat the tissue. Similarly, air, water, or other fluids can be used to cool the anal canal. There are many well-known methods for heating and cooling the tissue, and the examples of heating and cooling methods described above are not exhaustive.

[0011] However, none of the known methods provide accurate control of the temperature of the tissue to be treated before, during, and / or after laser treatment.

Means for Solving the Problem

[0012] Some aspects of the present invention are directed to a treatment device comprising a cover sized to be inserted into the anal sphincter region and connected to a handpiece, at least one optical fiber configured to partially emit a laser beam, the laser beam being oriented perpendicular to at least one axis of the optical fiber, at least one laser light source coupled to the at least one optical fiber, a thermometer connected to the cover, and a controller configured to control the laser light source based on a temperature measurement received from the thermometer.

[0013] In some embodiments, the at least one optical fiber is a radial emission fiber. In some embodiments, the at least one optical fiber is a side-fire fiber and the device further comprises an actuator configured to rotate the side-fire fiber about the axis of the fiber. In some embodiments, the device further comprises one or more optical elements configured to direct the laser beam in a direction perpendicular to the axis of the optical fiber. In some embodiments, the one or more optical elements are selected from lenses, mirrors, prisms, and splitters.

[0014] In some embodiments, the device further comprises a sleeve inserted into the cover and at least partially surrounding the optical fiber, the sleeve comprising an optically transparent portion configured to enable delivery of the laser beam to the anal sphincter region during treatment. In some embodiments, the optically transparent portion comprises at least one of an optically transparent material and one or more windows configured to enable delivery of the laser beam.

[0015] In some embodiments, the cover comprises an optically transparent portion configured to enable delivery of the laser beam to the anal sphincter region during treatment. In some embodiments, the optically transparent portion comprises at least one of an optically transparent material and one or more windows configured to enable delivery of the laser beam.

[0016] In some embodiments, the thermometer is disposed at the distal end of the cover remote from the handpiece. In some embodiments, the device further comprises an axial movement element for axially sliding the sleeve within the cover.

[0017] In some embodiments, the device further comprises a heating unit configured to apply heat to the anal sphincter region during treatment. In some embodiments, the controller is further configured to control the heating unit based on temperature measurements received from the thermometer. In some embodiments, the controller is configured to receive the temperature measurements, control the heating unit to heat the anal sphincter region until the anal sphincter region reaches a desired temperature, and control the laser light source to generate a laser beam only after the target temperature is reached. In some embodiments, the controller is further configured to continuously receive the temperature measurements and configured to terminate the generation of the laser if the temperature exceeds a predefined threshold temperature. In some embodiments, the heating unit is selected from a radio frequency (RF) electrode attached to the cover, an ultrasonic probe disposed within the cover, and a resistance wire disposed within the cover.

[0018] In some embodiments, the device further comprises at least one pressure sensor disposed on the outer surface of the sleeve.

[0019] Some further aspects of the present invention are directed to a method for treating a patient's sphincter tissue, the method comprising inserting a treatment device into the patient's anal sphincter region, measuring the temperature at at least one location of the sphincter tissue, and irradiating the patient's anal sphincter region with a laser beam based on the measured temperature value. In some embodiments, the treatment device is dimensioned to be inserted into the anal sphincter region and includes a cover connected to a handpiece, at least one optical fiber configured to partially emit a laser beam, the laser beam being in a direction perpendicular to at least one of its optical axes, a laser light source coupled to the at least one optical fiber, a thermometer connected to the cover, and a controller configured to control the laser light source based on the temperature measurement value received from the thermometer.

[0020] In some embodiments, the method further comprises heating the sphincter tissue to a desired temperature, and irradiating comprises irradiating the patient's anal sphincter region only when the temperature of the sphincter tissue reaches a target temperature.

[0021] In some embodiments, the method further comprises monitoring the temperature at at least one location of the sphincter tissue and terminating laser irradiation when the temperature exceeds a pre-defined threshold temperature.

[0022] In some embodiments, the method further comprises receiving a pressure measurement value from the anal sphincter region and determining the patient's fecal incontinence state based on the received pressure measurement value. In some embodiments, the pressure measurement value is received from one or more pressure sensors included in the treatment device.

[0023] The subject matter regarded as the invention is particularly pointed out and distinctly claimed at the conclusion of this specification. However, the invention will be best understood by reference to the following detailed description in conjunction with the accompanying drawings, both as to its construction and method of treatment, as well as its objects, features, and advantages.

Brief Description of the Drawings

[0024]

Figure 1

Figure 2A

Figure 2B

Figure 3

Figure 4A

Figure 4B

Figure 4C

Figure 5

Mode for Carrying Out the Invention

[0025] It should be understood that, for the sake of brevity and clarity, the elements shown in the drawings are not necessarily drawn to an exact scale. For example, for clarity, the dimensions of some elements may be exaggerated relative to other elements. Further, reference numerals may be repeated between the drawings to indicate corresponding or similar elements where appropriate.

[0026] Those skilled in the art will understand that the present invention can be embodied in other specific forms without departing from its spirit or essential characteristics. Therefore, the above embodiments are not intended to limit the invention described herein, but should be considered exemplary in all respects. Accordingly, the scope of the present invention is indicated by the appended claims rather than the above description, and thus all modifications within the meaning and scope of equivalence of the claims are intended to be included in the claims.

[0027] Some aspects of the present invention are directed to various laser-based systems and methods for treating sphincter and adjacent tissue region dysfunctions within the body. For example, such systems and methods may be particularly well-suited for treating these dysfunctions in the lower gastrointestinal tract, such as the intestine, rectum, and anal canal. It should be understood that the disclosed systems and methods are applicable, for example, to restore or tighten the compliance of internal tissue or muscle regions, or for use in treating other dysfunctions elsewhere in the body. The systems and methods embodying the features of the present invention are also adaptable for use in systems and surgical techniques that are not necessarily laser-based.

[0028] Anatomical Structure of the Rectum and Anal Canal Reference is now made to FIG. 1, which shows the anatomical structure of the rectum and anal canal. The rectum is the terminal portion of the large intestine 12. The rectum 10 extends from the sigmoid colon flexure 14 (the narrowest part of the colon) to the external anal orifice 16. The rectum 10 has an overall length of approximately 15 - 17 cm. The upper or superior portion of the rectum 10 extends downward from the sigmoid colon flexure 14. This portion of the rectum 10 is almost completely surrounded by the peritoneum. The inside of this portion of the rectum 10 is covered with mucosa. This mucosa is thicker, darker in color, and more vascular than the other parts of the colon. There are several permanent crescent-shaped folds called Houston's valves 18 in the upper portion of the rectum 10.

[0029] As shown in FIG. 1, there are usually three Houston valves 18. There may be four, or there may be only two found. When the rectum 10 is empty, the Houston valves 18 overlap each other. The valves 18 support the weight of the feces and slow down the speed of descending towards the anal orifice 16. When the lower part or the lower portion of the rectum 10 contracts to expel the feces, several additional folds are formed in the mucosa of the upper part of the rectum 10 to urge the feces downward. The middle part of the rectum 10 is covered in front and on the sides by the peritoneum extending from the upper part. However, as the rectum 10 extends further downward, the outer peritoneum gradually recedes. The lower part or the lower portion of the rectum 10 is called the anal canal 20. This usually extends about 4 - 5 cm upward from the anal orifice 16. The anal canal 20 is surrounded by the internal sphincter 22 and at the end is surrounded by the external sphincter 26.

[0030] Treatment device Reference is now made to FIGS. 2A and 2B, which are perspective and cross-sectional views of a treatment device according to some embodiments of the present invention. The treatment device 100 can be configured to provide controlled laser treatment to tissues such as sphincter muscles. The device 100 can include a cover 110 sized to be inserted into a body cavity such as the rectum 10 through the anal orifice 16 and the sphincter regions 22 and 26. The cover 110 can be connected to a handpiece 112. The cover 110 can be made of or include a medical grade polymer, metal, or alloy. In some embodiments, the cover 110 can include an optically transparent portion configured to allow delivery of a laser beam to the anal sphincter region during treatment. In some embodiments, the optically transparent portion can include at least one of an optically transparent material and one or more windows that allow delivery of the laser beam.

[0031] The handpiece 112 is configured to be held by a user (e.g., a physician) and can be configured to enable operation of the device 100 during use.

[0032] In some embodiments, the apparatus 100 may further include at least one optical fiber 120 that is inserted into the cover 110, for example, slidably inserted into the cover 110. In some embodiments, the optical fiber 120 may be coated / covered by a sleeve or may be a bare fiber. The optical fiber 120 may be configured to emit a laser beam. In some embodiments, the laser beam may be in a direction perpendicular to the optical axis of at least one optical fiber. Some non-limiting examples of such optical fibers are shown and described with respect to FIGS. 4A, 4B, and 4C. The sleeve 122 can at least partially surround and protect the fiber 120. Without limitation, laser energy can be transmitted through an optical fiber having a diameter of 300 to 1000 μm. The optical fiber 120 can be a side-firing fiber that can emit energy at an angle such as 70 to 90° from the optical axis, a radial fiber that emits light at an angle of 360° from the optical axis, or a diffused end fiber in which light is scattered around the distal end and the light emission pattern of the diffused fiber exhibits a uniform distribution along the distal end (for example, the diffused distal portion has a length of 0.5 to 4 cm and emits light at 360° along the diffused length), but is not limited thereto.

[0033] In some embodiments, device 100 may further include a sleeve 122 that is slidably inserted into the cover 110 and at least one optical fiber 120 that is at least partially inserted into the sleeve 122. The sleeve 122 may be made of or include a medical grade polymer, metal, or alloy. In some embodiments, the sleeve 122 may include an optically transparent portion 128 configured to enable delivery of a laser beam to the anal sphincter region during treatment. In some embodiments, the optically transparent portion 118 includes an optically transparent material and one or more windows or apertures that enable delivery of the laser beam. For example, the sleeve 122 and / or the portion 128 can be made of a transparent polymer. In yet another example, the sleeve 122 may be made of an opaque material and may include one or more windows or apertures that enable delivery of the laser beam.

[0034] In some embodiments, device 100 may further include one or more holders 115 for holding the sleeve 122 at a certain distance from the wall of the cover 110. Thus, the holder 115 can ensure a safe distance between the optical fiber 120 and, for example, the tissue of the anal canal.

[0035] Device 100 may further include a laser light source 130 coupled to at least one optical fiber 120. The laser light source 130 may include any light source configured to generate a medical laser. The laser light source may include a pumping laser diode, a laser cavity, one or more mirrors, and any additional optical elements as necessary. The laser light source may generate a continuous laser or a pulsed laser. For example, the laser light source 130 may generate a pulsed laser having a wavelength of 700 - 2200 nm. The wavelength can be an individual wavelength or a combination of wavelengths such as, but not limited to, 980 nm (moderate penetration depth), 1064 nm (greater penetration depth), or 1470 nm (penetration depth closer to the surface). All of these wavelengths can be achieved with a diode laser having an output of 5 - 60 watts (continuous or pulsed).

[0036] The device 100 may further include a thermometer 140 connected to the cover 110. In a non-limiting example shown in the enlarged area of FIG. 2A, the thermometer 140 is disposed at the distal end of the cover 110 away from the handpiece 112. The thermometer 140 may be configured to measure the temperature of tissue, such as anal sphincter tissue. In some embodiments, two or more thermometers 140 can be attached at different positions along the cover 110. In some embodiments, one or more thermometers 140 are configured to measure the temperature of the anal sphincter tissue before, during, and / or after the application of laser therapy, for example, periodically (e.g., every 30 seconds) as defined, or continuously in real-time mode. The thermometer 140 may include any suitable temperature sensor, such as a thermocouple, an infrared (IR)-based sensor, etc.

[0037] The device 100 may further include a controller 150 configured to control the laser light source 130 based on the temperature measurements received from the thermometer 140. The controller 150 may include a processing unit and a memory for storing instructions executed by the processing unit, such as instructions to control the laser light source 130 based on the temperature measurements received from the thermometer 140. The controller 150 may further include a communication unit for communicating with the laser light source 130 and the thermometer 140.

[0038] In some embodiments, the device 100 may further include an axial movement element 124 for axially sliding the sleeve 122 within the cover 110. For example, the user can operate the sleeve 122 back and forth within the cover 110 to change the position of the tip of the fiber 120. In some embodiments, the device 100 may further include a dilator 126.

[0039] In some embodiments, the apparatus 100 may further include a heating unit 160 configured to apply heat to the anal sphincter region during treatment. By way of non-limiting example, the heating unit 160 may include one or more radio frequency (RF) electrodes attached to the cover 110 (shown), for example, at the distal end of the cover 110. Some further non-limiting examples may include an ultrasonic probe disposed within the cover 110, a resistance wire disposed within the cover 110, and the like.

[0040] In some embodiments, the controller 150 may be configured to control the heating unit 160 based on temperature measurements received from the thermometer 140.

[0041] For example, the controller 150 may be configured to receive the temperature measurements and control the heating unit 160 to heat the anal sphincter region until the anal sphincter region reaches a desired temperature of 38-45 °C (e.g., 42 °C), and to control the laser light source 130 to generate a laser beam only after the target temperature is reached. In some embodiments, the controller 150 may further be configured to continuously receive temperature measurements from the thermometer 140 and terminate the generation of the laser if the temperature exceeds a predefined threshold temperature of 42-46 °C (e.g., 44 °C).

[0042] In some embodiments, the apparatus 100 may further include at least one pressure sensor 170 disposed on the outer surface of the cover 110 for measuring the pressure exerted by the external sphincter 26. For example, the pressure can be measured before the application of the laser treatment and after the end of the laser treatment to estimate the continuous effectiveness of the treatment. In some embodiments, the parameters of the laser generation can be determined based on the pressure measurements. In some embodiments, the pressure measurements may be useful for determining whether another laser treatment cycle is required and / or for determining the duration of the laser application.

[0043] In some embodiments, the cover 110 may hold one or more communication cables and / or power cables for supplying power to at least one of the thermometer 140, the heating unit 160, and the pressure sensor 170 and for transmitting / receiving communication signals between at least one of the thermometer 140, the heating unit 160, and the pressure sensor 170.

[0044] Reference is now made to FIG. 3, which is a diagram of another treatment device according to some embodiments of the present invention. FIG. 3 shows a handheld portion of a device for treating dysfunction of the external sphincter 26, or the internal sphincter 22, or both. In FIG. 3, the device 200 may include, for example, a handpiece made of molded plastic. The handpiece 230 is sized to be easily held by a physician in the same manner as an anoscope. A monitor screen 220 can be mounted nearby / used nearby so that the user can monitor the temperature during the procedure. The monitor screen 220 can be disposed on the handpiece 230 as shown, but it should be understood that it can also be disposed at any other location where the physician can view it during treatment. In some embodiments, the monitor screen 220 can communicate with or be included in a controller such as the controller 150.

[0045] The device 200 may also include a cover 202 (e.g., a transparent barrel) having a distal end 206. A thermometer (e.g., a temperature probe) 203 can be disposed near the introduction portion 207 of the cover 202 (e.g., a bullet-shaped at least partially transparent introduction portion). In a non-limiting example shown in FIG. 3, the bullet-shaped introduction portion 207 extends a certain distance beyond the distal end 206. The cover 202 and the introduction portion 207 are sized to be inserted from the anal orifice 16 into the rectum 10 (e.g., with a maximum outer diameter of about 30 mm to 33 mm). The introduction portion 207 may assist in passing through the anal canal 20.

[0046] The device 200 may further include an optical fiber 201 (e.g., a radial laser fiber) and a resistive heating element 205. The device 200 is connected to an auxiliary component through a channel 210. The auxiliary component can provide energy, heating, cooling, control signals, and feedback.

[0047] Reference is now made to FIGS. 4A, 4B, and 4C, which are diagrams of the tips of various optical fibers and the shapes of the laser beams emitted from each tip. FIG. 4A shows a radial emission fiber 120a configured to emit a radial laser beam 5a perpendicular to the optical axis of the fiber 120a. FIG. 4B is a diagram of a bare fiber configured to emit a laser beam 5b in the direction of the optical axis of the fiber 120b. One or more optical elements can be incorporated within the device 100 to direct the laser beam 5b in a direction perpendicular to the optical axis of the fiber 120b. For example, the one or more optical elements can be selected from lenses, mirrors, prisms, splitters, and the like.

[0048] FIG. 4C is a diagram of a side-fire fiber 120c configured to emit a laser beam 5c perpendicular to the optical axis of the fiber 120a. In such a configuration, the device 100 further includes an actuator (not shown) configured to rotate the side-fire fiber about the axis of the fiber, thereby providing circular treatment of the anal sphincter region.

[0049] Method for treating sphincter tissue Reference is now made to FIG. 5, which is a flowchart of a method for treating a patient's sphincter tissue according to some embodiments of the present invention. The method of FIG. 5 can be performed by a user (e.g., a physician, a patient) using either the device 100 or 200.

[0050] In step 510, a treatment device can be inserted into a patient's body cavity, such as the anal sphincter region. For example, a physician can insert the treatment device 100 or 200 into the anal sphincter region of a patient suffering from, for example, fecal incontinence.

[0051] In step 520, the temperature at at least one location of the sphincter tissue is measured, for example, using thermometer 140.

[0052] In step 530, based on the temperature measurement value, a laser beam can be irradiated onto the anal sphincter region of the patient. For example, the laser beam is generated by laser light source 130, emitted from the tip of optical fiber 120 in a direction perpendicular to the axis of optical fiber 120, and can irradiate the anal sphincter region. In some embodiments, the laser light source is moved based on several marks over the entire length of the sphincter under temperature control.

[0053] In some embodiments, before irradiating the tissue with the laser beam, the sphincter tissue can be heated to a desired temperature of 38 - 45 °C (for example, 42 °C). In some embodiments, the desired temperature can be determined based on data related to the patient, such as age, gender, severity of the medical condition (for example, fecal incontinence). In some embodiments, irradiation of the patient's anal sphincter region is initiated only when the temperature of the sphincter tissue reaches the target temperature.

[0054] In some embodiments, this method may further include monitoring the temperature at at least one location of the tissue and terminating the laser irradiation when the temperature exceeds a predefined threshold temperature of 42 - 46 °C (for example, 44 °C).

[0055] In some embodiments, this method may further include receiving a pressure measurement value from the anal sphincter region and determining the state of fecal incontinence of the patient based on the received pressure measurement value. For example, the pressure exerted by the sphincter (for example, internal sphincter 22) can be measured using pressure sensor 170. In some embodiments, the state of fecal incontinence can be used to determine the treatment parameters (for example, energy application, duration, etc.) of the laser beam.

[0056] In some embodiments, the various treatment devices disclosed herein can be supplied to a physician as part of a sterilization kit. The kit packages a specific treatment device in a sealed state as a disposable item within a sheet of plastic film material that is sealed around and is broken or peeled off during use. The kit can include instructions for using the device according to one or more of the methods disclosed herein, provided together with or separately from the specific treatment device.

[0057] Unless explicitly stated otherwise, embodiments of the methods described herein are not limited to a particular order or sequence. Further, all of the described manners are intended merely as examples, and other or different manners can be used. Additionally, some of the embodiments of the methods described or elements thereof can occur or be performed at the same time.

[0058] While specific features of the invention have been illustrated and described herein, those skilled in the art will envision many modifications, substitutions, changes, and equivalents. Accordingly, it should be understood that the appended claims are intended to cover all such modifications and changes that fall within the true spirit of the invention.

[0059] Various embodiments have been presented. Each of these embodiments, of course, may include features from other presented embodiments, and embodiments not specifically described may also include various features described herein.

Claims

1. It is a medical device, A cover that is sized to be inserted into the anal sphincter region and connected to the handpiece, A partially configured laser beam is emitted from at least one optical fiber, the laser beam being oriented perpendicular to at least one axis of the optical fiber, A laser light source coupled to at least one optical fiber, A thermometer connected to the cover, A controller configured to control the laser light source based on a temperature measurement received from the thermometer, A treatment device equipped with the following features.

2. The therapeutic apparatus according to claim 1, wherein the at least one optical fiber is a radial radiation fiber.

3. The therapeutic apparatus according to claim 1, wherein the at least one optical fiber is a side-fire fiber, and the apparatus further comprises an actuator configured to rotate the side-fire fiber about the axis of the fiber.

4. The therapeutic apparatus according to claim 1, further comprising one or more optical elements configured to orient the laser beam perpendicular to the axis of the optical fiber.

5. The therapeutic apparatus according to claim 4, wherein the one or more optical elements are selected from lenses, mirrors, prisms, and splitters.

6. The treatment apparatus according to claim 1, further comprising a sleeve inserted within the cover and at least partially surrounding the optical fiber, wherein the sleeve has an optically transparent portion configured to allow delivery of the laser beam to the anal sphincter region during treatment.

7. The therapeutic apparatus according to claim 6, wherein the optically transparent portion comprises at least one of an optically transparent material and one or more windows that allow delivery of the laser beam.

8. The treatment apparatus according to claim 1, wherein the cover comprises an optically transparent portion configured to allow delivery of the laser beam to the anal sphincter region during treatment.

9. The therapeutic apparatus according to claim 8, wherein the optically transparent portion comprises at least one of an optically transparent material and one or more windows that allow delivery of the laser beam.

10. The therapeutic apparatus according to claim 1, wherein the thermometer is positioned at the distal end of the cover, away from the handpiece.

11. The treatment apparatus according to claim 1, further comprising an axial movement element for sliding the sleeve axially within the cover.

12. The treatment device according to claim 1, further comprising a heating unit configured to apply heat to the anal sphincter region during treatment.

13. The therapeutic apparatus according to claim 12, wherein the controller is further configured to control the heating unit based on the temperature measurement value received from the thermometer.

14. The aforementioned controller, a. Upon receiving the temperature measurement value, b. Control the heating unit to heat the anal sphincter region until the anal sphincter region reaches the desired temperature. c. Control the laser light source so that it generates the laser beam only after the target temperature has been reached. The treatment device according to claim 12, configured as described above.

15. The aforementioned controller, d. Continuously receive temperature measurement data. e. Terminate laser generation when the temperature exceeds a predefined threshold temperature. The therapeutic device according to claim 14, further configured as follows.

16. The therapeutic apparatus according to claim 12, wherein the heating unit is selected from a high-frequency (RF) electrode attached to the cover, an ultrasonic probe disposed inside the cover, and a resistance wire disposed inside the cover.

17. The treatment device according to claim 1, further comprising at least one pressure sensor disposed on the outer surface of the sleeve.

18. A method for treating the sphincter tissue of a patient, The treatment involves inserting a device into the patient's anal sphincter area, Measuring the temperature at at least one location in the sphincter tissue, Based on temperature measurements, a laser beam is irradiated onto the patient's anal sphincter area, The treatment device includes, A cover that is sized to be inserted into the anal sphincter region and connected to the handpiece, A partially configured optical fiber that emits a laser beam, wherein the laser beam is oriented perpendicular to at least one of its optical axes, A laser light source coupled to at least one optical fiber, A thermometer connected to the cover, A controller configured to control the laser light source based on a temperature measurement received from the thermometer, A method that includes [a certain feature].

19. Heating the sphincter tissue to a desired temperature. The method according to claim 18, further comprising irradiating the patient's anal sphincter region only when the temperature of the sphincter tissue reaches the target temperature.

20. Monitoring the temperature at at least one location in the sphincter tissue, The laser irradiation is terminated when the temperature exceeds a predefined threshold temperature. The method according to claim 19, further comprising:

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