Surgical device for treating body tissue and diagnosing a patient

Abstract

A surgical device for treating bodily tissue and diagnosing a patient is provided. The surgical device, e.g., a treatment device, can allow a surgeon to treat target tissue using ultraviolet (UV) light ablation therapy. In one example, the treatment device is configured to treat menorrhagia. In this case, the treatment device can be configured to affect or destroy the endometrium during a procedure to treat menorrhagia.

Description

[0001] Priority Statement

[0002] This application claims priority to U.S. Serial No. 62 / 955,721, filed December 31, 2019, entitled “SURGICAL DEVICES FOR TREATINGBODY TISSUE AND DIAGNOSING PATIENTS”, the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] This document generally relates to, but in a non-limiting manner, surgical devices, and more specifically, devices for diagnosing patients and devices for manipulating body tissues. Background Technology

[0004] Menorrhagia is a medical condition defined as abnormally heavy and prolonged menstrual bleeding and pain. Specifically, menorrhagia refers to menstrual bleeding that lasts longer than 7 days and may often include heavy bleeding. Each year, menorrhagia affects more than ten million women in the United States, meaning that approximately one in five women nationwide suffers from it. Untreated menorrhagia can cause anemia, a common blood problem where patients lack enough healthy red blood cells to carry sufficient oxygen throughout the body.

[0005] Excessive menstrual bleeding can be caused by uterine problems, hormonal issues, or other conditions. Certain specific causes may include, but are not limited to, uterine growths or tumors, uterine or cervical cancer, pregnancy-related problems such as miscarriage or ectopic pregnancy, bleeding disorders, certain types of contraception, kidney disease, thyroid disease, or liver disease, infections of the female reproductive organs such as pelvic inflammatory disease, menopause, childbirth, fibroids or polyps in the endometrium or muscle, and taking certain medications such as aspirin or a combination thereof. Summary of the Invention

[0006] There are several methods available to manage menorrhagia. For decades, hormonal medications or hysterectomy have been used to treat menorrhagia. More recently, surgeons have begun using various ablation devices to treat menorrhagia by exposing the endometrium to various energy sources, which often results in a reduction in menstrual bleeding and pain. This treatment can be called global endometrial ablation (GEA). GEA methods can use a variety of ablation techniques to ablate the endometrium and prevent menorrhagia. Some of these methods can include radiofrequency (RF) energy, microwave energy, cryogenic agents, thermal energy, steam, and plasma ablation techniques.

[0007] However, some currently available ablation devices have various drawbacks. For example, some ablation devices require the surgeon to manipulate or move the axis from side to side and / or rotate the axis within the uterus to expose the endometrium to the energy source, which can be cumbersome for the surgeon and painful for the patient. Methods using materials (such as steam, cryogenic agents) require additional devices to reduce the risk of material leakage into areas outside the endometrial tissue.

[0008] Some ablation devices require a large outer shaft diameter to accommodate large current-carrying conductors. It's conceivable that inserting such a large-diameter shaft into a patient could be painful and potentially cause cervical trauma. Because the shaft diameter necessitates painful dilation of the cervix, this procedure is performed as an inpatient procedure requiring hospitalization and anesthesia. Furthermore, some ablation devices are difficult to operate. For example, while some ablation devices are designed for single-handed operation, others require a plug to seal the uterus during treatment, necessitating the use of a second hand. Additionally, some ablation devices require various media (e.g., gases, vapors, liquids), requiring additional equipment and ports or channels to contain these media, which can be cumbersome and increase the overall complexity and cost of the procedure.

[0009] To help increase efficacy, reduce complications, and improve surgical convenience, this disclosure specifically describes a treatment device for treating intrauterine tissue. The treatment device includes: an ultraviolet (UV) light-transparent dilatation member, which is translationally movable within a cannula-like axis and configured to dilate the patient's uterus; and a UV light source configured to extend from a distal opening and apply energy sufficient to ablate the intrauterine tissue.

[0010] This disclosure also describes a method for treating menorrhagia in patients. The method may include: introducing a portion of a treatment device into a patient's body cavity; expanding the body cavity by means of a UV-transparent expansion member extending from a cannula-like shaft to expand the body cavity; and treating the body cavity by irradiating it with UV light generated from a UV light source.

[0011] In addition, diagnosis is necessary before treating various gynecological diseases. Gynecologists use hysteroscopy to diagnose various problems and recommend different treatment options to patients. During hysteroscopy, an endoscope is inserted into the uterus to examine the uterine lining, for example. For practitioners, diagnostic imaging techniques such as hysteroscopy have enabled the visualization of the uterine lining with minimal complications and pain. This imaging tool has been used in various forms for detailed and diverse examinations.

[0012] In the medical field, the large number of permanently or semi-permanently installed devices presents a challenge. The purchase and maintenance costs, as well as the complexity of the equipment, necessitate skills training for staff.

[0013] Furthermore, technical equipment occupies space, requires a fixed power supply and / or fluid supply, and may not be within easy reach of practitioners during surgical procedures, thus sometimes hindering staff and potentially making them difficult to use. In addition, many diagnostic procedures are performed as inpatient procedures, where patients are admitted to the hospital because the necessary equipment is typically already there and the procedure may involve some form of sedation or anesthesia. Patients may be reluctant to undergo diagnostic hysteroscopy due to uncertainty about insurance coverage and the costs and time associated with inpatient procedures.

[0014] Sterility and reusability are closely related. Operating room equipment / devices typically must be cleaned and even sterile before use. Sterility can be achieved by using single-use devices, but large electrical fixtures, including endoscopes and operating room monitors, are often too expensive for single-use.

[0015] Existing endoscopes are typically two-unit devices consisting of a relatively inexpensive scope with a camera or fiber optic cable and a very expensive control unit that forms part of the operating room equipment. The scope and control unit are connected via cables, including fiber optic cables. Existing endoscopes are complex to use and require adjustments to the settings between the scope and control unit. Furthermore, sterility can be compromised when a non-sterile control unit is connected to a sterile scope via cables.

[0016] To help provide an easily accessible diagnostic tool that can readily aid in patient diagnosis. Because it requires no large equipment or complex electrical wiring, this diagnostic tool can be used as an outpatient procedure performed in a doctor's office. This benefits not only patients with access to healthcare providers but also those without. For example, patients can receive a quick and easy diagnosis, such as in a doctor's office, before requiring more complex treatment. If women can have diagnostic procedures performed in offices accessible to more doctors, this will encourage more women to access diagnosis, as the device / equipment is extremely inexpensive. Furthermore, in developing countries, doctors will be able to perform aseptic procedures to diagnose patients who would otherwise be unable to be diagnosed due to the lack of access to currently available, complex diagnostic tools.

[0017] This disclosure particularly describes an apparatus for visualizing the internal tissues of a body cavity, the apparatus comprising: a cannula-like shaft extending from a proximal end to a distal end having a distal opening; an expansion member translatable within the cannula-like shaft and configured to expand the body cavity; a light source configured to extend from the distal opening and illuminate the internal tissues of the body cavity; and an image visualization structure configured to visualize the internal tissues of the body cavity to a user.

[0018] This disclosure also describes a method for visualizing the internal tissues of a body cavity, the method comprising: introducing a portion of a device into a patient's body cavity; expanding the body cavity by means of an expansion member extending from a distal opening to expand the body cavity; and illuminating the body cavity with light generated from a light source.

[0019] Apparatus and methods for visualizing internal tissues provide devices with a small overall diameter (e.g., less than 6 mm), enabling diagnosis to be performed as an outpatient procedure and for single-use purposes. That is, the entire device can be single-use, or the shaft can be single-use, such that after use of the device, the shaft can be detached from the handle, and another shaft can be coupled to the handle.

[0020] This overview is intended to provide an overview of the subject matter of this patent application. It is not intended to provide an exclusive or exhaustive explanation of the invention. Detailed descriptions are included to provide more information about this patent application. Attached Figure Description

[0021] In accompanying drawings that are not necessarily drawn to scale, the same reference numerals can describe similar parts in different views. The same reference numerals with different letter suffixes can indicate different instances of similar parts. The accompanying drawings generally illustrate the various examples discussed in this document by way of example rather than limitation.

[0022] Figure 1A A side view of a treatment device according to an example of this disclosure is shown.

[0023] Figure 1B It shows Figure 1A Part of the treatment device shown.

[0024] Figure 1C It shows Figure 1B Part of the treatment device shown.

[0025] Figure 2 A cross-sectional view of the distal end of a treatment device according to an example of this disclosure is shown.

[0026] Figure 3 It shows Figure 2 A cross-sectional view of the distal end of the treatment device shown.

[0027] Figure 4 A cross-sectional view of a body cavity and a portion of a treatment device located inside the body cavity, as exemplified by this disclosure, is shown.

[0028] Figure 5 A flowchart illustrating an example of a method for treating a patient condition such as menorrhagia is shown.

[0029] Figure 6 A side view of an apparatus for visualizing the internal tissues of a body cavity, according to an example of this disclosure, is shown.

[0030] Figure 7 It shows Figure 6 Part of the apparatus shown.

[0031] Figure 8 A cross-sectional view of a portion of an example apparatus for visualizing the internal tissues of a body cavity, according to an example of this disclosure, is shown.

[0032] Figure 9 A portion of another apparatus for visualizing the internal tissues of a body cavity, according to an example of this disclosure, is shown.

[0033] Figure 10 A cross-sectional view of a portion of an example apparatus for visualizing the internal tissues of a body cavity, according to an example of this disclosure, is shown.

[0034] Figure 11 A portion of another apparatus for visualizing the internal tissues of a body cavity, according to an example of this disclosure, is shown.

[0035] Figure 12 A flowchart illustrating an example of a method for treating a patient's condition, such as menorrhagia, is shown.

[0036] Figure 13 A side view of a treatment device according to an example of this disclosure is shown.

[0037] Figure 14 A cross-sectional view of a treatment device according to an example of this disclosure is shown.

[0038] Figure 15 A side view of a portion of a treatment device according to an example of this disclosure is shown.

[0039] Figure 16 A side view of a portion of a treatment device according to an example of this disclosure is shown.

[0040] Figure 17This is a schematic line diagram illustrating an example of a method for delivering UV ablation to a target tissue according to this disclosure.

[0041] Figure 18 This is a schematic line diagram illustrating an example of a method for delivering UV ablation to a target tissue according to this disclosure.

[0042] Figure 19 This is a schematic line diagram illustrating an example of a method for delivering UV ablation to a target tissue according to this disclosure. Detailed Implementation

[0043] This disclosure relates to a surgical device, such as a treatment device, that allows a surgeon to treat target tissue using ablation therapy. The treatment device can be used to treat various target tissues, such as blood vessels, tissues, veins, arteries, cavities such as the uterus, tumors, etc., or combinations thereof. In one example, the treatment device is configured to treat menorrhagia. In this case, the treatment device can be configured to affect or destroy the endometrium during the treatment of menorrhagia.

[0044] Although the device disclosed in this application can be used to treat menorrhagia, it should be understood that the device can also be used in other applications. For example, the device can be used to treat the bladder, vagina, esophagus, trachea, urethra, ureter, prostate, kidney, intestinal tissue during growth or abnormal tissue of the intestine, cancerous tissue, etc.

[0045] Using therapeutic devices based on these teachings to affect target tissue can mean treating the target tissue by ablation, vaporization, or other methods of tissue removal. Effects or treatment may mean that tissue or anatomical features are destroyed, coagulated, and / or degenerated.

[0046] The treatment device may be a total endometrial ablation (GEA) device. The treatment device may be an ablation device. The treatment device may include one or more energy sources. The treatment device may have a UV light source (e.g., an energy source) in electrical communication with one or more power sources. The power sources may be used to generate, supply, and / or transmit power to the UV light source via one or more conductors or wires, such that the UV light source can generate or produce energy capable of treating target tissue. The power source may be part of the treatment device, for example, included within a handle. The power source may be a discrete component electrically connected to the UV light source via one or more electrical conductors or wires. The power source may be an AC energy source, a DC energy source, or both. The energy source may be a battery.

[0047] UV light sources can be selected from UV-A, UV-B, or UV-C light, and within the UV light wavelength range of 100 nanometers (nm) to 400 nm. The UV light source can be selected based on the patient's condition or disease. UV light sources can especially generate heat that can treat (e.g., ablate) target tissues. The wavelength of light to be used to treat the patient is selected based on the wavelength that will best treat the patient's condition or disease.

[0048] The treatment device may include a UV-transparent expansion member having both a non-expanded position and an expanded position. The UV-transparent expansion member may extend from a distal opening of the cannula-like shaft of the treatment device to expand a body cavity, such as the uterus. The UV-transparent expansion member may be formed of a suitable biocompatible and expandable material. For example, the UV-transparent expansion member may be formed of silicone, PET, polyurethane, rubber, etc. The UV-transparent expansion member may be substantially transparent or transparent, such that it does not interfere with UV light dispersed from the UV light source and is not damaged by the energy generated by the UV light source.

[0049] As discussed herein, the disclosed treatment device enables highly effective treatment of target tissues, allowing treatment (e.g., ablation) to be delivered to the patient with minimal equipment while minimizing manipulation or movement required during treatment. For example, compared to ablation devices that require an energy source to contact the target tissue, this disclosure can deliver an energy source to the target tissue without direct contact with the energy source. Furthermore, this disclosure does not use additional materials (e.g., steam or gas) that require plugs, pumps, or containment devices to prevent material leakage into areas other than endometrial tissue.

[0050] Figure 1A A side view of a treatment device 10 (also referred to herein as “device 10”) is shown, which has portions that are sized and shaped for insertion into a patient’s body (e.g., the patient’s uterus). Figure 1B and Figure 1C It shows Figure 1A This is a portion of the treatment device 10 shown. Device 10 may include an insertable shaft 12, a UV light transparent expansion member 20, a UV light source 22, and a handheld device 24. Device 10 may include, for example, a treatment apparatus for generating one or more effects on intrauterine tissue (e.g., ablation of endometrial tissue using energy generated in the body).

[0051] Device 10 may include one or more portions, such as a cannula 12 (also referred to herein as "shaft 12"), which may be sized, shaped, arranged, or otherwise configured to allow insertion into a patient, for example, through an incision in the abdomen or via a transcervical pathway into the uterus. Shaft 12 may extend from a proximal end 14 to a distal end 16. Device 10 may include a handle, such as a handle 24, attached to the proximal end 16 of the cannula 12. Handle 24 may be retained outside the patient and is accessible to a physician or other user when a portion of shaft 12 is inserted into the patient.

[0052] The shaft 12 serves to allow a portion of the device to be inserted into the patient's body or anatomical structure while another portion remains outside the patient or anatomical structure. The shaft 12 can be a tubular member. The shaft 12 can be an elongated member extending along a longitudinal axis. The proximal end 16 of the shaft 12 can be connected to a handle 24. The distal end 14 of the shaft 12 can define a distal opening 15 through which the UV light-transparent expansion member 20 and the UV light source 22 extend. The shaft 12 can have a relatively small diameter. For example, the diameter of the shaft 12 can be approximately 6 mm or less. Such a relatively small shaft 12 can minimize patient trauma during insertion into and / or removal from a body cavity, thereby enabling the procedure to be performed as an outpatient procedure without hospitalization or anesthesia.

[0053] The shaft 12 may be at least partially hollow and may define an internal portion therein. The hollow portion or internal portion of the shaft 12 is sufficiently sized such that the UV light transparent expansion member 20, the UV light source 22, or other instruments such as a camera can reside inside the shaft 12 and / or move inside or relative to the shaft 12.

[0054] Shaft 12 may be substantially straight, and may include one or more angles, bends, or arcs or combinations thereof. Shaft 12 may be substantially rigid, substantially flexible, substantially elastic, or combinations thereof.

[0055] Device 10 may include an energy source, such as a UV light source 22. The UV light source 22 is positioned within shaft 12 and configured to extend from shaft 12 during use. For example, the UV light source 22 may be movable relative to shaft 12 and handheld device 24. The UV light source 22 is electrically connected to a power source 26 via one or more electrical conductors. Alternatively, the UV light source 22 may be located at the distal end of shaft 19, which may convert forces to allow the UV light source 22 to move relative to shaft 12 and handheld device 24 during use. In one example, the UV light source 22 may be movable relative to UV light transparent expansion member 20.

[0056] The UV light source 22 can be coupled to the power supply 26. Although shown as being included within the handheld component 24, the power supply 26 can be external to the handheld component 26. In one example, the power supply 26 can be a battery or a power cord that is directly plugged into an AC outlet and / or utilizes a DC converter.

[0057] The device 10 may include a UV-transparent expansion member 20, which may be configured to extend from the distal opening 15 of the cannulated shaft 12 and expand the body cavity, such that energy generated from the UV light source 22 can be efficiently applied to the target tissue. For example, the UV-transparent expansion member 20 may be movable relative to the shaft 12 and the handheld component 24. For example, the UV-transparent expansion member 20 may be located at the distal end of a shaft 18, which may convert forces to allow the UV-transparent expansion member 20 to move relative to the shaft 12 and the handheld component 24 during use. In some examples, the UV-transparent expansion member 20 may be movable relative to the UV light source 22.

[0058] like Figure 1A As shown, the UV light-transparent expansion member 20 is in the expanded position. As discussed herein, once the cavity is expanded, the UV light source 22 can be advanced to extend from the distal end 14 of the cannula shaft to apply the generated energy. As discussed in the discussion of the UV light source 22 advancing after the cavity expansion, it is also conceivable that the UV light source 22 and the UV light-transparent expansion member 20 can move simultaneously. That is, the user can actuate the device 10 such that the UV light source 22 and the UV light-transparent expansion member 20 extend together from the distal opening 15 simultaneously.

[0059] like Figures 2 to 4 As shown, the UV-transparent expansion member 20 may include an elongated member that is in a compressed state when located within the axis 12 and in an expanded or partially expanded state when extending beyond the distal end 14. Although shown for simplicity as the UV-transparent expansion member 20 comprising two separate elongated arms, more elongated arms are contemplated. Additionally, other structures for expanding the body cavity are contemplated.

[0060] Reference Figures 1A to 1CThe device 10 may include one or more user controls 32, 34 for operating and / or controlling the device 10. One or more user controls 32, 34 may be one or more switches, levers, buttons, triggers, knobs, rotary wheels, or combinations thereof. Manipulation of one or more user controls may result in: extending or retracting the UV light-transparent expansion member 20 relative to the shaft 12 and / or the handheld device 24 and / or the UV light source 22; extending or retracting the UV light source 22 relative to the shaft 12 and / or the handheld device 24 and / or the UV light-transparent expansion member 20; applying or stopping the application of energy to or changing the energy intensity of the UV light source 22; or a combination of the above. One or more user controls may also be a foot pedal communicated with the treatment device 10, the UV light source 22, the UV light-transparent expansion member 20, the power supply 26, or a combination thereof.

[0061] In one example, the treatment device 10 may include within the handheld component 24 a mechanism 28 coupled to the control component 32 for moving the UV light-transparent expansion member 20. Additionally, the treatment device 10 may include a mechanism 30 coupled to the control component 34 for moving the UV light source 22. Figure 1B and Figure 1C As shown, the control 32 (e.g., a handle) can be actuated by the user to cause the control 32 to move from... Figure 1B The initial position 32-1 shown is moved to Figure 1C The first position 32-2 is shown. When the actuation control 32 is activated, the mechanism 28 is activated and the UV light transparent expansion member 20 can advance from the distal end 14 through the distal opening 15, and in the non-expanded position shown (in Figure 3 (shown as compressed state) and expanded position (in) Figure 4 (shown in extended state) moving between.

[0062] like Figure 1C As can be seen, the control element 34 may include an initial position 34-1, a first position 34-2, and a second position 34-3. For example... Figure 1C As shown, the user can actuate the control element 34 (e.g., a trigger) to move the control element 34 from an initial position 34-1 to a first position 34-2. When the control element 34 is actuated, the mechanism 30 is activated and the UV light source 22 can advance from the distal end 14 through the distal opening 15. When the control element 34 is moved from the first position 34-2 to the second position 34-3, the power supply 26 can provide power to the UV light source 22 to generate the energy required to treat the target tissue. The UV light source 22 can be transmitted via one or more conductors 36 (in... Figure 2 and Figure 3 (As shown in the figure) Electrically coupled to power supply 26, such that when the control element 34 is moved from the first position 34-2 to the second position 34-3, the power supply can apply power to the UV light source 22.

[0063] Figure 2 and Figure 3 The distal portion of the treatment device 10 is shown. Figure 2 A UV light source 22 and a UV light transparent expansion member 20 are shown within axis 12. As shown, the UV light transparent expansion member 20 is in a non-expanded (e.g., compressed) position. Figure 3 A UV light source 22 and a UV light transparent expansion member 20 extending from the distal opening 15 of the shaft 12 are shown. As shown, the UV light transparent expansion member 20 is in an expanded (e.g., uncompressed) position.

[0064] Device 10 may include a UV transparent cover 38 coupled to shaft 19. In the event of damage to the UV light source 22, the UV transparent cover 38 can protect the UV light source 22 and surrounding anatomical structures. In one example, the UV light source 22 may be a flash lamp, which is a gas discharge lamp that produces a short-duration, high-intensity light output. The UV light source 22 should be capable of generating high-intensity UV light. According to the invention, various flash lamps can be successfully used. In one example, the flash lamp is a xenon flash lamp. Power supply 26 ( Figures 1A to 1C The electrical connection between the UV light source 22 and the UV light source 22 (shown in the diagram) enables the UV light source 22 to generate ablation energy.

[0065] In one example, the UV light source 22 may include a cold cathode UV lamp. In another example, the UV light source 22 may be connected to a circuit board. The circuit board may include a controller / software and a timing mechanism having commands for turning the UV light source 22 on / off, controlling the length of treatment time within a given time period, etc.

[0066] While examples of flash lamps or cold cathode UV bulbs have been provided, other high-intensity UV light sources can be envisioned. UV light can provide energy (e.g., light and / or heat), which eliminates the need for lasers and light guides when the UV light is placed close to the target tissue. Laser systems are less ideal because light guides tend to attenuate the UV region of the spectrum, and laser systems require very expensive support electronics. Furthermore, the expansion of body cavities, combined with the use of UV light sources, provides a device capable of efficiently treating target tissues with minimal equipment and cost.

[0067] This invention can use common flash electronics, such as those found in film cameras equipped with disposable flash units, and therefore the entire power unit can be discarded economically after use. This UV light source is capable of generating high-intensity light in the UV region. The generated light is applied to various parts of the body for a variety of purposes, including ablation of tissue, heating, crosslinking, activation of drugs introduced near tissue, and / or observation of the tissue's spectral response.

[0068] Although the optical device of the present invention has been described in conjunction with an endoscope so far, other interventional devices such as guidewires, stents, needles, and cannulas can also be used to introduce the optical device into the body near the tissue to be irradiated, provided that the interventional device has an inner diameter sufficient to accommodate the optical device and has an aperture, port, or window for transmitting the generated light. The device can be operated by a physician, who can physically manipulate the device and activate the energy source, or remotely control the device under visual guidance and using an electronic remote control. According to the present invention, the optical device can be placed near the tissue to be irradiated such that selected areas of the tissue can receive ablation energy.

[0069] Figure 4 A body cavity 40, serving as the uterus, is shown. During the medical procedure, a shaft 12 is inserted into the body cavity 40. The treatment device 10 may include a UV-transparent expansion member 20 and a UV light source 22. After the shaft 12 is inside the body cavity 40, the UV-transparent expansion member 20 may move relative to the shaft 12 and the UV light source 22 and enter the body cavity 40, thereby changing from a non-expanded position to an expanded position to expand the body cavity 40. Once the body cavity 40 is expanded, the UV light source 22 may move relative to the shaft 12 and the UV-transparent expansion member 20 and enter the body cavity 40. Energy generated from the UV light source 22 may be dispersed from the UV light, pass through the UV transparent cover 38 and the UV-transparent expansion member 20, and reach the wall 40, or may be the endometrium lining the tissue of the body cavity 40 to act medically on the wall 40. The light source 22 may be any one or more UV light sources 22 as described herein capable of generating sufficient energy to act on the wall 40 or the tissue lining the body cavity 40.

[0070] Figure 5 A flowchart of a method 50 for treating a patient using an ablation device is shown. Method 50 may include: inserting the device into the patient's uterus (52); dilating the uterus (54); applying high-intensity UV light to the target tissue to ablate the target tissue on the surface of the uterus; and removing the device from the uterus (58).

[0071] First, in step 52, the operator can insert the device into the patient's uterus. The operator can insert the distal end of the device into the patient transcervically without any additional incision or entry point. In this step, the UV-transparent dilator is in a compressed state. The cross-sectional diameter of the distal end of the device entering the patient is less than about 6 mm. This can, for example, make transcervical insertion more efficient and reduce patient discomfort.

[0072] Subsequently, in step 54, the operator can manipulate one or more user controls, such as control 32 ( Figures 1A to 1C(As shown in the diagram) to dilate the uterus. As the control 32 is manipulated, the UV light transparent dilator extends from the axis and changes from a compressed state to an uncompressed state, causing the uterus to be dilated in preparation for treatment.

[0073] In step 56, energy from the UV light source is applied to the surrounding tissue. For example, initially, control 34 can be moved from an initial position to a first position to move the UV light source relative to the axis and into the expanded body cavity. Once in place, control 34 (or other controls) can be manipulated to generate energy from the UV light source. The generated energy can ablate the target tissue. The application of the generated energy can be completed in a single constant time period or in pulses. The type of UV light source and the type of target tissue determine the exact scheme for applying the generated energy, and the way to treat the target tissue quickly and efficiently. Finally, at step 58, the operator can turn off the device and remove it from the patient.

[0074] The proposed device and method discussed in this paper allow for the delivery of energy generated from a UV light source to ablate endometrial tissue with a low risk of generating or leaking vapor outside the uterus—e.g., into the vagina—and increases the ease of ablation. Additionally, the device itself is small and compact.

[0075] Variations, modifications, and other implementations of the content described herein will occur to those skilled in the art without departing from the spirit and scope of the claimed invention. Therefore, the invention is not limited by the foregoing illustrative description, but rather by the spirit and scope of the appended claims.

[0076] The inventors recognize that, with Figures 1A to 4 Devices similar to the one shown are also helpful in diagnosing various conditions. Therefore, Figures 6 to 10 A device for visualizing internal tissues is disclosed. Due to its minimal equipment requirements and size, this device can be used to easily diagnose a variety of conditions in a physician's office, enabling patients to consider various treatment options before undergoing more invasive procedures that may require hospitalization and anesthesia using more complex treatment devices. Additionally, in underdeveloped areas, the visualization device can enable those without access to clinics and hospitals to have sterile, safe, and simple procedures to diagnose conditions that might go undetected without the visualization device.

[0077] One object of the present invention is to improve the sterility, operational safety, and simplicity of devices for hysteroscopy, and to reduce the risk of setup errors, poor connections, or lack of compatibility between releasable connection units of the device. Another object is to simplify insertion and improve hysteroscopy.

[0078] In one example, the device is used for visualization of the internal tissues of a patient's uterus. The device may include a working axis comprising an insertable external axis, an expansion member, a light source, and an image visualization structure. The device may include a handheld component, such as a handle, attached to the working axis. As discussed herein, the entire device may be single-use, allowing it to be discarded after a single use. In one example, the working axis is reversibly connected to the handle, enabling the working axis to be discarded after a single use, and the handle to be reversibly connected to another working axis after sterilization.

[0079] The handle can be sized for a user's hand to hold and can include various components such as a power supply, control mechanisms, mechanical devices, and an image display section. An expansion member can be mechanically connected to the control and mechanical devices such that, when actuated, the expansion member extends from the distal opening of the cannula shaft and transitions from a compressed to an uncompressed state to expand the body cavity. A light source and an image visualization structure can then be advanced from the distal opening, and the light source can be activated to illuminate the body cavity, allowing the image visualization structure to capture images or videos of the body cavity. For example, both the light source and the image visualization structure can be mechanically connected to the control and mechanical devices such that, when actuated, they can be advanced from the distal opening. The light source can be electrically connected to a power source that can supply power to illuminate the light source. The image visualization structure can be electrically connected to the power supply and the image display, allowing the user to visualize the internal tissues of the body cavity. In one example, the image display can be a monitor capable of displaying images or videos captured by the image visualization structure. In another example, the image display can be a connection station capable of connecting to a separate display monitor. Furthermore, the image display can be a lens through which the user can view and visualize the internal tissues of the body cavity.

[0080] In one example, the image visualization structure is configured to communicate video signals with a monitor, and the cannula-like shaft containing the expansion member, light source, and image visualization structure is sized for insertion through the cervix into the patient's uterus and has a diameter of less than 6 mm.

[0081] Because the handle is sized for the user's hand to hold, and because the working shaft is connected to or reversibly connected to the handle, the handle can be used without connecting to any external device. Therefore, the device according to the invention becomes easy to use directly upon removal from the packaging without the need to assemble cables or attach external camera devices or monitors. This reduces the risk of errors, the risk of combining incompatible items, and the risk of contaminating the device during connection to external components.

[0082] In one example, the working shaft is reversibly connected to the handle, allowing it to be removed from the handle and discarded after use, while the handle can be sterilized and reused with another working shaft. As described herein, the interior of the cannulated shaft is not in fluid communication with the interior of the handle, thereby minimizing any potential contamination between patients.

[0083] The handle can be independently powered by a battery and can be fully equipped with any necessary components, such as a monitor. In this way, the device can form a complete, standalone hysteroscopy apparatus, for example, suitable for single use. Similarly, the entire device (handle and working shaft) can be single-use, or the working shaft can be single-use.

[0084] The image visualization structure may consist of a lens located at its distal end, and the device may include an optical fiber or other cable extending from the lens through an elongated conduit into the control unit for a camera. In one embodiment, the image capture structure consists of a camera located at its distal end, such as a camera with electronic circuitry for converting the image into an electrical signal. In this embodiment, the captured image may be transmitted by a cable through an elongated conduit for further electronic processing in the control unit. The term "camera device" herein covers any type of structure used to capture an image or a series of images, such as for creating a video sequence. In particular, the camera device may include a CCD, a CMOS chip, a lens, and other elements known in the art for capturing images.

[0085] The device may include a light source capable of illuminating the interior of the uterus. For example, the light source may be one or more LEDs. The image visualization structure may be specifically configured to transmit images in the form of analog electrical signals. This reduces the need for digital electronic circuitry at the distal end of the elongated member and thus enables a more compact design, which is desirable for providing easier and potentially less painful transcervical access.

[0086] It should be understood that although embodiments of the invention have been shown, detailed descriptions and specific examples are given by way of illustration only, as various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art based on such detailed descriptions.

[0087] The tissue visualization device includes an image visualization structure configured to capture images of a desired tissue. The image visualization structure can be configured for non-electronic capture or for electronic capture of the image. An example of an image capture structure for non-electronic capture is a lens through which the image is transmitted via an elongated member to a camera device in a handle. An example of an image capture structure for electronic capture is, for example, a camera device based on one or more CCDs sensitive in one or more wavelengths. The electronically captured image is transmitted to the handle via a cable passing through a cannulated shaft. The image can be a still image and / or video using any methods and formats known per se.

[0088] Figure 6 A device 60 for visualizing the internal tissues of a body cavity, such as the uterus, is shown. Device 10 may include a working shaft 62 connected to or reversibly connected to a handle 80. The working shaft 62 may include a cannula-like shaft 64, an expansion member 72, a light source 76, and an image visualization structure 74. Device 60 is similar to device 10 described above, but device 60 does not include a therapeutic light source (e.g., a UV light source), instead including a light source 76 solely for illuminating the body cavity. In one example, the expansion member 72 may be the same as the UV-transparent expansion member 20; however, the expansion member 72 may be formed of any transparent material, not necessarily a UV-transparent material. Additionally, device 60 may include an image visualization structure 74, which may be incorporated into device 10. As discussed herein, device 60 may also include an image display 88, which may be a display monitor displaying pictures or videos, or a lens through which a user looks. Furthermore, the image display 88 may be a connection capable of being connected to an external display monitor.

[0089] Device 10 may include one or more portions, such as a cannula shaft 64 (also referred to herein as "shaft 64"), which is sized, shaped, arranged, or otherwise configured to allow insertion into a patient, for example, through an abdominal incision or via a transcervical path into the uterus. Shaft 64 may extend from a proximal end 66 to a distal end 68 having a distal opening 70. Device 60 may include a handle, such as a handle 80, attached to the proximal end 66 of cannula shaft 64. When a portion of shaft 64 is inserted into a patient, handle 80 may remain outside the patient and be usable by a physician or other user.

[0090] For patient comfort, shaft 64 should be made as small as possible. In one example, the diameter of shaft 64 could be approximately 6 mm or less. This relatively small shaft 12 can minimize patient trauma during insertion into and / or removal from the body cavity, thus allowing the procedure to be performed as an outpatient procedure without hospitalization and anesthesia.

[0091] The hollow or internal portion of axis 12 is large enough that the expansion member 72, the light source 76, and the image visualization structure 74 can reside and / or move within or relative to axis 64.

[0092] The light source 76 is positioned within the shaft 64 and is configured to extend from the shaft 64 during use. For example, the light source 76 may be movable relative to the shaft 64 and the handheld device 80. The light source 76 is electrically connected to a power supply 87 via one or more electrical conductors. Although shown as being included within the handheld device 87, the power supply 87 may be external to the handheld device 87. In one example, the power supply 87 may be a battery or a power cord that plugs directly into an AC outlet and / or utilizes a DC converter.

[0093] Device 60 may include an expansion member 72, which may be configured to extend from the distal opening 70 of the cannula shaft 64 and expand the body cavity such that light generated from the light source 76 can be effectively applied to the body cavity. As discussed herein, the expansion member 72 may be the same as the expansion member 20 of device 10.

[0094] Similarly, the handle 80 may include one or more user controls 90, 92 for operating and / or controlling the device 60. The one or more user controls 90, 92 may be one or more switches, levers, buttons, triggers, knobs, rotary wheels, or combinations thereof. Operation of the one or more user controls may be used to extend or retract the expansion member 72, the light source 76, and the image visualization structure 74. The one or more user controls may also be foot pedals communicating with the device 60, the light source 76, the expansion member 72, the image visualization structure 74, the power supply 87, or combinations thereof.

[0095] In one example, within the handheld component 24, the treatment device 10 may include one or more mechanical devices 82, 84, 86 connected to control devices 90, 92 for moving the expansion member 72, the light source 76, and the image visualization structure 74. For example, when the control device 92 is actuated, the mechanical device 82 is activated and the expansion member 72 can advance from the distal end 68 through the distal opening 70 and, as shown... Figure 3 and Figure 4 The movement between the non-expansion position and the expansion position discussed herein.

[0096] Additionally, the expansion member 74 and the image visualization structure 76 can be mechanically connected to the same axis, for example... Figure 7 Axis 94 is shown. Figure 7 In the example shown, the image visualization structure 74 is located at the distal end of axis 94 and the light source 76 is positioned along axis 94. The light source 76 is electrically connected to a power supply via electrical connection 96, and the camera device is connected to an image display 88 via connection 98 (see [link to image display]). Figure 6 This will depend on the type of image visualization structure 74 used. Figure 7 The expansion member 72 is shown in an expanded state, with the image visualization structure 74 and the light source 76 moved through the distal opening. A space 100 can be maintained between the light source 76 and the image visualization structure 74 when they are mounted / attached to the axis 94. In this example, the space 100 along the longitudinal axis of the cannulated axis 64 is fixed because both the image visualization structure 74 and the light source 76 are connected to the same axis 94. However, in other examples, the space 100 can be changed during use.

[0097] Figure 8 A cross-sectional view along the light source 76 is shown when the light source 76 surrounds the image visualization structure 74. That is, there is no longitudinal space between the image visualization structure 74 and the light source 76. Figure 8 As shown, the expansion member 72 includes four elongated arms 72 (sometimes shown as two for simplicity).

[0098] Figure 9 and Figure 10 An example of device 60 is shown, in which image visualization structure 74 and light source 76 are both located at the far end of axis 94. Figure 9 The device 60 is shown in its expanded position. Figure 10 The diagram shows a cross-section along axis 94 of the light source 76 and the image visualization structure 74 when the light source 76 and the image visualization structure 74 are positioned within the tubular shaft 64.

[0099] Figure 11 An example of device 60 is shown, wherein the image visualization structure 74 and the light source 76 are respectively connected to separate axes 106 and 105, allowing the image visualization structure 74 and the light source 76 to move relative to each other. Figure 11 As shown, the image visualization structure 74 can move from a first position 74-1 to a second position 74-2, and the light source 76 can move from a first position 76-1 to a second position 76-2. In one example, the longitudinal axes of both the light source 76 and the image visualization structure 74 can be offset from the longitudinal axis 102 of the cannulated axis 64.

[0100] Figure 12 A flowchart of a method 1200 for visualizing the internal tissues of a body cavity is shown. Method 1200 may include inserting a device into a patient's uterus (1202), dilating the uterus (1204), irradiating the body cavity (1206), and removing the device from the uterus (1208).

[0101] First, in step 1202, the operator can insert the device into the patient's uterus. The operator can insert the distal end of the device into the patient transcervically without requiring additional incisions or entry points. In this step, the dilator is compressed. The cross-sectional diameter of the distal end of the device entering the patient is less than about 6 mm. This can, for example, allow for more efficient transcervical insertion with less patient pain.

[0102] Subsequently, in step 1204, the operator can dilate the uterus by manipulating one or more user control devices. When a control device coupled to the dilation member is manipulated, the dilation member extends from an axis that transitions from a compressed state to an uncompressed state, thereby dilating the uterus.

[0103] In step 1206, power is supplied to the light source, enabling it to generate light and illuminate the body cavity for visualization. The light source and the image visualization structure can be manipulated to move along the longitudinal axis, allowing the target tissue to be visualized and seen by the physician. Once the body cavity is visualized, the physician can shut off the power to the light source, move the dilation member back into the cannula axis, and remove the device. The proposed apparatus and method discussed herein allow for a rapid, single-use visualization tool that can be used by a variety of experts to quickly visualize and diagnose conditions within the body cavity.

[0104] Returning to the reference UV ablation, UV light generation can occur inside or outside the patient's body. Furthermore, the type of UV light applied can vary across different examples. For instance, some UV light wavelengths can generate more heat and penetration than others. Therefore, it would be beneficial to be able to provide the patient with different UV light during a single ablation treatment. In one example, the endometrium varies between patients and depends on the condition being treated and the specific anatomy; if different UV light could be applied to the patient, more effective treatment might result.

[0105] Figure 13 This is a schematic diagram of a treatment device 200 (also referred to herein as "device 200") capable of applying UV light to target tissue. The treatment device 200 generates UV light outside the body, allowing various light sources 212 to be coupled to the treatment device 200 to provide different wavelengths within the UV band for ablation of the target tissue.

[0106] The treatment device 200 may include a handle or handheld component 202, an outer shaft 204, and a surgical instrument 206. The surgical instrument 206 can deliver UV light to target tissue. The surgical instrument 206 may include a therapeutic light system 208 and optionally an optical system 210 and / or an imaging system. The therapeutic light system 208 may include a light source 212, a light delivery shaft 214, a light conductor 216, and a light emitter 218.

[0107] Optical system 210 may include any means that allow an operator to view target tissue. In an example, optical system 210 may include a light source 220, a light delivery axis 222, a light conductor 224, and an end cap 226. Optical system 210 and / or imaging system may be used to identify target tissue, immediately measure treatment on the target tissue to determine if further treatment is needed, and determine whether the procedure has been completed. An example of such an optical system is disclosed in U.S. Provisional Patent Application 62 / 940,328, filed November 26, 2019, entitled “Surgical devices with Integrated Lighting Systems,” the entire contents of which are incorporated herein by reference.

[0108] The outer shaft 204 may include an elongated member extending from a proximal portion 228 to a distal portion 230. The outer shaft 204 defines an inner cavity 232 extending from the proximal portion 228 to the distal portion 230, the distal portion including a distal opening 234. A handheld member 202 may be mounted or attached to the proximal portion 228 of the outer shaft 204. Parts of the therapeutic light system 208 and the optical system 210 may extend within or along the outer shaft 204, for example, from the proximal portion 228 to the distal portion 230.

[0109] In the example, the outer shaft 204 can be sized, shaped, or arranged for use in conjunction with laparoscopy to perform laparoscopic surgery and transcervical procedures. Thus, the shaft 204 can be inserted into an incision in the patient's skin, through the patient's body cavity and into an organ, or through the cervix into the uterus. Therefore, it is desirable that the diameter or cross-sectional shape of the shaft 204 be as small as possible to facilitate minimally invasive surgery and minimal cervical dilation. The outer shaft 204 can be rigid and formed of metal or plastic materials. In the example, the outer shaft 204 can have a diameter of less than about 6 mm. When the device 200 is in use, the proximal portion 228 can be close to the operator.

[0110] The handheld component 202 may include any means suitable for facilitating the manipulation and operation of the treatment device 200. The handheld component 202 may be located at the proximal portion 228 or at another suitable location along the axis 204. In examples, the handheld component 202 may include a pistol grip, a knob, a hand grip, etc.

[0111] Optical conductor 216 may include a medium for transmitting light from light source 212 to optical emitter 218. Optical conductor 216 may be located within an optical transport axis 214 extending from a proximal portion 228 to a distal portion 230 of optical emitter 228. Optical conductor 216 may include a material suitable for transmitting electromagnetic radiation waves at various wavelengths, particularly within the UV band of 100 nm to 400 nm. Optical conductor 216 may be coupled to light source 212 via cable 242 and connector 240. Cable 242 may include an extension of optical conductor 216 and may be made of the same material as optical conductor 216. In an example, optical conductor 216 and cable 242 may include an optical fiber cable. In an example, the optical fiber cable may include glass optical fiber and plastic optical fiber sheathed with one or more protective coatings. Optical emitter 218 may be located at or near the distal end of optical conductor 216. Optical emitter 218 may be coupled to optical conductor 216 by any suitable means. In the example, light emitter 218 may include a lens for focusing or a diffuser for diffusing light waves from light conductor 216. Light emitter 218 may be unidirectional or omnidirectional. Light emitter 218 may include a glass or plastic body made of transparent material. However, in another example, a separate light emitter is not used, and light conductor 216 may include an end-emitting optical fiber, such that the distal end or terminal of light emitter 218 may include light emitter 218.

[0112] Optical system 210 may include components similar to therapeutic light system 208, but provides visible light that can be coupled to a camera. Therefore, light conductor 224 may include a medium for transmitting light from light source 220 to light emitter 226. Light conductor 224 may be located within the light transport axis 222 of light emitter 226 extending from proximal portion 228 to distal portion 230. Light conductor 224 may include materials suitable for transmitting electromagnetic radiation waves of various wavelengths. Light conductor 224 may be coupled to light source 220 via cable 246 and connector 244. Cable 246 may include an extension of light conductor 224 and may be made of the same material as light conductor 224. In an example, light conductor 24 and cable 246 may include fiber optic cables. In an example, fiber optic cables may include glass and plastic fibers sheathed with one or more protective coatings. Light emitter 226 may be the same as light emitter 218.

[0113] Actuators 236 and 238 may be attached to the handheld device 202 to operate the treatment device 200. Actuators 236 and 238 may include one or more of a button, trigger, lever, knob, dial, etc., and may include any suitable means for allowing operation of the treatment device 200 from the handheld device 202. In the example, actuator 236 may be actuated to operate the therapeutic light system 208 via any type of linkage, such as a mechanical linkage, electronic linkage, electrical linkage, fluid linkage, or acoustic linkage, and actuator 238 may be actuated to operate the optical system 210 via the aforementioned linkage.

[0114] In one example, the light delivery axis 214 of the therapeutic light system 208 and the light delivery axis 222 of the optical system 210 can be coupled such that they cannot move relative to each other. That is, they can be linearly locked together so that they move together within the outer axis 202. In another example, the light delivery axis 214 of the therapeutic light system 208 and the light delivery axis 222 of the optical system 210 are not linearly locked and can move relative to each other.

[0115] As mentioned, the therapeutic light source 212 can be coupled to the therapeutic light conductor 216 via cable 240. Connector 240 can include any suitable means for linking the light conductor 216 and cable 242 so that the optical fibers disposed therein can be adjacent end-to-end. In this way, the therapeutic light source 212 can be positioned remotely from the treatment device 200. In one example, the light source 212 can include a separate module that can be coupled to the treatment device 200 via cable 242. In another example, the light source 212 can be directly attached to the exterior of the handheld device 202 via connector 24 without using cable 242. In this way, the light source 212 can be removable, allowing attachment of different light generators producing different intensities or wavelengths, as discussed herein, which can allow the application of various types of UV light during a single treatment session. In yet another example, the light source 212 can be incorporated into the handheld device 202, eliminating the need for connector 240.

[0116] Figure 14 An example of a treatment device 300 capable of delivering more than one type of UV light to target tissue is shown. Figure 14 A cross-sectional view of the treatment device 300 is shown. The treatment device 300 can be coupled to the handle 20 (see [reference]). Figure 13 The treatment device 300 may include an outer shaft 204, an optical system 225 including an optical light conductor 224, and a treatment light system 227 including more than one treatment light conductor, such as treatment light conductors 216-A and 216-B. Figure 14As seen in the diagram, the optical system is located within the wall of the outer axis 204, such that the optical light conductor 224 extends along the wall of the outer axis 224. However, other configurations are conceivable, such as the optical light conductor 224 extending within the cavity 232 of the outer axis 204 or being included within the therapeutic optical axis 214, which includes therapeutic light conductors 216-A and 216B.

[0117] Figure 14 The therapeutic light system in the image may include more than one therapeutic light system 227, such as... Figure 13 The therapeutic light system 208 disclosed in the text. (For example...) Figure 14 As seen in the diagram, therapeutic light conductors 216-A and 216-B are both located within a therapeutic optical axis 214, such as an optical fiber cable. However, therapeutic light conductors 216-A and 216-B can be separated from each other. Each therapeutic light conductor can be coupled to a light source that can generate different wavelengths within the UV band. For example, therapeutic light conductor 216-A can be coupled to a light source configured to generate wavelengths between 100 nm and 200 nm, and therapeutic light conductor 216-B can be coupled to a light source configured to generate wavelengths between 200 nm and 400 nm. Therefore, a single treatment device 300 can provide more than one UV light source to treat target tissue. Figure 13 compared to, Figure 14 The device 300 allows the operator to easily activate different UV lights during surgery as needed without having to disassemble the first light source and couple a second light source. Although shown with two therapeutic light conductors, the therapeutic device 300 may include more than two therapeutic light conductors.

[0118] although Figure 13 and Figure 14 It shows the generation of UV light externally, but Figure 15 and Figure 16 Treatment devices 400 and 500, which generate UV light within the body while simultaneously providing UV ablation, are shown respectively. Figure 15 As seen herein, the treatment device 400 includes an outer shaft 204, an optical system 210, and a therapeutic light system 228. As discussed herein, the therapeutic light system 228 can generate UV light within the body by activating materials (e.g., gases) to emit UV light that can treat tissues.

[0119] The optical system 210 can provide visible light that can be coupled to a camera, allowing the operator to view the target tissue. The optical system 210 can be coupled with... Figure 13 and Figure 14 The same optical system is disclosed herein. Therefore, the light conductor 224 may include a medium for transmitting light from the light source 220 to the light emitter 226. The light conductor 224 may be located within the light transport shaft 222. The light conductor 224 may include a material suitable for transmitting electromagnetic radiation waves of various wavelengths.

[0120] The device 400 may include a therapeutic light system 228 comprising a UV light source 230. The UV light source 230 is positioned within an axis 204 and configured to extend from the axis 204 during use. For example, the UV light source 230 may be movable relative to the axis 204. The UV light source 230 is electrically connected to a power source via one or more electrical conductors.

[0121] The UV light source 230 can be, for example, a bulb or a UV light transparent tube, configured to circulate material that can generate UV light when activated. In one example, the UV light source 230 can be in fluid communication with an inlet cavity 235 and an outlet cavity 236. The inlet cavity 235 is coupled to a material source 232, which can provide material to be activated and apply UV light to treat target tissue. In one example, the material can be a gas that can be activated to produce an output of UV light that can ablate tissue. The material flowing through the therapeutic light system 228 can be activated within the UV light source 230 (e.g., a bulb). However, other configurations are possible.

[0122] In one example, material source 232 can be switched from a first material to a second material to allow for easy use of different materials to apply different UV wavelengths for tissue treatment. For example, the first material used can provide UV wavelengths from 100 nm to 200 nm, and the second material can be used to provide UV wavelengths from 200 nm to 400 nm.

[0123] Device 400 may include a shaft coupled to (similar to) Figure 3 The UV transparent cover 238 (axis 19) is provided. In the event of damage to the UV light source 230, the UV transparent cover 238 can protect the UV light source 230 and the surrounding anatomical structures.

[0124] Figure 16 A treatment device 500 is shown that can be used to apply two different UV wavelengths to treat target tissue. The treatment device 500 is similar to... Figure 15 The treatment device 400 in the middle, however, for simplicity, has two light sources and the optical system is not shown. (Alternative replacement) Figure 15 Material source 232, Figure 16This includes two therapeutic light sources (e.g., UV light sources 230 and 303). Each UV light source 230 and 303 is coupled to material sources 232 and 302, respectively. For example, light source 230 is coupled to an inlet cavity 235 and an outlet cavity 236 to circulate material contained within material source 232. Similarly, light source 303 is coupled to an inlet cavity 304 and an outlet cavity 306 to circulate material contained within material source 302. As discussed herein, the material contained within material sources 232 and 302 can be any known material capable of generating UV light sufficient to treat (ablate) target tissue. Figure 16 As seen in the image, UV light sources 230 and 303 are wound spiral tubes. However, other configurations are possible. This achieves 360-degree coverage during treatment without requiring the device to be rotated or twisted during use.

[0125] Figure 17 This is a line diagram illustrating a method 1700 for delivering UV ablation to target tissue. Method 1700 may include applying UV light to target tissue within a patient. At step 1702, method 1700 may include inserting a device into a body cavity. That is, the distal portion of the outer shaft may be inserted into the patient. At step 1704, method 1700 may include generating UV light outside the body cavity. For example, a device may be used... Figure 13 and Figure 14 The devices 200 and 303 shown are used to generate UV light outside the body cavity. After generating the UV light, at step 1706, method 1700 may include transmitting the UV light into the body cavity to apply the UV light to target tissue. For example, the generated UV light may be transmitted via a photoconductor to a distal end of the treatment device so that the generated UV light can treat (e.g., ablate) the target tissue. After applying the UV light, at step 1708, the device may be removed from the body cavity.

[0126] Figure 18 This is a line diagram illustrating a method 1800 for delivering UV ablation to target tissue. Method 1800 may include applying UV light to the target tissue within a patient. At step 1802, method 1800 may include inserting a device into a body cavity. That is, the distal portion of the outer shaft may be inserted into the patient. At step 1804, method 1800 may include applying a first UV light to the body cavity. As discussed herein, the first UV light may be applied to the target tissue. After (or simultaneously with) the application of the first UV light, at step 1806, a second UV light may be applied to the body cavity. In one example, a first UV light with a wavelength in the range of 100 nm to 200 nm may be applied, and a second UV light with a wavelength in the range of 200 nm to 400 nm may subsequently (or simultaneously) be applied. After the application of the first and second UV lights, at step 1808, the device may be removed from the body cavity.

[0127] Figure 19 This is a line diagram illustrating a method 1900 for delivering UV ablation to target tissue. Method 1900 may include applying UV light to target tissue within a patient. At step 1902, method 1900 may include inserting a device into a body cavity. That is, the distal portion of the outer shaft may be inserted into the patient. At step 1904, method 1900 may include a therapeutic light system that circulates a first material through the device. For example, a therapeutic light system may be used... Figure 15 and Figure 16 The treatment device in the method circulates a first material through a treatment light system. At step 1906, the first material can be activated to generate first UV light. For example, the first material can be activated to generate UV light with a wavelength in the range of 100 nm to 200 nm. At step 1908, method 1900 may include circulating a second material through the treatment light system of the device. For example, a second material can be used... Figure 15 and Figure 16 The treatment device 400 allows the first material to circulate through the treatment light system. For treatment device 500, material source 232 can be switched to allow a second material to circulate through the device. For treatment device 500, a second material source 302 is included to allow the second material to circulate through the device. At step 1908, the second material can be activated to generate second UV light. For example, the second material can be activated to generate UV light with a wavelength in the range of 200 nm to 400 nm. After the UV light has been applied and the operator has determined that the target tissue has been adequately treated, the treatment device can be removed.

[0128] Variations, modifications, and other implementations of the content described herein will occur to those skilled in the art without departing from the spirit and scope of the claimed invention. Therefore, the invention is not limited by the foregoing illustrative description, but rather by the spirit and scope of the appended claims.

[0129] Various examples and annotations

[0130] Each of these non-restrictive examples can exist independently, or can be combined with one or more of the other examples in various permutations or combinations.

[0131] Example 1 provides a therapeutic device for treating intrauterine tissue, the device comprising: an insertable shaft extending from a proximal end to a distal end having a distal opening; a UV-transparent dilatation member translatable within the insertable shaft, the UV-transparent dilatation member being configured to extend from the distal opening and dilate the patient's uterus; and a UV light source configured to extend from the distal opening and apply energy to the intrauterine tissue.

[0132] In Example 2, the subject of Example 1 may optionally include: wherein the UV-transparent expansion member has a non-expanded position and an expanded position.

[0133] In Example 3, the subject of Example 2 may optionally include: wherein, in the non-expanded position, the UV-transparent expansion member is compressed within the tubular shaft.

[0134] In Example 4, the subject of Example 2 may optionally include: wherein, at the extended position, a UV-transparent expansion member is extended and configured to expand the patient's uterus for treatment.

[0135] In Example 5, the subject matter of Example 2 may optionally include: a handle coupled to a cannulated shaft, the handle including: a first actuator coupled to a UV-transparent expanding member to transition the UV-transparent expanding member between a non-expanded position and an expanded position.

[0136] In Example 6, the subject of Example 5 may optionally include: wherein the handle further includes: a second actuator mechanically and electrically coupled to a UV light source, the second actuator being configured to advance the UV light source from the cannulated shaft and deliver energy for processing intrauterine tissue.

[0137] In Example 7, the subject of Example 6 may optionally include: wherein the second actuator has an initial position, a first actuation position, and a second actuation position.

[0138] In Example 8, the subject matter of Example 7 may optionally include: wherein, when the second actuator moves from the initial position to the first actuation position, the UV light source advances from the distal opening of the cannulated shaft.

[0139] In Example 9, the subject matter of Example 8 may optionally include: wherein, when the second actuator moves from the first actuation position to the second actuation position, the UV light source generates energy delivered to the intrauterine tissue.

[0140] In Example 10, the subject of Examples 1 through 9 may optionally include: where the UV light source is a flash.

[0141] In Example 11, the subject of Example 10 may optionally include: wherein the flash is a xenon flash.

[0142] In Example 12, the subject matter of Examples 1 to 11 may optionally include: wherein the UV light source is a cold cathode UV lamp.

[0143] In Example 13, the subject matter of Examples 1 to 12 may optionally include: wherein the treatment device does not include a fluid medium.

[0144] In Example 14, the subject matter of Example 13 may optionally include: wherein the fluid medium includes at least one of gas, vapor and liquid.

[0145] Example 15 provides a method of treating a patient, the method comprising: introducing a portion of a treatment device into a patient's body cavity, the treatment device comprising: an insertable shaft extending from a proximal end to a distal end having a distal opening; a UV-transparent dilatant member translatably within the insertable shaft; and a UV light source; dilating the body cavity by means of the UV-transparent dilatant member extending from the distal opening for dilating the body cavity; and treating the body cavity by applying energy generated by the UV light source to the body cavity.

[0146] In Example 16, the subject of Example 15 is optionally provided, wherein the UV-transparent expansion member has a non-expanded position and an expanded position.

[0147] In Example 17, the subject matter of Example 16 may optionally include: wherein a UV-transparent expansion member extends from a distal opening to transition the UV-transparent expansion member from a non-expanded position to an expanded position.

[0148] In Example 18, the subject matter of Example 16 may optionally include: wherein the treatment device further includes: a handle coupled to an intubation shaft, the handle including: a first actuator coupled to a UV light-transparent expansion member to actuate the UV light-transparent expansion member between a non-expanded position and an expanded position; and a second actuator mechanically and electrically coupled to a UV light source, the second actuator being configured to advance the UV light source from the intubation shaft and deliver energy for treating the body cavity.

[0149] In Example 19, the subject matter of Example 18 may optionally include: wherein expanding the body cavity includes: activating a first actuator to move the UV-transparent expansion member from the cannulated axis, thereby transitioning the UV-transparent expansion member from a non-expanded position to an expanded position.

[0150] In Example 20, the subject of Example 18 may optionally include: wherein the second actuator has an initial position, a first actuation position, and a second actuation position.

[0151] In Example 21, the subject matter of Example 20 may optionally include: wherein processing the body cavity includes: moving a second actuator from an initial position to a first actuated position to advance a UV light source from a distal opening of a cannulated shaft; and moving the second actuator from the first actuated position to a second actuated position to generate energy and process the body cavity.

[0152] Example 22 provides an apparatus for visualizing the internal tissues of a body cavity, the apparatus comprising: a cannula-like shaft extending from a proximal end to a distal end having a distal opening; an expansion member translatable within the cannula-like shaft and configured to expand the body cavity; a light source configured to extend from the distal opening and illuminate the internal tissues of the body cavity; and an image visualization structure configured to visualize the internal tissues of the body cavity to a user.

[0153] In Example 23, the subject of Example 22 may optionally include: wherein the expansion member is formed of a light-transparent material.

[0154] In Example 24, the subject of Example 22 may optionally include: wherein the expansion member has a non-expanded position and an expanded position.

[0155] In Example 25, the subject matter of Example 24 may optionally include: wherein, in the non-expanded position, the expansion member is compressed within the tubular shaft.

[0156] In Example 26, the subject matter of Example 25 may optionally include: wherein, at the extended position, the expansion member is extended and configured to expand the patient's body cavity.

[0157] In Example 27, the subject matter of Example 22 may optionally include: wherein the device further includes: a handle coupled to a cannulated shaft, the handle including: a first actuator coupled to an expansion member to actuate the expansion member between a non-expanded position and an expanded position.

[0158] In Example 28, the subject of Example 27 may optionally include, wherein the handle further includes: a second actuator mechanically and electrically coupled to the light source, the second actuator being configured to advance the light source from the insert shaft and deliver power to the light source.

[0159] In Example 29, the subject of Example 27 may optionally include: wherein a second actuator is also mechanically coupled to an image visualization structure, the second actuator being configured to advance the image visualization structure from the cannulated axis.

[0160] In Example 30, the subject of Example 29 may optionally include: wherein the light source and the image visualization structure have a predetermined space between the light source and the image visualization structure.

[0161] In Example 31, the subject of Example 22 may optionally include: wherein the light source is light emitted by a light-emitting diode (LED).

[0162] In Example 32, the subject of Example 22 may optionally include: wherein the image visualization structure is at least one of a charge-coupled device (CCD), a complementary metal-oxide-semiconductor (CMOS) chip, and a lens.

[0163] In Example 33, the subject of Example 22 may optionally include: wherein the image visualization structure and the light source are positioned along the longitudinal axis of the tubular axis.

[0164] In Example 34, the subject of Example 32 may optionally include: the visualized structure is positioned at a distance relative to the light source.

[0165] In Example 35, the subject of Example 32 may optionally include: wherein the visualized structure is positioned near the light source.

[0166] In Example 36, the subject of Example 32 may optionally include: where the light source is coaxial with the visualization structure.

[0167] In Example 37, the subject of Example 32 may optionally include: in which the light source and the visualization structure are concentric with each other.

[0168] In Example 38, the subject of Example 22 may optionally include: wherein at least one of the light source and the visualization structure is offset from the longitudinal axis of the tubular axis.

[0169] In Example 39, the subject of Example 22 may optionally include: a monitor configured to receive and display video signals from an image visualization structure.

[0170] Example 40 provides a method for visualizing the internal tissues of a body cavity, the method comprising: introducing a portion of a device into a patient's body cavity, the device comprising: an intubation shaft extending proximally to distally, the distal end having a distal opening; an expansion member translatably within the intubation shaft, the expansion member being configured to expand the body cavity; a light source configured to extend from the distal opening and illuminate the internal tissues of the body cavity; and an image visualization structure configured to visualize the internal tissues of the body cavity to a user; expanding the body cavity by means of the expansion member extending from the distal opening for expanding the body cavity; and illuminating the body cavity with light generated from the light source.

[0171] In Example 41, the subject of Example 40 may optionally include: wherein the expansion member has a non-expanded position and an expanded position.

[0172] In Example 42, the subject matter of Example 41 may optionally include: wherein an expansion member extends from the distal opening such that the expansion member extends from a non-expanded position to an expanded position.

[0173] In Example 43, the subject of Example 42 may optionally include: wherein the visualized structure is positioned near the light source.

[0174] Example 44 provides an example.

[0175] In Example 45, the subject of Example 44 may optionally include: wherein the visualized structure is positioned near the light source.

[0176] In Example 46, the subject of Example 44 may optionally include: wherein the visualized structure is positioned near the light source.

[0177] In Example 47, the subject of Example 44 may optionally include: wherein the visualized structure is positioned near the light source.

[0178] In Example 48, the subject of Example 4 may optionally include: wherein at least one working axis includes multiple working axes.

[0179] Example 49 provides a therapeutic device for treating intrauterine tissue, the therapeutic device comprising: an insertable shaft extending from a proximal end to a distal end having a distal opening; and a therapeutic light system configured to apply UV light to treat the intrauterine tissue, wherein the therapeutic light system comprises: a light source configured to generate wavelengths within a UV band; a light conductor coupled to the light source; and a light emitter connected to the light conductor to emit UV light from the light conductor toward the intrauterine tissue.

[0180] In Example 50, the subject of Example 49 may optionally include: wherein UV light is generated outside the patient and transmitted to a light emitter via a light conductor.

[0181] Example 51 provides a method of applying UV light to intrauterine tissue, the method comprising: introducing a portion of a treatment device into a patient's body cavity, the treatment device comprising: an insertable shaft extending from a proximal end to a distal end having a distal opening; a treatment light system comprising: a light source configured to generate wavelengths within a UV band; a light conductor coupled to the light source; and a light emitter connected to the light conductor to emit UV light from the light conductor toward the intrauterine tissue; generating UV light outside the patient's body cavity; and transmitting the UV light via the light conductor to the light emitter positioned within the body cavity to apply the UV light to the body cavity.

[0182] Example 52 provides a therapeutic device for treating intrauterine tissue, the therapeutic device comprising: an insertable shaft extending from a proximal end to a distal end having a distal opening; and a therapeutic light system configured to apply UV light to treat intrauterine tissue, wherein the therapeutic light system comprises: a first UV light source configured to generate first UV light having a wavelength in the range of 100 nanometers (nm) to 200 nm; a light conductor reversely coupled to the first light source; a light emitter connected to the light conductor to emit the first UV light from the light conductor toward the intrauterine tissue; and a second UV light source reversely coupled to the light conductor, the second UV light source being configured to generate second UV light having a wavelength in the range of 200 nm to 400 nm.

[0183] Example 53 provides a method of applying UV light to intrauterine tissue, the method comprising: introducing a portion of a treatment device into a patient's body cavity, the treatment device comprising: an insertable shaft extending from a proximal end to a distal end having a distal opening; a treatment light system comprising: a first UV light source configured to generate first UV light having a wavelength in the range of 100 nm to 200 nm; a second UV light source configured to generate first UV light having a wavelength in the range of 200 nm to 400 nm; generating the first UV light outside the patient's body cavity; transmitting the first UV light into the body cavity to apply UV light to the body cavity; generating second UV light outside the patient's body cavity; and transmitting the second UV light into the body cavity to apply UV light to the body cavity.

[0184] Example 54 provides a method of applying UV light to intrauterine tissue, the method comprising: introducing a portion of a treatment device into a patient's body cavity, the treatment device comprising: an insertable shaft extending from a proximal end to a distal end having a distal opening; a treatment light system comprising: a first UV light source configured to generate first UV light having a wavelength in the range of 100 nm to 200 nm; a second UV light source configured to generate first UV light having a wavelength in the range of 200 nm to 400 nm; generating the first UV; applying the first UV to intrauterine tissue; generating the second UV; and applying the second UV to intrauterine tissue.

[0185] In Example 55, a combination of any of the items in Examples 1 through 54 is included.

[0186] The above detailed description includes reference to the accompanying drawings, which form part of the detailed description. The drawings illustrate specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “examples.” Such examples may include elements other than those shown or described. However, the inventors also contemplate examples in which only those elements shown or described are provided. Furthermore, the inventors also contemplate examples (or examples or aspects thereof) using any combination or arrangement of those elements shown or described with respect to a particular example (or one or more aspects thereof) shown or described herein, or with respect to other examples (or one or more aspects thereof).

[0187] In this document, as is common in patent literature, the terms "a" or "an" are used to include one or more, regardless of any other instance or usage of "at least one" or "one or more". In this document, unless otherwise indicated, the term "or" is used to refer to a non-exclusive "or", such that "A or B" includes "A but not B", "B but not A", and "A and B". In this document, the terms "comprising" and "in" are used as concise Chinese equivalents of the corresponding terms "including" and "wherein". Furthermore, in the appended claims, the terms "comprising" and "including" are open-ended, meaning that a system, apparatus, article, composition, formulation, or process that includes elements other than those listed after such terms in the claims is still considered to fall within the scope of the claims. Additionally, in the appended claims, the terms "first", "second", and "third", etc., are used only as designations and are not intended to impose numerical requirements on their objects.

[0188] The above description is intended to be illustrative and not restrictive. For example, the examples (or one or more aspects of the examples) described above may be used in combination with each other. Other embodiments may be used by those skilled in the art upon review of the above description. An abstract is provided to conform to 37C.FR §1.72(b) to allow the reader to quickly determine the nature of the technical disclosure. It should be understood that the submitted abstract is not intended to interpret or limit the scope or meaning of the claims. Furthermore, in the above detailed description, various features may be combined to organize the disclosure. This should not be construed as meaning that all unclaimed disclosed features are necessary for any claim. Rather, the subject matter of the invention may lie in fewer than all features of a particular disclosed embodiment. Therefore, the appended claims are thus incorporated into the detailed description as examples or embodiments, wherein each claim is an independent, separate embodiment, and such embodiments are contemplated to be combined with each other in various combinations or arrangements. The scope of the invention should be determined by reference to the full scope of the appended claims together with the equivalents conferred by such claims.

Claims

1. A treatment device for treating intrauterine tissue, the treatment device comprising: A cannulated shaft, the cannulated shaft extending from a proximal end to a distal end, the distal end having a distal opening; as well as A therapeutic light system configured to apply ultraviolet (UV) light to treat the intrauterine tissue, wherein the therapeutic light system comprises: A first UV light source, the first UV light source being configured to generate first UV light having a first wavelength; and A second UV light source is configured to generate second UV light having a second wavelength different from the first wavelength of the first UV light. The first UV light source and the second UV light source are configured to extend from the tubular shaft; A first material, configured to circulate through the first UV light source and generate the first UV light when activated; and A second material is configured to circulate through the second UV light source and generate the second UV light when activated.

2. The treatment device according to claim 1, wherein, The first UV light has a wavelength in the range of 100 nanometers (nm) to 200 nm.

3. The treatment device according to claim 2, wherein, The second UV light has a wavelength in the range of 200 nanometers (nm) to 400 nm.

4. The treatment device according to any one of claims 1 to 3, wherein, The therapeutic light system also includes: A light conductor configured to be reversibly coupled to the first UV light source and the second UV light source; and A light emitter connected to the light conductor, the light emitter being configured to emit first UV light when the first UV light source is coupled to the light conductor and to emit second UV light when the second UV light source is coupled to the light conductor.

5. The treatment device according to any one of claims 1 to 3, wherein, The therapeutic light system also includes: A first optical conductor, the first optical conductor being coupled to the first UV light source; A first light emitter is connected to the first light conductor and is configured to emit the first UV light.

6. The treatment device according to claim 5, wherein, The therapeutic light system also includes: A second optical conductor, which is coupled to the second UV light source; A second light emitter is connected to the second light conductor and is configured to emit the second UV light.

7. The treatment device according to any one of claims 1 to 3, wherein, The first UV light source and the second UV light source each include a bulb.

8. The treatment device according to any one of claims 1 to 3, wherein, The first UV light source includes a first bulb and the second UV light source includes a second bulb, the first bulb and the second bulb being interwoven and configured to extend from the tubular shaft.

9. The treatment device according to any one of claims 1 to 3, further comprising: A UV-transparent dilatation member is translatable within the cannula axis and configured to extend from the distal opening and dilate the patient's uterus.

10. The treatment device according to claim 9, wherein, The UV-transparent expansion member has a non-expanded position and an expanded position.

11. The treatment device according to claim 10, wherein, In the non-expanded position, the UV-transparent dilatant is compressed within the cannula shaft, and in the expanded position, the UV-transparent dilatant expands and is configured to dilate the patient's uterus for treatment.

12. The treatment device according to claim 1, wherein, At least one of the first UV light source and the second UV light source is a flash lamp.

13. The treatment device according to claim 12, wherein, The flash is a xenon flash.

14. The treatment device according to any one of claims 1 to 3, further comprising: A light source, configured to extend from the distal opening and irradiate the internal tissues of the body cavity; as well as An image visualization structure configured to make the internal tissues of the body cavity visible to a user.

15. The treatment device according to claim 14, wherein, The light source configured to extend from the distal opening is a light-emitting diode (LED), and the image visualization structure is at least one of a charge-coupled device (CCD), a complementary metal-oxide-semiconductor (CMOS) chip, and a lens.

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