Fiber optic medical treatment device for treatment of the urinary tract of a subject - Patents.com

Abstract

Various aspects disclosed herein relate to a fiber optic medical treatment device for treatment of a subject's urinary tract, particularly the bladder, the device comprising a first treatment laser source and a fiber optic device including at least one optical fiber, the fiber optic device having a proximal end and a distal end, the distal end configured to be advanced through a working channel of a cystoscope into the subject's urinary tract, particularly the bladder, the first treatment laser source configured to output first treatment laser radiation for treatment of a medical condition of the urinary tract, particularly the bladder, and optically couple the first treatment laser radiation to the fiber optic device, the device configured to emit the first treatment laser radiation from the distal end toward tissue of the urinary tract, particularly the bladder, to be treated.

Description

[Technical field]

[0001] The present disclosure relates to a fiber optic medical treatment device for treatment of a subject's urinary tract, and in particular the bladder. [Background technology]

[0002] Many medical conditions can be treated by applying laser light to the tissue to be treated. Often such treatments are performed by directing treatment laser radiation via optical fibers to the tissue to be treated.

[0003] In many procedures, the optical fiber is advanced through the working channel of a flexible endoscope. Laser ablation and / or coagulation therapy for bladder cancer is performed using a cystoscope. A cystoscope is an endoscope configured to perform cystoscopy, in which the cystoscope is advanced through the urethra and into the bladder. For this purpose, the cystoscope includes a very thin, flexible tube. During laser ablation and / or coagulation therapy for bladder cancer, the healthcare provider inserts a fiber optic device through the working channel of the cystoscope and into the patient's bladder. The fiber optic device is then used to direct the laser to the specific area of ​​tissue that needs to be treated.

[0004] Generally, it is desirable to provide a fiber optic medical treatment device for treatment of a subject's urinary tract, and in particular the bladder, that allows for efficient, safe and reliable treatment of bladder cancer.

[0005] It would further be desirable to provide a fiber optic medical treatment device for treatment of a subject's urinary tract, and particularly the bladder, that is easy to manipulate.

[0006] It would further be desirable to provide a fiber optic medical treatment device for treatment of a subject's urinary tract, and particularly the bladder, that causes relatively little pain or discomfort to the treated patient.

[0007] Notwithstanding previous efforts, it remains desirable to provide a fiber optic medical treatment device for treatment of a subject's urinary tract, particularly the bladder, that overcomes one or more of the above and / or other problems and / or has other advantages or at least offers an alternative to existing solutions. Summary of the Invention

[0008] In this background, various aspects disclosed herein relate to a fiber optic medical treatment device for treatment of a subject's urinary tract, particularly the bladder, the device comprising: a first treatment laser source; and a fiber optic device including at least one optical fiber, the fiber optic device having a proximal end and a distal end, the distal end configured to be advanced through a working channel of a cystoscope into the subject's urinary tract, particularly the bladder, the first treatment laser source configured to output first treatment laser radiation for treatment of a medical condition of the urinary tract, particularly the bladder, and optically couple the first treatment laser radiation to the fiber optic device, particularly at or near the proximal end of the fiber optic device, the device configured to emit the first treatment laser radiation from the distal end toward tissue of the urinary tract, particularly the bladder, to be treated.

[0009] According to a first aspect relating to a fiber optic medical treatment device, in particular for the treatment of the urinary tract, in particular the bladder, of a subject, the first treatment laser radiation has a wavelength of 750 nm to 950 nm, for example 780 nm to 820 nm, or 900 nm to 950 nm, for example 905 nm to 925 nm. Water has a relatively low absorption in these wavelength ranges, while the tissue to be treated has a relatively high absorption in this wavelength range. In particular, lipids have a high absorption in the wavelength range of 900 nm to 950 nm, and the absorption of hemoglobin is also relatively high. Therefore, using wavelengths in these wavelength ranges allows efficient ablation and / or coagulation of tissue by emitting the laser radiation from a fiber tip positioned inside the urinary tract, in particular inside the bladder, away from the tissue, thereby allowing simultaneous irradiation of a relatively large area or tissue without attenuating the laser radiation by passing through the surrounding water. Furthermore, since the wavelength is outside the visible range, it does not adversely affect visual inspection, for example by a camera, especially when the wavelength range is 900 nm to 950 nm.

[0010] It will be appreciated that the emission of the first treatment laser radiation at a wavelength of 750 nm to 950 nm may be performed in combination with treatment laser radiation applied in short bursts as discussed in relation to the third aspect, or in combination with treatment laser radiation applied otherwise, e.g., over a longer period of time, e.g., during the period during which a user command is received, e.g., a foot pedal is activated. It will further be appreciated that the emission of the first treatment laser radiation at a wavelength of 750 nm to 950 nm may be performed in combination with illumination of central and peripheral regions at different intensities, or in combination with other spatial intensity distributions, e.g., illumination at a uniform intensity across the illumination spot.

[0011] Generally, according to a second aspect relating to a fiber optic medical treatment device for treatment of a subject's urinary tract, particularly the bladder, the device is configured to emit a first treatment laser radiation from a distal end toward tissue of the urinary tract, particularly the bladder, to be treated so as to irradiate a target spot on the tissue to be treated, the target spot having a peripheral region and a central region, the device being configured to irradiate the peripheral region with a peripheral illumination intensity and to irradiate the central region with a central illumination intensity that is less than the peripheral illumination intensity.

[0012] In some embodiments, the target spot has a spot diameter and the central region has a central region diameter that is 10% to 80% of the spot diameter. In some embodiments, the central illumination intensity is 0% to 90%, such as 1% to 90%, such as 10% to 90%, of the peripheral illumination intensity. In some embodiments, the peripheral region is an annular peripheral region surrounding the central region. In particular, in some embodiments, the peripheral illumination intensity is substantially uniform circumferentially along the annular periphery. More particularly, in some embodiments, the peripheral illumination intensity varies circumferentially along the annular periphery by less than 10%, in particular less than 5%.

[0013] By irradiating the peripheral area of ​​the irradiated target spot with a higher intensity than the central area, a more uniform heating of the entire target spot is achieved, thus allowing uniform treatment of a large target spot and reducing the risk of damaging the bladder wall in some places or under-treating the tumor tissue in others. Thus, safe and efficient simultaneous treatment of a larger tissue area is facilitated by emitting the first treatment laser radiation from a fiber tip positioned away from the tissue to be treated. It will be understood that irradiation of the central and peripheral areas with different intensities may be performed with treatment laser radiation at wavelengths discussed in connection with the first embodiment or at other wavelengths, e.g., in the range of 750 nm to 1000 nm, e.g., 950 nm to 1000 nm. Furthermore, it will be understood that irradiation of the central and peripheral areas with different intensities may be performed with treatment laser radiation applied in short bursts as discussed in connection with the third embodiment, or otherwise applied, e.g., over a longer period of time, e.g., during the period during which a user command is received, e.g., during the period during which a foot pedal is activated.

[0014] Generally, according to a third aspect relating to a fiber optic medical treatment device for treatment of a subject's urinary tract, particularly the bladder, the device is configured to emit a burst of first treatment laser radiation from a distal end toward tissue of the urinary tract, particularly the bladder, to be treated, in response to a user command to emit the first treatment laser radiation, the burst having a burst duration of 1 ms to 1 s.

[0015] In some embodiments, the device is configured to emit a burst of the first treatment laser radiation at a power output between 10W and 200W.

[0016] Generally, unless otherwise specified, references to numerical values ​​of the power of the laser radiation discussed herein refer to the maximum power of the laser radiation. For example, if the laser radiation is pulsed, the numerical value corresponds to the maximum power of an individual pulse, not the average power of the pulse train. The latter may be less than the maximum power and may be related to the maximum power by a factor indicative of the duty cycle of the pulse train.

[0017] By irradiating the tissue to be treated with a short, intense burst of the first treatment laser radiation, a therapeutically efficient amount of energy can be deposited within the tissue to be treated to effectively ablate the tissue. However, the level of discomfort experienced by the patient is reduced when the first treatment laser radiation only impinges on the tissue for short bursts at a time.

[0018] During a burst, the laser radiation may be emitted continuously or as pulsed laser radiation. The latter may be appropriate when the burst duration is greater than 5 ms, e.g., greater than 10 ms. The individual pulses may have a duration of, for example, 0.5 ms to 100 ms, e.g., less than 20 ms, e.g., less than 10 ms, e.g., less than 5 ms.

[0019] In response to a user command, the device may emit a single burst or a series of, for example, 2, 3, 4 or 5 bursts. The user command may include, for example, a user manipulating a foot pedal. For example, the device may be configured to emit a predetermined amount of laser energy as a single burst of laser radiation or as a series of several bursts of laser radiation. The predetermined amount of energy may be selected by the user. In some embodiments, the predetermined amount of energy may be determined at least in part in response to a measured distance between the distal end and the tissue to be treated, for example, to deliver a predetermined amount of energy per unit area of ​​tissue being irradiated by the treatment laser radiation. The amount of energy may be controlled by adjusting the power and / or burst duration and / or, in the case of emission of pulsed radiation, the duty cycle of the pulsed laser radiation.

[0020] It will be appreciated that the emission of the first treatment laser radiation in one or more bursts may be performed at a wavelength discussed in connection with the first embodiment or at other wavelengths, for example treatment laser radiation in the range of 750 nm to 1000 nm, for example 950 nm to 1000 nm. It will further be appreciated that the emission of the first treatment laser radiation in one or more bursts may be performed in combination with illumination of central and peripheral regions at different intensities, or in combination with other spatial intensity distributions, for example in combination with illumination at a uniform intensity across the illumination spot.

[0021] As mentioned above, the present disclosure is directed to different aspects, including various aspects of a fiber optic medical procedure device discussed above and further below, It will be understood that each of the aspects of the fiber optic medical procedure device may have one or more embodiments that correspond to the embodiments described in relation to one or more of the other aspects and / or disclosed in the appended claims.

[0022] Generally, in some embodiments of a fiber optic medical treatment device according to any of the aspects disclosed herein, the device further comprises a second treatment laser source configured to output a second treatment laser radiation for treatment of said medical condition of the urinary tract, particularly the bladder, and optically couple the second treatment laser radiation to the fiber optic device, wherein the second laser radiation has a different wavelength than the wavelength of the first treatment laser radiation.

[0023] In particular, in some embodiments, the second treatment laser radiation has a wavelength of 1000 nm to 2000 nm, for example 1400 nm to 2000 nm. Thus, the second treatment laser radiation may be at a wavelength at which water has high absorption and at which the fiber optic device has high transmittance. When the second treatment laser radiation is emitted towards the tissue to be treated, the water between the fiber tip and the tissue to be treated is heated and impinges on the tissue to be treated, resulting in the generation of bubbles that facilitate the ablated tissue to be removed. When the first treatment laser radiation and the second treatment laser radiation are applied alternately, the tissue portion ablated by the application of the first treatment laser radiation can be removed from the treatment site by a subsequent application of the second treatment laser radiation. This allows the underlying layer of tissue to be inspected and, if necessary, ablated by further application of the first treatment laser radiation. The selective and alternating application of the first treatment laser radiation and the second treatment laser radiation is preferably performed in response to the receipt of a corresponding control input by the operator. Thus, an operator may control the device to selectively emit either the first treatment laser radiation or the second treatment laser radiation.

[0024] In some embodiments of the fiber optic medical treatment device according to any of the aspects disclosed herein, the device further comprises a pilot light source configured to output a visible pilot light and optically couple the pilot light to the fiber optic device, the device configured to emit a pilot beam of said pilot light from the distal end toward the tissue of the urinary tract, in particular the bladder, to be treated, so as to illuminate a target spot on the tissue to be treated with the visible pilot light. In particular, in some embodiments, the visible pilot light is a polychromatic light, which may include two or more color components detectable by the camera of the medical treatment device, for example, may include at least two detectable color components that are at least 40 nm apart. The at least two color components may be part of a broadband emission spectrum having a bandwidth of 40 nm or more, and the intensity of the emitted pilot light may be substantially uniform across the bandwidth or may vary across the bandwidth. Each of the two detectable color components may have a sufficiently high intensity to be detectable by the camera or similar detector of the medical treatment device such that the spot illuminated by the pilot beam is visible to a human observer in the camera image as an illuminated spot having a color resulting as a mixture of the at least two color components, for example, as a white or substantially white spot. Preferably, the pilot beam is configured to illuminate the target spot illuminated by at least the first treatment laser radiation. The pilot beam may be emitted before and, optionally, during application of the first treatment laser radiation. The pilot beam may be delivered through the same optical fiber as the first treatment laser radiation or through a separate optical fiber. The inventors have found that the multi-color pilot beam provides improved visibility and is less tiring for the operator when using the device for extended periods of time.

[0025] In some embodiments, the device is configured to control the visual attributes, particularly the intensity, color and / or color distribution, of the visible pilot light in response to one or more of a user command, an operating parameter of the first treatment laser radiation, and a sensor signal obtained by the sensor module. For example, the device may control the visual attributes of the pilot beam, e.g., vary the color and / or intensity of the pilot beam, in response to a user manipulating a foot pedal or other input device to activate the treatment laser radiation. Alternatively or additionally, the device may control the visual attributes in response to one or more operating parameters of at least a first setting, e.g., a selected laser power and / or duty cycle, and / or whether the device is currently emitting the first or second treatment laser radiation. Further alternatively or additionally, the device may control the visual attributes in response to one or more sensor signals, e.g., a sensed distance between the distal tip and the tissue to be treated, a detected tissue characteristic. The detected tissue characteristic may indicate, for example, the presence of tissue within range of the distal tip, and / or a sensed stage of photocoagulation or ablation, etc. The tissue properties may be sensed by sensing one or more spectral characteristics of the radiation reflected by the tissue to be treated, or otherwise, and thus the intensity, color, or other visible characteristics of the pilot beam may be used to indicate one or more status or operating parameters to a user.

[0026] In some embodiments of the optical fiber medical treatment device according to any of the aspects disclosed herein, the device comprises a medical treatment device and an optical fiber device, the medical treatment device comprises at least a first treatment laser source, and the optical fiber device is a disposable optical fiber device configured to be detachably and optically coupled to the medical treatment device. Thus, the operating costs are reduced since only the relatively inexpensive optical fiber device is inserted into the urinary tract, particularly the bladder, and is discarded after use.

[0027] In some embodiments of the fiber optic medical treatment device according to any of the aspects disclosed herein, the optical fiber is at least a double-clad optical fiber, and the device is configured to output the first treatment laser radiation through the cladding of the at least double-clad optical fiber. Thus, the device allows multiple types of radiation to be delivered through the fiber optic device without unduly interfering with each other. For example, the device may include an interferometric distance sensor that employs at least a single-mode core of a double-clad optical fiber, while the relatively high-power first treatment laser radiation may be delivered through a multimode cladding of at least a double-clad optical fiber.

[0028] In particular, in some embodiments, the fiber optic medical treatment device comprises an optical side combiner configured to couple the first treatment radiation into the at least one clad of the at least double-clad optical fiber. Coupling the first treatment laser radiation into the at least one clad of the at least double-clad optical fiber by the side combiner facilitates irradiation of the target spot with the first treatment laser radiation having an intensity distribution with a peripheral region of higher intensity and a central region of lower intensity. This in turn promotes more uniform heating of the tissue to be treated throughout the target spot.

[0029] In some embodiments of the fiber optic medical treatment device according to any of the aspects disclosed herein, the device is configured to emit a first treatment laser radiation from the distal end as a diverging first treatment beam configured to irradiate a target spot on the tissue to be treated. In particular, in some embodiments, the fiber optic medical treatment device is configured to irradiate a target spot with a spot diameter of 1 mm to 10 mm, e.g., 1 mm to 7 mm, when the distal end is displaced from the tissue to be treated by a difference of 1 mm to 10 mm, e.g., 2 mm to 5 mm. Thus, a relatively large target spot can be irradiated and treated simultaneously while providing the operator with a better overall view of the target site.

[0030] In some embodiments of a fiber optic medical treatment device according to any of the aspects disclosed herein, the tissue to be treated is soft tissue, in particular cancerous soft tissue.

[0031] In addition to various aspects of the fiber optic medical procedure device, the present disclosure further relates to additional devices, systems, methods, and / or articles of manufacture, each of which provides one or more of the benefits and advantages described in connection with one or more of the other aspects, and each of which has one or more embodiments corresponding to the embodiments described in connection with one or more of the other aspects and / or disclosed in the appended claims.

[0032] In particular, according to one aspect, disclosed herein are embodiments of methods for treating cancer of the urinary tract, particularly the bladder, of a subject by laser ablation and / or coagulation, the method comprising irradiating tissue of the urinary tract, particularly the bladder, to be treated with a first treatment laser radiation having a wavelength of 750 nm to 950 nm.

[0033] According to yet another aspect, disclosed herein are embodiments of methods for treating cancer of the urinary tract, particularly the bladder, of a subject by laser ablation and / or coagulation, the method comprising irradiating a target spot on the tissue to be treated, the target spot defining a peripheral region of the target spot and a central region of the target spot, and the irradiating comprises irradiating the peripheral region with a peripheral irradiation intensity and irradiating the central region with a central irradiation intensity that is less than the peripheral irradiation intensity.

[0034] According to yet another aspect, disclosed herein are embodiments of methods for treating cancer of the urinary tract, particularly the bladder, of a subject by laser ablation and / or coagulation, the method comprising, in response to receiving a user command to emit a first treatment laser radiation, directing a burst of first treatment laser radiation to tissue of the urinary tract, particularly the bladder, to be treated, the burst having a burst duration of 1 ms to 1 s.

[0035] In some embodiments of the method according to any of the above aspects, the method comprises alternately irradiating the tissue to be treated with a first treatment laser radiation and a second treatment laser radiation, the second treatment laser radiation having a different wavelength than a wavelength of the first treatment radiation.

[0036] Those of ordinary skill in the art will appreciate still further aspects of the present application upon reading and understanding the accompanying description. [Brief description of the drawings]

[0037] These and other aspects are illustrated by way of example, and not limitation, in the figures of the accompanying drawings, in which like reference numerals refer to like elements and in which:

[0038] [Figure 1] 1 diagrammatically illustrates an example of a fiber optic medical procedure device according to embodiments disclosed herein. [Diagram 2] 13A-13C diagrammatically illustrate the operation of an example of a fiber optic medical treatment device whose optical fiber is positioned away from the bladder tissue to be treated, according to embodiments disclosed herein. [Diagram 3] 1 shows diagrammatically the absorption spectra of different materials; [Figure 4A] 13A-13C diagrammatically illustrate illumination of a target spot by an example fiber optic medical procedure device according to embodiments disclosed herein. [Figure 4B] 13A-13C diagrammatically illustrate illumination of a target spot by an example fiber optic medical procedure device according to embodiments disclosed herein. [Diagram 5] 1 shows an example of a side combiner. [Figure 6] 1 illustrates optical coupling of a first treatment laser radiation into an optical fiber of a fiber optic medical treatment device according to various embodiments disclosed herein. [Figure 7] 13A-13C diagrammatically illustrate further examples of fiber optic medical procedure devices according to embodiments disclosed herein; [Figure 8] 13A-13C diagrammatically illustrate further examples of fiber optic medical procedure devices according to embodiments disclosed herein; [Figure 9] 13A-13C diagrammatically illustrate further examples of fiber optic medical procedure devices according to embodiments disclosed herein; [Figure 10] 1 diagrammatically illustrates an example of a disposable fiber optic device with an optical fiber inserted into and advanced through a working channel of an endoscope, according to embodiments disclosed herein. [Figure 11] 1 diagrammatically illustrates an example of a disposable fiber optic device according to embodiments disclosed herein. [Figure 12] 1 illustrates a schematic diagram of an example of an optical combiner module of a connector module of a disposable fiber optic device according to an embodiment disclosed herein. [Figure 13] 13A and 13B diagrammatically illustrate another example of an optical combiner module of a connector module of a disposable fiber optic device according to embodiments disclosed herein, where at least the double clad optical fiber includes a tapered region. [Figure 14] 1A and 1B diagrammatically illustrate a cross-sectional view of an example multi-core double-clad optical fiber for use in a disposable optical fiber device according to embodiments disclosed herein. [Figure 15] 12A and 12B diagrammatically illustrate the operation of the tapered region of the optical combiner module of FIG. [Figure 16A] 13A-13C diagrammatically illustrate cross-sectional views of further examples of at least double-clad optical fibers for use in disposable optical fiber devices according to embodiments disclosed herein; [Figure 16B] 13A-13C diagrammatically illustrate cross-sectional views of further examples of at least double-clad optical fibers for use in disposable optical fiber devices according to embodiments disclosed herein; [Figure 16C] 13A-13C diagrammatically illustrate cross-sectional views of further examples of at least double-clad optical fibers for use in disposable optical fiber devices according to embodiments disclosed herein; [Figure 16D] 13A-13C diagrammatically illustrate cross-sectional views of further examples of at least double-clad optical fibers for use in disposable optical fiber devices according to embodiments disclosed herein; [Figure 16E] 13A-13C diagrammatically illustrate cross-sectional views of further examples of at least double-clad optical fibers for use in disposable optical fiber devices according to embodiments disclosed herein; [Figure 16F] 13A-13C diagrammatically illustrate cross-sectional views of further examples of at least double-clad optical fibers for use in disposable optical fiber devices according to embodiments disclosed herein; [Figure 17A] 1A-1D diagrammatically illustrate longitudinal cross-sectional views of example fiber tip designs of at least double-clad optical fibers for use in a disposable optical fiber device according to embodiments disclosed herein. [Figure 17B] 1A-1D diagrammatically illustrate longitudinal cross-sectional views of example fiber tip designs of at least double-clad optical fibers for use in a disposable optical fiber device according to embodiments disclosed herein. [Figure 17C] 1A-1D diagrammatically illustrate longitudinal cross-sectional views of example fiber tip designs of at least double-clad optical fibers for use in a disposable optical fiber device according to embodiments disclosed herein. [Figure 18] 2A and 2B diagrammatically illustrate more detailed examples of fiber optic medical procedure devices according to embodiments disclosed herein. [Figure 19] 1 diagrammatically illustrates an example of an optical combiner module for combining multiple optical paths fed through at least double-clad optical fibers; [Figure 20] 1A-1D diagrammatically illustrate the operation of an example fiber optic medical procedure device according to various embodiments disclosed herein. [Figure 21A] 4 illustrates an example of a distance sensing signal obtained by a sensor module of a fiber optic medical procedure device according to various embodiments disclosed herein. [Figure 21B] 4 illustrates an example of a distance sensing signal obtained by a sensor module of a fiber optic medical procedure device according to various embodiments disclosed herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0039] The following describes embodiments of fiber optic medical procedure devices that may alleviate one or more of the above and / or other disadvantages of existing devices, or at least serve as a replacement for existing devices.

[0040] FIG. 1 diagrammatically illustrates an example of a fiber optic medical procedure device according to embodiments disclosed herein.

[0041] The fiber optic medical procedure device comprises a medical procedure device 2000 and a fiber optic device 1000. The fiber optic device 1000 may be configured to be removably optically coupled to the medical procedure device 2000. In particular, the fiber optic device 1000 may be disposable, for example, after a single use.

[0042] The optical fiber device 1000 comprises an optical fiber 1200, for example a multimode fiber, or a double or multi-clad optical fiber.

[0043] The optical fiber 1200 may have a diameter suitable for insertion into the working channel of a cystoscope or other type of endoscope, i.e. the choice of diameter may depend on the type of endoscope. A suitable diameter may be 0.1 mm to 1 mm, e.g. 0.1 mm to 0.4 mm, preferably 0.1 mm to 0.3 mm, e.g. 0.1 mm to 0.25 mm. Optical fibers having a diameter of 1 mm or less, preferably 0.4 mm or less, e.g. 0.3 mm or less, are sufficiently thin that the tensile and compressive stresses induced at the fiber end allow bending with relatively small values. The length of the at least double clad optical fiber may depend on the type of endoscope. A suitable length may be 2 m to 4 m.

[0044] Generally, in at least some embodiments, the at least double-clad optical fiber that emits radiation toward the tissue to be treated may have a fiber diameter of 100 μm to 1000 μm, e.g., 100 μm to 300 μm, e.g., 150 μm to 200 μm. In some embodiments, the numerical aperture of the multimode cladding that transmits the treatment laser radiation has a numerical aperture of 0.17 to 0.50, e.g., 0.22 to 0.45. Here, the numerical aperture of the inner cladding can be defined as the square root of the difference between the square of the refractive index of the inner cladding and the square of the refractive index of the outer cladding that surrounds the inner cladding.

[0045] The distal end 1201 of the optical fiber 1200 may be beveled, preferably with rounded edges, for easy insertion into the working channel of the endoscope and to reduce the risk of the edges of the optical fiber breaking during insertion.

[0046] Generally, the medical treatment device 2000 includes a first treatment laser source 2200 configured to output a first treatment laser radiation for ablation and / or coagulation treatment of bladder cancer or another medical condition of the urinary tract, in particular a first treatment laser radiation suitable for treating tumor tissue of the urinary tract, in particular the bladder, by ablation and / or coagulation. The first treatment laser source 2200 may include a suitable type of laser, for example a diode laser, configured to emit the first treatment laser radiation at a wavelength and power suitable for the medical treatment to be performed. If the medical treatment device is for treatment of tumors of the urinary tract, in particular the bladder, by ablation and / or coagulation, the first treatment laser source may comprise a high brightness diode laser. The first treatment laser radiation may be optically coupled into the optical fiber 1200, for example at or near the proximal end of the optical fiber. The optical fiber is preferably configured to receive the first treatment laser radiation, in particular a first treatment laser radiation having a power of 10 W to 200 W. The preferred wavelength range of the first treatment laser radiation will be discussed in connection with FIG.

[0047] FIG. 2 diagrammatically illustrates the operation of one example of a fiber optic medical treatment device whose optical fiber is positioned away from the bladder tissue to be treated, according to embodiments disclosed herein.

[0048] Generally, various embodiments of the disposable optical fiber device are for treating the urinary tract, for example, treating the bladder, and in particular for treating bladder cancer. In use, the distal end 1201 of the optical fiber 1200 is inserted into a working channel of a cystoscope adapted for insertion through the urethra into the urinary tract, in particular into the bladder. The working channel of the cystoscope typically has a diameter of 1.5 mm to 2 mm, for example 1.8 mm. The cystoscope must typically be able to bend with a small bending radius, for example a bending radius of 10 mm or less, or even 5 mm or less. Once inserted into the urinary tract, in particular the bladder, the distal end 1201 of the optical fiber 1200 is brought into an operating position away from the tissue 210 to be treated, which may be a tumor of the bladder 200. The device emits a first laser treatment radiation from the distal end 210 of the optical fiber 1200 towards the tissue to be treated, so as to cause ablation and / or coagulation of the tissue 210.

[0049] When the optical fiber 1200 emits the first treatment radiation as a diverging beam 100, a relatively large target spot can be irradiated and therefore treated at once, thereby reducing the need to move the fiber to irradiate different locations while providing uniform treatment of the larger target spot.

[0050] In some embodiments, during the first emission, the distance between the distal end of the optical fiber 1200 and the tissue 210 to be treated is between 2 mm and 6 mm, for example between 3 mm and 5 mm.

[0051] FIG. 3 shows diagrammatically the absorption spectra of different materials.

[0052] The use of 980 nm diode lasers to treat bladder tumors has been suggested, see, e.g., GLPedersen et al., "Outpatient Photodynamic Diagnosis-guided Laser Destruction of Bladder Tumors Is as Good as Conventional Inpatient Photodynamic Diagnosis-guided Transurethral Tumor Resection in Patients with Recurrent Intermediate-risk Low-grade Ta Bladder Tumors. A Prospective Randomized Noninferiority Clinical Trial," European Urology (2022) https: / / doi.org / 10.1016 / j.eururo.2022.08.012.

[0053] The inventors have recognized that lower wavelengths have certain advantages for the ablation and / or coagulation treatment of bladder cancer, especially when a larger target area is to be treated with a diverging beam, as shown in FIG.

[0054] As can be seen, radiation in the wavelength range 750nm to 950nm, for example 780nm to 820nm or 900nm to 950nm, for example 905nm to 925nm, for example about 815nm, has a lower absorption by water, while having a high absorption by lipids and also a relatively high absorption by hemoglobin. Thus, treatment radiation at these wavelengths can be efficiently emitted from an optical fiber immersed in water, away from the tissue to be treated. Furthermore, the radiation has a relatively high absorption by the tissue to be treated, thus allowing efficient ablation and / or coagulation.

[0055] Thus, in some embodiments, the first treatment laser source is configured to output the first treatment laser radiation at a wavelength selected to provide low water absorption and high absorption by the tissue to be treated. Preferably, the first treatment laser radiation has a wavelength of 750 nm to 950 nm, for example 780 nm to 820 nm, or 900 nm to 950 nm, for example 905 nm to 925 nm, for example about 915 nm.

[0056] 4A and 4B diagrammatically illustrate illumination of a target spot by an example fiber optic medical procedure device according to embodiments disclosed herein.

[0057] Figure 4A shows an example of a target spot 110 illuminated by an embodiment of a fiber optic medical treatment device according to embodiments disclosed herein, for example, when operated as shown in Figure 2. When the emission axis from the optical fiber is substantially perpendicular to the tissue region being treated, the illuminated spot may be substantially circular.

[0058] In various embodiments of the fiber optic medical treatment device disclosed herein, the device is configured to provide non-uniform illumination of the target spot, particularly along a radial direction of the target spot. In particular, the fiber optic treatment device illuminates an annular peripheral region 112 of the target spot with a higher intensity than a central region 111 surrounded by the peripheral region, as shown, for example, diagrammatically in FIG. 4B.

[0059] FIG. 4B shows diagrammatically the intensity profile, and in particular the irradiance profile, of the illumination along the diameter 113 of the target spot.

[0060] The intensity of the central region is preferably 0% to 90%, such as 1% to 90%, such as 10% to 90%, such as 10% to 80% of the maximum intensity in the peripheral region. The diameter of the central region having an intensity of 0% to 90%, such as 1% to 90%, such as 10% to 90%, such as 10% to 80% of the maximum intensity in the peripheral region is preferably at least 10%, such as 10% to 80%, of the diameter of the target spot.

[0061] It will be appreciated that the boundary of the target spot is not defined by a sharp line, but rather the intensity of the illumination gradually decreases radially around the circumference of the target spot. For purposes of determining the diameter of the target spot, the boundary line may be defined as the circumferential line where the intensity is reduced to 50% of the maximum intensity.

[0062] Preferably, the strength of the peripheral region is substantially uniform along the circumferential direction.

[0063] Providing non-uniform irradiance radially of the target spot results in more uniform heating of the target spot, thereby facilitating uniform ablation and / or coagulation of the target spot while reducing the risk of localized damage or even perforation of the bladder wall.

[0064] A non-uniform intensity profile with an annular maximum can be provided in different ways, for example as described in connection with FIGS. 5 and 6 below.

[0065] In particular, in some embodiments, the optical fiber 1200 may be a double-clad (or another multi-clad) optical fiber having a central core surrounded by at least two claddings. The first treatment laser radiation may be optically coupled to a cladding, in particular the inner cladding of the double-clad optical fiber.

[0066] When the first treatment laser radiation is coupled into the cladding of the double-clad optical fiber by a side combiner, the beam emitted at the distal end of the fiber irradiates the tissue to be treated with a non-uniform intensity distribution having an annular maximum, as shown in FIG. 2.

[0067] Fig. 5 shows a schematic example of a side combiner, sometimes called a side-pump combiner, i.e. a combiner configured to laterally couple radiation between a multimode fiber and an inner cladding of a double-clad optical fiber while the core of the double-clad optical fiber section passes through the side combiner. Fig. 5 shows a schematic of a double-clad optical fiber 1200 having an inner core 1213, an inner cladding 1211, and an outer cladding 1214. A first treatment laser radiation is received from a first treatment laser source via a supply fiber 1137, e.g. a multimode fiber, optically coupled to the inner cladding 1211 of the double-clad fiber 1200, in particular at a suitable angle relative to the longitudinal axis of the double-clad optical fiber 1200. Thus, the side combiner couples / fuses a multimode secondary fiber (here a multimode supply fiber 1137) at an angle to the circumferential outside of the pass-through primary fiber (here a double-clad optical fiber section 1213). Preferably, the multimode delivery fiber 1137 has a diameter smaller than that of the double-clad optical fiber 1200 .

[0068] 6 shows, in a schematic manner, another example of coupling a first treatment laser radiation into an optical fiber 1200 to cause the optical fiber to emit at its distal end a first treatment beam that results in a non-uniform illumination of the target spot, as shown in FIG. 2. In particular, FIG. 6 shows how an incident laser beam 37 from a first treatment laser source is directed through a collimating or focusing lens 40 configured to couple the incident laser beam into a proximal end 39 of the optical fiber 1200. In particular, when the incident laser beam 37 is directed toward the proximal end 39 along a direction that is radially offset from the longitudinal axis of the optical fiber 1200, the incident laser beam 37 is coupled into the optical fiber 1200 at an angle, thus causing the fiber to emit at its distal end an output beam that produces a non-uniform illumination, as shown in FIG. 2.

[0069] 7 diagrammatically illustrates another example of a fiber optic medical procedure device according to embodiments disclosed herein. The device of FIG. 7 is similar to the device of FIG. 1 in that it includes a medical procedure device 2000 and a fiber optic device 1000. The fiber optic device 1000 includes an optical fiber 1200, and the medical procedure device includes a first treatment laser source 2200, all as described in connection with FIG.

[0070] In this embodiment, the medical treatment device 2000 further includes a second treatment laser source 2610 configured to output a second treatment laser radiation at a wavelength different from the wavelength of the first treatment laser radiation. In particular, the second treatment laser radiation may have a wavelength of 1000 nm to 2000 nm, for example, 1400 nm to 2000 nm.

[0071] The second treatment laser radiation may be optically coupled into the optical fiber 1200, for example, at or near the proximal end of the optical fiber. Alternatively, the second treatment laser radiation may be optically coupled into a separate optical fiber.

[0072] The medical treatment device may be configured to selectively output the first treatment laser radiation and / or the second medical treatment radiation towards the tissue to be treated, particularly from the distal end 1201 of the optical fiber. In some embodiments, the medical treatment device 2000 is configured to emit either only the first treatment laser radiation or only the second treatment laser radiation at any given time, while in other embodiments, the medical treatment device 2000 is configured to emit the first and second treatment radiations simultaneously.

[0073] Figure 8 diagrammatically illustrates another example of a fiber optic medical procedure device according to embodiments disclosed herein. The device of Figure 8 is similar to the device of Figure 1 in that it includes a medical procedure device 2000 and a fiber optic device 1000. The fiber optic device 1000 includes an optical fiber 1200, and the medical procedure device includes a first treatment laser source 2200, all as described in connection with Figure 1.

[0074] In this embodiment, the medical treatment device 2000 further includes a sensor module 2300. The sensor module 2300 may include a sensor laser source 2310 configured to output a sensor laser radiation. The medical treatment device is configured to output the sensor laser radiation via an optical fiber. For this purpose, the optical fiber 1200 may be at least a double-clad optical fiber and the medical treatment device may be configured to output the sensor laser radiation via a core of the at least double-clad optical fiber 1200. At least one core of the at least double-clad optical fiber may have a V-number of less than 10, preferably less than 8, such as less than 6, for example less than 3 or even 2.4, at the wavelength of the sensor laser radiation. That is, at least one core may be a few-mode core or even a single-mode core at the wavelength of the sensor laser radiation.

[0075] In some embodiments, the sensor laser radiation includes multiple wavelengths. Thus, the V-number of at least one core of the at least double-clad optical fiber may be different for different wavelengths of the sensor radiation. For example, the core may be a single-mode core at one or several wavelengths of the sensor laser radiation, and a few-mode core (or even a multimode core) at other wavelengths of the laser radiation. In particular, in some embodiments, the medical treatment device includes multiple sensor modules, for example, an interferometric distance sensor module and a spectroscopic sensor module. The different sensor modules may operate at different wavelengths. In such embodiments, at least one core of the at least double-clad optical fiber may be a few-mode core with a small V-number, or even a single-mode core (e.g., having a V-number less than 4, for example 3 or even less than 2.4) at the wavelength of the sensor laser radiation of one of the sensor modules, for example, the interferometric sensor module. At least one core of the at least double-clad optical fiber may be a few-mode core with a larger V-number (e.g., 3 to 10, for example 3 to 6) at the wavelength of the sensor laser radiation of the other sensor module, for example, the spectroscopic sensor module.

[0076] In various embodiments, the medical treatment device 2000 comprises an interferometric distance sensor module configured to perform interferometric distance sensing of the distance between the distal end of the optical fiber 1200 and the tissue to be treated. In particular, in some embodiments, the interferometric distance sensor is a common path sensor in which the distal end of the optical fiber is operable as a reflector of the reference optical path, thus providing a particularly compact system that does not require any additional fibers. The medical treatment device is preferably further configured to control the first treatment laser emission at least partially in response to the measured distance.

[0077] It will be appreciated that the medical treatment device 2000 of the FIG. 8 embodiment may also include a second treatment laser source, as described in connection with the FIG. 7 embodiment.

[0078] It will be appreciated that the medical treatment device of any of the above embodiments may include a pilot light source, e.g., a pilot laser source or other type of light source adapted to emit a suitable visible light as a pilot beam to illuminate the portion of tissue to be treated and serve as an aiming guide to a physician or other user of the device. The pilot beam may be delivered through the same optical fiber as the treatment laser emission or through a separate optical fiber. In some embodiments, the pilot beam may be multicolored. In some embodiments, the device may be configured to control the visual attributes, e.g., color and / or intensity, of the pilot light in response to one or more operating parameters, user inputs, and / or sensor signals.

[0079] FIG. 9 diagrammatically illustrates yet another example of a fiber optic medical procedure device according to embodiments disclosed herein.

[0080] The apparatus of Figure 7 is similar to the apparatus of Figure 1 in that it includes a medical treatment device 2000 and a fiber optic device 1000. The fiber optic device 1000 includes an optical fiber 1200, and the medical treatment device includes a first treatment laser source 2200, all as described in relation to Figure 1.

[0081] In this embodiment, the disposable fiber optic device 1000 is configured to be removably optically coupled to a medical procedure device.

[0082] To this end, the disposable fiber optic device 1000 comprises at least a double clad optical fiber 1200. The disposable fiber optic device 1000 may further comprise a connector module 1100 for coupling the at least double clad optical fiber 1200 to a medical procedure device 2000.

[0083] The optical fiber 1200 is at least double clad, i.e., may be double clad, or may be multi-clad with more than two clads, e.g., triple clad. Generally, a double clad optical fiber includes three layers of optical material. The innermost layer is called the core. It is surrounded by an inner clad, which is surrounded by an outer clad. The three layers are typically made of materials having different refractive indices. The distal end 1201 of the at least double clad optical fiber 1200 is configured to be advanced through a working channel of an endoscope, such as a cystoscope. Preferably, the core is a single mode core, being single mode at least at one or more target wavelengths or ranges of target wavelengths. Optionally, the at least double clad optical fiber 1200 includes two or more cores, preferably single mode cores, e.g., a few-mode or single mode central core and one or more few-mode or single mode side cores. Optionally, the at least double clad optical fiber has a medical grade buffer coating, e.g., blue EFTE, Teflon, nylon, etc. The optical fiber may have a circular inner cladding or a hexagonal or octagonal inner cladding for mode scrambling. The inner cladding may be a multi-core cladding.

[0084] The at least double clad optical fiber 1200 may have a diameter suitable for being inserted into the working channel of an endoscope, in particular a cystoscope, i.e. the choice of diameter may depend on the type of endoscope. A suitable diameter may be 0.1 mm to 1 mm, e.g. 0.1 mm to 0.4 mm, preferably 0.1 mm to 0.3 mm, e.g. 0.1 mm to 0.25 mm. An optical fiber having a diameter of 1 mm or less, preferably 0.4 mm or less, e.g. 0.3 mm or less, is thin enough that the tensile and compressive stresses induced at the fiber end allow bending with relatively small values. The length of the at least double clad optical fiber may depend on the type of endoscope. A suitable length may be 2 m to 4 m.

[0085] The distal end 1201 of at least the double-clad optical fiber 1200 may be beveled, preferably with rounded edges, for easier insertion into the working channel of the endoscope and reduced risk of the edges of the at least double-clad optical fiber being damaged during insertion.

[0086] The connector module 1100 may be configured to optically couple at least the proximal end of the double-clad optical fiber 1200 to the medical procedure device 2000. To this end, the connector module 1100 comprises one or more optical connectors. In some embodiments, the connector module 1100 is configured to separately couple at least the core and the clad of the double-clad optical fiber 1200, respectively, to the medical procedure device 2000. To this end, the connector module 1100 may have a first optical connector and a second optical connector. The first optical connector may be configured to removably connect to a first mating optical connector of the medical procedure device 2000. The second optical connector may be configured to removably connect to a second mating optical connector of the medical procedure device. An embodiment of the disposable optical fiber device 1000 is described in more detail below with reference to Figures 10 and 11.

[0087] The medical treatment device 2000 comprises a first treatment laser source 2200 configured to output a first treatment laser radiation for the treatment of a medical condition. In particular, the medical treatment device is configured to output the first treatment laser radiation through at least a double-clad optical fiber 1200 towards the tissue to be treated. The first treatment laser source 2200 may comprise a suitable type of laser, for example a diode laser, configured to emit the first treatment laser radiation at a wavelength and power suitable for the medical treatment to be performed. If the medical treatment device is for the treatment of tumors of the urinary tract, in particular the bladder, by ablation and / or coagulation, the first treatment laser source may comprise a high-intensity diode laser. A preferred wavelength range of the first treatment laser radiation is described in relation to FIG. 3.

[0088] The medical treatment device is configured to output the first treatment laser radiation at least through the cladding, particularly the inner cladding, of the double-clad optical fiber 1200. The cladding may be a multimode cladding.

[0089] The medical procedure device 2000 further comprises a sensor module 2300. The sensor module is configured to output and receive a sensor laser radiation through the at least double clad optical fiber 1200 and to optically measure one or more parameters of the procedure based on the received sensor laser radiation. For this purpose, the sensor module 2300 may include a sensor laser source 2311 configured to output a sensor laser radiation. The medical device is configured to output a sensor laser radiation through a core of the at least double clad optical fiber 1200. For this purpose, at least one core of the at least double clad optical fiber has a V-number at the wavelength of the sensor laser radiation core less than 10, preferably less than 8, such as less than 6, such as less than 3 or even 2.4. That is, at least one core is a few-mode core or even a single-mode core at the wavelength of the sensor laser radiation. In some embodiments, the sensor laser radiation comprises multiple wavelengths. Thus, the V-number of at least one core of the at least double clad optical fiber may be different for different wavelengths of the sensor radiation. For example, the core may be a single mode core at one or several wavelengths of the sensor laser radiation and a few mode core (or even a multimode core) at other wavelengths of the laser radiation. In particular, in some embodiments, the medical treatment device includes multiple sensor modules, for example, an interferometric distance sensor module and a spectroscopic sensor module. The different sensor modules may operate at different wavelengths. In such an embodiment, at least one core of the at least double-clad optical fiber may be a few mode core with a small V number, or even a single mode core (e.g., having a V number less than 4, for example 3 or even less than 2.4) at the wavelength of the sensor laser radiation of one of the sensor modules, for example, the interferometric sensor module. At least one core of the at least double-clad optical fiber may be a few mode core with a larger V number (e.g., 3 to 10, for example 3 to 6) at the wavelength of the sensor laser radiation of the other sensor module, for example, the spectroscopic sensor module.

[0090] The sensor module 2300 may further comprise a detector 2312 for receiving and detecting radiation received from the tissue to be treated, in particular radiation reflected by the tissue in response to being illuminated by the sensor laser radiation from the sensor laser source 2311. The detector 2312 may be configured to receive radiation from the tissue via at least one core and / or cladding of the at least one double clad optical fiber 1200 of the disposable optical fiber device. The detector 2312 may be configured to receive radiation from the tissue via at least one core and / or cladding of the at least double clad optical fiber 1200 of the disposable optical fiber device.

[0091] The medical treatment device is configured to time-division multiplex the power of the first treatment laser radiation and the optical measurement of at least one or more parameters. Thus, some embodiments of the medical treatment device alternately emit the first treatment laser radiation and perform the optical measurement. That is, some embodiments of the medical treatment device intermittently interrupt the emission of the first treatment laser radiation to perform the optical measurement, or at least substantially reduce the emission, thereby allowing reliable optical measurements to be performed during the treatment. In some embodiments, the medical treatment device is configured to adjust one or more parameters of the first treatment laser radiation, in particular the power, duty cycle and / or pulse duration, in response to the measured one or more parameters. Thus, the medical treatment device may be configured to control the first treatment laser source to resume the emission of the intermittently interrupted first treatment laser radiation with the adjusted one or more parameters. In general, it will be understood that time division multiplexing may include a complete cessation of emission of the first treatment laser radiation to perform optical measurements, or at least a substantial reduction in the first treatment laser radiation emitted while performing optical measurements, for example a reduction in the power of the first treatment laser radiation used during a treatment cycle to 5% or less, for example to 1% or less.

[0092] In some embodiments, the medical treatment device is configured to output the first treatment laser radiation as a pulsed laser radiation, i.e., as a train of first treatment laser pulses separated from one another by time intervals between the first treatment laser pulses. The medical treatment device is configured to emit the sensor laser radiation during some or all of the time intervals between the first treatment laser pulses. An example of the operation of the medical treatment device is described in more detail below with reference to FIG. 20.

[0093] In some embodiments, the sensor laser radiation and the first treatment laser radiation have different wavelengths. In particular, the sensor laser radiation may have one or more sensor wavelengths in a first wavelength range, and the first treatment laser radiation may have one or more treatment wavelengths in a second wavelength range different from the first wavelength range, preferably spaced apart from the first wavelength range. Thus, some or all of the first treatment laser radiation and the sensor laser radiation may be spatially separated, time division multiplexed and spaced apart in wavelength / frequency at least within the core and cladding of the double-clad optical fiber.

[0094] The medical treatment device 2000 comprises a control unit 2400 configured to control the operation of the medical treatment device 2000. In particular, the control unit may control the operation of the first treatment laser source 2200 and the sensor module. In some embodiments, the control unit controls the time division multiplexing of the laser emission and optical measurement based on the sensor laser emission. The control unit 2400 may be configured to control various other optical treatment and / or sensor modules of the medical treatment device. The control unit may be configured to control the first treatment laser source, the sensor laser source, and / or other radiation sources and / or sensors in response to the received sensor signal. The control unit may include a suitable driver and / or communication interface and a processing device, for example a suitable programmed central processing unit.

[0095] In various embodiments, the one or more parameters measured include a distance between at least the distal end 1201 of the double clad optical fiber 1200 and the tissue to be treated. To this end, in various embodiments, the sensor module 2300 comprises a first optical sensor module, in particular an interferometric distance sensor module, configured to perform interferometric distance sensing of the distance between at least the distal end 1201 of the double clad optical fiber 1200 and the tissue to be treated. In particular, in some embodiments, the interferometric distance sensor is a common path sensor, in which at least the distal end 1201 of the double clad optical fiber is operable as a reflector of the reference optical path, thus providing a particularly compact system without the need for any additional fiber. The medical treatment device 2000, in particular the control unit 2400 of the medical treatment device, is preferably further configured to control the first treatment laser radiation in response to the measured distance. In particular, the control unit may be configured to control the laser power or another operating parameter of the first treatment laser radiation in response to the sensed distance, such as the duty cycle of the pulse train of the laser cycle, the pulse width or duration of the emission of the laser radiation, etc. For example, the control unit may be configured to control a laser power or other operating parameter of the first treatment laser radiation in response to the sensed distance such that an intensity of the laser radiation impinging on the tissue to be treated remains substantially constant despite changing distance. In another example, the control unit may be configured to control a laser power or other operating parameter of the first treatment laser radiation in response to the sensed distance such that an energy of the laser radiation impinging on the tissue to be treated during a period of time remains substantially constant despite changing distance.

[0096] The first optical sensor module may be further configured to detect and distinguish between a plurality of different types of materials located in front of the distal end of at least the double-clad optical fiber. In such an embodiment, the control unit may be further configured to control the laser power and / or other operating parameters of the first treatment laser radiation in response to the type of material detected. In particular, the first optical sensor module may be configured to distinguish between a living tissue, such as a soft living tissue, and a non-living material, in particular a surface of an artificial material, such as an inner or outer surface of an endoscope. Alternatively or additionally, the first optical sensor module may be configured to detect and distinguish whether at least the distal end of the double-clad optical fiber is immersed in a liquid, in particular water, or whether the distal end is immersed in air. Examples of measurement signals obtained by the interferometric distance sensor module and the use of the signals for distance sensing and detection of different types of materials are described in more detail below with reference to Figures 21A-C.

[0097] In some embodiments, the sensor module 2300 comprises a second optical sensor module, in particular a spectroscopic sensor module, configured for spectroscopic analysis of the tissue to be treated and for calculating an indication of the progress of the treatment. For this purpose, the spectroscopic sensor may be configured to sense one or more spectral characteristics of the radiation reflected by the tissue to be treated. The medical treatment device is preferably further configured to determine a measure indicative of a state or progress of the treatment from the sensed one or more spectral characteristics. Preferably, the medical treatment device is configured to control the first treatment laser radiation in response to the determined state or progress, in particular in response to the sensed distance and the determined state or progress.

[0098] The spectroscopic sensor module may comprise a supercontinuum white light source for illuminating at least through a single mode core of the double clad optical fiber 1200. Alternatively, the spectroscopic sensor module may comprise a number of WDM multiplexed LEDs for illuminating at least through a single mode core of the double clad optical fiber 1200. The spectroscopic sensor module may be operable to measure the reflective state of the tissue to be treated, in particular, by measuring the wavelength dependent back reflection, for example, through at least a multimode inner cladding of the double clad optical fiber 1200. The spectroscopic sensor module may comprise two or more LEDs that are turned on / off one by one, and the detector may be operable to detect the power of the back reflected light using a simple photodetector. The detected power difference between the signals at different wavelengths may be used by the control unit of the medical treatment device to estimate the reflective state of the tissue. The spectroscopic sensor module may measure the state of hemoglobin, for example, by measuring the reflected light in the range of 500 nm to 600 nm, where Hb absorbs. The spectroscopic sensor module may emit short wavelength light, for example blue light, to excite fluorophores in the tissue and detect the fluorescence. In any case, the control unit may use the signal from the spectroscopic sensor to determine optimal settings for the first treatment laser.

[0099] An embodiment of the medical treatment device 2000 is described in more detail below with reference to Figure 18. As will become apparent from the disclosure below, the medical treatment device may include additional or alternative radiation sources and / or additional photodetectors.

[0100] In use, the disposable fiber optic device 1000 is removably and optically connected to the medical procedure device 2000 via the connector module 1100, and at least the distal end 1201 of the double-clad optical fiber 1200 is inserted into the working channel of an endoscope, for example, as shown in FIG. 10.

[0101] FIG. 10 diagrammatically illustrates an example of an optical fiber 1200, for example, of any of the aforementioned embodiments of an optical fiber medical procedure device, inserted and advanced into a working channel 3100 of an endoscope 3000, particularly a cystoscope. In the example of FIG. 10, a distal end 1201 of the optical fiber 1200 extends out of the working channel of the endoscope. In use, the endoscope is inserted into a patient's blood vessel or organ, particularly into the bladder via the urethra. The endoscope 3000 may be inserted with the optical fiber 1200 already inserted into the working channel 3100. Alternatively, the optical fiber 1200 may be inserted into the working channel 3100 after insertion of the endoscope 3000 into the target organ or blood vessel.

[0102] Endoscopes adapted for various medical procedures are known as such in the art and will not be described in more detail herein. In particular, different types of endoscopes may have working channels of approximately standardized diameters. A typical working channel of an endoscope has a diameter of 1 mm to 5 mm. Some endoscopes may further include a camera 3600 and / or one or more illumination lights, e.g., LEDs 3500, located at the distal end of the endoscope 3000 to allow the physician to observe the progress of the medical procedure.

[0103] Generally, various embodiments of the medical fiber optic treatment device are for treating the urinary tract, for example, treating the bladder, and in particular for treating bladder cancer. Thus, in some embodiments, the endoscope is a cystoscope adapted for insertion through the urinary tract into the bladder. The working channel of the cystoscope typically has a diameter of 1.5 mm to 2 mm, for example 1.8 mm. The cystoscope must typically be able to bend with a small bending radius, for example, a bending radius of 10 mm or less, or even 5 mm or less.

[0104] FIG. 11 diagrammatically illustrates an example of a disposable fiber optic device 1000 according to embodiments disclosed herein.

[0105] The disposable fiber optic device 1000 comprises at least a double-clad optical fiber 1200 having a proximal end and a distal end 1201. The distal end 1201 is configured to be advanced through a working channel of an endoscope, for example, as described in connection with FIG. 2. The at least double-clad optical fiber 1200 has at least one core, an inner cladding surrounding the core, and at least one outer cladding surrounding the inner cladding. In particular, the at least double-clad optical fiber 1200 may be a double-clad optical fiber having one or more cores, inner claddings, and outer claddings.

[0106] The disposable optical fiber device 1000 further comprises a connector module 1100 for optically connecting at least the proximal end of the double-clad optical fiber 1200 to a medical procedure device (not shown in FIG. 3), for example as described in connection with FIG. 9.

[0107] In the embodiment of Fig. 11, the connector module 1100 is configured to separately couple the core and inner cladding of at least a double-clad optical fiber 1200 to a medical treatment device. The connector module 1100 comprises a first optical fiber 1110, a second optical fiber 1120, a first optical connector 1111 for removably and optically connecting the first optical fiber 1110 to the medical treatment device, a second optical connector 1121 for removably and optically connecting the second optical fiber 1120 to the medical treatment device, and an optical combiner module 1300 configured to couple radiation between the first optical fiber 1110 and at least one core of the at least double-clad optical fiber 1200 and to couple radiation between the second optical fiber 1120 and at least one cladding of the at least double-clad optical fiber 1200.

[0108] The first optical connector 1111 is configured to be removably connected to a first mating optical connector of the medical treatment device and to optically couple at least the core of the double-clad optical fiber to the first mating optical connector. The second optical connector 1121 is configured to be removably connected to a second mating optical connector of the medical treatment device and to optically couple at least the inner clad of the double-clad optical fiber to the second mating optical connector.

[0109] In some embodiments, the first treatment laser source of the medical treatment device is optically coupled to the second optical connector 1121 of the disposable optical fiber device 1000 via a second mating optical connector. Thus, the second optical connector is preferably configured to receive the first treatment laser beam, in particular a first treatment laser beam having a power output of 10W to 200W.

[0110] The sensor laser module of the medical procedure device may be optically coupled to the first optical connector 1111 of the disposable fiber optic device via a first mating optical connector. Thus, the first optical connector is preferably configured to receive the sensor laser beam and output reflected laser radiation.

[0111] Generally, a removable connection refers to a connection during normal use made by a user of a medical treatment device, which can be disconnected again during normal use. In particular, a removable connection of an optical connector of a disposable optical fiber device means that the corresponding mating connector of the medical treatment device to which the optical connector is connected is not destroyed during connection or disconnection. Preferably, the optical connector of the disposable optical fiber device is not destroyed even during disconnection, i.e., the optical connector of the disposable optical fiber device can be reversibly and repeatedly connected to the medical treatment device. An optical connection means that radiation can pass between the medical treatment device and the corresponding optical fiber of the connector module to which the optical connector is coupled.

[0112] Generally, in various embodiments, the connector module may comprise a housing 1170. The first optical fiber 1110, the second optical fiber 1120 and the optical combiner module 1300 may be fully or partially housed within the housing. The housing 1170 may be a plastic housing or a housing made of another suitable material, for example, a rigid material or a soft material. The housing may be, for example, a box made of a rigid material, or may be provided in another form, for example, as an elongated flexible sleeve. The housing may form a single compartment or multiple compartments. The housing has one end configured to be connected to a medical treatment device, whereby the first and second optical connectors can be connected to corresponding first and second mating optical connectors of the medical treatment device. For this purpose, the first and / or second optical connectors, which may be spring-loaded, may be mounted directly on or within a side wall of the housing, thus enabling an easy and reliable connection. Alternatively, the first and / or second optical connectors, which may be spring-loaded, may be attached to the housing via one or more flexible fiber optic cables. Thus, in general, the components of a connector module may all be contained within a single housing, or they may be distributed among two or more separate housings and interconnected via one or more fiber optic cables, or the like.

[0113] Generally, the first and / or second optical connectors may be spring-loaded. To this end, the first and / or second optical connectors may include a spring or other resilient element for holding the first or second optical connector, respectively, in place when connected to a medical procedure device. The spring or other resilient element may be any suitable component for providing a resilient force, e.g., a leaf spring, a coil spring, or the like.

[0114] The housing 1170 may include additional mechanical connectors or guides 1171, e.g., guide rails, which further promote a reliable and secure connection by ensuring a suitable mechanical force on the connector, e.g., spring-loaded, to secure it to the medical procedure device. To this end, the guide rails or other mechanical connectors may include a click-on mechanism.

[0115] The housing 1170 further includes an opening through which at least the double-clad optical fiber 1200 protrudes from the housing. The housing 1170 may include a soft cone 1172 or other form of stress and / or bend relief at the opening through which at least the double-clad optical fiber 1200 protrudes from the housing.

[0116] The first optical fiber 1110 may be a single mode optical fiber, or an optical fiber having a single mode core (e.g., a double clad optical fiber), or may include a single mode optical fiber section. The first optical fiber, or at least the core of the first optical fiber, may be single mode at least at a predetermined target wavelength, particularly a wavelength used by a sensor module of a medical procedure device, such as an interferometric distance sensor module. The first optical fiber 1110 may be a single fiber section, or may include multiple fiber sections optically coupled to each other, such as spliced ​​or otherwise connected to each other.

[0117] The first optical connector 1111 may be a low-reflectivity optical single-mode fiber connector, for example a connector that provides physical contact between the respective fiber ends of the optical fibers optically connected by the optical connector, i.e., the first optical fiber 1110 and the corresponding optical fiber of the medical treatment device. In particular, the first optical connector may be an angled physical contact (APC) connector. In some embodiments, the low-reflectivity optical single-mode fiber connector has a reflectivity of less than -40 dB, for example -50 dB, preferably less than -60 dB, for example less than -70 dB, for example -80 dB. In general, the first optical connector may be configured to couple few-mode or single-mode laser radiation, in particular radiation that can be characterized by a V number less than 10, such as less than 3, to the first optical fiber. The first optical connector may be configured to couple single-mode laser radiation having a power output of less than 1 W, for example less than 200 mW, for example less than 100 mW, to the first optical fiber.

[0118] Thus, efficient optical coupling between single-mode or few-mode optical fibers with little back reflection is provided, which is particularly advantageous when the radiation passing through the core of at least the double-clad optical fiber 1200 is laser radiation for sensor applications, especially interferometric measurements such as interferometric distance measurements.

[0119] Generally, the term single mode radiation or single mode laser radiation as used herein refers to laser radiation transmitted by being emitted from a single mode optical fiber or other single mode waveguide. Similarly, the term multimode radiation or multimode laser radiation as used herein refers to laser radiation transmitted through and / or emitted from a multimode optical fiber or other multimode waveguide.

[0120] The second optical fiber 1120 may be a multimode optical fiber or may include a multimode fiber section. The second optical fiber 1120 may be a single fiber section or may include multiple fiber sections optically coupled to one another, e.g., spliced ​​or otherwise connected to one another.

[0121] The second optical connector 1121 may be a high power optical multimode connector, such as an SMA 905 connector or a collimated beam connector. A collimated beam connector is an optical fiber connector including a collimating lens operable to collimate the beam exiting the optical fiber connector. In particular, the collimating lens may be arranged inside the connector housing of the connector. The collimating lens allows mating of the collimated beam connector with a corresponding collimated beam connector with particularly low power losses. Thus, a high power connection suitable for example for high power treatment laser radiation is provided. The second optical connector may be a free-standing fiber tip connector with no physical contact between the fiber ends. Here, the term high power optical connector is intended to refer to an optical connector adapted for optical connection of an optical fiber conveying high power laser radiation, in particular laser radiation with a power suitable for medical treatment of tissue, for example by ablation and / or coagulation. The second optical connector 1121 may be adapted for optical connection of an optical fiber conveying laser radiation with a power of 10 W or more, such as 100 W or more, such as 200 W or more, for example between 10 W and 500 W. In general, the second optical connector may be configured to couple multimode laser radiation, in particular radiation that can be characterized by a V number greater than 10, to the second optical fiber.

[0122] In general, two optical connectors may be operable to be connected to each other via a mating sleeve. Thus, in some embodiments, each of the mating optical connectors of the medical procedure device that are operable to be coupled to the optical connector of the disposable optical fiber device may comprise or be attached to a respective mating sleeve. The mating sleeve of the second mating optical connector of the medical procedure device that is operable to be coupled to the second optical connector of the disposable optical fiber device may be made, at least in part, from a suitable material that has a sufficiently high melting point and / or low thermal expansion to enable a high-power optical connection. Examples of suitable materials include tungsten carbide.

[0123] Generally, the first optical connector 1111 and the second optical connector 1121 provide separate optical coupling of the first optical fiber 1110 and the second optical fiber 1120, respectively, to a medical treatment device. In particular, the first optical connector 1111 provides optical coupling of the first optical fiber 1110 with a corresponding first fiber of the medical treatment device, and the second optical connector 1121 provides optical coupling of the second optical fiber 1120 with a corresponding second fiber of the medical treatment device, the corresponding second fiber of the medical treatment device being different from the corresponding first fiber of the medical treatment device.

[0124] In some embodiments, the first and second optical connectors are physically separate connectors. In particular, the optical connector 1111 may have a first connector housing, e.g., including a first ferrule, and the second optical connector 1121 may have a second connector housing, e.g., including a second ferrule, that is different from the first connector housing. In other embodiments, the first optical connector 1111 and the second optical connector 1121 may be housed within a single connector housing or otherwise formed as a single composite connector having multiple optical ends. For example, the single connector housing may be a two ferrule connector housing, such as a Diamond DM4 connector having multiple optical ends.

[0125] The at least double clad optical fiber 1200 may deliver a single mode low power sensor laser radiation through its core towards the tissue to be treated. The at least double clad optical fiber 1200 may further deliver a single mode reflected radiation through its core from the distal end of the at least double clad optical fiber to the medical treatment device via the first optical connector 1111. The reflected radiation may be the sensor laser radiation reflected by the distal end 1201 of the at least double clad optical fiber 1200 and / or the sensor laser radiation reflected by the tissue to be treated and captured by the distal end 1201 of the at least double clad optical fiber 1200. Thus, the core of the at least double clad optical fiber 1200 is preferably a single mode core at least at the wavelength or wavelengths of the sensor laser radiation. The at least double clad optical fiber 1200 may further deliver a high power multimode treatment laser radiation through its inner cladding towards the tissue to be treated.

[0126] For the purposes of this description, the term "tissue to be treated" is intended to refer not only to tissue prior to being treated, but also to tissue undergoing treatment, as well as tissue already affected by a treatment. Generally, the tissue to be treated is a living tissue, such as a soft tissue.

[0127] An example of the optical combiner module 1130 is described in more detail with reference to FIGS.

[0128] Optionally, the connector module 1100 may include additional components.

[0129] In particular, in some embodiments, the connector module comprises a temperature sensor 1161, e.g., a thermistor, configured to sense the temperature of the optical combiner module 1130. The temperature sensor may be a PTC or NTC sensor. The temperature sensor 1161 may be electrically connectable to the medical treatment device via the electrical connector 1162, thus enabling the medical treatment device to monitor the temperature of the optical combiner module during operation and, optionally, control the operation of the first treatment laser source in response to the sensed temperature. For example, the medical treatment device may be controlled to reduce the power and / or duty cycle of the first treatment laser, or even to turn off the first treatment laser or close a shutter / optical switch, to prevent overheating of the optical combiner module 1130.

[0130] Alternatively or additionally, the connector module may include a cooling member 1131 configured for passive or active cooling of the optical combiner module 1130. The cooling member may include, for example, a heat sink, cooling ribs, and / or a thermal conductor configured to transport heat to a heat sink of the medical treatment device when the connector module is connected to the medical treatment device.

[0131] Further alternatively or additionally, the disposable fiber optic device 1000, and particularly the connector module 1100, may include an RFID chip 1140 or other form of device identifier, e.g., a radio-readable ID tag, that allows a medical procedure device to automatically register the identifier of the disposable fiber optic device 1000. This may be advantageous when the medical procedure device is configured to operate with different types of disposable fiber optic devices. This allows the medical procedure device to adapt one or more of its operating parameters to the particular type of disposable fiber optic device to which it is connected.

[0132] FIG. 12 diagrammatically illustrates an example of an optical combiner module 1130 of a connector module of a disposable fiber optic device according to embodiments disclosed herein.

[0133] The optical combiner module 1130, according to embodiments disclosed herein, couples radiation between the first optical fiber 1110 of the connector module and the core of at least the double-clad optical fiber 1200 of the disposable optical fiber device. The optical combiner module 1130 further couples radiation between the second optical fiber 1120 of the connector module and the cladding, particularly the inner cladding, of at least the double-clad optical fiber 1200.

[0134] Thus, the first optical fiber 1110 may be a single mode optical fiber, at least at one or more target wavelengths, and the second optical fiber 1120 may be a multimode optical fiber.

[0135] The optical combiner module 1130 comprises at least a double clad optical fiber portion 1135 having a core and a cladding. The core of the at least double clad optical fiber portion 1135 is a few-mode, preferably single mode core, at a target wavelength of radiation received via the first optical fiber. The at least double clad optical fiber portion 1135 may include a low index acrylate coating, optionally with a fluorinated silica (F-SiO2) cladding. The core of the at least double clad optical fiber portion may have a diameter of 5 μm to 10 μm and / or a numerical aperture of 0.07 to 0.15. The core of the at least double clad optical fiber portion is a few-mode, preferably single mode core, at a target wavelength of radiation received via the first optical fiber. sensor In this case, V<10@λ sensor , preferably V<8@λ sensor , e.g. V<7@λ sensor , e.g. V<2.4@λ sensor It has a V number of .

[0136] The V-number is a dimensionless parameter that is often used in the context of optical fibers, such as step-index fibers. It is a normalized frequency parameter that determines the number of modes in an optical fiber, such as a step-index fiber. It is defined as:

[0137]

number

[0138] where λ is the vacuum wavelength, α is the radius of the fiber core, and NA is the numerical aperture. core and n cladding denote the refractive indices of the core and the inner cladding, respectively.

[0139] For purposes of this description, unless otherwise specified, the terms single mode fiber and single mode core refer to fibers and cores, respectively, having V numbers less than 2.4 at the relevant wavelengths, the terms few mode fiber and few mode core refer to fibers and cores, respectively, having V numbers greater than 2.4 and less than 10 at the relevant wavelengths, and the terms multimode fiber and multimode core refer to fibers and cores, respectively, having V numbers greater than 10.

[0140] The optical combiner module 1130 further comprises a first junction 1136 for coupling radiation between the first optical fiber 1110 and at least a core of the double-clad optical fiber portion 1135. The first junction 1136 may be provided with a cladding mode stripper configured for stripping of return multimode radiation into the first optical fiber 1110. Alternatively or additionally, the first junction 1136 may comprise a scattering surface or a high index glue and / or coating.

[0141] The optical combiner module 1130 further comprises a multimode fiber section 1137 and a second junction 1138 for coupling radiation between the second optical fiber 1120 and the multimode fiber section 1137. The multimode fiber section 1137 may have a core diameter of 50 μm to 100 μm and / or a numerical aperture of 0.27 or less, such as 0.22 or less. The core of the multimode fiber section 1137 may have a V-number V>10.

[0142] The optical combiner module 1130 further comprises an optical fiber combiner 1132 configured for coupling radiation between the multimode fiber portion 1137 and an inner cladding of at least the double-clad optical fiber portion 1135. The optical fiber combiner 1132 may be a side combiner, sometimes called a side-pump combiner, i.e. a combiner configured to laterally couple radiation between the multimode fiber portion 1137 and an inner cladding of at least the double-clad optical fiber portion 1135 while the core of the at least the double-clad optical fiber portion passes through the side combiner. Thus, the side combiner couples / fuses the multimode secondary fiber (here the multimode fiber portion 1137) obliquely to the circumferential outer side of the pass-through primary fiber (here the at least the double-clad optical fiber portion 1135). Preferably, the secondary fiber has a smaller diameter than the primary fiber. For example, the double-clad feed-through fiber may have a diameter of 200 μm (or another suitable diameter) and the secondary fiber may have a fiber diameter of 125 μm (or another suitable diameter smaller than the diameter of the feed-through double-clad fiber). The side coupling may result in an up-conversion of the numerical aperture (NA) of the multimode inner cladding of at least the double-clad optical fiber portion 1135 and thus an up-conversion of the numerical aperture (NA) of at least the double-clad optical fiber 1200, e.g., from 0.22 to about 0.45. This in turn results in a larger spot size of the first treatment laser radiation on the tissue to be treated. Furthermore, the side combiner allows the sensor laser radiation propagating in the core of at least the double-clad optical fiber portion to pass through the side combiner without reflection by splices or the like.

[0143] The optical coupler module 1130 further comprises a third junction 1134 for coupling at least the double-clad optical fiber portion 1135 to the proximal end of at least the double-clad optical fiber 1200, particularly for coupling the core and cladding of the respective fibers.

[0144] 13 diagrammatically illustrates another example of an optical combiner module 1130 of a connector module of a disposable fiber optic device according to embodiments disclosed herein. The optical combiner module 1130 is similar to the optical combiner module of FIG. 4 in that it includes at least a double clad optical fiber portion 1135, a multimode fiber portion 1137, an optical fiber combiner 1132, a first junction 1136, a second junction 1138, and a third junction 1134, all as described in connection with FIG. 12.

[0145] 12 and 13 may be omitted. For example, the at least double-clad optical fiber portion 1135 may be formed by the proximal end of the at least double-clad optical fiber 1200. Alternatively or additionally, the multimode fiber portion 1137 may be part of the second optical fiber 1120 attached to the second optical connector.

[0146] The optical combiner module of Figure 13 differs from the optical combiner module of Figure 12 in that it is configured to combine first and second optical fibers 1110 and 1120, respectively, with a multi-core, at least double-clad, optical fiber 1200. That is, the optical combiner module of Figure 13 is for use with embodiments of a disposable optical fiber device that include a multi-core, at least double-clad, optical fiber.

[0147] FIG. 14 diagrammatically illustrates an example of a multi-core double-clad optical fiber 1200. The optical fiber 1200 includes an outer cladding 1214 and an inner cladding 1211, e.g., a multimode inner cladding that may be made of quartz. The optical fiber further includes a central single-mode core 1213 and two single-mode side cores 1212. In other embodiments, the optical fiber may include only a single side core or more than two side cores. In general, multi-core optical fibers provide increased reliability because they provide multiple redundant paths for radiation, e.g., sensor laser radiation. This may improve the signal-to-noise ratio of the sensor signal or improve the reliability of sensor detection, e.g., allowing for continuous distance measurements despite portions of the tip of the fiber being contaminated with tissue or other contaminants.

[0148] 13, the optical combiner module 1130 further comprises a tapered fiber region 1220 at a proximal end of the at least double-clad optical fiber 1200. The tapered region 1200 is configured for coupling of radiation between a single core of the at least double-clad optical fiber 1200 and one or more additional cores of the at least double-clad optical fiber 1200. The tapered region 1220 may be packaged in a ferrule with air surrounding the taper waist to enable a high numerical aperture to support the upconverted clad radiation.

[0149] Figure 15 illustrates the operation of the tapered region 1220. In particular, Figure 15 illustrates at least a proximal portion 1221 of the double-clad optical fiber 1200 extending between the fiber optic combiner 1132 and the tapered fiber region 1220 of the embodiment of Figure 13, and at least a distal portion 1225 of the double-clad optical fiber 1200 extending from a housing of a combiner module and configured for insertion into a working channel of an endoscope. It will be understood that Figure 15 is not drawn to scale, and that the distal portion 1225 is typically much longer than the proximal portion 1221 because the tapered region is preferably disposed with a housing of a connector module.

[0150] In the example of Figure 15, the at least double-clad optical fiber 1200 is a multi-core at least double-clad optical fiber having one central core and two side cores, as shown in Figure 14. However, in other embodiments, the multi-core fiber may have a different number of side cores.

[0151] In operation, the central core of the proximal fiber section 1221 transmits radiation from the first optical fiber 1110. In particular, the radiation may be single mode sensor laser radiation, e.g. for interferometric distance measurements, and / or other types of sensor radiation, e.g. for spectroscopy. In the proximal fiber section 1221, the side cores preferably transmit no radiation or only minimal radiation.

[0152] The optical fiber is tapered down in a down taper region 1222 to a reduced diameter fiber section 1223 and then tapered up again in an up taper region 1224 to its normal diameter at a distal portion 1225 .

[0153] The downtapering and subsequent uptapering allows for coupling of radiation from the central core to the side cores. The length of the neck 1223 may be selected to allow equal coupling to all cores or to couple all of the radiation from the central core to the side core. Thus, in the proximal portion 1225, the optical fiber 1200 transmits radiation from the first optical fiber 1110 only in the side cores or in all of the cores.

[0154] At the distal end 1201 of the at least double clad optical fiber 1200, the radiation may be partially reflected back by the tip. The remaining radiation exits the fiber and is reflected back from the tissue towards which the at least double clad optical fiber 1200 is directed. Thus, the reflected light is captured again by the at least double clad optical fiber 1200 and may be used for sensor purposes, e.g., for interferometric distance sensing of the distance between the distal end 1201 of the at least double clad optical fiber and the reflecting tissue, and / or for spectroscopic analysis of one or more properties of the reflecting tissue.

[0155] The reflected light propagating backwards through the side cores of the distal portion 1225 is then re-focused by the tapered region 1220 to the central core of the proximal portion 1221, thus allowing the reflected radiation to be fed back to the medical treatment device via the first optical fiber and the first optical connector of the connector module.

[0156] 16A-16F diagrammatically illustrate further examples of at least double-clad optical fibers for use in disposable optical fiber devices according to embodiments disclosed herein.

[0157] Generally, in various embodiments, the at least double-clad optical fiber has a core, e.g., a silica core, that is single-mode at least at the wavelength of the sensor laser radiation. The at least double-clad optical fiber has an inner cladding, e.g., a silica cladding, surrounding the core. The inner cladding can operate as a multimode core. The at least double-clad fiber further comprises an outer cladding surrounding the inner cladding. The outer cladding may be a silica or polymer cladding, e.g., a FSiO2 layer or a low index acrylate coating. The at least double-clad optical fiber may further comprise an outermost protective buffer, e.g., a biocompatible coating, which may be made of nylon, Teflon, or other suitable material.

[0158] In various embodiments, the refractive index of the core, n c is the refractive index of the inner cladding, n i is greater than the refractive index of the inner cladding, n i is the refractive index of the outer cladding, n o Greater than.

[0159] In particular, Figure 16A diagrammatically illustrates a cross-sectional view of one example of a single-core double-clad optical fiber 1200. The single-core double-clad optical fiber 1200 includes an outer cladding 1214 and an inner cladding 1211, a multimode inner cladding that may be made, for example, from quartz. The optical fiber further comprises a central single-mode core 1213, for example, from doped quartz. In some embodiments, the core may be a few-mode core (e.g., may be characterized by a V-number less than 10).

[0160] FIG. 16B shows a schematic cross-sectional view of another example of a single-core double-clad optical fiber 1200. As in the previous example, the single-core double-clad optical fiber 1200 includes an outer cladding 1214 and an inner cladding 1211, a multimode inner cladding that may be made of, for example, quartz. The optical fiber further comprises a central single-mode core 1213. However, in this example, the inner cladding has a hexagonal cross-section. It will be understood that other embodiments may have other cross-sectional shapes, for example an octagonal cladding. A hexagonal or octagonal cladding or another appropriately shaped cladding scrambles the modes and allows for a more uniform intensity distribution in the multimode cladding.

[0161] Figure 16C diagrammatically illustrates a cross-sectional view of yet another example of a double-clad optical fiber 1200. This example is similar to the example of Figure 16B, except that the double-clad optical fiber of Figure 16C is a two-core double-clad optical fiber having a side core 1212 in addition to the central core 1213. Both cores may be single mode cores or few mode cores.

[0162] Figure 16D diagrammatically illustrates a cross-sectional view of yet another example of at least a double-clad optical fiber 1200. This example is similar to the example of Figure 8C, except that the optical fiber of Figure 16D further comprises a down-doped silica layer 1215 surrounding the shaped cladding 1211. It will be understood that the single-core example with shaped cladding of Figure 16B may also be provided with such a down-doped silica layer.

[0163] FIG 16E diagrammatically illustrates a cross-sectional view of yet another example of at least a double-clad optical fiber. This example is similar to the example of FIG 16D, except that the optical fiber of FIG 16E further comprises an outer coating / buffer 1216, which may be made of, for example, plastic, EFTE, Teflon, nylon, or another suitable material. It will be understood that any of the examples of FIG 14, FIG 16A-FIG 16D, and FIG 16F may also be provided with such an outer buffer / coating.

[0164] In some embodiments, the at least double-clad optical fiber is an air-clad optical fiber. In this regard, FIG. 16F diagrammatically illustrates a cross-sectional view of yet another example of at least a double-clad optical fiber 1200, specifically an example of an air-clad optical fiber. The air-clad fiber comprises a core 1213, an inner cladding 1211, an air cladding 1217, and an outer cladding 1214, the inner and outer claddings being radially separated by the air cladding. The air cladding 1217 is formed by a plurality of air channels extending along the length of the fiber. The air channels are distributed around the inner cladding 1211.

[0165] In various embodiments of the air-clad fiber, the refractive index of the core, n c is the refractive index of the inner cladding, n i is greater than the refractive index of the inner cladding, n i is the refractive index of the air cladding, n ac The refractive index of the outer cladding, n o is the refractive index of the inner cladding, n imay be substantially equal to

[0166] Air-clad fibers can be provided with high numerical apertures without the need for special plastic coatings, thus allowing the use of soft buffer coatings, which reduce microbending losses on the fiber. Large numerical apertures, for example up to 0.65@980 nm, can be provided in some embodiments, thus providing a large spot size of the treatment spot. The air clad can also act as a mode scrambler, thereby providing a more uniform beam profile of the beam exiting the fiber at its distal end.

[0167] In some embodiments, the air channels in the air cladding may be collapsed over a short section, for example about 50 μm or less, at the proximal end of the fiber, thereby reducing multimode connection loss.

[0168] In some embodiments, the air channels in the air cladding may be collapsed in part, for example about 50 μm or more, at the distal end of the fiber, thereby allowing beam expansion of the multimode beam before exiting the fiber.

[0169] In some embodiments, the air-clad fiber includes a fluorine-doped layer 1218 radially inward of the air clad, which promotes more light capture at the junction, reduces splice losses, and reduces heating issues at the junction. In some embodiments, the air-clad fiber with a fluorine clad may have a numerical aperture of 0.22 to 0.30, matching or exceeding the numerical aperture of the side combiner of the connector module.

[0170] Generally, in various embodiments, for example in the embodiments of Figures 14 and 16A-16F, the core or cores of at least the double clad optical fiber may have different dimensions, for example as shown in Figures 17A-17C. The choice of core dimensions may balance between fiber bendability, signal to noise ratio, etc. A large core diameter, for example 5 μm or more, for example 10 μm to 15 μm, provides high signal strength, for example for interferometric distance sensor signals. A smaller core diameter, for example less than 10 μm, for example about 5 μm, facilitates tighter bends. In some embodiments, the fiber may have a core diameter of 5 μm to 10 μm with a recessed cladding to improve bending.

[0171] 17A-17C diagrammatically show examples of fiber tip designs of at least a double-clad optical fiber for use in a disposable optical fiber device according to embodiments disclosed herein. Each of FIGS. 17A-17C shows a distal portion of at least a double-clad optical fiber 1200 including a distal end 1201. In each of the examples, the distal end is provided as a beveled tip, preferably with rounded edges. The tip is beveled at an angle α, which may be selected, for example, between 3° and 10°. It will be understood that in embodiments using other types of optical fibers, the fiber tip at the distal end may also be beveled as described above.

[0172] Generally, in various embodiments, the optical fiber has a diameter small enough to be advanced through a working channel of an endoscope, such as a cystoscope, hi some embodiments, the optical fiber 1200 has a diameter of 2 mm or less, e.g., 1.5 mm or less, e.g., 1 mm or less, e.g., 0.75 mm or less, e.g., 0.6 mm or less.

[0173] For small fibers, it is often not feasible to attach a lens or other optical element to the distal end of the fiber, i.e., the optics are preferably designed to accommodate the situation where radiation diverges from the tip of the fiber towards the tissue to be treated.

[0174] FIG. 17A shows a single-core fiber that has a single-mode core with a numerical aperture of 0.14 and a diameter of 6 μm, thus allowing for tight bending.

[0175] 17B shows a single-core fiber having a single mode core with a numerical aperture of 0.075 and a diameter of 10 μm, thus providing high signal strength, for example, for an interferometric distance sensor signal. Generally, in some embodiments, at least the double-clad optical fiber may have a large core (e.g., having a diameter of 10 μm to 15 μm) step-index fiber with a surrounding low-index cladding groove to allow for tighter bending.

[0176] 17C shows a single-core fiber having a single mode core with an expanded tip, e.g., a thermally expanded tip, that has been expanded from 5 μm to 8 μm, e.g., from a core diameter of 6 μm to an expanded core diameter of 10 μm. Such a tip design provides a reduced core numerical aperture through a thermal process while expanding the fiber mode at the fiber end.

[0177] FIG. 18 diagrammatically illustrates a more detailed example of a fiber optic medical procedure device according to an embodiment disclosed herein.

[0178] The fiber optic medical procedure device includes a medical procedure device 2000 and a fiber optic device 1000, all as described in connection with Figures 1 and 9. An embodiment of a single-use fiber optic device is described in connection with Figures 10-13. The single-use fiber optic device 1000 is configured to be removably optically coupled to the medical procedure device 2000. The single-use fiber optic device 1000 includes at least a double clad optical fiber 1200 and a connector module 1100, all as described in connection with any of the previous figures.

[0179] The illustrated fiber optic medical procedure device is configured for the treatment of bladder cancer by laser ablation and / or coagulation using a cystoscope, however, it will be understood that other embodiments of the fiber optic medical procedure device may be configured for other types of medical procedures and / or for use with other types of endoscopes.

[0180] The medical treatment device 2000 includes various laser sources, photodetectors and associated control circuits, a user interface, etc. The medical treatment device 2000 may be embodied with all of its modules housed in a single housing, or with each module housed in a different housing.

[0181] The medical treatment device 2000 comprises a user interface module 2110 comprising a display, e.g., a touch-sensitive display, and suitable user input devices, e.g., keyboard, touch screen, etc., that allow an operator to control user-controllable functions of the medical treatment device and enable the medical treatment device to output information related to the treatment. In some embodiments, the user interface module comprises an audible and / or visible power / progress indicator configured to output an audible and / or visible indication indicating the current laser power of the first treatment laser radiation or the current status of the treatment. For example, the power indicator may indicate the power of the first treatment laser or a measured treatment status so that the physician knows when to move the fiber to the next spot. The audible indicator may indicate the power level or treatment status by the volume or pitch of an audible signal, by the repetition rate of a repeated sound, or in another suitable manner.

[0182] The medical treatment device 2000 may further include one or more controls 2120, such as a foot pedal, for example, to allow a physician to activate a treatment laser while manipulating the cystoscope.

[0183] The medical treatment device further comprises a control unit 2400, electrically and / or otherwise communicatively connected to the user interface module 2110 and the one or more controllers 2120. The control unit 2400 comprises circuitry configured to control various optical treatment and / or sensor modules of the medical treatment device. In particular, the control unit may be configured to control the first treatment laser source, the sensor laser source, and / or other radiation sources and / or sensors in response to inputs received from the user interface module and / or the one or more controllers. The control unit may further control the first treatment laser source, the sensor laser source, and / or other radiation sources and / or sensors in response to received sensor signals. The control unit may include a suitable driver and / or communication interface and a processing device, for example a suitable programmed central processing unit.

[0184] The medical treatment device 2000 comprises a first laser source laser source 2200, in particular a treatment laser source, configured to output a first treatment laser radiation suitable for treating tumor tissue of the bladder by ablation and / or coagulation. In some embodiments, the treatment laser source is preferably configured to output the first treatment laser radiation at a wavelength selected to provide low water and high tissue absorption, for example, 750 nm to 950 nm, for example, 780 nm to 820 nm, or 900 nm to 950 nm, for example, 905 nm to 925 nm, as described in relation to FIG. 3. The first treatment laser radiation may have a suitable power, for example, 10 W to 200 W. The first treatment laser radiation from the treatment laser source 2200 is preferably delivered through the second optical connector 1121 of the disposable optical fiber device 1000 and at least the cladding of the double-clad optical fiber 1200.

[0185] The medical treatment device further comprises a sensor module 2300. The sensor module comprises at least a first optical sensor module 2310 configured for interferometric distance sensing of the distance between the distal end of the double-clad optical fiber 1200 and the tissue to be treated.

[0186] Preferably, the medical treatment device 2000 may be configured to control the treatment laser source 2200 in response to a sensed distance between at least the distal end of the double-clad optical fiber 1200 and the tissue to be treated, for example, by reducing the power and / or duty cycle of the first treatment laser radiation, or even by stopping the first treatment laser radiation when the tip of the fiber approaches the tissue. This may prevent unintended damage to the tissue to be treated.

[0187] Interferometric distance sensing may be performed using broadband interferometry, known per se from optical coherence tomography (OCT). For this purpose, the first optical sensor module may comprise a suitable sensor laser source 2311 configured to output a single-mode laser radiation at a suitable wavelength, for example selected in the range of 800 nm to 1100 nm. For applications such as cystoscopy, the wavelength of the sensor laser radiation is preferably selected at a low water absorption wavelength, for example at a wavelength below 900 nm or at a wavelength of about 1050 nm. The sensor laser radiation may have a power of 1 mW to 500 mW, i.e. a power significantly smaller than the power of the first treatment laser radiation, for example at least two or three orders of magnitude smaller.

[0188] The first optical sensor module 2310 further comprises a spectrometer 2312 for performing broadband interferometry. For this purpose, the first optical sensor module receives the radiation reflected back through the disposable optical fiber device, in particular the reference radiation reflected by at least the tip of the double clad optical fiber 1200 and the radiation reflected by the tissue to be treated and captured by the tip of the at least double clad optical fiber 1200. Based on the reflected radiation, the medical treatment device determines the distance between the distal end of at least the double clad optical fiber 1200 and the tissue to be treated in a manner known per se in the art. Thus, the first optical sensor module 2310 may output a sensor laser radiation through at least the single mode or few mode core of the double clad optical fiber and receive the radiation reflected through at least the single mode or few mode core of the double clad optical fiber as a basis for the distance measurement.

[0189] Various embodiments of the interferometric range sensor of the first optical sensor module 2310 provide an axial resolution of 5 μm to 200 μm, such as 10 μm to 150 μm, such as 50 μm to 100 μm.

[0190] The interferometric distance sensor of the first optical sensor module 2310 may be implemented in different ways. In some embodiments, the interferometric distance sensor employs spectral domain OCT using SLEDs and a spectrometer. The inventors have found that such a system provides sufficient axial resolution with the bandwidth of the SLEDs of about 10 nm to 30 nm. Thus, the spectrometer only needs to cover a relatively small bandwidth. Preferably, the spectrometer has a resolution of 0.01 nm to 0.05 nm, thereby obtaining a sufficient axial range suitable for distance measurements during the procedure. The interferometric distance sensor may operate at wavelengths ranging from about 800 nm to about 900 nm, where CMOS detectors / spectrometers have good sensitivity and where InGaAs or GaAs SLEDs are readily available. This maximum axial range of the distance sensor may be about 3 mm to 10 mm, for example about 3 mm to 9 mm.

[0191] In another embodiment, the interferometric distance sensor may employ spectral domain OCT using a swept-source laser and detector. This embodiment has the advantage of an extended maximum axial range of between about 10 mm and 20 mm. A power output of 100 mW or more can be obtained using a suitable laser source, for example a 1-2 mW 1060 nm InGaAs or GaAs swept-source laser, by seeding a Yb fiber amplifier or amplifier chain with the laser radiation to boost the power output to between 2 mW and 500 mW. This embodiment may be implemented similarly to conventional swept-source OCT systems, with data acquisition synchronized to the laser sweep. The sweep range may be selected to be between 10 nm and 40 nm, for example about 20 nm or less, and the sweep frequency may be selected to be between 1 kHz and 100 kHz, for example 10 kHz or less.

[0192] To accommodate measurements via a fiber advanced through a flexible endoscope that is bent and moved during a procedure, various embodiments of the interferometric distance sensor employ common-path interferometry, in which at least the double-clad optical fiber 1200 is used as both the reference and sample paths. Reflections from the distal end of at least the double-clad optical fiber are used as a reference signal. Thus, a separate reference arm is avoided, thereby reducing system complexity and cost.

[0193] In such an embodiment, a suitable amplitude of the reference signal ensures a good interference signal on the spectrometer. To this end, a suitable reference signal amplitude may be obtained by selecting a suitable fiber tip angle at the distal end of at least the double-clad optical fiber, for example an angle between 2 and 10 degrees depending on the fiber type and laser power.

[0194] In various embodiments, radiation from the sensor laser source 2311 of the interferometric distance sensor 2310 and the back-reflected radiation are fed through at least the single mode core of the double clad optical fiber 1200 and through the first optical connector 1111 of the disposable optical fiber device 1000. The inventors have recognized that the signal path from the spectrometer of the interferometric distance sensor to the distal end of at least the double clad optical fiber has a low back reflection loss, preferably less than -60 dB. Thus, in some embodiments, the first optical connector 1111 of the disposable optical fiber device through which the sensor signal for the interferometric distance measurement is fed is preferably a low reflection connector, for example a fiber optic connector with physical contact between the fibers, optionally a beveled connector such as an E2000 connector.

[0195] The sensor module 2300 may preferably comprise a second optical sensor module 2320 configured for spectroscopic analysis of the tissue to be treated. In particular, the spectral characteristics of the radiation reflected by the tissue to be treated may be used as an indicator of the progress of the treatment. To this end, the medical treatment device may be configured to measure the condition of the tissue using reflectance spectroscopy, for example using white light reflectance spectroscopy.

[0196] When tissue is phototreated, it changes state from an absorbing state to a more scattering state. Light of lower wavelengths is reflected more than light of longer wavelengths, and by measuring the difference in reflected power at one or more wavelengths, the scattering state of the tissue can be estimated. Thus, measuring the difference in power between two or more wavelengths of back-reflected radiation provides a measure of the photocoagulation state of the tissue, and thus the state or progress of the treatment. Thus, in various embodiments, the medical treatment device is configured to use reflectance spectroscopy to monitor the state of coagulation induced by the treatment laser.

[0197] In some embodiments, the second sensor module 2320 comprises an illumination source using a supercontinuum laser covering a wavelength range, for example, from 400 nm to 1100 nm, for example, from 400 nm to 800 nm. Alternatively, the illumination source may use one or more monochromatic LEDs at the respective wavelengths, for example, at one or more of the following wavelengths: about 400 nm, about 500 nm, about 600 nm, and about 700 nm, and / or other wavelengths in the range from 400 nm to 700 nm.

[0198] In any case, the second optical sensor module 2320 is configured to receive radiation reflected by the tissue to be treated. The second optical sensor module 2320 may therefore comprise a suitable detector for measuring the reflected radiation. The detector may comprise, for example, a grating CCD / CMOS spectrometer, covering a suitable wavelength range, for example, from 400 nm to 1100 nm, for example, from 400 nm to 800 nm, with a resolution of, for example, down to 1 nm. Alternatively, the detector may comprise a photodetector, which may be time multiplexed with multiple LEDs.

[0199] In order to maintain good signal strength of the radiation reflected back from the tissue, it is preferred that the illumination light passes through the first optical connector 1111 and through the single mode core of at least the double clad optical fiber 1200 of the disposable optical fiber device 1000, i.e., the illumination light shares a path through the same disposable optical fiber device as the interferometric distance measurement radiation. Spectroscopy is a non-interferometric method and is therefore more limited by noise than interferometric distance measurement. Thus, in various embodiments, the multimode cladding of at least the double clad optical fiber 1200 of the disposable optical fiber device 1000 captures the reflected light of the spectroscopic illumination. That is, the second optical sensor module 2320 receives the radiation reflected back from the tissue to be treated in response to being illuminated by the illumination source of the second optical sensor module 2320 through the cladding of at least the double clad optical fiber 1200 and through the second optical connector 1121 of the disposable optical fiber device 1000.

[0200] Thus, the medical treatment device may display or otherwise output a proceeding indication, or even automatically control the first treatment laser source 2200, for example, to prevent unintended overtreatment that may otherwise result in undesired tissue damage. In some embodiments, the second optical sensor module 2320 may output sensor laser radiation through at least a single mode or few mode core of a double clad optical fiber and receive sensor laser radiation reflected through at least a single mode or few mode core of a double clad optical fiber or through a multimode clad. The wavelength used for the spectral analysis may preferably be selected at a low water absorption wavelength, such as a wavelength below 900 nm or a wavelength of about 1050 nm. In particular, in some embodiments, the wavelength used for the spectral analysis may preferably be selected to coincide with an absorption maximum of hemoglobin and / or another suitable molecular marker.

[0201] In some embodiments, the medical treatment device may include additional or alternative optical elements, such as one or more of the following additional components: Some embodiments of the medical treatment device 2000 include at least one additional treatment laser 2610, configured, for example, for cutting tissue, but not for ablation and / or coagulation. The cutting laser may output treatment laser radiation at a suitable wavelength, for example infrared radiation, for example at 1940 nm, which is absorbed by water. The treatment laser radiation from the cutting laser 2610 is preferably delivered through the second optical connector 1121 and the cladding of at least the double clad optical fiber 1200 of the disposable optical fiber device 1000. In some embodiments, the additional treatment laser 2610 outputs treatment laser radiation, configured to be absorbed by water in the vicinity of the tissue to be treated and to facilitate removal of the treated tissue from the treatment site. To this end, the additional treatment laser 2610 may be configured to output treatment laser radiation at a wavelength of 1000 nm to 2000 nm, for example 1200 nm to 2000 nm.

[0202] Alternatively or additionally, the medical treatment device 2000 may include a Raman sensor 2620 or other suitable sensor configured to determine characteristics of the tumor to be treated. The Raman sensor may use, for example, a 785 nm, 300 mW Raman laser. The sensor laser radiation from the Raman laser is preferably provided through the first optical connector 1111 of the disposable optical fiber device 1000 and through the single mode core of at least the double clad optical fiber 1200. The return radiation to the Raman sensor is preferably provided through the cladding of at least the double clad optical fiber 1200 of the disposable optical fiber device 1000 and through the second optical connector 1121.

[0203] Further alternatively or additionally, the medical treatment device may include a pilot light source, e.g., a pilot laser source or other type of light source adapted to emit visible light suitable as a pilot beam to illuminate the portion of tissue to be treated and to serve as an aiming guide to a physician or other user of the device. The pilot beam may be delivered through at least the double-clad optical fiber 1200, e.g., through the core and / or inner cladding of at least the double-clad optical fiber 1200. In some embodiments, the pilot beam may be polychromatic. In particular, the pilot beam may include two or more color components detectable by a camera of the medical treatment device, e.g., at least two detectable color components that are at least 40 nm apart. The at least two color components may be part of a broadband emission spectrum having a bandwidth of 40 nm or more, and the intensity of the emitted pilot light may be substantially uniform across the bandwidth or may vary across the bandwidth. Each of the two detectable color components may have a sufficiently high intensity to be detectable by a camera or similar detector of the medical treatment device such that a spot illuminated by the pilot beam is visible to a human observer in the camera image as an illuminated spot having a color resulting from a mixture of the at least two color components, e.g., as a white or substantially white spot.

[0204] In some embodiments, the medical treatment device comprises a handheld communication device 2130. The handheld communication device may be communicatively coupled to the medical treatment device 2000, for example, via a wired or wireless connection. The handheld communication device comprises a user input device, e.g., a push button, configured to receive user input from the patient during treatment with the medical treatment device. The user input may indicate pain or discomfort experienced by the patient during treatment. To this end, the patient may be instructed to press the button if the patient experiences pain or discomfort during treatment. In some embodiments, the user input device may be configured to measure a force or pressure applied to the user input. Thus, the medical treatment device may derive the degree of pain or discomfort from the measured force or pressure. Thus, the control unit 2400 of the medical treatment device may be configured to select a laser power, a pulse duration or another operating parameter of the treatment laser radiation at least in part in response to the received user input. To this end, the control unit may compare information from the user device with current, calculated, or selected operating parameters of the treatment laser radiation and adjust the operating parameters to minimize pain for the patient. For example, the control unit may compare information from the user device with a current, calculated, or selected laser power output and adjust the maximum power output of the treatment laser radiation to minimize pain to the patient.

[0205] The medical treatment device 2000 further comprises an optical combiner module 2700 having optical interfaces to the first treatment laser source 2200, a first optical sensor module 2310 having an interferometric distance sensor, and an optional second optical sensor 2320. In embodiments having additional optical processing and / or sensor units, the optical combiner module also has optical interfaces to any such units, e.g., the ablation laser 2610 and / or the Raman sensor 2620.

[0206] As described above, the first treatment laser source 2200 emits a relatively high power first treatment laser radiation that is delivered through the multimode cladding of at least the double clad optical fiber, while the interferometric distance sensor of the first optical sensor module 2310 emits and receives a lower power radiation through the single mode or few mode core of at least the double clad optical fiber. The second optical sensor module 2320 emits radiation that is delivered through the single mode or few mode core of at least the double clad optical fiber 1200 of the disposable optical fiber device, and receives radiation through the cladding of at least the double clad optical fiber 1200 of the disposable optical fiber device.

[0207] Thus, the optical combiner module 2700 is configured to couple together the optical paths fed through at least the core of the double clad optical fiber 1200 via the first optical connector 1111 of the disposable optical fiber device 1000. The optical combiner module 2700 is further configured to couple the optical paths fed through at least the clad of the double clad optical fiber 1200 via the second optical connector 1121 of the disposable optical fiber device 1000. To this end, the optical combiner module 2700 may comprise a suitable fused fiber combiner for combining the signal paths fed through at least the single mode core of the double clad optical fiber 1200. Similarly, the optical combiner module may comprise suitable free space components, lenses and dichroic filters for performing multimode output and wavelength splitting / combining of the radiation fed through at least the clad of the double clad optical fiber 1200.

[0208] The optical combiner module 2700 comprises two optical interfaces coupled to the disposable optical fiber device 1000, respectively a single-mode or few-mode interface 2810 (e.g., which may be characterized by a V number less than 10) and a multimode interface 2820 (e.g., which may be characterized by a V number greater than 20).

[0209] An example of an optical combiner module is described in more detail below with reference to FIG.

[0210] The medical procedure device preferably comprises a sacrificial interface module 2800 having corresponding optical interfaces for interfacing with the single mode or few mode interface 2810 and the multimode interface 2820, respectively. The sacrificial interface module 2800 optically connects the single mode or few mode interface 2810 with a first mating optical connector 2101 to which the first optical connector 1111 of the disposable fiber optic device 1000 is connectable. Furthermore, the sacrificial interface module 2800 optically connects the multimode interface 2820 with a second mating optical connector 2102 to which the second optical connector 1121 of the disposable fiber optic device 1000 is connectable. During operation of the medical procedure device, different disposable fiber optic devices may be interchangeably connected to the mating first and second optical connectors 2101 and 2102 of the sacrificial interface module 2800, respectively, since the disposable fiber optic device 1000 is typically a disposable device that is replaced by a new disposable fiber optic device between each procedure. Thus, the first and second mating optical connectors of the sacrificial interface may be subject to wear. Thus, providing a relatively easily replaceable sacrificial interface module 2800 facilitates maintenance of the medical procedure device 2000.

[0211] It will be appreciated that radiation from / to each optical module of the medical procedure device does not necessarily have to be delivered simultaneously through the disposable fiber optic device. Instead, at least some of the radiation are time multiplexed in a suitable manner to avoid them interacting in an undesirable manner. An example of a time multiplexing operation is described in more detail below with reference to FIG. 20.

[0212] FIG. 19 illustrates diagrammatically one example of an optical combiner module for combining multiple optical paths fed through at least double-clad optical fibers.

[0213] The optical combiner module 2700 includes optical interfaces 2701-2708 to the various optical elements of the medical treatment device, in particular the first treatment laser source, and the sensor module.

[0214] In the illustrated embodiment, the optical combiner module 2700 has an optical interface 2705 for receiving a multimode first treatment laser radiation from a first treatment laser source of the medical treatment device. The optical combiner module 2700 further has an optical interface 2701 for receiving a single mode sensor laser radiation from an interferometric distance sensor module of the medical treatment device, and an optical interface 2702 for returning a single mode response radiation reflected by the tissue to be treated in response to being illuminated by the sensor laser radiation from the interferometric distance sensor module to the interferometric distance sensor module of the medical treatment device. Similarly, in an embodiment in which the medical treatment device further comprises a spectroscopic sensor module, the optical combiner module 2700 further has an optical interface 2703 for receiving a single mode or few mode sensor laser radiation from the spectroscopic sensor module of the medical treatment device, and an optical interface 2704 for returning a multimode response radiation reflected by the tissue to be treated in response to being illuminated by the sensor laser radiation from the spectroscopic sensor module to the spectroscopic sensor module of the medical treatment device.

[0215] Additionally, in embodiments where the medical treatment device further comprises an additional treatment laser source, e.g., a cutting laser, the optical combiner module 2700 further comprises an optical interface 2706 for receiving multimode treatment laser radiation from the additional treatment laser source of the medical treatment device. In embodiments where the medical treatment device further comprises an additional sensor module, e.g., a Raman sensor, the optical combiner module 2700 similarly further comprises an optical interface 2707 for receiving single mode or few mode sensor laser radiation from the additional sensor module of the medical treatment device, and an optical interface 2708 for returning multimode response radiation reflected by the tissue to be treated in response to being illuminated by the sensor laser radiation from the additional sensor module to the additional sensor module of the medical treatment device. It will be appreciated that alternative embodiments of the combiner module 2700 may have fewer, additional, and / or alternative optical interfaces for fewer, additional, and / or alternative optical modules of the medical treatment device.

[0216] The optical combiner module 2700 is configured to combine together optical paths provided through at least the cores of the double-clad optical fibers, and is further configured to combine together optical paths provided through at least the inner claddings of the double-clad optical fibers.

[0217] To this end, the optical combiner module 2700 comprises a suitable fused fiber combiner for combining the signal paths fed through at least the single mode core of the double clad optical fiber 1200. In particular, the optical combiner module 2700 comprises a first fused fiber combiner 2710, e.g. a single mode output splitter, connected to the optical interfaces 2710 and 2702 via respective single mode optical fibers 2741 and 2742, respectively. The optical combiner module 2700 further comprises a second fused fiber combiner 2720, e.g. configured for wavelength multiplexing, connected to the first fused fiber combiner 2710 via a single mode fiber 2743 and connected to the optical interface 2703 via a single mode optical fiber 2744. The second fused fiber combiner 2720 may be operable to perform wavelength multiplexing between single mode radiation at the wavelength of the interferometric distance sensor and few mode radiation at the wavelength of the spectroscopic sensor module. In an embodiment having additional sensor modules, the optical combiner module 2700 may further comprise a third fused fiber combiner 2730, e.g., configured for wavelength multiplexing, connected to the second fused fiber combiner 2720 via a single mode fiber 2745 and connected to the optical interface 2707 via a single mode optical fiber 2746. The combined single mode and few mode radiation is output by the optical combiner module via a single mode fiber 2747. The single mode fibers 2741-2747 are single mode at least at the wavelength of the sensor laser radiation of the interferometric sensor module. The single mode fibers 2741-2747 may have a core with a diameter of less than 15 μm, e.g., less than 10 μm. The single mode fibers 2741-2747 may have a V number of less than 10 at the respective wavelengths being coupled.

[0218] The optical combiner module 2700 further comprises suitable free space components 2750, including, for example, lenses and dichroic filters, to perform multimode output and wavelength splitting / combining of the radiation fed through at least the inner cladding of the double-clad optical fiber. For this purpose, the free space components are optically coupled to the optical interfaces 2704, 2705, 2706, and 2708, respectively, via respective multimode fibers 2781-2784. The combined multimode radiation is output by the optical combiner module via multimode fiber 2785. The multimode fibers 2781-2785 may have a core diameter of 30 μm to 500 μm, for example 50 μm to 400 μm, for example 100 μm to 200 μm. The multimode fibers 2781-2785 may have a V number of 20 or more.

[0219] Thus, the optical combiner module 2700 comprises two optical interfaces that are coupled to a disposable optical fiber device, respectively a single-mode or few-mode interface 2810 (e.g., which may be characterized by a V number less than 10) and a multimode interface 2820 (e.g., which may be characterized by a V number greater than 20).

[0220] Generally, in various embodiments, the medical procedure device includes an optical combiner module that includes one or more fused fiber couplers configured to multiplex a sensor laser radiation from an interferometric distance sensor with a sensor laser radiation from a spectroscopic sensor onto an optical fiber that is single mode at least at the wavelength of the sensor laser radiation of the interferometric distance sensor. In particular, the wavelength of the sensor laser radiation of the interferometric distance sensor may be different from the wavelength of the spectroscopic sensor. The fiber couplers may be fused 3 dB couplers.

[0221] In various embodiments, the medical treatment device includes an optical combiner module configured to multiplex the multimode treatment laser radiation and the multimode sensor radiation into a multimode optical fiber. To this end, the optical combiner module may include free space components including one or more lenses and one or more dichroic mirrors. The multimode sensor radiation may include multimode response radiation reflected by the tissue to be treated in response to being illuminated by the sensor laser radiation emitted by the spectroscopic sensor module.

[0222] Various embodiments for operating the medical treatment device will now be described. Generally, in various embodiments, the medical treatment device comprises a control unit configured to emit a burst of first treatment laser radiation from a distal end towards tissue of the urinary tract, in particular the bladder, to be treated in response to a received user input, the burst having a burst duration of 1 ms to 1 s.

[0223] In some embodiments, the medical treatment device, in response to the received user input, a) activating a first optical sensor module, in particular an interferometric distance sensor, to sense a distance between a distal end of at least a double-clad optical fiber and a tissue to be treated; b) activating a second optical sensor module, in particular a spectroscopic sensor, to detect one or more spectroscopic characteristics of the tissue to be treated, c) controlling the first treatment laser source depending at least in part on the sensed distance and / or the detected characteristic; The control unit is configured to:

[0224] For example, controlling the first treatment laser source at least partially dependent on the sensed distance and / or the detected characteristic may include the control unit selecting a laser power and / or another operating parameter of the first treatment laser radiation at least partially dependent on the sensed distance and / or the detected characteristic and controlling the first treatment laser source to emit the first treatment laser radiation at the selected laser power and / or the selected other operating parameter. Examples of the other operating parameters may include a duty cycle, pulse width, etc. of a pulse train of laser pulses, a duration of emission of the first treatment laser radiation, etc. The control unit may be configured to control the first treatment laser source at least partially dependent on the sensed distance and / or the detected characteristic to control the laser energy deposited at the treatment site.

[0225] Preferably, the control unit is configured to repeat operations a) to c) while said user input is received or until an end input is received.

[0226] In this regard, the control unit may be configured to automatically control the first treatment laser source depending at least in part on the sensed distance and / or the detected characteristic, or the control unit may be configured to perform said control in an operator-assisted manner. For example, the control unit may be configured as follows: A laser power and / or another operating parameter of the first treatment laser radiation is calculated or otherwise selected depending at least in part on the sensed distance and / or the detected characteristic. Display or otherwise communicate the calculated or otherwise selected laser power and / or other operating parameters to an operator operating the apparatus, request acceptance / manual activation of the displayed / communicated values, and / or allow the operator to manually change and activate the values. The first treatment laser source is controlled at least in part depending on operator approved or operator altered laser power and / or other operating parameters.

[0227] In various embodiments described herein, time-multiplexing optical measurements based on the first treatment laser radiation and the sensor laser radiation using the same at least double-clad optical fiber allows the fiber to be very thin while avoiding detrimental interference between the sensing system and the first treatment laser, e.g., caused by retro-reflected first treatment laser radiation impinging on the detector of the sensor module. In particular, in various embodiments, the medical treatment device is configured to time-multiplex the interferometric distance sensor signal, the spectroscopic sensor signal, and the first treatment laser radiation for use in surgery, particularly minimally invasive surgery, such as ablation and / or coagulation of cancer of the urinary tract, particularly the bladder.

[0228] User input and / or termination signals may be received via a foot pedal or other suitable user-actuated input device.

[0229] To perform time division multiplexing efficiently, the medical treatment device may be operable to switch between various laser sources fast enough, for example within 1 ms or faster. For this purpose, if one or more laser sources, for example the first treatment laser source, are diode lasers, the fast switching may be performed by directly switching the drive current. If the interferometric distance sensor includes SLED or swept sources, or if the spectroscopic sensor includes supercontinuum lasers, these lasers may need to be switched in another way to obtain fast switching, since they may require time to stabilize when switched on. Thus, the switching may be performed, for example, by an acousto-optical tunable filter (AOTF), a MEMS-based device, or in another suitable way. Such external switching may cause reflections. Therefore, if used to switch the sensor laser emission of the interferometric distance sensor, it may preferably be placed between the sensor laser source and the coupler / circulator for the receiver. In the spectroscopic engine, the switching may be placed on the laser output.

[0230] In some embodiments, the control unit is configured to receive information regarding a single-use fiber optic device connected to the medical procedure device and select a laser power based at least in part on a user selected laser power, the sensed distance, and the received information regarding the single-use fiber optic device connected to the medical procedure device.

[0231] In some embodiments, the control unit is configured to output a camera control signal operable to control the operation of the camera of the endoscope, and the control unit is configured to synchronize the operation of the camera with the operation of the first treatment laser source such that image data is recorded by the camera only when the medical treatment device does not emit the first treatment laser radiation or only emits the first treatment laser radiation at a substantially reduced intensity, in particular at a reduced intensity such that the reduced treatment radiation does not unduly affect the camera image. To this end, the first treatment laser radiation may be reduced to 5% or less, e.g. 1% or less, of the intensity of the first treatment laser radiation during the preceding treatment cycle.

[0232] In some embodiments, the control unit is configured to control a laser power of the first treatment laser radiation in response to the type of material detected. To this end, the first optical sensor module may be further configured to detect and distinguish between a plurality of different types of materials located at least in front of the distal end of the double clad optical fiber.

[0233] 20 diagrammatically illustrates the operation of an example of a fiber optic medical treatment device according to various embodiments disclosed herein, such as the medical treatment device described in relation to one or more of the previous figures, in particular a device for treatment of the urinary tract, in particular the bladder, the process being controlled by a control unit of the medical treatment device.

[0234] Initially, in response to activation of the medical treatment device, for example, by a user input, the medical treatment device may be operated in a safe mode. Activation by user input may include, for example, a user pressing a button or selecting an operating mode. In the safe mode, an interferometric distance sensor module of the medical treatment device may be activated and may provide a sensor laser radiation 4100 through at least a double-clad optical fiber of a disposable optical fiber device connected to the medical treatment device. The interferometric distance sensor module further receives a reflected radiation received by a distal end of at least a double-clad optical fiber in response to the emitted sensor laser radiation. The medical treatment device is configured to analyze the received reflected radiation to detect whether the distal end is immersed in a liquid, in particular water, and / or whether the distal end is positioned in proximity to a surface other than biological tissue. An example of this detection is described below with reference to FIG. 21. If the distal end is in proximity to a surface other than biological tissue or if the distal end is not immersed in a liquid, in particular water, the control unit may prevent the medical treatment device from emitting a first treatment laser radiation. Detection of a surface other than biological tissue may indicate that at least the distal end of the double clad fiber has not yet been inserted into the endoscope, or at least not completely passed through the working channel of the endoscope, or that the endoscope has been bent such that the distal end is actually pointed outside of the endoscope. Thus, preventing the medical treatment device from emitting the first treatment laser radiation in this situation prevents unintentional damage to the endoscope or other surfaces by the first treatment laser radiation.

[0235] Failure to detect liquid, particularly water, may indicate that at least the distal end of the double-clad fiber has not yet been positioned proximate to the treatment site, particularly not yet inserted into the bladder. Preventing the medical treatment device from emitting the first treatment laser radiation in this situation prevents unintended damage to tissue other than the intended tissue.

[0236] Preventing the emission of the first treatment laser radiation may include preventing the first treatment laser source from being powered on and / or preventing a suitable shutter / optical switch from being opened, or preventing the emission of the first treatment laser radiation in another suitable manner.

[0237] If, and specifically only if, the medical treatment device detects biological tissue near at least the distal end of the double-clad optical fiber and water between the distal end and the detected biological tissue, the control unit allows the medical treatment device to exit the safety mode and enter the treatment mode.

[0238] When operated in the treatment mode, the operator can initiate emission of a first treatment laser radiation by actuating an appropriate user input device, such as a foot pedal. Once the user input device is actuated, the control unit receives an actuation signal 4200, for example, for as long as the foot pedal remains actuated. In some embodiments, each actuation of the foot pedal may cause emission of a single burst (or another predetermined number of bursts) of treatment laser radiation, for example, corresponding to a predetermined, e.g., user-selected, amount of laser energy to be delivered to the tissue to be treated (e.g., a predetermined amount of laser energy per unit area).

[0239] In response to the activation signal, the control unit repeatedly executes a treatment cycle, e.g., emitting a single burst of laser radiation, for as long as the activation signal 4200 is received, or until a termination signal is received, or for a predetermined amount of time.

[0240] During each treatment cycle, the control unit first causes the interferometric distance sensor to emit sensor laser radiation 4110 to sense the distance between at least the distal end of the double-clad optical fiber and the tissue to be treated. The distance sensor may perform one or more distance measurements during a suitable measurement period, for example 10 ms or less. For example, the control unit may calculate an average over multiple distance measurements. If the interferometric distance sensor detects that the front surface of the distal end is a surface other than biological tissue, or if the distal end is not immersed in a liquid, in particular water, the control unit causes the medical treatment device to exit treatment mode and return to safety mode.

[0241] Otherwise, once the distance measurement is completed, the control unit deactivates the sensor laser emission from the interferometric distance sensor and activates the spectroscopic sensor to emit the spectroscopic sensor laser emission 4310. The spectroscopic sensor receives light reflected by the tissue to be treated in response to being illuminated with the spectroscopic laser emission and determines the status / progress of the treatment based on absolute or relative reflected intensity or power in one or more wavelength bands, e.g., at an emission peak of hemoglobin or another suitable molecular marker indicative of the progress of the laser treatment. The spectroscopic measurement may continue for a suitable measurement period, e.g., 10 ms or less. The control unit may then deactivate the sensor emission from the spectroscopic distance sensor.

[0242] Based at least in part on the determined distance and / or the determined progress, in step 4410 the control unit determines a power and / or duty cycle or other suitable parameters of the first treatment laser radiation to be emitted. For example, the control unit may select a smaller power and / or duty cycle if the measured distance is small and a larger power and / or duty cycle if the measured distance is large. The control unit may even prevent emission of the first treatment laser radiation if the detected distance is less than a safety threshold.

[0243] In some embodiments, the selection of the power (or other suitable parameter) of the first treatment laser radiation may be further based on a user-selected reference power (or other suitable parameter). For example, the control unit may automatically adjust the reference power in response to the detected distance, e.g., attenuate the laser power relative to the reference power in response to a decreased distance.

[0244] Alternatively or additionally, the control unit may select the power, duty cycle, and / or other suitable parameters of the first treatment laser radiation in response to the detected treatment status / progress, for example attenuating the laser power and / or duty cycle in response to increased progress.

[0245] The control unit may further receive information regarding the characteristics of the single-use fiber optic device currently connected to the medical procedure device, for example, by reading an ID tag, such as an RFID tag, a QR code, or other machine-readable identifier. Thus, the control unit may select a laser power output based on the sensor data from the distance sensor (and, optionally, the spectroscopic sensor), from a preset reference power output at device startup, and from the received information regarding the characteristics of the single-use fiber optic device. The information regarding the characteristics of the single-use fiber optic device may include, for example, information regarding the fiber diameter, numerical aperture, etc.

[0246] The control unit then controls the first treatment laser source to emit the first treatment laser radiation 4510 at the selected power. To this end, the control unit may control the first treatment laser source to output the first treatment laser radiation at a suitable power, for example, at a selected power at an interval between 10 W and 2200 W or another suitable interval. In some embodiments, the first treatment laser radiation may be emitted as a pulse train of first treatment laser pulses. The pulses may have a pulse duration of 1 ms to 10 ms or another suitable pulse duration. The control unit may control the first treatment laser to emit the first treatment laser radiation for a treatment period, which may be preset, for example, as a preconfigured duration or a user selected duration, or the treatment period may be selected at least in part automatically based on the sensed distance and / or detected progress. In some embodiments, the treatment period may correspond to between 5 and 100 laser pulses, for example, between 10 and 20 pulses. Once the treatment period is completed, the control unit shuts off the emission of the first treatment laser radiation.

[0247] Once the treatment cycle is complete, the control unit again controls the interferometric distance sensor to perform distance measurements by emitting corresponding sensor laser radiation 4120, followed by spectroscopic measurements 4320, as described above.

[0248] Based at least in part on the determined distance and / or the determined progress, in step 4420, the control unit determines the power, duty cycle, and / or other suitable parameters of the first treatment laser radiation to be emitted during the subsequent treatment period. In some embodiments, the determination of the laser power (or other parameter) is based not only on the most recent measurement, but also on measurements made during one or more previous treatment cycles. To this end, the control unit may include a storage device for storing the results of one or more previous distance measurements and / or status / progress measurements. The results of one or more previous distance measurements may be used to determine the change in distance due to, for example, relative motion between at least the distal end of the double-clad optical fiber and the tissue to be treated. Thus, the control unit may base the selection of the laser power or other parameter not only on the currently measured distance, but also on the observed change in distance, for example, the rate of change, such as whether the distance increases or decreases, and optionally at what rate. Similarly, the control unit may base the selection of the laser power or other parameter on the observed rate of change in the treatment state.

[0249] In some embodiments, the control unit further bases the selected laser power or other parameters on patient feedback received via a suitable user device, e.g., a handheld user device, operated by the patient during the course of treatment. For example, the patient may activate the user device if the patient experiences pain or discomfort during treatment. The user device may communicate a corresponding patient feedback signal 4700 to the control unit, which may then adjust the laser power or other parameters for a subsequent treatment cycle in response to the received feedback.

[0250] The control unit then controls the first treatment laser source to emit the first treatment laser radiation 4520 at the selected power and / or other parameters for another treatment period.

[0251] The control unit may repeatedly execute a treatment cycle for as long as the activation signal 4200 is activated, e.g., to emit a predetermined burst of laser radiation, or until a termination signal is received, or for a predetermined treatment duration. As described above, the control unit may also abort treatment in response to a detected unsafe condition, e.g., the fiber is directed toward a non-tissue surface, the fiber is no longer immersed in water and / or is too close to the tissue to be treated, or if spectroscopic measurements indicate that treatment of the tissue is complete.

[0252] In some embodiments, an endoscope used with embodiments of the medical treatment device disclosed herein may include a camera, and the endoscope may be communicatively coupled to the medical treatment device to enable the medical treatment device to control at least some functions of the endoscope. In particular, a control unit of the medical treatment device may be operable to control the operation of the camera of the endoscope. To this end, the control unit may be operable to output a camera control signal 4600 configured to control the camera to capture image data only when the first treatment laser radiation is off, e.g., only during the measurement period and / or during the interval between the laser pulses. Thus, possible interference between the first treatment laser radiation and the camera image is avoided.

[0253] It will be appreciated that some modifications may be made to the process for operating the medical treatment device. For example, if the medical treatment device includes additional sensors, measurement periods of these additional sensors may also be included in one or more of the treatment cycles, for example in a time-multiplexed manner as described above with respect to distance measurements and spectroscopic measurements. In some embodiments, some or all of the measurements, for example spectroscopic measurements, may not necessarily be performed during each treatment cycle, but may be performed only during a subset of the treatment cycles.

[0254] 21A-21B show example distance sensing signals obtained by a sensor module of a fiber optic medical procedure device according to various embodiments disclosed herein.

[0255] In particular, FIG. 21A shows an example of a measured interferometric distance signal, where the interferometric distance sensor is configured to emit a sensor laser radiation within a predetermined wavelength range and record the power of the corresponding reflected radiation. FIG. 21B and FIG. 21C show an example of a depth scan calculated by Fourier transform from the acquired spectrum of the interferometric distance sensor. In particular, FIG. 21B and FIG. 21C show respective plots of the calculated Fourier power as a function of distance from the distal end of at least a double-clad optical fiber. In the example of FIG. 21B, the biological tissue was positioned approximately 1.25 mm in front of the distal end of the fiber, as indicated by dashed line 5100. In the example of FIG. 21C, a flat reflective surface was positioned approximately 1.8 mm in front of the distal end of the fiber, as indicated by dashed line 5200.

[0256] From a comparison of the depth scans of Figures 21B and 21C, it is clear that biological tissue and artificial surfaces such as the inner or outer surface of an endoscope can be easily distinguished based on the interferometric signal, for example by peak detection and peak analysis techniques known per se in the art of signal processing. Similarly, the depth scan can be used to detect the presence or absence of water in the space between the distal tip and the surface.

[0257] Various aspects have been described with reference to various embodiments. Modifications and alterations will occur to others upon reading this disclosure. It is intended that the invention be construed as including all such modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.

Claims

1. 1. A fiber optic medical treatment device for treatment of a subject's urinary tract, particularly the bladder, the device comprising: a first treatment laser source; and a fiber optic device including at least one optical fiber, the fiber optic device having a proximal end and a distal end, the distal end being configured to be advanced through a working channel of a cystoscope into the urinary tract, particularly the bladder, of a subject, the first treatment laser source being configured to output a first treatment laser radiation for treatment of a medical condition of the urinary tract, particularly the bladder, and to optically couple the first treatment laser radiation to the fiber optic device, the device being configured to emit the first treatment laser radiation from the distal end towards tissue of the urinary tract, particularly the bladder, to be treated, the first treatment laser radiation having a wavelength of 750 nm to 950 nm. Fiber optic medical procedure devices.

2. The first treatment laser radiation has a wavelength of 905 nm to 925 nm or 780 nm to 820 nm.

10. The fiber optic medical procedure device of claim 1.

3. the device is configured to emit the first treatment laser radiation from the distal end to irradiate a target spot on the tissue to be treated, the target spot having a peripheral region and a central region, the device being configured to irradiate the peripheral region with a peripheral irradiance intensity and to irradiate the central region with a central irradiance intensity that is less than the peripheral irradiance intensity; 10. A fiber optic medical procedure device according to any one of the preceding claims.

4. 1. A fiber optic medical treatment device for treatment of a subject's urinary tract, in particular the bladder, the device comprising: a first treatment laser source; and a fiber optic device including at least one optical fiber, the fiber optic device having a proximal end and a distal end, the distal end being configured to be advanced through a working channel of a cystoscope into the urinary tract, in particular the bladder, of the subject, the first treatment laser source being configured to output a first treatment laser radiation for treatment of a medical condition of the urinary tract, in particular the bladder, and to optically couple the first treatment laser radiation to the fiber optic device, the device being configured to emit the first treatment laser radiation from the distal end towards tissue of the urinary tract, in particular the bladder, to be treated, so as to irradiate a target spot on the tissue to be treated, the target spot having a peripheral region and a central region, the device being configured to irradiate the peripheral region with a peripheral illumination intensity and to irradiate the central region with a central illumination intensity that is less than the peripheral illumination intensity. Fiber optic medical procedure devices.

5. the target spot has a spot diameter and the central region has a central region diameter that is between 10% and 80% of the spot diameter.

5. The optical fiber medical treatment device of claim 3.

6. the central illumination intensity is 0% to 90%, e.g., 1% to 90%, e.g., 10% to 90%, of the peripheral illumination intensity; 6. A fiber optic medical treatment device according to any one of claims 3 to 5.

7. The peripheral region is an annular peripheral region surrounding the central region.

7. The optical fiber medical treatment device of claim 3.

8. the peripheral illumination intensity is substantially uniform circumferentially along the annular periphery; 8. The fiber optic medical procedure device of claim 7.

9. the peripheral illumination intensity varies circumferentially along the annular periphery by less than 10%, in particular by less than 5%; 9. The fiber optic medical procedure device of claim 8.

10. the device is configured to emit a burst of the first treatment laser radiation having a burst duration of 1 ms to 1 s in response to a user command to emit the first treatment laser radiation; 10. A fiber optic medical procedure device according to any one of the preceding claims.

11. 1. A fiber optic medical treatment device for treatment of a subject's urinary tract, particularly the bladder, the device comprising: a first treatment laser source; and a fiber optic device including at least one optical fiber, the fiber optic device having a proximal end and a distal end, the distal end being configured to be advanced through a working channel of a cystoscope into the urinary tract, particularly the bladder, of the subject, the first treatment laser source being configured to output a first treatment laser radiation for treatment of a medical condition of the urinary tract, particularly the bladder, and to optically couple the first treatment laser radiation to the fiber optic device, the device being configured to emit a burst of the first treatment laser radiation from the distal end towards tissue of the urinary tract, particularly the bladder, to be treated, in response to a user command to emit the first treatment laser radiation, the burst having a burst duration of 1 ms to 1 s. Fiber optic medical procedure devices.

12. the device is configured to emit the burst of the first treatment laser radiation at a power output of 10 W to 200 W; 12. The optical fiber medical treatment device of claim 10 or 11.

13. the device further comprises a second treatment laser source configured to output a second treatment laser radiation for the treatment of the medical condition of the urinary tract, in particular the bladder, and to optically couple the second treatment laser radiation to the optical fiber device, the second laser radiation having a wavelength different from a wavelength of the first treatment laser radiation.

10. A fiber optic medical procedure device according to any one of the preceding claims.

14. The second treatment laser radiation has a wavelength of 1000 nm to 2000 nm, for example 1400 nm to 2000 nm.

14. The fiber optic medical procedure device of claim 13.

15. the device further comprises a pilot light source configured to output a visible pilot light and optically couple the pilot light to the optical fiber device, the device being configured to emit a pilot beam of the pilot light from the distal end towards tissue of the urinary tract, in particular the bladder, to be treated, so as to illuminate a target spot on the tissue to be treated with a visible pilot light.

10. A fiber optic medical procedure device according to any one of the preceding claims.

16. the visible pilot light is a multi-colored visible pilot light; 16. The fiber optic medical procedure device of claim 15.

17. the polychromatic visible pilot light comprises at least two detectable color components that are at least 40 nm apart; 17. The fiber optic medical procedure device of claim 16.

18. the device is configured to control visual attributes of the visible pilot light, in particular its intensity and / or color and / or color distribution, in response to one or more of user commands, operating parameters of at least the first treatment laser radiation, and a sensor signal obtained by a sensor module.

18. A fiber optic medical procedure device according to any one of claims 15 to 17.

19. a medical treatment device and the fiber optic device, the medical treatment device comprising at least the first treatment laser source, the fiber optic device being a disposable fiber optic device configured to be removably and optically coupled to the medical treatment device; 10. A fiber optic medical procedure device according to any one of the preceding claims.

20. the optical fiber is at least a double-clad optical fiber, and the device is configured to output the first treatment laser radiation through a cladding of the at least double-clad optical fiber.

10. A fiber optic medical procedure device according to any one of the preceding claims.

21. an optical side combiner configured to couple the first treatment radiation into the at least one cladding of the at least double-clad optical fiber; 21. The fiber optic medical procedure device of claim 20.

22. the device is configured to emit the first treatment laser radiation from the distal end as a diverging first treatment beam configured to irradiate a target spot on the tissue to be treated; 10. A fiber optic medical procedure device according to any one of the preceding claims.

23. configured to irradiate a target spot with a spot diameter of 1 mm to 10 mm when the distal tip is displaced from the tissue to be treated by a difference of 1 mm to 10 mm, e.g., 2 mm to 5 mm; 23. The fiber optic medical procedure device of claim 22.

24. The tissue to be treated is a soft tissue, in particular a cancerous soft tissue; 10. A fiber optic medical procedure device according to any one of the preceding claims.

25. A method for treating cancer of the urinary tract, in particular the bladder, of a subject by laser ablation and / or coagulation, said method comprising irradiating tissue of the urinary tract, in particular the bladder, to be treated with a first treatment laser radiation having a wavelength of 750 nm to 950 nm, A method of treating cancer of the urinary tract, particularly the bladder, of a subject by laser ablation and / or coagulation.

26. A method for treating cancer of the urinary tract, in particular the bladder, of a subject by laser ablation and / or coagulation, the method comprising irradiating a target spot on the tissue to be treated, the target spot defining a peripheral region of the target spot and a central region of the target spot, and irradiating comprises irradiating the peripheral region with a peripheral irradiation intensity and irradiating the central region with a central irradiation intensity that is less than the peripheral irradiation intensity. A method of treating cancer of the urinary tract, particularly the bladder, of a subject by laser ablation and / or coagulation.

27. 1. A method of treating cancer of the urinary tract, particularly the bladder, of a subject by laser ablation and / or coagulation, the method comprising: in response to receiving a user command to emit a first treatment laser radiation, directing a burst of first treatment laser radiation to tissue of the urinary tract, particularly the bladder, to be treated, the burst having a burst duration of 1 ms to 1 s. A method of treating cancer of the urinary tract, particularly the bladder, of a subject by laser ablation and / or coagulation.

28. and alternatingly irradiating the tissue to be treated with the first treatment laser radiation and the second treatment laser radiation, the second treatment laser radiation having a wavelength different from a wavelength of the first treatment radiation.

28. The method of any one of claims 25 to 27.

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