Disposable Fiber Optic Device

Abstract

A disposable fiber optic device comprising: at least a double clad optical fiber having a proximal end and a distal end, the distal end configured to be advanced through a working channel of an endoscope, the at least double clad optical fiber having at least one core and at least two clads, and a connector module for optically connecting the proximal end of the at least double clad optical fiber to a medical procedure device, the connector module comprising: a first optical fiber, a second optical fiber, a first optical connector for removably optically connecting the first optical fiber to the medical procedure device, a second optical connector for removably optically connecting the second optical fiber to the medical procedure device, and an optical combiner module configured to couple radiation between the first optical fiber and at least one core of the at least double clad optical fiber and to couple radiation between the second optical fiber and at least one of the at least two clads of the at least double clad optical fiber.

Description

[Technical field]

[0001] SUMMARY The present disclosure relates to disposable fiber optic devices and fiber optic medical procedure devices including such disposable fiber optic devices. [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] Furthermore, in some applications, in addition to directing the treatment laser radiation to the tissue to be treated, it is also desirable to provide other radiation to the tissue to be treated. For example, when the treatment is performed in a non-contact mode, the distance between the tip of the fiber and the tissue to be treated has a significant impact on the treatment speed and risk, for example, because accurate manual manipulation of the fiber can be difficult, especially when the patient moves or the tissue moves due to movements inside the patient's body. Therefore, it is desirable to measure the distance between the tip of the fiber and the tissue to be treated.

[0004] US2010 / 0228119 discloses a system for measuring relative motion during a surgical procedure. This prior art system is for use with a cannula insertable into human and animal tissue. The system includes a probe having a probe tip insertable into the cannula, and means for determining relative motion between the cannula and the probe tip.

[0005] In many procedures, the optical fiber is advanced through a working channel of a flexible endoscope. For this purpose, there are endoscopes tailored to different types of medical procedures. For example, a cystoscope is an endoscope configured to perform cystoscopy, in which the cystoscope is advanced through the urethra into the bladder. Among other procedures, cystoscopes are used for the laser treatment of cancer of the bladder.

[0006] Cystoscopes and other types of endoscopes are limited in diameter, and in many procedures it is desirable for the endoscope to be highly bendable. For example, the working channel of a cystoscope typically has a diameter of only 1.8 mm. During use, cystoscopes are often bent to bending radii of up to 10 mm or even smaller, which can further reduce the effective diameter of the working channel. Therefore, it is desirable for the optical fibers used in such procedures to also be very thin and highly bendable.

[0007] Moreover, the above problems are further amplified if, in addition to the treatment laser radiation, additional sensor radiation is delivered towards the tissue to be treated, for example for distance measurement purposes. It is therefore desirable to deliver different types of radiation through the working channel of the endoscope via a fiber optic device without damaging the fiber optic device and without excessively degrading the different types of radiation. This can be difficult because the treatment and sensor radiation may impose different, sometimes even contradictory, requirements or limitations on the fiber optic device.

[0008] It would therefore be desirable to provide a fiber optic device with an optical fiber that can be advanced even through the narrow working channel of an endoscope, such as a cystoscope.

[0009] It would further be desirable to provide a fiber optic device having a highly bendable optical fiber.

[0010] It is further desirable to keep the manufacturing costs of fiber optic devices low because fiber optic devices are disposable, eg, discarded or recycled after one or at least a few uses.

[0011] Additionally, it would be desirable to provide a fiber optic device that can direct different types of radiation to a target area.

[0012] It is further desirable to provide a fiber optic medical treatment device that allows for accurate and efficient monitoring of the distance between the tip of the fiber and the tissue to be treated, and / or accurate and efficient monitoring of the status or progress of the treatment. Summary of the Invention

[0013] Aspects of the present disclosure address at least some of the above concerns and others.

[0014] In particular, the present disclosure provides embodiments of a disposable fiber optic device. The disposable fiber optic device comprises at least a double clad optical fiber having a proximal end and a distal end, the distal end configured to be advanced through a working channel of an endoscope, the at least double clad optical fiber having at least one core and at least two clads. The disposable fiber optic device further comprises a connector module for optically connecting the proximal end of the at least double clad optical fiber to a medical procedure device. The connector module comprises: a first optical fiber; a second optical fiber; and a first optical connector for removably and optically connecting the first optical fiber to a medical treatment device; a second optical connector for removably optically connecting the second optical fiber to the medical procedure device; an optical combiner module configured to couple radiation between the first optical fiber and at least one core of the at least double-clad optical fiber and to couple radiation between the second optical fiber and at least one clad of the at least two clads of the at least double-clad optical fiber; Equipped with.

[0015] Thus, the disposable optical fiber device allows different types of radiation to be delivered through a single at least double-clad optical fiber, which can therefore be kept thin and highly bendable.

[0016] Furthermore, by coupling radiation into the core and cladding of at least a double-clad optical fiber, respectively, via different optical connectors, different types of radiation can be efficiently delivered through a single optical fiber, while different optical connectors can be adapted for each type of radiation, e.g., high-power treatment laser radiation and low-power sensor radiation sensitive to signal disturbances.

[0017] According to another aspect, disclosed herein are embodiments of a fiber optic medical procedure device including a medical procedure device as disclosed above and below, and a disposable fiber optic device configured to be removably optically coupled to the medical procedure device.

[0018] 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]

[0019] 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:

[0020] [Figure 1] 1 diagrammatically illustrates an example of a fiber optic medical procedure device according to embodiments disclosed herein. [Diagram 2] 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. [Diagram 3] 1 diagrammatically illustrates an example of a disposable fiber optic device according to embodiments disclosed herein. [Figure 4] 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. [Diagram 5]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 6] 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 7] 6 illustrates diagrammatically the operation of the tapered region of the optical combiner module of FIG. 5; [Figure 8A] 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 8B] 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 8C] 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 8D] 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 8E] 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 8F] 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 9A] 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 9B]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 9C] 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 10] 2A and 2B diagrammatically illustrate more detailed examples of fiber optic medical procedure devices according to embodiments disclosed herein. [Figure 11] 1 diagrammatically illustrates an example of an optical combiner module for combining multiple optical paths fed through at least double-clad optical fibers; [Figure 12] 13A-13C diagrammatically illustrate further examples of disposable fiber optic devices according to embodiments disclosed herein; [Figure 13] 13A-13C diagrammatically illustrate further examples of disposable fiber optic devices according to embodiments disclosed herein; [Figure 14A] 1 illustrates a schematic diagram of an example of a first optical connector of an embodiment of a disposable optical fiber device disclosed herein. [Figure 14B] 1 illustrates a schematic diagram of an example of a first optical connector of an embodiment of a disposable optical fiber device disclosed herein. [Figure 15A] 13A illustrates a schematic diagram of an example of a second optical connector of an embodiment of a disposable optical fiber device disclosed herein. [Figure 15B] 13A illustrates a schematic diagram of an example of a second optical connector of an embodiment of a disposable optical fiber device disclosed herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0021] The following describes embodiments of a disposable fiber optic device that may alleviate one or more of the above and / or other shortcomings of existing devices, or at least serve as a replacement for existing devices. The following further describes embodiments of a fiber optic medical procedure device.

[0022] FIG. 1 diagrammatically illustrates an example of a fiber optic medical procedure device according to embodiments disclosed herein.

[0023] The fiber optic medical procedure device comprises a medical procedure device 2000 and a disposable fiber optic device 1000. The disposable fiber optic device 1000 is configured to be removably optically coupled to the medical procedure device.

[0024] To this end, the disposable fiber optic device 1000 comprises at least a double clad optical fiber 1200 and a connector module 1100 .

[0025] 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 cladding or a hexagonal or octagonal cladding for mode scrambling. The inner cladding may be a multi-core cladding.

[0026] The at least double clad optical fiber 1200 may have a diameter suitable for insertion into the working channel of an 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. 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 to allow bending with relatively small tensile and compressive stresses induced at the fiber end. The length of the at least double clad optical fiber may depend on the type of endoscope and / or the type of medical procedure. A suitable length may be 2 m to 4 m.

[0027] 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.

[0028] At least the distal end 1201 of the double-clad optical fiber 1200 may be beveled, preferably with rounded edges, for easier insertion into the working channel of the endoscope and to reduce the risk of the edges of the optical fiber being damaged during insertion.

[0029] The connector module 1100 is configured to optically connect the proximal end of at least the double-clad optical fiber 1200 to the medical treatment device 2000, and in particular to separately couple the core and clad of at least the double-clad optical fiber, respectively, to the medical treatment device.

[0030] To this end, the connector module has a first optical connector 1111 and a second optical connector 1121. The first optical connector 1111 is configured to be removably connected to a first mating optical connector 2101 of the medical treatment device 2000. The second optical connector 1121 is configured to be removably connected to a second mating optical connector 2102 of the medical treatment device.

[0031] An embodiment of a disposable fiber optic device 1000 is described in more detail below with reference to FIG.

[0032] Generally, the medical treatment device 2000 may include a treatment laser source 2200 configured to output treatment laser radiation for the treatment of a medical condition. The treatment laser source 2200 may include a suitable type of laser, for example a diode laser, configured to emit 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 bladder by photocoagulation and / or ablation, the treatment laser source may comprise a high brightness diode laser. The medical treatment device is configured to output treatment laser radiation at least through the cladding, in particular the inner cladding, of the double clad optical fiber 1200. For this purpose, the treatment laser source is optically coupled to the second mating optical connector 2102 for connection to the second optical connector 1121 of the disposable optical fiber device 1000. The second optical connector is thus preferably configured to receive a treatment laser beam, in particular a treatment laser beam having a power of 10 W to 200 W.

[0033] 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.

[0034] The medical treatment device 2000 may further comprise 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 at least a core of the double-clad optical fiber 1200. For this purpose, the sensor laser module is optically coupled to the first mating optical connector 2101 for connection to the first optical connector 1111 of the disposable optical fiber device. 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, such as 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.

[0035] 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.

[0036] The first optical connector is preferably configured to receive the sensor laser beam and output reflected laser radiation. The sensor module 2300 may further comprise a detector 2320 for 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 2310. The detector may be configured to receive radiation from the tissue via at least the double clad optical fiber 1200 of the disposable optical fiber device, in particular via a core and / or clad of at least the double clad optical fiber 1200.

[0037] In various embodiments, the medical treatment device comprises an interferometric distance sensor module configured to perform interferometric distance sensing of the distance between at least the distal end 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 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 fiber. The medical treatment device is preferably further configured to control treatment laser radiation in response to the measured distance.

[0038] In some embodiments, the medical treatment device further comprises a spectroscopic sensor for sensing 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 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.

[0039] An embodiment of the medical treatment device 2000 is described in more detail below with reference to Figure 10. As will become apparent from the disclosure below, the medical treatment device may include additional or alternative radiation sources and / or additional photodetectors.

[0040] 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. 2.

[0041] FIG. 2 diagrammatically illustrates an example of a disposable fiber optic device with at least a double clad optical fiber 1200 inserted and advanced into a working channel 3100 of an endoscope 3000. The disposable fiber optic device comprises at least a double clad optical fiber 1200 and a connector module 1100, all as described in relation to FIG. 1. In the example of FIG. 2, a distal end 1201 of at least the double clad optical fiber 1200 extends out of the working channel of the endoscope. In use, the endoscope is inserted into a vessel or organ of a patient, depending on the nature of the medical procedure. The endoscope 3000 may be inserted with at least the double clad optical fiber 1200 already inserted into the working channel 3100. Alternatively, at least the double clad optical fiber 1200 may be inserted into the working channel 3100 after insertion of the endoscope 3000 into the target organ or vessel.

[0042] 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.

[0043] Generally, the various embodiments of the single-use fiber optic device are for treatment of the urinary tract, for example, for treatment of the bladder, and in particular for treatment of bladder cancer.

[0044] 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.

[0045] FIG. 3 diagrammatically illustrates an example of a disposable fiber optic device 1000 according to embodiments disclosed herein.

[0046] 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, and at least one outer 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.

[0047] 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), e.g., as described in connection with FIG. 1.

[0048] 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 a medical treatment device, a second optical connector 1121 for removably and optically connecting the second optical fiber 1120 to a 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 clad of the at least two clads of the at least double-clad optical fiber 1200.

[0049] 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.

[0050] 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.

[0051] 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.

[0052] The housing may include additional mechanical connectors or guides 1171, e.g., guide rails, which further promote a positive 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.

[0053] 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.

[0054] 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.

[0055] 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 first optical fiber of the medical treatment device, as described, for example, in connection with Figures 14A and 14B. 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 less than 1 W, for example less than 200 mW, for example less than 100 mW, to the first optical fiber.

[0056] Thus, efficient optical coupling between single-mode or few-mode 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 sensor laser radiation, for example for sensor applications, especially interferometric measurements such as interferometric distance measurement.

[0057] 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.

[0058] 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.

[0059] 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, i.e. a connector configured for optical coupling without physical contact between the fiber ends of the optically coupled fibers, as described for example in connection with Figs. 15A and 15B. Here, the term high-power optical connector is intended to refer to an optical connector adapted for optical connection of optical fibers conveying high-power laser radiation, in particular laser radiation of a power suitable for medical treatment of tissue, for example by photocoagulation and / or ablation. The second optical connector 1121 may be adapted for optical connection of an optical fiber carrying laser radiation having a power output of 10 W or more, such as 100 W or more, such as 200 W or more, such as 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, into the second optical fiber.

[0060] 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.

[0061] 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, with a medical treatment device, i.e., they may be different connectors. 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.

[0062] 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.

[0063] 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.

[0064] 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 treatment. Generally, the tissue to be treated is a living tissue, such as a soft tissue.

[0065] Examples of optical combiner modules 1130 are described in more detail with reference to Figures 4 and 5, respectively.

[0066] Optionally, the connector module 1100 may include additional components.

[0067] 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 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 treatment laser, or even to turn off the treatment laser or close a shutter or optical switch, to prevent overheating of the optical combiner module 1130.

[0068] 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.

[0069] 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.

[0070] FIG. 4 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.

[0071] 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.

[0072] 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.

[0073] 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 The V number may be:

[0074] 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:

[0075]

number

[0076] 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.

[0077] 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.

[0078] 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.

[0079] The optical combiner module 1130 further comprises a multimode fiber section 1137 and a second junction 1138 that couples radiation between the second optical fiber 1120 and the multimode fiber section 1137 .

[0080] 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 therefore 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 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.

[0081] The optical combiner 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.

[0082] 5 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. 4.

[0083] 4 and 5 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.

[0084] The optical combiner module of Figure 5 differs from the optical combiner module of Figure 4 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 5 is for use with embodiments of a disposable optical fiber device that include a multi-core, at least double-clad, optical fiber.

[0085] FIG. 6 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.

[0086] 5, 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.

[0087] Figure 7 illustrates the operation of the tapered region 1220. In particular, Figure 7 illustrates at least a proximal portion 1221 of the double-clad optical fiber 1200 extending between the fiber optic combiner 1132 of the embodiment of Figure 5 and the tapered fiber region 1220, 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 7 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.

[0088] In the example of Figure 7, 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 6. However, in other embodiments, the multi-core fiber may have a different number of side cores.

[0089] 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.

[0090] 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 .

[0091] 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.

[0092] At the distal end 1201 of the 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.

[0093] 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.

[0094] 8A-8F diagrammatically illustrate further examples of at least double-clad optical fibers for use in disposable optical fiber devices according to embodiments disclosed herein.

[0095] 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 is operable 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. Some embodiments further comprise an air cladding separating the inner cladding and the outer cladding.

[0096] At least the double-clad optical fiber may further comprise an outermost protective buffer, for example a biocompatible coating, which may be made from nylon, Teflon, or other suitable material.

[0097] 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.

[0098] In particular, Figure 8A 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).

[0099] FIG. 8B 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.

[0100] Figure 8C 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 8B, except that the double-clad optical fiber of Figure 8C 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.

[0101] Figure 8D 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 8D 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 8B may also be provided with such a down-doped silica layer.

[0102] FIG. 8E 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. 8D, except that the optical fiber of FIG. 8E 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. 6, FIG. 8A-FIG. 8D, and FIG. 8F may also be provided with such an outer buffer / coating.

[0103] In some embodiments, the at least double-clad optical fiber is an air-clad optical fiber. In this regard, FIG. 8F diagrammatically illustrates a cross-sectional view of yet another example of at least a double-clad optical fiber, in particular 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.

[0104] 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 i may be substantially equal to

[0105] 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.

[0106] 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.

[0107] 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.

[0108] 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.

[0109] Generally, in various embodiments, for example in the embodiments of Figures 6 and 8A-8F, the core or cores of the optical fiber may have different dimensions, for example as shown in Figures 9A-9C. 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.

[0110] 9A-9C diagrammatically show longitudinal cross-sections of 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. 9A-9C 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°.

[0111] 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.

[0112] 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.

[0113] FIG. 9A 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.

[0114] 9B 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.

[0115] 9C 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.

[0116] FIG. 10 diagrammatically illustrates a more detailed example of a fiber optic medical procedure device according to an embodiment disclosed herein.

[0117] The fiber optic medical procedure device includes a medical procedure device 2000 and a disposable fiber optic device 1000, all as described in connection with Figure 1. An embodiment of the disposable fiber optic device is described in connection with Figures 2-5. The disposable fiber optic device 1000 is configured to be removably optically coupled to the medical procedure device 2000. The disposable 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.

[0118] The illustrated fiber optic medical procedure device is configured for the treatment of bladder cancer by laser photocoagulation and / or ablation 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.

[0119] 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.

[0120] 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 device to output information related to the treatment. In some embodiments, the user interface module comprises an audible and / or visual power / progress indicator configured to output an audible and / or visible indication of the current laser power of the treatment laser radiation or the current status of the treatment. For example, the power indicator may indicate the power of the 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. The medical treatment device 2000 may further comprise one or more controls 2120, e.g., a foot pedal, to allow the physician to operate the treatment laser while manipulating the cystoscope.

[0121] 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 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 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 suitable drivers and / or communication interfaces and a processing unit, for example a suitable programmed central processing unit.

[0122] The medical treatment device 2000 comprises a treatment laser source 2200 configured to output treatment laser radiation suitable for treating tumor tissue of the bladder by photocoagulation and / or ablation. In some embodiments, the treatment laser source is configured to output treatment laser radiation at a wavelength preferably selected to provide high water and hemoglobin absorption and / or low water and high hemoglobin absorption, for example at about 980 nm or another suitable wavelength, for example in the range of 750 nm to 1000 nm, for example 790 nm to 820 nm or 900 nm to 1000 nm, for example 900 nm to 940 nm, for example 905 nm to 925 nm, or 970 nm to 1000 nm, for example 970 nm to 990 nm. The treatment laser radiation may have a suitable power, for example 10 W to 200 W. The 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 .

[0123] The medical treatment device further comprises a first optical sensor module 2300 configured for interferometric distance sensing of the distance between the distal end of the optical fiber 1200 and the tissue to be treated.

[0124] Preferably, the medical treatment device 2000 may be configured to control the treatment laser source 2200 in response to a sensed distance between the distal end of the optical fiber 1200 and the tissue to be treated, for example, by reducing the power of the treatment laser radiation, modifying the pulse duration or pulse duty cycle, or even by stopping the treatment laser radiation when the tip of the fiber approaches the tissue. This may prevent unintended damage to the tissue to be treated.

[0125] 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 2310 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 that is significantly smaller than the power of the treatment laser radiation, for example at least two or three orders of magnitude smaller.

[0126] The first optical sensor module 2300 further comprises a spectrometer 2320 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 2300 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.

[0127] Various embodiments of the interferometric distance sensor of the first optical sensor module 2300 provide an axial resolution of 5 μm to 200 μm, such as 10 μm to 150 μm, such as 50 μm to 100 μm.

[0128] The interferometric distance sensor of the first optical sensor module 2300 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.

[0129] 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.

[0130] 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.

[0131] 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.

[0132] In various embodiments, radiation from the sensor laser source 2310 of the interferometric distance sensor 2300 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.

[0133] The medical treatment device 2000 may preferably comprise a second optical sensor module 2500 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.

[0134] 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.

[0135] In some embodiments, the second sensor module comprises an illumination source using, for example, a supercontinuum laser covering a wavelength range 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.

[0136] In any case, the second optical sensor module 2500 is configured to receive radiation reflected by the tissue to be treated. The second optical sensor module 2500 may therefore comprise a suitable detector for measuring the reflected radiation. The detector may comprise, for example, a grating CCD / CMOS spectrometer, for example with a resolution down to 1 nm, covering a suitable wavelength range, for example from 400 nm to 1100 nm, for example from 400 nm to 800 nm. Alternatively, the detector may comprise a photodetector, which may be time multiplexed with multiple LEDs.

[0137] 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 2500 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 2500 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.

[0138] Thus, the medical treatment device may display or otherwise output a progress indication, or even automatically control the 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 2500 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 the absorption maximum of hemoglobin and / or another suitable molecular marker.

[0139] 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 cutting tissue, rather than for photocoagulation and / or ablation, for example. 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.

[0140] 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.

[0141] 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.

[0142] 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.

[0143] 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 a 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 partially in response to the received user input.

[0144] The medical treatment device 2000 further comprises an optical combiner module 2700 having optical interfaces to a treatment laser source 2200, a first optical sensor module 2300 having an interferometric distance sensor, and an optional second optical sensor 2500. In embodiments having additional optical processing and / or sensor units, the optical combiner module also has optical interfaces to any such units, e.g., a cutting laser 2610 and / or a Raman sensor 2620.

[0145] As described above, the treatment laser source 2200 emits relatively high power 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 2300 emits and receives lower power radiation through the single mode or few mode core of at least the double clad optical fiber. The second optical sensor module 2500 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.

[0146] 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.

[0147] 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).

[0148] 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.

[0149] It will be appreciated that the radiation from / to each optical module of the medical procedure device need not necessarily be fed through the disposable fiber optic device simultaneously, instead they may be time multiplexed in a suitable manner to avoid them interacting in undesirable ways.

[0150] 11 shows a schematic of an example of an optical combiner module for combining multiple optical paths fed through at least double-clad optical fibers. The optical combiner module 2700 has optical interfaces 2701-2708 to various optical elements of a medical treatment device, in particular the treatment laser source, and the sensor module.

[0151] In the illustrated embodiment, the optical combiner module 2700 has an optical interface 2705 for receiving a multimode treatment laser radiation from a 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 to the interferometric distance sensor module of the medical treatment device the 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. 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 to the spectroscopic sensor module of the medical treatment device the 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.

[0152] 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.

[0153] 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.

[0154] 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.

[0155] 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.

[0156] 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).

[0157] 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.

[0158] 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.

[0159] FIG. 12 diagrammatically illustrates another example of a disposable fiber optic device 1000 according to embodiments disclosed herein.

[0160] The disposable optical fiber device 1000 is similar to the optical fiber device described in connection with FIG. 3 in that it comprises at least a double-clad optical fiber 1200 having a proximal end and a distal end 1201, all as described in connection with FIG. 3.

[0161] 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), e.g., as described in connection with FIG. 1.

[0162] 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 a medical treatment device, a second optical connector 1121 for removably and optically connecting the second optical fiber 1120 to a 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 clad of the at least two clads of the at least double-clad optical fiber 1200, all as described in relation to FIG. 3.

[0163] The connector module 1170 further comprises a housing 1170 in which a portion of the first optical fiber 1110, a portion of the second optical fiber 1120, and the optical combiner module 1300 are housed. The connector module 1100 of FIG. 12 differs from the example of FIG. 3 in that the first optical connector 1111 and the second optical connector 1121 are not integrated into the housing 1170, but are connected to the housing 1170 via flexible fiber optic cables 1112 and 1122, respectively, through which the first and second optical fibers 1110 and 1120, respectively, extend. In the example of FIG. 12, the first and second optical connectors 1111 and 1121 each have their separate connector housing.

[0164] FIG. 13 diagrammatically illustrates another example of a disposable fiber optic device 1000 according to embodiments disclosed herein.

[0165] The disposable fiber optic device 1000 is similar to the fiber optic device described in connection with Figure 13, except that the first and second optical connectors 1111 and 1121 are housed within a common connector housing 1150 that is connected to a housing 1170 that houses the optical combiner 1130 via a flexible fiber optic cable 1112 through which the first optical fiber 1110 and the second optical fiber 1120 extend. It will be appreciated that in an alternative example, the connector housing 1150 may be connected to the housing 1170 via two separate fiber optic cables for the first and second optical fibers, respectively.

[0166] Although not explicitly shown or described, it will be understood that each of the examples of Figures 12 and 13 may include one or more of the additional components described in connection with Figure 3, such as a temperature sensor, an RFID chip, and / or a cooling member. Similarly, the connector housing 1150 of the example of Figure 13 may include mechanical connectors or guides as described in connection with the housing of Figure 3.

[0167] 14A and 14B show schematic diagrams of an example of a first optical connector, particularly a low reflectance optical single mode fiber connector, of an embodiment of a disposable optical fiber device disclosed herein. The first optical connector 1111 is for removably and optically connecting a first optical fiber 1110 of the optical fiber device to a medical treatment device 2000, particularly to a mating optical connector 2101 of the medical treatment device 2000. FIG. 14A shows the first optical connector in a non-connected state, while FIG. 14B shows the first optical connector 1111 in a connected state. That is, the first optical connector 1111 is removably connected to the mating optical connector 2101, and the first optical fiber 1110 is optically coupled to the optical fiber 2111 of the medical treatment device 2000. The first optical connector 1111 is configured to optically couple the proximal end 111 of the first optical fiber 1110 to the end face 211 of the optical fiber 2110 of the medical treatment device 2000 when the first optical connector 1111 is removably connected to the mating optical connector 2101. In particular, the first optical connector 1111 is a physical contact connector, i.e. an optical connector configured to removably connect the proximal end 111 of the first optical fiber 1110 to the medical treatment device 2000 with the proximal end 111 of the first optical fiber 1110 abutting the end face 211 of the optical fiber 2111 of the medical treatment device. To this end, the end faces of the first optical fiber and the optical fiber of the medical treatment device may be beveled and / or rounded to provide improved optical coupling when in physical contact. The first optical fiber and / or the optical fiber of the medical treatment device may be spring-loaded mounted within their respective connector housings to ensure physical contact between the fiber ends. It will be appreciated that the optical fibers may be circumferentially surrounded by respective ferrules, which are preferably configured such that the fiber ends extend at least to the axial ends of the respective ferrules to ensure physical contact of the fiber end faces when the first optical connector is removably connected to the mating optical connector 2101.

[0168] 15A and 15B show schematic diagrams of an example of a second optical connector, particularly a high-power optical multimode connector, of an embodiment of a single-use optical fiber device disclosed herein. The second optical connector 1112 is for removably and optically connecting a second optical fiber 1120 of the optical fiber device to a medical procedure device 2000, particularly to a mating optical connector 2102 of the medical procedure device 2000. FIG. 15A shows the second optical connector in a non-connected state, while FIG. 15B shows the second optical connector 1112 in a connected state. That is, the second optical connector 1112 is removably connected to the mating optical connector 2102, and the second optical fiber 1120 is optically coupled to an output optical fiber 2112 of the medical procedure device 2000. The second optical connector 1112 is configured to optically couple the proximal end 112 of the second optical fiber 1120 to the end face 221 of the output optical fiber 2112 of the medical procedure device 2000 when the second optical connector 1112 is removably connected to the mating optical connector 2102. In particular, the second optical connector 1112 is a free-standing fiber tip connector, i.e., a connector configured to optically couple without physical contact between the fiber ends of the optically coupled fibers. The second optical connector 1112 is configured to removably connect the proximal end 112 of the second optical fiber 1120 to the medical procedure device 2000 with the proximal end 111 of the second optical fiber 1120 positioned away from the end face 221 of the output optical fiber 2112 of the medical procedure device 2000. To this end, the second optical connector 1112 may include a lens 120, such as a collimating lens, configured to couple light emitted from the end face 221 of the output optical fiber 2112 to the end face 112 of the second optical fiber 1120. Alternatively or additionally, the mating optical connector 2101 may include one or more lenses. It will be appreciated that the optical fibers may be circumferentially surrounded by respective ferrules. Generally, the second optical connector is configured to allow light to be coupled into the second optical fiber without direct physical contact of the proximal end of the second optical fiber with an optical element of the medical treatment device when removably connected to the medical treatment device.It will be understood that the space separating the proximal end 112 of the second optical fiber 1120 and the end face 112 of the output optical fiber 2112 may be a void filled with air or another material that is suitably transparent to the laser radiation transmitted through the second optical fiber.

[0169] 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 disposable optical fiber device, comprising: at least a double-clad optical fiber having a proximal end and a distal end, the distal end configured to be advanced through a working channel of an endoscope, the at least double-clad optical fiber having at least one core and at least two clads; a connector module for optically connecting the proximal end of the at least double-clad optical fiber to a medical procedure device; Equipped with The connector module includes: a first optical fiber; a second optical fiber; and a first optical connector for removably optically connecting the first optical fiber to the medical procedure device; a second optical connector for removably optically connecting the second optical fiber to the medical procedure device; an optical combiner module configured to couple radiation between the first optical fiber and the at least one core of the at least double-clad optical fiber and to couple radiation between the second optical fiber and at least one clad of the at least two clads of the at least double-clad optical fiber; Equipped with Disposable fiber optic devices.

2. the first optical fiber is a single mode or few mode optical fiber or has a single mode or few mode core; 10. The disposable fiber optic device of claim 1.

3. the second optical fiber is a multimode optical fiber; A disposable optical fiber device according to any one of the preceding claims.

4. The first optical connector is a low reflectance optical single mode connector. A disposable optical fiber device according to any one of the preceding claims.

5. the second optical connector is a high power optical multimode connector; A disposable optical fiber device according to any one of the preceding claims.

6. the first and / or second optical connectors are spring loaded; A disposable optical fiber device according to any one of the preceding claims.

7. the optical combiner module includes a side combiner; A disposable optical fiber device according to any one of the preceding claims.

8. the side combiner is configured to laterally couple radiation between the second optical fiber or a section of multimode fiber optically coupled to the second optical fiber and the at least one clad of the at least double-clad optical fiber, and the at least one core of the at least double-clad optical fiber passes through the side combiner.

8. The disposable fiber optic device of claim 7.

9. the side combiner is configured to laterally couple radiation between a multimode fiber section having a first fiber diameter and at least one clad of at least a double-clad optical fiber, at least one core of the at least double-clad optical fiber passing through the side combiner, the double-clad optical fiber having a diameter larger than the diameter of the multimode fiber section; 9. A disposable optical fiber device according to claim 7 or 8.

10. the connector module includes a temperature sensor; A disposable optical fiber device according to any one of the preceding claims.

11. the connector module comprising a cooling member configured to cool the optical combiner module; A disposable optical fiber device according to any one of the preceding claims.

12. the at least double-clad optical fiber is a multicore fiber having two or more cores, the at least double-clad optical fiber comprising a tapered region configured for coupling of radiation between a first core of the two or more cores and at least a second core of the two or more cores that is different from the first core. A disposable optical fiber device according to any one of the preceding claims.

13. a distal end of the at least one double-clad optical fiber having a beveled tip; A disposable optical fiber device according to any one of the preceding claims.

14. the connector module includes a first housing that accommodates at least the optical combiner module, at least a portion of the first optical fiber, and at least a portion of the second optical fiber. A disposable optical fiber device according to any one of the preceding claims.

15. the first housing further accommodates the first and second optical connectors; 15. The disposable fiber optic device of claim 14.

16. the first optical connector and / or the second optical connector are disposed outside the first housing and are connected to the first housing via a flexible optical fiber cable that accommodates a portion of the first optical fiber and / or the second optical fiber.

15. The disposable fiber optic device of claim 14.

17. the first optical fiber has a proximal end and a distal end, the first optical connector is configured to optically couple the proximal end of the first optical fiber to an end face of an optical fiber of the medical treatment device, and the first optical connector is configured to removably connect the proximal end of the first optical fiber to the medical treatment device with the proximal end of the first optical fiber abutting the end face of the optical fiber of the medical treatment device. A disposable optical fiber device according to any one of the preceding claims.

18. the first optical connector is configured to couple a single mode laser radiation having a V number less than 10, such as less than 3; A disposable optical fiber device according to any one of the preceding claims.

19. the second optical fiber has a proximal end and a distal end, the second optical connector configured to optically couple the proximal end of the second optical fiber to an output optical fiber of the medical treatment device, and the second optical connector configured to removably connect the proximal end of the second optical fiber to the medical treatment device with the proximal end of the second optical fiber positioned away from an end face of the output optical fiber of the medical treatment device. A disposable optical fiber device according to any one of the preceding claims.

20. the second optical connector is configured to couple a multimode laser radiation having a V number greater than 10 and a power output of 10 W or greater to the second optical fiber. A disposable optical fiber device according to any one of the preceding claims.

21. A medical treatment device; A disposable optical fiber device according to any one of the preceding claims, Equipped with the disposable fiber optic device is configured to be removably optically coupled to the medical procedure device; Fiber optic medical procedure devices.

22. The medical treatment device includes: a treatment laser source configured to output treatment laser radiation for the treatment of a medical condition, the medical treatment device being configured to output the treatment laser radiation through the cladding of the at least double-clad optical fiber; a sensor module including a sensor laser source configured to output a sensor laser radiation, the medical procedure device being configured to output the sensor laser radiation through the at least one core of the at least double clad optical fiber; Equipped with 22. The fiber optic medical procedure device of claim 21.

23. The sensor module comprises an interferometric distance sensing module and / or a spectroscopic sensor module.

23. The fiber optic medical procedure device of claim 22.

24. the treatment laser radiation is multimode radiation and the sensor laser radiation is single-mode or few-mode laser radiation; 24. The fiber optic medical procedure device of any one of claims 22-23.

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