Medical laser device

Abstract

Various aspects disclosed herein relate to a medical laser device comprising: at least one therapeutic laser source configured to output therapeutic laser radiation for treating a medical condition; one or more optical ports configured for coupling the device to a fiber optic device, the fiber optic device comprising at least one optical fiber and having a proximal end and a distal end, the distal end configured to advance through a working channel of an endoscope towards a treatment site of a subject to be treated, the one or more optical ports comprise an optical output port for outputting therapeutic laser radiation; at least one sensor configured to acquire at least one sensor signal indicative of one or more predetermined safety indicators, the one or more security indicators include at least a connection indicator indicating whether the fiber optic device is coupled to the optical output port and one or more fiber tip position indicators indicating whether a distal end of an optical fiber of the coupled fiber optic device is positioned at a secure location; and a control module configured to receive the at least one sensor signal from the at least one sensor and enable output of the therapeutic laser radiation via the optical output port only when the at least one sensor signal indicates that the fiber optic device is coupled to the optical output port and is positioned distally at a safe position.

Description

Technical Field

[0001] This disclosure relates to a medical laser device for providing laser treatment via minimally invasive surgery using an endoscope. Background Technology

[0002] Many medical conditions can be treated by applying laser light to the tissue to be treated. Typically, this treatment is performed by directing the therapeutic laser radiation towards the tissue via optical fiber to cause ablation and / or coagulation within the tissue.

[0003] In many procedures, optical fibers advance through the working channel (often referred to as the lumen) of an endoscope, particularly a flexible endoscope. Various types of endoscopes exist, configured to visualize and / or treat different parts of the body, such as the gastrointestinal tract, respiratory tract, or urethra. Endoscopes are specifically configured to reach specific areas of the body. Examples of such endoscopes include cystoscopes, colonoscopes, and rhinoscopes. For example, a cystoscope is used for laser ablation and / or coagulation treatment of bladder cancer. A cystoscope is an endoscope configured to perform a cystoscopy, in which the cystoscope is advanced through the urethra into the bladder. For this purpose, a cystoscope includes a very thin, flexible tube. During laser ablation and / or coagulation treatment of bladder cancer, the healthcare provider inserts a fiber optic device into the patient's bladder through the working channel of the cystoscope. The fiber optic device is then used to target a laser to a specific area of ​​the tissue that needs treatment.

[0004] Therefore, it is generally desirable to provide a medical laser device that allows for effective, safe, and reliable treatment of a subject. In some embodiments, it is particularly desirable to provide a medical laser device that allows for effective, safe, and reliable treatment of the urethra, especially the bladder, and urethra with bladder cancer.

[0005] In particular, laser treatments such as ablation and / or coagulation therapies typically require strong laser radiation to be effective. Therefore, the operation of medical laser devices capable of generating such strong radiation involves the risk of unintentional exposure of the operator and / or patient to potentially hazardous laser radiation. Consequently, the operation of such medical laser devices typically involves personnel protective measures to protect the laser operator and / or patient, such as safety goggles, door switches, and procedural safety measures. Examples of such protective measures include eye protection. It is desirable to reduce or even eliminate the need for such personnel protective measures while still ensuring the safe operation of the medical laser device. Specifically, it is desirable to ensure that the operation of the device has no, or at least presents an acceptablely low risk of unintentionally exposing the operator or patient's eyes (or other untreated sensitive body parts) to hazardous laser radiation.

[0006] Overall, the goal is to provide an easy-to-operate medical laser device.

[0007] Despite previous efforts, it remains desirable to provide a medical laser device that addresses one or more of the aforementioned problems and / or other issues, and / or offers other benefits, or at least provides an alternative to existing solutions. Summary of the Invention

[0008] In this context, the various aspects disclosed herein relate to a medical laser device comprising: - At least one therapeutic laser source is configured to output therapeutic laser radiation for treating medical conditions. - One or more optical ports configured to couple the device to an optical fiber device, the optical fiber device including at least one optical fiber and having a proximal end and a distal end, the distal end being configured to advance toward a treatment point on the subject through the working channel of the endoscope, the one or more optical ports including an optical output port for outputting therapeutic laser radiation. - A control module is configured to receive at least one sensor signal indicating one or more predetermined safety indicators, the one or more safety indicators including at least a connection indicator indicating whether the fiber optic device is coupled to the optical output port, and one or more fiber tip position indicators indicating whether the distal end of the fiber of the coupled fiber optic device is positioned in a safe location, wherein the control module is further configured to enable the output of therapeutic laser radiation via the optical output port only when the at least one sensor signal indicates that the fiber optic device is coupled to the optical output port and the distal end is positioned in a safe location.

[0009] In some embodiments, the one or more safety indicators further include one or more fiber integrity indicators. The one or more fiber integrity indicators may indicate sufficient integrity of the coupled fiber optic device, for example, that the fiber is not broken and / or not bent below a predetermined bending radius. Sufficient integrity refers to an acceptable degree of integrity, such as an acceptable degree of light loss, an acceptable bending radius, etc., as defined by one or more predetermined criteria. The one or more fiber integrity indicators may indicate the structural and / or operational integrity of the coupled fiber optic device, i.e., whether the coupled fiber optic device is structurally and / or operationally intact. At least one of the one or more fiber integrity indicators may indicate detected damage to the fiber of the coupled fiber optic device, such as indicating a broken fiber. At least one of the one or more fiber integrity indicators may indicate light loss detected in the fiber and / or in another portion of the optical path between the treatment laser source and the distal end of the fiber, and / or may be one or more other indicators indicating whether the fiber and / or in another portion of the optical path between the treatment laser source and the distal end of the fiber operates as expected. Therefore, the control module may also be configured to enable the output of treatment laser radiation via the optical output port only when the at least one sensor signal indicates that the fiber integrity is intact. For example, fiber integrity can be detected by measuring the reflected light from the end face of the fiber tip through one or more optical paths.

[0010] In some embodiments, a medical laser device or a system including the medical laser device is configured for treating a subject's urethra, particularly the bladder. Thus, the endoscope may be a cystoscope. In other embodiments, the device may be configured to treat other conditions, such as conditions in another part of the subject's body.

[0011] In some embodiments, the device includes at least one sensor configured to acquire at least one of the at least one sensor signals indicating one or more predetermined safety indicators; that is, the control module may be configured to receive at least one of the at least one sensor signals from one or more sensors of the device. Alternatively or additionally, the control module may receive at least one of the at least one sensor signals from one or more sensors external to the medical laser device. Therefore, the control module may receive the at least one sensor signal from one or more internal and / or external sensors, i.e., from one or more sensors included in the device and / or from one or more sensors external to the device.

[0012] The at least one sensor may include an optical sensor for a medical laser device, which may be configured to receive and detect radiation from at least one of the one or more optical ports. Thus, detected light is received at the distal end of the optical fiber and coupled from the proximal end of the optical fiber to the at least one of the optical ports. The optical sensor may be a passive sensor, i.e., configured to detect light not originating from the optical sensor itself (or otherwise caused by the optical sensor), or it may be an active sensor, i.e., configured to detect light originating from the optical sensor itself (or otherwise caused by the optical sensor). A passive optical sensor may, for example, be configured to detect ambient light or light originating from another light source, such as illumination light from an endoscope.

[0013] In some embodiments, the optical sensor is configured to detect light emitted from the tip of an endoscope, such as light emitted from the tip of a cystoscope, which is received at the distal end of an optical fiber. In some embodiments, an endoscope lamp (e.g., an endoscope LED) may be configured to emit light with a predetermined modulation (e.g., pulsed or amplitude-modulated light, or frequency-modulated light, with a modulation / pulse frequency high enough to be invisible) or to emit light with an embedded coded signal / signature. The optical sensor can detect endoscopic light by detecting light with the predetermined modulation. In other embodiments, the optical sensor may be configured to detect another property, such as the spectral properties of the endoscopic light.

[0014] In some embodiments, the medical laser device includes an active optical sensor comprising a sensor radiation source configured to emit sensor radiation, and an optical sensor for detecting returned radiation, such as sensor radiation reflected by a surface (e.g., the end face of an optical fiber, by the tissue to be treated, or another surface struck by the sensor laser radiation), or other returned radiation returned by material struck thereon by the sensor radiation. For this purpose, the device is configured to output sensor radiation via at least one of the one or more optical ports and receive returned radiation via at least one of the one or more optical ports. It should be understood that the device may include more than one optical port, such as an optical output port for outputting therapeutic laser radiation, one or more optical input ports, and / or one or more additional optical output ports. In some embodiments, one or more of the optical ports may operate as both input and output ports. The one or more optical ports may all be coupled to the same fiber optic device, and in particular, to the same optical fiber. Thus, sensor radiation is coupled into the proximal end of the optical fiber and emitted from the distal end of the optical fiber. Similarly, returned light is received at the distal end of the optical fiber and coupled back from the proximal end of the optical fiber to at least one of the optical ports. The sensor radiation source can be a sensor laser source configured to emit sensor laser radiation or another light source for emitting sensor light. Preferably, the sensor radiation is harmless radiation, such as sensor laser radiation with a sufficiently low output power that poses no danger to the human eye, particularly sensor laser radiation classified as Class 1 lasers according to IEC 60825-1:07-2015. Examples of active optical sensors include interferometric sensors, such as broadband interferometric sensors, also referred to herein as OCT sensors. Other examples include spectrometer sensors. In other embodiments, the fiber optic device may include multiple optical fibers and / or the device may be configured for coupling, for example, to more than one fiber optic device via respective optical ports in the optical ports.

[0015] Optical sensors can detect when the distal end of an optical fiber is inserted into a fluid and / or urethra and / or an endoscope. The type of fluid can depend on the type of medical treatment being performed. In particular, the fluid can be water, an aqueous solution, or another liquid with water as a main component, such as a saline solution, urine, etc. In some embodiments, the optical sensor of the device includes an SLED for emitting a superluminescent diode (SLED) source signal. Thus, the optical sensor can use the SLED source signal to detect the presence of a fluid, such as water, saline, and / or urine, at the fiber facet (i.e., at the distal end of the fiber) via a single-mode or multimode optical fiber path.

[0016] Optical sensors can detect the bladder wall or other treatment sites / biological tissues to be treated.

[0017] The one or more fiber optic tip position indicators may include one or more of the following indicators: a) Insertion indicators, indicating that the optical fiber has been inserted into a liquid such as water, saline, and / or urine, and / or that the optical fiber has been inserted into an endoscope. b) Endoscopic tip indicator, indicating that the optical fiber is positioned at the distal end of the working channel of the endoscope, for example, as indicated by detecting that light emitted from the endoscope tip (e.g., from the cystoscope tip) is received at the distal end of the optical fiber, and / or as indicated by detecting that light emitted from the distal end of the optical fiber is received at the camera of the endoscope, for example by detection by a camera chip located at the endoscope tip receiver. c) Treatment point indicators, indicating the proximity of the distal end of the optical fiber to a potential treatment point, such as, as indicated by an optical sensor that has detected a potential treatment point between the distal ends of the optical fiber and the treatment point, such as biological tissue, particularly tissues inside the patient's body, such as the bladder wall. Sufficient proximity can be defined by the detection range of the laser sensor or by a predetermined threshold distance.

[0018] In this context and below, the term "potential treatment site" does not necessarily mean that the site where treatment is intended to be performed must be detected. The term simply means a site from the perspective of the laser operation viewpoint where treatment can be safely performed; that is, there is no (or at least no unacceptable) risk of the operator being exposed to hazardous radiation or the patient's eyes or skin being unintentionally exposed to such radiation. For example, it is not always necessary to detect a bladder tumor to be treated if bladder wall tissue is detected. Conversely, the term "potential treatment site" is not intended to be limited to sites that have not yet been treated; it can also refer to treatment sites where treatment has begun or even been completed.

[0019] In some embodiments, the control module may be configured to enable therapeutic laser radiation to be output only when the connection criteria and two or more (such as three or more) fiber tip position criteria are met, such as including one or more of the fiber tip position criteria a)-c) above and / or one or more alternative or additional fiber tip position criteria.

[0020] In some embodiments, the control module may be configured to enable therapeutic laser radiation to be output only when a connectivity index, a fiber integrity index, and one (such as two, three, or more) fiber tip position index are met, such as including one (such as two, three) of the fiber tip position indices a)-c) above and / or alternative or additional fiber tip position indices.

[0021] In some embodiments, the one or more fiber tip position indicators include an insertion indicator indicating that the fiber has been inserted into the liquid and a treatment point indicator indicating that the distal end of the fiber is close to a potential treatment point, and the control module is configured to enable therapeutic laser radiation to be output only when at least the insertion indicator and the treatment point indicator are satisfied.

[0022] In some embodiments, the control module may be configured to enable the output of therapeutic laser radiation only when at least two of the following are detected by two separate sensors and / or using two separate optical channels: a connectivity indicator, a fiber integrity indicator, and one or more fiber tip position indicators, thereby increasing the fault tolerance of the system.

[0023] In some embodiments, the control module can be configured to enable the output of therapeutic laser radiation only when at least one safety indicator selected from connectivity indicators, fiber integrity indicators, and fiber tip position indicators is detected by two separate sensors preferably independently and / or using two separate optical and / or signal processing channels, thereby increasing the fault tolerance of the system. For example, one or more conditions can be detected by two separate sensors using two separate optical channels, one channel being a single-mode / few-mode channel with V < 10, and the other channel being a multimode channel with V > 10.

[0024] For example, interferometry (OCT) systems can be used to detect proximity to tissues and / or the penetration of fiber optic tips into liquids such as water, saline, and / or urine.

[0025] In general, interferometric distance measurement refers to the distance measurement of a target surface / tissue by measuring the optical interference between a reference reflection and a reflection from the target surface / tissue. The reference reflection can be, for example, a reflection from the tip of an optical fiber (thus facilitating calibration or even eliminating the need for calibration).

[0026] Spectroscopic measurements can be used to detect light from a cystoscope / endoscope and / or to detect the penetration of an optical fiber tip into a liquid. In some embodiments, the device is configured to process sensor signals from at least one sensor, particularly from at least one optical sensor, using two separate signal processing channels / pipelines to obtain two separate safety index values ​​for at least one of the safety indices. In particular, sensor data from one or each sensor can be processed (in the electrical domain) using two parallel and partially or completely separate computational "arms" and / or two different computational units and / or two different computational algorithms (software algorithms). The control module can be configured to allow therapeutic laser radiation to be output during processing only if the individual processing pipelines produce the same result, particularly if the two separate safety index values ​​are equal or at least differ from each other within a predetermined margin.

[0027] In some embodiments, the control module may be configured to enable the output of therapeutic laser radiation only when at least two (such as at least three, such as at least four) of the above safety indicators are met in the expected time sequence, for example only when the connection indicator is met before the above fiber tip position indicator a), and the above fiber tip position indicator a) is met before the fiber tip indicators b) and / or c).

[0028] In some embodiments, the device includes a user input interface such as a button or touchscreen, configured to receive user confirmation that the fiber optic device is positioned with its distal end inside the patient's body (or in another safe location) and that the device is ready for operation. User confirmation may include confirmation that all prescribed procedural safety measures have been successfully performed, for example, that certain checks have been performed. The control module may be configured to allow therapeutic laser radiation to be output only upon receipt of the user confirmation, thus providing an additional layer of safety.

[0029] In some embodiments, the control module is configured to keep the output path of the therapeutic laser radiation blocked by the shutter (“non-contact mode” or “safe mode”) during safety measurements (e.g., including interferometric distance measurements (an additional laser safety feature)). This may optionally be coupled / connected to a general laser safety interlock, such as a laser safety interlock for the output of the therapeutic laser radiation that is only enabled when the fiber optic device is coupled to the optical output port. In some embodiments, the absence of the coupled fiber optic device may also be detected by an optical sensor, such as a laser sensor.

[0030] In some embodiments, the one or more sensors are configured to perform time-of-flight measurements between the fiber input (at the near end of the fiber) and the fiber output surface (at the far end of the fiber); for a returned signal in a 3m fiber, the timing difference may be, for example, about 30 ns. The time-of-flight measurement can be used as an indicator of fiber integrity. Additionally or alternatively, the detected amplitude of the reflected pulse from the far end will vary depending on whether the fiber tip is in air or a liquid, thus serving as an indicator of whether the far end of the fiber is immersed in a liquid such as water, saline solution, or urine. Therefore, in some embodiments, the device includes a time-of-flight sensor operable to emit an optical pulse through a connected fiber (e.g., through the cladding of a multi-clad fiber) and detect a corresponding returned pulse reflected by the fiber output surface. A decrease in the amplitude of the detected returned pulse from an elevated level to a lower level indicates that the fiber is immersed in water, saline solution, or urine. Similarly, a permanently low amplitude level of the returned pulse can indicate fiber damage, improper connection, or other compromise of the optical path integrity.

[0031] The device can use non-optical detection methods to detect fiber optic insertion into an endoscope and / or liquids such as water, saline, and / or urine, for example, by using a pair of wires along the side of the fiber optic buffer.

[0032] The detection of the target location and / or the distance between the target location and the fiber tip can be based on interferometry (OCT) of biological tissue to verify the presence of tissue.

[0033] The device may include an optical sensor configured to detect ambient light entering the distal end of the optical fiber, for example, to perform a distinction between light and dark. This can be used to detect whether the fiber tip is inside the working channel of the endoscope. Therefore, the control module can be configured to always turn off the treatment laser in darkness (e.g., as defined by a suitable light threshold), as this could indicate that the fiber tip is inside the working channel or indicate that the endoscope light is off. Endoscopic / cystoscopic light can be detected based on typical or even characteristic light levels and / or spectral properties (e.g., detecting LED or xenon light) and / or based on specific amplitude or frequency modulation or otherwise specifically encoded endoscopic / cystoscopic light.

[0034] In some embodiments, the medical laser device may receive sensor signals from external sensors and acquire one or more safety indicators based at least in part on the sensor signals received from the external sensors. Examples of such external sensors include sensors that advance optical fibers into an endoscope. Examples of endoscope sensors include the endoscope's camera; that is, the received sensor signals may include or may be acquired from camera signals from such a camera. For example, the device may acquire an optical fiber tip insertion indicator from sensor signals received from the endoscope's sensors. In particular, according to some embodiments, the device further includes a light source for emitting light via at least one of the one or more optical ports, the emitted light being detectable by the endoscope's camera, and a control module configured to receive camera signals from the camera, process the received camera signals to detect whether the camera has captured the emitted light, and enable the output of therapeutic laser radiation via the optical output port only if the control module has detected that the camera has captured the emitted light.

[0035] In some embodiments, the device is configured to monitor whether one or more of the aforementioned safety conditions, specifically one or more of the connectivity indicators, fiber tip position indicators, and fiber integrity indicators, such as all of them, are maintained while the output of therapeutic laser radiation is enabled. For example, the device may be configured to automatically disable the output of therapeutic laser radiation in response to at least one condition no longer being met. - For example, if the fiber optic device is disconnected from one or more of the optical ports, particularly from the optical output port, - If the optical fiber is pulled back into the endoscope's working channel, or even pulled out of the endoscope's working channel, - If no fluids such as water, saline, and / or urine are detected, - If the distance to the target location exceeds the safety threshold or no biological tissue is detected, - If a reduction in fiber integrity is detected, for example, if it drops below a predetermined / acceptable threshold.

[0036] In some embodiments, the therapeutic laser source is configured to receive a heartbeat signal and to stop emitting therapeutic laser radiation in response to failure to receive a heartbeat signal.

[0037] The heartbeat signal can indicate the normal operation of one or more components of the device, particularly the control module and / or at least one sensor. The therapeutic laser source can be configured to receive the heartbeat signal from the control module and / or directly or indirectly from said at least one sensor.

[0038] In some embodiments, the control module may be configured to send a heartbeat signal to the therapeutic laser source. The control module may also be configured to monitor the operation of at least some components of the device. For example, the control module may be configured to monitor the operation of at least one sensor, for instance, based on received sensor signals and / or based on the corresponding sensor heartbeat signal received by the control module. Therefore, the inability to receive a heartbeat signal from the control module may indicate malfunction of the control module and / or malfunction of a monitored aspect of the device's operation. In some embodiments, the control module may be configured to transmit a heartbeat signal only when and as long as a safety criterion is met.

[0039] In some embodiments, for example, the at least one sensor can send a sensor heartbeat signal to the control module and / or directly to the therapeutic laser source. The therapeutic laser source can be configured to receive the sensor heartbeat signal instead of the heartbeat signal from the control module, or receive only the heartbeat signal from the control module. Therefore, the control module and / or the therapeutic laser source can be configured to disable the output of therapeutic laser radiation if no heartbeat signal is received or if no sensor heartbeat signal is received within a predicted time period.

[0040] The heartbeat signal can be an intermittent signal, particularly a periodic signal transmitted at a suitable heartbeat rate, such as between 10 Hz and 100 Hz, or at another suitable update rate. For example, in some embodiments, the heartbeat signal may be transmitted between every 10 ms and every 20 ms.

[0041] The therapeutic laser source can be configured to emit pulsed therapeutic laser radiation. Specifically, the therapeutic laser source can be configured to emit only a predetermined number of pulses, such as a single pulse or a pulse train of a predetermined length, and to cease emitting additional pulses within a predetermined time period unless a heartbeat signal has been received. It should be understood that the heartbeat rate can be selected based on the predetermined number of pulses and / or the duty cycle of the pulse train. For example, when the therapeutic laser source is configured to emit only a single pulse of 10 ms, a heartbeat rate between once every 10 ms and once every 20 ms may be a suitable choice. It should be understood that other embodiments may employ other heartbeat rates and / or other pulse durations.

[0042] Therefore, the therapeutic laser source may include a heartbeat monitoring circuit configured to stop the therapeutic laser source if a heartbeat signal is not received. Preferably, the heartbeat monitoring circuit is implemented in hardware, for example, as a hardware timer reset by a heartbeat signal. In some embodiments, the therapeutic laser source may be configured to output therapeutic laser radiation only when other conditions are met, such as upon receiving other signals, for example, upon receiving an activation signal indicating that the operator has pressed the foot pedal or otherwise activated laser treatment.

[0043] The control module can be configured to monitor the reception of acceptable signals from the at least one sensor and transmit its heartbeat signal only if an acceptable signal is received. For example, in response to a safety criterion being met and the operator having initiated treatment, the control module can optionally receive the sensor heartbeat signal and control the therapeutic laser source to emit a pre-programmed pulse sequence. The control module can continue transmitting its heartbeat signal to cause the therapeutic laser source to continue emitting another pulse sequence, or a subsequent pulse sequence, only if the safety criterion is still met, optionally only if the operator is still activating the laser, and optionally, while the sensor heartbeat signal is still being received. The therapeutic laser source can be configured, preferably implemented only in hardware, such as a hardware timer, to automatically shut down the therapeutic laser source after the pre-programmed sequence. The therapeutic laser source can also be configured to emit again if a heartbeat signal is received from the control module.

[0044] In some embodiments, the device includes a therapeutic laser source and fiber optic equipment.

[0045] The device can be configured to optically couple therapeutic laser radiation into an optical fiber device, particularly at or near the proximal end of the optical fiber device. The device can also be configured to emit therapeutic laser radiation from a distal end toward tissue at the treatment site, such as tissue of the urethra, and especially tissue of the bladder.

[0046] Therapeutic laser radiation can have wavelengths suitable for the treatment to be performed. In some embodiments, wavelengths are between 750 nm and 1000 nm, such as between 950 nm and 1000 nm, or between 750 nm and 950 nm, such as between 780 nm and 820 nm, or between 900 nm and 950 nm, such as between 905 nm and 925 nm. Other useful wavelengths include those between 1000 nm and 2000 nm, such as those between 1400 nm and 2150 nm. Suitable therapeutic laser sources include diode lasers, erbium lasers, thulium lasers, holmium lasers, and / or other lasers. Wavelengths in which water has high absorption and fiber optic devices have high transmittance may be useful. When therapeutic laser radiation of such wavelengths is emitted toward the tissue to be treated, the water or aqueous solution between the fiber tip and the tissue is heated, causing the formation of bubbles that impact the tissue and facilitate the removal of ablated tissue. Wavelengths in which water has relatively low absorption and the tissue to be treated has relatively high absorption are also useful. In particular, lipids exhibit high absorption in the wavelength range between 900 nm and 950 nm, and hemoglobin also has relatively high absorption. Therefore, using wavelengths within this range allows for the efficient ablation and / or coagulation of tissue by emitting laser radiation from the tip of an optical fiber positioned within the urethra, particularly the bladder, at a distance from the tissue. This allows for the simultaneous irradiation of relatively large areas or tissues without attenuation of the laser radiation due to surrounding water or aqueous solutions. Furthermore, wavelengths outside the visible range may be useful, as these do not negatively affect visual examination, e.g., via a camera, especially when the wavelength range is between 900 nm and 950 nm. It should be understood that the emission of therapeutic laser radiation at multiple wavelengths can also be used, e.g., simultaneously or alternately. The therapeutic laser radiation can be applied in longer or shorter pulses, or otherwise, e.g., over longer time periods, such as during the period of receiving a user command, such as during the period of activating a foot pedal.

[0047] In some embodiments, the device is configured to emit therapeutic laser radiation with an output power of at least 10 mW, such as at least 50 mW, such as at least 100 mW, such as at least 200 mW, such as at least 500 mW, such as at least 1 W. In some embodiments, the device may even be configured to emit therapeutic laser radiation with a higher output power, such as pulses between 10 W and 200 W.

[0048] In general, unless otherwise specified, references to the power values ​​of laser radiation discussed herein are intended to refer to the peak power of the laser radiation. For example, when the laser radiation is pulsed, the values ​​correspond to the peak power of a single pulse, not the average power of the pulse train. The latter can be less than the peak power and is related to the peak power by a factor indicating the duty cycle of the pulse train.

[0049] In some embodiments, the device includes more than one therapeutic laser source, each configured to output a corresponding therapeutic laser radiation for treating the medical condition, such as a medical condition of the urethra, particularly the bladder, and optically coupled the corresponding therapeutic laser radiation into the fiber optic device via at least one optical port, particularly via an optical output port. The therapeutic laser sources can produce therapeutic laser radiation of corresponding wavelengths that are different from each other.

[0050] For example, the selective and alternating application of therapeutic laser radiation can be performed in response to the operator receiving corresponding control input. Therefore, the operator can control the device to selectively emit different types of therapeutic laser radiation.

[0051] In some embodiments, the device further includes a guide light source configured to output visible guide light and optically couple the guide light into an optical fiber device, wherein the device is configured to emit a guide beam of the guide light from a distal end toward the tissue to be treated, so as to illuminate a target spot on the tissue to be treated with the visible guide light. Specifically, in some embodiments, the visible guide light is multicolor light, which may include two or more color components detectable by a camera of a medical laser device, for example, including at least two detectable color components spaced 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 greater, wherein the intensity of the emitted guide light may be substantially uniform across the entire bandwidth or vary across the bandwidth. The two detectable color components may each have a sufficiently high intensity to be detectable by a camera or similar detector of a medical laser device, such that the spot illuminated by the guide beam is visible to a human observer in the camera image as an illuminated spot having a color produced as a mixture of the at least two color components, for example, a white or substantially white spot. Preferably, the guide beam is configured to at least illuminate the target spot illuminated by therapeutic laser radiation. The guide beam can be emitted before and optionally during the application of therapeutic laser radiation. The guide beam can be fed via the same optical fiber as the therapeutic laser radiation or via a separate optical fiber. The inventors have recognized that multi-color guide beams provide improved visibility and less operator fatigue when the device is used for extended periods. However, other types of guide beams are also conceivable.

[0052] In some embodiments, the device includes a medical treatment apparatus and a fiber optic device. The medical treatment apparatus may include a housing and at least a therapeutic laser source housed within the housing. The fiber optic device may be a disposable fiber optic device configured to be detachably and optically coupled to the medical treatment apparatus, particularly to one or more optical ports of the medical treatment apparatus, and more particularly to the optical output port of the medical treatment apparatus. Therefore, operating costs are reduced because the relatively inexpensive fiber optic device, which is inserted into the patient only during treatment, is discarded after use.

[0053] In some embodiments, the optical fiber is at least double-clad, and the device is configured to output therapeutic laser radiation via the cladding of the at least double-clad optical fiber. Therefore, the device allows multiple types of radiation to be fed through the optical fiber device without inappropriately interfering with each other. For example, the device may include an interferometric distance sensor employing a single-mode core of the at least double-clad optical fiber, while relatively high-power therapeutic laser radiation can be fed through the multimode cladding of the at least double-clad optical fiber.

[0054] In particular, in some embodiments, the device includes an optical lateral combiner configured to couple therapeutic laser radiation into at least one cladding of a double-clad optical fiber. Coupling the therapeutic laser radiation into at least one cladding of the double-clad optical fiber via the lateral combiner facilitates irradiation of the target spot with an intensity distribution of higher intensity in the peripheral region and lower intensity in the central region. This, in turn, facilitates more uniform heating of the tissue to be treated across the entire target spot.

[0055] In some embodiments, the device is configured to emit therapeutic laser radiation as a diverging first therapeutic beam from a distal end, the diverging first therapeutic beam being configured to irradiate a target spot on the tissue to be treated. Specifically, in some embodiments, the medical laser device is configured to irradiate a target spot with a diameter between 1 mm and 10 mm, such as 1 mm and 7 mm, when the distal end is displaced between 1 mm and 10 mm from the tissue to be treated, such as between 2 mm and 5 mm. Therefore, relatively large target spots can be irradiated and treated simultaneously, while providing the operator with a better overall view of the target location.

[0056] In some embodiments, the tissue to be treated is soft tissue, particularly cancerous soft tissue.

[0057] This disclosure relates to various aspects, including medical laser devices discussed above and further discussed below. It should be understood that each aspect may have one or more embodiments corresponding to those described in conjunction with one or more of the other aspects and / or those disclosed in the appended claims.

[0058] In particular, according to one aspect, embodiments of methods for operating a medical laser device, such as a device for treating cancer of the urethra, especially the bladder, by laser ablation and / or coagulation.

[0059] According to another aspect, this article discloses embodiments of methods for treating cancers of the urethra, particularly the bladder, by laser ablation and / or coagulation.

[0060] According to another aspect, an embodiment of a medical laser device is disclosed herein, the device comprising: - At least one therapeutic laser source is configured to output therapeutic laser radiation for treating medical conditions; - One or more optical ports configured to couple the device to an optical fiber device, the optical fiber device including at least one optical fiber and having a proximal end and a distal end, the distal end being configured to advance toward a treatment point on the subject through the working channel of the endoscope, the one or more optical ports including an optical output port for outputting therapeutic laser radiation; - A light source for emitting light via at least one of the one or more optical ports, the emitted light being detectable by the endoscope's camera; - The control module is configured to receive camera signals from the camera, process the received camera signals to detect whether the camera has captured the emitted light, and enable the output of therapeutic laser radiation via the optical output port only when the control module has detected that the camera has captured the emitted light.

[0061] According to another aspect, an embodiment of a medical laser device is disclosed herein, the device comprising: - At least one therapeutic laser source is configured to output therapeutic laser radiation for treating medical conditions; - One or more optical ports configured to couple the device to an optical fiber device, the optical fiber device including at least one optical fiber and having a proximal end and a distal end, the distal end being configured to advance toward a treatment point on the subject through the working channel of the endoscope, the one or more optical ports including an optical output port for outputting therapeutic laser radiation; The therapeutic laser source is configured to receive a heartbeat signal and stop emitting therapeutic laser radiation in response to failure to receive a heartbeat signal.

[0062] According to another aspect, this document discloses an embodiment of a system comprising: -As disclosed in this article, and - An endoscope, particularly a cystoscope, having a working channel for receiving optical fibers, and also including a camera for capturing one or more images of a target location located in front of the distal end of the endoscope.

[0063] Other aspects of this application will be recognized by those skilled in the art after reading and understanding the appended specification. Attached Figure Description

[0064] The above and other aspects are shown by way of example and are not limited to the accompanying drawings, wherein like reference numerals indicate similar elements, and wherein:

[0065] Figure 1 An example of a medical laser device according to embodiments disclosed herein is illustrated schematically;

[0066] Figure 2 The illustration schematically shows an example of the operation of a medical laser device according to an embodiment disclosed herein, wherein its optical fiber is positioned at a distance from bladder tissue or other treatment sites to be treated.

[0067] Figure 3 This illustration schematically shows another example of a medical laser device according to embodiments disclosed herein;

[0068] Figure 4 An example of a disposable fiber optic device according to an embodiment disclosed herein is illustrated, wherein the fiber optic cable has been inserted into and advanced through the working channel of an endoscope.

[0069] Figure 5 An example of a disposable fiber optic device according to embodiments disclosed herein is illustrated schematically;

[0070] Figure 6 An example of an optical combiner module of a connector module for a disposable fiber optic device according to embodiments disclosed herein is illustrated schematically;

[0071] Figure 7 Another example of an optical combiner module of a connector module of a disposable fiber optic device according to embodiments disclosed herein is illustrated schematically, wherein at least double-clad optical fibers include a gradually narrowing region;

[0072] Figure 8 A more detailed example of a medical laser device according to embodiments disclosed herein is illustrated schematically;

[0073] Figure 9The illustrations schematically depict examples of operation of medical laser devices according to various embodiments disclosed herein;

[0074] Figure 10 and Figure 11 The illustrations show corresponding examples of medical laser devices according to embodiments disclosed herein;

[0075] Figure 12 This illustration schematically shows another example of a medical laser device according to embodiments disclosed herein;

[0076] Figure 13 Another example of a medical laser device according to embodiments disclosed herein is illustrated schematically. Detailed Implementation

[0077] The following describes embodiments of medical laser devices that mitigate one or more of the above and / or other disadvantages of existing devices, or at least can be used as alternatives to existing devices.

[0078] Figure 1 An example of a medical laser device according to embodiments disclosed herein is illustrated schematically.

[0079] Various embodiments of the medical laser device are intended for use in clinical settings, particularly in settings operated by hospital / clinical / medical personnel.

[0080] The medical laser device includes a medical treatment device 2000 and a fiber optic device 1000. The fiber optic device 1000 can be configured to be detachably and optically coupled to the medical treatment device 2000; in particular, the fiber optic device 1000 can be disposable, for example, discarded after a single use. The fiber optic device can be coupled to the medical treatment device via one or more suitable connectors.

[0081] The fiber optic device 1000 includes fiber optic cable 1200, such as multimode fiber, double-clad fiber, or multi-clad fiber.

[0082] The optical fiber 1200 can have a diameter suitable for insertion into the working channel of a cystoscope or other type of endoscope; that is, the choice of diameter can depend on the type of endoscope. Suitable diameters can be between 0.1 mm and 1 mm, such as between 0.1 mm and 0.4 mm, preferably between 0.1 mm and 0.3 mm, such as between 0.1 mm and 0.25 mm. An optical fiber with a diameter of 1 mm or less, preferably 0.4 mm or less, such as 0.3 mm or less, is sufficiently thin to allow bending under relatively small tensile and compressive stresses at the fiber edges. The length of the at least double-clad optical fiber can depend on the type of endoscope. Suitable lengths can be between 2 m and 4 m.

[0083] In general, at least in some embodiments, the optical fiber emitting radiation toward the tissue to be treated is at least a double-clad optical fiber. It may have an optical fiber diameter between 100 µm and 1000 µm, such as between 100 µm and 300 µm, or such as between 150 µm and 200 µm. In some embodiments, the numerical aperture of the multimode cladding transmitting the therapeutic laser radiation has a numerical aperture between 0.17 and 0.50, such as between 0.22 and 0.45. Here, the numerical aperture of the inner cladding may 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 surrounding the inner cladding.

[0084] In some embodiments, the distal end 1201 of the optical fiber 1200 may be angled, preferably with rounded edges, to facilitate insertion into the working channel of the endoscope and reduce the risk of the optical fiber edge breaking during insertion.

[0085] Generally, the medical treatment device 2000 includes a therapeutic laser source 2200 configured to output therapeutic laser radiation for treating a medical condition. In some embodiments, the therapeutic laser radiation is used for ablation and / or coagulation treatment of another medical condition of bladder cancer or urethra, particularly therapeutic laser radiation suitable for treating tumor tissue of the urethra, especially the bladder, by ablation and / or coagulation. The therapeutic laser source 2200 may include a suitable type of laser, such as a diode laser, configured to emit therapeutic laser radiation at a wavelength and power suitable for the medical treatment to be performed. When the medical laser device is used to treat tumors of the urethra, especially the bladder, by ablation and / or coagulation, the therapeutic laser source may include a high-brightness diode laser. The therapeutic laser radiation may be optically coupled to an optical fiber 1200, for example, at or near the proximal end of the fiber. Preferably, the optical fiber is configured to receive the therapeutic laser radiation, particularly therapeutic laser radiation having an output power of at least 10 mW and a suitable wavelength, for example, as discussed in the above summary section.

[0086] In this embodiment, the medical treatment device 2000 further includes a sensor module 2300. The sensor module can be configured to receive light entering the distal end 1201 of the optical fiber 1200 and includes one or more optical sensors for detecting the received light.

[0087] In some embodiments, sensor module 2300 may include a sensor laser source configured to output sensor laser radiation. The medical laser device may be configured to output sensor laser radiation via an optical fiber. For this purpose, optical fiber 1200 may be at least double-clad, and the medical laser device may be configured to output sensor laser radiation via the core of the at least double-clad optical fiber 1200. The at least one core of the at least double-clad optical fiber may have a V number 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, the at least one core may be a few-mode core or even a single-mode core at the wavelength of the sensor laser radiation.

[0088] In some embodiments, the sensor laser radiation may include multiple wavelengths. Therefore, the V number of at least one core of the at least double-clad optical fiber may differ for different wavelengths of sensor radiation. For example, a core may be a single-mode core at one or more wavelengths of sensor laser radiation, and a few-mode core (or even a multimode core) at other wavelengths of laser radiation. Specifically, in some embodiments, the medical laser device includes more than one sensor module, such as an interferometric distance sensor module and a spectral sensor module. Different sensor modules may operate at different wavelengths. In such embodiments, the at least one core of the at least double-clad optical fiber may be a few-mode core or even a single-mode core (e.g., having a V number less than 4, such as less than 3 or even 2.4) with a small V number at the wavelength of the sensor laser radiation of one of the sensor modules (e.g., the interferometric sensor module). The 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., between 3 and 10, such as between 3 and 6) at the wavelength of the sensor laser radiation of another sensor module (e.g., the spectral sensor module).

[0089] In various embodiments, the medical treatment device 2000 includes an interferometric distance sensor module configured to perform interferometric distance sensing of the distance between the distal end of the optical fiber 1200 and the tissue to be treated. In particular, in some embodiments, the interferometric distance sensor is a common-path sensor, wherein the distal end of the optical fiber can operate as a reflector for a reference optical path, thereby providing a particularly compact system that requires no additional optical fiber. Preferably, the medical treatment device is also configured to control therapeutic laser radiation at least in part in response to the measured distance.

[0090] In some embodiments, the sensor module is configured to detect light emitted by the endoscope, particularly at the distal end of the endoscope, and light reflected from tissue or other material positioned in front of the distal end of the endoscope. Thus, endoscopic light can be received by the distal end of the optical fiber and detected by the sensor module 2300.

[0091] Fiber optic devices are configured to be inserted into the working channel of an endoscope, such as a cystoscope, for example, in combination with... Figure 2 And / or as described in 4. The endoscope / cystoscope may be a conventional endoscope / cystoscope or an endoscope / cystoscope particularly suited for use with the medical laser devices disclosed herein.

[0092] Medical treatment device 2000 can provide a single fiber optic connector for coupling fiber optic cables to medical treatment devices that transmit therapeutic laser radiation and sensor radiation, for example, combining... Figure 11 As described. In other embodiments, the medical treatment device 2000 may provide two (or more) separate fiber optic connectors for coupling corresponding optical fibers to the medical treatment device, which can then be combined into a single optical fiber in a separate combiner module, for example, by combining... Figure 3 , 5 -8 and / or 10 as described.

[0093] The medical treatment device may include a control module 2400 for controlling the operation of the therapeutic laser source and / or other components of the medical treatment device (e.g., shutter, sensor module 2300, etc.). For this purpose, the control module may receive sensor signals or data based on sensor signals from the sensor module 2300. Generally, the control module may be implemented as an MCU or in another suitable manner. The control module may be implemented as a single circuit or multiple devices or circuits that can perform various aspects or parts of the control operation.

[0094] Figure 2 The illustration schematically shows an example of the operation of a medical laser device according to an embodiment disclosed herein, wherein its optical fiber is positioned at a distance from bladder tissue or other treatment sites to be treated.

[0095] In general, various embodiments of the medical laser device are used for the treatment of the urethra, such as for the treatment of the bladder, particularly for the treatment of bladder cancer. In use, the distal end 1201 of the optical fiber 1200 is inserted into the working channel of a cystoscope adapted for insertion through the urethra into the urethra, particularly the bladder. The working channel of the cystoscope typically has a diameter between 1.5 mm and 2 mm, such as 1.8 mm. The cystoscope must typically be able to bend with a small radius of curvature, such as 10 mm or less, or even 5 mm or less. When inserted into the urethra, particularly the bladder, the distal end 1201 of the optical fiber 1200 is brought to an operating position at a distance from the tissue 210 to be treated, which may be a tumor of the bladder 200. The device emits therapeutic laser radiation from the distal end 210 of the optical fiber 1200 toward the tissue to be treated, causing the tissue 210 to ablate and / or coagulate.

[0096] Therapeutic laser radiation can be directed to the target tissue in a variety of ways. For example, when the fiber 1200 emits therapeutic laser radiation as a diverging beam 100, a relatively large target spot can be irradiated, and thus a single treatment can be performed, thereby reducing the need to move the fiber to irradiate different locations, while providing uniform treatment of a larger target spot.

[0097] In some embodiments, during the first transmission, the distance between the distal end of the optical fiber 1200 and the tissue to be treated 210 is between 2 mm and 6 mm, such as between 3 mm and 5 mm.

[0098] It should be understood that any medical laser device described herein may include a guiding light source, such as a guiding laser source or other type of light source adapted to emit visible light suitable as a guiding beam to illuminate a portion of tissue to be treated and to serve as aiming guidance for a physician or other user of the device. The guiding beam may be fed via the same optical fiber as the therapeutic laser radiation or via a separate optical fiber. In some embodiments, the guiding beam may be multicolored. In some embodiments, the device may be configured to control the visible properties of the guiding light, such as color and / or intensity, in response to one or more operating parameters, user input, and / or sensor signals.

[0099] Figure 3 This illustration shows yet another example of a medical laser device according to embodiments disclosed herein.

[0100] Figure 3 equipment and Figure 1 The similarities between the devices are that they include a medical treatment device 2000 and a fiber optic device 1000. The fiber optic device 1000 includes an optical fiber 1200, and the medical treatment device includes a therapeutic laser source 2200, a control module 2400, and a sensor module 2300, all combined as shown. Figure 1 As described.

[0101] A disposable fiber optic device 1000 is configured to be detachably and optically coupled to a medical treatment device. For this purpose, the disposable fiber optic device 1000 of this embodiment includes an optical fiber 1200. The disposable fiber optic device 1000 may also include a connector module 1100 for coupling the optical fiber 1200 to the medical treatment device 2000.

[0102] In this embodiment, the optical fiber 1200 is at least double-clad; that is, it can be double-clad, or it can be multi-clad, such as triple-clad, with more than two clads. Generally, the double-clad optical fiber comprises three layers of optical material. The innermost layer is called the core. It is surrounded by an inner cladding, which in turn is surrounded by an outer cladding. These three layers are typically made of materials with different refractive indices. Other embodiments may use other types of optical fibers.

[0103] The distal end 1201 of the at least double-clad optical fiber 1200 is configured to advance through the working channel of an endoscope (such as a cystoscope). Preferably, the core is a single-mode core, which is single-mode at least for one or more target wavelengths or target wavelength ranges. Optionally, the at least double-clad optical fiber 1200 comprises two or more cores, preferably single-mode cores, for example, a few-mode or single-mode center 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, such as blue EFTE, Teflon, Nylon, etc. The optical fiber may have a circular, hexagonal, or octagonal inner cladding for mode perturbation. The inner cladding may be a multi-core cladding.

[0104] Connector module 1100 can be configured to optically connect the proximal end of at least double-clad optical fiber 1200 to medical therapeutic device 2000. For this purpose, connector module 1100 includes one or more optical connectors. In some embodiments, connector module 1100 is configured to individually couple the core and cladding of at least double-clad optical fiber 1200 to medical therapeutic device 2000. For this purpose, connector module 1100 may have a first optical connector and a second optical connector. The first optical connector can be configured for detachably connecting to the medical therapeutic device 2000 as a first mating optical connector. The second optical connector can be configured for detachably connecting to the medical therapeutic device as a second mating optical connector. An embodiment of disposable fiber optic device 1000 will be referred to below. Figure 4 and Figure 5 To describe in more detail.

[0105] Medical laser devices can be configured to output therapeutic laser radiation via the cladding of at least double-clad optical fiber 1200, particularly the inner cladding. The cladding can be a multimode cladding.

[0106] In this embodiment, the sensor module 2300 is configured to output and receive sensor laser radiation through at least a double-clad optical fiber 1200, and to optically measure one or more parameters of treatment based on the received sensor laser radiation. For this purpose, the sensor module 2300 may include a sensor laser source 2311 configured to output sensor laser radiation. The medical laser device may be configured to output sensor laser radiation through the core of the at least double-clad optical fiber 1200.

[0107] The sensor module 2300 may further include a detector 2312 for receiving and detecting radiation received from the treatment site (e.g., from the tissue to be treated), particularly in response to irradiation by sensor laser radiation from sensor laser source 2311 and / or in response to radiation reflected from the target site by light emitted from the distal end of the endoscope. The detector 2312 may be configured to receive radiation from the target site via at least a double-clad optical fiber 1200 of a disposable optical fiber device. The detector 2312 may be configured to receive radiation from the target site via at least one core of the at least double-clad optical fiber 1200 of the disposable optical fiber device and / or via the cladding.

[0108] Medical laser devices can be configured to time-division multiplex the output of therapeutic laser radiation and at least optical measurements of one or more parameters. Therefore, some embodiments of the medical laser device alternately emit therapeutic laser radiation and perform optical measurements; that is, some embodiments of the medical laser device intermittently interrupt the emission of therapeutic laser radiation—or at least substantially reduce the emission of therapeutic laser radiation—to perform optical measurements, thereby allowing reliable optical measurements to be performed during treatment. In some embodiments, the medical laser device is configured to adjust one or more parameters of the therapeutic laser radiation in response to measured one or more parameters, particularly output power, duty cycle, and / or pulse duration. Therefore, the medical laser device can be configured to control the therapeutic laser source to resume the intermittently interrupted emission of therapeutic laser radiation using the adjusted one or more parameters. Generally, it should be understood that time-division multiplexing can include completely interrupting the emission of therapeutic laser radiation to perform optical measurements, or at least significantly reducing the emitted therapeutic laser radiation when performing optical measurements, for example, reducing it to no more than 5% of the output power of the therapeutic laser radiation used during the treatment cycle, such as reducing it to no more than 1%.

[0109] In some embodiments, the medical laser device is configured to output therapeutic laser radiation as pulsed laser radiation, that is, to output a series of therapeutic laser pulses separated by time intervals between the therapeutic laser pulses. The medical laser device may be configured to emit sensor laser radiation during some or all of the time intervals between the therapeutic laser pulses.

[0110] The following will refer to Figure 9 Examples of how to operate a medical laser device are described in more detail.

[0111] In some embodiments, the sensor laser radiation and the therapeutic laser radiation have different wavelengths. Specifically, the sensor laser radiation may have one or more sensor wavelengths within a first wavelength range, and the therapeutic laser radiation may have one or more therapeutic wavelengths within a second wavelength range, which is different from and preferably spaced apart from the first wavelength range. Therefore, the therapeutic laser radiation and some or all of the sensor laser radiation can be spatially separated, time-division multiplexed, and wavelength / frequency-spaced within the core and cladding of at least double-clad optical fibers.

[0112] Sensor laser radiation can have a lower output power than therapeutic laser radiation. For example, sensor laser radiation can have an output power of less than 5 mW, such as less than 3 mW, such as less than 2 mW, such as less than 1 mW, such as less than 0.5 mW. Sensor laser radiation can be so weak that it will not cause damage to the human eye, and in particular, it can be classified as a Class 1 laser according to IEC 60825-1:07-2015. As described herein, therapeutic laser radiation can have an output power of 10 mW or greater. The beam of therapeutic laser radiation can be dangerous to the human eye when viewed by an unprotected observer. This also applies to specular or diffuse reflection of therapeutic laser radiation. However, embodiments of the medical laser devices disclosed herein provide protective measures to ensure that personnel operating the device, patients, or other persons near the device do not inadvertently view the dangerous radiation emissions.

[0113] The medical treatment device 2000 includes a control unit 2400 configured to control the operation of the medical treatment device 2000. Specifically, the control unit can control the operation of a therapeutic laser source 2200 and sensor modules. In some embodiments, the control unit controls time-division multiplexing and optical measurement of laser radiation based on sensor laser radiation. The control unit 2400 can be configured to control various other optical therapeutic and / or sensor modules of the medical treatment device. The control unit can be configured to control the therapeutic laser source, 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 processing units, such as a suitable programmable central processing unit. In particular, the control unit may be operable to selectively enable the output of therapeutic laser radiation only when one or more detectable safety indicators are met. To this end, the control unit can operate a mechanical shutter and / or other types of shutters, and / or selectively allow or prevent the therapeutic laser source from being turned on.

[0114] In various embodiments, one or more parameters are measured, including the distance between the distal end 1201 of the at least double-clad optical fiber 1200 and the tissue to be treated. To this end, in various embodiments, the sensor module 2300 includes a first optical sensor module, particularly an interferometric distance sensor module, configured to perform interferometric distance sensing of the distance between the distal end 1201 of the at least 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, wherein the distal end 1201 of the at least double-clad optical fiber can operate as a reflector of a reference optical path, thereby providing a particularly compact system that does not require any additional optical fiber. The medical treatment device 2000, particularly the control unit 2400 of the medical treatment device, is preferably also configured to control the therapeutic laser radiation in response to the measured distance. Specifically, the control unit may be configured to control the laser power of the therapeutic laser radiation or another operating parameter, such as the duty cycle of the pulse train of the laser period, the pulse width or duration of the emitted laser radiation, etc., in response to the sensed distance. For example, the control unit can be configured to control the laser power of the therapeutic laser radiation in response to a sensed distance, such that the intensity of the laser radiation impacting the tissue to be treated remains substantially constant, regardless of distance variations. In another example, the control unit can be configured to selectively enable / disable the output of therapeutic laser radiation from a medical treatment device in response to a sensed distance, such that the therapeutic laser radiation is only enabled when the distal end of the fiber is in front of the treatment point, particularly in an operating position very close to the treatment point. The control unit can also be configured to selectively control the laser power or other operating parameters of the therapeutic laser radiation in response to a sensed distance, such that the energy of the laser radiation impacting the tissue to be treated remains substantially constant over a specific period of time, regardless of distance variations.

[0115] The first optical sensor module may also be configured to detect and distinguish various different types of materials located in front of the distal end of the at least double-clad optical fiber. In such embodiments, the control unit may also be configured to selectively disable / enable the emission of therapeutic laser radiation and / or control the laser power and / or other operating parameters of the therapeutic laser radiation in response to the detected material type. In particular, the first optical sensor module may be configured to distinguish between biological tissue, such as soft biological tissue, and non-biological materials, particularly the surface of artificial materials, such as the internal or external surface of an endoscope. Alternatively or additionally, the first optical sensor module may be configured to detect and distinguish whether the distal end of the at least double-clad optical fiber is immersed in a liquid, particularly water or an aqueous solution such as saline or urine, or whether the distal end is immersed in air.

[0116] In some embodiments, sensor module 2300 includes a second optical sensor module, particularly a spectral sensor module, configured to perform spectral analysis on the tissue to be treated and calculate indicators of treatment progress. For this purpose, the spectral sensor may be configured to sense one or more spectral properties of radiation reflected by the tissue to be treated. The medical treatment device may also be configured to determine a metric indicating the state or progress of treatment based on the sensed one or more spectral properties. Preferably, the medical treatment device is configured to control the therapeutic laser radiation in response to the determined state or progress, particularly in response to a sensed distance and the determined state or progress.

[0117] The spectral sensor module may include a supercontinuum white light source for illumination through a single-mode core of at least double-clad optical fiber 1200. Alternatively, the spectral sensor module may include multiple WDM-multiplexed LEDs for illumination through a single-mode core of at least double-clad optical fiber 1200. The spectral sensor module may be operable to measure the reflectance state of a tissue to be treated, particularly by measuring wavelength-dependent back-reflection, such as via the multimode inner cladding of the at least double-clad optical fiber 1200. The spectral sensor module may include two or more LEDs that are switched on / off one after another, and a detector may be operable to detect the power of the back-reflected light using a simple photodetector. The detected power difference between signals at different wavelengths can be used by the control unit of the medical treatment device to estimate the reflectance state of the tissue. The spectral sensor module may measure the hemoglobin state, for example, in the range between 500 nm and 600 nm, where Hb absorbs light, by measuring the reflected light. The spectral sensor module may emit short-wavelength light, such as blue light, to excite fluorophores in the tissue and detect fluorescence. In any case, the control unit can use signals from the spectral sensor to determine the optimal settings for the treatment laser.

[0118] The following will refer to Figure 8 Embodiments of the medical treatment device 2000 are described in more detail below. As will be apparent from the following disclosure, the medical treatment device may include additional or alternative radiation sources and / or additional optical detectors.

[0119] In use, the disposable fiber optic device 1000 is detachably and optically connected to the medical treatment device 2000 via connector module 1100, and the distal end 1201 of at least double-clad fiber optic cable 1200 is inserted into the working channel of the endoscope, for example, as Figure 4 As shown in the image.

[0120] Figure 4An example of fiber optic 1200 is illustrated schematically, such as fiber optic 1200 in any embodiment of the medical laser device described herein. Figure 4 The optical fiber 1200 is shown inserted and advanced into the working channel 3100 of the endoscope 3000, particularly the cystoscope. Figure 4 In the example, the distal end 1201 of the optical fiber 1200 extends into the working channel of the endoscope. In use, the endoscope is inserted into a patient's blood vessel or organ, particularly via the urethra into the bladder. The endoscope 3000 may have the optical fiber 1200 already inserted into the working channel 3100; alternatively, the optical fiber 1200 may be inserted into the working channel 3100 after the endoscope 3000 has been inserted into the target organ or blood vessel.

[0121] Endoscopes suitable for a wide range of medical procedures are known in the art and will not be described in more detail herein. In particular, different types of endoscopes may have working channels of more or less standardized diameters. A typical working channel of an endoscope has a diameter between 1 mm and 5 mm. Some endoscopes may also include a camera 3600 and / or one or more illumination lights, such as LEDs 3500, disposed at the distal end of the endoscope 3000 to allow the physician to observe the progress of the medical procedure. In other examples, the illumination light may be fed to the distal end of the endoscope via optical fiber.

[0122] Figure 5 An example of a disposable fiber optic device 1000 according to an embodiment disclosed herein is illustrated schematically.

[0123] The disposable fiber optic device 1000 includes at least a double-clad optical fiber 1200 having a near end and a far end 1201. The far end 1201 is configured to advance through the working channel of an endoscope, for example, as in combination with... Figure 4 As described. The at least double-clad optical fiber 1200 has at least one core, an inner cladding surrounding the core, and at least one outer cladding surrounding the inner cladding. In particular, the at least double-clad optical fiber 1200 may be a double-clad optical fiber having one or more cores, inner claddings, and outer claddings.

[0124] The disposable fiber optic device 1000 also includes a connector module 1100 for optically connecting the proximal end of at least double-clad optical fiber 1200 to a medical therapeutic device. Figure 5 (not shown in the image), for example, as in combination Figure 3 As described.

[0125] exist Figure 5In one embodiment, connector module 1100 is configured to individually couple the core and inner cladding of at least double-clad optical fiber 1200 to a medical therapeutic device. Connector module 1100 includes a first optical fiber 1110, a second optical fiber 1120, a first optical connector 1111 for detachably and optically connecting the first optical fiber 1110 to the medical therapeutic device, a second optical connector 1121 for detachably and optically connecting the second optical fiber 1120 to the medical therapeutic device, and an optical combiner module 1300 configured to couple radiation between the first optical fiber 1110 and at least one core of the at least double-clad optical fiber 1200, and to couple radiation between the second optical fiber 1120 and at least one cladding of the at least double-clad optical fiber 1200.

[0126] A first optical connector 1111 is configured for detachable connection to a first mating optical connector of a medical therapeutic device, and optically couples the core of at least double-clad optical fiber to the first mating optical connector. A second optical connector 1121 is configured for detachable connection to a second mating optical connector of a medical therapeutic device, and optically couples the inner cladding of at least double-clad optical fiber to the second mating optical connector.

[0127] In some embodiments, the therapeutic laser source of the medical treatment device is optically coupled to the second optical connector 1121 of the disposable fiber optic device 1000 via a second mating optical connector. Therefore, the second optical connector is preferably configured to receive a therapeutic laser beam, particularly a therapeutic laser beam with an output power greater than 10 mW.

[0128] The sensor laser module of the medical treatment device can be optically coupled to the first optical connector 1111 of the disposable fiber optic device via a first mating optical connector. Therefore, the first optical connector is preferably configured to receive the sensor laser beam and output reflected laser radiation.

[0129] In general, a detachable connection refers to a connection that can be disconnected again during normal use by the user of the medical laser device. Specifically, a detachable connection of the optical connector of a disposable fiber optic device means that the corresponding mating connector of the medical therapeutic device connected to the optical connector is not damaged during connection or disconnection. Preferably, the optical connector of the disposable fiber optic device is also not damaged during disconnection; that is, the optical connector of the disposable fiber optic device can be reversibly and repeatedly connected to the medical therapeutic device. An optical connection means that radiation can pass between the medical therapeutic device and the corresponding optical fiber of the connector module to which the optical connector is coupled.

[0130] In general, in some embodiments, the connector module may include a housing 1170. The first optical fiber 1110, the second optical fiber 1120, and the optical combiner module 1300 may be wholly or partially housed within the housing. The housing 1170 may be a plastic housing or a housing made of another suitable material, such as a rigid or soft material. The housing may be, for example, a box made of a rigid material, or it may be provided in another form, such as as an elongated flexible sleeve. The housing may form a single compartment or multiple compartments. The housing may have one end configured to connect to a medical therapeutic device, thereby connecting the first and second optical connectors to corresponding first and second mating optical connectors of the medical therapeutic device. For this purpose, the spring-loaded first and / or second optical connectors may be directly mounted on or within the sidewall of the housing, allowing for easy and reliable connection. Alternatively, the spring-loaded first and / or second optical connectors may be mounted to the housing via one or more flexible fiber optic cables. Therefore, typically, the components of the connector module may be entirely housed in a single housing, or they may be distributed between two or more separate housings that may be interconnected via one or more fiber optic cables or other means.

[0131] Generally, the first optical connector and / or the second optical connector may be spring-loaded. Therefore, the first optical connector and / or the second optical connector may include springs or other elastic elements to hold the first or second optical connector in place when connected to a medical therapeutic device. The springs or other elastic elements may be any suitable components for applying elastic force, such as leaf springs, coil springs, etc.

[0132] The housing 1170 may include additional mechanical connectors or guides 1171, such as rails, which, for example, ensure secure attachment to the medical device by utilizing appropriate mechanical force on a spring-loaded connector, further contributing to a reliable and safe connection. For this purpose, the rail or other mechanical connector may include a locking mechanism.

[0133] The housing 1170 also includes an opening through which at least double-clad optical fibers 1200 protrude to the outside of 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 double-clad optical fibers 1200 protrude to the outside of the housing.

[0134] The first optical fiber 1110 may be a single-mode optical fiber or an optical fiber with a single-mode core (e.g., double-clad optical fiber), or it may comprise single-mode optical fiber segments. 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 therapeutic device (e.g., an interferometric distance sensor module). The first optical fiber 1110 may be a single optical fiber segment or comprise multiple optical fiber segments optically coupled to each other, for example, spliced ​​together or otherwise interconnected.

[0135] The first optical connector 1111 can be a low-reflectivity optical single-mode fiber optic connector, such as a connector that provides physical contact between the respective fiber ends of optical fibers optically connected by the optical connector (i.e., the first optical fiber 1110 and the corresponding optical fiber of the medical treatment device). In particular, the first optical connector can be an angled physical contact (APC) connector. In some embodiments, the low-reflectivity optical single-mode fiber optic connector has a reflectivity of less than -40 dB, such as -50 dB, preferably less than -60 dB, such as less than -70 dB, such as -80 dB. Generally, the first optical connector can be configured to couple few-mode or even single-mode laser radiation, particularly radiation characterized by a V number less than 10, such as less than 3, into the first optical fiber. The first optical connector can be configured to couple single-mode laser radiation with a power of less than 1 W into the first optical fiber, such as less than 200 mW, such as less than 100 mW, such as less than 10 mW, such as less than 5 mW, such as less than 2 mW.

[0136] Therefore, efficient optical coupling is provided between single-mode or few-mode fibers with minimal back reflection. This is particularly advantageous when the radiation through the core of at least double-clad fiber 1200 is laser radiation for sensor applications, especially for interferometric measurements such as interferometric distance measurements.

[0137] In general, as used herein, the term single-mode radiation or single-mode laser radiation refers to laser radiation transmitted through a single-mode fiber or other single-mode waveguide. Similarly, as used herein, the term multimode radiation or multimode laser radiation refers to laser radiation transmitted through and / or emitted from a multimode fiber or other multimode waveguide.

[0138] The second optical fiber 1120 may be a multimode optical fiber or include multimode optical fiber segments. The second optical fiber 1120 may be a single optical fiber segment or include multiple optical fiber segments optically coupled to each other, such as splicing them together or otherwise interconnecting them.

[0139] The second optical connector 1121 can be a high-power optical multimode connector, such as an SMA905 connector or a collimating beam connector. A collimating beam connector is an optical fiber connector that includes a collimating lens operable to collimate the beam exiting the optical fiber connector. Specifically, the collimating lens can be disposed within the connector housing of the connector. The collimating lens allows the collimating beam connector to mate with the corresponding collimating beam connector with particularly low power loss. Thus, a high-power connection suitable for, for example, high-power therapeutic laser radiation is provided. The second optical connector can be a freestanding optical fiber tip connector without physical contact between the fiber ends. Here, the term "high-power optical connector" is intended to refer to an optical connector suitable for optical connections of optical fibers to perform high-power laser radiation, particularly laser radiation at powers suitable for medical treatment of tissue, for example, by ablation and / or coagulation. The second optical connector 1121 can be adapted for optical connection of an optical fiber emitting laser radiation having a power of 10 mW or greater, such as 100 mW or greater, such as 200 mW or greater, such as 1 W or greater, such as 10 W or greater, such as 100 W or greater, such as 200 W or greater, such as between 10 W and 500 W. Generally, the second optical connector can be configured to couple multimode laser radiation, particularly radiation characterized by a V number greater than 10, into the second optical fiber.

[0140] Generally, the two optical connectors are operable to be interconnected via mating sleeves. Therefore, in some embodiments, each mating optical connector of the medical therapeutic device is operable to couple to an optical connector of a disposable fiber optic device, which may include or be attached to a corresponding mating sleeve. The mating sleeve of the second mating optical connector of the medical therapeutic device operable to couple to the second optical connector of the disposable fiber optic device may be at least partially made of a suitable material having a sufficiently high melting point and / or low thermal expansion to allow for high-power optical connections. Examples of suitable materials include tungsten carbide.

[0141] Generally, the first optical connector 1111 and the second optical connector 1121 provide separate optical coupling between the first optical fiber 1110 and the second optical fiber 1120 and the medical therapeutic device, respectively. Specifically, the first optical connector 1111 provides optical coupling between the first optical fiber 1110 and a corresponding first optical fiber of the medical therapeutic device, and the second optical connector 1121 provides optical coupling between the second optical fiber 1120 and a corresponding second optical fiber of the medical therapeutic device, the corresponding second optical fiber of the medical therapeutic device being different from the corresponding first optical fiber of the medical therapeutic device.

[0142] In some embodiments, the first optical connector and the second optical connector are physically separate connectors. Specifically, optical connector 1111 may have a first connector housing, such as including a first clamp, and the second optical connector 1121 may have a second connector housing different from the first connector housing, such as including a second clamp. In other embodiments, the first optical connector 1111 and the second optical connector 1121 are housed in a single connector housing, or they may be otherwise formed as a single combined connector with multiple optical termini. For example, the single connector housing may be a double-clamp connector housing with multiple optical termini, such as the Diamond DM4 connector.

[0143] The at least double-clad optical fiber 1200 can feed single-mode, low-power sensor laser radiation through its core toward the tissue to be treated. The at least double-clad optical fiber 1200 can also feed single-mode reflected radiation from its core to the medical treatment device via a first optical connector 1111. The reflected radiation can be sensor laser radiation already reflected by the distal end 1201 of the at least double-clad optical fiber 1200 and / or sensor laser radiation already reflected by the tissue to be treated and captured by the distal end 1201 of the at least double-clad optical fiber 1200. Therefore, the core of the at least double-clad optical fiber 1200 is preferably a single-mode core at least at one or more wavelengths of the sensor laser radiation. The at least double-clad optical fiber 1200 can also feed high-power multimode therapeutic laser radiation toward the tissue to be treated through its inner cladding.

[0144] For the purposes of this specification, the term "tissue to be treated" is intended to refer not only to tissue prior to treatment but also to tissue during treatment, including tissue already affected by treatment. Generally, tissue to be treated is biological tissue, such as soft tissue.

[0145] Reference Figures 6 to 7 An example of the optical combiner module 1130 is described in more detail.

[0146] Alternatively, the connector module 1100 may include additional components.

[0147] Specifically, in some embodiments, the connector module includes a temperature sensor 1161, such as 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 can be electrically connected to a medical therapeutic device via an electrical connector 1162, allowing the medical therapeutic device to monitor the temperature of the optical combiner module during operation and, optionally, control the operation of the therapeutic laser source in response to the sensed temperature. For example, the medical therapeutic device may be controlled to reduce the power and / or duty cycle of the therapeutic laser, or even shut down the therapeutic laser or turn off the shutter / optical switch, to prevent overheating of the optical combiner module 1130.

[0148] 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, for example, include a heat sink, cooling fins, and / or a heat conductor configured to transfer heat to the heat sink of the medical therapeutic device when the connector module is connected to the medical therapeutic device.

[0149] Alternatively or additionally, the disposable fiber optic device 1000, particularly the connector module 1100, may include an RFID chip 1140 or other form of device identifier, such as a wirelessly readable ID tag, to allow the medical therapeutic device to automatically register the identifier of the disposable fiber optic device 1000. This can be advantageous when the medical therapeutic device is configured to operate with different types of disposable fiber optic devices. It allows the medical therapeutic device to adapt one or more of its operating parameters to the specific type of disposable fiber optic device being connected.

[0150] Figure 6 An example of an optical combiner module 1130 of a connector module of a disposable fiber optic device according to an embodiment disclosed herein is illustrated.

[0151] According to the embodiments disclosed herein, the optical combiner module 1130 couples the radiation between the first optical fiber 1110 of the connector module and the core of the at least double-clad optical fiber 1200 of the disposable optical fiber device. The optical combiner module 1130 further couples the radiation between the second optical fiber 1120 of the connector module and the cladding (particularly the inner cladding) of the at least double-clad optical fiber 1200.

[0152] Therefore, the first optical fiber 1110 can be a single-mode optical fiber at least at one or more target wavelengths, and the second optical fiber 1120 can be a multimode optical fiber.

[0153] The optical combiner module 1130 includes at least a double-clad fiber segment 1135 having a core and a cladding. The core of the at least double-clad fiber segment 1135 is a few-mode fiber, preferably a single-mode core at the target wavelength of radiation received via the first fiber. The at least double-clad fiber segment 1135 may include a low-refractive-index acrylate coating and optionally has a fluorinated silica (F-SiO2) cladding. The core of the at least double-clad fiber segment may have 5... m and 10 The diameter is between m and / or the numerical aperture is between 0.07 and 0.15. At least the core of the double-clad fiber segment is at the wavelength of the sensor's laser radiation. sensor The V value is V < 10 @ sensor Preferably, V < 8 @ sensor , such as V < 7 @ sensor For example, V < 2.4 @ sensor .

[0154] The V-number is a dimensionless parameter commonly used in optical fibers, such as step-index fibers. It is a normalized frequency parameter that determines the mode number of an optical fiber (such as a step-index fiber). It is defined as: in, It is the vacuum wavelength. a It is the radius of the fiber core, and NA It is the numerical aperture. n core and n cladding These refer to the refractive indices of the core and the inner cladding, respectively.

[0155] For the purposes of this specification, unless otherwise stated, the terms single-mode fiber and single-mode core refer to fiber and core with a V number less than 2.4 at the relevant wavelength, respectively. The terms few-mode fiber and few-mode core refer to fiber and core with a V number greater than 2.4 and less than 10 at the relevant wavelength, respectively. The terms multimode fiber and multimode core refer to fiber and core with a V number greater than 10, respectively.

[0156] The optical combiner module 1130 also includes a first splice point 1136 that couples radiation between the core of the first optical fiber 1110 and the core of at least a double-clad optical fiber segment 1135. The first splice point 1136 may be provided with a cladding mode canceller configured to remove multimode radiation returning to the first optical fiber 1110. Alternatively or additionally, the first splice point 1136 may be provided with a scattering surface or a high-refractive-index adhesive and / or coating.

[0157] The optical combiner module 1130 also includes a multimode fiber segment 1137 and a second splice point 1138, which couples the radiation between the second fiber 1120 and the multimode fiber segment 1137. The multimode fiber segment 1137 may have a core diameter between 50 μm and 100 μm and / or a numerical aperture of 0.27 or less, for example, 0.22 or less. The core of the multimode fiber segment 1137 may have a V number V > 10.

[0158] The optical combiner module 1130 also includes an optical fiber combiner 1132 configured to couple radiation between a multimode fiber segment 1137 and the inner cladding of at least a double-clad fiber segment 1135. The optical fiber combiner 1132 can be a lateral combiner, sometimes referred to as a side pump combiner; that is, the combiner is configured to laterally couple radiation between the multimode fiber segment 1137 and the inner cladding of at least a double-clad fiber segment 1135, while the core of the at least double-clad fiber segment passes through the lateral combiner. Therefore, the lateral combiner couples / fused the multimode secondary fiber (here, the multimode fiber segment 1137) at an angle to the circumferential outside of the through primary fiber (here, the at least double-clad fiber segment 1135). Preferably, the diameter of the secondary fiber is smaller than the diameter of the primary fiber. For example, the double-clad feedthrough fiber can have a diameter of 200 μm (or another suitable diameter), and the secondary fiber can have a fiber diameter of 125 μm (or another suitable diameter smaller than the feedthrough double-clad fiber). Side coupling can cause an upconversion of the numerical aperture (NA) of the multimode inner cladding of the at least double-clad fiber segment 1135, and thus an upconversion of the NA in the at least double-clad fiber 1200, for example, from 0.22 to about 0.45. This, in turn, results in a larger spot size of the therapeutic laser radiation on the tissue to be treated. Furthermore, the side combiner allows sensor laser radiation propagating in the core of the at least double-clad fiber segment to pass through the side combiner without reflections caused by splicing, etc.

[0159] The optical coupler module 1130 also includes a third splice point 1134 for coupling at least double-clad fiber segment 1135 to the near end of at least double-clad fiber 1200, particularly for coupling the core and cladding of the respective fiber.

[0160] Figure 7 This schematically illustrates another example of an optical combiner module 1130 of a connector module for a disposable fiber optic device according to embodiments disclosed herein. The optical combiner module 1130 is related to... Figure 6 The optical combiner module is similar in that it includes at least a double-clad fiber segment 1135, a multimode fiber segment 1137, a fiber combiner 1132, a first splicing point 1136, a second splicing point 1138, and a third splicing point 1134, all of which are combined as shown in the figure. Figure 6 As described.

[0161] Figure 7 Optical combiner module and Figure 6 The difference in the optical combiner module is that it is configured to couple the first optical fiber 1110 and the second optical fiber 1120 to the multi-core, at least double-clad optical fiber 1200, respectively. Figure 7 The optical combiner module is used in embodiments of disposable fiber optic devices that include multi-core, at least double-clad optical fibers.

[0162] In some embodiments, this can be omitted. Figure 6 and Figure 7 One or more of the splicing points shown. For example, at least double-clad fiber segment 1135 may be formed from the near end of at least double-clad fiber 1200. Alternatively or additionally, multimode fiber segment 1137 may be part of the attachment of second fiber 1120 to a second optical connector.

[0163] Refer again Figure 7 The optical combiner module 1130 of this embodiment also includes a gradually narrowing fiber region 1220 at the near end of the at least double-clad fiber 1200. The gradually narrowing fiber region 1200 is configured to couple radiation between a single core of the at least double-clad fiber 1200 and one or more additional cores of the at least double-clad fiber 1200. The gradually narrowing region 1220 can be encapsulated in a hoop, wherein air surrounds the gradually narrowing waist to achieve a high numerical aperture, thereby supporting upconverted cladding radiation.

[0164] Figure 8 A more detailed example of a medical laser device according to embodiments disclosed herein is illustrated schematically.

[0165] The medical laser device includes a medical treatment device 2000 and a fiber optic device 1000, all of which are combined... Figure 1 and Figure 7 As described.

[0166] An exemplary medical laser device is configured for treating bladder cancer using laser ablation and / or coagulation via a cystoscope. However, it should be understood that other embodiments of the medical laser device may be configured for use in other types of medical procedures and / or for use with other types of endoscopes.

[0167] The medical treatment device 2000 includes various laser sources, optical detectors, and accompanying control circuits, user interfaces, etc. The medical treatment device 2000 can be implemented such that all its modules are housed in a single housing, or that the corresponding modules are housed in different housings.

[0168] The medical treatment device 2000 includes a user interface module 2110, which includes, for example, a display, such as a touch-sensitive display, and suitable user input devices, such as a keyboard, touchscreen, etc., to allow an operator to control user-controllable functions of the medical treatment device and to allow the medical treatment device to output treatment-related information. In some embodiments, the user interface module includes audible and / or visual power / progress indicators configured to output audible and / or visual indications of the current laser power of the treatment laser radiation or the current state of the treatment. For example, the power indicator may indicate the output power of the treatment laser or the measured treatment state, allowing the physician to know when to move the fiber to the next spot. The audible indicator may indicate the power level or treatment state by the volume or pitch of an audible signal, by the repetition rate of a repeated tone, or by another suitable method.

[0169] The medical treatment device 2000 may also include one or more control devices 2120, such as foot pedals, for example, to allow a physician to activate a treatment laser while manipulating a cystoscope.

[0170] The medical treatment device also includes a control unit 2400, which is electrically and / or otherwise communicatively connected to the user interface module 2110 and the one or more control devices 2120. The control unit 2400 includes circuitry configured to control various optical treatment and / or sensor modules of the medical treatment device. Specifically, the control unit may be configured to control a therapeutic laser source, a sensor laser source, and / or other radiation sources and / or sensors in response to input received from the user interface module and / or the one or more control devices. The control unit may also control the therapeutic laser source, 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, as well as a processing unit, such as a suitable programmable central processing unit.

[0171] The medical treatment device 2000 includes a therapeutic laser source 2200 configured to output therapeutic laser radiation, particularly suitable for treating tumor tissue of the bladder by ablation and / or coagulation. The therapeutic laser radiation from the therapeutic laser source 2200 is preferably fed through a second optical connector 1121 and the cladding of at least double-clad optical fiber 1200 of a disposable optical fiber device 1000.

[0172] The medical treatment device also includes a sensor module 2300. The sensor module includes a first optical sensor module 2310, which is configured for interferometric distance sensing of the distance between the distal end of at least double-clad optical fiber 1200 and the tissue to be treated.

[0173] Preferably, the medical treatment device 2000 can be configured to control the treatment laser source 2200 in response to a sensed distance between the distal end of the at least double-clad optical fiber 1200 and the tissue to be treated, for example by reducing the output power and / or duty cycle of the treatment laser radiation, or even shutting off the treatment laser radiation when the fiber tip is close to the tissue. This can prevent unintentional damage to the tissue to be treated.

[0174] Interferometric distance sensing can be performed using broadband interferometry, such as that known from optical coherence tomography (OCT). For this purpose, the first optical sensor module may include a suitable sensor laser source 2311 configured to output single-mode laser radiation at a suitable wavelength selected, for example, in the range of 800 nm to 1100 nm. In applications such as cystoscopy, it is preferable that the wavelength of the sensor laser radiation is selected at a low water absorption wavelength, such as less than 900 nm or about 1050 nm. The sensor laser radiation may have an output power much smaller than that of the therapeutic laser radiation, for example, at least two or three orders of magnitude smaller.

[0175] The first optical sensor module 2310 also includes a spectrometer 2312 to perform broadband interferometric measurements. For this purpose, the first optical sensor module receives reflected radiation via a disposable fiber optic device, specifically reference radiation reflected by the tip of the at least double-clad fiber 1200 and radiation reflected by the tissue to be treated and captured by the tip of the at least double-clad fiber 1200. Based on the reflected radiation, the medical treatment device determines the distance between the distal end of the at least double-clad fiber 1200 and the tissue to be treated in a manner known in the art. Therefore, the first optical sensor module 2310 can output sensor laser radiation via a single-mode or few-mode core of the at least double-clad fiber and receive reflected radiation via a single-mode or few-mode core of the at least double-clad fiber as the basis for distance measurement.

[0176] Various embodiments of the interferometric distance sensor of the first optical sensor module 2310 provide an axial resolution between 5 μm and 200 μm, such as between 10 μm and 150 μm, for example between 50 μm and 100 μm.

[0177] The interferometric distance sensor of the first optical sensor module 2310 can be implemented in different ways. In some embodiments, the interferometric distance sensor employs a spectral-domain OCT using an SLED and a spectrometer. The inventors have found that such a system provides sufficient axial resolution, where the bandwidth of the SLED is approximately 10 nm–30 nm. Therefore, the spectrometer only needs to cover a relatively small bandwidth. Preferably, the spectrometer has a resolution between 0.01 nm and 0.05 nm, thereby obtaining a sufficient axial range suitable for distance measurement during treatment. The interferometric distance sensor can be manipulated at wavelengths in the range of approximately 800 nm to approximately 900 nm, where the CMOS detector / spectroscopy has good sensitivity and InGaAs or GaAs SLEDs are readily available. This maximum axial range of the distance sensor can be between approximately 3 mm and 10 mm, such as between approximately 3 mm and 9 mm.

[0178] In an alternative embodiment, the interferometric distance sensor can employ spectral-domain OCT using a swept-source laser and detector. This embodiment has the advantage of extending the maximum axial range to between approximately 10 mm and 20 mm. This embodiment can be implemented similarly to a conventional swept-source OCT system, where data acquisition is synchronized with laser scanning. The scanning range can be selected between 10 nm and 40 nm, such as approximately 20 nm or less, and the scanning frequency can be selected between 1 kHz and 100 kHz, such as 10 kHz or less.

[0179] To accommodate measurements via an optical fiber that travels through a flexible endoscope that bends and moves during treatment, various embodiments of the interferometric distance sensor employ common-path interferometry, where at least a double-clad optical fiber 1200 serves as both a reference path and a sample path. Reflections from the distal end of the at least double-clad optical fiber are used as a reference signal. This avoids the need for a separate reference arm, thereby reducing system complexity and cost.

[0180] 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 can be obtained by selecting a suitable fiber tip at the distal end of at least a double-clad fiber, for example, at an angle between 2 and 10 degrees, depending on the fiber type and laser power.

[0181] In various embodiments, radiation from the sensor laser source 2311 of the interferometric distance sensor 2310, as well as back-reflected radiation, is fed through a single-mode core of at least double-clad optical fiber 1200 and through a first optical connector 1111 of a disposable fiber optic device 1000. The inventors have recognized that the signal path from the spectrometer of the interferometric distance sensor to the distal end of the at least double-clad optical fiber has a low back-reflection loss, preferably less than -60 dB. Therefore, in some embodiments, the sensor signal for interferometric distance measurement, through which it is fed, is preferably a low-reflection connector, such as a fiber optic connector with physical contact between the fibers, optionally an angled connector, such as an E2000 connector.

[0182] In some embodiments, the interferometric distance sensor can also be used to detect whether the connected optical fiber is immersed in a liquid such as water, saline solution, or urine. When the connected optical fiber is immersed in such a liquid, the level of the returned light reflected from the output surface of the connected optical fiber decreases as described herein. This decrease is observable over a wide wavelength range and can therefore be detected by the interferometric distance sensor as a decrease in the intensity of the reflected light over a wide wavelength range, thus serving as a reliable indicator that the fiber tip is immersed in water, saline solution, urine, etc.

[0183] Sensor module 2300 may preferably include a second optical sensor module 2320 configured for spectral analysis of the tissue to be treated. Specifically, the spectral properties of the radiation reflected by the tissue to be treated can be used as an indicator of treatment progress. For this purpose, the medical treatment device may be configured to use reflectance spectroscopy, such as white light reflectance spectroscopy, to measure tissue state.

[0184] When tissue is treated with light, it changes from an absorptive state to a more scattering state. Lower wavelength light will be reflected more than longer wavelength light, and the scattering state of the tissue can be estimated by measuring the difference in reflected power at one or more wavelengths. Measuring the power difference between two or more wavelengths of back-reflected radiation produces a measurement of the tissue's photocoagulation state, and thus a measurement of the treatment status or progress. Therefore, in various embodiments, the medical treatment device is configured to monitor the coagulation state induced by the therapeutic laser using reflectance spectroscopy.

[0185] In some embodiments, the second sensor module 2320 includes an illumination source using a supercontinuum laser, for example covering a wavelength range between 400 nm and 1100 nm, such as between 400 nm and 800 nm. Alternatively, the illumination source may use one or more monochromatic LEDs having their own wavelengths, such as 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 between 400 nm and 700 nm.

[0186] In any case, the second optical sensor module 2320 is configured to receive radiation reflected by the tissue to be treated. Therefore, the second optical sensor module 2320 may include a suitable detector for measuring the reflected radiation. The detector may, for example, include a grating CCD / CMOS spectrometer, having a resolution up to 1 nm to cover a suitable wavelength range, such as between 400 nm and 1100 nm, or between 400 nm and 800 nm. Alternatively, the detector may include a photodetector that can be time-multiplexed with multiple LEDs.

[0187] To maintain a good signal intensity of the radiation reflected from the tissue, it is preferable that the illumination light passes through the first optical connector 1111 and through the single-mode core of the at least double-clad fiber 1200 of the disposable fiber optic device 1000; that is, the illumination light shares the same path through the disposable fiber optic device as the interferometric distance measurement radiation. Spectroscopy is a non-interferometric measurement method and is therefore more noise-limited than interferometric distance measurement. Therefore, in various embodiments, the multimode cladding of the at least double-clad fiber 1200 of the disposable fiber optic device 1000 captures the reflected light of the spectral illumination; that is, the second optical sensor module 2320 receives the radiation reflected from the tissue to be treated in response to illumination from the illumination source of the second optical sensor module 2320 via the cladding of the at least double-clad fiber 1200 and via the second optical connector 1121 of the disposable fiber optic device 1000.

[0188] Therefore, the medical laser device can display or otherwise output progress indications, or even automatically control the therapeutic laser source 2200, for example, to prevent unintentional overtreatment that may otherwise cause undesirable tissue damage. In some embodiments, the second optical sensor module 2320 can output sensor laser radiation via a single-mode or few-mode core of at least double-clad optical fiber, and receive reflected sensor laser radiation via a single-mode or few-mode core of at least double-clad optical fiber or via a multimode cladding. The wavelengths used for spectral analysis can preferably be selected at low water absorption wavelengths, such as wavelengths less than 900 nm or about 1050 nm. In particular, in some embodiments, the wavelengths used for spectral analysis can preferably be selected such that they correspond to the maximum absorption of hemoglobin and / or another suitable molecular marker.

[0189] In some embodiments, the medical treatment device may include additional or alternative optical components, such as one or more of the following other components. Some embodiments of the medical treatment device 2000 include at least one additional treatment laser 2610, configured, for example, for cutting tissue rather than for ablation and / or coagulation. The cutting laser may output treatment laser radiation of a suitable wavelength, such as infrared radiation like 1940 nm, which is absorbed by water. The treatment laser radiation from the cutting laser 2610 is preferably fed through the cladding of the second optical connector 1121 and at least double-clad optical fiber 1200 of the disposable fiber optic device 1000. In some embodiments, the output of the additional treatment laser 2610 is configured to be absorbed by water near the tissue to be treated and to facilitate removal of the treated tissue from the treatment site. For this purpose, the additional treatment laser 2610 may be configured to output treatment laser radiation with a wavelength between 1000 nm and 2000 nm, such as between 1200 nm and 2000 nm.

[0190] Alternatively or additionally, the medical treatment device 2000 may include a Raman sensor 2620 or other suitable sensors configured to determine the nature of a tumor to be treated. The Raman sensor may, for example, employ a 785 nm, 300 mW Raman laser. Sensor laser radiation from the Raman laser is preferably fed through a first optical connector 1111 of a disposable fiber optic device 1000 and a single-mode core of at least double-clad fiber optic cable 1200. Return radiation to the Raman sensor is preferably fed through the cladding of at least double-clad fiber optic cable 1200 and a second optical connector 1121 of the disposable fiber optic device 1000.

[0191] However, alternatively or additionally, the medical treatment device may include a guiding light source, such as a guiding laser source or other type of light source adapted to emit visible light suitable as a guiding beam to illuminate a portion of the tissue to be treated and to serve as aiming guidance for a physician or other user of the device. The guiding beam may be fed through at least double-clad optical fiber 1200, for example through the core and / or inner cladding of at least double-clad optical fiber 1200. In some embodiments, the guiding beam may be multicolor. In particular, the guiding beam may include two or more color components detectable by a camera of the medical laser device, for example, including at least two detectable color components spaced 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 greater, wherein the intensity of the emitted guiding light may be substantially uniform across the entire bandwidth or vary across the bandwidth. The two detectable color components can each have a sufficiently high intensity so that they can be detected by a camera or similar detector of a medical laser device, such that the spot illuminated by the guide beam is visible to a human observer in the camera image as an illuminated spot of color produced by the mixture of the at least two color components, for example as a white or substantially white spot.

[0192] In some embodiments, the medical laser device includes 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 includes a user input device, such as a button, configured to receive user input from a patient during treatment using the medical laser device. The user input may indicate pain or discomfort experienced by the patient during treatment. Therefore, if the patient experiences pain or discomfort during treatment, the patient may be instructed to press the button. In some embodiments, the user input device may be configured to measure the force or pressure applied to the user input. Thus, the medical treatment device can obtain the degree of pain or discomfort from the measured force or pressure. Therefore, the control unit 2400 of the medical treatment device may be configured to select the laser power or pulse duration or another operating parameter of the treatment laser radiation, at least in part, in response to the received user input. To this end, the control unit may compare information from the user device with the current, calculated, or selected operating parameters of the treatment laser radiation and adjust the operating parameters to minimize the patient's pain. For example, the control unit may compare information from the user device with the current, calculated, or selected laser power and adjust the maximum power of the treatment laser radiation to minimize the patient's pain.

[0193] In some embodiments, the medical treatment device 2000 further includes an optical combiner module 2700 having an optical interface to a treatment laser source 2200, a first optical sensor module 2310 having an interferometric distance sensor, and an optional second optical sensor 2320. In embodiments with additional optical treatment and / or sensor units, the optical combiner module also has an optical interface to any such unit, such as an optical interface to a cutting laser 2610 and / or a Raman sensor 2620.

[0194] As described above, the therapeutic laser source 2200 emits relatively high-power therapeutic laser radiation to be fed through the multimode cladding of at least two double-clad optical fibers. Simultaneously, the interferometric distance sensor of the first optical sensor module 2310 emits and receives low-power radiation through the single-mode or few-mode core of the at least double-clad optical fiber. The second optical sensor module 2320 emits radiation to be fed through the single-mode or few-mode core of the at least double-clad optical fiber 1200 of the disposable optical fiber device, and receives radiation through the cladding of the at least double-clad optical fiber 1200 of the disposable optical fiber device.

[0195] Therefore, the optical combiner module 2700 is configured to combine optical paths fed through the core of the at least double-clad fiber 1200 via the first optical connector 1111 of the disposable fiber optic device 1000. The optical combiner module 2700 is also configured to combine optical paths fed through the cladding of the at least double-clad fiber 1200 via the second optical connector 1121 of the disposable fiber optic device 1000. For this purpose, the optical combiner module 2700 may include a suitable fused fiber combiner for coupling signal paths fed through the single-mode core of the at least double-clad fiber 1200. Similarly, the optical combiner module may include suitable free-space components, lenses, and dichroic filters to perform multimode power and wavelength splitting / combining of radiation fed through the cladding of the at least double-clad fiber 1200.

[0196] The optical combiner module 2700 includes two optical interfaces to be coupled to a one-time fiber optic device 1000: a single-mode or few-mode interface 2810 (e.g., characterized by a V number less than 10) and a multimode interface 2820 (e.g., characterized by a V number greater than 20).

[0197] Generally, the optical combiner module may include one or more fused fiber couplers configured to multiplex sensor laser radiation from an interferometric distance sensor with sensor laser radiation from a spectral sensor into an optical fiber that is single-mode at least at the wavelength of the interferometric distance sensor's sensor laser radiation. Specifically, the wavelength of the interferometric distance sensor's sensor laser radiation may differ from the wavelength of the spectral sensor. The fiber coupler may be a fused 3 dB coupler.

[0198] In various embodiments, the optical combiner module can be configured to multiplex multimode therapeutic laser radiation and multimode sensor radiation into a multimode optical fiber. For this purpose, the optical combiner module may include a free-space component comprising one or more lenses and one or more dichroic mirrors. The multimode sensor radiation may include multimode response radiation that has been reflected by the tissue to be treated in response to irradiation by the sensor laser radiation emitted by the spectral sensor module.

[0199] The medical laser device preferably includes a sacrificial interface module 2800, which has corresponding optical interfaces for connection to a single-mode or few-mode interface 2810 and a multimode interface 2820, respectively. The sacrificial interface module 2800 optically connects the single-mode or few-mode interface 2810 to a first mating optical connector 2101, to which a first optical connector 1111 of a disposable fiber optic device 1000 can be connected. Furthermore, the sacrificial interface module 2800 optically connects the multimode interface 2820 to a second mating optical connector 2102, to which a second optical connector 1121 of the disposable fiber optic device 1000 can be connected. During operation of the medical laser device, different disposable fiber optic devices can be interchangeably connected to the first mating optical connector 2101 and the second mating optical connector 2102 of the sacrificial interface module 2800, because the disposable fiber optic device 1000 is typically a single-use device that is replaced by a new disposable fiber optic device between treatments. The first and second mating optical connectors of the sacrificial interface may be subject to wear. Therefore, the relatively easy-to-replace sacrificial interface module 2800 facilitates the maintenance of the medical treatment device 2000.

[0200] It should be understood that radiation from / to the corresponding optical modules of a medical treatment device does not necessarily need to be simultaneously fed through a disposable fiber optic device. Instead, at least some of the radiation is time-division multiplexed in a suitable manner to avoid them interacting with each other in undesirable ways. The following will refer to... Figure 9 A more detailed example of time-division multiplexing operations.

[0201] Various embodiments of operating a medical laser device will now be described. Generally, in each embodiment, the medical laser device includes a control unit configured to emit therapeutic laser radiation from a distal end toward tissue in the urethra in response to received user input.

[0202] In some embodiments, the medical laser device includes a control unit configured to, in response to received user input, be capable of: 1) Activate the first optical sensor module, particularly the interferometric distance sensor, to sense the distance between the distal end of the at least double-clad optical fiber and the tissue to be treated; and / or 2) Activate the second optical sensor module, particularly the spectral sensor, to detect one or more spectral properties of the tissue to be treated; 3) and control the therapeutic laser source at least in part based on the sensed distance and / or detected properties and in accordance with one or more safety conditions / indicators.

[0203] Specifically, the control module may be configured to receive at least one sensor signal from the first optical sensor module and / or the second optical sensor module, and to enable the output of therapeutic laser radiation via at least one optical port (particularly via the optical output port) only when the at least one sensor signal indicates that the fiber optic device is coupled to one or more of the optical connectors / optical output ports of the medical treatment device and the distal end of the fiber is positioned in a safe location, as described in more detail below.

[0204] Controlling a therapeutic laser source at least in part based on sensed distance and / or detected properties may include: a control unit selecting a laser power and / or another operating parameter for the therapeutic laser radiation at least in part based on the sensed distance and / or detected properties, and controlling the therapeutic laser source to emit the therapeutic laser radiation with the selected laser power and / or the selected other operating parameters. Examples of other operating parameters may include the duty cycle of the laser pulse train, pulse width, etc., the emission duration of the therapeutic laser radiation, etc. The control unit may be configured to control the therapeutic laser source at least in part based on the sensed distance and / or detected properties in order to control the laser energy deposited at the treatment site.

[0205] Preferably, the control unit is configured to repeat actions 1) to 3) upon receiving the user input or until a termination input is received.

[0206] In this regard, the control unit can be configured to automatically control the therapeutic laser source, at least in part, based on sensed distance and / or detected properties, or the control unit can be configured to perform the control in an operator-assisted manner. For example, the control unit can be configured to: i) Calculate or otherwise select the laser power and / or another operating parameter for therapeutic laser radiation, at least in part, based on the sensed distance and / or the detected properties; ii) Display or otherwise communicate the calculated or otherwise selected laser power and / or other operating parameters to the operator of the device, and request approval / manual activation of the displayed / communicated values, and / or allow the operator to manually change and activate these values. iii) Control the treatment laser source at least in part according to the laser power and / or other operating parameters approved by the operator or modified by the operator.

[0207] In the various embodiments described herein, the use of the same at least double-clad optical fiber for time-division multiplexing of therapeutic laser radiation and optical measurements based on sensor laser radiation allows the fiber to be very thin while avoiding harmful interference between the sensing system and the therapeutic laser, such as harmful interference caused by reflected therapeutic laser radiation striking the detector of the sensor module. Specifically, in various embodiments, the medical laser device is configured to time-division multiplex interferometric distance sensor signals, spectral sensor signals, and therapeutic laser radiation for use in surgical procedures, particularly minimally invasive procedures, such as ablation and / or coagulation of cancers in the urethra, especially the bladder.

[0208] User input and / or stop signals can be received via a foot pedal or other suitable user-activated input device.

[0209] To effectively perform time-division multiplexing, medical therapeutic devices can operate to switch various laser sources sufficiently quickly, such as within 1 ms or faster. For this purpose, when one or more laser sources (e.g., therapeutic laser sources) are diode lasers, rapid switching can be performed by directly switching the drive current. When the interferometric distance sensor includes an SLED or swept-frequency light source, or when the spectral sensor includes a supercontinuum laser, these may require alternative switching methods to achieve rapid switching, as such lasers may require time to stabilize upon turn-on. Therefore, switching can be performed, for example, by an acousto-optic tunable filter (AOTF), a MEMS-based device, or another suitable method. Such external switching may cause reflections. Therefore, when switching the sensor laser radiation used for the interferometric distance sensor, it can preferably be arranged between the sensor laser source and the coupler / circulator for the receiver. In the spectral engine, the switching can be located on the laser output.

[0210] In some embodiments, the control unit is configured to receive information about a disposable fiber optic device connected to a medical treatment device, and is configured to select a laser power at least in part based on a user-selected laser power, a sensed distance, and the received information about the disposable fiber optic device connected to the medical treatment device.

[0211] In some embodiments, the control unit is configured to output an operable camera control signal to control the operation of the endoscope's camera. The control unit is configured to synchronize the camera's operation with the operation of the therapeutic laser source, such that image data is recorded only when the medical laser device is not emitting therapeutic laser radiation or is emitting therapeutic laser radiation only at a significantly reduced intensity. Specifically, the reduced intensity is minimized so that the reduced therapeutic radiation does not unduly affect the camera image. For this purpose, the therapeutic laser radiation can be reduced to 5% or less of the intensity of the therapeutic laser radiation during the previous treatment cycle, for example, to 1% or less.

[0212] In some embodiments, the control unit is configured to control the laser power of the therapeutic laser radiation in response to the detected material type. For this purpose, the first optical sensor module may also be configured to detect and distinguish multiple different types of material located in front of the distal end of at least a double-clad optical fiber.

[0213] Figure 9 The illustration schematically depicts examples of the operation of medical laser devices according to various embodiments disclosed herein, such as the medical laser devices described in conjunction with one or more of the foregoing figures, particularly devices for treating the urethra, especially the bladder. The process is controlled by a control unit of the medical laser device.

[0214] Initially, the medical treatment device can operate in a non-activation mode. In non-activation mode, neither the emission of sensor laser radiation nor the emission of the treatment laser radiation source is enabled.

[0215] In response to user input activation of the medical treatment device, the device can operate in a safe mode. Activation via user input may involve, for example, the user pressing a button or selecting an operating mode. In some embodiments, operation of the device in safe mode is enabled only if the device detects that the fiber optic device is actually connected to the medical treatment device. In safe mode, the interferometric distance sensor module of the medical treatment device can be activated, and sensor laser radiation 4100 is fed through at least a double-clad fiber optic cable connected to the disposable fiber optic cable of the medical treatment device. The interferometric distance sensor module also receives reflected radiation received by the distal end of the at least double-clad fiber optic cable in response to the emitted sensor laser radiation. The medical treatment device is configured to analyze the received reflected radiation to detect whether the distal end is immersed in a liquid, particularly water, saline, and / or urine, and / or whether the distal end is positioned near a surface other than biological tissue. If the distal end is near a surface other than biological tissue, or if the distal end is not immersed in a liquid, particularly water, the control unit can prevent the medical treatment device from emitting therapeutic laser radiation. Detection of surfaces outside biological tissue can indicate that the distal end of at least double-clad optical fibers has not been inserted into the endoscope or has not at least not fully passed through the endoscope's working channel, or that the endoscope has been bent such that the distal end is actually being guided toward the outside of the endoscope. Therefore, preventing the medical treatment device from emitting therapeutic laser radiation in this situation prevents unintentional damage to the endoscope or other surfaces caused by the therapeutic laser radiation.

[0216] The failure to detect liquid (especially water) can indicate that the distal end of at least double-clad optical fibers has not been positioned close to the treatment site, particularly not yet inserted into the bladder. In this case, preventing the medical treatment device from emitting therapeutic laser radiation prevents unintentional damage to tissues other than the intended target tissue.

[0217] Preventing the emission of therapeutic laser radiation may include preventing the therapeutic laser source from being powered on and / or preventing a suitable shutter / optical switch from being opened or preventing the emission of therapeutic laser radiation in another suitable manner.

[0218] The control unit allows the medical device to exit safety mode and enter treatment mode, specifically only when the medical device detects biological tissue near the distal end of at least double-clad optical fibers and water between the distal end and the detected biological tissue.

[0219] When operating in treatment mode, the output of therapeutic laser radiation is enabled; that is, the operator can initiate the emission of therapeutic laser radiation by activating a suitable user input device (e.g., a foot pedal). When the user input device is activated, for example, as long as the foot pedal remains active, the control unit receives an activation signal 4200. In some embodiments, each activation of the foot pedal can cause the emission of a single pulse of therapeutic laser radiation (or another predetermined number of pulses), for example, corresponding to a predetermined (e.g., user-selected) amount of laser energy to be delivered to the tissue to be treated (e.g., a predetermined amount of laser energy per unit area).

[0220] In response to the activation signal, the control unit can repeatedly execute the treatment cycle, for example, as soon as the activation signal 4200 is received or until the termination signal is received, or for a predetermined duration, such as to emit a single pulse of laser radiation.

[0221] In some embodiments, during each treatment cycle, the control unit initially causes the interferometric distance sensor to emit sensor laser radiation 4110 and senses the distance between the distal end of at least double-clad optical fiber and the tissue to be treated. The distance sensor may perform one or more distance measurements during a suitable measurement cycle (e.g., 10 ms or less). For example, the control unit may calculate the average of multiple distance measurements. If the interferometric distance sensor detects that the surface in front of the distal end is a surface other than biological tissue, or if the distal end is not immersed in liquid, particularly water, the control unit causes the medical treatment device to exit the treatment mode and return to a safety mode.

[0222] Otherwise, upon completion of the distance measurement, the control unit deactivates the sensor laser radiation from the interferometric distance sensor and activates the spectral sensor to emit spectral sensor laser radiation 4310. The spectral sensor receives light reflected by the tissue to be treated in response to irradiation with the spectral laser radiation and determines the status / progress of the treatment, for example, based on the absolute or relative reflection intensity or power in one or more wavelength bands, such as at the emission peak of hemoglobin or another suitable molecular marker indicating the progress of laser treatment. The spectral measurement can be sustained for a suitable measurement period, such as 10 ms or less. The control unit can then deactivate the sensor radiation from the spectral distance sensor.

[0223] Based at least in part on the determined distance and / or the determined progress, in step 4410, the control unit determines the power and / or duty cycle or other suitable parameters of the therapeutic laser radiation to be emitted. For example, if the measured distance is small, the control unit can select a smaller power and / or duty cycle, and if the measured distance is large, a larger power and / or duty cycle can be selected. If the detected distance is less than a safety threshold, the control unit can even prevent the emission of the therapeutic laser radiation.

[0224] In some embodiments, the selection of the power (or other suitable parameter) of the therapeutic laser radiation can be further based on a user-selected baseline power (or other suitable parameter). For example, the control unit can automatically adjust the baseline power in response to a detected distance, such as reducing the laser power relative to the baseline power in response to a decreasing distance.

[0225] Alternatively or additionally, the control unit may select the power, duty cycle and / or other suitable parameters of the therapeutic laser radiation in response to the detected treatment status / progress, such as reducing the laser power and / or duty cycle in response to increased progression.

[0226] The control unit can further receive information about the characteristics of the disposable fiber optic device currently connected to the medical treatment equipment, for example, by reading ID tags, such as RFID tags, QR codes, or other machine-readable identifiers. Therefore, the control unit can select the laser power from a preset baseline power at device activation and the received information about the characteristics of the disposable fiber optic device, based on sensor data from a distance sensor (and optionally, sensor data from a spectral sensor). The information about the characteristics of the disposable fiber optic device may include, for example, information about the fiber diameter, numerical aperture, etc.

[0227] Subsequently, the control unit controls the therapeutic laser source to emit therapeutic laser radiation 4510 at a selected power. For this purpose, the control unit can control the therapeutic laser source to output therapeutic laser radiation at a suitable output power, for example, a selected output power within an interval between 10 W and 2200 W or in another suitable interval. In some embodiments, the therapeutic laser radiation can be emitted as a pulse train of therapeutic laser pulses. The pulses can have a pulse duration between 1 ms and 10 ms or another suitable pulse duration. The control unit can control the therapeutic laser to emit therapeutic laser radiation within a predetermined treatment cycle (e.g., a pre-configured duration or user-selected), or the treatment cycle can be automatically selected at least in part based on sensed distance and / or detected progress. In some embodiments, the treatment cycle can correspond to 5 to 100 laser pulses, for example, 10 to 20 pulses. At the end of the treatment cycle, the control unit deactivates the emission of the therapeutic laser radiation.

[0228] At the end of the treatment cycle, the control unit again controls the interferometric distance sensor to perform distance measurement by emitting the corresponding sensor laser radiation 4120, followed by spectral measurement 4320, as described above.

[0229] Based at least in part on the determined distance and / or determined progress, in step 4420, the control unit determines the power, duty cycle, and / or other suitable parameters of the therapeutic laser radiation to be emitted during subsequent treatment cycles. In some embodiments, the determination of the laser power (or other parameters) is based not only on the most recent measurement but also on measurements taken during one or more previous treatment cycles. For this purpose, the control unit may include memory for storing the results of one or more previous distance measurements and / or status / progress measurements. The results of one or more previous distance measurements may, for example, be used to determine the change in distance caused by the relative motion between the distal end of the at least double-clad optical fiber and the tissue to be treated. Therefore, the control unit may select the laser power or other parameters based not only on the currently measured distance but also on the observed change in distance, such as based on the rate of change, for example based on whether the distance is increasing or decreasing, and optionally based on the rate at which it is increasing or decreasing. Similarly, the control unit may select the laser power or other parameters based on the observed rate of change in the treatment status.

[0230] In some embodiments, the control unit also selects the laser power or other parameters based on patient feedback received via a suitable user device (e.g., a handheld user device operated by the patient during the treatment process). For example, the patient may activate the user device when experiencing pain or discomfort during treatment. The user device may communicate the corresponding patient feedback signal 4700 to the control unit, which may then adjust the laser power or other parameters for subsequent treatment cycles in response to the received feedback.

[0231] Subsequently, the control unit controls the therapeutic laser source to emit therapeutic laser radiation 4520 at the selected power and / or other parameters during another treatment cycle.

[0232] As long as the activation signal 4200 is activated, or until a termination signal is received, or within the predetermined treatment duration, the control unit can repeatedly execute treatment cycles, for example, to emit predetermined pulses of laser radiation. As described above, the control unit can also interrupt treatment in response to detected unsafe conditions, such as detecting that the optical fiber is oriented on a non-tissue surface, that the optical fiber is no longer immersed in water and / or too close to the tissue to be treated, or when spectral measurements indicate that treatment of the tissue has been completed.

[0233] It should be understood that several modifications can be made to the procedures used to operate a medical laser device. For example, if the medical laser device includes additional sensors, the measurement cycles of these additional sensors can also be included in one or more treatment cycles, for example, in a time-division multiplexing manner as described above with respect to distance and spectral measurements. In some embodiments, some or all measurements, such as spectral measurements, may not necessarily be performed during every treatment cycle, but may be performed, for example, only during a subset of treatment cycles.

[0234] While the above embodiments are primarily described in the context of fiber optic devices having two separate connectors and connector / combiner modules, other embodiments are also possible, including embodiments in which therapeutic radiation and sensor radiation are combined into a single optical fiber within a medical therapeutic device.

[0235] For example, Figure 10 One embodiment is shown in which the medical treatment device 2000 has two optical output ports, and the outputs from these ports are combined into a single optical fiber 1200 in a separate combiner module 1100. In this embodiment, the 2-port system facilitates the detection of the presence of water via OCT signals. Figure 11 An example is shown where the outputs from the therapeutic laser source and the sensor laser source are combined internally within the medical treatment device 2000, requiring only a single output port. In this embodiment, detection of insertion into water / into an endoscope / cystoscope can be based on cystoscope signals (e.g., modulated LEDs), via TOF between fiber optic surfaces, or via a pair of electrodes.

[0236] In both embodiments, the sensor radiation is low-power radiation with a sufficiently small output power to be classified as a Class 1 laser according to IEC 60825-1:07-2015, while the therapeutic laser radiation has such a high output power that, without special technical safety features, it cannot be classified as a Class 1 laser according to IEC 60825-1:07-2015, but rather as, for example, Class 4. This means that the operator and patient must typically wear laser goggles, and there must typically be an interlocking device connected to a door switch and a “laser on” light outside the room. Therefore, for the purposes of this specification, the laser source and optical output port are also referred to as Class 1 and Class 4, respectively. However, the embodiments of the medical laser device disclosed herein provide safeguards to ensure that the person operating the device, the patient, or others near the device will not inadvertently see the dangerous radiation emissions, preferably such that the device can be classified as a Class 1C laser according to IEC 60825-1:07-2015. Therefore, the operation of the embodiments of the medical laser device disclosed herein requires fewer operational safety precautions, such as goggles, interlocking devices connected to door switches, etc., and is therefore more user-friendly and efficient to use without compromising safety.

[0237] In general, this document discloses embodiments of a medical laser device for performing surgical treatments. The device includes a medical treatment apparatus having one or more optical ports. The optical ports include at least one optical output port. The device includes an optical fiber attached to the optical output port for delivering therapeutic laser radiation into the body of the patient.

[0238] Medical treatment devices consist of a housing and a therapeutic laser source housed within the housing. The therapeutic laser source can be a hazardous laser, particularly a Class 4 laser according to IEC 60825-1:07-2015.

[0239] The medical treatment device includes a safety device that ensures no dangerous laser radiation is emitted from the optical output port unless an optical fiber is connected to the optical output port and the distal end of the fiber is located inside the body being treated. Preferably, the safety device is configured such that the medical laser device is safe to use with little or no personal protective equipment, preferably to the extent that the device can be classified as Class 1C.

[0240] In general, security systems can be based on the following procedures: 1) For example, by using a shutter to block / disable the therapeutic laser (Class 4 laser) inside the housing of the laser device. 2) Selectively enable the output of four types of laser radiation through the following steps: i) Detect the connection / insertion of the fiber optic connector to the optical output port of the device. ii) Connect Class 1 light, optionally based on the detection in step i). iii) Check the (sufficient) integrity of the connected optical fibers. iv) Detecting the insertion of the connected fiber optic cable into the cystoscope and into the bladder by detecting the immersion of the fiber optic tip in a liquid (such as water, saline, urine, etc.) and / or by detecting a valid bladder tissue signal. v) If conditions i) and iv) have already been met, open the shutter or otherwise enable the Class 4 laser. Independent security system

[0241] In some embodiments, the safety device provides a standalone safety system that can operate with conventional endoscopes (such as conventional cystoscopes) without requiring specific functions from the endoscope / cystoscope.

[0242] In particular, the device can be configured to transmit and detect sensor signals, especially non-hazardous optical sensor signals when the distal end of the optical fiber is in a safe location (particularly inside the body to be treated).

[0243] Therefore, the device may include two optical ports, specifically two optical output ports: one optical output port emits Class 4 light, particularly therapeutic laser radiation, for therapeutic purposes; the other optical output port emits and receives Class 1 light for sensing purposes.

[0244] Type 4 and Type 1 light can be combined inside the device's housing and output via a single optical output port, for example... Figure 11 As shown. Alternatively, the device includes two optical output ports. In this case, the optical paths for Class 4 and Class 1 light can be external to the device, for example, via... Figure 10 The combiner module shown is combined into a single optical fiber.

[0245] When a (one-time) optical fiber is connected to the optical output port or each of the optical output ports, and when a connection is detected, the device operates in a safe mode. In this mode, Class 1 light (Class 1 refers to laser radiation that is safe under all circumstances) is enabled or can be enabled. When the device includes more than one optical output port, such as one for Class 4 light as described above and one for Class 1 light, operation in safe mode may require fiber optic equipment to be connected to each optical output port. In safe mode, Class 1 light is emitted from the fiber tip, and the reflected signal is collected by the fiber. The Class 4 port remains disabled, i.e., the output of therapeutic laser radiation is prevented by electrical and / or software and / or mechanical means (such as a mechanical shutter in the beam path).

[0246] The output of a Class 4 laser is enabled or can be enabled when the reflected Class 1 light delivers a signal to a device that verifies the fiber tip is inside the body or in another safe (for humans) location (such as by a suitable sensor of that device).

[0247] This verification may involve verifying the satisfaction of one or more conditions / indicators, such as the fiber optic tip being immersed in a liquid such as water, saline, and / or urine, and / or the fiber optic tip receiving light from the endoscope tip, and / or the fiber optic tip being in close proximity to the tissue to be treated, etc.

[0248] In general, it should be understood that the term "enabling laser radiation output" does not necessarily mean that laser radiation must be emitted. Actual emission may depend on the operator activating the output, for example, by pressing a foot pedal. Therefore, "enabling laser radiation output" is intended to mean that the operator can enable the laser radiation to be emitted. When the output is not enabled, it prevents the user from initiating the emission of laser radiation. In other words, "enabling therapeutic laser radiation output" is intended to instruct the user to control the device to output therapeutic laser radiation.

[0249] Therefore, the control process used to implement a safety system may include the following: i) In response to, for example, the detection of fiber optic connector insertion / coupling to (or each) optical output port using a laser safety interlocking system, Class 1 radiation output is enabled for transmission to the fiber tip. Since Class 1 light is non-hazardous, in alternative embodiments, Class 1 radiation emission can always be enabled. Optionally, sufficient integrity of the coupled fiber is detected. ii) The presence of water at the fiber optic tip can be detected, for example, by detecting changes in reflection, such as from about 3.5% (silica / air) to about 0.2% (silica / water) (e.g., corresponding to a change in reflected power from the fiber optic tip of about 20 times, corresponding to a detection range of about 13 dB). When water is detected, the fiber optic tip is located in the water-filled channel of the endoscope / cystoscope or in a water-filled bladder / urethra. Detection can be performed by detecting changes in reflected power or based on pulse time-of-flight measurements, where a reflected pulse is present or absent (no water / water present). iii) Detecting the light emitted by the cystoscope / endoscope light emitter (e.g., detecting the visible power / spectral properties of typical cystoscope / endoscope light) - Alternatively, a special cystoscope / endoscope with frequency modulation or otherwise encoded light emission can be used, which allows the device to detect the frequency modulation / encoding to ensure that only cystoscope / endoscope light is detected - see the integrated solution described below. iv) Move the fiber tip forward through the working channel toward the treatment point, for example, between 1 mm and 10 mm from the tissue to be treated, and detect tissue reflection, for example, using interferometric distance measurement. v) When condition ii) and / or condition iii) and / or condition iv) satisfy condition i), enable the Class 4 optical output port (by electrical, software and / or mechanical means). vi) Disable Category 4 optical output ports: o If the device detects that the cystoscope / endoscope is not emitting light (e.g., due to the fiber being pulled back, or due to endoscope malfunction). o If the device detects that there is no water at the tip (e.g., the optical fiber is in the air), or If the device detects no effective tissue reflection... o If a fiber optic connector is detected to be disconnected or if the integrity of the fiber optic path is detected to be compromised, for example, if the fiber is broken or damage in the optical path has been detected.

[0250] The Class 1 channel can preferably be a fiber optic waveguide with physical contact from the laser source to the fiber tip in order to reduce unwanted reflections in the optical path from the laser to the fiber tip. For this purpose, the Class 1 optical output port can include a fiber optic connector that provides physical contact between the respective fiber ends of the fiber connected by the Class 1 optical output port. If the two optical paths are combined inside the housing using free-space optics, the water detection range can be reduced, for example, from 13 dB to 3 dB. Furthermore, interferometry / OCT detection of tissue will be less feasible. If the two optical channels (i.e., the treatment and sensor paths) are combined inside the housing using optical fibers, the connector at the optical output port may be less reliable. Endoscopic integrated safety system

[0251] In some embodiments, the safety device provides an endoscope-integrated safety system that relies on the specific functionality of an endoscope / cystoscope configured to operate therewith. Specifically, the safety system may rely on the endoscope emitting illumination having one or more properties specific to the endoscope illumination, particularly light modulated according to a predetermined modulation scheme.

[0252] Specifically, the device may include two optical ports: one optical output port that emits Class 4 light for treatment, and another optical port that receives and optionally emits Class 1 light for sensing. As mentioned above, these two optical ports can be separated from each other, for example, as... Figure 10 As shown, or they can be combined into a single optical port, for example, as Figure 11 As shown.

[0253] The endoscope / cystoscope can be configured to emit modulated / encoded light (e.g., weak frequency modulation using a frequency that does not affect endoscope / cystoscope imaging) from one or more endoscope / cystoscope light emitters located at the distal end of the endoscope / cystoscope. When a (disposable) optical fiber is connected to this optical port (or each optical port) and detected, the device will detect the light received at the distal end of the connected optical fiber and search for light with a cystoscope modulation code / frequency. When cystoscope / endoscope modulation is detected, this indicates that the fiber tip is located at the distal end of the cystoscope, and a Class 4 laser can be activated.

[0254] If cystoscopy / endoscopy modulation is suddenly no longer detected, the output of Class 4 laser radiation is disabled, for example, for a short period of time, such as 100 ms or less.

[0255] Therefore, the control process used to implement a safety system may include the following: i) For example, using a laser safety interlocking system to detect fiber optic connector insertion / coupling to the optical output port or each optical output port. ii) Light emitted by a cystoscope / endoscope light emitter with an encoded / modulated light emitter was detected. iii) When conditions i) and ii) are met, enable the Category 4 optical output port (via electrical, software, and / or mechanical means). iv) If the laser detects that the cystoscope / endoscope is not emitting light or detects that the fiber optic connector is disconnected, then disable the Category 4 optical output port.

[0256] Alternatively, water detection and / or tissue detection and / or fiber optic integrity detection, described in the context of a stand-alone system, can be used as additional conditions. This may require the device to output, for example, Class 1 sensor light as described above.

[0257] The endoscope integration solution can be easily implemented at two ports inside the housing.

[0258] Alternatively or additionally, in order to detect light emitted by the endoscope / cystoscope and received at the distal end of the connected optical fiber, the device may use another mechanism for determining the fiber tip insertion index, particularly for detecting whether the distal end of the connected optical fiber extends beyond the distal end of the endoscope / cystoscope.

[0259] For example, many endoscopes / cystoscopes include a camera configured to capture images of target locations, such as in the form of a video stream, in front of the distal end of the endoscope / cystoscope. The camera may be implemented by a camera chip located at the distal end of the endoscope or otherwise. The endoscope / cystoscope may be coupled to a display device to allow a physician or other person operating the endoscope to view the images captured by the camera. The display device may be integrated into the medical laser device disclosed herein, or it may be detached from the medical laser device, for example, by a detachment device having its own housing separate from the housing of the medical laser device.

[0260] Medical laser devices may include a light source configured to emit visible light or light otherwise detectable by a camera of an endoscope / cystoscope. The light source may be, for example, a dedicated light source, or it may be a guiding light source, or a light source for one of the device's optical sensors, such as a supercontinuum white light source or other suitable light source for a spectral sensor, or another suitable light source for the device. The device may be configured to emit camera-detectable light via a connected fiber optic cable. The device may also be configured to receive a camera signal indicating one or more images captured by the camera while the device is emitting camera-detectable light via the connected fiber optic cable. The device may further be configured to process the received camera signal to detect whether the camera has captured camera-detectable light. In response to detecting that the camera has captured camera-detectable light, the device may determine that the fiber tip of the connected fiber optic cable is located at or even protrudes from the distal end of the endoscope / cystoscope. Therefore, the device may enable the emission of therapeutic laser radiation (particularly Class 4 laser radiation) only in response to detecting that the camera has captured camera-detectable light. The process of emitting camera-detectable light and detecting that the endoscope / cystoscope has captured camera-detectable light can be performed before the emission of therapeutic laser radiation, and optionally, continuously or at least intermittently during the emission of therapeutic laser radiation, for example, between consecutive pulses of therapeutic laser radiation. Therefore, failure to detect that the camera has captured camera-detectable light can disable the emission of therapeutic laser radiation.

[0261] Preferably, the device is configured to embed a detectable signature into camera-detectable light, for example by pulsed or otherwise modulating the camera-detectable light, such as by modulating the intensity or spectral composition of the camera-detectable light or otherwise. Therefore, the device can be configured to detect the embedded signature in a camera signal.

[0262] Reference Figure 12 An example of detecting a camera-based fiber optic tip insertion index is described, which schematically illustrates another example of a medical laser device according to embodiments disclosed herein. Figure 12 equipment and Figure 1 and Figure 3The similarities between the devices are that they include a medical treatment device 2000 and a fiber optic device, which includes an optical fiber 1200 and a connector module 1100. The medical treatment device 2000 includes a therapeutic laser source 2200, a control module 2400, and a sensor module 2300, all of which are combined as shown in the diagram. Figure 1 and / or combination Figure 3 As described.

[0263] Fiber optic cable 1200 is configured to be inserted and advanced into the working channel of endoscope 3000 (particularly cystoscope), for example, as in combination Figure 4 As described, the distal end 1201 of the optical fiber 1200 extends beyond the working channel of the endoscope. In use, the endoscope is inserted into a patient's blood vessels or organs, particularly into the bladder via the urethra. The endoscope 3000 includes a camera 3600, specifically a camera chip, at its distal end. The camera 3600 provides camera signals to a display device 3700 coupled to the endoscope 3000, allowing a physician to view the images captured by the camera 3600 on the display device 3700.

[0264] In this embodiment, the sensor module 2300 includes a sensor light source 2311 (e.g., an LED), a sensor laser source, etc. The sensor light source 2311 is configured to output visible sensor light through the optical fiber 1200. When the optical fiber is at least double-clad, the medical laser device can be configured to output visible sensor light through the core or cladding of the at least double-clad optical fiber. It should be understood that the sensor light does not necessarily have to be visible, as long as it is within the spectral range detectable by the camera 3600. Instead of the light source of the sensor module, the medical device can use another light source to emit light that can be detected by the camera 3600, for example, a dedicated guide light source or a separate light source.

[0265] The light source 2311 can be configured and / or controlled by the control module 2400 to emit camera-detectable light as pulsed light at a suitable predetermined pulse rate detectable by the camera. Alternatively or additionally, the light source 2311 can be configured and / or controlled to modulate the emitted camera-detectable light in a different predetermined manner, or otherwise embed a detectable signature into the emitted camera-detectable light. For example, the emitted camera-detectable light can alternate between two colors or be modulated in different ways.

[0266] The control module 2400 of the medical laser device 2000 is configured to enable the emission of therapeutic laser radiation via the optical fiber 1200 only when the optical fiber is inserted into the endoscope / cystoscope 3000 (where the distal end 1201 of the optical fiber protrudes from the distal end of the endoscope / cystoscope). As described herein, the control module can selectively enable or disable the emission of therapeutic laser radiation in various ways, such as by operating the shutter or by turning the therapeutic laser source on / off.

[0267] For this purpose, the medical laser device 2000 receives camera signals from the display device 3700, for example, via an HDMI cable or via another suitable wired or wireless connection capable of relaying camera signals. Thus, the camera 3600 is an example of an external sensor outside the medical laser device 2000, and the camera signal received from the display device 3700 is an example of a sensor signal received from an external sensor. However, it should be understood that in some embodiments, the display device 3700 and the medical laser device may be integrated into the same device, particularly into a single housing. In such and other embodiments, the control module 2400 may receive camera signals in different ways, such as directly from the camera 3600, via an internal signal path, etc.

[0268] The control module 2400 can process the received camera signal to detect an embedded signature, for example, to detect the light intensity of a change between predetermined colors at a predetermined pulse rate and / or to detect another predetermined modulation, or otherwise. In response to the detection of an embedded signature, and optionally in response to one or more other security indicators, the control module can enable the emission of therapeutic laser radiation, for example, as described herein. In response to the failure to detect an embedded signature, or optionally in response to the failure to detect one or more other security indicators, the control module can disable the emission of therapeutic laser radiation, for example, as described herein.

[0269] It should be understood that the control module can be configured to enable the emission of therapeutic laser radiation via fiber optic 1200 only when additional or alternative sensor signals indicate that the fiber optic device is coupled to the optical output port and the distal end is positioned in a safe location.

[0270] Because the medical laser device 2000 controls the emission of camera-detectable light, including embedding a suitable signature into the camera-detectable light, and because the medical laser device 2000 performs the extraction of the embedded signature from the camera signal, this embodiment does not depend on the specific properties of the endoscope / cystoscope other than the presence of the camera. In particular, this embodiment does not depend on any detectable properties of the light emitted by the endoscope / cystoscope, which can vary greatly between endoscopes / cystoscopes of different constructions and models.

[0271] In addition, the therapeutic laser source 2200, control module 2400, sensor module 2300 and / or fiber optic device of this embodiment may be implemented as described in conjunction with any previous embodiment or otherwise.

[0272] According to another aspect, an embodiment of a medical laser device is disclosed herein, the device comprising: - At least one therapeutic laser source is configured to output therapeutic laser radiation for treating medical conditions; - One or more optical ports configured to couple the device to an optical fiber device, the optical fiber device including at least one optical fiber and having a proximal end and a distal end, the distal end being configured to advance toward a treatment point on the subject through the working channel of the endoscope, the one or more optical ports including an optical output port for outputting therapeutic laser radiation. The therapeutic laser source is configured to receive a heartbeat signal and stop emitting therapeutic laser radiation in response to failure to receive a heartbeat signal.

[0273] In general, the heartbeat signal can indicate the normal operation of one or more components of the device, particularly the normal operation of the device's control module and / or the normal operation of at least one sensor of the device. The therapeutic laser source can be configured to receive the heartbeat signal from the control module and / or directly or indirectly from said at least one sensor.

[0274] In some embodiments, the device may include a control module configured to send a heartbeat signal to the therapeutic laser source. The control module may be configured to monitor the operation of at least some components of the device. For example, the control module may be configured to monitor the operation of at least one sensor, for instance, based on sensor signals received from such a sensor and / or based on a corresponding sensor heartbeat signal received by the control module from such a sensor. Therefore, the failure of the therapeutic laser source to receive a heartbeat signal from the control module may indicate malfunction of the control module and / or malfunction of a monitored aspect of the device's operation. In some embodiments, the control module may be configured to transmit the heartbeat signal only when one or more safety indicators are met, and only as long as one or more safety indicators are met, such as the one or more safety indicators described herein.

[0275] In some embodiments, the device includes at least one sensor that can transmit a sensor heartbeat signal to, for example, a control module and / or directly to a therapeutic laser source. The therapeutic laser source can be configured to receive the sensor heartbeat signal, rather than receiving a heartbeat signal from the control module, or other than receiving a heartbeat signal from the control module. Therefore, the control module and / or the therapeutic laser source can be configured to disable the output of therapeutic laser radiation if no sensor heartbeat signal is received within a predicted time period.

[0276] The heartbeat signal can be an intermittent signal, particularly a periodic signal transmitted at a suitable heartbeat rate, such as between 10 Hz and 100 Hz, or at another suitable update rate. For example, in some embodiments, the heartbeat signal may be transmitted between every 10 ms and every 20 ms.

[0277] The therapeutic laser source can be configured to emit pulsed therapeutic laser radiation. Specifically, the therapeutic laser source can be configured to emit only a predetermined number of pulses, such as a single pulse or a pulse train of a predetermined length, and to cease emitting additional pulses within a predetermined time period unless a heartbeat signal has been received. It should be understood that the heartbeat rate can be selected based on the predetermined number of pulses and / or the duty cycle of the pulse train. For example, when the therapeutic laser source is configured to emit only a single pulse of 10 ms, a heartbeat rate between once every 10 ms and once every 20 ms may be a suitable choice. It should be understood that other embodiments may employ other heartbeat rates and / or other pulse durations.

[0278] Therefore, the therapeutic laser source may include a heartbeat monitoring circuit configured to stop the therapeutic laser source if a heartbeat signal is not received. Preferably, the heartbeat monitoring circuit is implemented in hardware, for example, as a hardware timer reset by a heartbeat signal. In some embodiments, the therapeutic laser source may be configured to output therapeutic laser radiation only if other conditions are met, such as if other signals are received, for example, if an activation signal indicating that the operator has pressed the foot pedal or otherwise activated laser treatment is received.

[0279] The control module can be configured to monitor the reception of acceptable signals from at least one sensor and only transmit its heartbeat signal if an acceptable signal is received. For example, in response to safety criteria being met and the operator having initiated treatment, the control module can optionally control the therapeutic laser source to emit a pre-programmed pulse sequence upon receiving a sensor heartbeat signal. The control module can continue transmitting its heartbeat signal to cause the therapeutic laser source to continue emitting another pulse sequence, or a subsequent pulse sequence, only if safety characteristics are still met, optionally only if the operator is still activating the laser, and optionally, while the sensor heartbeat signal is still being received. The therapeutic laser source can be configured, preferably implemented solely by hardware circuitry, such as a hardware timer, to automatically shut off the therapeutic laser source after the pre-programmed sequence. The therapeutic laser source can also be configured to re-emitter if a heartbeat signal is received from the control module.

[0280] Figure 13 An example of a medical laser device according to an embodiment disclosed herein is illustrated, wherein the therapeutic laser source includes a heart rate monitoring circuit. Figure 13 Equipment and, for example Figure 1 , 3 The device in the previous figures of or 12 is similar in that it includes a medical treatment device 2000 and a fiber optic device including an optical fiber 1200 and a connector module 1100. The medical treatment device 2000 includes a therapeutic laser source 2200, a control module 2400, and a sensor module 2300, all as shown in conjunction with one or more previous figures (e.g., Figure 1 , 3 Or as described in 12).

[0281] Fiber optic cable 1200 is configured to be inserted and advanced into the endoscope. Figure 13 (not explicitly shown in the text), especially in the working channel of the cystoscope, for example, such as when combined with Figure 4 As described, the distal end 1201 of the optical fiber 1200 extends outside the working channel of the endoscope. In use, the endoscope is inserted into a patient's blood vessels or organs, particularly into the bladder via the urethra.

[0282] In this embodiment, the therapeutic laser source 2200 includes a heartbeat monitoring circuit 2210, which can monitor the reception of heartbeat signals from the control module and / or sensor module, and only enable the emission of therapeutic laser radiation when the heartbeat monitoring circuit receives one or more regular heartbeat signals. The heartbeat monitoring circuit can be configured to stop the therapeutic laser source when no heartbeat signal is received. Figure 13In this example, the heartbeat monitoring circuit receives heartbeat signals from a control module that can monitor the operation of the sensor module 2300 and / or other components of the medical laser device. In other embodiments, the heartbeat monitoring circuit may receive heartbeat signals directly from the sensor module and / or from other components; these heartbeat signals may be additional or alternative signals to the heartbeat signals from the control module.

[0283] In addition, the therapeutic laser source 2200, control module 2400, sensor module 2300 and / or fiber optic device of this embodiment may be implemented as described in conjunction with any previous embodiment or otherwise.

[0284] Various aspects have been described with reference to the various embodiments. Modifications and alterations will occur to others upon reading this disclosure. The invention is intended to be construed as including all such modifications and alterations, including those falling within the scope of the appended claims and their equivalents.

Claims

1. A medical laser device, the device comprising: - At least one therapeutic laser source is configured to output therapeutic laser radiation for treating medical conditions. - One or more optical ports configured to couple the device to an optical fiber device including at least one optical fiber and having a proximal end and a distal end, the distal end being configured to advance toward a treatment point on the subject through the working channel of an endoscope, the one or more optical ports including an optical output port for outputting the therapeutic laser radiation. - A control module is configured to receive at least one sensor signal indicating one or more predetermined safety indicators, the one or more safety indicators including at least a connection indicator indicating whether the fiber optic device is coupled to the optical output port, and one or more fiber tip position indicators indicating whether the distal end of the fiber of the coupled fiber optic device is positioned in a safe location, wherein the control module is further configured to enable the therapeutic laser radiation to be output through the optical output port only when the at least one sensor signal indicates that the fiber optic device is coupled to the optical output port and the distal end is positioned in a safe location.

2. The medical laser device according to claim 1, wherein, The one or more safety indicators also include one or more fiber optic integrity indicators, and wherein the control module is further configured to allow the therapeutic laser radiation to be output via the optical output port only when the at least one sensor signal indicates that the fiber optic integrity is sufficiently intact.

3. The medical laser device according to claim 1 or 2, wherein, The one or more fiber optic tip position indicators include one or more of the following indicators: a) Insertion indicator, indicating that the optical fiber has been inserted into the liquid and / or has been inserted into the endoscope. b) Endoscope tip indicator, indicating that the optical fiber is positioned at the distal end of the endoscope's working channel. c) Treatment point indicator, indicating that the distal end of the optical fiber is close to a potential treatment point.

4. The medical laser device according to claim 3, wherein, The control module is configured to allow the therapeutic laser radiation to be output only when at least two of the insertion index, the endoscope tip index, and the treatment point index are satisfied, such as only when at least three of the insertion index, the endoscope tip index, and the treatment point index are satisfied.

5. The medical laser device according to claim 3 or 4, wherein, The control module is configured to output therapeutic laser radiation only when at least two of the following indicators are detected by two separate sensors and / or using two separate optical channels: the connectivity indicator, the fiber integrity indicator, and one or more fiber tip position indicators.

6. The medical laser device according to any one of claims 3 to 5, wherein, The control module is configured to allow the therapeutic laser radiation to be output only when at least one safety indicator is detected by two separate sensors and / or using two separate optical channels.

7. The medical laser device according to any one of the preceding claims, wherein, The one or more fiber tip position indicators include an insertion indicator indicating that the fiber has been inserted into the liquid and a treatment point indicator indicating that the distal end of the fiber is close to a potential treatment point, and wherein the control module is configured to allow the therapeutic laser radiation to be output only when at least the insertion indicator and the treatment point indicator are satisfied.

8. The medical laser device according to any one of the preceding claims, wherein, The control module is configured to allow the therapeutic laser radiation to be output only when at least two of the safety indicators are met in the expected time series, such as only when at least three of the safety indicators are met in the expected time series, such as only when at least four of the safety indicators are met in the expected time series.

9. The medical laser device according to any one of the preceding claims, comprising: One or more sensors, the one or more sensors being configured to acquire one or more sensor signals from the at least one sensor signal, and wherein the control module is configured to receive the one or more sensor signals from the at least one sensor signal acquired by the one or more sensors.

10. The medical laser device according to claim 9, wherein, At least one of the one or more sensors is configured to detect the presence of liquid in front of the distal end of the optical fiber by detecting the level of reflection of sensor light from the distal end of the optical fiber and / or by performing time-of-flight measurements of the reflection of sensor light from the distal end of the optical fiber and / or by interferometry.

11. The medical laser device according to claim 9 or 10, wherein, when depending on claim 3, At least one of the one or more sensors is configured to detect at least one endoscope tip indicator by detecting light emitted from the distal end of the endoscope.

12. The medical laser device according to claim 11, wherein, The at least one sensor is configured to identify light emitted from the distal end of the endoscope by detecting the spectral properties of the light and / or by detecting the intensity of the light and / or by detecting a predetermined modulation of the light and / or encoding the light.

13. The medical laser device according to any one of claims 9 to 12, wherein, At least one of the one or more sensors includes an optical sensor configured to receive and detect radiation from at least one of the one or more optical ports.

14. The medical laser device according to claim 13, wherein, The optical sensor includes a sensor radiation source configured to emit sensor radiation.

15. The medical laser device according to claim 14, wherein, The sensor radiation has an output power of 5 mW or less, particularly 2 mW or less, such as 1 mW or less, such as 0.5 mW or less.

16. The medical laser device according to any one of claims 13 to 15, wherein, The optical sensor is configured to perform interferometric distance measurement and / or spectral measurement.

17. The medical laser device according to any one of the preceding claims, wherein, The therapeutic laser radiation has an optical output power of 10mW or greater.

18. The medical laser device according to any one of the preceding claims, comprising: A medical treatment device and the optical fiber device, wherein the medical treatment device includes at least the therapeutic laser source, and wherein the optical fiber device is a disposable optical fiber device configured to be detachably and optically coupled to the medical treatment device.

19. The medical laser device according to any one of the preceding claims, wherein, The optical fiber is at least double-clad, and the device is configured to output the therapeutic laser radiation via the cladding of the at least double-clad optical fiber.

20. The medical laser device according to claim 19, comprising: An optical lateral combiner configured to couple the therapeutic laser radiation into at least one cladding of the at least double-clad optical fiber.

21. The medical laser device according to any one of the preceding claims, wherein, The therapeutic laser source is configured to receive a heartbeat signal and to stop outputting the therapeutic laser radiation in response to failure to receive the heartbeat signal.

22. The medical laser device according to any one of the preceding claims is configured to use two separate signal processing pipelines to process sensor signals from at least one sensor.

23. The medical laser device according to any one of the preceding claims further comprises: A light source is provided for emitting light via at least one of the one or more optical ports, the emitted light being detectable by a camera of the endoscope, and wherein the control module is configured to receive a camera signal from the camera to process the received camera signal to detect whether the camera has captured the emitted light, and the control module is configured to allow the therapeutic laser radiation to be output via the optical output port only when the control module has detected that the camera has captured the emitted light.

24. A medical laser device, the device comprising: - At least one therapeutic laser source is configured to output therapeutic laser radiation for treating medical conditions. - One or more optical ports configured to couple the device to an optical fiber device including at least one optical fiber and having a proximal end and a distal end, the distal end being configured to advance toward a treatment point on the subject through the working channel of an endoscope, the one or more optical ports including an optical output port for outputting the therapeutic laser radiation. - A light source for emitting light via at least one of the one or more optical ports, the emitted light being detectable by the camera of the endoscope. - A control module is configured to receive camera signals from the camera, process the received camera signals to detect whether the camera has captured the emitted light, and is configured to allow the therapeutic laser radiation to be output via the optical output port only when the control module has detected that the camera has captured the emitted light.

25. A medical laser device, the device comprising: - At least one therapeutic laser source is configured to output therapeutic laser radiation for treating medical conditions. - One or more optical ports configured to couple the device to an optical fiber device including at least one optical fiber and having a proximal end and a distal end, the distal end being configured to advance toward a treatment point on the subject through the working channel of an endoscope, the one or more optical ports including an optical output port for outputting the therapeutic laser radiation. The therapeutic laser source is configured to receive a heartbeat signal and to stop outputting the therapeutic laser radiation in response to failure to receive the heartbeat signal.

26. A system comprising: - A medical laser device as defined in any one of the preceding claims, and, - An endoscope, particularly a cystoscope, having a working channel for receiving the optical fiber, and further including a camera for capturing one or more images of a target location located in front of the distal end of the endoscope.

Images