Medical laser device

Abstract

A medical laser device includes at least one therapeutic laser source configured to output therapeutic laser radiation for the treatment of a medical condition, and one or more optical ports configured to couple the device to an optical fiber device, the optical fiber device comprising at least one optical fiber having a proximal end and a distal end, the distal end of which is configured to be advanced toward a treatment site of a target for treatment through a working channel of an endoscope, and a control module configured to receive at least one sensor signal from at least one sensor and to enable output of therapeutic laser radiation through the optical output port only when the at least one sensor signal indicates that the optical fiber device is coupled to the optical output port and the distal end is in a safe position.

Description

Technical Field

[0001] The present disclosure relates to a medical laser device for providing laser treatment through minimally invasive procedures using an endoscope.

Background Art

[0002] Many medical conditions can be treated by applying laser light to the tissue to be treated. In many cases, such treatment is performed by directing treatment laser radiation through an optical fiber towards the tissue to be treated so as to cause ablation and / or coagulation of the tissue to be treated, or ablation and / or coagulation within the tissue to be treated.

[0003] In many procedures, the optical fiber is advanced through the working channel (often also referred to as the lumen) of an endoscope, particularly a flexible endoscope. There are various types of endoscopes configured to visualize and / or treat various parts of the body such as the gastrointestinal tract, airway, or urinary tract. There are endoscopes specifically configured to reach a particular region of the body. Examples of such endoscopes include cystoscopes, colonoscopes, nasal endoscopes, etc. For example, laser ablation and / or coagulation therapy for bladder cancer is performed using a cystoscope. A cystoscope is an endoscope configured for performing cystoscopy, through which the cystoscope is advanced into the bladder through the urethra. For this purpose, the cystoscope includes a very thin flexible tube. During laser ablation and / or coagulation therapy for bladder cancer, the healthcare provider inserts an optical fiber device through the working channel of the cystoscope into the patient's bladder. The optical fiber device is then used to direct the laser towards a particular region of the tissue that needs to be treated.

[0004] Therefore, it is generally desirable to provide a medical laser device that enables efficient, safe, and reliable treatment of the target. In some embodiments, it is particularly desirable to provide a medical laser device that enables efficient, safe, and reliable treatment of the urinary tract, especially the bladder, in cases of bladder cancer.

[0005] In particular, laser therapies such as excision and / or coagulation therapy typically require effective, powerful laser radiation. Therefore, the operation of medical laser devices capable of generating such powerful radiation carries the risk of unintentional exposure of the device operator and / or patient to potentially dangerous laser radiation. Thus, the operation of such medical laser devices often involves personal protective measures to protect the laser operator and / or patient, such as protective 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 personal protective measures while still ensuring the safe operation of medical laser devices. In particular, it is desirable to ensure that the device operates with no risk, or at least an acceptablely low risk, of unintentional exposure of the operator's or patient's eyes (or other sensitive body parts not being treated) to dangerous laser radiation.

[0006] In general, it is desirable to provide medical laser devices that are easy to operate.

[0007] Despite previous efforts, it remains desirable to provide a medical laser device that solves one or more of the above-mentioned problems and / or other problems, and / or has other benefits, or at least provides an alternative to existing solutions. [Overview of the Initiative]

[0008] In this context, various embodiments disclosed herein relate to medical laser devices, and these devices are (a) at least one therapeutic laser source configured to emit therapeutic laser radiation for the treatment of a medical condition, (b) One or more optical ports configured to couple the device to an optical fiber device, the optical fiber device comprising at least one optical fiber having a proximal end and a distal end, the distal end configured to be advanced through the working channel of the endoscope toward the treatment site of the object to be treated, and one or more optical ports comprising an optical output port for outputting therapeutic laser radiation, (c) A control module configured to receive at least one sensor signal indicating one or more predetermined safety indicators, wherein the one or more safety indicators include a connection indicator indicating whether an optical fiber device is coupled to an optical output port, and one or more fiber tip position indicators indicating whether the distal end of the optical fiber of the coupled optical fiber device is in a safe position, and further configured to enable the output of therapeutic laser radiation through the optical output port only when at least one sensor signal indicates that an optical fiber device is coupled to the optical output port and the distal end is in a safe position, It is equipped with.

[0009] In some embodiments, one or more safety indicators further include one or more fiber integrity indicators. One or more fiber integrity indicators can indicate sufficient integrity of the coupled optical fiber device, for example, that the optical fibers will not break and / or bend below a predetermined bending radius. Sufficient integrity means an acceptable degree of integrity, such as an acceptable degree of optical loss, an acceptable bending radius, etc., as defined by one or more predetermined criteria. One or more fiber integrity indicators can indicate the structural and / or operational integrity of the coupled optical fiber device, i.e., whether the coupled optical fiber device is structurally and / or operationally intact. At least one of the one or more fiber integrity indicators may indicate detected damage to the fibers of the coupled optical fiber device, for example, fiber breakage. At least one of one or more fiber integrity indicators may indicate detected optical loss in another portion of the optical path between the fiber and / or the therapeutic laser source and the distal end of the optical fiber, and / or one or more other indicators may indicate whether another portion of the optical path between the optical fiber and / or the therapeutic laser source and the distal end of the optical fiber is functioning as expected. Thus, the control module may further be configured to enable output of therapeutic laser radiation via the optical output port only when at least one sensor signal indicates that the fiber integrity is intact. Fiber integrity can be detected, for example, by measuring 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 a medical laser device, is configured for the treatment of the urinary tract, particularly the bladder. Thus, the endoscope may be a cystoscope. In other embodiments, the device may be configured for the treatment of other conditions, such as conditions in other parts of the body.

[0011] In some embodiments, the device comprises at least one sensor configured to acquire at least one of at least one sensor signals indicating one or more predetermined safety indicators, i.e., the control module may be configured to receive at least one of at least one sensor signals from one or more sensors of the device. Alternatively, or in addition, the control module may receive at least one of at least one sensor signals from one or more sensors outside the medical laser device. Thus, the control module can receive at least one sensor signal from one or more internal and / or external sensors, i.e., from one or more sensors included within the device and / or from one or more sensors outside the device.

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

[0013] In some embodiments, the optical sensor is configured to detect light emitted from the tip of an endoscope, for example, from the tip of a cystoscope, which is received at the distal end of an optical fiber. In some embodiments, the endoscope light (e.g., an endoscope LED) may be configured to emit light with a predetermined modulation (e.g., pulsed or amplitude-modulated light with a modulation / pulse frequency high enough not to be visible, or frequency-modulated light), or light with an otherwise encoded signal / signature embedded in it. The optical sensor may detect the endoscope light by detecting light having the predetermined modulation. In other embodiments, the optical sensor may be configured to detect another characteristic, for example, the spectral characteristics of the endoscope light.

[0014] In some embodiments, a medical laser device includes an active optical sensor comprising a sensor radiation source configured to emit sensor radiation, and an optical sensor for detecting return radiation, such as reflected sensor radiation reflected by a surface (e.g., by the end face of an optical fiber, by the tissue to be treated, or by another surface to which the sensor laser radiation strikes) or other return radiation returned by the material to which the sensor radiation strikes. For this purpose, the device is configured to output sensor radiation through at least one of one or more optical ports and to receive return radiation through at least one of one or more optical ports. It will be understood that the device may include a plurality of optical ports, e.g., 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 be capable of operating as both input and output ports. All one or more optical ports may be coupled to the same optical fiber device, in particular to the same optical fiber. Thus, the sensor radiation is coupled to the proximal end of the optical fiber and emitted by the distal end of the optical fiber. Similarly, the reflected light is received at the distal end of the optical fiber and coupled back to at least one of the optical ports from the proximal end of the optical fiber. The sensor radiation source may be a sensor laser source configured to emit sensor laser radiation, or another light source for emitting sensor light. Preferably, the sensor radiation is non-harmful radiation, e.g., sensor laser radiation having an output low enough not to be harmful to the human eye, in particular sensor laser radiation that can be classified as laser class 1 according to IEC60825-1:07-2015. Examples of active optical sensors include interference sensors such as broadband interference sensors, also referred to herein as OCT sensors. Other examples include spectroscopic sensors. In other embodiments, the optical fiber device may include a plurality of fibers, and / or the device may be configured to be coupled to a plurality of optical fiber devices, for example, via each of the optical ports.

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

[0016] The optical sensor may detect the bladder wall or other treatment site / biological tissue being treated.

[0017] One or more fiber tip position indicators, a) An insertion indicator that shows that the optical fiber has been inserted into a liquid such as water, saline solution and / or urine, and / or that the optical fiber has been inserted into the endoscope, b) An endoscope tip indicator indicating that an optical fiber is located at the distal end of the working channel of the endoscope, for example, by detecting that light emitted from the tip of the endoscope (e.g., from the tip of the cystoscope) is received at the distal end of the optical fiber, and / or by detecting that light emitted by the distal end of the optical fiber is received in the camera of the endoscope, for example, by a camera chip located in the endoscope tip receiver, c) A treatment site indicator that shows the distal end of the optical fiber is in close proximity to a potential treatment site, such as indicated by an optical sensor that detects a potential treatment site, such as biological tissue, in particular tissue inside the patient's body (such as the bladder wall) that is sufficiently close between the distal ends of the optical fiber (sufficient proximity can be defined by the detection range of the laser sensor or by a predetermined threshold distance), It may include one or more of the following indicators.

[0018] In this specification and the following description, 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 implies a site where treatment can be safely performed from the standpoint of laser operation, i.e., without the risk of the operator of the device being exposed to dangerous radiation, or the patient's eyes or skin being unintentionally exposed to such radiation (or at least without an unacceptable risk). For example, detection of the bladder tumor to be treated may not necessarily be required, as long as the bladder wall tissue is generally detected. Conversely, the term "potential treatment site" is not intended to be limited to sites that have not yet been treated, and it may also refer to a treatment site where treatment has already been initiated or may have already been completed.

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

[0020] In some embodiments, the control module may be configured to output therapeutic laser radiation only when one (e.g., two, such as three or more) fiber tip position indicators, including a connection indicator, a fiber integrity indicator, and one such indicator (e.g., three of the fiber tip position indicators a to c described above, and / or alternative or additional fiber tip position indicators), is satisfied.

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

[0022] In some embodiments, the control module allows treatment laser emission to be output only when at least two of the connection indicator, the fiber integrity indicator, and one or more fiber tip position indicators are detected by two separate sensors and / or when detected using two separate optical paths, thereby increasing the fault tolerance of the system.

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

[0024] For example, an optical coherence tomography (OCT) system may be used to detect proximity to tissue and / or to detect immersion of the fiber tip into a liquid such as water, saline, and / or urine.

[0025] Generally, interferometric distance measurement refers to distance measurement by measuring the optical interference between a reference reflection and a reflection from a target surface / tissue whose distance is to be determined. The reference reflection can be, for example, a reflection from the distal fiber tip (thus facilitating calibration or even avoiding the need for calibration).

[0026] Spectroscopic measurement may be used for detecting light from the cystoscope / endoscope and / or for detecting the immersion of the fiber tip into the liquid.

[0027] In some embodiments, the apparatus is configured to process sensor signals from at least one sensor, particularly from at least one optical sensor, using two separate signal processing paths / pipelines to obtain two separate safety indicator values of at least two of the at least one said safety indicators. In particular, sensor data from one or each sensor can be processed (in the electrical domain) using two parallel partial or completely separate computational "arms" and / or using two different computational units and / or two different computational algorithms (software algorithms). The control module may be configured such that during processing, the output of the therapeutic laser radiation is only possible when the separate processing pipelines result in the same result, particularly when the two separate safety indicator values are equal or differ from each other only within at least a predetermined margin.

[0028] In some embodiments, the control module is configured to enable the output of the therapeutic laser radiation only when at least two, for example at least three, for example at least four of the above-mentioned safety indicators are satisfied in a predetermined time sequence, for example when the connection indicator is satisfied before the above-mentioned fiber tip position indicator a (which is then satisfied before the fiber tip indicator b and / or c).

[0029] In some embodiments, the device includes a user input interface, such as a button, touchscreen, and / or equivalent, configured to receive user confirmation that the optical fiber device has its distal end positioned inside the patient's body (or another safe location) and the device is ready to operate. 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 the therapeutic laser radiation to be emitted only when such user confirmation is received, thereby providing an additional layer of safety.

[0030] In some embodiments, the control module is configured to maintain the output path of the therapeutic laser radiation blocked by a shutter ("non-contact mode" or "safe mode") while performing safety measurements, such as interferometric distance measurement (additional laser safety function). This can optionally be coupled / connected to a common laser safety interlock (e.g., a laser safety interlock that allows the output of therapeutic laser radiation only when an optical fiber device is coupled to the optical output port). In some embodiments, the absence of a coupled optical fiber device may also be detected by an optical sensor, such as a laser sensor.

[0031] In some embodiments, one or more sensors are configured to perform a time-of-flight measurement between the fiber input (at the proximal end of the optical fiber) and the fiber output surface (at the distal end of the optical fiber), where the timing difference may be, for example, about 30 ns for the return signal in a 3 m fiber. The time-of-flight measurement can function as a fiber integrity indicator. In addition, or alternatively, the detected amplitude of the reflected pulse from the distal end will change depending on whether the fiber tip is in air or liquid, thereby serving as an indicator of whether the distal end of the fiber is immersed in a liquid such as water, saline, or urine. Thus, in some embodiments, the device includes a time-of-flight sensor that can operate to emit an optical pulse through a connected optical fiber, for example, through the cladding of a multi-clad fiber, and detect the corresponding return pulse reflected by the fiber output surface. A decrease in the amplitude of the detected return pulse from a high level to a low level indicates immersion of the optical fiber in water, saline, or urine. Similarly, a permanently low amplitude level of the return pulse may indicate that the optical fiber is damaged, improperly connected, or otherwise the integrity of the optical path is compromised.

[0032] The device may use, for example, a pair of wires carried along the side of the fiber buffer to detect the insertion of the optical fiber into the endoscope and / or into a liquid such as water, saline solution, and / or urine.

[0033] Detection of the target site and / or the distance between the target site and the fiber tip may be based on optical coherence to tissue (OCT) detection to verify the presence of tissue.

[0034] The device may include an optical sensor configured, for example, to distinguish between light and dark, to detect ambient light entering the distal end of the optical fiber. This may be used to detect whether the fiber tip is inside the working channel of the endoscope. Thus, the control module may be configured to always turn off the therapeutic laser when in darkness (e.g., defined by an appropriate light threshold), as this may indicate that the fiber tip is inside the working channel or that the endoscopic light is off. Endoscopic / cystoscopic light may be detected based on the detection of light levels and / or spectral characteristics typical or more characteristic of endoscopic / cystoscopic light (e.g., detecting LED light or xenon light), and / or based on specific amplitude or frequency modulation or otherwise specifically encoded endoscopic / cystoscopic light.

[0035] In some embodiments, a medical laser device may receive sensor signals from an external sensor and obtain one or more safety indicators based at least in part on the sensor signals received from the external sensor. Examples of such external sensors include sensors in an endoscope into which an optical fiber enters. An example of an endoscope sensor includes an endoscope camera, i.e., the received sensor signal may include or be derived from a camera signal from such a camera. For example, the device can derive a fiber tip insertion indicator from a sensor signal received from an endoscope sensor. In particular, according to some embodiments, the device further comprises a light source for emitting light through at least one of one or more optical ports, the emitted light being detectable by an endoscope camera, and a control module is configured to receive a camera signal from the camera, process the received camera signal to detect whether the camera has captured the emitted light, and enable output of a therapeutic laser radiation through an optical output port only when the control module has detected that the camera has captured the emitted light.

[0036] In some embodiments, the apparatus is configured to monitor whether one or more of the safety conditions discussed above, particularly one or more (e.g., all) of the connection indicator, fiber tip position indicator(s), and fiber integrity indicator(s), remain met while the output of the therapeutic laser radiation is enabled. For example, the apparatus may: (1) When an optical fiber device is disconnected from one or more optical ports, particularly from optical output ports, (2) If the optical fiber is pulled back into the working channel of the endoscope, or even out of the working channel of the endoscope, (3) If no liquid such as water, saline solution and / or urine is detected, (4) If the distance to the target site exceeds the safety threshold, or if no biological tissue is detected, (5) If a decrease in fiber integrity is detected, for example, if a decrease below a predetermined / acceptable threshold is detected, The system may be configured to automatically disable the output of the therapeutic laser radiation in response to the fact that at least one of the conditions is no longer met.

[0037] In some embodiments, the therapeutic laser source is configured to receive a heartbeat signal and to stop outputting therapeutic laser radiation in response to a failure to receive the heartbeat signal.

[0038] The heart rate 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 may be configured to receive the heart rate signal directly or indirectly from the control module and / or at least one sensor.

[0039] In some embodiments, the control module may be configured to transmit a heart rate signal to a 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 example, based on received sensor signals and / or based on each sensor heart rate signal received by the control module. Thus, the inability to receive a heart rate signal from the control module may indicate a failure of operation of the monitored aspect of the operation of the control module and / or the device. In some embodiments, the control module may be configured to emit a heart rate signal only when a safety indicator is met, and as long as the safety indicator is met.

[0040] In some embodiments, at least one sensor may transmit the sensor heart rate signal to, for example, a control module and / or directly to a therapeutic laser source. The therapeutic laser source may be configured to receive the sensor heart rate signal instead of, or in addition to, the heart rate signal from the control module. Therefore, the control module and / or the therapeutic laser source may be configured to disable the output of the therapeutic laser radiation if the sensor heart rate signal is not received or has not been received for a predetermined period of time.

[0041] The heart rate signal may be an intermittent signal, particularly a periodic signal emitted at an appropriate heart rate, for example, between 10 Hz and 100 Hz, or at another appropriate update rate. For example, in some embodiments, the heart rate signal may be emitted between every 10 ms and every 20 ms.

[0042] The therapeutic laser source may be configured to emit pulsed therapeutic laser radiation. Specifically, the therapeutic laser source may be configured to emit only a predetermined number of pulses, e.g., a single pulse or a pulse train of a predetermined length, and to stop emitting further pulses unless a heartbeat signal is received within a predetermined period. It will be understood that the heart rate may be selected according to the duty cycle of a predetermined number of pulses and / or pulse train. For example, when the therapeutic laser source is configured to emit only a single pulse of 10 ms, a heart rate between one heartbeat every 10 ms and one heartbeat every 20 ms may be a suitable choice. It will be understood that other embodiments may employ other heart rates and / or other pulse durations.

[0043] Therefore, the therapeutic laser source may include a heart rate monitoring circuit configured to stop the therapeutic laser source when a heart rate signal cannot be received. Preferably, the heart rate monitoring circuit is implemented in hardware, for example, as a hardware timer that is reset by the heart rate signal. In some embodiments, the therapeutic laser source may be configured to output only therapeutic laser radiation, subject to other conditions being met (for example, the reception of another signal, such as the operator pressing a foot pedal or the reception of an activation signal indicating other activated laser treatment).

[0044] The control module can monitor for the reception of an acceptable signal from at least one sensor and be configured to transmit its heart rate signal only in response to the reception of an acceptable signal. For example, in response to a safety indicator being met and the operator initiating treatment, the control module may optionally receive the sensor heart rate signal and control the treatment laser source to emit a pre-programmed pulse sequence. Depending only in response to the safety configuration still being met, optionally in response to the operator still activating the laser, and optionally in response to the sensor heart rate signal still being received, the control module may continue to transmit its heart rate signal, causing the treatment laser source to continue emitting another pulse sequence and a subsequent pulse sequence. The treatment laser source may preferably be implemented solely in hardware, such as a hardware timer, and may be configured to automatically switch off after a pre-programmed sequence. The treatment laser source may further be configured to emit again if a heart rate signal is received from the control module.

[0045] In some embodiments, the apparatus comprises a therapeutic laser source and an optical fiber device.

[0046] The device may be configured to optically couple therapeutic laser radiation into the optical fiber device, particularly at or near the proximal end of the optical fiber device. The device may also be configured to emit therapeutic laser radiation from the distal end toward the tissue of the treatment site to be treated, for example, the tissue of the urinary tract to be treated, in particular the tissue of the bladder.

[0047] Therapeutic laser radiation can have wavelengths suitable for the treatment being performed. In some embodiments, wavelengths are 750nm–1000nm (e.g., 950nm–1000nm), 750nm–950nm (e.g., 780nm–820nm), or 900nm–950nm (e.g., 905nm–925nm). Other useful wavelengths include those between 1000nm and 2000nm, e.g., between 1400nm and 2150nm. Suitable therapeutic laser sources include diode lasers, erbium lasers, thulium lasers, holmium lasers, and / or others. Wavelengths in which water has a high absorption rate and the optical fiber device has a high transmittance may be useful. When therapeutic laser radiation of such wavelengths is emitted toward the tissue being treated, the water or aqueous solution between the fiber tip and the tissue being treated is heated, resulting in the formation of bubbles, which collide with the tissue being treated and facilitate the ablate of the tissue to be removed. Wavelengths in which water has relatively low absorption and the tissue being treated has relatively high absorption may also be useful. In particular, lipids exhibit high absorption in the 900nm–950nm wavelength range, and absorption and hemoglobin are also relatively high. Therefore, by using wavelengths in these ranges, efficient tissue excision and / or coagulation becomes possible by emitting laser radiation from a fiber tip located at a distance from the tissue and inside the urinary tract, especially inside the bladder, thereby enabling simultaneous illumination of a relatively large area or tissue without attenuation of the laser radiation by passing through the surrounding water or aqueous solution. Furthermore, wavelengths outside the visible range may be useful, especially when the wavelength range is 900nm–950nm, as they do not adversely affect visual inspection, for example, with a camera. It will also be understood that the emission of therapeutic laser radiation at multiple wavelengths may also be used, for example, simultaneously or alternately. The therapeutic laser radiation may be applied in longer or shorter bursts, or otherwise, for example, over a longer period of time, such as during the period when a user command is received, for example, during the period when a foot pedal is activated.

[0048] In some embodiments, the device is configured to emit therapeutic laser radiation with an output power of at least 10 mW, for example, at least 50 mW, for example, at least 100 mW, for example, at least 200 mW, for example, at least 500 mW, for example, at least 1 W. In some embodiments, the device may further be configured to emit therapeutic laser radiation with higher output power, for example, in bursts between 10 W and 200 W.

[0049] In general, unless otherwise specified, references to numerical values ​​of laser radiation power discussed herein refer to the peak power of the laser radiation. For example, if the laser radiation is pulsed, the numerical value corresponds to the peak power of individual pulses, not the average power of the pulse train. The latter may be smaller than the peak power and may be related to the peak power by a factor indicating the duty cycle of the pulse train.

[0050] In some embodiments, the apparatus comprises a plurality of therapeutic laser sources, each configured to emit its own therapeutic laser radiation for the treatment of, for example, the medical condition of the urinary tract, particularly the bladder, and to optically couple each therapeutic laser radiation to an optical fiber device via at least one of the optical ports, particularly via an optical output port. The therapeutic laser sources can generate therapeutic laser radiation at their respective wavelengths, which are different from each other.

[0051] For example, the selective and alternating application of each therapeutic laser radiation may be performed in response to the reception of corresponding control inputs by the operator. Thus, the operator can control the device to selectively emit different types of therapeutic laser radiation.

[0052] In some embodiments, the apparatus further comprises a pilot light source configured to output visible pilot light and optically couple the pilot light to an optical fiber device, wherein the apparatus is configured to emit a pilot beam of the pilot light toward the tissue to be treated from the distal end to illuminate a target spot on the tissue to be treated by the visible pilot light. In particular, in some embodiments, the visible pilot light may be polychromatic light containing two or more color components detectable by a camera of the medical laser apparatus (e.g., containing at least two detectable color components separated by at least 40 nm). The at least two color components may be part of a broadband emission spectrum having a bandwidth of 40 nm or more, and the intensity of the emitted pilot light may be substantially uniform across the bandwidth or vary across the bandwidth. Each of the two detectable color components may have an intensity high enough to be detectable by a camera or similar detector of the medical laser apparatus such that the spot illuminated by the pilot beam is visible to a human observer in a camera image as an illuminated spot having a color resulting as a mixture of the at least two color components (e.g., as a white or substantially white spot). Preferably, the pilot beam is configured to illuminate at least the target spot to be irradiated by the therapeutic laser radiation. The pilot beam can be emitted before and optionally during the irradiation of the therapeutic laser radiation. The pilot beam may be supplied through the same optical fiber as the therapeutic laser radiation or through a separate optical fiber. The inventors have found that a multicolor pilot beam provides improved visibility and reduces operator fatigue when the device is used over extended periods. However, other types of pilot beams are also conceivable.

[0053] In some embodiments, the apparatus comprises a medical treatment device and an optical fiber device. The medical treatment device may comprise a housing and at least a therapeutic laser source housed within the housing. The optical fiber device may be a disposable optical fiber device configured to be detachably and optically coupled to the medical treatment device, particularly to one or more optical ports of the medical treatment device, more specifically to the optical output ports of the medical treatment device. Thus, operating costs are reduced because only relatively inexpensive optical fiber devices inserted into the patient's body during treatment are disposed of after use.

[0054] In some embodiments, the optical fiber is at least a double-clad optical fiber, and the device is configured to output therapeutic laser radiation through the cladding of at least a double-clad optical fiber. Thus, the device allows multiple types of radiation to be supplied through the optical fiber device without excessive interference with each other. For example, the device may include an interference distance sensor employing a single-mode core of at least a double-clad optical fiber, and relatively high-power therapeutic laser radiation may be supplied through the multi-mode cladding of at least a double-clad optical fiber.

[0055] In particular, in some embodiments, the apparatus includes an optical side combiner configured to couple therapeutic laser radiation to at least one cladding of at least double-clad optical fibers. By coupling therapeutic laser radiation to at least one cladding of at least double-clad optical fibers using a side combiner, illumination of the target spot with therapeutic laser radiation having an intensity distribution with a peripheral region of higher intensity and a central region of lower intensity is facilitated. This, in turn, promotes more uniform heating of the tissue being treated across the entire target spot.

[0056] In some embodiments, the device is configured to emit therapeutic laser radiation from its distal end as a divergent first therapeutic beam configured to illuminate a target spot on the tissue to be treated. In particular, in some embodiments, the medical laser device is configured to illuminate a target spot with a spot diameter of 1 mm to 10 mm (e.g., 1 mm to 7 mm) when the distal end is displaced 1 mm to 10 mm (e.g., 2 mm to 5 mm) from the tissue to be treated. Thus, a relatively large target spot may be illuminated and treated simultaneously while providing the operator with a better overall view of the target site.

[0057] In some embodiments, the tissue to be treated is soft tissue, particularly cancerous soft tissue.

[0058] This disclosure relates to different aspects, including medical laser devices, which are discussed above and further discussed below. It will be understood that each aspect may have one or more embodiments corresponding to embodiments described in relation to one or more other aspects and / or embodiments disclosed in the appended claims.

[0059] In particular, according to one embodiment, disclosed herein is an embodiment of a method for operating a medical laser device, for example, a device for treating cancer of the urinary tract, particularly the bladder, by laser cutting and / or coagulation.

[0060] In yet another embodiment, embodiments of a method for treating cancer of the urinary tract, particularly the bladder, by laser cutting and / or coagulation are disclosed herein.

[0061] In yet another aspect, disclosed herein is an embodiment of a medical laser device, which is: (a) at least one therapeutic laser source configured to emit therapeutic laser radiation for the treatment of a medical condition, (b) One or more optical ports configured to couple the device to an optical fiber device, the optical fiber device comprising at least one optical fiber having a proximal end and a distal end, the distal end configured to be advanced through the working channel of the endoscope toward the treatment site of the object to be treated, and one or more optical ports comprising an optical output port for outputting therapeutic laser radiation, (c) A light source for emitting light through at least one of one or more optical ports, wherein the emitted light is detectable by the camera of the endoscope, (d) A control module configured to receive a camera signal from the camera, process the received camera signal to detect whether the camera has captured the synchrotron radiation, and enable the output of the therapeutic laser radiation via the optical output port only when the control module detects that the camera has captured the synchrotron radiation. Includes.

[0062] In yet another aspect, disclosed herein is an embodiment of a medical laser device, which is: (a) at least one therapeutic laser source configured to emit therapeutic laser radiation for the treatment of a medical condition, (b) One or more optical ports configured to couple the device to an optical fiber device, the optical fiber device comprising at least one optical fiber having a proximal end and a distal end, the distal end configured to be advanced through the working channel of the endoscope toward the treatment site of the object to be treated, and one or more optical ports comprising an optical output port for outputting therapeutic laser radiation, the optical ports comprising, The therapeutic laser source is configured to receive a heartbeat signal and to stop the output of the therapeutic laser radiation in response to a failure to receive the heartbeat signal.

[0063] In yet another aspect, disclosed herein are embodiments of a system, which is (a) Medical laser devices disclosed herein, (b) an endoscope, particularly a cystoscope, wherein the endoscope has a working channel for receiving the optical fiber, and the endoscope further comprises a camera for capturing one or more images of a target site located anterior to the distal end of the endoscope, Includes.

[0064] Those skilled in the art will recognize yet another aspect of this application upon reading and understanding the accompanying description.

[0065] The above and other embodiments are shown as examples and are not limited to the drawings in the attached drawings. Similar reference numerals in the drawings indicate similar elements. [Brief explanation of the drawing]

[0066] [Figure 1] This figure schematically illustrates an example of a medical laser device according to embodiments disclosed herein. [Figure 2] The operation of an embodiment of a medical laser device, including an optical fiber positioned at a certain distance from the target site to be treated, according to an embodiment disclosed herein, is schematically illustrated. [Figure 3] Further embodiments of medical laser devices according to embodiments disclosed herein are illustrated schematically. [Figure 4] This section schematically illustrates an embodiment of a disposable optical fiber device, with its optical fiber, inserted into and advanced through the working channel of an endoscope, according to embodiments disclosed herein. [Figure 5] An example of a disposable optical fiber device according to the embodiments disclosed herein is graphically illustrated. [Figure 6] This figure schematically illustrates an example of an optical combiner module for a connector module of a disposable optical fiber device according to embodiments disclosed herein. [Figure 7]This figure schematically illustrates another example of an optical combiner module for a connector module of a disposable optical fiber device according to embodiments disclosed herein, wherein at least a double-clad optical fiber includes a tapered region. [Figure 8] A more detailed example of a medical laser device according to the embodiments disclosed herein is illustrated graphically. [Figure 9] This figure schematically illustrates the operation of an example of a medical laser device according to various embodiments disclosed herein. [Figure 10] Each embodiment of a medical laser device according to the embodiments disclosed herein is illustrated schematically. [Figure 11] Each embodiment of a medical laser device according to the embodiments disclosed herein is illustrated schematically. [Figure 12] This figure schematically illustrates another example of a medical laser device according to embodiments disclosed herein. [Figure 13] Another embodiment of a medical laser device according to the embodiments disclosed herein is schematically illustrated.

[0067] Detailed explanation The following describes embodiments of medical laser devices that can mitigate one or more of the above and / or other shortcomings of existing devices, or at least function as a replacement for existing devices.

[0068] Figure 1 schematically shows an example of a medical laser device according to an embodiment disclosed herein.

[0069] Various embodiments of medical laser devices are intended for use in clinical settings, particularly those operated by hospital / clinical / medical staff.

[0070] The medical laser device comprises a medical treatment device 2000 and an optical fiber device 1000. The optical fiber device 1000 can be configured to be detachably and optically coupled to the medical treatment device 2000. In particular, the optical fiber device 1000 can be disposable, for example, after a single use. The optical fiber device may be connected to the medical treatment device via one or more suitable connectors.

[0071] The optical fiber device 1000 includes optical fibers 1200, such as multimode fibers or double or multi-clad optical fibers.

[0072] The optical fiber 1200 may have a diameter suitable for insertion into the working channel of a cystoscope or other type of endoscope; that is, the choice of diameter may depend on the type of endoscope. A suitable diameter may be 0.1 mm to 1 mm (e.g., 0.1 mm to 0.4 mm), preferably 0.1 mm to 0.3 mm (e.g., 0.1 mm to 0.25 mm). An optical fiber having a diameter of 1 mm or less, preferably 0.4 mm or less, for example 0.3 mm or less, is sufficiently thin, allowing for bending with relatively little tensile and compressive stress induced at the fiber edge. The length of at least double-clad optical fiber may depend on the type of endoscope. A suitable length may be 2 m to 4 m.

[0073] In general, in at least some embodiments, the optical fiber emitting radiation toward the tissue to be treated is at least a double-clad optical fiber. This can have a fiber diameter of 100 μm to 1000 μm, e.g., 100 μm to 300 μm, e.g., 150 μm to 200 μm. In some embodiments, the numerical aperture of the multimode cladding that transmits the therapeutic laser radiation has a numerical aperture of 0.17 to 0.50 (e.g., 0.22 to 0.45). Here, the numerical aperture of the inner cladding can be defined as the square root of the difference between the square of the refractive index of the inner cladding and the square of the refractive index of the outer cladding surrounding the inner cladding.

[0074] In some embodiments, the distal end 1201 of the optical fiber 1200 may be angled, preferably with a rounded edge, to facilitate insertion into the working channel of the endoscope and to reduce the risk of damage to the edge of the optical fiber during insertion.

[0075] Generally, the medical treatment device 2000 includes a treatment laser source 2200 configured to emit a treatment laser radiation for the treatment of a medical condition. In some embodiments, the treatment laser radiation is for the resection and / or coagulation treatment of bladder cancer or another medical condition of the urinary tract, and in particular, is a treatment laser radiation suitable for treating tumorous tissue of the urinary tract, particularly the bladder, by resection and / or coagulation. The treatment laser source 2200 may include a suitable type of laser, such as a diode laser, configured to emit a treatment laser radiation at a wavelength and power suitable for the medical procedure to be performed. If the medical laser device is for treating tumors of the urinary tract, particularly the bladder, by resection and / or coagulation, the treatment laser source may comprise a high-intensity diode laser. The treatment laser radiation may be optically coupled into the optical fiber 1200, for example, at or near the proximal end of the optical fiber. The optical fiber is preferably configured to receive the treatment laser radiation, in particular, a treatment laser radiation having an output power of at least 10 mW and a suitable wavelength, as discussed in the summary section above, for example.

[0076] In this embodiment, the medical treatment device 2000 further includes a sensor module 2300. The sensor module may be configured to receive light entering the distal end 1201 of the optical fiber 1200, and may include one or more optical sensors for detecting the received light.

[0077] In some embodiments, the 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, the optical fiber 1200 may be at least double-clad optical fiber, and the medical laser device may be configured to output sensor laser radiation via the core of at least double-clad optical fiber 1200. At least one core of the at least double-clad optical fiber may have a V number of less than 10, preferably less than 8, e.g., less than 6, e.g., less than 3, or even 2.4 at the wavelength of sensor laser radiation. That is, at least one core may be a multi-mode core or even a single-mode core at the wavelength of sensor laser radiation.

[0078] In some embodiments, the sensor laser radiation may include multiple wavelengths. Therefore, the V-number of at least one core of the double-clad optical fiber may differ for different wavelengths of the sensor radiation. For example, the core may be a single-mode core at one or more wavelengths of the sensor laser radiation and a multi-mode core (or even a multi-mode core) at other wavelengths of the laser radiation. In particular, in some embodiments, the medical laser device includes multiple sensor modules, e.g., an interference distance sensor module and a spectral sensor module. Different sensor modules may operate at different wavelengths. In such embodiments, at least one core of the double-clad optical fiber may be a multi-mode core with a small V-number at the wavelength of the sensor laser radiation of one of the sensor modules, e.g., an interference sensor module, or even a single-mode core (e.g., having a V-number less than 4, e.g. less than 3, or even 2.4). At least one core of the double-clad optical fiber may be a multi-mode core with a larger V-number (e.g., 3 to 10, e.g., 3 to 6) at the wavelength of the sensor laser radiation of another sensor module, e.g., a spectral sensor module.

[0079] In various embodiments, the medical treatment device 2000 includes an interference distance sensor module configured to sense the interference distance between the distal end of an optical fiber 1200 and the tissue to be treated. In particular, in some embodiments, the interference distance sensor is a common path sensor, and the distal end of the optical fiber can act as a reflector in the reference optical path, thus providing a particularly compact system that does not require any additional fibers. The medical treatment device is preferably further configured to control the therapeutic laser radiation in response at least partially to the measured distance.

[0080] In some embodiments, the sensor module is configured to detect light emitted by the endoscope, particularly at the distal end of the endoscope, and reflected from tissue or other material located in front of the distal end of the endoscope. Thus, the endoscope light can be received by the distal end of the optical fiber and detected by the sensor module 2300.

[0081] The optical fiber device is configured to be inserted into the working channel of an endoscope, such as a cystoscope, as described in relation to Figures 2 and / or 4. The endoscope / cystoscope may be a conventional endoscope / cystoscope or an endoscope / cystoscope specifically adapted for use with a medical laser device disclosed herein.

[0082] The medical therapeutic device 2000 may provide a single fiber connector for coupling a fiber to a medical therapeutic device that transmits therapeutic laser radiation and sensor radiation, as described, for example, in relation to Figure 11. In other embodiments, the medical therapeutic device 2000 may provide two (or more) separate fiber connectors for coupling each fiber to the medical therapeutic device, which may then be coupled to a single fiber in a separate combiner module, as described, for example, in relation to Figures 3, 5-8, and / or 10.

[0083] A medical treatment device may include a control module 2400 for controlling the operation of a treatment laser source and / or other components of the medical treatment device, such as a shutter, a sensor module 2300, etc. For this purpose, the control module can 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 preferred form. The control module may be implemented as a single circuit or as multiple devices or circuits capable of performing each aspect or part of the control operation.

[0084] Figure 2 schematically illustrates the operation of an embodiment of a medical laser device, as disclosed herein, with an optical fiber positioned at a certain distance from the bladder tissue or other treatment site being treated.

[0085] Generally, various embodiments of medical laser devices are for the treatment of the urinary tract, for example, the bladder, and in particular, bladder cancer. When in use, the distal end 1201 of the optical fiber 1200 is inserted through the urethra into the working channel of a cystoscope adapted for insertion into the urinary tract, particularly the bladder. The working channel of the cystoscope typically has a diameter of 1.5 mm to 2 mm, such as 1.8 mm. The cystoscope must typically be bent with a small bending radius, for example, 10 mm or less, or even 5 mm or less. Once inserted into the urinary tract, particularly the bladder, the distal end 1201 of the optical fiber 1200 is brought to a working position at a certain distance from the tissue to be treated 210, which may be a tumor in 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 so as to cause excision and / or coagulation of the tissue 210.

[0086] The therapeutic laser radiation may be directed to the target tissue in several ways. For example, when an optical fiber 1200 emits therapeutic laser radiation as a divergent beam 100, a relatively large target spot is illuminated and therefore can be treated at once, thus reducing the need to move the fiber to illuminate different locations while providing uniform treatment of a larger target spot.

[0087] In some embodiments, during the first emission, the distance between the distal end of the optical fiber 1200 and the tissue 210 being treated is 2 mm to 6 mm, such as 3 mm to 5 mm.

[0088] It will be understood that any of the medical laser devices among the embodiments described herein may include a pilot light source, for example, a pilot laser source, or other types of light sources adapted to emit visible light suitable as a pilot beam, which illuminates a portion of the tissue to be treated and serves as a aiming guide for a physician or other user of the device. The pilot beam may be supplied through the same optical fiber as the treatment laser radiation or through a separate optical fiber. In some embodiments, the pilot beam may be multicolored. In some embodiments, the device may be configured to control the visible attributes of the pilot light, for example, color and / or intensity, in response to one or more operating parameters, user inputs, and / or sensor signals.

[0089] Figure 3 schematically illustrates yet another embodiment of a medical laser device according to the embodiments disclosed herein.

[0090] The apparatus in Figure 3 is similar to the apparatus in Figure 1 in that it comprises a medical treatment device 2000 and an optical fiber device 1000. The optical fiber device 1000 includes an optical fiber 1200, and the medical treatment device includes a treatment laser source 2200, a control module 2400, and a sensor module 2300, all as described in relation to Figure 1.

[0091] The disposable optical fiber device 1000 is configured to be removable and optically coupled to a medical treatment device. For this purpose, the disposable optical fiber device 1000 of this embodiment comprises an optical fiber 1200. The disposable optical fiber device 1000 may further comprise a connector module 1100 for coupling the optical fiber 1200 to the medical treatment device 2000.

[0092] In this embodiment, the optical fiber 1200 is at least double-clad, i.e., it may be double-clad, or it may be multi-clad with more than two cladding layers (e.g., triple-clad). Generally, a double-clad optical fiber contains three layers of optical material. The innermost layer is called the core. The core is surrounded by an inner cladding, and the inner cladding is surrounded by an outer cladding. The three layers are typically made of materials having different refractive indices. Other embodiments may use other types of optical fibers.

[0093] The distal end 1201 of at least a double-clad optical fiber 1200 is configured to be advanced through the working channel of an endoscope such as a cystoscope. Preferably, the core is a single-mode core and is single-mode in at least one target wavelength or range of target wavelengths. Optionally, the at least double-clad optical fiber 1200 includes two or more cores, preferably single-mode cores, e.g., a multi-mode or single-mode central core and one or more multi-mode or single-mode lateral cores. Optionally, the at least double-clad optical fiber has a medical-grade buffer coating such as Blue EFTE, Teflon®, or nylon. The optical fiber may have a round inner cladding or a hexagonal or octagonal inner cladding for mode scrambling. The inner cladding may be multi-core cladding.

[0094] The connector module 1100 may be configured to optically connect the proximal end of at least a double-clad optical fiber 1200 to a medical treatment device 2000. For this purpose, the connector module 1100 comprises one or more optical connectors. In some embodiments, the connector module 1100 is configured to separately connect the core and cladding of at least a double-clad optical fiber 1200 to the medical treatment device 2000, respectively. For this purpose, the connector module 1100 may have a first optical connector and a second optical connector. The first optical connector may be configured to detachably connect to a first mating optical connector of the medical treatment device 2000. The second optical connector may be configured to detachably connect to a second mating optical connector of the medical treatment device. Embodiments of the disposable optical fiber device 1000 are described in more detail below with reference to Figures 4 and 5.

[0095] A medical laser device can be configured to emit therapeutic laser radiation through the cladding, particularly the inner cladding, of at least a double-cladded optical fiber 1200. The cladding may be multimode cladding.

[0096] 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 at least the core of the double-clad optical fiber 1200.

[0097] The sensor module 2300 may further include a detector 2312 for receiving and detecting radiation reflected by the target site in response to illumination from the treatment site, for example, from the tissue being treated, particularly in response to illumination by sensor laser radiation from the sensor laser source 2311 and / or 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 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 and / or via the cladding of at least double-clad optical fiber 1200 of a disposable optical fiber device.

[0098] A medical laser device can be configured to time-division multiplex the output of therapeutic laser radiation and optical measurements of at least one parameter. Thus, some embodiments of the medical laser device alternately emit therapeutic laser radiation and perform optical measurements; i.e., some embodiments of the medical laser device intermittently interrupt or at least substantially reduce the emission of therapeutic laser radiation to perform optical measurements, thereby enabling 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 particular output power, duty cycle, and / or pulse duration, in response to one or more parameters measured. Thus, the medical laser device may be configured to control the therapeutic laser source to resume intermittently interrupted therapeutic laser radiation emission using the adjusted one or more parameters. Generally, it will be understood that time-division multiplexing may include complete interruption of therapeutic laser radiation emission to perform optical measurements, or at least a substantial reduction of the therapeutic laser radiation emitted while performing optical measurements, e.g., a reduction to 5% or less of the output of the therapeutic laser radiation used during a treatment cycle (e.g., a reduction to 1% or less).

[0099] In some embodiments, the medical laser device is configured to output a therapeutic laser radiation as pulsed laser radiation, i.e., as a series of therapeutic laser pulses separated from each other by the time intervals between therapeutic laser pulses. The medical laser device may be configured to emit sensor laser radiation during some or all of the time intervals between therapeutic laser pulses.

[0100] The operation of a medical laser device will be explained in more detail below, with reference to Figure 9.

[0101] 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 that is different from, and preferably spaced apart from, the first wavelength range. Thus, some or all of the therapeutic laser radiation and the sensor laser radiation may be time-division multiplexed within the core and cladding of at least a double-clad optical fiber, and spatially separated by wavelength / frequency spacing.

[0102] Sensor laser radiation can have a lower output power than therapeutic laser radiation. For example, sensor laser radiation may have an output power of less than 5 mW, e.g., less than 3 mW, e.g., less than 2 mW, e.g., less than 1 mW, e.g., less than 0.5 mW. Sensor laser radiation may be a laser radiation weak enough not to cause damage to the human eye, in particular a laser radiation that can be classified as a Class 1 laser according to IEC60825-1:07-2015. Therapeutic laser radiation may have an output power of 10 mW or more, as described herein. The beam of therapeutic laser radiation can be harmful to the human eye when viewed by an unprotected observer. The same can be said for specular or diffuse reflection of therapeutic laser radiation. However, embodiments of medical laser devices disclosed herein provide protective measures to ensure that harmful radiation is not unintentionally seen by the person operating the device, the patient, or other people in the vicinity of the device.

[0103] 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 may control the operation of the treatment laser source 2200 and sensor modules. In some embodiments, the control unit controls the time-division multiplexing of laser radiation and optical measurements based on sensor laser radiation. The control unit 2400 may be configured to control various other optical treatment and / or sensor modules of the medical treatment device. The control unit may be configured to control the treatment laser source, sensor laser source, and / or other radiation sources and / or sensors in response to received sensor signals. The control unit may include a suitable driver and / or communication interface and a processing unit, e.g., a suitably programmed central processing unit. In particular, the control unit may be operable to selectively enable the output of the treatment laser radiation only when one or more detectable safety indicators are met. For this purpose, the control unit may operate a mechanical shutter and / or other types of shutters and / or selectively enable or prevent the turning on of the treatment laser source.

[0104] In various embodiments, one or more parameters to be measured include the distance between the distal end 1201 of at least a double-clad optical fiber 1200 and the tissue to be treated. For this purpose, in various embodiments, the sensor module 2300 comprises a first optical sensor module, in particular an interference distance sensor module, configured to perform interference distance sensing of the distance between the distal end 1201 of at least a double-clad optical fiber 1200 and the tissue to be treated. In particular, in some embodiments, the interference distance sensor is a common path sensor, and the distal end 1201 of at least a double-clad optical fiber can act as a reflector in the reference optical path, thus providing a particularly compact system that does not require any additional fiber. The medical treatment device 2000, in particular a control unit 2400 of the medical treatment device, is preferably further configured to control the treatment laser emission in response to the measured distance. In particular, the control unit may be configured to control the laser output of the treatment laser emission or another operating parameter, such as the duty cycle of the pulse train of the laser cycle, the pulse width or duration of the emission of the laser emission, etc., in response to the sensed distance. For example, the control unit may be configured to control the laser output of the therapeutic laser radiation in response to a sensed distance such that the intensity of the laser radiation striking the tissue to be treated remains substantially constant despite the changing distance. In another example, the control unit may be configured to selectively enable / disable the output of the therapeutic laser radiation from the medical treatment device in response to a sensed distance such that the therapeutic laser radiation is activated only when the distal end of the optical fiber is in an operating position in front of the treatment site, particularly in an operating position close to the treatment site. The control unit may further be configured to selectively control the laser output or other operating parameters of the therapeutic laser radiation in response to a sensed distance such that the energy of the laser radiation striking the tissue to be treated over a given period remains substantially constant despite the changing distance.

[0105] The first optical sensor module may further be configured to detect and distinguish between several different types of materials located in front of the distal end of at least a double-clad optical fiber. In such embodiments, the control unit may further be configured to selectively disable / enable the emission of therapeutic laser radiation and / or control the laser output and / or other operating parameters of the therapeutic laser radiation in response to the type of material detected. In particular, the first optical sensor module may be configured to distinguish between biological tissues, such as soft biological tissue, and non-biological materials, particularly the surface of artificial materials, such as the inner or outer surface of an endoscope. Alternatively or additionally, the first optical sensor module may be configured to detect and distinguish whether at least the distal end of a double-clad optical fiber is immersed in a liquid, particularly an aqueous solution such as water or saline or urine, or whether the distal end is immersed in air.

[0106] In some embodiments, the sensor module 2300 includes a second optical sensor module, in particular a spectroscopic sensor module, configured for spectral analysis of the tissue being treated and for calculating an indicator of the progress of the treatment. For this purpose, the spectroscopic sensor may be configured to sense one or more spectral characteristics of the radiation reflected by the tissue being treated. The medical treatment device may further be configured to determine a measure indicating the state or progress of the treatment from the sensed one or more spectral characteristics. Preferably, the medical treatment device is configured to control the treatment laser radiation in accordance with the determined state or progress, in particular in accordance with the sensed distance and the determined state or progress.

[0107] The spectroscopic sensor module may include a supercontinuum white light source for illumination through a single-mode core of at least a double-clad optical fiber 1200. Alternatively, the spectroscopic sensor module may include several WDM multiplexed LEDs for illumination through a single-mode core of at least a double-clad optical fiber 1200. The spectroscopic sensor module may be operable to measure the reflectivity of tissue being treated, for example, by measuring wavelength-dependent backreflection through a multimode inner cladding of at least a double-clad optical fiber 1200. The spectroscopic sensor module may include two or more LEDs that are switched on / off one by one, and the detector may be operable to detect the power of backreflected light using a simple photodetector. The detected power difference between signals at different wavelengths may be used by the control unit of the medical treatment device to estimate the reflectivity of the tissue. The spectroscopic sensor module can measure hemoglobin status, for example, by measuring reflected light in the 500 nm to 600 nm range that Hb absorbs. The spectroscopic sensor module may emit short-wavelength light, such as blue light, to excite fluorophores in the tissue and detect fluorescence. At any given event, the control unit may use the signal from the spectroscopic sensor to determine the optimal settings for the therapeutic laser.

[0108] Embodiments of the medical therapeutic device 2000 are described in more detail below with reference to Figure 8. As will become apparent from the following disclosure, the medical therapeutic device may include additional or alternative radiation sources and / or additional photodetectors.

[0109] During use, the disposable optical fiber device 1000 is detachably and optically connected to the medical treatment device 2000 via a connector module 1100, and at least the distal end 1201 of the double-clad optical fiber 1200 is inserted into the working channel of the endoscope, for example, as shown in Figure 4.

[0110] Figure 4 schematically illustrates an embodiment of the optical fiber 1200, for example, one of the embodiments of the optical fiber 1200 in a medical laser device described herein. Figure 4 shows the optical fiber 1200 inserted into and advanced in the working channel 3100 of an endoscope 3000, particularly a cystoscope. In the embodiment of Figure 4, the distal end 1201 of the optical fiber 1200 extends outside the working channel of the endoscope. When in use, the endoscope is inserted into a patient's blood vessel or organ, in particular into the bladder via the urethra. The endoscope 3000 may be inserted with the optical fiber 1200 already inserted into the working channel 3100. Alternatively, the optical fiber 1200 may be inserted into the working channel 3100 after the endoscope 3000 has been inserted into the target organ or blood vessel.

[0111] Endoscopes adapted for various medical procedures are known in the art and will not be described in further detail herein. In particular, different types of endoscopes may have working channels of more or less standardized diameters. Typical working channels of endoscopes have a diameter of 1 mm to 5 mm. Some endoscopes may further include a camera 3600 and / or one or more illumination lights, e.g., LED 3500, positioned 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 supplied to the distal end of the endoscope via an optical fiber.

[0112] Figure 5 schematically illustrates an example of a disposable optical fiber device 1000 according to an embodiment disclosed herein.

[0113] The disposable optical fiber device 1000 includes at least a double-clad optical fiber 1200 having a proximal end and a distal end 1201. The distal end 1201 is configured to be advanced through the working channel of an endoscope, for example, as described in relation to Figure 4. 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, an inner cladding, and an outer cladding.

[0114] The disposable optical fiber device 1000 further comprises a connector module 1100 for optically connecting the proximal end of at least a double-clad optical fiber 1200 to a medical treatment device (not shown in Figure 5), as described, for example, in relation to Figure 3.

[0115] In the embodiment shown in Figure 5, the connector module 1100 is configured to separately couple the core and inner cladding of at least a double-cladded optical fiber 1200 to a medical treatment device. The connector module 1100 comprises a first optical fiber 1110, a second optical fiber 1120, a first optical connector 1111 for detachably and optically connecting the first optical fiber 1110 to a medical treatment device, a second optical connector 1121 for detachably and optically connecting the second optical fiber 1120 to a medical treatment device, and an optical combiner module 1300 configured to couple radiation between the first optical fiber 1110 and at least one core of at least a double-cladded optical fiber 1200, and between radiation between the second optical fiber 1120 and at least one cladding of at least a double-cladded optical fiber 1200.

[0116] The first optical connector 1111 is configured to be detachably connected to a first mating optical connector of a medical treatment device, and to optically couple the core of at least a double-clad optical fiber to the first mating optical connector. The second optical connector 1121 is configured to be detachably connected to a second mating optical connector of a medical treatment device, and to optically couple the inner cladding of at least a double-clad optical fiber to the second mating optical connector.

[0117] In some embodiments, the therapeutic laser source of a medical treatment device is optically coupled to a second optical connector 1121 of a disposable optical fiber device 1000 via a second mating optical connector. The second optical connector is therefore preferably configured to receive a therapeutic laser beam, particularly a therapeutic laser beam having an output of 10 mW or more.

[0118] The sensor laser module of the medical treatment device can be optically coupled to the first optical connector 1111 of a disposable optical fiber device via a first mating optical connector. The first optical connector is therefore preferably configured to receive the sensor laser beam and output the reflected laser radiation.

[0119] Generally, a detachable connection refers to a connection made by a user of a medical laser device during normal use, which can be disconnected again during normal use. In particular, a detachable connection of an optical connector on a disposable optical fiber device means that the corresponding mating connector on the medical treatment device to which the optical connector is connected is not damaged during connection or disconnection. Preferably, the optical connector on the disposable optical fiber device is not damaged even during disconnection, i.e., the optical connector on the disposable optical fiber device can be reversibly and repeatedly connected to the medical treatment device. An optical connection means that radiation can pass between the medical treatment device and the corresponding optical fiber of the connector module to which the optical connector is coupled.

[0120] In general, in some embodiments, the connector module may comprise a housing 1170. The first optical fiber 1110, the second optical fiber 1120, and the optical combiner module 1300 may be housed entirely or partially within the housing. The housing 1170 may be a plastic housing or a housing made of another suitable material, such as a rigid or flexible material. The housing may be a box made of a rigid material, for example, or in another form, such as an elongated flexible sleeve. The housing may form a single compartment or multiple compartments. The housing has one end configured to connect to a medical treatment device, thereby allowing the first and second optical connectors to be connected to the corresponding first and second mating optical connectors of the medical treatment device. For this purpose, the first and / or second optical connectors, which may be spring-loaded, may be mounted directly on or within the sidewalls of the housing, thus enabling easy and reliable connection. Alternatively, a first and / or second optical connector(s), which may be spring-loaded, may be mounted in the housing via one or more flexible optical fiber cables. Thus, generally, all components of the connector module may be housed in a single housing, or they may be distributed between two or more separate housings that can be interconnected via one or more optical fiber cables or otherwise.

[0121] In general, the first and / or second optical connectors may be spring-loaded. For this purpose, the first and / or second optical connectors may include springs or other elastic elements to hold the first or second optical connector in place when connected to a medical treatment device. The springs or other elastic elements may be any suitable component for providing elastic force, such as leaf springs, coil springs, etc.

[0122] The housing 1170 may be equipped with additional mechanical connectors or guides 1171, such as guide rails, which further facilitate a reliable and secure connection by ensuring, for example, that the spring-loaded connector is secured to the medical treatment device with appropriate mechanical force. For this purpose, the guide rail or other mechanical connector may include a click-on mechanism.

[0123] The housing 1170 further includes an opening through which at least double-clad optical fibers 1200 protrude from the housing. The housing 1170 may include a flexible cone 1172 or other form of stress and / or bending relief portion at the opening through which at least double-clad optical fibers 1200 protrude from the housing.

[0124] The first optical fiber 1110 may be a single-mode optical fiber, an optical fiber having a single-mode core (e.g., a double-clad optical fiber), or may include a single-mode optical fiber portion. The first optical fiber or at least the core of the first optical fiber may be single-mode at least a predetermined target wavelength, particularly the wavelength used by a sensor module of a medical treatment device, for example, by an interference distance sensor module. The first optical fiber 1110 may be a single fiber portion, or may include multiple fiber portions that are optically coupled to one another, for example, spliced ​​together or otherwise connected.

[0125] The first optical connector 1111 can be a low-reflectance single-mode optical fiber connector, for example, a connector that provides physical contact between each fiber end of the optical fiber optically connected by the optical connector, i.e., between the first optical fiber 1110 and the corresponding optical fiber of a medical treatment device. In particular, the first optical connector may be an angled physical contact (APC) connector. In some embodiments, the low-reflectance single-mode optical fiber connector has a reflectance of less than -40 dB, e.g., -50 dB, preferably less than -60 dB, e.g., less than -70 dB, e.g., -80 dB. Generally, the first optical connector can be configured to couple a minority-mode or single-mode laser radiation, in particular radiation characterized by a V number less than 10, such as less than 3, to the first optical fiber. The first optical connector can be configured to couple a single-mode laser radiation having a power of less than 1 W, e.g., less than 200 mW, e.g., less than 100 mW, e.g., less than 10 mW, e.g., less than 5 mW, e.g., less than 2 mW, to the first optical fiber.

[0126] Therefore, efficient optical coupling between single-mode or multi-mode optical fibers with minimal back reflection is provided. This is particularly advantageous when the radiation passing through the core of at least double-clad optical fiber 1200 is laser radiation for sensor applications, especially for interferometry such as interference distance measurement.

[0127] Generally, as used herein, the terms single-mode radiation or single-mode laser radiation refer to laser radiation transmitted by being emitted from a single-mode optical fiber or other single-mode waveguide. Similarly, as used herein, the terms multi-mode radiation or multi-mode laser radiation refer to laser radiation transmitted through and / or emitted from a multi-mode optical fiber or other multi-mode waveguide.

[0128] The second optical fiber 1120 may be a multimode optical fiber or may include a multimode fiber portion. The second optical fiber 1120 may be a single fiber portion or may include multiple fiber portions that are optically coupled to one another, for example, spliced ​​together or otherwise connected.

[0129] The second optical connector 1121 may be a high-power optical multimode connector such as an SMA905 connector or a collimated beam connector. A collimated beam connector is an optical fiber connector that includes a collimating lens that can operate to parallelize the beam emanating from the optical fiber connector. In particular, the collimating lens may be located inside the connector housing of the connector. The collimating lens allows the collimated beam connector to be mated with a corresponding collimated beam connector, particularly with low power loss. Thus, high-power connections are suitable, for example, to provide high-power therapeutic laser radiation. The second optical connector may be a self-standing fiber end connector with no physical contact between the fiber ends. Here, the term high-power optical connector is intended to refer to an optical connection of an optical fiber that carries high-power laser radiation, in particular laser radiation of an output suitable for medical treatment of tissue, for example, by excision and / or coagulation. The second optical connector 1121 can be adapted to optical connections of optical fibers carrying laser radiation having an output of 10mW or more, for example 100mW or more, for example 200mW or more, for example 1W or more, for example 10W or more, for example 100W or more, for example 200W or more, for example between 10W and 500W. In general, the second optical connector can be configured to couple multimode laser radiation, particularly radiation characterized by a V number greater than 10, to the second optical fiber.

[0130] In general, two optical connectors may be operable to connect to each other via a mating sleeve. Thus, in some embodiments, each mating optical connector of a medical treatment device, operable to couple to the optical connector of a disposable optical fiber device, may have or be fitted with its respective mating sleeve. The mating sleeve of a second mating optical connector of a medical treatment device, operable to couple to a second optical connector of a disposable optical fiber device, may be made from a suitable material having a sufficiently high melting point and / or low thermal expansion to enable high-power optical connections, at least in part. An example of a suitable material is tungsten carbide.

[0131] In general, the first optical connector 1111 and the second optical connector 1121 provide separate optical couplings of the first optical fiber 1110 and the second optical fiber 1120 to the medical therapeutic device, respectively. Specifically, the first optical connector 1111 provides optical coupling of the first optical fiber 1110 to the corresponding first fiber of the medical therapeutic device, and the second optical connector 1121 provides optical coupling of the second optical fiber 1120 to the corresponding second fiber of the medical therapeutic device, where the corresponding second fiber of the medical therapeutic device is different from the corresponding first fiber of the medical therapeutic device.

[0132] In some embodiments, the first and second optical connectors are physically separate connectors. In particular, optical connector 1111 may have a first connector housing including, for example, a first ferrule, and the second optical connector 1121 may have a second connector housing including, for example, a second ferrule different from that of the first connector housing. In other embodiments, the first optical connector 1111 and the second optical connector 1121 may be housed in a single connector housing, or otherwise formed as a single composite connector having multiple optical ends. For example, the single connector housing may be a two-ferrule connector housing, such as a Diamond DM4 connector, having multiple optical ends.

[0133] The optical fiber 1200, which is at least double-clad, can supply single-mode, low-power sensor laser radiation through its core to the tissue to be treated. The optical fiber 1200, which is at least double-clad, may further supply single-mode reflected radiation through its core from the distal end of the optical fiber at least double-clad, via the first optical connector 1111, to a medical treatment device. The reflected radiation may be sensor laser radiation reflected by the distal end 1201 of the optical fiber 1200, and / or sensor laser radiation reflected by the tissue to be treated and captured by the distal end 1201 of the optical fiber 1200, which is at least double-clad, and / or sensor laser radiation. Therefore, the core of the optical fiber 1200, which is at least double-clad, is preferably a single-mode core at least at the wavelength(s) of the sensor laser radiation. The optical fiber 1200, which is at least double-clad, may further supply high-power, multi-mode therapeutic laser radiation through its inner cladding to the tissue to be treated.

[0134] For the purposes of this explanation, the term "tissue being treated" is intended to refer not only to tissue before treatment, but also to tissue already affected by treatment, including tissue during treatment. Generally, tissue being treated is biological tissue such as soft tissue.

[0135] An example of the optical combiner module 1130 is described in more detail with reference to Figures 6 and 7.

[0136] Optionally, the connector module 1100 may include additional components.

[0137] In particular, 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 may be electrically connectable to a medical therapeutic device via an electrical connector 1162, thereby enabling 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 further to turn off the therapeutic laser or close the shutter / optical switch, in order to prevent overheating of the optical combiner module 1130.

[0138] Alternatively or additionally, the connector module may include a cooling member 1131 configured for passive or active cooling of the optical combiner module 1130. The cooling member may include, for example, a heatsink, cooling ribs, and / or thermal conductors configured to transport heat to the heatsink of the medical treatment device when the connector module is connected to the medical treatment device.

[0139] Alternatively or additionally, the disposable optical fiber device 1000, particularly the connector module 1100, may include an RFID chip 1140 or other form of device identifier, such as a radio-readable ID tag, which enables a medical therapeutic device to automatically register the identifier of the disposable optical fiber device 1000. This may be advantageous when the medical therapeutic device is configured to operate with different types of disposable optical fiber devices. This allows the medical therapeutic device to adapt one or more of its operating parameters to the specific type of disposable optical fiber device it is connected to.

[0140] Figure 6 schematically shows an example of an optical combiner module 1130 of a connector module for a disposable optical fiber device according to an embodiment disclosed herein.

[0141] The optical combiner module 1130 couples radiation between the first optical fiber 1110 of the connector module and the core of at least double-clad optical fiber 1200 of the disposable optical fiber device according to embodiments disclosed herein. The optical combiner module 1130 further couples radiation between the second optical fiber 1120 of the connector module and the cladding, particularly the inner cladding, of at least double-clad optical fiber 1200.

[0142] Therefore, the first optical fiber 1110 may be a single-mode optical fiber in at least one target wavelength, and the second optical fiber 1120 may be a multimode optical fiber.

[0143] The optical combiner module 1130 comprises at least double-clad optical fiber section 1135 having a core and cladding. The core of the at least double-clad optical fiber section 1135 is a multimode, preferably single-mode, core at the target wavelength of radiation received through the first optical fiber. The at least double-clad optical fiber section 1135 may optionally include a low refractive index acrylate coating having a fluorinated silica (F-SiO2) cladding. The core of the at least double-clad optical fiber section may have a diameter of 5 μm to 10 μm and / or an numerical aperture of 0.07 to 0.15. The core of the at least double-clad optical fiber section has a V < 10 @ l sensor Preferably V < 8 @ l sensor For example, V < 7 @ l sensor For example, V < 2.4 @ l sensor Wavelength l of the sensor laser radiation sensor It has a V value in this context.

[0144] The V-number is a dimensionless parameter often used in the context of optical fibers, such as step-index fibers. It is a normalized frequency parameter that determines the number of modes in optical fibers, such as step-index fibers. JPEG2026514798000002.jpg19170 is defined as follows, where l is the frequency of vacuum, NA is the numerical aperture, and n core and n cladding These refer to the refractive indices of the core and the inner cladding, respectively.

[0145] For the purposes of this explanation, unless otherwise specified, the terms single-mode fiber and single-mode core refer to fibers and cores having a V number less than 2.4 at the relevant wavelength, respectively. The terms minority-mode fiber and minority-mode core refer to fibers and cores having 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 fibers and cores having a V number greater than 10, respectively.

[0146] The optical combiner module 1130 further comprises a first splice point 1136 for coupling radiation between the first optical fiber 1110 and the core of at least a double-clad optical fiber portion 1135. The first splice point 1136 may be provided with a clad-mode stripper configured for removing return multimode radiation into the first optical fiber 1110. Alternatively or additionally, the first splice point 1136 may comprise a scattering surface or a high-index glue and / or coating.

[0147] The optical combiner module 1130 further comprises a multimode fiber section 1137 and a second junction point 1138 that couples radiation between the second optical fiber 1120 and the multimode fiber section 1137. The multimode fiber section 1137 may have a core diameter of 50 μm to 100 μm and / or an numerical aperture of 0.27 or less (e.g., 0.22 or less). The core of the multimode fiber section 1137 may have a V number such that V > 10.

[0148] The optical combiner module 1130 further comprises an optical fiber combiner 1132 configured to couple radiation between the multimode fiber section 1137 and the inner cladding of at least the double-clad optical fiber section 1135. The optical fiber combiner 1132 may also be a side combiner, sometimes called a side-pump combiner, that is, a combiner configured to couple radiation laterally between the multimode fiber section 1137 and the inner cladding of at least the double-clad optical fiber section 1135 while the core of at least the double-clad optical fiber section passes through the side combiner. Thus, the side combiner couples / fusions the multimode secondary fiber (here, the multimode fiber section 1137) with respect to the circumferential outward direction of the pass-through primary fiber (here, at least the double-clad optical fiber section 1135) at a certain angle. Preferably, the secondary fiber has a smaller diameter than the primary fiber. For example, the double-clad feedthrough fiber may have a diameter of 200 μm (or another preferred diameter), and the secondary fiber may have a fiber diameter of 125 μm (or another preferred diameter smaller than the diameter of the feedthrough double-clad fiber). The side combiner can result in an upconversion of the numerical aperture (NA) of the multimode inner cladding of at least the double-clad optical fiber portion 1135, and therefore at least the double-clad optical fiber 1200, for example, from 0.22 to about 0.45. This, in turn, results in an increase in the spot size of the therapeutic laser radiation on the tissue being treated. Furthermore, the side combiner allows the sensor laser radiation propagating within the core of at least the double-clad optical fiber portion to pass through the side combiner without reflection by splices or the like.

[0149] The optical coupler module 1130 further comprises a third junction point 1134 for coupling at least a double-clad optical fiber portion 1135 with the proximal end of at least a double-clad optical fiber 1200, in particular for coupling the core and cladding of each fiber.

[0150] Figure 7 schematically shows another example of an optical combiner module 1130 of a connector module for a disposable optical fiber device according to embodiments disclosed herein. The optical combiner module 1130 is similar to the optical combiner module in Figure 6 in that it comprises at least a double-clad optical fiber section 1135, a multimode fiber section 1137, an optical fiber combiner 1132, a first junction point 1136, a second junction point 1138, and a third junction point 1134, all of which are described in relation to Figure 6.

[0151] The optical combiner module in Figure 7 differs from the optical combiner module in Figure 6 in that the first and second optical fibers 1110 and 1120 are configured to be coupled with a multicore, at least double-clad optical fiber 1200, respectively. In other words, the optical combiner module in Figure 7 is intended for use with an embodiment of a disposable optical fiber device comprising a multicore, at least double-clad optical fiber.

[0152] In some embodiments, one or more of the junctions shown in Figures 6 and 7 can be omitted. For example, the at least double-clad optical fiber portion 1135 may be formed by the proximal end of the at least double-clad optical fiber 1200. Alternatively or additionally, the multimode fiber portion 1137 may be a portion of a second optical fiber 1120 attached to a second optical connector.

[0153] Referring again to Figure 7, the optical combiner module 1130 of this embodiment further comprises a tapered fiber region 1220 at the proximal end of at least a double-clad optical fiber 1200. The tapered region 1200 is configured for coupling radiation between a single core of at least a double-clad optical fiber 1200 and one or more further cores of at least a double-clad optical fiber 1200. The tapered region 1220 may be packaged within a ferrule having air surrounding the tapered waist to allow for a high numerical aperture to support upconverted clad radiation.

[0154] Figure 8 schematically shows a more detailed example of a medical laser device according to embodiments disclosed herein.

[0155] The medical laser device includes a medical treatment device 2000 and an optical fiber device 1000, as described in relation to Figures 1 and 7.

[0156] The exemplary medical laser device is configured for the treatment of bladder cancer by laser resection and / or coagulation using a cystoscopy. However, it will be understood that other embodiments of the medical laser device may be configured for other types of medical procedures and / or for use with other types of endoscopes.

[0157] The medical treatment device 2000 comprises various laser sources, photodetectors, and associated control circuits, user interfaces, etc. The medical treatment device 2000 may be embodied with all its modules housed in a single housing, or each module may be embodied with each module housed in a different housing.

[0158] The medical treatment device 2000 includes, for example, a user interface module 2110 which includes a display (e.g., a touch-sensitive display) and a suitable user input device (e.g., a keyboard, a touchscreen), enabling an operator to control user-controllable functions of the medical treatment device and enabling the medical treatment device to output treatment-related information. In some embodiments, the user interface module includes an audible and / or visible output / progress indicator configured to output an audible and / or visual indication showing the current laser power of the treatment laser radiation or the current state of treatment. For example, a power indicator may show the output power of the treatment laser or a measured treatment state so that the physician knows when to move the fiber to the next spot. An audible indicator may show the power level or treatment state by volume or pitch of an audible signal, by the repetition rate of a repeating tone, or in another preferred manner.

[0159] The medical treatment device 2000 may further include one or more control devices 2120, such as a foot pedal, to enable a physician to activate a treatment laser while operating a cystoscope.

[0160] The medical treatment device further comprises a control unit 2400 electrically and / or otherwise communicably connected to a user interface module 2110 and one or more control devices 2120. The control unit 2400 comprises 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 treatment laser source, a sensor laser source, and / or other radiation sources and / or sensors in response to inputs received from the user interface module and / or one or more control devices. The control unit may further control a treatment laser source, a sensor laser source, and / or other radiation sources and / or sensors in response to received sensor signals. The control unit may include a suitable driver and / or communication interface and a processing unit, for example, a suitable programmed central processing unit.

[0161] The medical treatment device 2000 comprises a treatment laser source 2200 configured to emit treatment laser radiation, particularly radiation suitable for treating tumorous tissue of the bladder by excision and / or coagulation. The treatment laser radiation from the treatment laser source 2200 is preferably supplied through a second optical connector 1121 and the cladding of at least double-clad optical fiber 1200 of a disposable optical fiber device 1000.

[0162] The medical treatment device further comprises a sensor module 2300. The sensor module includes a first optical sensor module 2310 configured for interference distance sensing of the distance between at least the distal end of a double-clad optical fiber 1200 and the tissue being treated.

[0163] Preferably, the medical treatment device 2000 may be configured to control the treatment laser source 2200 in response to a sensed distance between the distal end of at least a 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 by stopping the treatment laser radiation when the fiber tip approaches the tissue. This can prevent unintended damage to the tissue to be treated.

[0164] Interferential distance sensing can be performed using broadband interferometry, as known from optical coherence tomography (OCT), etc. For this purpose, the first optical sensor module may include a suitable sensor laser source 2311 configured to output a single-mode laser emission of a suitable wavelength selected, for example, in the range of 800 nm to 1100 nm. For applications such as cystoscopy, the wavelength of the sensor laser emission is preferably selected to be a low-water absorption wavelength, such as a wavelength less than 900 nm or a wavelength of about 1050 nm. The sensor laser emission can have an output power considerably lower than the output power of the therapeutic laser emission, for example, an output power at least two or three orders of magnitude lower.

[0165] The first optical sensor module 2310 further comprises a spectrometer 2312 for performing broadband interferometry. For this purpose, the first optical sensor module receives reflected radiation returning through a disposable optical fiber device, in particular reference radiation reflected by the tip of at least double-clad optical fiber 1200, and radiation reflected by the tissue to be treated and captured by the tip of at least double-clad optical fiber 1200. Based on the reflected radiation, the medical treatment device determines the distance between the distal end of at least double-clad optical fiber 1200 and the tissue to be treated in a manner known in the art. Thus, the first optical sensor module 2310 can output sensor laser radiation through a single-mode or multi-mode core of at least double-clad optical fiber and receive reflected radiation through a single-mode or multi-mode core of at least double-clad optical fiber as the basis for distance measurement.

[0166] Various embodiments of the interference distance sensor of the first optical sensor module 2310 provide an axial resolution of 5 μm to 200 μm, for example 10 μm to 150 μm, for example 50 μm to 100 μm.

[0167] The interference distance sensor of the first optical sensor module 2310 can be implemented in different ways. In some embodiments, the interference distance sensor employs spectral domain OCT using an SLED and a spectrometer. The inventors have found that such a system provides sufficient axial resolution with an SLED bandwidth of about 10 nm to 30 nm. Therefore, the spectrometer only needs to cover a relatively small bandwidth. Preferably, the spectrometer has a resolution of 0.01 nm to 0.05 nm, thereby obtaining a sufficient axial range suitable for distance measurement during treatment. The interference distance sensor can operate at wavelengths in the range of about 800 nm to about 900 nm, CMOS detectors / spectrometers have good sensitivity, and InGaAs or GaAs SLEDs are readily available. This maximum axial range of the distance sensor can be about 3 mm to 10 mm, for example, about 3 mm to 9 mm.

[0168] In an alternative embodiment, the interference distance sensor may employ a spectral domain OCT using a sweep source laser and a detector. This embodiment has the advantage of an extended maximum axial range between approximately 10 mm and 20 mm. This embodiment can be implemented by data acquisition synchronized with the laser sweep, similar to conventional sweep source OCT systems. The sweep range may be selected to be between 10 nm and 40 nm, for example, less than or equal to approximately 20 nm, and the sweep frequency may be selected to be between 1 kHz and 100 kHz, for example, less than or equal to 10 kHz.

[0169] To adapt to measurements via fiber, which are advanced through a flexible endoscope and bent and moved during treatment, various embodiments of the interferometric distance sensor employ common-path interferometry, where at least double-clad optical fiber 1200 is used as both the reference path and the sample path. The reflection from the distal end of at least double-clad optical fiber is used as the reference signal. Thus, a separate reference arm is avoided, thereby reducing the complexity and cost of the system.

[0170] In such embodiments, a suitable amplitude of the reference signal ensures a good interference signal for the spectrometer. For this purpose, a suitable amplitude of the reference signal can be obtained by selecting a suitable fiber tip angle at least at the distal end of the double-clad optical fiber, for example, an angle between 2 and 10 degrees, depending on the fiber type and laser power.

[0171] In various embodiments, the radiation from the sensor laser source 2311 of the interference distance sensor 2310, as well as the back-reflected radiation, is supplied through a single-mode core of at least a double-clad optical fiber 1200 and through a first optical connector 1111 of a disposable optical fiber device 1000. The inventors have recognized that the signal path from the spectrometer of the interference distance sensor to the distal end of at least a double-clad optical fiber preferably has a low back-reflected loss of less than -60 dB. Therefore, in some embodiments, the first optical connector 1111 of the disposable optical fiber device through which the sensor signal for interference distance measurement is supplied is preferably a low-reflectivity connector, such as a fiber optical connector with physical contact between fibers, and optionally an angled connector such as an E2000 connector.

[0172] In some embodiments, the interference distance sensor may 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 reflected light reflected by the output facets 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 interference distance sensor as a decrease in the intensity of the reflected light over a wide wavelength range, thereby serving as a reliable indicator that the fiber tip is immersed in water, saline solution, urine, etc.

[0173] The sensor module 2300 may preferably include a second optical sensor module 2320 configured for spectral analysis of the tissue being treated. In particular, the spectral characteristics of radiation reflected by the tissue being treated may be used as an indicator of the progress of treatment. For this purpose, the medical treatment device may be configured to measure the tissue condition using reflectance spectroscopy, for example, using white light reflectance spectroscopy.

[0174] When tissue is phototreated, it changes from an absorbing state to a more scattered state. Low-wavelength light is reflected more than long-wavelength light, and the scattering state of the tissue can be estimated by measuring the difference in reflected power at one or more wavelengths. Therefore, measuring the power difference between two or more wavelengths of backreflected radiation leads to a measurement of the photocoagulation state of the tissue, and thus a measurement of the state or progression of treatment. Accordingly, in various embodiments, medical treatment devices are configured to use reflection spectroscopy to monitor the state of coagulation caused by a treatment laser.

[0175] In some embodiments, the second sensor module 2320 includes an illumination source using a supercontinuum laser that covers a wavelength range, for example, between 400 nm and 1100 nm, or between 400 nm and 800 nm. Alternatively, the illumination source may use one or more monochromatic LEDs at each wavelength, for example, one or more of the other wavelengths in the range of 400 nm to 700 nm, such as about 400 nm, about 500 nm, about 600 nm, and about 700 nm and / or 400 nm to 700 nm.

[0176] In any case, the second optical sensor module 2320 is configured to receive radiation reflected by the tissue being treated. Therefore, the second optical sensor module 2320 may include a suitable detector for measuring the reflected radiation. The detector may include a grating CCD / CMOS spectrometer with a resolution to, for example, 1 nm, covering 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-division multiplexed by multiple LEDs.

[0177] To maintain a good signal intensity of radiation reflected back from the tissue, it is preferable that the illumination light passes through the first optical connector 1111 and the single-mode core of at least double-clad optical fiber 1200 of the disposable optical fiber device 1000, i.e., the illumination light shares the same path through the same disposable optical fiber device as the coherent distance measurement radiation. Spectroscopy is non-coherent and is therefore more limited by noise than coherent distance measurement. Therefore, in various embodiments, the multimode cladding of at least double-clad optical fiber 1200 of the disposable optical fiber device 1000 captures the reflected light of the spectroscopic illumination. That is, the second optical sensor module 2320 receives radiation reflected back from the tissue to be treated in response to being illuminated by the illumination source of the second optical sensor module 2320, via the cladding of at least double-clad optical fiber 1200 and via the second optical connector 1121 of the disposable optical fiber device 1000.

[0178] Therefore, the medical laser device may, for example, display or output the progress, or even automatically control the treatment laser source 2200, to prevent unintended overtreatment that could otherwise result in unwanted tissue damage. In some embodiments, the second optical sensor module 2320 may output sensor laser radiation via a single-mode or multi-mode core of at least double-clad optical fiber and receive reflected sensor laser radiation via a single-mode or multi-mode core of at least double-clad optical fiber or via multi-mode cladding. The wavelength used for spectroscopic analysis may preferably be selected at a low water absorption wavelength, such as a wavelength less than 900 nm or a wavelength of about 1050 nm. In particular, in some embodiments, the wavelength used for spectroscopic analysis may preferably be selected to correspond to the maximum absorption hemoglobin and / or another suitable molecular marker.

[0179] In some embodiments, the medical treatment device may include additional or alternative optical components, such as one or more of the following further components. Some embodiments of the medical treatment device 2000 include at least one additional treatment laser 2610 configured for cutting tissue, rather than for excision and / or coagulation. The cutting laser may emit treatment laser radiation of a suitable wavelength, such as infrared radiation, e.g., 1940 nm, which is absorbed by water. The treatment laser radiation from the cutting laser 2610 is preferably supplied through the cladding of at least double-clad optical fiber 1200 of the second optical connector 1121 and disposable optical fiber device 1000. In some embodiments, the additional treatment laser 2610 emits treatment laser radiation configured to be absorbed by water near the tissue being treated, thereby facilitating the removal of the treated tissue from the treatment site. For this purpose, the additional treatment laser 2610 may be configured to emit treatment laser radiation of a wavelength of 1000 nm to 2000 nm (e.g., 1200 nm to 2000 nm).

[0180] Alternatively, or in addition, the medical treatment device 2000 may include a Raman sensor 2620 or other suitable sensors configured to determine the characteristics of the tumor being treated. The Raman sensor may be, for example, a 300 mW Raman laser at 785 nm. The sensor laser radiation from the Raman laser is preferably supplied through a first optical connector 1111 and a single-mode core of at least double-clad optical fiber 1200 of the disposable optical fiber device 1000. The return radiation to the Raman sensor is preferably supplied through the cladding of at least double-clad optical fiber 1200 and a second optical connector 1121 of the disposable optical fiber device 1000.

[0181] As an alternative, or in addition, the medical treatment device may include other types of light sources, such as a pilot light source, e.g., a pilot laser source, or a pilot beam suitable for emitting visible light to illuminate a portion of the tissue being treated and to serve as a aiming guide for the physician or other user of the device. The pilot beam may be supplied 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 pilot beam may be polychromatic. In particular, the pilot beam may contain two or more color components detectable by a camera of the medical laser device, for example, at least two detectable color components separated by at least 40 nm. The at least two color components may be part of a broadband emission spectrum having a bandwidth of 40 nm or more, and the intensity of the emitted pilot light may be substantially uniform across the bandwidth or vary across the bandwidth. Each of the two detectable color components may have an intensity high enough to be detectable by a camera or similar detector of a medical laser device, such that the spot illuminated by the pilot beam is visible to a human observer as an illuminated spot having a color resulting from a mixture of the at least two color components in the camera image, for example, as a white or substantially white spot.

[0182] In some embodiments, the medical laser device includes a handheld communication device 2130. The handheld communication device may be communicatively coupled to a medical treatment device 2000, for example, via a wired or wireless connection. The handheld communication device includes a user input device (e.g., a push button) configured to receive user input from a patient during treatment with the medical laser device. The user input may indicate pain or discomfort experienced by the patient during treatment. For this purpose, the patient may be instructed to press a button if they experience pain or discomfort during treatment. 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 derive the degree of pain or discomfort from the measured force or pressure. Accordingly, 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 therapeutic laser emission in at least partially in response to the received user input. For this purpose, the control unit may compare the information from the user device with the current, calculated, or selected operating parameters of the therapeutic laser emission 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 output and adjust the maximum output of the therapeutic laser radiation to minimize patient pain.

[0183] In some embodiments, the medical treatment device 2000 further comprises an optical combiner module 2700 having an optical interface to a treatment laser source 2200, a first optical sensor module 2310 with an interference distance sensor, and an optional second optical sensor 2320. In embodiments having additional optical treatment and / or sensor units, the optical combiner module also has an optical interface to any such unit, for example, a cutting laser 2610 and / or a Raman sensor 2620.

[0184] As described above, the therapeutic laser source 2200 emits relatively high-power therapeutic laser radiation supplied through a multimode cladding of at least double-cad optical fiber, while the interference distance sensor of the first optical sensor module 2310 emits and receives low-power radiation through a single-mode or multimode core of at least double-cad optical fiber. The second optical sensor module 2320 emits radiation supplied through a single-mode or multimode core of at least double-cladding optical fiber 1200 of a disposable optical fiber device, and receives radiation through the cladding of at least double-cladding optical fiber 1200 of the disposable optical fiber device.

[0185] Therefore, the optical combiner module 2700 is configured to couple optical paths supplied through the core of at least double-clad optical fiber 1200 via a first optical connector 1111 of the disposable optical fiber device 1000. The optical combiner module 2700 is further configured to couple optical paths supplied through the cladding of at least double-clad optical fiber 1200 via a second optical connector 1121 of the disposable optical fiber device 1000. For this purpose, the optical combiner module 2700 may include a suitable fused fiber combiner for coupling signal paths supplied through the single-mode core of at least double-clad optical fiber 1200. Similarly, the optical combiner module may include suitable free-space components, lenses, and dichroic filters for performing multimode power and wavelength division / coupling of radiation supplied through the cladding of at least double-clad optical fiber 1200.

[0186] The optical combiner module 2700 has two optical interfaces that are coupled to the disposable optical fiber device 1000: (a) Single-mode or multi-mode interface 2810 (which can be characterized by, for example, a V number less than 10) and (b) Multimode interface 2820 (which can be characterized by, for example, a voltage greater than 20), Each is equipped with one of these features.

[0187] Generally, an optical combiner module may include one or more fused fiber couplers configured to multiplex the sensor laser radiation from an interference distance sensor together with the sensor laser radiation from a spectroscopic sensor in an optical fiber that is single-mode at least the wavelength of the sensor laser radiation of the interference distance sensor. In particular, the wavelength(s) of the sensor laser radiation of the interference distance sensor may be different from the wavelength(s) of the spectroscopic sensor. The fiber couplers may be fused 3dB couplers.

[0188] In various embodiments, the optical combiner module may be configured to multiplex multimode therapeutic laser radiation and multimode sensor radiation in a multimode optical fiber. For this purpose, the optical combiner module may include free-space components comprising one or more lenses and one or more dichroic mirrors. The multimode sensor radiation may include multimode response radiation reflected by the tissue to be treated in response to being irradiated by the sensor laser radiation emitted by the spectroscopic sensor module.

[0189] The medical laser device preferably comprises a sacrificial interface module 2800 having corresponding optical interfaces that interface with a single-mode or multi-mode interface 2810 and a multi-mode interface 2820, respectively. The sacrificial interface module 2800 optically connects the single-mode or multi-mode interface 2810 to a first mating optical connector 2101 to which a first optical connector 1111 of a disposable optical fiber device 1000 can be connected. Furthermore, the sacrificial interface module 2800 optically connects the multi-mode interface 2820 to a second mating optical connector 2102 to which a second optical connector 1121 of the disposable optical fiber device 1000 can be connected. During operation of the medical laser device, since the disposable optical fiber device 1000 is typically a disposable device that is replaced by a new disposable optical fiber device between each treatment, different disposable optical fiber devices may be interchangeably connected to the mating first and second optical connectors 2101 and 2102 of the sacrificial interface module 2800, respectively. Therefore, the first and second mating optical connectors of the sacrificial interface may be subject to wear. Thus, providing a sacrificial interface module 2800 that can be replaced relatively easily facilitates the maintenance of the medical treatment device 2000.

[0190] It will be understood that the radiation from and to each optical module of a medical treatment device does not necessarily have to be supplied simultaneously through disposable optical fiber devices. Instead, at least some of the radiation is time-multiplexed in a suitable manner to avoid them interacting in an undesirable way. An example of time-division multiplexing operation is described in more detail below with reference to Figure 9.

[0191] Next, various embodiments for operating a medical laser device will be described. Generally, in various embodiments, the medical laser device includes a control unit configured to emit therapeutic laser radiation from its distal end toward the tissues of the urinary tract in response to received user input.

[0192] In some embodiments, the medical laser device responds to received user input, 1) To sense the distance between the distal end of at least a double-clad optical fiber and the tissue to be treated, activate a first optical sensor module, in particular an interference distance sensor, and / or 2) Activate a second optical sensor module, in particular a spectral sensor, to detect one or more spectral characteristics of the tissue being treated. 3) Controlling the therapeutic laser source, at least in part depending on the perceived distance and / or detected characteristics, and provided that one or more safety conditions / indicators are met. It is equipped with a control unit configured in such a way.

[0193] In particular, the control module may be configured to receive at least one sensor signal from a first and / or second optical sensor module only if at least one sensor signal indicates that the optical fiber device is coupled to one or more of the optical connectors / optical output ports of a medical treatment device, and that the distal end of the optical fiber is positioned in a safe location, for example, as described in more detail below, and to enable the output of a therapeutic laser radiation via at least one optical port, in particular via an optical output port.

[0194] Controlling a therapeutic laser source in accordance with a sensed distance and / or detected characteristics may include a control unit selecting the laser power and / or other operating parameters of the therapeutic laser emission in accordance with a sensed distance and / or detected characteristics, and controlling the therapeutic laser source to emit the therapeutic laser emission at the selected laser power and / or other selected operating parameters. Examples of other operating parameters may include the duty cycle, the pulse width of the laser pulse train, the duration of emission of the therapeutic laser emission, etc. The control unit may be configured to control the therapeutic laser source in accordance with a sensed distance and / or detected characteristics in order to control the laser energy deposited on the treatment site.

[0195] Preferably, the control unit is configured to repeat operations 1) to 3) while user input is being received or until an end input is received.

[0196] In this regard, the control unit may be configured to automatically control the therapeutic laser source in at least part in accordance with the sensed distance and / or detected characteristics, or the control unit may be configured to perform the control in an operator-assisted manner. For example, the control unit may 1) Calculate or select the laser power and / or other operating parameters of the therapeutic laser emission, depending at least in part on the perceived distance and / or detected characteristics. 2) Display, otherwise communicate, the calculated or otherwise selected laser power and / or other operating parameters to the operator operating the device, and request approval / manual activation of the displayed / communicated values, and / or enable the operator to manually change and activate the values. 3) Control the therapeutic laser source in accordance with the laser output and / or other operating parameters approved or modified by the operator, It can be configured in this way.

[0197] In various embodiments described herein, time-division multiplexing therapeutic laser radiation and optical measurements based on sensor laser radiation using the same at least double-clad optical fiber allows for extremely thin fibers while avoiding harmful interference between the sensing system and the therapeutic laser, such as that caused by back-reflected therapeutic laser radiation striking the detector of the sensor module. In particular, in various embodiments, the medical laser apparatus is configured to time-division multiplex interference distance sensor signals, spectral sensor signals and therapeutic laser radiation for use in surgery, especially minimally invasive surgery, such as the resection and / or coagulation of cancer in the urinary tract, especially the bladder.

[0198] User input and / or termination signals may be received via a foot pedal or other suitable user-activated input device.

[0199] To efficiently perform time-division multiplexing, medical therapeutic devices may be capable of operating quickly enough to switch between various laser sources, for example, within 1 ms or faster. For this purpose, if one or more laser sources, for example the therapeutic laser source, are diode lasers, rapid switching can be achieved by directly switching the drive current. When the interference distance sensor includes an SLED or sweep source, or when the spectroscopic sensor includes a supercontinuum laser, these lasers may require time to stabilize when switched on, so they may need to be switched in a different way to obtain rapid switching. Therefore, switching may be performed, for example, by an acousto-optic tunable filter (AOTF), a MEMS-based device, or in another suitable way. Such external switches may produce reflections. Therefore, when used to switch the sensor laser radiation of an interference distance sensor, it is preferable to place them between the sensor laser radiation source and the coupler / circulator for the receiver. In a spectroscopic engine, the switch may be located on the laser output.

[0200] In some embodiments, the control unit is configured to receive information about a disposable optical fiber device connected to a medical treatment device and to select the laser output, at least partially depending on the laser output selected by the user, the sensed distance, and the received information about the disposable optical fiber device connected to the medical treatment device.

[0201] In some embodiments, the control unit is configured to output camera control signals operable to control the operation of the endoscope camera, and the control unit is configured to synchronize the camera operation with the operation of the therapeutic laser source so that image data is recorded by the camera only when the medical laser device emits no therapeutic laser radiation or only therapeutic laser radiation at a substantially reduced intensity, in particular at an intensity reduced so that the reduced therapeutic radiation does not excessively affect the camera image. For this purpose, the therapeutic laser radiation may be reduced to 5% or less, e.g., 1% or less, of the intensity of therapeutic laser radiation during the preceding treatment cycle.

[0202] In some embodiments, the control unit is configured to control the laser output of the therapeutic laser radiation in response to the type of material detected. For this purpose, the first optical sensor module may be further configured to detect and distinguish between several different types of materials located in front of the distal end of at least a double-clad optical fiber.

[0203] Figure 9 schematically illustrates the operation of an embodiment of a medical laser device, for example, a medical laser device described in relation to one or more of the figures above, according to various embodiments disclosed herein, specifically a device for the treatment of the urinary tract, specifically the bladder. This process is controlled by a control unit of the medical laser device.

[0204] First, the medical treatment device may be operated in inactive mode. In inactive mode, neither the emission of sensor laser radiation nor the emission of treatment laser radiation is enabled.

[0205] In response to activation of the medical treatment device by user input, the medical treatment device can be operated in a safe mode. User-input activation may include, for example, the user pressing a button or selecting an operating mode. In some embodiments, operation of the device in safe mode may be enabled only when the device detects that the optical fiber device has actually been connected to the medical treatment device. In safe mode, the interference distance sensor module of the medical treatment device can be activated to supply sensor laser radiation 4100 through at least double-clad optical fiber of a disposable optical fiber device connected to the medical treatment device. The interference distance sensor module further receives reflected radiation received by the distal end of at least double-clad optical fiber in response to the emitted sensor laser radiation. The medical treatment device is configured to analyze the received reflected radiation to detect whether the distal end is immersed in a liquid, particularly water, saline, and / or urine, and / or whether the distal end is located in close proximity to a surface other than biological tissue. If the distal end is in close proximity to a surface other than biological tissue, or if the distal end is not immersed in a liquid, particularly water, the control unit may prevent the medical treatment device from emitting therapeutic laser radiation. Detection of a non-biological tissue surface may indicate that at least the distal end of the double-clad fiber has not yet been inserted into the endoscope, or at least has not fully passed through the working channel of the endoscope, or that the endoscope has been bent so that the distal end is actually facing outwards. Therefore, preventing the medical treatment device from emitting therapeutic laser radiation in this situation prevents unintended damage to the endoscope or other surfaces by therapeutic laser radiation.

[0206] Failure to detect liquids, particularly water, may indicate that at least the distal end of the double-clad fiber is not yet positioned near the treatment site, and especially not yet inserted into the bladder. In this situation, preventing the medical treatment device from emitting therapeutic laser radiation prevents unintended damage to tissues other than the intended tissue.

[0207] Preventing the emission of therapeutic laser radiation may include preventing the power to the therapeutic laser source from being turned on and / or preventing a suitable shutter / optical switch from being opened, or preventing the emission of therapeutic laser radiation in another suitable manner.

[0208] In particular, the control unit allows the medical treatment device to exit safety mode and enter treatment mode only when the medical treatment device detects biological tissue near at least the distal end of the double-clad optical fiber and water between the distal end and the detected biological tissue.

[0209] When operated in treatment mode, the output of the treatment laser radiation is enabled, meaning the operator can initiate the emission of the treatment laser radiation by activating an appropriate user input device, such as a foot pedal. When a user input device is activated, the control unit receives an activation signal 4200, for example, as long as the foot pedal remains activated. In some embodiments, each activation of the foot pedal may trigger the emission of a single burst (or another predetermined number of bursts) of treatment laser radiation, corresponding to a predetermined amount of laser energy delivered to the tissue being treated, for example, a user-selected amount (e.g., a predetermined amount of laser energy per unit area).

[0210] In response to the activation signal, the control unit may repeatedly execute the treatment cycle, for example, as long as the activation signal 4200 is received, or until an termination signal is received, or for a predetermined amount of time, and may emit, for example, a single burst of laser radiation.

[0211] In some embodiments, during each treatment cycle, the control unit first causes an interference distance sensor to emit a sensor laser radiation 4110 to sense the distance between the distal end of at least a double-clad optical fiber and the tissue being treated. The distance sensor can perform one or more distance measurements within a suitable measurement period, e.g., 10 ms or less. For example, the control unit can calculate the average over multiple distance measurements. If the interference 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 a liquid, particularly water, the control unit causes the medical treatment device to exit treatment mode and return to safety mode.

[0212] Otherwise, once the distance measurement is complete, the control unit deactivates the sensor laser radiation from the interference distance sensor and activates the spectroscopic sensor to emit spectroscopic sensor laser radiation 4310. The spectroscopic sensor, in response to being irradiated with the spectroscopic laser radiation, receives the light reflected by the tissue to be treated and determines the state / progress of the treatment based on the absolute or relative reflectance or power in, for example, one or more wavelength bands at, for example, the hemoglobin emission peak or another suitable molecular marker indicating the progress of the laser treatment. The spectroscopic measurement may last for a suitable measurement period, e.g., 10 ms or less. The control unit may then deactivate the sensor radiation from the spectroscopic distance sensor.

[0213] Based at least in part on the determined distance and / or determined progression, in step 4410, the control unit determines the power and / or duty cycle or other preferred parameters of the therapeutic laser radiation to be emitted. For example, the control unit may select a lower power and / or duty cycle if the measured distance is small, and a higher power and / or duty cycle if the measured distance is large. The control unit may even prevent the emission of therapeutic laser radiation if the detected distance is smaller than a safety threshold.

[0214] In some embodiments, the selection of the therapeutic laser radiation output (or other preferred parameters) may further be based on a user-selected baseline output (or other preferred parameters). For example, the control unit can automatically adjust the baseline output according to the detected distance, for instance, by attenuating the laser output relative to the baseline output in accordance with the decreased distance.

[0215] Alternatively, or in addition, the control unit may select the power, duty cycle, and / or other suitable parameters of the therapeutic laser radiation in response to the detected state / progress of treatment, for example, by attenuating the laser power and / or duty cycle in response to increased progress.

[0216] The control unit can receive further information regarding the characteristics of the disposable optical fiber device currently connected to the medical treatment device by reading, for example, an ID tag, such as an RFID tag, a QR code (registered trademark), or other computer-readable identifier. Therefore, the control unit can select the laser output based on sensor data from the distance sensor (and optionally, sensor data from the spectroscopic sensor), a preset baseline output at device startup, and the received information regarding the characteristics of the disposable optical fiber device. Information regarding the characteristics of the disposable optical fiber device may include, for example, information regarding fiber diameter, numerical aperture, etc.

[0217] Next, the control unit controls the therapeutic laser source to emit therapeutic laser radiation 4510 at a selected power. For this purpose, the control unit may control the therapeutic laser source to output therapeutic laser radiation at a suitable power, e.g., an output power selected in intervals between 10W and 2200W or another suitable interval. In some embodiments, the therapeutic laser radiation may be emitted as a pulse train of therapeutic laser pulses. The pulses may have a pulse duration of 1ms to 10ms or another suitable pulse duration. The control unit may control the therapeutic laser to emit therapeutic laser radiation for a therapeutic period, for example, which may be preset as a pre-configured duration or which may be user-selectable, or the therapeutic period may be at least partially automatically selected based on the perceived distance and / or detected progress. In some embodiments, the therapeutic period may correspond to 5 to 100 laser pulses, e.g., 10 to 20 pulses. Once the therapeutic period is complete, the control unit stops emitting therapeutic laser radiation.

[0218] Once the treatment cycle is complete, the control unit again controls the interference distance sensor to perform distance measurement by emitting the corresponding sensor laser radiation 4120 as described above, followed by spectroscopic measurement 4320.

[0219] Based at least in part on the determined distance and / or determined progression, in step 4420, the control unit determines the power, duty cycle, and / or other preferred parameters of the therapeutic laser radiation to be emitted during the subsequent treatment period. 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 a memory for storing the results of one or more previous distance measurements and / or state / progression measurements. The results of one or more previous distance measurements may be used, for example, to determine the change in distance due to the relative motion between the distal end of at least double-clad optical fiber and the tissue being treated. Thus, the control unit can select the laser power or other parameters based not only on the currently measured distance but also on the observed change in distance, e.g., whether the distance is increasing or decreasing, and optionally, on the rate of change of what speed it is. Similarly, the control unit may select the laser power or other parameters based on the observed rate of change of the treatment state.

[0220] In some embodiments, the control unit further selects the laser output or other parameters based on patient feedback received via a suitable user device operated by the patient during the course of treatment, such as a handheld user device. For example, the patient may activate the user device when the patient experiences pain or discomfort during treatment. The user device may transmit a corresponding patient feedback signal 4700 to the control unit, which may then adjust the laser output or other parameters for subsequent treatment cycles in response to the received feedback.

[0221] The control unit then controls the treatment laser source to emit treatment laser radiation 4520 at the selected output and / or other parameters during a separate treatment period.

[0222] The control unit may repeatedly execute the treatment cycle, for example, as long as the activation signal 4200 is activated to emit a predetermined burst of laser radiation, or until an termination signal is received, or for a predetermined treatment duration. As described above, the control unit may also interrupt the treatment if an unsafe condition is detected, such as the fiber being directed towards a non-tissue surface, the fiber no longer being immersed in water, and / or being too close to the tissue being treated, or when spectroscopic measurements indicate that the tissue treatment is complete.

[0223] It will be understood that some modifications may be made to the process for operating the medical laser device. For example, if the medical laser device includes additional sensors, the measurement periods of these additional sensors may be included in one or more treatment cycles in a time-division multiplexing scheme, as described above with respect to distance measurement and spectroscopic measurement. In some embodiments, some or all of the measurements, such as spectroscopic measurements, may not necessarily be performed during each treatment cycle, but may be performed only during some treatment cycles, for example.

[0224] Although the embodiments described above have been primarily described in the context of optical fiber devices having two separate connectors and connector / combiner modules, other embodiments are also possible, including embodiments in which therapeutic radiation and sensor radiation are coupled into a single optical fiber within a medical therapeutic device.

[0225] For example, Figure 10 shows an embodiment in which the medical treatment device 2000 has two optical output ports, and the outputs from these ports are coupled to a single optical fiber 1200 in a separate combiner module 1100. In this embodiment, detection of the presence of water by OCT signaling is facilitated by the two-port system. Figure 11 shows an embodiment in which the outputs from the treatment laser source and the sensor laser source are coupled inside the medical treatment device 2000 so that only a single output port is required. In this embodiment, detection of insertion into water / endoscopy / cystoscope may be based on a cystoscope signal (e.g., modulated LED), by TOF between fiber facets, or by a pair of electrodes.

[0226] In both embodiments, the sensor radiation is low-power radiation with sufficient output power to be classified as a Class 1 laser according to IEC60825-1:07-2015, while the therapeutic laser radiation has such high output power that it cannot be classified as a Class 1 laser according to IEC60825-1:07-2015 without special technical safety features, but is, for example, Class 4. This means that the operator and patient must typically wear laser goggles, and there must be an interlock connected to a door switch and a "laser on" lamp outside the room. Thus, 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, embodiments of medical laser devices disclosed herein preferably provide protective means to ensure that harmful radiation is not unintentionally seen by the person operating the device, the patient, or other persons near the device, so that the device can be classified as a Class 1C laser according to IEC60825-1:07-2015. Therefore, the operation of the embodiments of medical laser devices disclosed herein requires fewer operational safety precautions such as goggles and interlocks connected to door switches, and is thus more user-friendly and efficient in use without compromising safety.

[0227] Generally, embodiments of medical laser devices for performing surgical treatments are disclosed herein. The device includes a medical treatment device 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 a patient undergoing a treatment.

[0228] The medical treatment device comprises a housing and a therapeutic laser source housed inside the housing. The therapeutic laser source may be a hazardous laser, in particular a Class 4 laser according to IEC60825-1:07-2015.

[0229] The medical treatment device includes safety measures to ensure that no harmful 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 optical fiber is located inside the body being treated. Preferably, the safety measures are configured such that the medical laser device is safe to use without personal protective equipment, or with at least minimal personal protective equipment, to the extent that the device can be declassified to Class 1C.

[0230] Generally speaking, safety systems are 1) For example, blocking / disabling the therapeutic laser (Class 4 laser) by using a shutter inside the housing of the laser device. 2) Selectively enable the output of Class 4 laser radiation according to a) to e), a) To detect the connection / insertion of a fiber optic connector to the optical output port of the device. (i) Optionally, turn on the Class 1 light on the condition that step i) is detected. (c) To detect the (sufficient) integrity of the connected fiber, (e) Detecting the insertion of a fiber connected to the cystoscope and bladder by detecting the immersion of the fiber tip in a liquid (e.g., water, saline solution, urine, etc.) and / or by detecting a valid bladder tissue signal. (o) Provided that conditions (a) and (d) are met, open the shutter or enable the Class 4 laser. This can be obtained based on the following procedure.

[0231] Standalone safety system: In some embodiments, the safety means provides a standalone safety system that can operate with conventional endoscopes, such as conventional cystoscopes, without requiring specific functionality from the endoscope / cystoscope.

[0232] In particular, the device may be configured to emit and detect sensor signals, in particular non-toxic optical sensor signals for detecting that the distal end of the optical fiber is in a safe position, especially inside the body being treated.

[0233] For this purpose, the device may include two optical ports, in particular two optical output ports, one optical output port emitting Class 4 light, in particular therapeutic laser radiation, for treatment, and the other optical output port emitting and receiving Class 1 light for sensing.

[0234] Class 4 and Class 1 light can be coupled within the device housing and output through a single optical output port, for example, as shown in Figure 11. Alternatively, the device may have two optical output ports. In this case, the optical paths of Class 4 and Class 1 light can be coupled into a single fiber outside the device by a combiner module, for example, as shown in Figure 10.

[0235] If a (disposable) fiber is connected to an optical output port or to each optical output port, and the connection is detected, the device operates in safe mode, in which Class 1 light is enabled or can be enabled (Class 1 refers to laser radiation that is safe under all circumstances). If the device has multiple optical output ports, for example, one for Class 4 light and one for Class 1 light as described above, operation in safe mode may require that an optical fiber device be connected to each of the optical output ports. 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 means and / or software means and / or mechanical means such as a mechanical shutter in the beam path.

[0236] The output of a Class 4 laser beam may be enabled when the reflected Class 1 light sends a signal to the device (sensed by a suitable sensor in the device) that verifies that the fiber tip is inside the body or in another (people-safe) location.

[0237] This verification may involve verifying that one or more conditions / indicators are met, such as the fiber tip being immersed in a liquid such as water, saline solution, and / or urine, and / or the fiber tip receiving light from the endoscope tip, and / or the fiber tip being in close proximity to the tissue being treated, and / or similar.

[0238] It will generally be understood that the term "enabling laser radiation output" does not necessarily mean that laser radiation is emitted. Actual emission may also 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 cause the laser radiation to be emitted. When the output is not enabled, the user will be prevented from initiating the emission of laser radiation. In other words, enabling therapeutic laser radiation output is intended to mean that the user can control the device to emit therapeutic laser radiation.

[0239] Therefore, the control process for implementing the safety system is 1) For example, using a laser safety interlock system to enable the output of Class 1 radiation for transmission to the fiber tip in response to the detection of insertion / coupling to the optical output port (or each respective optical output port) of the fiber connector (since Class 1 light is not hazardous, in an alternative embodiment, the emission of Class 1 radiation can always be enabled; optionally, the "sufficient" integrity of the coupled fiber can be detected), 2) For example, detecting the presence of water at the fiber tip by detecting a change in reflection from approximately 3.5% (silica / air) to approximately 0.2% (silica / water) (for example, roughly corresponding to a 20-fold (a factor of 20) change in reflected power from the fiber tip corresponding to a detection range of approximately 13 dB) (when water is detected, the fiber tip is located in a water-filled channel of an endoscope / cystoscope or in a water-filled bladder / urinary tract. Detection can be performed by detecting a change in reflected power, or based on pulse time-of-flight measurements of "water / no water" pulses where a reflected pulse is present or absent). 3) Detecting light emitted by a cystoscope / endoscopic light emitter (e.g., detecting the visible output / spectral attributes of typical cystoscope / endoscopic light), or employing a special cystoscope / endoscopic with frequency-modulated or otherwise encoded light emitter, which enables the device to detect the frequency modulation / encoding and ensure that only cystoscope / endoscopic light is detected (see the comprehensive solution described below). 4) Move the fiber tip forward through the working channel toward the treatment site, for example, between 1 mm and 10 mm from the tissue to be treated, and detect the tissue reflex using, for example, interference distance measurement. 5) If condition 1) is met in combination with condition 2) and / or condition 3) and / or condition 4), the Class 4 optical output port is enabled (by electrical, software and / or mechanical means), 6) In the cases of 6a) to 6d) below, that is, 6a) If the device detects that there is no light emission from the bladder / endoscopy (for example, due to the fiber being pulled back or due to a malfunction of the endoscope), 6b) If the device detects that there is no water at the tip (for example, the fiber is in the air), 6c) If the device detects that there is no effective tissue reflex, 6d) If a fiber connector is detected to be disconnected, or if the integrity of the fiber path is detected to be compromised, for example, if the fiber is damaged or damage to the optical path is detected, Disable the Class 4 optical output port.

[0240] The Class 1 path may preferably be a fiber waveguide with physical contact from the laser source to the fiber tip to reduce undesirable reflections in the optical path from the laser to the fiber tip. For this purpose, the Class 1 optical output port may be equipped with a fiber connector that brings physical contact between the respective fiber ends of the fibers connected by the Class 1 optical output port. When the two optical paths are coupled, using a free-space optical system inside the housing, the water detection range can be reduced, for example, from 13 dB to 3 dB. Also, tissue interference / OCT detection is not readily achievable. When the two optical paths, i.e., the treatment and sensor paths, are coupled inside the housing using optical fibers, the connector at the optical output port may be less reliable.

[0241] Comprehensive safety system for endoscopes In some embodiments, the safety means provides an overall safety system for the endoscope, depending on the specific functionality of the endoscope / cystoscope in which it is configured to operate. In particular, the safety system may depend on the endoscope emitting illumination having one or more attributes specific to endoscopic illumination, in particular light that is adjusted according to a predetermined adjustment scheme.

[0242] In particular, the device may include two optical ports, one of which emits Class 4 light for therapeutic purposes, and the other optical port which receives and optionally emits Class 1 light for sensing purposes. As described above, the two optical ports may be separated from each other, for example as shown in Figure 10, or they may be coupled to a single optical port, for example as shown in Figure 11.

[0243] The endoscope / cystoscope may be configured to emit modulated / encoded light (e.g., weakly frequency-modulated at a frequency that does not affect endoscopic / cystoscope imaging) from the endoscopic / cystoscope light emitter(s) located at the distal end of the endoscope / cystoscope. When a (disposable) fiber is connected to and detected by the optical port(s) (or each respective optical port), the device detects the light received at the distal end of the connected optical fiber and searches for light with a cystoscope modulation code / frequency. When cystoscope / endoscopic modulation is detected, this indicates that the fiber tip is located at the distal end of the cystoscope and that a Class 4 laser can be activated.

[0244] If the modulation of the cystoscope / endoscopy is suddenly no longer detected, the output of the Class 4 laser radiation is disabled within a sufficiently short time, for example, within 100 ms.

[0245] Therefore, the control process for implementing the safety system is 1) For example, using a laser safety interlock system to detect the optical output port of a fiber connector or insertion / coupling to each optical output port, 2) Detecting light emitted by a cystoscope / endoscopic light source having an encoded / modulated light source, 3) When conditions 1) and 2) are met, the Class 4 optical output port is enabled (by electrical, software and / or mechanical means), 4) If the laser detects the absence of a cystoscope / endoscopic emitter, or if a fiber connector is severed, disable the Class 4 optical output port. It may include.

[0246] Optionally, water detection and / or tissue detection and / or fiber integrity detection, as described in the context of a standalone system, may be used as additional conditions. This may require the device to output Class 1 sensor light, for example, as described above.

[0247] The endoscope-integrated solution facilitates the implementation of two ports within the housing.

[0248] Alternatively, or in addition, 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 indicator, in particular for detecting whether the distal end of the connected optical fiber extends beyond the distal end of the endoscope / cystoscope.

[0249] For example, many endoscopes / cystoscopes include a camera configured to capture images of a target area anterior to the distal end of the endoscope / cystoscope, for example, in the form of a video stream. 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 so that the physician or other person operating the endoscope can view the images captured by the camera. The display device may be integrated with the medical laser device disclosed herein, or it may be separated from it by a separate device having its own housing separate from the housing of the medical laser device, for example.

[0250] The medical laser device may include a light source configured to emit visible light or other light detectable by the camera of an endoscope / cystoscope. The light source may be, for example, a dedicated light source, a pilot light source, or one of the light sources of the device's optical sensors, such as a supercontinuum white light source or another suitable light source of the spectroscopic sensor, or another suitable light source of the device. The device may be configured to emit camera-detectable light through a connected optical fiber. The device may further be configured to receive a camera signal from the camera, the camera signal indicating one or more images captured by the camera while the device is emitting camera-detectable light through the connected optical fiber. 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 the detection that the camera has captured camera-detectable light, the device may even determine that the fiber tip of the connected optical fiber is located at the distal end of the endoscope / cystoscope, or even protruding from the distal end of the endoscope / cystoscope. Therefore, the device can only enable the emission of therapeutic laser radiation, particularly Class 4 laser radiation, in response to the camera detecting that it has captured detectable light. The above process of the camera emitting detectable light and the camera detecting that the camera of the endoscope / cystoscope has captured detectable light may optionally be performed continuously or at least intermittently during the emission of therapeutic laser radiation, for example, between consecutive pulses of therapeutic laser radiation, before enabling the emission of therapeutic laser radiation. Therefore, failure of the camera to detect that it has captured detectable light may cause the device to disable the emission of therapeutic laser radiation.

[0251] Preferably, the device is configured to embed a detectable signature into camera-detectable light, for example, by modulating the intensity or spectral composition of the camera-detectable light, or otherwise by pulsing or otherwise modulating the camera-detectable light. Thus, the device may be configured to detect the signature embedded in the camera signal.

[0252] An example of camera-based detection of a fiber tip insertion indicator will be illustrated with reference to Figure 12, which schematically illustrates another example of a medical laser apparatus according to embodiments disclosed herein. The apparatus in Figure 12 is similar to the apparatus in Figures 1 and 3 in that it comprises a medical therapeutic device 2000 and an optical fiber device including an optical fiber 1200 and a connector module 1100. The medical therapeutic device 2000 includes a therapeutic laser source 2200, a control module 2400, and a sensor module 2300, all as described in relation to Figures 1 and / or 3.

[0253] The optical fiber 1200 is configured to be inserted into and advanced through the working channel of the endoscope 3000, particularly into a cystoscope, as described in relation to Figure 4, for example, so that the distal end 1201 of the optical fiber 1200 extends from the working channel of the endoscope. When in use, the endoscope is inserted into the patient's blood vessels or organs, particularly into the bladder via the urethra. The endoscope 3000 is equipped with a camera 3600, particularly a camera tip, at its distal end. The camera 3600 provides camera signals to a display device 3700 connected to the endoscope 3000 so that a physician can view images captured by the camera 3600 on a display device 3700.

[0254] In this embodiment, the sensor module 2300 includes a sensor light source 2311, such as an LED or a sensor laser source. The sensor light source 2311 outputs visible sensor light through the optical fiber 1200. If the optical fiber is at least double-clad, the medical laser device may be configured to output visible sensor light through the core or cladding of at least double-clad optical fiber. It will be understood that the sensor light does not need 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 may use another light source, such as a pilot light source dedicated to this purpose or a separate light source, to emit light detectable by the camera 3600.

[0255] The light source 2311 may be configured and / or controlled by the control module 2400 to emit camera-detectable light as pulsed light at a preferred predetermined pulse rate detectable by the camera. Alternatively, or in addition, the light source 2311 may be configured and / or controlled to modulate the emitted camera-detectable light in different predetermined ways, or otherwise to embed a detectable signature into the emitted camera-detectable light. For example, the emitted camera-detectable light may alternate between two colors, or may be modulated in different ways.

[0256] The control module 2400 of the medical laser device 2000 is configured to enable the emission of therapeutic laser radiation through the optical fiber 1200 only when the optical fiber is inserted into the endoscope / cystoscope 3000 and the distal end 1201 of the optical fiber protrudes from the distal end of the endoscope / cystoscope. As described herein, the control module may selectively enable or disable the emission of therapeutic laser radiation in various ways, such as by operating a shutter or by switching the therapeutic laser source on or off.

[0257] 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 transmitting camera signals. Thus, the camera 3600 is an example of an external sensor outside the medical laser device 2000, and the camera signals received from the display device 3700 are an example of sensor signals received from an external sensor. Nevertheless, it will be understood that in some embodiments, the display device 3700 and the medical laser device may be integrated into the same device, in particular into a single housing. In such embodiments and other embodiments, the control module 2400 may receive camera signals in different ways, for example, directly from the camera 3600, via an internal signal path, and / or equivalent.

[0258] The control module 2400 may process the received camera signal in a manner such as detecting an embedded signature, for example, detecting a light intensity that changes between predetermined colors at a predetermined pulse rate, and / or detecting another predetermined modulation. In response to the detection of an embedded signature, or optionally in response to one or more other safety indicators, the control module may enable the emission of therapeutic laser radiation, as described herein, for example. In response to failure to detect an embedded signature, or optionally in response to failure to detect one or more other safety indicators, the control module may disable the emission of therapeutic laser radiation, as described herein, for example.

[0259] It will be understood that the control module may be configured to allow the emission of therapeutic laser radiation through the optical fiber 1200 only when additional or alternative sensor signals indicate that the optical fiber device is coupled to the optical output port and the distal end is positioned in a safe location.

[0260] Since the medical laser device 2000 controls the emission of camera-detectable light, including embedding appropriate signatures into the camera-detectable light, and since the medical laser device 2000 performs extraction of the embedded signatures from the camera signal, this embodiment does not depend on any specific characteristics of the endoscope / cystoscope other than the presence of the camera. In particular, this embodiment does not depend on any detectable characteristics of the light emitted by the endoscope / cystoscope, which can vary considerably between different types and models of endoscopes / cystoscopes.

[0261] Otherwise, the therapeutic laser source 2200, control module 2400, sensor module 2300, and / or optical fiber device of this embodiment may be implemented as described in relation to any of the embodiments described above, or otherwise.

[0262] In yet another aspect, disclosed herein is an embodiment of a medical laser device, which is: (a) at least one therapeutic laser source configured to emit therapeutic laser radiation for the treatment of a medical condition, (b) One or more optical ports configured to couple the device to an optical fiber device, the optical fiber device comprising at least one optical fiber having a proximal end and a distal end, the distal end configured to be advanced through the working channel of the endoscope toward the treatment site of the object to be treated, and one or more optical ports comprising an optical output port for outputting therapeutic laser radiation, Equipped with, The therapeutic laser source is configured to receive a heartbeat signal and to stop the output of the therapeutic laser radiation in response to a failure to receive the heartbeat signal. Generally, the heart rate signal may 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 may be configured to receive the heart rate signal directly or indirectly from the control module and / or at least one sensor.

[0263] In some embodiments, the apparatus may comprise a control module configured to transmit a heartbeat signal to a treatment laser source. The control module may be configured to monitor the operation of at least some components of the apparatus. For example, the control module may be configured to monitor the operation of at least one sensor based on, for example, a sensor signal received from such a sensor and / or based on each sensor heartbeat signal received by the control module from such a sensor. Thus, a failure to receive a heartbeat signal from the control module by the treatment laser source may indicate a failure in the operation of the control module and / or in the operation of the monitored aspects of the apparatus. In some embodiments, the control module may be configured to emit a heartbeat signal only when one or more safety indicators, for example, one or more of the safety indicators described herein, are satisfied and as long as they are satisfied.

[0264] In some embodiments, the apparatus comprises at least one sensor configured to transmit a sensor heartbeat signal, for example, to the control module and / or directly to the treatment laser source. The treatment laser source may be configured to receive the sensor heartbeat signal instead of or in addition to the heartbeat signal from the control module. Thus, the control module and / or the treatment laser source may be configured to disable the output of the treatment laser radiation if the sensor heartbeat signal is not received or not received over a predetermined period.

[0265] The heartbeat signal may be an intermittent signal, particularly a periodic signal emitted at an appropriate heart rate, for example, at a heart rate of 10 Hz to 100 Hz or at another appropriate update rate. For example, in some embodiments, the heartbeat signal may be emitted every 10 ms and every 20 ms.

[0266] The therapeutic laser source may be configured to emit pulsed therapeutic laser radiation. Specifically, the therapeutic laser source may be configured to emit only a predetermined number of pulses, e.g., a single pulse or a pulse train of a predetermined length, and to stop emitting further pulses unless a heartbeat signal is received within a predetermined period. It will be understood that the heart rate may be selected according to the duty cycle of a predetermined number of pulses and / or pulse train. For example, when the therapeutic laser source is configured to emit only a single pulse of 10 ms, a heart rate between one heartbeat every 10 ms and one heartbeat every 20 ms may be a suitable choice. It will be understood that other embodiments may employ other heart rates and / or other pulse durations.

[0267] Therefore, the therapeutic laser source may include a heart rate monitoring circuit configured to stop the therapeutic laser source if it fails to receive a heart rate signal. Preferably, the heart rate monitoring circuit is implemented in hardware, for example, as a hardware timer that is reset by the heart rate signal. In some embodiments, the therapeutic laser source may be configured to output only therapeutic laser radiation, subject to other conditions being met, subject to the reception of another signal, for example, the operator pressing a foot pedal or an activation signal indicating that another laser treatment has been activated.

[0268] The control module can be configured to monitor for the reception of an acceptable signal from at least one sensor and to transmit its heart rate signal only in response to the reception of an acceptable signal. For example, in response to a safety indicator being met and the operator initiating treatment, the control module may optionally control the treatment laser source to emit a pre-programmed pulse sequence, conditional on the reception of a sensor heart rate signal. Optionally, only if the safety feature is still met, only if the operator is still activating the laser, and only if the sensor heart rate signal is still being received, the control module may continue to transmit its heart rate signal, causing the treatment laser source to continue emitting another pulse sequence and subsequent pulse sequences. The treatment laser source may preferably be implemented solely by hardware circuitry, such as a hardware timer, and may be configured to automatically switch off after a pre-programmed sequence. The treatment laser source may further be configured to emit again if a heart rate signal is received from the control module.

[0269] Figure 13 schematically illustrates an example of a medical laser apparatus according to an embodiment disclosed herein, in which the therapeutic laser source includes a heart rate monitoring circuit. The apparatus in Figure 13 is similar to the apparatus in the preceding figures, for example, Figures 1, 3, or 12, in that it comprises a medical therapeutic device 2000 and an optical fiber device including an optical fiber 1200 and a connector module 1100. The medical therapeutic device 2000 includes a therapeutic laser source 2200, a control module 2400, and a sensor module 2300, all of which are described in relation to one or more of the preceding figures, for example, Figures 1, 3, or 12.

[0270] The optical fiber 1200 is configured to be inserted into and advanced through the working channel of an endoscope (not explicitly shown in Figure 13), in particular, into a cystoscope, such as the one described in relation to Figure 4, with the distal end 1201 of the optical fiber 1200 extending from the working channel of the endoscope. When in use, the endoscope is inserted into the patient's blood vessels or organs, in particular into the bladder via the urethra.

[0271] In this embodiment, the therapeutic laser source 2200 may include a heart rate monitoring circuit 2210 that monitors the reception of heart rate signals (or more) from a control module and / or sensor module, and may enable the emission of therapeutic laser radiation only when the heart rate monitoring circuit receives one or more regular heart rate signals (or more). The heart rate monitoring circuit may be configured to shut down the therapeutic laser source if it fails to receive heart rate signals. In the example in Figure 13, the heart rate monitoring circuit receives heart rate signals from the control module, which can then monitor the operation of the sensor module 2300 and / or other components of the medical laser device. In other embodiments, the heart rate monitoring circuit may receive heart rate signals directly from the sensor module and / or other components, and these heart rate signals may be added to or replace the heart rate signals from the control module.

[0272] Otherwise, the therapeutic laser source 2200, control module 2400, sensor module 2300, and / or optical fiber device of this embodiment may be implemented as described in relation to any of the embodiments described above, or otherwise.

[0273] Various aspects have been described with reference to various embodiments. Reading this disclosure, others will likely consider modifications and changes. The present invention is intended to be construed as including all such modifications and changes, to the extent that they fall within the scope of the appended claims and their equivalents.

Claims

1. A medical laser device, wherein the device, (1) At least one therapeutic laser source configured to emit therapeutic laser radiation for the treatment of a medical condition, (2) One or more optical ports configured to couple the apparatus to an optical fiber device, wherein the optical fiber device includes at least one optical fiber having a proximal end and a distal end, the distal end being configured to advance toward the treatment site of the target to be treated through the working channel of the endoscope, and having one or more optical ports for outputting a treatment laser beam, (3) A control module that receives at least one sensor signal indicating one or more predetermined safety indicators, The one or more safety indicators include a connection indicator that shows whether the optical fiber device is coupled to the optical output port, The system includes at least one fiber tip position indicator that indicates whether the distal end of the optical fiber in the coupled optical fiber device is positioned in a safe position, The control module is further configured to enable the output of therapeutic laser radiation through the optical output port only when the at least one sensor signal indicates that the optical fiber device is coupled to the optical output port and the distal end is positioned in the safe position. Medical laser device.

2. The one or more safety indicators further include one or more fiber integrity indicators, The control module is further configured to enable the output of therapeutic laser radiation through the optical output port only when the at least one sensor signal indicates that the fiber integrity remains sufficiently complete. A medical laser apparatus according to claim 1.

3. The one or more fiber tip position indicators are: a) An insertion indicator that shows that the optical fiber has been inserted into the liquid and / or the endoscope, b) An endoscope tip indicator indicating that the optical fiber is located at the distal end of the working channel of the endoscope, c) A treatment site indicator that shows the distal end of the optical fiber is close to a potential treatment site. Characterized by including one or more of the following: A medical laser apparatus according to claim 1 or 2.

4. The control module is configured such that it can output treatment laser radiation only when at least two of the following conditions are met: at least three of the insertion indicator, the endoscope tip indicator, and the treatment site indicator. A medical laser apparatus according to claim 3.

5. The control module is configured to enable the output of therapeutic laser radiation only when at least two of the connection indicator, the fiber integrity indicator, and the one or more fiber tip position indicators are detected by two separate sensors and / or using two separate optical paths. A medical laser apparatus according to claim 3 or 4.

6. The control module is configured such that a therapeutic laser beam is output only when at least one of the safety indicators is detected by two separate sensors and / or using two separate optical paths. A medical laser apparatus according to any one of claims 3 to 5.

7. The one or more fiber tip position indicators are: An insertion indicator that shows when the optical fiber has been inserted into the liquid, The optical fiber includes a treatment site indicator that shows the distal end of the optical fiber is close to a potential treatment site, The control module is configured to enable the output of therapeutic laser radiation only when at least the insertion indicator and the treatment site indicator are achieved. A medical laser device according to any one of the preceding claims.

8. The control module is configured to enable the output of a therapeutic laser beam only when at least two, for example, at least three, or for example, at least four of the safety indicators are met in a predetermined time sequence. A medical laser device according to any one of the preceding claims.

9. One or more sensors configured to acquire one or more of the at least one sensor signals, wherein the control module is configured to receive one or more of the at least one sensor signals acquired from the one or more sensors, A medical laser device according to any one of the preceding claims.

10. 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 face of the optical fiber, and / or by measuring the time of flight of the reflection of sensor light from the distal end face, and / or by interferometry. A medical laser apparatus according to claim 9.

11. In the case of claim 3, at least one of the one or more sensors is configured to detect at least one of the endoscope tip indicators by detecting light emitted from the distal end of the endoscope, A medical laser apparatus according to claim 9 or 10.

12. At least one sensor is configured to recognize light emitted from the distal end of the endoscope by detecting the spectral characteristics of the light and / or detecting the intensity of the light and / or detecting predetermined modulation and / or encoding of the light. A medical laser apparatus according to claim 11.

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

14. The optical sensor is characterized by comprising a sensor radiation source configured to emit sensor radiation. A medical laser apparatus according to claim 13.

15. The sensor radiation is characterized by having an output of 5 mW or less, particularly 2 mW or less, for example, 1 mW or less or 0.5 mW or less. A medical laser device according to claim 14.

16. The optical sensor is configured to perform interference distance measurement and / or spectroscopic measurement, A medical laser apparatus according to any one of claims 13 to 15.

17. The therapeutic laser radiation is characterized by having an optical output of 10 mW or more. A medical laser device according to any one of the preceding claims.

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

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

20. The optical side combiner is configured to couple therapeutic laser radiation into at least one cladding of the at least double-cladded optical fiber, A medical laser apparatus according to claim 19.

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

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

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

24. A medical laser device, wherein the device, (1) At least one therapeutic laser source configured to emit therapeutic laser radiation for the treatment of a medical condition, (2) One or more optical ports configured to couple the apparatus to an optical fiber device, wherein the optical fiber device includes at least one optical fiber and has a proximal end and a distal end, the distal end being configured to be advanced through the working channel of the endoscope toward the treatment site of the target to be treated, and the optical port includes an optical output port for outputting a treatment laser beam, (3) A light source for emitting light through at least one of one or more optical ports, wherein the emitted light is detectable by the camera of the endoscope, (4) A control module, which receives a camera signal from the camera, processes the received camera signal to detect whether the camera has captured the light emitted, and enables the output of therapeutic laser radiation via the optical output port only when the control module detects that the camera has captured the light emitted, Medical laser devices, including [specific type of laser device].

25. A medical laser device, wherein the device, (1) At least one therapeutic laser source configured to emit therapeutic laser radiation for the treatment of a medical condition, (2) One or more optical ports configured to couple the apparatus to an optical fiber device, wherein the optical fiber device includes at least one optical fiber having a proximal end and a distal end, the distal end of which is configured to be advanced through the working channel of the endoscope toward the treatment site of the target to be treated, and the optical port includes an optical output port for outputting a treatment laser beam, The therapeutic laser source is configured to receive a heartbeat signal and to stop the output of the therapeutic laser radiation in response to a failure to receive the heartbeat signal. Medical laser device.

26. It is a system, (1) A medical laser device according to any one of the preceding claims, (2) The endoscope, in particular a cystoscope, wherein the endoscope has a working channel for receiving the optical fiber, and the endoscope further comprises a camera for capturing one or more images of a target site located in front of the distal end of the endoscope, A system that includes this.

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