Efficient multifunctional endoscopic instrument

Abstract

An instrument for endoscopic applications, including urology. The instrument may include both an irrigation channel and an aspiration channel, effective aspiration and withdrawal of tissue and body stone fragments, enhanced clarity of observation of the operating zone, an illumination fiber with steering functionality in a flexible form for endoscopes. In some embodiments, the distal head is configured to position the mouth of the working channel within a viewing angle of the visualization system. In some embodiments, a transparent cover is disposed at the distal end of the endoscope to provide enhanced viewing of the operating zone. The irrigation channel and the suction channel may be arranged such that the stabilized water flow will draw tissue and body stone particles and remove hot liquid. The illumination fiber may be used as a pull link or a push-pull link for deflection and steering of flexible embodiments of the endoscope.

Description

[0001] This application is a divisional application of a patent application (international application date January 20, 2020, application number 202080009944.9, invention name “High-efficiency and multifunctional endoscopic instrument”).

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims the benefit of U.S. Provisional Application No. 62 / 794,328, filed on January 18, 2019, the disclosure of which is hereby incorporated herein by reference in its entirety. Technical Field

[0004] The present application generally relates to endoscopic devices and methods. More specifically, the present application relates to flexible, semi-rigid and rigid laser endoscopes for laser treatment of calculi and tissue in humans and animals. Background Art

[0005] Kidney stones affect one in five hundred Americans each year, causing tremendous pain and medical costs. Surgical options for patients with symptomatic kidney stones include extracorporeal shock wave lithotripsy (ESWL), ureteroscopy, and percutaneous nephrolithotomy (PCNL). A person's renal anatomy, stone composition, and body constitution all play a role in determining the outcome and surgical approach.

[0006] The role of ureteroscopy has increased over the past decade due to the advent of holmium (Ho) and thulium (Tm) lasers, reduced diameters of flexible catheter shafts, increased steering and deflection capabilities, improved video imaging, miniaturization of baskets and instruments, and advances in lithotripsy (stone fragmentation). More than 45% of kidney stone surgeries in the United States are now performed using miniaturized ureteroscopic techniques and lasers.

[0007] Ureteroscopy involves the use of a small flexible or rigid device called a ureteroscope to directly view and treat kidney stones. A ureteroscope, which provides video images and has a small "working" channel, is inserted into the bladder and up the ureter until the kidney stone is encountered. The kidney stone can then be broken up using laser energy transmitted to the target site through fiber optics (laser fibers), and / or extracted using a basket. The advantage of this type of surgical procedure is that it uses a body orifice for entry and does not require an incision.

[0008] Ureteroscopy is often a good option for small kidney stones in the ureter or kidney. The success rate of ureteroscopic removal of smaller kidney stones is generally higher than shock wave lithotripsy. With laser ureteroscopy, kidney stones can be broken into small particles less than 1 mm or even less than 0.25 mm in maximum dimension using laser settings optimized for this purpose. In this case, due to the natural outflow from the kidney to the bladder, the ablation products can be removed by flushing flow or after the surgical procedure to provide a stone-free outcome.

[0009] However, ureteroscopy does not always work well with very large kidney stones (e.g., having a size greater than 20 mm) because the larger size requires long processing times and it may be difficult to remove fragments of such stones. In addition, medium-sized stones or fragments (e.g., having a maximum dimension of 1 mm to 5 mm) may be difficult to treat with a laser using contact techniques. For example, a ureteroscope operated in contact mode may be subject to a strong back-off effect, necessitating operation in a non-contact mode (e.g., "popcorning"), which is time consuming and does not guarantee a stone-free result. As a result, ureteroscopy does not always work well with very large kidney stones because the larger size requires long processing times and it may be difficult to remove fragments of such stones. In such cases, a percutaneous approach may be the best available option. Devices and accompanying technologies that mitigate or address these shortcomings of ureteroscopy would be welcome. Summary of the invention

[0010] Various embodiments of the present disclosure present endoscopic surgical instruments and methods that mitigate certain disadvantages of conventional ureteroscopy while reducing procedure time, providing a higher probability of stone-free results, and increasing the safety of the procedure.

[0011] Conventional ureteroscopes include a working channel that passes through the catheter shaft and defines an entrance at the distal end. The primary function of the working channel is to serve as a conduit for laser fiber optics and other instruments, and to deliver an irrigation stream. Some conventional ureteroscopes utilize an input face of an imaging assembly that is approximately located on the same plane as the distal opening of the working channel or very close to the plane. Other conventional ureteroscopes have a distal opening of the working channel that is located behind the plane of the input face of the imaging assembly. See, for example, U.S. Pat. No. 9,775,675 to Irby, III ("Irby"), the disclosure of which (except for the patent claims and the explicit definitions contained therein) is hereby incorporated herein by reference. Irby teaches that in order to reduce the diameter of the distal head catheter shaft, it is beneficial to terminate the working channel behind the distal face. Conventional ureteroscopes typically define a viewing angle of ±45 degrees from the axis of the catheter. Therefore, conventional ureteroscopes do not include an entrance of the working channel that is located within the viewing angle of the imaging assembly. This may impair functional visualization of the target area.

[0012] Furthermore, successful laser ablation of body stones requires contact or quasi-contact between the laser fiber and the stone. For conventional laser ureteroscopes, such contact requires that the distal tip of the laser fiber be extended beyond the distal end of the catheter (typically, beyond 2 mm to 6 mm) so that the operator can view and control the exact position of the laser fiber relative to the stone surface during lithotripsy. The stone surface (and preferably, the tip of the fiber) must be within the field of view of the imaging optics and also at the working distance of the imaging optics. Another important reason for extending the fiber and visualizing the fiber is to prevent soft tissue (mucosal) damage due to accidental ablation of soft tissue. Such ablation and perforation of the ureter or kidney may result in the need for open surgical intervention. A clear image of the distal tip of the laser fiber and the soft tissue surface can prevent soft tissue ablation accidents.

[0013] Various embodiments of the present disclosure are configured such that the mouth of the working channel is within the field of view of the visualization system. In some embodiments, the use of a transparent cover provides a line of sight between the imaging receptor and the distal end of the laser fiber, thereby enhancing observation of the operating area. The presence of the transparent cover also enables the line of sight to be unobstructed by debris generated during the ablation process.

[0014] The conventional method of laser lithotripsy involves delivering laser radiation through a laser fiber to ablate the stone into very small particles ("powder") or fragments. The ablation can be performed in contact or quasi-contact mode, or in a non-contact ("popcorn phenomenon") mode. The non-contact technique is typically used in conventional ureteroscopy to treat medium-sized and small stone fragments (typically, less than 3 mm-5 mm in size) when pushback does not allow effective operation in contact or quasi-contact mode. For the non-contact technique, the distal end of the laser fiber is positioned in a fixed target area close to the stone or fragment, and the laser is activated without contact between the laser fiber and the stone or fragment. Vaporization and bubble implosion and flushing of the target area cause the liquid medium (mainly water) in the target area to flow, which in turn causes the smaller stone fragments to be agitated. The non-contact technique relies on the fragments or stones to enter the effective range of the laser emission located in the fixed target area for further ablation, fragmentation and powderization.

[0015] The limitations and effects of this conventional approach are taken into account. The laser power is limited to a relatively low level to prevent overheating of the target area and a strong push-back effect. In contact mode, the push-back effect (especially for medium-sized stones or fragments) requires additional laser-free time to track or "hunt" the target, further extending the total treatment time. Tracking each of such fragments is difficult and time-consuming. The contactless mode is inefficient because actual ablation occurs only when agitation of the stones or fragments occurs within the effective laser pulse range at the distal end of the optical fiber. Such an "effective ablation" time interval typically accounts for only 10%-30% of the total laser time in contactless mode. A stone-free result (which is the clinical goal of the treatment) is difficult to ensure because some small fragments are moved out of the treatment area due to agitation. Such limitations and effects of conventional laser lithotripsy extend the total treatment time and introduce safety risks due to the risk of overheating of the liquid medium in the target area.

[0016] Various embodiments of the present disclosure enable shorter treatment times for laser lithotripsy because body stones are drawn to the laser fiber and there is less need to "hunt down" body stones within the treated organ. The efficiency of breaking up body stones is improved because stones and fragments are drawn (attracted) toward the mouth of the suction channel and the distal end of the ablation laser fiber. The size, shape and / or position of the outlet relative to the mouth can be configured to provide a flow field that increases the entrainment of particles in the flow field, thereby drawing the body stones and ablation products into the mouth of the suction channel. In addition, in some embodiments, the irrigation flow can be adjusted relative to the suction flow to continuously provide such a flow field during the ablation treatment. In order to enhance monitoring of the ablation, the mouth of the suction channel can be positioned distal to the imaging receptor of the visualization system.

[0017] Furthermore, incidental heat generated by the laser ablation process can be efficiently dissipated by the irrigation fluid and removed by aspiration of the hot irrigation fluid, thereby reducing the risk of unintended thermal damage to surrounding tissue. Efficient heat dissipation of the treatment zone enables further increase of laser power without the attendant risk of thermal damage to surrounding soft tissue.

[0018] Conventional flexible and semi-rigid endoscopes also include metal pull wires for applying a bending angle at the distal end of the endoscope. These wires are attached to the distal end and are routed to the steering mechanism through the catheter. These wires have a footprint that occupies a portion of the cross-section of the catheter. In addition, a secure connection to the distal end requires a connector that also occupies the cross-sectional space at the distal end of the catheter. In addition, the catheter after steering often requires a torsion sleeve so that the rotation of the shaft at the proximal end of the catheter is converted into a rotation of the distal end. The torsion sleeve also occupies a cross-sectional footprint. These aspects of the steering and aiming system require an increase in the total cross-section of the catheter, particularly the total cross-section at the distal end. The typical diameter of a conventional ureteroscope is in the range of 3 mm to 4 mm. It is achievable to further reduce the diameter to a range of 1.7 mm to 2.5 mm by eliminating some functional elements (e.g., steering components), such as disclosed by Irby.

[0019] Multiple embodiments of the present disclosure present a distal head having a more compact radial profile than conventional endoscopes by eliminating the need for pull wires and twist sleeves. The use of an illumination fiber for steering opens up the cross-sectional space in the endoscope, specifically the cross-sectional space in the distal portion, to allow the use of both the irrigation channel and the suction channel within a common catheter shaft. In some embodiments, the illumination fiber is used not only to "pull" the distal portion of the catheter, but also to "push" the distal portion, thereby providing bidirectional steering with a single illumination fiber. This enables all functions of the catheter (illumination, imaging, irrigation, suction, and ablation (within a cross-sectional size within a range of 2 mm to 2.5 mm (including 2 mm and 2.5 mm))). As discussed by Irby, cross-sectional sizes within this range can enable ureteroscopic removal of body stones without the need for the patient to undergo general anesthesia.

[0020] Structurally, for multiple embodiments of the present disclosure, an endoscopic surgical instrument is disclosed, the endoscopic surgical instrument comprising: a catheter shaft, the catheter shaft defining a central axis and extending along the central axis, and including a proximal portion and a distal portion; a distal head portion, the distal head portion is located at the distal portion of the catheter shaft, the distal head portion includes a distal surface; and a working channel, the working channel extends from the proximal portion through the distal head portion in the catheter shaft, the distal head portion defines a mouth located at the distal surface, the working channel is configured to receive a laser fiber; an illuminator, the illuminator can be disposed at the distal head portion; and an imaging receiver, the imaging receiver is disposed at the distal head portion, the imaging receiver is positioned proximal to the distal end of the distal surface and an axial distance from the distal end, the axial distance being within a range of greater than or equal to 1 mm and less than or equal to 10 mm. In some embodiments, the mouth is at least partially located within the viewing angle of the imaging receiver.

[0021] In some embodiments, the working channel is defined by and integral with the catheter shaft. A laser fiber for insertion into the working channel may be included. In some embodiments, the catheter shaft includes an axial cross section perpendicular to the central axis of the catheter shaft, the axial cross section defining an elliptical shape, the axial cross section defining a major axis passing through the maximum dimension of the elliptical shape and a minor axis perpendicular to the major axis. In some embodiments, the maximum dimension of the axial cross section is in the range of 2.2 mm to 2.5 mm (including 2.2 mm and 2.5 mm). In some embodiments, the minimum dimension of the axial cross section is in the range of 1.7 mm to 2.5 mm (including 1.7 mm and 2.5 mm). The elliptical shape may be an oval.

[0022] The distal head portion may include a distal end portion in contact with the distal portion of the catheter shaft, and an imaging receiver is mounted to the distal end. In some embodiments, the distal end portion includes the distal side. The distal end portion may be integral with the catheter shaft. In some embodiments, the distal head portion includes a transparent medium located distal to the distal end portion and attached to the distal end portion, the transparent medium including the distal side. The mouth may be visible at least partially through the transparent medium via an imaging receiver. In some embodiments, the working channel is a suction channel.

[0023] In some embodiments of the present disclosure, the flushing channel is in fluid communication with an outlet defined by the distal head. The flushing channel may be defined by an internal hollow portion of the catheter shaft other than the suction channel, the internal hollow portion extending from the proximal portion of the catheter shaft to the distal portion of the catheter shaft. In some embodiments, the outlet of the flushing channel is configured to have an outlet angle relative to the distal direction along the central axis. The distal head portion includes a distal end portion in contact with the distal portion of the catheter shaft, and the outlet is defined by the distal end portion. In some embodiments, the outlet angle is in the range of 0 degrees to 170 degrees (including 0 degrees and 170 degrees); in some embodiments, the outlet angle is in the range of 10 degrees to 70 degrees (including 10 degrees and 70 degrees); in some embodiments, the outlet angle is in the range of 20 degrees to 45 degrees (including 20 degrees and 45 degrees).

[0024] The distal head portion may include a distal tip portion in contact with the distal portion of the catheter shaft, and a transparent medium located distal to and attached to the distal tip portion, the outlet being defined by the distal tip portion and configured to direct the irrigation flow onto a proximal side of the transparent medium. In some embodiments, the distal end of the laser fiber can be selectively positioned over a range of multiple axial positions relative to the distal-most position of the mouth. In some embodiments, the range of multiple axial positions is no more than 1 mm from the most distal position of the mouth and no more than 3 mm from the most distal position proximal to the most distal position; in some embodiments, the range of multiple axial positions is from a position flush with the most distal position of the mouth to a position no more than 1 mm from the most distal end proximal to the most distal end; in some embodiments, the range of multiple axial positions is no less than 0.1 mm from the most distal position of the distal end and no more than 0.6 mm from the most distal end proximal to the most distal end. In some embodiments, the illuminator is a fiber optic device, which is fixed to the distal head portion. The catheter shaft can be flexible when the proximal portion of the catheter shaft is coupled to a handle, and the handle includes a steering mechanism, which is coupled to the distal head portion via the fiber optic device to steer the distal head portion.

[0025] In multiple embodiments of the present disclosure, a surgical instrument is disclosed, the surgical instrument comprising: a catheter, the catheter comprising a flexible catheter shaft coupled to a distal head; a first optical fiber, the first optical fiber extending through the catheter and extending into the distal head, the first optical fiber being fixed to the distal head; and a steering handle, the steering handle being coupled to the catheter and the optical fiber, the steering handle being configured to apply a force on the first optical fiber for articulation of the distal head. The first optical fiber can be fixed to the distal head with an adhesive. In some embodiments, the first optical fiber defines an elliptical cross-section, the elliptical cross-section defines a major axis dimension and a minor axis dimension, the major axis dimension being the largest dimension of the elliptical cross-section, the minor axis dimension being smaller than the major axis dimension and being perpendicular to the major dimension at the central axis of the catheter.

[0026] In some embodiments, the surgical instrument includes a second optical fiber extending through the catheter and extending into the distal head, the second optical fiber being fixed to the distal head. The first optical fiber and the second optical fiber can be fixed in the distal head at a position located near the outer radial dimension of the catheter, the position being opposite in the diameter direction around the central axis of the catheter and located near the outer radial surface of the catheter. In some embodiments, the first optical fiber is one of the first optical fibers and the second optical fiber is one of the second optical fibers. Each of the first optical fibers and the second optical fiber can be arranged sequentially at the distal head in a tangential direction around the central axis of the catheter. Each of the first optical fibers and the second optical fiber can be centered at the distal head about a corresponding plane. In some embodiments, the first optical fiber and the second optical fiber each define an elliptical cross-section, the elliptical cross-section defining a major axis dimension and a minor axis dimension, the major axis dimension being the largest dimension of the elliptical cross-section, the minor axis dimension being smaller than the major axis dimension and being perpendicular to the major axis dimension at the central axis of the catheter. The major axis size may be in the range of 0.2 mm to 2.0 mm (inclusive); the minor axis diameter may be in the range of 0.1 mm to 1.0 mm (inclusive). In some embodiments, the ratio of the major axis diameter to the minor axis diameter is in the range of 2:1 to 5:1 (inclusive).

[0027] In some embodiments of the present disclosure, the steering handle includes a rotating cam directly coupled to the first optical fiber and the second optical fiber. In some embodiments, when the rotating cam is actuated along a first rotational direction to articulate the distal head along a first lateral direction, the first optical fiber is pulled to be in a tensioned state, and when the rotating cam is actuated along a second rotational direction to articulate the distal head along a second lateral direction, the second optical fiber is pulled to be in a tensioned state. The second rotational direction may be opposite to the first rotational direction. In addition, the second lateral direction may be opposite to the first lateral direction. In some embodiments, the first optical fiber and the second optical fiber are coupled to the rotating cam. The rotating cam is coupled to a rotatable shaft and may be coupled to a thumb lever.

[0028] The first optical fiber and the second optical fiber can be operably coupled to an illumination source and routed from the illumination source to the rotating cam and from the rotating cam to the distal head. In some embodiments, the illumination source is a light emitting diode. The illumination source can be housed in the steering handle. In some embodiments, the transparent medium defines a pressure relief portion extending from the mouth. The pressure relief portion can extend radially to the outer periphery of the transparent medium and can extend radially to the outer periphery of the distal side. In some embodiments, a pressure sensor is operably coupled to the working channel. The optical fiber is configured to transmit visible light to a target area located distal to the distal head.

[0029] In various embodiments of the present disclosure, an endoscopic surgical instrument for removing body stones from internal organs is disclosed, the endoscopic surgical instrument comprising: a catheter shaft, the catheter shaft defining a central axis and extending along the central axis, and having a proximal portion coupled to a handle; a distal end portion, the distal end portion being coupled to the distal portion of the catheter shaft; a transparent medium, the transparent medium being coupled to the distal end portion and comprising a distal side; and a working channel, the working channel extending from the proximal portion of the catheter shaft through the catheter shaft and the transparent medium and extending through the distal side of the transparent medium, the working channel defining a mouth. An illuminator may be disposed at the distal end; an imaging receptor is disposed at the distal end and is located proximal to the transparent medium. The distal side of the transparent medium may include a distal end of the working channel and is positioned at an axial distance from the imaging receptor, the axial distance being in the range of 1 mm to 10 mm (inclusive). In some embodiments, the distal end of the working channel is positioned an axial distance from the imaging receptor that is in the range of 1.2 mm to 5 mm, inclusive.

[0030] In some embodiments of the present disclosure, the irrigation channel defines at least one outlet, which is located at the distal tip and is used to direct the irrigation flow at an angle in the range of 0 degrees to 170 degrees (including 0 degrees and 170 degrees) relative to the central axis; in some embodiments, the angle is in the range of 10 degrees to 70 degrees (including 10 degrees and 70 degrees); in some embodiments, the angle is in the range of 20 degrees to 45 degrees (including 20 degrees and 45 degrees).

[0031] Some embodiments include a laser fiber, a portion of which extends through the catheter shaft. The laser fiber can be inserted into the working channel. In some embodiments, the laser fiber is permanently integrated into the catheter shaft. The distal end of the laser fiber can be selectively positioned at a plurality of axial positions, the plurality of axial positions ranging from a position 1 mm distal to the most distal position of the mouth to a position 3 mm proximal to the distal side of the distal side and including a position 1 mm distal to the most distal position of the mouth and a position 3 mm proximal to the distal side. In some embodiments, the plurality of axial positions range from a position flush with the distal side to a position 1 mm proximal to the distal side and including a position flush with the distal side and a position 1 mm proximal to the distal side; in some embodiments, the plurality of axial positions range from a position proximal to the distal side greater than or equal to 0.1 mm and less than or equal to 0.6 mm from the distal side. The cross-sectional area of ​​the mouth of the working channel may be in the range of 5% to 50% smaller than the cross-sectional area of ​​the working channel near the mouth.

[0032] In some embodiments, the transparent medium defines a pressure relief portion extending from the mouth. The pressure relief portion may extend radially to the outer periphery of the transparent medium. In some embodiments, the pressure relief portion may extend radially to the outer periphery of the distal side. A pressure sensor may be operably coupled to the working channel. In some embodiments, the working channel is defined by and integral with the catheter shaft.

[0033] In various embodiments of the present disclosure, a method for removing body stone material from an internal organ is disclosed, the method comprising: positioning a distal tip of a catheter assembly proximate to body stone material contained within the internal organ, the distal tip comprising a distal side of a mouth defining a working channel of the catheter assembly, the body stone material being located distal to the mouth; and positioning an imaging receptor proximate to the distal tip with a spacing distance between the mouth and the imaging receptor when the distal tip is proximate to the body stone material, the spacing distance being in the range of 1 mm to 10 mm (inclusive). In some embodiments, the spacing distance during the step of positioning the imaging receptor is in the range of 1.2 mm to 5 mm. Some embodiments comprise: illuminating a target area around the stone material with visible light. Some embodiments comprise: using an imaging receptor to obtain an image of the targeted stone and the target area. Some embodiments comprise: positioning a laser fiber within the working channel, the distal end of the laser fiber being located near the mouth. Some embodiments include: selectively positioning the distal end of the laser fiber within a distance range, the distance range being no more than 3 mm proximal to the distal most position of the mouth and no more than 1 mm distal to the distal most position of the mouth, the distance range being parallel to the axis of the working channel at the mouth; Some embodiments include: selectively positioning the distal end of the laser fiber within a distance range, the distance range being flush with the mouth and no more than 1 mm proximal to the mouth, the distance range being parallel to the axis of the working channel at the mouth.

[0034] Some embodiments include selectively positioning the distal end of the laser fiber within a distance range that is no more than 0.6 mm proximal to the mouth and no less than 0.1 mm proximal to the mouth, the distance range being parallel to the axis of the working channel at the mouth. Some embodiments include using the laser fiber to ablate the body stone. The average laser power delivered by the laser fiber during the method may be in the range of 120 watts to 200 watts, inclusive. Some embodiments include operating the working channel as an aspiration channel and removing ablation products through the working channel. Some embodiments include delivering an irrigation fluid through the distal tip of the catheter. Some embodiments of the present disclosure include: delivering the irrigation fluid flow at a guidance angle in the range of 0 degrees to 170 degrees (inclusive) relative to the distal direction along the central axis of the distal tip; some embodiments of the present disclosure include: delivering the irrigation fluid flow at a guidance angle in the range of 10 degrees to 70 degrees (inclusive) relative to the distal direction along the central axis of the distal tip; some embodiments of the present disclosure include: delivering the irrigation fluid flow at a guidance angle in the range of 20 degrees to 45 degrees (inclusive) relative to the distal direction along the central axis of the distal tip; during the method, the working channel can be a suction channel.

[0035] In various embodiments of the present disclosure, a method for removing body stone material from an internal organ is disclosed, the method comprising providing a catheter assembly and providing operating instructions for the catheter assembly on a non-transitory tangible medium, the operating instructions comprising: positioning a distal tip of the catheter assembly proximate to a portion of the body stone material contained within the internal organ, the distal tip comprising a distal side of a mouth defining a working channel of the catheter assembly, the body stone material being located distal to the mouth; and positioning an imaging receptor proximal to the distal tip, wherein the mouth and the imaging receptor are spaced apart by a distance in the range of 1 mm to 10 mm (inclusive) when the distal tip is proximate to the body stone material. The operating instructions may include irradiating a target area around the stone material with visible light, may include using an imaging receptor to obtain an image of the targeted stone and the target area, and may include positioning a laser fiber within the working channel such that the distal end of the laser fiber is located proximate to the mouth. In some embodiments, the operating instructions include: selectively positioning the distal end of the laser fiber within a distance range, the distance range being no more than 3 mm from the distal most position of the mouth at a proximal side and no more than 1 mm from the distal most position of the mouth, the distance range being parallel to the axis of the working channel at the mouth; In some embodiments, the operating instructions include: selectively positioning the distal end of the laser fiber within a distance range, the distance range being flush with the mouth and no more than 1 mm from the mouth at a proximal side of the mouth, the distance range being parallel to the axis of the working channel at the mouth; In some embodiments, the operating instructions include: selectively positioning the distal end of the laser fiber within a distance range, the distance range being no more than 0.6 mm from the mouth at a proximal side of the mouth and no less than 0.1 mm from the mouth at a proximal side of the mouth, the distance range being parallel to the axis of the working channel at the mouth. The operating instructions may include using the laser fiber to ablate the body stone, and may include delivering an average laser power in the range of 120 watts to 200 watts, inclusive. In some embodiments, the operating instructions include removing ablation products through the working channel, and may include delivering an irrigation fluid through the distal tip of the catheter.In some embodiments, the operating instructions include: operating the catheter assembly to deliver the irrigation fluid flow at a guide angle within a range of 0 degrees to 170 degrees (including 0 degrees and 170 degrees) relative to the distal direction along the central axis of the distal tip; in some embodiments, the operating instructions include: operating the catheter assembly to deliver the irrigation fluid flow at a guide angle within a range of 10 degrees to 70 degrees (including 10 degrees and 170 degrees) relative to the distal direction along the central axis of the distal tip; in some embodiments, the operating instructions include: operating the catheter assembly to deliver the irrigation fluid flow at a guide angle within a range of 20 degrees to 45 degrees (including 20 degrees and 45 degrees) relative to the distal direction along the central axis of the distal tip. In some embodiments, the operating instructions include: operating the working channel as an aspiration channel.

[0036] Various embodiments of the present disclosure include a method for removing body stone material from an internal organ, the method comprising:

[0037] An endoscopic surgical instrument is inserted, the endoscopic surgical instrument comprising a catheter shaft, at least one illuminator, a laser fiber and an irrigation channel, the catheter shaft defining a central axis and extending along the central axis, the catheter shaft comprising a proximal portion coupled to a handle and a distal tip portion at a distal portion, the catheter shaft comprising a suction channel extending from the proximal portion to the distal tip portion, the distal tip portion having an imaging receiver disposed at the distal tip, the imaging receiver being positioned at an axial position that is within a range of greater than or equal to 1 mm and less than or equal to 10 mm from a distal face of the distal tip portion, the at least one illuminator being disposed at the distal tip, the laser fiber being disposed in the suction channel and the distal end of the laser fiber being disposed at a distal end of the distal tip portion. Capable of extending to a distance within a range from 1 mm distal to the distal side of the distal side at the distal end to 3 mm proximal to the distal side of the distal side, the irrigation channel being defined by an internal void extending along the length of the catheter shaft, the irrigation channel having an outlet at the distal end, the irrigation channel being configured to direct an irrigation flow at an angle within a range greater than or equal to 0 degrees and less than or equal to 170 degrees relative to the central axis; obtaining an image of the targeted stone and surrounding area; placing the distal side proximal to the body stone material; starting an irrigation flow so that the irrigation flow passes through the irrigation channel; starting a suction flow so that the suction flow passes through the suction channel to remove ablation products through the suction channel; and starting a laser coupled to the laser fiber to ablate the targeted stone material. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Figure 1is a schematic diagram of an endoscopic system for laser lithotripsy according to an embodiment of the present disclosure;

[0039] Figure 2 According to an embodiment of the present disclosure, Figure 1 An end view of a distal head portion of an endoscope system that may be configured for common irrigation and aspiration ports;

[0040] Figure 2A According to an embodiment of the present disclosure, Figure 2 A cross-sectional view of the distal head portion taken along plane IIA-IIA;

[0041] Figure 3 According to an embodiment of the present disclosure, Figure 1 An end view of a distal head portion of an endoscope system that may be configured for separate irrigation and aspiration ports;

[0042] Figure 3A According to an embodiment of the present disclosure, Figure 3 , Figure 4 and Figure 5 A cross-sectional view of the distal head portion taken along plane III-III;

[0043] Figure 3B According to an embodiment of the present disclosure, Figure 3 , Figure 4 and Figure 5 A cross-sectional view of the distal head portion taken along plane III-III;

[0044] Figure 3C According to the embodiment of the present disclosure Figure 3B A cross-sectional view of the catheter taken along plane IIIC-IIIC;

[0045] Figure 4 According to an embodiment of the present disclosure, Figure 1 an end view of a distal head portion of an endoscope having an illumination fiber optic extending into an expanded irrigation port of the distal head portion;

[0046] Figure 5 According to an embodiment of the present disclosure, Figure 1 an end view of a distal head portion of an endoscope having a flushing port at an outer tangential perimeter of a transparent cover of the distal head portion;

[0047] Figure 6 and Figure 7 According to an embodiment of the present disclosure, Figure 1 an end view of a distal head portion of an endoscope system configured for an irrigation port coplanar with a suction port;

[0048] Figure 8 is a top view of a distal head portion having an oval flushing port at the distal tip of a catheter according to an embodiment of the present disclosure;

[0049] Fig. 9 According to an embodiment of the present disclosure, Figure 1 a top view of a distal head portion of an endoscope system having a reduced cross-section and having an oblong flushing port at the distal end of the catheter;

[0050] Fig.10 According to an embodiment of the present disclosure, Figure 1 A perspective view of a distal head portion of an endoscope system having an extension with a pressure relief portion and a transparent cover;

[0051] Fig.11 According to the embodiment of the present disclosure Fig.10 a lateral view of the distal head portion of the;

[0052] Fig.12 According to an embodiment of the present disclosure, Figure 1 a perspective view of a distal head portion of an endoscope system of the present invention, the distal head portion having a transparent cover having a flushing port and an illumination fiber secured thereto, and an integral pressure relief portion defined within the transparent cover;

[0053] Fig. 12A According to the embodiment of the present disclosure Fig.12 a top view of the distal head portion of the

[0054] Fig. 12B According to the embodiment of the present disclosure Fig.12 a lateral elevational view of the distal head portion of;

[0055] Fig.13 According to an embodiment of the present disclosure, Figure 1 a top view of a distal head portion of an endoscope system of the present invention, the distal head portion having a transparent cover having an illumination optical fiber secured thereto and an integral pressure relief portion defined within the transparent cover;

[0056] Fig.14 According to the embodiment of the present disclosure Fig.13 a lateral view of the distal head portion of the;

[0057] Fig.15 According to the embodiment of the present disclosure Fig.13 a side view of the distal head portion of the embodiment of the present invention, depicting the flow field and the diffusion of light from the illumination fiber optics;

[0058] Fig.16 According to an embodiment of the present disclosure, Figure 1an end view of a distal head portion of an endoscope system of the present invention, the distal head portion having a single push-pull fiber optic configured to deflect the distal head portion for steering of the catheter;

[0059] Fig.16A According to an embodiment of the present disclosure, Fig.16 A cross-sectional view of the distal head portion taken along plane XVIA-XVIA;

[0060] Fig.17 According to an embodiment of the present disclosure, Fig.16 A perspective view of a distal head portion of the catheter partially assembled with a distal tip portion of components extending through a catheter shaft, wherein an asymmetrical dome-shaped transparent cover is depicted in phantom;

[0061] Fig.18 According to the embodiment of the present disclosure Fig.17 a cross-sectional view of the distal tip portion and the catheter shaft;

[0062] Fig.19 According to an embodiment of the present disclosure, Fig.17 A front view of the components in an assembled state;

[0063] Fig.19A is a replacement according to an embodiment of the present disclosure Fig.19 An elevation view of a component;

[0064] Fig. 20 According to the embodiment of the present disclosure Figure 1 an end view of a distal head portion of an endoscope system without a transparent cover and having an imaging receptor axially offset from a mouth of the distal head portion;

[0065] Fig. 20A According to an embodiment of the present disclosure, Fig. 20 A cross-sectional view of the distal head portion taken along plane XVA-XVA;

[0066] Fig.21 According to the embodiment of the present disclosure Figure 1 an end view of a distal head portion of an endoscope system without a transparent cover and having an imaging receptor axially offset from a mouth of the distal head portion and having a dedicated flushing port;

[0067] Fig.21A According to an embodiment of the present disclosure, Fig.21 A cross-sectional view of the distal head portion taken along plane XXIA-XXIA;

[0068] Fig. 21B According to an embodiment of the present disclosure, Fig.21 A cross-sectional view of the distal head portion taken along plane XXIB-XXIB;

[0069] Fig. 21C is a cross-sectional view of an alternative configuration of the distal head portion of FIG. 25 taken along plane XXIB-XXIB according to an embodiment of the present disclosure;

[0070] FIG. 22A to FIG. 22D is a cross-sectional view of a fiber optic device for illumination having an elliptical cross section according to an embodiment of the present disclosure;

[0071] Fig.23 is a partial interior view of a steering handle having a push-pull fiber optics link mounted to a rotating cam and coupled to a light source in accordance with an embodiment of the present disclosure;

[0072] FIG. 24A to FIG. 24C is a schematic diagram of a terminal for attaching a fiber optic push link to the distal head portion according to an embodiment of the present disclosure;

[0073] Fig.25A According to the embodiment of the present disclosure, Fig.10 a photograph of the target area observed from the distal head portion of the embodiment of the present invention, wherein the transparent cover is removed;

[0074] Fig.25B According to the embodiment of the present disclosure, Fig.10 A photograph of a target area observed from a distal head portion of the transparent cover having a cover thickness of 1 mm;

[0075] Fig.25C According to the embodiment of the present disclosure, Fig.10 A photograph of a target area observed from a distal head portion of the transparent cover having a cover thickness of 1.25 mm; and

[0076] Fig.25D According to the embodiment of the present disclosure, Fig.10 A photograph of the target area observed in the distal head portion, where the transparent cover has a cover thickness of 1.5 mm. DETAILED DESCRIPTION

[0077] refer to Figure 1, schematically depicts an endoscopic system 30 for laser lithotripsy according to an embodiment of the present disclosure. The endoscopic system 30 includes a catheter 32 having a proximal portion 36 coupled to a handle 38 and a distal portion 35 including a distal head portion 34. The catheter 32 may include a flexible (depicted), rigid, or semi-rigid catheter shaft 33. The handle 38 may house a steering mechanism 39 coupled to the distal head portion 34. The handle 38 is integrated with various external components or external systems 40 for controlling and transmitting to the distal head portion 34 via the catheter 32. The external systems 40 may include an irrigation system 42, a suction or aspiration system 44, an ablation laser system 46, an illumination system 52, and a visualization system 54. Some components of the endoscopic system 30 may be partially or completely integrated into the handle 38, the catheter 32, or the distal head portion 34. The handle 38 may include, for example, control mechanisms for the suction system 44 and the irrigation system 42, and mechanisms for adjusting the position of the distal end of the laser fiber, among other components. The mechanism for positioning the optical fiber may include a clamp (not depicted) that can be engaged once the distal end of the optical fiber is in the desired position. Clamping the optical fiber typically fixes the position of the distal end of the optical fiber with an accuracy in the range of 0.05 mm to 0.1 mm. The direction from the catheter shaft 33 to the distal head portion 34 along the central axis 110 is referred to herein as the distal direction 50. The direction opposite to the distal direction 50 is referred to herein as the proximal direction 51.

[0078] Functionally, the steering mechanism 39 enables articulation of the distal portion 35 of the catheter 32, particularly for embodiments containing a flexible or semi-flexible catheter shaft 33, so as to be routed through a patient's body tract to a target zone 56 and so as to align the distal head portion 34 to lock onto or find a single body stone 58 within the target zone 56. The illumination system 52 generates visible light that is delivered to the target zone 56 to illuminate the body stone 58 and surrounding tissue, such as stones within the kidney, ureter, or bladder. The ablation laser system 46 includes, for example, a thulium or holmium optical fiber or a solid-state laser for delivering laser energy to the target zone 56 to ablate and fragment the body stone 58. Laser optical fibers (e.g., silica or other optical fiber materials) may be used to achieve delivery of laser energy. The irrigation system 42 provides pressurized irrigation fluid to cool the target zone 56 and move fragments of the body stone 58 within the target zone 56. The suction system 44 draws liquid medium away from the target area 56, including particles from the body stones 58 that may be suspended in the medium. In some embodiments, the suction system 44 includes a pressure sensor 48 that monitors the suction pressure. The pressure sensor can also be used to monitor the irrigation pressure.

[0079] As used herein, "body stones" encompass any stone produced by the human body, including kidney stones and ureteral stones and their types, including calcium stones, uric acid stones, struvite stones, and cysteine ​​stones. "Body stones" may also include stones found in organs of the body or formed by other elements of the body, such as bladder stones, gallstones, prostate stones, pancreatic stones, salivary gland stones, and abdominal stones. The present disclosure describes (but is generally not limited to) systems and techniques for decomposing kidney stones and ureteral stones. In view of the present disclosure, those familiar with body stone therapy will recognize the application of various aspects disclosed herein for repairing body stones other than kidney stones and ureteral stones, and for the treatment of hard and soft tissues.

[0080] refer to Figure 2 and Figure 2A , depicting a distal head portion 34a according to an embodiment of the present disclosure. Herein, the distal head portion is collectively or generally referred to by the reference numeral 34, while individual or specific embodiments of the distal head portion are referred to by the reference numeral 34 followed by an alphabetical suffix (e.g., "distal head portion 34a"). The distal head portion 34a includes a distal tip portion 96 having a distal side 98 and an outer tangential surface 97. In some embodiments, the distal tip portion 96 is integral with the catheter shaft 33 (e.g., Figure 2A , Figure 3A and Figure 3B ); In other embodiments, the distal end portion 96 is formed separately from the catheter shaft 33 and attached to the catheter shaft 33 (eg, Figures 16 to 21C ). In some embodiments, a transparent cover 100 is secured to a distal side 98 of the distal end portion 96. The transparent cover 100 includes a proximal side 104 and a distal side 106, the proximal side 104 and the distal side 106 defining an axial cover thickness 99 therebetween. In some embodiments, the transparent cover 100 defines an inclined surface 101 extending proximally from the distal side 106, for example, a chamfered (as shown) or curved corner. The transparent cover 100 is made of a material suitable for transmitting visible light and may include a low absorption coefficient and a high damage threshold at the operating wavelength of the ablation laser system 46. Non-limiting example materials for the transparent cover 100 include sapphire, quartz, optical ceramics, and mineral or organic glass. In some embodiments, the refractive index of the transparent cover 100 is about 1.31 to 1.35 to roughly match the refractive index of the liquid medium (substantially water). In some embodiments, the distal end 96 may be made of the same transparent material as the transparent cover 100.

[0081] In some embodiments, the distal head portion 34a includes one or more illuminators 130. The illuminator 130 can be located at the distal end of an illumination or illumination fiber optic 132 for transmitting light in the visible spectrum and operably coupled to the illumination system 52 at the handle 38. The illumination fiber optic 132 passes through an illumination fiber optic port 134 formed in the distal end portion 96 and can extend into the transparent cover 100. Alternatively, the illuminator 130 can be a light emitting diode (LED) (not shown) located near the proximal side 104 of the transparent cover 100 and powered by electrical wires extending through the catheter 32. The illumination fiber optic 132 acts as an optical waveguide and can extend through the catheter 32 and be coupled to the illumination system 52 at the handle 38.

[0082] In some embodiments, one or more illumination fiber optics 132 are mechanically attached (e.g., with an adhesive) to the distal head portion 34a, e.g., to the illumination fiber optic port 134, or to the transparent cover 100, or to both. The fiber optics 132 may extend through a lumen 107 ( Figure 2A , Figure 3A and Figure 3C ), and remain free to slide within the cavity 107. The illumination fiber optic 132 can extend distally from the steering mechanism 39 disposed within the handle 38 to translate within the cavity 107. (Attached to Fig.23 An example of the steering mechanism 39 is illustrated. ) Thus, the distal head portion 34d is coupled to the steering mechanism 39 of the handle 38 via the illumination fiber optics 132. For catheters 32 having a flexible or semi-flexible shaft 33, the coupling and routing of the illumination fiber optics 132 so arranged enables the illumination fiber optics 132 to also function as a pull link or push-pull link for steering of the distal head portion 34d, thereby eliminating the need for a separate pull wire and connector associated with coupling the pull wire to the distal head portion 34a.

[0083] The distal head portion 34a defines a working channel 102, which passes through the distal end portion 96 and through the proximal side 104 and the distal side 106 of the transparent cover 100. The working channel 102 defines a mouth 108 located at the distal side 106. The working channel 102 can be used as, for example, a suction port, in which case the mouth 108 and the working channel define a suction inlet. The working channel 102 extends through the catheter 32 and can be coupled to the suction system 44, for example, at the handle 38. The distal head portion 34a can define, for example, a circular or elliptical cross-section, which defines a central axis 110 and is concentric with the central axis 110. The working channel 102 includes a working port 103 and defines the mouth 108, which is formed in and passes through the distal head portion 34a. In some embodiments, the working port 103 includes a cover working port 103a and a distal end working port 103b that are fluidly connected to each other. The cover working port 103a passes through the transparent cover 100, defining a cover working port axis 111. In some embodiments, the distal end working port 103b passes through the distal end portion 96 to transition between the catheter shaft 33 and the transparent cover 100. Alternatively, embodiments are also considered in which the transparent cover 100 is directly coupled to the catheter shaft 33 (e.g., without a transition to the distal end portion), such that the working port 103 includes only the cover working port 103a. Embodiments in which the distal head 34 includes a distal end portion 96 without a transparent cover are also disclosed herein. (See below Fig. 20 and Fig.21 and the accompanying discussion.)

[0084] A laser fiber optic 112 for transmitting ablative laser energy is disposed in the working channel 102, a distal end 114 of the laser fiber optic 112 is positioned near the distal side 106 of the transparent cover 100, and a proximal end of the laser fiber optic 112 is connected to the ablation laser system 46 via the handle 38. The core diameter of the laser fiber optic 112 can be in the range of 0.05 mm to 0.4 mm (for catheters with a flexible shaft) and can be up to 1.5 mm (for catheters with a rigid shaft). In some embodiments, the laser fiber optic 112 is substantially concentric with the cover working port axis 111, or otherwise extends through a central portion of the cover working port 103a to define an annular region 116 between the laser fiber optic 112 and the cover working port 103a. In some embodiments, the position of the distal end 114 of the laser fiber optic 112 can be controlled within a range of + / -5 mm (inclusive) relative to the distal side 106 of the transparent cover 100, where "+" and "-" refer to the distal direction 50 and the proximal direction 51 of the working port axis 111, respectively. In some embodiments, the position of the distal end 114 can be controlled within a range of + / -3 mm (inclusive) relative to the distal side 106. In some embodiments, the position of the distal end 114 can be controlled within a range of +1 mm to -3 mm (inclusive) relative to the distal side 106. In some embodiments, the position of the distal end 114 can be controlled within a range of -0 mm to -3 mm (inclusive) relative to the distal side 106. In some embodiments, the position of the distal end 114 can be controlled within a range of -0.05 mm to -1 mm (including -0.05 mm and -1 mm) relative to the distal side. In this article, the range referred to as "including" includes the endpoint values ​​of the range and all values ​​between the endpoint values.

[0085] In some embodiments, one or more working ports 122 are defined extending through the transparent distal head portion 34. The working ports 103 and 122 may be perpendicular to the common working channel 109, such as Figure 2 and Figure 2A. In some embodiments, the working channel 109 is alternately used as a suction channel and an irrigation channel. In this article, a "working channel" can be used as an irrigation channel, a suction channel, or both. The working channel as used herein can optionally be configured to accommodate working objects, such as laser fibers and baskets. For a flexible catheter utilizing a 0.05 mm core laser fiber, the inner diameter of the working port 103 can be in the range of from 0.5 mm to 1.5 mm (including 0.5 mm and 1.5 mm).

[0086] Similar to the working port 103, each of the working ports 122 may include a cover working port 122a and a distal end working port 122b that are in fluid communication with each other. The cover working port 122a passes through the transparent cover 100. In some embodiments, the distal end working port 122b passes through the distal end portion 96 to transition between the catheter shaft 33 and the transparent cover 100. Alternatively, embodiments in which the transparent cover 100 is directly coupled to the catheter shaft 33 (e.g., without the transition of the distal end portion) are also considered, so that the working port 122 includes only the cover working port 122a.

[0087] In some embodiments, the distal head portion 34a includes an imaging receptor 142, which may include image forming optics that define a field of view 148 of the endoscope system 30 (characterized by a viewing angle β). In some embodiments, the imaging receptor 142 defines a viewing angle β in the range of 90 degrees to 120 degrees (inclusive) (±45 degrees to ±60 degrees (inclusive) from the visual axis of the imaging receptor). The imaging receptor 142 may be an imaging device 144 (as shown), such as a complementary metal oxide semiconductor (CMOS) sensor (including a semiconductor wafer, imaging optics, or supporting electronics) or a charge coupled device (CCD) camera sensor. In some embodiments, the imaging surface of the imaging receptor 142 ranges from 0.5 mm×0.5 mm to 1.5 mm×1.5 mm. An example of the described CMOS image sensor is the NANEYE2D supplied by AWAIBA CMOS Image Sensors of Aargau, Switzerland. See https: / / ams.com / naneye, last accessed on January 16, 2020.

[0088] The imaging device 144 may include a cable 146 that extends through the catheter 32 and can be coupled to the visualization system 54 at the handle 38. The cable 146 can be routed through a cable port 145 defined by the distal tip 96. In some embodiments, the imaging device 144 is disposed in a recess 147 located at the distal surface 98 of the distal tip portion 96. The imaging device 144 can define a viewing angle β within ±45 degrees of the normal. Optionally, the imaging receptor 142 is located at the distal end of an optical system and image fiber optics (not depicted) extending through the catheter 32 and coupled to the visualization system 54 at the handle 38. The distal surface 106 of the transparent cover 100 can be flat (as shown) or alternatively formed as a lens (not shown) to image onto the imaging receptor 142.

[0089] refer to Figure 3 and Figure 3A , depicting a distal head portion 34b according to an embodiment of the present disclosure. The distal head portion 34b may include many of the same components and attributes as the distal head portion 34a, which are represented by the same numerical reference numerals. The difference between the distal head portion 34b is that the working port 122 is separate from the working port 103. In some embodiments, the inner diameter of the working port 122 for flushing is in the range of 0.5 mm to 1.5 mm. Functionally, the separate ports 103 and 122 served by separate working channels 102 and 124 enable flushing and aspiration to occur simultaneously and continuously during laser treatment.

[0090] refer to Figure 3B and Figure 3C According to an embodiment of the present disclosure, the distal head portion 34b is depicted as a catheter 32 having a distal tip portion 96 and a tubular shaft 120. Figure 3B and Figure 3C In some embodiments, the working port 122 is in fluid communication with a single working channel 124 defined by an outer portion 126 of the catheter shaft 33. That is, in some embodiments, the catheter shaft 33 defines a cross-section 128 perpendicular to the central axis 110, the central axis 110 defining a hollow portion 129 extending from the proximal portion 36 to the distal portion 35, the hollow portion 129 being occupied by a plurality of components serving the distal head portion 34 of the catheter 32. The occupied components may include, but are not limited to, the working channel 102, the laser fiber optics 112, the illumination fiber optics 132 and the cavity 107, and the cable 146. Sterilization of the hollow portion 129 may be performed for a single-use endoscope by an ethylene oxide (ETO) gas sterilization method.

[0091] With this arrangement, the working channel 102 is disposed within and effectively surrounded by the single working channel 124. The irrigation system 42 may be coupled to the catheter shaft 33 so that irrigation fluid may flow through the remainder of the hollow portion 129, i.e., the portion not occupied by the components. The tubular shaft 120 may be formed of Figures 3 to 9 Any of the distal head portions 34 depicted may be implemented.

[0092] For various disclosed endoscope systems 30 that implement suction and irrigation simultaneously, the total processing time can be reduced and the safety of the surgery can be improved. The method according to an embodiment of the present disclosure may include some or all of the following:

[0093] (1) using ultrasound, fluoroscopy, or other diagnostic methods available to the technician to identify stones in the patient's internal organs;

[0094] (2) inserting the catheter 32 into the patient's body and bringing the distal end of the catheter to the proximal side of the target area 56;

[0095] (3) obtaining an image of the targeted body stone 58 or stone fragment;

[0096] (4) bringing the distal end 114 of the laser fiber optic device 112 into contact or quasi-contact with the targeted body stone or debris;

[0097] (5) starting the flushing flow and the suction flow; and

[0098] (6) The laser energy from the ablation laser system 46 is transmitted through the laser fiber 112 to ablate the stones 58 into large fragments (larger than 1 mm), small fragments (smaller than 1 mm) or particles (smaller than 0.25 mm).

[0099] The above method can be used for both contact and contactless treatment of body stones 58.

[0100] refer to Figure 4, depicts a distal head portion 34c according to an embodiment of the present disclosure. The distal head portion 34c may include many of the same components and attributes as the distal head portion 34b, which are represented by the same numerical reference numerals. The difference of the distal head portion 34c is that the illumination fiber optic device port 134 and the working port 122 are superimposed so that the illumination fiber optic device 132 intrudes into the boundary of the working port 122. Another difference of the distal head portion 34c is that the working port 122 is shaped to increase the flow cross-section without increasing the overall profile of the distal head portion 34c. In the embodiment shown in the figure, the working port 122 of the distal head portion 34c is elliptical to achieve the increase, but other shapes are also considered, including asymmetric port cross-sections. Attached below is Figure 8 and Fig. 9 Additional discussion of asymmetric working ports 122 is discussed.

[0101] Functionally, positioning the distal end 114 of the laser fiber 112 within the distal head 34 protects the distal end 114 of the fiber from stone ablation products and can also increase laser ablation efficiency while reducing total laser treatment time. Such placement minimizes or eliminates fiber burn-back and eliminates the need to reposition the distal end 114 of the fiber during laser surgery. The transparent cover 100 provides a clear visual path between the imaging receptor 142 and the distal side 106 of the transparent cover 100, thereby eliminating or substantially reducing debris (e.g., ablation particles) that would otherwise be present in the near field of view 148 between the imaging receptor 142 and the laser fiber optics 112. The reduction in debris in the near field of view 148 enables the operator to better visualize the mouth 108, the distal end 114 of the laser fiber optics 112, and a given body stone 58 being targeted, and also reduces the attenuation of light emitted by the illuminator 130, thereby better irradiating the target area 56. In addition, the distal side 106 of the transparent cover 100 (which can be more easily visualized than the smaller distal end 114 of the laser fiber optics 112) can help the operator position the distal head portion 34a to better control the distance between the distal end 114 of the laser fiber optics 112 and the targeted body stone 58. The improved control results in increased ablation efficiency because there is minimal or no gap (the gap is typically no more than 1 mm) between the distal end 114 and the targeted body stone 58 or debris. The reduction of debris in the near field of view 148 also reduces the attenuation of light from the illuminator 130, thereby better illuminating the target area 56 and more clearly observing the image of the target area 56. The placement of the imaging device 144 in the recess 147 enables the proximal side 104 of the transparent cover to be planar to be seated on the proximal side by the distal side 98 of the distal end portion 96. The angled surface 101 reduces trauma during delivery of the distal head portion 34 a through the body passage to the target area 56 .

[0102] The steering mechanism 39 coupled to the handle 38 via the illumination fiber optics 132 enables the illumination fiber optics 132 to also function as a pull link, and in some embodiments, a push-pull link, to steer the flexible or semi-rigid shaft 33. Thus, the need for a separate pull wire and connector associated with the coupling of the pull wire to the distal head portion 34d is eliminated, allowing a larger cross-sectional area to be dedicated to the working channel, or reducing the cross-sectional profile of the catheter 32, or a combination thereof. Arranging the illumination fiber optics 132 to intrude the boundaries of the working port 122 provides a larger cross-sectional area for irrigation flow.

[0103] By positioning the laser fiber optics 112 in the working channel 102, the distal end 114 can be recessed relative to the distal side 106 of the transparent cover 100 because the attraction of solution into the working channel 102 will tend to pull or attract the body stone 58 toward the laser fiber optics 112. Recessing the distal end 114 mechanically protects the laser fiber optics 112 during insertion and operation. In some embodiments, the distal end 114 of the laser fiber optics 112 can oscillate laterally during the laser treatment due to the force of the irrigation or aspiration flow, and the bubbling and flow in the liquid induced by the laser. Such oscillation may be desirable and can be controlled by the control parameters of the laser and the irrigation and / or aspiration flow (e.g., by modulating the flow rate).

[0104] In addition, pulling or attracting the body stone 58 toward the laser fiber optic device 112 can reduce or overcome the "push-back" effect that occurs when ablation heat forms a vapor pocket on the ablated face of the body stone 58. The push-back effect is described in more detail in International Application No. PCT / US19 / 42491, filed by Altshuler et al. on July 8, 2019 and owned by the owner of the present application, the disclosure of which (except for the explicit definitions and patent claims contained therein) is hereby incorporated by reference in its entirety. In addition, because the distal end 114 can be viewed through the transparent cover 100, the visualization and control of the distance between the distal end 114 of the laser fiber optic device 112 and the targeted body stone 58 is not compromised or compromised. In addition, the incidental heat generated by the laser ablation process can be efficiently dissipated by the irrigation fluid and removed by drawing the hot irrigation fluid through the working channel 102, thereby reducing the risk of unintended thermal damage to surrounding tissue.

[0105] refer to Figure 5 , depicting a distal head portion 34d according to an embodiment of the present disclosure. The distal head portion 34d includes many of the same components and attributes as the distal head portion 34a, which are represented by the same numerical reference numerals. As with the distal head portion 34a, the distal head portion 34d can use the illumination fiber optics 132 as a push-pull element for steering a catheter 32 having a flexible shaft 33. In some embodiments, the illumination fiber optics 132 has an elliptical cross-section 164. Typically, the "elliptical" cross-section 164 has a major axis dimension 166 and a minor axis dimension 168 that are perpendicular to each other, the major axis dimension 166 being the largest dimension of the elliptical cross-section 164, and the minor axis dimension 168 being the smallest dimension perpendicular to the major axis dimension 166 and specified to be smaller than the major axis dimension 166.

[0106] In some embodiments, the major axis dimension 166 of the elliptical cross section 164 extends tangentially (i.e., approximately parallel to the tangential direction θ relative to the central axis 110 of the distal head portion 34d), and the minor axis dimension 168 extends radially (i.e., parallel to the radial direction r relative to the central axis 110 of the distal head portion 34d). In the embodiment shown in the figure, the working port 122a can be disposed at the outer tangential perimeter 170 of the transparent cover 100, the working port 122a passes through the proximal surface 104 and the distal surface 106 of the transparent cover 100, and opens at the distal surface 106 and along the outer tangential perimeter 170 of the transparent cover 100 (e.g., along the inclined surface 101).

[0107] refer to Figure 6 and Figure 7 , depicts distal head portions 34e and 34f utilizing an illumination fiber optic 132 having an elliptical cross-section 164 and a working port 122 located proximate the annular region 116 of the working port 103 in accordance with an embodiment of the present disclosure. The distal head portions 34e and 34f may include many of the same components and attributes as the distal head portion 34d, which are indicated by the same numerical reference numerals. The difference with the distal head portion 34e is that the working port 122 surrounds the annular region 116. As with the distal head portion 34a, the distal head portions 34e and 34f may use the illumination fiber optic 132 as a push-pull element for steering a catheter 32 having a flexible shaft 33. For the distal head portion 34e, the working port 122 is circular. For the distal head portion 34f, the working port 122 is curved. Multiple working ports 122, such as in Figures 3 to 9 In some embodiments, the ratio of the area of ​​the working port 122 to the area of ​​the mouth 108 is in the range of 1.2 to 3.0 (inclusive).

[0108] Functionally, when the working channel 102 is used for suction, the proximity of the working port 122 around the mouth 108 creates a flow field 256 that flows outward from the working port 122 and folds inward toward the mouth 108. Fig.15 The flow field concept is further discussed.

[0109] refer to Figure 8 and Fig. 9, depicting the distal head portions 34g and 34h according to an embodiment of the present disclosure to illustrate the general aspects of the layout of the working port 122. The head portion 34g and the distal tip portion 96 of the catheter 32 define a circular cross-section 167a ( Figure 8 ). The working port 122 may be elliptical to provide a larger flow cross section than would be provided by a circular flushing port. The circular distal head portion 34g is characterized by a generally uniform outer diameter dimension OD. The head portion 34h and the distal tip portion 96 define an elliptical cross section 167b ( Fig. 9 and other figures), such as oval, elliptical, oblong, or rounded rectangular cross-sections.

[0110] The elliptical cross-section 167b is achieved by positioning the working port 122 and the illumination fiber optic 132 closer to the central axis 110, so that the elliptical cross-section 167b has a reduced profile (i.e., has a smaller cross-sectional area) relative to the circular cross-section 167a. The elliptical cross-section 167b defines a major axis 171 that passes through a maximum outer diameter dimension OD1 of the elliptical cross-section 167b, and a minor axis 169 that is perpendicular to the major axis 171. The minor axis 169 can define a minimum outer diameter dimension OD2 of the elliptical cross-section 167b. In some embodiments, the outer diameters OD and OD1 of the cross sections 167a and 167b are in the range of 2 mm to 3.2 mm (including 2 mm and 3.2 mm); in some embodiments, the outer diameters OD and OD1 are in the range of 1.7 mm to 2.6 mm (including 1.7 mm and 2.6 mm); in some embodiments, the outer diameters OD and OD1 are in the range of 2.2 mm to 2.5 mm (including 2.2 mm and 2.5 mm). In some embodiments, the outer diameter OD2 of the cross section 167b is in the range of 1.7 mm to 2.5 mm (including 1.7 mm and 2.5 mm); in some embodiments, the outer diameter OD2 is in the range of 1.7 mm to 2.0 mm (including 1.7 mm and 2.0 mm).

[0111] refer to Fig.10 and Fig.11, depicts a distal head portion 34i of an extension 182 having a working port 103 according to an embodiment of the present disclosure. The distal head portion 34i includes many of the same components and attributes as the distal head portion 34b, which are identified by the same numerical reference numerals. The cover working port 103a defines the mouth 108 located near the distal side 106 of the transparent cover 100. For the distal head portion 34i, the mouth 108 of the cover working port 103a is defined at the distalmost end 186 of the extension 182. At least one pressure relief portion 192 extends proximally from the mouth 108. The pressure relief portion 192 can be one or more notches 194. The notch can extend radially through the wall 196 of the extension 182.

[0112] For the distal head portion 34i, the distal end working port 122b defined by the distal end portion 96 extends through a corresponding chamfer 214 formed at the distal end portion 96 of the catheter 32. Alternatively, the distal end portion 96 can be chamfered (not shown) around the tangential perimeter 216 of the outer tangential surface 97 to define the chamfer 214. In some embodiments, the proximal side 104 of the transparent cover 100 extends radially beyond the chamfer 214 to define the outlet 218 of the distal end working port 122b. Therefore, for the distal head portion 34i as shown, there is no cover flushing port passing through the transparent cover 100. Instead, the flushing port 122b terminates the working channel 124 near the transparent cover 100 and is configured to direct flow onto the proximal side 104 of the transparent cover 100.

[0113] In some embodiments, each of the illumination fiber optics 132 is disposed within a corresponding distal end working port 122b, wherein the illumination fiber optics extends into the transparent cover 100 of the distal head portion 34i. Each illumination fiber optic 132 can be configured to diffuse, refract, scatter, or otherwise redirect the visible light 222 radially into the transparent cover 100. The transparent cover can also be configured to diffuse or scatter the visible light 222. The transparent cover 100 can contact the distal portion 224 of the at least one illumination fiber optic 132, for example, to achieve fixation of the illumination fiber optic 132 to the distal head portion 34. In some embodiments, the interface 226 between the distal portion 224 of the illumination fiber optic 132 and the transparent cover 100 can be configured to guide the visible light 222 radially away from the illumination fiber optic. For example, in order to enhance the redirection of the visible light 222, the distal portion 224 of the illumination fiber optic 132 can be uncoated. The redirection of the visible light 222 can occur along the entire length of the interface 226. In another example, the interface 226 includes a transparent or translucent adhesive that scatters or refracts the visible light 222 away from the illumination fiber optics 132. In another example, the illumination fiber optics 132 defines a relatively large numerical aperture (e.g., in the range of 0.35 to 0.65 (inclusive)). The above example aspects facilitate redirection of the visible light 222 through the transparent cover 100.

[0114] refer to Fig.12, depicts a distal head portion 34j having a recessed pressure relief portion 192 according to an embodiment of the present disclosure. The distal head portion 34j includes many of the same components and attributes as the distal head portion 34i, which are identified by the same numerical reference numerals. The difference of the distal head portion 34j is that the pressure relief portion 192 extends proximally from the distal side 106 of the transparent cover 100. That is, the mouth 108 of the cover working port 103a is flush with the distal side 106 of the transparent cover 100. Another difference of the distal head portion 34j is that the working port 122 includes a cover working port 122a that extends into the transparent cover 100 instead of extending through the distal side 106. As an alternative, the outlet 218 of the cover working port 122a extends through the radial surface 244 of the transparent cover 100. In some embodiments, the bevel 214 is formed in the radial surface 244 of the transparent cover 100 to define the outlet 218. In some embodiments, each distal tip working port 122b is in fluid communication with a corresponding cover working port 122a. The transparent cover 100 may include a distal end portion 246 that extends radially beyond the cover working port 122a.

[0115] refer to Figures 13 to 15 , depicts a distal head portion 34k having a recessed pressure relief portion 192 according to an embodiment of the present disclosure. The distal head portion 34k includes many of the same components and attributes as the distal head portion 34j, which are identified by the same numerical reference numerals. The difference of the distal head portion 34k is that the pressure relief portion 192 extends radially to the outer tangential perimeter 170 of the distal side 106 of the transparent cover 100.

[0116] Functionally, redirecting the visible light 222 out of the illumination fiber optics 132 and into the transparent cover 100 can provide more uniform irradiation of the target zone 56. The pressure relief portion 192 of the distal head portion 34i to 34k helps stabilize the captured and targeted body stone 58 at the mouth 108 of the cover working port 103a in the suction mode. Without the pressure relief portion 192, the targeted body stone 58 may effectively block the working port 103, thereby creating a greater pressure differential across the body stone 58. The high pressure differential creates greater forces acting on the targeted body stone 58. These greater forces may cause, for example, the capture of the targeted body stone 58 to become unstable, causing the body stone 58 to fall out of the working port 103. In another example, greater forces may cause oversized fragments of the targeted body stone 58 to become lodged in the working port 103 or to become stuck between the laser fiber optics 112 and the working port 103, thereby contaminating the distal head portion 34 and damaging the laser fiber optics 112. The pressure relief portion 192 enables the suction flow to surround the captured body stone 58, thereby reducing the pressure differential across the body stone 58 and the attendant forces applied to the body stone 58. The reduced pressure and force mitigate capture instability and reduce the incidence of oversized fragments becoming lodged in the working port 103.

[0117] The transparent cover 100 is arranged to extend radially beyond the slope portion 214 ( Fig.10 , Fig.11 , Fig.14 , Fig.15 and Fig.19 ) or alternatively arranged so that the distal portion 246 of the transparent cover 100 extends beyond the inclined portion of the distal portion 246 ( Fig.12 ) will deflect the flushing flow in the radial direction r to establish the flow field 256, such as Fig.15 As shown. The outlet 218 delivers a flushing flow 252 directed radially outward, while the suction flow 254 draws the flow into the mouth 108. In some embodiments, the peak outflow angle α of the flushing flow 252 (i.e., the angle at which the maximum flux of the flushing flow occurs) is in the range of 10 degrees to 90 degrees (including 10 degrees and 90 degrees) centered on the central axis 110. In some embodiments, the peak outflow angle α is in the range of 10 degrees to 60 degrees (including 10 degrees and 60 degrees).

[0118] In operation, the radially outward outlet 218 creates a flow field 256 that flows outward from the distal head portion 34k and folds inward toward the mouth 108. The flow of the distal head portions 34i and 34j can behave in a similar manner. When the working channel 102 is used for suction, sufficiently small (e.g., less than 0.5 mm) fragments of the body stone 58 are entrained in the flow field 256 and discharged through the mouth 108 and the working channel 102. Other body stones 58 or fragments thereof that are too large (e.g., 1 mm to 3 mm) are drawn by the flow field 256 to be aimed near the distal end 114 of the laser fiber optic device 112. As these larger stones are brought into range of the laser fiber optic device 112, the ablation laser system 46 can be energized to ablate the body stones 58. The ablation breaks the body stone 58 into smaller fragments, which are then drawn into the working channel 102 through the mouth 108.

[0119] When a large bodily stone 58 enters or approaches the ostium 108 during aspiration, the working channel 102 may experience a pressure drop due to the stone blocking the ostium 108. Thus, in some embodiments, the ablation laser system 46 may be triggered by the pressure drop in the working channel 102 detected by the pressure sensor 48 of the aspiration system 44 ( Figure 1 ) to ablate the body stones 58 causing the blockage.

[0120] Functionally, establishing the flow field 256 to pull the body stone 58 toward the laser fiber optics 112 accelerates the process of laser lithotripsy. For example, when operating in a contactless mode with a peak outflow angle α (in the range of 10 degrees to 60 degrees), the irrigation flow 252 sweeps small stones and stone fragments toward the mouth 108 of the suction channel 103 to operate more efficiently. The irrigation flow 252 and the suction flow 254 (either alone or both) can be continuous or pulsed. In some embodiments, the pulsed flow is synchronized with the laser pulses to enhance the ablation and removal of ablation particles. Because the flow field pulls the body stone 58 into the effective range of the laser fiber optics 112 (typically 0 mm to 3 mm), the need to search and hunt for the body stone 58 is reduced. In addition, after having been pulled into the effective range of the fiber optics 112, the body stone 58 is more efficiently fragmented by the ablation process. Navigation within the target area 56 is improved because redirection of some of the visible light 222 provides more uniform illumination of the target area 56. Because of the aspiration and because of the presence of the transparent cover 100 in the near field of view 148, the amount of attenuation due to smaller fragments and particles from the body stone 58 in the field of view 148 is reduced.

[0121] refer to Figures 16 to 19A , depicting distal head portions 34l and 34m according to an embodiment of the present disclosure. The distal head portions 34e and 34m may include many of the same components and attributes as the other distal head portions 34 described above, some of which are represented by the same numerical reference numerals. The differences in the distal head portion 34l include a single illumination fiber optic 132, a transparent cover 100 having a convex or dome-shaped profile 262, a distal end working port 122b defining an asymmetric flow cross section 264, and a laser fiber optic 112 supported by a laser fiber optic port 266 offset from the cover working port axis 111.

[0122] The single illumination fiber optic 132 can be configured to apply both pulling and pushing forces to the distal head portion 341. In some embodiments, the cross-section of the single illumination fiber optic 132 measures 0.2 mm x 0.5 mm.

[0123] Functionally, similar to e.g. Figure 5 The single illumination fiber optic 132 can occupy less cross-section of the distal head portion 34l than the pair of illumination fiber optics 112 of the distal head portion 34d. In addition to having less fiber optic cross-section, the associated structural cross-section required to secure the fiber optic (the structure to which the fiber optic is attached) is also reduced. The reduction in cross-section provides more area for other components of the distal head portion 34l (e.g., working ports 103, 122b), or the reduction in the total cross-section of the distal head portion 34l provides more area for other components of the distal head portion 34l (e.g., working ports 103, 122b), or a combination of the two. For example, in one embodiment, the maximum outer diameter dimension OD1 is in the range of 2 mm to 2.5 mm (inclusive), and the minimum outer diameter dimension OD2 is in the range of 1.7 mm to 2 mm (inclusive), while still providing a flow area with an increased cross-section relative to other embodiments.

[0124] The dome-shaped profile 262 of the transparent cover 100 may be generally hemispherical and define a cover working port 103a therethrough. In some embodiments, the distal head portion 341 is elliptical, defining a major axis 171 and a minor axis 169 and associated outer diameter dimensions OD1 and OD2, similar to the distal head portion 34h ( Fig. 9 In some embodiments, the dome-shaped profile 262 is asymmetric. For the distal head portion 341 as shown, the dome-shaped profile 262 is asymmetric along the major axis 171 ( Fig.16A), while being symmetrical along the minor axis 169 ( Fig.18 ). The dome-shaped profile 262 (as shown) defines a maximum axial dimension Z parallel to the central axis 110 of the distal head portion 341. In some embodiments, the maximum axial dimension Z of the dome-shaped profile 262 is located above the imaging receptor 142. The distal head portion 341 may also include a pressure relief portion 192 recessed into the dome-shaped profile 262.

[0125] Functionally, the dome-shaped profile 262 of the transparent cover can allow the distal head portion 341 to smoothly and easily pass through body passages (such as ureters and renal calyces), especially when turning the distal head portion 341 through a bend. Arranging the maximum axial dimension Z of the transparent cover 100 to align with the imaging receptor 142 increases the path perpendicular to the imaging receptor relative to other transparent covers 100 (e.g., Figure 2A , Figure 3A and Figure 3B ) to increase the length of the flat distal side 106 (and thus increase clarity). The convex surface of the dome-shaped profile 262 can also be configured to act as a lens to magnify the image observed by the imaging receiver 142. The pressure relief portion 192 is provided as an Fig.13 and Fig.14 Works as described.

[0126] The asymmetric flow cross section 264 of the distal end working port 122b can be configured to occupy a larger portion of the cross-sectional area of ​​the distal head portion 34l than an axisymmetric working port, such as the circular working port 122 of the distal head portion 34b or the elliptical working port 122 of the distal head portions 34c, 34g, 34h. Effectively, a structure for defining the working port 103 and for mounting the laser fiber optics 112, the illumination fiber optics 132, and the imaging receptor 142 is provided in the distal end portion 96. The remainder of the elliptical cross section 167b of the distal head portion 34l is configured to provide the asymmetric flow cross section 264.

[0127] The laser fiber optics port 266 protrudes radially into the working port 103 and can be sized to provide a tight sliding fit with the laser fiber optics 112. The working port 103 defines a maximum inner radius R. The protrusion of the fiber optics port 266 intrudes into the maximum inner radius R to define a minimum inner diameter dimension 268 of the working port 103. The laser fiber 112 can be installed in the port 266 during manufacturing and sterilized with the catheter 32. Various methods of mounting the laser fiber can be used, including (but not limited to) friction-controlled mechanical attachment, overmolding, adhesive bonding, or other suitable techniques. Pre-integrating the laser fiber into the endoscope in this way reduces surgical preparation time because the surgeon does not need to insert the fiber into the endoscope.

[0128] The distal end 114 of the optical fiber 112 may be recessed into the working port 103 near the surface distal side 106 to mitigate fiber burn-back effects.

[0129] Functionally, the asymmetric flow cross section 264 serves to increase the flow cross section of the distal tip working port 122b relative to a circular, elliptical or other axisymmetric cross section, thereby providing a larger cross section for, for example, irrigation flow or passage for a catheter tool. Likewise, the offset of the laser fiber optic port 266 and the laser fiber optic 112 provides a larger unobstructed flow cross section for the working port 103. That is, for a working port 103 having a given cross-sectional flow area, an arrangement having a laser fiber optic 112 substantially centered within the working port 103 (e.g., as Figures 2 to 9 The minimum inner diameter dimension 265 of the distal head portion 341 is slightly smaller than the inner radius of the working port 103, while the minimum inner diameter dimension 268 of the working port 103 of the distal head portion 341 can be substantially larger than the maximum inner radius R ( Fig.16 ). For embodiments where the working port 103 and mouth 108 are used as aspiration inlets, the larger minimum inner diameter dimension enables aspiration of larger stone fragments from the target zone 56 compared to concentrically positioning the laser fiber optics 112. In addition, the laser fiber optics port 266 can provide additional injury-free protection for the laser fiber optics 112 due to the passage of stone fragments at the constriction defining the minimum inner diameter dimension 268 of the working port 103.

[0130] The distal head portion 341 depicts the transparent cover 100 as extending radially beyond the beveled portion 214 of the distal tip portion 96, similar to the above-discussed Fig.10 , Fig.11 , Fig.14 and Fig.15 The transparent cover 100 may include a transition 261 between the proximal side 104 and the dome-shaped profile 262. The transition 261 may be, for example, curved (as shown) or chamfered. The transition 261 may enable smooth movement of the catheter 32 in the proximal direction (e.g., during removal through a body passage). Alternatively or in addition, one or more bevels 267 may be defined on the transparent cover 100, such as in Fig.19A The chamfer 267 (or alternatively, the chamfer) on the transparent cover 100 has the effect of directing the irrigation flow 252 radially outward. In some embodiments, the distal end portion 96 defines an outlet 269 (as shown) that is coplanar with the distal side 98 of the distal end portion 96. Embodiments in which the radially outward outlet 218 is combined with the chamfer 267 are also contemplated.

[0131] refer to Fig. 20 and 20A , depicting a distal head portion 34n according to an embodiment of the present disclosure. The distal head portion 34n may include many of the same components and attributes as other distal head portions 34 described herein, some of which are represented by the same numerical reference numerals. The characteristic of the distal head portion 34n is that the distal tip portion 96 includes an extension portion 286 extending from a base platform 288 to the distal side 98. The working port 103 extends through the extension portion 286 and the distal side to define the mouth 108 located at the distal side 98. In some embodiments, the extension portion 286 includes a reduced flange 290 extending radially inward to define the mouth 108. The reduced flange 290 defines a diameter of the mouth 108 that is smaller than the inner diameter of the working port 103 near the reduced flange 290. In some embodiments, the reduced flange 290 reduces the area of ​​the mouth 108 relative to the area of ​​the working channel 102 near the reduced flange 290 by 5% to 50%.

[0132] The reduced flange 290 may also be implemented by the distal head portion 34 in which the mouth 108 is defined by the transparent cover 100. The transparent cover 100 having the reduced flange 290 is Figure 2A , and can be implemented by making necessary modifications to the details of any transparent cover 100 disclosed herein.

[0133] The maximum axial offset Δ of the imaging receptor is defined as the distance from the distal-most end 291 of the extension portion 286 to the imaging receptor 142, the distance being parallel to the working port axis 111. For embodiments where the distal surface 98 defines a plane 292 perpendicular to the working port axis 111 (in Fig. 20A and Fig.21A ), the distal end 291 of the extension 286 is any point on the plane 292, and the maximum axial length Δ is the distance from the plane 292 to the imaging receptor 142, the distance being parallel to the working port axis 111. For embodiments where the distal surface 98 is a wavy surface (e.g., similar to Fig.16A , Fig.17 , Fig.19 and Fig.19A The dome-shaped profile 262 of the transparent cover 100 of the distal head portion 341 and 34m in FIG. 1 ) may be a single distal end 291 of the mouth 108. An example of a single distal end on the transparent cover 100 of the distal head portion 341 is shown in FIG. Fig.16A In some embodiments, the maximum axial length Δ is in the range of 1 mm to 10 mm (inclusive). In some embodiments, the maximum axial length Δ is in the range of 1 mm to 5 mm (inclusive).

[0134] The distal end 114 of the laser fiber optic 112 is positioned proximate the mouth 108. The axial position δ of the distal end 114 of the laser fiber 112 is defined relative to the distal-most position 292 of the mouth 108. For embodiments where the mouth 108 defines a plane 292 perpendicular to the working port axis 111 (in Fig. 20A and Fig.21A ), the distal-most position 292 is any point on the plane 292, and the axial position δ is the distance from the plane 292 along the working port axis 111. For embodiments where the mouth 108 is defined on a contoured surface (e.g., such as having Fig.16A , Fig.17 , Fig.19 and Fig.19A The dome-shaped profile 262 of the transparent cover 100 of the distal head portions 341 and 34m in FIG. 1 ), the distal-most position 292 of the mouth 108 may be a single, such as in Fig.16A In the case where the distal-most position 292 is single, the axial position δ is defined as the distance between the distal end 114 of the laser fiber and the distal-most position 292 , the distance being parallel to the working port axis 111 .

[0135] In some embodiments, the positioning of the distal end 114 of the laser fiber optics 112 can be selected within a range including a plurality of axial positions δ. In some embodiments, the distal end 114 of the laser fiber 112 can be selectively positioned (i.e., is "selectively positionable") at an axial distance ranging from 1 mm (inclusive) distal to the distal-most position 292 to 3 mm (inclusive) proximal to the distal-most position 292. In some embodiments, the axial position δ ranges from a position flush with the distal-most position 292 to a position 1 mm proximal to the distal-most position 292 (inclusive). In some embodiments, the axial position δ ranges from a position proximal to the distal-most position 292 at a distance from the distal-most position 292 of 0.05 mm to 0.6 mm (inclusive).

[0136] The recess 147 for holding the imaging receptor 142 is formed on the base platform 288 and is arranged to face the distal side. In some embodiments, the distal side 98 and the base platform 288 define substantially parallel planes (as shown). In some embodiments, a shoulder 294 transitions between the outer tangential surface 97 of the distal end portion 96 and the base platform 288 at the tangential perimeter 216. Similarly, a shoulder 296 transitions between the tangential surface 298 of the extension portion 286 and the distal side 98. The shoulders 294, 296 can be, for example, curved (as shown), rounded, or beveled.

[0137] The pressure relief portion 192 extends axially from the distal surface 98 and radially passes through the extension portion 286 and the outer tangential surface 97. The pressure relief portion 192 can be one or more notches. The axial depth of the cross-sectional dimension of the notch can be from 0.1 mm to 1 mm (including 0.1 mm and 1 mm) and its tangential width can be from 0.2 mm to 0.5 mm (including 0.2 mm to 0.5 mm). Figures 10 to 15 The function of the pressure relief portion 192 is described.

[0138] refer to Figures 21 to 21C, depicting a distal head portion 34o according to an embodiment of the present disclosure. The distal head portion 34o includes many of the individual components and attributes of the distal head portion 34n, some of which are represented by the same numerical reference numerals. In addition, the distal head portion 34o includes a distal end working port 122b extending through the distal tip portion 96 and in fluid communication with the working channel 124 for flushing. The distal end working port 122b can be configured to guide the flushing flow 252 through the base platform 288 or the tangential surface 97 of the distal tip 96. The outlet of the distal end working port 122 can define an outlet angle φ along the distal direction 50 relative to the working port axis 111 for guiding the flushing flow 252. In some embodiments, the outlet angle φ is in the range of 0 degrees to 170 degrees (including 0 degrees and 170 degrees) relative to the distal direction along the central axis 110. In some embodiments, the outlet angle φ is in the range of 10 degrees to 70 degrees (inclusive). In some embodiments, the outlet angle φ is in the range of 20 degrees to 45 degrees (inclusive).

[0139] In some embodiments, laser parameters for processing with various disclosed embodiments herein are selected according to the following guidelines:

[0140] (1) Wavelengths in the range of 1.9 mm to 2.1 mm to match the water absorbance peaks of the primary initial chromophores used for body stone ablation.

[0141] (2) Limiting the pulse energy to prevent the stone pushback effect, thereby overcoming the suction effect and pushing the treated stone away from the opening of the suction working port 103. For this purpose, the laser pulse energy for stone pulverization can be as low as 0.001 joule to 0.2 joule. For stone fragmentation, the laser pulse energy can be in the range of 0.2 joule to 2 joule (including 0.2 joule and 2 joule).

[0142] (3) For simultaneous suction and irrigation applications, heat energy absorbed by the liquid medium in the body organ can be partially or completely discharged due to the suction. For a suction flow 254 ranging from 50 ml / min to 100 ml / min (inclusive) and an irrigation flow 252 ranging from 10 ml / min to 150 ml / min (inclusive), the average laser power delivered to the target area 56 by the ablation laser system 46 can be increased over conventional laser lithotripsy techniques without side effects. The maximum average power for ureteral applications can be as high as 30 watts to 50 watts (inclusive); for renal applications, the maximum average power can be 60 watts to 120 watts (inclusive); for bladder applications, the maximum average power can be as high as 200 watts (inclusive). These average powers represent a several-fold increase over conventional laser lithotripsy techniques without increasing the temperature of the liquid medium beyond critical levels for the ureter, kidney, or bladder. For example, conventional laser lithotripsy is typically limited to 10 to 30 watts for ureteral applications and 30 to 50 watts for renal applications. Thus, the proposed increase in average laser power represents a 1.5 to 2.5 times increase over conventional systems. An increase in average laser power (or pulse repetition rate for fixed laser pulse energy systems) provides a proportional increase in ablation rate.

[0143] Functionally, an endoscope system 30 implementing the distal head portion 34n operates in a manner similar to an endoscope system 30 utilizing the distal head portion 34a (i.e., wherein aspiration and irrigation occur sequentially using the working channel 102 as a common working channel 109). An endoscope system 30 implementing the distal head portion 34o operates in a manner similar to an endoscope system 30 (e.g., having the distal head 34b) in which aspiration and irrigation are simultaneously implemented. For both distal heads 34n and 34o, the maximum axial offset Δ between the imaging receptor 142 and the distal-most end 291 of the extension portion 286 enables the mouth 108 to be disposed within the viewing angle β of the imaging receptor 142. Being within the viewing angle β does not necessarily mean that the mouth can be visible through the visualization system 54, but only means that at least a portion of the mouth 108 falls within the viewing angle β of the imaging receptor 142. For the ostium 108 supported by an opaque structure (e.g., the extension 286 made of an opaque polymer or rubber), the ostium 108 may not be visible. In the case where the ostium 108 is obscured by the opaque structure, the target zone 56 is still largely visible, and the reaction of the body stone 58 or its fragments to the ablation process and the flow field 256 can be monitored. For embodiments where the ostium 108 is supported by a transparent or translucent medium (e.g., a transparent cover 100 of the distal head portion 34a to 34m), the ostium will be visible through the medium, which enables complete visualization of the ablation process.

[0144] Unlike conventional ureteroscopes, the distal side 98 of the disclosed distal head portion 34 is designed to be in contact or quasi-contact with the targeted stone 58 or fragment. For axial positions δ proximal to the mouth 108 and above about 0.2 mm from the mouth 108, the distal end 114 of the laser fiber optics 112 is not always in direct contact with the body stone 58 or stone fragment (even during the activation of suction). Although there is a lack of direct contact, laser energy can be effectively transmitted to the stone 58 in the liquid medium environment and through a distance of up to about 3 mm. By operating the laser at a wavelength at or near the peak absorption rate of water, water first absorbs the laser energy to quickly form a steam channel between the distal end 114 of the laser fiber 112 and the stone material, thereby greatly reducing the attenuation of the laser energy. At the same time, the stone 58 or fragment can oscillate or rotate at the mouth 108, so that the surface of the stone 58 or fragment moves perpendicular to the axis of the laser fiber 112. Such oscillation and rotation increase the ablation rate. The phenomena and effects of vapor channeling and laser fiber oscillation are described in further detail in International Patent Application No. PCT / US19 / 42491 to Altshuler et al., which is incorporated by reference above.

[0145] The reduced flange 290 is used to prevent blockage of the working channel 102 and the working port 103. During aspiration, some of the debris generated during ablation will have a size equal to or greater than the inner diameter of the working channel 102. The presence of the laser fiber 112 reduces the flow cross-section of the working channel 102, causing the debris to be embedded between the laser fiber 112 and the working channel 102. The reduced area of ​​the mouth 108 when defined by the reduced flange 290 is used to reduce the size of debris that can enter the working channel 102, thereby reducing the incidence of blockage.

[0146] Different exit angles φ of the distal head portion 34o are suitable for different operating modes. In the contact mode operation for ablating large stones and stone fragments, the irrigation stream 252 should be directed so as not to hit the larger stones or fragments. Therefore, the distal tip 96 with an exit angle φ defined in the range from 20 degrees to 170 degrees (including 20 degrees and 170 degrees) can be utilized. In the non-contact mode, the irrigation stream 252 keeps agitating the small fragments in the target area 56. Therefore, the distal tip 96 with an exit angle φ defined in the range from 20 degrees to 45 degrees (including 20 degrees and 45 degrees) can be utilized.

[0147] When the working channel 102 is operated in suction mode, attracting the fragments toward the working channel can partially or completely overcome the push-back effect in contact mode and accelerate the treatment of small fragments in non-contact mode. When the laser is operated in a powdering mode, the disclosed endoscope system 30 operates efficiently, wherein ablated particles smaller than the inner size of the working channel 102 can be discharged from the human body by suction to provide a stone-free treatment result. For example, an ultra-pulsed thulium fiber laser with a pulse energy from 0.02J to 1J can provide fragmentation and powdering ablation for particle sizes below 0.5 mm. If the laser fiber 112 has a core diameter in the range of 0.05 mm to 0.2 mm and an outer diameter below 0.4 mm, and the inner diameter of the working channel 102 is greater than 1 mm, particles with a size of less than 0.5 mm can be discharged through the working channel 102.

[0148] When performing a laser lithotripsy procedure, a suction flow 254 of about 200 ml per minute may be utilized. The suction typically creates a negative pressure within the kidney. Such a negative pressure should not deviate from the ambient pressure by more than 20%.

[0149] Operationally, the suction flow 254 and the flush flow 252 can be balanced to maintain a positive flush net flow. In some embodiments, the flush flow 252 exceeds the suction flow 254 by up to 50 ml / min. In some embodiments, the positive flush net flow is in the range of 100 ml / min to 30 ml / min (inclusive).

[0150] refer to FIG. 22A to FIG. 22D , depicting proposed elliptical cross-sections 164a to 164d for illumination fiber optics 132a to 132d according to embodiments of the present disclosure. The illumination fiber optics 132 and their corresponding elliptical cross-sections 164 are collectively or generally referred to herein by reference numerals 132 and 164, respectively, and specifically by reference numerals 132 and 164 followed by a letter suffix (e.g., illumination fiber optics 132a with elliptical cross-section 164a). Exemplary and non-limiting cross-sections 164 include: a generally rectangular shape with a semicircular end 272 ( Fig.22A The "oblong" cross-section 164a of the illumination fiber optic 132a); a generally rectangular shape with rounded corners 274 ( Fig. 22B of the illumination fiber optic 132b); a generally elliptical shape 276 ( Fig. 22Cand a plurality of or a bundle of illumination optical fibers 132d having a circular shape 278 that is combined to define a band (a cross-section 164d of the combined illumination optical fiber optics 132d). For the cross-section 164d, the bundle of illumination optical fibers 132d may be arranged such that the circular shape 278 is continuous along the tangential direction θ around the central axis of the catheter 32 at the distal head portion 34. In some embodiments, the bundle of illumination optical fibers 132d may be centered about a plane (as shown).

[0151] The irradiation fiber optic device 132 may also include a buffer layer 282 and a protective layer 284 ( Fig.22A In some embodiments, the buffer layer 282 is, for example, a FPL-9 layer having a thickness in the range of 10 μm to 20 μm (inclusive). In some embodiments, the protective layer 284 is, for example, a fluoropolymer having a thickness in the range of 20 μm to 50 μm (inclusive), such as blue TEFZELRRR. ® Although for Fig.22A The illumination fiber optic 132a depicts the coatings 282 and 284, but it should be understood that the coatings 282 and 284 can be combined with any illumination fiber optic 132, including FIG. 22B to FIG. 22D In some embodiments, the major axis dimension 166 of the laser fiber optic 132 is in the range of 0.2 mm to 2.0 mm, inclusive. In some embodiments, the minor axis dimension 168 is in the range of 0.1 mm to 1.0 mm, inclusive. In one embodiment, the major axis dimension 166 of the laser fiber optic 132 is 0.6 mm and the minor axis dimension is 0.2 mm. In some embodiments, the ratio of the major axis dimension to the minor axis dimension is in the range of between 2:1 and 5:1, inclusive.

[0152] Functionally, the elliptical cross section 164 of the illumination fiber optic 132 enables the cross-sectional dimensions of the catheter 32 and distal head portion 34d to be reduced relative to the distal head portion 34a. The elliptical cross section 164 can be arranged to provide a smaller profile in the radial direction while increasing the size (and stiffness) in the tangential direction. The protective layer 284 provides protection for the cladding 282 and provides lubricity to facilitate sliding of the illumination fiber optic 132 within the cavity 107 during steering operations. In some embodiments, the protective layer extends adjacent to the distal head portion 34 rather than through the distal head portion 34. For the illumination fiber optic 132d, the protective layer 284 can also hold the individual circular fiber optics together to bond together and stabilize the elliptical cross section 164d of the ribbon.

[0153] In addition to serving as an optical waveguide for transmitting visible light, each elliptical cross section 164 also provides enhanced stiffness along the major axis dimension 166 (i.e., along the tangential direction θ) of the illumination fiber optic 132, while enabling and facilitating bending of the elliptical cross section 164 along the minor axis dimension 168 (i.e., along a radial coordinate R perpendicular to the major axis dimension 166). Thus, the elliptical cross section 164 of the illumination fiber optic 132 provides torsional stiffness to the catheter 32 having a flexible shaft, thereby partially or completely eliminating the need for a torsional sleeve conventionally used in conventional flexible catheters.

[0154] Thus, the elimination of twist sleeves and pull wires and associated connectors can be achieved using the illumination fiber optics 132 defining an elliptical cross-section 164. As a result, the radial profile of the distal head portion 34d can be reduced to reduce invasiveness and enhance the safety of the laser lithotripsy procedure.

[0155] refer to Fig.23, depicts a steering handle 300 used as the handle 38 according to an embodiment of the present disclosure. For example, the steering handle 300 can be implemented for a flexible catheter shaft 33. The steering handle 300 is coupled to the catheter 32 and a pair of illumination fiber optics 132, and can be configured to apply force on the illumination fiber optics 132 for articulation of the distal head portion 34. In some embodiments, the steering mechanism 39 of the steering handle 300 includes a rotating cam 310 directly coupled to the illumination fiber optics 132. Exemplary embodiments of suitable steering handles are further described in U.S. Provisional Patent Application No. 62 / 868,271 filed on June 28, 2019 and U.S. Provisional Patent Application No. 62 / 868,105 filed on June 28, 2019, both of which are owned by the assignee of the present application and the contents of which are hereby incorporated herein by reference in their entirety (except for the explicit definitions and patent claims contained therein).

[0156] The illumination fiber optics 132 can be attached to the rotating cam 310, for example, with an adhesive 312 (as shown). The steering mechanism 39 can also include a shaft 316 about which the rotating cam 310 rotates. In some embodiments, the steering mechanism 39 includes a thumb lever 318 coupled to the rotating cam 310. In some embodiments, the illumination fiber optics 132 are routed from the illumination system 52 to the rotating cam 310, from the rotating cam 310 to a routing sheath 320, and from the routing sheath 320 to the distal head portion 34 via the catheter shaft 33. In some embodiments, the illumination system 52 includes a light emitting diode 322 as a visible light source. In some embodiments, the illumination system 52 is housed within the steering handle 38 and is powered by one or more batteries 324 (as shown).

[0157] refer to FIG. 24A to FIG. 24C , depicts a terminal 325 for securing the illumination fiber optics 132 to the distal head portion 34 according to an embodiment of the present disclosure. The terminal is collectively and generally referred to by the reference numeral 325, and individually and specifically referred to by the reference numeral 325 followed by an alphabetical suffix (e.g., "terminal 325a"). For terminal 325a ( Fig.24A ), a straight irradiated fiber optic 132 is routed into the fiber optic port 134 and bonded to the transparent cover 100 by a transparent or translucent bonding adhesive 327. In some embodiments, the buffer layer 282 is peeled off from the portion of the fiber optic inserted into the transparent cover 100.

[0158] For terminal 325b ( Fig. 24B ), a terminal joint 329 is formed at the distal end of the irradiation optical fiber 132. The terminal joint 329 is formed at the distal end of the irradiation optical fiber 132. Fig. 24B 100, but is more generally characterized as having a radial dimension greater than the radial dimension of the axis of the illumination fiber optic 132 and having rounded surfaces. The end header 329 is encapsulated within the fiber optic port 134 defined by the transparent cover 100 using a transparent or translucent bonding adhesive 327.

[0159] For terminal 325c ( Fig.24C ), again using a transparent or translucent bonding adhesive 327 to encapsulate the end header 329 within the fiber optics port formed only in the distal end portion 96 of the distal head portion 34. The transparent cover 100 extends over the distal end of the fiber optics port 134.

[0160] Functionally, the effect of stripping the buffer 282 is to enhance the redirection of the visible light 222, as discussed above. In the event that there may be a mismatch in the refractive index between the illumination fiber optics 132 and the bonding adhesive 327, the refraction of the visible light 222 through the rounded surface of the end cap 329 provides a greater beam divergence. The larger size of the end cap 329 relative to the size of the axis of the illumination fiber optics 132 also provides structural integrity for the fixation at the end connectors 325b and 325c.

[0161] In operation, when the rotating cam 310 is actuated in a first rotational direction 326 to articulate the distal head portion 34 in a first lateral direction, a first illumination fiber optic of the illumination fiber optics 132 is pulled in a tensioned state. When the rotating cam 310 is actuated in a second rotational direction 328 to articulate the distal head portion 34 in a second lateral direction, a second illumination fiber optic of the illumination fiber optics 132 is pulled in a tensioned state.

[0162] refer to FIG. 25A to FIG. 25D , presenting images 340 of the target zone 56 generated by the visualization system 54 for various configurations of the distal head portion 34j. These images 340 are collectively or generally referred to herein by the reference numeral 340, and individually or specifically by the reference numeral 340 followed by a letter suffix (e.g., image 430a). Fig.25A An image 340a of the target zone 56 is presented for the distal head portion 34j without the transparent cover 100 (ie, the axial cover thickness 99 is zero). The image 340a exhibits a dark shaded stripe 344 along the lower edge.

[0163] Image 340b (observed through an axial cap thickness of 99 of 1 mm Fig.25B ) reduces the dark shadow stripes 344 relative to the image 340a and exhibits a focused and illuminated region 346 that transitions between the focused and well-illuminated region 342 and the dark shadow stripes 344, thereby providing more uniform illumination relative to image 340a. Image 340c ( Fig.25C ) further reduces the dark shadow region 344. Image 340d ( Fig.25D ) provides a substantially uniformly illuminated image.

[0164] Image 340 shows that as the axial cap thickness 99 increases, the illumination light is spread out to more uniformly irradiate the target zone 56, as viewed through the visualization system 54. At some point, for greater axial cap thickness 99 and greater maximum axial offset Δ( Fig.16A and Fig.17 ), the spacing between the imaging receptor 142 and the distal surface 106 may cause unacceptable image darkening. Therefore, in some embodiments, the axial cover thickness 99 ranges from 1 mm to 10 mm (including 1 mm and 10 mm); in some embodiments, the axial cover thickness 99 ranges from 1.2 mm to 5 mm (including 1.2 mm and 5 mm).

[0165] For images 340b, 340c and 340d, the mouth 108 of the distal head portion 34j is within the field of view 148. Surprisingly, despite the presence of the extended structure ( Fig.10 and Fig.11 ), but the presence of the mouth 108 and the working port 103 leading to the mouth 108 introduces little or no distortion to the images 340b, 340c, and 340d. Other disclosed configurations of the transparent cover 100 having less structure than the distal head portion 34j may also introduce little or no distortion to the images.

[0166] In some embodiments, the previous operating method is provided as instructions on a tangible, non-transitory medium that is supplied to the catheter 32. Non-limiting examples of tangible, non-transitory media include paper documents and computer-readable media, including optical disks and magnetic storage devices (e.g., hard disks, flash drives, cartridge memories, floppy disk drives). The computer-readable medium can be local or accessible via the Internet. The instructions can be complete on a single medium, or distributed between two or more media. For example, some instructions can be written on a paper document, instructing a user to access one or more steps of the method via the Internet, while the Internet-accessible steps are stored on a computer-readable medium or media. The instructions can be in the form of text, graphics, and / or video presentations.

[0167] Example 1

[0168] according to Figures 13 to 15 In the embodiment shown, a prototype distal portion 35 of the catheter 32 is constructed with a transparent cover 100 made of quartz. The transparent cover 100 of this embodiment is attached to the distal tip of a conventional ureteroscope having an outer diameter of 3 mm at the distal tip and having an imaging receptor 142 and a working channel 102 having a size of 1×1 mm, the working channel 102 having an inner diameter of 1.2 mm and terminating in the same plane as the input of the imaging receptor 142. The outer diameter OD of the transparent cover 100 is 3 mm with an axial cover thickness 99 of 2 mm. The inner diameter of the cover working port 103a is 0.8 mm and has two notches 194, each 0.3 mm wide, extending to the outer tangential perimeter 170 of the distal face 106 to serve as a pressure relief portion 192. The illumination light is delivered through two illumination fiber optics 132 having a core diameter of 0.12 mm and a numerical aperture of 0.6, thereby delivering visible light from the LED at a power of no more than 0.1 watt. The laser fiber 112 used for stone ablation has a core diameter of 0.2 mm, an outer diameter of 0.38 mm, and a numerical aperture of 0.22. The distal end 114 of the laser fiber 112 is positioned completely within the working port 103a and is 0.2 mm proximal to the mouth 108. In the configuration of Example 1, the working channel 102 is used for suction and to deliver irrigation through the hollow portion 129 of the shaft 33 of a conventional ureteroscope, such as that provided with Figure 3B As described.

[0169] An ultra-pulsed thulium fiber laser (FiberLase U2, with a wavelength of 1940 nm and a peak power of 500 watts, manufactured by IPG Photonics, Oxford, Massachusetts, USA) was used to ablate the stones in all experiments, and the ultra-pulsed thulium fiber laser was operated at a pulse energy of 0.1 joule, a pulse repetition rate of 300 Hz, and an average power of 30 watts. As a body stone model, a model made of BEGOSTONE material (a generally accepted body stone model) was used. The treatment simulation was performed in a cuvette filled with water. Five model stones, each about 1.5 mm in diameter, were used for the simulation; the weight and time were measured accurately, but the size of the model stones was approximate.

[0170] A comparison was made between the configuration of Example 1 and a conventional configuration operating with a working channel 102 delivering an irrigation fluid. For the conventional configuration, the cover was removed so that the end of the catheter shaft was exposed. The laser fiber was positioned so that the distal tip extended 3.5 mm beyond the end of the shaft. For the configuration of Example 1, completion of treatment was defined as ablation of the stone sample into particles that were all expelled through the suction channel. For the conventional configuration, completion of treatment was defined as fragmentation of the stone sample into particles less than 0.5 mm (these particles were removed by a 10 ml / min suction flow at a distance of approximately 40 cm). The results are summarized in Table 1.

[0171] Table 1. Lithotripsy efficiency of conventional configurations relative to disclosed configurations

[0172]

[0173] As can be seen from Table 1, compared with the conventional configuration, the configuration of Example 1 increases the lithotripsy efficiency by more than 4 times in the contact mode and by more than 3.5 times in the non-contact mode without increasing the laser power.

[0174] Each of the additional figures and methods disclosed herein may be used separately, or in combination with other features and methods, to provide improved devices and methods for making and using them. Therefore, the combination of features and methods disclosed herein may not be necessary to practice the present disclosure in its broad sense, and instead, are disclosed only to particularly describe representative and preferred embodiments.

[0175] Various modifications to the embodiments may be apparent to those skilled in the art after reading this disclosure. For example, one of ordinary skill in the relevant art will recognize that the various features described for different embodiments may be appropriately combined, uncombined, and recombined with other features in a separate manner or in different combinations. Likewise, the various features described above are all to be considered exemplary embodiments, and do not limit the scope or spirit of this disclosure.

[0176] Those skilled in the relevant art will recognize that multiple embodiments may include fewer features than illustrated in any single embodiment described above. The embodiments described herein are not intended to be an exhaustive presentation of the ways in which the various features may be combined. Therefore, the embodiments are not mutually exclusive combinations of features; rather, the claims may include combinations of different individual features selected from different individual embodiments, as understood by those skilled in the art.

[0177] The following references are hereby incorporated by reference in their entirety, except for the patent claims and explicit definitions contained therein: International Application No. PCT / US19 / 42491, filed on July 18, 2019, by Altshuler et al., and owned by the owner of the present application; U.S. Patent Application No. 9,775,675, by Irby, III. Any document incorporated herein by reference is limited so as not to incorporate subject matter that is contrary to the explicit disclosure herein.

[0178] Unless otherwise indicated, references to "embodiments," "disclosure," "present disclosure," "embodiments of the present disclosure," "disclosed embodiments," etc. contained herein refer to the specification (text, including claims and drawings) of this patent application that is not admitted to be prior art.

[0179] For purposes of claim interpretation, it is expressly intended that the provisions of 35 USC 112(f) shall not be invoked unless the specific terms "means for" or "step for" are recited in the corresponding claim.

Claims

1. A laser lithotripsy endoscope, comprising: a flexible catheter extending along an axis from a proximal portion to a distal portion; an irrigation channel formed longitudinally in the catheter from the proximal portion to a plurality of irrigation outlets proximate the distal portion of the catheter; a working channel formed longitudinally in the catheter from the proximal portion to an aspiration opening on the distal portion of the catheter; a transparent tip having an outer surface extending the working channel from the distal portion of the catheter to a distal surface of the tip; a mouth formed by an edge of the distal surface of the transparent tip for drawing body stones toward the suction opening without eliminating suction; a laser fiber having a distal end extending through the working channel to a location between the distal portion of the catheter and the mouth to break up bodily stones into fragments small enough to be drawn through the working channel; and An imager is disposed proximate the distal portion of the catheter and is configured with a viewing angle through the outer surface of the transparent tip to position the laser fiber to break up bodily stones in the mouth.

2. The laser lithotripsy endoscope according to claim 1, wherein: The imager is configured such that the mouth and the distal end of the laser fiber are at least partially located within the field of view of the imager.

3. The laser lithotripsy endoscope according to claim 2, wherein: The mouth is positioned distally from the imager.

4. The laser lithotripsy endoscope according to claim 1, further comprising: A handle is coupled to the proximal portion of the catheter and is configured to adjust a position of the distal end of the laser fiber.

5. The laser lithotripsy endoscope according to claim 4, wherein: The handle includes a clamp configured to position the distal end of the laser fiber.

6. The laser lithotripsy endoscope according to claim 1, further comprising: A handle is configured to articulate the distal portion of the flexible catheter.

7. The laser lithotripsy endoscope according to claim 1, wherein: The irrigation channel is formed by an inner hollow portion of the catheter excluding the working channel.

8. The laser lithotripsy endoscope according to claim 7, wherein: The plurality of irrigation outlets direct irrigation flow at an angle (α) relative to the axis of the catheter.

9. The laser lithotripsy endoscope according to claim 1, wherein: The transparent tip defines a pressure relief portion extending from the mouth.

10. The laser lithotripsy endoscope according to claim 1, wherein: The transparent tip has a circular cross-section.

11. A method of laser lithotripsy endoscopic surgery, the method comprising: A laser lithotripsy endoscope is provided, the laser lithotripsy endoscope comprising: a flexible catheter extending along an axis from a proximal portion to a distal portion; an irrigation channel formed longitudinally in the catheter from the proximal portion to a plurality of irrigation outlets proximate the distal portion of the catheter; a working channel formed longitudinally in the catheter from the proximal portion to an aspiration opening on the distal portion of the catheter; a transparent tip having an outer surface extending the working channel from the distal portion of the catheter to a distal surface of the tip; a mouth formed by an edge of the distal surface of the transparent tip for drawing body stones toward the suction opening without eliminating suction; a laser fiber having a distal end extending through the working channel to a location between the distal portion and the port of the catheter; and an imager disposed proximate the distal portion of the catheter and configured with a viewing angle through the outer surface of the transparent tip to position the laser fiber to break up body stones in the mouth; inserting the laser lithotripsy endoscope into a patient's body; positioning the mouth so that the mouth is in contact or quasi-contact with the body stone or a fragment of the body stone; ablating the body stone using laser energy emitted by the laser fiber; and Ablation products are removed through the aspiration opening of the working channel.

12. The method according to claim 11, wherein: Ablation of the body stone and removal of the ablation products are performed simultaneously.

13. The method according to claim 11, further comprising: The position of the distal end of the laser fiber is adjusted using a handle coupled to the proximal portion of the catheter.

14. The method according to claim 11, further comprising: The laser lithotripsy endoscope is connected to a suction source for irrigation, wherein the irrigation stream draws the body stone or fragments of the body stone toward the mouth.

15. The method according to claim 14, further comprising: The heated irrigation fluid is removed from the treatment area by drawing the heated irrigation fluid through the working channel.

16. The method according to claim 11, further comprising: connecting the laser lithotripsy endoscope to a source of irrigation fluid; and Irrigation fluid is passed through the plurality of irrigation outlets such that a flow of the irrigation fluid is directed in a radial direction r to create a flow field causing the irrigation fluid to flow radially outward along a vector while a suction flow draws fluid into the stoma.

17. The method according to claim 11, wherein: The laser lithotripsy endoscope is arranged such that the imager is configured such that the mouth and the distal end of the laser optical fiber are at least partially located within the field of view of the imager.

18. The method according to claim 11, wherein: The laser lithotripsy endoscope is configured such that the wavelength of the laser energy emitted by the laser fiber matches a water absorption peak.

19. The method according to claim 11, wherein: The laser lithotripsy endoscope is configured such that the irrigation channel is formed by an inner hollow portion of the catheter excluding the working channel, and the plurality of irrigation outlets direct irrigation flow at an angle (α) relative to the axis of the catheter.

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