Efficient multifunctional endoscopic instruments

Abstract

To provide endoscopic surgical instruments and methods that mitigate certain shortcomings of conventional ureteroscopy while decreasing the treatment time, providing a higher probability of elimination of stone, and increasing the safety of the treatment.SOLUTION: An instrument for endoscopic applications, including urology, may include both irrigation and aspiration channels, effective attraction and suction of tissue and body stone fragments, enhanced viewing clarity of an operational area, and illumination fibers with a steering function for a flexible version of scopes. A distal head is configured to locate a mouth of a working channel within a viewing angle of a visualization system. A transparent cap is disposed at a distal end of endoscope to provide an enhanced view of the operational area. The irrigation and aspiration channels may be arranged such that a consistent water flow attracts tissue and body stone particles and remove heated liquid.SELECTED DRAWING: Figure 15

Description

[Technical Field]

[0001] Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 62 / 794,328, filed January 18, 2019, the disclosure of which is incorporated herein by reference in its entirety.

[0002] This application is directed generally to endoscopic devices and methods, and more particularly to flexible, semi-rigid, and rigid laser endoscopes for the laser treatment of stones and tissue in humans and animals. [Background technology]

[0003] Kidney stones affect 1 in 500 Americans each year, causing significant pain and medical expenses. 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 habits all play major roles in determining outcomes and surgical approaches.

[0004] The role of ureteroscopy has increased over the past decade due to advances in lithotripsy (stone destruction) with reduced diameter flexible catheter shafts, enhanced steering and deflection capabilities, improved video imaging, smaller baskets and instruments, and the advent of holmium (Ho) and thulium (Tm) lasers. More than 45% of all kidney stone surgeries in the United States are now performed using miniature ureteroscope techniques and lasers.

[0005] Ureteroscopy involves the direct visualization and treatment of kidney stones using a small, flexible or rigid instrument called a ureteroscope. The ureteroscope, which provides video imaging 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 destroyed with laser energy delivered to the target site via an optical fiber (laser fiber) and / or extracted using a small basket. The advantage of this type of surgery is that a body orifice is used for access; no incision is required.

[0006] Ureteroscopic surgery is often a good option for small kidney stones in the ureter or kidney. The success rate for ureteroscopy to remove smaller kidney stones is generally higher than that for shock wave lithotripsy. Laser ureteroscopy uses purpose-optimized laser settings to break up kidney stones into small particles with maximum dimensions of less than 1 millimeter or even less than 0.25 millimeters. In this case, the ablation products can be removed by irrigation or by natural outflow from the kidney to the bladder after surgery, providing a stone-free outcome.

[0007] However, ureteroscopy is not always successful with very large kidney stones (e.g., larger than 20 mm) because their large size requires long treatment times and can be difficult to remove. Furthermore, medium-sized stones or fragments (e.g., 1 to 5 mm in maximum dimensions) can be difficult to treat with lasers using contact techniques. For example, ureteroscopes operating in contact mode can experience a strong repulsion effect, which necessitates non-contact operation (e.g., "popcorning"), which is time-consuming and does not guarantee a stone-free outcome. As a result, ureteroscopy is not always successful with very large kidney stones because their large size requires long treatment times and can be difficult to remove. In such cases, a percutaneous approach may be the best available option. Devices and accompanying technologies that mitigate or resolve these drawbacks of ureteroscopy would be welcome. [Prior art documents] [Patent documents]

[0008] [Patent Document 1] U.S. Patent No. 9,775,675 [Patent Document 2] International Application No. PCT / US19 / 42491 [Patent Document 3] U.S. Provisional Patent Application No. 62 / 868271 [Patent Document 4] U.S. Provisional Patent Application No. 62 / 868105 Summary of the Invention [Problem to be solved by the invention]

[0009] Various embodiments of the present disclosure present endoscopic surgical instruments and methods that mitigate some of the drawbacks of traditional ureteroscopy while reducing treatment time, increasing the probability of stone-free outcomes, and increasing treatment safety. [Means for solving the problem]

[0010] 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 optical fibers and other instruments and to deliver irrigation flow. Some conventional ureteroscopes utilize an imaging assembly input face that is essentially in the same plane as, or very close to, the distal opening of the working channel. Other conventional ureteroscopes position the distal opening of the working channel behind the plane of the imaging assembly input face. See, for example, U.S. Patent No. 6,249,999 to Irby, III ("Irby"), the disclosure of which is incorporated herein by reference except for the claims and express definitions contained therein. Irby teaches that terminating the working channel behind the distal face is beneficial to reduce the distal head catheter shaft diameter. Conventional ureteroscopes typically define a viewing angle that is ±45 degrees from the catheter axis. Therefore, conventional ureteroscopes do not include an entrance to the working channel within the viewing angle of the imaging assembly. This can impair functional visualization of the target zone.

[0011] Furthermore, successful laser ablation treatment of intracorporeal stones requires contact or near-contact between the laser fiber and the stone. In conventional laser ureteroscopes, such contact requires the operator to extend the distal tip of the laser fiber beyond the distal end of the catheter (typically 2 to 6 mm) to allow the operator to see and control the precise 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 viewing angle and working distance of the imaging optics. Another important reason for extending and visualizing the fiber is to prevent soft tissue (mucosa) damage due to accidental ablation. Such ablation and perforation of the ureter or kidney can lead to the need for open surgical intervention. A clear image of the distal tip of the laser fiber and the soft tissue surface can prevent accidental soft tissue ablation.

[0012] Various embodiments of the present disclosure are configured so that the opening of the working channel is within the viewing angle of the visualization system. In some embodiments, a transparent cap is used to provide a line of sight between the imaging receiver and the distal end of the laser fiber, enhancing the view of the operating area. The presence of the transparent cap also allows for the line of sight to be unobstructed by debris generated during the ablation process.

[0013] Conventional methods of laser lithotripsy involve delivering laser radiation through a laser fiber to ablate stones into very small particles ("dust") or fragments. Ablation can be performed in contact or quasi-contact mode, or in non-contact ("popcorning") mode. Non-contact techniques are typically used to treat medium-sized and small stone fragments (typically less than 3 to 5 mm in size) during conventional ureteroscopy, unless repulsion prevents effective operation in contact or quasi-contact mode. In non-contact techniques, the distal end of the laser fiber is positioned in a fixed target zone near the stone or fragment, and the laser is activated without contact between the laser fiber and the stone or fragment. Vaporization and bubble implosion, as well as irrigation of the target zone, induce a flow of liquid medium (primarily water) within the target zone, which in turn agitates the small stone fragments. Non-contact techniques rely on the fragments or stones coming within the effective range of the laser radiation within the fixed target zone for further ablation and fragmentation.

[0014] Consider the limitations and effects of this conventional approach. Laser power is limited to a relatively low level to prevent overheating of the target zone and a strong repulsion effect. In contact mode, the repulsion effect, especially for medium-sized stones or fragments, requires additional non-lasing time to track or "track" the target, further lengthening the total treatment time. Tracking each and every such fragment is difficult and time-consuming. Non-contact mode is inefficient because actual ablation occurs only when an agitated stone or fragment happens to be within the effective laser pulse range of the distal tip of the fiber. Such "effective ablation" time intervals typically account for only 10%–30% of the total lasing time in non-contact mode. A stone-free outcome, the clinical goal of treatment, is difficult to guarantee because some small fragments migrate out of the treatment zone due to agitation. These limitations and effects of conventional laser lithotripsy increase the total treatment time and pose safety risks due to the risk of overheating the liquid medium in the target zone.

[0015] Various embodiments of the present disclosure enable shorter treatment times for laser lithotripsy because the stones are attracted to the laser fiber, reducing the need to "track" the stones within the treatment organ. The stones and fragments are drawn (aspirated) toward the opening of the aspiration channel and the distal end of the ablation laser fiber, improving the efficiency of breaking up the stones. The size, shape, and / or location of the irrigation outlet relative to the opening can be configured to provide a flow field that enhances particle entrainment in the flow field that draws the stones and products of ablation into the opening of the aspiration channel. Furthermore, in some embodiments, the irrigation flow can be adjusted relative to the aspiration flow to provide such a flow field continuously during the ablation treatment. To enhance monitoring of the ablation, the opening of the aspiration channel can be positioned distal to the imaging receiver of the visualization system.

[0016] Additionally, collateral heat generated by the laser ablation process can be efficiently dissipated by the irrigation fluid and removed by suction of the heated irrigation fluid, thereby reducing the risk of accidental thermal damage to surrounding tissue. Efficient dissipation of heat from the treatment zone also allows for increased laser power without increased risk of burns to surrounding soft tissue.

[0017] Conventional flexible and semi-rigid endoscopes also include metal pull wires to impart a bending angle at the distal tip of the endoscope. The wires are attached to the distal tip and routed through the catheter to the steering mechanism. The wires have a footprint that occupies a portion of the catheter's cross-section. Furthermore, a rigid connection to the distal tip requires a connector at the distal end of the catheter, which also occupies cross-sectional space. Steered catheters also often require a torsion sleeve so that shaft rotation at the proximal end of the catheter is translated into rotation at the distal tip. The torsion sleeve also occupies a cross-sectional footprint. These aspects of the steering and aiming system require an increase in the overall cross-sectional area of ​​the catheter, particularly at the distal tip. The typical diameter of a conventional ureteroscope is in the 3 to 4 mm range. Further reduction of the diameter to the 1.7 to 2.5 mm range can be achieved by eliminating some functional elements, such as steering components, as disclosed by Irby.

[0018] Various embodiments of the present disclosure present a distal head with a more compact radial cross-section than conventional endoscopes by eliminating the need for pull wires and twisting sleeves. Using an illumination fiber for steering increases the cross-sectional space in the scope, particularly in the distal section, allowing for the use of both irrigation and aspiration channels within a common catheter shaft. In some embodiments, the illumination fiber is utilized not only to "pull" the distal section of the catheter but also to "push" the distal section, thereby providing bidirectional steering with a single illumination fiber. This allows for all catheter functions—illumination, imaging, irrigation, aspiration, and ablation—within a cross-sectional dimension ranging from 2 to 2.5 millimeters, inclusive. Cross-sectional dimensions within this range may allow for ureteroscopic removal of intracorporeal stones without subjecting the patient to general anesthesia, as discussed by Irby.

[0019] Structurally, various embodiments of the present disclosure disclose an endoscopic surgical instrument including a catheter shaft defining a central axis extending along the central axis and including a proximal portion and a distal portion, wherein a distal head portion is disposed on the distal portion of the catheter shaft, the distal head portion including a distal surface, a working channel extending within the catheter shaft from the proximal portion through the distal head portion, the distal head portion defining an opening at the distal surface, the working channel configured to receive a laser fiber. An illuminator can be disposed on the distal head portion, and an imaging receiver is disposed on the distal head portion, the imaging receiver being disposed a predetermined axial distance proximal to the distal-most end of the distal surface, the axial distance being within a range of 1 millimeter to 10 millimeters, inclusive. In some embodiments, the opening is at least partially within the field of view of the imaging receiver.

[0020] In some embodiments, the working channel is defined by and integral with the catheter shaft. A laser fiber can be included for insertion into the working channel. In some embodiments, the catheter shaft includes a shaft cross-section perpendicular to a central axis of the catheter shaft that defines an oval shape, the shaft cross-section defining a major axis passing through the largest dimension of the oval shape and a minor axis perpendicular to the major axis. In some embodiments, the largest dimension of the shaft cross-section is in the range of 2.2 millimeters to 2.5 millimeters, inclusive. In some embodiments, the smallest dimension of the shaft cross-section is in the range of 1.7 millimeters to 2.0 millimeters, inclusive. The oval shape can be elliptical.

[0021] The distal head portion can include a distal tip portion that contacts the distal portion of the catheter shaft, and the imaging receiver is mounted at the distal tip. In some embodiments, the distal tip portion includes a distal face. The distal tip portion can be integral with the catheter shaft. In some embodiments, the distal head portion includes a transparent medium secured distally to the distal tip portion, and the transparent medium includes a distal face. The opening is at least partially visible through the transparent medium via the imaging receiver. In some embodiments, the working channel is a suction channel.

[0022] In some embodiments of the present disclosure, the irrigation channel is in fluid communication with the outlet, the outlet being defined by the distal head. The irrigation channel can be defined by an internal cavity of the catheter shaft, excluding the suction channel, the internal cavity extending from a proximal portion of the catheter shaft to a distal portion of the catheter shaft. In some embodiments, the outlet of the irrigation channel is configured at a predetermined outlet angle relative to a distal direction along the central axis. The distal head portion includes a distal tip portion that contacts the distal portion of the catheter shaft, the outlet being defined by the distal tip portion. In some embodiments, the predetermined outlet angle is in the range of 0 degrees to 170 degrees, inclusive. In some embodiments, the predetermined outlet angle is in the range of 10 degrees to 70 degrees, inclusive. In some embodiments, the predetermined outlet angle is in the range of 20 degrees to 45 degrees, inclusive.

[0023] The distal head portion can include a distal tip portion that contacts the distal portion of the catheter shaft and a transparent medium secured distally to the distal tip portion, with the outlet defined by the distal tip portion and configured to direct irrigation flow onto a proximal surface of the transparent medium. In some embodiments, the distal end of the laser fiber is selectively positionable over a predetermined range of axial positions relative to the distal-most location of the opening. In some embodiments, the predetermined range of axial positions is no more than 1 millimeter distal to the distal-most location of the opening and no more than 3 millimeters proximal to the distal-most location. In some embodiments, the predetermined range of axial positions is from level with the distal-most location of the opening to no more than 1 millimeter proximal to the distal-most end. In some embodiments, the range of axial positions is no more than 0.1 millimeter distal to the distal-most location of the distal tip and no more than 0.6 millimeters proximal to the distal-most end. In some embodiments, the illuminator is an optical fiber, and the optical fiber is secured to the distal head portion. The catheter shaft can be flexible with a proximal portion of the catheter shaft coupled to a handle, and the handle includes a steering mechanism coupled to the distal head portion via an optical fiber for manipulating the distal head portion.

[0024] In various embodiments of the present disclosure, a surgical instrument is disclosed that includes a catheter including a flexible catheter shaft coupled to a distal head, a first optical fiber extending through the catheter into the distal head, the first optical fiber secured to the distal head, and a steering handle coupled to the catheter and the optical fiber, the steering handle configured to apply a force to the first optical fiber to articulate the distal head. The first optical fiber can be secured to the distal head with an adhesive. In some embodiments, the first optical fiber defines an oval cross-section defining a major dimension and a minor dimension, the major dimension being the largest dimension of the oval cross-section, the minor dimension being smaller than the major dimension and perpendicular to the major dimension at a central axis of the catheter.

[0025] In some embodiments, the surgical instrument includes a second optical fiber extending through the catheter 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 within the distal head at diametrically opposed locations proximate the outer radial dimension of the distal head and proximate the outer radial surface of the distal head around the central axis of the catheter. In some embodiments, the first optical fiber is one of a first bundle of optical fibers, and the second optical fiber is one of a second bundle of optical fibers. Each of the first bundle of optical fibers and the second bundle of optical fibers can be sequentially arranged tangentially around the central axis of the catheter at the distal head. Each of the first bundle of optical fibers and the second bundle of optical fibers can be concentrated around a respective plane at the distal head. In some embodiments, the first optical fiber and the second optical fiber each define an elliptical cross-section defining a major dimension and a minor dimension, the major dimension being the largest dimension of the elliptical cross-section, the minor dimension being smaller than the major dimension and perpendicular to the major dimension at the central axis of the catheter. The major dimension can range from 0.2 millimeters to 2.0 millimeters, inclusive. The minor dimension can range from 0.1 millimeters to 1.0 millimeters, inclusive. In some embodiments, the ratio of the major dimension to the minor dimension is in the range of 2:1 and 5:1, inclusive.

[0026] In some embodiments of the present disclosure, the steering handle includes a rotating cam directly coupled to a first optical fiber and a second optical fiber. In some embodiments, the first optical fiber is pulled under tension when the rotating cam is actuated in a first rotational direction to articulate the distal head in a first lateral direction, and the second optical fiber is pulled under tension when the rotating cam is actuated in a second rotational direction to articulate the distal head in a second lateral direction. The second rotational direction can be opposite the first rotational direction, and the second lateral direction can be opposite the first lateral direction. In some embodiments, the first optical fiber and the second optical fiber are bonded to the rotating cam. The rotating cam is coupled to a rotatable shaft and can be coupled to a thumb lever.

[0027] The first optical fiber and the second optical fiber can be operably coupled to the illumination source and are 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 within the steering handle. In some embodiments, the transparent medium defines a pressure relief portion extending from the opening. 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 face. In some embodiments, a pressure sensor is operably coupled to the working channel. The optical fiber is configured to deliver visible light to a target zone distal to the distal head.

[0028] In various embodiments of the present disclosure, an endoscopic surgical instrument for removing intracorporeal stones from an internal organ is disclosed, comprising a catheter shaft defining a central axis extending along the central axis and having a proximal portion coupled to a handle, a distal tip portion coupled to the distal portion of the catheter shaft, a transparent medium coupled to the distal tip portion and including a distal surface, a working channel extending through the catheter shaft and the transparent medium from the proximal portion of the catheter shaft through the distal surface of the transparent medium, the working channel defining an opening. An illuminator can be disposed at the distal tip, and an imaging receiver is disposed proximal to the distal tip relative to the transparent medium. The distal surface of the transparent medium can comprise the distal end of the working channel, which is disposed an axial distance ranging from 1 millimeter to 10 millimeters, inclusive, from the imaging receiver. In some embodiments, the distal end of the working channel is disposed an axial distance ranging from 1.2 millimeters to 5 millimeters, inclusive, from the imaging receiver.

[0029] In some embodiments of the present disclosure, the irrigation channel defines at least one outlet at the distal tip to direct irrigation flow at an angle relative to the central axis that is within the range of 0 degrees to 170 degrees, inclusive. In some embodiments, the angle is within the range of 10 degrees to 70 degrees, inclusive. In some embodiments, the angle is within the range of 20 degrees to 45 degrees, inclusive.

[0030] 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 positionable at an axial position ranging from 1 millimeter distal to the distal-most location of the opening, inclusive, to 3 millimeters proximal to the distal face. In some embodiments, the axial position ranges from flush with the distal face, inclusive, to 1 millimeter proximal to the distal face. In some embodiments, the axial position ranges from 0.1 millimeter to 0.6 millimeters proximal to the distal face, inclusive. The cross-sectional area of ​​the distal end of the working channel can be 5% to 50% smaller than the cross-sectional area of ​​the working channel in the remainder of the catheter shaft.

[0031] In some embodiments, the transparent medium defines a pressure relief portion extending from the opening. The pressure relief portion can extend radially to the outer periphery of the transparent medium. In some embodiments, the pressure relief portion extends radially to the outer periphery of the distal face. A pressure sensor can be operably coupled to the working channel. In some embodiments, the working channel is defined by and integral with the catheter shaft.

[0032] In various embodiments of the present disclosure, a method for removing internal stone material from an internal organ is disclosed, comprising the steps of: positioning a distal tip of a catheter assembly proximate to internal stone material contained within the internal organ, the distal tip including a distal surface defining an opening of a working channel of the catheter assembly, the internal stone material being distal to the opening; and, while the distal tip is proximate to the internal stone material, positioning an imaging receiver proximal to the distal tip at a predetermined separation distance between the opening and the imaging receiver, the separation distance being in the range of 1 millimeter to 10 millimeters, inclusive. In some embodiments, the separation distance during the step of positioning the imaging receiver is in the range of 1.2 millimeters to 5 millimeters. Some embodiments include illuminating a target zone surrounding the stone material with visible light. Some embodiments include acquiring an image of the target stone and the target zone using the imaging receiver. Some embodiments include positioning a laser fiber within the working channel, the distal end of the laser fiber being proximate to the opening. Some embodiments include selectively positioning the distal end of the laser fiber within a distance that is no more than 3 millimeters proximal to the distal-most location of the opening and no more than 1 millimeter distal to the distal-most location of the opening, the range of distances being parallel to the axis of the working channel at the opening.Some embodiments include selectively positioning the distal end of the laser fiber within a distance that is no more than 1 millimeter proximal to the opening, the range of distances being parallel to the axis of the working channel at the opening.

[0033] Some embodiments include selectively positioning the distal end of the laser fiber within a distance range that is 0.6 millimeters or less proximal to the opening and 0.1 millimeters or more proximal to the opening, the distance range being parallel to the axis of the working channel at the opening. Some embodiments include ablating intracorporeal stone material using the laser fiber. The average laser power delivered by the laser fiber during this method can range from 120 watts to 200 watts, inclusive. Some embodiments include operating the working channel as a suction channel and removing ablation products through the working channel. Some embodiments include delivering irrigation fluid through the distal tip of the catheter. Some embodiments of the present disclosure include delivering the irrigation fluid flow at a direction angle ranging from 0 degrees to 170 degrees, inclusive, relative to a distal direction along a central axis of the distal tip. Some embodiments include delivering the irrigation fluid flow at a direction angle ranging from 10 degrees to 70 degrees, inclusive, relative to a distal direction along a central axis of the distal tip. Some embodiments include delivering the flow of irrigation fluid at a directed angle that is within a range of 20 degrees to 45 degrees relative to a distal direction along a central axis of the distal tip. During this method, the working channel can be an aspiration channel.

[0034] In various embodiments of the present disclosure, a method for removing internal stone material from an internal organ is disclosed, comprising: providing a catheter assembly; and providing, on a non-transitory, tangible medium, operational instructions for the catheter assembly, the operational instructions including positioning a distal tip of the catheter assembly in proximity to internal stone material contained within the internal organ, the distal tip including a distal surface defining an opening of a working channel of the catheter assembly, the internal stone material being distal to the opening; and positioning an imaging receiver proximal to the distal tip, wherein a separation distance between the opening and the imaging receiver while the distal tip is in proximity to the internal stone material is in the range of 1 millimeter to 10 millimeters, inclusive. The operational instructions may include illuminating a target zone surrounding the stone material with visible light, acquiring an image of the target stone and the target zone using the imaging receiver, and positioning a laser fiber within the working channel such that a distal end of the laser fiber is in proximity to the opening. In some embodiments, the operating instructions include selectively positioning the distal end of the laser fiber within a distance range that is no more than 3 millimeters proximal to the distal-most location of the opening and no more than 1 millimeter distal to the distal-most location of the opening, the range of distances being parallel to the axis of the working channel at the opening. In some embodiments, the operating instructions include selectively positioning the distal end of the laser fiber within a distance range that is flush with the opening and no more than 1 millimeter proximal to the opening, the range of distances being parallel to the axis of the working channel at the opening. In some embodiments, the operating instructions include selectively positioning the distal end of the laser fiber within a distance range that is no more than 0.6 millimeters proximal to the opening and no more than 0.1 millimeter proximal to the opening, the range of distances being parallel to the axis of the working channel at the opening. The operating instructions can include ablating intracorporeal stone material using the laser fiber, and can 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 delivering irrigation fluid through the distal tip of the catheter. In some embodiments, the operating instructions include operating the catheter assembly to deliver a flow of irrigation fluid at a direction angle ranging from 0 degrees to 170 degrees, inclusive, relative to a distal direction along a central axis of the distal tip. In some embodiments, the operating instructions include operating the catheter assembly to deliver a flow of irrigation fluid at a direction angle ranging from 10 degrees to 70 degrees, inclusive, relative to a distal direction along a central axis of the distal tip. In some embodiments, the operating instructions include operating the catheter assembly to deliver a flow of irrigation fluid at a direction angle ranging from 20 degrees to 45 degrees, inclusive, relative to a distal direction along a central axis of the distal tip. In some embodiments, the operating instructions include operating the working channel as an aspiration channel.

[0035] Various embodiments of the present disclosure include a method for removing intracorporeal stone material from an internal organ, comprising the steps of inserting an endoscopic surgical instrument including a catheter shaft defining and extending therealong, the catheter shaft including a proximal portion coupled to a handle and a distal tip portion at a distal end, the catheter shaft including an aspiration channel extending from the proximal portion to the distal tip portion, and an imaging receiver disposed at the distal tip, the imaging receiver being positioned axially at a location ranging from 1 millimeter to 10 millimeters, inclusive, from a distal surface of the distal tip portion, at least one illuminator disposed at the distal tip, and a laser fiber disposed in the aspiration channel, the distal end of the laser fiber being axially spaced 1 millimeter from the distal surface of the distal tip. the catheter shaft is extendable to a distance ranging from distal to 3 millimeters proximal to the distal face, with irrigation channels defined by internal gaps extending along the length of the catheter shaft, the irrigation channels having outlets at the distal tip configured to direct irrigation flow at angles relative to the central axis ranging from 0 degrees to 170 degrees, inclusive; acquiring images of the target stone and surrounding area; positioning the distal face proximate to the intracorporeal stone material; activating irrigation flow through the irrigation channels; activating aspiration flow through the aspiration channels to remove products of ablation through the aspiration channels; and activating a laser coupled to the laser fiber to ablate the targeted stone material. [Brief explanation of the drawings]

[0036] [Figure 1] FIG. 1 is a schematic diagram of an endoscopic system for laser lithotripsy according to one embodiment of the present disclosure. [Figure 2] FIG. 2 is an end view of a distal head portion for the endoscopic system of FIG. 1 that can be configured for a common irrigation and suction port according to an embodiment of the present disclosure. [Figure 2A] FIG. 3 is a cross-sectional view of the distal head portion of FIG. 2 taken along plane IIA-IIA according to one embodiment of the present disclosure. [Figure 3]FIG. 2 is an end view of a distal head portion for the endoscopic system of FIG. 1 that can be configured for separate irrigation and suction ports according to an embodiment of the present disclosure. [Figure 3A] FIG. 6 is a cross-sectional view of the distal head portion of FIGS. 3, 4, and 5 taken along plane III-III according to one embodiment of the present disclosure. [Figure 3B] FIG. 6 is a cross-sectional view of the distal head portion of FIGS. 3, 4, and 5 taken along plane III-III according to one embodiment of the present disclosure. [Figure 3C] FIG. 3C is a cross-sectional view of a catheter taken along plane IIIC-IIIC of FIG. 3B according to an embodiment of the present disclosure. [Figure 4] 2 is an end view of a distal head portion for the endoscope of FIG. 1 having an illumination optical fiber entering an extended irrigation port in the distal head portion in accordance with an embodiment of the present disclosure. FIG. [Figure 5] FIG. 2 is an end view of a distal head portion for the endoscopic system of FIG. 1 having irrigation ports around the outer tangential periphery of the transparent cap of the distal head portion according to one embodiment of the present disclosure. [Figure 6] FIG. 2 is an end view of a distal head portion for the endoscopic system of FIG. 1 configured for irrigation ports flush with the suction ports according to one embodiment of the present disclosure. [Figure 7] FIG. 2 is an end view of a distal head portion for the endoscopic system of FIG. 1 configured for irrigation ports flush with the suction ports according to one embodiment of the present disclosure. [Figure 8] FIG. 10 is a top view of a distal head portion with an oval irrigation port at the distal tip of a catheter according to an embodiment of the present disclosure. [Figure 9] FIG. 2 is a top view of a distal head portion for the endoscopic system of FIG. 1 with a reduced cross-section and an oval irrigation port at the distal tip of the catheter according to one embodiment of the present disclosure. [Figure 10] FIG. 2 is a perspective view of a distal head portion for the endoscopic system of FIG. 1 having an extension with a transparent cap and pressure relief according to one embodiment of the present disclosure. [Figure 11] FIG. 11 is a side view of the distal head portion of FIG. 10 according to one embodiment of the present disclosure. [Figure 12]FIG. 2 is a perspective view of a distal head portion for the endoscopic system of FIG. 1 having a transparent cap with an irrigation port and an illumination fiber secured thereto, and an integrated pressure relief portion defined within the transparent cap, according to one embodiment of the present disclosure. [Figure 12A] FIG. 13 is a top view of the distal head portion of FIG. 12 according to one embodiment of the present disclosure. [Figure 12B] FIG. 13 is a side elevational view of the distal head portion of FIG. 12 according to one embodiment of the present disclosure. [Figure 13] FIG. 2 is a top view of a distal head portion for the endoscopic system of FIG. 1 having a transparent cap with an illumination fiber secured thereto and an integrated pressure relief portion defined within the transparent cap according to one embodiment of the present disclosure. [Figure 14] FIG. 14 is a side view of the distal head portion of FIG. 13 according to one embodiment of the present disclosure. [Figure 15] FIG. 14 is a side view of the distal head portion of FIG. 13 showing the flow field and diffusion of light from the illumination optical fiber according to an embodiment of the present disclosure. [Figure 16] FIG. 2 is an end view of a distal head portion for the endoscopic system of FIG. 1 having a single push-pull optical fiber configured to deflect the distal head portion for steering a catheter according to one embodiment of the present disclosure. [Figure 16A] FIG. 17 is a cross-sectional view of the distal head portion of FIG. 16 taken along plane XVIA-XVIA according to an embodiment of the present disclosure. [Figure 17] FIG. 17 is a perspective view of the distal tip portion of the distal head portion of FIG. 16 partially assembled with components extending through the catheter shaft, showing the asymmetric dome-shaped transparent cap in phantom, according to one embodiment of the present disclosure. [Figure 18] FIG. 18 is a cross-sectional view of the distal tip portion and catheter shaft of FIG. 17 according to an embodiment of the present disclosure. [Figure 19] FIG. 18 is an elevation view of the assembled components of FIG. 17 according to one embodiment of the present disclosure. [Figure 19A] FIG. 20 is an elevation view of an alternative to the assembly of FIG. 19 according to an embodiment of the present disclosure. [Figure 20]1 without a transparent cap and having an imaging receiver axially offset from the opening of the distal head portion, according to one embodiment of the present disclosure. [Figure 20A] FIG. 21 is a cross-sectional view of the distal head portion of FIG. 20 taken along plane XXA-XXA according to an embodiment of the present disclosure. [Figure 21] FIG. 2 is an end view of a distal head portion for the endoscopic system of FIG. 1 without a transparent cap, having an imaging receiver axially offset from the opening in the distal head portion, and with a dedicated irrigation port, according to one embodiment of the present disclosure. [Figure 21A] FIG. 22 is a cross-sectional view of the distal head portion of FIG. 21 taken along plane XXIA-XXIA according to an embodiment of the present disclosure. [Figure 21B] FIG. 22 is a cross-sectional view of the distal head portion of FIG. 21 taken along plane XXIB-XXIB according to an embodiment of the present disclosure. [Figure 21C] FIG. 23 is a cross-sectional view of an alternative configuration for the distal head portion of FIG. 21 along plane XXIB-XXIB according to an embodiment of the present disclosure. [Figure 22A] 1 is a cross-sectional view of an illuminating optical fiber having an oval cross-section according to one embodiment of the present disclosure. [Figure 22B] 1 is a cross-sectional view of an illuminating optical fiber having an oval cross-section according to one embodiment of the present disclosure. [Figure 22C] 1 is a cross-sectional view of an illuminating optical fiber having an oval cross-section according to one embodiment of the present disclosure. [Figure 22D] 1 is a cross-sectional view of an illuminating optical fiber having an oval cross-section according to one embodiment of the present disclosure. [Figure 23] FIG. 1 is a partial internal view of a steering handle with a push-pull fiber optic linkage attached to a rotating cam and coupled to a light source, according to one embodiment of the present disclosure. [Figure 24A] 10 is a schematic diagram of a termination for securing a fiber optic push linkage to a distal head portion according to an embodiment of the present disclosure. FIG. [Figure 24B] 10 is a schematic diagram of a termination for securing a fiber optic push linkage to a distal head portion according to an embodiment of the present disclosure. FIG. [Figure 24C] 10 is a schematic diagram of a termination for securing a fiber optic push linkage to a distal head portion according to an embodiment of the present disclosure. FIG. [Figure 25A] 11 is a photograph of the target zone as viewed through the distal head portion of FIG. 10 with the transparent cap removed according to an embodiment of the present disclosure. [Figure 25B] 11 is a photograph of the target zone as viewed through the distal head portion of FIG. 10 with a transparent cap having a cap thickness of 1 millimeter according to an embodiment of the present disclosure. [Figure 25C] 11 is a photograph of the target zone as viewed through the distal head portion of FIG. 10 with a transparent cap having a cap thickness of 1.25 millimeters according to an embodiment of the present disclosure. [Figure 25D] 11 is a photograph of the target zone as viewed through the distal head portion of FIG. 10 with a transparent cap having a cap thickness of 1.5 millimeters according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0037] Referring to FIG. 1 , an endoscopic system 30 for laser lithotripsy is shown schematically in accordance with one 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 catheter shaft 33 that is flexible (schematic), rigid, or semi-rigid. The handle 38 may house a steering mechanism 39 coupled to the distal head portion 34. The handle 38 integrates various external components or systems 40 for controlled delivery of material through the catheter 32 to the distal head portion 34. 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 of the components of the endoscopic system 30 may be partially or fully integrated into the handle 38, the catheter 32, or the distal head portion 34. The handle 38 can include, for example, control mechanisms for the aspiration and irrigation systems 42 and 44, mechanisms for adjusting the position of the distal end of the laser fiber, and other components. The fiber positioning mechanism can include a clamp (not shown) that can be engaged once the distal tip of the fiber is in a desired position. Clamping the fiber fixes the position of the fiber distal tip, typically with an accuracy in the range of 0.05 to 0.1 millimeters. The direction along the central axis 110 from the catheter shaft 33 to the distal head portion 34 is referred to herein as the distal direction 50. The direction opposite the distal direction 50 is referred to herein as the proximal direction 51.

[0038] Functionally, the steering mechanism 39 enables articulation of the distal portion 35 of the catheter 32, particularly for embodiments incorporating a flexible or semi-flexible catheter shaft 33, through the patient's body canal to the target zone 56 and position the distal head portion 34 to focus on individual stones 58 within the target zone 56. The illumination system 52 generates visible light that is delivered to the target zone 56 to illuminate the stones 58 and surrounding tissue, such as stones in the kidney, ureter, or bladder. The ablation laser system 46 includes, for example, a thulium or holmium fiber or solid-state laser for delivering laser energy to the target zone 56 to ablate and destroy the stones 58. Delivery of laser energy can be achieved using a laser fiber, e.g., silica or other fiber optic material. The irrigation system 42 provides pressurized irrigation fluid to cool the target zone 56 and displace fragments of the stones 58 within the target zone 56. The suction system 44 draws the liquid medium, including particles from the intracorporal stone 58 that may be suspended in the medium, from the target zone 56. 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.

[0039] As used herein, "body stones" encompass all stones produced by the human body, including kidney stones and ureteral stones, as well as varieties thereof including calcium stones, uric acid stones, struvite stones, and cysteine ​​stones. "Body stones" can also include stones found in or formed by other organs of the body, such as bladder stones, gallbladder stones, prostate stones, pancreatic stones, salivary gland stones, and abdominal stones. This disclosure describes systems and techniques for destroying kidney and ureteral stones, but is generally not limited thereto. In light of this disclosure, those skilled in the art of body stone therapy will recognize the application of various aspects disclosed herein to the repair of body stones other than kidney and ureteral stones, as well as the treatment of hard and soft tissues.

[0040] Referring to Figures 2 and 2A, a distal head portion 34a according to one embodiment of the present disclosure is shown. Distal head portions are collectively or generally referred to herein 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 a letter suffix (e.g., "distal head portion 34a"). The distal head portion 34a includes a distal tip portion 96 having a distal surface 98 and an outer tangential surface 97. In some embodiments, the distal tip portion 96 is integral with the catheter shaft 33 (e.g., Figures 2A, 3A, and 3B). In other embodiments, the distal tip portion 96 is formed separately from and secured to the catheter shaft 33 (e.g., Figures 16-21C). In some embodiments, a transparent cap portion 100 is secured to the distal surface 98 of the distal tip portion 96. The transparent cap portion 100 includes a proximal surface 104 and a distal surface 106 that define an axial cap thickness 99 therebetween. In some embodiments, the transparent cap portion 100 defines a distal surface 106, e.g., a beveled surface 101 extending proximally from a chamfered (as shown) or arcuate corner. The transparent cap portion 100 is fabricated from a material suitable for transmitting visible light and may include low absorption and a high damage threshold at the operating wavelength of the ablation laser system 46. Non-limiting example materials for the transparent cap 100 include sapphire, quartz, optical ceramics, and mineral or organic glasses. In some embodiments, the refractive index of the transparent cap 100 is about 1.31 to 1.35 to approximately match the refractive index of the liquid medium (substantially water). In some embodiments, the distal tip 96 can be fabricated from the same transparent material as the transparent cap 100.

[0041] In some embodiments, the distal head portion 34a includes one or more illuminators 130. The illuminators 130 may be the distal ends of illumination or lighting optical fibers 132 for transmitting light in the visible spectrum and are operably coupled to the illumination system 52 at the handle 38. The illumination optical fibers 132 may extend through illumination optical fiber ports 134 formed in the distal tip portion 96 and into the transparent cap 100. Optionally, the illuminators 130 may be light-emitting diodes (LEDs) (not shown) powered by electrical leads extending through the catheter 32 near the proximal face 104 of the transparent cap 100. The illumination optical fibers 132 act as light guides and may extend through the catheter 32 and be coupled to the illumination system 52 at the handle 38.

[0042] In some embodiments, one or more illumination optical fibers 132 are mechanically secured to the distal head portion 34a (e.g., with an adhesive), e.g., to the illumination optical fiber port 134 or the transparent cap 100, or to both the illumination optical fiber port 134 and the transparent cap 100. The optical fibers 132 may extend through and freely slide within a lumen 107 ( FIGS. 2A , 3A , and 3C ) defined by or disposed within the catheter 32. The illumination optical fibers 132 may extend distally from a steering mechanism 39 disposed within the handle 38 for translation within the lumen 107. (An example of a steering mechanism 39 is described in conjunction with FIG. 23 .) The distal head portion 34a is thereby coupled to the steering mechanism 39 of the handle 38 via the illumination optical fibers 132. In a catheter 32 having a flexible or semi-flexible shaft 33, coupling and routing of the illumination optical fiber 132 arranged in this manner allows the illumination optical fiber 132 to also function as a pull linkage or push-pull linkage for steering the distal head portion 34a, thereby eliminating the need for separate pull wires and the connectors associated with coupling them to the distal head portion 34a.

[0043] The distal head portion 34a defines a working channel 102 that passes through the distal tip portion 96 and through the proximal and distal surfaces 104, 106 of the transparent cap portion 100. The working channel 102 defines an opening 108 at the distal surface 106. The working channel 102 can function, for example, as an aspiration port, in which case the opening 108 and the working channel define a suction inlet. The working channel 102 extends through the catheter 32 and can be coupled, for example, at the handle 38, to the aspiration system 44. The distal head portion 34a can, for example, define a central axis 110 and define a circular or oval cross-section about the central axis 110. The working channel 102 includes a working port 103 formed in the distal head portion 34a and passing therethrough, defining the opening 108. In some embodiments, the working port 103 includes a cap working port 103a and a distal tip working port 103b that are in fluid communication with each other. Cap working port 103a passes through transparent cap 100 and defines cap working port axis 111. In some embodiments, distal tip working port 103b passes through distal tip portion 96, transitioning between catheter shaft 33 and transparent cap 100. Alternatively, embodiments are contemplated in which transparent cap 100 is directly coupled to catheter shaft 33 (e.g., without a distal tip portion transition), such that working port 103 includes only cap working port 103a. Also disclosed herein are embodiments in which distal head 34 includes distal tip portion 96 without a transparent cap. (See Figures 20 and 21 below and the accompanying discussion.)

[0044] A laser optical fiber 112 for transmitting ablative laser energy is disposed in the working channel 102, with a distal end 114 of the laser optical fiber 112 positioned proximate the distal face 106 of the transparent cap portion 100, and a proximal end of the laser optical fiber 112 coupled to the ablation laser system 46 via the handle 38. The core diameter of the laser optical fiber 112 can range from 0.05 to 0.4 millimeters for catheters with flexible shafts and up to 1.5 millimeters for catheters with rigid shafts. In some embodiments, the laser optical fiber 112 is substantially concentric with the cap working port axis 111 or otherwise extends through a central portion of the cap working port 103a, defining an annular region 116 between the laser optical fiber 112 and the cap working port 103a. In some embodiments, the position of the distal end 114 of the laser optical fiber 112 can be controlled within a range of + / - 5 millimeters, inclusive, relative to the distal surface 106 of the transparent cap portion 100, with "+" and "-" referring to the distal direction 50 and the proximal direction 51, respectively, along the working port axis 111. In some embodiments, the position of the distal end 114 can be controlled within a range of + / - 3 millimeters, inclusive, relative to the distal surface 106. In some embodiments, the position of the distal end 114 can be controlled within a range of +1 millimeter to -3 millimeters, inclusive, relative to the distal surface 106. In some embodiments, the position of the distal end 114 can be controlled within a range of -0 millimeter to -3 millimeters, inclusive, relative to the distal surface 106. In some embodiments, the position of the distal end 114 can be controlled within a range of -0.05 millimeter to -1 millimeter, inclusive, relative to the distal surface 106. As used herein, ranges referred to as "inclusive" include the endpoints of the range as well as all values ​​between the endpoints.

[0045] 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 can be plumbed into a common working channel 109, as shown in FIGS. 2 and 2A. In some embodiments, the working channel 109 alternately functions as an aspiration and irrigation channel. As used herein, a "working channel" can function as an irrigation channel, an aspiration channel, or both an irrigation channel and an aspiration channel. The working channel, as used herein, can optionally be configured to accommodate a working object such as a laser fiber and a basket. The inner diameter of the working port 103 can range from 0.5 millimeters to 1.5 millimeters, inclusive, for a flexible catheter utilizing a 0.05 millimeter core laser fiber.

[0046] Similar to working port 103, each of working ports 122 can include a cap working port 122a and a distal tip working port 122b that are in fluid communication with one another. Cap working port 122a passes through transparent cap 100. In some embodiments, distal tip working port 122b passes through distal tip section 96, transitioning between catheter shaft 33 and transparent cap 100. Alternatively, embodiments are contemplated in which transparent cap 100 is directly coupled to catheter shaft 33 (e.g., without a distal tip section transition), such that working port 122 includes only cap working port 122a.

[0047] In some embodiments, the distal head portion 34a includes an imaging receiver 142, which can include image-forming optics that define a field of view 148 of the endoscope system 30, characterized by a field of view angle β. In some embodiments, the imaging receiver 142 defines a field of view angle β that is within a range of 90 degrees to 120 degrees, inclusive (±45 degrees to 60 degrees, inclusive, from the visual axis of the imaging receiver). The imaging receiver 142 can be an imaging device 144 (shown), such as a complementary metal-oxide semiconductor (CMOS) sensor (including a semiconductor chip, imaging optics, and supporting electronics) or a charge-coupled device (CCD) camera sensor. In some embodiments, the imaging plane of the imaging receiver 142 is from 0.5 millimeters by 0.5 millimeters to 1.5 millimeters by 1.5 millimeters. One example of a CMOS image sensor described is the NANEYE 2D, offered by AWAIBA CMOS Image Sensors of Aargau, Switzerland. See https: / / ams.com / naneye, last visited January 16, 2020.

[0048] 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 in the distal surface 98 of the distal tip portion 96. The imaging device 144 can define a field of view angle β that is ±45 degrees of the normal. Optionally, the imaging receiver 142 is the distal end of an optical system and imaging optical fiber (not shown) that extends through the catheter 32 and is coupled to the visualization system 54 at the handle 38. The distal surface 106 of the transparent cap 100 may be flat (as shown) or may be shaped as a lens (not shown) for focusing an image onto the imaging receiver 142.

[0049] 3 and 3A, distal head portion 34b is shown according to one embodiment of the present disclosure. Distal head portion 34b can include many of the same components and features as distal head portion 34a, which are designated with the same numerical references. Distinguishing distal head portion 34b is that working port 122 is separate from working port 103. In some embodiments, the inner diameter of working port 122 for irrigation ranges from 0.5 millimeters to 1.5 millimeters, inclusive. Functionally, having separate ports 103 and 122 utilizing separate working channels 102 and 124 allows for simultaneous and continuous irrigation and aspiration during laser treatment.

[0050] 3B and 3C, the distal head portion 34b is shown with a catheter 32 having a distal tip portion 96 and a tubular shaft 120 according to one embodiment of the present disclosure. In the embodiment of FIGS. 3B and 3C, the working port 122 is in fluid communication with a single working channel 124 bounded 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 that defines a cavity 129 extending from the proximal portion 36 to the distal portion 35, the cavity 129 being occupied by various components utilized in 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 optical fiber 112, the illumination optical fiber 132 and lumen 107, and the cable 146. Sterilization of the cavity 129 can be performed by an ethylene oxide (ETO) gas sterilization process in single-use endoscopes.

[0051] With this configuration, working channels 102 are disposed within and effectively enclosed by a single working channel 124. Irrigation system 42 can be coupled to catheter shaft 33 such that irrigation fluid can flow through the remainder of cavity 129 not occupied by components. Tubular shaft 120 can be implemented with any of the distal head portions 34 shown in Figures 3-9.

[0052] With various disclosed endoscopic systems 30 performing simultaneous suction and irrigation, the total treatment time can be reduced while increasing procedural safety. A method according to an embodiment of the present disclosure can include some or all of the following: (1) identifying a stone in a patient's internal organ using ultrasound, fluoroscopy, or other diagnostic methods available to those skilled in the art; (2) inserting catheter 32 into the patient's body and bringing the distal end of the catheter proximal to target zone 56; (3) acquiring an image of the target intracellular stone 58 or stone fragment; (4) bringing the distal end 114 of the laser optical fiber 112 into contact or near contact with the target intracellular stone or fragment; (5) activating the irrigation and aspiration flows; and (6) Delivering laser energy from the ablation laser system 46 through the laser fiber 112 to ablate the stone 58 into large fragments (larger than 1 millimeter), small fragments (less than 1 millimeter), or particles (less than 0.25 millimeters). The above method can be used for contact as well as non-contact treatment of intracorporeal stones 58.

[0053] Referring to FIG. 4, a distal head portion 34c according to an embodiment of the present disclosure is shown. The distal head portion 34c can include many of the same components and features as the distal head portion 34b, which are designated with the same numerical reference designators. A distinction of the distal head portion 34c is that the illumination fiber optic port 134 and the working port 122 overlap, such that the illumination fiber optic 132 penetrates the boundaries of the working port 122. A further distinction of the distal head portion 34c is that the working port 122 is shaped to increase the cross-sectional flow area without increasing the overall profile of the distal head portion 34c. In the illustrated embodiment, the working port 122 of the distal head portion 34c is oval to achieve this increase, although other shapes, including asymmetric port cross-sections, are contemplated. Additional discussion of aspects of the asymmetric working port 122 is discussed below in conjunction with FIGS. 8 and 9.

[0054] Functionally, locating the distal end 114 of the laser fiber 112 inside the distal head 34 protects the fiber's distal end 114 from damage caused by stone ablation products, reducing total laser treatment time while also increasing laser ablation efficiency. Such placement minimizes or eliminates fiber burnback and eliminates the need to reposition the fiber's distal end 114 during the laser procedure. The transparent cap 100 provides a clear visual path between the imaging receiver 142 and the distal surface 106 of the transparent cap 100, thus eliminating or substantially reducing debris (e.g., ablation particles) in the near field 148 that would otherwise be present between the imaging receiver 142 and the laser optical fiber 112. Reducing debris in the near field 148 allows the operator to better visualize the opening 108, the distal end 114 of the laser optical fiber 112, and a given target intracorporeal stone 58, and also reduces attenuation of light emitted by the illuminator 130 for better illumination of the target zone 56. Additionally, the distal surface 106 of the transparent cap 100 is easier to visualize than the smaller distal end 114 of the laser optical fiber 112, aiding the operator in positioning the distal head portion 34a to better control the distance between the distal end 114 of the laser optical fiber 112 and the target stone 58. Because there is little to no gap between the distal end 114 and the target stone 58 or fragments (the gap typically does not exceed 1 millimeter), improved control leads to increased ablation efficiency. Reducing debris in the near field 148 also reduces attenuation of light from the illuminator 130, allowing for better illumination of the target zone 56 and a clearer image of the target zone 56. Positioning the imaging device 144 in the recess 147 allows the proximal surface 104 of the transparent cap to be flat and seated against the distal surface 98 of the distal tip portion 96. The angled surface 101 reduces the trauma of the distal head portion 34a traveling through the body canal to reach the target zone 56.

[0055] Coupling to the steering mechanism 39 of the handle 38 via the illumination optical fiber 132 allows the illumination optical fiber 132 to function as a pull linkage, and in some embodiments, also as a push-pull linkage, for steering a catheter 32 having a flexible or semi-rigid shaft 33. This negates the need for separate pull wires and the connectors associated with coupling them to the distal head portion 34c, allowing for more cross-section to be devoted to the working channel, or a reduced cross-sectional profile of the catheter 32, or a combination thereof. Positioning the illumination fiber 132 so that it penetrates the confines of the working port 122 provides a larger cross-sectional area for irrigation flow.

[0056] By placing the laser optical fiber 112 in the working channel 102, the distal end 114 can be recessed relative to the distal surface 106 of the transparent cap 100, since aspiration of solution into the working channel 102 tends to draw the intracellular stone 58 toward the laser optical fiber 112. Recessing the distal end 114 mechanically protects the laser optical fiber 112 during insertion and operation. In some embodiments, the distal end 114 of the laser fiber 112 may vibrate laterally during laser treatment due to the forces of the irrigation or aspiration flow and the laser-induced bubbling and flow in the liquid. Such vibration may be desirable and can be controlled through control of the laser parameters and the irrigation and / or aspiration flow (e.g., by adjusting the flow rate).

[0057] Additionally, drawing the intracellular stone 58 toward the laser optical fiber 112 can reduce or overcome the "rebound" effect that occurs when the heat of ablation forms a vapor pocket on the ablation surface of the intracellular stone 58. The rebound effect is described in more detail in commonly owned U.S. Patent Application Publication No. 2019 / 01099984 to Altshuler et al., filed July 18, 2019, the disclosure of which is incorporated herein by reference in its entirety, except for the express definitions and claims contained therein. Furthermore, the distal end 114 can be viewed through the transparent cap 100, thereby ensuring unimpaired visualization and control of the distance between the distal end 114 of the laser optical fiber 112 and the targeted intracellular stone 58. Additionally, collateral heat generated by the laser ablation process can be efficiently dissipated by the irrigation fluid and removed by suction of the heated irrigation fluid through the working channel 102, thereby reducing the risk of accidental thermal damage to surrounding tissue.

[0058] Referring to FIG. 5, a distal head portion 34d according to one embodiment of the present disclosure is shown. The distal head portion 34d includes many of the same components and features as the distal head portion 34a, which are designated by the same numerical reference designators. Like the distal head portion 34a, the distal head portion 34d can utilize an illumination optical fiber 132 as a push-pull element for steering a catheter 32 having a flexible shaft 33. In some embodiments, the illumination optical fiber 132 has an oval cross-section 164. Generally, the “oval” cross-section 164 has a major dimension 166 and a minor dimension 168 that are perpendicular to each other, with the major dimension 166 being the largest dimension of the oval cross-section 164 and the minor dimension 168 being the smallest dimension that is perpendicular to and designated as being smaller than the major dimension 166.

[0059] In some embodiments, the major dimension 166 of the oval cross-section 164 extends tangentially (i.e., substantially parallel to a tangent direction θ relative to the central axis 110 of the distal head portion 34d) and the minor dimension 168 extends radially (i.e., parallel to a radial direction r relative to the central axis 110 of the distal head portion 34d). In the illustrated embodiment, the working port 122a can be disposed at the outer tangential perimeter 170 of the transparent cap 100, passing through the proximal and distal faces 104, 106 of the transparent cap 100 and opening at the distal face 106 and along the outer tangential perimeter 170 of the transparent cap 100 (e.g., along the angled face 101).

[0060] 6 and 7, distal head portions 34e and 34f are shown utilizing an illumination optical fiber 132 having an oval cross-section 164 and a working port 122 adjacent to the annular region 116 of the working port 103, according to one embodiment of the present disclosure. Distal head portions 34e and 34f can include many of the same components and features as distal head portion 34d, which are designated with the same reference numerals. The distinction between distal head portions 34e and 34f is that the working port 122 surrounds the annular region 116. Similar to distal head portion 34a, distal head portions 34e and 34f can utilize the illumination optical fiber 132 as a push-pull element for steering a catheter 32 having a flexible shaft 33. In distal head portion 34e, the working port 122 is circular. In distal head portion 34f, the working port 122 is arc-shaped. Multiple working ports 122, such as those shown in Figures 3-9, can be provided with irrigation flow through a single working channel 124. In some embodiments, the ratio of the area of ​​the working port 122 to the opening 108 is in the range of 1.2 to 3.0, inclusive.

[0061] Functionally, when working channel 102 is utilized for suction, the proximity of working port 122 surrounding opening 108 creates a flow field 256 that flows outward from working port 122 and bends inward toward opening 108. The concept of flow fields is further discussed in conjunction with FIG.

[0062] 8 and 9, distal head portions 34g and 34h are shown to illustrate general aspects of the layout of a working port 122 according to an embodiment of the present disclosure. Head portion 34g and distal tip portion 96 of catheter 32 define a circular cross-section 167a (FIG. 8) perpendicular to central axis 110. Working port 122 may be oval to provide a larger flow cross-section than would be provided by a circular irrigation port. Circular distal head portion 34g is characterized by a substantially uniform outer dimension OD. Head portion 34h and distal tip portion 96 define an oval cross-section 167b (FIG. 9 and elsewhere), such as an oval, elliptical, oval, or rounded rectangular cross-section.

[0063] The oval cross-section 167b is achieved by positioning the working port 122 and the illumination optical fiber 132 near the central axis 110, such that the oval cross-section 167b has a reduced outer diameter (i.e., a smaller cross-sectional area) relative to the circular cross-section 167a. The oval cross-section 167b defines a major axis 171 passing through the largest outer dimension OD1 of the oval cross-section 167b and a minor axis 169 perpendicular to the major axis 171. The minor axis 169 can define the smallest outer dimension OD2 of the oval cross-section 167b. In some embodiments, the outer dimensions OD, OD1 of the cross-sections 167a, 167b are in the range of 2 millimeters to 3.2 millimeters, inclusive. In some embodiments, the outer dimensions OD, OD1 are in the range of 1.7 millimeters to 2.6 millimeters, inclusive. In some embodiments, the outer dimensions OD, OD1 are in the range of 2.2 millimeters to 2.5 millimeters, inclusive. In some embodiments, the outer dimension OD2 of cross section 167b is in the range of 1.7 millimeters to 2.5 millimeters, inclusive. In some embodiments, the outer dimension OD2 is in the range of 1.7 millimeters to 2.0 millimeters, inclusive.

[0064] 10 and 11, a distal head portion 34i having an extension 182 of a working port 103 is shown, according to one embodiment of the present disclosure. The distal head portion 34i includes many of the same components and features as the distal head portion 34b, which are identified with the same numerical reference designators. The cap working port 103a defines an opening 108 proximate the distal face 106 of the transparent cap 100. In the distal head portion 34i, the opening 108 of the cap working port 103a is defined at the distal-most end 186 of the extension 182. At least one pressure relief 192 extends proximally from the opening 108. The pressure relief 192 may be a notch 194. The notch extends radially through the wall 196 of the extension 182. It is possible.

[0065] In the distal head portion 34i, the distal tip working ports 122b defined by the distal tip portion 96 extend through respective beveled surfaces 214 formed in the distal tip portion 96 of the catheter 32. Alternatively, the distal tip portion 96 can be chamfered (not shown) around the tangential perimeter 216 of the outer tangential surface 97 to define the beveled surfaces 214. In some embodiments, the proximal face 104 of the transparent cap 100 extends radially over the beveled surfaces 214 to define the outlets 218 of the distal tip working ports 122b. Thus, in the distal head portion 34i as shown, there are no cap irrigation ports passing through the transparent cap 100. Instead, the irrigation ports 122b terminate the working channels 124 proximally relative to the transparent cap 100 and are configured to direct flow onto the proximal face 104 of the transparent cap 100.

[0066] In some embodiments, each of the illumination optical fibers 132 is disposed within a corresponding one of the distal tip working ports 122b, and the illumination optical fiber extends into the transparent cap 100 of the distal head portion 34i. Each illumination optical fiber 132 can be configured to diffuse, refract, scatter, or otherwise redirect visible light 222 radially into the transparent cap 100. The transparent cap can also be configured to diffuse or scatter the visible light 222. The transparent cap 100 can contact a distal end portion 224 of at least one illumination optical fiber 132 to, for example, secure the illumination optical fiber 132 to the distal head portion 34i. In some embodiments, an interface 226 between the distal end portion 224 of the illumination optical fiber 132 and the transparent cap 100 is configured to direct the visible light 222 radially away from the illumination optical fiber. For example, to increase the redirection of the visible light 222, the distal end portion 224 of the illumination optical fiber 132 can be unclad. The redirection of visible light 222 can occur along the entire length of interface 226. In another example, interface 226 includes a transparent or translucent adhesive that scatters or refracts visible light 222 away from illumination optical fiber 132. In another example, illumination optical fiber 132 defines a relatively large numerical aperture (e.g., within the range of 0.35 to 0.65, inclusive). The above example embodiments facilitate the redirection of visible light 222 through transparent cap 100.

[0067] Referring to FIG. 12 , a distal head portion 34j is shown with a recessed pressure relief portion 192 according to one embodiment of the present disclosure. The distal head portion 34j includes many of the same components and features as the distal head portion 34i, which are identified with the same numerical reference designators. A distinction in the distal head portion 34j is that the pressure relief portion 192 extends proximally from the distal surface 106 of the transparent cap 100. That is, the opening 108 of the cap working port 103a is flush with the distal surface 106 of the transparent cap 100. Another distinction in the distal head portion 34j is that the working port 122 includes a cap working port 122a that extends into the transparent cap 100 but does not pass through the distal surface 106. Instead, the outlet 218 of the cap working port 122a extends through the radial surface 244 of the transparent cap 100. In some embodiments, the beveled surface 214 is formed in a radial surface 244 of the transparent cap 100 and defines an outlet 218. In some embodiments, each distal tip working port 122b is in fluid communication with a corresponding cap working port 122a. The transparent cap 100 can include a distal end portion 246 that extends radially above the cap working port 122a.

[0068] 13-15, a distal head portion 34k is shown with an extended recessed pressure relief portion 192 according to one embodiment of the present disclosure. Distal head portion 34k includes many of the same components and features as distal head portion 34j, which are identified with the same numerical reference designators. What distinguishes distal head portion 34k is that pressure relief portion 192 extends radially to the outer tangential perimeter 170 of distal face 106 of transparent cap 100.

[0069] Functionally, redirecting the visible light 222 away from the illumination optical fiber 132 and into the transparent cap 100 allows for more uniform illumination of the target zone 56. The pressure relief 192 on the distal head portions 34i-34k helps stabilize the trapped and targeted concretion 58 at the opening 108 of the cap working port 103a in aspiration mode. Without the pressure relief 192, the targeted concretion 58 could effectively block the working port 103, creating a larger pressure differential across the concretion 58. The high pressure differential generates large forces acting on the targeted concretion 58. These large forces could, for example, destabilize the capture of the targeted concretion 58 and cause the concretion 58 to become dislodged from the working port 103. In another example, this high force can cause excessively large fragments of the targeted concretion 58 to become lodged in the working port 103 or become lodged between the laser optical fiber 112 and the working port 103, thereby blocking the distal head portion 34 and damaging the laser optical fiber 112. The pressure relief 192 allows for suction flow around the trapped concretion 58, thereby reducing the pressure differential across the concretion 58 and the accompanying forces applied to the concretion 58. The reduced pressure and force reduces capture instability and reduces the occurrence of excessively large fragments becoming lodged in the working port 103.

[0070] Positioning the transparent cap 100 to extend radially over the beveled portion 214 (FIGS. 10, 11, 14, 15, and 19), or extending the distal end portion 246 of the transparent cap 100 over the beveled portion of the distal end portion 246 (FIG. 12), deflects the irrigation flow in the radial direction r to establish a flow field 256, as shown in FIG. 15. The outlets 218 deliver irrigation flow 252 that is vectored radially outward, while aspiration flow 254 draws flow into the openings 108. In some embodiments, the peak exit angle α of the irrigation flow 252 (i.e., the angle at which the maximum irrigation flow flux occurs) is centered between 10 degrees and 90 degrees, inclusive, relative to the central axis 110. In some embodiments, the peak exit angle α is between 10 degrees and 60 degrees, inclusive.

[0071] During operation, the radially outward outlet 218 creates a flow field 256 that flows outward from the distal head portion 34k and bends inward toward the opening 108. The flow for the distal head portions 34i and 34j can behave in a similar manner. When the working channel 102 is used for suction, fragments of the intracoolant stone 58 that are sufficiently small (e.g., less than 0.5 millimeters) are entrained by the flow field 256 and expelled through the opening 108 and the working channel 102. Other intracoolant stones 58 or fragments thereof that are too large to pass (e.g., 1 to 3 millimeters) are drawn by the flow field 256 into a targeted vicinity of the distal end 114 of the laser optical fiber 112. Once these larger stones are brought within range of the laser optical fiber 112, the ablation laser system 46 can be energized to ablate the intracoolant stone 58. Ablation breaks the intracoolant stone 58 into smaller fragments, which are then drawn through the opening 108 and into the working channel 102.

[0072] If a large concretion 58 enters or approaches the opening 108 during aspiration, the working channel 102 may experience a drop in pressure as the stone blocks the opening 108. Thus, in some embodiments, the ablation laser system 46 (FIG. 1) can ablate the obstructing concretion 58 induced by a pressure drop in the working channel 102 detected by the pressure sensor 48 of the aspiration system 44.

[0073] Functionally, establishing a flow field 256 speeds up the laser lithotripsy process by drawing the stone 58 toward the laser optical fiber 112. For example, when operating in non-contact mode with a peak outflow angle α ranging from 10 to 60 degrees, the irrigation flow 252 sweeps the small stone and stone fragments toward the opening 108 of the suction channel 103 for more efficient operation. The irrigation flow 252 and the suction flow 254, individually or both, can be continuous or pulsed. In some embodiments, the pulsed flow is synchronized with the laser pulse to enhance ablation and removal of ablation particles. The flow field draws the stone 58 within the effective range of the laser optical fiber 112 (typically 0 to 3 millimeters), reducing the need to pursue and track the stone 58. Also, by being drawn into the effective range of the optical fiber 112, the stone 58 is more efficiently fragmented by the ablation process. Some redirection of the visible light 222 results in more uniform illumination of the target zone 56, thereby improving navigation within the target zone 56. The amount of attenuation due to smaller fragments and particles from the intracellular stone 58 in the field of view 148 is reduced by suction and by the presence of the transparent cap 100 in the near field 148.

[0074] 16-19A, distal head portions 34l and 34m are shown according to embodiments of the present disclosure. Distal head portions 34l and 34m can include many of the same components and features as the other distal head portions 34 described above, some of which are designated with the same numerical reference designators. Distinct features of distal head portion 34l include a single illumination optical fiber 132, a transparent cap 100 having a convex or dome-shaped contour 262, a distal tip working port 122b defining an asymmetric flow cross-section 264, and a laser optical fiber 112 supported by a laser optical fiber port 266 that is offset from the cap working port axis 111.

[0075] The single illumination optical fiber 132 can be configured to apply both a pulling force and a pushing force to the distal head portion 341. In some embodiments, the cross section of the single illumination optical fiber 132 is 0.2 millimeters by 0.5 millimeters.

[0076] Functionally, the single illumination optical fiber 132 can occupy less cross-section of the distal head portion 34l than, for example, the pair of illumination optical fibers 112 of the distal head portion 34d of FIG. 5. In addition to the reduced cross-section of the optical fiber, the associated structural cross-section required to secure the optical fiber (i.e., the structure to which the optical fiber is adhered) is also reduced. The reduced cross-section provides more area for other components of the distal head portion 34l (e.g., for the working ports 103, 122b), or a reduced overall cross-section of the distal head portion 34l, or a combination of both. For example, in one embodiment, the maximum outer dimension OD1 is in the range of 2 to 2.5 millimeters, inclusive, and the minimum outer dimension OD2 is in the range of 1.7 to 2 millimeters, inclusive, while still providing an increased cross-sectional flow area relative to other embodiments.

[0077] The dome-shaped contour 262 of the transparent cap 100 is generally hemispherical and can define a cap working port 103a therethrough. In some embodiments, the distal head portion 34l is oval and, similar to the distal head portion 34h (FIG. 9), defines a major axis 171 and a minor axis 169 and associated outer dimensions OD1 and OD2. In some embodiments, the dome-shaped contour 262 is asymmetric. In the illustrated distal head portion 34l, the dome-shaped contour 262 is asymmetric along the major axis 171 (FIG. 16A) but symmetric along the minor axis 169 (FIG. 18). The dome-shaped contour 262 defines a maximum axial dimension Z parallel to the central axis 110 of the distal head portion 34l, as shown. In some embodiments, the maximum axial dimension Z of the dome-shaped contour 262 is disposed above the imaging receiver 142. The distal head portion 34l can also include a pressure relief portion 192 recessed into the dome-shaped contour 262.

[0078] Functionally, the dome-shaped contour 262 of the transparent cap allows for smooth and easy passage of the distal head portion 34l through body canals such as the ureter and renal calyces, particularly when steering the distal head portion 34l through rotation. By aligning the maximum axial dimension Z of the transparent cap 100 with the imaging receiver 142, the length (and therefore clarity) of the path perpendicular to the imaging receiver is increased relative to the flat distal surface 106 of other transparent caps 100 (e.g., FIGS. 2A, 3A, and 3B). The convex surface of the dome-shaped contour 262 can also be configured to act as a lens to magnify the image as seen by the imaging receiver 142. The pressure relief portion 192 functions as described in conjunction with FIGS. 13 and 14.

[0079] The asymmetric flow cross-section 264 of distal tip working port 122b can be configured to occupy a larger portion of the cross-sectional area of ​​distal head portion 34l than axisymmetric working ports, such as the circular working port 122 of distal head portion 34b or the oval working ports 122 of distal head portions 34c, 34g, and 34h. In effect, structure is provided in distal tip portion 96 for bounding working port 103 and for mounting laser optical fiber 112, illumination optical fiber 132, and imaging receiver 142. The remainder of oval cross-section 167b of distal head portion 34l is configured to provide the asymmetric flow cross-section 264.

[0080] The laser fiber optic port 266 protrudes radially into the working port 103 and can be sized to provide a sliding fit with the laser fiber optic 112. The working port 103 defines a maximum inner radius R. The protruding portion of the fiber optic port 266 penetrates the maximum inner radius R to define a minimum inner dimension 268 of the working port 103. The laser fiber 112 can be mounted within the port 266 during manufacturing and sterilized along 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. This pre-integration of the laser fiber into the scope reduces surgical preparation time because the surgeon does not need to insert the fiber into the scope.

[0081] The distal end 114 of the fiber 112 can be recessed within the working port 103 proximal to the distal surface 106 to reduce the effects of fiber burn-back.

[0082] Functionally, the asymmetric flow cross-section 264 acts to increase the flow cross-section of the distal tip working port 122b relative to a circular, oval, or other axisymmetric cross-section, providing a larger cross-section for, for example, irrigation flow or passage of a catheter tool. Similarly, the offset of the laser optical fiber port 266 and the laser optical fiber 112 provides a larger, unimpeded flow cross-section for the working port 103. That is, for a working port 103 having a given cross-sectional flow area, the minimum internal dimension 265 (FIG. 7) for a configuration with the laser optical fiber 112 substantially concentrated within the working port 103 (e.g., as shown in FIGS. 2-9) is somewhat smaller than the inner diameter of the working port 103, while the minimum internal dimension 268 of the working port 103 in the distal head portion 34l can be substantially larger than the maximum inner radius R (FIG. 16) of the working port 103. In embodiments in which the working port 103 and opening 108 function as an aspiration inlet, the larger minimum internal dimension allows for the aspiration of larger stone fragments from the target zone 56 than the concentrically positioned laser optical fiber 112. Additionally, the laser optical fiber port 266 may further protect the laser optical fiber 112 from damage caused by stone chips passing through the constriction of the working port 103, which defines a minimum internal dimension 268.

[0083] Distal head portion 34l, similar to FIGS. 10, 11, 14, and 15 discussed above, illustrates transparent cap 100 as extending radially over beveled portion 214 of distal tip portion 96. Transparent cap 100 may include a transition 261 between proximal surface 104 and dome-shaped contour 262. Transition 261 may be, for example, arc-shaped (as shown) or chamfered. Transition 261 may allow for smooth proximal movement of catheter 32 (e.g., during removal through a body canal). Alternatively, or in addition, one or more beveled surfaces 267 may be defined on transparent cap 100, as shown for distal head portion 34m in FIG. 19A. Beveled surfaces 267 (or chamfered portions) on transparent cap 100 have the effect of directing irrigation flow 252 radially outward. In some embodiments, the distal tip portion 96 defines an outlet 269 (as shown) that is flush with the distal face 98 of the distal tip portion 96. Embodiments in which the radially outward outlet 218 is combined with a beveled surface 267 are also contemplated.

[0084] 20 and 20A , a distal head portion 34n according to one embodiment of the present disclosure is shown. The distal head portion 34n can include many of the same components and features as the other distal head portions 34 described herein, some of which are designated with the same numerical reference designators. A feature 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 face 98. The working port 103 extends through the extension portion 286 and the distal face to define an opening 108 in the distal face 98. In some embodiments, the extension portion 286 includes a reduced flange 290 that protrudes radially inward and defines the opening 108. The reduced flange 290 defines a diameter of the opening 108 that is smaller than the inner diameter of the working port 103 proximal to the reduced flange 290. In some embodiments, reduction flange 290 reduces the area of ​​opening 108 by 5% to 50% relative to the area of ​​working channel 102 proximal to reduction flange 290 .

[0085] The reduced flange 290 may also be implemented in the distal head portion 34 where the opening 108 is defined by the transparent cap 100. A transparent cap 100 with a reduced flange 290 is shown in FIG. 2A and may be implemented, mutatis mutandis, in any of the transparent caps 100 disclosed herein.

[0086] The maximum axial offset Δ of the imaging receiver is defined as the distance from the distal-most end 291 of extension portion 286 to imaging receiver 142, which is parallel to working port axis 111. In embodiments in which distal surface 98 defines a plane 292 (shown in FIGS. 20A and 21A ) that is perpendicular to working port axis 111, distal-most end 291 of extension portion 286 is any point on plane 292, and the maximum axial length Δ is the distance from plane 292 to imaging receiver 142, which is parallel to working port axis 111. In embodiments in which distal surface 98 is a shaped surface (e.g., similar to the dome-shaped contour 262 of transparent cap 100 of distal head portions 34l and 34m in FIGS. 16A , 17 , 19 , and 19A ), distal-most end 291 of opening 108 can be unique. An example of a unique distal-most end on the transparent cap 100 of the distal head portion 34l is identified by reference numeral 291' in FIG. 16A. In some embodiments, the maximum axial length Δ is within the range of 1 millimeter to 10 millimeters, inclusive. In some embodiments, the maximum axial length Δ is within the range of 1 millimeter to 5 millimeters, inclusive.

[0087] The distal end 114 of the laser optical fiber 112 is disposed proximate to the opening 108. An axial location δ of the distal end 114 of the laser fiber 112 is defined relative to a distal-most location 292 of the opening 108. In embodiments in which the opening 108 defines a plane 292 perpendicular to the working port axis 111 (as shown in FIGS. 20A and 21A ), the distal-most location 292 is any point on the plane 292, and the axial location δ is the distance along the working port axis 111 from the plane 292. In embodiments in which the opening 108 is defined on a molded surface (e.g., such as the dome-shaped contour 262 of the transparent cap 100 of the distal head portions 34l and 34m in FIGS. 16A , 17 , 19 , and 19A ), the distal-most location 292 of the opening 108 can be unique, as identified in FIG. 16A . If the most distal location 292 is singular, then the axial location δ is defined as the distance between the distal end 114 of the laser fiber and the most distal location 292 parallel to the working port axis 111 .

[0088] In some embodiments, the positioning of the distal end 114 of the laser optical fiber 112 is selective over a range of axial locations 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 millimeter distal to the most distal location 292 to 3 millimeters proximal to the most distal location 292, inclusive. In some embodiments, the axial location δ ranges from flush with the most distal location 292 to 1 millimeter proximal to the most distal location 292, inclusive. In some embodiments, the axial location δ ranges from 0.05 millimeters to 0.6 millimeters proximal to the most distal location 292, inclusive.

[0089] A recess 147 for holding the imaging receiver 142 is formed on the base platform 288 and is positioned to face distally. In some embodiments, the distal face 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 tip 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 face 98. The shoulders 294, 296 can be, for example, arc-shaped (as shown), radiused, or beveled.

[0090] The pressure relief portion 192 extends axially from the distal face 98 and radially through the extension portion 286 and the outer tangential surface 97. The pressure relief portion 192 may be one or more notches. The cross-sectional size of the notches may be 0.1 to 1 millimeter, inclusive, in axial depth and 0.2 to 0.5 millimeter, inclusive, in tangential width. The function of the pressure relief portion 192 is described above in connection with Figures 10-15.

[0091] 21-21C , a distal head portion 34o according to one embodiment of the present disclosure is shown. The distal head portion 34o includes various components and features, such as the distal head portion 34n, some of which are designated by the same numerical reference designator. Additionally, the distal head portion 34o includes a distal tip working port 122b extending through the distal tip portion 96 and in fluid communication with a working channel 124 used for irrigation. The distal tip working port 122b can be configured to direct irrigation flow 252 through the base platform 288 or the tangential surface 97 of the distal tip 96. The outlet of the distal tip working port 122 can define an outlet angle φ relative to the working port axis 111 in the distal direction 50 to direct the irrigation flow 252. In some embodiments, the outlet angle φ is within the range of 0 degrees to 170 degrees, inclusive, relative to the distal direction along the central axis 110. In some embodiments, the outlet angle φ is within the range of 10 degrees to 70 degrees, inclusive. In some embodiments, the exit angle φ is in the range of 20 degrees to 45 degrees inclusive.

[0092] In some embodiments, the laser parameters for treatment in the various disclosed embodiments herein are selected according to the following guidelines. (1) Wavelengths in the range of 1.9 micrometers to 2.1 micrometers correspond to the absorption peak of water, which is the main initial chromophore for intracorporeal stone ablation. (2) Limiting the pulse energy to prevent the stone's repulsive effect so as not to weaken the suction effect and to propel the treated stone away from the opening of the suction working port 103. The laser pulse energy for stone pulverization can be as low as 0.001 Joules to 0.2 Joules for this purpose. For stone fragmentation, the laser pulse energy can range from 0.2 Joules to 2 Joules inclusive. (3) In simultaneous suction and irrigation applications, thermal energy absorbed by the liquid medium within the body organ can be partially or completely removed due to suction. With an aspiration flow rate 254 ranging from 50 milliliters per minute to 100 milliliters per minute, inclusive, and an irrigation flow rate 252 ranging from 10 milliliters per minute to 150 milliliters per minute, inclusive, the average laser power delivered by the ablative laser system 46 to the target zone 56 can be increased over conventional laser lithotripsy techniques without adverse effects. Maximum average powers for ureteral applications can be as high as 30 watts to 50 watts, inclusive, for kidney applications, 60 watts to 120 watts, inclusive, for kidney applications, and up to 200 watts, inclusive, for bladder applications. These average powers represent several-fold increases over conventional laser lithotripsy techniques and do not increase 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 watts to 30 watts for ureteral applications and 30 watts to 50 watts for kidney applications. The proposed average laser power increase therefore represents a 1.5 to 2.5 times greater increase than conventional systems. Increasing the average laser power (or pulse repetition rate in fixed laser pulse energy systems) increases the ablation rate proportionally.

[0093] Functionally, an endoscopic system 30 implementing distal head portion 34n operates in a manner similar to an endoscopic system 30 utilizing distal head portion 34a (i.e., suction and irrigation are performed sequentially using working channel 102 as a common working channel 109). An endoscopic system 30 implementing distal head portion 34o operates in a manner similar to an endoscopic system 30 implementing simultaneous suction and irrigation (e.g., with distal head 34b). For both distal heads 34n and 34o, the maximum axial offset Δ between the imaging receiver 142 and the distal-most end 291 of extension portion 286 allows opening 108 to be positioned within viewing angle β of imaging receiver 142. Being within viewing angle β does not necessarily mean that the opening can be visualized by visualization system 54, but merely that at least a portion of opening 108 falls within viewing angle β of imaging receiver 142. In embodiments in which the opening 108 is supported by an opaque structure (e.g., the extension portion 286 is made of an opaque polymer or rubber), the opening 108 may not be visible. Even when the opening 108 is obscured by the opaque structure, the target zone 56 remains largely visible, allowing the ablation process and the response of the intracellular stone 58 or fragments thereof to the flow field 256 to be monitored. In embodiments in which the opening 108 is supported by a transparent or translucent medium (e.g., the transparent cap 100 of the distal head portions 34a-34m), the opening will be visible through the medium, allowing full visualization of the ablation process.

[0094] In contrast to conventional ureteroscopes, the distal face 98 of the disclosed distal head portion 34 is designed to be in contact or near-contact with the target stone 58 or fragment. At an axial location δ greater than approximately 0.2 mm proximal to the aperture 108, the distal end 114 of the laser optical fiber 112 is not always in direct contact with the intracorporeal stone 58 or stone fragment, even during active aspiration. Despite the lack of direct contact, laser energy can be effectively delivered to the stone 58 in a liquid medium environment through a distance of up to approximately 3 mm. By operating the laser at a wavelength at or near the peak absorption for water, the water initially absorbs the laser energy, rapidly forming a vapor channel between the distal end 114 of the laser fiber 112 and the stone material, significantly reducing laser energy attenuation. Additionally, the stone 58 or fragment can be vibrated or rotated within the aperture 108, causing the surface of the stone 58 or fragment to move perpendicular to the axis of the laser fiber 112. Such vibration and rotation increases the rate of ablation. The phenomena and effects of vapor channeling and laser fiber vibration are explained in further detail in US Pat. No. 6,223,999 to Altshuler et al., incorporated by reference above.

[0095] The reduction flange 290 acts to prevent blockage of the working channel 102 and working port 103. During aspiration, some fragments generated during ablation will have dimensions that are 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 fragments to become trapped between the laser fiber 112 and the working channel 102. The reduced area of ​​the opening 108 as defined by the reduction flange 290 acts to reduce the size of the fragments that can pass into the working channel 102, thereby reducing the occurrence of blockages.

[0096] Different exit angles φ of the distal head portion 34o are suitable for different modes of operation. In contact mode operation, used to ablate large stones or stone fragments, the irrigation flow 252 should be directed so as not to impinge on the larger stones or fragments. Therefore, a distal tip 96 defining an exit angle φ in the range of 20 degrees to 170 degrees, inclusive, may be utilized. In non-contact mode, the irrigation flow 252 maintains agitation of small fragments within the target zone 56. Therefore, a distal tip 96 defining an exit angle φ in the range of 20 degrees to 45 degrees, inclusive, may be utilized.

[0097] When the working channel 102 is operated with suction, the repulsion effect in contact mode can be partially or completely overcome by drawing fragments toward the working channel, accelerating the treatment of small fragments in non-contact mode. The disclosed endoscopic system 30 operates efficiently when the laser is operated in dusting mode, allowing ablation particles smaller than the inner dimensions of the working channel 102 to be expelled from the body by suction, providing stone-free treatment results. For example, a SUPERPULSE Thulium fiber laser with pulse energy of 0.02 J to 1 J can provide fragmentation and dusting ablation for particle sizes less than 0.5 millimeters. If the laser fiber 112 has a core diameter ranging from 0.05 millimeters to 0.2 millimeters and an outer diameter less than 0.4 millimeters, and the inner diameter of the working channel 102 is greater than 1 millimeter, particles with dimensions less than 0.5 millimeters can be expelled through the working channel 102.

[0098] When performing a laser lithotripsy procedure, an aspiration flow 254 of approximately 200 milliliters per minute may be utilized. The aspiration typically creates a negative pressure within the kidney. Such negative pressure should not deviate from ambient environmental pressure by more than 20%.

[0099] In operation, the aspiration flow 254 and the irrigation flow 252 can be balanced to maintain a net positive irrigation flow. In some embodiments, the irrigation flow 252 exceeds the aspiration flow 254 by up to 50 milliliters per minute. In some embodiments, the net positive irrigation flow is in the range of 10 milliliters per minute to 30 milliliters per minute, inclusive.

[0100] 22A-22D, proposed oval cross sections 164a-164d for illumination optical fibers 132a-132d are shown, according to embodiments of the present disclosure. Illumination optical fibers 132 and their respective oval cross sections 164 are referred to herein collectively and generally by reference numerals 132 and 164, respectively, and specifically by reference numerals 132 and 164 followed by a letter suffix (e.g., illumination optical fiber 132a with oval cross section 164a). Example non-limiting cross sections 164 include a generally rectangular shape with semicircular ends 272 (the "oval" cross section 164a of illumination optical fiber 132a in FIG. 22A), a generally rectangular shape with rounded corners 274 (the "rounded rectangular" cross section 164b of illumination optical fiber 132b in FIG. 22B), a generally elliptical shape 276 (cross section 164c of illumination optical fiber 132c in FIG. 22C), and a plurality or bundle of illumination fibers 132d (combined cross sections 164d of illumination optical fibers 132d) having circular shapes 278 that combine to define a ribbon. In cross section 164d, the bundle of illumination fibers 132d can be arranged such that the circular shapes 278 are continuous in 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 can be gathered about a plane (as shown).

[0101] The illumination optical fiber 132 can also include a buffer layer 282 and an overcoat layer 284 ( FIG. 22A ). In some embodiments, the buffer layer 282 is an FPL-9 layer having a thickness ranging from, for example, 10 micrometers to 20 micrometers, inclusive. In some embodiments, the overcoat layer 284 is a fluoropolymer such as blue TEFZEL® having a thickness ranging from, for example, 20 micrometers to 50 micrometers, inclusive. While the coating layers 282 and 284 are shown for the illumination optical fiber 132 a in FIG. 22A , it will be understood that the coating layers 282 and 284 can be incorporated into any illumination optical fiber 132, including the illumination optical fibers 132 b, 132 c, and 132 d in FIGS. 22B-22D . In some embodiments, the major dimension 166 of the laser optical fiber 132 ranges from 0.2 millimeters to 2.0 millimeters, inclusive. In some embodiments, the minor dimension 168 ranges from 0.1 millimeters to 1.0 millimeters, inclusive. In one embodiment, the major dimension 166 of the laser optical fiber 132 is 0.6 millimeters and the minor dimension is 0.2 millimeters. In some embodiments, the ratio of the major dimension to the minor dimension is in the range of 2:1 to 5:1 inclusive.

[0102] Functionally, the elliptical cross-section 164 of the illumination optical fiber 132 allows 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 configured to increase the dimension (and stiffness) in the tangential direction while reducing the radial profile. The overcoat layer 284 protects the cladding layer 282 and provides lubricity to facilitate sliding of the illumination optical fiber 132 within the lumen 107 during steering operations. In some embodiments, the overcoat layer extends proximal to, but does not pass through, the distal head portion 34. In the illumination optical fiber 132d, the overcoat layer 284 can also hold and bond the individual circular optical fibers together, stabilizing the ribbon's elliptical cross-section 164d.

[0103] In addition to acting as an optical waveguide for transmitting visible light, each elliptical cross-section 164 enables and promotes bending of the elliptical cross-section 164 along its minor dimension 168 (i.e., along a radial coordinate r perpendicular to the major dimension 166) while enhancing stiffness along the major dimension 166 (i.e., along the tangential direction θ) of the illumination optical fiber 132. Thus, the elliptical cross-sections 164 of the illumination optical fiber 132 provide torsional stiffness to the catheter 32 having a flexible shaft, partially or completely negating the need for a separate torsion sleeve that is customary in conventional flexible catheters.

[0104] Thus, by utilizing an illumination optical fiber 132 defining an oval cross section 164, it is possible to eliminate the torsion sleeve and pull wire and associated connectors. As a result, the radial profile of the distal head portion 34d can be reduced to reduce invasiveness and increase the safety of laser lithotripsy procedures.

[0105] Referring to FIG. 23 , a steering handle 300 for use as the handle 38 is shown, according to one embodiment of the present disclosure. The steering handle 300 can be implemented, for example, on a flexible catheter shaft 33. The steering handle 300 can be coupled to the catheter 32 and a pair of illumination optical fibers 132 and configured to apply a force to the illumination optical fibers 132 to articulate the distal head portion 34. In some embodiments, the steering mechanism 39 of the steering handle 300 includes a rotating cam 310 coupled directly to the illumination optical fibers 132. Example embodiments of suitable steering handles are further described in U.S. Patent Application Publication No. 2019 / 0129999, filed June 28, 2019, and U.S. Patent Application Publication No. 2019 / 0129999, filed June 28, 2019, both of which are owned by the assignee of the present application, the contents of which are incorporated herein by reference in their entirety, except for the express definitions and claims contained therein.

[0106] The illumination optical fiber 132 can be secured to the rotating cam 310 with, for example, bonding adhesive 312 (shown). The steering mechanism 39 also includes 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 optical fiber 132 is routed from the illumination system 52 to the rotating cam 310, from the rotating cam 310 to the routing sheath 320, and from the routing sheath 320 through the catheter shaft 33 to the distal head portion 34. 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 powered by one or more batteries 324 (shown).

[0107] 24A-24C , a termination 325 for securing an illumination optical fiber 132 to the distal head portion 34 is shown, according to an embodiment of the present disclosure. The terminations are referred to collectively and generally by reference number 325, and individually and specifically by reference number 325 followed by a letter suffix (e.g., "termination 325a"). In termination 325a ( FIG. 24A ), a straight illumination optical fiber 132 is routed into the optical fiber port 134 and adhered to the transparent cap 100 with a transparent or translucent bonding adhesive 327. In some embodiments, the buffer layer 282 is stripped from the portion of the optical fiber that is inserted into the transparent cap 100.

[0108] In termination section 325b (FIG. 24B), a termination head 329 is formed at the distal end of illumination fiber 132. Termination head 329 is shown as a sphere in FIG. 24B, but more typically has a radial dimension greater than the radial dimension of the shaft of illumination optical fiber 132 and is characterized by a rounded surface. Termination head 329 is encased within optical fiber port 134 defined by transparent cap 100 using a transparent or translucent bonding adhesive 327.

[0109] In termination 325c (FIG. 24C), termination head 329 is encased in a fiber optic port formed only in distal tip portion 96 of distal head portion 34, also using a transparent or translucent bonding adhesive 327. Transparent cap 100 extends over the distal end of fiber optic port 134.

[0110] Functionally, the effect of stripping away buffer 282, as discussed above, is to enhance the redirection of visible light 222. Refraction of visible light 222 through the rounded surfaces of termination head 329 increases beam divergence when there may be a refractive index mismatch between illumination optical fiber 132 and bonding adhesive 327. Increasing the dimensions of termination head 329 relative to the dimensions of the shaft of illumination optical fiber 132 also provides structural integrity for the fixation at terminations 325b and 325c.

[0111] In operation, when the rotating cam 310 is actuated in a first rotational direction 326, the first illumination optical fiber 132 is pulled under tension, causing the distal head portion 34 to articulate in a first lateral direction. When the rotating cam 310 is actuated in a second rotational direction 328, the second illumination optical fiber 132 is pulled under tension, causing the distal head portion 34 to articulate in a second lateral direction.

[0112] 25A-25D, images 340 of the target zone 56 as generated by the visualization system 54 are presented for various configurations of the distal head portion 34j. The images 340 are referred to herein collectively and generally by reference number 340, and individually or specifically by reference number 340 followed by a letter suffix (e.g., image 340a). Image 340a of the target zone 56 for the distal head portion 34j without the transparent cap 100 (i.e., an axial cap thickness 99 of zero) is presented in FIG. 25A. Image 340a shows a dark shadow fringe 344 along the bottom edge.

[0113] Image 340b (FIG. 25B), viewed through a 1 millimeter axial cap thickness 99, shows reduced dark shadow fringes 344 relative to image 340a and a focused illuminated zone 346 that transitions between a focused, well-illuminated zone 342 and a dark shadow fringe 344, providing more uniform illumination relative to image 340a. Image 340c (FIG. 25C), viewed through a 1.25 millimeter axial cap thickness 99, further reduces dark shadow zone 344. Image 340d (FIG. 25D), viewed through a 1.5 millimeter axial cap thickness 99, provides a substantially uniformly illuminated image.

[0114] Image 340 shows that as axial cap thickness 99 increases, the illumination light spreads out to more uniformly illuminate target zone 56 as viewed by visualization system 54. At some point, for larger axial cap thicknesses 99 and for larger maximum axial offsets Δ of distal head portions 34o and 34p (FIGS. 21B and 21C), the separation between imaging receiver 142 and distal face 106 may cause unacceptable dimness of the image. Thus, in some embodiments, the range of axial cap thickness 99 is between 1 millimeter and 10 millimeters, inclusive. In some embodiments, the range of axial cap thickness 99 is between 1.2 millimeters and 5 millimeters, inclusive.

[0115] In images 340b, 340c, and 340d, opening 108 in distal head portion 34j is in field of view 148. Surprisingly, the presence of opening 108 and working port 103 leading to opening 108 introduces little or no distortion into images 340b, 340c, and 340d, despite the presence of extended structure, extension 182, and pressure relief portion 192 (FIGS. 10 and 11). Other disclosed configurations for transparent cap 100, which have less structure than distal head portion 34j, also introduce little or no distortion into the images.

[0116] In some embodiments, the aforementioned operating methods are provided as instructions on tangible, non-transitory media supplied to the catheter 32. Non-limiting examples of tangible, non-transitory media include paper documents and computer-readable media, including compact discs and magnetic storage devices (e.g., hard disks, flash drives, cartridges, floppy drives). The computer-readable media may be local or accessible via the Internet. The instructions may be completed on a single medium or split among two or more media. For example, a paper document may contain instructions instructing a user to access one or more of the steps of the method via the Internet, with the Internet-accessible steps stored on one or more computer-readable media. The instructions may be in the form of text, graphics, and / or video.

[0117] [Example 1] A prototype distal section 35 for a catheter 32 was constructed using a transparent cap 100 fabricated from quartz according to the embodiment shown in Figures 13-15. This embodiment of the transparent cap 100 was attached to the distal tip of a conventional ureteroscope having an outer diameter of 3 millimeters at the distal tip, an imaging receiver 142 having dimensions of 1 millimeter by 1 millimeter, and a working channel 102 with an inner diameter of 1.2 millimeters and terminating flush with the input of the imaging receiver 142. The outer diameter OD of the transparent cap 100 was 3 millimeters, and the axial cap thickness 99 was 2 millimeters. The inner diameter of the cap working port 103a was 0.8 millimeters, and two notches 194, each 0.3 millimeters wide, extended to the outer tangential perimeter 170 of the distal face 106 to function as pressure reliefs 192. Illumination light was delivered through two illumination optical fibers 132 with a core diameter of 0.12 millimeters and a numerical aperture of 0.6, which delivered visible light from an LED with a power output not exceeding 0.1 watts. The laser fiber 112 used for stone ablation had 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 was positioned completely inside the working port 103a at a distance of 0.2 mm proximal to the opening 108. In the configuration of Example 1, the working channel 102 was used for aspiration, and irrigation was delivered through the cavity 129 of the shaft 33 of a conventional ureteroscope, as described in conjunction with FIG. 3B.

[0118] A SUPERPULSE Thulium fiber laser (FiberLase U2, 1940 nm wavelength and 500 Watt peak power, IPG Photonics, Oxford, Massachusetts, USA) operating at 0.1 Joule pulse energy, 300 Hz pulse repetition rate, and 30 Watt average power was used for stone ablation in all experiments. A phantom made of BEGOSTONE material (a widely accepted model of an intracorporeal stone) was used as a model of an intracorporeal stone. Treatment simulations were performed in a water-filled cuvette. Five phantom stones, each approximately 1.5 mm in diameter, were used for the simulation. Weight and time were precisely measured, but the dimensions of the phantom stones were approximate.

[0119] A comparison was made between the configuration of Example 1 and a conventional configuration in which the working channel 102 delivered irrigation fluid. In the conventional configuration, the cap was removed to expose the end of the catheter shaft. The laser fiber was positioned so that its distal tip extended 3.5 millimeters beyond the end of the shaft. In the configuration of Example 1, completion of treatment was defined as ablation of the stone sample into particles that were completely removed through the suction channel. In the conventional configuration, completion of treatment was defined as fragmentation of the stone sample into particles smaller than 0.5 millimeters (which were removed with an aspiration flow of 10 milliliters / minute over a distance of approximately 40 centimeters). The results are summarized in Table 1.

[0120] [Table 1]

[0121] As can be seen from Table 1, the configuration of Example 1 achieves four times the stone fragmentation efficiency in contact mode compared to the conventional configuration without requiring an increase in laser power. This brings about an increase of over 3.5 times in contactless mode.

[0122] Each of the additional features and methods disclosed herein can be used separately or in conjunction with other features and methods to provide improved apparatus and methods for making and using the same. Accordingly, combinations of the features and methods disclosed herein are not required to practice the present disclosure in its broadest sense, but instead are disclosed merely to specifically describe representative and preferred embodiments.

[0123] Various modifications of the embodiments may be apparent to those skilled in the art upon reading this disclosure. For example, those skilled in the relevant art will recognize that the various features described in the different embodiments may be suitably combined, uncombined, and recombined with other features, either alone or in different combinations. Similarly, all of the various features described above should be considered as example embodiments rather than limitations on the scope or spirit of the disclosure.

[0124] Those skilled in the relevant art will recognize that various embodiments may include fewer features than those illustrated in any individual embodiment described above. The embodiments described herein are not meant to be an exhaustive listing of ways in which various features can be combined. Thus, 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 would be understood by one skilled in the art.

[0125] The following documents are hereby incorporated by reference in their entirety, except for the claims and express definitions contained therein: U.S. Patent No. 6,219,233 to Altshuler et al., filed July 18, 2019, and owned by the present owner; and U.S. Patent No. 6,219,233 to Irby, III. Any incorporation by reference herein is limited so as not to incorporate subject matter contrary to the express disclosure herein.

[0126] Unless otherwise indicated, references contained herein to "embodiments," "disclosure," "the disclosure," "disclosed embodiments," "disclosed embodiments," and the like refer to the specification (text and drawings, including claims) of this patent application, which is not admitted prior art.

[0127] For purposes of claim interpretation, it is expressly intended that the provisions of 35 U.S.C. §112(f) shall not apply unless the specific terms "means for" or "step for" are recited in each claim. [Explanation of symbols]

[0128] 30 Endoscopy System 32 Catheter 33 Catheter shaft 34 Distal head portion 35 distal portion 36 Proximal part 38 Handle 39 Steering mechanism 40 External Systems 42 Irrigation System 44 Suction System 46 Ablation Laser System 48 Pressure Sensor 52 Lighting System 54 Visualization Systems 56 Target Zone 58 Internal stones 96 Distal tip 97 Outer tangent surface 98 distal surface 99 Axial Cap Thickness 100 Transparent cap part 101 Slope 102 working channels 103 Working Port 103a Cap Work Port 103b Distal tip working port 104 Proximal surface 106 Distal surface 107 Lumen 108 Opening 109 Working Channel 110 Center axis 111 Cap work port shaft 112 Laser Optical Fiber 114 Distal end 116 Annular Region 120 Tubular shaft 122 Working Port 122a Cap Work Port 122b Distal tip working port 124 working channels 126 Outer part 128 cross section 129 Cavity 130 Lighting equipment 132 Lighting Optical Fiber 134 fiber optic lighting ports 142 Imaging receiver 144 Imaging Device 145 cable port 146 Cable 147 depression 148 Field of View 164 oval cross section 166 Long dimension 167a Circular cross section 167b Oval cross section 168 Short dimension 169 Short axis 170 Outside tangent perimeter 171 Long axis 182 Extension 186 Distal end 192 Pressure relief section 194 Notch 214 Slope 216 Tangent Perimeter 218 Exit 222 Visible light 224 Distal end section 226 Interface 244 Radial surface 246 Distal end section 252 Irrigation flow 254 Suction flow 256 Flow Field 261 Transition 262 Domed Contour 264 Asymmetric flow cross section 265 Minimum inner dimensions 266 Laser Fiber Optic Port 267 Slope 268 Minimum inner dimensions 269 ​​Exit 272 End 274 corner 276 Nearly elliptical shape 278 circular shape 282 Buffer Layer 284 Overcoat Layer 286 Extension part 288 Base Platform 290 Reduced Flange 291 Distal end 292 Most distal location 294 Shoulder 296 Shoulder 300 Steering Wheel 310 Rotating Cam 312 Bonding Adhesives 316 Shaft 318 Thumb Lever 320 Routing Sheath 322 Light-emitting diode 324 battery 325 Termination 326 First Rotation Direction 327 Bonding Adhesives 328 Second Rotation Direction 329 Terminal Head 340 images 342 Focused and well-lit zone 344 Dark Shadow Fringe 346 Focused illuminated zone

Claims

1. An endoscopic surgical instrument, comprising: a catheter shaft defining a central axis and extending along the central axis, the catheter shaft having a proximal portion coupled to the handle; a distal tip portion coupled to a distal portion of the catheter shaft, the distal tip portion including a distal surface defining an opening; a working channel extending through the catheter shaft from the proximal portion of the catheter shaft to the distal surface of the distal tip portion, the working channel configured as a suction channel; a laser fiber disposed in the working channel, the laser fiber positioned such that a distal end of the laser fiber is selectively positionable at an axial position proximal to the opening in the distal surface; An endoscopic surgical instrument comprising:

2. The endoscopic surgical instrument of claim 1 , wherein the distal end of the laser fiber is selectively positionable axially relative to the opening at a position ranging from −0.05 millimeters to −1.00 millimeters inclusive.

3. The endoscopic surgical instrument of claim 2, wherein the distal end of the laser fiber is selectively positionable axially relative to the opening at a position ranging from −0.05 millimeters to −0.6 millimeters inclusive.

4. 2. The endoscopic surgical instrument of claim 1, further comprising an imaging receiver disposed at the distal tip portion, the imaging receiver positioned such that at least a portion of the opening and the distal end of the laser fiber are within a field of view of the imaging receiver.

5. The endoscopic surgical instrument of claim 1 , wherein the handle includes a clamp configured to position the distal end of the laser fiber at a desired location.

6. The endoscopic surgical instrument of claim 1 , wherein the laser fiber is supported by a laser fiber optic port.

7. The endoscopic surgical instrument of claim 6 , wherein the laser fiber is installed in the laser fiber optic port during manufacture of the endoscopic surgical instrument.

8. 2. The endoscopic surgical instrument of claim 1, further comprising an internal cavity of the catheter shaft excluding the suction channel, the internal cavity extending from the proximal portion to the distal portion of the catheter shaft and defining an irrigation channel.

9. 9. The endoscopic surgical instrument of claim 8, wherein the irrigation channel defines at least two outlets at the distal tip portion for directing irrigation flow at an angle (α) relative to the central axis ranging from 0 degrees to 170 degrees inclusive.

10. the irrigation channel defines at least two outlets at the distal tip portion, the two outlets configured to direct a flow of irrigation fluid in a radial direction (r) to create a flow field such that the irrigation fluid flows with a radially outward vector; The working channel is configured to draw aspiration flow into the opening.

9. An endoscopic surgical instrument according to claim 8.

11. The laser fiber The wavelength matches the absorption peak of water, the pulse energy is in the range of 0.001 Joules to 2 Joules, inclusive; Maximum average power output is in the range of 30 watts to 200 watts inclusive configured to emit laser energy The endoscopic surgical instrument of claim 1 .

Images