Efficient multi-functional endoscopic instruments

Abstract

This paper presents endoscopic surgical instruments and methods that mitigate some of the shortcomings of conventional ureteroscopy, while shortening treatment time, increasing the probability of stone-free treatment, and enhancing treatment safety. [Solution] An instrument for endoscopic applications, including urology. The instrument may include both irrigation and aspiration channels 102, an illumination fiber 112 with steering capabilities for a flexible version of the scope, effective aspiration and suction of tissue and internal calculus fragments, improved visibility of the surgical area. In some embodiments, the distal head is configured to position the opening 108 of the working channel within the field of view of the visualization system. In some embodiments, a transparent cap 100 is placed at the distal end of the endoscope to improve the field of view of the surgical area. The irrigation and aspiration channels 102 may be positioned so that a consistent flow of water attracts tissue and internal calculus particles and removes heated fluid.

Description

Technical Field

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

[0002] This application generally relates to endoscopic devices and methods. More specifically, this application relates to flexible, semi-rigid, and rigid laser endoscopes for laser treatment of stones and tissues in humans and animals.

Background Art

[0003] Kidney stones affect one in 500 Americans each year, causing significant pain and medical costs. Surgical options for symptomatic kidney stone patients include extracorporeal shock wave lithotripsy (ESWL), ureteroscopy, and percutaneous nephrolithotomy (PCNL). The anatomical structure of the human kidney, the composition of the stones, and the body's habits all play major roles in determining the outcome and surgical approach.

[0004] Advances in ureteroscopy over the past decade have been driven by a reduction in the diameter of flexible catheter shafts, enhanced steering and deflection capabilities, improved video imaging, miniaturization of baskets and instruments, and the emergence of holmium (Ho) and thulium (Tm) lasers for lithotripsy (stone destruction). More than 45% of all kidney stone surgeries in the United States are now performed using miniaturized ureteroscopy techniques and lasers.

[0005] Ureteroscopy involves directly observing and treating kidney stones using a small, flexible or rigid device called a ureteroscope. A ureteroscope with a small "working" channel, providing video imaging, is inserted into the bladder and advanced up the ureter until it encounters the kidney stone. The kidney stone can then be destroyed with laser energy transmitted 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 body openings are used for access, and no incisions are required.

[0006] Ureteroscopy 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, using laser settings optimized for the purpose, can break kidney stones into tiny particles with a maximum size of less than 1 millimeter or even less than 0.25 millimeters. In this case, the ablation product can be removed by irrigation flow or by natural outflow from the kidney to the bladder after surgery, providing a stone-free treatment outcome.

[0007] However, ureteroscopy is not always successful with very large kidney stones (e.g., larger than 20 millimeters in size) because the larger size requires longer treatment times and can make it difficult to remove fragments of such stones. Furthermore, medium-sized stones or fragments (e.g., with a maximum size of 1 to 5 millimeters) can be difficult to treat with lasers using contact techniques. For example, a ureteroscope operating in contact mode may experience a strong repulsive effect, which necessitates operation in non-contact mode (e.g., "pop-corning"), but this is time-consuming and does not guarantee a stone-free outcome. Consequently, ureteroscopy is not always successful with very large kidney stones because the larger size requires longer treatment times and can make it difficult to remove fragments of such stones. In such cases, a percutaneous approach may be the best available option. Devices and associated techniques that mitigate or resolve these shortcomings of ureteroscopy would be welcome. [Prior art documents] [Patent Documents]

[0008] [Patent Document 1] U.S. Patent No. 9775675 [Patent Document 2] International Application No. PCT / US19 / 42491 [Patent Document 3] U.S. Patent Provisional Application No. 62 / 868271 [Patent Document 4] U.S. Patent Provisional Application No. 62 / 868105 [Overview of the Initiative] [Problems that the invention aims to solve]

[0009] Various embodiments of this disclosure present endoscopic surgical instruments and methods that mitigate some of the shortcomings of conventional ureteroscopy while shortening treatment time, increasing the probability of stone-free treatment, and enhancing treatment safety. [Means for solving the problem]

[0010] Conventional ureteroscopes include a working channel that passes through the catheter shaft and defines an entry point at the distal end. The primary functions of the working channel are to serve as a conduit for laser optical fibers and other instruments, and to deliver irrigation flow. Some conventional ureteroscopes utilize the input surface of the imaging assembly which is essentially on 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 input surface of the imaging assembly. See, for example, Patent Document 1 to Irby, III ("Irby"), its disclosure is incorporated herein by reference except for the claims and express definitions contained herein. Irby teaches that it is beneficial to terminate the working channel behind the distal surface in order to reduce the distal head catheter shaft diameter. Conventional ureteroscopes typically define a field of view that is ±45 degrees from the axis of the catheter. Therefore, conventional ureteroscopes do not include the entry point to the working channel within the field of view of the imaging assembly. This can impair the functional visualization of the target zone.

[0011] Furthermore, successful laser ablation of internal kidney stones requires contact or near-contact between the laser fiber and the stone. In conventional laser ureteroscopy, such contact requires the distal tip of the laser fiber to extend beyond the distal end of the catheter (usually 2 to 6 millimeters) to allow the surgeon to confirm 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 field of view of the imaging optical system and within the working distance of the imaging optical system. Another important reason for extending and visualizing the fiber is to prevent damage to soft tissue (mucosa) due to accidental ablation of soft tissue. Such ablation and perforation of the ureter or kidney can lead to the need for open surgical intervention. Clear images of the distal tip of the laser fiber and the soft tissue surface can prevent accidental soft tissue ablation.

[0012] Various embodiments of this disclosure are configured such that the opening of the working channel is within the field of view 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, thereby enhancing the field of view of the working area. The presence of the transparent cap also makes it possible to prevent the line of sight from being obstructed by debris generated during the ablation process.

[0013] Conventional laser lithotripsy methods involve the step of delivering laser radiation through a laser fiber to ablate the stone into very small particles ("dust") or fragments. Ablation can be performed in contact or semi-contact mode, or in non-contact ("pop-corning") mode. Non-contact techniques are typically used for treating medium-sized and small stone fragments (usually less than 3 to 5 mm in size) when conventional ureteroscopy does not allow for effective operation in contact or semi-contact mode due to repulsion. In non-contact techniques, the distal end of the laser fiber is positioned in a fixed target zone close to the stone or fragment, and the laser is started without contact between the laser fiber and the stone or fragment. Vaporization and bubble implosion, as well as irrigation of the target zone, cause a flow of liquid medium (mainly water) within the target zone, which in turn agitates the small stone fragments. Non-contact techniques rely on the fragment or stone entering the effective range of the laser radiation within the fixed target zone for further fragmentation and dusting by ablation.

[0014] The limitations and effects of this conventional approach should be considered. Laser power is limited to relatively low levels to prevent overheating of the target zone and strong repulsive effects. In contact mode, the repulsive effect, especially for medium-sized stones or fragments, requires additional non-raising time to trace or "track" the target, further increasing the total treatment time. Tracking each and every one of these fragments is difficult and time-consuming. Non-contact mode is inefficient because actual ablation occurs only when agitated stones or fragments happen 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% to 30% of the total raising time in non-contact mode. The clinical goal of the treatment, a stone-free outcome, is difficult to guarantee because some small fragments move out of the treatment zone due to agitation. These limitations and effects of conventional laser lithotripsy result in longer total treatment times and safety risks due to the risk of overheating the liquid medium in the target zone.

[0015] Various embodiments of this disclosure allow for shorter treatment times for laser lithotripsy because internal stones are attracted to the laser fiber, reducing the need to "track" the internal stones within the treatment organ. The efficiency of destroying internal stones is improved because stones and fragments are attracted (suctioned) toward the opening of the suction channel and the distal end of the ablation laser fiber. The size, shape, and / or position of the irrigation outlet relative to the opening can be configured to provide a flow field that enhances the entrainment of particles in that flow field, drawing internal stones and ablation products into the opening of the suction channel. Furthermore, in some embodiments, the irrigation flow can be adjusted in relation to the suction flow to continuously provide such a flow field during ablation treatment. To enhance monitoring of the ablation, the opening of the suction channel can be positioned distal to the imaging receiver of a visualization system.

[0016] Furthermore, the secondary heat generated by the laser ablation process is efficiently dissipated by the irrigation fluid and removed by the suction of the heated irrigation fluid, thereby reducing the risk of accidental thermal damage to surrounding tissues. The efficient dissipation of heat from the treatment zone also allows for an increase in laser power without increasing the risk of burns to surrounding soft tissues.

[0017] Conventional flexible and semi-rigid endoscopes also include a metal pull wire to provide a bending angle at the distal end of the endoscope. The wire is attached to the distal end and routed through the catheter to the steering mechanism. The wire has a mounting area that occupies a portion of the catheter's cross-section. Furthermore, a connector is required at the distal end of the catheter to provide a rigid connection, which also occupies cross-sectional space. Also, steering catheters often require a torsion sleeve so that rotation of the shaft at the proximal end of the catheter is converted into rotation at the distal end. The torsion sleeve also occupies cross-sectional mounting area. Such embodiments of steering and aiming systems require an increase in the total cross-sectional area of ​​the catheter, particularly at the distal end. The typical diameter of conventional ureteroscopes ranges from 3 to 4 millimeters. Further reducing the diameter to the range of 1.7 to 2.5 millimeters can be achieved by eliminating some functional elements, such as steering components, as disclosed by Irby.

[0018] Various embodiments of this disclosure present distal heads having a more compact radial cross-section than conventional endoscopes by eliminating the need for pull wires and torsion sleeves. By using illumination fibers for steering, the cross-sectional space in the scope, specifically the tip portion, is expanded, making it possible to use both irrigation and aspiration channels within a common catheter shaft. In some embodiments, the illumination fiber is used not only to "pull" the distal portion of the catheter but also to "push" it, thereby providing bidirectional steering with a single illumination fiber. This allows all the functions of the catheter, namely illumination, imaging, irrigation, aspiration, and ablation, to be performed within a cross-sectional dimension ranging from 2 to 2.5 millimeters, including both ends. Within this range of cross-sectional dimensions, it is possible to remove internal stones by ureteroscopy without placing the patient under general anesthesia, as discussed by Irby.

[0019] Structurally, various embodiments of the present disclosure disclose an endoscopic surgical instrument comprising a catheter shaft defining and extending along a central axis, including a proximal and distal portion, wherein a distal head portion is located in the distal portion of the catheter shaft, the distal head portion includes a distal surface, a working channel extends within the catheter shaft from the proximal portion through the distal head portion, the distal head portion defines an opening in the distal surface, and the working channel is configured to receive a laser fiber. An illuminator may be located in the distal head portion, and an imaging receiver is located in the distal head portion, the imaging receiver is located a predetermined axial distance proximal to the most distal end of the distal surface, the axial distance being in the range of 1 to 10 millimeters, including both ends. 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 integrated with the catheter shaft. A laser fiber for insertion into the working channel may be included. In some embodiments, the catheter shaft includes a shaft cross section perpendicular to the central axis of the catheter shaft defining an oval shape, the shaft cross section defining a major axis passing through the maximum dimension of the oval shape and a minor axis perpendicular to the major axis. In some embodiments, the maximum dimension of the shaft cross section is in the range of 2.2 to 2.5 millimeters, including both ends. In some embodiments, the minimum dimension of the shaft cross section is in the range of 1.7 to 2.0 millimeters, including both ends. The oval shape can be elliptical.

[0021] The distal head portion may include a distal tip portion that contacts the distal portion of the catheter shaft, and the imaging receiver is mounted on the distal tip. In some embodiments, the distal tip portion includes a distal surface. The distal tip portion may be integrated with the catheter shaft. In some embodiments, the distal head portion includes a transparent medium fixed distal to the distal tip portion, and the transparent medium includes a distal surface. The opening can be at least partially viewed 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 an outlet, and the outlet is defined by a distal head. The irrigation channel can be defined by an internal cavity of the catheter shaft excluding the suction channel, and the internal cavity extends 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 with respect to the distal direction along the central axis. The distal head portion includes a distal tip portion that contacts the distal portion of the catheter shaft, and the outlet is defined by the distal tip portion. In some embodiments, the predetermined outlet angle is in the range of 0 degrees to 170 degrees including both ends. In some embodiments, the predetermined outlet angle is in the range of 10 degrees to 70 degrees including both ends. In some embodiments, the predetermined outlet angle is in the range of 20 degrees to 45 degrees including both ends.

[0023] The distal head portion can include a distal tip portion that contacts the distal portion of the catheter shaft and a transparent medium fixed distally with respect to the distal tip portion, and the outlet is defined by the distal tip portion and is configured to direct an irrigation flow onto the proximal surface of the transparent medium. In some embodiments, the distal end of the laser fiber can be selectively disposed over a predetermined range of axial positions with respect to the most distal location of the opening. In some embodiments, the predetermined range of axial positions is distal 1 millimeter or less and proximal 3 millimeters or less with respect to the most distal location of the opening. In some embodiments, the predetermined range of axial positions is from the same height as the most distal location of the opening to 1 millimeter or less proximal to the most distal end. In some embodiments, the range of axial positions is distal 0.1 millimeter or more and proximal 0.6 millimeter or less with respect to the most distal location of the distal tip. In some embodiments, the illuminator is an optical fiber, and the optical fiber is fixed to the distal head portion. The catheter shaft can be flexible with the 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 having 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 being fixed to the distal head, a steering handle coupled to the catheter and the optical fiber, the steering handle being configured to apply a force to the first optical fiber to articulate the distal head. The first optical fiber can be fixed to the distal head with an adhesive. In some embodiments, the first optical fiber defines an oval cross-section defining a longitudinal dimension and a short dimension, the longitudinal dimension being the maximum dimension of the oval cross-section, the short dimension being smaller than the longitudinal dimension and perpendicular to the longitudinal dimension about the 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 and second optical fibers can be fixed within the distal head at a location adjacent to the outer radial dimension of the distal head and facing diametrically adjacent to the outer radial surface of the distal head around the central axis of the catheter. In some embodiments, the first optical fiber is one in a first bundle of optical fibers, and the second optical fiber is one in a second bundle of optical fibers. Each of the optical fibers in the first and second bundles can be sequentially arranged tangentially around the central axis of the catheter in the distal head. Each of the optical fibers in the first and second bundles can be concentrated around their respective planes in the distal head. In some embodiments, each of the first and second optical fibers defines an elliptical cross-section defining a long dimension and a short dimension, where the long dimension is the maximum dimension of the elliptical cross-section, and the short dimension is smaller than the long dimension and perpendicular to the long dimension at the central axis of the catheter. The length can range from 0.2 mm to 2.0 mm, including both ends. The minor axis can range from 0.1 mm to 1.0 mm, including both ends. In some embodiments, the ratio of the length to the minor axis is in the range of 2:1 and 5:1, including both ends.

[0026] In some embodiments of this 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, causing the distal head to articulate 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, causing the distal head to articulate in a second lateral direction. The second rotational direction may be opposite to the first rotational direction. Similarly, the second lateral direction may be opposite to the first lateral direction. In some embodiments, the first and second optical fibers are bonded to the rotating cam. The rotating cam may be coupled to a rotatable shaft and to a thumb lever.

[0027] The first and second optical fibers can be operably coupled to an illumination source and routed from the illumination source to a rotating cam, and from the rotating cam to a distal head. In some embodiments, the illumination source is a light-emitting diode. The illumination source can be housed within a steering handle. In some embodiments, a transparent medium defines a pressure relief section extending from an opening. The pressure relief section can extend radially to the outer periphery of the transparent medium and can extend radially to the outer periphery of the distal surface. In some embodiments, a pressure sensor is operably coupled to a working channel. The optical fibers are configured to deliver visible light to a target zone distal to the distal head.

[0028] In various embodiments of this disclosure, an endoscopic surgical instrument for removing internal stones from viscera is disclosed, comprising a catheter shaft having a proximal portion that defines and extends along a central axis and is coupled to a handle, wherein the distal tip portion is coupled to the distal portion of the catheter shaft, a transparent medium is coupled to the distal tip portion and includes a distal surface, and a working channel extends through the catheter shaft and the transparent medium from the proximal portion of the catheter shaft through the distal surface of the transparent medium, with the working channel defining an opening. An illuminator may be positioned at the distal tip, and an imaging receiver is positioned at the distal tip proximal to the transparent medium. The distal surface of the transparent medium may include the distal end of the working channel and is positioned at an axial distance from the imaging receiver in the range of 1 to 10 millimeters, including both ends. In some embodiments, the distal end of the working channel is positioned at an axial distance from the imaging receiver in the range of 1.2 to 5 millimeters, including both ends.

[0029] In some embodiments of this disclosure, the irrigation channel defines at least one outlet at its distal tip to guide the irrigation flow at an angle with respect to the central axis that is in the range of 0 to 170 degrees, including both ends. In some embodiments, this angle is in the range of 10 to 70 degrees, including both ends. In some embodiments, this angle is in the range of 20 to 45 degrees, including both ends.

[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 positioned in an axial location ranging from 1 millimeter distal to the most distal point of the opening, including both ends, to 3 millimeters proximal to the distal surface. In some embodiments, the axial position ranges from the same height as the distal surface, including both ends, to 1 millimeter proximal to the distal surface. In some embodiments, the axial position ranges from 0.1 millimeters to 0.6 millimeters proximal to the distal surface, including both ends. The cross-sectional area of ​​the distal end of the working channel can be in the range of 5% to 50% smaller than the cross-sectional area of ​​the working channel in the rest of the catheter shaft.

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

[0032] Various embodiments of this disclosure disclose a method for removing internal calculus material from an internal organ, which includes the steps of: positioning the distal tip of a catheter assembly in close proximity to internal calculus material contained within an internal organ, wherein the distal tip includes a distal surface defining an opening of a working channel of the catheter assembly, and the internal calculus material is distal to the opening; and positioning an imaging receiver proximal to the distal tip at a predetermined separation distance between the opening and the imaging receiver, while the distal tip is in close proximity to the internal calculus material, the separation distance ranging from 1 to 10 millimeters, including both ends. In some embodiments, the separation distance during the step of positioning the imaging receiver ranges from 1.2 to 5 millimeters. Some embodiments include the step of illuminating a target zone surrounding the calculus material with visible light. Some embodiments include the step of acquiring images of the target calculus and the target zone using the imaging receiver. Some embodiments include the step of positioning a laser fiber within a working channel, with the distal end of the laser fiber in close proximity to the opening. Some embodiments include the step of selectively positioning the distal end of a laser fiber within a distance range that is no more than 3 millimeters proximal to the most distal point of the opening and no more than 1 millimeter distal to the most distal point of the opening, the distance range being parallel to the axis of the working channel at the opening. Some embodiments also include the step of selectively positioning the distal end of a laser fiber within a distance range that is the same height as the opening and no more than 1 millimeter proximal to the opening, the distance range being parallel to the axis of the working channel at the opening.

[0033] Some embodiments include the step of selectively positioning the distal end of a laser fiber within a distance range that is no more than 0.6 mm proximal to the opening and at least 0.1 mm proximal to the opening, the distance range being parallel to the axis of the working channel at the opening. Some embodiments include the step of ablating internal calculus material using the laser fiber. The average laser power delivered by the laser fiber during this method can be in the range of 120 watts to 200 watts, including both ends. Some embodiments include the steps of operating the working channel as a suction channel and removing the ablation product through the working channel. Some embodiments include the step of delivering an irrigation fluid through the distal tip of a catheter. Some embodiments of this disclosure include the step of delivering a flow of irrigation fluid at a directed angle in the range of 0 to 170 degrees, including both ends, with respect to the distal direction along the central axis of the distal tip. Some embodiments include the step of delivering a flow of irrigation fluid at a directed angle in the range of 10 to 70 degrees, including both ends, with respect to the distal direction along the central axis of the distal tip. Some embodiments include the step of delivering a flow of irrigation fluid at a directed angle, which is in the range of 20 to 45 degrees with respect to the distal direction along the 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 calculus material from an internal organ is disclosed, which includes the steps of providing a catheter assembly and providing an action command to the catheter assembly on a non-temporary, tangible medium, the action command being to position the distal tip of the catheter assembly in close proximity to internal calculus material contained within an internal organ, the distal tip including a distal surface defining an opening of a working channel of the catheter assembly, the internal calculus material being distal to the opening, and positioning an imaging receiver proximal to the distal tip, the separation distance between the opening and the imaging receiver while the distal tip is in close proximity to the internal calculus material being in the range of 1 to 10 millimeters, including both ends. The action command may include illuminating a target zone surrounding the calculus material with visible light, acquiring images of the target calculus and the target zone using an imaging receiver, and positioning a laser fiber within the working channel such that the distal end of the laser fiber is in close proximity to the opening. In some embodiments, the operation command includes selectively positioning the distal end of the laser fiber within a distance range that is no more than 3 millimeters proximal to the most distal point of the opening and no more than 1 millimeter distal to the most distal point of the opening, the distance range being parallel to the axis of the working channel at the opening. In some embodiments, the operation command includes selectively positioning the distal end of the laser fiber within a distance range that is the same height as the opening and no more than 1 millimeter proximal to the opening, the distance range being parallel to the axis of the working channel at the opening. In some embodiments, the operation command includes 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 millimeters proximal to the opening, the distance range being parallel to the axis of the working channel at the opening. The operation command may include ablation of lithic material in the body using the laser fiber, and may include delivering an average laser output in the range of 120 watts to 200 watts, including both ends.In some embodiments, the operation command may include removing the ablation product through the working channel and delivering irrigation fluid through the distal tip of the catheter. In some embodiments, the operation command may include operating the catheter assembly to deliver a flow of irrigation fluid at a directed angle ranging from 0 to 170 degrees, including both ends, with respect to the distal direction along the central axis of the distal tip. In some embodiments, the operation command may include operating the catheter assembly to deliver a flow of irrigation fluid at a directed angle ranging from 10 to 70 degrees, including both ends, with respect to the distal direction along the central axis of the distal tip. In some embodiments, the operation command may include operating the catheter assembly to deliver a flow of irrigation fluid at a directed angle ranging from 20 to 45 degrees, with respect to the distal direction along the central axis of the distal tip. In some embodiments, the operation command may include operating the working channel as a suction channel.

[0035] Various embodiments of the present disclosure include a method for removing internal lithological material from an internal organ, the step of inserting an endoscopic surgical instrument including a catheter shaft having a defined central axis and extending thereto, wherein the catheter shaft includes a proximal portion coupled to a handle and a distal tip portion at the distal end, the catheter shaft includes a suction channel extending from the proximal portion to the distal tip portion, and an imaging receiver located at the distal tip, the imaging receiver being positioned axially within a range of 1 to 10 millimeters including both ends from the distal surface of the distal tip portion, at least one illuminator located at the distal tip, a laser fiber being placed in the suction channel, the distal end of the laser fiber being 1 millimeter relative to the distal surface of the distal tip The catheter is extendable to a distance ranging from the distal end to 3 millimeters proximal to the distal surface, and an irrigation channel is defined by an internal gap extending along the length of the catheter shaft, the irrigation channel having an outlet at the distal tip configured to guide the irrigation flow at an angle with respect to the central axis ranging from 0 to 170 degrees, including both ends; an image of the target stone and surrounding region; a position of the distal surface in close proximity to the internal calculus material; initiating an irrigation flow through the irrigation channel; initiating an aspiration flow through the aspiration channel to remove the ablation product through the aspiration channel; and initiating a laser coupled to a laser fiber to ablate the target calculus material. [Brief explanation of the drawing]

[0036] [Figure 1] This is a schematic diagram of an endoscopic system for laser lithotripsy according to one embodiment of the present disclosure. [Figure 2] Figure 1 is an end view of the distal head portion for an endoscope system that can be configured for a common irrigation and suction port according to one embodiment of the present disclosure. [Figure 2A] This is a cross-sectional view of the distal head portion of Figure 2 along the plane IIA-IIA according to one embodiment of the present disclosure. [Figure 3]This is an end view of the distal head portion for the endoscopic system of Figure 1, which can be configured for separate irrigation and suction ports according to one embodiment of the present disclosure. [Figure 3A] These are cross-sectional views of the distal head portion of Figures 3, 4, and 5 along plane III-III according to one embodiment of the present disclosure. [Figure 3B] These are cross-sectional views of the distal head portion of Figures 3, 4, and 5 along plane III-III according to one embodiment of the present disclosure. [Figure 3C] This is a cross-sectional view of a catheter along the plane IIIC-IIIC according to one embodiment of the present disclosure, as shown in Figure 3B. [Figure 4] Figure 1 is an end view of the distal head portion for an endoscope, which has an illumination optical fiber that penetrates the expanded irrigation port of the distal head portion according to one embodiment of the present disclosure. [Figure 5] This is an end view of the distal head portion for an endoscope system of Figure 1, which has an irrigation port around the outer tangent of the transparent cap of the distal head portion according to one embodiment of the present disclosure. [Figure 6] This is an end view of the distal head portion of the endoscopic system shown in Figure 1, configured for an irrigation port that is coplanar with a suction port according to one embodiment of the present disclosure. [Figure 7] This is an end view of the distal head portion of the endoscopic system shown in Figure 1, configured for an irrigation port that is coplanar with a suction port according to one embodiment of the present disclosure. [Figure 8] This is a top view of the distal head portion of a catheter according to one embodiment of the present disclosure, which is equipped with an oval irrigation port at its distal tip. [Figure 9] Figure 1 is a top view of the distal head portion for an endoscopic system, which has a reduced cross-section and an oval irrigation port at the distal tip of a catheter according to one embodiment of the present disclosure. [Figure 10] This is a perspective view of a distal head portion for an endoscope system shown in Figure 1, having an extension with a transparent cap and a pressure relief section, according to one embodiment of the present disclosure. [Figure 11] Figure 10 is a side view of the distal head portion according to one embodiment of the present disclosure. [Figure 12]Figure 1 is a perspective view of a distal head portion for an endoscope system, having a transparent cap with an irrigation port and an illumination fiber fixed thereto, and an integrated pressure relief portion defined within the transparent cap, according to one embodiment of the present disclosure. [Figure 12A] This is a top view of the distal head portion shown in Figure 12, according to one embodiment of the present disclosure. [Figure 12B] This is a side elevation view of the distal head portion according to one embodiment of the present disclosure. [Figure 13] Figure 1 is a top view of the distal head portion for an endoscope system, which has a transparent cap on which an illumination fiber is fixed according to one embodiment of the present disclosure, and an integrated pressure relief portion defined within the transparent cap. [Figure 14] This is a side view of the distal head portion according to one embodiment of the present disclosure. [Figure 15] Figure 13 is a side view of the distal head portion showing the flow field and light diffusion from the illumination optical fiber according to one embodiment of the present disclosure. [Figure 16] Figure 1 is an end view of the distal head portion for an endoscopic system 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] This is a cross-sectional view of the distal head portion of Figure 16 along the plane XVIA-XVIA according to one embodiment of the present disclosure. [Figure 17] Figure 16 is a perspective view of the distal tip portion of the distal head portion, partially assembled with components extending through the catheter shaft according to one embodiment of the present disclosure, and showing a hypothetical asymmetrical dome-shaped transparent cap. [Figure 18] This is a cross-sectional view of the distal tip portion and catheter shaft according to one embodiment of the present disclosure, as shown in Figure 17. [Figure 19] This is an elevation view of the assembled components of Figure 17 according to one embodiment of the present disclosure. [Figure 19A] This is an elevation view of an alternative assembly to Figure 19 according to one embodiment of the present disclosure. [Figure 20]This is an end view of the distal head portion for an endoscope system of Figure 1, according to one embodiment of the present disclosure, which has no transparent cap and has an imaging receiver offset in the axial direction from the opening of the distal head portion. [Figure 20A] This is a cross-sectional view of the distal head portion of Figure 20 along the plane XXA-XXA according to one embodiment of the present disclosure. [Figure 21] This is an end view of the distal head portion for an endoscope system of Figure 1, according to one embodiment of the present disclosure, which has no transparent cap, an imaging receiver offset axially from the opening of the distal head portion, and a dedicated irrigation port. [Figure 21A] This is a cross-sectional view of the distal head portion of Figure 21 along the plane XXIA-XXIA according to one embodiment of the present disclosure. [Figure 21B] This is a cross-sectional view of the distal head portion of Figure 21 along the planar line XXIB-XXIB according to one embodiment of the present disclosure. [Figure 21C] This is a cross-sectional view of an alternative configuration for the distal head portion of Figure 21, along the planar line XXIB-XXIB, according to one embodiment of the present disclosure. [Figure 22A] This is a cross-sectional view of a light-emitting optical fiber having an oval cross-section according to one embodiment of the present disclosure. [Figure 22B] This is a cross-sectional view of a light-emitting optical fiber having an oval cross-section according to one embodiment of the present disclosure. [Figure 22C] This is a cross-sectional view of a light-emitting optical fiber having an oval cross-section according to one embodiment of the present disclosure. [Figure 22D] This is a cross-sectional view of a light-emitting optical fiber having an oval cross-section according to one embodiment of the present disclosure. [Figure 23] This is a partial internal view of a steering handle according to one embodiment of the present disclosure, which includes a push-pull optical fiber linkage attached to a rotating cam and coupled to a light source. [Figure 24A] This is a schematic diagram of a termination portion for fixing an optical fiber push linkage to the distal head portion according to an embodiment of the present disclosure. [Figure 24B] This is a schematic diagram of a termination portion for fixing an optical fiber push linkage to the distal head portion according to an embodiment of the present disclosure. [Figure 24C] This is a schematic diagram of a termination portion for fixing an optical fiber push linkage to the distal head portion according to an embodiment of the present disclosure. [Figure 25A] This is a photograph of the target zone as seen through the distal head portion of Figure 10 with the transparent cap removed, according to one embodiment of the present disclosure. [Figure 25B] This is a photograph of the target zone as seen through the distal head portion of Figure 10, which is equipped with a transparent cap having a cap thickness of 1 millimeter according to one embodiment of the present disclosure. [Figure 25C] This is a photograph of the target zone as seen through the distal head portion of Figure 10, which is equipped with a transparent cap having a cap thickness of 1.25 millimeters according to one embodiment of the present disclosure. [Figure 25D] This is a photograph of the target zone as seen through the distal head portion of Figure 10, which is equipped with a transparent cap having a cap thickness of 1.5 millimeters according to one embodiment of the present disclosure. [Modes for carrying out the invention]

[0037] Referring to Figure 1, an endoscopic system 30 for laser lithotripsy according to one embodiment of the present disclosure is schematically shown. 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 having flexibility (schematic), rigidity, or semi-rigidity. 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 control and delivery of the catheter 32 to the distal head portion 34. The external systems 40 may include an irrigation system 42, a suction or inhalation 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 completely integrated into the handle 38, the catheter 32, or the distal head portion 34. The handle 38 may include, for example, control mechanisms for the suction and irrigation systems 42 and 44, a mechanism for adjusting the position of the distal end of the laser fiber, and other components. The fiber positioning mechanism may include a clamp (not shown) that can engage when the distal tip of the fiber is in a desired position. By clamping the fiber, the position of the distal tip of the fiber is fixed, typically with an accuracy in the range of 0.05 mm to 0.1 mm. 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 to the distal direction 50 is referred to herein as the proximal direction 51.

[0038] Functionally, the steering mechanism 39 allows articulated movement of the distal portion 35 of the catheter 32 to guide it through the patient's internal tubule to the target zone 56, particularly in embodiments incorporating a flexible or semi-flexible catheter shaft 33, and to align the distal head portion 34 to focus on individual internal stones 58 within the target zone 56. The illumination system 52 generates visible light delivered to the target zone 56 to illuminate the internal stones 58 and surrounding tissues, 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 internal stones 58. Delivery of laser energy can be achieved using a laser fiber, such as silica or other optical fiber material. The irrigation system 42 provides a pressurized irrigation fluid to cool the target zone 56 and move fragments of internal stones 58 within the target zone 56. The suction system 44 removes the liquid medium from the target zone 56, including any particles from internal stones 58 that may be suspended in the medium. In some embodiments, the suction system 44 includes a pressure sensor 48 that monitors the suction pressure. The pressure sensor can also be used to monitor the irrigation pressure.

[0039] In this specification, “body stone” encompasses all stones produced by the human body, including kidney stones and ureteral stones, as well as their species, including calcium stones, uric acid stones, struvite stones, and cysteine ​​stones. “Body stone” may also include stones found in or formed in other organs of the body, such as bladder stones, gallstones, prostate stones, pancreatic stones, salivary gland stones, and abdominal stones. This disclosure describes, but is not limited to, systems and techniques for destroying kidney and ureteral stones. In consideration of this disclosure, those skilled in the art of body stone therapy will recognize that the various embodiments disclosed herein can be applied to the repair of body stones other than kidney and ureteral stones, as well as to 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. In this specification, the distal head portion is referred to collectively or generally by reference numeral 34, while individual or specific embodiments of the distal head portion are referred to by 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 the catheter shaft 33 and fixed to it (e.g., Figures 16 to 21C). In some embodiments, a transparent cap portion 100 is fixed 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 defining an axial cap thickness 99 between them. In some embodiments, the transparent cap portion 100 defines a distal surface 106, for example, a beveled (illustrated) or arc-shaped inclined surface 101 extending proximal to a corner. The transparent cap portion 100 is manufactured from a material suitable for transmitting visible light and may include low absorptivity and a high damage threshold at the operating wavelength of the ablation laser system 46. Non-limiting examples of materials for the transparent cap 100 include sapphire, quartz, optical ceramics, and mineral or organic glass. In some embodiments, the refractive index of the transparent cap 100 is about 1.31 to 1.35, so as to be substantially consistent with the refractive index of a liquid medium (substantially water). In some embodiments, the distal tip 96 may be manufactured 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 illuminator 130 may be the distal end of an illumination or lighting optical fiber 132 for transmitting light in the visible spectrum and is operably coupled to the illumination system 52 by a handle 38. The illumination optical fiber 132 may extend into the transparent cap 100 through an illumination optical fiber port 134 formed in the distal tip portion 96. Optionally, the illuminator 130 may be a light-emitting diode (LED) (not shown) supplied by an electrical lead extending through the catheter 32 in close proximity to the proximal surface 104 of the transparent cap 100. The illumination optical fiber 132 may act as an optical waveguide and extend through the catheter 32 and be coupled to the illumination system 52 by a handle 38.

[0042] In some embodiments, one or more illumination optical fibers 132 are mechanically fixed to the distal head portion 34a (for example, with adhesive) to, for example, the illumination optical fiber port 134 or the transparent cap 100 or both the illumination optical fiber port 134 and the transparent cap 100. The optical fibers 132 can extend through the lumen 107 (Figures 2A, 3A, and 3C) defined by or located within the catheter 32 and continue to slide freely within it. The illumination optical fibers 132 can extend distally from a steering mechanism 39 located within the handle 38 to translate within the lumen 107. (An example of the steering mechanism 39 is illustrated with reference to Figure 23). The distal head portion 34a is thus coupled to the steering mechanism 39 of the handle 38 via the illumination optical fibers 132. In a catheter 32 equipped with a flexible or semi-flexible shaft 33, the coupling and routing of the illumination fiber 132 in this manner allows the illumination 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 connectors associated with coupling them to the distal head portion 34a.

[0043] The distal head portion 34a defines the distal tip portion 96 and a working channel 102 that passes through the proximal surface 104 and distal surface 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 a suction 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 connected, for example, to a suction system 44 with a handle 38. The distal head portion 34a can define, for example, a central axis 110 and define a circular or oval cross-section centered thereon. The working channel 102 includes a working port 103 formed in the distal head portion 34a and passing through it to define an 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. The cap work port 103a passes through the transparent cap 100 and defines the cap work port axis 111. In some embodiments, the distal tip work port 103b passes through the distal tip portion 96 and transitions between the catheter shaft 33 and the transparent cap 100. Alternatively, embodiments are also conceived in which the transparent cap 100 is directly coupled to the catheter shaft 33 (e.g., without the transition of the distal tip portion), so that the work port 103 includes only the cap work port 103a. Embodiments in which the distal head 34 includes the distal tip portion 96 without a transparent cap are also disclosed herein. (See Figures 20 and 21 and the accompanying discussion below.)

[0044] A laser optical fiber 112 for transmitting ablation laser energy is positioned in the working channel 102, with its distal end 114 positioned close to the distal surface 106 of the transparent cap portion 100, and its proximal end coupled to the ablation laser system 46 via a handle 38. The core diameter of the laser optical fiber 112 can range from 0.05 mm to 0.4 mm for catheters with a flexible shaft and up to 1.5 mm for catheters with a rigid shaft. In some embodiments, the laser optical fiber 112 is substantially concentric with the cap working port axis 111, or otherwise extends through the central portion of the cap working port 103a to define 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 mm, including both ends, relative to the distal surface 106 of the transparent cap portion 100, where "+" and "-" refer to the distal direction 50 and the proximal direction 51 along the work port axis 111, respectively. In some embodiments, the position of the distal end 114 can be controlled within a range of + / - 3 mm, including both ends, relative to the distal surface 106. In some embodiments, the position of the distal end 114 can be controlled within a range of +1 mm to -3 mm, including both ends, relative to the distal surface 106. In some embodiments, the position of the distal end 114 can be controlled within a range of -0 mm to -3 mm, including both ends, 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 mm to -1 mm, including both ends, relative to the distal surface 106. In this specification, the range referred to as "inclusive" includes the endpoint values ​​of the range, as well as all values ​​between the endpoint values.

[0045] In some embodiments, one or more work ports 122 extending through the transparent distal head portion 34 are defined. Work ports 103 and 122 can be piped to a common work channel 109, as shown in Figures 2 and 2A. In some embodiments, the work channel 109 functions alternately as a suction and irrigation channel. As used herein, “work channel” can function as an irrigation channel, a suction channel, or both an irrigation channel and a suction channel. Work channels as used herein are optional and can be configured to accommodate workpieces such as laser fibers and baskets. The inner diameter of the work port 103 can range from 0.5 mm to 1.5 mm, including both ends, in a flexible catheter utilizing a laser fiber with a 0.05 mm core.

[0046] Similar to the work port 103, each of the work ports 122 may include a cap work port 122a and a distal tip work port 122b that are in fluid communication with each other. The cap work port 122a passes through the transparent cap 100. In some embodiments, the distal tip work port 122b passes through the distal tip portion 96 and transitions between the catheter shaft 33 and the transparent cap 100. Alternatively, embodiments are conceivable in which the transparent cap 100 is directly coupled to the catheter shaft 33 (for example, without the transition of the distal tip portion), and the work port 122 includes only the cap work port 122a.

[0047] In some embodiments, the distal head portion 34a includes an imaging receiver 142, which may include an image forming optical system that defines 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 within a range of 90 to 120 degrees (±45 to 60 degrees from the visual axis of the imaging receiver, including both ends). The imaging receiver 142 may be an imaging device 144 (illustrated), such as a complementary metal oxide semiconductor (CMOS) sensor (including a semiconductor chip, imaging optical system, and supporting electronics) or a charge-coupled device (CCD) camera sensor. In some embodiments, the imaging plane of the imaging receiver 142 ranges from 0.5 mm × 0.5 mm to 1.5 mm × 1.5 mm. An example of a CMOS image sensor described is the NANEYE 2D, provided by AWAIBA CMOS Image Sensors of Aargau, Switzerland. See https: / / ams.com / naneye, last visited on 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 a 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 positioned in a recess 147 of the distal surface 98 of the distal tip portion 96. The imaging device 144 can define a field of view β which 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 a handle 38. The distal surface 106 of the transparent cap 100 may be flat (illustrated) or may be molded as a lens (not shown) for imaging onto the imaging receiver 142.

[0049] Referring to Figures 3 and 3A, a distal head portion 34b according to one embodiment of the present disclosure is shown. The distal head portion 34b may include many of the same components and characteristics as the distal head portion 34a, which are indicated by the same reference numerals. The distinction of the distal head portion 34b is that the work port 122 is separated from the work port 103. In some embodiments, the inner diameter of the work port 122 for irrigation ranges from 0.5 mm to 1.5 mm, including both ends. Functionally, having separate ports 103 and 122 utilizing separate work channels 102 and 124 makes it possible to perform irrigation and aspiration simultaneously and continuously during laser treatment.

[0050] Referring to Figures 3B and 3C, the distal head portion 34b is shown together 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 embodiments of Figures 3B and 3C, the working port 122 is in fluid communication with a single working channel 124 bounded by the outer portion 126 of the catheter shaft 33. That is, in some embodiments, the catheter shaft 33 defines a cross section 128 perpendicular to a central axis 110 that defines a cavity 129 extending from the proximal portion 36 to the distal portion 35, and the cavity 129 is 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 fiber 112, the illumination fiber 132 and the 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] In this configuration, the working channel 102 is located within a single working channel 124 and is thereby effectively surrounded. The irrigation system 42 can be coupled to the catheter shaft 33 so that the irrigation fluid can flow through the remaining cavity 129 that is not occupied by the components. The tubular shaft 120 can be implemented with any of the distal head portions 34 shown in Figures 3 to 9.

[0052] Various disclosed endoscopic systems 30 that perform aspiration and irrigation simultaneously can reduce the total treatment time while increasing the safety of the procedure. A method according to one embodiment of the present disclosure may include some or all of the following: (1) A step of identifying stones in the patient's internal organs using ultrasound, fluoroscopy, or other diagnostic methods available to those skilled in the art, (2) Insert the catheter 32 into the patient's body and bring the distal end of the catheter proximal to the target zone 56. (3) Step of obtaining an image of the target internal calculus 58 or calculus fragment, (4) The step of bringing the distal end 114 of the laser optical fiber 112 into contact with or near contact with the target internal calculus or fragment, (5) Steps to initiate the irrigation flow and the suction flow, (6) A step of delivering laser energy from the ablation laser system 46 through the laser fiber 112 to ablate the calculus 58 into large fragments (larger than 1 mm), small fragments (less than 1 mm), or particles (less than 0.25 mm). The above method can be used for both contact and non-contact treatment of internal kidney stones 58.

[0053] Referring to Figure 4, a distal head portion 34c according to an embodiment of the present disclosure is shown. The distal head portion 34c may include many of the same components and characteristics as the distal head portion 34b, which are indicated by the same reference numerals. The distinction of the distal head portion 34c is that the illumination fiber port 134 and the work port 122 overlap so that the illumination fiber 132 penetrates the boundary of the work port 122. A further distinction of the distal head portion 34c is that the work port 122 is shaped to increase the flow cross-sectional area without increasing the overall contour of the distal head portion 34c. In the illustrated embodiment, the work port 122 of the distal head portion 34c is oval to achieve this increase, but other shapes are intended, including a port cross-section that is asymmetrical. An additional discussion of the asymmetric work port 122 is discussed below in conjunction with Figures 8 and 9.

[0054] Functionally, by positioning the distal end 114 of the laser fiber 112 inside the distal head 34, the distal end 114 of the fiber is protected from damage by the products of calculus ablation, and the laser ablation efficiency can be increased while reducing the total laser treatment time. Such positioning minimizes or eliminates fiber burnback and eliminates the need to reposition the distal end 114 of the fiber during laser treatment. 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 fiber 112. By reducing debris in the near field 148, the operator can better visualize the aperture 108, the distal end 114 of the laser fiber 112, and the given target calculus 58 in the body, and the attenuation of light emitted by the illuminator 130 is also reduced for better illumination of the target zone 56. Furthermore, the distal surface 106 of the transparent cap 100 can be more easily visualized than the smaller distal end 114 of the laser optical fiber 112, which can assist the surgeon 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 internal calculus 58. Because there is little to no gap between the distal end 114 and the target internal calculus 58 or fragment (the gap is usually no more than 1 millimeter), the improved control leads to increased ablation efficiency. By reducing the fragments in the near field of view 148, the attenuation of light from the illuminator 130 is also reduced, allowing the target zone 56 to be better illuminated and the image of the target zone 56 to be more clearly visible. By positioning the imaging device 144 in the recess 147, the proximal surface 104 of the transparent cap can be made flat and seated with the distal surface 98 of the distal tip portion 96. The inclined surface 101 reduces the risk of the distal head portion 34a passing through the internal tube to reach the target zone 56.

[0055] By connecting the illumination fiber 132 to the steering mechanism 39 of the handle 38, the illumination fiber 132 can be made to function as a pull linkage and, in some embodiments, as a push-pull linkage for steering the catheter 32 having a flexible or semi-rigid shaft 33. This eliminates the need for separate pull wires and connectors associated with connecting them to the distal head portion 34c, allowing more cross-section to be allocated to the working channel, or reducing the cross-sectional contour of the catheter 32, or a combination of these. By positioning the illumination fiber 132 to penetrate the boundary of the working port 122, a larger cross-sectional area for the irrigation flow is provided.

[0056] By positioning the laser 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, as the aspiration of the solution into the working channel 102 tends to attract the internal stone 58 toward the laser fiber 112. Recessing the distal end 114 mechanically protects the laser 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 force of the irrigation or suction flow, as well as the laser-induced bubbling and flow in the liquid. Such vibrations may be desirable and can be controlled through controlling the laser parameters, as well as the irrigation and / or suction flow (e.g., by adjusting the flow rate).

[0057] Furthermore, by attracting the internal calculus 58 toward the laser optical fiber 112, the “repulsion” effect that occurs when the heat of ablation forms a vapor pocket on the ablation surface of the internal calculus 58 can be reduced or overcome. The repulsion effect is described in more detail in Patent Document 2 by Altshuler et al., filed July 18, 2019, owned by the owner of this application, and its disclosure is incorporated herein by reference, except for the explicit definitions and claims contained therein. In addition, since the distal end 114 can be seen through the transparent cap 100, the visualization and control of the distance between the distal end 114 of the laser optical fiber 112 and the target internal calculus 58 is not impaired. Moreover, the side heat generated by the laser ablation process is efficiently dissipated by the irrigation fluid and removed by the 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 Figure 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 characteristics as the distal head portion 34a, which are indicated by the same reference numerals. Similar to the distal head portion 34a, the distal head portion 34d can utilize an illumination fiber optic 132 as a push-pull element for steering a catheter 32 having a flexible shaft 33. In some embodiments, the illumination fiber optic 132 has an oval cross section 164. Generally, the “oval” cross section 164 has a long dimension 166 and a short dimension 168 perpendicular to each other, where the long dimension 166 is the maximum dimension of the oval cross section 164, and the short dimension 168 is perpendicular to the long dimension 166 and is specified to be smaller than the long dimension 166.

[0059] In some embodiments, the long dimension 166 of the oval cross-section 164 extends tangentially (i.e., substantially parallel to the tangential direction θ with respect to the central axis 110 of the distal head portion 34d), and the short dimension 168 extends radially (i.e., parallel to the radial direction r with respect to the central axis 110 of the distal head portion 34d). In the illustrated embodiment, a work port 122a can be located around the outer tangential perimeter 170 of the transparent cap 100, passing through the proximal and distal surfaces 104 and 106 of the transparent cap 100, and opening at the distal surface 106 and along the outer tangential perimeter 170 of the transparent cap 100 (for example, along the inclined surface 101).

[0060] Referring to Figures 6 and 7, distal head portions 34e and 34f are shown according to one embodiment of the present disclosure, utilizing an illumination optical fiber 132 having an oval cross-section 164 and a work port 122 adjacent to the annular region 116 of the work port 103. Distal head portions 34e and 34f may contain many of the same components and characteristics as distal head portion 34d, which are indicated by the same reference numerals. The distinction between distal head portions 34e and 34f is that the work port 122 encloses the annular region 116. Similar to distal head portion 34a, distal head portions 34e and 34f may 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 work port 122 is circular. In distal head portion 34f, the work port 122 is arc-shaped. Multiple work ports 122, as shown in Figures 3 to 9, can be provided by an irrigation flow through a single work channel 124. In some embodiments, the ratio of the area of ​​the work ports 122 to the opening 108 is in the range of 1.2 to 3.0, including both ends.

[0061] Functionally, when the working channel 102 is used for suction, the proximity of the working port 122 surrounding the opening 108 creates a flow field 256 in which the flow flows outward from the working port 122 and curves inward toward the opening 108. The concept of the flow field will be discussed further in conjunction with Figure 15.

[0062] Referring to Figures 8 and 9, distal head portions 34g and 34h are shown to illustrate a general configuration of the layout of the work port 122 according to embodiments of the present disclosure. The head portion 34g and distal tip portion 96 of the catheter 32 define a circular cross-section 167a (Figure 8) perpendicular to the central axis 110. The work port 122 may be oval to provide a larger flow cross-section that would be provided by a circular irrigation port. The circular distal head portion 34g is characterized by a substantially uniform outer dimension OD. The head portion 34h and distal tip portion 96 define an oval cross-section 167b (Figure 9 and elsewhere), such as an egg-shaped, elliptical, oval, or rounded rectangular cross-section.

[0063] The oval cross-section 167b is achieved by positioning the work port 122 and the illumination fiber optic 132 close to the central axis 110, so that the oval cross-section 167b has a reduced profile (i.e., a smaller cross-sectional area) compared to the circular cross-section 167a. The oval cross-section 167b defines a major axis 171 passing through the maximum 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 minimum outer dimension OD2 of the oval cross-section 167b. In some embodiments, the outer dimensions OD, OD1 of cross-sections 167a, 167b range from 2 mm to 3.2 mm, including both ends. In some embodiments, the outer dimensions OD, OD1 range from 1.7 mm to 2.6 mm, including both ends. In some embodiments, the outer dimensions OD, OD1 range from 2.2 mm to 2.5 mm, including both ends. In some embodiments, the outer dimension OD2 of the cross section 167b is in the range of 1.7 mm to 2.5 mm, including both ends. In some embodiments, the outer dimension OD2 is in the range of 1.7 mm to 2.0 mm.

[0064] Referring to Figures 10 and 11, a distal head portion 34i having an extension 182 of a work port 103 is shown according to one embodiment of the present disclosure. The distal head portion 34i includes many of the same components and characteristics as the distal head portion 34b, which are identified by the same reference numerals. The cap work port 103a defines an opening 108 adjacent to the distal surface 106 of the transparent cap 100. In the distal head portion 34i, the opening 108 of the cap work port 103a is defined at the most distal end 186 of the extension 182. At least one pressure relief portion 192 extends proximal from the opening 108. The pressure relief portion 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 port 122b, defined by the distal tip portion 96, extends through the respective bevels 214 formed on the distal tip portion 96 of the catheter 32. Alternatively, the distal tip portion 96 may define a bevel (not shown) around the tangential perimeter 216 of the outer tangential surface 97. In some embodiments, the proximal surface 104 of the transparent cap 100 extends radially over the bevels 214 to define the outlet 218 of the distal tip working port 122b. Thus, in the distal head portion 34i as shown, there is no cap irrigation port passing through the transparent cap 100. Instead, the irrigation port 122b terminates its working channel 124 proximal to the transparent cap 100 and is configured to direct the flow onto the proximal surface 104 of the transparent cap 100.

[0066] In some embodiments, each illumination fiber 132 is positioned within a corresponding distal end work port 122b, and the illumination fiber extends into a transparent cap 100 of the distal head portion 34i. Each illumination 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 visible light 222. The transparent cap 100 can contact the distal end portion 224 of at least one illumination fiber 132 to fix the illumination fiber 132 to the distal head portion 34, for example. In some embodiments, the interface 226 between the distal end portion 224 of the illumination fiber 132 and the transparent cap 100 is configured to guide the visible light 222 radially away from the illumination fiber. For example, the distal end portion 224 of the illumination fiber 132 may not be cladded to increase the redirection of visible light 222. 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 the visible light 222 away from the illumination optical fiber 132. In another example, the illumination optical fiber 132 defines a relatively large numerical aperture (e.g., in the range of 0.35 to 0.65, including both ends). The embodiments of the above example facilitate the redirection of visible light 222 passing through the transparent cap 100.

[0067] Referring to Figure 12, a distal head portion 34j with a recessed pressure relief section 192 is shown according to one embodiment of the present disclosure. The distal head portion 34j contains many of the same components and characteristics as the distal head portion 34i, which are identified by the same reference numerals. The distinction of the distal head portion 34j is that the pressure relief section 192 extends proximal from the distal surface 106 of the transparent cap 100. That is, the opening 108 of the cap work port 103a is at the same height as the distal surface 106 of the transparent cap 100. Another distinction of the distal head portion 34j is that the work port 122 includes a cap work 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 work port 122a extends through the radial surface 244 of the transparent cap 100. In some embodiments, the bevel 214 is formed on the radial surface 244 of the transparent cap 100 to define the outlet 218. In some embodiments, each distal tip working port 122b is in fluid communication with the corresponding cap working port 122a. The transparent cap 100 may include a distal end portion 246 that extends radially over the cap working port 122a.

[0068] Referring to Figures 13 to 15, a distal head portion 34k with an extended concave pressure relief section 192 is shown according to one embodiment of the present disclosure. The distal head portion 34k contains many of the same components and characteristics as the distal head portion 34j, which are identified by the same reference numerals. The distinguishing feature of the distal head portion 34k is that the pressure relief section 192 extends radially to the outer tangent circumference 170 of the distal surface 106 of the transparent cap 100.

[0069] Functionally, the target zone 56 can be illuminated more uniformly by redirecting the visible light 222 away from the illumination optical fiber 132 and into the transparent cap 100. The pressure relief section 192 from the distal head portion 34i to 34k helps stabilize the internal calculus 58 captured and targeted at the opening 108 of the cap work port 103a in suction mode. Without the pressure relief section 192, the target internal calculus 58 could effectively block the work port 103, creating a larger pressure difference across the internal calculus 58. A high pressure difference generates a large force acting on the target internal calculus 58. These large forces could, for example, destabilize the capture of the target internal calculus 58, causing the internal calculus 58 to detach from the work port 103. In another example, this large force could cause excessively large fragments of the target internal calculus 58 to remain in the work port 103 or become lodged between the laser optical fiber 112 and the work port 103, thereby blocking the distal head portion 34 and damaging the laser optical fiber 112. The pressure relief section 192 allows for suction flow around the captured internal calculus 58, thereby easing the pressure difference across the internal calculus 58 and the associated forces applied to it. The easing of pressure and force reduces capture instability and decreases the occurrence of excessively large fragments remaining in the work port 103.

[0070] By positioning the transparent cap 100 so as to extend radially over the sloping portion 214 (Figures 10, 11, 14, 15, and 19), or by extending the distal end portion 246 of the transparent cap 100 over the sloping portion of the distal end portion 246 (Figure 12), the irrigation flow is deflected radially r to set the flow field 256, as shown in Figure 15. The outlet 218 delivers the irrigation flow 252, which is a radially outward vector, while the suction flow 254 draws the flow into the opening 108. In some embodiments, the peak outflow angle α of the irrigation flow 252 (i.e., the angle at which the maximum flux of the irrigation flow occurs) is concentrated in the range of 10 to 90 degrees with respect to the central axis 110, including both ends. In some embodiments, the peak outflow angle α is in the range of 10 to 60 degrees, including both ends.

[0071] During operation, the radially outward-facing outlet 218 creates a flow field 256 that flows outward from the distal head portion 34k and curves 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 aspiration, sufficiently small fragments of internal calculus 58 (e.g., less than 0.5 mm) are carried into the flow field 256 and discharged through the opening 108 and the working channel 102. Other internal calculus 58 or fragments that are too large to pass through (e.g., 1 to 3 mm) are drawn by the flow field 256 into the target vicinity of the distal end 114 of the laser optical fiber 112. Once these larger stones are carried within the range of the laser optical fiber 112, the ablation laser system 46 can be energized to ablate the internal calculus 58. Ablation breaks the internal calculus 58 into smaller fragments, which are then drawn through the opening 108 into the working channel 102.

[0072] If a large internal calculus 58 enters or approaches the opening 108 during aspiration, the working channel 102 may experience a pressure drop as the calculus blocks the opening 108. Therefore, in some embodiments, the ablation laser system 46 (Figure 1) can ablate internal calculus 58 that causes obstruction induced by a pressure drop in the working channel 102 detected by the pressure sensor 48 of the aspiration system 44.

[0073] Functionally, the laser lithotripsy process is sped up by establishing a flow field 256 that attracts the in-vivo calculus 58 towards 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 its small stones and fragments towards the opening 108 of the suction channel 103 for more efficient operation. The irrigation flow 252 and suction flow 254 can be continuous or pulsed, individually or together. In some embodiments, the pulsed flow is synchronized with the laser pulse to enhance ablation and removal of ablation particles. Because the flow field attracts the in-vivo calculus 58 into the effective range (typically 0 to 3 millimeters) of the laser optical fiber 112, the need to pursue and track the in-vivo calculus 58 is reduced. Also, having been attracted into the effective range of the optical fiber 112, the in-vivo calculus 58 is more efficiently fragmented by the ablation process. Some redirection of visible light 222 makes the illumination of the target zone 56 more uniform, thus improving navigation within the target zone 56. The amount of attenuation by smaller fragments and particles from the internal calculus 58 in the field of view 148 is reduced by aspiration and by the presence of the transparent cap 100 in the near field of view 148.

[0074] Referring to Figures 16 to 19A, distal head portions 34l and 34m according to embodiments of the present disclosure are shown. The distal head portions 34l and 34m may include many of the same components and characteristics as the other distal head portions 34 described above, some of which are indicated by the same reference numerals. Distinctions of the distal head portion 34l include a single illumination optical fiber 132, a transparent cap 100 having a convex or domed contour 262, a distal tip working port 122b defining an asymmetric flow section 264, and a laser optical fiber 112 supported by a laser optical fiber port 266 offset from the cap working port axis 111.

[0075] A single illumination optical fiber 132 can be configured to apply both tensile and compressive forces to the distal head portion 34l. In some embodiments, the cross-section of the single illumination optical fiber 132 is 0.2 mm × 0.5 mm.

[0076] Functionally, a single illumination fiber 132 can occupy less cross-sectional area in the distal head portion 34l than, for example, a pair of illumination fibers 112 in the distal head portion 34d in Figure 5. In addition to the reduced cross-sectional area of ​​the fiber, the associated structural cross-sectional area required to secure the fiber (i.e., the structure to which the fiber is bonded) is also reduced. The reduction in cross-sectional area provides more area for other components of the distal head portion 34l (e.g., for work ports 103, 122b), or a reduction in the overall cross-sectional area 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 mm including both ends, and the minimum outer dimension OD2 is in the range of 1.7 to 2 mm including both ends, still providing an increased cross-sectional flow area compared to other embodiments.

[0077] The dome-shaped contour 262 of the transparent cap 100 is substantially hemispherical and can define a cap work port 103a through which it passes. In some embodiments, the distal head portion 34l is oval and, like the distal head portion 34h (Figure 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 asymmetrical. In the illustrated distal head portion 34l, the dome-shaped contour 262 is asymmetrical along the major axis 171 (Figure 16A) but symmetrical along the minor axis 169 (Figure 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 located above the imaging receiver 142. The distal head portion 34l may 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 the distal head portion 34l to pass smoothly and easily through internal tubules such as the ureter and renal calyces, especially when steering the distal head portion 34l through rotation. By positioning the maximum axial dimension Z of the transparent cap 100 to coincide with the imaging receiver 142, the length (and therefore sharpness) of the path perpendicular to the imaging receiver is increased compared to the flat distal surface 106 of other transparent caps 100 (e.g., Figures 2A, 3A, and 3B). The convex surface of the dome-shaped contour 262 can also be configured to act as a lens that magnifies the image as seen by the imaging receiver 142. The pressure relief portion 192 functions as described in conjunction with Figures 13 and 14.

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

[0080] The laser fiber port 266 can be sized to project radially into the working port 103 and to slide-fit with the laser fiber 112. The working port 103 defines a maximum inner radius R. The projection of the fiber port 266 penetrates into the maximum inner radius R and defines the minimum inner dimension 268 of the working port 103. The laser fiber 112 is mounted in the port 266 during manufacturing and can be sterilized together with the catheter 32. Various methods can be used to mount the laser fiber, including (but not limited to) friction-controlled mechanical mounting, overmolding, adhesive bonding, or other suitable techniques. Such 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 burnback effect of the fiber can be reduced by recessing the distal end 114 of the fiber 112 into the working port 103 proximal to the distal surface 106.

[0082] Functionally, the asymmetric flow cross-section 264 acts to increase the flow cross-section of the distal tip working port 122b compared to a circular, oval, or other axially symmetric cross-section, thereby increasing the cross-section for, for example, irrigation flow or the passage of a catheter tool. Similarly, the offset of the laser fiber port 266 and the laser fiber 112 provides a larger, unobstructed flow cross-section for the working port 103. That is, for a working port 103 having a given cross-sectional flow area, the minimum inner dimension 265 (Figure 7) for a configuration having the laser fiber 112 substantially concentrated within the working port 103 (e.g., Figures 2 to 9 as shown) is somewhat smaller than the inner diameter of the working port 103, but the minimum inner dimension 268 of the working port 103 in the distal head portion 34l can be substantially larger than the maximum inner radius R (Figure 16) of the working port 103. In embodiments where the working port 103 and opening 108 function as suction inlets, a larger minimum inner dimension allows for the suction of larger stone fragments from the target zone 56 than the concentrically positioned laser fiber 112. Furthermore, the laser optical fiber port 266 provides additional protection for the laser optical fiber 112 from damage caused by the passage of stone fragments at the constriction of the work port 103, where the minimum internal dimension 268 is defined.

[0083] The distal head portion 34l shows the transparent cap 100 as extending radially over the beveled portion 214 of the distal tip portion 96, similar to Figures 10, 11, 14, and 15 discussed above. The transparent cap 100 may include a transition section 261 between the proximal surface 104 and the dome-shaped contour 262. The transition section 261 may be, for example, arc-shaped (illustrated) or chamfered. The transition section 261 may allow for smooth movement of the catheter 32 in the proximal direction (e.g., during removal through the internal tube). Alternatively, or in addition, one or more bevels 267 may be defined on the transparent cap 100, as shown for the distal head portion 34m in Figure 19A. The bevels 267 (or chamfers) on the transparent cap 100 have the effect of directing the irrigation flow 252 radially outward. In some embodiments, the distal tip portion 96 defines an outlet 269 that is coplanar with the distal surface 98 of the distal tip portion 96 (illustrated). Embodiments are also conceivable in which a radially outward-facing outlet 218 is combined with a slope 267.

[0084] Referring to Figures 20 and 20A, a distal head portion 34n according to one embodiment of the present disclosure is shown. The distal head portion 34n may include many of the same components and characteristics as other distal head portions 34 described herein, some of which are indicated by the same reference numerals. A feature of the distal head portion 34n is that the distal tip portion 96 includes an extension portion 286 that extends from the base platform 288 to the distal surface 98. The working port 103 extends through the extension portion 286 and the distal surface to define an opening 108 at the distal surface 98. In some embodiments, the extension portion 286 includes a retraction flange 290 that projects radially inward to define the opening 108. The retraction flange 290 defines a diameter of the opening 108 that is smaller than the inner diameter of the working port 103 proximal to the retraction flange 290. In some embodiments, the reducing flange 290 reduces the area of ​​the opening 108 by 5% to 50% relative to the area of ​​the working channel 102 proximal to the reducing flange 290.

[0085] The reducing flange 290 can 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 the reducing flange 290 is shown in Figure 2A, which can be implemented by modifying any of the transparent caps 100 disclosed herein as needed.

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

[0087] The distal end 114 of the laser optical fiber 112 is positioned close to the aperture 108. The axial location δ of the distal end 114 of the laser fiber 112 is defined with respect to the most distal location 292 of the aperture 108. In embodiments where the aperture 108 defines a plane 292 perpendicular to the work port axis 111 (shown in Figures 20A and 21A), the most distal location 292 is any point on the plane 292, and the axial location δ is the distance from the plane 292 along the work port axis 111. In embodiments where the aperture 108 is defined on a molded surface (for example, as the dome-shaped contour 262 of the transparent cap 100 of the distal head portions 34l and 34m in Figures 16A, 17, 19, and 19A), the most distal location 292 of the aperture 108 can be unique, as identified in Figure 16A. If the furthest distal location 292 is unique, the axial location δ is defined as the distance between the distal end 114 of the laser fiber, which is parallel to the working port axis 111, and the furthest distal location 292.

[0088] In some embodiments, the placement of the distal end 114 of the laser optical fiber 112 is selective over a range of axial location δ. In some embodiments, the distal end 114 of the laser fiber 112 can be selectively positioned (i.e., "selectively positionable") within an axial distance range from 1 millimeter distal to the most distant location 292 to 3 millimeters proximal to the most distant location 292 (including both ends). In some embodiments, the axial location δ ranges from the same height as the most distant location 292 to 1 millimeter proximal to the most distant location 292 (including both ends). In some embodiments, the axial location δ ranges from 0.05 millimeters to 0.6 millimeters proximal to the most distant location 292, including both ends.

[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 surface 98 and the base platform 288 define substantially parallel planes (illustrated). In some embodiments, the shoulder portion 294 transitions between the outer tangential surface 97 of the distal tip portion 96 and the tangential perimeter 216 of the base platform 288. Similarly, the shoulder portion 296 transitions between the tangential surface 298 of the extension portion 286 and the distal surface 98. The shoulder portions 294, 296 can be, for example, arc-shaped (illustrated), rounded, or sloped.

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

[0091] Referring to Figures 21 to 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 characteristics, such as the distal head portion 34n, some of which are indicated by the same reference numerals. In addition, the distal head portion 34o includes a distal tip working port 122b that extends through the distal tip portion 96 and is in fluid communication with a working channel 124 used for irrigation. The distal tip working port 122b can be configured to guide the 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 with respect to the working port axis 111 in the distal direction 50 to guide the irrigation flow 252. In some embodiments, the outlet angle φ is in the range of 0 to 170 degrees, including both ends, with respect to the distal direction along the central axis 110. In some embodiments, the outlet angle φ is in the range of 10 to 70 degrees, including both ends. In some embodiments, the exit angle φ is in the range of 20 to 45 degrees, including both ends.

[0092] In some embodiments, the laser parameters for treatment in the various embodiments disclosed herein are selected according to the following guidelines. (1) Wavelengths in the range of 1.9 micrometers to 2.1 micrometers that coincide with the water absorption peak, which is the primary initial chromophore for in-vitro lithotripsy. (2) Limit the pulse energy to prevent the stone's rebound effect so as not to weaken the suction effect and to propel the treated stone away from the opening of the suction work port 103. For this purpose, the laser pulse energy for stone pulverization can be as low as 0.001 joules to 0.2 joules. For stone fragmentation, the laser pulse energy can be in the range of 0.2 joules to 2 joules, including both ends. (3) In applications where aspiration and irrigation are performed simultaneously, the thermal energy absorbed by the fluid medium within the internal organs can be partially or completely removed by aspiration. With aspiration flows 254 ranging from 50 to 100 milliliters per minute including both ends and irrigation flows 252 ranging from 10 to 150 milliliters per minute including both ends, the average laser power delivered to the target zone 56 by the ablation laser system 46 can be increased without adverse effects compared to conventional laser lithotripsy techniques. The maximum average power for ureteral applications can be as high as 30 to 50 watts including both ends, for kidney applications as high as 60 to 120 watts including both ends, and for bladder applications as high as 200 watts including both ends. These average powers represent an increase of several times greater than conventional laser lithotripsy techniques and do not increase the temperature of the fluid medium beyond critical levels for the ureter, kidney, or bladder. For example, conventional laser lithotripsy is typically limited to 10 to 30 watts for ureteral applications and 30 to 50 watts for kidney applications. The proposed increase in average laser power therefore represents an increase of 1.5 to 2.5 times greater than that of conventional systems. The increase in average laser power (or pulse repetition rate in fixed laser pulse energy systems) increases the ablation rate proportionally.

[0093] Functionally, the endoscope system 30 implementing the distal head portion 34n operates in the same manner as the endoscope system 30 utilizing the distal head portion 34a (i.e., aspiration and irrigation are performed sequentially using the working channel 102 as a common working channel 109). The endoscope system 30 implementing the distal head portion 34o operates in the same manner as the endoscope system 30 performing aspiration and irrigation simultaneously (for example, with the distal head 34b). For both distal heads 34n and 34o, the maximum axial offset Δ between the imaging receiver 142 and the most distal end 291 of the extension portion 286 makes it possible to position the aperture 108 within the field of view β of the imaging receiver 142. Being within the field of view β does not necessarily mean that the aperture can be visualized by the visualization system 54, but merely that at least a portion of the aperture 108 is within the field of view β of the imaging receiver 142. In embodiments where the opening 108 is supported by an opaque structure (for example, the extension portion 286 is made of an opaque polymer or rubber), the opening 108 may be invisible. Even when the opening 108 is obscured by an opaque structure, the target zone 56 is still largely visible, allowing monitoring of the ablation process of the internal calculus 58 or its fragments and their response to the flow field 256. In embodiments where the opening 108 is supported by a transparent or translucent medium (for example, a transparent cap 100 over the distal head portions 34a to 34m), the opening will be visible through the medium, thereby enabling full visualization of the ablation process.

[0094] In contrast to conventional ureteroscopes, the distal surface 98 of the disclosed distal head portion 34 is designed to be in contact with or near contact with the target stone 58 or fragment. At a proximal axial location δ greater than approximately 0.2 mm relative to the opening 108, the distal end 114 of the laser optical fiber 112 is not always in direct contact with the internal stone 58 or stone fragment, even during active aspiration. Despite the absence 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 with peak absorption for water or near it, the water initially absorbs the laser energy, rapidly forming a vapor channel between the distal end 114 of the laser fiber 112 and the calculus material, significantly reducing the attenuation of laser energy. Additionally, the stone 58 or fragment can vibrate or rotate in the opening 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 increase the ablation rate. The phenomena and effects of vapor channeling and laser fiber vibration are described in more detail in Patent Document 2 by Altshuler et al., which is incorporated by reference above.

[0095] The reducing flange 290 acts to prevent blockage of the work channel 102 and work port 103. During suction and ablation, some fragments generated will have dimensions greater than or equal to the inner diameter of the work channel 102. The presence of the laser fiber 112 reduces the flow cross-section of the work channel 102, causing fragments to remain between the laser fiber 112 and the work channel 102. The reducing area of ​​the opening 108, when defined by the reducing flange 290, acts to reduce the size of fragments that can pass into the work channel 102, thereby reducing the occurrence of blockage.

[0096] The different outlet angles φ of the distal head portion 34o are suitable for different operating modes. In contact mode operation, used to ablate large stones or stone fragments, the irrigation stream 252 should be guided so as not to collide with larger stones or fragments. Therefore, the distal tip 96 can be utilized to define an outlet angle φ in the range of 20 to 170 degrees, including both ends. In non-contact mode, the irrigation stream 252 maintains agitation of small fragments within the target zone 56. Therefore, the distal tip 96 can be utilized to define an outlet angle φ in the range of 20 to 45 degrees, including both ends.

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

[0098] When performing laser lithotripsy, a suction flow of approximately 200 milliliters per minute can be utilized. Suction generally creates negative pressure within the kidney. This negative pressure should not deviate from the ambient pressure by more than 20%.

[0099] Operationally, the suction 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 suction flow 254 up to 50 milliliters per minute. In some embodiments, the net positive irrigation flow is in the range of 10 to 30 milliliters per minute, including both ends.

[0100] Referring to Figures 22A to 22D, proposed oval sections 164a to 164d for illumination optical fibers 132a to 132d according to embodiments of the present disclosure are shown. In this specification, illumination optical fibers 132 and their respective oval sections 164 are referred collectively and generally by reference numerals 132 and 164, respectively, specifically by reference numerals 132 and 164 followed by letter suffixes (for example, illumination optical fiber 132a with oval section 164a). The non-limiting cross-sections 164 of the example include a substantially rectangular shape with semicircular ends 272 ("oval" cross-section 164a of illumination fiber 132a in Figure 22A), a substantially rectangular shape with rounded corners 274 ("rounded rectangular" cross-section 164b of illumination fiber 132b in Figure 22B), a substantially elliptical shape 276 (cross-section 164c of illumination fiber 132c in Figure 22C), and multiple or bundled illumination fibers 132d (combined cross-section 164d of illumination fiber 132d) having circular shapes 278 that combine to define a ribbon. In cross-section 164d, the bundled 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 bundled illumination fibers 132d can be gathered around a plane (illustrated).

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

[0102] Functionally, the oval cross-section 164 of the illumination fiber 132 allows for a reduction in the cross-sectional dimensions of the catheter 32 and distal head portion 34d relative to the distal head portion 34a. The oval cross-section 164 can be configured to increase tangential dimensions (and stiffness) while reducing the radial profile. The overcoat layer 284 protects the cladding layer 282 and provides lubrication to allow the illumination fiber 132 to slide easily within the lumen 107 during steering operations. In some embodiments, the overcoat layer extends proximal to the distal head portion 34 but does not pass through it. In the illumination fiber 132d, the overcoat layer 284 can also hold and bond the individual circular fiber optics together, stabilizing the oval cross-section 164d of the ribbon.

[0103] In addition to acting as an optical waveguide that transmits visible light, each oval section 164 enhances the rigidity along the long dimension 166 of the illumination optical fiber 132 (i.e., along the tangential direction θ) while allowing and facilitating the bending of the oval section 164 along the short dimension 168 (i.e., along the radial coordinate r perpendicular to the long dimension 166). Thus, the oval sections 164 of the illumination optical fiber 132 provide torsional rigidity to the catheter 32 having a flexible shaft, partially or completely eliminating the need for a separate torsion sleeve which is conventional in conventional flexible catheters.

[0104] Therefore, by utilizing the illumination optical fiber 132 that defines the oval cross-section 164, it becomes possible to eliminate the twisted sleeve, pull wire, and associated connectors. As a result, the radial contour of the distal head portion 34d can be reduced to reduce invasiveness and improve the safety of the laser lithotripsy procedure.

[0105] Referring to Figure 23, a steering handle 300 for use as a handle 38 according to one embodiment of the present disclosure is shown. The steering handle 300 can be implemented, for example, on a flexible catheter shaft 33. The steering handle 300 can be coupled to a catheter 32 and a pair of illumination fibers 132 and configured to apply force to the illumination 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 directly coupled to the illumination fibers 132. Examples of suitable steering handle embodiments are further described in Patent Document 3 filed June 28, 2019, and Patent Document 4 filed June 28, 2019, both of which are owned by the assignee of this application, and their contents are incorporated herein by reference in their entirety, except for the express definitions and claims contained herein.

[0106] The illumination fiber optic cable 132 can be fixed to the rotating cam 310, for example, with a bonding adhesive 312 (illustrated). The steering mechanism 39 may also include a shaft 316 around which the rotating cam 310 rotates. In some embodiments, the steering mechanism 39 includes a thumb lever 318 coupled to the rotating cam 310. In some embodiments, the illumination fiber optic cable 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 to the distal head portion 34 via the catheter shaft 33. In some embodiments, the illumination system 52 includes a light-emitting diode 322 as a visible light source. In some embodiments, the illumination system 52 is housed in a steering handle 38 and powered by one or more batteries 324 (illustrated).

[0107] Referring to Figures 24A to 24C, a termination 325 for securing the illumination optical fiber 132 to the distal head portion 34 is shown according to embodiments of the present disclosure. The termination is collectively and generally referred to as reference numeral 325, and individually and specifically referred to as reference numeral 325 followed by a letter suffix (for example, "termination 325a"). In termination 325a (Figure 24A), a straight illumination optical fiber 132 is routed into the optical fiber port 134 and bonded to the transparent cap 100 with a transparent or translucent bonding adhesive 327. In some embodiments, a buffer layer 282 is stripped from the portion of the optical fiber inserted into the transparent cap 100.

[0108] At the termination section 325b (Figure 24B), a termination head 329 is formed at the distal end of the illumination fiber 132. The termination head 329 is shown as a sphere in Figure 24B, but more generally it is characterized by having a radial dimension larger than the radial dimension of the shaft of the illumination optical fiber 132 and having a rounded surface. The termination head 329 is placed inside the optical fiber port 134 defined by the transparent cap 100 using a transparent or translucent bonding adhesive 327.

[0109] At the termination section 325c (Figure 24C), the termination head 329 is placed within the optical fiber port formed only at the distal tip portion 96 of the distal head portion 34, using a transparent or translucent bonding adhesive 327. The transparent cap 100 extends over the distal end of the optical fiber port 134.

[0110] Functionally, the effect of stripping the buffer 282 is to enhance the redirection of the visible light 222, as discussed above. The refraction of the visible light 222 through the rounded surface of the termination head 329 increases the beam divergence if there is a mismatch in refractive index between the illumination optical fiber 132 and the bonding adhesive 327. By increasing the dimensions of the termination head 329 relative to the dimensions of the shaft of the illumination optical fiber 132, the fixing at the terminations 325b and 325c also becomes structurally complete.

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

[0112] Referring to Figures 25A to 25D, images 340 of the target zone 56 as generated by the visualization system 54 for various configurations of the distal head portion 34j are presented. In this specification, images 340 are referred to collectively and generally by reference numeral 340, and individually or specifically by reference numeral 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., axial cap thickness 99 is zero) is presented in Figure 25A. Image 340a shows a dark shadow fringe 344 along the lower edge.

[0113] Image 340b (Figure 25B) is viewed through an axial cap thickness of 99 mm of 1 mm, and compared to image 340a, the dark shadow fringe 344 is reduced, and the focused illuminated zone 346 transitions between the focused and well-lit zone 342 and the dark shadow fringe 344, resulting in more uniform illumination compared to image 340a. Image 340c (Figure 25C) is viewed through an axial cap thickness of 99 mm of 1.25 mm, and the dark shadow zone 344 is further reduced. Image 340d (Figure 25D) is viewed through an axial cap thickness of 99 mm of 1.5 mm, and provides a substantially uniformly illuminated image.

[0114] Image 340 shows that as the axial cap thickness 99 increases, the illumination light spreads out, illuminating the target zone 56 more uniformly when viewed by the visualization system 54. At some point, for even larger axial cap thicknesses 99, and for larger maximum axial offsets Δ of the distal head portions 34o and 34p (Figures 21B and 21C), separation between the imaging receiver 142 and the distal surface 106 can cause unacceptable dimming of the image. Therefore, in some embodiments, the range of the axial cap thickness 99 is between 1 mm and 10 mm, including both ends. In some embodiments, the range of the axial cap thickness 99 is between 1.2 mm and 5 mm, including both ends.

[0115] In images 340b, 340c, and 340d, the opening 108 of the distal head portion 34j is in the field of view 148. Surprisingly, the presence of the opening 108 and the work port 103 connected to the opening 108 causes little to no distortion in images 340b, 340c, and 340d, despite the presence of the extension structures, the extension 182 and the pressure relief 192 (Figures 10 and 11). Other disclosed configurations for the transparent cap 100, which have fewer structures than the distal head portion 34j, also cause little to no distortion in the images.

[0116] In some embodiments, the aforementioned method of operation is provided as instructions on a tangible, non-temporary medium supplied to the catheter 32. Non-limiting examples of tangible, non-temporary media include paper documents and computer-readable media, including compact disks and magnetic storage devices (e.g., hard disks, flash drives, cartridges, floppy drives). Computer-readable media may be locally accessible or accessible via the Internet. Instructions may be completed on a single medium or divided across two or more media. For example, several instructions instructing a user to access one or more steps of this method via the Internet could be written on a paper document, with the Internet-accessible steps stored on one or more computer-readable media. Instructions may be in the form of text, diagrams, and / or videos.

[0117] [Example 1] A prototype distal portion 35 of a catheter 32 was constructed using a transparent cap 100 made from quartz according to the embodiments shown in Figures 13 to 15. The transparent cap 100 of this embodiment was attached to the distal end of a conventional ureteroscope having an outer diameter of 3 mm at the distal tip, an imaging receiver 142 having dimensions of 1 mm × 1 mm, and a working channel 102 with an inner diameter of 1.2 mm that ends in the same plane as the input of the imaging receiver 142. The outer diameter OD of the transparent cap 100 was 3 mm, and the axial cap thickness 99 was 2 mm. The inner diameter of the cap working port 103a was 0.8 mm, and two notches 194, each 0.3 mm wide, extended to the outer tangent circumference 170 of the distal surface 106 to function as pressure relief sections 192. Illumination light was delivered through two illumination optical fibers 132 having a core diameter of 0.12 mm and a numerical aperture of 0.6, thereby delivering visible light from an LED at an 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 an 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, as described in conjunction with Figure 3B, the working channel 102 was used for suction and irrigation was delivered through the cavity 129 of the shaft 33 of a conventional ureteroscope.

[0118] A SUPERPULSE Thulium fiber laser (FiberLase U2, wavelength 1940 nm and peak power 500 watts, manufactured by IPG Photonics, Oxford, Massachusetts, USA), operating at a pulse energy of 0.1 joules, pulse repetition rate of 300 Hz, and average power of 30 watts, was used for ablation of gallstones in all experiments. A model made of BEGOSTONE material (a widely accepted model of gallstones) was used as a model of the gallstone in the body. Treatment simulations were performed in cuvettes filled with water. Five model gallstones, each approximately 1.5 mm in diameter, were used in the simulations. Weight and time were measured precisely, but the dimensions of the model gallstones were approximate.

[0119] A comparison was made between the configuration of Example 1 and a conventional configuration in which the working channel 102 delivers the irrigation fluid. In the conventional configuration, the cap was removed so that the end of the catheter shaft was exposed. The laser fiber was positioned so that its distal tip extended more than 3.5 mm 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 and complete removal of these particles through the aspiration channel. In the conventional configuration, completion of treatment was defined as fragmentation of the stone sample into particles smaller than 0.5 mm (these were removed with an aspiration flow of 10 ml / min at a distance of approximately 40 cm). The results are summarized in Table 1.

[0120] [Table 1]

[0121] As can be seen from Table 1, the configuration of Example 1, compared to the conventional configuration, does not require an increase in laser output, and the stone fragmentation efficiency in contact mode is four times higher. This has resulted in a massive increase, with a more than 3.5-fold increase in contactless mode.

[0122] Each of the additional figures and methods disclosed herein, either individually or in combination with other features and methods, can provide improved apparatus and methods for producing and using the same. Therefore, combinations of features and methods disclosed herein are not necessarily required to carry out the disclosure in its broadest sense, but are instead disclosed simply to illustrate representative and preferred embodiments.

[0123] Various modifications to the embodiments may be apparent to those skilled in the art by reading this disclosure. For example, those skilled in the art in the relevant technology will recognize that the various features described in different embodiments may be appropriately combined, not combined, and again, individually or in different combinations with other features. Similarly, all of the features described above should be considered as illustrative embodiments rather than limitations on the scope or intent of this disclosure.

[0124] Those skilled in the art will recognize that various embodiments may include fewer features than those exemplified in any individual embodiment described above. The embodiments described herein are not intended to be an exhaustive presentation of how various features can be combined. Thus, the embodiments are not mutually exclusive combinations of features. Rather, the claims may include different individual features selected from different individual embodiments, as will be understood by those skilled in the art.

[0125] The following documents, namely, Patent Document 2 by Altshuler et al., filed on 18 July 2019 and owned by the owner of this application, and Patent Document 1 to Irby, III, are incorporated herein by reference in their entirety, except for the claims and express definitions contained herein. Any incorporation by reference of documents herein is limited so as not to include subject matter contrary to the express disclosure herein.

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

[0127] For the purpose of interpreting the claims, it is explicitly intended that unless the specific terms "means for" or "step for" are included in each claim, the provisions of Section 112(f) of the U.S. Patent Act should not apply. [Explanation of Symbols]

[0128] 30 Endoscopic Systems 32 Catheters 33 Catheter shaft 34. Distal head portion 35 Distal portion 36 Proximal portion 38 handle 39. Steering mechanism 40 External Systems 42 Irrigation System 44 Suction System 46 Ablation Laser Systems 48 Pressure Sensor 52 Lighting Systems 54 Visualization Systems 56 Target Zones 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 Work Port 103a Cap work port 103b Distal tip working port 104 Proximal surface 106 Distal surface 107 Lumen 108 Opening 109 Working Channels 110 Center axis 111 Cap work port shaft 112 Laser optical fiber 114 Distal end 116 Circular Region 120 Tubular shaft 122 work ports 122a Cap work port 122b Distal tip working port 124 working channels 126 Outer part 128 Cross-section 129 Cavity 130 Lighting fixtures 132 Lighting Fiber Optics 134 Lighting Fiber Optic Ports 142 Imaging receiver 144 Imaging device 145 Cable Ports 146 Cable 147 Indentation 148 Field of view 164 Oval Section 166 Length 167a Circular cross-section 167b Oval cross section 168 Short dimensions 169 Short axis 170 Outside tangent perimeter 171 Long axis 182 Extension 186 Distal end 192 Pressure relief section 194 Notches 214 Slope 216 Around the tangent 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 Section 262 Dome-shaped contour 264 Asymmetric flow section 265 Minimum internal dimensions 266 Laser Fiber Optic Ports 267 Slope 268 Minimum internal dimensions 269 ​​Exit 272 End 274 corner 276 Approximately Elliptical Shape 278 Circular shape 282 Buffer Layers 284 Overcoat layer 286 Extension part 288 base platforms 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 Diodes 324 battery 325 Termination 326 First direction of rotation 327 Bonding Adhesive 328 Second direction of rotation 329 Termination head 340 images 342 Focused and well-lit zone 344 Dark Shadow Fringe 346 Focused and illuminated zone

Claims

1. It is a laser lithotripsy endoscope, A flexible catheter extending from the proximal to the distal portion, A suction channel is formed longitudinally within the flexible catheter, having an axis, from the proximal portion to a suction opening that opens to the distal portion of the flexible catheter, The opening formed from the edge of the aforementioned suction opening, A laser fiber having a distal end that extends through the suction channel to a variable position proximal to the opening, and which breaks the stone into pieces small enough to move proximal through the suction channel, A guide installed within the suction channel, which receives the laser fiber at a position radially spaced from the axis of the suction channel, thereby increasing the size of the stone fragments that can be aspirated by the endoscope, A laser-assisted lithotripsy endoscope.

2. The laser lithotripsy endoscope according to claim 1, wherein the rim is non-planar, allowing for the suction of stones without impairing suction.

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

4. The laser lithotripsy endoscope according to claim 1, further comprising an imager positioned near the distal portion of the flexible catheter.

5. The laser lithotripsy endoscope according to claim 4, wherein the imager is configured to visualize at least a portion of the opening and the distal end of the laser fiber.

6. The laser lithotripsy endoscope according to claim 4, wherein the opening is located distal to the imager.

7. The laser lithotripsy endoscope according to claim 1, wherein the suction opening of the suction channel has a diameter smaller than the diameter of the proximal portion of the suction channel.

8. The laser stone-breaking endoscope according to claim 1, further comprising a thulium laser source selectively coupled to the laser fiber.

Images