Nephroscope with flexible and articulatable distal portion

Abstract

To provide a device which removes a kidney stone.SOLUTION: A nephroscope can include a body that is at least partially insertable into a kidney of a patient. An articulation controller on a grippable proximal portion of the body can adjust a position of a flexible distal portion of the body to locate a kidney stone when the body is inserted into the kidney of the patient. The articulation controller can optionally releasably lock the articulation of the flexible distal portion, to fixedly position the flexible distal portion at a specified location proximate the kidney stone. The distal end of the body can include an illuminator to illuminate the kidney stone, a camera to provide a video image of the illuminated kidney stone, an optical fiber to deliver laser light that ablate the kidney stone, and an irrigation lumen and a suction lumen to flush the kidney stone and remove kidney stone fragments.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 968,360, filed January 31, 2020, the contents of which are incorporated herein in their entirety.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates generally to medical procedures and associated devices for removing kidney stones. [Background technology]

[0003] A medical procedure called percutaneous nephrolithotomy (PCNL) may be used to remove kidney stones, especially those that are relatively large and hard and resistant to other forms of stone treatment or some combination thereof. A nephroscope is a viewing device, such as for viewing kidney stones or other objects within the kidney area. Summary of the Invention [Means for solving the problem]

[0004] In one example, a nephroscope may include a body at least partially insertable into a patient's kidney. The body may include a graspable proximal portion, an elongated rigid portion extending from the graspable proximal portion, and a flexible distal portion extending distally from the elongated rigid portion to a distal end. The nephroscope may include an articulation controller on the graspable proximal portion of the body. The articulation controller may adjust the position of the flexible distal portion to locate a kidney stone when the body is inserted into the patient's kidney. The distal end of the body may further illuminate the kidney stone, provide a video image of the illuminated kidney stone, ablate the kidney stone, and remove kidney stone fragments.

[0005] In one example, a nephroscope may include a body partially insertable into a patient's kidney. The body may include a graspable proximal portion, an elongated rigid portion extending from the graspable proximal portion, and a flexible distal portion extending distally from the elongated rigid portion to a distal end. The nephroscope may include an articulation controller located on the graspable proximal portion of the body. The articulation controller may adjust the position of the flexible distal portion to locate a kidney stone when the body is inserted into the patient's kidney. The distal end of the body may further illuminate the kidney stone, provide a video image of the illuminated kidney stone, and deliver laser light to the kidney stone to ablate the kidney stone into kidney stone fragments. The distal end of the body may further irrigate the kidney stone and kidney stone fragments with an irrigation fluid and remove the irrigation fluid and kidney stone fragments.

[0006] In one example, a nephroscope may include a body partially insertable into a patient's kidney. The body may include a graspable proximal portion, an elongated rigid portion extending from the graspable proximal portion, and a flexible distal portion extending distally from the elongated rigid portion to a distal end. The nephroscope may include a plurality of pull wires extending along the body to the flexible distal portion. The pull wires may be located at a plurality of angular positions on the body and on the flexible distal portion, respectively. The nephroscope may include an articulation controller located on the graspable proximal portion of the body. The articulation controller may adjust the position of the flexible distal portion by controllably exerting a proximally directed force on a first pull wire of the plurality of pull wires at a first angular position to radially move the flexible distal portion of the body toward the first angular position. The plurality of pull wires and the articulation controller may adjust the position of the flexible distal portion to locate the kidney stone when the body is inserted into the patient's kidney. The nephroscope may include a circuit board located at the distal end of the body. The nephroscope may include at least one light emitting diode on the circuit board. The at least one light emitting diode may emit light distally, away from the distal end of the body, to illuminate the kidney stone. The nephroscope may include a camera on the circuit board. The camera may capture a video image of the illuminated kidney stone. The nephroscope may include an optical fiber extending along a working channel in the body to the distal end of the body. The optical fiber may deliver laser light to the kidney stone to ablate the kidney stone into kidney stone fragments. The nephroscope may include an irrigation lumen extending along the body to the distal end of the body. The irrigation lumen may deliver irrigation fluid to the kidney stone and kidney stone fragments. The nephroscope may include an aspiration lumen extending along the body to the distal end of the body. The aspiration lumen may remove irrigation fluid and kidney stone debris from the kidney. [Brief explanation of the drawings]

[0007] [Figure 1] FIG. 1 is a perspective view of an example of a nephroscope having a flexible distal portion. [Figure 2] FIG. 2 is a side view of the nephroscope of FIG. 1. [Figure 3] FIG. 2 is a plan view of the nephroscope of FIG. 1. [Figure 4] FIG. 2 is an end view of the distal tip of the nephroscope of FIG. 1. [Figure 5] FIG. 2 is a cross-sectional view of the elongated rigid portion of the nephroscope of FIG. 1. [Figure 6] FIG. 1 is a perspective view of an example of a nephroscope having a flexible distal portion and a video monitor attached to or integrally formed with the nephroscope. [Figure 7] 1 is a schematic representation of the kidneys in the abdominal cavity taken in the coronal plane. [Figure 8] 1 is a flow chart illustrating a method for operating a nephroscope. [Figure 9] 1 is a flow chart illustrating an example of a method for imaging using a nephroscope.

[0008] Corresponding reference characters indicate corresponding parts throughout the several views. Elements in the figures are not necessarily drawn to scale. Configurations shown in the figures are merely examples and should not be construed as limiting in any manner. DETAILED DESCRIPTION OF THE INVENTION

[0009] A medical procedure called percutaneous nephrolithotomy (PCNL) may be used to remove kidney stones, particularly those that are relatively large, hard, refractory to other forms of stone treatment, or any combination thereof. In PCNL, a practitioner may insert a rigid scope into the patient's kidney through an incision in the patient's back. With the scope, the practitioner may locate the kidney stone, break it into smaller pieces, and extract the stone fragments from the kidney. The scope may include an endoscope, a nephroscope, and / or a cystoscope.

[0010] In some procedures, the practitioner may break the stone into smaller fragments by applying a mechanical force, such as a vibratory force, to the stone, for example, by applying pulses of variable amplitude and / or frequency generated outside the patient's body, or by using an ultrasonic breaker to apply a vibratory force similar to the action of a jackhammer. Once the stone has been broken into relatively small fragments, the practitioner may extract the small fragments with a scope.

[0011] Additionally or alternatively, the practitioner may use a relatively powerful infrared laser beam to break up the stone into smaller pieces by illuminating the stone through a scope. The laser beam may ablate the kidney stone into smaller pieces.

[0012] In some procedures, the practitioner may use one instrument to break up the stone into smaller fragments and another separate instrument to visually inspect another area of ​​the kidney. For example, the practitioner may use a rigid nephroscope to provide a vibrating (or pulsating) force. The rigid nephroscope limits the viewing capabilities, allowing the practitioner to see a relatively small area near the location of the jackhammer vibrating force but may not be able to see anything located away from that small area. To view another part of the kidney, the practitioner may withdraw the rigid nephroscope and then use a flexible cystoscope to visually inspect another area of ​​the kidney, helping the practitioner ensure that all of the kidney stone fragments have been captured and removed. If the practitioner misses a stone fragment, the practitioner may then withdraw the flexible cystoscope, reinsert the rigid nephroscope to remove the missed stone fragment, and then reinsert the flexible cystoscope to repeat the visual inspection of another area of ​​the kidney.

[0013] There are disadvantages to using multiple instruments within such a procedure. For example, repeatedly withdrawing one instrument and inserting another is time-consuming. Additionally, sterilizing a flexible cystoscope for subsequent surgery is relatively costly.

[0014] As an improvement over procedures that use one instrument to break up stones into smaller fragments and another instrument to explore another area of ​​the kidney, the nephroscopes described herein may combine the functions of these two separate instruments into a single device. In addition to saving the practitioner time that would otherwise be spent changing instruments, the nephroscopes described herein may be configured for single use, thereby reducing the costs associated with sterilizing reusable flexible cystoscopes.

[0015] For example, a nephroscope may include a body at least partially insertable into a patient's kidney. The body may include a graspable proximal portion, an elongated rigid portion extending from the graspable proximal portion, and a flexible distal portion extending distally from the elongated rigid portion to a distal end. The nephroscope may include an articulation controller on the graspable proximal portion of the body. The articulation controller may adjust the position of the flexible distal portion to locate a kidney stone when the body is inserted into the patient's kidney. The articulation controller optionally releasably locks the articulation of the flexible distal portion to securely position the flexible distal portion at a designated location proximate the kidney stone. The distal end of the body may illuminate the kidney stone, provide a video image of the illuminated kidney stone, ablate the kidney stone, and remove kidney stone fragments.

[0016] Figure 1 is a perspective view of an example of a nephroscope 100 having a flexible distal portion. Figure 2 is a side view of the nephroscope 100 of Figure 1. Figure 3 is a plan view of the nephroscope 100 of Figure 1. Figure 4 is an end view of the distal tip of the nephroscope 100 of Figure 1. Figure 5 is a cross-sectional view of the elongated rigid portion of the nephroscope 100 of Figure 1. The nephroscope 100 of Figures 1-5 is just one example of a nephroscope 100, and other suitable configurations may also be used.

[0017] The nephroscope 100 may include a body 102 that is at least partially insertable into a patient's kidney. The body 102 may include a handle, hub, or other graspable proximal portion 104. The graspable proximal portion 104 may be formed from plastic, metal, or another suitable material.

[0018] The body 102 may include an elongated rigid portion 106 extending from the graspable proximal portion 104. The elongated rigid portion 106 may be formed from plastic, metal, and / or another suitable material. For example, the elongated rigid portion 106 may include a polymer outer portion surrounding a stainless steel wire mesh, which in turn surrounds additional components of the nephroscope 100, described in detail below. The elongated rigid portion 106 may remain rigid relative to the graspable proximal portion 104 when a practitioner inserts the nephroscope 100 into a patient's body and when the practitioner passes one or more stone fragmentation instruments, such as an ultrasonic breaker, through the nephroscope 100.

[0019] The body 102 may include a flexible distal portion 108 extending distally from the elongated rigid portion 106 to a distal end 110. The flexible distal portion 108 may be more flexible than the elongated rigid portion 106. For example, the flexible distal portion 108 may include a series of rigid rings, each ring connected to an adjacent ring by a respective joint including a pivot pin, each pivot pin being circumferentially offset by 90 degrees from an adjacent pin. The pins and rings may form a maneuverable structure that may bend in either direction.

[0020] One or more pull wires 112 (see FIG. 5 ) may extend along the body 102 to the flexible distal portion 108. The pull wires 112 may control the bending of the flexible distal portion 108. The pull wires 112 may be located at multiple angular positions in the body 102 and in the flexible distal portion 108, respectively. For examples in which the body 102 has one or more portions with a circular cross-section, the angular positions may correspond to circumferential positions around the circular cross-section of the body 102. In the particular example of FIG. 5 , there are four pull wires 112 positioned at angular positions of 45 degrees, 135 degrees, 225 degrees, and 315 degrees relative to the horizontal axis (or vertical axis) of FIG. 5 . Other numbers of pull wires and other angular positions may also be used.

[0021] The articulation controller 114 may be located at the graspable proximal portion 104 of the body 102. The articulation controller 114 may be positioned to be actuable by the thumb of a human hand when the human hand grasps the graspable proximal portion 104 of the body 102. The articulation controller 114 may adjust the position of the flexible distal portion 108. The articulation controller 114 may adjust the position by controllably applying a proximally directed force to the first pull wire 112, where the first pull wire 112 is located at a first angular position. The proximally directed force may move the flexible distal portion 108 of the body 102 radially toward the first angular position. The pull wire 112 and the articulation controller 114 may adjust the position of the flexible distal portion 108 to locate a kidney stone when the body 102 is inserted into a patient's kidney.

[0022] In one particular example, nephroscope 100 may include four pull wires 112 positioned at angular positions of 45 degrees, 135 degrees, 225 degrees, and 315 degrees relative to the horizontal axis (or vertical axis) in FIG. 5. In this particular example, the 45 degree and 225 degree pull wires 112 are joined together around a first gear within graspable proximal portion 104, and the 135 degree and 315 degree pull wires 112 are joined together around a second gear within graspable proximal portion 104. In this particular example, articulation controller 114 includes a first knob coupled to the first gear, which may controllably pull one of the 45 degree and 225 degree pull wires 112 and push the other of the 45 degree and 225 degree pull wires 112. Similarly, the articulation controller 114 may include a second knob coupled to a second gear that may controllably pull one of the 135-degree and 315-degree pull wires 112 and compress the other of the 135-degree and 315-degree pull wires 112.

[0023] Once the practitioner locates the stone, the practitioner may lock the articulation of the flexible distal portion 108 using the articulation controller 114 or another suitable element. For example, the articulation controller 114 or another suitable element may lock the pull wire 112 in place by removably pushing the pull wire 112 against one or more locking elements within the graspable proximal portion 104 of the body 102, which then locks the position of the flexible distal portion 108. Another suitable locking mechanism may also be used. The articulation controller 114 may deploy the locking mechanism via a button, lever, slider, switch, dial, or another suitable deployment mechanism. With the articulation locked, the practitioner may deploy the breaker as needed. This locking of the articulation of the flexible distal portion 108 may be referred to as the flexible distal portion 108 being selectively flexible.

[0024] The articulation controller 114 or another suitable element may also unlock the articulation of the flexible distal portion 108. For example, the articulation controller 114 or another suitable element may release the pull wires 112 from one or more locking elements in the graspable proximal portion 104 of the body 102. The articulation controller 114 may deploy the unlocking mechanism using a locking mechanism. For example, the locking mechanism may include depressing a button, and the unlocking mechanism may include releasing or pulling the button. The articulation controller 114 may unlock the articulation of the flexible distal portion 108 using a separate button, lever, slider, switch, dial, or another suitable deployment mechanism. With the articulation unlocked, the practitioner may reposition the flexible distal portion 108 as needed to examine additional portions of the kidney. Other locking and / or unlocking mechanisms may also be used. The articulation controller 114 may be switched between a first configuration in which the position of the flexible distal portion 108 is adjustable and a second configuration in which the position of the flexible distal portion 108 is fixable at a selectable position. This is just one example configuration for the pull wires 112 and articulation controller 114; other configurations may also be used.

[0025] The flexible distal portion 108 may be flexible relative to the handle or elongated rigid portion 106 once inside the kidney and undergoing imaging. The flexible distal portion 108 may have sufficient columnar strength to ensure that it may be inserted through a puncture. The flexible distal portion 108 may be configured similarly to a flexible endoscope. The flexible distal portion 108 may include torque carriers and additional support structures, such as braids or meshes, that may help provide columnar strength and increase pushability, yet still be flexible relative to the elongated rigid portion 106. The articulation controller 114 controls the articulation of the flexible distal portion 108 so that the flexible distal portion 108 is rigid (relative to its relative stiffness relative to the elongated rigid portion 106) during insertion through a puncture into the kidney, and may be actuated to adjust the stiffness so that the flexible distal portion 108 can be moved distally to image once inside the kidney. Once the stone is located, the articulation controller 114 may again be actuated so that the flexible distal portion 108 has sufficient rigidity and its articulation is fixed. The flexible distal portion 108 may then be stationary relative to the elongated rigid portion 106 and will not move further during stone ablation. After ablation, the practitioner may further articulate the flexible distal portion 108 to perform additional imaging.

[0026] A substrate 116 (see FIG. 4 ) may be located at the distal end 110 of the body 102. The substrate 116 may include one or more of a circuit board, a hybrid chip, a ceramic component, or another suitable component or element. The substrate 116, and any components located on the substrate 116, may be formed separately from the body 102 and subsequently attached to the distal end 110 of the body 102. The substrate 116, and any components located on the substrate 116, may be integrally formed with the distal end 110 of the body 102. The substrate 116 may be integrally formed with the distal end 110 of the body 102 and any components located on the substrate 116 may be subsequently attached to the substrate 116.

[0027] To visualize the kidney stone fragments, the nephroscope 100 may include a visualization system at the distal end 110 of the body 102. The visualization system may illuminate a working area of ​​the kidney stone and may generate a video image or one or more still images of the illuminated area of ​​the kidney stone.

[0028] 6 is a perspective view of an example nephroscope 100A having a flexible distal portion and a video monitor 602 attached to or integrally formed with the nephroscope 100A. A visualization system may direct a video image to a display, such as the video monitor 602. The display may be external to the nephroscope 100 and may be viewable during the kidney stone removal procedure. The video monitor 602 may be used with any or all of the elements of the nephroscope 100 of FIGS. 1-5.

[0029] Referring back to FIGS. 1-5, the visualization system may include at least one light-emitting diode 118 (see FIG. 4) located on a substrate 116. The substrate 116 may be a circuit board, with the board circuitry providing mechanical support and power to each light-emitting diode 118. The light-emitting diode(s) 118 may emit light distally, away from the distal end 110 of the body 102, to illuminate the kidney stone. One or more light-emitting diodes 118 may emit white light to illuminate the kidney stone. The white light may allow a practitioner to observe bleaching or another color-based effect in the kidney stone or in tissue proximate the distal end 110 of the body 102. One or more light-emitting diodes 118 may emit blue light to illuminate the kidney stone. The blue light may be suitable for indicating thermal tissue evolution, thereby detecting damage within the tissue. Other colors and / or color bands, such as red, amber, yellow, green, etc., may also be used.

[0030] The substrate 116 may include an optional lens 120 (see FIG. 4) for each light emitting diode 118, which may adjust the light output from the light emitting diode 118 to an angular configuration. The lens 120 may narrow the light output from the light emitting diode 118. The lens 120 may widen the light output from the light emitting diode 118. Such angular adjustment may help ensure that kidney stones and tissue are adequately illuminated within a specified viewing angle.

[0031] The visualization system may include a camera 122 (see FIG. 4 ) located on a substrate 116. The substrate 116 may be a circuit board that mechanically supports and powers the camera 122. The camera 122 may capture a video image of the illuminated kidney stone or one or more still images. The video image may be real-time or near real-time with a relatively low latency for processing, allowing a practitioner to observe the kidney stone and surrounding tissue as the practitioner steers the body 102 to control the nephroscope 100. The camera 122 may include a lens and a multi-pixel sensor located in the focal plane of the lens. The sensor may be a color sensor, such as a sensor that provides intensity values ​​for red, green, and blue light for each pixel in the video image. The circuit board may generate a digital video signal representing the captured video image of the illuminated kidney stone. The digital video signal may have a video refresh rate of 10 Hz, 20 Hz, 24 Hz, 25 Hz, 30 Hz, 40 Hz, 50 Hz, 60 Hz, or another suitable video refresh rate.

[0032] The at least one light-emitting diode 118 may include two light-emitting diodes 118. The camera 122 may be located between the two light-emitting diodes 118. The at least one light-emitting diode 118 may include multiple light-emitting diodes 118 surrounding the camera 122. Each of the multiple light-emitting diodes 118 may emit the same color band or different color bands. For example, one light-emitting diode of the multiple light-emitting diodes 118 may emit white light and another may emit blue light. Different light sources may be used to better visualize different elements inside the body, such as kidney stones or tissue, as described above. These orientations of the light-emitting diodes 118 and the camera 122 may be advantageous in that illumination may be relatively uniform across the field of view of the camera 122 (e.g., illumination may have relatively little bias toward one side of the field of view).

[0033] The visualization system may include an electrical port 124 coupled to a substrate 116, such as a circuit board, on the body 102. For example, one or more wires 126 may extend along the body 102 from the electrical port 124 to the substrate 116. The electrical port 124 may receive and provide electrical power to the circuit board. The electrical port 124 may provide a wired connection for a digital video signal via a suitable, optionally multi-pin, electrical connector. The circuit board 116 may wirelessly communicate the digital video signal to a display device, such as a user device, a display, a computer monitor, a heads-up display, a wearable display, a virtual reality display, an augmented reality display, or the like, that is external to the nephroscope 100.

[0034] The optical fiber 128 (see FIG. 5) may extend along a working channel 130 (see FIG. 5) within the body 102 to the distal end 110 of the body 102. The optical fiber 128 may deliver a laser beam to the kidney stone to ablate the kidney stone into kidney stone fragments.

[0035] In some examples, the optical fiber 128 may be integrated into the nephroscope 100. For example, the optical fiber 128 may be delivered with the nephroscope 100 and / or may remain with the nephroscope 100 after use. In some examples, the optical fiber 128 may be separate from the nephroscope 100. For example, the optical fiber 128 may be fed along the working channel of the nephroscope 100 before use and / or may be retrieved from the working channel of the nephroscope 100 after use.

[0036] A laser or laser emitter external to the nephroscope 100 may generate laser light. The laser light may be coupled to the proximal end of the optical fiber 128 via a suitable connector. The laser light may have a wavelength corresponding to the absorption spectral peak of human blood and saline, such as 2100 nm, 1942 nm, etc. For example, a wavelength in the range between 1900 nm and 3000 nm may correspond to the spectral region where water absorbs, while a wavelength between 400 nm and 520 nm may correspond to the spectral region where oxygenated hemoglobin and / or deoxyhemoglobin absorbs. For example, a thulium fiber laser may generate laser light at a wavelength of 1908 nm or 1940 nm, a thulium YAG laser may generate laser light at a wavelength of 2010 nm, a holmium YAG laser may generate laser light at a wavelength of 2120 nm, and an erbium YAG laser may generate laser light at a wavelength of 2940 nm. Other wavelengths within these ranges may also be used. Generally, it may be advantageous to provide laser light with significant absorption in blood and saline because such laser light may be minimally invasive to surrounding tissue, which may reduce or eliminate damage to tissue at or near the kidney stone. The laser may provide light with an output power within a suitable range of output power, such as between 20 watts and 120 watts, between about 20 watts and about 120 watts, etc. These ranges of output power are merely examples, and other suitable output powers or ranges of output power may also be used. The optical fiber 128 may be a multimode fiber or a single-mode fiber.

[0037] A laser controller 132 (see FIG. 2 ) may be located on the graspable proximal portion 104 of the body 102. The laser controller 132 may toggle the state of the laser light between an activated state (“on”) and an inactivated state (“off”). For example, the laser controller 132 may direct a wired and / or wireless signal to a laser located external to the nephroscope 100. The signal may turn the laser on and off. In some implementations, a practitioner may adjust one or more settings for the laser, such as output power, on the laser housing. In some implementations, a practitioner may adjust one or more settings for the laser via the laser controller 132.

[0038] During a typical procedure, the practitioner may operate the laser for a period of time such as 1 minute, 2 minutes, 3 minutes, 4 minutes, or any suitable time by manipulating the laser controller 132. During the laser operation, the practitioner may manipulate the body 102 to move the delivered laser light across the surface of the kidney stone. In some examples, the laser power level and exposure time may be such that the practitioner can safely manually turn the laser power on and off without the need for a mechanized or automated exposure mechanism. The laser power may also be low enough that accidental exposure of surrounding tissue does not cause tissue damage.

[0039] A practitioner may ablate a kidney stone by performing what is called dusting of the surface of the kidney stone. Dusting may abrade the kidney stone in a controlled manner, thereby generating kidney stone particles that may be smaller than the kidney stone fragments obtained from fragmenting or breaking up the kidney stone. For example, a typical kidney stone may be between about 1 mm and about 20 mm in size. Fragmenting or breaking up a kidney stone may generate kidney stone fragments that may be smaller than the size of the stone, such as between a few mm and less than about 10 mm in size. Dusting a kidney stone may generate kidney stone particles that may be less than about 1 mm in size.

[0040] To remove kidney stone fragments, the practitioner may use a stone retrieval device, such as a basket, which may be passed through an orifice in the nephroscope 100. The practitioner may use the stone retrieval device to select and remove individual fragments. In addition to, or as an alternative to, the stone retrieval device, the nephroscope 100 may include an irrigation system to wash away stone fragments.

[0041] The nephroscope 100 may include an irrigation system at the distal end 110 of the body 102. The irrigation system may controllably deliver a flow of irrigant, such as saline, to the ablation site and may controllably remove irrigant and kidney stone fragments from the ablation site.

[0042] The irrigation system may include an irrigation lumen 134 (see FIG. 4), which extends along the body 102 to the distal end 110 of the body 102. The irrigation lumen 134 may provide irrigation fluid to the kidney stones and kidney stone fragments. The proximal end of the irrigation lumen 134 may be connected via a suitable connector to a suitable irrigation fluid source (e.g., a pump that may transfer irrigation fluid from an irrigation fluid reservoir).

[0043] The irrigation system may also include a suction lumen 136 (see FIG. 4 ), which extends along the body 102 to the distal end 110 of the body 102. The suction lumen 136 may remove irrigation fluid and kidney stone debris from the kidney. The proximal end of the suction lumen 136 may be connected, via a suitable connector, to a suitable suction or vacuum source, which may appropriately dispose of the irrigation fluid and kidney stone debris.

[0044] The irrigation system may include an irrigation control 138 (see FIG. 2 ) located on the grippable proximal portion 104 of the body 102. The irrigation control 138 may control the flow of irrigation fluid through the irrigation lumen 134 and the suction in the aspiration lumen 136. The irrigation control 138 may include a depressible irrigation control button that, when repeatedly pressed, cycles through one or more irrigation and / or aspiration levels before turning off irrigation and aspiration. For example, successive presses of the irrigation control button may toggle irrigation and aspiration from off to the lowest level, then from the lowest level to a medium level, then from a medium level to the highest level, then from the highest level to off, off to the lowest level, and so on. The irrigation control 138 may control irrigation and aspiration together with a single control. Another suitable irrigation control element, such as a positionable slide, a positionable lever, or a positionable dial, may also be used to specify the irrigation and / or aspiration levels. The irrigation controller 138 may select from one of a plurality of designated discrete irrigation / aspiration levels. The irrigation controller 138 may also designate irrigation / aspiration levels in a continuous (e.g., non-discrete) manner.

[0045] The nephroscope 100 may optionally include a tube, chamber, additional working channel, or another passageway 140 within the body of the nephroscope 100. The practitioner may use the passageway 140 to deploy a separate tool or instrument, such as a stone breaker, stone retrieval basket, or another suitable tool or instrument.

[0046] In some implementations, the entire nephroscope 100 may be disposed of after a single use. In some implementations, one or more elements of the nephroscope 100 may be disposable, while one or more elements of the nephroscope 100 may be reused for a subsequent procedure. For example, the elongated rigid portion 106 and the flexible distal portion 108 may be detachable from (and / or reattachable to) the graspable proximal portion 104, such that the graspable proximal portion 104 may be cleaned and / or sterilized and reused, while the elongated rigid portion 106 and the flexible distal portion 108 may be discarded after a single use. As another example, the flexible distal portion 108 may be detachable from the elongated rigid portion 106, such that the graspable proximal portion 104 and the elongated rigid portion 106 may be cleaned and / or sterilized and reused, while the flexible distal portion 108 may be discarded after a single use.

[0047] 7 is a schematic diagram of a kidney K within an abdominal cavity AC taken in the coronal plane. The abdominal cavity AC may be defined by a superficial layer E, which provides a barrier to access of the kidney K. A nephroscope 100 may be inserted through the superficial layer E into the kidney K. The kidney K may include an outer cortex Cx, a medulla M, and a calyx Cy. Kidney stones form in various locations within the kidney K, particularly within the calyx Cy.

[0048] During use, a practitioner may insert the flexible distal portion 108 partially or completely into a patient's body, particularly into the patient's kidney. During use, the distal portion 702 of the elongated rigid portion 106 may be located within the patient's body, while the proximal portion 704 of the elongated rigid portion 106 may remain outside the patient's body. The graspable proximal portion 104 of the body 102 remains outside the patient's body before, during, and after use of the nephroscope 100. The graspable proximal portion 104 of the body 102 may be configured to be graspable by a human hand.

[0049] 8 is a flow chart of an example method 800 for operating a nephroscope. Method 800 may be performed in nephroscope 100 of FIGS. 1-5 or in another suitable nephroscope. Method 800 is only one example of a method for operating a nephroscope. Other suitable methods may also be used.

[0050] In operation 802, a practitioner may partially insert the body of a nephroscope into a patient's kidney. The body may include a graspable proximal portion, an elongated rigid portion extending from the graspable proximal portion, and a flexible distal portion extending distally from the elongated rigid portion to a distal end.

[0051] In operation 804, the practitioner may locate the kidney stone by manipulating an articulation controller located on the graspable proximal portion of the body to adjust the position of the flexible distal portion while the body is inserted into the patient's kidney.

[0052] In operation 806, the practitioner may illuminate the kidney stone with the distal end of the body.

[0053] In operation 808, the practitioner may provide a video image of the illuminated kidney stone via the distal end of the body.

[0054] In optional operation 810, the practitioner may deliver laser light to the kidney stone through the distal end of the body to ablate the kidney stone into kidney stone fragments.

[0055] In optional operation 812, the practitioner may irrigate the kidney stones and kidney stone fragments with irrigation fluid through the distal end of the body.

[0056] In optional operation 814, the practitioner may remove irrigation fluid and kidney stone fragments with the distal end of the body.

[0057] 9 is a flow diagram of an example method 900 for imaging using a nephroscope. Method 900 may be performed in nephroscope 100 of FIGS. 1-5 or in another suitable nephroscope. Method 900 is only one example of a method for imaging using a nephroscope. Other suitable methods may also be used.

[0058] In operation 902, the practitioner may use the nephroscope to illuminate an area proximate to the distal end of the nephroscope with the distal end of the nephroscope.

[0059] In operation 904, the practitioner may use the nephroscope to locate the first target by selectively articulating a flexible distal portion of the nephroscope to adjust the position of the distal end of the nephroscope.

[0060] In operation 906, the practitioner may use the nephroscope to identify a first target in an area proximate to the distal end of the nephroscope from an image of the illuminated area when the distal end of the nephroscope is in a first position.

[0061] In operation 908, the practitioner may use the nephroscope to rigidly position the distal end of the nephroscope in a first position by locking the articulation of the flexible distal portion of the nephroscope.

[0062] In an optional operation 910, the practitioner may use the nephroscope to unlock the articulation of the flexible distal portion of the nephroscope.

[0063] In optional operation 912, the practitioner may use the nephroscope to locate a second target by selectively articulating the flexible distal portion of the nephroscope to adjust the position of the distal end of the nephroscope.

[0064] In optional operation 914, the practitioner may use the nephroscope to identify a second target in an area proximate to the distal end of the nephroscope from the image of the illuminated area when the distal end of the nephroscope is in a second position. [Example]

[0065] To further illustrate the devices, related systems, and / or related methods discussed herein, a non-limiting list of examples is provided below. Each of the following non-limiting examples may stand alone or may be combined in any permutation or combination with any one or more of the other examples.

[0066] In Example 1, the nephroscope includes a body insertable at least partially into a patient's kidney, the body including a graspable proximal portion, an elongated rigid portion extending from the graspable proximal portion, and a flexible distal portion extending distally from the elongated rigid portion to a distal end; and an articulation controller at the graspable proximal portion of the body, the articulation controller configured to adjust the position of the flexible distal portion to locate a kidney stone when the body is inserted into the patient's kidney, the distal end of the body further configured to illuminate the kidney stone, provide a video image of the illuminated kidney stone, ablate the kidney stone, and remove kidney stone fragments.

[0067] In Example 2, the nephroscope of Example 1 may optionally be configured such that the articulation controller is coupled to a plurality of pull wires extending along the body to the flexible distal portion, the pull wires being located at a plurality of angular positions in the body and in the flexible distal portion, and the articulation controller is configured to adjust the position of the flexible distal portion by controllably exerting a proximally directed force on a first pull wire of the plurality of pull wires at a first angular position to move the flexible distal portion of the body radially toward the first angular position.

[0068] In Example 3, the nephroscope of any one of Examples 1 to 2 may be configured such that the graspable proximal portion of the main body is formed so as to be graspable by a human hand, and the articulation controller may be optionally configured to be positioned so as to be operable by the thumb of the human hand when the human hand grasps the graspable proximal portion of the main body.

[0069] In Example 4, the nephroscope of any one of Examples 1 to 3 may optionally be configured to include a substrate located at the distal end of the body, at least one light-emitting diode located on the substrate and configured to emit light distally, away from the distal end of the body, to illuminate the kidney stone, and a camera located on the substrate and configured to capture a video image of the illuminated kidney stone.

[0070] In Example 5, the nephroscope of any one of Examples 1 to 4 may optionally be configured such that the at least one light-emitting diode includes two light-emitting diodes and the camera is located between the two light-emitting diodes.

[0071] In Example 6, the nephroscope of any one of Examples 1 to 5 may optionally be configured such that the circuit board is configured to generate a digital video signal representing a captured video image of the illuminated kidney stone.

[0072] In Example 7, the nephroscope of any one of Examples 1 to 6 may optionally further include an electrical port on the body coupled to the circuit board, the electrical port optionally configured to receive electrical power to power the circuit board and provide a wired connection for a digital video signal.

[0073] In Example 8, the nephroscope of any one of Examples 1 to 7 may optionally further include a display coupled to the graspable proximal portion of the body and configured to display a captured video image of the illuminated kidney stone.

[0074] In Example 9, the nephroscope of any one of Examples 1 to 8 may optionally further include an optical fiber extending along the working channel within the body to the distal end of the body, the optical fiber configured to deliver laser light to the kidney stone to ablate the kidney stone into kidney stone fragments.

[0075] In Example 10, the nephroscope of any one of Examples 1 to 9 is optionally configured such that the laser light has a wavelength corresponding to an absorption spectrum peak of human blood and saline.

[0076] In Example 11, the nephroscope of any one of Examples 1-10 may optionally be configured such that the laser light has a wavelength of 2100 nm.

[0077] In Example 12, the nephroscope of any one of Examples 1 to 11 may optionally further include a laser controller located in the graspable proximal portion of the body and configured to toggle the state of the laser light between an operable state and an inoperable state.

[0078] In Example 13, the nephroscope of any one of Examples 1 to 12 may optionally further include an irrigation lumen extending along the body to the distal end of the body and configured to supply irrigation fluid to kidney stones and kidney stone fragments, and an aspiration lumen extending along the body to the distal end of the body and configured to remove irrigation fluid and kidney stone fragments from the kidney.

[0079] In Example 14, the nephroscope of any one of Examples 1 to 13 may optionally further include an irrigation controller located in the graspable proximal portion of the body and configured to control the flow of irrigation fluid through the irrigation lumen and the suction in the suction lumen.

[0080] In Example 15, the nephroscope of any one of Examples 1 to 14 may optionally be configured such that the irrigation controller includes a depressible irrigation control button that, when repeatedly pressed, cycles through one or more irrigation levels before turning off irrigation and suction.

[0081] In Example 16, a nephroscope may include a body partially insertable into a patient's kidney, the body including a graspable proximal portion, an elongated rigid portion extending from the graspable proximal portion, and a flexible distal portion extending distally from the elongated rigid portion to a distal end; and an articulation controller located on the graspable proximal portion of the body and configured to adjust the position of the flexible distal portion to locate a kidney stone when the body is inserted into the patient's kidney, wherein the distal end of the body is further configured to illuminate the kidney stone, provide a video image of the illuminated kidney stone, deliver laser light to the kidney stone to ablate the kidney stone into kidney stone fragments, irrigate the kidney stone and kidney stone fragments with an irrigation fluid, and remove the irrigation fluid and the kidney stone fragments.

[0082] In Example 17, the nephroscope of Example 16 may include an articulation controller coupled to a plurality of pull wires extending along the body to the flexible distal portion, the pull wires being located at a plurality of angular positions in the body and in the flexible distal portion, and the articulation controller may be optionally configured to adjust the position of the flexible distal portion by controllably exerting a proximally directed force on a first pull wire of the plurality of pull wires at a first angular position, thereby radially moving the flexible distal portion of the body toward the first angular position.

[0083] In Example 18, the nephroscope of any one of Examples 16 to 17 may optionally be configured such that the distal end of the body includes a circuit board on the distal end of the body, at least one light-emitting diode on the circuit board configured to emit light distally away from the distal end of the body to illuminate the kidney stone, and a camera on the circuit board configured to capture a video image of the illuminated kidney stone.

[0084] In Example 19, a nephroscope includes a body partially insertable into a patient's kidney, the body including a graspable proximal portion, an elongated rigid portion extending from the graspable proximal portion, and a flexible distal portion extending distally from the elongated rigid portion to a distal end; a plurality of pull wires extending along the body to the flexible distal portion, the plurality of pull wires being located at a plurality of angular positions on the body and on the flexible distal portion, respectively; and an articulation controller located on the graspable proximal portion of the body and configured to adjust the position of the flexible distal portion by exerting a controllable proximally directed force on a first pull wire of the plurality of pull wires at a first angular position to radially move the flexible distal portion of the body toward the first angular position, wherein when the body is inserted into the patient's kidney, the plurality of pull wires and the articulation controller adjust the position of the flexible distal portion to remove kidney stones. a circuit board located at the distal end of the body; at least one light emitting diode located on the circuit board and configured to emit light distally, away from the distal end of the body, to illuminate the kidney stone; a camera located on the circuit board and configured to capture video images of the illuminated kidney stone; an optical fiber extending along a working channel in the body to the distal end of the body, the optical fiber configured to deliver laser light to the kidney stone to ablate the kidney stone into kidney stone fragments; an irrigation lumen extending along the body to the distal end of the body, the irrigation lumen configured to deliver irrigation fluid to the kidney stone and kidney stone fragments; and an aspiration lumen extending along the body to the distal end of the body, the aspiration lumen configured to remove irrigation fluid and kidney stone fragments from the kidney.

[0085] In Example 20, the nephroscope of Example 19 may optionally further include a display coupled to the graspable proximal portion of the body and configured to display a captured video image of the illuminated kidney stone.

[0086] In Example 21, the nephroscope of any one of Examples 1 to 20 may optionally be configured such that the articulation controller is further configured to removably fix the position of the flexible distal portion relative to the graspable proximal portion in a selectable position.

[0087] In Example 22, the nephroscope of any one of Examples 1 to 21 may optionally be configured such that the articulation controller is further configured to be switchable between a first configuration in which the position of the flexible distal portion is adjustable and a second configuration in which the position of the flexible distal portion is fixable at a selectable position.

[0088] In Example 23, the nephroscope of any one of Examples 1 to 21 may optionally be configured such that the articulation controller is further configured to releasably fix the position of the flexible distal portion by fixing the position of each of the plurality of pull wires.

[0089] In Example 24, a method for imaging using a nephroscope may include illuminating an area adjacent to the distal end of the nephroscope with the distal end of the nephroscope, selectively articulating a flexible distal portion of the nephroscope to adjust the position of the distal end of the nephroscope to locate a first target, identifying a first target in the area adjacent to the distal end of the nephroscope from an image of the illuminated area when the distal end of the nephroscope is in a first position, and fixing the articulation of the flexible distal portion of the nephroscope to fixedly position the distal end of the nephroscope at the first position.

[0090] In Example 25, the method of Example 24 may be optionally configured such that selectively articulating the flexible distal portion includes selectively articulating the flexible distal portion with an articulation controller located at a proximal portion of the nephroscope, fixing the articulation of the flexible distal portion includes fixing the articulation with the articulation controller, and fixing and positioning the distal end of the nephroscope in a first position includes fixing and positioning the distal end of the nephroscope in a first position relative to the proximal portion of the nephroscope.

[0091] In Example 26, the method of any one of Examples 24 to 25 may optionally further include unlocking the articulation of the flexible distal portion of the nephroscope, selectively articulating the flexible distal portion of the nephroscope to adjust the position of the distal end of the nephroscope to locate a second target, and identifying a second target in an area adjacent to the distal end of the nephroscope from an image of the illuminated area when the distal end of the nephroscope is in the second position.

Claims

[Claim 1] A nephroscope, a body at least partially insertable into a patient's kidney, the body including a graspable proximal portion, an elongated rigid portion extending from the graspable proximal portion, and a flexible distal portion extending distally from the elongated rigid portion to a distal end; an articulation controller on the graspable proximal portion of the body configured to adjust the position of the flexible distal portion to locate a kidney stone when the body is inserted into the kidney of the patient; and Equipped with The distal end of the body is further configured to illuminate the kidney stone, provide a video image of the illuminated kidney stone, ablate the kidney stone, and remove kidney stone fragments.

Images