A pyeloscope having a flexible and articulable distal portion
The integrated nephroscope device addresses inefficiencies in kidney stone removal procedures by combining stone fragmentation and visualization functions, enhancing procedural efficiency and reducing costs through a single-use design.
Patent Information
- Application Number
- JP2021014611
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2020-01-31
- Filing Date
- 2021-02-01
- Publication Date
- 2025-07-11
- Estimated Expiration
- 2041-02-01
AI Technical Summary
Existing medical procedures for removing kidney stones, such as PCNL, require multiple instruments for breaking and visualizing stones, leading to inefficiencies like time wastage and high sterilization costs due to reusable flexible cystoscopes.
A combined nephroscope device that integrates stone fragmentation and visualization capabilities into a single instrument, featuring a flexible distal portion controlled by an articulation mechanism, illumination, video imaging, laser ablation, irrigation, and suction, allowing for a single-use configuration.
Enhances procedural efficiency by reducing instrument exchange time and lowering sterilization costs while providing comprehensive stone removal capabilities.
Smart Images

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Abstract
Description
Technical Field
[0001] Cross - reference to Related Applications This application claims the benefit of priority of U.S. Provisional Patent Application No. 62 / 968,360, filed on January 31, 2020, the contents of which are incorporated herein by reference in their entirety.
[0002] The present disclosure generally relates to an apparatus related to a medical procedure for removing kidney stones.
Background Art
[0003] A medical procedure called percutaneous nephrolithotomy (PCNL) may be used to remove kidney stones, particularly relatively large and hard stones that are difficult to remove with other forms of stone treatment or any combination thereof. A nephroscope is an observation device for observing kidney stones or other objects inside the region of the kidney.
Summary of the Invention
Means for Solving the Problems
[0004] In one example, the nephroscope may include a body that is at least partially insertable into a patient's kidney. The body may include a graspable proximal portion, an elongate rigid portion extending from the graspable proximal portion, and a flexible distal portion extending distally from the elongate 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 a kidney stone, provide a video image of the illuminated kidney stone, abrade the kidney stone, and remove kidney stone fragments.
[0005] In one example, a pyeloscope may include a body that is partially insertable into a patient's kidney. The body may include a graspable proximal portion, an elongate rigid portion extending from the graspable proximal portion, and a flexible distal portion extending distally from the elongate rigid portion to a distal end. The pyeloscope may include an articulation controller located at 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 supply 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 pyeloscope may include a body that is 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 pyeloscope may include a plurality of pull wires extending along the body to the flexible distal portion. The pull wires may be located at respective plural angular positions in the body and in the flexible distal portion. The pyeloscope may include an articulation controller located at the graspable proximal portion of the body. The articulation controller may adjust the position of the flexible distal portion by controllably applying a proximally directed force to 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 in the direction of the first angular position. The plurality of pull wires and 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 pyeloscope may include a circuit board located at the distal end of the body. The pyeloscope 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 pyeloscope may include a camera on the circuit board. The camera may capture a video image of the illuminated kidney stone. The pyeloscope may include an optical fiber extending along a working channel in the body to the distal end of the body. The optical fiber may supply laser light to the kidney stone to abrade the kidney stone into kidney stone fragments. The pyeloscope may include an irrigation lumen extending along the body to the distal end of the body. The irrigation lumen may supply irrigation fluid to the kidney stone and the kidney stone fragments. The pyeloscope may include a suction lumen extending along the body to the distal end of the body. The suction lumen may remove irrigation fluid and kidney stone fragments from the kidney.
Brief Description of the Drawings
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[0008] Corresponding reference numerals indicate corresponding parts throughout several views. The elements in the figures are not necessarily drawn to scale. The configurations shown in the figures are merely examples and should not be construed as limitations in any way.
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, difficult to treat with other forms of lithotripsy, 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 position of the kidney stone, break the kidney stone into smaller fragments, and extract the stone fragments from the kidney. The scope may include an endoscope, a pyeloscope, and / or a cystoscope.
[0010] In some procedures, the practitioner may break the stone into smaller fragments by applying mechanical forces such as vibratory forces to the stone, for example, by applying pulses having variable amplitudes and / or frequencies that occur outside the patient's body, or by using an ultrasonic lithotripter to apply a vibratory force similar to that of a jackhammer. Once the stone has been broken into relatively small fragments, the practitioner may extract the small fragments with a scope.
[0011] In addition or as an alternative, the practitioner may break the stone into smaller fragments by illuminating the stone through a scope using a relatively powerful infrared laser beam. The laser beam may abrade the kidney stone into smaller fragments.
[0012] In some procedures, the practitioner may use one instrument for breaking the stone into smaller fragments and another separate instrument for visually examining another area of the kidney. For example, the practitioner may use a rigid nephroscope to provide a vibrating (or pulsating) force. By limiting the visual ability, the rigid nephroscope allows the practitioner to see a relatively small area near the location of the jackhammer vibratory force, but may not allow the practitioner to see things 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 examine another area of the kidney to help ensure that the practitioner has captured all of the fragments of the kidney stone and removed them. If the practitioner misses a piece of the stone, the practitioner may then withdraw the flexible cystoscope, reinsert the rigid nephroscope to remove the missed piece of the stone, and then reinsert the flexible cystoscope to repeat the visual examination of another area of the kidney.
[0013] There are disadvantages to using multiple instruments within such procedures. For example, repeatedly withdrawing one instrument and inserting another is a waste of time. In addition, sterilizing the flexible cystoscope for later surgery is relatively costly.
[0014] As an improvement to procedures that use one instrument to break up kidney stones into smaller fragments and another instrument to examine another area of the kidney, the pyeloscope described herein may combine the functions of these two separate instruments into a single device. In addition to saving the practitioner's time that would otherwise be spent exchanging instruments, the pyeloscope described herein may be configured for single use, thereby reducing the costs associated with sterilizing reusable flexible cystoscopes.
[0015] For example, the pyeloscope may include a body that is at least partially insertable into a patient's kidney. The body may include a graspable proximal portion, an elongate rigid portion extending from the graspable proximal portion, and a flexible distal portion extending distally from the elongate rigid portion to a distal end. The pyeloscope may include an articulation controller at 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 may optionally releasably lock the articulation of the flexible distal portion to position and hold the flexible distal portion at a designated location proximate to the kidney stone. The distal end of the body may illuminate a kidney stone, provide a video image of the illuminated kidney stone, abrade the kidney stone, and remove kidney stone fragments.
[0016] FIG. 1 is a perspective view of an example of a pyeloscope 100 having a flexible distal portion. FIG. 2 is a side view of the pyeloscope 100 of FIG. 1. FIG. 3 is a top view of the pyeloscope 100 of FIG. 1. FIG. 4 is an end view of the distal tip of the pyeloscope 100 of FIG. 1. FIG. 5 is a cross-sectional view of the elongate rigid portion of the pyeloscope 100 of FIG. 1. The pyeloscope 100 of FIGS. 1-5 is merely an example of a pyeloscope 100, and another suitable configuration may also be used.
[0017] The renal endoscope 100 may include a body 102 that is at least partially insertable into a patient's kidney. The body 102 may include a handle, a hub, or another 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 elongate rigid portion 106 extending from the graspable proximal portion 104. The elongate rigid portion 106 may be formed from plastic, metal, and / or another suitable material. For example, the elongate rigid portion 106 may include a polymeric outer portion surrounding a stainless steel wire mesh, which in turn surrounds additional components of the renal endoscope 100 described in detail below. The elongate rigid portion 106 may remain rigid compared to the graspable proximal portion 104 when the practitioner inserts the renal endoscope 100 into the patient's body and when the practitioner passes one or more stone fragmentation instruments, such as a lithotripter, through the renal endoscope 100.
[0019] The body 102 may include a flexible distal portion 108 extending distally from the elongate rigid portion 106 to a distal end 110. The flexible distal portion 108 may be more flexible than the elongate rigid portion 106. For example, the flexible distal portion 108 may include a series of rigid rings and 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 an operable structure that may bend in any 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 respective plural angular positions in the body 102 and in the flexible distal portion 108. For an example in which the body 102 has one or more portions having a circular cross section, the angular positions may correspond to circumferential positions around the circular cross section of the body 102. As in the specific example of FIG. 5, there are four pull wires 112 arranged at angular positions of 45 degrees, 135 degrees, 225 degrees, and 315 degrees with respect to the horizontal axis (or vertical axis) of FIG. 5. A different number of pull wires and different 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 such that it is operable 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, in which case the first pull wire 112 is located at the first angular position. The proximally directed force may radially move the flexible distal portion 108 of the body 102 in the direction of 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 a particular example, the pyeloscope 100 may include four pull wires 112 disposed at angular positions of 45 degrees, 135 degrees, 225 degrees, and 315 degrees with respect to the horizontal axis (or vertical axis) of FIG. 5. In this particular example, the pull wires 112 at 45 degrees and 225 degrees are joined together around a first gear within the grippable proximal portion 104, and the pull wires 112 at 135 degrees and 315 degrees are joined together around a second gear within the grippable proximal portion 104. In this particular example, the articulation controller 114 includes a first knob coupled to the first gear, and the first knob may controllably pull one of the pull wires 112 at 45 degrees and 225 degrees and press the other of the pull wires 112 at 45 degrees and 225 degrees. Similarly, the articulation controller 114 may include a second knob coupled to the second gear, and the second knob may controllably pull one of the pull wires 112 at 135 degrees and 315 degrees and press the other of the pull wires 112 at 135 degrees and 315 degrees.
[0023] Once the practitioner locates the position of the stone, the practitioner may fix 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 fix the pull wire 112 in place by removably pushing the pull wire 112 against one or more fixing elements within the grippable proximal portion 104 of the body 102, and then fix the position of the flexible distal portion 108. Another suitable fixing mechanism may also be used. The articulation controller 114 may deploy the fixing mechanism via a button, lever, slider, switch, dial, or another suitable deployment mechanism. With the articulation fixed, the practitioner may deploy the crusher as needed. This fixing of the articulation of the flexible distal portion 108 may be referred to as the flexible distal portion 108 being selectively flexible.
[0024] The joint motion controller 114 or another suitable element may also release the joint motion of the flexible distal portion 108. For example, the joint motion controller 114 or another suitable element may release the pull wire 112 from one or more fixing elements within the grippable proximal portion 104 of the body 102. The joint controller 114 may deploy a release mechanism using a fixing mechanism. For example, the fixing mechanism may include pressing a button, and the release mechanism may include releasing or pulling the button. The joint controller 114 may release the joint motion of the flexible distal portion 108 using a separate button, lever, slider, switch, dial, or another suitable deployment mechanism. With the joint motion released, the practitioner may reposition the flexible distal portion 108 as needed to inspect additional portions of the kidney. Another fixing and / or releasing mechanism may also be used. The joint 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 of a configuration for the pull wire 112 and the joint motion controller 114, and another configuration may also be used.
[0025] The flexible distal portion 108 may be flexible when inside the kidney and during imaging, as compared to the handle or the elongate rigid portion 106. By having sufficient cylindrical strength, the flexible distal portion 108 may be ensured to be insertable by puncture. The flexible distal portion 108 may be configured similarly to a flexible endoscope. The flexible distal portion 108 may include a torque carrier such as a composition or mesh and an additional support structure that may help provide cylindrical strength and may help increase pushability, yet still be flexible as compared to the elongate rigid portion 106. The articulation controller 114 may control the articulation of the flexible distal portion 108 such that the flexible distal portion 108 may be rigid (with respect to specific stiffness relative to the elongate rigid portion 106) during insertion by puncture into the kidney, and may be actuated to adjust the stiffness such that the flexible distal portion 108 is moved distally and imaged once inside the kidney. Once the position of the stone is located, the articulation controller 114 may be actuated again such that the flexible distal portion 108 has sufficient rigidity, and its articulation is fixed. The flexible distal portion 108 may thus be stationary relative to the elongate rigid portion 106 and not move any further during stone ablation. After ablation, the practitioner may further articulate the flexible distal portion 108 for further imaging.
[0026] The 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 may be attached subsequent to the distal end 110 of the body 102. The substrate 116, and any components located on the substrate 116, may be formed integrally with the distal end 110 of the body 102. The substrate 116 may be formed integrally with the distal end 110 of the body 102, and any components located on the substrate 116 may subsequently be attached to the substrate 116.
[0027] To visualize kidney stone fragments, the pyeloscope 100 may include a visualization system at the distal end 110 of the body 102. The visualization system may illuminate the 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] FIG. 6 is a perspective view of an example of a pyeloscope 100A, which has a flexible distal portion and has a video monitor 602 attached to or integrally formed with the pyeloscope 100A. The visualization system may direct a video image to a display such as the video monitor 602. The display may be external to the pyeloscope 100 and may be viewable during a kidney stone removal procedure. The video monitor 602 may be used by any or all of the elements of the pyeloscope 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 that mechanically supports and supplies 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 illuminate the kidney stone by emitting white light. The white light may enable a practitioner to observe discoloration or another color-based effect in the kidney stone or in tissue proximate to the distal end 110 of the body 102. One or more light-emitting diodes 118 may illuminate the kidney stone by emitting blue light. The blue light may detect damage within the tissue by being appropriate for representing thermal tissue development. Another color and / or color band, such as red, amber, yellow, green, etc., may also be used.
[0030] The substrate 116 may include optional lenses 120 (see FIG. 4) for each of the light-emitting diodes 118, and the lenses may adjust the light output from the light-emitting diodes 118 into an angular state. 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 the kidney stone and tissue are sufficiently illuminated within the specified field of view angle.
[0031] The visualization system may include a camera 122 (see FIG. 4) located on the 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 or one or more still images of the illuminated kidney stone. By the video image being in real time or approximately in real time with a relatively short latency for processing, the practitioner may observe the kidney stone and surrounding tissue when the practitioner maneuvers 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 light, green light, 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] At least one light emitting diode 118 may include two light emitting diodes 118. A camera 122 may be located between the two light emitting diodes 118. At least one light emitting diode 118 may include a plurality of light emitting diodes 118 surrounding the camera 122. Each of the plurality of light emitting diodes 118 may emit the same color band or different color bands. For example, one of the plurality of 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 tissues, as described above. These orientations of the light emitting diode 118 and the camera 122 may be advantageous in that the illumination may be relatively uniform across the field of view of the camera 122 (e.g., the illumination may have relatively little bias towards 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 power and supply power to the circuit board. The electrical port 124 may provide a wired connection to a digital video signal, preferably via a multi-pin electrical connector. A substrate 116, such as a circuit board, may wirelessly communicate the digital video signal to a display device, which is external to the nephroscope 100 and may be, for example, a user device, a display, a computer monitor, a head-up display, a wearable display, a virtual reality display, an augmented reality display, or the like.
[0034] An 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 supply a laser beam to a kidney stone to ablate the kidney stone into kidney stone fragments.
[0035] In some examples, the optical fiber 128 may be integrated with the pyeloscope 100. For example, the optical fiber 128 may be fed out together with the pyeloscope 100 and / or may be left in the pyeloscope 100 after use. In some examples, the optical fiber 128 may be separated from the pyeloscope 100. For example, the optical fiber 128 may be fed along the working channel of the pyeloscope 100 before use and / or may be retrieved from the working channel of the pyeloscope 100 after use.
[0036] A laser or laser emitter external to the pyeloscope 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 peaks of human blood and saline, such as 2100 nm, 1942 nm, and the like. For example, wavelengths in the range between 1900 nm and 3000 nm may correspond to the spectral region absorbed by water, while wavelengths between 400 nm and 520 nm may correspond to the spectral region absorbed by oxyhemoglobin and / or deoxyhemoglobin. 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. In general, it may be advantageous to supply laser light having significant absorption in blood and saline, because such laser light, which may reduce or eliminate damage to tissue at or near the kidney stone, may be minimally invasive to surrounding tissue. The laser may provide light having an output power within a suitable range of output powers, such as between 20 watts and 120 watts, about 20 watts and about 120 watts, and the like. 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] The laser controller 132 (see FIG. 2) may be located at the graspable proximal portion 104 of the body 102. The laser controller 132 may toggle the state of the laser light between an operating state ("on") and a non-operating state ("off") with a toggle switch. 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, the practitioner may adjust one or more settings for the laser, such as output power, on the housing of the laser. In some implementations, the practitioner may adjust one or more settings for the laser via the laser controller 132.
[0038] During a typical procedure, the laser may be operable for a period of 1 minute, 2 minutes, 3 minutes, 4 minutes, or any suitable time, etc., by the practitioner manipulating the laser controller 132. During the period of laser operation, the practitioner may manipulate the body 102 to move the laser light supplied across the surface of the kidney stone. In some examples, the laser power level and irradiation time may be such that the practitioner can safely toggle the laser power on and off manually without the need for a mechanized or automated irradiation mechanism. The laser power may also be low enough such that accidental irradiation of surrounding tissue may not damage the tissue.
[0039] The practitioner may abrade the kidney stone by performing what is called dusting of the surface of the kidney stone. Dusting may wear down the kidney stone in a controlled manner, thereby generating kidney stone particles that may be smaller than kidney stone fragments obtained from fragmenting or destroying the kidney stone. For example, a typical kidney stone may be sized between about 1 mm and about 20 mm. Fragmenting or destroying the kidney stone may generate kidney stone fragments that are smaller than the size of the kidney stone, such as between a few mm and less than about 10 mm. Dusting of the kidney stone may generate kidney stone particles that are less than about 1 mm in size.
[0040] To remove kidney stone fragments, a practitioner may use a stone retrieval device such as a basket, which may pass through an orifice within the pyeloscope 100. The practitioner may select and remove individual fragments using the stone retrieval device. In addition to or as an alternative to the stone retrieval device, the pyeloscope 100 may include a cleaning system for flushing the kidney stone fragments.
[0041] The pyeloscope 100 may include a cleaning system at the distal end 110 of the body 102. The cleaning system may controllably supply a flow of irrigation agent, such as saline, to the ablation site and may controllably remove the irrigation agent and kidney stone fragments from the ablation site.
[0042] The cleaning 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 supply irrigation fluid to the kidney stone 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, such as a pump that may transfer irrigation fluid from an irrigation fluid reservoir.
[0043] The cleaning 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 fragments 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 agent and kidney stone fragments.
[0044] The cleaning system may include a cleaning controller 138 (see FIG. 2) located at a grippable proximal portion 104 of the body 102. The cleaning controller 138 may control the flow of irrigation fluid through the irrigation lumen 134 and the suction within the suction lumen 136. The cleaning controller 138 may include a push-button cleaning control button that, when repeatedly depressed, cycles through one or more irrigation levels and / or suction levels before turning irrigation and suction off. For example, continuously depressing the cleaning control button may cycle irrigation and suction from off to the lowest level, then from the lowest level to the intermediate level, then from the intermediate level to the highest level, then from the highest level to off, from off to the lowest level, and so on. The cleaning controller 138 may control irrigation and suction together with a single control. Another suitable cleaning control element, such as a placement-type slide, a placement-type lever, or a placement-type dial, may also be used to specify the irrigation level and / or suction level. The cleaning controller 138 may select from one of a plurality of specified discrete irrigation / suction levels. The cleaning controller 138 may specify the irrigation / suction level in a continuous (e.g., non-discrete) manner.
[0045] The nephroscope 100 may optionally include a tube, a chamber, an additional working channel, or another passageway 140 within the body of the nephroscope 100. The practitioner may deploy a separate tool or instrument, such as a lithotripter, a stone retrieval basket, or another suitable tool or instrument, using the passageway 140.
[0046] In some implementations, the entire renal endoscope 100 may be disposed of after a single use. In some implementations, one or more elements of the renal endoscope 100 may be disposable, while one or more elements of the renal endoscope 100 may be reused for subsequent procedures. For example, the elongate rigid portion 106 and the flexible distal portion 108 may be removable (and / or reattachable thereto) from the graspable proximal portion 104, such that the graspable proximal portion 104 may be cleaned and / or sterilized and reused, whereas the elongate 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 removable from the elongate rigid portion 106, such that the graspable proximal portion 104 and the elongate rigid portion 106 may be cleaned and / or sterilized and reused, whereas the flexible distal portion 108 may be discarded after a single use.
[0047] FIG. 7 is a schematic view of a kidney K within the abdominal cavity AC taken in the coronal plane. The abdominal cavity AC may be defined by an epidermal layer E that provides a barrier to access to the kidney K. The renal endoscope 100 may be inserted into the kidney K through the epidermal layer E. The kidney K may include an outer cortex Cx, a medulla M, and a renal calyx Cy. Kidney stones are formed at various locations within the kidney K, particularly within the renal calyx Cy.
[0048] During use, the practitioner may insert the flexible distal portion 108 partially or fully into the patient's body, particularly into the patient's kidney. During use, the distal portion 702 of the elongate rigid portion 106 may be located inside the patient's body, whereas the proximal portion 704 of the elongate 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 renal endoscope 100. The graspable proximal portion 104 of the body 102 may be formed to be graspable by a human hand.
[0049] FIG. 8 is a flowchart of an example of a method 800 for operating a nephroscope. Method 800 may be performed in the nephroscope 100 of FIGS. 1-5 or in another suitable nephroscope. Method 800 is merely an example of a method for operating a nephroscope. Another suitable method may also be used.
[0050] In operation 802, the practitioner may partially insert the body of the nephroscope into the patient's kidney. The body may include a graspable proximal portion, an elongate rigid portion extending from the graspable proximal portion, and a flexible distal portion extending distally from the elongate rigid portion to a distal end.
[0051] In operation 804, while the body is inserted into the patient's kidney, the practitioner may maneuver an articulation controller located at the graspable proximal portion of the body to adjust the position of the flexible distal portion to locate the position of the kidney stone.
[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 with the distal end of the body.
[0054] In optional operation 810, the practitioner may supply laser light to the kidney stone with 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 stone and kidney stone fragments with irrigation fluid with the distal end of the body.
[0056] In optional operation 814, the practitioner may remove the irrigation fluid and kidney stone fragments with the distal end of the body.
[0057] Figure 9 is a flowchart of an example of a method 900 for imaging using a nephroscope. Method 900 may be performed in the nephroscope 100 of FIGS. 1-5, or in another suitable nephroscope. Method 900 is merely an example of a method for imaging using a nephroscope. Another suitable method may also be used.
[0058] In operation 902, the practitioner may illuminate an area proximate to the distal end of the nephroscope using the distal end of the nephroscope.
[0059] In operation 904, the practitioner may locate the position of a first target by selectively articulating the flexible distal portion of the nephroscope to adjust the position of the distal end of the nephroscope using the nephroscope.
[0060] In operation 906, when the distal end of the nephroscope is in a first position, the practitioner may identify a first target within an area proximate to the distal end of the nephroscope from an image of the illuminated area using the nephroscope.
[0061] In operation 908, the practitioner may fixedly position the distal end of the nephroscope in the first position by fixing the articulation of the flexible distal portion of the nephroscope using the nephroscope.
[0062] In optional operation 910, the practitioner may unfix the articulation of the flexible distal portion of the nephroscope using the nephroscope.
[0063] In optional operation 912, the practitioner may locate the position of a second target by selectively articulating the flexible distal portion of the nephroscope to adjust the position of the distal end of the nephroscope using the nephroscope.
[0064] In optional operation 914, when the distal end of the nephroscope is in a second position, the practitioner may identify a second target within an area proximate to the distal end of the nephroscope from an image of the illuminated area using the nephroscope. EXAMPLE
[0065] To further illustrate the devices, related systems, and / or related methods discussed in this specification, a non-limiting enumeration of examples is provided below. Each of the following non-limiting examples may stand alone or may be combined in any substitution or combination with any one or more of the other examples.
[0066] In Example 1, a nephroscope is a body that can be at least partially inserted into a patient's kidney, including a graspable proximal portion, an elongate rigid portion extending from the graspable proximal portion, and a flexible distal portion extending distally from the elongate rigid portion to a distal end, and an articulation controller at the graspable proximal portion of the body that is configured to adjust the position of the flexible distal portion to locate the position of a kidney stone when the body is inserted into the patient's kidney. The distal end of the body is further configured to illuminate a kidney stone, provide a video image of the illuminated kidney stone, abrade the kidney stone, and remove kidney stone fragments.
[0067] In Example 2, for the nephroscope of Example 1, the articulation controller may optionally be configured such that it is coupled to a plurality of pull wires that extend along the body to the flexible distal portion, the pull wires are located at respective plural 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 to radially move the flexible distal portion of the body in the direction of the first angular position by controllably applying a proximally directed force to a first pull wire among the plurality of pull wires at the first angular position.
[0068] In Example 3, for the nephroscope of any one of Examples 1 - 2, the graspable proximal portion of the body may optionally be configured to be graspable by a human hand, and the articulation controller may optionally be positioned to be operable by the thumb of a human hand when the human hand grasps the graspable proximal portion of the body.
[0069] In Example 4, any one of the pyeloscopes of Examples 1 to 3 may optionally be configured to include a substrate located at the distal end of the main body, at least one light-emitting diode located on the substrate and configured to emit light distally away from the distal end of the main body to illuminate a 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, any one of the pyeloscopes of Examples 1 to 4 may optionally be configured such that 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, any one of the pyeloscopes of Examples 1 to 5 may optionally be configured such that the circuit board is configured to generate a digital video signal representing the captured video image of the illuminated kidney stone.
[0072] In Example 7, any one of the pyeloscopes of Examples 1 to 6 may optionally further include an electrical port on the main body coupled to the circuit board, the electrical port being configured to receive power and supply power to the circuit board and optionally provide a wired connection to the digital video signal.
[0073] In Example 8, any one of the pyeloscopes of Examples 1 to 7 may optionally further include a display coupled to the grippable proximal portion of the main body and configured to display the captured video image of the illuminated kidney stone.
[0074] In Example 9, any one of the pyeloscopes of Examples 1 to 8 may optionally further include an optical fiber extending along a working channel within the main body to the distal end of the main body, the optical fiber being configured to supply laser light to the kidney stone to abrade the kidney stone into kidney stone fragments.
[0075] In Example 10, any one of the pyeloscopes of Examples 1 to 9 is optionally configured such that the laser light has a wavelength corresponding to the absorption spectrum peak of human blood and physiological saline.
[0076] In Example 11, any one of the pyeloscopes of Examples 1 to 10 may be optionally configured such that the laser light has a wavelength of 2100 nm.
[0077] In Example 12, any one of the pyeloscopes of Examples 1 to 11 may optionally further include a laser controller located at the graspable proximal portion of the body and configured to switch the state of the laser light with a toggle switch between an operable state and a non-operable state.
[0078] In Example 13, any one of the pyeloscopes of Examples 1 to 12 optionally further includes an irrigation lumen extending along the body to the distal end of the body and configured to supply irrigation fluid to the kidney stone and kidney stone fragments, and a suction lumen extending along the body to the distal end of the body and configured to remove the irrigation fluid and kidney stone fragments from the kidney.
[0079] In Example 14, any one of the pyeloscopes of Examples 1 to 13 may optionally further include a cleaning controller located at the graspable proximal portion of the body and configured to control the flow of irrigation fluid through the irrigation lumen and the suction within the suction lumen.
[0080] In Example 15, any one of the pyeloscopes of Examples 1 to 14 may be optionally configured such that the cleaning controller includes a push-type cleaning control button, and when the push-type cleaning control button is repeatedly pressed, it circulates one or more irrigation levels before turning off irrigation and suction.
[0081] In Example 16, the pyeloscope is a main body that can be partially inserted into a patient's kidney, and includes a proximal portion that can be gripped, an elongated rigid portion extending from the proximal portion that can be gripped, and a flexible distal portion extending distally from the elongated rigid portion to a distal end; a main body; and an articulation controller positioned at the proximal portion of the main body that can be gripped and configured to adjust the position of the flexible distal portion to locate the renal calculus when the main body is inserted into the patient's kidney. The distal end of the main body is further configured to illuminate the renal calculus, provide a video image of the illuminated renal calculus, supply laser light to the renal calculus to abrade the renal calculus into renal calculus fragments, irrigate the renal calculus and the renal calculus fragments with an irrigation fluid, and remove the irrigation fluid and the renal calculus fragments.
[0082] In Example 17, for the pyeloscope of Example 16, the articulation controller is coupled to a plurality of pull wires that extend along the main body to the flexible distal portion. The pull wires are located at respective plural angular positions on the main body and at the flexible distal portion. The articulation controller may be optionally configured to radially move the flexible distal portion of the main body in the direction of the first angular position by adjusting the position of the flexible distal portion by controllably applying a proximally directed force to a first pull wire among the plurality of pull wires at the first angular position.
[0083] In Example 18, for the pyeloscope of any one of Examples 16 to 17, it may be optionally configured such that the distal end of the main body includes a circuit board on the distal end of the main body, at least one light-emitting diode on the circuit board and configured to emit light distally away from the distal end of the main body to illuminate the renal calculus, and a camera on the circuit board and configured to capture a video image of the illuminated renal calculus.
[0084] In Example 19, the pyeloscope is a main body that can be partially inserted into a patient's kidney, including a grippable proximal portion, an elongated rigid portion extending from the grippable 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 main body to the flexible distal portion, the plurality of pull wires being located at respective plural angular positions on the main body and on the flexible distal portion; an articulation controller located at the grippable proximal portion of the main body, configured to adjust the position of the flexible distal portion by controllably applying a proximally directed force to a first pull wire among the plurality of pull wires at a first angular position, so as to radially move the flexible distal portion of the main body in the direction of the first angular position, and when the main body is inserted into the patient's kidney, the plurality of pull wires and the articulation controller are configured to adjust the position of the flexible distal portion to locate a kidney stone; a circuit board located at the distal end of the main body; at least one light-emitting diode located on the circuit board, configured to emit light distally away from the distal end of the main body to illuminate the kidney stone; a camera located on the circuit board, configured to capture a video image of the illuminated kidney stone; an optical fiber extending along a working channel in the main body to the distal end of the main body, configured to supply laser light to the kidney stone to abrade the kidney stone into kidney stone fragments; an irrigation lumen extending along the main body to the distal end of the main body, configured to supply irrigation fluid to the kidney stone and the kidney stone fragments; and a suction lumen extending along the main body to the distal end of the main body, configured to remove the irrigation fluid and the kidney stone fragments from the kidney.
[0085] In Example 20, the pyeloscope of Example 19 may optionally further include a display coupled to the grippable proximal portion of the main body and configured to display the captured video image of the illuminated kidney stone.
[0086] In Example 21, any one of the pyeloscopes 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 to a selectable position.
[0087] In Example 22, any one of the pyeloscopes 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, any one of the pyeloscopes 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 a plurality of pull wires.
[0089] In Example 24, a method for imaging using a pyeloscope may include illuminating a region proximate to the distal end of the pyeloscope by the distal end of the pyeloscope, selectively articulating the flexible distal portion of the pyeloscope to adjust the position of the distal end of the pyeloscope to locate a first target, identifying the first target within the region proximate to the distal end of the pyeloscope from an image of the illuminated region when the distal end of the pyeloscope is at a first position, and fixing the articulation of the flexible distal portion of the pyeloscope to fix and dispose the distal end of the pyeloscope at the first position.
[0090] In Example 25, the method of Example 24 may optionally be configured such that selectively articulating the flexible distal portion includes selectively articulating the flexible distal portion by an articulation controller located at the proximal portion of the pyeloscope, fixing the articulation of the flexible distal portion includes fixing the articulation by the articulation controller, and fixing and disposing the distal end of the pyeloscope at the first position includes fixing and disposing the distal end of the pyeloscope at the first position relative to the proximal portion of the pyeloscope.
[0091] In Example 26, any one of the methods of Examples 24 to 25 may optionally further include unlocking the articulation of the flexible distal portion of the pyeloscope, selectively articulating the flexible distal portion of the pyeloscope to adjust the position of the distal end of the pyeloscope to locate the second target, and identifying the second target in the region adjacent to the distal end of the pyeloscope from the image of the illuminated region when the distal end of the pyeloscope is in the second position.
Claims
**Claim 1** A pyeloscope, comprising: a body at least partially insertable into a patient's kidney, the body including a graspable proximal portion, an elongate rigid portion extending from the graspable proximal portion, and a flexible distal portion extending distally from the elongate rigid portion to a distal end; an articulation controller located at the graspable proximal portion of the body and configured to adjust the position of the flexible distal portion to locate a renal calculus when the body is inserted into the patient's kidney; a substrate located at the distal end of the body; an irrigation lumen extending along the body to the distal end of the body and configured to supply irrigation fluid to the renal calculus and renal calculus fragments; a suction lumen extending along the body to the distal end of the body and configured to remove the irrigation fluid and renal calculus fragments from the kidney; wherein: the distal end of the body is further configured to illuminate the renal calculus, provide a video image of the illuminated renal calculus, abrade the renal calculus, and remove renal calculus fragments; the substrate includes a camera configured to capture the video image of the illuminated renal calculus; the substrate is disposed at an axially offset position from a line connecting the irrigation lumen and the suction lumen; the articulation controller has a plurality of pull wires extending along the body to the flexible distal portion; the articulation controller is further configured to fix the position of the flexible distal portion by removably securing the plurality of pull wires to the graspable proximal portion; a pyeloscope. **Claim 2** A pyeloscope, comprising: a body at least partially insertable into a patient's kidney, the body including a graspable proximal portion, an elongate rigid portion extending from the graspable proximal portion, and a flexible distal portion extending distally from the elongate rigid portion to a distal end; an articulation controller located at the graspable proximal portion of the body and configured to adjust the position of the flexible distal portion to locate a renal calculus when the body is inserted into the patient's kidney; a substrate located at the distal end of the body; an irrigation lumen extending along the body to the distal end of the body and configured to supply irrigation fluid to the renal calculus and renal calculus fragments; A suction lumen extending along the body to the distal end of the body and configured to remove the perfusion fluid and the renal calculus fragments from the kidney. Comprising The distal end of the body is further configured to illuminate the renal calculus, provide a video image of the illuminated renal calculus, abrade the renal calculus, and remove renal calculus fragments. The substrate includes a camera configured to capture the video image of the illuminated renal calculus. The substrate is disposed at a position offset from a line connecting the perfusion lumen and the suction lumen in an axial view. The arthrokinematic controller is further configured to switch 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 can be fixed at a selectable position. **Claim 3**: A pyeloscope A body at least partially insertable into a patient's kidney, including a graspable proximal portion, an elongate rigid portion extending from the graspable proximal portion, and a flexible distal portion distally extending from the elongate rigid portion to a distal end. An arthrokinematic controller located at the graspable proximal portion of the body and configured to adjust the position of the flexible distal portion to locate the position of a renal calculus when the body is inserted into the patient's kidney. A substrate located at the distal end of the body. A perfusion lumen extending along the body to the distal end of the body and configured to supply perfusion fluid to the renal calculus and the renal calculus fragments. A suction lumen extending along the body to the distal end of the body and configured to remove the perfusion fluid and the renal calculus fragments from the kidney. Comprising The distal end of the body is further configured to illuminate the renal calculus, provide a video image of the illuminated renal calculus, abrade the renal calculus, and remove renal calculus fragments. The substrate includes a camera configured to capture the video image of the illuminated renal calculus. The substrate is disposed at a position offset from a line connecting the perfusion lumen and the suction lumen in an axial view. The arthrokinematic controller is coupled to a plurality of pull wires extending along the body to the flexible distal portion. The pull wires are located at respective plural angular positions in the body and in the flexible distal portion. The articulation controller is configured to adjust the position of the flexible distal portion by controllably acting on a proximally directed force on a first pull wire of the plural pull wires at a first angular position to radially move the flexible distal portion of the body in the direction of the first angular position. A nephroscope.
4. The nephroscope according to claim 3, wherein the articulation controller is further configured to releasably fix the position of the flexible distal portion by fixing the respective positions of the plural pull wires.
5. The grippable proximal portion of the body is formed to be grippable by a human hand. The nephroscope according to claim 1, wherein the articulation controller is positioned to be operable by the thumb of the human hand when the human hand grips the grippable proximal portion of the body.
6. The distal end of the body further The nephroscope according to claim 1, comprising 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.
7. The at least one light-emitting diode includes two light-emitting diodes. The nephroscope according to claim 6, wherein the camera is located between the two light-emitting diodes.
8. The substrate is configured to generate a digital video signal representing the captured video image of the illuminated kidney stone, and further includes an electrical port on the body coupled to the substrate. The electrical port is configured to receive power to supply power to the substrate and provide a wired connection to the digital video signal. The nephroscope according to claim 6.
9. The nephroscope according to claim 6, further comprising a display coupled to the grippable proximal portion of the body and configured to display the captured video image of the illuminated kidney stone.
10. A nephroscope, A body at least partially insertable into a patient's kidney, the body including a grippable proximal portion, an elongate rigid portion extending from the grippable proximal portion, and a flexible distal portion extending distally from the elongate rigid portion to a distal end. An articulation controller that is located in the graspable proximal portion of the body and is configured to adjust the position of the flexible distal portion to locate the position of a kidney stone when the body is inserted into the kidney of the patient. A substrate located at the distal end of the body. An irrigation lumen that extends along the body to the distal end of the body and is configured to supply irrigation fluid to the kidney stone and the kidney stone fragments. A suction lumen that extends along the body to the distal end of the body and is configured to remove the irrigation fluid and the kidney stone fragments from the kidney. Comprising: 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 the kidney stone fragments. The substrate includes a camera configured to capture the video image of the illuminated kidney stone. The substrate is disposed at a position offset from a line connecting the irrigation lumen and the suction lumen in an axial view. The endoscope further includes an optical fiber that extends along a working channel in the body to the distal end of the body, and the optical fiber is configured to supply laser light to the kidney stone to ablate the kidney stone into the kidney stone fragments, and the laser light has a wavelength corresponding to the absorption spectrum peak of human blood and physiological saline.
11. The endoscope according to claim 10, further comprising a laser controller located in the graspable proximal portion of the body and configured to toggle the state of the laser light with a toggle switch between an operable state and an inoperable state.
12. The endoscope according to claim 1, further comprising a cleaning 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.
13. The cleaning controller includes a push-type cleaning control button, and when the push-type cleaning control button is repeatedly pressed, it circulates through one or more irrigation levels before turning off irrigation and suction. The endoscope according to claim 12.
14. An endoscope, A body that can be partially inserted 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, wherein the pull wires are located at a plurality of angular positions in the body and in the flexible distal portion respectively, a plurality of pull wires; An articulation controller located at the graspable proximal portion of the body, configured to adjust the position of the flexible distal portion by controllably applying a proximally directed force to a first pull wire among the plurality of pull wires at a first angular position, so as to radially move the flexible distal portion of the body in the direction of the first angular position. When the body is inserted into the kidney of the patient, the plurality of pull wires and the articulation controller are configured to adjust the position of the flexible distal portion to locate the position of the kidney stone, an articulation controller; A circuit board located at 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; A camera on the circuit board, configured to capture a video image of the illuminated kidney stone; An optical fiber extending along a working channel in the body to the distal end of the body, configured to supply laser light to the kidney stone to abrade the kidney stone into kidney stone fragments; An irrigation lumen extending along the body to the distal end of the body, configured to supply irrigation fluid to the kidney stone and the kidney stone fragments; A suction lumen extending along the body to the distal end of the body, configured to remove the irrigation fluid and the kidney stone fragments from the kidney; Comprising; The substrate is arranged at a position offset from a line connecting the irrigation lumen and the suction lumen in an axial view; A nephroscope.
15. The nephroscope according to claim 14, wherein the articulation controller is further configured to switch 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 can be fixed at a selectable position.
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