WO2022072755A1 - Lithotomy devices, systems, and methods - Google Patents

Lithotomy devices, systems, and methods Download PDF

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Publication number
WO2022072755A1
WO2022072755A1 PCT/US2021/053049 US2021053049W WO2022072755A1 WO 2022072755 A1 WO2022072755 A1 WO 2022072755A1 US 2021053049 W US2021053049 W US 2021053049W WO 2022072755 A1 WO2022072755 A1 WO 2022072755A1
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WO
WIPO (PCT)
Prior art keywords
probe
impact
shaft
distal end
calculus
Prior art date
Application number
PCT/US2021/053049
Other languages
French (fr)
Inventor
Corey Lee TEIGEN
Frank Anthony CRANDALL
Jeffrey D. PENMAN
Dustin Edward GORRINGE
Brian Russell CURTIS
Original Assignee
Teigen Corey Lee
Crandall Frank Anthony
Penman Jeffrey D
Gorringe Dustin Edward
Curtis Brian Russell
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Teigen Corey Lee, Crandall Frank Anthony, Penman Jeffrey D, Gorringe Dustin Edward, Curtis Brian Russell filed Critical Teigen Corey Lee
Publication of WO2022072755A1 publication Critical patent/WO2022072755A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003Steerable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003Steerable
    • A61B2017/00305Constructional details of the flexible means
    • A61B2017/00309Cut-outs or slits
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A61B2017/22014Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement the ultrasound transducer being outside patient's body; with an ultrasound transmission member; with a wave guide; with a vibrated guide wire
    • A61B2017/22015Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement the ultrasound transducer being outside patient's body; with an ultrasound transmission member; with a wave guide; with a vibrated guide wire with details of the transmission member
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A61B2017/22014Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement the ultrasound transducer being outside patient's body; with an ultrasound transmission member; with a wave guide; with a vibrated guide wire
    • A61B2017/22015Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement the ultrasound transducer being outside patient's body; with an ultrasound transmission member; with a wave guide; with a vibrated guide wire with details of the transmission member
    • A61B2017/22017Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement the ultrasound transducer being outside patient's body; with an ultrasound transmission member; with a wave guide; with a vibrated guide wire with details of the transmission member the ultrasonic transmitting members being fibres
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/320068Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B2017/320072Working tips with special features, e.g. extending parts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00General characteristics of surgical instruments
    • A61B2217/002Auxiliary appliance
    • A61B2217/005Auxiliary appliance with suction drainage system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36Image-producing devices or illumination devices not otherwise provided for
    • A61B90/361Image-producing devices, e.g. surgical cameras

Definitions

  • the present disclosure relates generally to devices and systems to remove calculi from the body of a patient and devices and systems to deliver ultrasonic energy into the body, such as to treat organs containing a calculus. More specifically, in some embodiments, the present disclosure relates to devices and systems percutaneously inserted into an organ to break up and/or remove a calculus.
  • FIG. 1A is a side view of an embodiment of a lithotomy system that includes a shaft assembly or endoscope having an articulable shaft and an impact assembly having an impact probe that is positioned within the shaft in an undeployed state.
  • FIG. 1 B is an end view of a distal end of the lithotomy system of FIG. 1 A.
  • FIG. 2 is a side elevation view of the impact assembly of FIG. 1A that includes an ultrasound energy generator and an impact probe shown in a straight configuration.
  • FIG. 3A is a side view of a distal portion of the lithotomy system of FIG. 1 A with a shaft of the endoscope in a straight state and the impact probe of the impact assembly in an advanced or deployed state.
  • FIG. 3B is a side view of the distal portion of the lithotomy system of FIG. 1A with the shaft in an articulated state and the impact probe in an advanced or deployed state.
  • FIG. 4 is a side view of the lithotomy system of FIG. 1 A with the shaft in the articulated state and the impact probe in a deployed state with a distal tip thereof at a treatment location.
  • FIG. 5A is a side view of another embodiment of a lithotomy system that includes an articulable shaft and an impact probe within the shaft in an undeployed state.
  • FIG. 5B is an end view of a distal end of the lithotomy system of FIG. 5A.
  • FIG. 6 is a side view of a distal end of an impact probe of the lithotomy system of FIG. 5A in a straight configuration with articulated configurations of the impact probe shown in broken lines.
  • FIG. 7 is a side view of the distal end of the lithotomy system of FIG. 5A with the impact probe in an articulated and deployed state.
  • FIG. 8 is a side view of the lithotomy system of FIG. 5A with the shaft in the articulated state and the impact probe in a deployed and articulated state with a distal tip thereof at a treatment location.
  • FIG. 9A is a perspective view of another embodiment of a lithotomy system that includes an articulable shaft and an impact probe in a deployed state in which a distal end of the impact probe extends distally past a distal tip of the shaft.
  • FIG. 9B is a perspective view of a proximal portion of a handle of the lithotomy system of FIG. 9A.
  • FIG. 10A is a perspective cross-sectional view of a distal portion of the lithotomy system of FIG. 9A, a sleeve portion thereof is not shown to facilitate viewing of components internal to the sleeve.
  • FIG. 10B is an end view of the distal portion of the lithotomy system of FIG. 9A.
  • FIG. 11 A is a perspective view of an embodiment of a bending member of the lithotomy system of FIG. 9A.
  • FIG. 11 B is an end view of the bending member of the lithotomy system of
  • FIG. 12A is a perspective view of a distal portion of an embodiment of an impact probe of FIG. 9A.
  • FIG. 12B is a side view of an end portion of the impact probe of FIG. 12A.
  • FIG. 13A is a side elevation view of a distal portion of the lithotomy system of FIG. 9A with an impact probe in an undeployed state.
  • FIG. 13B is a side elevation view of the distal portion of the lithotomy system of FIG. 9A with the impact probe in a deployed state.
  • FIG. 13C is a top plan view of the distal portion of the lithotomy system of FIG. 9A with a shaft and the impact probe in a bent or articulated state and with the impact probe in the deployed state.
  • FIG. 14 is a perspective view of a tip of the lithotomy system of FIG. 9A.
  • FIG. 15 is a side elevation view of an embodiment of the lithotomy system of FIG. 9A with a portion of the handle removed to facilitate viewing of components within the handle.
  • FIG. 16 is side elevation view of another embodiment of an impact probe.
  • FIG. 17A is a perspective view of an embodiment of a probe tip compatible with the impact probe of FIG. 16.
  • FIG. 17B is a cross-sectional view of the probe tip of FIG. 17A taken along the view line 17B-17B in FIG. 17C.
  • FIG. 170 is a top view of the probe tip of FIG. 17A.
  • FIG. 17D is a bottom view of the probe tip of FIG. 17A.
  • FIG. 18 is a side elevation view of another embodiment of an impact probe.
  • FIG. 19A is a perspective view of an embodiment of a probe tip compatible with the impact probe of FIG. 18.
  • FIG. 19B is a cross-sectional view of the probe tip of FIG. 19A taken along the view line 19B-19B in FIG. 19C.
  • FIG. 19C is a top view of the probe tip of FIG. 19A.
  • FIG. 19D is a bottom view of the probe tip of FIG. 19A.
  • FIG. 20 is a side elevation view of another embodiment of an impact probe.
  • FIG. 21 A is a perspective view of an embodiment of a probe tip compatible with the impact probe of FIG. 20.
  • FIG. 21 B is a cross-sectional view of the probe tip of FIG. 21 A taken along the view line 21 B-21 B in FIG. 21 C.
  • FIG. 21 C is a top view of the probe tip of FIG. 21 A.
  • FIG. 21 D is a bottom view of the probe tip of FIG. 21 A.
  • FIG. 22 is a side elevation view of another embodiment of an impact probe.
  • FIG. 23A is a side elevation view of another embodiment of an impact probe.
  • FIG. 23B is another side elevation view of the impact probe of FIG. 23A taken from an opposite side of the impact probe.
  • a calculus or stone forms within an organ of a patient.
  • the calculus may form in the kidney, the gall bladder, the pancreas, or other locations.
  • the calculus can be too large to pass out of the organ by normal organ function.
  • the calculus may cause severe pain to the patient as the organ attempts to excrete or pass the calculus.
  • Certain lithotomy treatments include removal of the calculus using surgical methods.
  • the calculus may be broken into fragments before being removed from the organ, whether such removal is by medical instruments or by natural excretion by the body.
  • a calculus can, in various methods, be broken into fragments by a lithotripsy procedure that focuses energy, either extra corporeally or corporeally, at the calculus.
  • the energy is ultrasound energy.
  • Corporeal treatment of the calculus can be achieved by access to the organ through a bodily orifice in communication with the organ or by accessing the organ directly by percutaneous puncture of the skin adjacent the organ.
  • Devices and methods within the scope of this disclosure relate to delivery of ultrasound energy to the body to treat various regions of the body, including treatments to break up a calculus within the body and/or removal of calculi or calculus fragments from the body.
  • Certain embodiments herein describe percutaneous methods to treat or break up a calculus within an organ and/or that remove a calculus and/or pieces of a disrupted calculus.
  • Devices and methods within the scope of this disclosure include percutaneous delivery through a patient’s skin. In other embodiments, advancement through a lumen of the body to access an organ or other location.
  • elongate energy delivery devices within the scope of this disclosure may access a patient’s kidney by piercing the skin and advancing through tissue adjacent the kidney.
  • elongate energy delivery devices may access the kidney by being advanced along the urinary tract, either directly or through a working channel of a separately placed scope or sheath.
  • a working channel of a separately placed scope or sheath may be used as a separate placed scope or sheath.
  • access of the kidney and treatment of kidney stones are described herein, such disclosure can be analogously applied to treatment of other locations, such as the gall bladder, pancreas, and so forth.
  • a treatment system may include a shaft, such as an elongate tubular body, and may further include one or more of an impact probe, a visualization member, and a working lumen disposed within the shaft.
  • the impact probe may be configured to deliver energy to a treatment location adjacent a distal end of the shaft.
  • the impact probe may be coupled to a micro displacement member, such as an ultrasound energy generator, to cause the impact probe to axially vibrate and conduct energy from a proximal location to the treatment location.
  • a distal portion of the impact member may be disposed in contact with or adjacent a calculus to deliver energy to the calculus to break up the calculus.
  • the impact probe may be in a fixed longitudinal relationship to the shaft, and in further embodiments, energy may be delivered from the impact probe at the distal end of the treatment device.
  • an impact probe may be longitudinally displaceable with respect to the shaft or tubular body.
  • the shaft can have a bendable, deflectable, curvable, flexible, or articulable distal end.
  • the impact probe may include a bendable, deflectable, curvable, flexible, or articulable region that is capable of conforming to a bent shape of the deflectable end of the shaft.
  • the probe may be advanced through the shaft such that a distal end of the probe extends past a distal tip of the shaft while a portion of the probe is bent within the shaft.
  • the probe can be configured to suitably deliver energy through the bent portion thereof to the distal end to break up or otherwise disrupt a calculus or other target.
  • the impact probe may be independently bendable, deflectable, curvable or articulable so as to move out of alignment with the axis of at least a distal portion of the shaft.
  • the impact probe can be deployed from the distal tip of the shaft in a straight configuration (e.g., can be advanced rectilinearly beyond the distal tip of the shaft) and/or manipulated into an articulated or bent configuration, such as a configuration having an arcuate shape, e.g., at a position beyond a distal tip of the shaft.
  • the terms “articulate,” “articulable,” and variants thereof generally denote the formation of or the ability to form an arcuate or bent shape. These terms do not necessarily require segments or joints to achieve such arcing or bending, although some embodiments may be segmented or jointed.
  • treatment systems described herein include integrated treatment devices comprising an impact probe and optical components such as a visualization system or visual imaging member.
  • the visualization system may include, for example, a lens coupled to a camera and a lighting member such as a light emitting diode (LED) and/or an optical fiber coupled to a light source.
  • the visualization system may be utilized to position the impact probe adjacent to or in contact with the calculus or other treatment site.
  • One or more working lumens may be integrated with the shaft and may be used to irrigate a lithotripsy site surrounding the impact probe to cool the impact probe and/or to evacuate the calculus fragments.
  • the impact probe may define a lumen (e.g., a working lumen) that extends through the shaft and through which calculi or calculus fragments may be removed from the patient.
  • a shaft is percutaneously inserted into an organ to be treated such that the distal end of the shaft is positioned adjacent a calculus.
  • a clinician may visually confirm placement of the shaft using a visualization member.
  • the impact probe is deployed from the shaft in either a straight or articulated configuration to access a desired treatment position.
  • the distal end of the impact probe may be disposed adjacent to or in contact with the calculus.
  • An energy applicator or displacement member e.g., a micro displacement member
  • the impact probe may be configured to axially vibrate at a rate of from about 20 kilohertz to about 5 megahertz.
  • the vibration causes the distal end of the impact probe to deliver energy to the calculus, by directly striking the calculus or by imparting energy to tissue, fluid, and/or other material adjacent the calculus. This energy can be delivered until the calculus breaks into fragments. The fragments may be removed through the working lumen.
  • axial vibration introduced at a proximal position along the impact probe can be transmitted along the length of the impact probe, including energy transmission through a curved, angled, rounded or articulated distal portion of the impact probe. That is, a distal portion of the impact probe may be axially vibrated along an axis disposed at an angle to an axial vibration axis of a proximal portion of the impact probe. In other words, the impact probe may be configured to transmit or conduct axial vibration from one axis or plane into a second axis or plane.
  • Percutaneous nephrolithotomy or nephrolithotripsy procedures are generally used to treat large kidney stones. These procedures involve the percutaneous placement of a nephroscope into the kidney and in the vicinity of a kidney stone. An ultrasonic probe is advanced through the nephroscope into contact with or close proximity to the kidney stone and is energized to break up the stone or calculus.
  • a traditional nephroscope generally includes an elongated, stiff metallic shaft that is rectilinear in form, which is inserted through the skin of the patient and into the kidney. The ultrasonic probe that is advanced through the shaft for disruption of the calculus is likewise rectilinear.
  • a nephroscope includes a shaft that has a steerable, deflectable, bendable, articulable, or otherwise directable distal end.
  • the distal end of the shaft can be deflectable relative to a longitudinal axis of a proximal portion of the shaft in a single direction or in two opposite directions within a single plane.
  • the shaft may be deflectable in four (e.g., mutually orthogonal) directions.
  • a lithotripter assembly may be usable with a nephroscope.
  • a nephroscope assembly may include a nephroscope with a shaft having a bendable distal end, such as previously described, and may further include a lithotripter assembly that includes a lithotripter configured to bend or conform to a shape of the shaft.
  • the lithotripter assembly can include an energy generator, such as, for example, an ultrasonic transducer, coupled with a lithotripter, or an elongated member configured to deliver energy from the ultrasonic transducer to the stone or calculus.
  • the lithotripter assembly is integrated into the nephroscope and may be deployed from a retracted position in which the lithotripter is within the shaft of the nephroscope to a deployed position in which a distal end of the lithotripter extends past a distal end of the shaft.
  • the lithotripter assembly may be separate from the nephroscope and the lithotripter thereof may be insertable through the nephroscope.
  • the lithotripter can include a bendable region capable of conforming to a bent shape of the nephroscope shaft. The lithotripter can deliver ultrasonic energy around the bend sufficient to disrupt a calculus.
  • the steerable nephroscopes and lithotripters can facilitate percutaneous nephrolithotomy procedures, such as, for example, by providing greater maneuverability within the kidney.
  • FIGS. 1A and 1B schematically illustrate an embodiment of a lithotomy system 100 that includes a shaft assembly, such as an endoscope 105, and an impact assembly 107.
  • the impact assembly 107 can include an impact probe 120 that can extend (e.g., be selectively extended) from a shaft 110 of the endoscope 105.
  • the endoscope 105 may be a nephroscope.
  • FIG. 2 illustrates an illustrative embodiment of the impact assembly 107 that includes an ultrasound energy generator 155 coupled to an impact probe 120 that is in a straight configuration.
  • FIG. 3A illustrates a distal portion of the lithotomy system 1(X) with a shaft and the impact probe in a deployed and straight state.
  • FIG. 3B illustrates the distal portion of the lithotomy system 100 with the shaft 110 in an articulated state and the impact probe 120 in a deployed state.
  • a distal end of the impact probe 120 extends rectilinearly past a distal end of the shaft 110, and a more proximally positioned portion of the impact probe 120 is bent so as to conform to a curvature of a bent portion of the shaft 110.
  • FIG. 4 illustrates the lithotomy system 100 with the shaft 110 in the articulated state and the impact probe 120 deployed so as to be adjacent a calculus.
  • FIGS. 5A and 5B schematically illustrate an embodiment of another lithotomy system 200.
  • FIG. 6 illustrates a distal portion of an impact probe 220 of the lithotomy system 200 in straight and articulated states.
  • FIG. 7 illustrates the distal portion of the lithotomy system 200 with a shaft 210 and the impact probe 220 in a deployed and articulated state.
  • FIG. 8 illustrates the lithotomy system 200 with the shaft 210 in an articulated state and the impact probe 220 in the deployed and articulated state with a distal tip thereof adjacent a calculus.
  • each device may be coupled to, or shown with, additional components not included in every view.
  • the lithotomy system 100 can be configured to remove calculi or fragmented portions of calculi from a patient. Lithotomy procedures typically involve the removal of calculus material from a patient.
  • Lithotripsy procedures while focused on the breaking apart or otherwise disrupting or reducing a size of a calculus, typically also involve the removal of calculus material from the patient, particularly where a lithotripter has been inserted into the patient for purposes of breaking apart the calculus.
  • the term “lithotomy” includes all ordinary or accepted meanings of this term, and is also broad enough to include a variety of lithotripsy procedures. For example, typical lithotripsy procedures in which a lithotripter is introduced into the patient to break apart a calculus and in which the resultant calculus fragments are removed from the patient by the practitioner are included in the term “lithotomy,” as used herein.
  • lithotripsy procedures in which a lithotripter is inserted into the body to disrupt a calculus, but in which there is no subsequent removal of the disrupted calculus by the practitioner (e.g., in which the calculus material is instead permitted to pass from the patient’s body via natural processes) are included in the term “lithotomy,” as used herein.
  • the lithotomy system 100 includes the endoscope 105.
  • the endoscope 105 can be a nephroscope, and thus may alternatively be referred to herein as the nephroscope 105.
  • the nephroscope 105 can have a bending section, which is a novel feature relative to traditional nephroscopes 105, which have a straight and stiff shaft.
  • the endoscope 105 can include visualization features to permit viewing of a treatment area within the patient by the practitioner.
  • the endoscope 100 may, however, more generally be referred to as a shaft assembly, shaft member, elongated tubular member, etc.
  • the endoscope 105 may include a shaft with a lumen into which at least a portion of the impact assembly 107 may be accepted, and little or nothing else.
  • the impact assembly 107 may be integral with the endoscope 105.
  • the impact assembly 107 may not be readily removable from the endoscope 105 under normal use, or stated otherwise, may be nonremovable from the endoscope 105 (e.g., from a handle of the endoscope).
  • the impact assembly 107 is fixedly secured to the endoscope 105, and thus may not move appreciably or may not move at all relative to the endoscope 105. In other embodiments, the impact assembly 107 is moveable relative to the endoscope 105.
  • the impact assembly 107 may be advanceable and retractable relative to the endoscope, such as by being capable of longitudinal or axial movement relative to the endoscope 105.
  • the impact assembly 107 is integral with the endoscope 105 and movable relative to the endoscope 105 via an actuator 121, as further discussed below.
  • the actuator 121 is configured to advance and retract the impact assembly 107 relative to the endoscope 105.
  • the impact assembly 107 may be insertable into and fully removable from the endoscope 105.
  • the system 100 can include the impact probe 120, which may be integrally formed with the endoscope 105 or separately insertable and/or removable therefrom.
  • the impact probe 120 is fixedly secured to the endoscope 105 such that a fixed length of the impact probe 120 is positioned past a distal tip of a shaft 110.
  • the impact probe 120 is integrally formed with the endoscope 105, but is axially advanceable and retractable relative to the shaft 110.
  • the impact probe 120 is separate from the endoscope 105 and is insertable therein and removable therefrom.
  • the impact probe 120 may alternatively be referred to as a lithotripter, impact member, energy transfer member, elongate member, etc.
  • the impact assembly 107 may alternatively be referred to as an impact system, a lithotripter assembly or system, an energy transfer assembly or system, etc.
  • the lithotomy system 100 may more generally be referred to as a treatment system, a medical system, etc.
  • the illustrated actuator 121 by which the impact assembly 107 is advanceable or deployable and retractable relative to the endoscope 105, includes a rotational actuation mechanism 122 that is rotational relative to a handle 150 of the endoscope 105.
  • the rotational actuation mechanism 122 may, for example, include a knob attached to a threaded member that extends through a wall of and is rotated relative to the handle 150 to impart translational movement to the impact assembly 107.
  • the rotational actuation mechanism 122 can include suitable mechanical linkage to the impact assembly 107 to achieve the translational movement relative to the endoscope 105.
  • other embodiments can include a variety of other actuators 121 and actuation mechanisms 122, which may or may not include an element of rotation.
  • buttons, slides, or other mechanical mechanisms may be used to move the impact assembly 107 relative to the endoscope 105.
  • the nephroscope or endoscope 105 can include the handle 150 and the shaft 110.
  • the shaft 110 can be fixedly secured to the handle 150.
  • the shaft 110 can be an elongate member with one or more lumens therethrough.
  • the shaft 110 can an elongate tubular member, which can include a circular cross-sectional shape.
  • a diameter of the shaft 110 can range from about 3 millimeters to about 6.5 millimeters, or may be 19.5 French or larger.
  • a length of the shaft 110 can range from about 45 centimeters to about 65 centimeters, or may be about 65 centimeters or larger.
  • the shaft 110 can be formed from a variety of flexible materials, such as polyurethane, for example.
  • the shaft 110 includes an impact probe 120 disposed within a channel 112, an imaging member 130 positioned at an opening 113 at a distal end of the tubular body 110, and an optical fiber 132 and/or optical components for distributing light from the optical fiber 132 positioned at an opening 114 at a distal end of the shaft 110.
  • the shaft 110 of the depicted embodiment includes a working channel 111.
  • the working channel 111 and the probe channel 112 may extend between a distal end 115 and a proximal end 116 of the shaft 110.
  • the shaft 110 can include more or fewer channels and/or elements.
  • the shaft 110 may include an additional channel for disposition of a laser probe used to break up the calculus.
  • the imaging member 130 may for example, be a visual imaging member.
  • the imaging member 130 may comprise a charge-coupled device (CCD) for capturing images or video from a region beyond the distal end 115 of the shaft 110.
  • the CCD may be configured to receive light directly from the region for imaging.
  • the visual imaging member 130 can include a lens 131 disposed at the distal end 115 of the shaft 110.
  • the lens 131 may be configured to provide a visual image of a lithotripsy site adjacent to or otherwise beyond the distal end 115.
  • an optical fiber may be coupled to the lens 131 and configured to transmit light received from the lens 131.
  • a CCD can be coupled to the lens 131.
  • the optical fiber 132 terminates at the distal end 115 of the shaft 110.
  • the optical fiber 132 may be configured to transmit light to illuminate the lithotripsy site.
  • a light diffusion lens may be coupled to the optical fiber 132 to facilitate diffusion of light from the optical fiber 132.
  • Other light sources such as one or more light emitting diodes (LEDs), disposed at proximal or distal locations along the shaft 110 are likewise within the scope of this disclosure.
  • the optical fiber 132 or optical components may be replaced with one or more other light sources, such as one or more LEDs, positioned at the tip of the shaft 110.
  • the working channel 111 is open at the distal end 115 of the shaft 110.
  • the working channel 111 may be configured to facilitate delivery of fluid (e.g., saline) to a lithotripsy site, to aspirate fluid and calculus fragments from the lithotripsy site, to facilitate delivery of an instrument to the lithotripsy site, etc.
  • fluid e.g., saline
  • Any instrument suitable to facilitate treatment of the patient may be delivered through the working channel 111.
  • such instruments can include a basket, a laser probe, a grasper, a ureteroscope, etc.
  • the impact assembly 107 can be positioned relative to the endoscope 105 such that the impact probe 120 is disposed within the shaft 110 such that a terminal distal end of the impact probe 120 within the distal end 115 of the shaft 110. This may be referred to as a retracted position or undeployed state of the impact assembly 107 and/or the impact probe 120.
  • the impact probe 120 when the impact assembly 107 and/or the impact probe 120 are advanced to a deployed (e.g., fully deployed) state, the impact probe 120 may extend from the distal end 115 of the shaft 110 by a distance of from about 1 centimeter to about 2 centimeters. Additional detail regarding the impact probe 120 will be provided below, including disclosure recited in connection with FIGS. 2A and 2B.
  • the handle 150 of the illustrated system 100 may be disposed at and coupled to the proximal end 116 of the shaft 110.
  • the handle 150 is shown to include and/or be coupled with a camera 151, an access port 153, and a steering or deflection actuator 156.
  • the impact assembly 107 can include an energy applicator or displacement member 154 (e.g., a micro displacement member 154), which can be attached to and energize the impact probe 120, as discussed further below.
  • the displacement member 154 can be coupled with the handle 150.
  • the displacement member 154 is coupled with the actuator 121 so as to be movable relative to the handle 150 by actuation of the actuator 121.
  • the displacement member 154 is housed within the handle 150.
  • the handle 150 may include more or fewer elements.
  • the handle 150 may include a laser light source coupled to a laser probe that may be disposed within the shaft 110.
  • the camera 151 is coupled to the visual imaging member 130.
  • an optical fiber is disposed between the visual imaging member 130 and the camera 151 and configured to transmit light to the camera 151 from the lithotripsy site.
  • the camera 151 may convert the light into a digital image for viewing by the clinician.
  • an electrical wire is disposed between the camera 151 and a CCD disposed adjacent to the lens 131 of the visual imaging member 130.
  • the electrical wire is configured to transmit an electrical signal from the CCD to the camera 151.
  • the camera 151 is configured to process the electrical signal into a digital image for viewing by the clinician.
  • the camera 151 may transmit a digital image to a remote monitor for viewing.
  • the camera 151 may include any suitable camera or optical sensor disposed at a distal tip of the device 100, and a separate processor to which the device 100 is electrically or otherwise communicatively coupled may process the images obtained via the camera 151. Stated otherwise, the camera 151 may have a different physical arrangement than the dedicated camera processor 151 depicted in FIG. 1A.
  • a light source may be coupled to the optical fiber 132.
  • the light source is configured to provide visible light to the optical fiber 132.
  • the optical fiber 132 may transmit the visible light to the distal end 115 to illuminate the lithotripsy site, including the calculus to be broken into fragments.
  • the light source may be configured to control an intensity of the transmitted visible light to allow for appropriate illumination.
  • the handle 150 may have the light source integrated therein.
  • the handle 150 may include an LED coupled with a proximal end of the optical fiber 132.
  • the access port 153 is in fluid communication with the working channel 111 and can be configured to facilitate passage of fluid, instruments, or calculus fragments into and/or out of the working channel 111.
  • the access port 153 can include a fitting of any suitable type, such as a universal Luer fitting, barb fitting, quick connect fitting, etc. to facilitate coupling of external components to the access port 153.
  • a fluid line is coupled to the access port 153 to provide fluid to the working channel 111 and to withdraw fluid and calculus fragments through the working channel 111.
  • a collection container may be disposed in line with the fluid line to capture the calculus fragments.
  • the deflection actuator 156 may be coupled to the distal end 115 of the shaft 110 and configured to flex, bend, deflect, steer, or otherwise control a shape of the distal end 115 of the shaft 110 to orient the shaft 110 as desired, such as for viewing a region distally beyond the distal end 115 of the shaft 110, and/or to direct the impact probe 120 toward the calculus.
  • the deflection actuator 156 may be coupled to the distal end 115 of the shaft 110 via at least one pull wire 117. Each pull wire 117 may extend from the actuator 156 to the distal end 115 within the shaft 110.
  • the deflection actuator 156 can include any suitable variety of articulation mechanism to control the pull wires 117.
  • each pull wire 117 can be coupled to the deflection actuator 156, such that movement of the actuator 156 effects deflection of the distal end 115.
  • the deflection actuator 156 can include, for example, an articulation mechanism such as a knob, a lever, a slide, a motor, etc. to apply tension to the pull wire 117 to bend the distal end 115.
  • the deflection actuator 156 and pull wires 117 can be configured to bend the distal end 115 in one plane from zero degrees to about 30, 45, 60, 75, or 90 degrees in one or in each of two directions relative to a longitudinal axis of the shaft 110. Other angles are contemplated.
  • the actuator 156 is configured to bend the distal end 115 in multiple planes and in one or two directions in each plane relative to the longitudinal axis of the shaft 110. Any suitable deflection mechanisms for deflection of the distal end of the shaft 110 is contemplated.
  • the displacement member 154 is functionally, e.g., phycially coupled to a proximal end of the impact probe 120 and configured to axially displace or axially vibrate the impact probe 120 to break a calculus into fragments. Stated otherwise, the displacement member 154 physically or mechanically moves a proximal end of the impact probe 120, and this energy is physically transported along the length of the impact probe 120 to a distal end thereof.
  • the back-and-forth displacements or vibrations can be substantially smaller, such as two, three, or more orders of magnitude (e.g., 100, 1 ,000, or 10,000 times) smaller than a total length of the impact probe 120.
  • the displacement member 154 can include any suitable mechanism capable of axially displacing, vibrating, or otherwise physically imparting energy (e.g., kinetic or mechanical energy) to the impact probe, such as, e.g., at a rate of between about 20 kilohertz and about 5 megahertz.
  • the displacement member 154 may also be referred to as an energy applicator, energization member, etc.
  • the displacement member 154 can apply physical forces to the impact probe 120 to effect physical movement of the impact probe 120, such as rapid movement.
  • the amount of displacement achieved at the distal end of the impact probe 120 is very small, such as on the order on microns.
  • the displacement member 154 may, in some instances, be referred to as a micro displacement member. In various embodiments, the displacement distance at the distal tip of the impact probe 120 is from about 1 micron to about 5 microns.
  • the micro displacement member 154 includes an ultrasound energy generator, such as, for example, an ultrasound or ultrasonic transducer, which may include a piezoelectric stack.
  • the displacement member 154 e.g., micro displacement member
  • the displacement member 154 may be a pneumatic pulse generator.
  • the displacement member 154 may be an electromagnetic impulse generator.
  • the displacement member 154 may include any combination of displacement or micro displacement members.
  • FIG. 2 illustrates the impact assembly 107, which includes the displacement member 154 and the impact probe 120 coupled together.
  • the displacement member 154 can include any suitable variety or arrangement of ultrasonic generator and/or ultrasonic stack.
  • the impact probe 120 includes a probe body, elongated member, or probe shaft 123 coupled to a connector 129 at a proximal end of the probe shaft 123.
  • the probe shaft 123 is a cylindrical or other cross-sectionally profiled solid rod and includes a squared off distal end 124. In other embodiments, the probe shaft 123 may be tubular.
  • the probe shaft 123 may be radial inwardly tapered from the proximal end to the distal end 124, which can concentrate a force applied to the calculus to a small cross-sectional area. In some instances, a narrowed or tapered distal tip may yield improved fragmentation of the calculus relative to other orientations. In other embodiments, the distal end 124 may include a conical tip to concentrate the force applied to the calculus. In the illustrated embodiment, the probe shaft 123 defines a substantially constant cross-sectional profile along a full length thereof. Other configurations are contemplated. The probe shaft 123 can be formed of any suitable material.
  • the probe shaft 123 is formed from a superelastic shape-memory metal alloy, such as nitinol. In other embodiments, the probe shaft 123 can be formed of a relative strong and/or durable material, such as, e.g., titanium. [0078] In certain embodiments, the impact probe 120 can be disposed within the shaft 110 in a fixed longitudinal arrangement relative to the shaft 110. For example, the impact probe 120 may be fixed relative to the shaft 110 in a fixed orientation in which the probe 120 extends past a distal tip of the shaft 110, such as in the orientation depicted in FIG. 3A.
  • the distal end 124 of the impact probe 120 extends beyond the distal end 115 of the shaft 110 and can be directed toward the calculus to be fragmented via movement of the shaft 110.
  • the distal end 124 of the impact probe 120 may be flush with or recessed relative to the distal end 115 of the shaft 110.
  • the impact probe 120 may be longitudinally displaceable with respect to the shaft 110, such as in manners previously discussed.
  • the impact probe 120 may be initially disposed at the distal end 115 of the shaft 110, and may be recessed relative to or flush with a distalmost tip of the shaft 110, when in a retracted state, and may be longitudinally displaced from the channel 112 (e.g., moved distally beyond a distal end of the channel 112) into a deployed state during a treatment procedure. When displaced or deployed, the impact probe 120 can be directed toward the calculus to be fragmented.
  • the impact probe 120 can then be passed through at least a portion of the shaft 110. For example, in some embodiments, the impact probe 120 is advanced through the proximal end 116 to the distal end 115 of the shaft 110, and, in further instances, may be moved distally beyond the distal end 115.
  • the shaft 110 can be articulated at a bending (or bend) section or region 118, causing the probe shaft 123 of the impact member 120 to selectively bend, for example, due to resilient properties of a superelastic material of which it is formed in some embodiments, into an arcuate shape at an intermediate portion that is adjacent the distal end 124.
  • the portion of the impact member 120 that is so permitted to bend may be referred to as a bending (or bend) section or region 135 of the impact member 120.
  • the distal end 124 is shown to extend rectilineariy from a distal opening 136 (see also FIG. 1 B) of the channel 112 while the bend region 135, or at least a portion of the bend region 135, is maintained in an arcuate shape by the bend region 118 of the shaft 110.
  • the articulated shaft 110 can cause the probe shaft 123 to bend through any suitable angle, such as an angle up to about 30, 45, 60, 75, or 90 degrees, from about one degree to about 90 degrees. More generally, in various embodiments, a maximum angle through which the probe 120 can be bent can be no less than about 30, 45, 60, 75, or 90 degrees.
  • the articulated or bend region of the shaft 110 can guide or channel the probe shaft 123 along a curved or bent pathway defined thereby.
  • the distal end 124 of the probe shaft 123 may initially bend as the probe shaft 123 first enters the bend region 118 of the nephroscope shaft 110 and as said at least a portion of the distal end 124 passes through the bend region 118.
  • the probe shaft 123 may follow a curvature defined by the bend region 118 of the shaft 110 as the probe 120 is advanced through the shaft 110.
  • the bent portion or entirety of the distal end 124 of the probe shaft 123 may return to a substantially rectilinear shape and may remain substantially rectilinear upon further advancement of the probe shaft 123 through the nephroscope shaft 110.
  • the portion of the probe shaft 123 that is positioned within the bend region 118 of the shaft 110 can substantially conform to the curved pathway defined by the bend region 118.
  • the impact member 120 can be configured to efficiently transmit energy through its bend region 135 to the distal end 124.
  • the shaft 110 may be articulated to position the impact member 120 in a desired treatment location.
  • the shaft 110 may be articulable across a range of angles and the impact member 120 may be configured to bend with the articulated shaft 110.
  • the impact member 120 may be configured to transmit energy or longitudinal displacement along an axis of the impact member 120, including transfer of energy or longitudinal displacement around a bend when the impact member 120 is disposed within a curved or articulated region of the shaft 110. Stated otherwise, at least a portion of the bend section 135 of the impact member 120 may be maintained in a bent configuration by the bent region 118 of the shaft 118, and the bend section
  • the shaft 110 may thus be configured to facilitate placement of the distal end 124 of the impact member 120 at, in, or adjacent to a desired treatment site and the impact member 120 may be configured to transmit energy to that treatment site, including transmission of energy around a curve or bend.
  • the distal end of the impact member 120 may thereby be placed at or near the target material and activated.
  • the impact member 120 may be longitudinally advanceable relative to the shaft 110
  • the impact member 120 may be urged longitudinally through the channel 112.
  • the shaft 110 may impart a curve to the impact member 120 only in the curved or articulated region of the shaft 110. As the impact member 120 is advanced through the channel 112 and the distal opening 136, it may thus maintain a generally rectilinear form as it is advanced. Stated otherwise, the impact member 120 may advance straight out of the distal opening
  • the opening 136 at the distal end of the channel 112 of the shaft 110 may function to “aim” the impact member 120 in a desired direction, and the impact member 120 extends rectilinearly as it is advanced distally past a distalmost tip 137 of the shaft 110.
  • the impact member 120 may thus not be independently curvable on its own, but rather, curved due to constraints or forces imparted by the shaft 110 and/or channel 112.
  • the displacement member 154 includes an ultrasound energy generator 155.
  • the ultrasound energy generator 155 includes a horn 160, a stack of piezoelectric ceramic plates 161, electrodes 162, a rear mass 163, and a preload bolt 164.
  • the electrodes 162 are disposed between the piezoelectric ceramic plates 161.
  • the electrodes 162 may be coupled to an integrated or remote controller (not shown).
  • the controller can activate the electrodes at any suitable frequency, such as, for example, frequencies ranging from about 20 kilohertz and about 5 megahertz. When activated, the electrodes 162 can cause the piezoelectric ceramic plates 161 to change shape and generate ultrasound energy.
  • the ultrasound energy can be transmitted to the horn 160, causing the horn 160 to vibrate.
  • the vibration of the horn 160 can be transmitted to the connector 129 and to the impact probe 120, causing the impact probe 120 to axially vibrate at the input frequency from the controller.
  • the rear mass 163, disposed proximally of the piezoelectric ceramic plates 161 can facilitate directing of the ultrasound energy toward the horn 160.
  • the preload bolt 164 can be disposed through at least a portion of the ultrasound energy generator 155. In various instances, the preload bolt can attach various components together, can provide a preload to the stack for known reasons, and/or can facilitate axial alignment and stacking of the components of the ultrasound energy generator 155.
  • the axial vibration of the impact probe 120 causes the distal end 124 (including a distalmost tip thereof) to be axially displaced in a direction in alignment with the longitudinal axis of the probe shaft 123 when the probe shaft 123 is in a straight configuration.
  • the intermediate, deflectable, bendable, flexible, or directable portion 135 of the impact probe 120 is in the arcuate shape, as depicted in FIG. 3B, the axial vibration of the impact probe 120 causes the distal end 124 of the impact probe 12 to be axially or rectilinearly displaced in a direction in alignment with an axis of the distal end 124.
  • the direction of axial displacement of the distal end 124 may be redirected from about zero degrees to about 90 degrees relative to the longitudinal axis of a proximal length of the probe shaft 123, such as may be due to a curvature imparted to the impact member 120 by a sheath within which it is retained, as previously discussed.
  • the impact probe 120 and related components may be configured such that axial or rectilinear displacement, or other forms of energy traveling in longitudinal waves along a proximal axis of the impact probe 120, may be directed around a curved or articulated portion to deliver axial displacement, or other forms of energy traveling in longitudinal waves along a distal axis of the impact probe 120.
  • the distal axis may be disposed at an angle to the proximal axis and/or may be disposed in a different plane than the proximal axis.
  • the impact probe 120 is configured to transport ultrasonic energy through a curved region sufficient to achieve lithotripsy or breakup of a calculus at a distal end of the impact probe 120 that defines a distal axis at an angle of no less than about 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, or 90 degrees relative to a proximal axis defined by a proximal portion of the impact probe 120.
  • the lithotomy system 100 can be used to perform a percutaneous lithotripsy procedure to fracture and remove a calculus from an organ, such as a kidney, ureter, bladder, urethra, pancreas, gall bladder, and any other location where a calculus may be found within a patient.
  • the elongate treatment member 100 may be inserted into the organ using any suitable technique. For example, a needle may be inserted through the skin into the organ and a guidewire inserted through the needle into the organ. The needle may be removed and a dilator and/or introducer sheath or tube passed over the guidewire into the organ. The guidewire and the dilator may then be removed, leaving the introducer sheath or tube in the organ.
  • the elongate treatment member 100 can be passed through the introducer sheath or tube into the organ.
  • FIG. 4 depicts the elongate treatment member 100 disposed in an organ 104 (e.g., a kidney) at a lithotripsy site 103 adjacent a calculus 102.
  • organ 104 e.g., a kidney
  • the distal end 115 of the shaft 110 may be articulated (e.g., via rotation or, in other embodiments, other forms of actuation of the actuator 156) such that the distal end 115 is directed toward the calculus 102.
  • the impact probe 120 may be axially or rectilinearly extending from the distal end 115.
  • the impact probe 120 may be deployable from the distal end 115 by a linear or translational displacement mechanism, such as previously described, whereby the impact probe 120 is axially translatable relative to the shaft 110.
  • the impact assembly 107 can be advanced relative to the endoscope 105 via the actuator 121.
  • the actuator 121 is in an unactuated state, with the impact assembly 107 in a retracted or undeployed state.
  • the actuator 121 has been actuated, so as to be in an actuated state, thereby advancing or translating the impact assembly 107 distally relative to the endoscope 105 to advance the impact probe 120 out of the distal end of the shaft 110.
  • the distal end 124 Prior to deployment of the impact probe 120, the distal end 124 may be constrained to a straight configuration by the shaft 110. Following deployment from the curved shaft 110, the distal end 124 can remain in a straight configuration in the region that is distally beyond the curved portion of the shaft 110.
  • the light source may be used to illuminate the lithotripsy site 103 and the calculus 102 such that the camera 151 can capture visual images of the lithotripsy site 103, which may be displayed in any suitable manner (e.g., whether via the device 100 itself or via a display with which the device 100 is in communication).
  • the camera 151 may supply a continuous video feed to any suitable display.
  • the visual images can be used to direct the distal end 115 of the shaft 110 and the distal end 124 of the impact probe 120 toward the lithotripsy site 103 and the calculus 102. As depicted in FIG.
  • the distal end 124 can be directed toward the calculus 102 by articulation of the distal end 115 of the shaft 110, such that the distal end 124 is disposed adjacent the calculus 102 or in contact with the calculus 102.
  • a portion of the impact probe 120 can be bent within the shaft 110 while the distal end 124 extends rectilinearly from the distal end 115.
  • the impact probe 120 may be extended past the distal tip of the shaft 110 prior to articulation, such that the impact probe 120 is bent concurrently with the bending of the shaft 110. In other instances, the impact probe 120 may initially be retracted within the shaft 110.
  • a portion of the impact probe 120 may also bend.
  • the impact probe 120 may then be advanced distally relative to the shaft 110.
  • a portion of the impact probe 120 that is positioned within the bent portion of the shaft 110 may remain bent as the impact probe 120 is advanced distally.
  • the impact probe 120 may be said to follow, conform to, or comply with the curvature of the shaft 110.
  • the distal portion of the impact probe 120 may be substantially straight so as to advance rectilinearly from the tip of the shaft 110.
  • the distal end 124 of the impact probe 120 can be directed toward the calculus 102 by longitudinal movement of the entirety of the lithotomy system 100 within the organ 104, and the distal end 124 is disposed adjacent the calculus 102 or in contact with the calculus 102.
  • the micro displacement member 154 is activated when the distal end 124 is disposed adjacent to the calculus 102.
  • the impact probe 120 is axially vibrated, as previously discussed, such that the distal end 124 is axially displaced to deliver treatment energy to the calculus 102.
  • the distal end 124 of the impact probe 120 can be axially displaced when the distal end 124 is axially aligned with a distal end of the shaft 110.
  • the distal end 124 may be angularly offset relative an axis defined by the distal end of the shaft 110 (see FIG. 8).
  • the treatment energy may include axial vibration.
  • the vibrations may, in some instances, be at, e.g., ultrasonic frequencies previously mentioned to cause fragmentation of the calculus 102.
  • the distal end 124 is advanced to a point adjacent to but not in contact with the calculus 102.
  • the micro displacement member 154 is activated when the distal end 124 is in contact with the calculus 102.
  • the impact probe 120 is axially vibrated, as previously discussed, such that the distal end 124 strikes or impacts the calculus 102, or delivers energy to tissue, fluid, or other matter adjacent the calculus 102, to cause fragmentation of the calculus 102.
  • the fragments of the fragmented calculus 102 are removed from the organ 104 through the working channel 111 (see FIG. 1 B).
  • a suction force may be provided through the working channel 111 such that fluid and the fragments are pulled into and through the working channel 111.
  • the fluid and fragments can pass through the access port 153 and into a fluid line 157 coupled to the access port 153.
  • a fragment trap 158 is disposed in fluid communication with the fluid line 157 to capture the fragments for further analysis.
  • the fragments of the fragmented calculus 102 are excreted from the organ 104 by normal organ function.
  • a tool may be advanced through the working channel 111 to grasp or otherwise capture calculus material that may be too large for retraction through the working channel 111 , and the system 100 may be withdrawn from the patient with the captured calculus to remove the calculus from the patient.
  • FIGS. 5A-8 depict an embodiment of a lithotomy system 200 that resembles the lithotomy system 100 described above in certain respects. Accordingly, like features are designated with like reference numerals, with the leading digit incremented to “2.”
  • the embodiment depicted in FIGS. 5A-8 includes an elongate tubular member or shaft 210 that may, in some respects, resemble the elongate tubular member or shaft 110 of FIG. 1 A.
  • Relevant disclosure set forth above regarding similarly identified features thus may not be repeated hereafter.
  • specific features of the lithotomy system 100 and related components shown in FIGS. 1A-4B may not be shown or identified by a reference numeral in the drawings or specifically discussed in the written description that follows.
  • FIGS. 5A and 5B illustrate the lithotomy system 200.
  • the lithotomy system 200 includes a shaft 210 and an impact probe 220 disposed within the shaft 210.
  • a distal end 224 of the impact probe 220 may include a pre-formed arcuate shape that is set, fabricated, or formed during manufacture of the impact probe 220.
  • the arcuate shape may displace the distal end 224 by any suitable amount, such as through an angle of no less than about 15, 30, 45, 60, 75, or 90 degrees, or from about zero degrees to about 90 degrees, relative to a longitudinal axis of a proximally adjacent portion of the impact probe 220.
  • the distal end 224 may assume the preform arcuate shape when deployed from the shaft 210 as shown in FIG.
  • the distal end 224 can assume the pre-form arcuate shape following deployment and warming (such as warming to body temperature) of the distal end 124 formed from the shape memory material (e.g., nitinol).
  • the distal end 224 may be articulated into the arcuate shape following deployment.
  • the distal end 224 may be articulable by a practitioner, rather than having a predetermined preformed shape.
  • the distal end 224 may include features (e.g., slits or cuts, such as those depicted in FIGS. 12A and 12B) that allow the distal end 224, a portion of the distal end 224, and/or a region proximally adjacent to the distal end 224 to bend into the arcuate shape.
  • One or more pull wires or other articulation members may be coupled to the distal end 224 and to a probe articulation member or probe actuator, similar to deflection mechanisms discussed above with respect to the pull wires 117 and the actuator 156.
  • the probe articulation member can include any suitable mechanism to selectively apply tension to the pull wires.
  • the mechanism may include a rotatable knob, a rotatable lever, a linear slide, etc.
  • the distal end 224 can be directed toward the calculus 202 by one or more of articulation of the distal end 215 of the shaft 210 and articulation of the distal end 224 of the impact probe 220 when deployed, such that the distal end 224 is disposed adjacent the calculus 202 or in contact with the calculus 202.
  • a portion of the impact probe 220 can be bent within the shaft 210 while the distal end 224 extends rectilinearly from the distal end 215.
  • only the distal end 224 may be articulated to direct the distal end 224 toward the calculus 202.
  • only the distal end 215 is articulated to direct the distal end 224 toward the calculus 202, as previously described.
  • FIGS. 9A and 9B depict an illustrative embodiment of another lithotomy system 300.
  • the lithotomy system 300 includes an endoscope 305, such as, in particular, a nephroscope, and an impact assembly 307.
  • the endoscope 305 and the impact assembly 307 resemble like-named and like- numbered features previously described with respect to the system 100, such that prior disclosures herein, where appropriate, are equally applicable to the features of the system 300.
  • the system 100 includes a handle 350 much like the handle 150 described above. In some instances, the handle 350 may generally be considered to be a part of the endoscope 305.
  • a tubular member or shaft 310 can be fixedly secured to the handle 350.
  • the impact assembly 307 can include an impact probe 320.
  • the impact assembly 307 is integrally coupled with the endoscope 305 and is movable relative thereto.
  • the handle 350 includes an actuator 321 that is coupled with the impact assembly 307.
  • the actuator 321 may be referred to as a deployment actuator, an impact assembly actuator, a lithotripter actuator, etc.
  • the actuator 321 is configured to effect movement of the impact assembly 307 relative to the handle 350 (e.g., or stated otherwise, relative to the shaft 310 or relative to the endoscope 305).
  • the actuator 321 is capable of manipulation or actuation so as to move the impact assembly 307 between a retracted or undeployed position or state and an advanced or deployed position or state.
  • the impact probe 320 is shown in the deployed state in which a distal end of the impact probe 320 extends distally past a distal tip of the shaft 310.
  • the actuator 321 can comprise any suitable mechanism for effecting movement, e.g., translation, of the impact assembly 307 relative to the handle 350, such as mechanisms previously described.
  • the actuator 321 includes a rotational actuation mechanism 122, and in particular, a lever that is rotatable relative to the handle 350 (e.g., relative to a housing portion of the handle 350).
  • Rotation of the actuation mechanism or lever 122 in a first direction effects distal advancement or deployment of the impact probe 307.
  • Rotation of the lever in a second direction opposite the first direction effects proximal retraction or withdrawal (e.g., into the shaft 310) of the impact probe 307. Further discussion of the actuator 321 is provided hereafter.
  • the shaft 310 can include a lumen 333 (FIG. 10A) extending between and through a distal end 315 and a proximal end 316 of the shaft 310.
  • a lumen 333 FIGS. 10A and 10B
  • an inner tube 330 is disposed within the lumen 333 and the impact probe 320 is disposed within a lumen of the inner tube 330.
  • the impact probe 320 is a substantially tubular structure, and may be referred to as an impact tube.
  • the impact probe 320 may define an aspiration lumen 383.
  • the inner tube 330 may also be referred to, for example, as an irrigation tube.
  • the inner tube 330 (other than a distal end thereof) is oriented substantially coaxially relative to an outer surface of the shaft 310.
  • the distal end of the inner tube 330 tapers at one side thereof to conform to a substantially D-shaped opening 349 in a tip 340 of the sheath 310.
  • the impact probe 320 can be substantially centered relative to the D-shaped opening 349, and as a result, may be slightly offset relative to the common longitudinal axis that extends through a center of the vast majority of the length of the inner tube 330 and through the shaft 310.
  • the irrigation tube 330 may define an inner diameter that is at least slightly larger than an outer diameter of the impact probe 320. This can provide a substantially annular or tubular space 331 or substantially annular or tubular lumen between the irrigation tube 330 and the impact probe 320.
  • the inner circle of the substantially annular space 331 may be offset from a center of the outer circle, due to the offset axes of the impact probe 320 and the irrigation tube 330.
  • irrigation fluid e.g., saline
  • irrigation fluid may flow through the annular space 331 between the inner tube 330 and the impact probe 320 to cool the impact probe 320 and/or to irrigate a region distal to the tip 340.
  • the inner tube 330 may be formed of any suitable polymeric material, such as polyethylene and polyurethane, or a metal material, such as stainless steel, titanium, and nickel-titanium alloy. Other materials are contemplated within the scope of this disclosure.
  • the irrigation tube 330 may extend into the handle 350 and may terminate at a connector 380.
  • the connector 380 is a Y-shaped connector 380 that includes two branches. One branch is aligned with a longitudinal axis of the proximal end of the irrigation tube 330.
  • This branch includes any suitable sealing member 381 therein, such as, for example, an O-ring.
  • the sealing member 381 can permit movement of the impact probe 320 therethrough while maintaining a fluid-tight seal with an external surface of the impact probe 320.
  • the other branch of the connector 380 extends at an angle relative to the longitudinal axis of the irrigation tube 330 and is coupled with an extension tube 381, which leads to an irrigation port 353.
  • the irrigation fluid can be introduced into the system 300 via the irrigation port 353.
  • Irrigation fluid that enters the irrigation port 353 can pass through the extension tube 381 into the connector 380.
  • the seal 381 can prevent the fluid that enters thusly into the connector 380 from thereafter egressing proximally from the connector 381.
  • the fluid can instead flow from the connector 380 into the annular or tubular space 331 between the impact probe 320 and the irrigation tube 330 (see also FIGS. 10A and 10B).
  • the lithotomy system 300 can apply suction to the treatment region, which can clear calculus material (e.g., calculus fragments) from the treatment region.
  • the suction may be applied through the suction lumen 383 defined by the impact probe 320.
  • a fluid barrier 384 can be applied to the impact probe 320 to maintain fluidic separation between the suction lumen 383 inside the impact probe 320 and the substantially annular irrigation lumen 331 outside the impact probe 320.
  • the impact probe 320 includes a series of slots, cuts, or gaps that might otherwise reduce suction and/or result in suction of aspiration fluid before the fluid is able to be delivered past the distal tip 340.
  • the fluid barrier 384 may take any suitable form.
  • the fluid barrier 384 includes a polymeric sleeve that forms fluid tight seals with an external surface of the impact probe 320 at each of a proximal and distal end of a bending section that is formed by the lateral slots.
  • suction can be applied to the impact probe 320 via an aspiration or suction port 360, which is positioned at a proximal end of the handle 350 in the illustrated embodiment.
  • the suction port 360 can be connected to an aspiration tube 362 that is in fluid communication with a proximal leg 364 of a working channel 311 of the system 300.
  • the working channel 311 is also shown in, e.g., FIGS. 10A and 10B.
  • the working channel 311 can extend through a displacement member 354 and through the impact probe 320, which is fixedly attached to the displacement member 354. Any suitable suction source may be coupled to the aspiration port 360.
  • the aspiration port 360 may include, for example, a connector such as, e.g., a barbed tubing connector, suitable for coupling to, e.g., a hospital suction line.
  • a valve 363 at a proximal end of the working channel 311 can be fluidically sealed so as to maintain suction within the suction tube 362 and along the working channel 311.
  • the system 300 includes a suction actuator 361 that may provide variable suction force within the impact member 320.
  • the suction actuator 361 may be shaped and/or positioned as a trigger.
  • the actuator 361 may be centered along one side of the handle 350 and may be readily accessible and depressible by the pointer finger of the hand of a user as the hand grips the handle 350.
  • the illustrated arrangement can permit ready use of the actuator 361 by the index finger of either hand, or stated otherwise, ambidextrous use of the actuator 361 is facilitated.
  • the actuator 361 can be coupled with a ratchet member 373 or any other suitable mechanism to retain the suction actuator 361 in any of a plurality of positions that cause a compression member 368 to compress the aspiration tube 362 by varying amounts, depending on position, to control a magnitude of suction that is permitted within the fluid path that extends through the tube 362, the working channel 311 , and the impact probe 320.
  • Other suitable forms of the suction actuator 361 are within the scope of this disclosure.
  • the valve 363 can selectively seal a proximal end of the working channel 311.
  • the valve 363 can be in fluid communication with the lumen 383 of the impact probe 320 via a proximal branch 364 of the working channel 311 , which is formed as a tubular member that extends from the valve 363 to or through at least a portion of the displacement member 354.
  • the displacement member 354 can define a lumen therethrough, which may or may not include a tubular element therein. Whether or not one or more tubular elements extend into or through the displacement member 354 from one or both of a proximal and distal end thereof, the lumen through displacement member 354 permits passage of the working channel 311 therethrough.
  • the displacement member 354 may be said to define and/or encompass a section of the working channel 311.
  • the lumen 383 of the impact probe 320 likewise can constitute a segment of the working channel 311 , and may be in fluid communication with each of the aforementioned sections of the working channel 311.
  • calculus material can be suctioned from the treatment site into the working channel 311 and out through the suction tube 362 and the suction port 360.
  • the calculus material which may be smaller than an opening 385 (FIG. 10B) at a distal tip of the impact probe, can be aspirated through the suction lumen 383 of the impact probe 320, through the displacement member 354, through the aspiration tube 362, and out through the suction port 363.
  • the valve 363 and the working channel 311 may provide, e.g., individually, passage of a guidewire and any of a variety of tools to the treatment site.
  • the various tools may include, for example, a laser fiber positioned adjacent the calculus to break up the calculus with laser energy, a basket grabber that may be positioned at the treatment site to grab and withdraw calculus fragments through the valve 363 and working channel 311 , and/or a biopsy tool that may be positioned at the treatment site to obtain a tissue sample for examination.
  • the valve 363 may include, for example, any suitable hemostasis valve.
  • the valve 363 includes a membrane having a slit configured to seal around the tool or guidewire.
  • the unfragmented calculus, a fragment, or even multiple fragments can be grasped by the tool that has been extended through the working channel 311 and past the distal tip of the impact probe 320.
  • the calculus material can be retracted from the patient while being held at a position external to the shaft 310 and/or the impact probe 320.
  • the calculus material may be too large to be retracted (e.g., suctioned or grasped and pulled) through the working channel 311.
  • a tool that has been inserted through the working channel 311 may be used to securely ensnare, grab, grasp, or otherwise hold the calculus material, and the entirety of the lithotomy system 300 can be removed from the patient while the tool continues to hold the calculus material to thereby remove the calculus material from the patient.
  • the shaft 310 may be straightened after the calculus material has been grasped and prior to removal of the shaft 310 and the tool in unison from the patient.
  • the lithotomy system 300 may then be reintroduced into the patient for further calculus or calculus fragment removal.
  • the shaft 310 can include an articulating or bending portion 318 disposed proximal to a shaft tip 340.
  • the shaft 310 can include an outer jacket, cover, sheath, or sleeve 339 that extends along a full length of the shaft 310.
  • the outer sleeve 339 may be of any suitable construction, and may include a polymeric material, braided material, and/or other structural reinforcements to provide pushability and/or torqueability.
  • the outer sleeve 339 is not shown in FIG. 10A to facilitate viewing of structures internal thereto.
  • the bending portion 318 can include a backbone member 370 of any suitable variety. In the embodiment depicted in FIGS.
  • the backbone member 370 includes a plurality of wedge-shaped slots 371 disposed along opposing sides.
  • the slots 371 may be configured to allow the backbone member 370 to bend toward the slots 371 from about zero degrees to about 90 degrees and from about 45 degrees to about 60 degrees relative to a longitudinal axis of the backbone member 370. Other bending angles and ranges are contemplated.
  • the backbone member 370 may include slots of any suitable shape to allow bending of the backbone member 370.
  • the backbone member 370 further includes pull wire passages 372 configured to retain one or more pull wires (see, e.g., FIG. 1 A) extending from the handle 350.
  • the backbone member 370 When tension is applied to a pull wire on one side of the backbone member 370, the backbone member 370 is bent toward that side.
  • two pull wires may extend through the pull wire passages 372 on opposing sides of the backbone member 370 and coupled (e.g., welded) to a distal end of the backbone member 370.
  • a single pull wire may extend distally through the pull wire passages 372 on one side of the backbone member 370, looped over the distal end of the backbone member 370, and extended proximally through the pull wire passages 372 on the opposing side of the backbone member 370.
  • the backbone member 370 may be formed of any suitable material, such as stainless steel, titanium, nickel-titanium alloy, polymeries (e.g., may be molded), etc.
  • the impact probe 320 of the illustrated embodiment of the system 300 is shown in further detail in FIGS. 12A and 12B.
  • the impact probe 320 includes a bending portion 335 that includes a plurality of slits 322 disposed proximal to a distal end of the impact probe 320.
  • the bending portion 335 is radially aligned with the bending portion 318 of the shaft 310 when the impact probe is disposed within the inner tube 330.
  • the bending portion 335 of the impact probe 320 has a length that is greater than a length of the bending portion 318 of the shaft 310, which in some instances, can facilitate advancement of the impact probe 320 through the shaft 310 when the shaft 310 is in a bent configuration.
  • the bending portion 335 is proximally offset from the distal end of the impact probe 320. In some instances, this can cause a distal end portion 324 of the impact probe 320 to be relatively stiff. In various embodiments, the distal end portion 324 may have a length of between about 1 centimeter to about 2 centimeters, may be no greater than about 1 or 2 centimeters, or may be no less than about 1 or 2 centimeters. In some embodiments, the slits 322 are sized and/or spaced from each other in a manner that allows the impact probe 320 to bend from about zero degrees to about 90 degrees, from about 45 degrees to about 60 degrees, or some other angle or angle range, relative to a longitudinal axis of the impact probe 320.
  • the slits 322 extend through the impact probe 320 such that a single narrow strip of continuous material, or a solid wall section 323, is disposed between (e.g., extends through or between) opposing ends of the slits 322.
  • the solid wall section 323 can transmit energy (e.g., ultrasonic energy) from a proximal portion of the impact probe 320, along the length of the bending portion 335, and to the distal end portion 324.
  • the solid wall section 323 may have an arc length ranging from about 10 degrees to about 120 degrees, of no less than 10, 15, 20, 25, 30, 45, 60, 75, or 90 degrees, or of no greater than 25, 30, 45, 60, 75, 90, or 120 degrees.
  • the bending portion 335 may bend away from the solid wall section 323, such that the slits contract and such that the solid wall section 323 defines an external arc of the end (e.g., defines the largest radius of curvature of the bend).
  • the size and spacing of the slits can be formed such that adjacent segments of material, or lands, contact one another when the bending portion 335 is bent. In some instances, this contact can assist in transmission of energy to the distal end of the impact probe. In other or further instances, this contact can delimit a maximum bend angle of the bending portion 335.
  • the bending portion 335 may bend toward the solid wall section 323, such that the slits expand and the solid wall section 323 defines an internal arc (e.g., the smallest radius of curvature) of the bend.
  • FIG. 13A illustrates a distal portion of the lithotomy system 300 in which the impact probe 320 is in an undeployed or retracted state.
  • the impact probe 320 is retracted within the shaft 310 when in the undeployed state.
  • FIG. 13B illustrates the distal portion of the lithotomy system 300 with the impact probe 320 in a deployed state.
  • the impact probe 320 is axially displaced relative to the shaft 310 such that a distal portion of the impact probe 320 extends beyond the shaft tip 340.
  • the bending portion 318 of the shaft 310 is bent to direct the impact probe 320, e.g., toward the calculus.
  • the bending portion 318 any suitable bending angle amount is contemplated, as previously discussed.
  • the bending angle may be no less than about 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, or 70 degrees.
  • a maximum achievable bending radius at which energy is effectively delivered to the distal tip of the impact probe 320 is about 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, or 90 degrees.
  • the bending portion 318 may be bent in a single plane extending radially outward from the longitudinal axis. In other embodiments, the bending portion 318 may be bent in two or more planes extending radially outward from the longitudinal axis.
  • the shaft tip 340 is fixedly secured to a distal end of the inner tube 330 (e.g., in a fluid-tight connection).
  • the shaft tip 340 can also be connected to a distal end of the backbone member 370 (which may also be referred to as a backbone).
  • the shaft tip 340 is connected to the backbone 370 via a band 341.
  • the band 341 may be joined to a distal end of the backbone member 370 and may further be joined to the shaft tip 340.
  • the band 341 may, for example, be a relatively rigid or stiff cylindrical ring.
  • the shaft tip 340 can include the opening 349, which may provide passage therethrough of irrigation fluid and/or the impact probe 320, as previously discussed.
  • the tip 340 can further include a visualization opening 343, and one or more illumination openings 344.
  • the visualization opening 343 may be configured for positioning of a visual imaging member as previously described.
  • the illumination openings 344 may be configured to position a visual fiber or an LED as previously described.
  • a distally facing surface 345 is proximally tapered or beveled.
  • a bevel may facilitate advancement of the shaft 310 and/or steering of the shaft 310 as it is directed toward a treatment site.
  • the beveled surface 345 may, for example, prevent the shaft tip 340 from catching on tissue and can allow the shaft tip 340 to deflect from objects.
  • the handle 350 includes the irrigation port 353, which can be in fluid communication with the annular space 331.
  • the irrigation port 353 may include a fluid control valve 367 configured to control a flow rate of irrigation fluid through the irrigation port 353.
  • a micro displacement member 354 is disposed within the handle 350 and operatively coupled to the impact probe 320 to provide micro displacement of the impact probe 320.
  • a power switch 369 is coupled to the displacement member 354 to activate and deactivate the displacement member.
  • a separate switch may be provided for video or image control.
  • the additional switch may commence or terminate image gathering via the image sensor.
  • no image controls are provided.
  • the system 300 is configured to continuously gather a video stream when the system 300 is in use. Other arrangements are contemplated.
  • the illustrated lithotomy system 300 includes a deflection actuator 356 positioned adjacent to the deployment actuator 321.
  • each of the deflection actuator 356 and the deflection actuator 321 can individually be actuated by the thumb of one hand of the user while the user holds the handle 350 with that hand.
  • both actuators 321 , 356 may be actuated simultaneously, if desired, depending on their relative positions. In many instances, serial actuation of the deflection actuator 356 followed or preceded by actuation of the deployment actuator 321 may be desired. As previously discussed, the deployment actuator 321 can be used to extend the impact probe 320 relative to the shaft 310. The deflection actuator 356 can resemble the actuator 156 previously discussed, and may be used to deflect or steer the distal end of the shaft 315.
  • the actuators 321 , 356 may be centered along a side of the handle 350 that is opposite the suction actuator or suction trigger 361 , and may be readily accessible and movable or rotatable by the thumb of either hand of a user, or stated otherwise, ambidextrous use of the actuators 321 , 356 is facilitated.
  • the deflection actuator 356 can include a lever 327 that is coupled to at least one pull wire (such as the pull wires 117 in FIG. 1A) in any suitable manner.
  • the at least one pull wire can be coupled to the backbone member 370 to provide articulating or bending forces to the backbone member 370.
  • each of the lever 327 and the one or more pull wires are attached to a wheel 366, which may provide some mechanical advantage to the deflection actuator 356 to bend the backbone member 370.
  • tension may be applied to a first pull wire causing the backbone member 370 to bend in a first direction or plane.
  • tension may be applied to a second pull wire causing the backbone member 370 to bend in a second direction or plane.
  • the deflection actuator 356 may cause the backbone member 370 to bend in either the first direction and/or the second direction relative longitudinal axis of the backbone member 370.
  • the deflection actuator 356 may be of any suitable form, such as a knob, a tab, a slide, etc. Any other suitable tensioning mechanism is contemplated, included steering mechanisms known in the art.
  • the deployment actuator 321 can include a lever 325 that is similarly attached (e.g., directly attached) to, for example, a wheel such as the wheel 366 discussed above. While this specific wheel is not shown, it can be thought of as an extension of the lever 325 that resides inside a housing of the handle 350, and in any event, can be substantially the same as the wheel 366 that is shown in FIG. 15. Accordingly, the positioning and functioning of the internal wheel (e.g., extension of the lever 325) can be readily understood from the drawings and present description.
  • the lever 325 (and associated wheel) can be mechanically (e.g., pivotally) coupled with a linkage 392 of any suitable variety that can convert rotational movement of the lever 325 into longitudinal movement of the impact assembly 307.
  • a proximally positioned pivot can be coupled to the internal wheel (and the lever 325), and a distal pivot of the linkage 392 can be coupled with the impact assembly 307.
  • rotation of the lever 325 in a first direction effects distal movement of the impact assembly 307 relative to the handle 350 for distal advancement or deployment of the impact assembly 307
  • rotation of the lever 325 in a second direction opposite the first direction effects proximal movement of the impact assembly 307 relative to the handle 350 for retraction of the impact assembly 307.
  • Any other suitable linkage is contemplated.
  • alterations or adjustments may be made to provide a predictable and/or intuitive correspondence between an amount of movement of the lever 325 and a corresponding movement of the impact probe 320.
  • the handle 350 includes a nest or inner housing 390 that is positioned at an interior of the handle 350 and within which the energy applicator or displacement member 354 of the impact assembly 307 is configured to reciprocate (e.g., translate distally or proximally, depending on a movement directly of the lever 325).
  • a pair of positioning elements 391 are positioned at substantially opposite ends of the displacement member 354. The positioning elements 391 can maintain a suitable spacing between the inner housing 390 and the displacement member 354, can facilitate relative movement of these elements, and/or can dampen or otherwise cushion the handle 350 from vibrations of the displacement member 354 when activated. Other suitable arrangements for permitting relative movement between the impact assembly 307 and the handle 350 are contemplated.
  • a first end of a power and/or communication cable 359 is coupled to the handle 350.
  • a second end of the power and/or communication cable 359 may be coupled to a power source and/or controller for the micro displacement member 354, an image or video processing unit for the visual imaging member, and/or a light or power source for the illumination member.
  • the deployment actuator 321 may be disposed adjacent the deflection actuator 356 and coupled to the impact probe 320 to axially displace the impact probe 320 distally to deploy the impact probe 320 beyond the shaft tip 340, such as to break the calculus into fragments, and/or to proximally retract the impact probe 320 into the inner tube 330 (FIG.
  • the advancement actuator 321 can comprise a lever that when displaced distally moves the impact probe 320 distally and when displaced proximally moves the impact probe proximally.
  • the deployment actuator 321 may be configured to displace the impact probe 320 from about 1 centimeter to about 2 centimeters beyond the distalmost tip of the shaft 310, in some embodiments.
  • FIG. 16 illustrates another embodiment of an impact probe 420 suitable for use with certain of the lithotomy systems described herein.
  • the impact probe 420 includes a shaft 423, an adapter 425, a bending portion 421 , and a probe tip 480.
  • the shaft 423 includes a tube formed of a nickel-titanium alloy or any other suitable material.
  • the adapter 425 is coupled to a distal end of the shaft 423. In some embodiments, the adapter 425 may be press fit into the shaft 423. In other embodiments, the adapter 425 may be welded, braised, or soldered onto the distal end of the shaft 423.
  • the bending portion 421 includes two or more wires 426 coupled to and extending between the adapter 425 and the probe tip 480.
  • the impact probe 420 includes two wires 426.
  • the impact probe 420 may include three or more wires, four or more wires 426, or some other number of wires.
  • the wires 426 may have a diameter ranging from about 0.25 millimeters to about 1.0 millimeters and a length ranging from about 40 millimeters to about 80 millimeters and may be about 55 millimeters.
  • the wires 426 may be formed of nickel-titanium alloy material or any other suitable material.
  • a hollow sleeve e.g., a tube of any suitable material, such as flexible metal or polymer
  • the hollow sleeve may resemble the fluid barrier 384 discussed above with respect to FIG. 10A, and can serve the same function of fluidically isolating an interior of the impact probe 420 from an exterior thereof, which can segregate a suction region at an interior of the impact probe 420 from an irrigation region at an exterior of the impact probe 420.
  • the probe tip 480 is generally cylindrical in shape.
  • the probe tip 480 can be formed of nickel-titanium alloy material or any other suitable material.
  • the probe tip 480 may desirably be relatively hard to efficiently and/or durably break down calculi.
  • a length of the probe tip 480 can range, in certain embodiments, from about 12 millimeters to about 25 millimeters and a diameter can range from about 3 millimeters to about 5 millimeters. Other dimensions are contemplated.
  • the probe tip 480 includes a distal end including impact members 481 and flow spaces 482 disposed between the impact members 481. In the depicted embodiment, the number of impact members 481 is five.
  • the number of impact members 481 may be two, three, four, or more.
  • the impact members 481 are triangular in shape. In certain embodiments, the impact members 481 may have any suitable shape, such as a circular or polygonal shape.
  • a proximal end of the probe tip 480 can include wire holes 483 configured to receive the wires 426 to couple the probe tip 480 to the wires 426.
  • a bore 486 extends through the probe tip 480 and is in fluid communication with the flow spaces 482.
  • a neck portion 485 of the bore 486 is adjacent the distal end and a main portion 487 extends proximally from the neck portion 485.
  • a diameter of the neck portion 485 is smaller than a diameter of the main portion 487.
  • the diameter of the neck portion 485 can be, in some embodiments, about 1.3 millimeters and the diameter of the main portion 487 can be about 1.6 millimeters.
  • This configuration can provide for improved passage of calculus fragments through the main portion 487.
  • fragments generated by the probe tip 480 can be small enough to first pass through the narrow neck portion 485 before entering the main portion 487.
  • An outside surface of the probe tip 480 can include a recess 484 having a diameter smaller than a diameter of the impact members 481 and a proximal portion 488.
  • the diameter of the recess portion 484 can be, in some embodiments, about 3.3 millimeters and the diameter of the proximal portion 488 can be about 3.6 millimeters.
  • the recess 484 can provide an annular passage between the probe tip 480 and the calculus for irrigation fluid when the probe tip 480 is disposed within a drilled hole of the calculus. The irrigation fluid can cool the probe tip 480 and provide for aspiration of calculus fragments through the probe tip.
  • the impact probe 420 can be axially vibrated such that the probe tip 480 breaks apart a calculus and/or drills a hole in the calculus as the impact members 481 impact the calculus or adjacent to the calculus.
  • the wires carry energy from the proximal portion of the impact probe 420 to the probe tip 480. If a hole is drilled, a diameter of the hole can be substantially equivalent to the diameter of the probe tip 480.
  • the irrigation fluid can flow along or about an outer surface of the proximal portion 488 and the annular space surrounding the recess portion 484 when the recess portion 484 is partially disposed within the drilled hole.
  • the irrigation fluid can be drawn inwardly through the flow spaces 482 into the neck portion 485 of the bore 486 by a suction force within the bore 486. As the irrigation fluid flows into the bore 486, fragments of the calculus are caught in the fluid flow to pass through the neck portion 485 and into the main portion 487 to clear the drilled hole of calculus fragments.
  • FIG. 18 illustrates another embodiment of an impact probe 520 suitable for use with certain of the lithotomy systems described herein.
  • the impact probe 520 includes a shaft 523, an adapter 525, a bending portion 521 , and a probe tip 580.
  • the shaft 523 includes a tube formed of a nickel-titanium alloy or any other suitable material.
  • the adapter 525 is coupled to a distal end of the shaft 523. In some embodiments, the adapter 525 may be press fit into the shaft 523. In other embodiments, the adapter 525 may be welded, braised, or soldered onto the distal end of the shaft 523.
  • the bending portion 521 includes two or more wires 526 coupled to and extending between the adapter 525 and the probe tip 580.
  • the impact probe 520 includes two wires 526.
  • the impact probe 520 may include four or more wires 526.
  • the wires 526 may have a diameter ranging from about 0.25 millimeters to about 1.0 millimeters and a length ranging from about 40 millimeters to about 80 millimeters and may be about 55 millimeters.
  • the wires 526 may be formed of nickel-titanium alloy material or any other suitable material.
  • the probe tip 580 is generally cylindrical in shape.
  • the probe tip 580 can be formed of nickel-titanium alloy material or any other suitable material.
  • a length of the probe tip 580 can range from about 12 millimeters to about 25 millimeters and a diameter can range from about 3 millimeters to about 5 millimeters.
  • the probe tip 580 includes a distal end including impact members 581 and flow spaces 582 disposed between the impact members 581.
  • the number of impact members 581 is five. In other embodiments, the number of impact members 581 may be two, three, four, or more.
  • the impact members 581 are triangular in shape.
  • the impact members 581 may be of any suitable shape, such as circular or any polygonal shape.
  • a proximal end of the probe tip 580 can include wire holes 583 configured to receive the wires 526 to couple the probe tip 580 to the wires 526.
  • a bore 586 extends through the probe tip 580.
  • a neck portion 585 of the bore 586 is adjacent the distal end and a main portion 587 extends proximally from the neck portion 585.
  • a diameter of the neck portion 585 is smaller than a diameter of the main portion 587.
  • the diameter of the neck portion 585 can be about 1.3 millimeters and the diameter of the main portion 587 can be about 1.6 millimeters. This configuration can provide for improved passage of calculus fragments through the main portion 587 because the fragments are small enough to first pass through the narrow neck portion 585 before entering the main portion 587.
  • the impact probe 520 can be axially vibrated such that the probe tip 580 breaks apart a calculus and/or drills a hole in the calculus as the impact members 581 impact the calculus or adjacent to the calculus. If a hole is drilled, a diameter of the hole can be substantially equivalent to the diameter of the probe tip 580.
  • Irrigation fluid can flow along an exterior surface of the probe tip 580.
  • the irrigation fluid can be drawn through the flow spaces 582 into the neck portion 585 of the bore 586 by a suction force within the bore 586. As the irrigation fluid flows into the bore 586, fragments of the calculus can be caught in the fluid flow to pass through the neck portion 585 and into the main portion 587 to clear the drilled hole of calculus fragments.
  • FIG. 20 illustrates another embodiment of an impact probe 620 suitable for use with any of the lithotomy systems previously described.
  • the impact probe 620 includes a shaft 623, an adapter 625, a bending portion 621 , and a probe tip 680.
  • the shaft 623 includes a tube formed of a nickel-titanium alloy or any other suitable material.
  • the adapter 625 is coupled to a distal end of the shaft 623. In some embodiments, the adapter 625 may be press fit into the shaft 623. In other embodiments, the adapter 625 may be welded, braised, or soldered onto the distal end of the shaft 623.
  • the bending portion 621 includes two or more wires 626 coupled to and extending between the adapter 625 and the probe tip 680.
  • the impact probe 620 includes two wires 626.
  • the impact probe 620 may include four or more wires 626. Wire dimensions and/or composition may be similar to those previously described with respect to other wires.
  • FIGS. 21A-D illustrate another embodiment of a probe tip 680.
  • the probe tip 680 is generally cylindrical in shape.
  • the probe tip 680 can be formed of nickel-titanium alloy material or any other suitable material.
  • a length of the probe tip 680 can range from about 12 millimeters to about 25 millimeters and a diameter can range from about 3 millimeters to about 5 millimeters.
  • the probe tip 680 includes a distal end including distally directed pointed impact members 681 and a proximally directed longitudinal tapered flow notch or space 690 disposed between the impact members 681 at a perimeter of the distal end.
  • the number of impact members 681 is two. In other embodiments, the number of impact members 681 may be three, four, five, or more.
  • a proximal end of the probe tip 680 can include wire holes 683 configured to receive the wires of an impact probe similar to those previously described.
  • a bore 686 extends through the probe tip 680.
  • a neck portion 685 of the bore 686 is adjacent the distal end and a main portion 687 extends proximally from the neck portion 685.
  • a diameter of the neck portion 685 is smaller than a diameter of the main portion 687.
  • the diameter of the neck portion 685 can be about 1.3 millimeters and the diameter of the main portion 687 can be about 1.6 millimeters. This configuration can provide for improved passage of calculus fragments through the main portion 687 because the fragments are small enough to first pass through the narrow neck portion 685 before entering the main portion 687.
  • a suction hole 689 is disposed through a wall of the probe tip 680 into the bore 686.
  • the impact probe can be axially vibrated such that the probe tip 680 breaks apart a calculus and/or drills a hole in a calculus as the impact members 681 impact the calculus or adjacent to the calculus. If a hole is formed, a diameter of the hole can be substantially equivalent to the diameter of the probe tip 680.
  • Irrigation fluid can flow along an exterior surface of the probe tip 680.
  • the irrigation fluid can be drawn through the tapered flow notches 699 into the neck portion 685 of the bore 686 by a suction force within the bore 686.
  • the suction hole 689 can be positioned outside of the bored hole in the calculus to provide the suction force within the bore
  • FIG. 22 illustrates another embodiment of an impact probe 720.
  • the impact probe 720 includes a shaft 723, a bending portion 721 , and a distal portion 724.
  • the bending portion 721 is disposed between the shaft 723 and the distal portion 724.
  • the bending portion 721 includes a pair of parallelly extending rails 727.
  • the rails 727 may be formed by a micro electric discharge machining (EDM) process or any other suitable process.
  • EDM micro electric discharge machining
  • the rails 727 may be polished after machining to remove burrs or other defects that may act as stress concentrators when the impact probe 720 is vibrated causing breakage of the rails 727.
  • the various embodiments of impact probes depicted in FIGS. 18-22 can include a hollow sleeve or fluid barrier (such as the fluid barrier 384), as discussed with respect to the impact probe 420. Additionally, it is noted that although much discussion is made of axial vibration of probe tips, it should be understood that lateral vibrations may also be present. In some instances, lateral vibration modes may be less pronounced than axial vibration modes. In other instances, lateral vibration modes may be less pronounced than axial vibration modes. In still other instances, substantially equal amounts of energy may be present in lateral vibration modes and axial vibration modes. Any vibration modes that can suitably break up or otherwise usefully disrupt calculi may be employed.
  • FIGS. 23A and 23B depict another embodiment of an impact probe 820, which can resemble the impact probe 320 and other impact probes described herein in many respects.
  • the impact probe 820 includes an additional set of slits and an additional narrow strip of continuous material, or a solid wall section, that extends between adjacent slit ends.
  • the longitudinally extending solid wall sections are diametrically opposed.
  • the impact probe 820 can bend in two opposite directions. In one direction, a first set of slits is compressed and the other expands. The opposite occurs when the impact probe 820 is bent in the other direction.
  • Embodiments of impact probes described herein may also or alternatively be referred to as lithotripters.
  • Embodiments within the scope of this disclosure may thus comprise a shaft that can be articulated out of a plane and/or an impact probe that can be articulated out of a plane.
  • both the shaft and the impact probe are articulable while in other embodiments only the shaft or only the impact probe is articulable.
  • articulation in these instances may refer to members with preformed shapes that articulate when unconstrained and/or members with mechanical or other systems to bend or otherwise articulate the member.
  • a system with one or more articulable members may facilitate or enable guidance of the treatment system to a treatment location. For example, in some instances, displacement of bodily tissues to conform to a treatment device that is linear and rigid can be avoided. Treatments within the scope of this disclosure can include methods of articulating a treatment device to direct treatment energy along one or more axes to access a treatment location.
  • lithotripters and lithotripter assemblies may be useable with other forms of endoscopes.
  • any methods disclosed herein comprise one or more steps or actions for performing the described method.
  • the method steps and/or actions may be interchanged with one another.
  • the order and/or use of specific steps and/or actions may be modified.
  • a method of performing lithotripsy comprising positioning a distal end of a lithotomy system adjacent a lithotripsy site, displacing an impact probe beyond the distal end of the lithotomy system, directing a distal end of the impact probe toward a calculus, activating a micro displacement member coupled to a proximal end of the impact probe, and axially vibrating the impact probe adjacent to the calculus.
  • Other steps are also contemplated.
  • Coupled to and “in communication with” refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction.
  • Two components may be coupled to or in communication with each other even though they are not in direct contact with each other.
  • two components may be coupled to or in communication with each other through an intermediate component.
  • distal and proximal are given their ordinary meaning in the art. That is, the distal end of a medical device means the end of the device furthest from the practitioner during use.
  • the proximal end refers to the opposite end, or the end nearest to the practitioner during use.
  • the proximal end of the device refers to the end nearest to the handle and the distal end refers to the opposite end, the end nearest to the free end of the tubular body.
  • Fluid is used in its broadest sense, to refer to any fluid, including body fluids, liquids, and gases as well as solutions, compounds, suspensions, etc., which generally behave as fluids.

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Abstract

Devices, systems, and methods used to perform a percutaneous lithotomy procedure are disclosed. In some embodiments, the devices include a system having a shaft and a handle. The shaft may include an impact probe that is deployed from the shaft. The impact probe may be axially vibrated by a displacement member. When axially vibrated, the impact probe may break up a calculus within an organ into small fragments.

Description

LITHOTOMY DEVICES, SYSTEMS, AND METHODS
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional Patent Application No. 63/085,679, filed on September 30, 2020, titled PERCUTANEOUS LITHOTOMY DEVICES AND METHODS, the entire contents of which are hereby incorporated by reference herein.
TECHNICAL FIELD
[0002] The present disclosure relates generally to devices and systems to remove calculi from the body of a patient and devices and systems to deliver ultrasonic energy into the body, such as to treat organs containing a calculus. More specifically, in some embodiments, the present disclosure relates to devices and systems percutaneously inserted into an organ to break up and/or remove a calculus.
BRIEF DESCRIPTION OF THE DRAWINGS
[0003] The embodiments disclosed herein will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. These drawings depict only typical embodiments, which will be described with additional specificity and detail through use of the accompanying drawings in which:
[0004] FIG. 1A is a side view of an embodiment of a lithotomy system that includes a shaft assembly or endoscope having an articulable shaft and an impact assembly having an impact probe that is positioned within the shaft in an undeployed state.
[0005] FIG. 1 B is an end view of a distal end of the lithotomy system of FIG. 1 A.
[0006] FIG. 2 is a side elevation view of the impact assembly of FIG. 1A that includes an ultrasound energy generator and an impact probe shown in a straight configuration.
[0007] FIG. 3A is a side view of a distal portion of the lithotomy system of FIG. 1 A with a shaft of the endoscope in a straight state and the impact probe of the impact assembly in an advanced or deployed state. [0008] FIG. 3B is a side view of the distal portion of the lithotomy system of FIG. 1A with the shaft in an articulated state and the impact probe in an advanced or deployed state.
[0009] FIG. 4 is a side view of the lithotomy system of FIG. 1 A with the shaft in the articulated state and the impact probe in a deployed state with a distal tip thereof at a treatment location.
[0010] FIG. 5A is a side view of another embodiment of a lithotomy system that includes an articulable shaft and an impact probe within the shaft in an undeployed state.
[0011] FIG. 5B is an end view of a distal end of the lithotomy system of FIG. 5A.
[0012] FIG. 6 is a side view of a distal end of an impact probe of the lithotomy system of FIG. 5A in a straight configuration with articulated configurations of the impact probe shown in broken lines.
[0013] FIG. 7 is a side view of the distal end of the lithotomy system of FIG. 5A with the impact probe in an articulated and deployed state.
[0014] FIG. 8 is a side view of the lithotomy system of FIG. 5A with the shaft in the articulated state and the impact probe in a deployed and articulated state with a distal tip thereof at a treatment location.
[0015] FIG. 9A is a perspective view of another embodiment of a lithotomy system that includes an articulable shaft and an impact probe in a deployed state in which a distal end of the impact probe extends distally past a distal tip of the shaft.
[0016] FIG. 9B is a perspective view of a proximal portion of a handle of the lithotomy system of FIG. 9A.
[0017] FIG. 10A is a perspective cross-sectional view of a distal portion of the lithotomy system of FIG. 9A, a sleeve portion thereof is not shown to facilitate viewing of components internal to the sleeve.
[0018] FIG. 10B is an end view of the distal portion of the lithotomy system of FIG. 9A.
[0019] FIG. 11 A is a perspective view of an embodiment of a bending member of the lithotomy system of FIG. 9A.
[0020] FIG. 11 B is an end view of the bending member of the lithotomy system of
FIG. 11A
[0021] FIG. 12A is a perspective view of a distal portion of an embodiment of an impact probe of FIG. 9A. [0022] FIG. 12B is a side view of an end portion of the impact probe of FIG. 12A.
[0023] FIG. 13A is a side elevation view of a distal portion of the lithotomy system of FIG. 9A with an impact probe in an undeployed state.
[0024] FIG. 13B is a side elevation view of the distal portion of the lithotomy system of FIG. 9A with the impact probe in a deployed state.
[0025] FIG. 13C is a top plan view of the distal portion of the lithotomy system of FIG. 9A with a shaft and the impact probe in a bent or articulated state and with the impact probe in the deployed state.
[0026] FIG. 14 is a perspective view of a tip of the lithotomy system of FIG. 9A.
[0027] FIG. 15 is a side elevation view of an embodiment of the lithotomy system of FIG. 9A with a portion of the handle removed to facilitate viewing of components within the handle.
[0028] FIG. 16 is side elevation view of another embodiment of an impact probe.
[0029] FIG. 17A is a perspective view of an embodiment of a probe tip compatible with the impact probe of FIG. 16.
[0030] FIG. 17B is a cross-sectional view of the probe tip of FIG. 17A taken along the view line 17B-17B in FIG. 17C.
[0031] FIG. 170 is a top view of the probe tip of FIG. 17A.
[0032] FIG. 17D is a bottom view of the probe tip of FIG. 17A.
[0033] FIG. 18 is a side elevation view of another embodiment of an impact probe.
[0034] FIG. 19A is a perspective view of an embodiment of a probe tip compatible with the impact probe of FIG. 18.
[0035] FIG. 19B is a cross-sectional view of the probe tip of FIG. 19A taken along the view line 19B-19B in FIG. 19C.
[0036] FIG. 19C is a top view of the probe tip of FIG. 19A.
[0037] FIG. 19D is a bottom view of the probe tip of FIG. 19A.
[0038] FIG. 20 is a side elevation view of another embodiment of an impact probe.
[0039] FIG. 21 A is a perspective view of an embodiment of a probe tip compatible with the impact probe of FIG. 20.
[0040] FIG. 21 B is a cross-sectional view of the probe tip of FIG. 21 A taken along the view line 21 B-21 B in FIG. 21 C.
[0041] FIG. 21 C is a top view of the probe tip of FIG. 21 A.
[0042] FIG. 21 D is a bottom view of the probe tip of FIG. 21 A. [0043] FIG. 22 is a side elevation view of another embodiment of an impact probe.
[0044] FIG. 23A is a side elevation view of another embodiment of an impact probe.
[0045] FIG. 23B is another side elevation view of the impact probe of FIG. 23A taken from an opposite side of the impact probe.
DETAILED DESCRIPTION
[0046] In certain instances, a calculus or stone forms within an organ of a patient. For example, the calculus may form in the kidney, the gall bladder, the pancreas, or other locations. In some instances, the calculus can be too large to pass out of the organ by normal organ function. In certain of such instances, the calculus may cause severe pain to the patient as the organ attempts to excrete or pass the calculus. Certain lithotomy treatments include removal of the calculus using surgical methods. In other instances, the calculus may be broken into fragments before being removed from the organ, whether such removal is by medical instruments or by natural excretion by the body. A calculus can, in various methods, be broken into fragments by a lithotripsy procedure that focuses energy, either extra corporeally or corporeally, at the calculus. In some embodiments the energy is ultrasound energy. Corporeal treatment of the calculus can be achieved by access to the organ through a bodily orifice in communication with the organ or by accessing the organ directly by percutaneous puncture of the skin adjacent the organ.
[0047] Devices and methods within the scope of this disclosure relate to delivery of ultrasound energy to the body to treat various regions of the body, including treatments to break up a calculus within the body and/or removal of calculi or calculus fragments from the body. Certain embodiments herein describe percutaneous methods to treat or break up a calculus within an organ and/or that remove a calculus and/or pieces of a disrupted calculus. Devices and methods within the scope of this disclosure include percutaneous delivery through a patient’s skin. In other embodiments, advancement through a lumen of the body to access an organ or other location. For example, elongate energy delivery devices within the scope of this disclosure may access a patient’s kidney by piercing the skin and advancing through tissue adjacent the kidney. In other examples, elongate energy delivery devices may access the kidney by being advanced along the urinary tract, either directly or through a working channel of a separately placed scope or sheath. Though specific examples relating to access of the kidney and treatment of kidney stones are described herein, such disclosure can be analogously applied to treatment of other locations, such as the gall bladder, pancreas, and so forth.
[0048] In some embodiments within the scope of this disclosure, a treatment system may include a shaft, such as an elongate tubular body, and may further include one or more of an impact probe, a visualization member, and a working lumen disposed within the shaft. The impact probe may be configured to deliver energy to a treatment location adjacent a distal end of the shaft. For example, the impact probe may be coupled to a micro displacement member, such as an ultrasound energy generator, to cause the impact probe to axially vibrate and conduct energy from a proximal location to the treatment location. In some instances, a distal portion of the impact member may be disposed in contact with or adjacent a calculus to deliver energy to the calculus to break up the calculus. In certain embodiments, the impact probe may be in a fixed longitudinal relationship to the shaft, and in further embodiments, energy may be delivered from the impact probe at the distal end of the treatment device.
[0049] In some devices within the scope of this disclosure, an impact probe may be longitudinally displaceable with respect to the shaft or tubular body. In some embodiments, the shaft can have a bendable, deflectable, curvable, flexible, or articulable distal end. The impact probe may include a bendable, deflectable, curvable, flexible, or articulable region that is capable of conforming to a bent shape of the deflectable end of the shaft. The probe may be advanced through the shaft such that a distal end of the probe extends past a distal tip of the shaft while a portion of the probe is bent within the shaft. The probe can be configured to suitably deliver energy through the bent portion thereof to the distal end to break up or otherwise disrupt a calculus or other target. In other or further embodiments, the impact probe may be independently bendable, deflectable, curvable or articulable so as to move out of alignment with the axis of at least a distal portion of the shaft. For example, the impact probe can be deployed from the distal tip of the shaft in a straight configuration (e.g., can be advanced rectilinearly beyond the distal tip of the shaft) and/or manipulated into an articulated or bent configuration, such as a configuration having an arcuate shape, e.g., at a position beyond a distal tip of the shaft. As used herein, the terms “articulate,” “articulable,” and variants thereof generally denote the formation of or the ability to form an arcuate or bent shape. These terms do not necessarily require segments or joints to achieve such arcing or bending, although some embodiments may be segmented or jointed.
[0050] In some embodiments, treatment systems described herein include integrated treatment devices comprising an impact probe and optical components such as a visualization system or visual imaging member. The visualization system may include, for example, a lens coupled to a camera and a lighting member such as a light emitting diode (LED) and/or an optical fiber coupled to a light source. The visualization system may be utilized to position the impact probe adjacent to or in contact with the calculus or other treatment site. One or more working lumens may be integrated with the shaft and may be used to irrigate a lithotripsy site surrounding the impact probe to cool the impact probe and/or to evacuate the calculus fragments. In some embodiments, the impact probe may define a lumen (e.g., a working lumen) that extends through the shaft and through which calculi or calculus fragments may be removed from the patient.
[0051] In some treatments within the scope of this disclosure, a shaft is percutaneously inserted into an organ to be treated such that the distal end of the shaft is positioned adjacent a calculus. A clinician may visually confirm placement of the shaft using a visualization member. The impact probe is deployed from the shaft in either a straight or articulated configuration to access a desired treatment position. For example, the distal end of the impact probe may be disposed adjacent to or in contact with the calculus. An energy applicator or displacement member (e.g., a micro displacement member) may be activated to cause vibration of the impact probe; for example, the impact probe may be configured to axially vibrate at a rate of from about 20 kilohertz to about 5 megahertz. The vibration causes the distal end of the impact probe to deliver energy to the calculus, by directly striking the calculus or by imparting energy to tissue, fluid, and/or other material adjacent the calculus. This energy can be delivered until the calculus breaks into fragments. The fragments may be removed through the working lumen.
[0052] In some embodiments, axial vibration introduced at a proximal position along the impact probe can be transmitted along the length of the impact probe, including energy transmission through a curved, angled, rounded or articulated distal portion of the impact probe. That is, a distal portion of the impact probe may be axially vibrated along an axis disposed at an angle to an axial vibration axis of a proximal portion of the impact probe. In other words, the impact probe may be configured to transmit or conduct axial vibration from one axis or plane into a second axis or plane.
[0053] Percutaneous nephrolithotomy or nephrolithotripsy procedures are generally used to treat large kidney stones. These procedures involve the percutaneous placement of a nephroscope into the kidney and in the vicinity of a kidney stone. An ultrasonic probe is advanced through the nephroscope into contact with or close proximity to the kidney stone and is energized to break up the stone or calculus. A traditional nephroscope generally includes an elongated, stiff metallic shaft that is rectilinear in form, which is inserted through the skin of the patient and into the kidney. The ultrasonic probe that is advanced through the shaft for disruption of the calculus is likewise rectilinear. Due to the rectilinearity of such systems, it can be difficult, impractical, or impossible in various instances to bring a tip of the ultrasonic probe into close proximity to some kidney stones and/or to readjust a position or trajectory of the nephroscope shaft and/or the ultrasonic probe once the nephroscope has been advanced into the kidney.
[0054] Certain embodiments disclosed herein include nephroscopes and/or lithotripter assemblies that ameliorate or remedy one or more drawbacks of traditional nephroscopes and/or lithotripters and/or nephrolithotomy or nephrolithotripsy procedures. In certain embodiments, a nephroscope includes a shaft that has a steerable, deflectable, bendable, articulable, or otherwise directable distal end. For example, in various embodiments, the distal end of the shaft can be deflectable relative to a longitudinal axis of a proximal portion of the shaft in a single direction or in two opposite directions within a single plane. In other embodiments, the shaft may be deflectable in four (e.g., mutually orthogonal) directions.
[0055] In some embodiments, a lithotripter assembly may be usable with a nephroscope. For example, in various embodiments, a nephroscope assembly may include a nephroscope with a shaft having a bendable distal end, such as previously described, and may further include a lithotripter assembly that includes a lithotripter configured to bend or conform to a shape of the shaft. The lithotripter assembly can include an energy generator, such as, for example, an ultrasonic transducer, coupled with a lithotripter, or an elongated member configured to deliver energy from the ultrasonic transducer to the stone or calculus. In some embodiments, the lithotripter assembly is integrated into the nephroscope and may be deployed from a retracted position in which the lithotripter is within the shaft of the nephroscope to a deployed position in which a distal end of the lithotripter extends past a distal end of the shaft. In other embodiments, the lithotripter assembly may be separate from the nephroscope and the lithotripter thereof may be insertable through the nephroscope. The lithotripter can include a bendable region capable of conforming to a bent shape of the nephroscope shaft. The lithotripter can deliver ultrasonic energy around the bend sufficient to disrupt a calculus. In various embodiments, the steerable nephroscopes and lithotripters can facilitate percutaneous nephrolithotomy procedures, such as, for example, by providing greater maneuverability within the kidney. These and/or other advantages of various embodiments will be apparent from the disclosure that follows.
[0056] FIGS. 1A and 1B schematically illustrate an embodiment of a lithotomy system 100 that includes a shaft assembly, such as an endoscope 105, and an impact assembly 107. The impact assembly 107 can include an impact probe 120 that can extend (e.g., be selectively extended) from a shaft 110 of the endoscope 105. In various embodiments, the endoscope 105 may be a nephroscope. FIG. 2 illustrates an illustrative embodiment of the impact assembly 107 that includes an ultrasound energy generator 155 coupled to an impact probe 120 that is in a straight configuration. FIG. 3A illustrates a distal portion of the lithotomy system 1(X) with a shaft and the impact probe in a deployed and straight state. FIG. 3B illustrates the distal portion of the lithotomy system 100 with the shaft 110 in an articulated state and the impact probe 120 in a deployed state. A distal end of the impact probe 120 extends rectilinearly past a distal end of the shaft 110, and a more proximally positioned portion of the impact probe 120 is bent so as to conform to a curvature of a bent portion of the shaft 110. FIG. 4 illustrates the lithotomy system 100 with the shaft 110 in the articulated state and the impact probe 120 deployed so as to be adjacent a calculus.
[0057] FIGS. 5A and 5B schematically illustrate an embodiment of another lithotomy system 200. FIG. 6 illustrates a distal portion of an impact probe 220 of the lithotomy system 200 in straight and articulated states. FIG. 7 illustrates the distal portion of the lithotomy system 200 with a shaft 210 and the impact probe 220 in a deployed and articulated state. FIG. 8 illustrates the lithotomy system 200 with the shaft 210 in an articulated state and the impact probe 220 in the deployed and articulated state with a distal tip thereof adjacent a calculus. [0058] In certain views each device may be coupled to, or shown with, additional components not included in every view. Further, in some views only selected components are illustrated, to provide detail into the relationship of the components. Some components may be shown in multiple views, but not discussed in connection with every view. Disclosure provided in connection with any figure is relevant and applicable to disclosure provided in connection with any other figure or embodiment. [0059] With more particular reference to FIGS. 1A and 1 B, the lithotomy system 100 can be configured to remove calculi or fragmented portions of calculi from a patient. Lithotomy procedures typically involve the removal of calculus material from a patient. Lithotripsy procedures, while focused on the breaking apart or otherwise disrupting or reducing a size of a calculus, typically also involve the removal of calculus material from the patient, particularly where a lithotripter has been inserted into the patient for purposes of breaking apart the calculus. Accordingly, as used herein, the term “lithotomy" includes all ordinary or accepted meanings of this term, and is also broad enough to include a variety of lithotripsy procedures. For example, typical lithotripsy procedures in which a lithotripter is introduced into the patient to break apart a calculus and in which the resultant calculus fragments are removed from the patient by the practitioner are included in the term “lithotomy,” as used herein. For purposes of this disclosure, even lithotripsy procedures in which a lithotripter is inserted into the body to disrupt a calculus, but in which there is no subsequent removal of the disrupted calculus by the practitioner (e.g., in which the calculus material is instead permitted to pass from the patient’s body via natural processes) are included in the term “lithotomy,” as used herein.
[0060] As previously noted, in some embodiments, the lithotomy system 100 includes the endoscope 105. In many embodiments, the endoscope 105 can be a nephroscope, and thus may alternatively be referred to herein as the nephroscope 105. As discussed further below, the nephroscope 105 can have a bending section, which is a novel feature relative to traditional nephroscopes 105, which have a straight and stiff shaft. In some embodiments, the endoscope 105 can include visualization features to permit viewing of a treatment area within the patient by the practitioner. The endoscope 100 may, however, more generally be referred to as a shaft assembly, shaft member, elongated tubular member, etc. For example, in some embodiments, the endoscope 105 may include a shaft with a lumen into which at least a portion of the impact assembly 107 may be accepted, and little or nothing else.
[0061] In some embodiments, the impact assembly 107 may be integral with the endoscope 105. For example, the impact assembly 107 may not be readily removable from the endoscope 105 under normal use, or stated otherwise, may be nonremovable from the endoscope 105 (e.g., from a handle of the endoscope). In certain of such embodiments, the impact assembly 107 is fixedly secured to the endoscope 105, and thus may not move appreciably or may not move at all relative to the endoscope 105. In other embodiments, the impact assembly 107 is moveable relative to the endoscope 105. For example, the impact assembly 107 may be advanceable and retractable relative to the endoscope, such as by being capable of longitudinal or axial movement relative to the endoscope 105. In the illustrated embodiment, the impact assembly 107 is integral with the endoscope 105 and movable relative to the endoscope 105 via an actuator 121, as further discussed below. In particular, the actuator 121 is configured to advance and retract the impact assembly 107 relative to the endoscope 105. In other embodiments, the impact assembly 107 may be insertable into and fully removable from the endoscope 105. [0062] Stated otherwise, the system 100 can include the impact probe 120, which may be integrally formed with the endoscope 105 or separately insertable and/or removable therefrom. For example, in some embodiments, the impact probe 120 is fixedly secured to the endoscope 105 such that a fixed length of the impact probe 120 is positioned past a distal tip of a shaft 110. In other embodiments, the impact probe 120 is integrally formed with the endoscope 105, but is axially advanceable and retractable relative to the shaft 110. In still other embodiments, the impact probe 120 is separate from the endoscope 105 and is insertable therein and removable therefrom.
[0063] In various embodiments, the impact probe 120 may alternatively be referred to as a lithotripter, impact member, energy transfer member, elongate member, etc. In other or further embodiments, the impact assembly 107 may alternatively be referred to as an impact system, a lithotripter assembly or system, an energy transfer assembly or system, etc. In various embodiments, the lithotomy system 100 may more generally be referred to as a treatment system, a medical system, etc. [0064] With continued reference to FIG. 1 A, the illustrated actuator 121 , by which the impact assembly 107 is advanceable or deployable and retractable relative to the endoscope 105, includes a rotational actuation mechanism 122 that is rotational relative to a handle 150 of the endoscope 105. The rotational actuation mechanism 122 may, for example, include a knob attached to a threaded member that extends through a wall of and is rotated relative to the handle 150 to impart translational movement to the impact assembly 107. The rotational actuation mechanism 122 can include suitable mechanical linkage to the impact assembly 107 to achieve the translational movement relative to the endoscope 105. Moreover, other embodiments can include a variety of other actuators 121 and actuation mechanisms 122, which may or may not include an element of rotation. For example, in other embodiments, buttons, slides, or other mechanical mechanisms may be used to move the impact assembly 107 relative to the endoscope 105.
[0065] With reference to FIGS. 1A and 1 B, the nephroscope or endoscope 105 can include the handle 150 and the shaft 110. The shaft 110 can be fixedly secured to the handle 150. In the illustrated embodiment, the shaft 110 can be an elongate member with one or more lumens therethrough. For example, the shaft 110 can an elongate tubular member, which can include a circular cross-sectional shape. In certain embodiments, a diameter of the shaft 110 can range from about 3 millimeters to about 6.5 millimeters, or may be 19.5 French or larger. In various embodiments, a length of the shaft 110 can range from about 45 centimeters to about 65 centimeters, or may be about 65 centimeters or larger. Other diameters and/or lengths are contemplated. The shaft 110 can be formed from a variety of flexible materials, such as polyurethane, for example. In the depicted embodiment of FIG. 1 B, the shaft 110 includes an impact probe 120 disposed within a channel 112, an imaging member 130 positioned at an opening 113 at a distal end of the tubular body 110, and an optical fiber 132 and/or optical components for distributing light from the optical fiber 132 positioned at an opening 114 at a distal end of the shaft 110.
[0066] The shaft 110 of the depicted embodiment includes a working channel 111. The working channel 111 and the probe channel 112 may extend between a distal end 115 and a proximal end 116 of the shaft 110. In other embodiments, the shaft 110 can include more or fewer channels and/or elements. For example, the shaft 110 may include an additional channel for disposition of a laser probe used to break up the calculus. [0067] The imaging member 130 may for example, be a visual imaging member. For example, the imaging member 130 may comprise a charge-coupled device (CCD) for capturing images or video from a region beyond the distal end 115 of the shaft 110. In certain embodiments, the CCD may be configured to receive light directly from the region for imaging. In other embodiments, the visual imaging member 130 can include a lens 131 disposed at the distal end 115 of the shaft 110. The lens 131 may be configured to provide a visual image of a lithotripsy site adjacent to or otherwise beyond the distal end 115. In some embodiments, an optical fiber may be coupled to the lens 131 and configured to transmit light received from the lens 131. In other embodiments, a CCD can be coupled to the lens 131.
[0068] The optical fiber 132 terminates at the distal end 115 of the shaft 110. The optical fiber 132 may be configured to transmit light to illuminate the lithotripsy site. In some embodiments, a light diffusion lens may be coupled to the optical fiber 132 to facilitate diffusion of light from the optical fiber 132. Other light sources, such as one or more light emitting diodes (LEDs), disposed at proximal or distal locations along the shaft 110 are likewise within the scope of this disclosure. For example, in some embodiments, the optical fiber 132 or optical components may be replaced with one or more other light sources, such as one or more LEDs, positioned at the tip of the shaft 110.
[0069] In the illustrated embodiment, the working channel 111 is open at the distal end 115 of the shaft 110. The working channel 111 may be configured to facilitate delivery of fluid (e.g., saline) to a lithotripsy site, to aspirate fluid and calculus fragments from the lithotripsy site, to facilitate delivery of an instrument to the lithotripsy site, etc. Any instrument suitable to facilitate treatment of the patient may be delivered through the working channel 111. For example, such instruments can include a basket, a laser probe, a grasper, a ureteroscope, etc.
[0070] In certain embodiments, the impact assembly 107 can be positioned relative to the endoscope 105 such that the impact probe 120 is disposed within the shaft 110 such that a terminal distal end of the impact probe 120 within the distal end 115 of the shaft 110. This may be referred to as a retracted position or undeployed state of the impact assembly 107 and/or the impact probe 120. In various embodiments, when the impact assembly 107 and/or the impact probe 120 are advanced to a deployed (e.g., fully deployed) state, the impact probe 120 may extend from the distal end 115 of the shaft 110 by a distance of from about 1 centimeter to about 2 centimeters. Additional detail regarding the impact probe 120 will be provided below, including disclosure recited in connection with FIGS. 2A and 2B.
[0071] With continued reference to FIG. 1A, the handle 150 of the illustrated system 100 may be disposed at and coupled to the proximal end 116 of the shaft 110. The handle 150 is shown to include and/or be coupled with a camera 151, an access port 153, and a steering or deflection actuator 156. Moreover, in some embodiments, the impact assembly 107 can include an energy applicator or displacement member 154 (e.g., a micro displacement member 154), which can be attached to and energize the impact probe 120, as discussed further below. The displacement member 154 can be coupled with the handle 150. In some embodiments, the displacement member 154 is coupled with the actuator 121 so as to be movable relative to the handle 150 by actuation of the actuator 121. In the illustrated embodiment, the displacement member 154 is housed within the handle 150. In other embodiments, the handle 150 may include more or fewer elements. For example, the handle 150 may include a laser light source coupled to a laser probe that may be disposed within the shaft 110.
[0072] In the illustrated embodiment, the camera 151 is coupled to the visual imaging member 130. In some embodiments, an optical fiber is disposed between the visual imaging member 130 and the camera 151 and configured to transmit light to the camera 151 from the lithotripsy site. The camera 151 may convert the light into a digital image for viewing by the clinician. In another embodiment, an electrical wire is disposed between the camera 151 and a CCD disposed adjacent to the lens 131 of the visual imaging member 130. The electrical wire is configured to transmit an electrical signal from the CCD to the camera 151. The camera 151 is configured to process the electrical signal into a digital image for viewing by the clinician. In some embodiments, the camera 151 may transmit a digital image to a remote monitor for viewing. In some embodiments, the camera 151 may include any suitable camera or optical sensor disposed at a distal tip of the device 100, and a separate processor to which the device 100 is electrically or otherwise communicatively coupled may process the images obtained via the camera 151. Stated otherwise, the camera 151 may have a different physical arrangement than the dedicated camera processor 151 depicted in FIG. 1A.
[0073] In some embodiments, a light source may be coupled to the optical fiber 132. The light source is configured to provide visible light to the optical fiber 132. The optical fiber 132 may transmit the visible light to the distal end 115 to illuminate the lithotripsy site, including the calculus to be broken into fragments. The light source may be configured to control an intensity of the transmitted visible light to allow for appropriate illumination. In certain embodiments, the handle 150 may have the light source integrated therein. For example, the handle 150 may include an LED coupled with a proximal end of the optical fiber 132.
[0074] In the depicted embodiment, the access port 153 is in fluid communication with the working channel 111 and can be configured to facilitate passage of fluid, instruments, or calculus fragments into and/or out of the working channel 111. The access port 153 can include a fitting of any suitable type, such as a universal Luer fitting, barb fitting, quick connect fitting, etc. to facilitate coupling of external components to the access port 153. For example, in some embodiments, a fluid line is coupled to the access port 153 to provide fluid to the working channel 111 and to withdraw fluid and calculus fragments through the working channel 111. In certain embodiments, a collection container may be disposed in line with the fluid line to capture the calculus fragments.
[0075] The deflection actuator 156 may be coupled to the distal end 115 of the shaft 110 and configured to flex, bend, deflect, steer, or otherwise control a shape of the distal end 115 of the shaft 110 to orient the shaft 110 as desired, such as for viewing a region distally beyond the distal end 115 of the shaft 110, and/or to direct the impact probe 120 toward the calculus. For example, in some embodiments, the deflection actuator 156 may be coupled to the distal end 115 of the shaft 110 via at least one pull wire 117. Each pull wire 117 may extend from the actuator 156 to the distal end 115 within the shaft 110. The deflection actuator 156 can include any suitable variety of articulation mechanism to control the pull wires 117. A proximal end of each pull wire 117 can be coupled to the deflection actuator 156, such that movement of the actuator 156 effects deflection of the distal end 115. The deflection actuator 156 can include, for example, an articulation mechanism such as a knob, a lever, a slide, a motor, etc. to apply tension to the pull wire 117 to bend the distal end 115. In certain embodiments, the deflection actuator 156 and pull wires 117 can be configured to bend the distal end 115 in one plane from zero degrees to about 30, 45, 60, 75, or 90 degrees in one or in each of two directions relative to a longitudinal axis of the shaft 110. Other angles are contemplated. In other embodiments, the actuator 156 is configured to bend the distal end 115 in multiple planes and in one or two directions in each plane relative to the longitudinal axis of the shaft 110. Any suitable deflection mechanisms for deflection of the distal end of the shaft 110 is contemplated.
[0076] With reference to FIGS. 1A and 2, in the illustrated embodiment, the displacement member 154 is functionally, e.g., phycially coupled to a proximal end of the impact probe 120 and configured to axially displace or axially vibrate the impact probe 120 to break a calculus into fragments. Stated otherwise, the displacement member 154 physically or mechanically moves a proximal end of the impact probe 120, and this energy is physically transported along the length of the impact probe 120 to a distal end thereof. The back-and-forth displacements or vibrations can be substantially smaller, such as two, three, or more orders of magnitude (e.g., 100, 1 ,000, or 10,000 times) smaller than a total length of the impact probe 120. In some embodiments, the displacement member 154 can include any suitable mechanism capable of axially displacing, vibrating, or otherwise physically imparting energy (e.g., kinetic or mechanical energy) to the impact probe, such as, e.g., at a rate of between about 20 kilohertz and about 5 megahertz. The displacement member 154 may also be referred to as an energy applicator, energization member, etc. The displacement member 154 can apply physical forces to the impact probe 120 to effect physical movement of the impact probe 120, such as rapid movement. In some embodiments, the amount of displacement achieved at the distal end of the impact probe 120 is very small, such as on the order on microns. The displacement member 154 may, in some instances, be referred to as a micro displacement member. In various embodiments, the displacement distance at the distal tip of the impact probe 120 is from about 1 micron to about 5 microns. In the depicted embodiment, the micro displacement member 154 includes an ultrasound energy generator, such as, for example, an ultrasound or ultrasonic transducer, which may include a piezoelectric stack. In other embodiments, the displacement member 154 (e.g., micro displacement member) may be a pneumatic pulse generator. In still other embodiments, the displacement member 154 may be an electromagnetic impulse generator. In yet other embodiments, the displacement member 154 may include any combination of displacement or micro displacement members.
[0077] FIG. 2 illustrates the impact assembly 107, which includes the displacement member 154 and the impact probe 120 coupled together. As just discussed, any suitable variety of displacement member is contemplated, such as a micro displacement member. For example, in various embodiments, the displacement member 154 can include any suitable variety or arrangement of ultrasonic generator and/or ultrasonic stack. In the illustrated embodiment, the impact probe 120 includes a probe body, elongated member, or probe shaft 123 coupled to a connector 129 at a proximal end of the probe shaft 123. In the illustrated embodiment, the probe shaft 123 is a cylindrical or other cross-sectionally profiled solid rod and includes a squared off distal end 124. In other embodiments, the probe shaft 123 may be tubular. Other configurations are contemplated. In some embodiments, the probe shaft 123 may be radial inwardly tapered from the proximal end to the distal end 124, which can concentrate a force applied to the calculus to a small cross-sectional area. In some instances, a narrowed or tapered distal tip may yield improved fragmentation of the calculus relative to other orientations. In other embodiments, the distal end 124 may include a conical tip to concentrate the force applied to the calculus. In the illustrated embodiment, the probe shaft 123 defines a substantially constant cross-sectional profile along a full length thereof. Other configurations are contemplated. The probe shaft 123 can be formed of any suitable material. In some embodiments, the probe shaft 123 is formed from a superelastic shape-memory metal alloy, such as nitinol. In other embodiments, the probe shaft 123 can be formed of a relative strong and/or durable material, such as, e.g., titanium. [0078] In certain embodiments, the impact probe 120 can be disposed within the shaft 110 in a fixed longitudinal arrangement relative to the shaft 110. For example, the impact probe 120 may be fixed relative to the shaft 110 in a fixed orientation in which the probe 120 extends past a distal tip of the shaft 110, such as in the orientation depicted in FIG. 3A. In various embodiments, the distal end 124 of the impact probe 120 extends beyond the distal end 115 of the shaft 110 and can be directed toward the calculus to be fragmented via movement of the shaft 110. In other embodiments, the distal end 124 of the impact probe 120 may be flush with or recessed relative to the distal end 115 of the shaft 110. In still other embodiments, the impact probe 120 may be longitudinally displaceable with respect to the shaft 110, such as in manners previously discussed. For example, the impact probe 120 may be initially disposed at the distal end 115 of the shaft 110, and may be recessed relative to or flush with a distalmost tip of the shaft 110, when in a retracted state, and may be longitudinally displaced from the channel 112 (e.g., moved distally beyond a distal end of the channel 112) into a deployed state during a treatment procedure. When displaced or deployed, the impact probe 120 can be directed toward the calculus to be fragmented. In yet other embodiments, after the shaft 110 of the endoscope 105 has been positioned, and in further embodiments, articulated, the impact probe 120 can then be passed through at least a portion of the shaft 110. For example, in some embodiments, the impact probe 120 is advanced through the proximal end 116 to the distal end 115 of the shaft 110, and, in further instances, may be moved distally beyond the distal end 115.
[0079] As illustrated in FIG. 3B, in some embodiments, the shaft 110 can be articulated at a bending (or bend) section or region 118, causing the probe shaft 123 of the impact member 120 to selectively bend, for example, due to resilient properties of a superelastic material of which it is formed in some embodiments, into an arcuate shape at an intermediate portion that is adjacent the distal end 124. The portion of the impact member 120 that is so permitted to bend may be referred to as a bending (or bend) section or region 135 of the impact member 120. The distal end 124 is shown to extend rectilineariy from a distal opening 136 (see also FIG. 1 B) of the channel 112 while the bend region 135, or at least a portion of the bend region 135, is maintained in an arcuate shape by the bend region 118 of the shaft 110.
[0080] The articulated shaft 110 can cause the probe shaft 123 to bend through any suitable angle, such as an angle up to about 30, 45, 60, 75, or 90 degrees, from about one degree to about 90 degrees. More generally, in various embodiments, a maximum angle through which the probe 120 can be bent can be no less than about 30, 45, 60, 75, or 90 degrees. The articulated or bend region of the shaft 110 can guide or channel the probe shaft 123 along a curved or bent pathway defined thereby. For example, in some embodiments, as the probe shaft 123 is advanced through the nephroscope shaft 110, at least a portion of the distal end 124 of the probe shaft 123 may initially bend as the probe shaft 123 first enters the bend region 118 of the nephroscope shaft 110 and as said at least a portion of the distal end 124 passes through the bend region 118. The probe shaft 123 may follow a curvature defined by the bend region 118 of the shaft 110 as the probe 120 is advanced through the shaft 110. Upon further advancement, the bent portion or entirety of the distal end 124 of the probe shaft 123 may return to a substantially rectilinear shape and may remain substantially rectilinear upon further advancement of the probe shaft 123 through the nephroscope shaft 110. At any given stage of advancement, the portion of the probe shaft 123 that is positioned within the bend region 118 of the shaft 110 can substantially conform to the curved pathway defined by the bend region 118. As further discussed below, the impact member 120 can be configured to efficiently transmit energy through its bend region 135 to the distal end 124.
[0081] Regardless of whether the impact member 120 is longitudinally fixed with respect to the shaft 110 or longitudinally displaceable with respect to the shaft 110, the shaft 110 may be articulated to position the impact member 120 in a desired treatment location. The shaft 110 may be articulable across a range of angles and the impact member 120 may be configured to bend with the articulated shaft 110. The impact member 120 may be configured to transmit energy or longitudinal displacement along an axis of the impact member 120, including transfer of energy or longitudinal displacement around a bend when the impact member 120 is disposed within a curved or articulated region of the shaft 110. Stated otherwise, at least a portion of the bend section 135 of the impact member 120 may be maintained in a bent configuration by the bent region 118 of the shaft 118, and the bend section
135 can be configured to transmit energy therethrough from a proximal portion of the impact member 120 to the distal end 124 (e.g., to a distalmost tip 125) of the impact member 120. The shaft 110 may thus be configured to facilitate placement of the distal end 124 of the impact member 120 at, in, or adjacent to a desired treatment site and the impact member 120 may be configured to transmit energy to that treatment site, including transmission of energy around a curve or bend.
[0082] In certain integrated embodiments where there may be no or minimal relative longitudinal movement of the impact member 120 with respect to the shaft 110 (e.g., where the impact member 120 is fixed relative to the shaft 110), the distal end of the impact member 120 may thereby be placed at or near the target material and activated. In other embodiments, where the impact member 120 is longitudinally advanceable relative to the shaft 110, the impact member 120 may be urged longitudinally through the channel 112. The shaft 110 may impart a curve to the impact member 120 only in the curved or articulated region of the shaft 110. As the impact member 120 is advanced through the channel 112 and the distal opening 136, it may thus maintain a generally rectilinear form as it is advanced. Stated otherwise, the impact member 120 may advance straight out of the distal opening
136 of the channel 112 substantially without curvature. Stated one way, the opening 136 at the distal end of the channel 112 of the shaft 110 may function to “aim” the impact member 120 in a desired direction, and the impact member 120 extends rectilinearly as it is advanced distally past a distalmost tip 137 of the shaft 110. In the embodiment of FIGS. 1A-4, the impact member 120 may thus not be independently curvable on its own, but rather, curved due to constraints or forces imparted by the shaft 110 and/or channel 112.
[0083] As shown in the embodiment of FIG. 2, the displacement member 154 includes an ultrasound energy generator 155. In the illustrated embodiment, the ultrasound energy generator 155 includes a horn 160, a stack of piezoelectric ceramic plates 161, electrodes 162, a rear mass 163, and a preload bolt 164. The electrodes 162 are disposed between the piezoelectric ceramic plates 161. The electrodes 162 may be coupled to an integrated or remote controller (not shown). The controller can activate the electrodes at any suitable frequency, such as, for example, frequencies ranging from about 20 kilohertz and about 5 megahertz. When activated, the electrodes 162 can cause the piezoelectric ceramic plates 161 to change shape and generate ultrasound energy. The ultrasound energy can be transmitted to the horn 160, causing the horn 160 to vibrate. The vibration of the horn 160 can be transmitted to the connector 129 and to the impact probe 120, causing the impact probe 120 to axially vibrate at the input frequency from the controller. The rear mass 163, disposed proximally of the piezoelectric ceramic plates 161 , can facilitate directing of the ultrasound energy toward the horn 160. The preload bolt 164 can be disposed through at least a portion of the ultrasound energy generator 155. In various instances, the preload bolt can attach various components together, can provide a preload to the stack for known reasons, and/or can facilitate axial alignment and stacking of the components of the ultrasound energy generator 155.
[0084] The axial vibration of the impact probe 120 causes the distal end 124 (including a distalmost tip thereof) to be axially displaced in a direction in alignment with the longitudinal axis of the probe shaft 123 when the probe shaft 123 is in a straight configuration. When the intermediate, deflectable, bendable, flexible, or directable portion 135 of the impact probe 120 is in the arcuate shape, as depicted in FIG. 3B, the axial vibration of the impact probe 120 causes the distal end 124 of the impact probe 12 to be axially or rectilinearly displaced in a direction in alignment with an axis of the distal end 124. In some embodiments, the direction of axial displacement of the distal end 124 may be redirected from about zero degrees to about 90 degrees relative to the longitudinal axis of a proximal length of the probe shaft 123, such as may be due to a curvature imparted to the impact member 120 by a sheath within which it is retained, as previously discussed. Stated another way, the impact probe 120 and related components may be configured such that axial or rectilinear displacement, or other forms of energy traveling in longitudinal waves along a proximal axis of the impact probe 120, may be directed around a curved or articulated portion to deliver axial displacement, or other forms of energy traveling in longitudinal waves along a distal axis of the impact probe 120. Due to the articulation, the distal axis may be disposed at an angle to the proximal axis and/or may be disposed in a different plane than the proximal axis. In various embodiments, the impact probe 120 is configured to transport ultrasonic energy through a curved region sufficient to achieve lithotripsy or breakup of a calculus at a distal end of the impact probe 120 that defines a distal axis at an angle of no less than about 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, or 90 degrees relative to a proximal axis defined by a proximal portion of the impact probe 120.
[0085] With reference to, e.g., FIG. 4, in various embodiments, the lithotomy system 100 can be used to perform a percutaneous lithotripsy procedure to fracture and remove a calculus from an organ, such as a kidney, ureter, bladder, urethra, pancreas, gall bladder, and any other location where a calculus may be found within a patient. The elongate treatment member 100 may be inserted into the organ using any suitable technique. For example, a needle may be inserted through the skin into the organ and a guidewire inserted through the needle into the organ. The needle may be removed and a dilator and/or introducer sheath or tube passed over the guidewire into the organ. The guidewire and the dilator may then be removed, leaving the introducer sheath or tube in the organ. The elongate treatment member 100 can be passed through the introducer sheath or tube into the organ.
[0086] FIG. 4 depicts the elongate treatment member 100 disposed in an organ 104 (e.g., a kidney) at a lithotripsy site 103 adjacent a calculus 102. As depicted, the distal end 115 of the shaft 110 may be articulated (e.g., via rotation or, in other embodiments, other forms of actuation of the actuator 156) such that the distal end 115 is directed toward the calculus 102. The impact probe 120 may be axially or rectilinearly extending from the distal end 115. In some embodiments, the impact probe 120 may be deployable from the distal end 115 by a linear or translational displacement mechanism, such as previously described, whereby the impact probe 120 is axially translatable relative to the shaft 110. For example, as can be seen by comparing the lithotomy system 100 as depicted in FIGS. 1A and 4, the impact assembly 107 can be advanced relative to the endoscope 105 via the actuator 121. In FIG. 1A, the actuator 121 is in an unactuated state, with the impact assembly 107 in a retracted or undeployed state. In FIG. 4, the actuator 121 has been actuated, so as to be in an actuated state, thereby advancing or translating the impact assembly 107 distally relative to the endoscope 105 to advance the impact probe 120 out of the distal end of the shaft 110.
[0087] Prior to deployment of the impact probe 120, the distal end 124 may be constrained to a straight configuration by the shaft 110. Following deployment from the curved shaft 110, the distal end 124 can remain in a straight configuration in the region that is distally beyond the curved portion of the shaft 110.
[0088] During a treatment, the light source may be used to illuminate the lithotripsy site 103 and the calculus 102 such that the camera 151 can capture visual images of the lithotripsy site 103, which may be displayed in any suitable manner (e.g., whether via the device 100 itself or via a display with which the device 100 is in communication). For example, in some instances, the camera 151 may supply a continuous video feed to any suitable display. The visual images can be used to direct the distal end 115 of the shaft 110 and the distal end 124 of the impact probe 120 toward the lithotripsy site 103 and the calculus 102. As depicted in FIG. 4, the distal end 124 can be directed toward the calculus 102 by articulation of the distal end 115 of the shaft 110, such that the distal end 124 is disposed adjacent the calculus 102 or in contact with the calculus 102. When the distal end 115 is articulated, a portion of the impact probe 120 can be bent within the shaft 110 while the distal end 124 extends rectilinearly from the distal end 115. As previously discussed, in some instances, the impact probe 120 may be extended past the distal tip of the shaft 110 prior to articulation, such that the impact probe 120 is bent concurrently with the bending of the shaft 110. In other instances, the impact probe 120 may initially be retracted within the shaft 110. As the shaft 110 bends, a portion of the impact probe 120 may also bend. The impact probe 120 may then be advanced distally relative to the shaft 110. A portion of the impact probe 120 that is positioned within the bent portion of the shaft 110 may remain bent as the impact probe 120 is advanced distally. The impact probe 120 may be said to follow, conform to, or comply with the curvature of the shaft 110. In some embodiments, as the distal end of the impact probe 120 advances past the curved portion of the shaft 110 and/or past the distal tip of the shaft 110, the distal portion of the impact probe 120 may be substantially straight so as to advance rectilinearly from the tip of the shaft 110. In some instances, the distal end 124 of the impact probe 120 can be directed toward the calculus 102 by longitudinal movement of the entirety of the lithotomy system 100 within the organ 104, and the distal end 124 is disposed adjacent the calculus 102 or in contact with the calculus 102.
[0089] In certain embodiments, the micro displacement member 154 is activated when the distal end 124 is disposed adjacent to the calculus 102. The impact probe 120 is axially vibrated, as previously discussed, such that the distal end 124 is axially displaced to deliver treatment energy to the calculus 102. In certain embodiments, the distal end 124 of the impact probe 120 can be axially displaced when the distal end 124 is axially aligned with a distal end of the shaft 110. In other embodiments, the distal end 124 may be angularly offset relative an axis defined by the distal end of the shaft 110 (see FIG. 8). The treatment energy may include axial vibration. For example, as previously noted, the vibrations may, in some instances, be at, e.g., ultrasonic frequencies previously mentioned to cause fragmentation of the calculus 102. In some treatments, the distal end 124 is advanced to a point adjacent to but not in contact with the calculus 102. In another embodiment, the micro displacement member 154 is activated when the distal end 124 is in contact with the calculus 102.
The impact probe 120 is axially vibrated, as previously discussed, such that the distal end 124 strikes or impacts the calculus 102, or delivers energy to tissue, fluid, or other matter adjacent the calculus 102, to cause fragmentation of the calculus 102. [0090] In the depicted embodiment of FIG. 4, the fragments of the fragmented calculus 102 are removed from the organ 104 through the working channel 111 (see FIG. 1 B). A suction force may be provided through the working channel 111 such that fluid and the fragments are pulled into and through the working channel 111. The fluid and fragments can pass through the access port 153 and into a fluid line 157 coupled to the access port 153. A fragment trap 158 is disposed in fluid communication with the fluid line 157 to capture the fragments for further analysis. In another embodiment, the fragments of the fragmented calculus 102 are excreted from the organ 104 by normal organ function. In other or further instances, a tool may be advanced through the working channel 111 to grasp or otherwise capture calculus material that may be too large for retraction through the working channel 111 , and the system 100 may be withdrawn from the patient with the captured calculus to remove the calculus from the patient.
[0091] FIGS. 5A-8 depict an embodiment of a lithotomy system 200 that resembles the lithotomy system 100 described above in certain respects. Accordingly, like features are designated with like reference numerals, with the leading digit incremented to “2.” For example, the embodiment depicted in FIGS. 5A-8 includes an elongate tubular member or shaft 210 that may, in some respects, resemble the elongate tubular member or shaft 110 of FIG. 1 A. Relevant disclosure set forth above regarding similarly identified features thus may not be repeated hereafter. Moreover, specific features of the lithotomy system 100 and related components shown in FIGS. 1A-4B may not be shown or identified by a reference numeral in the drawings or specifically discussed in the written description that follows. However, such features may clearly be the same, or substantially the same, as features depicted in other embodiments and/or described with respect to such embodiments. Accordingly, the relevant descriptions of such features apply equally to the features of the lithotomy system 200 and related components depicted in FIGS. 5A-8. Any suitable combination of the features, and variations of the same, described with respect to the lithotomy system 100 and related components illustrated in FIGS. 1A-4B can be employed with the lithotomy system 200 and related components of FIGS. 5A-8, and vice versa. This pattern of disclosure applies equally to further embodiments depicted in subsequent figures and described hereafter, wherein the leading digits may be further incremented.
[0092] FIGS. 5A and 5B illustrate the lithotomy system 200. As shown in FIG. 5B, the lithotomy system 200 includes a shaft 210 and an impact probe 220 disposed within the shaft 210.
[0093] In some embodiments, such as depicted in FIG. 6, a distal end 224 of the impact probe 220 may include a pre-formed arcuate shape that is set, fabricated, or formed during manufacture of the impact probe 220. The arcuate shape may displace the distal end 224 by any suitable amount, such as through an angle of no less than about 15, 30, 45, 60, 75, or 90 degrees, or from about zero degrees to about 90 degrees, relative to a longitudinal axis of a proximally adjacent portion of the impact probe 220. In one embodiment, the distal end 224 may assume the preform arcuate shape when deployed from the shaft 210 as shown in FIG. 7 due to the superelastic characteristic of the material (e.g., nitinol) from which it is formed. In another embodiment, the distal end 224 can assume the pre-form arcuate shape following deployment and warming (such as warming to body temperature) of the distal end 124 formed from the shape memory material (e.g., nitinol).
[0094] In some embodiments, the distal end 224 may be articulated into the arcuate shape following deployment. In such embodiments, the distal end 224 may be articulable by a practitioner, rather than having a predetermined preformed shape. In some such embodiments, the distal end 224 may include features (e.g., slits or cuts, such as those depicted in FIGS. 12A and 12B) that allow the distal end 224, a portion of the distal end 224, and/or a region proximally adjacent to the distal end 224 to bend into the arcuate shape. One or more pull wires or other articulation members may be coupled to the distal end 224 and to a probe articulation member or probe actuator, similar to deflection mechanisms discussed above with respect to the pull wires 117 and the actuator 156. The probe articulation member can include any suitable mechanism to selectively apply tension to the pull wires. For example, the mechanism may include a rotatable knob, a rotatable lever, a linear slide, etc.
[0095] As depicted in FIG. 8, the distal end 224 can be directed toward the calculus 202 by one or more of articulation of the distal end 215 of the shaft 210 and articulation of the distal end 224 of the impact probe 220 when deployed, such that the distal end 224 is disposed adjacent the calculus 202 or in contact with the calculus 202. When the distal end 215 is articulated, a portion of the impact probe 220 can be bent within the shaft 210 while the distal end 224 extends rectilinearly from the distal end 215. In other embodiments, only the distal end 224 may be articulated to direct the distal end 224 toward the calculus 202. In certain embodiments, only the distal end 215 is articulated to direct the distal end 224 toward the calculus 202, as previously described.
[0096] FIGS. 9A and 9B depict an illustrative embodiment of another lithotomy system 300. As shown in FIG. 9A, the lithotomy system 300 includes an endoscope 305, such as, in particular, a nephroscope, and an impact assembly 307. The endoscope 305 and the impact assembly 307 resemble like-named and like- numbered features previously described with respect to the system 100, such that prior disclosures herein, where appropriate, are equally applicable to the features of the system 300. In the illustrated embodiment, the system 100 includes a handle 350 much like the handle 150 described above. In some instances, the handle 350 may generally be considered to be a part of the endoscope 305. A tubular member or shaft 310 can be fixedly secured to the handle 350.
[0097] The impact assembly 307 can include an impact probe 320. In the illustrated the impact assembly 307 is integrally coupled with the endoscope 305 and is movable relative thereto. In particular, with reference to FIGS. 9A and 9B, the handle 350 includes an actuator 321 that is coupled with the impact assembly 307. The actuator 321 may be referred to as a deployment actuator, an impact assembly actuator, a lithotripter actuator, etc. The actuator 321 is configured to effect movement of the impact assembly 307 relative to the handle 350 (e.g., or stated otherwise, relative to the shaft 310 or relative to the endoscope 305). In particular, the actuator 321 is capable of manipulation or actuation so as to move the impact assembly 307 between a retracted or undeployed position or state and an advanced or deployed position or state. In FIG. 9A, the impact probe 320 is shown in the deployed state in which a distal end of the impact probe 320 extends distally past a distal tip of the shaft 310.
[0098] The actuator 321 can comprise any suitable mechanism for effecting movement, e.g., translation, of the impact assembly 307 relative to the handle 350, such as mechanisms previously described. In the illustrated embodiment, the actuator 321 includes a rotational actuation mechanism 122, and in particular, a lever that is rotatable relative to the handle 350 (e.g., relative to a housing portion of the handle 350). Rotation of the actuation mechanism or lever 122 in a first direction effects distal advancement or deployment of the impact probe 307. Rotation of the lever in a second direction opposite the first direction effects proximal retraction or withdrawal (e.g., into the shaft 310) of the impact probe 307. Further discussion of the actuator 321 is provided hereafter.
[0099] With reference to FIGS. 9A and 10A, the shaft 310 can include a lumen 333 (FIG. 10A) extending between and through a distal end 315 and a proximal end 316 of the shaft 310. As illustrated in FIGS. 10A and 10B, in some embodiments, an inner tube 330 is disposed within the lumen 333 and the impact probe 320 is disposed within a lumen of the inner tube 330. In the illustrated embodiment, the impact probe 320 is a substantially tubular structure, and may be referred to as an impact tube. The impact probe 320 may define an aspiration lumen 383. The inner tube 330 may also be referred to, for example, as an irrigation tube. In the illustrated embodiments, the inner tube 330 (other than a distal end thereof) is oriented substantially coaxially relative to an outer surface of the shaft 310. The distal end of the inner tube 330, however, tapers at one side thereof to conform to a substantially D-shaped opening 349 in a tip 340 of the sheath 310. The impact probe 320 can be substantially centered relative to the D-shaped opening 349, and as a result, may be slightly offset relative to the common longitudinal axis that extends through a center of the vast majority of the length of the inner tube 330 and through the shaft 310.
[00100] The irrigation tube 330 may define an inner diameter that is at least slightly larger than an outer diameter of the impact probe 320. This can provide a substantially annular or tubular space 331 or substantially annular or tubular lumen between the irrigation tube 330 and the impact probe 320. The inner circle of the substantially annular space 331 may be offset from a center of the outer circle, due to the offset axes of the impact probe 320 and the irrigation tube 330. In some embodiments, irrigation fluid (e.g., saline) may flow through the annular space 331 between the inner tube 330 and the impact probe 320 to cool the impact probe 320 and/or to irrigate a region distal to the tip 340. Irrigation of the treatment region can assist in the clearing of calculus fragments from the treatment region during a treatment procedure. For example, the irrigation fluid may capture fragments therein, and the fragment-laden irrigation fluid can be suctioned from the treatment site. The inner tube 330 may be formed of any suitable polymeric material, such as polyethylene and polyurethane, or a metal material, such as stainless steel, titanium, and nickel-titanium alloy. Other materials are contemplated within the scope of this disclosure.
[00101] With reference to FIG. 15, the irrigation tube 330 may extend into the handle 350 and may terminate at a connector 380. In the illustrated embodiment, the connector 380 is a Y-shaped connector 380 that includes two branches. One branch is aligned with a longitudinal axis of the proximal end of the irrigation tube 330. This branch includes any suitable sealing member 381 therein, such as, for example, an O-ring. The sealing member 381 can permit movement of the impact probe 320 therethrough while maintaining a fluid-tight seal with an external surface of the impact probe 320.
[00102] The other branch of the connector 380 extends at an angle relative to the longitudinal axis of the irrigation tube 330 and is coupled with an extension tube 381, which leads to an irrigation port 353. The irrigation fluid can be introduced into the system 300 via the irrigation port 353. Irrigation fluid that enters the irrigation port 353 can pass through the extension tube 381 into the connector 380. The seal 381 can prevent the fluid that enters thusly into the connector 380 from thereafter egressing proximally from the connector 381. The fluid can instead flow from the connector 380 into the annular or tubular space 331 between the impact probe 320 and the irrigation tube 330 (see also FIGS. 10A and 10B).
[00103] With reference to FIGS. 10A and 10B the lithotomy system 300 can apply suction to the treatment region, which can clear calculus material (e.g., calculus fragments) from the treatment region. The suction may be applied through the suction lumen 383 defined by the impact probe 320. In some embodiments, a fluid barrier 384 can be applied to the impact probe 320 to maintain fluidic separation between the suction lumen 383 inside the impact probe 320 and the substantially annular irrigation lumen 331 outside the impact probe 320. As further discussed below, in some embodiments, the impact probe 320 includes a series of slots, cuts, or gaps that might otherwise reduce suction and/or result in suction of aspiration fluid before the fluid is able to be delivered past the distal tip 340. The fluid barrier 384 may take any suitable form. For example, in some embodiments, the fluid barrier 384 includes a polymeric sleeve that forms fluid tight seals with an external surface of the impact probe 320 at each of a proximal and distal end of a bending section that is formed by the lateral slots.
[00104] With reference to FIG. 15, suction can be applied to the impact probe 320 via an aspiration or suction port 360, which is positioned at a proximal end of the handle 350 in the illustrated embodiment. The suction port 360 can be connected to an aspiration tube 362 that is in fluid communication with a proximal leg 364 of a working channel 311 of the system 300. The working channel 311 is also shown in, e.g., FIGS. 10A and 10B. As further discussed below, the working channel 311 can extend through a displacement member 354 and through the impact probe 320, which is fixedly attached to the displacement member 354. Any suitable suction source may be coupled to the aspiration port 360. The aspiration port 360 may include, for example, a connector such as, e.g., a barbed tubing connector, suitable for coupling to, e.g., a hospital suction line. A valve 363 at a proximal end of the working channel 311 can be fluidically sealed so as to maintain suction within the suction tube 362 and along the working channel 311.
[00105] In some embodiments, the system 300 includes a suction actuator 361 that may provide variable suction force within the impact member 320. The suction actuator 361 may be shaped and/or positioned as a trigger. For example, as shown in FIG. 9B, the actuator 361 may be centered along one side of the handle 350 and may be readily accessible and depressible by the pointer finger of the hand of a user as the hand grips the handle 350. In some instances, the illustrated arrangement can permit ready use of the actuator 361 by the index finger of either hand, or stated otherwise, ambidextrous use of the actuator 361 is facilitated. The actuator 361 can be coupled with a ratchet member 373 or any other suitable mechanism to retain the suction actuator 361 in any of a plurality of positions that cause a compression member 368 to compress the aspiration tube 362 by varying amounts, depending on position, to control a magnitude of suction that is permitted within the fluid path that extends through the tube 362, the working channel 311 , and the impact probe 320. Other suitable forms of the suction actuator 361 are within the scope of this disclosure.
[00106] The valve 363 can selectively seal a proximal end of the working channel 311. The valve 363 can be in fluid communication with the lumen 383 of the impact probe 320 via a proximal branch 364 of the working channel 311 , which is formed as a tubular member that extends from the valve 363 to or through at least a portion of the displacement member 354. The displacement member 354 can define a lumen therethrough, which may or may not include a tubular element therein. Whether or not one or more tubular elements extend into or through the displacement member 354 from one or both of a proximal and distal end thereof, the lumen through displacement member 354 permits passage of the working channel 311 therethrough. The displacement member 354 may be said to define and/or encompass a section of the working channel 311. The lumen 383 of the impact probe 320 likewise can constitute a segment of the working channel 311 , and may be in fluid communication with each of the aforementioned sections of the working channel 311.
[00107] As can be appreciated from the foregoing, calculus material can be suctioned from the treatment site into the working channel 311 and out through the suction tube 362 and the suction port 360. In particular, the calculus material, which may be smaller than an opening 385 (FIG. 10B) at a distal tip of the impact probe, can be aspirated through the suction lumen 383 of the impact probe 320, through the displacement member 354, through the aspiration tube 362, and out through the suction port 363. [00108] Additionally or alternatively, the valve 363 and the working channel 311 may provide, e.g., individually, passage of a guidewire and any of a variety of tools to the treatment site. For example, the various tools may include, for example, a laser fiber positioned adjacent the calculus to break up the calculus with laser energy, a basket grabber that may be positioned at the treatment site to grab and withdraw calculus fragments through the valve 363 and working channel 311 , and/or a biopsy tool that may be positioned at the treatment site to obtain a tissue sample for examination. The valve 363 may include, for example, any suitable hemostasis valve. In some embodiments, the valve 363 includes a membrane having a slit configured to seal around the tool or guidewire.
[00109] In some instances, rather than suctioning a calculus or one or more fragments thereof through the working channel 311 and the valve 363, the unfragmented calculus, a fragment, or even multiple fragments can be grasped by the tool that has been extended through the working channel 311 and past the distal tip of the impact probe 320. The calculus material can be retracted from the patient while being held at a position external to the shaft 310 and/or the impact probe 320. For example, in some instances, the calculus material may be too large to be retracted (e.g., suctioned or grasped and pulled) through the working channel 311. In certain of such instances, a tool that has been inserted through the working channel 311 may be used to securely ensnare, grab, grasp, or otherwise hold the calculus material, and the entirety of the lithotomy system 300 can be removed from the patient while the tool continues to hold the calculus material to thereby remove the calculus material from the patient. For example, in some instances, the shaft 310 may be straightened after the calculus material has been grasped and prior to removal of the shaft 310 and the tool in unison from the patient. In some instances, the lithotomy system 300 may then be reintroduced into the patient for further calculus or calculus fragment removal.
[00110] With reference to FIGS. 9A and 10A, the shaft 310 can include an articulating or bending portion 318 disposed proximal to a shaft tip 340. The shaft 310 can include an outer jacket, cover, sheath, or sleeve 339 that extends along a full length of the shaft 310. The outer sleeve 339 may be of any suitable construction, and may include a polymeric material, braided material, and/or other structural reinforcements to provide pushability and/or torqueability. The outer sleeve 339 is not shown in FIG. 10A to facilitate viewing of structures internal thereto. [00111] The bending portion 318 can include a backbone member 370 of any suitable variety. In the embodiment depicted in FIGS. 11 A and 11 B, the backbone member 370 includes a plurality of wedge-shaped slots 371 disposed along opposing sides. The slots 371 may be configured to allow the backbone member 370 to bend toward the slots 371 from about zero degrees to about 90 degrees and from about 45 degrees to about 60 degrees relative to a longitudinal axis of the backbone member 370. Other bending angles and ranges are contemplated. In other embodiments, the backbone member 370 may include slots of any suitable shape to allow bending of the backbone member 370. The backbone member 370 further includes pull wire passages 372 configured to retain one or more pull wires (see, e.g., FIG. 1 A) extending from the handle 350. When tension is applied to a pull wire on one side of the backbone member 370, the backbone member 370 is bent toward that side. In a certain embodiments, two pull wires may extend through the pull wire passages 372 on opposing sides of the backbone member 370 and coupled (e.g., welded) to a distal end of the backbone member 370. In another embodiment, a single pull wire may extend distally through the pull wire passages 372 on one side of the backbone member 370, looped over the distal end of the backbone member 370, and extended proximally through the pull wire passages 372 on the opposing side of the backbone member 370. The backbone member 370 may be formed of any suitable material, such as stainless steel, titanium, nickel-titanium alloy, polymeries (e.g., may be molded), etc.
[00112] The impact probe 320 of the illustrated embodiment of the system 300 is shown in further detail in FIGS. 12A and 12B. The impact probe 320 includes a bending portion 335 that includes a plurality of slits 322 disposed proximal to a distal end of the impact probe 320. The bending portion 335 is radially aligned with the bending portion 318 of the shaft 310 when the impact probe is disposed within the inner tube 330. In some embodiments, the bending portion 335 of the impact probe 320 has a length that is greater than a length of the bending portion 318 of the shaft 310, which in some instances, can facilitate advancement of the impact probe 320 through the shaft 310 when the shaft 310 is in a bent configuration. The bending portion 335 is proximally offset from the distal end of the impact probe 320. In some instances, this can cause a distal end portion 324 of the impact probe 320 to be relatively stiff. In various embodiments, the distal end portion 324 may have a length of between about 1 centimeter to about 2 centimeters, may be no greater than about 1 or 2 centimeters, or may be no less than about 1 or 2 centimeters. In some embodiments, the slits 322 are sized and/or spaced from each other in a manner that allows the impact probe 320 to bend from about zero degrees to about 90 degrees, from about 45 degrees to about 60 degrees, or some other angle or angle range, relative to a longitudinal axis of the impact probe 320. The slits 322 extend through the impact probe 320 such that a single narrow strip of continuous material, or a solid wall section 323, is disposed between (e.g., extends through or between) opposing ends of the slits 322. The solid wall section 323 can transmit energy (e.g., ultrasonic energy) from a proximal portion of the impact probe 320, along the length of the bending portion 335, and to the distal end portion 324. In various embodiments, the solid wall section 323 may have an arc length ranging from about 10 degrees to about 120 degrees, of no less than 10, 15, 20, 25, 30, 45, 60, 75, or 90 degrees, or of no greater than 25, 30, 45, 60, 75, 90, or 120 degrees. In some embodiments, when the impact probe 320 is bent, the bending portion 335 may bend away from the solid wall section 323, such that the slits contract and such that the solid wall section 323 defines an external arc of the end (e.g., defines the largest radius of curvature of the bend). In some instances, the size and spacing of the slits can be formed such that adjacent segments of material, or lands, contact one another when the bending portion 335 is bent. In some instances, this contact can assist in transmission of energy to the distal end of the impact probe. In other or further instances, this contact can delimit a maximum bend angle of the bending portion 335. In other embodiments, the bending portion 335 may bend toward the solid wall section 323, such that the slits expand and the solid wall section 323 defines an internal arc (e.g., the smallest radius of curvature) of the bend.
[00113] FIG. 13A illustrates a distal portion of the lithotomy system 300 in which the impact probe 320 is in an undeployed or retracted state. In the illustrated embodiment, the impact probe 320 is retracted within the shaft 310 when in the undeployed state. FIG. 13B illustrates the distal portion of the lithotomy system 300 with the impact probe 320 in a deployed state. In the illustrated embodiment, the impact probe 320 is axially displaced relative to the shaft 310 such that a distal portion of the impact probe 320 extends beyond the shaft tip 340. FIG. 130 illustrates the distal portion of the lithotomy system 300 in an articulated or bent state where the bending portion 318 of the shaft 310 is bent to direct the impact probe 320, e.g., toward the calculus. The bending portion 318 any suitable bending angle amount is contemplated, as previously discussed. In various embodiments, the bending angle may be no less than about 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, or 70 degrees. In various embodiments, a maximum achievable bending radius at which energy is effectively delivered to the distal tip of the impact probe 320 is about 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, or 90 degrees. In certain embodiments, the bending portion 318 may be bent in a single plane extending radially outward from the longitudinal axis. In other embodiments, the bending portion 318 may be bent in two or more planes extending radially outward from the longitudinal axis.
[00114] As illustrated in FIG. 10A, in some embodiments, the shaft tip 340 is fixedly secured to a distal end of the inner tube 330 (e.g., in a fluid-tight connection). The shaft tip 340 can also be connected to a distal end of the backbone member 370 (which may also be referred to as a backbone). For example, in the illustrated embodiment, the shaft tip 340 is connected to the backbone 370 via a band 341. The band 341 may be joined to a distal end of the backbone member 370 and may further be joined to the shaft tip 340. The band 341 may, for example, be a relatively rigid or stiff cylindrical ring.
[00115] As illustrated in FIGS. 10B and 14, the shaft tip 340 can include the opening 349, which may provide passage therethrough of irrigation fluid and/or the impact probe 320, as previously discussed. The tip 340 can further include a visualization opening 343, and one or more illumination openings 344. The visualization opening 343 may be configured for positioning of a visual imaging member as previously described. The illumination openings 344 may be configured to position a visual fiber or an LED as previously described. A distally facing surface 345 is proximally tapered or beveled. In some embodiments, a bevel may facilitate advancement of the shaft 310 and/or steering of the shaft 310 as it is directed toward a treatment site. The beveled surface 345 may, for example, prevent the shaft tip 340 from catching on tissue and can allow the shaft tip 340 to deflect from objects.
[00116] As illustrated in FIGS. 9A and 15, and as previously discussed, the handle 350 includes the irrigation port 353, which can be in fluid communication with the annular space 331. The irrigation port 353 may include a fluid control valve 367 configured to control a flow rate of irrigation fluid through the irrigation port 353. A micro displacement member 354 is disposed within the handle 350 and operatively coupled to the impact probe 320 to provide micro displacement of the impact probe 320. [00117] With continued reference to FIG. 15, in some embodiments, a power switch 369 is coupled to the displacement member 354 to activate and deactivate the displacement member. In further embodiments, a separate switch may be provided for video or image control. For example, the additional switch may commence or terminate image gathering via the image sensor. In other embodiments, such as that depicted in the drawings, no image controls are provided. For example, in some embodiments, the system 300 is configured to continuously gather a video stream when the system 300 is in use. Other arrangements are contemplated.
[00118] With reference to FIGS. 9A, 9B, and 15, the illustrated lithotomy system 300 includes a deflection actuator 356 positioned adjacent to the deployment actuator 321. For example, in the illustrated embodiment, each of the deflection actuator 356 and the deflection actuator 321 can individually be actuated by the thumb of one hand of the user while the user holds the handle 350 with that hand.
In some instances, both actuators 321 , 356 may be actuated simultaneously, if desired, depending on their relative positions. In many instances, serial actuation of the deflection actuator 356 followed or preceded by actuation of the deployment actuator 321 may be desired. As previously discussed, the deployment actuator 321 can be used to extend the impact probe 320 relative to the shaft 310. The deflection actuator 356 can resemble the actuator 156 previously discussed, and may be used to deflect or steer the distal end of the shaft 315. The actuators 321 , 356 may be centered along a side of the handle 350 that is opposite the suction actuator or suction trigger 361 , and may be readily accessible and movable or rotatable by the thumb of either hand of a user, or stated otherwise, ambidextrous use of the actuators 321 , 356 is facilitated.
[00119] With reference to FIGS. 9B and 15, the deflection actuator 356 can include a lever 327 that is coupled to at least one pull wire (such as the pull wires 117 in FIG. 1A) in any suitable manner. The at least one pull wire can be coupled to the backbone member 370 to provide articulating or bending forces to the backbone member 370. For example, in some embodiments, each of the lever 327 and the one or more pull wires are attached to a wheel 366, which may provide some mechanical advantage to the deflection actuator 356 to bend the backbone member 370. When the deflection actuator 356 is displaced in a first axial direction (e.g., proximally), tension may be applied to a first pull wire causing the backbone member 370 to bend in a first direction or plane. When the deflection actuator 356 is displaced in a second axial direction (e.g., distally) tension may be applied to a second pull wire causing the backbone member 370 to bend in a second direction or plane. The deflection actuator 356 may cause the backbone member 370 to bend in either the first direction and/or the second direction relative longitudinal axis of the backbone member 370. In other embodiments, the deflection actuator 356 may be of any suitable form, such as a knob, a tab, a slide, etc. Any other suitable tensioning mechanism is contemplated, included steering mechanisms known in the art.
[00120] With further concurrent reference to FIGS. 9B and 15, the deployment actuator 321 can include a lever 325 that is similarly attached (e.g., directly attached) to, for example, a wheel such as the wheel 366 discussed above. While this specific wheel is not shown, it can be thought of as an extension of the lever 325 that resides inside a housing of the handle 350, and in any event, can be substantially the same as the wheel 366 that is shown in FIG. 15. Accordingly, the positioning and functioning of the internal wheel (e.g., extension of the lever 325) can be readily understood from the drawings and present description. The lever 325 (and associated wheel) can be mechanically (e.g., pivotally) coupled with a linkage 392 of any suitable variety that can convert rotational movement of the lever 325 into longitudinal movement of the impact assembly 307. For example, in the illustrated embodiment, a proximally positioned pivot can be coupled to the internal wheel (and the lever 325), and a distal pivot of the linkage 392 can be coupled with the impact assembly 307. In the illustrated embodiment, rotation of the lever 325 in a first direction (e.g., downwardly or distally, when the handle 350 is held upright) effects distal movement of the impact assembly 307 relative to the handle 350 for distal advancement or deployment of the impact assembly 307, whereas rotation of the lever 325 in a second direction opposite the first direction (e.g., upwardly or proximally, when the handle 350 is held upright) effects proximal movement of the impact assembly 307 relative to the handle 350 for retraction of the impact assembly 307. Any other suitable linkage is contemplated. For example, alterations or adjustments may be made to provide a predictable and/or intuitive correspondence between an amount of movement of the lever 325 and a corresponding movement of the impact probe 320.
[00121] In the illustrated embodiment, the handle 350 includes a nest or inner housing 390 that is positioned at an interior of the handle 350 and within which the energy applicator or displacement member 354 of the impact assembly 307 is configured to reciprocate (e.g., translate distally or proximally, depending on a movement directly of the lever 325). In the illustrated embodiment, a pair of positioning elements 391 are positioned at substantially opposite ends of the displacement member 354. The positioning elements 391 can maintain a suitable spacing between the inner housing 390 and the displacement member 354, can facilitate relative movement of these elements, and/or can dampen or otherwise cushion the handle 350 from vibrations of the displacement member 354 when activated. Other suitable arrangements for permitting relative movement between the impact assembly 307 and the handle 350 are contemplated.
[00122] With continued reference to FIG. 15, a first end of a power and/or communication cable 359 is coupled to the handle 350. A second end of the power and/or communication cable 359 may be coupled to a power source and/or controller for the micro displacement member 354, an image or video processing unit for the visual imaging member, and/or a light or power source for the illumination member. [00123] As previously discussed, and as stated otherwise, the deployment actuator 321 may be disposed adjacent the deflection actuator 356 and coupled to the impact probe 320 to axially displace the impact probe 320 distally to deploy the impact probe 320 beyond the shaft tip 340, such as to break the calculus into fragments, and/or to proximally retract the impact probe 320 into the inner tube 330 (FIG. 10A). The advancement actuator 321 can comprise a lever that when displaced distally moves the impact probe 320 distally and when displaced proximally moves the impact probe proximally. The deployment actuator 321 may be configured to displace the impact probe 320 from about 1 centimeter to about 2 centimeters beyond the distalmost tip of the shaft 310, in some embodiments.
[00124] FIG. 16 illustrates another embodiment of an impact probe 420 suitable for use with certain of the lithotomy systems described herein. The impact probe 420 includes a shaft 423, an adapter 425, a bending portion 421 , and a probe tip 480. The shaft 423 includes a tube formed of a nickel-titanium alloy or any other suitable material. The adapter 425 is coupled to a distal end of the shaft 423. In some embodiments, the adapter 425 may be press fit into the shaft 423. In other embodiments, the adapter 425 may be welded, braised, or soldered onto the distal end of the shaft 423. The bending portion 421 includes two or more wires 426 coupled to and extending between the adapter 425 and the probe tip 480. For example, in the depicted embodiment, the impact probe 420 includes two wires 426. In other embodiments, the impact probe 420 may include three or more wires, four or more wires 426, or some other number of wires. In certain embodiments, the wires 426 may have a diameter ranging from about 0.25 millimeters to about 1.0 millimeters and a length ranging from about 40 millimeters to about 80 millimeters and may be about 55 millimeters. The wires 426 may be formed of nickel-titanium alloy material or any other suitable material.
[00125] In some embodiments, a hollow sleeve (e.g., a tube of any suitable material, such as flexible metal or polymer) may extend over the wires 426 and may be attached and fluidically sealed to the adapter 425 or the shaft 423 at a proximal end thereof and to the probe tip 480 at a distal end thereof. The hollow sleeve may resemble the fluid barrier 384 discussed above with respect to FIG. 10A, and can serve the same function of fluidically isolating an interior of the impact probe 420 from an exterior thereof, which can segregate a suction region at an interior of the impact probe 420 from an irrigation region at an exterior of the impact probe 420.
[00126] As illustrated in FIGS. 17A-17D, the probe tip 480 is generally cylindrical in shape. The probe tip 480 can be formed of nickel-titanium alloy material or any other suitable material. The probe tip 480 may desirably be relatively hard to efficiently and/or durably break down calculi. A length of the probe tip 480 can range, in certain embodiments, from about 12 millimeters to about 25 millimeters and a diameter can range from about 3 millimeters to about 5 millimeters. Other dimensions are contemplated. In the depicted embodiment, the probe tip 480 includes a distal end including impact members 481 and flow spaces 482 disposed between the impact members 481. In the depicted embodiment, the number of impact members 481 is five. In other embodiments, the number of impact members 481 may be two, three, four, or more. The impact members 481 are triangular in shape. In certain embodiments, the impact members 481 may have any suitable shape, such as a circular or polygonal shape. A proximal end of the probe tip 480 can include wire holes 483 configured to receive the wires 426 to couple the probe tip 480 to the wires 426.
[00127] In the illustrated embodiment, a bore 486 extends through the probe tip 480 and is in fluid communication with the flow spaces 482. A neck portion 485 of the bore 486 is adjacent the distal end and a main portion 487 extends proximally from the neck portion 485. A diameter of the neck portion 485 is smaller than a diameter of the main portion 487. For example, the diameter of the neck portion 485 can be, in some embodiments, about 1.3 millimeters and the diameter of the main portion 487 can be about 1.6 millimeters. This configuration can provide for improved passage of calculus fragments through the main portion 487. For example, fragments generated by the probe tip 480 can be small enough to first pass through the narrow neck portion 485 before entering the main portion 487.
[00128] An outside surface of the probe tip 480 can include a recess 484 having a diameter smaller than a diameter of the impact members 481 and a proximal portion 488. For example, the diameter of the recess portion 484 can be, in some embodiments, about 3.3 millimeters and the diameter of the proximal portion 488 can be about 3.6 millimeters. The recess 484 can provide an annular passage between the probe tip 480 and the calculus for irrigation fluid when the probe tip 480 is disposed within a drilled hole of the calculus. The irrigation fluid can cool the probe tip 480 and provide for aspiration of calculus fragments through the probe tip.
[00129] In use, the impact probe 420 can be axially vibrated such that the probe tip 480 breaks apart a calculus and/or drills a hole in the calculus as the impact members 481 impact the calculus or adjacent to the calculus. The wires carry energy from the proximal portion of the impact probe 420 to the probe tip 480. If a hole is drilled, a diameter of the hole can be substantially equivalent to the diameter of the probe tip 480. The irrigation fluid can flow along or about an outer surface of the proximal portion 488 and the annular space surrounding the recess portion 484 when the recess portion 484 is partially disposed within the drilled hole. The irrigation fluid can be drawn inwardly through the flow spaces 482 into the neck portion 485 of the bore 486 by a suction force within the bore 486. As the irrigation fluid flows into the bore 486, fragments of the calculus are caught in the fluid flow to pass through the neck portion 485 and into the main portion 487 to clear the drilled hole of calculus fragments.
[00130] FIG. 18 illustrates another embodiment of an impact probe 520 suitable for use with certain of the lithotomy systems described herein. The impact probe 520 includes a shaft 523, an adapter 525, a bending portion 521 , and a probe tip 580. The shaft 523 includes a tube formed of a nickel-titanium alloy or any other suitable material. The adapter 525 is coupled to a distal end of the shaft 523. In some embodiments, the adapter 525 may be press fit into the shaft 523. In other embodiments, the adapter 525 may be welded, braised, or soldered onto the distal end of the shaft 523. The bending portion 521 includes two or more wires 526 coupled to and extending between the adapter 525 and the probe tip 580. For example, in the depicted embodiment, the impact probe 520 includes two wires 526. In another embodiment, the impact probe 520 may include four or more wires 526. The wires 526 may have a diameter ranging from about 0.25 millimeters to about 1.0 millimeters and a length ranging from about 40 millimeters to about 80 millimeters and may be about 55 millimeters. The wires 526 may be formed of nickel-titanium alloy material or any other suitable material.
[00131] As illustrated in FIGS. 19A-19D, the probe tip 580 is generally cylindrical in shape. The probe tip 580 can be formed of nickel-titanium alloy material or any other suitable material. A length of the probe tip 580 can range from about 12 millimeters to about 25 millimeters and a diameter can range from about 3 millimeters to about 5 millimeters. In the depicted embodiment, the probe tip 580 includes a distal end including impact members 581 and flow spaces 582 disposed between the impact members 581. In the depicted embodiment, the number of impact members 581 is five. In other embodiments, the number of impact members 581 may be two, three, four, or more. The impact members 581 are triangular in shape. In certain embodiments, the impact members 581 may be of any suitable shape, such as circular or any polygonal shape. A proximal end of the probe tip 580 can include wire holes 583 configured to receive the wires 526 to couple the probe tip 580 to the wires 526.
[00132] A bore 586 extends through the probe tip 580. A neck portion 585 of the bore 586 is adjacent the distal end and a main portion 587 extends proximally from the neck portion 585. A diameter of the neck portion 585 is smaller than a diameter of the main portion 587. For example, the diameter of the neck portion 585 can be about 1.3 millimeters and the diameter of the main portion 587 can be about 1.6 millimeters. This configuration can provide for improved passage of calculus fragments through the main portion 587 because the fragments are small enough to first pass through the narrow neck portion 585 before entering the main portion 587. [00133] In use, the impact probe 520 can be axially vibrated such that the probe tip 580 breaks apart a calculus and/or drills a hole in the calculus as the impact members 581 impact the calculus or adjacent to the calculus. If a hole is drilled, a diameter of the hole can be substantially equivalent to the diameter of the probe tip 580. Irrigation fluid can flow along an exterior surface of the probe tip 580. The irrigation fluid can be drawn through the flow spaces 582 into the neck portion 585 of the bore 586 by a suction force within the bore 586. As the irrigation fluid flows into the bore 586, fragments of the calculus can be caught in the fluid flow to pass through the neck portion 585 and into the main portion 587 to clear the drilled hole of calculus fragments.
[00134] FIG. 20 illustrates another embodiment of an impact probe 620 suitable for use with any of the lithotomy systems previously described. The impact probe 620 includes a shaft 623, an adapter 625, a bending portion 621 , and a probe tip 680. The shaft 623 includes a tube formed of a nickel-titanium alloy or any other suitable material. The adapter 625 is coupled to a distal end of the shaft 623. In some embodiments, the adapter 625 may be press fit into the shaft 623. In other embodiments, the adapter 625 may be welded, braised, or soldered onto the distal end of the shaft 623. The bending portion 621 includes two or more wires 626 coupled to and extending between the adapter 625 and the probe tip 680. For example, in the depicted embodiment, the impact probe 620 includes two wires 626. In another embodiment, the impact probe 620 may include four or more wires 626. Wire dimensions and/or composition may be similar to those previously described with respect to other wires.
[00135] FIGS. 21A-D illustrate another embodiment of a probe tip 680. As illustrated the probe tip 680 is generally cylindrical in shape. The probe tip 680 can be formed of nickel-titanium alloy material or any other suitable material. A length of the probe tip 680 can range from about 12 millimeters to about 25 millimeters and a diameter can range from about 3 millimeters to about 5 millimeters. In the depicted embodiment, the probe tip 680 includes a distal end including distally directed pointed impact members 681 and a proximally directed longitudinal tapered flow notch or space 690 disposed between the impact members 681 at a perimeter of the distal end. As depicted, the number of impact members 681 is two. In other embodiments, the number of impact members 681 may be three, four, five, or more. A proximal end of the probe tip 680 can include wire holes 683 configured to receive the wires of an impact probe similar to those previously described.
[00136] A bore 686 extends through the probe tip 680. A neck portion 685 of the bore 686 is adjacent the distal end and a main portion 687 extends proximally from the neck portion 685. A diameter of the neck portion 685 is smaller than a diameter of the main portion 687. For example, the diameter of the neck portion 685 can be about 1.3 millimeters and the diameter of the main portion 687 can be about 1.6 millimeters. This configuration can provide for improved passage of calculus fragments through the main portion 687 because the fragments are small enough to first pass through the narrow neck portion 685 before entering the main portion 687. A suction hole 689 is disposed through a wall of the probe tip 680 into the bore 686. [00137] In use, the impact probe can be axially vibrated such that the probe tip 680 breaks apart a calculus and/or drills a hole in a calculus as the impact members 681 impact the calculus or adjacent to the calculus. If a hole is formed, a diameter of the hole can be substantially equivalent to the diameter of the probe tip 680. Irrigation fluid can flow along an exterior surface of the probe tip 680. The irrigation fluid can be drawn through the tapered flow notches 699 into the neck portion 685 of the bore 686 by a suction force within the bore 686. The suction hole 689 can be positioned outside of the bored hole in the calculus to provide the suction force within the bore
686. As the irrigation fluid flows into the bore 686, fragments of the calculus can be caught in the fluid flow to pass through the neck portion 685 and into the main portion
687.
[00138] FIG. 22 illustrates another embodiment of an impact probe 720. As illustrated, the impact probe 720 includes a shaft 723, a bending portion 721 , and a distal portion 724. The bending portion 721 is disposed between the shaft 723 and the distal portion 724. The bending portion 721 includes a pair of parallelly extending rails 727. The rails 727 may be formed by a micro electric discharge machining (EDM) process or any other suitable process. In some, embodiments the rails 727 may be polished after machining to remove burrs or other defects that may act as stress concentrators when the impact probe 720 is vibrated causing breakage of the rails 727.
[00139] The various embodiments of impact probes depicted in FIGS. 18-22 can include a hollow sleeve or fluid barrier (such as the fluid barrier 384), as discussed with respect to the impact probe 420. Additionally, it is noted that although much discussion is made of axial vibration of probe tips, it should be understood that lateral vibrations may also be present. In some instances, lateral vibration modes may be less pronounced than axial vibration modes. In other instances, lateral vibration modes may be less pronounced than axial vibration modes. In still other instances, substantially equal amounts of energy may be present in lateral vibration modes and axial vibration modes. Any vibration modes that can suitably break up or otherwise usefully disrupt calculi may be employed.
[00140] FIGS. 23A and 23B depict another embodiment of an impact probe 820, which can resemble the impact probe 320 and other impact probes described herein in many respects. As compared with the impact probe 320, the impact probe 820 includes an additional set of slits and an additional narrow strip of continuous material, or a solid wall section, that extends between adjacent slit ends. In the illustrated embodiment, the longitudinally extending solid wall sections are diametrically opposed. The impact probe 820 can bend in two opposite directions. In one direction, a first set of slits is compressed and the other expands. The opposite occurs when the impact probe 820 is bent in the other direction.
[00141] Embodiments of impact probes described herein may also or alternatively be referred to as lithotripters.
[00142] Embodiments within the scope of this disclosure may thus comprise a shaft that can be articulated out of a plane and/or an impact probe that can be articulated out of a plane. In other words, in some embodiments both the shaft and the impact probe are articulable while in other embodiments only the shaft or only the impact probe is articulable. Again, articulation in these instances may refer to members with preformed shapes that articulate when unconstrained and/or members with mechanical or other systems to bend or otherwise articulate the member.
[00143] During treatment, a system with one or more articulable members may facilitate or enable guidance of the treatment system to a treatment location. For example, in some instances, displacement of bodily tissues to conform to a treatment device that is linear and rigid can be avoided. Treatments within the scope of this disclosure can include methods of articulating a treatment device to direct treatment energy along one or more axes to access a treatment location.
[00144] Although much of the foregoing disclosure is provided in the context of lithotomy, and in particular, nephrolithotomy and nephrolithotripsy, other contexts are contemplated. For example, certain lithotripters and lithotripter assemblies may be useable with other forms of endoscopes.
[00145] Any methods disclosed herein comprise one or more steps or actions for performing the described method. The method steps and/or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and/or use of specific steps and/or actions may be modified. For example, a method of performing lithotripsy, comprising positioning a distal end of a lithotomy system adjacent a lithotripsy site, displacing an impact probe beyond the distal end of the lithotomy system, directing a distal end of the impact probe toward a calculus, activating a micro displacement member coupled to a proximal end of the impact probe, and axially vibrating the impact probe adjacent to the calculus. Other steps are also contemplated.
[00146] Embodiments may be understood by reference to the drawings, wherein like parts are designated by like numerals throughout. It will be readily understood by one of ordinary skill in the art having the benefit of this disclosure that the components of the embodiments, as generally described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of various embodiments, as represented in the figures, is not intended to limit the scope of the disclosure, but is merely representative of various embodiments. While the various aspects of the embodiments are presented in drawings, the drawings are not necessarily drawn to scale unless specifically indicated.
[00147] Reference throughout this specification to “an embodimenf or “the embodiment” means that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the quoted phrases, or variations thereof, as recited throughout this specification are not necessarily all referring to the same embodiment.
[00148] Similarly, in the above description of embodiments, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim requires more features than those expressly recited in that claim. Rather, as the following claims reflect, inventive aspects lie in a combination of fewer than all features of any single foregoing disclosed embodiment.
[00149] It will be appreciated that various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure. Many of these features may be used alone and/or in combination with one another. [00150] The phrases “coupled to” and “in communication with” refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components may be coupled to or in communication with each other even though they are not in direct contact with each other. For example, two components may be coupled to or in communication with each other through an intermediate component.
[00151] The directional terms “distal" and “proximal” are given their ordinary meaning in the art. That is, the distal end of a medical device means the end of the device furthest from the practitioner during use. The proximal end refers to the opposite end, or the end nearest to the practitioner during use. As specifically applied to a lithotomy system of this disclosure, the proximal end of the device refers to the end nearest to the handle and the distal end refers to the opposite end, the end nearest to the free end of the tubular body.
[00152] “Fluid" is used in its broadest sense, to refer to any fluid, including body fluids, liquids, and gases as well as solutions, compounds, suspensions, etc., which generally behave as fluids.
[00153] References to approximations are made throughout this specification, such as by use of the term “about.” For each such reference, it is to be understood that, in some embodiments, the value, feature, or characteristic may be specified without approximation. For example, where the qualifier “abouf is used, this term includes within its scope the qualified word in the absence of its qualifiers.
[00154] The terms “a" and “an" can be described as one, but not limited to one. For example, although the disclosure may recite a generator having “an electrode," the disclosure also contemplates that the generator can have two or more electrodes. [00155] Unless otherwise stated, all ranges include both endpoints and all numbers between the endpoints.
[00156] Recitation in the claims of the term “first” with respect to a feature or element does not necessarily imply the existence of a second or additional such feature or element.
[00157] The claims following this written disclosure are hereby expressly incorporated into the present written disclosure, with each claim standing on its own as a separate embodiment. This disclosure includes all permutations of the independent claims with their dependent claims. Moreover, additional embodiments capable of derivation from the independent and dependent claims that follow are also expressly incorporated into the present written description.
[00158] Without further elaboration, it is believed that one skilled in the art can use the preceding description to utilize the invention to its fullest extent. The claims and embodiments disclosed herein are to be construed as merely illustrative and exemplary, and not a limitation of the scope of the present disclosure in any way. It will be apparent to those having ordinary skill in the art, with the aid of the present disclosure, that changes may be made to the details of the above-described embodiments without departing from the underlying principles of the disclosure herein. In other words, various modifications and improvements of the embodiments specifically disclosed in the description above are within the scope of the appended claims. Moreover, the order of the steps or actions of the methods disclosed herein may be changed by those skilled in the art without departing from the scope of the present disclosure. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order or use of specific steps or actions may be modified. The scope of the invention is therefore defined by the following claims and their equivalents.

Claims

Claims
1. A system comprising: a shaft; an impact probe slidably disposed within the shaft; and a micro displacement member coupled to the impact probe, wherein the micro displacement member is configured to displace the impact probe in a direction in alignment with an axis of a distal end of the impact probe.
2. The system of claim 1 , further comprising a handle coupled to a proximal end of the shaft.
3. The system of any one of claim 1 or claim 2, further comprising a visual imaging member disposed within the shaft.
4. The system of claim 3, wherein the handle comprises a camera coupled to the visual imaging member.
5. The system of any one of claims 1-4, further comprising a working channel disposed through the tubular body.
6. The system of claim 5, wherein the handle further comprises an access port in fluid communication with the working lumen.
7. The system of any one of claims 1-6, wherein the impact probe comprises an elongate shaft, and wherein the distal end of the elongate shaft is articulable in a single plane through an angle of from one degree to 180 degrees.
8. The system of claim 7, wherein the elongate shaft is articulable away from a longitudinal axis of the elongate shaft in a single direction.
9. The system of claim 8, wherein the elongate shaft is articulable in the single direction through an angle of up to 30 degrees.
10. The system of claim 8, wherein the elongate shaft is articulable in the single direction through an angle of up to 60 degrees.
11. The system of claim 8, wherein the elongate shaft is articulable in the single direction through an angle of up to 90 degrees.
12. The system of claim 7, wherein the elongate shaft is articulable away from a longitudinal axis of the elongate shaft in either a first direction or a second direction that is opposite the first direction.
13. The system of claim 12, wherein the elongate shaft is articulable in the first direction through an angle of up to 30 degrees.
14. The system of claim 12, wherein the elongate shaft is articulable in the first direction through an angle of up to 60 degrees.
15. The system of claim 12, wherein the elongate shaft is articulable in the first direction through an angle of up to 90 degrees.
16. The system of any one of claims 13-15, wherein the elongate shaft is articulable in the second direction through an angle of up to 30 degrees.
17. The system of any one of claims 13-15, wherein the elongate shaft is articulable in the second direction through an angle of up to 60 degrees.
18. The system of any one of claims 13-15, wherein the elongate shaft is articulable in the second direction through an angle of up to 90 degrees.
19. The system of claim 7, wherein the elongate shaft comprises a superelastic shape-memory metal material.
20. The system of claim 19, wherein the superelastic shape-memory metal material is any one of nitinol and titanium.
21. The system of claim 19 or claim 20, wherein the elongate shaft is inwardly tapered from a proximal end to a distal end.
22. The system of any one of claims 19-21 , wherein the distal end of the elongate shaft is pre-formed with an arcuate shape.
23. The system of claim 22, wherein the elongate shaft is configured to transition to the pre-form arcuate shape when the impact probe is deployed at a lithotripsy site.
24. The system of any one of claims 19-23, wherein the impact probe comprises: a pull wire coupled to the distal end of the elongate shaft; and a plurality of slits disposed in a distal portion of the elongate shaft.
25. The system of any one of claims 2-24, wherein the handle further comprises an impact probe control member coupled to the impact probe and configured to longitudinally displace the impact probe and to articulate a distal portion of the impact probe.
26. The system of any one of claims 2 and 24, wherein the pull wire is coupled to the impact probe control member; and wherein the impact probe control member comprises an articulation mechanism.
27. The system of claim 26, wherein the articulation mechanism comprises any one of a lever, a rotatable knob, a slide, and any combination thereof.
28. The system of any one of claims 24-27, wherein the impact probe control member comprises a linear displacement mechanism configured to longitudinally displace the impact probe.
29. The system of claim 28, wherein the linear displacement mechanism is any one of a threaded knob, a lever, a slide, and any combination thereof.
30. The system of any one of claims 3-28, wherein the visual imaging member comprises: a lens disposed at a distal end of the shaft; and a light source disposed at the distal end of the shaft adjacent the lens.
31. The system of any one of claims 5-29, wherein the working lumen is configured to deliver fluid to a lithotripsy site, to aspirate fluid and debris from the lithotripsy site, and to deliver an instrument to the lithotripsy site.
32. The system of claim 31, wherein the instrument comprises any one of a basket, a laser probe, a grasper, a ureteroscope, and any combination thereof.
33. The system of any one of claims 6-32, wherein a sample collection container is in fluid communication with the access port.
34. The system of any one of claims 1-33, wherein the micro displacement member is any one of an ultrasound energy generator, a pneumatic ballistic generator, an electromagnetic impulse generator, and any combination thereof.
35. The system of claim 34, wherein the ultrasound wave generator comprises: a piezoceramic element; an electrode; a horn; and a rear mass.
36. The system of any one of claims 1-35, wherein the micro displacement member displaces the impact probe at a frequency ranging from 20 kilohertz to 5 megahertz.
37. The system of any one of claims 1-36, wherein the system is a nephroscope.
38. The system of any one of claims 1-37, wherein the tubular body comprises a bendable portion disposed adjacent a distal end of the tubular body.
39. The system of claim 38, wherein the bendable portion comprises a backbone member configured to allow the bendable portion to bend from zero degrees to 180 degrees in a single plane.
40. The system of claim 39, wherein the backbone member comprises a plurality of wedge-shaped slots.
41. The system of claim 39 or claim 40, further comprising a steering pull wire coupled to the backbone member.
42. The system of any one of claims 1-41 , wherein the tubular body comprises a shaft tip coupled to a distal end of the tubular body.
43. The system of claim 42, wherein the shaft tip comprises a working opening, a visualization opening, an illumination opening, and a proximally tapered surface.
44. The system of anyone of claims 1-43, wherein the impact probe comprises a bending portion disposed adjacent a distal end.
45. The system of claim 44, wherein the bending portion comprises at least two wires coupled to a distal end of an impact probe shaft.
46. The system of anyone of claims 1-45, wherein the impact probe comprises a probe tip disposed at a distal end of the impact probe.
47. The system of claim 46, wherein the probe tip comprises: a plurality of impact members disposed at a distal end; a plurality of flow spaces disposed between adjacent impact members; and a bore extending through the probe tip, wherein each of the plurality of flow spaces is in fluid communication with the bore.
48. The system of claim 46 or claim 47, wherein each of the plurality of impact members comprise a triangular shape.
49. The system of claim 46 or claim 47, wherein each of the plurality of impact members comprise a distally directed point.
50. The system of any one of claims 46-49, wherein the bore comprises: a neck portion disposed adjacent the plurality of flow spaces; and a main portion disposed proximally of the neck portion; wherein a diameter of the neck portion is smaller than a diameter of the main portion.
51. The system of any one of claims 46-50, wherein the probe tip further comprise a circumferential recess disposed in an outer surface of the probe tip and in fluid communication with the plurality of flow spaces.
52. The system of any one of claims 46-51 , wherein the probe tip comprises a suction hole extending through a wall of the probe tip and in fluid communication with the bore.
53. A method of performing lithotripsy, comprising: positioning a distal end of an system adjacent a lithotripsy site; displacing an impact probe beyond the distal end of the system; directing a distal end of the impact probe toward a calculus; activating a micro displacement member coupled to a proximal end of the impact probe; and axially vibrating the impact probe adjacent to the calculus.
54. The method of claim 53, further comprising striking the calculus with the distal end of the impact probe to break the calculus into fragments.
55. The method of claim 54, wherein the calculus is struck by the distal end of the impact probe at a frequency ranging from 20 kilohertz to 5 megahertz.
56. The method of any one of claims 53-55, further comprising articulating the distal end of the impact probe.
57. The method of any one of claims 53-56, further comprising visualizing the distal end of the impact probe and the calculus through an imaging member of the system.
58. The method of any one of claims 54-57, further comprising removing the fragments from the lithotripsy site by applying a suction force through a working lumen of the system.
59. The method of claim 58, further comprising collecting the fragments in a collection container.
60. The method of any one of claims 53-59, wherein the calculus is any one of a kidney stone, a gall stone, and a pancreatic stone.
61. A method of transmitting ultrasound energy along an elongate curved element, comprising: activating the ultrasound energy generator to produce ultrasound energy to vibrate the elongate curved element along a first longitudinal axis; transmitting the ultrasound energy through a bend of the elongate curved element, wherein a distal end is directed away from the first longitudinal axis of the elongate curved element; and axially vibrating the distal end of the elongate curved element in a direction in alignment with a second longitudinal axis of the distal end.
62. A method of delivering treatment energy to a treatment site, the method comprising: transmitting treatment energy along a first axis of a treatment device; and transmitting treatment energy along a second axis of the treatment device wherein the second axis is disposed at an angle to the first axis.
63. The method of claim 62, wherein the second axis is disposed in a different plane than the first axis.
64. The method of claim 62 or claim 63, wherein the treatment energy comprises waves transmitted along the longitudinal axis of a treatment member.
65. The method of any one of claims 62-64, wherein the treatment energy comprises ultrasound energy.
66. The method of any one of claims 62-65 further comprising delivering treatment energy to a calculus.
67. The method of any one of claims 62-66, further comprising adjusting the angle between the second axis and the first axis during treatment.
68. A device for transmitting treatment energy, the device comprising: a treatment member for transmitting the treatment energy, a proximal portion of the treatment member disposed along a proximal axis and a distal portion of the treatment member disposed along a distal axis, wherein the distal axis is disposed at an angle to the proximal axis.
69. The device of claim 68, wherein the distal axis is disposed in a different plane than the proximal axis.
70. The device of claim 68 or claim 69, wherein the distal axis is displaceable with respect to the proximal axis.
71. The device of any one of claims 68-70, wherein the treatment member is configured to transmit ultrasound energy.
72. The device of any one of claims 68-71 , wherein the treatment member is configured to transmit longitudinal waves around a bend.
PCT/US2021/053049 2020-09-30 2021-09-30 Lithotomy devices, systems, and methods WO2022072755A1 (en)

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4748971A (en) * 1987-01-30 1988-06-07 German Borodulin Vibrational apparatus for accelerating passage of stones from ureter
US4922902A (en) * 1986-05-19 1990-05-08 Valleylab, Inc. Method for removing cellular material with endoscopic ultrasonic aspirator
US20140309655A1 (en) * 2013-04-16 2014-10-16 Calcula Technologies, Inc. Device for removing kidney stones
US20180110535A1 (en) * 2013-05-09 2018-04-26 Gyrus Acmi, Inc. D/B/A Olympus Surgical Technologies America Oscillating lithotripter
US20190117300A1 (en) * 2002-06-14 2019-04-25 Atricure, Inc. Vacuum coagulation probes
WO2019141822A1 (en) * 2018-01-19 2019-07-25 Ferton Holding S.A. Device and method for the fragmentation of a calculus

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4922902A (en) * 1986-05-19 1990-05-08 Valleylab, Inc. Method for removing cellular material with endoscopic ultrasonic aspirator
US4748971A (en) * 1987-01-30 1988-06-07 German Borodulin Vibrational apparatus for accelerating passage of stones from ureter
US20190117300A1 (en) * 2002-06-14 2019-04-25 Atricure, Inc. Vacuum coagulation probes
US20140309655A1 (en) * 2013-04-16 2014-10-16 Calcula Technologies, Inc. Device for removing kidney stones
US20180110535A1 (en) * 2013-05-09 2018-04-26 Gyrus Acmi, Inc. D/B/A Olympus Surgical Technologies America Oscillating lithotripter
WO2019141822A1 (en) * 2018-01-19 2019-07-25 Ferton Holding S.A. Device and method for the fragmentation of a calculus

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