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WO2025038589A2 - Système de suture endoscopique à l'aide d'une aiguille d'entraînement linéaire - Google Patents

Système de suture endoscopique à l'aide d'une aiguille d'entraînement linéaire Download PDF

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Publication number
WO2025038589A2
WO2025038589A2 PCT/US2024/042009 US2024042009W WO2025038589A2 WO 2025038589 A2 WO2025038589 A2 WO 2025038589A2 US 2024042009 W US2024042009 W US 2024042009W WO 2025038589 A2 WO2025038589 A2 WO 2025038589A2
Authority
WO
WIPO (PCT)
Prior art keywords
needle
endosuturing
suture
cinch
tissue
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
PCT/US2024/042009
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English (en)
Other versions
WO2025038589A3 (fr
Inventor
Ryan C. Abbott
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Intuitive Surgical Operations Inc
Original Assignee
Intuitive Surgical Operations Inc
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 Intuitive Surgical Operations Inc filed Critical Intuitive Surgical Operations Inc
Publication of WO2025038589A2 publication Critical patent/WO2025038589A2/fr
Publication of WO2025038589A3 publication Critical patent/WO2025038589A3/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0482—Needle or suture guides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0487—Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06066—Needles, e.g. needle tip configurations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/062—Needle manipulators
    • A61B17/0625—Needle manipulators the needle being specially adapted to interact with the manipulator, e.g. being ridged to snap fit in a hole of the manipulator
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0467—Instruments for cutting sutures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/00296—Surgical instruments, devices or methods for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means mounted on an endoscope
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00349—Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0409—Instruments for applying suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0417—T-fasteners
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0464—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors for soft tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0487—Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks
    • A61B2017/0488—Instruments for applying suture clamps, clips or locks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B2017/0496—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials for tensioning sutures

Definitions

  • the present disclosure relates to endoscopic suturing devices.
  • Endoscopic suturing is a procedure that permits a medical professional to stitch inside a person (e.g., within the Gl tract).
  • Endoscopic suturing includes an endoscope equipped with a stitching device and a mechanism for cinching a suture strand.
  • An endoscope is medical tool including an image sensor and light source to view, in real time, the internal organs of a person.
  • endoscopic suturing involves suturing plication lines in stomach tissue to reduce the overall volume of the stomach.
  • the endoscope assists in accurate location and formation of the necessary plications within the stomach for a successful procedure.
  • Endoscopic suturing devices require complicated operation of the endoscope and associated stitching devices in order to properly suture the desired target zone.
  • an endosuturing system including a cinch linearly moveable along a longitudinal axis, the cinch including an inner cinch member and an outer cinch member selectively movable relative to one another to provide a suture lock.
  • the system further includes a suture needle having a distal needle tip and an opposite, proximal end, the suture needle having a nested position within the inner cinch member of the cinch.
  • the endosuturing system includes a needle driver coaxial with the cinch and linearly moveable along the longitudinal axis and a needle collet coaxial with the cinch and configured to releasably couple to the proximal end of the suture needle.
  • the outer cinch member includes a wedge-shaped inner surface and the inner cinch member includes a wedge-shaped outer surface, the wedge-shaped inner surface complementary to the wedge-shaped outer surface to form the suture lock.
  • the outer cinch member may include recessed channels and the inner cinch member may include shoulders to form a second suture lock.
  • the second suture lock may include a cutting surface disposed on the inner cinch member configured to cut a suture strand against a proximal end of the outer cinch member when the inner cinch member and outer cinch member form the second suture lock.
  • the endosuturing system may further include a cinch locking actuator and a cinch driver configured to control movement of the cinch along a second degree of freedom and a third degree of freedom.
  • the cinch driver may include tabs disposed in working channels of the outer cinch member that fall inward when the inner cinch member and the outer cinch member form the suture lock.
  • the cinch may include a recess in the outer cinch member and a shoulder disposed on the inner cinch member to lock a suture strand in the suture lock. Additionally, in some examples, advancement of the cinch locking actuator along the second degree of freedom advances the needle driver.
  • the needle collet includes a ribbon for moving the needle collet along a first degree of freedom.
  • the needle collet may include a selective latching mechanism having biased collet arms.
  • the endosuturing system also includes a drive guide coaxial with the cinch and linearly moveable along the longitudinal axis.
  • the drive guide can be movable along a fourth degree of freedom via an actuation member.
  • the drive guide aligns axial movement of the needle driver with a longitudinal axis of a distal needle receiver.
  • the drive guide can include a conical face configured to engage the distal needle receiver.
  • the drive guide can include a plurality of ribs to center the drive guide relative to a channel of an endoscope.
  • the endosuturing system can include a housing defining an endoscope aperture.
  • the endosuturing system can additionally include an alignment guide of the housing configured to engage an endoscope received within the endoscope aperture to engage a working channel of the endoscope.
  • the endosuturing system can include an arm extending distally from the housing, the arm including a portion at least partially angled relative to the longitudinal axis.
  • the endosuturing system can include a suture needle receiver disposed on a distal end of the arm and aligned relative to the alignment guide.
  • the needle receiver can include an entrance lip to stretch tissue and assist needle puncture.
  • the needle receiver can include a conical shape to assist in receiving the needle tip of the suture needle.
  • the alignment guide can include an aperture and working channel lip.
  • the needle receiver is axially aligned with the aperture.
  • the needle receiver can include a releasable needle tip locking mechanism.
  • the releasable needle tip locking mechanism may include one of a spring-controlled lever, an elastically deformable latch, and a deformable wire.
  • the releasable needle tip locking mechanism comprises a compliant member having a holding force that retains the needle with the needle receiver.
  • the compliant member comprises an opening configured to allow passage of at least a portion of the suture needle therethrough.
  • the opening is configured to allow passage of at least a portion of the suture strand coupled to the needle to pass through the opening of the compliant member.
  • the endosuturing system may further include a plurality of compliant members, the plurality of compliant members comprising spring rods with the opening positioned between the spring rods.
  • the releasable needle tip locking mechanism prevents the needle from being removed until the needle tip locking element is deflected or actuated via contact between the needle tip locking mechanism and the needle driver and/or needle collet.
  • the endosuturing system includes a drive guide coaxial with the cinch and linearly moveable along the longitudinal axis.
  • the drive guide is movable along a fourth degree of freedom via an actuation member.
  • the drive guide can align axial movement of the needle driver with the suture needle receiver.
  • the drive guide includes a conical face configured to engage the suture needle receiver.
  • the drive guide can include a plurality of ribs to center the drive guide with the alignment guide.
  • an endosuturing device including an endoscope housing defining an endoscope aperture.
  • the device may further include an alignment guide of the endoscope housing configured to engage an endoscope received within the endoscope aperture to engage a working channel thereof.
  • the device may include an arm extending distally from the endoscope housing, the arm including a portion at least partially angled relative to a longitudinal axis.
  • the device may include a suture needle receiver disposed on a distal end of the arm and aligned relative to the alignment guide.
  • the needle receiver may include an entrance lip to stretch tissue and assist needle puncture.
  • the needle receiver includes a conical shape to assist in receiving a needle tip.
  • the alignment guide may include an aperture and working channel lip. In such variations, the needle receiver is axially aligned with the aperture.
  • the needle receiver includes a releasable needle tip locking mechanism.
  • the releasable needle tip locking mechanism may include one of a spring- controlled lever, an elastically deformable latch, and a deformable wire.
  • the releasable needle tip locking mechanism comprises a compliant member having a holding force that retains the needle with the needle receiver.
  • the compliant member comprises an opening configured to allow passage of at least a portion of the suture needle therethrough.
  • the opening is configured to allow passage of at least a portion of the suture strand coupled to the needle to pass through the opening of the compliant member.
  • the endosuturing system can include a plurality of compliant members, the plurality of compliant members comprising spring rods with the opening positioned between the spring rods.
  • a housing defining an endoscope aperture having a first axis and a passageway defined in the endoscope housing adjacent to the endoscope aperture.
  • An outlet of the passageway may have a second axis, the second axis disposed at an angle relative to the first axis.
  • the endoscope housing may further include a tissue grabber received within the passageway and movable to pull tissue forward of the endoscope aperture.
  • the second axis is disposed between 60 degrees (°) and 80° relative to the first axis.
  • the tissue grabber may be moveable along the second axis. Further, the tissue grabber may be rotational about the second axis. In such examples, the tissue grabber includes a helical tissue grabber.
  • a method of operating an endosuturing device including a housing, a tissue grabber, a suture needle, and a distal needle receiver.
  • the method includes operating the tissue grabber to pull tissue between the endoscope housing and the needle receiver.
  • the method also includes driving the suture needle through the tissue with a needle driver along a first and second degree of freedom and securing the suture needle in the needle receiver.
  • the method further includes retracting the needle driver along the second degree of freedom with the suture needle secured within the needle receiver.
  • the method may additionally include operating the tissue grabber to release the tissue.
  • the method includes extending the needle driver along the second degree of freedom to couple to the suture needle and withdrawing the suture needle from the needle receiver with a needle collet and the needle driver along the first and second degrees of freedom.
  • the endosuturing device further includes a cinch having an inner cinch member and an outer cinch.
  • the method further includes releasing the suture needle from the needle driver and the needle receiver. The method may then include tensioning the suture strand and moving the inner cinch member distally along the second degree of freedom relative to the outer cinch member to lock the cinch.
  • moving the inner cinch member distally relative to the outer cinch member further includes cutting the suture strand.
  • the method may include driving the cinch out of a working channel of the endoscope along the third degree of freedom.
  • the method includes threading a suture strand through the cinch and the suture needle.
  • operating the tissue grabber includes rotating a helical tissue grabber.
  • securing the suture needle into the needle receiver includes withdrawing the needle driver along the second degree of freedom and not actuating a needle collet.
  • withdrawing the suture needle from the needle receiver includes: actuating the needle collet; and releasing a needle tip locking mechanism with the needle driver.
  • the method includes extending the needle driver along the second degree of freedom to couple to the suture needle further comprises extending a drive guide to guide movement of the needle driver into engagement with the needle.
  • extending the needle driver is along a fourth degree of freedom.
  • extending the drive guide can include engaging the drive guide with the needle receiver.
  • extending the needle driver is along a fourth degree of freedom.
  • FIG. 1A is a schematic diagram for a robotically-assisted manipulator system, according to some examples.
  • FIG. 1 B is a schematic diagram of an instrument system according to examples described herein.
  • FIG. 1C illustrates a distal portion of the instrument system of FIG. 1 B with an extended example of an instrument according to examples described herein.
  • FIG. 2 is a perspective view of a linear endosuturing device made in accordance with the present disclosure.
  • FIG. 3 is a cross-sectional side view of the linear endosuturing device of FIG. 2.
  • FIG. 4A is a perspective view of a receiver of the linear endosuturing device of
  • FIG. 4B is a perspective view of another receiver of the linear endosuturing device of FIG. 2.
  • FIG. 4C is a perspective view of the receiver of FIG. 4B.
  • FIG. 4D is a perspective view of another receiver of the linear endosuturing device of FIG. 2.
  • FIG. 5A is a cross-sectional perspective view of coaxial control mechanisms of the linear endosuturing device of FIG. 2.
  • FIG. 5B is a cross-sectional perspective view of an alternative coaxial control mechanisms of the linear endosuturing device of FIG. 2.
  • FIG. 6 is a perspective view of a cinch mechanism of the coaxial control mechanisms of FIG. 5A and 5B.
  • FIG. 7 is a cross-sectional, side-view of the cinch control mechanism.
  • FIG. 8 is a perspective view of an alternative linear endosuturing device of the present disclosure disposed adjacent a portion of tissue.
  • FIG. 9 is a perspective view of the linear endosuturing device of FIG. 8 with a helical tissue grabber deployed and engaging the tissue.
  • FIG. 10 is a perspective view of the linear endosuturing device of FIGS. 8-9 with the helical tissue grabber retracted to draw the tissue into the device.
  • FIG. 11 is a perspective view of the linear endosuturing device of FIGS. 8-10 showing a needle driver driving a suture needle and a suture strand through the tissue.
  • FIG. 12 is a perspective view of the linear endosuturing device of FIGS. 8-11 with the suture needle received in a needle receiver and the needle driver retracted from the tissue leaving the suture strand behind to form a plication.
  • FIG. 13 is a perspective view of the linear endosuturing device of FIGS. 8-12 with the helical tissue grabber released from the tissue.
  • FIG. 14 is a perspective view of the linear endosuturing device of FIGS. 8-13 after the needle driver has retrieved the suture needle from the needle receiver.
  • FIG. 15 is a perspective view of the linear endosuturing device of FIGS. 8-14 with the needle driver and suture needle in a fully retracted position.
  • FIG. 16 is a perspective view of the linear endosuturing device of FIGS. 8-15 with the needle driver partially extended and configured to drop the suture needle to form an anchor.
  • FIG. 17 is a perspective view of the linear endosuturing device of FIGS. 8-16 with a cinch deployed to tension and lock the suture strand.
  • FIG. 18 is a perspective view of the linear endosuturing device of FIGS. 8-17 dropping the cinch to form another anchor.
  • FIG. 19 is a perspective view of a plication line formed of multiple plications and properly tensioned suture strand remaining in the tissue following the steps performed with the linear endosuturing device of FIGS. 8-18.
  • FIG. 20 is a perspective view of a linear endosuturing device made in accordance with the present disclosure.
  • FIG. 21 is a perspective view of the endosuturing device of FIG. 20.
  • FIG. 22 is a perspective view of the endosuturing device of FIG. 20.
  • FIG. 23A is a perspective view of a drive guide of the endosuturing device of FIG.
  • FIG. 23B is a perspective view of the drive guide of FIG. 23A.
  • FIGS. 24A-24H depict views of operation of the endosuturing device of FIGS.
  • FIG. 25 is a perspective view of a linear endosuturing device made in accordance with the present disclosure.
  • FIG. 26 depicts a partial view of the linear endosuturing device of FIG. 25.
  • FIG. 27A-27D depict views of operation of the endosuturing device of FIGS. 25 and 26.
  • FIG. 28 is a perspective view of a linear endosuturing device made in accordance with the present disclosure.
  • FIG. 29A-29B depict alternative views of the linear endosuturing device of FIG. 28.
  • FIG. 30A-30D depict views of operation of the endosuturing device of FIGS. 28, 29A, and 29B.
  • FIG. 31 is a perspective view of another linear endosuturing device made in accordance with the present disclosure.
  • FIG. 32 is a side view of a linear endosuturing device made in accordance with the present disclosure.
  • FIG. 1 A illustrates an embodiment of a robotically-assisted manipulator system for use with the endoscopic suture systems described herein.
  • the manipulator system can be used, for example, in surgical, diagnostic, therapeutic, biopsy, or non-medical procedures, and is generally indicated by the reference numeral 100.
  • a robotically-assisted manipulator system 100 can include one or more manipulator assemblies 102 for operating one or more medical instrument systems 104 in performing various procedures on a patient P positioned on a table T in a medical environment 101.
  • the manipulator assembly 102 can drive catheter or end effector motion, can apply treatment to target tissue, and/or can manipulate control members.
  • the manipulator assembly 102 can be teleoperated, nonteleoperated, or a hybrid teleoperated and non-teleoperated assembly with select degrees of freedom of motion that can be motorized and/or teleoperated and select degrees of freedom of motion that can be non-motorized and/or non-teleoperated.
  • An operator input system 106 which can be inside or outside of the medical environment 101 , generally includes one or more control devices for controlling manipulator assembly 102.
  • Manipulator assembly 102 supports medical instrument system 104 and can optionally include a plurality of actuators or motors that drive inputs on medical instrument system 104 in response to commands from a control system 112.
  • the actuators can optionally include drive systems that when coupled to medical instrument system 104 can advance medical instrument system 104 into a naturally or surgically created anatomic orifice.
  • Other drive systems can move the distal end of medical instrument in multiple degrees of freedom, which can include three degrees of linear motion (e.g., linear motion along the X, Y, Z Cartesian axes) and in three degrees of rotational motion (e.g., rotation about the X, Y, Z Cartesian axes).
  • the manipulator assembly 102 can support various other systems for irrigation, treatment, or other purposes.
  • Such systems can include fluid systems (including, for example, reservoirs, heating/cooling elements, pumps, and valves), generators, lasers, interrogators, and ablation components.
  • Robotically-assisted manipulator system 100 also includes a display system 110 for displaying an image or representation of the surgical site and medical instrument system 104 generated by an imaging system 109 which can include an imaging system, such as an endoscopic imaging system.
  • Display system 110 and operator input system 106 can be oriented so an operator O can control medical instrument system 104 and operator input system 106 with the perception of telepresence.
  • a graphical user interface can be displayable on the display system 110 and/or a display system of an independent planning workstation.
  • the endoscopic imaging system components of the imaging system 109 can be integrally or removably coupled to medical instrument system 104.
  • a separate imaging device such as an endoscope
  • a separate manipulator assembly can be used with medical instrument system 104 to image the surgical site.
  • the endoscopic imaging system 109 can be implemented as hardware, firmware, software, or a combination thereof which interact with or are otherwise executed by one or more computer processors, which can include the processors of the control system 112.
  • Robotically-assisted manipulator system 100 can also include a sensor system 108.
  • the sensor system 108 can include a position/location sensor system (e.g., an actuator encoder or an electromagnetic (EM) sensor system) and/or a shape sensor system (e.g., an optical fiber shape sensor) for determining the position, orientation, speed, velocity, pose, and/or shape of the medical instrument system 104.
  • the sensor system 108 can also include temperature, pressure, force, or contact sensors or the like.
  • Robotically-assisted manipulator system 100 can also include a control system 112.
  • Control system 112 includes at least one memory 116 and at least one computer processor 114 for effecting control between medical instrument system 104, operator input system 106, sensor system 108, and display system 110.
  • Control system 112 also includes programmed instructions (e.g., a non-transitory machine-readable medium storing the instructions) to implement a procedure using the robotically-assisted manipulator system including for navigation, steering, imaging, engagement feature deployment or retraction, applying treatment to target tissue (e.g., via the application of energy), or the like.
  • Control system 112 can optionally further include a virtual visualization system to provide navigation assistance to operator O when controlling medical instrument system 104 during an image-guided surgical procedure.
  • Virtual navigation using the virtual visualization system can be based upon reference to an acquired pre-operative or intra-operative dataset of anatomic passageways.
  • the virtual visualization system processes images of the surgical site imaged using imaging technology such as computerized tomography (CT), magnetic resonance imaging (MRI), fluoroscopy, thermography, ultrasound, optical coherence tomography (OCT), thermal imaging, impedance imaging, laser imaging, nanotube X-ray imaging, and/or the like.
  • CT computerized tomography
  • MRI magnetic resonance imaging
  • fluoroscopy thermography
  • ultrasound ultrasound
  • OCT optical coherence tomography
  • thermal imaging impedance imaging
  • laser imaging laser imaging
  • nanotube X-ray imaging and/or the like.
  • the control system 112 can use a pre-operative image to locate the target tissue (using vision imaging techniques and/or by receiving user input) and create a pre-operative plan, including an optimal first location for performing treatment.
  • the pre-operative plan can include, for example, a planned size to expand an expandable device, a treatment duration, a treatment temperature, and/or multiple deployment locations.
  • FIG. 1 B shows a medical instrument system 120 according to some embodiments.
  • medical instrument system 120 can be used in an image- guided medical procedure.
  • medical instrument system 120 can be used for non-teleoperational exploratory procedures or in procedures involving traditional manually operated medical instruments, such as endoscopy.
  • medical instrument system 120 is interchangeable with, or a variation of, medical instrument system 104 of FIG. 1A.
  • Medical instrument system 120 includes elongate flexible device 122, such as a flexible catheter or endoscope (e.g., gastroscope, bronchoscope), coupled to a drive unit 124.
  • Elongate flexible device 122 includes a flexible body 136 having proximal end 137 and distal end, or tip portion, 138.
  • flexible body 136 has an approximately 14-20 mm outer diameter. Other flexible body outer diameters can be larger or smaller.
  • Flexible body 136 can have an appropriate length to reach certain portions of the anatomy, such as the lungs, sinuses, throat, or the upper or lower gastrointestinal region, when flexible body 136 is inserted into a patient’s oral or nasal cavity.
  • Medical instrument system 120 optionally includes a tracking system 150 for determining the position, orientation, speed, velocity, pose, and/or shape of distal end 138 and/or of one or more segments 144 along flexible body 136 using one or more sensors and/or imaging devices.
  • Tracking system 150 can optionally be implemented as hardware, firmware, software or a combination thereof which interact with or are otherwise executed by one or more computer processors, which can include the processors of control system 112 in Fig. 1A.
  • Tracking system 150 can optionally track distal end 138 and/or one or more of the segments 144 using a shape sensor 142. In some embodiments, tracking system 150 can optionally and/or additionally track distal end 138 using a position sensor system 140, such as an electromagnetic (EM) sensor system. In some examples, position sensor system 140 can be configured and positioned to measure six degrees of freedom, e.g., three position coordinates X, Y, Z and three orientation angles indicating pitch, yaw, and roll of a base point or five degrees of freedom, e.g., three position coordinates X, Y, Z and two orientation angles indicating pitch and yaw of a base point.
  • EM electromagnetic
  • Flexible body 136 includes one or more channels 141 sized and shaped to receive one or more medical instruments 146.
  • flexible body 136 includes two channels 141 for separate instruments 146, however, a different number of channels 141 can be provided.
  • FIG. 1C is a simplified diagram of flexible body 136 with medical instrument 146 extended according to some embodiments.
  • medical instrument 146 can be used for procedures and aspects of procedures, such as surgery, biopsy, ablation, mapping, imaging, illumination, irrigation, or suction. Medical instrument 146 can be deployed through channel 141 of flexible body 136 and used at a target location within the anatomy.
  • Medical instrument 146 can include, for example, image capture devices, biopsy instruments, ablation instruments, catheters, laser ablation fibers, and/or other surgical, diagnostic, or therapeutic tools.
  • Medical tools can include end effectors having a single working member such as a scalpel, a blunt blade, a lens, an optical fiber, an electrode, and/or the like.
  • Other end effectors can include, for example, forceps, graspers, balloons, needles, scissors, clip appliers, and/or the like.
  • Other end effectors can further include electrically activated end effectors such as electrosurgical electrodes, transducers, sensors, imaging devices and/or the like.
  • Medical instrument 146 can be advanced from the opening of channel 141 to perform the procedure and then retracted back into the channel when the procedure is complete. Medical instrument 146 can be removed from proximal end 137 of flexible body 136 or from another optional instrument port (not shown) along flexible body 136.
  • the medical instrument 146 can be used with an image capture device (e.g., an endoscopic camera) also within the elongate flexible device 122. Alternatively, the medical instrument 146 can itself be the image capture device.
  • Medical instrument 146 can additionally house cables, linkages, or other actuation controls (not shown) that extend between its proximal and distal ends to controllably the bend distal end of medical instrument 146.
  • Flexible body 136 can also house cables, linkages, or other steering controls (not shown) that extend between drive unit 124 and distal end 138 to controllably bend distal end 138 as shown, for example, by broken dashed line depictions 139 of distal end 138.
  • at least four cables are used to provide independent “up-down” steering to control a pitch motion of distal end 138 and “left-right” steering to control a yaw motion of distal end 138.
  • drive unit 124 can include drive inputs that removably couple to and receive power from drive elements, such as actuators, of the teleoperational assembly.
  • medical instrument system 120 can include gripping features, manual actuators, or other components for manually controlling the motion of medical instrument system 120.
  • the information from tracking system 150 can be sent to a navigation system 152 where it is combined with information from visualization system 151 and/or the preoperatively obtained models to provide the physician or other operator with real-time position information.
  • the medical instrument systems 104, 120 can include a flexible elongate device (e.g., an endoscope) 202 configured to be inserted through the mouth or anus of a patient, which will be generally referred to as an “endoscope” herein.
  • the endoscope is equipped with an endoscopic suturing device at its distal end to repair holes or openings in the gastrointestinal (Gl) tract and/or perform other procedures such as endoscopic sleeve gastroplasty (ESG).
  • Gl gastrointestinal
  • ESG endoscopic sleeve gastroplasty
  • the endoscopic suturing device is configured to be fixed to the distal end of the endoscope and can include a suture needle that is actuated linearly, and in some versions, parallel to a central axis of the distal end of the endoscope.
  • the endoscopic suturing device can also include an off-axis tissue grabber and a cinch mechanism disposed coaxially about the suture needle.
  • FIG. 2 illustrates a linear endosuturing system 200 made in accordance with the present disclosure.
  • the endosuturing system 200 includes an endoscope 202 and an endoscopic suturing device 201 fixed to a distal end 202a of the endoscope 202.
  • the distal end 202a of the endoscope 202 defines a longitudinal axis 206.
  • the endoscopic suturing device 201 includes a housing 204 releasably coupled to the endoscope 202 via a coupling mechanism 208.
  • the coupling mechanism 208 includes a plurality of slits in the housing 204.
  • the slits of the coupling mechanism 208 are configured to allow the housing 204 to flex and secure the housing 204 to the endoscope 202 via friction.
  • the housing 204 may be releasably secured to the endoscope 202 with any other coupling mechanism.
  • the endoscopic suturing device 201 may be permanently attached to or otherwise integrated into the endoscope 202.
  • the endoscope 202 further includes a distal face 210, an imaging system 212, first and second working channels 214a, 214b, and light sources 216a, 216b.
  • the endoscope 202 may include more or fewer components.
  • the endoscope 202 may include more or fewer working channels and/or more or fewer light sources.
  • the endoscopic suturing device 201 may be configured to work with existing off-the-shelf endoscopes, but in other examples, the endoscope 202 may be custom designed for use with the disclosed endoscopic suturing device 201 of the present disclosure.
  • the size and position of the working channels 214a, 214b of the endoscope 202 may be designed to specifically work with the endoscopic suturing device 201 and the needle driver and cinch mechanism used in connection with the endoscopic suturing device 201 .
  • the housing 204 of the endoscopic suturing device 201 includes a cylindrical opening 224 and an alignment guide 226.
  • the cylindrical opening 224 is configured to receive the distal end 202a of the endoscope 202.
  • the alignment guide 226 includes an inwardly extending tab configured to engage the distal face 210 and/or an inner surface of the working channel 214a to assist with properly aligning the endoscopic suturing device 201 and the endoscope 202.
  • the alignment guide 226 includes an aperture 228 passing through the tab and a shoulder 328 that may pass partially into the working channel 214a, as shown in FIG. 3, for example.
  • the housing 204 of the endoscopic suturing device 201 further includes an arm 230 including a proximal end 232a coupled to the housing 204 and a distal end 232b extending distally from the housing 204.
  • the arm 230 can be integrally formed or removably coupled with the housing 204. So configured, the arm 230 is cantilevered distally from the housing 204.
  • the distal end 232a of the arm 230 carries a needle receiver 234.
  • the arm 230 includes a first portion 235a substantially parallel with the longitudinal axis 206 of the endoscope 202 and a second portion 235b angled relative to the longitudinal axis 206 such that the needle receiver 234 is co-axially aligned with the working channel 214a of the endoscope 202 and the aperture 228 of the alignment guide 226.
  • the arm 230 may be configured in any manner to distally extend from the housing 204 and axially align the needle receiver 234 with the working channel 214a.
  • the endoscopic suturing device 201 may be configured to have the needle receiver 234 and alignment guide 226 axially aligned with the working channel 214b instead of the working channel 214a.
  • the disclosed version of the arm 230 further includes a passageway 236 disposed adjacent to the distal end 202a of the endoscope 202.
  • the passageway 236 is disposed at an angle 326 relative to the longitudinal axis 206 and configured to accommodate a tissue grabber 314 and an actuating rod 238 for controlling the tissue grabber 314.
  • the actuating rod 238 is configured to effect linear and rotational displacement of the tissue grabber 314, as will be described more completely below.
  • the linear displacement and the rotational displacement correspond to a linear degree of freedom and a rotational degree of freedom.
  • the actuating rod 238 extends from the tissue grabber 314 proximally along the entire length of the endoscope 202 such that the tissue grabber can be manipulated directly or indirectly by a medical practitioner, such as the operator O of FIG. 1A.
  • the tissue grabber 314 is a helical tissue grabber configured to pass through an outlet 316 of the passageway 236.
  • the outlet 316 is positioned such that the tissue grabber 314 extends distally to the distal end 202a of the endoscope 202 when the tissue grabber 314 is extended from the passageway 236.
  • the helical tissue grabber can be made of metal wire or other material with sufficient strength and rigidity to transform torque into a piercing force and push the helical tissue grabber into the tissue.
  • the helical tissue grabber includes a sharpened tip to facilitate the piercing action.
  • the helical tissue grabber is sufficiently rigid to pull and push tissue without experiencing any damage (e.g., plastic deformation).
  • the tissue grabber 314 is configured to move along a second longitudinal axis 324 defined relative to the outlet 316.
  • the second longitudinal axis 324 is disposed at the same angle 326.
  • the angle 326 may be greater than approximately 20 degrees (°), greater than approximately 30°, greater than approximately 45°, greater than approximately 60°, or any other suitable angle.
  • the tissue grabber 314 is configured to be moved along the second longitudinal axis 324 by pushing and pulling the actuating rod 238. Additionally the tissue grabber 314 is configured to rotate about the second longitudinal axis 324 by rotating the actuating rod 238. While the present version of the disclosure includes a helical tissue grabber, other tissue grabbers can be used including, for example, jaw-based grippers/pinchers or any other type of grabber that is suitable for the intended purpose.
  • the needle receiver 234 is disposed at the distal end 232a of the arm 230 and includes a generally barrel shaped component defining an internal bore 235 and a releasable needle tip locking mechanism 332.
  • the bore 235 includes an entry portion 237 and a needle seating portion 239.
  • the entry portion 237 is conically shaped to facilitate entry of a needle that may be slightly off-axis.
  • the needle seating portion 239 is configured to retain the needle during the suturing process.
  • the releasable needle tip locking mechanism 332 is positioned in the entry portion 237 for releasably locking and retaining the needle in the needle seating portion 239.
  • an elastically deformable latch has a first position configured to engage with a feature such as a shoulder disposed on the needle to retain the needle with the needle tip locking mechanism 332 and a second position deformed to disengage the needle from the shoulder and thereby disengage the needle from the needle tip locking mechanism 332.
  • a needle driver e.g., needle drivers 514, 1102 described further below
  • a needle driver is axially extended to engage the needle tip locking mechanism 332 and move the needle tip locking mechanism 332 into the second position.
  • the needle can thereby be disengaged from the needle receiver 234 via coupling a proximal end of the needle with a needle collet and axial retraction of the needle driver and needle collet.
  • the needle tip locking mechanism 332 prevents the needle from being removed until the needle tip locking mechanism 332 is deflected or actuated via contact between the needle tip locking mechanism 332 and the needle driver and/or needle collet.
  • the needle receiver 234 also includes an entrance lip 242 that includes a generally flat annular surface surrounding the entry portion 237 of the bore 235. The entrance lip 242 is configured to stretch tissue and assist needle puncture through patient tissue.
  • the entrance lip 242 is a flat, annular surface, but in other examples, the entrance lip 242 can include an annular surface that is concave, convex, or otherwise.
  • the entry portion 237 of the bore 235 is conically shaped, but in other examples, the entry portion 237 can have an ogive surface, a pyramidal surface, or other receptive surface structure suitable for the intended purpose.
  • the releasable needle tip locking mechanism 332 is described as an elastically deformable latch, but can be designed otherwise.
  • the locking mechanism 332 can include any other structure capable of releasably and selectively retaining the needle in the needle receiver 234 as intended.
  • FIG. 4A depicts a perspective view of an alternative needle receiver 434 of the endosuturing system 200 of FIGS. 2 and 3.
  • the alternative needle receiver 434 includes deformable wires 432 passing through slots 436 as a releasable needle tip locking mechanism 433.
  • the example needle receiver 434 includes three slots 436 and three deformable wires 432, but can include more or fewer slots 436 and deformable wires 432.
  • the deformable wires 432 can prevent the needle from being removed similarly to the deformable latch example.
  • the deformable wires prevent the needle from being removed until the deformable wires are deflected or actuated via contact between the needle tip locking mechanism and the needle driver and/or needle collet.
  • FIGS. 4B-4C depict a perspective view of another needle receiver 443 of the endosuturing system 200 of FIGS. 2 and 3. As shown in FIGS. 4B-4C, the needle receiver 443 includes a housing 446 with an embedded retaining member 448.
  • the retaining member 448 is an example of a releasable needle tip locking mechanism 449.
  • FIG 4B shows a portion of the housing 446 removed to visualize the retaining member 448.
  • the retaining member 448 is a compliant member that allows a portion of a suture needle (e.g., such as the tip 522 and/or suture needle body 521 of a suture needle 512 depicted in FIG. 5A) to pass through while providing a holding force that retains the needle to the needle receiver 443.
  • the retaining member 448 may be made of rubber (e.g., an o-ring), an elastomer, or other compliant material.
  • the retaining member 448 has an opening 450 (e.g., a central opening) configured to allow passage of the portions of the suture needle 512 therethrough. Along with passage of the suture needle 512 portions through the opening 450, the retaining member 448 allows a suture strand 452 coupled to the suture needle 512 to also pass through the opening 450 of the retaining member 448.
  • This configuration enables the needle receiver 443 to couple to the suture needle 512 and retain the needle 512 while also allowing the suture strand 452 to pass distally and/or proximally through the receiver 443 without snagging or tangling the suture strand.
  • the opening 450 of the retaining member 448 expands to accommodate portions of the suturing needle 512 and the suture strand 452 without snagging on the suture strand 452.
  • the retaining member 448 also provides a compressive force onto the suturing needle 512 to hold the suturing needle 512 in place and coupled to the needle receiver 443.
  • the retaining member 448 is shaped to engage suture needle 512 and is disengaged from the suture needle 512 via contact with the needle driver 514. In other examples, when a sufficient pulling force is applied to the suture needle 512, the suture needle 512 is released from retaining member 448.
  • the opening 450 in the retaining member 448 will expand slightly allow removal of the suture needle 512 and the suture strand 452 without snagging or catching.
  • the housing 446 may optionally include one or more slots or channels 454 to guide or hold the retaining member 448 in place.
  • the slots 454 may allow for expansion of the retaining member 448 during movement of the suture needle 512.
  • the slots 454 may be used to help couple or locate the retaining member 448 in place with the housing 446.
  • FIG. 4D depicts a perspective view of another needle receiver 456 of the endosuturing system 200 of FIGS. 2 and 3.
  • the needle receiver 456 includes one or more retaining members 458.
  • the retaining members 458 are an example of a releasable needle tip locking mechanism 458.
  • the retaining members 458 are compliant members that allow a portion of a suture needle (e.g., such as a tip 522 and/or a suture needle body 521 of the suture needle 512 depicted in FIG. 5A) to pass through while providing a holding force that retains the needle to the needle receiver 456.
  • the retaining members 458 may be in the form of spring rods that deflect outwardly when the suture needle 512 comes into engagement with the retaining members 458.
  • a gap is positioned between the retaining members 458 with a spacing that is larger than the diameter of suture strand 462 coupled to the suture needle 512 to allow the suture strand 462 to pass through the gap and not snag or catch.
  • the retaining member 548 is shaped to engage suture needle 512 and is disengaged from the suture needle 512 via contact with the needle driver 514. In other examples, when a sufficient pulling force is applied to the suture needle 512, the suture needle 512 is released from retaining member 548.
  • the endoscopic suturing device 201 includes a suture mechanism 312 disposed substantially coaxially with the needle receiver 234 about a first longitudinal axis 322.
  • the alignment guide 226 may include the shoulder 328 engaging an inner surface of the working channel 214a.
  • the suture mechanism 312 includes components that are axially movable along the first longitudinal axis 322 relative to the endoscope 202, the housing 204, and the needle receiver 234.
  • the first longitudinal axis 322 is parallel to the longitudinal axis 206 of the distal end 202a of the endoscope 202.
  • FIG. 5A illustrates a cross-sectional view of the suture mechanism 312.
  • the suture mechanism 312 generally includes a suture actuation mechanism 502 and a cinch 504.
  • the cinch 504 may include any of a variety of fixation devices that may be deposited in an anatomy and may be formed of metal, plastic, ceramic, or another biocompatible material.
  • the suture strand is passed through the cinch 504.
  • the cinch 504 allows the suture strand to slide through the cinch 504 and tensioning of the suture strand as the cinch 504 is forced against tissue.
  • the cinch 504 can then be locked onto the suture strand via actuation of a cinch locking actuator 342 (while the tension is applied to the suture strand) such that the suture strand no longer allows the suture strand to slide through the cinch.
  • the cinching may prevent a suture end from passing back through the tissue. This allows the locked cinch to maintain compression in the tissue and tension in the suture strand extending through the tissue.
  • the suture actuation mechanism 502 and the cinch 504 are arranged coaxially about a longitudinal axis 508.
  • the suture actuation mechanism 502 and the cinch 504 are not disposed coaxially, but may be slightly off- centered or adjacent.
  • the linear endosuturing system 200 has at least three linear degrees of freedom for controlling the suture needle 512 and the cinch 504. The structure of each degree of freedom is described in connection with FIGS. 3 and 5A-B and operation of the three degrees of freedom are described in greater detail in connection with FIGS. 8-18. Each degree of freedom corresponds to the movement of components of the linear endosuturing system 200 as can be controlled by the operator O such as through the operator input system 106 and/or the manipulator assembly 102 of FIG. 1.
  • the suture actuation mechanism 502 includes the suture needle 512, a needle driver 514 to push the suture needle 512, a needle collet 516 to engage a proximal end of the suture needle 512, and a ribbon 518 for retracting the needle collet 516.
  • the needle driver 514 and ribbon 518 extend proximally along the length of the endoscope 202 back to the proximal end of the endoscope 202 (e.g., proximal end 137 of the medical instrument system 120).
  • the needle driver 514 may be advanced distally to extend the needle 512 during a needle extension step during a suturing procedure, and the ribbon 518 can be retracted to pull the needle collet 516 and retract the needle 512 during a retraction step of a suturing procedure, for example.
  • forces may be applied to the needle driver 514 and/or ribbon 518 via a controller (e.g., controller 112 of FIG. 1A).
  • forces may be applied to the needle driver 514 and/or ribbon 518 manually by an operator or practitioner at the proximal end of the endoscope 202.
  • the suture needle 512 is nested within the cinch 504 (e.g., concentrically arranged) and the needle collet 516 is nested within the needle driver 514 (e.g., concentrically arranged).
  • the suture needle 512 includes a distal end 520a, a proximal end 520b, and a generally linear suture needle body 521.
  • the suture needle 512 includes a distal needle tip 522 disposed on the distal end 520a.
  • the suture needle 512 further includes a suture channel 524 passing through the needle body 521 with a suture termination member 526 disposed adjacent the needle tip 522.
  • the suture channel 524 and the suture termination member 526 are configured to secure a suture strand (not shown) to the suture needle 512 during use with the endosuturing system 200. As shown in FIG.
  • the suture termination member 526 is angled relative to the suture channel 524 to secure the suture strand to the suture needle 512 and may be in the form of a slot configured to retain and hold suture strand.
  • the suture termination member 526 can include any other mechanical structure to secure the suture strand to the needle 512. As a result, the suture strand will not separate from the suture needle 512 when passing through tissue or when used as a suture anchor.
  • the suture channel 524 includes an opening 528 disposed at approximately a midpoint along the suture needle body 521. Additionally, the suture channel 524 is disposed at an angle relative to the longitudinal axis 508 to facilitate a smooth coupling of the suture strand to the suture needle 512. In various embodiments, the suture channel 524 may have other configurations, orientations, and/or may be located at other portions of the needle.
  • the suture needle 512 includes an annular shoulder 532 and an annular notch 534 near its proximal end 520b.
  • the annular shoulder 532 and the annular notch 534 fully circumscribe the suture needle 512, but in other examples, the annular shoulder 532 and the annular notch 534 can include one or more portions discretely disposed about the suture needle 512 (e.g., separate protrusions and/or notches).
  • the annular shoulder 532 is configured to be engaged by the needle driver 514, as depicted in FIG. 5A. So configured, the needle driver 514 can provide a pushing force on the suture needle 512.
  • the needle collet 516 is configured to couple with the annular notch 534 of the suture needle 512 to transfer a pulling force, in a direction opposite to the pushing force, on the suture needle 512.
  • the system can push and pull the suture needle 512 along the longitudinal axis 508 via the needle driver 514 and/or needle collet 516. That is, a medical professional (e.g., operator O) may manually control the needle driver 514 and/or the needle collet directly by manipulating the needle driver 514 or the ribbon 518 by hand.
  • the system may control the needle driver 514 or the ribbon 518 under computer control via a controller (e.g., controller 112 of FIG. 1A) or other system, such as by an operator O operating a user input system (e.g., user input system 106 of FIG. 1A).
  • a controller e.g., controller 112 of FIG. 1A
  • other system such as by an operator O operating a user input system (e.g., user input system 106 of FIG. 1A).
  • the needle driver 514 includes a cylindrical tube that is sufficiently rigid to apply pushing forces to the suture needle 512 to force the suture needle 512 through tissue.
  • the cylindrical tube may be made of a metal, a polymer, a natural material, or other biocompatible material.
  • the needle collet 516 is sufficiently rigid to control the suture needle 512 during operation and may be made of a metal, a polymer, a natural material, or other biocompatible material.
  • the needle collet 516 is a selective latching mechanism.
  • the needle collet 516 includes biased collet arms 542 for engaging the notch 534 of the needle 512.
  • the needle collet 516 is movable between an open configuration where the collet arms 542 are splayed a first distance away from each other for releasing the suture needle 512, and a closed configuration where the collet arms 542 are disposed a second distance away from each other, the second distance being less than the first distance. Movement of the needle collet 516 by actuating the ribbon 518 is the first degree of freedom of the linear endosuturing system 200. As shown in FIG.
  • the collet arms 542 are disposed in the closed configuration because the needle collet 516 is restrained within the cylindrical tube of the needle driver 514. So configured, the needle driver 514 prevents the collet arms 542 from biasing outwards toward the open configuration away from each other and the longitudinal axis 508. Alternatively, when the needle collet 516 is not disposed within the needle driver 514, the collet arms 542 are biased toward the open configuration, away from each other and the longitudinal axis 508. In the open configuration, the collet arms 542 do not engage the notch 534 and are unable to transfer a pulling force between the suture needle 512 and the ribbon 518. But in various examples, the needle collet 516 can be differently actuated between a closed configuration configured to control the suture needle 512 and an open configuration configured to disengage from the suture needle 512.
  • the cinch 504 is linearly moveable along the longitudinal axis 508.
  • the cinch 504 includes an outer cinch member 552 and an inner cinch member 554 nested within the outer cinch member 552 (e.g., concentrically arranged).
  • the inner cinch member 554 is selectively movable relative to the outer cinch member 552 to provide a first suture lock 722 and a second suture lock 724, as will be described further below relative to FIG. 7.
  • Each of the outer and inner cinch members 552, 554 includes a hollow, generally-cylindrical structure.
  • the outer cinch member 552 includes a proximal end 552a, a distal end 552b, and a wedge-shaped inner surface 562 having a frustoconical shape converging in a direction from the proximal end 552a toward the distal end 552b.
  • the wedge-shaped inner surface 562 may be angled between approximately 1 degree (°) and approximately 10°.
  • the inner cinch member 554 includes a proximal end 554a, a distal end 554b, and a wedge-shaped outer surface 564 having a frustoconical shape converging in a direction from the proximal end 554a toward the distal end 554b.
  • the wedge- shaped outer surface 564 may be angled between approximately 1° and approximately 10°.
  • the wedge-shaped inner surface 562 of the outer cinch member 552 is complementary to the wedge-shaped outer surface 564 of the inner cinch member 554 to form the suture locks.
  • the wedge-shaped inner surface 562 and the wedge-shaped outer surface 564 are complementary because the wedge-shaped inner and outer surfaces 562, 564 are disposed at the same angle or approximately (e.g., within approximately ten degrees 10°) the same angle relative to a longitudinal axis extending between the proximal ends 552a, 554a and the distal ends 552b, 554b of the outer and inner cinch members 552, 554.
  • the outer surface 564 of the wedge-shaped inner cinch member 554 engages and is pushed against the wedge-shaped inner surface 562 of the outer cinch member 552.
  • This engagement of the wedge-shaped inner and outer surfaces 562, 564 provides the first suture lock 722, where a suture strand 720 can be pinched and secured between the wedge-shaped inner and outer surfaces 562, 564. Because the wedge-shaped inner and outer surfaces 562, 564 or similar angles, the suture strand 720 is gradually pinched between the wedge-shaped inner and outer surfaces 562, 564 and the friction on the suture strand 720 is greater than the friction angle for the suture strand 720.
  • the cinch 504 may optionally include a plurality of suture locking structures.
  • the proximal end 552a of the outer cinch member 552 can include a recessed channel 566 and the proximal end 554a of the inner cinch member 554 can include shoulders 568 to form the second suture lock 724.
  • the suture strand 720 passing between the cinch members 552, 554 can be further pinched between the shoulders 568 and the recessed channel 566 to further lock the suture strand 720.
  • the second suture lock 724 also includes a cutting surface 569 disposed on the inner cinch member 554.
  • the cutting surface 569 is configured to cut the suture strand 720 against a proximal end of the outer cinch member 552 when the inner cinch member 554 and outer cinch member 552 form the second suture lock 724.
  • the cutting surface 569 can include any structure configured to laterally cut a suture strand 720 such as a sharpened edge.
  • the cutting surface 569 can also assist in locking the suture strand 720 when the cinch is in a locked configuration (the locked configuration is described further below). Additionally or alternatively, the cutting surface 569 may be disposed on the outer cinch member 552.
  • the cutting edge 569 is configured to engage the outer cinch 552 and, in some examples, the cutting edge 569 secures the suture strand between the cutting edge 569 and the outer cinch member 552.
  • the cutting edge 569’ is similar to the cutting edge 569 shown in FIG. 5A, but the cutting edge 569’ is disposed closer to and/or on the proximal end 554a of the inner cinch member 554.
  • the cinch 504 includes a cinch locking actuator 342 (shown in FIG. 3) and a cinch driver 558 configured to control movement of the cinch 504. Movement of the cinch locking actuator 342 corresponds to the second degree of freedom.
  • the cinch locking actuator 342 is configured to control movement of the needle driver 514 and the inner cinch member 554. Movement of the cinch driver 558 corresponds to the third degree of freedom.
  • the cinch driver 558 controls movement of the outer cinch member 552. The operation of the cinch locking actuator 342 and the cinch driver 558 are described in connection with FIGS. 5A, 5B, and 6. As shown in FIG.
  • the cinch driver 558 includes tabs 612 disposed in tab channels 614 of the outer cinch member 552.
  • the tabs 612 are biased inwardly and abut against the inner cinch member 554 in the position depicted in FIGS. 5A, 5B, and 6. So configured, the tabs 612 reside in the tab channels 614 of the outer cinch member 552, and provide a coupling which allows the cinch driver 558 to hold, push, or pull the outer cinch member 554 along the longitudinal axis 508.
  • the cinch locking actuator 342 includes a cylindrical shoulder 344 that can move distally and bear against the proximal end 554a of the inner cinch member 554.
  • Movement of the cinch locking actuator 342 can move the inner cinch member 554 distally relative to the outer cinch member 552 to form the first and second suture locks 722, 724 described above.
  • the tabs 612 are free to bias inward out of the tab channels 614 and into a cavity 702 of the outer cinch member 554 (shown in FIG. 7). With the tabs 612 inwardly disposed, the tabs 612 do not engage the tab channels 614.
  • the cinch driver 558 can still exert a pushing force on a shoulder 704 disposed at the proximal end 554a of the inner cinch member 554.
  • the tabs 612 can still move the cinch 504 in the distal direction. But, because the inwardly disposed tabs 612 do not engage the tab channels 614, the cinch driver 558 may not be configured to pull the cinch 504.
  • FIG. 5B illustrates an alternative cinch driver 558’.
  • the cinch driver 558 of FIG. 5A includes a shoulder 559 configured to receive the proximal end 554a of the inner cinch 554.
  • the shoulder 559 provides more control over the inner cinch 554 during actuation of the cinch locking actuator 342 and the cinch driver 558.
  • the cinch driver 558’ does not include the shoulder 559.
  • the cinch 504 comprising the inner cinch member 554 and the outer cinch member 552 are more easily released from the endoscope 202.
  • the inner cinch member 554 further includes a locking wedge 712 at its proximal end 554a. So configured, when the cinch 504 is in the locked configuration, the locking wedge 712 engages a shoulder 714 of an aperture 716 in the outer cinch member 552. As a result, the outer and inner cinch members 552, 554 can be locked to each other in the locking configuration when the locking wedge 712 is disposed within the aperture 716.
  • FIG. 8 illustrates an endosuturing system 800 including an endoscope 802 and an endoscopic suturing device 801 similar to the endosuturing system 100 described above, but for the manner in which the endoscopic suturing device 801 secures to the endoscope 802. That is, the endoscopic suturing device 801 includes a housing 804, similar to the housing 204, but secured with a screw and collet securement mechanism 808 instead of by friction.
  • a first step in a suturing procedure as shown in FIG.
  • the endosuturing system 800 is disposed adjacent a portion of tissue 805 having a first tissue surface 852.
  • the tissue 805 can be a portion of stomach lining, esophagus, intestine, colon, etc.
  • the tissue may include a first tissue surface 852 and an opposite second tissue surface 854 and one or more tissue layers between the first tissue surface 852 and the second tissue surface 854.
  • the first tissue surface 852 may be an inner surface of the tissue 805 and the second tissue surface 854 may be an outer surface of the tissue 805.
  • the layers may include a mucosal layer (inner lining of the stomach), a submucosal layer, a muscularis layer, and a serosal layer (outermost layer).
  • the first tissue layer 852 may be the mucosal layer and the second tissue surface 854 may be the serosal layer.
  • the tissue 805 was identified by a medical practitioner as a starting point for a plication line. As shown in FIG. 8, the endosuturing system 800 is angled relative to the tissue 805 such that the needle receiver 834 is disposed adjacent the tissue surface 852 and the helical tissue grabber 814 is disposed approximately perpendicular to the tissue 805.
  • the endosuturing system 800 may be parallel to the tissue 805 or may be disposed at any other angle relative to the tissue 805.
  • the helical tissue grabber 814 is pushed toward and rotated to be inserted through the tissue surface 852 of the tissue 805 in accordance with the linear and rotational degrees of freedom for the helical tissue grabber 814.
  • the helical tissue grabber 814 pierces and engages the tissue 805.
  • the helical tissue grabber 814 pierces the tissue surface 852 and obtains a sufficient bite of the tissue 805 to allow retraction of a full thickness of the tissue.
  • the tissue grabber 814 may allow for retraction of all of the layers of the stomach such that when plicated or folded, the serosa of one portion of the folded tissue 805 is in contact with the serosa of a second portion of the folded tissue 805.
  • the helical tissue grabber 814 is retracted and the tissue 805 is drawn up between the endoscope 802 and the needle receiver 834.
  • the tissue 805 is folded to have a first folded portion 1002 and a second folded portion 1004.
  • the second folded portion 1004 is disposed adjacent to and pressed against the needle receiver 834.
  • the cinch locking actuator 342 pushes the needle driver 1102 which pushes the suture needle 1104 and suture strand 1106 through the tissue 805 in accordance with the second degree of freedom.
  • the suture strand 1106 is threaded through the suture needle 1104 (as described in connection with FIG. 5A) and through the cinch 1722 (shown in FIGS. 17-19).
  • the suture needle 1104 is configured to pass from the first tissue surface 852 of the first folded portion 1002 through the second tissue surface 854 of the first folded portion 1002 and then through the second tissue surface 854 of the second folded portion 1004 through the first tissue surface 852 of the second folded portion 1004.
  • the suture strand is partially disposed outside the tissue 805 (i.e., partially residing outside of the second tissue surface 854).
  • the tissue 805 is partially secured by the lip 242 of the needle receiver 834.
  • tissue 805 is drawn up by the tissue grabber 814 and the suture needle 1104 is passed through the tissue 805, the force applied by the needle 1104 presses the tissue 805 against the lip 242.
  • the tissue 805, pressed against the lip 242 and disposed over an aperture 844, is partially inhibited from stretching, and is thereby easier to puncture with the suture needle 1104.
  • the lip 242 creates a counter-traction to the needle 1104 so that the tissue 805 is not pulled into the needle receiver 834 along with the needle 1104.
  • the aperture 844 defines a conical space configured to receive a suture needle (e.g., suture needle 512).
  • the conical inner surface 445 guides the insertion of the suture needle 512 in the distal needle receiver 834.
  • the suture needle 1104 punctures a portion of tissue 805 disposed over the aperture 444, and only the portion of tissue 805 disposed over the aperture 444 is able to flex. Because only the small portion of tissue 805 is able to flex, the suture needle 1104 can more readily puncture through the portion of tissue 805. As a result, the lip 242 facilitates the suture needle 1104 passing through the tissue 805 and into the needle receiver 434. After the suture needle 1104 passes through the second folded portion 1004 of the tissue 805, the suture needle 1104 is received within the needle receiver 834.
  • the suture needle 1104 is actuated in response to operation of a manipulator assembly (e.g., manipulator assembly 102 of FIG. 1A).
  • the suture needle 1104 is extended forward via a torque controlled actuation system.
  • the manipulator assembly may be able to control the suture needle 1104 with position control.
  • the manipulator assembly can determine the location of the suture needle 1104 relative to the needle receiver 834 and/or the endoscope 802.
  • the suture needle 1104 is released from the collet 1612 and the needle driver 1102 while the suture needle 1104 is engaged with the needle receiver 834.
  • the suture needle 1104 is retained in the needle receiver 834, even after the needle driver 1102 and collet 516 are each retracted back into the endoscope 802 in accordance with the first and second degrees of freedom.
  • the suture strand 1106 still extends between the suture needle 1104 disposed in the needle receiver 834 and the endoscope 802 and through the tissue 805.
  • the suture strand may extend through the entire thickness of the tissue 805.
  • the needle receiver 834 may include a locking mechanism 1232 (e.g., the releasable needle tip locking mechanism 332, 433 of FIGS. 3 and 4).
  • a locking mechanism 1232 e.g., the releasable needle tip locking mechanism 332, 433 of FIGS. 3 and 4.
  • the needle driver 1102 can be retracted exposing the shoulder 532 of the suture needle 1104.
  • the needle tip locking mechanism 1232 is an elastically deformable latch (as shown in FIG. 3) and the latch resists movement of the suture needle 1104 in a proximal direction.
  • the needle tip locking mechanism 1232 can comprise one or more deformable wires (as shown in FIG.
  • the needle driver 1102 can be fully retracted while the suture needle 1104 is retained in the needle receiver 834. Additionally, the suture strand 1106 is disposed out of and into the tissue 805, forming a plication. The tissue grabber 814 can then release the tissue 805.
  • FIG. 14 shows the needle driver 1102 and the needle collet 1612 (e.g., needle collet 516 described in connection with FIG. 5A) after having been actuated to release the suture needle 1104 from the needle receiver 834.
  • the needle collet 1612 (shown in FIG. 16) is moved along the first degree of freedom and brought into contact with a proximal end of the suture needle 1104 while the suture needle 1104 remains engaged with the needle receiver 834. Then the cinch locking actuator 342 and the needle driver 1102 are extended along the second degree of freedom into at least a portion of the needle receiver 834.
  • the needle collet arms 1614 are configured to engage a notch (e.g., notch 534 described in connection with FIG. 5A) of the suture needle 1104. Additionally, the needle driver 1102 causes the needle tip locking mechanism 1232 (e.g., needle tip locking mechanism 332, 433) to disengage from the shoulder (e.g., shoulder 532 shown in FIG. 5A) of the suture needle 1104. As a result, the needle tip locking mechanism 1232 is no longer configured to restrain the suture needle 1104 in the needle receiver 834 and the needle collet 1612 can be pull the suture needle 1104 and the needle driver 1102 along the first degree of freedom and away from the needle receiver 834. As shown in FIG.
  • the suture needle 1104 and the needle driver 1102 may be fully retracted and nested within the endoscope 802, while in other embodiments, a portion of the suture needle 1104 and/or the needle driver 1102 may extend from the endoscope 802 following retraction of the components.
  • the endosuturing system 800 can be moved to another position against the tissue 805.
  • the process shown in FIGS. 8-13 can be repeated as necessary to form a complete plication line.
  • the process shown in FIGS. 8-13 can be repeated twice (as shown in FIGS. 16-18) or three or more times (as shown in FIG. 19), as may be necessary for any given procedure.
  • the suture needle 1104 is optionally configured to be decoupled from the endosuturing system 800 to act as a first anchor of the suture strand.
  • An anchor is a stopping mechanism attached to a suture strand that prevents the end of the suture strand from passing through the tissue, thus creating a reaction force between the suture strand and the tissue.
  • the anchor may be the needle 1104, but in other embodiments, the anchor may include any of a variety of fixation devices that may be deposited in an anatomy and may be formed of metal, plastic, ceramic, or another biocompatible material.
  • the first stitch 1602a and the second stitch 1602b form a complete plication line.
  • a complete plication line may include a different number of stitches, such as one, two, three, four, five, six, or more stitches. The stitches may be created in a variety of patterns by moving the endosuturing system 800 to desired locations and driving the needle driver 1102 to created the desired stitches.
  • the needle driver 1102 pushes the suture needle 1104 outside the endoscope 802 along the first and second degrees of freedom and then the needle driver 1102 is retracted along the second degree of freedom while the needle collet 1612 is not moved along the first degree of freedom.
  • the needle driver 1102 is retracted, the needle collet 1612 releases the suture needle 1104.
  • the needle collet arms 1614 are biased to open when not constrained by the needle driver 1102. As a result, when the needle driver 1102 is retracted the needle collet arms 1614 release the suture needle 1104.
  • the suture strand 1106 is tensioned 1712 and the cinch 1722 locks the suture strand 1106 in a tensioned configuration (as shown in FIG. 19).
  • the suture strand 1106 is tensioned by a medical professional operating the endosuturing system 800.
  • the suture strand 1106 may be auto-tensioned by a machine or other mechanical device or system.
  • the cinch locking actuator 342 moves the inner cinch member 1726 along the second degree of freedom toward the outer cinch member 1724 to lock the cinch 1722 and prevent the suture strand 1106 from loosening.
  • the cinch 1722 is then pushed along the third degree of freedom by the cinch driver (e.g., cinch driver 558 of FIG. 5A and 5B). As a result, the cinch 1722 forms a second anchor, opposite the suture needle 1104.
  • a medical professional may need to cut the suture strand 1106 but in other examples, the cinch 1722 cuts the suture strand 1106 by pressing the suture strand 1106 between the cutting surface (e.g., cutting surface 569) against an edge of the outer cinch member 552, or against another cutting edge of the system. As a result, the cinch 1722 locks and cuts the suture strand 1106 at the same time.
  • the cinch 1722 is pushed along the third degree of freedom and released from the endosuturing system 800.
  • a cinch locking actuator (similar to cinch locking actuator 342 described above) is moved distally to cause the outer cinch member 1724 and tabs 1802 (similar to tabs 612 described above) to be disposed distal of the endoscope 802.
  • the cinch driver tabs 1802 disengage from the outer cinch member 1724 (as discussed in connection with FIGS. 6 and 7) and disengage from the endoscope 802.
  • FIG. 19 illustrates a properly tensioned plication line in which the suture needle 1104 is an anchor and the cinch 1722 is the cinch for the suture strand.
  • the suture strand 1106 is tensioned and passes through the tissue 805 and the cinch 1722 prevents the suture strand from loosening.
  • the opening 528 in the suture needle body 521 is disposed at approximately a midpoint of the suture needle body 521 (as shown in FIG. 5A), when the suture needle 512 is left in the body as an anchor, the tension from the suture strand will be approximately evenly distributed on the suture body 521.
  • the cinch 504 When the cinch 504 is in the locking configuration, as shown in FIG. 7, the cinch 504 is configured to operate as a tensioning device and prevents the suture strand from releasing from the tissue.
  • the suture strand in the locking configuration, is locked between the outer cinch member 552 and the inner cinch member 554.
  • the outer cinch member 552 includes a suture channel 622 including a suture guide 624 (shown in FIG. 6).
  • the suture strand When the cinch 504 is disposed against the tissue, the suture strand may optionally be disposed near a midpoint of the cinch 504 and the pressure exerted on the tissue by the cinch 504 is distributed along the length of the cinch 504. In various embodiments, the suture strand may be disposed at different portions relative to a body of the cinch 504.
  • FIGS. 20-24H depict a linear endosuturing device 2000 and operation of the linear endosuturing device 2000 according to some embodiments.
  • the linear endosuturing device 2000 includes a drive guide 2300 configured to guide operation of a suture mechanism 2012 (similar to suture mechanism 312).
  • the endosuturing device 2000 includes a housing 2004 with an alignment guide 2026 similar to alignment guide 226, but extending further distally than the alignment guide 226 described above.
  • the drive guide 2300 and alignment guide 2026 are configured to aid with alignment during retraction of a suture needle 2012 when the needle 2012 is coupled to a distal needle receiver 2034.
  • the needle receiver 2034 may be an example of the receivers 234, 434, 443, 456.
  • the drive guide 2300 is positioned to engage an inner surface of the alignment guide 2026. As shown in FIGS. 23A-23B, the drive guide 2300 includes a plurality of ribs 2306. In some examples, the ribs 2603 center the drive guide 2300 in the alignment guide 2026. Because the drive guide 2300 remains axially aligned with the alignment guide, and because the alignment guide 2026 is axially aligned with the distal needle receiver 2034, the drive guide
  • the drive guide 2300 is axially aligned with the distal needle receiver 2034.
  • the drive guide 2300 includes a conical proximal face 2308 configured to engage a needle receiver (e.g., needle receiver 2034) and align a needle driver (e.g., needle driver 2414 described in connection with FIGS. 24D-24H) with a suture needle (e.g., suture needle 2412 shown in FIG. 24F) disposed in the needle receiver 2034.
  • a needle driver e.g., needle driver 2414 described in connection with FIGS. 24D-24H
  • a suture needle e.g., suture needle 2412 shown in FIG. 24F
  • the drive guide 2300 may include a central passageway through which a cinch (e.g., cinch 504) may pass through.
  • the central passageway of the drive guide 2300 is sized such that a needle 2012, a needle driver 2414, and the cinch are able to pass through the drive guide 2300 during various steps of the suturing process described further below.
  • the drive guide 2300 may include or be coupled to a proximally extending tubular actuation member 2301 and the actuation member
  • the drive guide 2300 may be actuated along a fourth degree of freedom to axially move the drive guide 2300. Additionally and/or alternatively, the drive guide 2300 may be removably coupled to the outer cinch (e.g., outer cinch 552).
  • FIGS. 23A-23B depict perspective views of the drive guide 2300.
  • the drive guide 2300 includes a substantially tubular body 2302 with a slot or recess 2304 extending along one end portion for accommodating a suture strand when the suture needle 2012 extends through the tubular body 2302.
  • the drive guide 2300 further includes a plurality of ribs 2306 circumferentially spaced around the tubular body 2302 to align the drive guide 2300 and suture mechanism 2012 within the channel of the endoscope and within the alignment guide 2026.
  • the drive guide 2300 aligns a longitudinal axis or axial movement of the suture mechanism 2012 (e.g., suture needle 2012 and the needle driver 2414) along the longitudinal axis when extended out past the alignment guide 2026 with a longitudinal axis of the needle receiver 2034 for retraction of the suture needle 2012.
  • the ribs 2306 include tapered ends to allow the drive guide 2300 to navigate through tortuous anatomy. Additionally, the ribs 2306 provide a space between the drive guide 2300 and the channel of the endoscope to permit the suture strand to pass outside the drive guide 2300.
  • FIGS. 24A-24H depict views of the endosuturing device 2000 in operation.
  • the suture mechanism 2012 and tissue grabber 2314 are in substantially retracted positions with the endoscope positioned near target anatomy for suturing.
  • the tissue grabber 2314 is extended and/or rotated to engage tissue 2402.
  • the tissue grabber 2314 may be rotated in a first direction to engage with the tissue 2402.
  • the tissue grabber 2314 is retracted to place the tissue 2402 into an orientation sufficient for the suture needle 2012 to penetrate the tissue when the suture mechanism 2012 is advanced.
  • the tissue 2402 is pulled against the alignment guide 2026.
  • the tissue 2402 may be placed in a folded configuration via the tissue grabber 2314 to allow for a full thickness bite of the tissue 2402 during suturing.
  • the tissue 2402 is folded to have a first folded portion 2404 and a second folded portion 2405.
  • the first folded portion 2404 is disposed adjacent to and pressed against the alignment guide 2026.
  • the suture mechanism 2012 including the suture needle 2412 and needle driver 2414, is advanced to extend the suture needle 2012 through the tissue and into engagement with the receiver 2034.
  • Passing the suture needle 2012 through the tissue 2402 includes actuating a needle driver 2414 along the second degree of freedom (similar to the second degree of freedom of the linear endosuturing system 200 of FIG. 2)
  • the drive guide 2300 may optionally be partially extended distally, for example, via actuation along the fourth degree of freedom.
  • the drive guide 2300 may be pressed against the tissue 2402 to provide a force against the tissue and facilitate puncturing of the suture needle 2316 through the tissue 2402.
  • the drive guide 2300 is not advanced and/or does not contact the tissue 2402 before or during tissue 2402 puncturing. As shown in FIG. 24E, the drive guide 2300 remains proximal to the folded tissue 2402 such that only the suture needle 2316, suture 2318, and the needle driver 2414 pass through the tissue 2402 when the tissue 2402 is punctured by the suture needle 2316.
  • the opening created by the suture needle 2316 is of a diameter less than the drive guide 2300 such that the drive guide 2300 remains proximal to the pierced tissue 2402.
  • the needle driver 2414 is disengaged with the suture needle 2012 while the suture needle 2316 remains engaged with the needle receiver 2034 (similarly as described above with respect to receivers 234, 434, 443, 456).
  • the tissue grabber 2314 is released from the tissue 2402.
  • the tissue grabber 2314 may be rotated in a second direction opposite to the first direction used to engage the tissue by the tissue grabber 2314 to release the tissue from the tissue grabber 2314.
  • the drive guide 2300 may be extended to provide a guide path for the needle driver 2414 to extend and engage the proximal end of the suture needle 2012.
  • the conical face 2308 of the drive guide 2300 engages the distal needle receiver 2034 and aligns the needle driver 2414 with the distal needle receiver 2034 along a common longitudinal axis 2422. With the needle driver 2414 aligned with the needle receiver 2034 by the drive guide 2300, the needle driver 2414 is extended.
  • a needle collet (not shown) engages the suture needle 2412 and the needle driver 2414 causes the needle collet to snap into engagement with the suture needle 2412.
  • the drive guide 2300 has a conical inner surface to guide the needle collet into engagement with the suture needle 2412.
  • the needle driver 2414 is extended to lock the needle collet onto the suture needle 2412, similar to the operation of the needle collet 542 as described in connection with FIG. 5A.
  • the entire suture mechanism 2012 and suture needle 2412 are retracted with the stitch 2432 having been completed.
  • the suturing process may be repeated in a number of locations and an anchor and a cinch applied to the suture strand 2418 to compress the plication as described above in connection with FIG. 19. Multiple plications may be performed in different regions as desired.
  • the endoscopic suturing device provides a linear drive needle and provides many benefits over typical endoscopic suturing systems.
  • the endoscopic suturing device is configured to be fixed to the distal end of the endoscope and can include a suture needle that is actuated linearly, and in some versions, parallel to a central axis of the distal end of the endoscope.
  • the endoscopic suturing device can also include an off-axis tissue grabber and a cinch mechanism disposed coaxially about the suture needle.
  • the off-axis tissue grabber pulls tissue between a suture needle receiver and both the endoscope and coaxial suture needle.
  • the tissue grabber is configured to selectively engage at least an inside surface of a tissue having the inside surface and an outside surface.
  • the tissue held by the tissue grabber between the endoscope and the needle receiver, is folded having a first half and a second half.
  • the tissue grabber is a helical tissue grabber.
  • the suture needle can pass through tissue. Because the tissue is folded, the suture needle passes from the inside surface to the outside surface of the first half and from the outside surface to the inside surface of the second half before being received in the needle receiver. As a result, a suture strand coupled to the suture needle passes from inside the tissue to outside the tissue, and back inside the tissue.
  • the needle receiver is disposed forwardly (or distally) of the endoscope and axially aligned with a working channel of the endoscope.
  • the needle receiver is configured to selectively secure the suture needle while a needle driver is retracted and the tissue is released. After the tissue is released, the needle driver can be actuated to release the suture needle and the endosuturing device moved to a new location to advance a plication line.
  • the cinch mechanism includes an inner cinch member and an outer cinch member that are movable relative to one another to lock a suture strand therebetween.
  • the outer cinch member and the inner cinch member have differently angled surfaces that, when the outer and the inner cinch member are driven together, press the suture strand between the outer surface of the inner cinch member and the inner surface of the outer cinch.
  • the cinch may include a channel and locking shoulder.
  • the inner cinch member may include a cutting surface to cut the suture strand when the inner cinch member is brought into the outer cinch.
  • the inner cinch member and the outer cinch member further include a locking mechanism to secure inner cinch member to the outer cinch member.
  • one or both of the cinch members may include a cutting surface that slices the suture strand between the inner cinch member and the outer cinch member. Once the cinch is locked, the cinch is released to form a second anchor opposite the needle.
  • FIG. 25 illustrates a linear endosuturing system 2500 made in accordance with the present disclosure. Similar to the linear endosuturing system 200 of FIG. 2, the endosuturing system 2500 includes an endoscope 2502 and an endoscopic suturing device 2501 fixed to a distal end 2502a of the endoscope 2502. The distal end 2502a of the endoscope 2502 defines a longitudinal axis 2506.
  • the endoscopic suturing device 2501 includes a housing 2504 releasably coupled to the endoscope 2502 via a coupling mechanism 2508. As shown in FIG. 25, the coupling mechanism 2508 includes a channel in the housing 2504.
  • the channel of the coupling mechanism 2508 is configured to allow the housing 2504 to flex and secure the housing 2504 to the endoscope 2502 via friction.
  • the housing 2504 may be releasably secured to the endoscope 2502 with any other coupling mechanism.
  • the endoscopic suturing device 2501 may be permanently attached to or otherwise integrated into the endoscope 2502.
  • the endoscope 2502 is substantially similar to the endoscope 202, including a distal face 2510 having a plurality of working channels 2512 that can receive an imaging system, light source, or other tool (similar to the endoscope 202 described in connection with FIG. 2). At least the working channel 2512a of the endoscope 2502 is configured to receive a tissue grabber 2516.
  • the tissue grabber 2516 is configured to move parallel to the longitudinal axis 2506 as well as rotate about a longitudinal axis 2517 of the tissue grabber 2516 parallel to the longitudinal axis 2506 of the endoscope 2502.
  • the housing 2504 of the endoscopic suturing device 2501 further includes an arm 2530 including a proximal end 2532a coupled to the housing 2504 and a distal end 2532b spaced distally from the housing 2504.
  • the arm 2530 can be integrally formed or removably coupled with the housing 2504. So configured, the arm 2530 is cantilevered distally from the housing 2504.
  • the distal end 2532b of the arm 2530 carries a needle receiver 2534.
  • the needle receiver 2534 is co-axially aligned with a cylindrical opening 2524 in an alignment guide 2526 of the housing 2504.
  • the arm 2530 may be configured in any manner to distally extend from the housing 2504 and axially align the needle receiver 2534 with cylindrical opening 2524.
  • FIG. 26 is a close-up view of the cylindrical opening 2524 of the alignment guide 2526.
  • the cylindrical opening 2524 is configured and sized to pass a suture mechanism 2610.
  • the suture mechanism 2610 is similar to the suture mechanism 312 of FIG. 3 and the suture mechanism 2012 of FIG. 20, but includes an alternative outer cinch member 2614.
  • the suture mechanism 2610 includes a linear suture needle 2615 and a suture strand 2616 similar to the suture needle 512 and suture strand 720 described above.
  • the suture mechanism 2610 includes a needle collet, needle driver, cinch driver, and cinch (not shown) that are similar in structure and function to the components of the suture mechanisms 312, 2012 described above, for example.
  • the cylindrical opening 2524 is configured to maintain a linear alignment of the suture mechanism 2610 relative to the needle receiver 2534.
  • the cylindrical opening 2524 includes ribs 2622 defining channels 2624 between adjacent ribs 2622. In the present embodiment, there are three ribs 2622, however a different number of ribs 2622 may be provided, including one rib, two ribs, or three or more ribs.
  • the ribs 2622 may engage an outer surface 2632 of the outer cinch member 2614 or may be positioned in close proximity to the outer surface 2632.
  • the outer cinch member 2614 is constrained radially by the ribs 2622 and the outer cinch member 2614 is limited in moving radially relative to the cylindrical opening 2524.
  • the outer cinch member 2614 includes radially extending rails 2634 disposed in the channels 2624. The rails 2634 further limit radial movement of the outer cinch member 2614 relative to the cylindrical opening 2524.
  • the ribs 2622, the channels 2624, the outer surface 2632, and the rails 2634 are each made of low-friction materials to facilitate linear actuation, but have minimal tolerances to reduce radial movement of the suture mechanism 2610 relative to the cylindrical opening 2524. As a result, as the suture mechanism 2610 is extended from the cylindrical opening 2524, the engagement of the suture mechanism 2610, the ribs 2622, and the rails 2634 maintain alignment of the suture needle 2615 and the needle receiver 2534.
  • FIG. 27A-27D illustrate the operation of the endosuturing system 2500.
  • the linear endosuturing system 2500 is brought into proximity to a portion of tissue 2702.
  • the linear endosuturing system 2500 is angled relative to the tissue so the tissue grabber 2516 can project from the endoscope 2502 and engage the tissue 2702.
  • the tissue grabber 2516 projects from the working channel 2512a of the endoscope 2502 as shown in FIG. 25.
  • the tissue grabber 2516 is rotated as the tissue grabber 2516 engages the tissue 2702. The rotation of the tissue grabber 2516 facilitates the helices of the tissue grabber 2516 holding the tissue 2702.
  • the tissue grabber 2516 is partially retracted into the working channel 2512a and the tissue 2702 is brought closer to the endoscope 2502.
  • the tissue 2702 is disposed adjacent to the needle receiver 2534.
  • the linear endosuturing system 2500 is pivoted such that the tissue 2702 is disposed between the cylindrical opening 2524 of the alignment guide 2526 and the needle receiver 2534.
  • the linear endosuturing system 2500 is pivoted up, away from the tissue 2702 (e.g., in a proximal direction), to facilitate a space between the arm 2530 and the tissue 2702. Then, as shown in FIG.
  • the needle receiver 2534 is pivoted such that the tissue 2702 is disposed between the cylindrical opening 2524 and the needle receiver 2534.
  • the needle receiver 2534 can be pivoted laterally such that the partially retracted tissue 2702 is disposed between needle receiver 2534 and the cylindrical opening 2524.
  • the tissue grabber 2516 can be fully retracted.
  • the needle receiver 2534 is pivoted even before a portion of the tissue 2702 is retracted.
  • the tissue grabber 2516 engages the tissue 2702 and the needle receiver 2534 is pivoted such that retraction of the tissue grabber 2516 will pull the tissue 2702 between the needle receiver 2534 and the cylindrical opening 2524.
  • the tissue 2702 is fully retracted and brought into close proximity to the distal end 2502a of the endoscope 2502, as shown in FIG. 27D.
  • the suture mechanism 2610 can be actuated to perform the suturing operation in a substantially similar manner as described above in connection with FIGS. 10-15 and 24C-24H.
  • FIG. 28 illustrates another linear endosuturing system 2800 made in accordance with the present disclosure. Similar to the linear endosuturing system 200 of FIG. 2, the endosuturing system 2800 includes an endoscope 2802 and an endoscopic suturing device
  • the endoscopic suturing device 2801 includes a housing 2804 releasably coupled to the endoscope 2802 via a coupling mechanism 2808.
  • the coupling mechanism 2808 includes a channel in the housing 2804. The channel of the coupling mechanism 2808 is configured to allow the housing 2804 to flex and secure the housing 2804 to the endoscope 2802 via friction.
  • the housing 2804 may be releasably secured to the endoscope 2802 with any other coupling mechanism.
  • the endoscopic suturing device 2801 may be permanently attached to or otherwise integrated into the endoscope 2802.
  • the endoscope 2802 is substantially similar to the endoscope 202, including a distal face 2810 having a plurality of working channels 2812 that can receive an imaging system, light source, or other tool (similar to the endoscope 202 described in connection with FIG. 2). At least the working channel 2812a is configured to receive the tissue grabber 2816.
  • the tissue grabber 2816 is configured to move parallel to the longitudinal axis 2806 as well as rotate about a longitudinal axis 2817 of the tissue grabber 2816 parallel to the longitudinal axis 2806.
  • the housing 2804 of the endoscopic suturing device 2801 further includes an arm 2830 including a proximal arm 2832a rigidly coupled to the housing 2804 and a distal arm 2832b rotatably or hingedly coupled with the proximal arm 2832a via a hinge 2832c.
  • the proximal arm 2832a can be integrally formed with the housing 2804 or coupled to the housing 2804 via another method (e.g., adhesive, welding, mechanical coupling, releasable coupling, etc.).
  • the distal arm 2832b carries a needle receiver 2834. As described in greater detail below, the distal arm 2832b is actuatable between a first position 2836a (shown in FIG.
  • the needle receiver 2834 is selectively co-axially aligned with the cylindrical opening 2824 of the housing 2804.
  • the needle receiver 2834 is co-axially aligned with the cylindrical opening 2824 when the distal arm 2832b is in the first position 2836a.
  • the needle receiver 2834 is non-co-axial with the cylindrical opening 2824 and the distal arm 2832b can be at least partially deflected away from target tissue.
  • FIGS. 29A and 29B illustrate the hinged connection between the proximal arm 2832a and the distal arm 2832b.
  • the housing 2804 includes a channel 2902 that passes through the proximal arm 2832a.
  • the channel 2902 is configured to receive an actuation element 2903.
  • the actuation element 2903 is a push-pull control member (e.g., a nitrinol control wire).
  • the push-pull control member can exert a pushing force or provide a tension force on the distal arm 2832b.
  • the actuation element 2903 could be a pull member while the distal arm 2832b is biased into one of the first position 2836a or the second position 2836b.
  • the pull member supplies a tensioning force to secure the distal arm 2832b in the first position 2836a.
  • the distal arm 2832b is biased towards the second position 2836b (e.g., which may be via a biasing member such as a spring element).
  • the distal arm 2832b could be biased to the first position 2836a, and the pull member could be arranged to provide a tensioning force that transitions the distal arm 2832b to the second position 2836b.
  • the actuation element 2903 passes through the channel 2902 and through a guide 2904 disposed on the distal arm 2832b.
  • the actuation element 2903 is then configured to pass through an aperture 2906 in the distal arm 2832b.
  • the actuation element 2903 can then be secured in the aperture 2906 or on a distal end of the aperture 2906.
  • the above push-pull or pull member can control the pivoting actuation of the distal arm 2832b about the hinge 2832c.
  • the actuation element 2903 can include two or more tension elements (e.g., pull wires) that can operate antagonistically.
  • one of the two tension elements pulls the distal arm 2832b in a first direction (e.g., towards the first position 2836a) and the second of the two tension elements pulls the distal arm 2832b in a second direction (e.g., towards the second position 2836b), opposite the first direction.
  • the arm 2830 could include a second channel to receive the second of the two tension elements and the distal arm 2832b.
  • the distal arm 2832b could be unbiased to either the first position 27836a or the second position 2836b.
  • the hinge 2832c can be replaced with another mechanical structure that moves the needle receiver 2834 in one or more alternative directions, to selectively move the needle receiver 2834 between the first position 2836a (co-axially aligned with the cylindrical opening 2824) and the second position 2836b (non-coaxially aligned with the cylindrical opening 2824).
  • the hinge 2832c or another pivot member could be oriented to rotate the distal arm 2832b in any other direction (e.g., side-to-side motion of the distal arm 2832b via a vertically oriented hinge 2832c, pivoting the distal arm 2832b around a longitudinal axis of the proximal arm 2832a).
  • the distal arm 2832b can be telescopically received within the proximal arm 2832a under a tensioning force (e.g., from a pull wire) and biased toward the second position 2836b when not under a tensioning force.
  • the arm 2830 can include a series of hinges to collapse to a shorter length when tensioned and expands when not under tension.
  • the arm 2830 includes a torque shaft, actuated by a screw, that transitions the distal arm 2832b between the first position 2836a and the second position 2836b. .
  • the distal arm 2832b includes a stop 2912 that engages the proximal arm 2832a.
  • the position of the stop 2912 and the rigidity of the distal arm 2832b causes the needle receiver 2834 to be aligned with the cylindrical opening 2824.
  • FIG. 30A-30D illustrate the operation of the linear endosuturing system 2800.
  • the linear endosuturing system 2800 is brought into proximity to a portion of tissue 3002.
  • the distal arm 2832b is transitioned to the second position 2836b.
  • the actuation element 2803 is actuated to apply a force to the distal arm 2832b to move the distal arm 2832b into the second position 2836b.
  • FIG. 30B when the distal arm 2832b is disposed in the second position 2836b, the distal end 2810 of the endoscope 2802 is brought into close proximity with the tissue 3002.
  • the endoscope 2802 is pivoted to be oriented at an angle with respect to the tissue 3002 with the distal end 2802a of the endoscope 2802 and the tissue grabber 2816 facing the tissue. Additionally, the tissue grabber 2816 is projected from the working channel 2812a of the endoscope 2802 and engages the tissue 3002.
  • the tissue grabber 2816 is retracted and the linear endosuturing system 2800 pulls the tissue 3002 towards the endoscope 2802. Because the needle receiver 2834 is angled away from the cylindrical opening 2824, the tissue 3002 is brought into contact with the cylindrical opening 2824.
  • FIG. 30D when the distal arm 2832b is returned to the first position 2836a and axially aligned with the cylindrical opening 2824, the tissue 3002 is disposed between the cylindrical opening 2824 and the needle receiver 2834. With the tissue 3002 disposed against the cylindrical opening 2823 and the needle receiver 2834 axially aligned with the cylindrical opening, the suturing mechanism 2811 can be actuated.
  • the operation of the suturing mechanism 2811 is, in various examples, substantially similar to the suturing operation described above in connection with FIGS. 10-15 and 24C-24H.
  • FIG. 31 illustrates another linear endosuturing system 3100 made in accordance with the present disclosure. Similar to the linear endosuturing system 200 of FIG. 2, the endosuturing system 3100 includes an endoscope 3102 and an endoscopic suturing device
  • the endoscopic suturing device 3101 includes a housing 3104 releasably coupled to the endoscope 3102 via a coupling mechanism 3108.
  • the coupling mechanism 3108 includes a channel in the housing 3104. The channel of the coupling mechanism 3108 is configured to allow the housing 3104 to flex and secure the housing 3104 to the endoscope 3102 via friction.
  • the housing 3104 may be releasably secured to the endoscope 3102 with any other coupling mechanism.
  • the endoscopic suturing device 3101 may be permanently attached to or otherwise integrated into the endoscope 3102.
  • the endoscope 3102 is substantially similar to the endoscope 202, including a distal face 3110 having a plurality of working channels 3112 that can receive an imaging system, light source, or other tool (similar to the endoscope 202 described in connection with FIG. 2).
  • At least the working channel 3112a is configured to receive a tissue grabber (not shown).
  • the tissue grabber is configured to move parallel to the longitudinal axis 3106 as well as rotate about a longitudinal axis of the tissue grabber parallel to the longitudinal axis 3106.
  • the housing 3104 of the endoscopic suturing device 3101 further includes an arm 3130 including a proximal end 3132a coupled to the housing 3104 and a distal end 3132b extending distally from the housing 3104.
  • the arm 3130 can be integrally formed or releasably attached with the housing 3104. So configured, the arm 3130 is cantilevered distally from the housing 3104.
  • the distal end 3132a of the arm 3130 carries a needle receiver 3134.
  • the needle receiver 3134 is co-axially aligned with the cylindrical opening 3124 of the housing 3104.
  • the arm 3130 may be configured in any manner to distally extend from the housing 3104 and axially align the needle receiver 3134 with cylindrical opening 3124.
  • the housing 3104 further includes a helical guide 3142.
  • the helical guide 3142 projects distally from the housing 3104 in a helical manner.
  • the helical guide terminates approximately midway between the cylindrical opening 3124 and the needle receiver 3134.
  • the helical guide 3142 terminates approximately coplanar with the cylindrical opening 3124 and the needle receiver 3134.
  • the helical guide 3142 could terminate closer to either the needle receiver 3134 or the cylindrical opening 3124 or terminate above or below the needier receiver 3134 and the cylindrical opening 3124 when viewed from the side (as shown in FIG. 32).
  • the linear endosuturing system 3100 operates to bring the tissue between the cylindrical opening 3124 and the needle receiver 3134.
  • the linear endosuturing system includes a tissue grabber similar to the tissue grabbers 2516, 2816.
  • the tissue grabber pulls tissue towards the endoscope 3102 while the helical guide 3142 diverts tissue between the cylindrical opening 3124 and the needle receiver 3234.
  • a suture mechanism can be operated, similar to the operation of the suture mechanisms 312, 2012, 2610 described above.
  • the endoscopic suturing system utilizing a linear drive needle has several benefits.
  • the linear drive needle passes straight through the tissue and does not scratch or cut tissue.
  • Other endosuturing devices rotate linear needles or partially curved needles through tissue. The pivoted needles cause damage to the tissue that is not necessary for forming a plication line.

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Abstract

Un système d'endosuture comprend une sangle mobile linéairement le long d'un axe longitudinal, la sangle comprenant un élément de sangle interne et un élément de sangle externe sélectivement mobiles l'un par rapport à l'autre pour fournir un serrage de la suture. Le système d'endosuture comprend également une aiguille de suture ayant une pointe d'aiguille distale et une extrémité proximale opposée, l'aiguille de suture ayant une position emboîtée à l'intérieur de l'élément de sangle interne de la sangle. Le système d'endosuture comprend en outre un dispositif d'entraînement d'aiguille coaxial avec la sangle et mobile linéairement le long de l'axe longitudinal, et une pince à aiguille coaxiale avec la sangle et conçue pour s'accoupler de manière amovible à l'extrémité proximale de l'aiguille de suture.
PCT/US2024/042009 2023-08-14 2024-08-13 Système de suture endoscopique à l'aide d'une aiguille d'entraînement linéaire Pending WO2025038589A2 (fr)

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Publication number Priority date Publication date Assignee Title
US7344545B2 (en) * 2002-01-30 2008-03-18 Olympus Corporation Endoscopic suturing system
US7530985B2 (en) * 2002-01-30 2009-05-12 Olympus Corporation Endoscopic suturing system
US20070203395A1 (en) * 2006-02-28 2007-08-30 Takayasu Mikkaichi Cap installable on distal end portion of endoscope
EP2230987B1 (fr) * 2008-01-03 2013-02-27 Cook Medical Technologies LLC Systèmes médicaux de suture de perforations par voie endoscopique
US8679136B2 (en) * 2008-06-17 2014-03-25 Apollo Endosurgery, Inc. Needle capture device
US20230181183A1 (en) * 2008-06-17 2023-06-15 Apollo Endosurgery Us, Inc. Endoscopic needle assembly
US20100113873A1 (en) * 2008-11-06 2010-05-06 Takayuki Suzuki Suturing device and suturing system
US8540735B2 (en) * 2010-12-16 2013-09-24 Apollo Endosurgery, Inc. Endoscopic suture cinch system
US10076323B2 (en) * 2014-09-10 2018-09-18 Boston Scientific Scimed, Inc. Longitudinal needle passer
US11141147B2 (en) * 2016-08-10 2021-10-12 Apollo Endosurgery Us, Inc. Endoscopic suturing system having external instrument channel
JP7142688B2 (ja) * 2017-06-15 2022-09-27 エンド・トゥールズ・セラピューティクス・エス・アー 内視鏡ツールを支持するための装置
CN112638284A (zh) * 2018-06-27 2021-04-09 波士顿科学国际有限公司 与基于缝合线的闭合装置一起使用的内窥镜附接机构
EP4329576B1 (fr) * 2021-04-26 2025-08-20 Boston Scientific Scimed, Inc. Dispositif de fermeture à base de suture

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