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WO2025054512A1 - Pince chirurgicale magnétique, système et procédé associés de manipulation de tissu - Google Patents

Pince chirurgicale magnétique, système et procédé associés de manipulation de tissu Download PDF

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Publication number
WO2025054512A1
WO2025054512A1 PCT/US2024/045669 US2024045669W WO2025054512A1 WO 2025054512 A1 WO2025054512 A1 WO 2025054512A1 US 2024045669 W US2024045669 W US 2024045669W WO 2025054512 A1 WO2025054512 A1 WO 2025054512A1
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WO
WIPO (PCT)
Prior art keywords
surgical
premagnetized
tissue
magnetic field
surgical clip
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/US2024/045669
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English (en)
Inventor
Hamidreza Marvi
Terry JUE
Tabsheer ASKARI
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Mayo Foundation for Medical Education and Research
Arizona State University ASU
Arizona State University Downtown Phoenix campus
Mayo Clinic in Florida
Original Assignee
Mayo Foundation for Medical Education and Research
Arizona State University ASU
Arizona State University Downtown Phoenix campus
Mayo Clinic in Florida
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Publication date
Application filed by Mayo Foundation for Medical Education and Research, Arizona State University ASU, Arizona State University Downtown Phoenix campus, Mayo Clinic in Florida filed Critical Mayo Foundation for Medical Education and Research
Publication of WO2025054512A1 publication Critical patent/WO2025054512A1/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
    • A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
    • A61B17/083—Clips, e.g. resilient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/02—Surgical instruments, devices or methods for holding wounds open, e.g. retractors; Tractors
    • A61B17/0218—Surgical instruments, devices or methods for holding wounds open, e.g. retractors; Tractors for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/10—Surgical instruments, devices or methods for applying or removing wound clamps, e.g. containing only one clamp or staple; Wound clamp magazines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/30—Surgical robots
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/70—Manipulators specially adapted for use in surgery
    • A61B34/73—Manipulators for magnetic surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/70—Manipulators specially adapted for use in surgery
    • A61B34/76—Manipulators having means for providing feel, e.g. force or tactile feedback
    • 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
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00269—Type of minimally invasive operation endoscopic mucosal resection EMR
    • 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
    • A61B2017/0034—Surgical instruments, devices or methods for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means adapted to be inserted through a working channel of an endoscope
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00876—Material properties magnetic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/101—Computer-aided simulation of surgical operations
    • A61B2034/105—Modelling of the patient, e.g. for ligaments or bones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046—Tracking techniques
    • A61B2034/2061—Tracking techniques using shape-sensors, e.g. fiber shape sensors with Bragg gratings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/30—Surgical robots
    • A61B34/37—Leader-follower robots

Definitions

  • Various types of minimally invasive surgery involve passing an endoscope or other instrument through an incision or orifice into an animal (e.g., human) body, according to categories including endoscopy, laparoscopy, and arthroscopy.
  • Minimally invasive surgery typically has less operative trauma, other complications, and adverse effects than a corresponding open-type surgery (involving a larger incision to permit direct viewing and manipulation of tissue by a surgeon).
  • ESD Endoscopic submucosal dissection
  • EMR endoscopic mucosal resection
  • One challenge during performance of endoscopic procedures is manipulating (e.g., retracting) tissue to permit a desired plane to be visualized and/or dissected.
  • tissue e.g., retracting
  • a surgeon can retract tissue with one hand and perform suitable operations (e.g., dissection) with another hand, but endoscopic procedures typically employ a single tubular body that is ill-suited to facilitate simultaneous tissue retraction and dissection.
  • Magnetic tissue anchors that permit tissue within a body to be grasped and manipulated by a manually moveable magnet, positioned external to the body, have been developed for use in endoscopic submucosal dissection. See Mortagy, M., et al., “Magnetic anchor guidance for endoscopic submucosal dissection and other endoscopic procedures,” World J. Gastroenterol. 2017 April 28; 23(16): 2883- 2890 (“Mortagy et al.”). Mortagy et al.
  • a magnetically actuated tissue anchor can provide dynamic traction independent of an endoscope, by applying an external magnetic pulling force to an internal magnetic anchor that includes a magnetic weight coupled by a connecting thread to microforceps configured to anchor tissue within a body.
  • Mortagy et al. disclose that limitations of magnetic anchor guided ESD include the coupling strength of magnets that decay with distance, which may limit effectiveness of the technique through thick abdominal walls.
  • a surgical clip (which may also be referred to as a “tissue anchor”) including a body structure and/or one or more internal elements comprising a premagnetized material, and an associated system and method for manipulating (e.g., moving or positioning) tissue during a surgical procedure, utilizing one or more surgical clips affixed to tissue within an animal body and configured to be delivered with an endoscope or similar surgical device.
  • At least one magnetic field source e.g., a permanent magnet, a ferroelectric magnet, or an electromagnet
  • at least one magnetic field generated by the at least one magnetic field source is used to alter position of the one or more surgical clips affixed to the tissue.
  • An exemplary surgical clip may include a tubular body structure, a grasping element (e.g., microforceps, a clamp, or the like), and internal elements within the body structure (the internal elements including an actuating mechanism), wherein at least a portion of one or more of (i) the body structure, and (ii) the internal elements, comprises a premagnetized material, and the premagnetized material is configured to cooperate with an end effector arranged external to the animal body to permit manipulation of tissue of the animal body when grasped by the grasping element.
  • a grasping element e.g., microforceps, a clamp, or the like
  • internal elements within the body structure the internal elements including an actuating mechanism
  • a robot actuator may be controlled by user manipulation of a user input device, which may have one or more associated end effectors to supply haptic feedback to the user through the user input device (e.g., proportional to one or more of magnetic field strength, magnetic field direction, surgical clip strain, and tissue displacement).
  • a camera and/or optical fiber associated with an endoscope may be provided within the animal body in or adjacent to a surgical field (e.g., proximate to the one or more surgical clips and/or a surgical tool) to enable visualization.
  • movement of at least one magnetic field source may be controlled responsive to signals received from a camera within the animal body.
  • robotic ex-situ actuation of at least one surgical clip may be supplemented with, or replaced with, in-situ actuation using at least one premagnetized element associated with a surgical instrument, wherein the premagnetized element may be moved to alter position of one or more surgical clips.
  • a surgical instrument may include an elongated body structure supporting at least one premagnetized element, wherein the elongated body structure may comprise one or more of a hollow tube, a catheter, an electrical conductor, a camera, and an optical fiber.
  • the term “animal body” is intended to encompass a body of a human or non-human animal.
  • the disclosure relates to a surgical clip configured to grasp tissue within an animal body
  • the surgical clip comprising: a tubular body structure; a grasping element extending from the body structure; and internal elements within the body structure, the internal elements including an actuating mechanism configured to actuate the grasping element; wherein the surgical clip is configured to be delivered through a passage of a surgical instrument to a desired location within the animal body; wherein at least a portion of one or more of (i) the body structure, and (ii) the internal elements, comprises a premagnetized material; and wherein the premagnetized material is configured to cooperate with an end effector arranged external to the animal body to permit manipulation of tissue of the animal body when grasped by the grasping element.
  • At least a portion of the body structure comprises the premagnetized material.
  • At least a portion of the internal elements comprises the premagnetized material.
  • the internal elements comprise a yoke and a tension member, the yoke being couplable to a control wire, the tension member being configured to outwardly bias arms of the grasping element, and the at least a portion of the internal elements that comprises the premagnetized material comprising one or more of the yoke and the tension member.
  • the internal elements comprise a yoke, a tension member, and an extension member coupled between at least a portion of the yoke and at least a portion of the tension member, the yoke being couplable to a control wire, the tension member being configured to outwardly bias arms of the grasping element, and the at least a portion of the internal elements that comprises the premagnetized material comprising one or more of the extension member, the yoke, and the tension member.
  • the premagnetized material comprises a neodymium magnet material.
  • the premagnetized material comprises a permanent magnet or a ferroelectric magnet.
  • the grasping element comprises first and second arms that are configured to be moved between an open configuration and a closed configuration.
  • a grasping element may include additional arms (e.g., three, four, or any suitable number), clamp(s), pincers, hooks, and/or lasso-type structures.
  • the tubular body structure is generally cylindrical.
  • the surgical clip comprises a maximum outer diameter of no greater than 3.1 mm.
  • the disclosure relates to a method for moving or positioning tissue during a surgical procedure, the method comprising: attaching one or more surgical clips as disclosed herein to tissue within an animal body; moving at least one magnetic field source arranged external to the animal body, using at least one robotic actuator; and applying at least one magnetic field generated by the at least one magnetic field source to alter position of the one or more surgical clips affixed to the tissue.
  • the at least one magnetic field source comprises a plurality of magnetic field sources.
  • the at least one robotic actuator comprises a plurality of robotic actuators.
  • the premagnetized material comprises a permanent magnet, or comprises a ferroelectric magnet.
  • the method further comprises controlling position of the at least one robotic actuator and magnetic field strength applied by the at least one magnetic field source by user manipulation of a user input device.
  • the method further comprises supplying haptic feedback to a user through the user input device proportional to at least one of the following: magnetic field strength, magnetic field direction, surgical clip strain, and tissue displacement.
  • movement of the at least one magnetic field source is controlled responsive to signals received from a camera of a surgical instrument positioned within the animal tissue proximate to the at least one surgical clip.
  • the method further comprises positioning a surgical instrument comprising an elongated body structure and at least one premagnetized element within the animal body proximate to the one or more surgical clips, and moving the at least one premagnetized element of the surgical instrument within the animal body to alter position of the one or more surgical clips affixed to the tissue.
  • the at least one premagnetized element of the surgical instrument comprises a permanent magnet or a ferroelectric magnet.
  • the at least one premagnetized element of the surgical instrument comprises an electromagnet.
  • the surgical instrument comprises a first channel permitting passage of a camera or an optical fiber, and comprises a second channel permitting passage of the at least one premagnetized element.
  • the at least one premagnetized element of the surgical instrument is rigidly coupled to the surgical instrument.
  • the elongated body structure of the surgical instrument comprises one or more of a hollow tube, a catheter, an electrical conductor, a camera, and an optical fiber.
  • the disclosure relates to a system configured for moving or positioning tissue during a surgical procedure, the system comprising: one or more surgical clips as disclosed herein; at least one magnetic field source configured to be arranged external to an animal body; at least one robotic actuator configured to move the at least one magnetic field source to effectuate movement of the one or more surgical clips when attached to the tissue; and a user input device configured to receive input signals from a user to control movement of the at least one robotic actuator.
  • the user input device comprises at least one feedback actuator configured supplying haptic feedback to a user through the user input device, wherein the haptic feedback is proportional at least one of the following: magnetic field strength, magnetic field direction, surgical clip strain, and tissue displacement.
  • the at least one magnetic field source comprises a plurality of magnetic field sources.
  • the at least one robotic actuator comprises a plurality of robotic actuators.
  • the premagnetized material comprises a permanent magnet, or comprises a ferroelectric magnet.
  • the disclosure relates to a method for moving or positioning tissue during a surgical procedure, the method comprising: affixing one or more surgical clips as disclosed herein to tissue within an animal body; positioning a surgical instrument comprising an elongated body structure and at least one premagnetized element within the animal body proximate to the one or more surgical clips; and moving the at least one premagnetized element to alter position of the one or more surgical clips affixed to the tissue.
  • the at least one premagnetized element comprises a permanent magnet or a ferroelectric magnet.
  • the at least one premagnetized element comprises an electromagnet.
  • the surgical instrument comprises a first channel permitting passage of a camera or an optical fiber, and comprises a second channel permitting passage of the at least one premagnetized element.
  • the at least one premagnetized element is rigidly coupled to the surgical instrument.
  • the elongated body structure of the surgical instrument comprises one or more of a hollow tube, a catheter, an electrical conductor, a camera, and an optical fiber.
  • any two or more features of aspects and/or embodiments disclosed herein may be combined for additional advantage.
  • FIG. 1 illustrates a surgical clip including a premagnetized weight arranged within a gastric cavity of an animal body, with a grasping or affixing element thereof attached to a portion of gastric wall tissue.
  • FIG. 2 is a schematic diagram showing interconnections between components of a system for moving or positioning tissue within an animal body during a surgical procedure according to one embodiment.
  • FIG. 3 is a perspective view of a robotic arm incorporating magnets to serve as an end effector to effectuate movement of one or more components of a steerable assembly and/or a system for moving or positioning tissue within an animal body during a surgical procedure according to one embodiment.
  • FIG. 4 is a schematic side view illustration of a portion of a fiber bragg grating sensor that may be utilized with components for determining position of a steerable assembly within an animal body.
  • FIG. 5 is a side cross-sectional view of a tissue clipping device configured to manipulate a surgical clip and configured for passage through an endoscope.
  • FIG. 5A is a magnified portion of FIG. 5, showing the surgical clip in an open position.
  • FIG. 6 is a side cross-sectional view of the surgical clip shown in FIGS. 5 and 5A in a closed position.
  • FIG. 7 is a perspective view of a surgical clip in an open position, the surgical clip including a tubular body structure having an internal yoke coupled to a tension member element for biasing arms of a grasping element, and including at least one premagnetized element according to one embodiment.
  • FIG. 8A is a side elevational view of the surgical clip of FIG. 7.
  • FIG. 8B is a cross-sectional view of the surgical clip of FIG. 7, taken along section line 8B-8B shown in FIG. 8A.
  • FIG. 8C is a top plan view of the surgical clip of FIG. 7.
  • FIG. 8D is a cross-sectional view of the surgical clip of FIG. 7, taken along section line 8D-8D shown in FIG. 8C.
  • FIG. 9 is a perspective view of the surgical clip of FIG. 7 in a closed position, in combination with a portion of an associated clipping device according to one embodiment.
  • FIG. 10A is a side elevational view of the surgical clip and clipping device portion of FIG. 9.
  • FIG. 10B is a cross-sectional view of the surgical clip and clipping device portion of FIG. 9, taken along section line 10B-10B shown in FIG. 10A.
  • FIG. 10C is a top plan view of the surgical clip and clipping device portion of FIG. 9.
  • FIG. 10D is a cross-sectional view of the surgical clip and clipping device portion of FIG. 9, taken along section line 10D-10D shown in FIG. 10C.
  • FIG. 11 is a perspective view of a surgical clip in a closed position, the surgical clip including a tubular body structure having an internal yoke, a tension member for biasing arms of a grasping element, and an extension member coupled between the yoke and the tension member, and including at least one premagnetized element according to another embodiment.
  • FIG. 12A is a side elevational view of the surgical clip of FIG. 11 .
  • FIG. 12B is a cross-sectional view of the surgical clip of FIG. 11 , taken along section line 12B-12B shown in FIG. 12A.
  • FIG. 12C is a top plan view of the surgical clip of FIG. 11.
  • FIG. 12D is a cross-sectional view of the surgical clip of FIG. 11 , taken along section line 12D-12D shown in FIG. 12C.
  • FIG. 13 is a perspective view of the surgical clip of FIG. 11 in an open position, in combination with a portion of an associated clipping device according to one embodiment.
  • FIG. 14A is a side elevational view of the surgical clip and clipping device portion of FIG. 13.
  • FIG. 14B is a cross-sectional view of the surgical clip and clipping device portion of FIG. 13, taken along section line 14B-14B shown in FIG. 10A.
  • FIG. 14C is a top plan view of the surgical clip and clipping device portion of FIG. 13.
  • FIG. 14D is a cross-sectional view of the surgical clip and clipping device portion of FIG. 13, taken along section line 14D-14D shown in FIG. 14C.
  • FIG. 15 is schematic diagram of a generalized representation of a computer system that can be included as one or more components of a system or method for manipulating tissue during a surgical procedure as disclosed herein.
  • a surgical clip (which may also be referred to as a “tissue anchor”) including a body structure and/or one or more internal elements comprising a premagnetized material, and an associated system and method for manipulating (e.g., moving or positioning) tissue during a surgical procedure, utilizing one or more surgical clips affixed to tissue within an animal body and configured to be delivered with an endoscope or similar surgical device.
  • at least one magnetic field source arranged external to the animal body is moved using at least one robotic actuator, and at least one magnetic field generated by the at least one magnetic field source is used to interact with the premagnetized material and thereby alter position of the one or more surgical clips affixed to the tissue.
  • the magnetic field source external to the animal body may comprise one or more paramagnetic, ferromagnetic, and/or electromagnetic materials.
  • a robotic actuator e.g., an articulating robotic arm
  • Magnetic field strength and direction may be calculated based on a surgeon’s desired manipulation of target tissue.
  • a robotic actuator may be controlled by user manipulation of a user input device, which may have one or more associated actuators to supply haptic feedback to the user through the user input device (e.g., proportional to one or more of magnetic field strength, magnetic field direction, surgical clip strain, and tissue displacement.
  • a user input device is a joystick, which may be provided in single or dual forms, optionally augmented with various items such as triggers, buttons, dials, and the like.
  • a camera and/or optical fiber associated with an endoscope may be provided within the animal body in or adjacent to a surgical field (e.g., proximate to the one or more surgical clip and/or a surgical tool) to enable visualization, such as by using one or more displays, whether in stand-alone or wearable (e.g., headset) form.
  • movement and/or activation of at least one magnetic field source may be controlled responsive to one or more of: (i) signals received from a camera within the animal body (which may detect tissue displacement), (ii) detected surgical clip strain (such as may be detected with a strain gauge associated with the surgical clip), (iii)) detected magnetic field strength, and (iv) detected magnetic field direction.
  • robotic ex-situ actuation of at least one surgical clip may be supplemented with, or replaced with, in-situ actuation using at least one premagnetized element associated with a surgical instrument, wherein the premagnetized element may be moved to alter position of one or more surgical clips.
  • a surgical instrument may include an elongated body structure supporting at least one premagnetized element, wherein the elongated body structure may comprise one or more of a hollow tube, a catheter, an electrical conductor, a camera, and an optical fiber.
  • in-situ actuation may be used to facilitate engagement of a magnetic surgical clip with targeted tissue, and ex-situ actuation may be used thereafter during a surgical procedure, to free up a surgical instrument for use in dissection or other operations.
  • in-situ actuation and ex-situ actuation may be performed at different times, or may be performed simultaneously.
  • in-situ actuation may be performed by moving a surgical instrument (e.g., a steerable surgical element) comprising at least one premagnetized element associated with an elongated structure within an animal body, wherein such actuation may be performed manually by a surgeon or aided by one or more actuators.
  • a surgical instrument e.g., a steerable surgical element
  • a surgical instrument may be steered via pushing, by exploiting asymmetric forces on an instrument (e.g., needle) tip during insertion.
  • an instrument e.g., needle
  • the instrument is rotated at the base to control the orientation of the tip, thus rotating the direction of the asymmetric force and permitting the trajectory of the instrument tip to be controlled.
  • a surgical instrument may comprise a magnetically responsive tip and by steered via magnetic pulling, by being used in conjunction with an instrument needle steering apparatus and method that alters strength and/or position of at least one magnetic field source (e.g., generated by one or more end effectors such as one or more robotic arm(s)) external to an animal body to interact with the instrument tip inserted into the animal body to effectuate movement of the instrument within the animal body.
  • a conventional elongated structure (e.g., shaft) of the surgical instrument may be replaced by an elastic shaft that is not load-bearing.
  • an exemplary surgical clip may include one or more premagnetized portions (e.g., embodied in as a permanent magnet or a ferroelectric magnet), and well as a grasping or affixing element (such as microforceps, a clamp, or the like).
  • the one or more premagnetized portions may include items such as a tubular body structure or elements within such a body structure, such as a yoke (configured to engage a control wire), a tension member (configured to outwardly bias arms of a grasping element), and/or an optional extension member intermediately coupled between the yoke and the tension member.
  • the grasping or affixing element is preferably not formed of a premagnetized material, so that application of an external magnetic field would not serve to inadvertently affect grasping or releasing of tissue.
  • a magnetic field is applied to at least one premagnetized element of a surgical clip (whether by a magnetic field source external to the animal body, and/or by a premagnetized element of a surgical instrument within the animal body)
  • the premagnetized material weight is pulled in the direction of the applied magnetic field. Since the grasping or affixing element is coupled with tissue within the animal body, application of a magnetic field causes the tissue to be locally displaced, which may provide access and/or visibility to a surgeon to perform a desired surgical procedure.
  • FIG. 1 schematically illustrates a tissue anchor 20 (as known as a surgical clip or a tissue clip , and including a magnetic weight 22 of premagnetized material, a coupling element 24, and a grasping or affixing element 26) arranged within a gastric cavity 33 of an animal body 30, with the grasping or affixing element 26 attached to a portion of gastric wall tissue 32.
  • a tissue anchor 20 as known as a surgical clip or a tissue clip , and including a magnetic weight 22 of premagnetized material, a coupling element 24, and a grasping or affixing element 26
  • a robotic manipulator 40 having an associated magnetic field source 52 is positioned external to the animal body 30, wherein the magnetic field source 52 is arranged to apply a magnetic field to apply an attracting force to the magnetic weight 22, thereby applying tension to the coupling element 24 and the grasping or affixing element 26 to pull the attached portion of gastric wall tissue 32 to provide access to an implement 80 (e.g., needle, cutting instrument, etc.) of an endoscopic device 70 or other surgical instrument.
  • an implement 80 e.g., needle, cutting instrument, etc.
  • the endoscopic device 70 includes a flexible body structure 74 and may include multiple bores or channels 76, 77 defined therein to receive items such as a camera, an optical fiber, and/or electrical conductors, wherein the bores or channels 76, 77 may also permit therapeutic or diagnostic material to be supplied to a surgical site, or permit tissue to be removed from a surgical site.
  • the robotic manipulator 44 may include one or more robotic arms 45, 47 and associated joints 44, 46, 48 with multiple degrees of freedom, and/or may include multiple magnetic field sources 52.
  • Each magnetic field source 52 includes magnets 23-1 , 23-2 (e.g., permanent magnets or electromagnets), wherein in certain embodiments, the magnets 23-1 , 23-
  • gastric wall 31 and gastric cavity 33 are shown, it is to be appreciated that any embodiments herein may be used with any suitable tissue within an animal (including but not limited to human) body.
  • FIG. 2 schematically illustrates components of a system 100 for moving or positioning tissue using one or more tissue clips (tissue anchors) comprising premagnetized materials during a surgical procedure according to one embodiment.
  • tissue clips tissue anchors
  • an elongated structure (e.g., surgical instrument) 152 extends through an opening or incision and is positioned within tissue of an animal body proximate to a tissue anchor 120 that comprises a premagnetized material 122 and comprises a grasping or affixing element 126.
  • the elongated structure 152 terminates at a tip 180 within the animal body 110, with the tip 180 comprising one or more of: a tool or other implement, a camera 184, and a premagnetized element 182, wherein any or all of the foregoing elements may be selectively deployed in certain embodiments.
  • the elongated structure 152 may further comprise a plurality of fiber bragg grating (FBG) sensors 154 associated with an optical fiber 151 arranged in or on the elongated structure.
  • FBG fiber bragg grating
  • Robotic manipulators 114-1 , 114-2 each having an associated magnetic field source 112-1 , 112-1 are positioned external to the body 110.
  • the robotic manipulators 114-1 , 114-2 may comprise robotic actuators (e.g., robotic arms, such as 6-degree-of-freedom (6DOF) robotic arms) arranged external to the animal body 110 to apply at least one magnetic field to manipulate and cause movement of the tissue anchor 120 within the animal (e.g., human) body 110.
  • robotic actuators e.g., robotic arms, such as 6-degree-of-freedom (6DOF) robotic arms
  • 6DOF 6-degree-of-freedom
  • the tissue anchor 120 may be additionally, or alternatively, controlled by movement of the premagnetized element 182 of the elongated body 152 (e.g., surgical instrument) located within the animal body 110 proximate to the tissue anchor 120.
  • a magnetic steering and control element 158 associated with the surgical instrument 152 may be used to control positioning (and/or applied field if the premagnetized element 182 comprises an electromagnet) of the premagnetized element 182 of the surgical instrument 152.
  • a premagnetized implement (e.g., needle tip) 180 is associated with the elongated structure 152 of a surgical instrument and may be moved through the animal tissue 110 by magnetic pulling with the robotic manipulators 114-1 , 114-2 and magnetic effectors 112-1 , 112-2 located external to the animal body, and after the premagnetized implement 180 is positioned in a surgical field, the premagnetized implement 180 may be retracted through a bore or channel (e.g., 76, 77 in FIG. 1 ) of the elongated structure 152, and a magnetically moveable tissue anchor 120 may be deployed through a bore or channel (e.g., 76, 77 in FIG. 1 ) of the elongated structure 152 into a surgical field within the animal tissue 110.
  • a premagnetized implement 180 e.g., needle tip
  • a user input device 119 controllable by user manipulation is arranged to permit control of the magnetic end effectors 112-1 , 112-2.
  • One or more feedback actuators 118 may be configured to supply haptic feedback to the user through the user input device 119 (e.g., proportional to one or more of magnetic field strength, magnetic field direction, tissue displacement, tissue density, deviation from desired trajectory, or the like).
  • One example of a user input device 119 is a joystick, which may be provided in single or dual forms, optionally augmented with various items such as triggers, buttons, dials, and the like.
  • a camera and/or optical fiber (coupled to camera imager 133) associated with the elongated body structure 152 may be provided within the body 110 (optionally within a surgical field for an animal body 110, such as proximate to a surgical tool at a top 180 of the elongated body 152) to enable visualization, such as by using one or more displays 148, whether in standalone or wearable (e.g., headset) form.
  • movement and/or activation of at least one magnetic field sourcel 12-1 , 112-2 may be controlled responsive to one or more of: (i) signals received from a camera 184 within the animal body (which may detect tissue displacement), (ii) detected tissue anchor strain (such as may be detected with a strain gauge associated with the anchor 120), (iii)) detected magnetic field strength, and (iv) detected magnetic field direction.
  • signals received from a camera 184 within the animal body which may detect tissue displacement
  • detected tissue anchor strain such as may be detected with a strain gauge associated with the anchor 120
  • detected magnetic field strength such as may be detected with a strain gauge associated with the anchor 120
  • detected magnetic field direction such as may be detected magnetic field strength
  • magnetic field direction such as may be detected magnetic field strength
  • position of the surgical instrument within the animal body may be estimated without continuous imaging techniques.
  • one or more fiber bragg grating (FBG) sensors 154 may be provided on an optical fiber 151 arranged in or on the elongated body structure 152 of a surgical instrument and inserted into tissue of an animal body 110 to determine position of the elongated body structure.
  • Light signals may be supplied to FBG sensors by a FBG driver/detector 150 arranged external to the animal body 110.
  • Reflected light signals received by the FBG driver/detector 150 may be used to determine one or more of force, strain, or shape of FBG sensors 150 associated with the elongated body structure 152, and thereby used to determine orientation of the elongated body structure 152.
  • a tracking subsystem for the elongated body 152 may include a DC motor 130 having a rotatable spool coupled thereto, a load cell and tensioner 132, and a rotary encoder (optionally integrated into a motor driver I speed computing element 140 coupled to the DC motor 130).
  • the foregoing items may be mounted on a moveable support structure (not shown), such as a platform mounted on linear guides that enable one-directional (e.g., horizontal) translation in one direction.
  • a moveable support structure that may be used is shown in International Patent Application Publication No. WO 2021/108690 A1 , with the disclosure thereof being hereby incorporated by reference herein.
  • a portion of the elongated body structure 152 may be wrapped on the spool coupled with a shaft of the DC motor 130.
  • the load cell 132 (or alternatively a force sensor) may be used to measure tensile or compressive loads applied to the moveable support structure, wherein the processor 130 may be used in combination with the rotary encoder (e.g., within motor driver / speed computing element 140) to calculate rotational velocity of the motor 130, which may be used to calculate insertion depth of the elongated body 152 in the body 110. Measurements from the load cell 132 may be used to calculate tension applied to the elongated structure 152.
  • a data acquisition device 136 sends control inputs to a motor driver 140 that supplies power to the DC motor 130 to which the elongated structure 152 is coupled.
  • the DC motor 130 may be used to provide controlled releasement of the elongated body structure 152 from a spool of the motor 130.
  • the processor 130 may be used to compare an output signal of at least one sensor 134 configured to sense a condition indicative of at least one of (i) position of a moveable support structure or (ii) pulling force applied to a moveable support structure, and configured to generate at least one output signal.
  • operation of the DC motor 130 may be controlled to adjust a feed rate of a length of elongated body structure 152 from a rotatable spool of the motor 130 responsive to comparison of the output signal to the desired range of output signal values.
  • operation of the DC motor 130 may be controlled to increase the releasement rate of the elongated body structure 152 from the rotatable spool of the motor.
  • operation of the DC motor 130 may be controlled to reverse rotational direction of the motor 130 responsive to comparison of the output signal to the desired range of output signal values
  • a three-dimensional (3D) model of tissue of an animal body is generated before a steerable assembly including the elongated body structure 152 (e.g., surgical instrument) is supplied to tissue of the animal body 110.
  • a 3D model may be generated by any suitable imaging device, such as a MRI, CT, ultrasound, fluoroscopy, or other imaging device.
  • the 3D model optionally received via a network interface 144 and/or generated from 3D model input data 142 as part of a 3D model interaction subsystem 141 , may be stored to memory 146 accessible to at least one processor 130, in preparation for receiving 3D trajectory information of a steerable assembly (including the elongated body 152) for superimposition onto the 3D model.
  • This 3D trajectory information may be determined by directly by imaging, or inferential ⁇ from a detected length of insertion of the elongated structure 152 into the animal body 110, in combination with a recorded directionality of a magnetic field applied (by magnetic effectors 112-1 , 112- 2) to a premagnetized material (e.g., magnetic tip 180) associated with the elongated body 152, optionally embodied in a surgical instrument.
  • a premagnetized material e.g., magnetic tip 180
  • insertion length of the elongated body structure 152 may be determined (or supplemented) by sensing position or velocity of a shaft of the DC motor 130 controlling releasement of the elongated body structure 152 during insertion of the elongated body structure 152 into the animal body 110.
  • position or velocity of a shaft of the motor 130 may be sensed with a rotary encoder, which may be integrated into a motor driver I speed computing element 140.
  • insertion length of the elongated body structure 152 may be determined by sensing linear position or displacement of at least a portion of the elongated body structure 152, such as by using a linear encoder (not shown) arranged between a spool coupled to the motor 130 and the animal body 110.
  • recording of directionality of a magnetic field applied to the elongated body 152 in the animal body 110 comprises recording control signals supplied to the stepper motor drivers 116 coupled with the robotic manipulators 114-1 , 114-2 configured to adjust position of magnetic end effectors 112-1 , 112-1 configured to apply one or more magnetic fields to a tip 180 of the elongated body 152.
  • recording of directionality of the magnetic field may comprise, or be supplemented by, collecting signals received from one or more magnetic field sensors 113.
  • one or more magnetic field sensors 113 may be positioned proximate to the animal body 110 into which the elongated body 152 is inserted.
  • a condition indicative of respiration rate and/or respiration amplitude of an animal body 110 may be sensed (e.g., using respiration sensors 115 and/or a ventilator or one or more chest sensors), and responsive to the such sensing, a 3D model of the animal body 110 (storable in memory 146) may be updated, and/or position of the magnetic end effectors 114-1 , 114-2 may be adjusted.
  • the foregoing control scheme may be used to maintain constant distance in the vertical direction between the tissue of the animal body 110 and the magnetic end effectors 114-1 , 114-2 so that a constant magnetic force is applied on a premagnetized needle at a tip 180 of the elongated body 152.
  • a body imaging apparatus (not shown) arranged external to the animal body 110 may be provided to periodically permit imaging of the body 110 and inserted portions of the elongated structure 152, as may be useful to confirm and/or correct FBG-calculated positional information derived from the FBG sensors 154 and FBG detector 150.
  • the system 100 may be configured to receiving signals for linear translation of an elongated body (for determining insertion depth of the elongated body structure 152) and signals for movement of the robotic manipulators 114-1 , 114-2 (for determining magnetic field direction) and processing the signals for forwarding to a computer processor 130 for superimposition of 3D trajectory of the elongated body 152 (e.g., optionally embodied in a surgical instrument) on a previously generated 3D model of tissue of an animal body 110 into which the elongated body 152 inserted.
  • a computer processor 130 for superimposition of 3D trajectory of the elongated body 152 (e.g., optionally embodied in a surgical instrument) on a previously generated 3D model of tissue of an animal body 110 into which the elongated body 152 inserted.
  • FIG. 3 is a perspective view of a robotic arm 14 incorporating magnets 13- 1 , 13-2 (e.g., permanent magnets or electromagnets) to serve as an end effector 12 to effectuate movement of a steerable assembly including a magnetic needle within tissue of an animal body according to certain embodiments.
  • the magnets 13-1 , 13-2 may be, or may be controlled to be, of the same polarity or opposing polarities.
  • the robotic arm 14 is mountable to a support surface 10B and includes multiple joints 15B, 16B, 17B, 18B, 19B to provide numerous degrees of freedom for movement of the robotic arm 14 relative to tissue of an animal body (such as a human patient, not shown) in order to effectuate movement of a surgical clip within the animal body, or to effectuate movement of an implement including a premagnetized portion (e.g., needle tip) of a surgical instrument within tissue of the animal body.
  • the robotic arm may be used initially to move an implement within tissue of the animal body, and thereafter to manipulate a surgical clip as disclosed herein.
  • an implement including a premagnetized portion and associated with an elongated structure may be moved through tissue by magnetic pulling with a robotic arm having a magnetic field generator located external to the animal body, and after the implement is positioned in a surgical field, the magnetic implement of the surgical instrument may be retracted through a channel of the elongated structure, and a magnetically moveable surgical clip may be deployed through a channel in the elongated structure into the surgical field.
  • FIG. 4 is a schematic view illustration of a portion of a fiber bragg grating (FBG) sensor 252 that may be utilized with components for determining position of a steerable assembly (e.g., a surgical instrument) within tissue of an animal body according to certain embodiments.
  • the FBG sensor 252 is embodied in an optical fiber 251 having a core 253 surrounded by cladding 255.
  • a portion of the core 253 constitutes an index modulation region 254 in which an index of refraction of glass material of the core 253 periodically varies.
  • an input signal 256A (having a propagating core mode) is transmitted through the core 253 and reaches the index modulation region 254, one spectral portion of the input signal is reflected to produce a reflected signal 256C, while another spectral portion is transmitted through the index modulation region 254 to provide a transmitted signal 256B.
  • the reflected signal 256C may be detected by a light detector associated with a FBG driver/detector unit (not shown), and analyzed to determine one or more of force, strain, or shape experienced by the FBG sensor 252.
  • one or more FBG sensors may be arranged in or on an elongated body structure of a steerable assembly, wherein an index modulation region may be provided proximate to a magnetic needle affixed to the elongated structure.
  • tissue clips are known.
  • One type of tissue clip includes hemostatic clips, which are useful to stop bleeding from openings created during surgery. In a simple form, these clips may be used these clips to grasp tissue surrounding a wound and bring ends of a wound together.
  • Endoscopic hemostatic clips are used to stop internal bleeding resulting from surgical procedures and/or tissue damage from disease, etc.
  • Specialized endoscopic clipping devices are used to deliver one or more clip to the desired location within a patient's body and to position and deploy the clip(s) at appropriate positions on the tissue. The endoscopic clipping device is then withdrawn, leaving the clip within the patient.
  • Endoscopic hemostatic clipping devices are designed to reach affected tissues within a patient's body, such as within the gastrointestinal tract, the pulmonary system, the vascular system, or within other lumens and ducts.
  • an endoscope is generally used to provide access to and visualization of the tissue to be treated.
  • An endoscopic clipping device may, for example, be introduced through a working lumen of the endoscope.
  • An endoscopic clipping device has to be sufficiently small to fit in the lumen of an endoscope and, at the same time, must be designed to provide for the positive placement and actuation of the hemostatic clip.
  • Feedback to the operator is preferably also provided so that the operator will not be confused as to whether the hemostatic clip has been properly locked in place on the tissue and released from the device before the device itself is withdrawn through the endoscope.
  • FIG. 5 is a side elevation view of a tissue clipping device 295 (e.g., hemostatic clipping device) configured for passage through an endoscope, wherein such view is reproduced from U.S. Patent No. 8,974,371 , which is hereby incorporated by reference herein.
  • This clipping device 295 is a hand operated tool that is used to insert a hemostatic clip through an endoscope lumen, position the clip over a wound, clamp it, and deploy it over the affected tissue. The tool is further designed to release the hemostatic clip once it has been clamped in place, and designed to be withdrawn through the endoscope.
  • the hemostatic clipping device 295 comprises three principal components, namely: a handle assembly 302, a shaft section 304, and a clip assembly 306, wherein a magnified view of the clip assembly 306 is provided in FIG. 5A.
  • the handle assembly 302 forms the component that supplies a mechanical actuation force to deploy and clamp the clip.
  • the clipping device 295 is hand operated.
  • the handle assembly 302 may be constructed in a manner similar to the type generally employed in endoscopic biopsy devices or in similar applications.
  • the handle assembly 302 allows the user to move a control wire 318 or other force transmission member, which extends through the shaft section 304 to the clip assembly 306 at a distal end of the clipping device 295.
  • the handle assembly 302 comprises a handle body 308 which can be grasped by the user to stabilize the device and apply a force to it.
  • a sliding spool 310 is connected to control wire 318 and is configured to slide along a slot 316 (which maintains alignment of the sliding spool 310 relative to the handle body 308), so that the user can easily pull or push the wire 318 as desired.
  • a user can manipulate the control wire 318 by grasping the handle body 308 and moving the sliding spool 310 along the slot 316.
  • a return spring 312 may be provided within the handle body 308 to bias the sliding spool 310, and thus the control wire 318 toward a desired position.
  • the handle assembly 302 also includes a connection portion 314, which receives the control wire 318 and attaches the shaft section 304 to the handle assembly 302. The control wire 318 transmits mechanical force applied to the handle 302 to the clip assembly 306.
  • a distal end of the control wire 318 ends in a ball 340 and is coupled (by a receiving socket 311 ) to a yoke 305 of the clip assembly 306 (all shown in FIG. 5A or FIG. 6).
  • the control wire 318 includes a reduced diameter section 342 that is designed to fail when a predetermined tension is applied thereto through the handle assembly 302, as useful to facilitate release of the clip assembly 306 from a remainder of the clipping device 295.
  • a wire stop 360 with flared fingers 362 is provided to prevent the clip assembly 306 from being pushed away from the bushing 303 before the ball 340 is separated from the control wire 318.
  • the shaft section 304 may include an inner sheath having a low friction bearing surface (e.g., formed of low friction material such as polytetrafluoroethylene, HDPE, or polypropylene, optionally supplemented with a biocompatible lubricant, such as a silicone lubricant.
  • the shaft section 304 may further include a slidable over-sheath 350, which may comprise a low friction polymer and which is designed to protect the inner lumen of the endoscope from the metal clip assembly 306 while the hemostatic clipping device 295 passes through a lumen of an endoscope (not shown).
  • the over-sheath 350 may be withdrawn to expose the distal portion of the clipping device.
  • the over-sheath 350 may include an elongated body 354 and a grip portion 349 designed as a handle to permit the oversheath 350 to be slid by a user over a shaft of the clipping device 295.
  • the clip assembly 306 is disposed at the distal end of the clipping device 295, and contains the mechanism that converts the proximal and distal movement of the control wire 318 into the actions necessary to deploy and release a hemostatic (tissue) clip 390.
  • FIG. 5A shows the clip assembly 306 with clip arms 309 in an open position
  • FIG. 6 shows the clip assembly 306 with the clip arms 309 in a closed position (e.g., prior to and during deployment through an endoscope).
  • the clip arms 309 include clip stop shoulders 322 and may contact a distal end 317 of the capsule 300.
  • the clip arms 309 also include a radius section 301 that approximately matches an inner diameter of the capsule 300 and applies a desired preload for frictional engagement therebetween, and include an intermediate section 309A arranged to curve inwardly when inside the capsule 300.
  • the clip assembly 306 includes a capsule 300 which provides a structural shell for the clip assembly 306, and clip arms 309 (having distal ends 353) which move between open and closed positions.
  • the clip assembly 306 further includes a bushing 303 attached to a coil 330 of the shaft section 304, a yoke 305 connecting to the ball 340 at an end of the control wire 318, and a tension member 307 that transmits forces applied by the control wire 318 to the clip arms 309, wherein the tension member 307 also biases proximal ends 352 of the clip arms 309 away from a center line of the device 300, with the proximal ends 352 being retained in overhangs 354 of the yoke 305.
  • a proximal end 307 of the capsule 300 slides over the distal end of the bushing 303, wherein a (releasable) locking arrangement between these components is provided by capsule tabs 313.
  • the clip assembly 306 is slidably mounted within the capsule 300 so that, when the clip assembly 306 is drawn proximally into the capsule 300, clip arms 309 of the clip assembly 306 are drawn together to a closed position, with an abutting surface of at least one of the clip arms 309 contacting a corresponding surface of the capsule 300 when the clip assembly 306 is drawn to a predetermined position within the capsule 300 to provide a first user feedback indicating closure of the clip assembly 306.
  • the tension member 307 connected to proximal ends 352 of the clip arms 309 biases the clip arms 309 toward an open, tissue receiving configuration.
  • the yoke 340 is slidably received within the capsule 300 and is releasably coupled to the tension member 307, with the yoke 340 including a ball cavity for receiving a ball connector 340 of a control wire 318 of the delivery device to maintain the clip assembly 306 coupled to the delivery device, wherein the control wire 318 is frangible to detach the yoke 305 from the delivery device and to provide a second user feedback and, wherein release of the yoke 305 from the tension member 307 provides a third user feedback.
  • a surgical clip of the type shown in FIGS. 5, 5A, and 6 may be rendered magnetically responsive by fashioning one or more portions of the surgical clip of premagnetized material.
  • a particularly preferred type of premagnetized material includes neodymium magnetic material, although other types of permanent magnetic materials or ferromagnetic materials could be used.
  • One or more premagnetized portions may include items such as a tubular body structure or elements within such a body structure, such as a yoke (configured to engage a control wire), a tension member (configured to outwardly bias arms of a grasping element), and/or an optional extension member intermediately coupled between the yoke and the tension member.
  • the grasping or affixing element is preferably not formed of a premagnetized material, so that application of an external magnetic field would not serve to inadvertently affect grasping or releasing of tissue.
  • Providing one or more elements of the surgical clip of premagnetized material preserves the familiar tissue clip form factor and deployment operation, but enables magnetic manipulation of tissues to which a surgical clip herein is affixed. This integrated approach is more streamlined than alternative designs using tethered magnetic weights (e.g., as suggested in FIG. 1 ).
  • FIG. 7 is a perspective view of a surgical clip 490 in an open position, the surgical clip including a tubular body structure 400 having an internal yoke (e.g., 405 in FIG. 8B) coupled to a tension member (e.g., 407 in FIG. 8B) element for biasing arms 408 that serve as a grasping element, with the surgical clip 490 including at least one premagnetized element according to one embodiment.
  • the tubular structure 400 includes a distal end 417 proximate to the arms 409, and includes a proximal end 415 along which tabs 413 are provided to permit releasable engagement with a bushing (403 in FIGS. 9 and 10A-10B).
  • Each arm 409 has an inwardly-facing shoulder 422.
  • FIGS. 8A and 8C are side elevational views of the surgical clip 490 of FIG. 7, while FIG. 8B is a cross-sectional view of the surgical clip 490 taken along section line 8B-8B shown in FIG. 8A, and FIG. 8D is a cross-sectional view of the surgical clip 490, taken along section line 8D-8D shown in FIG. 8C.
  • the arms 409 (which serve as a grasping element) are biased toward a longitudinal centerline by a tension member 407 that is intermediately arranged between the arms 409 and the yoke 405.
  • Inwardly curved portions 409A of the arms 409 are arranged between the shoulders 422 and the tension member 407, wherein portions of the arms 409 extend through the tension member 407, with proximal ends 452 of the arms 409 being engaged to the yoke 405.
  • the yoke 405 is arranged to receive a ball end 440 of a control wire 418.
  • the surgical clip 490 includes at least one premagnetized element according to one embodiment.
  • the yoke 405 alone, the tension member 407 alone, or both the yoke 405 and the tension member 407 comprise(s) premagnetized material.
  • FIG. 9 is a perspective view of the surgical clip 490 of FIG. 7, with the surgical clip 490 in an open position (i.e. , with the arms 409 spread apart relative to one another beyond the distal end 417 of the tubular member), in combination with a bushing portion 403 of an associated clipping device according to one embodiment.
  • FIG. 9 Although only a bushing portion 403 of a clipping device is shown, it is to be appreciated that various elements of a clipping device (e.g., clipping device 295 in FIGS. 5, 5A, and 6) as disclosed herein may be provided in combination with the surgical clip 490 of FIG. 9.
  • the tabs 413 along the proximal end of the tubular body structure 400 may be used to permit removable coupling between the bushing portion 403 and the tubular body structure 400.
  • a clipping device (and the bushing 403) used with the surgical clip 490 of FIG. 9 may resemble the clipping device 295 (incorporating bushing 303) previously described in connection with FIGS. 5, 5A, and
  • FIGS. 10A and 10C are side elevational views of the surgical clip 490 and clipping device portion (e.g., bushing 403) of FIG. 9, while FIG. 10B is a cross- sectional view of the same items (surgical clip 490 and bushing 403), taken along section line 10B-10B shown in FIG. 10A, and FIG. 10D is a cross-sectional view of the same items, taken along section line 10D-10D shown in FIG. 10C, with each view showing the surgical clip 490 in an open configuration.
  • FIGS. 10A and 10C are side elevational views of the surgical clip 490 and clipping device portion (e.g., bushing 403) of FIG. 9, while FIG. 10B is a cross- sectional view of the same items (surgical clip 490 and bushing 403), taken along section line 10B-10B shown in FIG. 10A, and FIG. 10D is a cross-sectional view of the same items, taken along section line 10D-10D shown in FIG. 10C, with each view showing the surgical clip 490 in
  • manipulation of one or more magnetic field sources e.g., 112-1 , 112-2 in FIG. 2 by adjusting position and/or field strength thereof applies force to premagnetized portions of the surgical clip 490, thereby permitting animal tissue retained between the arms 409 to be manipulated (e.g., tensioned and/or moved by pulling).
  • the surgical clip 490 may be released, such as by pulling on the tubular body structure 400 or other means, and the surgical clip 490 may be withdrawn through a passage of a surgical instrument such an endoscope.
  • a surgical clip having an extension member arranged between at least a portion of a yoke and at least a portion of a tension member, with the extension member optionally comprising a premagnetized material, will now be described.
  • One advantage of providing an extension member of premagnetized material is that a desired magnetic field strength may be adjusted by selecting a suitable length of the extension member, without sacrificing function of the yoke and the tension member.
  • an extension member may be coupled between portions of a yoke.
  • an extension member may be coupled between a portion of a yoke and a portion of a tension member.
  • FIG. 11 is a perspective view of a surgical clip 590 (being longer in character than the embodiment shown in FIGS. 7 to 10D) in an open position, the surgical clip 590 including a tubular body structure 500 having an internal yoke (e.g., yoke portions 505A, 505B in FIG. 12B), an extension member (e.g., 519 in FIG.
  • an internal yoke e.g., yoke portions 505A, 505B in FIG. 12B
  • an extension member e.g., 519 in FIG.
  • the tubular structure 500 includes a distal end 517 proximate to the arms 509, and includes a proximal end 515 along which tabs 513 are provided to permit releasable engagement with a bushing (503 in FIGS. 13 and 14A-14D).
  • Each arm 509 has an inwardly-facing shoulder 522.
  • FIGS. 12A and 12C are side elevational views of the surgical clip 590 of FIG. 11
  • FIG. 12B is a cross-sectional view of the surgical clip 590 taken along section line 12B-12B shown in FIG. 12A
  • FIG. 12D is a cross-sectional view of the surgical clip 590, taken along section line 12D-12D shown in FIG. 12C.
  • the arms 409 (which serve as a grasping element) are biased toward a longitudinal centerline by a tension member 507 that is intermediately arranged between the arms 509 and a distal yoke portion 505B.
  • Inwardly curved portions 509A of the arms 509 are arranged between the shoulders 522 and the tension member 507, wherein portions of the arms 509 extend through the tension member 507, with proximal ends 552 of the arms 509 being engaged to the distal yoke portion 505B.
  • An extension member 519 is coupled between the distal yoke portion 505B and a proximal yoke portion 505A. As shown in FIGS. 12B and 12D, the proximal yoke portion 505A is arranged to receive a ball end 540 of a control wire 518.
  • one, some, or all of the extension member 519, the tension member 507, the distal yoke portion 505B, and the proximal yoke portion 505A may comprise a premagnetized material.
  • FIG. 13 is a perspective view of the surgical clip 590 of FIG. 11 (and FIGS. 12A-12D), with the surgical clip 590 in an open position (i.e., with the arms 509 spread apart relative to one another beyond the distal end 517 of the tubular member), in combination with a bushing portion 503 of an associated clipping device according to one embodiment.
  • a bushing portion 503 of a clipping device is shown, it is to be appreciated that various elements of a clipping device (e.g., clipping device 295 in FIGS. 5, 5A, and 6) as disclosed herein may be provided in combination with the surgical clip 590 of FIG. 13.
  • the tabs 513 along the proximal end of the tubular body structure 500 may be used to permit removable coupling between the bushing portion 503 and the tubular body structure 500.
  • a clipping device (and the bushing 503) used with the surgical clip 590 of FIG. 13 may resemble the clipping device 295 (incorporating bushing 303) previously described in connection with FIGS. 5, 5A, and 6 in structure and function.
  • FIGS. 14A and 14C are side elevational views of the surgical clip 590 and clipping device portion (e.g., bushing 503) of FIG. 13, while FIG. 14B is a cross- sectional view of the same items (surgical clip 590 and bushing 503), taken along section line 14B-14B shown in FIG. 14A, and FIG. 14D is a cross-sectional view of the same items, taken along section line 14D-14D shown in FIG. 14C, with each view showing the surgical clip 590 in an open configuration.
  • a bushing portion 503 of a clipping device is shown, it is to be appreciated that various elements of a clipping device (e.g., clipping device 295 in FIGS.
  • FIGS. 14B and 14D advancement of the wire 518 and the yoke 507 toward the distal end 517 of the tubular body structure cause the inwardly curved portions 509A of the arms 509 to extend beyond the distal end 517, causing the arms 509 to spread apart and thereby place the surgical clip 590 into an open position. Movement of the wire 518 in an opposite direction (i.e., away from the distal end 517) will cause the arms to retract 509 into the tubular body structure 500 to place the surgical clip 590 into a closed position (as shown in FIGS. 7 and 8A-8D).
  • the surgical clip 590 is operated in substantially the same manner as the surgical clip 490 described previously herein, with the extension member 519 serving to transmit force between the distal and proximal yoke portions 505B, 505A.
  • the surgical clip 590 may be fed through a bore or channel of an elongated tubular structure of a surgical instrument (e.g., the endoscopic device 70 of FIG. 1 or the elongated structure 152 of FIG. 2) into an animal body (e.g., 110 in FIG. 2).
  • Actuation of a surgical instrument permits the wire 518 of the surgical clip 590 to be selectively opened or closed, thereby permitting the surgical clip 590 to grasp tissue (within the animal body) between the arms 509.
  • FIGS. 5, 5A, and 6 Further manipulation of the surgical instrument may permit the surgical clip 590 to be released from a bushing 503 (and remaining portions of a clipping device (e.g., clipping device 295 shown in FIGS. 5, 5A, and 6)).
  • a clipping device e.g., clipping device 295 shown in FIGS. 5, 5A, and 6
  • manipulation of one or more magnetic field sources e.g., 112-1 , 112-2 in FIG. 2 by adjusting position and/or field strength thereof applies force to premagnetized portions of the surgical clip 590, thereby permitting animal tissue retained between the arms 509 to be manipulated (e.g., tensioned and/or moved by pulling).
  • the surgical clip 590 may be released, such as by pulling on the tubular body structure 500 or other means, and the surgical clip 590 may be withdrawn through a passage of a surgical instrument such an endoscope.
  • FIG. 15 is schematic diagram of a generalized representation of a computer system 600 that can be included as one or more components of a system or method for manipulating tissue during a surgical procedure as disclosed herein, according to one embodiment.
  • the computer system 600 may be adapted to execute instructions from a computer-readable medium to perform these and/or any of the functions or processing steps described herein.
  • the computer system 600 may include a set of instructions that may be executed to program and configure programmable digital signal processing circuits for supporting scaling of supported communications services.
  • the computer system 600 may be connected (e.g., networked) to other machines in a local area network (LAN), an intranet, an extranet, or the Internet.
  • LAN local area network
  • intranet an intranet
  • extranet or the Internet.

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  • Surgical Instruments (AREA)

Abstract

L'invention concerne une pince chirurgicale, pourvue d'un ou de plusieurs éléments prémagnétisés, qui est conçue pour être apportée avec un endoscope ou un dispositif similaire, ainsi qu'un système et un procédé de manipulation d'un tissu pendant une intervention chirurgicale à l'aide d'une telle pince chirurgicale. Au moins une source de champ magnétique disposée à l'extérieur d'un corps animal est déplacée à l'aide d'au moins un actionneur robotique et un champ magnétique généré par celle-ci est utilisé pour modifier la position d'une ou de plusieurs pinces chirurgicales fixées au tissu. Une pince chirurgicale comprend une structure de corps tubulaire, un élément de préhension et des éléments internes à l'intérieur de la structure de corps, au moins des parties de la structure de corps et/ou des éléments internes comprenant un matériau prémagnétisé, conçu pour coopérer avec un effecteur terminal magnétique externe au corps animal, afin de permettre la manipulation de tissu.
PCT/US2024/045669 2023-09-08 2024-09-06 Pince chirurgicale magnétique, système et procédé associés de manipulation de tissu Pending WO2025054512A1 (fr)

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US202363581410P 2023-09-08 2023-09-08
US63/581,410 2023-09-08

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090054728A1 (en) * 2007-08-21 2009-02-26 Trusty Robert M Manipulatable guide system and methods for natural orifice translumenal endoscopic surgery
US20090306686A1 (en) * 2006-06-30 2009-12-10 Jichi Medical University Medical holding apparatus and method of using medical holding apparatus
US20190125339A1 (en) * 2017-10-30 2019-05-02 Ethicon Llc Clip applier comprising clip advancing systems
US20200289140A1 (en) * 2014-01-21 2020-09-17 Levita Magnetics International Corp. Laparoscopic graspers and systems therefor

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090306686A1 (en) * 2006-06-30 2009-12-10 Jichi Medical University Medical holding apparatus and method of using medical holding apparatus
US20090054728A1 (en) * 2007-08-21 2009-02-26 Trusty Robert M Manipulatable guide system and methods for natural orifice translumenal endoscopic surgery
US20200289140A1 (en) * 2014-01-21 2020-09-17 Levita Magnetics International Corp. Laparoscopic graspers and systems therefor
US20190125339A1 (en) * 2017-10-30 2019-05-02 Ethicon Llc Clip applier comprising clip advancing systems

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