Classifications

• • 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
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
  • A61B1/005—Flexible endoscopes
  • A61B1/0051—Flexible endoscopes with controlled bending of insertion part
  • A61B1/0052—Constructional details of control elements, e.g. handles
  • A61B1/0053—Constructional details of control elements, e.g. handles using distributed actuators, e.g. artificial muscles
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
  • A61B1/005—Flexible endoscopes
  • A61B1/0051—Flexible endoscopes with controlled bending of insertion part
  • A61B1/0055—Constructional details of insertion parts, e.g. vertebral elements
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
  • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
  • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
  • A61B17/07207—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously the staples being applied sequentially
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
  • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
  • A61B18/14—Probes or electrodes therefor
  • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
• • 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
  • A61B34/71—Manipulators operated by drive cable mechanisms
• • 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
  • A61B34/77—Manipulators with motion or force scaling
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B25—HAND TOOLS; PORTABLE POWER-DRIVEN TOOLS; MANIPULATORS
  • B25J—MANIPULATORS; CHAMBERS PROVIDED WITH MANIPULATION DEVICES
  • B25J13/00—Controls for manipulators
  • B25J13/02—Hand grip control means
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B25—HAND TOOLS; PORTABLE POWER-DRIVEN TOOLS; MANIPULATORS
  • B25J—MANIPULATORS; CHAMBERS PROVIDED WITH MANIPULATION DEVICES
  • B25J18/00—Arms
  • B25J18/06—Arms flexible
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B25—HAND TOOLS; PORTABLE POWER-DRIVEN TOOLS; MANIPULATORS
  • B25J—MANIPULATORS; CHAMBERS PROVIDED WITH MANIPULATION DEVICES
  • B25J9/00—Programme-controlled manipulators
  • B25J9/06—Programme-controlled manipulators characterised by multi-articulated arms
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B25—HAND TOOLS; PORTABLE POWER-DRIVEN TOOLS; MANIPULATORS
  • B25J—MANIPULATORS; CHAMBERS PROVIDED WITH MANIPULATION DEVICES
  • B25J9/00—Programme-controlled manipulators
  • B25J9/10—Programme-controlled manipulators characterised by positioning means for manipulator elements
  • B25J9/104—Programme-controlled manipulators characterised by positioning means for manipulator elements with cables, chains or ribbons
• • 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
  • A61B2017/003—Steerable
  • A61B2017/00318—Steering mechanisms
  • A61B2017/00323—Cables or rods
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/0042—Surgical instruments, devices or methods with special provisions for gripping
  • A61B2017/00424—Surgical instruments, devices or methods with special provisions for gripping ergonomic, e.g. fitting in fist
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/0042—Surgical instruments, devices or methods with special provisions for gripping
  • A61B2017/00438—Surgical instruments, devices or methods with special provisions for gripping connectable to a finger
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/28—Surgical forceps
  • A61B17/29—Forceps for use in minimally invasive surgery
  • A61B2017/2901—Details of shaft
  • A61B2017/2905—Details of shaft flexible
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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  • A61B17/28—Surgical forceps
  • A61B17/29—Forceps for use in minimally invasive surgery
  • A61B2017/2926—Details of heads or jaws
  • A61B2017/2927—Details of heads or jaws the angular position of the head being adjustable with respect to the shaft
• • 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
  • A61B2034/305—Details of wrist mechanisms at distal ends of robotic arms
  • A61B2034/306—Wrists with multiple vertebrae
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/03—Automatic limiting or abutting means, e.g. for safety
  • A61B2090/038—Automatic limiting or abutting means, e.g. for safety during shipment
• • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
  • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
  • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
  • Y10S901/00—Robots
  • Y10S901/19—Drive system for arm
  • Y10S901/21—Flaccid drive element
• • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
  • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
  • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
  • Y10T74/00—Machine element or mechanism
  • Y10T74/20—Control lever and linkage systems
  • Y10T74/20207—Multiple controlling elements for single controlled element
  • Y10T74/20305—Robotic arm
  • Y10T74/20323—Robotic arm including flaccid drive element
• • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
  • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
  • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
  • Y10T74/00—Machine element or mechanism
  • Y10T74/20—Control lever and linkage systems
  • Y10T74/20396—Hand operated
  • Y10T74/20402—Flexible transmitter [e.g., Bowden cable]

Definitions

• This invention relates to articulating mechanisms and applications thereof, including the remote guidance and manipulation of surgical or diagnostic instruments and tools.
• this invention relates to hand-actuated mechanisms for the remote manipulation of body tissue.
• procedures such as endoscopy and laparoscopy typically employ instruments that are steered within or towards a target organ or tissue from a position outside the body.
• endoscopic procedures include sigmoidoscopy, colonoscopy, esophagogastroduodenoscopy, and bronchoscopy.
• the insertion tube of an endoscope is advanced by pushing it forward, and retracted by pulling it back.
• the tip of the tube may be directed by twisting and general up/down and left/right movements. Oftentimes, this limited range of motion makes it difficult to negotiate acute angles (e.g., in the rectosigmoid colon), creating patient discomfort and increasing the risk of trauma to surrounding tissues.
• Laparoscopy involves the placement of trocar ports according to anatomical landmarks.
• the number of ports usually varies with the intended procedure and number of instruments required to obtain satisfactory tissue mobilization and exposure of the operative field.
• benefits of laparoscopic surgery e.g., less postoperative pain, early mobilization, and decreased adhesion formation, it is often difficult to achieve optimal retraction of organs and maneuverability of conventional instruments through laparoscopic ports. In some cases, these deficiencies may lead to increased operative time or imprecise placement of components such as staples and sutures.
• Steerable catheters are also well known for both diagnostic and therapeutic applications. Similar to endoscopes, such catheters include tips that can be directed in generally limited ranges of motion to navigate a patient's vasculature. [0007] There have been many attempts to design endoscopes and catheters with improved steerability. For example, U.S. 3,557,780 to Sato; U.S. 5,271,381 to Ailinger et al; U.S. 5,916,146 to Alotta et al.; and U.S. 6,270,453 to Sakai describe endoscopic . instruments with one or more flexible portions that may be bent by actuation of a single set of wires.
• the wires are actuated from the proximal end of the instrument by rotating pinions (Sato), manipulating knobs (Ailinger et al.), a steerable arm (Alotta et al.), or by a pulley mechanism (Sato).
• U.S. 5,916,147 to Boury et al. discloses a steerable catheter having four wires that run within the catheter wall. Each wire terminates at a different part of the catheter. The proximal end of the wires extend loosely from the catheter so that the physician may pull them. The physician is able to shape and thereby steer the catheter by selectively placing the wires under tension.
• each of the devices described above are remotely steerable, their range of motion is generally limited, at least in part because typically only a single cable set is employed in connecting links or segments of the steerable elements. As such, independent movement at each link or segment is not possible. Rather, the distal links or segments bend together as a unit or units.
• the steering mechanisms may also be laborious to use, such as in the catheter of Boury et al. where each wire must be separately pulled to shape the catheter. Further, in the case of, e.g., endoscopes and steerable catheters that use knob and pulley mechanisms, it requires a significant amount of training to become proficient in maneuvering the device through a patient's anatomy.
• a device with enhanced remote maneuverability to controllably navigate complex anatomy may allow more efficient and precise advancement and deployment of surgical and diagnostic instruments and tools, as well as help decrease trauma to surrounding tissues, minimize patient discomfort, and decrease operative time and perhaps even patient morbidity during various surgical procedures. It would also be advantageous for such a device to provide a more intuitive and facile user interface to achieve such enhanced maneuverability.
• a user interface that accurately translates finger movement of the human hand to a surgical instrument or tool is one way of achieving remote enhanced maneuverability.
• the present invention provides an articulating mechanism useful for a variety of purposes including but not limited to the remote manipulation of instruments such as surgical or diagnostic instruments or tools, including but not limited to endoscopes, catheters, Doppler flow meters, microphones, probes, retractors, dissectors, staplers, clamps, graspers, scissors or cutters, ablation or cauterizing elements, and the like.
• the articulating mechanism may be used to steer these instruments within a body region or to a target site within a body region of a patient, and can further be employed to actuate or facilitate actuation of such instruments and tools.
• the articulating mechanism includes multiple pairs of links, each link of each pair being maintained in a spaced apart relationship relative to the other link of the pair, and multiple sets of cables, with each cable set connecting the links of a discrete pair to one another and terminating at the links of each discrete pair, such that movement of one link of a pair causes corresponding relative movement of the other link of the pair.
• the relative movement at the distal end of the articulating mechanism corresponds to that at the proximal end.
• the articulating mechanism includes a continuous flexible member.
• the continuous flexible member includes multiple pairs of segments, with each segment of each pair being maintained in a spaced apart relationship relative to the other segment of the pair, and multiple sets of cables, with each set connecting the segments of a discrete pair to one another and terminating at the segments of each discrete pair, such that movement of one segment of a pair causes corresponding relative movement of the other segment of the pair.
• the continuous flexible member may be, e.g., a catheter with a plurality of lumens, where each cable set terminates at a different axial location along the length of the catheter.
• the continuous flexible member may have a helical arrangement, with each segment corresponding to one turn of the helix.
• Variations of the articulating mechanism can also include segments or links that may include a channel for receiving a locking rod that can secure and retain the proximal end of the articulating mechanism in a fixed position.
• a locking sleeve may be fitted over the proximal end of the mechanism to secure and retain the proximal end in a fixed position.
• a surgical or diagnostic tool may be attached to, and extend from, the distal end of articulating mechanisms according to the invention, or the articulating mechanisms may be otherwise incorporated into such tools.
• surgical or diagnostic tools include, but are not limited to, endoscopes, catheters, Doppler flow meters, microphones, probes, retractors, dissectors, staplers, clamps, graspers, scissors or cutters, and ablation or cauterizing elements.
• a plurality of articulating mechanisms may also be combined in such a way that a user's finger movements can be remotely mimicked to manipulate an object or body tissue.
• the mechanisms form a hand-actuated apparatus that includes multiple pairs of links, with each link of each discrete pair being maintained in a spaced apart relationship relative to the other link of the pair, the links incorporated into proximal and distal ends of the apparatus with the links of corresponding pairs located on the proximal and distal ends respectively, multiple sets of cables, with each set connecting the links of a discrete pair to one another, and a user hand interface at a proximal end of the apparatus configured to removably secure one or more digits of a human hand for movement, such that movement of said digit when secured to the interface moves one or more links of a pair at said proximal end and causes corresponding relative movement of the other one or more links of the pair at a distal end of the apparatus.
• the hand-actuated apparatus includes a proximal end having a user hand interface configured to removably secure one or more digits of a human hand for movement, such that flexion of the digit when secured is translated into a bending movement at the distal end effector portion.
• the user hand interface includes a finger slide where translational movement of the finger slide is translated into a bending movement at the effector portion.
• the hand-actuated devices of this invention also include one or more joints at their proximal and distal ends that have the range of motion of a distal interphalangeal (DIP) joint, proximal interphalangeal (PIP) joint, or metacarpal phalangeal (MCP) joint.
• DIP distal interphalangeal
• PIP proximal interphalangeal
• MCP metacarpal phalangeal
• control of movement of a proximal joint is independent of control of one or more distal joints, e.g., a PIP joint or DIP joint.
• movement at the proximal end of the device e.g., movement of one link of a pair or translational movement of a finger slide
• movement at the distal end of the mechanism is proportionally scaled to the movement at the distal end of the mechanism, e.g., at the other link of the pair or at the effector portion.
• Figures 1 A-IE show perspective views of an articulating mechanism according to one variation of the invention, with multiple pairs of links connected by corresponding sets of cables.
• Figure IA shows the mechanism in its natural configuration.
• Figures IB to IE show the mechanism in various states of manipulation.
• Figure IF is a perspective view of the distal end of an articulating mechanism similar to that of Figure IA with the end manipulated into multiple curvatures.
• Figures 2A-2E depict end, side, and perspective views of a link for use in an articulating mechanism according to another variation of the invention.
• Figures 3A-3C are cross-sectional views of links similar to those of Figures
• Figure 3D is a cross-sectional view of links for use in an articulating mechanism according to another variation of the invention with spherical elements disposed between the links.
• Figure 3E is a cross-sectional view of links and spherical elements similar to those of 3D and which also include a center channel extending through and communicating between the links and spherical elements.
• Figures 4A-4C are cross-sectional views of links for use in an articulating mechanism according to a variation of the invention showing various modes of connecting cables to the links.
• Figures 5A and 5B show an individual link for use in an articulating mechanism according to another variation of the invention.
• Figure 5 A is a perspective view.
• Figure SB is an end view.
• the depicted link includes lumens and channels for receiving and passing through of cables and other elements.
• Figures 6A-6C show perspective views of articulating mechanisms associated with a surgical clamp according to variations of the invention.
• Figure 7 is a perspective view of an articulating mechanism associated with a catheter according to a variation of the invention.
• Figure 8 is a perspective view of an articulating mechanism associated with an endoscope according to another variation of the invention.
• Figures 9A and 9B are perspective views of an articulating mechanism used to remotely form a retractor.
• the retractor is "u" shaped.
• the retractor has a triangular retracting surface.
• Figure 9C is a perspective view of an articulating mechanism according to another variation of the invention where the mechanism is attached to the hand of a user.
• Figures 1 OA-I OB show perspective views of an articulating mechanism according to another variation of the invention having a continuous flexible member that includes helical segments with multiple pairs of such segments connected by corresponding sets of cables.
• Figure 1OB is an enlarged view, with parts broken away, of the helical segments shown in Figure 1OA.
• Figure 11 is a perspective view of an articulating mechanism according to yet another variation of the invention having a continuous flexible member with a plurality of through lumens with multiple pairs of segments connected by corresponding sets of cables.
• Figures 12A-12B are perspective views of distal ends of an articulating mechanism according to a further variation of the invention having attached tissue ablation elements.
• Figures 13A-13F show the distal end of an articulating mechanism according to Figure 12 being remotely maneuvered to create ablative cardiac lesions.
• Figure 14 is a perspective view of a hand-actuated apparatus having finger loops according to one variation of the invention. The apparatus is shown in an unactuated state.
• Figure 15 shows placement of a human hand in the hand-actuated apparatus of
• Figure 16 is an expanded perspective view of the finger loops of Figure 14.
• Figure 17 is a perspective view of the hand-actuated apparatus of Figure 15 in an actuated state.
• Figure 18 is a perspective view of a hand-actuated apparatus having finger slides according to one variation of the invention. The apparatus is shown in an unactuated state.
• Figure 19 shows placement of a human hand in the hand-actuated apparatus of
• Figure 20 is a perspective view of the hand-actuated apparatus of Figure 19 in an actuated state.
• Figure 21 is a perspective view of a handle of the hand-actuated device according to one variation of the invention.
• Figure 22 is a side view of the slide mechanism according to one variation of the invention.
• Figure 23 is a side view of the slide mechanism according to Figure 18.
• Figure 24 is a perspective view of the slide mechanism of Figure 23, partially disassembled.
• Figure 25 is a cross-sectional view of the slide mechanism of Figure 23, taken along line B-B, showing an end joint roller having twice the diameter of a middle joint roller.
• Figure 26 is a perspective view of the slide mechanism of Figure 23 showing the cable connections to the rollers and a base joint according to one variation of the invention.
• Figure 27 is a perspective view of a handle showing routing of cables.
• Figure 28 is an expanded perspective view of a molded handle of a user hand interface according to one variation of the invention, with cables traveling through channels in the interface.
• Figure 29 is an expanded cross-sectional view of a hollow handle of a user hand interface according to another variation of the invention showing the cables being routed by a pulley.
• Figure 30 is an expanded cutaway view of the effector portion of the hand- actuated apparatus of Figure 14.
• Figures 31 A-31 C are expanded cutaway views of the effector j oints in Figure
• Figure 32 is an expanded side view of the effector joints in Figures 31 A and
• Figure 33 is an expanded side view of the effector joint in Figure 31C with the joints vertically oriented.
• Figure 34 is an exploded view of an effector link that forms a part of the effector portion of Figure 30.
• Articulating mechanisms generally include multiple pairs of links or segments and multiple sets of cables.
• the articulating mechanisms may be made from individual, spaced apart segments, i.e., links, or from segments formed from a continuous flexible member.
• the terms "link” and “segment” as used herein refer to a discrete portion or defined area at one end of the mechanism that corresponds to another discrete portion or defined area at the opposite end of the mechanism.
• the articulating mechanism will include a plurality of links or segments that are members of discrete pairs.
• the links or segments form a proximal end and a distal end, with one link or segment of each pair being situated at the proximal end, and the other link or segment at the distal end.
• links or segments formed from a continuous flexible member may be in the form of, e.g., a continuous tube, or may be situated in, e.g., a helical arrangement, where each segment corresponds to one turn of the helix.
• Each cable set connects the links or segments of a discrete pair to one another so that movement of one link or segment of a pair causes a corresponding movement of the other link or segment in the pair.
• the ability to manipulate individual links allows for the mechanism to readily form complex three-dimensional configurations and geometries as is further detailed herein.
• instrument and “tool” are herein used interchangeably and refer to devices that are usually handled by a user to accomplish a specific purpose.
• region refers to any solid organ (e.g., liver, kidney, brain, heart) or hollow organ (e.g., esophagus, intestines, stomach, bladder), any solid or luminal (e.g., blood vessels or ducts) tissue, or any body cavity (e.g., sinus, pleural or peritoneal space), in their diseased or nondiseased state.
• any solid organ e.g., liver, kidney, brain, heart
• hollow organ e.g., esophagus, intestines, stomach, bladder
• any solid or luminal e.g., blood vessels or ducts
• body cavity e.g., sinus, pleural or peritoneal space
• articulating mechanism 100 includes a plurality of links 102 that form a proximal end 106 and a distal end 108.
• Links A 1 and A 2 , B 1 and B 2 , and D 1 and D 2 are members of a discrete pair, and one link of a pair is at the proximal end 106 while the other is at the distal end 108.
• Links C 1 and C 2 are spacer links, as will be described in greater detail herein.
• the proximal links (A 1 , B 1 , D 1 ) are connected to the distal links (A 2, B 2> D 2 ) by cables 104.
• a spacer element 112 is disposed between the proximal end 106 and the distal end 108 to separate the proximal links from the distal links and to maintain them in a spaced apart relationship.
• the spacer element 112 may be of any length appropriate to the intended application, and is typically hollow so that it may accommodate all the cables 104 that connect the link pairs, as well as additional cables, wires, fiberoptics or other like elements associated with a desired tool or instrument used in conjunction with the mechanism.
• the links may be of any size and shape, as the purpose dictates, but their form usually depends on such factors as patient age, anatomy of the region of interest, intended application, and surgeon preference.
• Links 102 for example, are generally cylindrical, and include channels for passage of the cables that connect the link pairs as well as additional cables, wires, fiberoptics or other like elements associated with a desired tool or instrument used in conjunction with the mechanism.
• the channel diameters are usually slightly larger than the cable diameters, creating a slip fit.
• the links may also include one or more channels for receiving elements of attachable surgical instruments or diagnostic tools or for passage of cables that actuate them.
• the links may typically have a diameter from about 0.5 mm to about 15 mm or more depending on the application.
• representative diameters may range from about 2 mm to about 3 mm for small endoscopic instruments, about 5 mm to about 7 mm for mid-sized endoscopic instruments, and about 10 mm to about 15 mm for large endoscopic instruments.
• the diameter may range from about 1 mm to about 5 mm.
• Overall length of the links will vary, usually depending on the bend radius desired between links.
• links 200 are generally cylindrical and also include stem portion 202. Links 200 may be aligned so that the distal end 206 of stem portion 202 engages a corresponding recess 208 formed in the surface 210 of an adjacent segment.
• the distal end of the stem portion may be of various shapes.
• links 200a and 200b have convex ends 206a and 206b, respectively, ( Figures 3A, 3B) whereas link 200c has a ball-shaped end 206c ( Figure 3C).
• the corresponding recesses may be of various corresponding shapes, e.g., concave as in recesses 206b and 206c ( Figures 3B and 3C) or cone-shaped as in recess 206a ( Figure 3A), so long as it permits each link to engage one another and does not restrict the required range of motion for the articulating mechanism.
• the stem portion 202 may typically have a length between about 0.5 mm to greater than about 15 mm and a diameter between about 0.5 mm to about 2.5 mm. For endoscopic applications, the stem diameter may range from about 1 mm to about 1.5 mm.
• Links 200 also include a plurality of channels 212 for passage of the cables that connect the link pairs, as shown in Figures 2A-2E.
• Link 500 as shown in Figure 5, is designed with an attachment channel 502 that communicates with the segment exterior and is located toward the periphery of the segment, for mounting other elements, e.g., energy sources (for ablation or coagulation) or fiberoptics, or flexible endosocopes, at the distal end of the articulating mechanism.
• More than one link or segment may include an attachment channel so that the attachment channel may extend from the distal end to the proximal end of the mechanism. Cables, wires, fiberoptics, flexible endoscopes and the like, may also be run through a central channel 504 if desired.
• the links or segments may be made from any biocompatible material including, but not limited to, stainless steel; titanium; tantalum; and any of their alloys; and polymers, e.g., polyethylene or copolymers thereof, polyethylene terephthalate or copolymers thereof, nylon, silicone, polyurethanes, fluoropolymers, poly (vinylchloride); and combinations thereof.
• biocompatible material including, but not limited to, stainless steel; titanium; tantalum; and any of their alloys; and polymers, e.g., polyethylene or copolymers thereof, polyethylene terephthalate or copolymers thereof, nylon, silicone, polyurethanes, fluoropolymers, poly (vinylchloride); and combinations thereof.
• a lubricious coating may be placed on the links or segments if desired to facilitate advancement of the articulating mechanism.
• the lubricious coating may include hydrophilic polymers such as polyvinylpyrrolidone, fluoropolymers such as tetrafluoroethylene, or silicones.
• a radioopaque marker may also be included on one or more segments to indicate the location of the articulating mechanism upon radiographic imaging. Usually, the marker will be detected by fluoroscopy.
• Each link or segment at the proximal end of the articulating mechanism is connected to its corresponding link or segment at the distal end by two or more cables.
• Each cable set may be made up of at least two cables. As noted, movement of one pair is controlled by its corresponding cable set and is independent of any other pair. In certain variations, for example, a cable set will include three cables spaced 120 degrees apart. By using a set of three cables to connect each link or segment pair, each link or segment pair can be manipulated or moved in three degrees of freedom, independently of any other pairs. By combining a plurality of link or segment pairs, multiple degrees of freedom are achieved, allowing the articulating mechanism to be shaped into various complex configurations.
• the variation shown in Figure IF has a total of nine link pairs each independently connected by sets of three cables each, for possible motion in 27 degrees of freedom.
• Such multiple degrees of freedom are not available in typical conventional mechanisms where only a single set of cables is employed to manipulate the links.
• Cable diameters vary according to the application, and may range from about
• a representative diameter may range from about 0.15 mm to about 0.75 mm.
• a representative diameter may range from about 0.5 mm to about 3 mm.
• Cable flexibility may be varied, for instance, by the type and weave of cable materials or by physical or chemical treatments. Usually, cable stiffness or flexibility will be modified according to that required by the intended application of the articulating mechanism.
• the cables may be individual or multi-stranded wires made from material, including but not limited to biocompatible materials such as nickel-titanium alloy, stainless steel or any of its alloys, superelastic alloys, carbon fibers, polymers, e.g., poly (vinylchloride), polyoxyethylene, polyethylene terephthalate and other polyesters, polyolefin, polypropylene, and copolymers thereof; nylon; silk; and combinations thereof, or other suitable materials known in the art.
• biocompatible materials such as nickel-titanium alloy, stainless steel or any of its alloys, superelastic alloys, carbon fibers, polymers, e.g., poly (vinylchloride), polyoxyethylene, polyethylene terephthalate and other polyesters, polyolefin, polypropy
• cables fixed to a proximal link travel through a spacer element 112 to connect with a corresponding distal link of the pair.
• movement of proximal links results in inverted, reciprocal movement of distal links.
• the cables can be twisted or rotated 180 degrees while running through the spacer element 112 so that the reciprocal movement at the distal end 108 is mirrored.
• the articulating mechanisms of this invention may be configured to include cables twisted in any amount between 0 degrees to 360 degrees to provide for 360 degree range of reciprocal motion.
• the cables may be affixed to the links of a pair according to ways known in the art, such as by using an adhesive or by brazing, soldering, welding, and the like.
• Figure 4a shows cable 401 affixed within channel 402 of link 410 in such manner.
• a cable terminator 400 is mounted, e.g. crimped, brazed, welded, or glued, onto cable end 404 to prevent its slippage through the channel 402.
• the cable terminators 400 are swaged to form a chamfer within channel 402 so that a friction fit is made between the cable end 404 and cable terminators 400.
• Figures 1OA and 1OB show a variation of the invention.
• the segments of articulating mechanism 130 are formed from a continuous flexible member, depicted as an elongated coil. Each turn of the coil is a helical segment 131 of the articulating mechanism.
• the segments 131 are of a thickness that allow channels 105 to run through them, parallel to the axis of the coil.
• the helical segments at the proximal end 107 fonn discrete pairs with segments at the distal end 109. Each segment pair is connected by its own set of cables 111.
• a spacer element 113 is also disposed between the proximal end 107 and distal end 109 to separate the proximal segments from the distal segments.
• articulating mechanism 132 is formed of a continuous tube 115 having multiple lumens 117 running through the entire length of the tube.
• the continuous tube 115 may also optionally include central lumen 119.
• Cable sets may run the length of the tube and be anchored at varying corresponding axial locations at the proximal and distal ends with, e.g., an epoxy, or run between each segment of a pair and be anchored at or in the vicinity of each segment at the proximal and distal end.
• one cable set may be anchored at A 1 , another at Bi, and another at C 1 .
• Each cable set would then be anchored at a corresponding location at the mechanism distal end 123, e.g., at locations A 2 , B 2 , and C 2 .
• the cables that run between segment pairs may be precisely cut to a certain length, but if desired, may be cut to approximate that length.
• One method of placing the cables involves advancing the cables through the lumens using a pusher. A visual marker or tactile stop on the pusher would indicate how far to advance the pusher.
• a needle may be introduced into each lumen to deposit epoxy from, e.g., a syringe exterior to the tube, at each cable end.
• the needle may be directed to puncture through the wall of the tube at or near each desired cable attachment point to deliver epoxy to the cable at the desired point, thereby attaching each cable to each corresponding segment pair.
• articulating mechanism 101 of Figure IF has nine link pairs.
• Spacer links i.e., links not connected by discrete sets of cables (e.g., C 1 and
• C 2 in Figures 1 A-IE may also be included in the articulating mechanisms.
• These links can be inserted between active links at either the proximal or distal ends or both, and act as passive links that are not independently actuatable, but do allow for pass through of cable sets to neighboring active links.
• Spacer links can be desirable for providing additional length to the proximal or distal end.
• the inclusion of spacer links at one end of the mechanism allows for the proportional scaling of movement or motion of the corresponding other end. For example, the inclusion of spacer links at the distal end would require a more exaggerated movement by the user at the proximal end to achieve to achieve the desired motion at the distal end.
• spacer links could be provided on the proximal end, in which case the degree of distal end movements would be proportionally greater than those of the proximal end, which may also be desirable for particular applications.
• the articulating mechanisms of this invention may be used to direct a surgical or diagnostic instrument tool within a body region or to a target site within a body region of a patient either in its native, straight configuration, or after undergoing various manipulations at its proximal end from a location outside the patient.
• movement of the proximal end of the mechanism results in reciprocal movement at the distal end.
• the resulting directional movement of the distal end can be inverted, mirrored or otherwise, depending on the degree of rotation of the proximal end relative to the distal end.
• the proximal end provides for a user interface to control the steering and manipulation of the distal end that is convenient and easy to use relative to other conventional steering mechanisms that rely on e.g., pulleys or knobs to control steering wires.
• This user interface allows for example a user to readily visualize the shape and directional movement of distal end of the mechanism that is located e.g. within a patient based on the manipulated shape of the externally positioned proximal end user interface.
• Complex movements including up, down, right, left, oblique, and rotational movements, may be accomplished due to the formation of multiple pairs of segments or links connected by discrete cable sets, as described above.
• the most distal link at the distal end, A 2 may be actuated, while all other links remain stationary by actuation of the most distal link at the proximal end, A 1 .
• the distal-most link is shown to be rotated to form a right circular cone 114a 3 the base diameter of which increases with such factors as increased length of stem portions, enhanced cable flexibility, and addition of spacer links 103 (e.g., C 1 ) in addition to the other links.
• a middle link is actuated at the proximal end, e.g., B 1 , in Figure ID, while all other links remain straight or stationary to one another, than only the corresponding middle link at the distal end, B 2 , will be manipulated and may be rotated to form, e.g., a cone with curved sides 116a. Or, as shown in Figure IE, a larger cone with curved sides 116b may be formed by manipulating the distal-most link, A 1 , so that all proximal links bend into a curve. All links at the distal end will then mimic the curve, in an inverted fashion.
• Figure IF shows the distal end 120 of an articulating mechanism having multiple curvatures (122, 124, 126) along its length, each oriented in directions independent of one another.
• articulating mechanism 101 of Figure IF has nine pairs of links with three cable sets each providing for movement in 27 degrees of freedom, but other configurations of link pairs and cable sets will readily achieve similar complex movements and geometries.
• the ability of portions the mechanism to bend in, different directions at the same time and create active complex configurations is provided by the independent actuation of each link or segment pair as controlled through its corresponding cable set.
• the natural configuration of the segments, when connected by cable sets, is usually linear.
• a malleable tube slidable over the proximal segments may be shaped to keep the proximal segments, and thus, their corresponding distal segments in a particular configuration. This may be advantageous where, for example, a surgeon has navigated the mechanism to a desired target location and wishes to "lock" the mechanism in place while e.g. actuating a tool associated with the mechanism, or engaging in a separate procedure altogether.
• a locking rod may be inserted into one or more attachment channels extending through the links or segments to "lock" the proximal and distal segments of the articulating mechanism in place.
• the locking rod may be a malleable metal bar that may be shaped and then inserted into the attachment channels to set the proximal and distal segments into a particular configuration, or the locking rods may be provided in preshaped forms.
• each link 300 has a recessed socket 301 for receiving a spherical element or ball 302 disposed between the links.
• a tension force is applied linearly along the axis of the links, the links will lock into place due to frictional forces between the balls and sockets.
• Fig. 3E shows a link system of similar configuration, with each link 310 and ball 312 having aligned channels 313 and 314 for the passage of a tensioning cable.
• Other mechanisms for locking the articulating mechanism in place in a fixed, articulated position include but are not limited to those described in U.S. Application Serial No. 10/928,479, filed on August 26, 2004, incorporated herein in its entirety.
• the articulating mechanism may be employed for remote manipulation of surgical instruments, diagnostic tools, various catheters, and the like, into hollow or chambered organs and/or tissues including, but not limited to, blood vessels (including intracranial vessels, large vessels, peripheral vessels, coronary arteries, aneurysms), the heart, esophagus, stomach, intestines, bladder, ureters, fallopian tubes, ducts such as bile ducts, and large and small airways.
• the articulating mechanism may also be used to remotely direct surgical instruments, diagnostic tools, various catheters, and the like, to solid organs or tissues including, but not limited to, skin, muscle, fat, brain, liver, kidneys, spleen, and benign or malignant tumors.
• the articulating mechanism may be used in mammalian subjects, including humans (mammals include, but are not limited to, primates, farm animals, sport animals, cats, dogs, rabbits, mice, and rats). [0086]
• the articulating mechanisms may generally be used in any application or incorporated into other devices in which there is a user interface proximally, and an actuating element distally.
• the user interface may include the proximal end of an articulating mechanism, while the distal end may be attached to the actuating element.
• a remotely maneuverable surgical clamp 600 is shown.
• the clamp jaws 602 are attached to the distal end 604 of the articulating mechanism.
• the proximal end 606 is built into the clamp handle 608.
• a user is able to remotely position the clamp jaws 602 by manipulating the proximal end 606 of the articulating mechanism.
• a middle portion (“neck") 610 is also provided with the surgical instrument, the length and flexibility of which will vary with the application, with the neck providing the function of the spacer element.
• Figure 6C shows another variation, where clamp handle 632 of surgical clamp 630 extends from proximal end 634.
• the clamp jaws 602 may be exchanged for scissors or other cutting, element, a dissector, a tissue grasper or needle grasper, a stapling device, a cauterizing or ablation device, and or other like tool or instrument.
• the articulating mechanism itself may form the clamp jaws.
• the clamp 612 has a user end with the proximal segments 614 extending from pivot 616 of the clamp.
• the cables that originate in the proximal segments 614 bifurcate into two cables each in the area of the pivot 616 so that each cable in the proximal end may then terminate in two separate articulating mechanisms that form opposing clamp jaws 618, 618.
• the jaws 618 will remain aligned and be correspondingly remotely manipulated.
• the proximal segments 614 may extend and be manipulated from one of the handles 620 of the clamp.
• the jaws can further be configured with particular tissue engaging surfaces, as well as ablation elements.
• the articulating mechanism can be incorporated into a catheter and used to guide the catheter, e.g., in difficult central line placements, or in percutaneous or image-guided drainage catheter placement.
• a catheter 700 may include an articulating mechanism with the proximal end of the mechanism 702 configured as an integral component of the user interface, in this instance, handle 706.
• the distal segments 708 form the distal portion of the catheter, and may be remotely maneuvered to guide the catheter 700 as it is advanced.
• the articulating mechanism may be threaded through the catheter like a guidewire such that the proximal segments extend from the catheter proximal end, e.g., either directly from the catheter lumen, or from a bifurcated wye connector.
• the distal segments may extend from the catheter tip, and the catheter remotely guided to its target position as it is advanced.
• the articulating mechanism would then be removed to allow flow through the catheter.
• the articulating mechanism that is employed has a central lumen, its removal may not be necessary.
• endoscope 800 is configured such that the proximal end 806 of the articulating mechanism forms an integral part of the endoscope handle 804.
• the distal end 808 of the mechanism would constitute all or a part of the endoscope insertion tube 810.
• the insertion tube 810 may be remotely manipulated.
• the articulating mechanism could be used as a hand-held or self-retaining retractor 900.
• the proximal segments 902 and distal segments 904 may extend from the retractor handle 906. Manipulation of the proximal segments 902 will move the distal segments 904 in a reciprocal fashion.
• the distal segments can be manipulated to form a variety of complex shapes, the desired shape depending on the particular application. In operation, the distal end can be first positioned into the desired shape and then engaged with the target tissue. Alternatively, tissue retraction can be performed concurrently with manipulation of the distal end, i.e., the distal end can be engaged with the target tissue and through the act of manipulating the distal end, the tissue can be retracted.
• a retractor typically must maintain its shape in use.
• the retractor may be "locked” into place using e.g. methods previously described.
• the mechanism can include links with a ball and socket configuration together with a locking cable (not shown).
• a malleable sheath (not shown) may be placed over the proximal segments 902 prior to their manipulation or a locking rod (not shown) may be used to fix the retractor in a particular configuration, as has been previously described.
• the retractor 900 is "u" shaped.
• the retractor 900 has a triangular retracting surface.
• a retractor shape may be varied, depending on factors such as anatomical structure involved or type of surgical procedure.
• a number of articulating mechanisms can be combined in such a way that a user's finger movements can be remotely mimicked.
• proximal ends of the mechanisms can be affixed to a user's fingers, for example, either strapped to each digit or otherwise secured to a glove that the user can wear. The distal ends will then move according to the user's finger movements.
• mechanism 950 includes three articulating mechanisms operable by movement of a user's thumb, index, and middle fingers.
• proximal ends 951, 952 and 953 are affixed to a user's thumb, index finger and middle finger, respectively, by straps 957.
• the mechanism is further secured to the user's hand by strap 958 which secures the proximal end of spacer element 956 to the user's wrist. Movement of the user's thumb, index finger, and middle finger causes corresponding movement of distal ends 961, 962 and 963, respectively.
• a protective pliable sheath can be extended over the mechanism to avoid potential damage to tissue from individual links or cables.
• the articulating mechanisms or combinations of articulating mechanisms described above that mimic finger movement (also generally referred to herein as hand-actuated devices) and that include a user hand interface at the proximal end of the device for removably securing a digit of a human hand, may be further modified such that the user hand interface is also configured to removably engage with the palm (ventral surface) of the hand.
• the interface generally includes two portions, a finger portion for actuating movement and releasably securing one or more fingers to the interface, and a handle portion which partially abuts the palm and which provides another surface for releasably securing a user's hand and fingers.
• the ergonomics of this device configuration is particularly desirable since a user's hand may be quickly engaged and disengaged from the device.
• the ability to quickly and easily engage or disengage one's hand from the device may be particularly advantageous in, e.g., surgical settings where surgeons typically need to swap surgical tools rapidly.
• the devices are generally adapted for use by a human hand, and typically include three mechanisms to accommodate the index finger, middle finger, and thumb of the hand, the number of articulating mechanisms that may be included is not so limited, and may include as many mechanism as a user can control at once.
• the distal end of the hand-actuated devices usually includes an effector portion that generally mimics the structure and movement of human fingers and which is remotely actuated by corresponding movements at the finger portion of the interface.
• the effector portion is typically configured to provide such gross movements as gripping and pinching, but also provides for finer finger movements oftentimes required, e.g., for fine tissue manipulation.
• the effector may be used to clamp, provide traction, dissect, debride, suture, or otherwise manipulate body tissues.
• Anatomically, human fingers include bones called phalanges.
• the index finger, middle finger, ring finger, and pinky have three phalanges, commonly referred to as the proximal phalanx, middle phalanx, and distal phalanx.
• the thumb includes only two phalanges, a proximal phalanx and a distal phalanx.
• Movement of the phalanges are controlled by finger joints that join the head of one phalanx with the base of the more distal one.
• Joints at the base of the proximal phalanx are metacarpophalangeal (MCP) joints that typically allow flexion, extension, abduction, adduction, and circumduction (movement in two degrees of freedom) of the proximal phalanx.
• MCP metacarpophalangeal
• Interphalangeal (IP) joints on the other hand, which join the distal phalanx to the middle phalanx and/or the middle phalanx to the proximal phalanx, are typically uniaxial hinge joints that permit only flexion and extension (movement in a single degree of freedom).
• the hand-actuated devices of this invention are typically made from links adapted in such a way to generally correspond to the anatomical structure of human fingers and generally parallel the range of motion of human finger joints, but can also be configured to provide joint movement in any desired degree of freedom.
• links can be dimensioned and grouped together so that they look and work similar to human fingers and finger joints.
• links adapted to correspond to phalanges would be, e.g., longer than links used as part of the finger joints (MCP and IP joints).
• MCP and IP joints links used as part of the finger joints
• the links representative of phalanges may be of any dimension, so long as they are capable of functioning similar to human phalanges, but are typically longer than other links, as mentioned above, and will accordingly be referred to herein as "elongate links".
• the length of an elongate link may range from a less than a millimeter to a few centimeters, and in some non-medical applications, even several inches.
• the length of elongate links corresponding to proximal phalanges may be about 22 mm, for middle phalanges about 17 mm, and for distal phalanges about 15 mm.
• Elongate links at the proximal end of the device will be generally referred to as “finger links” and those at the distal end of the device will be referred to as "effector links”.
• the elongate links can take any form that can provide functionality similar to a human phalanx may be used.
• the elongate links can be made flexible.
• the diameter of the elongate links may also vary, depending on factors such as the finger that the link is being associated with (e.g., thumb, index finger, or middle finger) and the device application, but will typically be from about 1 mm to about 20 mm, or more than 20 mm.
• the diameter of a smaller elongate link may be about 1 mm to about 3 mm, for a mid-range elongate link about 3 mm to about 7 mm, and for a larger elongate link about 7 mm to about 10 mm or more.
• the elongate links may be made from any biocompatible material as previously mentioned for links, including, but not limited to, stainless steel; titanium; tantalum; and any of their alloys; and polymers, e.g., acrylonitrile-butadiene-styrene (ABS) terpolymer, Delrin® acetal hom ⁇ polymers and copolymers, polycarbonate, polyethylene or copolymers thereof, polyethylene terephthalate or copolymers thereof, nylon, silicone, polyurethanes, fiuoropolymers, poly (vinylchloride); and combinations thereof, or any other suitable material known in the art.
• ABS acrylonitrile-butadiene-styrene
• Delrin® acetal hom ⁇ polymers and copolymers polycarbonate, polyethylene or copolymers thereof, polyethylene terephthalate or copolymers thereof, nylon, silicone, polyurethanes, fiuoropolymers, poly (viny
• the elongate links may also be variously textured to enhance their gripping or traction ability, as will be apparent to one of skill in the art.
• the elongate links themselves can be textured or a textured material can be applied to the elongate links.
• the textured material can include tractive surfaces, as disclosed in U.S. 6,821,284, incorporated by reference herein in its entirety. [0100] Aa previously described, phalanges are joined to one another by human finger joints, i.e., the DIP, PIP, and MCP joints. In a similar fashion, elongate links are connected by joints in the mechanism.
• joint refers to discrete links or a discrete combination of links capable of having the range of motion of a DIP, PIP, or MCP joint.
• base joint the joints corresponding to DIP and PIP joints will be generally referred to as "finger joints”.
• effector base joint the joints corresponding to DIP and PIP joints will be generally referred to as "effector joints”.
• the joints may be made from any biocompatible material similar to that used for elongate links, as previously described.
• the hand-actuated devices may be formed from a plurality of individually attached elongate links and joints or from elongate links and joints formed integrally with one another.
• the links and link combinations used as elongate links or joints include those described herein, as well as other suitable links and link combinations, including, but not limited to, those disclosed in U.S. Application Serial No. 10/928,479, filed on August 26, 2004, U.S. Application Serial No. 10/948,911, filed on September 24, 2004, and U.S. Application entitled "Articulating Mechanisms and Link Systems With Torque Transmission In Remote Manipulation of Instruments and Tools", filed November 23, 2004, the disclosures of which are herein incorporated by reference in their entirety.
• Links that are designed to adjust for cable bias are also useful.
• active links are typically fully constrained so as to resist movement due to laterally applied forces, as is described in U.S. Application Serial Nos. 10/928,479 and 10/948,911.
• fully constrained links helps to preserve the integrity of the desired shape formed at the distal or proximal end of a manipulated mechanism when in use, and allows force to be distributed across the desired shape.
• Spacer links on the other hand are typically unconstrained.
• articulating mechanisms of this invention include links at a proximal and distal end of the mechanism.
• the proximal and distal links form discrete pairs and are connected to each other by cable sets so that movement of one link of a pair causes corresponding movement of the other link in the pair.
• hand- actuated devices of this invention include articulating mechanisms having a plurality of elongate links that form members of discrete pairs.
• the elongate links form a proximal end, or "finger portion”, and distal end, or “effector portion”, with one elongate link of each pair being situated at the finger portion end, and the other elongate link at the effector portion end.
• Cable sets run through the joints and connect the elongate links of a discrete pair to one another so that movement of one elongate link of a pair causes a corresponding movement of the other elongate link in the pair, independent of movement of other pairs of elongate links.
• the one to one correspondence of movement of elongate links may also be extrapolated to joints.
• articulation of the effector joints may be generally achieved by articulation of a base joint and finger joints at the proximal end of the device or may be achieved by actuation of a finger slide.
• proportional scaling of movement in the articulating mechanisms can in general be accomplished by the inclusion of additional spacer links.
• Proportional scaling of movement in the articulating mechanisms can also be accomplished in general by increasing or decreasing the cable channel pattern radius in the links, at either the proximal or distal end of the mechanism, as is further described in pending and commonly owned U.S. Application No. 10/948,911 incorporated herein by reference in its entirety. For example, if the radial distance of cables from central axis of links of the proximal end is greater than that in the distal end, the degree of bending or flex of the distal end will be proportionally greater than that of the proximal end. The result is that smaller degree of movement at the proximal end will produce a greater degree of movement at the distal end.
• Figures 14-17 depict a variation of a hand-actuated device in which articulation of the effector joints may be generally achieved by articulation of a base joint and finger joints at the proximal end of the device.
• the hand-actuated device 1700 has a proximal end 1711 and a distal end 1721.
• a user interface 1713 at the proximal end 1711 includes a finger portion 1712 and a handle portion 1717.
• the finger portion 1712 actuates movement at distal end 1701 and releasably secures one or more fingers to the interface 1713.
• Handle portion 1717 partially abuts the palm and provides another surface for releasably securing a user's hand and fingers.
• a user's thumb, index finger, and middle fingers will be releasably secured to finger portion 1712, but any combination of fingers may be releasably secured.
• finger portion 1712 is adapted to releasably secure a user's index finger, middle finger, and thumb in an index finger portion 1714, middle finger portion 1715, and thumb portion 1716, respectively.
• a user's fingers may be releasable secured or releasably engaged to finger portion 1712 by finger loops 1509, as shown in Figure 15.
• a user's index finger, middle finger, and thumb may be releasable secured to an index finger portion 1714, middle finger portion 1715, and thumb portion 1716, respectively.
• An enlarged view of an index finger portion is shown in Figure 16.
• Finger loops 1709 may be constructed from the same materials as the elongate links described above, and are attached to finger links ⁇ 101A, 1707B, and 1707C by techniques well known in the art, such as, but not limited to, fastening, e.g., such as with a mechanical fastener, welding and gluing. Extending between finger links 1707 A and 1707B is distal finger joint 1708 A, which is configured to have a range of motion similar to a DIP joint. Extending between finger links 1707B and 1707C is another distal finger joint 1708B, which is configured to have a range of motion similar to a PIP joint. Finger link 1707C is coupled to handle portion 1717 by proximal base joint 1708C, which is configured to have a range of motion similar to a MCP joint. The particular structure of the joints will be addressed further below.
• effector portion 1701 is shown to include three effectors, 1702, 1703, and 1704, but if desired, the device can be equipped with more or less than three effectors.
• effectors also include elongate links and joints. Elongate links and joints in the effector portion are generally referred to as "effector links” and “effector joints” respectively, and are also adapted in such a way to mimic human finger/hand movement.
• Effector links will typically correspond to phalanges, and the range of motion of effector joints will usually parallel that of DIP, PIP, or MCP joints.
• effector links 1705 A, 1705B, and 1705C are configured to correspond to a distal phalanx, middle phalanx, and proximal phalanx, respectively, and effector joints 1706A, 1706B, and 1706C are adapted to parallel the function or range of motion of the DIP, PIP, and MCP joints, respectively.
• Cables running through the finger links 1707A, 1707B, and 1707C, finger joints 1708A and 1708B, effector base joint 17Q8C, handle portion 1717, shaft 1710, and effector palm 1711, are actuated by the user's finger movement to produce a corresponding movement of effector portion 1701.
• movement of finger joint 1708A causes a corresponding articulation of effector joint 1706A
• movement of finger joint 1708B causes a corresponding articulation of effector joint 1706B
• movement of base joint 1708c causes a corresponding articulation of effector base joint 1706C.
• Mirrored movement at the effector portion 1701 may be generally achieved by rotating the cables approximately 180° as they travel through the handle portion 1717, or shaft 1710, or effector palm 1711. Mirrored movement may be more intuitive and also desirable in some instances because it allows the effector portion to, e.g., close when a user's fingers are closed, or move right when a user's finger moves right, or move left when a user's finger moves left. Alternatively, inverted movement may be generally achieved by not rotating the cables. In some instances, it may be desirable to provide a combination of mirrored motion and inverted motion in the effector portion.
• thumb, index finger, and middle finger portions are depicted in the user interfaces of Figures 14,15, and 17, as well as in other figures, the invention is not so limited.
• the interface may be configured to include a finger portion for releasably securing any number of fingers.
• the finger portions may be arranged on the handle portion as illustrated in Figures 14-17, but may also be varied to accommodate other arrangements and positions, so long as adequate actuation of the effector portion may be achieved.
• Figures 18-20 depict another variation of a hand-actuated device in which articulation of the effector joints may be generally achieved by actuation of finger slides.
• hand-actuated device 1800 has a proximal end 1801 and a distal end 1821.
• a user interface 1803 at the proximal end 1801 includes a finger portion 1804 and a handle portion 1805.
• the finger portion 1804 includes finger slides 1806 for actuating movement at the distal end 1821 and releasably securing one or more fingers to the interface 1803.
• Handle portion 1805 partially abuts the palm and provides another surface for releasably securing a user's hand and fingers.
• Distal portion 1802 includes an effector portion 1807 having effectors 1808,
• effectors are made up of effector links and effector joints as previously described.
• effector 1808 includes effector links 1811 A, 181 IB, and 1811C, and effector joints 1812A, 1812B, and 1812C.
• the function of effector joint 1812A parallels a DIP joint
• effector joint 1812B parallels a PIP joint
• effector base joint 1812C parallels a MCP joint.
• the user interface 1803 of this variation includes finger slides 1806 in addition to a base joint 1813 to actuate movement of effectors 1808, 1809, and 1810.
• movement of base j oint 1813 mimics MCP j oint movement and is capable of flexion, extension, abduction, adduction, and circumduction.
• movement of a user's fingers e.g., an index finger, middle finger, and thumb, from an open ( Figure 19) position to a closed, grasping position ( Figure 20), actuates finger slides 1806.
• index finger slide 1806 correspondingly articulates effector joints 1812A, 1812B, as described further below.
• Cables (not shown) running from finger slides 1806 and base joint 1813 through handle portion 1805, shaft 1815, and effector palm 1816, are actuated by the user's finger movement to produce a corresponding movement of the effector portion 1807.
• Mirrored movement at the effector portion 1807 may be generally achieved by rotating the cables approximately 180° as they travel through handle portion 1805, shaft 1815, and effector palm 1816.
• the shaft can be of varying length and can be rigid or flexible, as circumstances warrant.
• the arrangement of the finger portions on the handle portion of the interface may vary to improve ergonomics or depending on factors such as user preference or the type of procedure involved.
• the thumb slide 2101 is mated to the handle portion 2102 at a position different from that shown in Figures 14-20.
• the position of the thumb slide 2101 is lower than the index finger slide 2103 and middle finger slide 2104, and in some instances, also lies posterior to these slides.
• the general configuration of the finger slides may vary depending on many user-associated factors such as ergonomics and user preference, but are usually configured to include a holder, a slider, a transmission rod, and a pulley lever, such that translational movement of the holder produces rotational movement of the pulley lever, which in turn moves connecting cables to actuate effector joints and links.
• finger slide 2200 includes a housing
• Slider 2206 is coupled to housing 2201 by dowel 2211 placed through slider 2206 and track 2202 to prevent slider 2206 from rotating with respect to housing 2201.
• Holder 2203 is coupled to slider 2206 at pivotable hinge 2207 that accommodates finger flexion and extension. The tip of a digit may be placed in holder 2203, and upon flexion or extension of the PIP and DIP joints, movement of the holder 2203 causes translational movement of slide 2206 along track 2202.
• the holder 2203 depicted in Figure 27 has a top plate 2208 and bottom plate 2209 for removably securing the fingertip of a user.
• the holder configurations of this invention not only include the structure shown in Figure 27, but also contemplate loop-type structures 2310 ( Figure 23), or any configuration suitable for removably securing the fingertip of a user for actuation of the device.
• base joint 2210 extends from housing 2201 and may be rigidly fixed to housing 2201 or formed integrally therewith.
• joints such as base joint 2210 are configured to function similar to MCP joints having at least movement in two degrees of freedom.
• Finger slide actuation corresponds to articulation of DIP and PIP joints which are generally known to move in a single degree of freedom. [0117] Another finger slide variation is shown in Figures 23 and 24, and in Figures
• finger slide 1806 includes a housing 2301 with slide pins 2302, a curved slide 2303, a transmission rod 2304, a pulley lever 2307, a holder 2310, and pulleys (not shown).
• the provision of curved slide 2303 is particularly ergonomic because in operation the overall motion of the finger slide takes a curved path that mimics the path a user's fingertips make when the PIP and DIP joints are bent. Furthermore, use of this curved slide path more accurately mimics human finger movement because with this configuration, a user's DIP and PIP joints can be articulated without moving the MCP joint.
• actuation of effector joints 1812A and 1812B could easily occur independently of actuation of effector base joint 1812C.
• the curve of slide 2303 may be adapted to be a circular arc, ellipse, parabola, and the like, in order to achieve this motion.
• slide pins 2302 insert into track 2308 to couple curved slide 2303 to housing 2301.
• Pulley lever 2307 is pivotably connected to housing 2301 by a first dowel 2309.
• a transmission rod 2304 having a proximal end 2305 and a distal end 2306 operably connects pulley lever 2307 to holder 2310.
• a second dowel 2311 couples transmission rod proximal end 2305 to pulley lever 2307.
• transmission rod 2304 is pivotably connected to curved slide 2303 by a third dowel (not shown).
• a base joint 1813 that is rigidly fixed to housing 2301 is also shown.
• finger slide 1806 includes a curved slide 2303 having a distal end 2313. Distal end 2313 is fixedly connected to bracket 2314.
• Plate 2315 has a cylindrical opening 2316 that receives mandrel 2317, such that plate 2315 can rotate about mandrel 2317.
• Mandrel 2317 is pivotally coupled to bracket 2314 by dowel 2318. Plate 2315 can thus both pivot and rotate relative to bracket 2314, i.e., it can pivot about dowel 2318 as well as rotate relative to mandrel 2317.
• Holder 2310 is secured to plate 2315 and thus can also pivot and rotate with respect to bracket 2314.
• This finger slide configuration is particularly ergonomic because it accommodates natural finger movement when the fingers are abducted.
• the ability of the finger holder to rotate relative to the slide is advantageous as it more readily accommodates a combined flexion and abduction movement between fingers during which the fingertips naturally rotate slightly relative to one another.
• the finger slide of Figure 23 also includes cables for actuating movement of the effector portion as shown in the cross-section taken along line B-B in Figure 25 and in Figure 26.
• Cables 2503 and 2504 wrap around pulley 2317 and terminate in pulley lever 2307.
• Cables 2501 and 2502 wrap around pulley 2318 on the opposite side of pulley lever 2307 and similarly terminate in pulley lever 2307.
• flexion or extension of a user's finger at the DIP and PIP joints e.g., an index finger, secured to the finger slide, causes a rotational movement of pulley lever 2307 which thereby freely pulls cables 2501 and 2502 about pulley 2318, and freely pulls cables 2503 and 2504 about pulley 2317.
• cable 2501 is pulled about pulley 2318 and cable 2503 is pulled about pulley 2317.
• cable 2502 is pulled about pulley 2318 and cable 2504 is pulled about pulley 2317.
• Cables 2501, 2502, 2503, and 2504 then pass through channels 2604 in base joint 1813 to articulate movement of effector joints (e.g., joints 1812A and 1812B in Figure 30) as further described below.
• the pulleys may be configured to rotate about dowel 2309 or may be fixedly attached to pulley lever 2307, and generally have diameters that vary from one another. [0122] In some instances, it may be desirable to scale movement of the effectors in relation to movement occurring at the user interface. Typically, pulley diameters are selected so that the amount of cable pulled for a given rotat ' ion is equal to the cable that would be pulled if an articulating link were substituted in place of the pulley.
• the diameter of the pulley that controls the most distal effector link must be larger than that of the pulley that controls the distal effector link.
• pulley 2318 is shown to have a diameter approximately twice that of pulley 2317. Scaling of effector movement can be further adjusted by varying the pulley diameters while retaining the same ratio of the pulley diameters relative to one another and/or varying the ratio of the pulley diameters relative to one another.
• pulleys in Figures 25-26 are circular, other pulley shapes may be employed to adjust movement of the effector joints.
• a cam shape may be used to articulate an effector joint in a non-linear fashion.
• another way to scale effector movement is to adjust the position of transmission rod 23.04 along the length of pulley lever 2307 by lifting distal end of transmission rod 2305 closer to pulley 2317 such that dowel 2323 inserts into one of dowel apertures 2317. Effector movements will be scaled down as distal end 2305 is positioned closer to pulley 2505.
• Other ways to scale movement of the effectors include, but are not limited to, the inclusion of additional spacer links and/or varying the cable channel pattern radius in the links, as previously discussed. In some instances, e.g., in industrial applications, reverse scaling may be desirable.
• Movement of base joint 1813 is actuated by the user's fingers. As previously described, movement of base joint 1813 results in a corresponding movement at an effector base joint (e.g., 1812C in Figure 20).
• cables traveling from the proximal end are generally rotated approximately 180° prior to terminating at the distal end.
• all cables do not necessarily have to be rotated.
• the cables do not have to be rotated 180° in order to provide mirrored movement. The cables simply need to be moved to the other side of the pivot or hinge on one link of the pair relative to cable position on the other link of the pair.
• Figure 27 depicts cable rotation through handle portion 1805 by noting the entry and exit points of cables in handle portion 1805.
• cables enter handle portion 1805 in the general pattern shown at a first area 2703.
• cable 2602 is shown to enter first area 2703 at approximately the 2 o'clock position, and 2603 at the 5 o'clock position.
• a second area 2702 Upon exit at a second area 2702, a different cable pattern is seen. Instead of exiting at the 2 o'clock position, cable 2602 exits at approximately the 8 o'clock position, and for cable 2603, instead of exiting at the 5 o'clock position, it exits at approximately the 11 o'clock position.
• a rotation of 180° is needed only if mirrored movement is desired.
• the handle portion 2802 of the user hand interface may be a molded handle, as shown in Figure 28, with channels or tubes 2801 for routing cables.
• the channels may be rotated or crossed to effect mirrored or inverted movement.
• the handle portion 2901 may be hollow and include a pulley 2902 for alignment and routing of cables 2903.
• the cables 2903 in this variation can be rotated (crossed) either before reaching pulley 2902, or after travel around pulley 2902.
• Materials that may be used to make the molded or hollow handles of this invention include those previously described for elongate links, as well as others that may be suitable for making medical devices.
• the effector portion of the device typically includes three effectors that correspond to a user's index finger, middle finger, and thumb, but any number of effectors may be included.
• cables traveling from the user interface variously terminate at effector links to actuate effector movement.
• An understanding of joint articulation using a finger slide may be better obtained by viewing the cable termination points shown in Figure 30 in conjunction with Figures 18-20.
• the effector portion depicted in Figure 30 represents effector portion 1807 in Figures 18-20.
• effector 1808 corresponds to a user's index finger, and is generally configured to include an effector base joint 1812C, two effector joints 1812A and 1812B, and effector links 1811A, 1811B, and 1811C.
• Effector link 1811C corresponds to the proximal phalanx of an index finger;
• effector link 181 IB corresponds to the middle phalanx of an index finger;
• effector link 181 IA corresponds to the distal phalanx of an index finger.
• effector base joint 1812C corresponds to a MCP joint capable of movement in at least two degrees of freedom
• effector joint 1812B corresponds to a PIP joint capable of movement in a single degree of freedom
• effector joint 1812A corresponds to a DIP joint, also capable of movement in a single degree of freedom.
• effector link 181 IB which is representative, is formed by securing links 3101 to the ends of a tube, although other methods of forming the effector links will be readily apparent.
• Cables from the handle portion of the device are received through shaft (not shown) and are routed to the appropriate effector by effector palm 1816.
• Effectors emerge from effector palm 1816, as shown in Figure 30 and other figures, that extends from the shaft. However, if desired, the effectors may be adapted to emerge from different points along the shaft or effector palm 1816 to form, e.g., a staggered or more spread out effector configuration. In this manner, a more or less hand-like effector portion can be made.
• cables 2501, 2502, 2503, and 2504 from the slider which actuate movement of effector joints 1812A and 1812B terminate at one of the two effector links 181 IA and 181 IB.
• cables 2501 and 2502 which are pulled around the larger pulley, and which articulate movement of effector joint 1812A, terminate in distal-most effector link 181 IA.
• Cables 2503 and 2504 which are pulled around the smaller pulley, and which articulate effector joint 1812A, terminate in effector link 1811B, as shown in Figure 31B.
• cables 2601, 2602, and 2603 originating from base joint (1904 in Figure 20) and which articulate movement of effector base joint 1812C, generally terminate at effector link 1811C, as depicted in Figure 31C.
• Effector joints 1812A-1812C are typically configured to have a range of motion that mimics the range of motion of MCP, PIP, and DIP joints, respectively.
• effector base joint 1812C which corresponds to an MCP joint, is typically equipped to move in at least two degrees of freedom by including, e.g., two or more links 3105 each having a rib 3106 extending from the diameter of one surface of the link and having channels 3104 running across the diameter of their opposite surface.
• Channels 3104 are adapted to pivotably engage rib 3106 along the entire length of the channel, such that two links can pivot relative to one another about the axis of the channel.
• effector base joint 1812C the two links are positioned with their respective ribs oriented orthogonal to one another and with the rib of the most proximal link engaging a similar channel provided in effector palm 1 S 16, in order to provide movement in two degrees of freedom.
• Distal effector j oints 1812 A and 1812B generally only require movement in a single degree of freedom.
• Figure 33 is representative of effector base link 1812C also shown in Figures 30 and 31C.
• Another representative joint structure providing a single degree of freedom is depicted in Figures 31 A-31B, and Figure 32 and includes links 3101 having a rib 3102 extending from the diameter of one surface of the link and having a channel 3103 aligned with the extending rib on its other side.
• Channels 3103 are adapted to pivotably engage rib 3102 along the entire length of the channel, such that two links can pivot relative to one another about the axis of the channel, to provide a single degree of freedom.
• the finger portion of the interfaces described above may be configured to include a combination of finger slides and finger loops for articulation of effector joints.
• a finger loop type finger portion may provide more accurate mimicking of human thumb joint movement at the effector.
• finger loop input control allows for independent control of distal effector link movement, in contrast to finger slides which only allows coupled control of distal effector link movement.
• DIP and PIP joints of fingers such as the index finger, middle finger, and ring finger, are articulated, they usually flex or extend together. Accordingly, it may be more suitable for finger slides to actuate effector movement for these fingers.
• the hand-actuated devices may also adopt configurations that differ from the human hand. For example, in certain surgical applications, it may be desirable to shape the effector portion in such a way that it becomes a tool with functionality other than that of gripping of the hand.
• the articulating mechanism may be used for the endoscopic treatment of atrial fibrillation.
• the articulating mechanism of the invention can be adapted to facilitate the creation of ablative lesions in heart tissue, which has been demonstrated to be effective in treating atrial fibrillation, as described e.g. by Cox, J.L. (2000). "Minimally Invasive Maze-Ill Procedure,” Operative Techniques in Thoracic and Cardiovascular Surgery Vol. 5(l):79-92; Simha et al. (2001). "The Electrocautery Maze - How I Do It," The Heart Surgery Forum Vol. 4(4):340-345; and Prasad et al. (2001).
• Articulating mechanism 131 shown in Figure 12A includes ablative element
• the ablative element 125 connected to an electromagnetic energy source (not shown), such as an energy source which generated energy in radiofrequency (RF) or microwave frequency ranges.
• RF radiofrequency
• the ablative element is mounted to links on the distal end 141 of the mechanism by way of attachment member 134 which is fittingly engaged with in channels 144 of links 142.
• the ablative element includes an insulated portion 127, typically formed of a thermoplastic elastomer, with longitudinally extending antenna or wire 129 for transmitting energy into tissue disposed therein. Other antenna or wire geometries, including helical coils, printed circuits, and the like are equally effective.
• Insulated conducting leads 136 and 137 are provided for connecting the energy source to the antenna or wire in a monopolar configuration. Bipolar configurations are also contemplated. Additional connectors 138 and 139 to the ablative element are also provided and can function in a variety of capacities, such as providing temperature or other sensors or probes, or to deliver a cooling medium to the element to cool the surrounding tissue and prevent extensive tissue damage, as is described, e.g., in U.S. Patent Application Publication No. US 2003/0078644 to Phan. [0136] Figure 12B shows another variation of the articulating mechanism of the present invention configured for ablation.
• articulating mechanism 133 which is configured for bipolar use, includes distal end 143 having distal links 152 that contain opposing electrodes 159. The opposing electrodes are separated by channel 164. Insulated conducting leads, such as leads 166 and 167, connect each pair of electrodes to the energy source (not shown). When energized, energy is transmitted across the electrode pairs, creating ablative lesions in the surrounding tissue. Again, additional connections 168 and 169 are also provided to provide additional functions, including probes, sensors, and cooling fluids. [0137] While the above variations use ablative elements that rely on electromagnetic energy, articulating mechanisms according to the invention can also be readily adapted to incorporate other methods of ablation known in the art. For example, the ablative element could be a cryogenic or ultrasonic probe, or ablative elements that use laser energy, or other known ablative techniques.
• Epicardial ablative lesions can be created as shown in the example depicted in
• Access to the posterior of a patient's heart 929 by articulating mechanism 131 may be initially made through, e.g., a thoracotomy, mini-thoracotomy, or trocar port (e.g., a 5-10 mm port), placed in the anterior chest wall of a patient.
• the spacer element (not shown) of the articulating mechanism may serve the purpose of a fulcrum at the port.
• the distal links inside the patient mimic the curvature of the outside links in a reciprocal fashion, in order to wrap around the superior vena cava 933 (13 A) and continue to surround and the pulmonary veins 935 (13B) as the articulating mechanism is simultaneously advanced.
• the ablative element on the distal end of the articulating mechanism can then be activated to create a lesion, and as depicted here in particular, pulmonary encircling lesion 943 ( Figure 13C).
• kits for providing various articulating mechanisms and associated accessories for example, kits containing articulating mechanisms having different lengths, different segment diameters, and/or different types of surgical instruments, or different types of locking rods or malleable coverings may be provided.
• the kits may be tailored for specific procedures, e.g., endoscopy, retraction, or catheter placement, and/or for particular patient populations, e.g., pediatric or adult.

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