WO2007070693A2 - Dispositif et procedes de catheter robot - Google Patents

Dispositif et procedes de catheter robot Download PDF

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Publication number
WO2007070693A2
WO2007070693A2 PCT/US2006/048058 US2006048058W WO2007070693A2 WO 2007070693 A2 WO2007070693 A2 WO 2007070693A2 US 2006048058 W US2006048058 W US 2006048058W WO 2007070693 A2 WO2007070693 A2 WO 2007070693A2
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WO
WIPO (PCT)
Prior art keywords
instrument
guide instrument
left atrial
atrial appendage
guide
Prior art date
Application number
PCT/US2006/048058
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English (en)
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WO2007070693A3 (fr
Inventor
Frederic H. Moll
Christopher R. Carlson
Federico Barbagli
Daniel T. Wallace
David Lundmark
Original Assignee
Hansen Medical, Inc.
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Publication date
Application filed by Hansen Medical, Inc. filed Critical Hansen Medical, Inc.
Publication of WO2007070693A2 publication Critical patent/WO2007070693A2/fr
Publication of WO2007070693A3 publication Critical patent/WO2007070693A3/fr

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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, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12122—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
    • 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
    • A61B34/30—Surgical robots
    • A61B34/37—Master-slave robots
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B17/0644—Surgical staples, i.e. penetrating the tissue penetrating the tissue, deformable to closed position
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/0682—Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B2017/0649—Coils or spirals
    • 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
    • A61B2034/301—Surgical robots for introducing or steering flexible instruments inserted into the body, e.g. catheters or endoscopes

Definitions

  • the invention relates generally to robotically controlled systems, such as telerobotic surgical systems, and more particularly to a robotic catheter system for performing minimally invasive diagnostic and therapeutic procedures.
  • Robotic interventional systems and devices are well suited for use in performing minimally invasive medical procedures, as opposed to conventional techniques wherein the patient's body cavity is open to permit the surgeon's hands access to internal organs.
  • a highly controllable yet minimally sized system to facilitate imaging, diagnosis, and treatment of tissues which may lie deep within a patient, and which may be accessed via naturally-occurring pathways such as blood vessels or other lumens, via surgically-created wounds of minimized size, or both.
  • a robotically controlled guide instrument system comprises an elongate flexible guide instrument, a drive assembly coupled to a proximal portion of the guide instrument and configured to maneuver a distal portion of the guide instrument, and a master controller including a user interface that may be manipulated to actuate the drive assembly and thereby maneuver the distal portion the guide instrument.
  • the system further comprises an occlusive prosthesis detachably coupled to an elongate delivery member carried by the guide instrument, wherein the guide
  • . i . instrument is maneuverable to position the occlusive prosthesis into a left atrial appendage of a person's heart such that the prosthesis may be detached from the delivery member and implanted
  • the occlusive prosthesis may be self expanding, having a collapsed delivery configuration wherein carried in the guide instrument, and an expanded deployed configuration when deployed from the guide instrument into the left atrial appendage.
  • the occlusive prosthesis may alternately be configured to be manually expanded once deployed from the guide instrument into the left atrial appendage.
  • the system further comprises a closure device detachably coupled to a delivery member carried by the guide instrument, wherein the guide instrument is maneuverable to position the closure device proximate an opening of a left atrial appendage of a person's heart such that the prosthesis may be detached from the delivery member and implanted to substantially close off the left atrial appendage.
  • the closure device may be self expanding, having a collapsed delivery configuration wherein carried in the guide instrument, and an expanded deployed configuration when deployed from the guide instrument across an opening of the left atrial appendage.
  • the closure device may comprise a plurality of tissue engaging members configured to engage tissue surrounding the opening of the left atrial appendage.
  • the closure device comprises a clip.
  • the clip comprises a pair of opposing tissue engaging ends, each configured to engage tissue proximate an opening of the left atrial appendage.
  • the delivery member may comprise a clip applier configured to crimp the clip after it has been deployed into tissue.
  • the delivery member comprises a cinch member.
  • Figure 1 illustrates one embodiment of a robotic catheter system.
  • FIG. 2 illustrates another embodiment of a robotic catheter system.
  • Figure 2.1 illustrates the operator control station of one embodiment.
  • Figure 4 illustrates an isometric view of an instrument for use with one embodiment of an instrument driver.
  • Figure 5 illustrates an isometric view of two instruments arranged in a co-axial relationship for use with another embodiment of an instrument driver.
  • Figure 6 illustrates an exemplary scheme for mounting a coaxial instrument pair on a instrument driver.
  • Figure 7 A illustrates one embodiment of a method and apparatus wherein a robotic guide instrument coaxially positioned within a robotic sheath and navigated across the atrial septum of a patient's heart;
  • FIG. 7B illustrates one embodiment of a method and apparatus wherein a prosthesis is advanced on a delivery member through a robotic guide instrument into the left atrial appendage;
  • Figures 7C-D illustrate the expansion of the prosthesis of Fig. 7B in the left atrial appendage
  • Figure 7E illustrates the detaching of the prosthesis of Fig. 7B from the delivery member
  • Figure 7F illustrates the withdrawing of the delivery member into the guide instrument, and the guide instrument, in turn, withdrawing from the left atrium;
  • FIGS. 8A-F illustrate one embodiment of a method and apparatus for delivery of an implantable closure device through a robotic guide instrument on a delivery member into a left atrial appendage;
  • FIGS. 9A-D illustrate one embodiment of a method and apparatus for advancing a clip applier through a robotic guide instrument to deploy a clip directly into the tissue around the opening of a left atrial appendage;
  • Figures 1 OA-F illustrate another embodiment of a method and apparatus utilizing a clip applier to close the opening of a left atrial appendage from a precision positioning platform, such as the subject robotic catheter guide instrument;
  • Figures 1 1 A-G illustrate various embodiments of methods and apparatuses for closing an atrial septal defect with a distal end tool navigated and/or deployed with a robotic guide instrument;
  • FIG. 12A illustrates one embodiment of a catheter instrument configuration comprising one or more localization sensors
  • FIG. 12B is a block diagram illustrating one embodiment of a system wherein localization data is communicated between a robotic catheter system and a localization system;
  • FIG. 12C is a block diagram illustrating another embodiment of a system wherein a surface model of one or more pertinent tissue structures is imported and registered;
  • FIG. 12D is a block diagram illustrating another embodiment of a system wherein updated catheter information may be passed back to the localization system from the robotic catheter system;
  • Figures 13A-B illustrate embodiments of a catheter instrument wherein localization
  • -3A- sensors may be deployed at various positions
  • Figures 14A-D illustrate embodiments of a catheter instrument wherein localization sensors may be deployed at various positions.
  • a robotic catheter system (32), includes an operator control station (2) located remotely from an operating table (22), to which a instrument driver (16) and instrument (18) are coupled by a instrument driver mounting brace (20).
  • a communication link (14) transfers signals between the operator control station (2) and instrument driver (16).
  • the instrument driver mounting brace (20) of the depicted embodiment is a relatively simple, arcuate-shaped structural member configured to position the instrument driver (16) above a patient (not shown) lying on the table (22).
  • FIG. 2 another embodiment of a robotic catheter system is depicted, wherein the arcuate-shaped member (20) is replaced by a movable support-arm assembly (26).
  • OB- assembly (26) is configured to movably support the instrument driver (16) above the operating table (22) in order to position the instrument driver (16) for convenient access into desired locations relative to a patient (not shown).
  • the support assembly (26) in Figure 2 is also configured to lock the instrument driver 16 into position once it is positioned.
  • FIG 2.1 a view of another variation of an operator control station (2) is depicted having three displays (4), a touchscreen user interface (5), and a control button console (8).
  • the master input , device (12) depicted in the embodiment of Figure 2.1 is depicted and described in further detail in reference to Figure 105B.
  • a device disabling switch (7) configured to disable activity of the instrument temporarily.
  • the cart (9) depicted in Figure 2.1 is configured for easy movability within the operating room or catheter lab, one advantage of which is location of the operator control station (2) away from radiation sources, thereby decreasing radiation dosage to the operator.
  • Figure 2.2 depicts a reverse view of the embodiment depicted in Figure 2.1.
  • Figure 3 provides a closer view of the support assembly (26) depicted in the embodiment of Figure 2.1.
  • the support assembly (26) comprises a series of rigid links (36) coupled by electronically braked joints (34).
  • the joints (34) allow motion of the links (36) when energized by a control system (not shown), but otherwise prevent motion of the links.
  • the control system may be activated by a switch (e.g., a footswitch or thumb switch), or computer interface.
  • the rigid links (36) may be coupled by mechanically lockable joints, which may be locked and unlocked manually using, for example, locking pins, screws, or clamps.
  • the rigid links (36) preferably comprise a light but strong material, such as high-gage aluminum, shaped to withstand the stresses and strains associated with precisely maintaining a three-dimensional position of the approximately ten pound weight of a typical embodiment of
  • a support assembly (26), or support structure, is configured to allow for easy repositioning of an instrument driver or other device relative to an operating table when an actuation button is depressed, thereby activating a solenoid and releasing two electronic brakes.
  • the position of an instrument driver then may be easily fine-tuned, for example, or modified quickly and substantially to remove the instrument driver from the immediate area of a patient on an operating table for quick medical intervention with broad physical access.
  • Constraints limit the movement of the instrument driver relative to the operating table - i.e., a pan-rotate interface (13), a horizontal extension member (15) with a rotational position maintaining timing chain (73) for distally-coupled structures, and brake-lockable rotations about two axes of rotation (125, 119) which may be parallel and both perpendicular relative to the plane of the operating table - to provide desirable mechanics.
  • the support assembly (26) is configured to provide a robust structural platform upon which an instrument driver or other device may be positioned relative to an operating table.
  • Figures 4 and 5 depict isometric views of respective embodiments of instruments configured for use with an embodiment of the instrument driver (16), such as that depicted in Figures 1-3.
  • Figure 4 depicts an instrument (18) embodiment without an associated coaxial sheath coupled at its midsection.
  • Figure 5 depicts a set of two instruments (28), combining an embodiment like that of Figure 4 with a coaxially coupled and independently controllable sheath instrument (30).
  • the "non-slieath" instrument may also be termed the "guide"
  • FIG. 6 a set of instruments (28), such as those in Figure 5, is depicted adjacent an instrument driver (16) to illustrate an exemplary mounting scheme.
  • the sheath instrument (30) may be coupled to the depicted instrument driver (16) at a sheath instrument interface surface (38) having two mounting pins (42) and one interface socket (44) by sliding the sheath instrument base (46) over the pins (42).
  • the guide instrument base (48) may be positioned upon the guide instrument interface surface (40) by aligning the two mounting pins (42) with alignment holes in the guide instrument base (48).
  • further steps may be required to lock the instruments (18, 30) into place upon the instrument driver (16).
  • the instruments (18, 30) are provided for a medical procedure in sterile packaging, while the instrument driver (16) is not necessarily sterile.
  • the non- sterile instrument driver (16) is preferably isolated from the patient by a sterile barrier of some type.
  • the above-described and referenced robotic catheter system may be utilized to accurately position and deploy various intra-body implants and prostheses, such as those configured for deployment within the left atrial appendage ("LAA") of a patient's heart.
  • LAA left atrial appendage
  • a robotic guide instrument 1002 coaxially positioned within a robotic sheath 1004 may be extended form the sheath 1004 and navigated across the atrial septum 1006 of a patient's heart 1008, as is disclosed and described in published PCT application US2005007108, WO 2005/087128, in order to access the LAA.
  • a prosthesis 1010 such as ones available from Atritech, Inc., is advanced on a delivery member 1012 through the robotic guide instrument 1002, into the LAA 5 where it is pushed out of the distal end opening of the guide instrument 1002 and allowed to expand (in the case of a self- expanding prosthesis 1010), or is otherwise mechanically expanded, in the LAA (shown in Figures 7C and 7D). Subsequently, the guide instrument 1002 is withdrawn from the LAA (shown in Figure 7D), and the prosthesis 1010 is detached from the delivery member 1012 (shown in Figure 7E), remaining implanted in (thereby occluding) the LAA.
  • the delivery member 1012 is then withdrawn into the guide instrument 1002 (shown in Figures 7E and 7F), and the guide instrument 1002, in turn, may be withdrawn from the left atrium (LA), and from being deployed across the atrial septum 1006, and into the sheath 1004.
  • LA left atrium
  • a surgical sealant such as the product marketed by Baxter under the tradename CoSeal, deployed from the robotic guide instrument 1002 and/or use a conventional ablation catheter delivered through the robotic guide instrument 1002 to form one or more lesions over and around the closed LAA to form an appropriate mechanical and/or conductive block with RF energy, high-intensity focused ultrasound, low- temperature cryoablation, or the like.
  • a system includes the robotic catheter system, including the guide instrument 1002 and (optionally) the robotic sheath 1004, along with the delivery member 1012 and detachable prosthesis implant 1010.
  • Referring to Figures 8A-8F, in another embodiment, an implantable closure device 1020, such as nitinol clips developed by Coalescent Surgical, now Medtronic, is delivered through the robotic guide instrument 1002 on a delivery member 1022 into LAA.
  • the closure device 1020 self-expands when delivered out of the distal end opening of the robotic guide instrument 1002, as shown in Figure 8B, and has tissue engaging ends 1021 that attach to the tissue area around the mouth of the LAA.
  • the delivery member 1022 is pulled back into the robotic guide instrument 1002, thereby causing the tissue to be drawn together to close off the LAA, as indicated by the arrows 1024 in Figures 8C-D.
  • a washer-like member 1025 may be used to help cinch together the tissue engaging ends 1021 of the device 1020 as the delivery member 1022 is withdrawn into the guide instrument 1002.
  • a system includes the robotic catheter system, including the guide instrument 1002 and (optionally) the robotic sheath
  • FIGS. 9A-D depict a clip applier 1030 being advanced through the robotic guide instrument 1002 to deploy a clip 1032 directly into the tissue 1033 around the opening of the
  • the clip has tissue engaging ends 1035 that pierce and engage the tissue 1033 around the LAA opening, after which the ends 1035 of the clip 1032 are crimped together by the clip applier 1030 to close off the LAA, as seen in Figure 9D.
  • FIGs 1 OA-F depict another variation of a clip applier 1040, which may be utilized to close the opening of a LAA from a precision positioning platform, such as the subject robotic catheter guide instrument 1002.
  • the clip applier 1040 includes a slidable cinch member 1047 that is moved distally relative to the distal end opening of the guide instrument 1002 (as seen in Figures 1 OC-E) to thereby crimp the ends of a clip that is embedded in the tissue 1033 around the opening of he LAA (as indicated by arrow 1046 in Figure 10C).
  • a system includes the robotic catheter system, including the guide instrument 1002 and (optionally) the robotic sheath
  • a clip applier e.g., clip applier 1030 or clip applier 1040.
  • a atrial septal defect such as a patent fossa ovalis (“PFO") 1007 (i.e., an opening through the atrial septum wall 1006 in a person's heart 1008) may be closed using any one of a number of different distal end tools navigated and/or deployed with the subject robotic guide instrument 1002, which may optionally extend from a robotic sheath 1004.
  • PFO patent fossa ovalis
  • the PFO 1 107 is approached in the left atrium (LA) with a coxial guide/sheath robotic instrument pair 1002/1004 operated by a robotic catheter system, as is disclosed and described in published PCT application US2005007108, WO 2005/087128.
  • FIG. 1 IB depicts another embodiment, wherein a clip applier 1 120 is deployed from the guide instrument 1002 and utilized to engage the two sides of the PFO 1 107 using a clip 1 122.
  • Figure 1 1 D depicts another embodiment, in which one or more rotational tissue coaptation deployment members (i.e., small helical coils) 1 132 are delivered from a deployment member 1 130 carried in the guide instrument 1002, and rotated through the POF walls 1 107, where they are left in place to engage the two sides of the PFO 1 107 for healing.
  • one or more rotational tissue coaptation deployment members i.e., small helical coils
  • Figure 1 1 E depicts yet another embodiment, wherein RF energy is applied from an electrode 1 142 on an ablation catheter 1 140 carried in the guide instrument to the tissue area of the PFO 1 107, thereby cause a healing response that will close the PFO 1 107.
  • a line or matrix of ablations may be preferred, and ablations may be created with means other than RF energy, for example including low-temperature cryoablation and/or high-intensity focused ultrasound ablation.
  • puncturing or other mechanical irritation may be utilized to stimulate a healing response and thereby cause closure of a PFO.
  • a line or matrix of small punctures or irritations line or matrix formation indicated by the phantom punctures 1 152
  • a rotatable or rotating irritation and/or puncture device such as a burr 1 160 (rotation indicated be line 1 162) or similar device distally deployed from the robotic guide instrument 1002 may be engaged to the tissue forming the PFO 1 107 to cause inflammation sufficient to heal the PFO. Lateral movement of the burr 1 160 across the PFO 1 107 is indicated by line 1 164.
  • a system includes the robotic catheter system, including the guide instrument 1002 and (optionally) the robotic sheath 1004, along with any one or more of the toggle-bolt type prosthesis 1 112 (and delivery member 1 1 10), clip applier 1 120 (and clips 1 122), rotational tissue coaptation deployment members 1 132 (and deployment member 1 130), ablation catheter 1 140, stylet 1 150, and rotating burr 1 150.
  • the master input device coordinate system it is preferable to have the master input device coordinate system at least approximately synchronized with the coordinate system of at least one of the two views.
  • 1 1 diplays depicting both real or near-real time image data acquired, for example, using ultrasound, fluoroscopy, and/or localization techniques.
  • One way to increase instinctiveness of navigation of an instrument within, for example, a tissue structure is to build a model utilizing an active instrument, such as a guide instrument coaxially associated with an ablation catheter, such that the model is inherently registered with the coordinate system of the active instrument.
  • a model of structures surrounding an instrument may be created using localization sensing at the distal tip of the instrument.
  • a localization sensor such as those available from the Biosense Webster division of Johnson & Johnson, Inc., Ascension Technologies, Inc., or the Endocardial Solutions division of St.
  • Jude Medical, Inc. may be coupled to the distal tip of a guide instrument or other instrument, such as an ablation catheter, which itself is coupled Io the distal tip of a guide or other instrument.
  • a guide instrument or other instrument such as an ablation catheter
  • an ablation catheter which itself is coupled Io the distal tip of a guide or other instrument.
  • One embodiment with many localizationsensors (52) is depicted in Figure 12A. It may be desirable to provide at least one additional localization sensor (52) to help mitigate errors associated with absolute localization to an emitter (54) which may be, for example, under the operating table (56), and also for common mode rejection.
  • Localization sensors (52) may be integrated, for example, as purchased off the shelf into the body of an instrument (e.g., embedded in a wall or in an internal space within the instrument), but may also be deconstructed (i.e., the individual coils) and oriented appropriately in an integrated fashion at the end of an instrument, or several locations therein, as will be appreciated by those skilled in the art.
  • Wire leads provided to communicate current through the coils as result of magnetic flux may be integrated between polymer layers, braided layers, or almost any other layers of the instrument. For example, the leads may be woven into braided layers of the
  • instrument body construction and are preferably located in available void space (i.e., left from
  • an inner surface map may be iteratively created from a series of saved surface points.
  • a model may be created without a localization sensor utilizing another mode of position determination, such as the kinematics and mechanics of the known instrument system.
  • a surface model may be iteratively created. Suitable contact sensors for such embodiments include those described above.
  • a mismatch between a) commanded instrument position based upon instrument and instrument driver kinematics and b) actual instrument position based upon fluoroscopy, ultrasound, localization, or other real or near-real time modality may be interpreted as an indication of contact or instrument fault (i.e., a broken steering tension member).
  • Load cells configured to detect steering tension member tensions may also be utilized to determine that an instrument is in contact with surface other than free space.
  • Proximally-positioned load cells may also be utilized to detect relative load between coaxial instrument members, or direct loads applied by distally adjacent surfaces upon the most distally-positioned instrument tip.
  • strain gages may be utilized distally to detect contact and force, along with
  • Ultrasound may also be utilized with localization sensing to create
  • CT or MR imaging may be utilized to capture a relatively precise image of a tissue structure, such as the heart.
  • Gating may be utilized to capture various portions of the image sequentially during the same portion of the heart and/or breathing cycle. The portions may be assembled as a voxel three-dimensional image, and may be converted, for example, to a surface model (i.e., a triangular mesh) using segmentation software.
  • portions of an image may be acquired as categorized by the time sequence in the heart cycle, reassembled as a voxel "movie” projected over time, and segmented into a three-dimensional surface model configured to move with time in accordance with the movement of the associated tissue during the image acquisition.
  • Such surface models may be rendered as objects, and may be registered to the coordinate system of an instrument using algorithms configured to snap, rotate, and/or scale an object into position relative to other surrounding objects in three-dimensions based upon best fits to known anatomical locations.
  • an operator may drive an instrument to a known anatomical location using fluoroscopy, ultrasound, or other imaging modalities, then register the surface model to the other objects by establishing, for example, a least squares fit between the known anatomical locations and the same anatomical features found on the surface model).
  • the operator may instinctively navigate the instrument adjacent the surface model, and may continue to refine and/or build out the surface model using techniques such as those described above (with
  • imported and registered images may be preoperatively acquired - or may be acquired during the interventional procedure.
  • a gated CT voxel still image (“still shot”) may be acquired preoperatively, along with a CT voxel "movie" of the heart moving throughout the heart cycle. Both of these voxel models may be converted to surface models with segmentation software.
  • two or three dimensional ultrasound images may be registered to the imported and registered still shot CT surface model and/or the imported and registered movie CT surface model.
  • a model of the tissue surfaces local to the subject instrument may also be created iteratively using contact sensing or other modalities, as described above.
  • the operator may "dial up” or “dial down” the intensity of certain objects as appropriate. For example, if approaching the atrial septum from the inferior vena cava, the operator may wish to increase the intensity of an ICE ultrasound image relative to other objects, since the ICE image object may be particularly well suited for examining the septum and other adjacent tissue structures, e.g., for viewing a transseptal puncture and transseptal flow.
  • the operator may wish to increase the relative intensity or viewability of the still shot CT model, or bring in the movie CT model to observe the aortic outflow tract, dimensions of the left atrium, and possible structures to avoid, such as the adjacent esophagus, which may be displayed as a portion of either CT model.
  • the CT models may be highlighted to identify localized edema, a tumor, or other structures within a wall that may be otherwise difficult to see with fluoroscopy, optical imaging, ultrasound, or other images brought into the mix.
  • a system operator may utilize multiple imaging and modeling modalities in a robust navigation and intervention scenario.
  • localization sensors may be utilized to build models, register images, and generally navigate with known realtime or near-realtime position detection.
  • Two embodiments of integration of localization systems into the subject robotic catheter system are now described in view of the discussion above.
  • a localization system such as the Carto XP system by Biosense Webster, or the
  • - 16 - Ensite system by Endocardial Solutions, or a localization system by Ascension Technologies, Inc., may be configured to output location data (x, y, z coordinates) for each ' sensor, preferably along with orientation data (yaw, pitch, roll) for each sensor, and image "camera position" and/or
  • Sensor location and orientation, and camera orientation or position may be sent using a protocol such as TCPIP over an Ethernet connection at a frequency of, for example, between about 50Hz and about 100Hz, in the form of updated packets (for example, in a format like "beginning of packet....[bunch of numbers] end of packet").
  • Images may be transferred to the displays of the robotic system using standard video cables.
  • TCPIP the robotic system would receive a new packet every cycle containing location and orientation data which would be utilized by the robotic
  • true closed loop controlj i.e., where the operator can interactively navigate to a desired location and know that he is getting there
  • Knowledge of the kinematics and mechanics of the instrument system may be combined with other available information from localization and/or other imaging modalities in a symbiotic relationship which may be known as "adaptive kinematics", wherein the sum control knowledge of the information coming from kinematics, imaging, contact sensing, etc., creates a better understanding of the system, and also of each subsystem. For example, if localization data indicates that a relatively stiff catheter is straining or stretching a much more significant amount that the known kinematics and/or mechanics of the catheter dictate should be the case, the localization data may be ignored or
  • a surface model of one or more pertinent tissue structures is imported and registered - and with such registration and localization, utilized, for example, to: a) better understand the location and orientation of the distal tip of the subject instrument; b) provide haptic feedback regarding contact to surfaces; c) conduct "interpreted motion” as described above; d) conduct path and/or trajectory planning (preoperative, or offline intraoperatively); and e) provide "smart" automation functionality to the operator (for example, pick the best route to the selected points, use path/trajectory planning - and use the sensed position to follow that, make sure the operator knows that he is getting stuck on a surface, etc; indeed, points may be marked with master following mode offline - then the operator may select "execute” and observe the automation).
  • "reachability" analysis may be conducted with the "master following mode” offline to determine, for example, optimal sheath instrument location relative to guide instrument, and/or desirable position of a transseptal puncture to allow for desired reachability to key locations of the atrium.
  • updated catheter (or more generically, "instrument") information may be passed back to the localization system, preferably via a fast network and protocol, such as TCP/IP, to provide the localization system with information sufficient to present a depiction of the commanded catheter position upon the localization system display in the frame of reference of the localization system.
  • a fast network and protocol such as TCP/IP
  • various catheter or instrument system embodiments may comprise multiple instruments.
  • an ablation catheter may be positioned within a lumen of a robotically
  • systems may comprise more, or less, integrated
  • the catheter information comprises an updated complete surface model, such as a triangular mesh of the distal portion of the subject instrument, in the localization system frame of reference.
  • the surface model may be brought in as an object and depicted in 3-D space relative to other depicted structures or instruments.
  • the commanded catheter position surface model may be depicted in a different transparency or color than an "actual" position surface model, as determined by a localization system, which may also be depicted as an object within the display of the localization system.
  • differences in the position and orientation of various aspects of the commanded versus actual catheter tip objects may be interpreted as contact with a structure, errors in the control or mechanical systems, etc.
  • an offset may be selected to move the two objects on the display a given distance from each other.
  • Colors and transparencies may also be adjusted to provide an operator with better comparability during overlap scenarios, or in scenarios with desired offsetting.
  • the catheter information comprises an updated list of points representative of the commanded instrument surface model in the localization system frame of reference. Such points may be utilized by the localization system to build and display a surface model, such as a triangular mesh, of the commanded catheter position. Once built, each updated
  • - 19 - model may be utilized as described above in reference to the embodiment wherein the model itself is transferred from the robotic catheter system to the localization system. Transferring updated discrete sets of points is relatively efficient in terms of data transfer, in comparison to transferring a surface model, and the processing to build a surface model from the points may be distributed to other computing resources on the localization system.
  • an updated kinematic model of each instrument may be passed back to the localization system, to enable the localization system to build points and/or a surface model of the commanded catheter position for display as an object on the localization system display relative to other pertinent objects.
  • the kinematic models of the instruments change less often than the tip locations of the instruments, and thus a more streamlined packet of only tip locations may be passed to the localization system to generate an updated commanded catheter model, as opposed to a more robust packet containing both updated kinematic models and updated instrument tip locations.
  • the kinematics of an instrument may be similar in one three-dimensional envelope space, but may change to a more or less linear kinematic relationship outside of that envelope.
  • a first kinematic model may be passed to, or triggered from memory within, the localization system, and subsequent updates of catheter information while the instrument is in such first space may comprise merely tip position information.
  • a second kinematic model may be passed to, or triggered from memory within, the localization, and subsequent updates of catheter information while the instrument is in the second space may comprise merely tip position information.
  • the two coordinate systems may be coordinated fairly simply by knowing in each system where the catheter (or more generically "instrument") and image camera-eye view is with respect to the "world" coordinate system (that is, knowing position and orientation of each).
  • green reachable within normal system constraints
  • yellow reachable only with special maneuvers
  • red not reachable from the present location without re-positioning the instrument.
  • the reachability analysis will take into account the likelihood that the instrument will get hung up into tissue or some other structure in trying to navigate from the present to a desired location. If a location or point can be reached, reachability analysis may be utilized to determine, for example, whether the body of the instrument proximal to the distal tip may become hung up into tissue or some other nearby structure. In one embodiment, the instrument body may be analyzed as a series of segments, with collision detection algorithms
  • the location of such desired endpoint may be assigned a color designated to have a certain meaning to the operator. For example, if a collision is required for the instrument to reach a desired endpoint given the analysis of the segments, the location of such desired endpoint may be assigned a color designated to have a certain meaning to the operator. For example, if a collision is required for the instrument to reach a desired endpoint given the analysis of the segments, the location of such desired endpoint may be assigned a color designated to have a certain meaning to the operator. For example, if a collision
  • a green graphical user interface color may be assigned to such segment - meaning that the operator may navigate the instrument to that point without colliding with nearby structures; a pink color assignment may be utilized to mean that the desired maneuver is possible but in the current position of the instrument or instruments (for example, coaxially-interfaced guide and sheath instruments with another instrument positioned within a working lumen of the guide instrument) at least a portion thereof would collide with or deflect the adjacent tissue stmcture in order for the distal tip to be located at the desired endpoint; a red color assignment on the graphical user interface may be utilized in such a configuration to provide feedback to the operator that the desired endpoint is not reachable with the current instrument configuration.
  • the operator may use reachability analysis to understand what is reachable easily, reachable with some repositioning of instrumentation, or not reachable.
  • "reachability” may be expressed to the operator as a “yes” or “no", a scale of numerals, or other scaled gradation.
  • individual segments may be assigned colors pertinent to their particular impending collision status with nearby structures should a planned move be executed.
  • logic pertinent to the known kinematics of the given instrument may be interjected into the reachability analysis to an even further degree, such that sub-gradations of reachability are depicted for the operator, which are associated with the ease of reachability given the instrument performance.
  • kinematic logic regarding the instrument may be interjected to assign a dark green, for example, if the desired endpoint is reachable very easily without taking any of the instrument drive motors or tension elements past a preseleted load or defection envelope or threshold; the desired endpoint may be assigned a light green color, for example, if the drive motors or tension elements need to exceed a preselected envelope or threshold.
  • reachability analysis may be conducted offline (utilizing the computing systems of the subject robotic catheter system, but without an associated instrument or instrument driver attached; rather, a simulated instrument driver and instrument set may be utilized within the computer software) - perhaps before an operative procedure - for planning, training, interoperative time saving, or other reasons.
  • preoperatively acquired image data from CT, MR, radiography, and/or ultrasound, for example
  • reachability analysis to preoperatively simulate navigating the planned instrumentation configuration to all of the desired endpoints, choose interventional locations, such as transseptal crossing location, to maximize efficiency and safety during the
  • Such a configuration may be utilized for training and/or collaboration
  • pre-set logic may be blended into the reachability analysis or simulation to assist the operator in planning to avoid key sensitive structures.
  • the software may be configured to automaticalKy identify, and/or have the operator identify, structures such as the aortic outflow tract of the heart in the preoperative or intraoperative image data; the system may then be configured to assist the operator in avoiding collisions between such structure and any of the pertinent instrumentation given planned endpoints, paths, and/or trajectories.
  • such analysis may be utilized to assist the operator in affirmatively reaching and/or intervening with particular structures (for example, the system may be configured to assist the operator in reaching and safely crossing the atrial septum with a safe and desirable trajectory and displacement, and may be configured to select a portion of such atrial septum for crossing given the plans of the operator for using the instrument set in the left atrium subsequent to crossing such septum, as well as logical factors such as key structures to avoid when crossing such septum).

Abstract

La présente invention concerne un dispositif d’instrument de guidage à commande robotisée, comprenant un instrument de guidage souple allongé, un ensemble de commande couplé à une partie proximale de l’instrument et conçu pour manœuvrer une partie distale de celui-ci, une unité de commande principale comportant une interface utilisateur qui permet d’actionner l’ensemble de commande et de manœuvrer ainsi la partie distale de l’instrument, et un dispositif de fermeture couplé de manière libérable à un élément de placement porté par l’instrument de guidage. L’instrument de guidage peut être manœuvré pour placer le dispositif de fermeture à proximité d’une ouverture d’un appendice auriculaire gauche du cœur d’une personne de sorte que la prothèse puisse être séparée de l’élément de placement et implantée pour fermer sensiblement l’appendice auriculaire gauche.
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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016194262A1 (fr) * 2015-06-01 2016-12-08 オリンパス株式会社 Système manipulateur à usage médical
WO2018122993A1 (fr) * 2016-12-28 2018-07-05 オリンパス株式会社 Système médical, sur-tube médical et adaptateur de dispositif médical

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020087049A1 (en) * 1998-02-24 2002-07-04 Brock David L. Flexible instrument
US20030181942A1 (en) * 2002-01-25 2003-09-25 Sutton Gregg S. Atrial appendage blood filtration systems
US20030199923A1 (en) * 1998-11-06 2003-10-23 Ev3 Sunnyvale, Inc., A California Corporation Adjustable left atrial appendage implant deployment system
US20050065589A1 (en) * 2003-07-25 2005-03-24 Schneider Richard Lee Method and anchor for medical implant placement, and method of anchor manufacture
WO2005087128A1 (fr) * 2004-03-05 2005-09-22 Hansen Medical, Inc. Systeme de catheter robotique

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020087049A1 (en) * 1998-02-24 2002-07-04 Brock David L. Flexible instrument
US20030199923A1 (en) * 1998-11-06 2003-10-23 Ev3 Sunnyvale, Inc., A California Corporation Adjustable left atrial appendage implant deployment system
US20030181942A1 (en) * 2002-01-25 2003-09-25 Sutton Gregg S. Atrial appendage blood filtration systems
US20050065589A1 (en) * 2003-07-25 2005-03-24 Schneider Richard Lee Method and anchor for medical implant placement, and method of anchor manufacture
WO2005087128A1 (fr) * 2004-03-05 2005-09-22 Hansen Medical, Inc. Systeme de catheter robotique

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016194262A1 (fr) * 2015-06-01 2016-12-08 オリンパス株式会社 Système manipulateur à usage médical
JPWO2016194262A1 (ja) * 2015-06-01 2017-06-22 オリンパス株式会社 医療用マニピュレータシステム
CN107205789A (zh) * 2015-06-01 2017-09-26 奥林巴斯株式会社 医疗用机械手系统
US10117716B2 (en) 2015-06-01 2018-11-06 Olympus Corporation Medical manipulator system
US10201394B2 (en) 2015-06-01 2019-02-12 Olympus Corporation Medical manipulator system
US10314663B2 (en) 2015-06-01 2019-06-11 Olympus Corporation Medical overtube
US10335243B2 (en) 2015-06-01 2019-07-02 Olympus Corporation Drape unit
WO2018122993A1 (fr) * 2016-12-28 2018-07-05 オリンパス株式会社 Système médical, sur-tube médical et adaptateur de dispositif médical
JPWO2018122993A1 (ja) * 2016-12-28 2019-10-31 オリンパス株式会社 医療システム、医療用オーバーチューブ、及び医療デバイスアダプタ
US11337587B2 (en) 2016-12-28 2022-05-24 Olympus Corporation Medical over-tube, and medical device adapter having moving member and medical system having such medical over-tube

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