WO2020198259A1 - Devices and systems for treating the left atrial appendage - Google Patents

Devices and systems for treating the left atrial appendage Download PDF

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Publication number
WO2020198259A1
WO2020198259A1 PCT/US2020/024513 US2020024513W WO2020198259A1 WO 2020198259 A1 WO2020198259 A1 WO 2020198259A1 US 2020024513 W US2020024513 W US 2020024513W WO 2020198259 A1 WO2020198259 A1 WO 2020198259A1
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WO
WIPO (PCT)
Prior art keywords
implant
state
frame
atrial appendage
left atrial
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2020/024513
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English (en)
French (fr)
Inventor
Randall T. Lashinski
Joshua J. Dwork
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Laminar Inc
Original Assignee
Laminar Inc
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Filing date
Publication date
Application filed by Laminar Inc filed Critical Laminar Inc
Priority to EP20719075.2A priority Critical patent/EP3883483A1/en
Priority to CN202080038499.9A priority patent/CN113873957B/zh
Priority to JP2021558501A priority patent/JP7616746B2/ja
Publication of WO2020198259A1 publication Critical patent/WO2020198259A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
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    • 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
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Definitions

  • the device can be delivered via venous access through the groin and a transseptal crossing into the left atrium where a guide catheter and coaxial delivery catheter are positioned proximal to the left atrial appendage.
  • the implant for appendage exclusion is typically positioned at the distal most portion of the delivery catheter.
  • the device is typically positioned and deployed using fluoroscopy and echocardiography for guidance. Typical issues with conventional devices include complicated pre-procedural sizing algorithms used to determine the appropriate device size, migration of the implant, leakage around or through the implant, and/or fracture of the implant, all which may exacerbate the thrombus and stroke problem the device was designed to reduce.
  • the contact member can be configured to be moved against the inner wall surface of the left atrial appendage without changing a state or shape of the contact member, and/or the contact member can be configured to be movable or expandable from a first state to a second state.
  • Any embodiments of the methods disclosed herein can include advancing a delivery catheter having an implant coupled therewith into the heart, advancing a distal tip of the delivery catheter near an ostium of the LAA, and/or elongating the LAA in a first direction by at least expanding the implant in the first direction so that a ratio of a size of the ostium of the LAA in the first direction relative to a size of the ostium of the LAA in a second direction that is perpendicular to the first direction is at least 2 to 1.
  • the method can also include withdrawing the delivery catheter with the implant positioned in the LAA.
  • the device can further include a delivery catheter having an outer sheath and a guide lumen, the guide lumen configured to receive and track over the second guide device.
  • the first member of the clamp device can be rigid and the second member of the clamp device can comprise a suture.
  • Figure 4 shows the implant device of Figure 2A wherein the contact member is in a second, expanded state, the retention member is in a first, extended state, and the securing element is in a second, open state.
  • Figure 41 shows the treatment system of Figure 37, wherein the tab member of the securing element has been moved to the second, disengaged state by the axial advancement of a core member of the delivery system.
  • Figures 60A-60B show another embodiment of a securing element that can be used with any treatment system embodiments disclosed herein.
  • Figures 71A-71G show some details of some embodiments of a staple that can be used with any device disclosed herein for occluding the LAA.
  • Figures 72A-72F show an embodiment of a device and a method for forming a staple.
  • Figures 108A-108C show another embodiment of a device and an embodiment of a method for using such device for treating the LAA.
  • Figures 147A-147B show an embodiment of a method of using the device of Figures 146A-146C.
  • Figures 148A-148B show another embodiment of a device and a method of using such device for treating the LAA.
  • Figures 158A-158C show another embodiment of a device and a method of using such device for treating the LAA.
  • Figures 183A-183E show an embodiment of a treatment system and method of using such device to treat the LAA.
  • Figures 188A-188E show an embodiment of a treatment system and method of using such device to treat the LAA.
  • the contact member 104 of the implant device 102 can be advanced as far into the LAA is desired by the surgeon, or as is appropriate.
  • the contact member 104 can be advanced into contact with, adjacent to, or near to a distal end of the LAA before the contact member 104 is rotated. This will permit more of the implant to be positioned within the LAA and, in some embodiments, more of the tissue of the LAA to constrict around a body portion or other portion of the implant device 102.
  • the contact member 144 can be self-expanding in a radial direction so that, when a restraint is removed from the contact member 144, the contact member 144 can expand against an inner surface or wall of the LAA automatically.
  • the contact member 144 can be mechanically expandable, such as by a balloon expander, so as to expand against inside surface or wall of the LAA.
  • the system 200 can be configured so that the implant device 202 is biased in the proximal direction relative to the core member 218.
  • some embodiments of the implant device 202 can have a suture or thread 280 that extends through an inside of the core member 218 (such as through a lumen of the core member 218) and loops around the pin 268, thereby permitting a user to retract or withdraw the suture to pull the implant device 202 proximally relative to the core member 218.
  • This implant can anchor or couple via the cleats or barbs 1834 at the ends of the implant 1830 to the atrial wall, just outside the lateral radius of the LAA ostium. Deployed in its folded shape and placed to cover the LAA ostium, when advanced, the anchors 1834 dig into the atrial wall in a lateral outward motion, stretching the LAA ostium to be narrow as the implant flattens and then finally inverts. Once inverted, the delivery system can be removed from the implant 1830.
  • One characteristic of some of the embodiments of the implants disclosed herein is that they are not dependent of a certain depth of the LAA, since no part of the delivery catheter or implant ever enters into the LAA. Some embodiments of the implant are also configured to lock itself in place still, even if not all the anchors were engaged. This elongated embodiment can also leave less exposed material surface area than the circular embodiment.
  • the steps of deployment and implantation of some embodiments of the implant devices disclosed herein can include: inserting catheter into middle of LAA ostium; advancing implant until clip jaws are contacting the atrial wall and stretch bar has stretched LAA ostium; actuating the closing of the jaws, can be actuated with a pull wire, or other mechanism (can also be spring actuated to the normally closed state where it is held open before deployment and simply released after); locking the jaws in the closed state; and/or releasing the delivery catheter from the implant.
  • any embodiments or versions of the implants disclosed herein can be formed in a plurality of different ways in order to achieve the spring-like mechanism which is configured to apply lateral expansion force on the LAA ostium.
  • One embodiment of the implant, such as implant 2320 can have a length of wire in a U-shape configured to allow cantilever bending near the middle of the implant.
  • Another embodiment of an implant, such as implant 2322 can have a torsion spring wire-form near the middle of the implant.
  • the implant (such as implant 2390 shown in Figures 146A-146D) can also have a 4-bar scissor mechanism incorporated in the middle of the expander form which can be configured to allow the implant to clamp closed a first and a second portion (which can be a superior and an inferior portion) of the LAA ostium after stretching.
  • the 4-bar clamp mechanism 2390 would be in a narrow or compressed state.
  • the wire form would engage the latter ends of the LAA ostium, then the expansion would be permitted to continue to close the 4-bar clamp mechanism which is centered at the LAA ostium.
  • Figure 146A shows the implant 2390 before it has fully expanded.
  • anti-rotational features such as barbs or variable pitch changes along the length to hold intended position in the tissue.
  • a flush head configuration would allow for a smooth tissue formation in the left atrium so a receiver style acceptance in the screw may be beneficial.
  • This receiver could be a slot, hex, square or other torque transmission connection to the driver housed in the catheter body.
  • the head could be larger than the body of the screw as a machined flange, or an expandable disk or star to resist pullout through the tissue.
  • Each anchor could be preloaded into the catheter or loaded individually in a single lumen traversing from the proximal end to the distal end.
  • connection could be a passive joint where longitudinal force would allow the connection to be maintained or an interlock could be used to hold the driver and screw together where a safety mechanism would resist premature disconnection.
  • the driver could be constructed of a solid round wire, square or hex wire, or a hypotube with or without a flexible portion for adequate torque transmission to drive the anchors into the tissue.
  • the flexible portion could consist of a laser cut pattern selectively removed to allow for torque transmission but also increase the flexibility in curved sections of the catheter. These patterns could be helix, slots or other known patterns for driver tubes. Additionally, a twisted-wire torque driver could also be used to deliver the anchor.
  • LAA left atrial appendage
  • the device is applied to the LAA within the pericardial space, as will be described in greater detail.
  • the improved devices for closing or clamping the LAA disclosed herein can be configured to flatten and/or elongate the opening of the LAA, thereby resulting in an improved seal across the ostium of the LAA.
  • the clamp device embodiments disclosed herein can result in reduced leakage out of the LAA and potentially reduce tissue damage that may result from radially constricting devices.
  • the device can be applied across or over a neck portion of the LAA in the pericardial space, using guidewires or other devices to advance the closure device into the pericardial space and to the LAA.
  • Figure 184 is an anterior view of a heart illustrating the right ventricle RV, the left ventricle LV, and the left atrial appendage LAA.
  • the methods and apparatuses of the present disclosure are intended to place a closure mechanism over or otherwise close off the base region BR of the left atrial appendage. By closing off the base region BR, the exchange of materials between the left atrial appendage LAA and the left atrium LA can be significantly reduced or stopped. Thus, the release of emboli from the left atrial appendage into the left atrium can be significantly reduced or stopped.
  • Figure 185 illustrates the heart, located within the pericardial space PS located beneath the patient’s rib cage RC.
  • any embodiments of the clamp device 3210 can be provided in different sizes and/or shapes and can be mechanically actuated to clamp down when placed at the target location. Some embodiments of the clamp device 3210 can be adjustably cinched down at the lateral ends using a suture or otherwise to move the clamp device 3210 from the open state to the closed state. As such, any embodiments of the clamp device 3210 can include two rigid bars or clamping members (such as clamping members 3216, 3218) that can be configured to move together from an open state to a closed state. In the open state, the closure device can be passed over an outside surface of the LAA toward the neck region of the LAA.
  • Figures 188A-188E show the delivery stages of another embodiment of a clamp delivery system 3300 comprising a delivery catheter 3302, a first guide device 3304 (which can be a transseptal magnetic guidewire), a second guide device 3306 (which can be an epicardial magnetic guidewire), and a clamp device 3310 for closing an LAA.
  • a delivery catheter 3302 which can be a transseptal magnetic guidewire
  • a second guide device 3306 which can be an epicardial magnetic guidewire
  • clamp device 3310 for closing an LAA.
  • Any embodiments of the delivery system 3300 can have any of the same features, components, or other details of any other clamp delivery system embodiments disclosed herein, including without limitation any of the embodiments of the clamp delivery systems 100 or 200 disclosed above, in place of or in addition to any of the features, components, or other details disclosed below for delivery system 3300.
  • the device can be configured so that the device has a low profile shape in the portion of the device that remains in the left atrium following implantation of the device and is otherwise configured to minimize the impact of the device on the overall volume of the left atrium and the flow of blood through the atrium.
  • the portion of the device that extends into the left atrium following implantation of the device can be minimized.
  • the device of any embodiments disclosed herein can be configured such that only a small fraction of the overall length of the deployed device (for example and without limitation, approximately 10% or less, or approximately 15% or less, or in some embodiments approximately 20% or less of the overall length of the deployed device) extends into the left atrium following deployment.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
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  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
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US20230033509A1 (en) 2023-02-02
US11399843B2 (en) 2022-08-02

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