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EP-4452133-B1 - DEVICES FOR POSITIONING AN ANCHOR FOR AN ARTIFICIAL CHORDAE TENDINEAE

EP4452133B1EP 4452133 B1EP4452133 B1EP 4452133B1EP-4452133-B1

Inventors

  • GIESE, TROY ANTHONY
  • ELEID, MACKRAM F.
  • EGGERT, JOEL T.
  • KOUDELA, Christopher J.
  • KILLEEN, Larry Michael
  • BARRON, NICHOLAS
  • JONES, MATTHEW P.
  • OTT, Kristen Elizabeth
  • CAWTHRA, JAMES K.
  • RIHAL, CHARANJIT S.

Dates

Publication Date
20260513
Application Date
20220830

Claims (10)

  1. A delivery and deployment device (110) for transluminally delivering and/or deploying an implantable device at a deployment site within a body, the implantable device having a portion which shifts from a delivery configuration to a deployment configuration upon deployment, the delivery and deployment device (110) comprising: a delivery device (110) configured to deliver an implantable device; and three or more sensors (160) positioned along a distal end (101, 111) of the delivery device (110) and configured to generate a signal when the distal end (101, 111) of the delivery device (110) is in contact with tissue (T) to ensure purchase of tissue (T) by the implantable device upon deployment; wherein the implantable device is a tissue anchor (120) having two or more talons (122) shiftable from a delivery configuration to a deployment configuration; wherein the delivery device (110) is an anchor garage (130) configured to deliver the tissue anchor (120) to a deployment site; and wherein the tissue anchor (120) is clocked with respect to the anchor garage (130) to align at least one of the talons (122) of the tissue anchor (120) with a sensor (160) of the three or more sensors (160).
  2. The delivery and deployment device (110) of claim 1, wherein the three or more sensors (160) are positioned spaced apart along a periphery of a distal end (101, 111) of the delivery device (110).
  3. The delivery and deployment device (110) of any of claims 1-2, wherein the three or more sensors (160) are equidistantly spaced apart from one another.
  4. The delivery and deployment device (110) of any of claims 1-3, wherein the three or more sensors (160) include at least one sensor (160) associated with each talon (122) of the tissue anchor (120) delivered by the anchor garage (130).
  5. The delivery and deployment device (110) of any of claims 1-4, wherein the anchor garage (130) has a blunt distal end (131) along which the three or more sensors (160) are positioned.
  6. The delivery and deployment device (110) of any of claims 1-5, wherein the three or more sensors (160) include contact sensors.
  7. The delivery and deployment device (110) of any of claims 1-6, further comprising a delivery shaft (108) through which lead wires extend from the three or more sensors (160).
  8. The delivery and deployment device (110) of any of claims 1-7, further comprising the implantable device.
  9. The delivery and deployment device (110) of any of claims 1-8, wherein: the three or more sensors (160) include at least one sensor (160) associated with a talon (122) of the tissue anchor (120).
  10. The delivery and deployment device (110) of any of claims 1-9, wherein lead wires from the three or more sensors (160) extend within a projection along the anchor garage (130) to a device generating a signal indicating contact of the three or more sensors (160) with tissue (T).

Description

FIELD The present disclosure relates generally to the field of implantable medical devices. In particular, the present disclosure relates to medical devices, systems, and methods for delivering and deploying implantable devices. More particularly, the present disclosure relates to medical devices, systems, and methods for delivering and deploying an anchor to ensure engagement with and into cardiac tissue. BACKGROUND Devices, systems, and methods for delivering and deploying implantable devices with minimally invasive techniques, such as transluminally, are desirable for avoiding more complex and invasive open surgery procedures. For instance, various techniques for cardiac surgery, such as repairing or replacing artificial chordae tendineae, including anchoring the artificial chordae tendineae to heart tissue, have been developed using transcatheter techniques without requiring open heart surgery. Transcatheter or otherwise noninvasive procedures generally require simultaneous visualization of both the targeted anatomy and the implant tools (delivery and deployment tools, as well as the implant itself). Unfortunately, current visualization tools are incapable of identifying both tissue as well as inorganic materials from which implant tools are made (e.g., metals, polymers, ceramics, etc.). Ultrasound easily identifies tissue, but struggles with many foreign materials, especially metallic components commonly implemented in medical devices and associated mechanisms and systems. As such, the devices and systems tend to cast shadows with fluoroscopy, obstructing the view of targeted tissues and often the devices and mechanisms as well. Fluoroscopy is well suited for viewing dense materials, but is generally unsuitable for visualizing many soft tissues (such as heart leaflets). Solutions for verifying accurate positioning of a device for delivering and deploying an implant, such as an artificial chordae tendineae anchor with respect to heart tissue, and/or proper implantation of such anchor would be welcome. US 2007/0080188 Al discloses systems and methods for securing tissue including the annulus of a mitral valve, which may employ catheter based techniques and devices to plicate tissue and perform an annuloplasty. SUMMARY The present invention is directed to a device for positioning an anchor for an artificial chordae tendineae as defined in claims 1-10. This summary of the disclosure is given to aid understanding, and one of skill in the art will understand that each of the various aspects and features of the disclosure may advantageously be used separately in some instances, or in combination with other aspects and features of the disclosure in other instances. No limitation as to the scope of the claimed subject matter is intended by either the inclusion or non-inclusion of elements, components, or the like in this summary. In accordance with various principles of the present disclosure, a delivery device configured to deliver an implantable device includes three or more sensors positioned along a distal end of the delivery device and configured to generate a signal when the distal end of the delivery device is in contact with tissue to ensure purchase of tissue by the implantable device upon deployment. In some embodiments, the three or more sensors are positioned spaced apart along a periphery of a distal end of the delivery device. In some embodiments, the three or more sensors are equidistantly spaced apart from one another. In some embodiments, the delivery device is an anchor garage configured to deliver a tissue anchor to a deployment site, the tissue anchor having two or more talons shiftable from a delivery configuration to a deployment configuration. In some embodiments, the three or more sensors include at least one sensor associated with each talon of the tissue anchor delivered by the anchor garage. In some embodiments, the anchor garage has a blunt distal end along which the three or more sensors are positioned. In some embodiments, the three or more sensors include contact sensors. In some embodiments, the delivery and deployment device further includes a delivery shaft through which lead wires extend from the three or more sensors. In accordance with various principles of the present disclosure, a system for delivering and deploying an implantable device to a deployment site in a body includes an implantable device; a delivery device configured to deliver the implantable device to the deployment site, and three or more sensors positioned along a distal end of the delivery device and configured to generate a signal when the distal end of the delivery device is in contact with tissue to ensure purchase of tissue by the implantable device upon deployment without the need for imaging. In some embodiments, the three or more sensors are positioned spaced apart along a periphery of a distal end of the delivery device. In some embodiments, the implantable device is a tissue anchor; and the deliver