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EP-4740875-A2 - ANCHOR MAGAZINES

EP4740875A2EP 4740875 A2EP4740875 A2EP 4740875A2EP-4740875-A2

Abstract

A tube (1072) has a distal opening and a proximal end that defines a proximal opening. An extracorporeal unit (1274, 1474) is coupled to the proximal end, defines a deployment position, and comprises a track (1272, 1472) that leads to the deployment position. Each cartridge (1220, 1240) of a series holds a respective tissue anchor (1020) and is coupled to the extracorporeal unit at a respective initial position. Each cartridge is moveable along the track from the respective initial position to the deployment position such that the cartridge holds its tissue anchor opposite the proximal opening. An anchor driver (1060) can advance the tissue anchor distally out of its cartridge, through the proximal opening, and through the tube. Each cartridge is subsequently removable from the deployment position thereby vacating the deployment position for a successive cartridge of the series. Other applications are also described.

Inventors

  • HALABI, Ido
  • KASHER, Yuval
  • HERMAN, YARON
  • SHARON, Assaf
  • ZUARETZ, Yosef

Assignees

  • Edwards Lifesciences Innovation (Israel) Ltd.

Dates

Publication Date
20260513
Application Date
20210923

Claims (15)

  1. A system (1000) for use with a subject, including: a catheter device (1070) including: a distal member (1072) or distal portion configured to be advanced into the subject; and an extracorporeal unit (1074) at a proximal portion of the catheter device (1070); a tether (1012) including: a distal portion that includes a distal end of the tether (1012); and a proximal portion that includes a proximal end of the tether (1012); multiple tissue anchors (1020), each of the anchors including: a tissue-engaging element; and a head (1024) defining an eyelet (1026), wherein the eyelets (1026) of the multiple tissue anchors (1020) are threaded onto the tether (1012) such that the multiple tissue anchors (1020) are distributed in a series along the tether (1012); and an anchor driver (1060), wherein the anchor driver (1060), for each of the anchors consecutively, is configured be reversibly coupled to the anchor and to be used to advance the anchor, distally along the tether (1012) toward the distal end of the tether (1012).
  2. The system (1000) of any one of the preceding claims, wherein the distal member (1072) or distal portion includes a catheter that has a proximal opening (1073), has a distal opening (1015) that is configured to be advanced into the subject, and defines a lumen between the proximal opening (1073) and the distal opening (1015).
  3. The system (1000) of any one of the preceding claims, wherein the multiple tissue anchors (1020) are mounted in a series on the extracorporeal unit (1074) of the catheter device (1070).
  4. The system (1000) of any one of the preceding claims, wherein the system (1000) further includes a series of cartridges (1220).
  5. The system (1000) of claim 4, wherein each of the cartridges (1220) holds a respective tissue anchor (1020) of the multiple anchors or of the series of tissue anchors (1020).
  6. The system (1000) of claim 5, when dependent on claim 2, the anchor driver (1060) is, for each of the anchors, configured to be coupled to the anchor while the anchor is held by the respective cartridge (1220) opposite the proximal opening (1073), and to advance the anchor distally out of the respective cartridge (1220), through the proximal opening (1073), and through the catheter toward the distal opening (1015).
  7. The system (1000) of any one of claims 5 or 6, when dependent on claim 2, wherein each cartridge (1220) is coupled to the extracorporeal unit (1074) at a respective initial position of a series of initial positions.
  8. The system (1000) of claim 7, wherein each cartridge (1220), while remaining coupled to the extracorporeal unit (1074), is moveable from the respective initial position to a deployment position in which the cartridge (1220) holds the respective tissue anchor (1020) opposite the proximal opening (1073).
  9. The system (1000) of claim 8, wherein each cartridge (1220) is subsequently removable from the deployment position such that the deployment position is vacant for a successive cartridge (1220) in the series.
  10. The system (1000) of any one of the preceding claims, wherein the extracorporeal unit (1074) includes a housing and a tensioner (1080).
  11. The system (1000) of any one of the preceding claims, wherein the extracorporeal unit (1074) is a handle.
  12. The system (1000) of any one of claims 10 or 11, wherein the tether (1012) extends from the proximal portion, distally through the catheter device (1070) to the distal portion of the tether (1012), the distal portion being disposed distally from the tensioner (1080).
  13. The system (1000) of any one of claims 10 to 12, wherein the tensioner (1080) is configured to pull proximally on the tether (1012).
  14. The system (1000) of any one of the preceding claims, wherein the tissue anchors (1020) and the tether (1012) are components of an implant (1010).
  15. The system (1000) of claim 14, wherein the distal portion of the tether (1012) becomes chronically implanted with the anchors, and the proximal portion of the tether (1012) is removed from the subject after the anchors are anchored to the tissue.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS The present application claims priority to US Provisional Patent Application 63/083,571 to Halabi et al., filed September 25, 2020, and entitled "ANCHOR MAGAZINES," which is incorporated herein by reference in its entirety for all purposes. BACKGROUND Annuloplasty involves remodeling tissue of an annulus. This can be done by pulling tissue about the annulus to a new shape. Tissue anchors can be used to facilitate medical procedures including annuloplasty, other remodeling of tissues, and securing implants. In some instances, tissue anchors can be used as an alternative to sutures. For example, a tissue anchor may be used for a procedure in which there is no line-of-sight to the target. SUMMARY This summary is meant to provide some examples and is not intended to be limiting of the scope of the invention in any way. For example, any feature included in an example of this summary is not required by the claims, unless the claims explicitly recite the features. Also, the features, components, steps, concepts, etc. described in examples in this summary and elsewhere in this disclosure can be combined in a variety of ways. Various features and steps as described elsewhere in this disclosure may be included in the examples summarized here. For some applications, systems, apparatuses, and methods are provided for percutaneously (e.g., transluminally) delivering one or more anchors to tissue of a subject and anchoring the anchors to the tissue. For some such applications, the tissue anchors are components of an implant that further comprises a tether on which the tissue anchors are pre-threaded. For some such applications, a distal portion of the tether becomes chronically implanted with the anchors, and a proximal portion of the tether is removed from the subject after the anchors (and therefore the implant) is anchored to the tissue. The methods herein can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g., with the body parts, tissue, etc. being simulated), etc. Some applications relate to systems, apparatuses, and methods for determining successful (e.g., complete) anchoring of one or more tissue anchors to a tissue that is not in line-of-sight, such as during percutaneous (e.g., transluminal) techniques. In some applications, the tissue anchor includes a tissue-engaging element and a head. The tissue-engaging element can be or comprise one or more of hook(s), clip(s), dart(s), barb(s), staple(s), tine(s), needle(s), helical portion(s), screw(s), tissue-penetrating portion(s), etc. In some applications, an anchor driver can engage the anchor at the head (e.g., reversibly attaching to the head), and drives the tissue-engaging element into the tissue. Often, successful anchoring includes the tissue-engaging element becoming fully embedded in the tissue, e.g., such that the head abuts the surface of the tissue. For some applications, respective catheter systems are provided which include transluminally-advanceable catheters including respective mechanisms for controlling the advancement of tissue anchors stored within an anchor-storage zone of the transluminally-advanceable catheters and or of an extracorporeal unit (e.g., a controller and/or handle) coupled to the catheter. For some applications, the mechanism can include a helical thread that is rotatable to control the advancement of an anchor beyond the anchor-storage zone and to prevent the advancement of too many anchors at a given time out of the anchor-storage zone. For some applications, the mechanism can include a plurality of detents to control the advancement of an anchor beyond the anchor-storage zone and to prevent the advancement of too many anchors at a given time out of the anchor-storage zone. For some applications, the mechanism can include a dispenser to control the advancement of an anchor beyond the anchor-storage zone and to prevent the advancement of too many anchors at a given time out of the anchor-storage zone. For some applications, the mechanism can include a revolving stopper at the extracorporeal unit which controls the advancement of an anchor beyond the anchor-storage zone and prevents the advancement of too many anchors at a given time out of the anchor-storage zone. For some applications, respective catheter systems are provided which include respective anchor drivers for reversibly coupling to the tissue anchor and facilitating driving of the anchor into the tissue. For some applications, respective catheter systems are provided which include a tensioner that applies tension (e.g., a pre-determined and/or constant amount of tension) to the tether during implantation, e.g., to reduce a likelihood of inadvertent tangling or ensnaring. For some such applications, the anchors can be threaded, along the tether, between the tensioner and the distal end of the tether. For other applications, the tensioner can be disposed, along the tether, bet