Tissue anchor for heart implant
Inventors
Assignees
Edwards Lifesciences Innovation Israel Ltd
Publication Number
US-12097118-B2
Publication Date
2024-09-24
Expiration Date
2029-10-29
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Abstract
An anchor of an implant is transluminally advanced to a heart of a subject, the anchor including a distal helical element, and a post extending proximally from the distal helical element. The implant is anchored to tissue of the heart by driving the distal helical element into tissue of the heart, and compressing a fabric tube against the tissue by moving an annular member, coupled to the post, toward the tissue such that the fabric tube becomes sandwiched between the annular member and the tissue. Other embodiments are also described.
Core Innovation
The invention provides a tissue anchor configured for receiving and facilitating implantation of a tissue-repair implant at cardiac tissue of a patient, specifically at an annulus of an atrioventricular valve. The anchor includes a distal tissue coupling element, such as a helical anchor, that penetrates the tissue, and a proximal implant-penetrating element, typically a post extending from the distal element, which receives and secures the implant.
The anchor is advanced transluminally to the heart, where the distal element is driven into tissue and the implant is anchored by moving an annular member coupled to the post toward the tissue, compressing a fabric sleeve of the implant and sandwiching it against the tissue. The implant slides along the implant-penetrating element, which has a proximal restraining feature such as a barb or radially expandable arms, to prevent proximal separation from the anchor.
A problem being solved relates to repair of atrioventricular valves suffering from annulus dilation, which impairs valve leaflet coaptation and leads to mitral regurgitation, causing cardiac inefficiency and ventricular weakening. Prior methods use various sutures, anchors, linkers, and annuloplasty rings implanted invasively or non-invasively but may not provide an optimized anchoring mechanism for secure and minimally invasive implant deployment. This invention addresses these issues by providing tissue anchors with features that facilitate secure implant coupling, minimally-invasive transcatheter delivery, and adjustable, lockable fixation of implants such as annuloplasty rings.
Claims Coverage
The patent contains multiple independent claims focusing on methods of transluminally advancing and anchoring a heart implant using an anchor with a distal helical element and axial post, and associated structures for implant securing.
Method of transluminal advancement and anchoring using distal helical element and axial post
The method includes transluminally advancing an anchor that has a distal helical element and an axial post extending proximally, driving the helical element into heart tissue, and anchoring the implant by compressing a fabric sleeve against tissue via an annular member coupled to the axial post, sandwiching the fabric sleeve between the annular member and tissue with the post extending through the sleeve.
Use of a proximal passage with removable cord during advancement
The anchor's proximal part defines a passage through which a cord extends removable during advancement and anchoring, including advancing the anchor while the nitinol cord extends through the passage, and subsequently sliding the cord through the passage after anchoring.
Single-piece fabrication and dimensional features
The distal helical element and axial post may be fabricated from a single piece; the anchor has a length of 6–18 mm; the axial post has a length of 1–7 mm and a cross-sectional dimension of 0.2–0.4 mm; and the distal helical element length is 2–8 mm.
Method of implant anchoring with the post disposed within fabric sleeve
Anchoring includes moving an annular member coupled to the post toward tissue while the post is disposed within the fabric sleeve, compressing the sleeve against tissue by sandwiching it between the annular member and tissue.
The independent claims collectively cover the advance and secure anchoring method of the implant involving a distal helical tissue anchor and a proximally extending axial post, the use of a proximal passage for cord guidance, the structural specificities of the anchor components, and a locking method involving compression of a fabric sleeve between an annular member and tissue.
Stated Advantages
Facilitates minimally-invasive, transluminal implantation of tissue anchors and implants through vessels to cardiac tissue.
Provides secure fixation of implants to heart tissue via a helical anchor and implant-penetrating post with a restraining element to prevent implant separation.
Enables adjustable and lockable coupling of the implant which can be advanced and locked in position via a cord-guided system and locking mechanisms.
Improves repair of dilated atrioventricular valve annulus to restore valve function and reduce mitral regurgitation.
Documented Applications
Repair and anchoring of an atrioventricular valve, such as a mitral valve, through implantation of annuloplasty devices or prosthetic valves.
Transcatheter, minimally-invasive, or open-heart procedures to implant tissue anchors and valve repair implants at the annulus of a heart valve.
Anchoring tissue-repair implants in non-cardiac tissue, including stomach tissue, such as for gastric bypass rings.
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