Search

EP-4740874-A2 - HEART VALVE REGURGITATION ANCHOR AND DELIVERY TOOL

EP4740874A2EP 4740874 A2EP4740874 A2EP 4740874A2EP-4740874-A2

Abstract

A heart valve anchor apparatus may include a body having a proximal portion and a distal portion. The body may include a first radially expandable portion at the proximal portion of the body, a second radially expandable portion at the distal portion of the body, and a root portion extending from the first radially expandable portion to the second radially expandable portion, the root portion having an outer extent. The first radially expandable portion may be configured to self-expand to an outer extent greater than the outer extent of the root portion when radially unconstrained. The second radially expandable portion may be configured to self-expand to an outer extent greater than the outer extent of the root portion when radially unconstrained.

Inventors

  • BALDWIN, Katherine L.
  • ROHL, JAMES P.
  • CAWTHRA, JR., JAMES K.
  • DEARANI, Joseph A.
  • SHUEY, Daniel
  • GROTH, DALE

Assignees

  • Boston Scientific Scimed, Inc.
  • Mayo Foundation for Medical Education and Research

Dates

Publication Date
20260513
Application Date
20170816

Claims (15)

  1. A heart valve anchor apparatus, comprising: a body (100) having a proximal portion (102) and a distal portion (104), the body (100) comprising: a first radially expandable portion (110) at the proximal portion (102) of the body (100); a second radially expandable portion (120) at the distal portion (104) of the body (100); and a root portion (130) extending from the first radially expandable portion (110) to the second radially expandable portion (120), the root portion (130) having an outer extent; wherein the first radially expandable portion (110) is configured to self-expand to an outer extent greater than the outer extent of the root portion (130) when radially unconstrained; wherein the second radially expandable portion (120) is configured to self-expand to an outer extent greater than the outer extent of the root portion (130) when radially unconstrained.
  2. The heart valve anchor apparatus of claim 1, wherein the body (100) is adapted to engage tissue between the proximal portion (102) and the distal portion (104) in an unstressed configuration, such that one or more plications of tissue are formed between the proximal portion (102) and the distal portion (104), and wherein the body (100) is adapted to compress tissue between the proximal portion (102) and the distal portion (104) in a shortened configuration.
  3. The heart valve anchor apparatus of claim 2, wherein the root portion (130) is adapted to pass through tissue disposed between the proximal portion (102) and the distal portion (104).
  4. The heart valve anchor apparatus of claim 2 or claim 3, wherein the body (100) has an overall length in the unstressed configuration and the overall length is reduced when the body (100) is in the shortened configuration.
  5. The heart valve anchor apparatus of any one of the preceding claims, wherein the body (100) is formed from a plurality of wires oriented and/or formed into a braided configuration, more specifically wherein the first radially expandable portion (110), the second radially expandable portion (120) and the root portion (130) are unitarily formed.
  6. The heart valve anchor apparatus of any one of the preceding claims, wherein the root portion (130) is configured to expand or self-expand radially outward when radially unconstrained.
  7. The heart valve anchor apparatus of any one of the preceding claims, further comprising a suture element (1200, 1400) disposed through the body (100) along a longitudinal centerline defined by the body (100).
  8. The heart valve anchor apparatus of claim 7, wherein in an unstressed configuration, the longitudinal centerline extends away from a plane tangent to the root portion (130).
  9. The heart valve anchor apparatus of claim 7 or claim 8, further comprising: a needle (1100); and an elongated sheath (1300) having a deployment head (1310) fixedly attached at a proximal end (1302) of the elongated sheath (1300), wherein the suture element (1200) has a proximal end (1202) attached to the needle (1100), wherein the suture element (1200) passes distally into the deployment head (1310) and has a stop feature (1210) disposed within the deployment head (1310); wherein the body (100) is disposed at least partially within the elongated sheath (1300) in a delivery configuration.
  10. The heart valve anchor apparatus of claim 9, wherein translation of the elongated sheath (1300) proximally relative to the body (100) releases the body (100) such that the body (100) is free to assume an unstressed configuration.
  11. The heart valve anchor apparatus of any of claims 9-10, wherein in the delivery configuration, the first radially expandable portion (110) is disposed within the elongated sheath (1300) and the second radially expandable portion (120) is disposed distal of the elongated sheath (1300), and wherein the stop feature (1210) is disposed proximal of the first radially expandable portion (110).
  12. The heart valve anchor apparatus of any one of claims 1-8, further comprising: a tissue penetrating device including a lumen extending longitudinally therethrough, the body (100) being at least partially disposed within the lumen in the delivery configuration; and a push rod (2120) disposed within the lumen adjacent to the body (100).
  13. The heart valve anchor apparatus of claim 12, wherein translation of the push rod (2120) relative to the tissue penetrating device releases the body (100) from the lumen; and wherein after release from the lumen, the body (100) is free to assume the unstressed configuration.
  14. The heart valve anchor apparatus of any of claims 12-13, when dependent on claim 7, wherein the suture element (1200) extends longitudinally through the body (100) to a stop feature disposed opposite the push rod (2120).
  15. The heart valve anchor apparatus of claim 14, wherein placing the suture element (1200) in tension while applying an opposing force to the body (100) with the push rod (2120) places the body (100) into a shortened configuration wherein the tissue is compressed between the first radially expandable portion (110) and the second radially expandable portion (120).

Description

Cross Reference To Related Applications The present application claims the benefit of and priority to US Provisional Patent Application Serial No. 62/375,564, filed August 16, 2016, the disclosure of which is incorporated herein by reference. Technical Field The present disclosure pertains to medical devices, and methods for manufacturing and/or using medical devices. More particularly, the present disclosure pertains to configurations of heart valve regurgitation anchors and delivery tools for heart valve regurgitation anchors. Background A wide variety of intracorporeal medical devices have been developed for medical use, for example, surgical and/or intravascular use. Some of these devices include guidewires, catheters, medical device delivery systems (e.g., for stents, grafts, replacement valves, etc.), and the like. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. Of the known medical devices and methods, each has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices as well as alternative methods for manufacturing and/or using medical devices. Summary In a first aspect, a heart valve anchor apparatus may comprise a body having a proximal portion, a proximal end, a distal portion, and a distal end, the body having a delivery configuration, an unstressed configuration, and a shortened configuration. The body may comprise a first radially expandable portion at the proximal portion of the body, a second radially expandable portion at the distal portion of the body, and a root portion extending from the first radially expandable portion to the second radially expandable portion, the root portion having an outer extent. The first radially expandable portion may be configured to self-expand to an outer extent greater than the outer extent of the root portion when radially unconstrained. The second radially expandable portion may be configured to self-expand to an outer extent greater than the outer extent of the root portion when radially unconstrained. In the unstressed configuration, the body may define a longitudinal centerline that extends away from a plane tangent to the root portion. In addition or alternatively, and in a second aspect, the body is adapted to be housed at least partially within a tissue penetrating device in the delivery configuration. In addition or alternatively, and in a third aspect, the body is adapted to engage tissue between the proximal portion and the distal portion in the unstressed configuration and the shortened configuration, such that one or more plications of tissue are formed between the proximal portion and the distal portion. In addition or alternatively, and in a fourth aspect, the body is adapted to compress tissue between the proximal portion and the distal portion in the shortened configuration. In addition or alternatively, and in a fifth aspect, the root portion is adapted to pass through tissue disposed between the proximal portion and the distal portion. In addition or alternatively, and in a sixth aspect, the body has an overall length in the unstressed configuration and the overall length is reduced when the body is in the shortened configuration. In addition or alternatively, and in a seventh aspect, the heart valve anchor apparatus may further comprise a suture element disposed through the body along the longitudinal centerline. In addition or alternatively, and in an eighth aspect, the heart valve anchor apparatus may further comprise a needle, a suture element having a proximal end attached to the needle, and an elongated sheath having a deployment head fixedly attached at a proximal end of the elongated sheath.. The suture element may pass distally into the deployment head and have a stop feature disposed within the deployment head. The body may be disposed at least partially within the elongated sheath. In addition or alternatively, and in a ninth aspect, translation of the elongated sheath proximally relative to the body releases the body such that the body is free to assume the unstressed configuration. In addition or alternatively, and in a tenth aspect, in the delivery configuration, the first radially expandable portion is disposed within the elongated sheath and the second radially expandable portion is disposed distal of the elongated sheath. In addition or alternatively, and in an eleventh aspect, the stop feature is disposed proximal of the first radially expandable portion. In addition or alternatively, and in a twelfth aspect, the heart valve anchor apparatus may further comprise a tissue penetrating device including a lumen extending longitudinally therethrough, the body being disposed within the lumen in the delivery configuration, and a push rod disposed within the lumen adjacent to the body. Translation of the push rod relative to the tissue penetrating device may release the body from the