Heart valve regurgitation anchor and delivery tool

• US 10,702,384 B2
• Filed: 08/16/2017
• Issued: 07/07/2020
• Est. Priority Date: 08/16/2016
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation), Mayo Foundation For Medical Education And Research (Mayo Clinic)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Baldwin, Katherine L., Rohl, James P., Cawthra, Jr., James K., Dearani, Joseph A., Shuey, Daniel, Groth, Dale
• Primary Examiner(s): Nguyen, Vi X
• Application Number:
  US15/678,327
• Publication Number:
  US 20180049874A1
• Time in Patent Office: 1,056 Days
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/06 Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials puncturing needles A61B17/34; hypodermic needles A61M5/32 ; sewing needles D05B85/00
• CPC Class Codes: A61B 17/06066 Needles, e.g. needle tip configurations making needles B21G1/00
• CPC Class Codes: A61B 17/062 Needle manipulators
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 17/128 for applying or removing clamps or clips
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00336 with a protective sleeve, e.g. retractable or slidable
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle hollow suture needles A61B2017/061
• CPC Class Codes: A61B 2017/0608 J-shaped
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2466 : Delivery devices therefor
• CPC Class Codes: A61F 2210/0014 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0006 : circular

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. In an unstressed configuration, the body may define a longitudinal centerline that extends away from a plane tangent to the root portion.

Claims

1. A heart valve anchor apparatus, comprising:

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 comprising;

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;

wherein the first radially expandable portion is configured to self-expand to an outer extent greater than the outer extent of the root portion when radially unconstrained;

wherein the second radially expandable portion is configured to self-expand to an outer extent greater than the outer extent of the root portion when radially unconstrained;

wherein in the unstressed configuration, the body defines a longitudinal centerline that extends away from a plane tangent to the root portion,

wherein the body is adapted to be housed at least partially within a tissue penetrating device in the delivery configuration,

wherein the heart valve anchor apparatus further includes a suture element extending longitudinally through the body to a stop feature disposed opposite a push rod, wherein placing the suture element in tension while applying an opposing force to the body with the push rod places the body into a shortened configuration wherein tissue is compressed between the first radially expandable portion and the second radially expandable portion.

2. The heart valve anchor apparatus of claim 1, wherein 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.

3. The heart valve anchor apparatus of claim 2, wherein the body is adapted to compress tissue between the proximal portion and the distal portion in the shortened configuration.

4. The heart valve anchor apparatus of claim 2, wherein the root portion is adapted to pass through tissue disposed between the proximal portion and the distal portion.

5. The heart valve anchor apparatus of claim 1, wherein the body has an overall length in the unstressed configuration and the overall length is reduced when the body is in the shortened configuration.

6. The heart valve anchor apparatus of claim 1, further comprising a suture element disposed through the body along the longitudinal centerline.

7. The heart valve anchor apparatus of claim 1, further comprising:

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 passing distally into the deployment head and having a stop feature disposed within the deployment head;

wherein the body is disposed at least partially within the elongated sheath.

8. The heart valve anchor apparatus of claim 7, wherein translation of the elongated sheath proximally relative to the body releases the body such that the body is free to assume the unstressed configuration.

9. The heart valve anchor apparatus of claim 7, wherein 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.

10. The heart valve anchor apparatus of claim 7, wherein the stop feature is disposed proximal of the first radially expandable portion.

11. The heart valve anchor apparatus of claim 1, further comprising:

a tissue penetrating device including a lumen extending longitudinally therethrough, the body being disposed within the lumen in the delivery configuration; and

the push rod disposed within the lumen adjacent to the body;

wherein translation of the push rod relative to the tissue penetrating device releases the body from the lumen;

wherein after release from the lumen, the body is free to assume the unstressed configuration.