Systems and methods for deploying a cardiac anchor

• US 10,206,779 B2
• Filed: 09/08/2016
• Issued: 02/19/2019
• Est. Priority Date: 09/10/2015
• Status: Active Grant

• Current Assignee: Bioventrix, Inc.
• Original Assignee: Bioventrix, Inc.
• Inventors: Van Bladel, Kevin, Moshe, Meir, Dana, Michael S.
• Primary Examiner(s): Lacyk, John
• Application Number:
  US15/259,375
• Publication Number:
  US 20170071740A1
• Time in Patent Office: 894 Days
• Field of Search: 600 37, 606213
• 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 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00323 Cables or rods
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0411 Instruments for removing suture anchors for removing suture clamps, clips or locks A61B2017/049
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2002/249 Device completely embedded in the heart wall
• CPC Class Codes: A61M 2025/015 Details of the distal fixation of the movable mechanical means
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/0136 Handles therefor

Abstract

A heart implant alignment and delivery device includes an elongate body having an opening that is disposed near a distal end of the elongate body. The opening is configured so that a heart implant is positionable within the opening with the heart implant exposed to a surrounding environment and so that the heart implant is substantially aligned with the distal end of the elongate body. The device also includes an implant reposition member, such as a cable, that is releasably coupleable with the heart implant and that is operationally coupled with the elongate body so that a first operation of the implant reposition member causes the heart implant to be retractably deployed from the opening of the elongate body. The first operation of the implant reposition member may be effected via a handle mechanism that is attached to a proximal end of the elongate body.

Claims

1. A catheter for delivering and aligning a heart implant about a wall of a heart, the catheter comprising:

an elongate catheter body having a cylindrical wall and a lumen disposed there through;

a handle mechanism disposed at a proximal end of the elongate catheter body;

a channel formed within the cylindrical wall on a distal end of the elongate catheter body, the channel being configured to receive the heart implant such that at least a portion of the heart implant is exposed to an interior region of the heart; and

a cable positioned within the lumen of the elongate catheter body, the cable being releasably coupled with the heart implant positioned within the channel and being operationally coupled with the handle mechanism so that a first operation of the handle mechanism causes the cable to flex outward from the channel and thereby cause at least part of the heart implant to move outward from the channel;

wherein the cable is retractable within the lumen of the elongate body and through the channel so that a distal tip of the cable is positionable proximally of a proximal end of the channel.

2. The catheter of claim 1, wherein a second operation of the handle mechanism causes the cable to retract within the lumen of the elongate catheter body thereby enabling the heart implant to be repositioned within the channel.

3. The catheter of claim 2, wherein a third operation of the handle mechanism causes the cable to retract within the lumen of the elongate catheter body thereby enabling the heart implant to be released from the channel.

4. The catheter of claim 1, wherein the heart implant is pivotably coupled with a tension member.

5. The catheter of claim 1, wherein a distal tip of the elongate catheter body is plugged or capped so that the lumen does not extend through the distal tip, and wherein a distal end of the cable contacts the distal tip of the elongate catheter body such that distal sliding of the cable within the lumen causes the cable to flex outward from the channel.

6. The catheter of claim 1, wherein the channel is formed in the distal end of the elongate catheter body by removing more than ½

of the material of the elongate catheter body such that a strip of material connects a proximal portion and distal portion of the elongate catheter body on opposite sides of the channel.

7. The catheter of claim 1, wherein the cable is slidably disposed through a lumen of the heart implant.

8. The catheter of claim 1, wherein the distal end flexes or bends in response to the first operation of the handle mechanism, and wherein the heart implant pivots outward from the channel in response to the first operation of the handle mechanism.

9. A heart implant alignment and delivery device comprising:

an elongate body having a cylindrical wall;

an opening in the elongate body that is formed in the cylindrical wall and disposed near a distal end of the elongate body, the opening being configured such that a heart implant is positionable within the opening so that the heart implant is exposed to a surrounding environment and so that the heart implant is substantially aligned with the distal end of the elongate body; and

an implant reposition member that is releasably coupleable with the heart implant and that is operationally coupled with the elongate body such that a first operation of the implant reposition member causes the heart implant to be retractably deployed from the opening of the elongate body;

wherein the implant reposition member is retractable within a lumen of the elongate body and through the opening so that a distal end of the implant reposition member is positioned proximally of a proximal end of the opening.

10. The device of claim 9, further comprising a handle mechanism that is disposed at a proximal end of the elongate body, the handle mechanism being operably coupled with the implant reposition member to effect the first operation of the implant reposition member.

11. The device of claim 9, wherein retractably deploying the heart implant comprises pivoting the heart implant out of the opening.

12. The device of claim 9, wherein the implant reposition member is further configured such that a second operation of the implant reposition member causes the heart implant to be retracted into the opening with the heart implant substantially aligned with the distal end of the elongate body.

13. The device of claim 12, wherein the implant reposition member is further configured such that a third operation of the implant reposition member causes the heart implant to be permanently deployed from the opening of the elongate body.

14. The device of claim 12, wherein the implant reposition member is a cable that is slidably disposed within the lumen of the elongate body, and wherein the elongate body is configured such that the distal sliding of the cable within the lumen of the elongate body causes a portion of the cable to protrude outwardly from the opening.

15. A method of deploying a heart implant from a catheter that includes an elongate body having a cylindrical wall, a lumen disposed through the cylindrical wall, and a channel formed in the cylindrical wall, a cable disposed within the lumen, a handle mechanism disposed at a proximal end of the elongate body, and the heart implant positioned within the channel, the method comprising:

positioning a distal end of the elongate body within a chamber of a heart so that the channel and heart implant are adjacent a wall of the heart; and

performing a first operation via the handle mechanism to cause the cable to flex outward from the channel of the elongate body and thereby cause the heart implant to pivot out of the channel of the elongate body and into contact with the wall;

wherein the heart implant is retractable within the channel to enable repositioning of the elongate body within the heart and thereby ensure a proper alignment of the heart implant relative to the wall of the heart; and

wherein the cable is retractable within the lumen of the elongate body and through the channel so that a distal tip of the cable is positioned proximally of a proximal end of the channel.

16. The method of claim 15, further comprising performing a second operation via the handle mechanism to cause the cable to retract within the lumen of the elongate body and thereby cause the heart implant to retract into the channel, wherein the channel and heart implant are repositionable within the chamber of the heart after retraction of the cable and heart implant.

17. The method of claim 16, further comprising repositioning the channel and heart implant within the chamber of the heart so that the heart implant is repositioned relative to the wall and performing an additional first operation of the handle mechanism to cause the cable to flex outward from the channel and thereby cause the heart implant to pivot out of the channel and into contact with the wall.

18. The method of claim 15, further comprising performing a third operation with the handle mechanism to permanently deploy the heart implant from the channel of the elongate body.

19. The method of claim 15, wherein the heart implant is pivotably coupled with a tension member that extend distally from heart implant and through the wall of the heart.

20. The method of claim 15, wherein the cable is slidably disposed through a lumen of the heart implant.