Fixation devices, systems and methods for engaging tissue

• US 10,653,427 B2
• Filed: 05/09/2019
• Issued: 05/19/2020
• Est. Priority Date: 06/27/2001
• Status: Expired due to Term

• Current Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Inventors: Goldfarb, Eric A., Raschdorf, Alfred H., Erickson, Sylvia Wen-Chin, Dell, Kent D., Powell, Ferolyn T., Thornton, Troy L., Martin, Brian B.
• Primary Examiner(s): Anderson, Gregory A
• Application Number:
  US16/408,018
• Publication Number:
  US 20190282237A1
• Time in Patent Office: 376 Days
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/04 for suturing wounds; Holders or packages for needles or suture materials suture materials A61L17/00
• 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
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• CPC Class Codes: A61B 17/0625 the needle being specially adapted to interact with the manipulator, e.g. being ridged to snap fit in a hole of the manipulator A61B17/06109 takes precedence
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• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
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• CPC Class Codes: A61B 17/07207 the staples being applied sequentially
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
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• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/20 : using laser
• CPC Class Codes: A61B 2017/00243 : cardiac
• CPC Class Codes: A61B 2017/00314 : Separate linked members
• CPC Class Codes: A61B 2017/00318 : Steering mechanisms
• CPC Class Codes: A61B 2017/00327 : with actuating members moving in opposite directions
• CPC Class Codes: A61B 2017/00407 : Ratchet means
• CPC Class Codes: A61B 2017/00473 : Distal part, e.g. tip or head A61B2017/00464 takes precedence
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• CPC Class Codes: A61B 2017/00579 : Barbed implements
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• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
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• CPC Class Codes: A61B 8/10 : Eye inspection
• 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 2/2445 : Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/246 : Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2463 : Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2/2466 : Delivery devices therefor
• CPC Class Codes: A61M 2025/0161 : wherein the distal tips have two or more deflection regions
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• CPC Class Codes: A61M 25/04 : in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

Abstract

System for fixation of leaflets of a heart valve including an implantable fixation device including a first distal element and a second distal element, a first proximal element moveable relative to the first distal element between a first position and a second position, and a second proximal element moveable relative to the second distal element between a first position and a second position. The system further includes a delivery device including a catheter having a proximal end portion and a distal end portion, the implantable fixation device releasably coupled to the distal end portion of the catheter, the catheter defining at least one lumen extending between the proximal end portion and the distal end portion. The delivery device further includes a first proximal element line extending through the at least one lumen, the first proximal element line coupled to the first proximal element and actuatable to move the first proximal element between the first position and second position, and a second proximal element line extending through the at least one lumen, the second proximal element line coupled to the second proximal element and actuatable to move the second proximal element between the first position and second position. The first proximal element line and the second proximal element line are independently actuatable.

Claims

1. A system for fixation of leaflets of a heart valve comprising:

an implantable fixation device comprising;

a first distal element and a second distal element,

a first proximal element moveable relative to the first distal element between a first position and a second position, and

a second proximal element moveable relative to the second distal element between a first position and a second position; and

a delivery device comprising;

a catheter having a proximal end portion and a distal end portion, the implantable fixation device releasably coupled to the distal end portion of the catheter, the catheter defining at least one lumen extending between the proximal end portion and the distal end portion,

a first proximal element line extending through the at least one lumen, the first proximal element line coupled to the first proximal element and actuatable to move the first proximal element between the first position and second position, and

a second proximal element line extending through the at least one lumen, the second proximal element line coupled to the second proximal element and actuatable to move the second proximal element between the first position and second position,

wherein the first proximal element line and the second proximal element line are independently actuatable.

2. The system of claim 1, wherein at least the first proximal element comprises nitinol.

3. The system of claim 1, wherein the first proximal element is biased toward the first distal element;

and the second proximal element is biased toward the second distal element.

4. The system of claim 1, wherein the first proximal element and the second proximal element each comprises at least one barb extending therefrom.

5. A system for fixation of native leaflets of a heart valve comprising:

an implantable fixation device comprising;

a first distal element configured to engage a ventricular side of a first native leaflet and a second distal element configured to engage a ventricular side of a second native leaflet,

a first proximal element moveable relative to the first distal element between a first position and a second position and configured to grasp the first native leaflet between the first proximal element and the first distal element, and

a second proximal element moveable relative to the second distal element between a first position and a second position and configured to grasp the second native leaflet between the second proximal element and the second distal element; and

a delivery device comprising;

a catheter having a proximal end portion and a distal end portion, the implantable fixation device releasably coupled to the distal end portion of the catheter, the catheter defining at least one lumen extending between the proximal end portion and the distal end portion,

a first proximal element line extending through the at least one lumen, the first proximal element line coupled to the first proximal element and actuatable to move the first proximal element between the first position and second position, and

a second proximal element line extending through the at least one lumen, the second proximal element line coupled to the second proximal element and actuatable to move the second proximal element between the first position and second position,

wherein the first proximal element line and the second proximal element line are independently actuatable.

6. The system of claim 5, wherein at least the first proximal element comprises nitinol.

7. The system of claim 5, wherein the first proximal element is biased toward the first distal element;

and the second proximal element is biased toward the second distal element.

8. The system of claim 5, wherein the first proximal element and the second proximal element each comprises at least one barb extending therefrom.

9. A system for fixation of leaflets of a heart valve comprising:

an implantable fixation device comprising;

a first distal element and a second distal element, and

a gripping arrangement consisting essentially of;

a first proximal element moveable relative to the first distal element between a first position and a second position, and

a second proximal element moveable relative to the second distal element between a first position and a second position; and

a delivery device comprising;

a catheter having a proximal end portion and a distal end portion, the implantable fixation device releasably coupled to the distal end portion of the catheter, the catheter defining at least one lumen extending between the proximal end portion and the distal end portion,

a first proximal element line extending through the at least one lumen, the first proximal element line coupled to the first proximal element and actuatable to move the first proximal element between the first position and second position, and

a second proximal element line extending through the at least one lumen, the second proximal element line coupled to the second proximal element and actuatable to move the second proximal element between the first position and second position,

wherein the first proximal element line and the second proximal element line are independently actuatable.

10. The system of claim 9, wherein at least the first proximal element comprises nitinol.

11. The system of claim 9, wherein the first proximal element is biased toward the first distal element;

and the second proximal element is biased toward the second distal element.

12. The system of claim 9, wherein the first proximal element and the second proximal element each comprises at least one barb extending therefrom.