Fixation devices, systems and methods for engaging tissue

• US 7,736,388 B2
• Filed: 01/16/2007
• Issued: 06/15/2010
• Est. Priority Date: 04/09/1999
• Status: Expired due to Term

• Current Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Inventors: Sarabia, Jaime E., Komtebedde, Jan, Dell, Kent D., Goldfarb, Eric A., Powell, Ferolyn T., Wen Chin Fan, Sylvia, Raschdorf, Alfred H. Jr.
• Primary Examiner(s): Erezo; Darwin P
• Assistant Examiner(s): ANDERSON, GREGORY A
• Application Number:
  US11/623,590
• Publication Number:
  US 20070118155A1
• Time in Patent Office: 1,246 Days
• Field of Search: 606/139, 606/142, 606/151, 623/2.11, 600/37
• US Class Current: 623/2.11
• 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
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• 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
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• 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
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• 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
• CPC Class Codes: A61B 17/1227 Spring clips
• 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 2017/00575 : for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00579 : Barbed implements
• CPC Class Codes: A61B 2017/00588 : Rigid or stiff implements, e.g. made of several rigid parts linked by hinges
• CPC Class Codes: A61B 2017/00592 : Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 : Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00615 : Implements with an occluder on one side of the opening and holding means therefor on the other
• CPC Class Codes: A61B 2017/00619 : Locking means for locking the implement in expanded state
• CPC Class Codes: A61B 2017/00623 : Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00783 : Valvuloplasty
• CPC Class Codes: A61B 2017/00867 : shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0406 : Pledgets
• CPC Class Codes: A61B 2017/0409 : Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0417 : T-fasteners
• CPC Class Codes: A61B 2017/0419 : H-fasteners
• CPC Class Codes: A61B 2017/0429 : the barbs being expanded by a mechanical mechanism which also locks them in the expanded state
• CPC Class Codes: A61B 2017/0435 : the barbs being separate elements mechanically linked to the anchor, e.g. by pivots
• CPC Class Codes: A61B 2017/0458 : Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0464 : for soft tissue
• CPC Class Codes: A61B 2017/047 : having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body J-shaped suture needles A61B2017/0608
• CPC Class Codes: A61B 2017/0472 : Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0474 : Knot pushers
• CPC Class Codes: A61B 2017/0488 : Instruments for applying suture clamps, clips or locks for applying suture anchors A61B2017/0409; for applying wound clamps A61B17/10; for applying ligaturing clamps or clips A61B17/128
• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
• 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 2017/06057 : Double-armed sutures, i.e. sutures having a needle attached to each end
• CPC Class Codes: A61B 2017/06076 : helically or spirally coiled for sutures A61B2017/06171
• CPC Class Codes: A61B 2017/061 : hollow or tubular suture extending inside a hollow needle A61B2017/06052; hollow sutures A61B2017/06185
• CPC Class Codes: A61B 2017/06171 : helically or spirally coiled for needles A61B2017/06076
• CPC Class Codes: A61B 2017/0641 : having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/088 : Sliding fasteners
• CPC Class Codes: A61B 2017/2908 : Multiple segments connected by articulations
• CPC Class Codes: A61B 2017/2926 : Details of heads or jaws
• CPC Class Codes: A61B 50/30 : Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61B 8/10 : Eye inspection
• CPC Class Codes: A61F 2/24 : Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• 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
• CPC Class Codes: A61M 25/0136 : Handles therefor
• CPC Class Codes: A61M 25/0138 : having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0147 : with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/04 : in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

Abstract

The invention provides devices, systems and methods for tissue approximation and repair at treatment sites. The devices, systems and methods of the invention will find use in a variety of therapeutic procedures, including endovascular, minimally-invasive, and open surgical procedures, and can be used in various anatomical regions, including the abdomen, thorax, cardiovascular system, heart, intestinal tract, stomach, urinary tract, bladder, lung, and other organs, vessels, and tissues. The invention is particularly useful in those procedures requiring minimally-invasive or endovascular access to remote tissue locations, where the instruments utilized must negotiate long, narrow, and tortuous pathways to the treatment site. In addition, many of the devices and systems of the invention are adapted to be reversible and removable from the patient at any point without interference with or trauma to internal tissues.

Claims

1. A fixation device for engaging a heart valve tissue, said device comprising:

a coupling member;

a pair of fixation elements, each of the pair having a first end, a free end opposite the first end and an engagement surface therebetween for engaging the tissue, the first ends being pivotably coupled to the coupling member such that the fixation elements are movable from a closed position wherein the free ends are disposed at a separation angle of less than about 0°

up to about 45°

to a first open position wherein the free ends are disposed at a separation angle of up to about 360°

, and wherein the fixation elements are adapted to atraumatically grasp and release the heart valve tissue, wherein the free ends are adapted to minimize trauma to the heart valve tissue, and wherein the engagement surfaces comprise a concave region in which the coupling member at least partially nests when the pair of fixation elements are in the closed position thereby reducing profile of the device, and wherein the fixation elements are at least partially covered with a covering material adapted to permit ingrowth of tissue thereto; and

a pair of proximal elements, the pair of proximal elements each having a first end and a free end opposite the first end, the first ends being coupled to the coupling member such that the free ends of the proximal elements are movable relative to the coupling member, wherein each proximal element is at least partially recessed in the concave region of one of the pair of fixation elements when the heart valve tissue is not disposed therebetween.

2. The fixation device of claim 1, wherein the engagement surface further comprises an atraumatic surface.

3. The fixation device of claim 2, wherein the atraumatic surface is adapted to deflect the tissue when the fixation device is withdrawn.

4. The fixation device of claim 1, wherein at least one of the pair of proximal elements comprises a frictional accessory.

5. The fixation device of claim 4, wherein the frictional accessory atraumatically engages the tissue.

6. The fixation device of claim 4, wherein the frictional accessory comprises a barb.

7. The fixation device of claim 6, wherein the frictional accessory comprises a scalloped edge.

8. The fixation device of claim 6, wherein the barb projects radially outward and is angled toward the first end of one of the pair of proximal elements.

9. The fixation device of claim 1, wherein the proximal elements comprise a surface defining a plurality of openings therein.

10. The fixation device of claim 1, further comprising an actuation mechanism coupled to the fixation elements adapted to move the fixation elements between the closed position and the first open position.

11. The fixation device of claim 10, wherein the fixation elements are further moveable to any position between the closed position and the first open position.

12. The fixation device of claim 10, wherein the actuation mechanism comprises a pair of legs, each leg rotatably coupled to one of the fixation elements.

13. The fixation device of claim 1, wherein at least one of the fixation elements comprises a longitudinal edge which flares outwardly.

14. The fixation device of claim 1, wherein the pair of fixation elements comprises a plurality of apertures in the engagement surface to permit tissue ingrowth therein.

15. The fixation device of claim 1, wherein the proximal elements are resiliently biased toward the fixation elements.

16. The fixation device of claim 1, further comprising a proximal element line coupled to at least one of the proximal elements such that when the line is actuated, the at least one proximal element is retracted away from one of the fixation elements.

17. A fixation device for engaging a heart valve tissue, said device comprising:

a coupling member;

a pair of fixation elements, each of the pair having a first end, a free end opposite the first end and an engagement surface therebetween for engaging the heart valve tissue, the first ends being pivotably coupled to the coupling member such that the fixation elements are movable from a closed position wherein the free ends are disposed at a first separation angle to an open position, wherein the free ends are disposed at a second separation angle, and wherein the fixation elements are adapted to atraumatically grasp and release the heart valve tissue, wherein the free ends are adapted to minimize trauma to the tissue, and wherein the engagement surfaces comprise a concave region in which the coupling member at least partially nests when the pair of fixation elements are in the closed position thereby reducing profile of the device; and

a pair of proximal elements, the pair of proximal elements each having a first end and a free end opposite the first end, the first ends being coupled to the coupling member such that the free ends of the proximal elements are movable relative to the coupling member, wherein each proximal element is at least partially recessed in the concave region of one of the pair of fixation elements when the heart valve tissue is not disposed therebetween, and wherein the proximal elements comprise a surface defining a plurality of openings therein.

18. The fixation device of claim 17, wherein the engagement surface further comprises an atraumatic surface.

19. The fixation device of claim 18, wherein the atraumatic surface is adapted to deflect the tissue when withdrawing the fixation device.

20. The fixation device of claim 17, wherein at least one of the pair of proximal elements comprises a frictional accessory.

21. The fixation device of claim 20, wherein the frictional accessory atraumatically engages the tissue.

22. The fixation device of claim 20, wherein the frictional accessory comprises a barb.

23. The fixation device of claim 22, wherein the frictional accessory comprises a scalloped edge.

24. The fixation device of claim 22, wherein the barb projects radially outward and is angled toward the first end of one of the pair of proximal elements.

25. The fixation device of claim 17, wherein the first separation angle is any angle of about 0°

up to about 45°

.

26. The fixation device of claim 17, wherein the second separation angle is any angle up to about 360°

.

27. The fixation device of claim 17, further comprising an actuation mechanism coupled to the fixation elements adapted to move the fixation elements between the closed position and the open position.

28. The fixation device of claim 27, wherein the fixation elements are further moveable to a position wherein the free ends are disposed at a third separation angle between the first separation angle and the second separation angle.

29. The fixation device of claim 27, wherein the actuation mechanism comprises a pair of legs, each leg rotatably coupled to one of the fixation elements.

30. The fixation device of claim 17, wherein at least one of the fixation elements comprises a longitudinal edge which flares outwardly.

31. The fixation device of claim 17, wherein the pair of fixation elements comprises a plurality of apertures in the engagement surface to permit tissue ingrowth therein.

32. The fixation device of claim 17, wherein the proximal elements are resiliently biased toward the fixation elements.

33. The fixation device of claim 17, wherein the fixation elements are at least partially covered with a covering material adapted to permit ingrowth of tissue thereto.

34. The fixation device of claim 17, further comprising a proximal element line coupled to at least one of the proximal elements such that when the line is actuated, the at least one proximal element is retracted away from one of the fixation elements.