Fixation devices, systems and methods for engaging tissue

• US 8,057,493 B2
• Filed: 12/18/2009
• Issued: 11/15/2011
• Est. Priority Date: 04/09/1999
• Status: Expired due to Fees

• Current Assignee: Evalve, Inc. (Abbott Laboratories)
• Original Assignee: Evalve, Inc. (Abbott Laboratories)
• Inventors: Goldfarb, Eric A., Sarabia, Jaime E., Wen Chin Fan, Sylvia, Dell, Kent D., Komtebedde, Jan, Powell, Ferolyn T., Raschdorf, Alfred H. Jr.
• Primary Examiner(s): McDermott, Corrine M
• Assistant Examiner(s): Anderson, Gregory
• Application Number:
  US12/642,630
• Publication Number:
  US 20100100108A1
• Time in Patent Office: 697 Days
• Field of Search: 600/37, 606/1, 606/139, 606/142, 606/151, 606/191, 606/213, 606/221, 623/2.11
• US Class Current: 606/151
• 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
• CPC Class Codes: A61B 2017/0406 : Pledgets
• CPC Class Codes: A61B 2017/0409 : Instruments for applying suture anchors
• 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
• 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
• 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
• 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
• CPC Class Codes: A61B 2017/061 : hollow or tubular
• CPC Class Codes: A61B 2017/06171 : helically or spirally coiled
• 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 tissue comprising:

a pair of fixation elements each having a first end, a free end opposite the first end, and an engagement surface therebetween for engaging the tissue, the first ends being movably coupled together such that the fixation elements are moveable between a closed position wherein the engagement surfaces face each other to a first open position wherein the engagement surfaces are positioned away from each other; and

an actuation mechanism coupled to the fixation elements adapted to move the fixation elements between the closed position and the first open position; and

a pair of gripping elements, each gripping element moveable with respect to one of the fixation elements and being disposed in opposition to one of the engagement surfaces so as to capture tissue therebetween when the pair of fixing elements are in the first open position,

wherein each fixation element is at least partially concave and each gripping element is at least partially recessed within the fixation element in the deployed configuration, and

wherein the gripping elements are movable from an undeployed configuration in which each gripping element is separated from an opposing engagement surface, to a deployed configuration in which the gripping element is closer to the opposing engagement surface.

2. A fixation device as in claim 1, wherein the fixation elements are further moveable to a second open position between the closed position and the first open position.

3. A fixation device as in claim 2, wherein in the second open position the engagement surface of one fixation element forms an angle of about 5°

up to an angle less than about 180°

with the engagement surface of the other fixation element.

4. A fixation device as in claim 2, wherein in the second open position the engagement surface of one fixation element forms an angle of more than about 90 degrees up to an angle less than about 180 degrees with the engagement surface of the other fixation element.

5. A fixation device as in claim 1, wherein the gripping elements have frictional features configured to enhance grip on tissue engaged thereby.

6. A fixation device as in claim 1, wherein the gripping elements are movable independently of the fixation elements.

7. A fixation device as in claim 1, wherein the gripping elements are biased toward the engagement surfaces.

8. A fixation device as in claim 1, wherein the gripping elements are approximately parallel to each other in the undeployed configuration.

9. A fixation device as in claim 1, wherein in the closed position the engagement surface of one fixation element forms an angle of less than about 0°

up to an angle of about 5°

with the engagement surface of the other fixation element.

10. The fixation device of claim 1, further comprising a coupling member for detachably coupling the fixation device to a delivery device.

11. The fixation device of claim 10, wherein the delivery device comprises an elongate flexible shaft.

12. The fixation device of claim 10, wherein the delivery device comprises a delivery catheter.

13. The fixation device of claim 10, wherein the coupling member comprises an outer member having an axial channel, the outer member being coupled to one of either the fixation elements or the actuation mechanism, and an inner member extending slidably through the axial channel and coupled to the other of either the fixation elements or the actuation mechanism.

14. The fixation device of claim 13, wherein the outer member has a mating surface for engagement with the delivery device, the mating surface having a sigmoid shape.

15. The fixation device of claim 1, further comprising a covering on the fixation elements adapted for promoting tissue growth.

16. The fixation device of claim 1, further comprising a coating on the fixation elements adapted for delivering a therapeutic agent.

17. A fixation device as in claim 1, wherein the fixation elements have longitudinal edges between the first end and the free end, the longitudinal edges being curved about a longitudinal axis away from the engagement surfaces.

18. A fixation device as in claim 1, wherein the free ends of the fixation elements curve away from the engagement surfaces about a transverse axis generally parallel to the engagement surface.

19. A fixation device as in claim 18, wherein the free ends of the fixation elements are curved about a second axis not parallel to the transverse axis.

20. A fixation device for engaging tissue comprising:

a pair of fixation elements each having a first end, a free end opposite the first end, and an engagement surface therebetween for engaging the tissue, the first ends being movably coupled together such that the fixation elements are moveable between a closed position wherein the engagement surfaces face each other to an inverted position wherein the engagement surfaces face away from each other; and

an actuation mechanism coupled to the fixation elements adapted to move the fixation elements between the closed position and the inverted position; and

a pair of gripping elements, each gripping element moveable with respect to one of the fixation elements and being disposed in opposition to one of the engagement surfaces so as to capture tissue therebetween when the pair of fixation elements are in a position other than the closed position,

wherein each gripping element is at least partially positionable within the fixation element in the deployed configuration, and

wherein the gripping elements are movable from an undeployed configuration in which each gripping element is separated from an opposing engagement surface, to a deployed configuration in which the gripping element is closer to the opposing engagement surface.

21. A fixation device as in claim 20, wherein the fixation elements are further moveable to an open position between the closed position and the inverted position.

22. A fixation device as in claim 21, wherein in the open position the engagement surface of one fixation element forms an angle of about 5°

up to an angle less than about 180°

with the engagement surface of the other fixation element.

23. A fixation device as in claim 21, wherein in the open position the engagement surface of one fixation element forms an angle of more than about 90 degrees up to an angle less than about 180 degrees with the engagement surface of the other fixation element.

24. A fixation device as in claim 20, wherein the gripping elements have frictional features configured to enhance grip on tissue engaged thereby.

25. A fixation device as in claim 20, wherein the gripping elements are movable independently of the fixation elements.

26. A fixation device as in claim 20, wherein the gripping elements are biased toward the engagement surfaces.

27. A fixation device as in claim 20, wherein the gripping elements are approximately parallel to each other in the undeployed configuration.

28. A fixation device as in claim 20, wherein in the closed position the engagement surface of one fixation element forms an angle of less than about 0°

up to an angle of about 5°

with the engagement surface of the other fixation element.

29. The fixation device of claim 20, further comprising a coupling member for detachably coupling the fixation device to a delivery device.

30. The fixation device of claim 29, wherein the delivery device comprises an elongate flexible shaft.

31. The fixation device of claim 29, wherein the delivery device comprises a delivery catheter.

32. The fixation device of claim 29, wherein the coupling member comprises an outer member having an axial channel, the outer member being coupled to one of either the fixation elements or the actuation mechanism, and an inner member extending slidably through the axial channel and coupled to the other of either the fixation elements or the actuation mechanism.

33. The fixation device of claim 32, wherein the outer member has a mating surface for engagement with the delivery device, the mating surface having a sigmoid shape.

34. The fixation device of claim 20, further comprising a covering on the fixation elements adapted for promoting tissue growth.

35. The fixation device of claim 20, further comprising a coating on the fixation elements adapted for delivering a therapeutic agent.

36. A fixation device as in claim 20, wherein the fixation elements have longitudinal edges between the first end and the free end, the longitudinal edges being curved about a longitudinal axis away from the engagement surfaces.

37. A fixation device as in claim 20, wherein the free ends of the fixation elements curve away from the engagement surfaces about a transverse axis generally parallel to the engagement surface.

38. A fixation device as in claim 37, wherein the free ends of the fixation elements are curved about a second axis not parallel to the transverse axis.