DELIVERY DEVICE, SYSTEMS AND METHODS OF USE

• US 20070100356A1
• Filed: 11/13/2006
• Published: 05/03/2007
• Est. Priority Date: 04/09/1999
• Status: Abandoned Application

• Current Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Inventors: Goldfarb, Eric, Fan, Sylvia, Dell, Kent, Saenz, Sandra, Lucatero, Sylvester, Rogers, Larry
• Application Number:
  US11/559,247
• Publication Number:
  US 20070100356A1
• Time in Patent Office: Days
• US Class Current: 606/139
• 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

Devices, systems, methods and kits are provided for delivering interventional devices to a target location with a body. Such interventional devices particularly include fixation devices or any devices which approximate tissue, such as valve leaflets. The delivery devices and systems direct the interventional device to the target location through a minimally invasive approach, such as through the patient'"'"'s vasculature, and provide for manipulation of the interventional device at the target location, such as to approximate tissue. Optionally, the delivery devices and systems may provide for decoupling of the interventional device, allowing the interventional device to be left behind as an implant.

Claims

1. A delivery device comprising:

an elongated flexible shaft having a proximal end, a distal end, and a main lumen therebetween; and

at least one flexible tubular guide extending through the main lumen, the at least one flexible tubular guide having a first end constrained within the shaft, at or near the distal end of the shaft and a second end constrained, at or near the proximal end of the shaft, the at least one flexible tubular guide unconstrained relative to the shaft in at least one location between the first and second ends so as to be laterally moveable within the main lumen, at least a portion of the at least one flexible tubular guide being both flexible and tubular.

2. A delivery device as in claim 1, wherein the main lumen is occupied by fluid.

3. A delivery device as in claim 1, wherein the at least one flexible tubular guide comprises at least two flexible tubular guides.

4. A delivery device as in claim 3, wherein the at least one flexible tubular guide comprises at least three flexible tubular guides.

5. A delivery device as in claim 4, wherein the at least one flexible tubular guide comprises at least four flexible tubular guides.

6. A delivery device as in claim 1, wherein the at least one flexible tubular guide comprises a coil.

7. A delivery device as in claim 1, further comprising an interventional element coupled to the distal end of the shaft.

8. A delivery device as in claim 7, wherein the interventional element is removably coupled.

9. A delivery device as in claim 7, wherein the interventional element is adapted for tissue approximation.

10. A delivery device as in claim 7, wherein the interventional element is adapted for coaptation of valve leaflets.

11. A delivery device as in claim 7, wherein the interventional element has first and second tissue engaging elements adapted for engaging tissue therebetween.

12. A delivery device as in claim 1, wherein the shaft and the interventional element are adapted for positioning through a blood vessel.

13. A delivery device as in claim 1, further comprising an actuation element movably disposed in one of the at least one flexible tubular guide, the actuation element adapted for coupling with at least one movable element of an interventional element so that movement of the actuation element causes movement of the at least one movable element.

14. A delivery device as in claim 13, wherein the at least one movable element comprises first and second tissue engaging elements and wherein the actuation element comprises an actuator rod adapted so that movement of the actuator rod moves the first and second tissue engaging elements.

15. A delivery device as in claim 13, wherein the actuation element comprises a flexible line.

16. A delivery device as in claim 15, wherein the at least one movable element comprises a proximal element and wherein the flexible line comprises a proximal element line adapted so that movement of the proximal element line actuates the proximal element.

17. A system for approximating tissue at a treatment site comprising:

an elongated flexible shaft having a proximal end, a distal end, and a main lumen therebetween;

at least one flexible tubular guide extending through the main lumen, the at least one flexible tubular guide having a first end constrained, at or near the distal end of the shaft and a second end constrained within the shaft, at or near the proximal end of the shaft and being unconstrained in at least one location between the first and second ends so as to be laterally movable within the main lumen;

an actuation element movably disposed in the tubular guide; and

an approximation device coupled to the distal end of the shaft, the approximation device having first and second engaging elements for engaging tissue therebetween, at least one of the engaging elements being movable and coupled to the actuation element.

18. An endovascular heart valve repair device comprising:

an elongated flexible shaft having a proximal end, a distal end, and a main lumen therebetween, the elongated flexible shaft being adapted for positioning through a blood vessel into a chamber of the heart;

at least one flexible tubular guide extending from the proximal end to the distal end through the main lumen;

an actuation element movably disposed in one of the at least one flexible tubular guide; and

a fixation device releasably coupled to the distal end of the shaft and adapted for positioning in the chamber of the heart, the fixation device having at least one proximal element and at least one distal element adapted to engage a valve leaflet therebetween, at least one of the proximal and distal elements being coupled to the actuation element so that movement of the actuation element in relation to the at least one flexible tubular guide moves the at least one of the proximal and distal elements coupled thereto.

19. An endovascular heart valve repair device as in claim 18, wherein the at least one proximal element and the at least one distal element comprise a pair of proximal elements and a pair of distal elements.

20. An endovascular heart valve repair device as in claim 18, wherein the at least one flexible tubular guide comprises a coil.

21. An endovascular heart valve repair device as in claim 18, wherein the actuation element comprises a rod.

22. An endovascular heart valve repair device as in claim 18, wherein the actuation element comprises a flexible line.

23. An endovascular heart valve repair device as in claim 18, wherein the at least one tubular guide comprises a second tubular guide.

24. An endovascular heart valve repair device as in claim 23, further comprising a second actuation element disposed in the second tubular guide, wherein the other of the proximal and distal elements is coupled to the second actuation element.

25. An endovascular heart valve repair device as in claim 24, wherein the second actuation element comprises a flexible line.

26. A system as in claim 18, wherein the at least one flexible tubular guide is fixed to the shaft near the proximal end or near the distal end and is unconstrained therebetween so as to be laterally movable within the main lumen.

27. A system for approximating tissue at a treatment site comprising:

an elongated flexible shaft having a proximal end, a distal end, and a main lumen therebetween;

first and second movable elements extending through the main lumen from the proximal to the distal end and being movable relative to the shaft; and

an approximation device releasably coupled to the distal end of the shaft, the approximation device having first and second engaging elements for engaging and holding a tissue portion therebetween in approximation with another tissue portion, the first engaging element being coupled to the first movable element so that manipulation of the first engaging element moves the first movable element and the second engaging element being coupled to the second movable element so that manipulation of the second engaging element moves the second movable element.

28. A system as in claim 27, further comprising first and second flexible tubular guides extending from the proximal end to the distal end through the main lumen, the first and second tubular guides being fixed to the shaft near the proximal end or near the distal end and being unconstrained therebetween so as to be laterally movable within the main lumen, the first movable element extending through the first tubular guide and the second movable element movably disposed in the second tubular guide.

29. A system as in claim 27, wherein the first moveable element comprises an actuator rod.

30. A system as in claim 27, wherein the second movable element comprises a flexible line.

31. A system as in claim 27, further comprising an actuator handle connected to the proximal end of the shaft, the actuator handle having a body and a first actuation element movably coupled thereto, the first actuation element being coupled to the first movable element.

32. A system as in claim 31, wherein the actuator handle has a second actuation element moveably coupled thereto, the second actuation element being coupled to the second moveable element.

33. A system for approximating tissue at a treatment site comprising:

an elongated flexible shaft having a proximal end, a distal end, and a main lumen therebetween;

first and second flexible tubular guides extending from the proximal end to the distal end through the main lumen, the first and second tubular guides being fixed to the shaft at a location within the shaft, near the proximal end or near the distal end and being unconstrained therebetween so as to be laterally movable within the main lumen;

a first movable element movably disposed in the first tubular guide;

a second movable element movably disposed in the second tubular guide; and

an approximation device coupled to the distal end of the shaft, the approximation device having first and second movable engaging elements for engaging therebetween, the first engaging element being coupled to the first movable element, the second engaging element being coupled to the second movable element.

34. A system as in claim 33, further comprising an actuator rod extending from the proximal to the distal end through the main lumen and being movable relative to the shaft.

35. A system as in claim 33, wherein the approximation device further comprises a locking mechanism.