Multi-catheter steerable guiding system and methods of use

• US 20040092962A1
• Filed: 05/19/2003
• Published: 05/13/2004
• Est. Priority Date: 04/09/1999
• Status: Active Grant

• Current Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Inventors: Thornton, Troy L., Liao, Yen C., Martin, Brian B., Kolosi, William D., Raatikka, Amy R., Lucatero, Pedro
• Granted Patent: US 7,666,204 B2
• 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 endoscopically accessing a body cavity and providing a directed pathway toward a target tissue within the cavity. The directed pathway is provided by a multi-catheter guiding system which is positioned in a desired configuration, generally directed toward the target tissue. Interventional devices may then be passed through the guiding system to the target tissue. Depending on the location of the target tissue and the desired angle of approach, the guiding system may be required to maintain one or more curves in one or more planes to properly direct the interventional devices. The multi-catheter guiding system of the present invention comprises an outer guiding catheter and a coaxially positioned inner guiding catheter, each of which independently form curvatures so that together the curves properly direct the interventional device.

Claims

1. A multi-catheter guiding system for accessing a body cavity comprising:

an outer guiding catheter having a proximal end, a distal end and a central lumen therethrough, the outer guiding catheter capable of forming a primary curve near its distal end; and

an inner guiding catheter having a proximal end, a distal end and a central lumen therethrough, the inner guiding catheter positionable within the central lumen of the outer guiding catheter so that its distal end extends beyond the distal end of the outer guiding catheter, the inner guiding catheter capable of forming a secondary curve near its distal end.

2. A system as in claim 1, wherein the primary curve and secondary curve lie in different planes.

3. A system as in claim 2, wherein the primary curve and secondary curve lie in substantially orthogonal planes.

4. A system as in claim 1, wherein the primary curve has a radius of curvature in the range of 0.125 in. to 1.000 in.

5. A system as in claim 1, wherein the secondary curve has a radius of curvature in the range of approximately 0.050 in. to 0.750 in.

6. A system as in claim 1, wherein the distal end of the inner guiding catheter is moveable through an angle theta.

7. A system as in claim 6, wherein the secondary curve and the angle theta lie in different planes.

8. A system as in claim 7, wherein the secondary curve and the angle theta lie in substantially orthogonal planes.

9. A system as in claim 6, wherein the primary curve, secondary curve and the angle theta each lie in different planes.

10. A system as in claim 9, wherein the primary curve, secondary curve and the angle theta each lie in substantially orthogonal planes.

11. A system as in claim 6, wherein the angle theta is in the range of −

180°

to +180°

degrees.

12. A system as in claim 1, wherein the outer guiding catheter is capable of forming an additional curve near its distal end.

13. A system as in claim 12, wherein the additional curve and the primary curve lie in different planes.

14. A system as in claim 13, wherein the additional curve and the primary curve lie in substantially orthogonal planes.

15. A system as in claim 1, wherein the primary curve and/or secondary curve are preset so that forming of the curve(s) is by shape memory.

16. A system as in claim 1, further comprising a steering mechanism which forms the primary curve.

17. A system as in claim 16, wherein the steering mechanism forms an additional curve in the outer guiding catheter.

18. A system as in claim 1, further comprising a steering mechanism which forms the secondary curve.

19. A system as in claim 18, wherein the steering mechanism moves the distal end of the inner guiding catheter through an angle theta.

20. A system as in claim 1, further comprising a steering mechanism which forms the primary curve and another steering mechanism which forms the secondary curve.

21. A system as in claim 1, wherein the steering mechanism moves the distal end of the inner guiding catheter through an angle theta.

22. A multi-catheter guiding system for accessing a body cavity comprising:

an outer guiding catheter having a proximal end, a distal end and a central lumen therethrough, the outer guiding catheter capable of forming a curve;

an inner guiding catheter positionable at least partially within the central lumen of the outer guiding catheter, the inner guiding catheter capable of forming a curve which differs from the curve of the outer guiding catheter; and

a steering mechanism which forms the curve in one of the guiding catheters upon actuation.

23. A system as in claim 22, wherein the steering mechanism comprises at least one pullwire attached to the one of the guiding catheters, wherein actuation of the steering mechanism comprises applying tension to the at least one pullwire whereby the curve is formed.

24. A system as in claim 23, wherein the steering mechanism comprises at least two pullwires attached to the one of the guiding catheters in diametrically opposed locations, wherein applying tension to one of the pullwires curves the one of the guide catheters in one direction and applying tension to the pullwire attached in the diametrically opposed location curves the one of the guide catheters in another direction opposite to the one direction.

25. A system as in claim 24, wherein the steering mechanism comprises at least four pullwires wherein two of the at least four pullwires are attached to the one of the guiding catheters in diametrically opposed locations and another two of the at least four pullwires are attached to the one of the guiding catheters in diametrically opposed locations.

26. A system as in claim 25, wherein each of the two of the at least four pullwires and the another two of the at least four pullwires are attached to the one of the guiding catheters at locations which are 90 degrees apart.

27. A system as in claim 22, wherein a portion of the one of the guiding catheters comprises a series of articulating members and wherein the at least one pullwire is attached to one of the articulating members so that the curve is formed by at least some of the articulating members.

28. A system as in claim 27, wherein the articulating members comprise interfitting domed rings.

29. A system as in claim 22, wherein the steering mechanism forms the curve in the outer guiding catheter and the curve in the inner guiding catheter is preset so that it is formed by shape memory.

30. A system as in claim 22, wherein the steering mechanism forms the curve in the outer guiding catheter, the system further comprising another steering mechanism which forms the curve in the inner guiding catheter.

31. A system as in claim 22, wherein the steering mechanism forms the curve in the inner guiding catheter and the curve in the outer guiding catheter is preset so that it is formed by shape memory.

32. A system as in claim 22, further comprising a handle connectable with the steering mechanism, the handle having an actuator which actuates the steering mechanism.

33. A system as in claim 22, wherein the curve of the outer guiding catheter and the curve of the inner guiding catheter lie in substantially orthogonal planes.

34. A system as in claim 22, wherein the curve of the outer guiding catheter is a primary curve and the outer guiding catheter is capable of forming an additional curve.

35. A system as in claim 34, wherein the steering mechanism forms the primary curve and the additional curve.

36. A system as in claim 22, wherein the curve of the inner guiding catheter is a secondary curve and the inner guiding catheter is capable of moving through an angle theta, and wherein the steering mechanism forms the secondary curve and moves the inner guiding catheter through the angle theta.

37. A method of accessing a body cavity comprising:

positioning an outer guiding catheter having a proximal end, distal end and central lumen therethrough so that the distal end is at least partially within the body cavity;

forming a primary curve in the distal end of the outer guiding catheter;

advancing an inner guiding catheter through the central lumen of the outer guiding catheter; and

forming a secondary curve in the inner guiding catheter which differs from the primary curve.

38. A method as in claim 37, wherein the primary curve and secondary curves lie in different planes.

39. A method as in claim 38, wherein the primary curve and secondary curve lie in substantially orthogonal planes.

40. A method as in claim 37, further comprising moving the inner guiding catheter through an angle theta.

41. A method as in claim 40, wherein the secondary curve and the angle theta lie in different planes.

42. A method as in claim 41, wherein the secondary curve and the angle theta lie in substantially orthogonal planes.

43. A method as in claim 40, wherein the primary curve, secondary cure and angle theta each lie in different planes.

44. A method as in claim 43, wherein the primary curve, secondary curve and angle theta each lie in substantially orthogonal planes.

45. A method as in claim 37, further comprising forming an additional curve in the outer guiding catheter.

46. A method as in claim 45, wherein the additional curve and the primary curve lie in different planes.

47. A method as in claim 46, wherein the additional curve and the primary curve lie in substantially orthogonal planes.

48. A method as in claim 37, wherein forming the primary curve is achieved by allowing the outer guiding catheter to resume a shape memory configuration.

49. A method as in claim 37, wherein forming the secondary curve is achieved by allowing the inner guiding catheter to resume a shape memory configuration.

50. A method as in claim 37, wherein the outer guiding catheter includes a steering mechanism and forming the primary curve is achieved by actuating the steering mechanism.

51. A method as in claim 50, further comprising forming an additional curve in the outer guiding catheter, wherein forming the additional curve is achieved by actuating the steering mechanism.

52. A method as in claim 37, wherein the inner guiding catheter includes a steering mechanism and forming the secondary curve is achieved by actuating the steering mechanism.

53. A method as in claims 52, further comprising moving the inner guiding catheter through an angle theta, wherein moving the inner guiding catheter is achieved by actuating the steering mechanism.

54. A method as in claims 50 or 52, wherein the steering mechanism comprises at least one pullwire, wherein actuation of the steering mechanism comprises applying tension to the at least one pullwire.

55. A method as in claim 37, wherein the inner guiding catheter comprises a proximal end, a distal end and a central lumen therethrough, further comprising advancing an interventional device through the central lumen of the inner guiding catheter.

56. A method as in claim 37, wherein the body cavity comprises a chamber of the heart and forming the secondary curve directs the inner guiding catheter toward a valve.

57. A method as in claim 56, wherein the valve comprises a mitral valve.

58. A kit for accessing a body cavity:

a multi-catheter guiding system comprising;

an outer guiding catheter having a proximal end, a distal end and a central lumen therethrough,

an inner guiding catheter positionable at least partially within the central lumen;

instructions for using the multi-catheter guiding system, wherein the instructions set forth method steps including;

positioning the outer guiding catheter so that its distal end is at least partially within the body cavity;

forming a primary curve in the distal end of the outer guiding catheter;

advancing the inner guiding catheter through the central lumen of the outer guiding catheter; and

forming a secondary curve in the inner guiding catheter which differs from the primary curve.

59. A kit as in claim 58, further comprising an interventional device advancable through the inner guiding catheter.

60. A kit as in claim 58, further comprising a handle attachable to the outer guiding catheter.