SYSTEMS AND METHODS FOR SUPPORTING OR OCCLUDING A PHYSIOLOGICAL OPENING OR CAVITY

• US 20100094335A1
• Filed: 09/04/2009
• Published: 04/15/2010
• Est. Priority Date: 09/05/2008
• Status: Active Grant

• Current Assignee: Pulsar Vascular, Inc. (Johnson & Johnson)
• Original Assignee: Pulsar Vascular, Inc. (Johnson & Johnson)
• Inventors: CLARKE, Gilbert, GERBERDING, Brent C., ABRAMS, Robert M.
• Granted Patent: US 8,388,650 B2
• Time in Patent Office: Days
• US Class Current: 606/213
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12177 comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/00898 expandable upon contact with fluid
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes

Abstract

Implantable devices for placement at a cavity or opening such as an aneurysm are disclosed. The implantable devices, in a deployed condition, have a generally inverted U-shaped profile with a curved or angled framework support structure sized and configured for placement in proximity to tissue surrounding the opening and anchoring legs extending proximally from the framework structure sized and configured to contact the wall of a neighboring lumen at opposed locations. Occlusive and semi-occlusive membranes may be associated with the framework support structure and deployed over the opening to provide exclusion of the opening and flow diversion. Proximal anchoring segments providing additional lumen wall surface area contact for the implantable device following deployment may be incorporated.

Claims

1. An implantable device for placement at the opening of a physiological cavity adjustable from a generally small diameter delivery condition to a deployed condition in which it assumes a larger diameter configuration, wherein the implantable device, in the deployed condition, forms a substantially inverted U-shaped framework structure with at least two anchoring legs extending from the U-shaped framework structure, wherein the framework structure has at least one lateral area sized and configured to be positioned in proximity to the opening of the physiological cavity, and the at least two anchoring legs extend from the U-shaped support structure generally opposite one another and are sized and configured to contact tissue surface areas generally opposite one another on a neighboring lumen.

2. The implantable device of claim 1, wherein the framework structure has two lateral areas aligned on a longitudinal centerline, each lateral area being sized and configured to be positioned in proximity to the opening.

3. The implantable device of claim 1, wherein the U-shaped support structure curves away from a central longitudinal axis in both directions.

4. The implantable device of claim 1, wherein the U-shaped support structure has a perimeter structure with two lateral areas aligned on a longitudinal centerline of the framework structure and side walls tapering away from the central longitudinal axis substantially symmetrically in both directions from the longitudinal centerline.

5. The implantable device of claim 1, wherein the U-shaped support structure has a perimeter structure with two lateral areas aligned on a longitudinal centerline of the framework structure and side walls tapering away from the central longitudinal axis asymmetrically in both directions from the longitudinal centerline.

6. The implantable device of claim 1, wherein the U-shaped support structure has tapered, curved side walls.

7. The implantable device of claim 1, wherein the U-shaped support structure additionally incorporates a reinforcing structure located within the perimeter structure.

8. The implantable device of claim 7, wherein the U-shaped support structure incorporates a support rib within the perimeter structure and substantially aligned on a longitudinal centerline.

9. The implantable device of claim 1, wherein the U-shaped support structure and anchoring legs are integrally formed.

10. The implantable device of claim 1, wherein the U-shaped support structure comprises at least three walls including an elongated interface surface having at least one lateral area sized and configured to be positioned in proximity to the opening of the physiological cavity and aligned substantially on the longitudinal centerline and two side surfaces extending from opposite edges of the interface surface.

11. The implantable device of claim 1, wherein the U-shaped support structure is curved along its longitudinal centerline.

12. The implantable device of claim 11, wherein the U-shaped support structure is curved concavely along its longitudinal centerline.

13. The implantable device of claim 11, wherein the U-shaped support structure is curved convexly along its longitudinal centerline.

14. The implantable device of claim 1, wherein the U-shaped support structure incorporates a shaped, curved three-dimensional portion.

15. The implantable device of claim 1, wherein the U-shaped support structure is constructed from a material selected from the group consisting of:

stainless steels, biocompatible shape change alloys, super-elastic metallic materials, biocompatible flexible polymeric materials, composite materials and combinations thereof.

16. The implantable device of claim 1, wherein the anchoring legs span a wider distance where they extend from the support structure in a distal location and taper to span a narrower distance proximally.

17. The implantable device of claim 1, wherein the perimeter of the anchoring legs have a generally triangular configuration, terminating in a proximal apex.

18. The implantable device of claim 1, wherein the anchoring legs extend from U-shaped support structure along substantially parallel, opposed planes in deployed condition.

19. The implantable device of claim 1, wherein the anchoring legs comprise a combination of different geometrical structures.

20. The implantable device of claim 1, wherein the anchoring legs incorporate at least one curved flexure segment.

21. The implantable device of claim 1, wherein the anchoring legs incorporate a pivot mechanism.

22. The implantable device of claim 1, wherein the anchoring legs are constructed from a material selected from the group consisting of:

stainless steels, biocompatible shape change alloys, super-elastic metallic materials, biocompatible flexible polymeric materials, composite materials and combinations thereof

23. The implantable device of claim 1, additionally comprising proximal anchoring segments extending from each anchoring leg and out of the plane of the anchoring legs.

24. The implantable device of claim 23, wherein the proximal anchoring segments have terminal portions arranged substantially opposite one another.

25. The implantable device of claim 23, wherein the proximal anchoring segments have terminal portions arranged in different axial and circumferential locations than the terminal portions of the anchoring legs.

26. The implantable device of claim 1, additionally comprising a membrane associated with at least a portion of the support structure.

27. The implantable device of claim 26, wherein the membrane is substantially impermeable to fluids.

28. The implantable device of claim 26, wherein the membrane is substantially permeable to fluids.

29. The implantable device of claim 26, wherein the membrane is constructed from material selected from the group consisting of:

polymeric materials, polyurethanes, silicone materials, copolymeric materials, rubber materials, woven and non-woven fabrics, fluoropolymer compositions, expanded polytetrafluoroethylene materials, and combinations thereof.

30. The implantable device of claim 26, wherein the membrane is constructed from a metallic material.

31. The implantable device of claim 30, wherein the membrane is constructed from a material selected from the group consisting of:

stainless steels, biocompatible shape change alloys, super-elastic metallic materials, biocompatible flexible polymeric materials, composite materials and combinations thereof

32. The implantable device of claim 26, wherein the membrane has a mesh-like structure.

33. The implantable device of claim 26, wherein the membrane has pores in proximity to the perimeter structure.

34. The implantable device of claim 26, wherein the membrane has surface contours for directing flow.

35. The implantable device of claim 26, wherein the at least one of the membrane, the support structure, and the anchoring legs incorporate a material that promotes cellular attachment and growth.

36. The implantable device of claim 26, wherein at least one of the membrane, the support structure, and the anchoring legs are associated with an agent of the type selected from the group consisting of:

hydrophilic agents, hydrophobic agents, bonding agents, friction-reducing agents, thrombolytic agents, anti-clotting agents, anti-inflammatory agents, radioactive agents, therapeutic agents, and swellable agents.

37. The implantable device of claim 26, wherein at least one radiopaque marker is associated with the at least one of the framework structure, the membrane, and the anchoring legs.

38. The implantable device of claim 1, wherein at least one radiopaque marker is associated with the framework structure and at least one radiopaque marker is associated with at least one of the anchoring legs, and the radiopaque marker(s) associated with the framework structure and at least one of the anchoring legs are distinctive.

39. The implantable device of claim 1, wherein an additional structure projects from support structure in direction opposite of anchoring legs.

40. The implantable device of claim 39, wherein the additional structure is sized and configured to be positioned in the interior of the opening of the physiological cavity.

41. The implantable device of claim 40, wherein the additional structure is conformable to an interior surface of the opening of the physiological cavity.

42. The implantable device of claim 39, wherein the additional structure incorporates at least one coiled structure for placement in the interior of an aneurysm.

43. An implantable device for placement at the opening of a physiological cavity adjustable from a generally small diameter delivery condition to a deployed condition in which it assumes a larger diameter configuration, wherein the implantable device, in the deployed condition, forms a framework support structure having at least one lateral area sized and configured for positioning in proximity to tissue near the opening of the cavity, at least two anchoring legs that, in a deployed condition, are arranged substantially opposite one another and contact the walls of a neighboring vessel along opposed anchoring surface areas, and at least two proximal anchoring extensions that, in a deployed condition, contact walls of the neighboring vessel at surface areas proximal to the anchoring surface areas and at circumferential vessel wall locations different from the anchoring surface areas.

44. An implantable device for placement at the opening of a physiological cavity adjustable from a generally small diameter delivery condition to a deployed condition in which it assumes a larger diameter configuration, wherein the implantable device, in the deployed condition, forms a framework support structure and at least two anchoring legs extending away from the framework support structure and generally opposite one another, wherein the framework support structure has at least one lateral area having a widest dimension and the distance between the at least two anchoring legs, in the deployed condition, is less than the widest dimension of the framework support structure lateral area.

45. An implantable device assembly for placement at an opening or cavity in a target tissue comprising an elongated, flexible delivery catheter, at least one an elongated, flexible delivery mechanism axially movable with respect to the catheter, and an implantable device associated with a distal end of the delivery mechanism and positioned in a distal end of the delivery catheter, the implantable device being adjustable from a generally small diameter delivery condition to a deployed condition in which it assumes a larger diameter configuration outside the catheter, wherein the implantable device, in the deployed condition, comprises a generally U-shaped support structure and at least two anchoring legs extending from the U-shaped support structure substantially opposite one another.

46. An implantable device assembly for placement at an opening or cavity in a target tissue comprising an elongated, flexible sheath, at least one an elongated, flexible delivery mechanism axially movable with respect to the sheath, and an implantable device associated with a distal end of the delivery mechanism and arranged, in a deployed condition in a protective container, the implantable device being adjustable from the deployed condition in which it assumes a larger diameter configuration to a smaller diameter, deliver condition by positioning within a distal end of the flexible sheath, wherein the implantable device, in the deployed condition, comprises a generally U-shaped support structure and at least two anchoring legs extending from the U-shaped support structure substantially opposite one another.

47. A method for constructing an implantable device comprising:

providing a preformed assembly having a substantially planar, generally diamond-shaped framework structure with a longitudinal centerline joining two lateral areas and an axial centerline joining two axial areas; and

bending the two end points toward one another to form a generally U-shaped framework support structure with the longitudinal centerline substantially bisecting the framework support structure and two anchoring legs extending away from the U-shaped support structure generally opposite one another.

48. A method of deploying an implantable device in proximity to the neck of an aneurysm, comprising:

navigating the implantable device to a location in proximity to the neck of an aneurysm in small diameter delivery condition;

initiating deployment of the implantable device at the location in proximity to the neck of the aneurysm by advancing a distal portion of the implantable device incorporating lateral portions of a framework support structure and allowing the lateral portions to assume a larger diameter, deployed configuration;

positioning of the lateral portions of the framework support structure in close proximity to the neck of the aneurysm;

continuing to deploy the implantable device by fully deploying the framework support structure in proximity to the neck of the aneurysm; and

completing deployment of the implantable device by deploying at least two proximal anchoring legs that, in a deployed condition, are arranged substantially opposite one another to contact the walls of a neighboring vessel along opposed surface areas.

49. A method of deploying an implantable device in proximity to the neck of an aneurysm, comprising:

navigating the implantable device to a location in proximity to the neck of an aneurysm in small diameter delivery condition;

initiating deployment of the implantable device at the location in proximity to the neck of the aneurysm by advancing a distal portion of the implantable device incorporating a framework support structure and allowing the framework support structure to assume a larger diameter, deployed configuration and positioning at least a portion of the framework support structure in proximity to the neck of the aneurysm;

continuing deployment of the implantable device by deploying at least two anchoring legs that, in a deployed condition, are arranged substantially opposite one another and contact the walls of a neighboring vessel along opposed anchoring surface areas; and

completing deployment of the implantable device by deploying at least two proximal anchoring extensions that, in a deployed condition, contact walls of the neighboring vessel at surface areas proximal to the anchoring surface areas and at circumferential vessel wall locations different from the anchoring surface areas.

50. A generally planar diamond-shaped framework structure having a longitudinal centerline joining two side areas and an axial centerline joining two end areas, wherein the axial centerline is longer than the longitudinal centerline, and additionally comprising two legs extending angularly from each end areas.

51. The generally planar diamond-shaped framework structure of claim 50, wherein the framework structure is composed of four curved, tapered side walls having substantially the same configuration.

52. The generally planar diamond-shaped framework structure of claim 50, wherein at least two of lateral areas and axial areas of the generally diamond-shaped framework have a curved configuration.

53. The generally planar diamond-shaped framework structure of claim 50, wherein the framework structure additionally comprises a mesh structure joined to or formed as part of the framework structure in the area of the longitudinal centerline and extending for a distance on either side of the longitudinal centerline.

54. The generally planar diamond-shaped framework structure of claim 50, wherein the framework structure and the mesh structure are constructed from a shape memory alloy.

55. The generally planar diamond-shaped framework structure of claim 50, additionally comprising a membrane associated with at least a portion of the framework structure.

56. The generally planar diamond-shaped framework structure of claim 55, wherein the membrane is substantially impermeable to fluids.

57. The generally planar diamond-shaped framework structure of claim 50, constructed from a material selected from the group consisting of:

stainless steels, biocompatible shape change alloys, super-elastic metallic materials, biocompatible flexible polymeric materials, composite materials and combinations thereof