Methods and systems for endovascularly clipping and repairing lumen and tissue defects

• US 9,510,835 B2
• Filed: 09/09/2013
• Issued: 12/06/2016
• Est. Priority Date: 10/19/2005
• Status: Active Grant

• Current Assignee: Pulsar Vascular, Inc. (Johnson & Johnson)
• Original Assignee: Pulsar Vascular, Inc. (Johnson & Johnson)
• Inventors: Eskridge, Joseph, Clarke, Gilbert, Pease, Matthew, Mast, Gregory Martin, Muskivitch, John Conrad
• Primary Examiner(s): YABUT, DIANE D
• Application Number:
  US14/022,088
• Publication Number:
  US 20140142608A1
• Time in Patent Office: 1,184 Days
• Field of Search: 606/191, 606/200, 623/1.11
• US Class Current: 1/1
• 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 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• 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 2017/00867 shape memory effect for prostheses A61F2210/0014
• 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: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/06 Blood vessels

Abstract

An implantable closure structure is delivered using minimally invasive techniques, and inhibits the migration of liquid and particulate matter from inside a physiological cavity or opening, such as an aneurysm or a septal defect, as well as inhibiting the flow of liquid and particulate matter, such as from an associated blood vessel or chamber, into the physiological cavity or opening. The device has a closure structure that covers the neck or opening of a cavity and has one or more anchoring structures for supporting and retaining the closure structure in place across the cavity or opening.

Claims

1. An implantable device for repairing an opening or cavity in a target tissue defect, the implantable device being adjustable from a delivery condition in which it assumes a generally small diameter configuration to a deployed condition in which it assumes a larger diameter configuration, the implantable device comprising:

a closure structure sized to substantially cover the opening or cavity when the device is in the deployed condition;

a collar structure provided in proximity to a perimeter of the closure structure, the collar structure configured to engage at least a portion of tissue at the opening or cavity when the device is in the deployed condition;

a first anchoring structure extending in a first direction from a plane defined by the closure structure when the device is in the deployed condition; and

a second anchoring structure extending in a generally opposite second direction from the plane defined by the closure structure when the device is in the deployed condition,

wherein the first anchoring structure extending in the first direction faces generally toward the tissue defect and the second anchoring structure extending in the second direction faces generally away from the tissue defect,

wherein the first and second anchoring structures are integrally formed and comprise a generally atraumatic, single looped structure extending beyond a periphery of the collar structure when the device is in the deployed condition.

2. The implantable device of claim 1, further comprising at least one radiopaque marker associated with at least one of the first and second anchoring structures.

3. The implantable device of claim 1 wherein the closure structure has a substantially continuous occlusive surface area.

4. The implantable device of claim 1 wherein the closure structure has at least one opening to facilitate passage of another device.

5. The implantable device of claim 1 wherein the closure structure comprises a material selected from the group consisting of:

silicone materials;

rubber materials;

woven and non-woven fabrics;

fluoropolymer compositions;

polymeric materials, polyurethane materials, metallic materials and combinations thereof.

6. The implantable device of claim 1 wherein the closure structure comprises a thin film shape memory alloy.

7. The implantable device of claim 1 wherein the closure structure has a porous surface structure provided over at least a portion of its surface area.

8. The implantable device of claim 1 wherein the closure structure comprises a material that is permeable to liquids but substantially excludes cells from traversing the closure structure.

9. The implantable device of claim 1 wherein the collar structure is generally cylindrical and extends in a plane generally orthogonal to that of the closure structure when the device is in the deployed condition.

10. The implantable device of claim 1 wherein the first and second anchoring structures have a material density over their surface area that is less than the density of the closure structure over its surface area.

11. The implantable device of claim 1 wherein the first and second anchoring structures comprise a biocompatible shape memory alloy material.

12. The implantable device of claim 1 wherein the first and second anchoring structures have substantially the same configurations and/or dimensions.

13. The implantable device of claim 1 wherein the first and second anchoring structures are substantially aligned with one another in the deployed condition.

14. The implantable device of claim 1 wherein the implantable device further comprises one or more of the following:

agents that promote cellular ingrowth and attachment at the target site;

hydrophilic agents;

hydrophobic agents;

bonding agents;

friction-reducing agents;

radiopaque agents;

antibioticagents;

thrombogenic agents;

anti-thrombogenic agents;

therapeutic agents;

hydrogel compositions;

anti-inflammatory agents;

anti-restenosis agents;

radioactive agents; and

combinations thereof.

15. A device for treating a tissue defect in a physiological lumen of a human subject, wherein the device is selectively transformable between a low profile delivery configuration and a deployed configuration sized to fit within the opening of the tissue defect, and wherein, in the deployed configuration, the device comprises:

a closure system configured to repair and/or occlude an opening of the tissue defect in the physiological lumen, the closure system including—

a radially expandable collar structure configured to engage tissue on or proximate the opening;

a closure structure coupled to the collar structure and positioned within the collar structure, wherein the closure structure is sized to substantially cover the opening; and

expandable atraumatic anchoring structures distributed around a circumference of the collar structure and configured to engage tissue above and below the opening,

wherein the expandable atraumatic anchoring structures include at least a first anchoring structure extending in a first direction from a plane defined by the closure structure and a second anchoring structure extending in a second, opposite direction from the plane defined by the closure structure, wherein the first and second anchoring structures are integrally formed and comprise a single looped structure, and

wherein the first anchoring structure is positioned to engage tissue in a cavity of the tissue defect and above the opening, and the second anchoring structure opposite the first anchoring structure is positioned to engage tissue outside the cavity and below the opening.

16. The device of claim 15 wherein the closure system further comprises a skirt portion extending from the collar structure and toward tissue on or proximate the opening, the skirt portion configured to provide a seal between the device and the tissue on or proximate the opening.

17. The device of claim 16 wherein the skirt portion has a flared, curved shape when the device is in the deployed configuration.

18. The device of claim 16 wherein, when the device is in the deployed configuration, the collar structure has a first diameter and the skirt portion has a second diameter greater than the first diameter.

19. The device of claim 18 wherein the second diameter is 10% greater than the first diameter in the deployed configuration.

20. The device of claim 18 wherein the second diameter is 20% greater than the first diameter in the deployed configuration.

21. The device of claim 15 wherein the tissue defect an aneurysm in a blood vessel of the human subject, and wherein the device is configured to occlude the aneurysm from the blood vessel.

22. The device of claim 15 wherein the first and second anchoring structures are coupled by an intermediate structural support and are configured to receive tissue at the opening therebetween.

23. The device of claim 15 wherein the radially expandable collar structure is generally cylindrical and the closure structure extends in a plane generally orthogonal to that of the collar structure when the device in the deployed configuration.

24. The device of claim 15 wherein the expandable anchoring structures are configured to engage non-overlapping portions of tissue above and below the opening.

25. An implantable device configured for placement at an opening of a physiological cavity, the implantable device comprising:

a neck structure having an outer surface configured to be positioned in proximity to the opening of the physiological cavity;

a plurality of anchoring structures including at least a first anchoring structure projecting from the neck structure in a first direction toward the cavity and a second anchoring structure integrally formed with the first anchoring structure projecting from the neck structure in a second direction opposite the first direction and away from the cavity, wherein the first and second anchoring structures are integrally formed and comprise a generally atraumatic, single looped structure; and

a closure structure positioned within an interior of the neck structure, the closure structure configured to occlude the opening,

wherein the implantable device is selectively transformable between a delivery condition and a deployed condition sized to fit within the opening of the physiological cavity.

26. The implantable device of claim 25 wherein the neck structure is generally cylindrical and configured to radially expand to engage tissue at or in proximity to the opening with the outer surface when in the deployed condition.

27. The implantable device of claim 25 wherein a perimeter of the first and/or second anchoring structure defines a generally triangular configuration with an atraumatic terminal end when the implantable device is in the deployed condition.

28. The implantable device of claim 25, further comprising a skirt portion extending from the neck structure and configured to engage tissue outside of the physiological cavity to further occlude the opening when the implantable device is in the deployed condition.

29. The implantable device of claim 28 wherein, in the deployed condition, the neck structure radially expands to a first cross-sectional dimension and the skirt portion radially expands to a second cross-sectional dimension greater than the first cross-sectional dimension.