METHODS AND SYSTEMS FOR ENDOVASCULARLY CLIPPING AND REPAIRING LUMEN AND TISSUE DEFECTS

• US 20070191884A1
• Filed: 04/19/2007
• Published: 08/16/2007
• Est. Priority Date: 10/19/2005
• Status: Active Grant

• Current Assignee: Pulsar Vascular, Inc. (Johnson & Johnson)
• Original Assignee: Pulsar Vascular, Inc. (Johnson & Johnson)
• Inventors: Clarke, Gilbert, Eskridge, Joseph, Muskivitch, John, Mast, Gregory, Pease, Matthew
• Granted Patent: US 8,551,132 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 17/12109 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
• 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; and

a first anchoring structure extending in a first direction from the closure structure and a second anchoring structure extending in a generally opposite second direction from the closure structure when the device is in the delivery condition, the first and second anchoring structures forming generally circumferential structures having a diameter larger than that of the closure structure when the device is in the deployed condition.

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

3. An implantable device of claim 2, comprising at least one radiopaque marker associated with each of the first and second anchoring structures.

4. An implantable device of claim 1, additionally comprising a radiopaque marker positioned intermediate the first and second anchoring structures.

5. An implantable device of claim 1, additionally comprising a radiopaque marker associated with the closure structure.

6. An implantable device of claim 2, wherein the radiopaque marker comprises a composition selected from the group consisting of:

tantalum, gold, silver, barium, platinum, tungsten and combinations thereof.

7. An implantable device of claim 1, wherein the closure structure has a substantially continuous occlusive surface area.

8. An implantable device of claim 1, wherein the closure structure has at least one opening to facilitate passage of another device.

9. An implantable device of claim 1, wherein the closure structure has radial flexibility sufficient to mimic the structure and movement of the target tissue.

10. An 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.

11. An implantable device of claim 1, wherein the closure structure comprises a thin film shape memory alloy.

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

13. An 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.

14. An implantable device of claim 1, additionally comprising a reinforcing structure having framework structure in proximity to the perimeter of the closure structure.

15. An implantable device of claim 1, additionally comprising a collar structure provided in proximity to a perimeter of the closure structure, the collar structure forming a generally cylindrical structure and extending in a plane generally orthogonal to that of the closure structure in a delivery condition.

16. An implantable device of claim 1, wherein the anchoring structures are generally atraumatic and have a material density over their surface area that is less than the density of the closure structure over its surface area.

17. An implantable device of claim 1, wherein the anchoring structures comprise a biocompatible shape memory alloy material.

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

19. An implantable device of claim 1, wherein the first and second anchoring structures have different configurations and/or dimensions.

20. An implantable device of claim 1, wherein the first and second anchoring structures are substantially aligned with one another in a deployed condition.

21. An implantable device of claim 1, wherein the first and second anchoring structures are substantially staggered with respect to one another in a deployed condition.

22. An implantable device of claim 1, wherein the first and/or second anchoring structures have a mesh-like or porous configuration.

23. An implantable device of claim 1, incorporating a material selected from the group consisting of:

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

hydrophilic agents;

hydrophobic agents;

bonding agents;

friction-reducing agents;

radiopaque agents;

antibiotic agents;

thrombogenic agents;

anti-thrombogenic agents;

therapeutic agents;

hydrogel compositions;

anti-inflammatory agents;

anti-restenosis agents;

radioactive agents; and

combinations thereof.

24. A delivery system incorporating an implantable device for repairing an opening or cavity in a target tissue defect, comprising:

a delivery catheter having a distal end for delivery to a site in proximity to a target tissue defect;

an implantable device assuming a substantially cylindrical configuration in a delivery condition and comprising a closure structure sized to substantially cover the opening or cavity and a first and second set of anchoring structures extending in substantially opposite directions from the closure structure, the implantable device being positioned in a lumen in the distal end of the delivery catheter.

25. A delivery system of claim 24, additionally comprising a pusher positioned proximally to the implantable device.

26. A delivery system of claim 24, additionally comprising a detachment mechanism having a device wire and a detachable element associated with a proximal portion of the implantable device in the delivery condition.

27. A method for repairing an opening or cavity in a target tissue defect, comprising:

(a) guiding a repair device comprising a first anchoring portion, a second anchoring portion, and a closure structure located intermediate the first and second anchoring portions to the site of the target tissue defect using minimally invasive techniques;

(b) deploying the first anchoring portion inside the opening at the site of the target tissue defect and thereby positioning the first anchoring portion circumferentially in proximity to or in contact with a first tissue surface surrounding the opening;

(c) deploying the closure structure across the opening to substantially cover the opening; and

(d) deploying the second anchoring portion outside the opening at the site of the target tissue defect and thereby positioning the second anchoring portion circumferentially in proximity to or in contact with a second tissue surface surrounding the opening, the second tissue surface generally opposite the first tissue surface.

28. The method of claim 27, additionally comprising navigating a guidewire to a site in proximity to the target tissue defect and guiding the repair device to the site of the defect over the guidewire.

29. A method of claim 27, additionally comprising introducing an agent to the site of the target tissue defect selected from the group consisting of:

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

bonding agents;

radiopaque agents;

antibiotic agents;

thrombogenic agents;

anti-thrombogenic agents;

therapeutic agents;

hydrogel compositions;

anti-inflammatory agents;

anti-restenosis agents;

radioactive agents; and

combinations thereof.

30. A method for occluding an aneurysm in a body lumen, comprising:

(a) navigating an occluding device comprising a closure structure located intermediate first and second anchoring portions in a small diameter, delivery condition to a site in proximity to a neck of the aneurysm using minimally invasive techniques;

(b) deploying a distal region of the first anchoring portion through the neck of the aneurysm in the interior of the aneurysm, thereby positioning a first circumferential anchoring structure having a diameter larger than that of the opening in proximity to an internal aneurysm tissue surface surrounding the neck of the aneurysm;

(c) deploying the intermediate closure structure across the neck of the aneurysm, thereby substantially covering and occluding the opening; and

(d) deploying the second anchoring portion outside the neck of the aneurysm, thereby positioning a second circumferential anchoring structure having a diameter larger than that of the neck of the aneurysm in proximity to a surface of a blood vessel wall in proximity to the neck of the aneurysm.

31. A method for excluding an aneurysm from a parent vessel and promoting a reduction in the mass of the aneurysm comprising:

positioning a closure structure across an opening of the aneurysm that substantially covers the opening and restricts cellular communication between the aneurysm and the parent vessel; and

retaining the closure structure in position using at least one anchoring structure positioned inside and/or outside the opening of the aneurysm.