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

• US 10,499,927 B2
• Filed: 11/08/2016
• Issued: 12/10/2019
• 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:
  US15/346,503
• Publication Number:
  US 20170273688A1
• Time in Patent Office: 1,127 Days
• 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. A delivery system incorporating an implantable device for repairing an opening or cavity in a target tissue defect, comprising:

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

an implantable device slidably disposed in the delivery catheter, the implantable device comprising;

a closure structure sized to substantially cover the opening or cavity, the closure structure comprising a convex surface facing the target tissue defect and an opposing concave surface facing away from the target tissue defect; and

a first and second set of anchoring structures extending in substantially opposite directions from the closure structure, the set of anchoring structures comprise a generally atraumatic single looped structure extending beyond a perimeter of the closure structure when the device is in a deployed condition and capable of engaging tissue above the opening of the tissue defect, wherein the looped structures of the first and second set of anchoring structures have a diameter larger than that of the closure structure when the implantable device is in the deployed condition;

wherein the implantable device is positioned in a lumen in the distal end of the delivery catheter.

2. A delivery system of claim 1, further comprising:

a pusher positioned proximally to the implantable device.

3. A delivery system of claim 1, wherein the closure structure is sized to substantially cover and occlude the opening or cavity.

4. A delivery system of claim 1, further comprising:

a detachment mechanism having a device wire and a detachable element associated with a proximal portion of the implantable device in a delivery condition.

5. A delivery system of claim 1, wherein the delivery catheter further comprises a microcatheter having a small diameter and a generally high flexibility.

6. A delivery system of claim 1, wherein the delivery catheter further comprises one or more radiopaque markers.

7. A delivery system of claim 1, wherein the distal end of the delivery catheter is more flexible than a proximal end of the delivery catheter.

8. A delivery system of claim 1, further comprising:

one or more radiopaque markers at or near a distal end of the implantable device.

9. A delivery system of claim 1, wherein the first and second anchoring structures are substantially staggered with respect to one another in the deployed condition.

10. A delivery system of claim 1, wherein the 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. 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, the closure structure comprising a convex surface facing the target tissue defect and an opposing concave surface facing away from the target tissue defect;

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

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

(d) deploying the second anchoring portion, comprising a looped structure, 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;

wherein the looped structures of the first and second anchoring portions have a diameter larger than that of the closure structure when the implantable device is in the deployed configuration.

12. The method of claim 11, further comprising:

occluding the opening by deploying the closure structure across the opening.

13. The method of claim 11, further comprising:

navigating a guidewire to a site in proximity to the target tissue defect; and

guiding the repair device to the site of the target tissue defect over the guidewire.

14. The method of claim 11, further 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.

15. 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, the closure structure comprising a convex surface facing the aneurysm and an opposing concave surface facing away from the aneurysm;

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

(c) deploying the 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 closure structure, and 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.