Devices, systems and methods for closure of cardiac openings

• US 8,361,111 B2
• Filed: 05/19/2005
• Issued: 01/29/2013
• Est. Priority Date: 01/30/2004
• Status: Expired due to Fees

• Current Assignee: WL Gore and Associates Incorporated (W.L. Gore and Associates)
• Original Assignee: WL Gore and Associates Incorporated (W.L. Gore and Associates)
• Inventors: Widomski, David R., Devellian, Carol A., Heneberry, Eileen M., Chanduszko, Andrzej J., Carr, Robert M.
• Primary Examiner(s): McDermott, Corrine M
• Assistant Examiner(s): ANDERSON, GREGORY A
• Application Number:
  US11/132,498
• Publication Number:
  US 20050216054A1
• Time in Patent Office: 2,812 Days
• Field of Search: 623/23.73, 623/23.72, 606213-216, 606/191, 606/194
• US Class Current: 606/213
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 17/12195 comprising a curable material
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• 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 2017/00632 Occluding a cavity, i.e. closing a blind opening

Abstract

The invention generally relates to devices, systems, and methods for percutaneous closure of cardiac openings and obliteration of the cardiac cul-de-sacs. In one embodiment, a closure device includes a patch with an adhesive and/or a removable frame. The patch may be placed across a cardiac opening, such as a patent foramen ovale, or across a cardiac cul-de-sac, such as a left atrial appendage. In another embodiment, a closure device includes a balloon together with adhesives and/or substances for stimulating tissue growth coated on, or contained within, the balloon. The balloon may be inserted into a cardiac opening, such as the patent foramen ovale, or into a cardiac cul-de-sac, such as a left atrial appendage.

Claims

1. A method for closing a patent foramen ovale in a patient, comprising:

inserting a system for closing the patent foramen ovale into a heart of the patient via a percutaneous, transluminal procedure, the system comprising;

a first catheter comprising a proximal end, a distal end, and a lumen extending from the proximal end to the distal end;

a second catheter comprising a distal end, wherein the second catheter is movable between a retracted state where the distal end of the second catheter is enclosed within the lumen of the first catheter, and a deployed state where the distal end of the second catheter is extended beyond the distal end of the first catheter;

a lining coupled to the distal end of the first catheter and the distal end of the second catheter, wherein the lining is positioned within the lumen of the first catheter when the second catheter is in the retracted state, and wherein the lining is inverted and is positioned outside the lumen of the first catheter when the second catheter is in the deployed state; and

an adhesive material releasably sealed within the lining;

positioning the system with the distal end of the first catheter proximate the right atrial side opening of the patent foramen ovale with the second catheter in the retracted state;

inverting the lining into the patent foramen, by deploying the second catheter, thereby extending the distal end of the second catheter beyond the distal end of the first catheter;

applying the adhesive to tissues of the patient in the patent foramen ovale by contacting the tissues with the inverted liner, wherein deploying the second catheter causes the adhesive to be released from the lining and exposed to the tissues of the patient;

retracting the lining from the patent foramen ovale; and

withdrawing the system from the patient.

2. The method of claim 1, wherein the lining comprises a plurality of holes or cavities comprising the adhesive.

3. The method of claim 1, wherein the lining further comprises a surface coating of adhesive.

4. The method of claim 1, wherein the lining is a balloon.

5. The method of claim 1, wherein the adhesive comprises a plurality of particles disposed within the adhesive that expand upon contact with blood or water.

6. The method of claim 5, wherein the particles are selected from the group consisting of gelatin particles, biological particles, bioresorbable particles, and foam particles.

7. The method of claim 1, wherein the adhesive is selected from the group of adhesives consisting of cyanoacrylates, fibrin based adhesives, albumin gluteraldehyde adhesives, and light activated adhesives.

8. The method of claim 1, wherein the adhesive comprises a substance for stimulating tissue growth.

9. The method of claim 8, wherein the substance for stimulating tissue growth is selected from the group consisting of growth factors, pharmacological agents for stimulating tissue growth, irritants for encouraging an inflammatory response, cells, and genes.