Sealing device and delivery system

• US 9,468,430 B2
• Filed: 02/12/2015
• Issued: 10/18/2016
• Est. Priority Date: 06/22/2009
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Van Orden, Brad W.
• Primary Examiner(s): OU, JING RUI
• Application Number:
  US14/621,241
• Publication Number:
  US 20150196288A1
• Time in Patent Office: 614 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• 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 2017/00597 Implements comprising a membrane
• 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 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: B29C 65/02 by heating, with or without pressure
• CPC Class Codes: B29C 65/48 using adhesives , i.e. using supplementary joining material; solvent bonding
• CPC Class Codes: B29C 65/4805 characterised by the type of adhesives
• CPC Class Codes: B29L 2031/753 Medical equipment; Accessories therefor bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008
• CPC Class Codes: B29L 2031/7532 Artificial members, protheses

Abstract

The invention relates to a sealing device for repair of cardiac and vascular defects or tissue opening such as a patent foramen ovale (PFO) or shunt in the heart, the vascular system, etc. and particularly provides an occluder device and trans-catheter occluder delivery system. The sealing device would have improved conformity to heart anatomy and be easily deployed, repositioned, and retrieved at the opening site.

Claims

1. A deployment system comprising:

a sealing device;

a first tube configured to releasably couple to a proximal end portion of the sealing device, the sealing device comprising

an expandable frame formed from a plurality of wires, each of the wires extending from a proximal end of the frame to a distal end of the frame, wherein first and second end portions of each of the plurality of wires are wound around a longitudinal axis of the sealing device to define a proximal eyelet at the proximal end of the frame and a distal eyelet at the distal end of the frame, respectively, the plurality of wires also forming a proximal disk and a distal disk when the sealing device assumes an expanded configuration, the proximal disk and the distal disk each disposed between the proximal eyelet and the distal eyelet, each wire of the plurality of wires forming a respective petal of the proximal disk and forming a respective petal of the distal disk, wherein adjacent petals of the proximal disk overlap one another, adjacent petals of the distal disk overlap one another, and each of the petals is configured to conform to tissue, and

a sealing member at least partially encapsulating the frame; and

a second tube configured to releasably couple to a distal end portion of the sealing device;

a retrieval cord configured to releasably couple to a proximal end portion of the sealing device;

a housing having a slot with a length;

a first linear actuator located within the slot; and

the first linear actuator being configured to advance and retract the first tube independently from the second tube by advancing and retracting the first linear actuator along a portion of the slot length, and advance and retract the first tube and second tube by advancing and retracting the first linear actuator along another portion of the slot length.

2. The system of claim 1, wherein the first tube and the second tube extend into the handle, through an aperture at a distal end of the handle.

3. The system of claim 1, further comprising a second linear actuator.

4. The system of claim 3, wherein the second actuator is capable of actuating at least two components.

5. The system of claim 4, wherein the at least two components include a third tube and the second tube.

6. The system of claim 1, wherein the sealing device further comprises an intermediate eyelet defined by winding intermediate portions of the plurality of wires around the longitudinal axis.

7. The system of claim 1, wherein the intermediate eyelet is disposed between the proximal disk and the distal disk.

8. The system of claim 1, wherein the sealing member is wrapped around the second end portions of each of the plurality of wires defining the distal eyelet.

9. The system of claim 1, wherein the sealing member is wrapped around the first end portions of each of the plurality of wires defining the proximal eyelet.

10. The system of claim 1, wherein the sealing member comprises a material selected from the group consisting of polyester, polyethylene, polypropylene, fluoropolymer, polyurethane, silicone, nylon, and silk.

11. The system of claim 1, wherein the plurality of wires extend helically from the proximal end of the frame to the distal end of the frame.

12. A deployment system comprising:

a sealing device;

a handle having a housing having a slot with a length;

a first linear actuator located within the slot;

the first linear actuator being configured to advance and retract at least three separate components by advancing and retracting the actuator along the slot length, the at least three separate components comprising a first tube slidably disposed within a delivery catheter, a second tube slidably disposed within the first tube, and the sealing device;

wherein the sealing device comprising an expandable frame formed from a plurality of wires, each of the wires extending from a proximal end of the frame to a distal end of the frame, wherein first and second end portions of each of the plurality of wires are wound around a longitudinal axis of the sealing device to devine a proximal eyelet at the proximal end of the frame and a distal eyelet at the distal end of the frame, respectively, the plurality of wires also forming a proximal disk and a distal disk when the sealing device assumes an expanded configuration, the proximal disk and the distal disk each disposed between the proximal eyelet and the distal eyelet, each wire of the plurality of wires forming a respective petal of the proximal disk and forming a respective petal of the distal disk, wherein adjacent petals of the proximal disk overlap one another, adjacent petals of the distal disk overlap one another, and each of the petals is configured to conform to tissue; and

a sealing member at least partially encapsulating the expandable wire frame;

wherein the first linear actuator being further configured to advance and retract the first tube independently from the second tube by advancing and retracting the first linear actuator along a portion of the slot length, and advance and retract the first tube and second tube by advancing and retracting the first linear actuator along another portion of the slot length.

13. The system of claim 12, wherein the handle further comprises a second actuator.

14. The system of claim 13, wherein the second actuator is capable of releasing the sealing device when the sealing device is deployed.