Devices and methods for retrievable intra-atrial implants

• US 9,937,036 B2
• Filed: 12/31/2015
• Issued: 04/10/2018
• Est. Priority Date: 11/07/2006
• Status: Active Grant

• Current Assignee: Corvia Medical, Inc.
• Original Assignee: Corvia Medical, Inc.
• Inventors: Sugimoto, Hiroatsu, Forcucci, Stephen J., McNamara, Edward I., Finch, Matthew J., Magnin, Christopher J.
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US14/986,409
• Publication Number:
  US 20160166381A1
• Time in Patent Office: 831 Days
• Field of Search: 623 21- 219
• 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 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• 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 2017/22035 for retrieving or repositioning foreign objects
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/144 Wire
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2493 Transmyocardial revascularisation [TMR] devices
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/9522 : Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2002/061 : provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2210/0076 : multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0008 : Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0041 : using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/005 : using adhesives
• CPC Class Codes: A61F 2220/0058 : soldered or brazed or welded
• CPC Class Codes: A61F 2220/0066 : stapled
• CPC Class Codes: A61F 2230/0017 : Angular shapes
• CPC Class Codes: A61F 2230/0019 : rectangular
• CPC Class Codes: A61F 2230/005 : Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 : V-shaped
• CPC Class Codes: A61F 2230/0058 : X-shaped
• CPC Class Codes: A61F 2230/006 : Y-shaped
• CPC Class Codes: A61F 2230/0067 : conical
• CPC Class Codes: A61F 2230/0078 : hyperboloidal
• CPC Class Codes: A61F 2250/0036 : differing in thickness
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61L 31/022 : Metals or alloys

Abstract

Devices and methods to enhance the implantation, retrievability, or repositionability are provided. Embodiments of devices include pivotable sections providing the ability to maintain the device'"'"'s engagement with a delivery system during implantation where the deliver system approaches an opening of the septum at an angle. Embodiments of devices also include configurations that allow for improved retrieval into a delivery system in the event that a malfunction or a problem with the patients physiology is detected.

Claims

1. A percutaneously deliverable device for treating a heart condition in an atrial septum of a patient comprising:

a first flange section having a plurality of flange segments spaced about a longitudinal axis of the device; and

a second flange section comprising a plurality of flange segments, wherein the first and second flange sections are configured to be positioned on opposing sides of the atrial septum,

wherein a proximal portion of each of the plurality of flange segments of the first flange section has a pivotable section, the pivotable sections joining to form a proximal hub, wherein the pivotable sections allow for the proximal hub to be curved, bent, turned, or twisted relative to the first flange section as the first and second flange sections are deployed across and conform to the atrial septum.

2. The device of claim 1, wherein the pivotable sections are configured to be in releasable engagement with a delivery system.

3. The device of claim 2, wherein the pivotable sections allow for rotational displacement of the pivotable sections about the longitudinal axis of the device while the device is in releasable engagement with the delivery system.

4. The device of claim 1, wherein the pivotable sections are connected to the first flange section.

5. The device of claim 1, wherein the pivotable sections are integral with the first flange section.

6. The device of claim 1, wherein the flange segments of the proximal portion are arranged parallel to one another proximal to the pivotable sections and the flange segments in the pivotable sections comprise alternating radially concave inward and outward curves.

7. The device of claim 1, wherein the hub comprises two posts extending radially outward from the longitudinal axis of the device, each post pivotably connected to a flange segment.

8. The device of claim 1, wherein the pivotable sections allow for rotational displacement of the pivotable sections about the longitudinal axis of the device.

9. A method for percutaneously delivering a device for treating a heart condition, the method comprising:

releasably engaging the device with a delivery catheter;

advancing the device through the delivery catheter to a septal wall of a heart of a patient, a proximal portion of the device comprising a pivotable section;

positioning a first flange and a second flange of the device on opposing sides of septal wall; and

pivoting the pivotable section such that the pivotable section is angled away from a longitudinal axis of the device while the first and second flanges are deployed across and conform to the septal wall.

10. The method of claim 9, further comprising determining whether deployment of the device is satisfactory.

11. The method of claim 9, further comprising releasing the device from the delivery catheter.

12. The method of claim 9, further comprising releasing the device from the delivery catheter after determining that deployment of the device is satisfactory.

13. A percutaneously deliverable device for treating a heart condition in an atrial septum of a patient comprising:

a first flange section having a plurality of flange segments spaced about a longitudinal axis of the device;

a second flange section comprising a plurality of flange segments, wherein the first and second flange sections are configured to be positioned on opposing sides of the atrial septum; and

a pivotable end connecting to a proximal end of the first flange,

wherein the pivotable end of the first flange section is adapted to have a non-zero angle up to 180 degree rotational displacement angle relative to the longitudinal axis of the device.