Flow obstructor and transapical closure device

• US 9,023,080 B2
• Filed: 10/23/2012
• Issued: 05/05/2015
• Est. Priority Date: 10/23/2012
• Status: Active Grant

• Current Assignee: Medtronic Vascular Galway Limited (Medtronic Plc)
• Original Assignee: Medtronic Vascular Galway Limited (Medtronic Plc)
• Inventors: Ciobanu, Constantin, Donnelly, Evin, Harewood, Frank, Savage, Padraig
• Primary Examiner(s): Miles, Jonathan W
• Assistant Examiner(s): Ulsh, George J
• Application Number:
  US13/658,025
• Publication Number:
  US 20140114345A1
• Time in Patent Office: 924 Days
• Field of Search: 623/1.1, 623/2.36, 606/213, 606/208
• US Class Current: 606/213
• 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 2017/00579 Barbed implements
• 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 2017/00632 Occluding a cavity, i.e. closing a blind opening
• CPC Class Codes: A61B 2017/00884 enhancing wound closure

Abstract

Medical devices and methods for closing an anatomical aperture in a tissue are disclosed. The medical devices can include distal and proximal support structures, which can include a plurality of anchor members. A connection element can connect the distal and proximal support structures, and be configured to twist to create a seal within the medical device. In certain embodiments, a sheath about the medical device can be retracted to expose the distal support structure, which can allow it to revert to an anchoring configuration from a delivery configuration, such that the anchor members can engage an interior surface of the tissue. After twisting the connection element to form a seal, the sheath can be further retracted to expose the proximal support structure, which can allow it to revert to an anchoring configuration from a delivery configuration, such that the anchor members can engage an exterior surface of the tissue.

Claims

1. A medical device for closing an anatomical aperture in a tissue having an interior surface and an exterior surface, comprising:

a distal support structure comprising a ring having a distal face and a proximal face, the distal face having a first plurality of anchor members;

a proximal support structure comprising a ring having a distal face and a proximal face, the proximal face having a second plurality of anchor members; and

a connection element connecting the distal support structure and the proximal support structure, wherein the connection element is configured to be twisted about a central axis of the medical device to create a seal, such that the connection element in a twisted position closes a central lumen of the medical device that extends therethrough.

2. The medical device of claim 1, wherein the distal support structure is configured to revert to an anchoring configuration from a delivery configuration, such that the first plurality of anchor members engage the interior surface of the tissue, and wherein the proximal support structure is configured to revert to an anchoring configuration from a delivery configuration, such that the second plurality of anchor members engage the exterior surface of the tissue.

3. The medical device of claim 1, wherein the distal and proximal support structures each comprise a sinusoidal ring, wherein the anchor members are located at extradoses of the sinusoidal rings.

4. The medical device of claim 1, wherein the distal and proximal support structures are biased to an anchoring configuration.

5. The medical device of claim 4, wherein the distal and proximal support structures comprise a shape-memory alloy biased such that in the anchoring configuration, the distal face of the distal support structure is curled in the proximal direction, and the proximal face of the proximal support structure is curled in the distal direction.

6. The medical device of claim 1, wherein the anchor members are hooks.

7. The medical device of claim 1, wherein the connection element comprises a blood-impermeable material.

8. The medical device of claim 1, wherein the connection element further comprises a central support structure.

9. The medical device of claim 8, wherein the central support structure comprises a shape-memory alloy biased to the twisted position in which the central support structure twists about the central axis of the medical device.

10. The medical device of claim 1, wherein the connection element is rotatable 360 degrees from a delivery position to the twisted position.

11. A delivery system for delivering a medical device for closing an anatomical aperture in a tissue having an interior surface and an exterior surface, comprising:

a delivery catheter;

a sheath; and

a medical device restrained between the delivery catheter and the sheath in a delivery configuration, the medical device comprising;

a distal support structure comprising a ring having a distal face and a proximal face, the distal face having a first plurality of anchor members;

a proximal support structure comprising a ring having a distal face and a proximal face, the proximal face having a second plurality of anchor members; and

a connection element connecting the distal support structure and the proximal support structure, wherein the connection element is configured to be twisted about a central axis of the medical device to create a seal, such that the connection element in a twisted position prevents blood flow through a central lumen of the medical device that extends therethrough.

12. The delivery system of claim 11, wherein exposing the distal support structure from the sheath allows the distal support structure to revert to an anchoring configuration such that the first plurality of anchor members engage the interior surface of the tissue, and wherein exposing the proximal support structure from the sheath allows the proximal support structure to revert to an anchoring configuration such that the second plurality of anchor members engage the exterior surface of the tissue.

13. The delivery system of claim 11, wherein the medical device is loaded about an exterior of the delivery catheter, and wherein the exterior of the delivery catheter comprises a plurality of retaining elements, configured to retain the medical device about the delivery catheter.

14. The delivery system of claim 11, further comprising an inner shaft within an interior lumen of the delivery catheter, wherein the medical device is restrained about the inner shaft by the sheath.

15. The delivery system of claim 11, wherein the connection element further comprises a central support structure, and wherein at least the distal and proximal support structures comprise a shape-memory alloy.

16. The delivery system of claim 11, wherein the connection element is rotatable 360 degrees from the delivery configuration to the twisted position.