Vascular Closure Methods and Apparatuses

• US 20090254119A1
• Filed: 02/04/2009
• Published: 10/08/2009
• Est. Priority Date: 08/24/2005
• Status: Active Grant

• Current Assignee: Avasca Medical, Inc.
• Original Assignee: Avasca Medical, Inc.
• Inventors: Sibbitt, Randy R., Sibbitt, Wilmer L. JR.
• Granted Patent: US 8,048,108 B2
• Time in Patent Office: Days
• 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 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• CPC Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/00668 the implement being a tack or a staple
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body

Abstract

A vascular closure device comprised of a sheath-delivered expandable, umbrella-like device with structural radial members with terminal and non-terminal hooks that engage the vessel wall. Unlike other vascular closure umbrella-type devices that effect closure by opening of the umbrella to cover an opening, the present invention effects closure of the aperture with closure of the umbrella. The closure can be maintained by a retainer lock that slides down the members, causing contraction, bringing the members into a compressed configuration (e.g., a parallel orientation of linear members) and the wound edges together, permitting immediate vascular closure and healing of the blood vessel. The device can be delivered and recovered by an intravascular sheath.

Claims

1. A method of closing an opening in tissue having a proximal surface using a device having a plurality of tissue engagement elements capable of occupying a plurality of compressed configurations and at least one expanded configuration, said method comprising the steps of:

passing the device while in a first one of the compressed configurations through a sheath disposed adjacent to an opening in the proximal surface of the tissue;

expelling the device from the sheath into space beyond the proximal surface of the tissue such that the device assumes the at least one expanded configuration;

manipulating the device such that the tissue engagement elements engage the tissue; and

moving the device to bring edges of the opening into apposition.

2. The method of claim 1 further comprising the step of maintaining the device in a second one of the compressed configurations after bringing the edges of the opening into apposition.

3. The method of claim 2 wherein the second compressed configuration is expanded relative the first compressed configuration.

4. The method of claim 3 wherein the at least one expanded configuration is expanded relative to the second compressed configuration;

5. The method of claim 4, wherein the at least one expanded configuration defines a planar or conical shape.

6. The method of claim 2, wherein said maintaining step comprises constraining the tissue engagement elements with a locking element.

7. The method of claim 6, wherein the device includes a receiving element adapted to engage a flexible member and wherein said maintaining step comprises applying tensile force on the flexible member opposed to the force on the locking element to cause the device to occupy the second compressed configuration.

8. The method of claim 1, wherein said moving step comprises applying traction to the device.

9. The method of claim 8 wherein the device includes an attachment portion to which a flexible member is attached, and said manipulating step comprises pulling the flexible member to bias the device towards the tissue.

10. The method of claim 9 wherein the moving step causes the device to occupy a second one of the compressed configurations.

11. The method of claim 10, further comprising the steps of passing the flexible member through a locking element, passing the locking element down the flexible member to the device, pulling the flexible member such that a portion of the device engages the locking element and causes the device to assume the second compressed configuration.

12. The method of claim 6 wherein the lock defines a lumen and further comprising the step of passing a guidewire through the lumen.

13. The method of claim 12 further comprising the step of observing the sheath for bleeding after the retaining lock is seated and then removing the sheath and guidewire if no bleeding is observed.

14. The method of claim 1 wherein said manipulating step comprises pulling a flexible member coupled to the tissue engagement elements to bias the device towards the tissue.

15. The method of claim 1 wherein the device includes a covering extending between the tissue engaging elements.

16. The method of claim 15 wherein the covering comprises a therapeutic material and further comprising the step of eluting the therapeutic material.

17. The method of claim 1 wherein the opening in tissue comprises an external opening in a blood vessel.

18. The method of claim 17 wherein the opening comprises a vascular puncture wound.

19. The method of claim 1 wherein said passing step comprises passing the device while in a first one of the compressed configurations through a sheath extending through the opening in the proximal surface of the tissue.