Apparatus and methods for closing vascular penetrations

• US 7,322,976 B2
• Filed: 03/03/2004
• Issued: 01/29/2008
• Est. Priority Date: 03/04/2003
• Status: Active Grant

• Current Assignee: Cardiva Medical, Inc. (Haemonetics Corporation)
• Original Assignee: Cardiva Medical, Inc. (Haemonetics Corporation)
• Inventors: Yassinzadeh, Zia
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US10/795,019
• Publication Number:
  US 20040176758A1
• Time in Patent Office: 1,427 Days
• Field of Search: 606/50, 606/34, 606/37, 606/40, 606/41, 606/43, 606/49, 606/46, 128/898, 128/662.05, 128/662.06
• US Class Current: 606/50
• 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 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00672 Locating means therefor, e.g. bleed back lumen
• CPC Class Codes: A61B 2018/00273 Anchoring means for temporary attachment of a device to tissue
• CPC Class Codes: A61B 2018/0063 Sealing

Abstract

Apparatus for sealing vascular penetrations comprise a shaft having an electrode or other energy-applying element at a distal end. The shaft is placed in a tissue tract over a blood vessel penetration and located using a locator which engages an inner wall of the blood vessel. Once in position, an anchor is used to hold the shaft, allowing the locator to be removed. Energy is then applied through a distal tip of the shaft in order to induce desiccation and plug formation in a blood pool formed between the distal end of the shaft and the wall of the blood vessel.

Claims

1. A method for sealing a blood vessel penetration disposed at a distal end of a tissue tract, said method comprising:

introducing a sealing device through the tissue tract;

positioning a distal tip of the device within the tissue tract at a predetermined distance proximal to the distal end of the tissue tract to form a clotting region between the distal tip of the device and the distal end of the tissue tract;

inducing clotting in a blood pool located in the clotting region to form a plug; and

withdrawing the device proximally from the tissue tract while leaving the clot intact.

2. A method as in claim 1, wherein positioning comprises deploying a locator in a lumen of the blood vessel and pulling back on the device to engage the locator against an inner wall of the blood vessel.

3. A method as in claim 2, wherein deploying the locator comprises expanding an expandable element attached to the device in the blood vessel lumen.

4. A method as in claim 3, wherein expanding the expandable element comprises advancing a wire distally from the device into the lumen, wherein the wire is pre-shaped to assume the expanded configuration as it is advanced.

5. A method as in claim 4, wherein the expanded configuration is a planar coil disposed perpendicularly to an axis of the sealing device.

6. A method as in claim 1, further comprising anchoring the sealing device in the tissue tract after it has been positioned.

7. A method as in claim 6, wherein anchoring comprises fixing the sealing device to a surface engaged against skin surrounding the tissue tract.

8. A method as in claim 6, wherein anchoring comprises penetrating elements from the sealing device into the tissue surrounding the tissue tract.

9. A method as in claim 6, further comprising removing the locator after the anchor has been deployed.

10. A method as in claim 9, wherein the locator is removed prior to inducing clotting.

11. A method as in claim 9, wherein the locator is removed after inducing clotting.

12. A method as in claim 1, wherein inducing doffing comprises directing energy at the pool of blood.

13. A method as in claim 12, wherein the energy is selected from the group consisting of heat, radiofrequency, ultrasound, and laser.

14. A method as in claim 1, wherein inducing clotting comprises releasing a clotting factor into the blood pool.