Apparatus and methods for closing vascular penetrations

• US 20040176758A1
• Filed: 03/03/2004
• Published: 09/09/2004
• 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
• Granted Patent: US 7,322,976 B2
• Time in Patent Office: Days
• US Class Current: 606/32
• 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. Apparatus for sealing a blood vessel penetration disposed at the end of a tissue tract, said apparatus comprising:

a shaft having a proximal end and a distal tip, said shaft being configured to advance through the tissue tract;

a locator on the shaft for positioning the distal tip a predetermined proximal distance from the blood vessel penetration; and

means at the distal tip of the shaft for inducing plugging in a blood pool located in the tissue tract distally of the distal tip when the tip is positioned by the locator.

2. Apparatus as in claim 1, wherein the predetermined distance is in the range from 1.25 mm to 6.35 mm.

3. Apparatus as in claim 1, further comprising an anchor on the shaft, wherein the anchor is deployable to retain the shaft at the position determined by the locator after the locator has been withdrawn.

4. Apparatus as in claim 1, wherein the locator comprises an expandable element which is deployable within the blood vessel lumen so that the distal tip is positioned by pulling back the shaft to engage the locator against an inside wall of the blood vessel.

5. Apparatus as in claim 4, wherein the expandable element comprises a wire which is straightened when constrained in the shaft and which expands when advanced into the blood vessel lumen.

6. Apparatus as in claim 5, wherein the wire forms a planar coil disposed perpendicularly to the axis of the shaft when advanced from the shaft.

7. Apparatus as in claim 4, wherein the anchor comprises a surface which engages skin surrounding an opening to the tissue tract, wherein the surface can be selectively attached to the shaft after the shaft has been located.

8. Apparatus as in claim 3, wherein the anchor comprises tissue-penetrating elements which are laterally advanceable from the shaft into a side wall of the tissue tract after the shaft has been located.

9. Apparatus as in claim 1, wherein the plug inducing means comprises an electrode, a heated surface, a fiberoptic waveguide, or an ultrasonic transducer.

10. 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 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.

11. A method as in claim 10, 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.

12. A method as in claim 11, wherein deploying the locator comprises expanding an expandable element attached to the device in the blood vessel lumen.

13. A method as in claim 12, 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.

14. A method as in claim 13, wherein the expanded configuration is a planar coil disposed perpendicularly to an axis of the sealing device.

15. A method as in claim 10, further comprising anchoring the sealing device in the tissue tract after it has been positioned.

16. A method as in claim 15, wherein anchoring comprises fixing the sealing device to a surface engaged against skin surrounding the tissue tract.

17. A method as in claim 15, wherein anchoring comprises penetrating elements from the sealing device into the tissue surrounding the tissue tract.

18. A method as in any of claim 15, further comprising removing the locator after the anchor has been deployed.

19. A method as in claim 18, wherein the locator is removed prior to inducing clotting.

20. A method as in claim 18, wherein the locator is removed after inducing clotting.

21. A method as in claim 10, wherein inducing clotting comprises directing energy at the pool of blood.

22. A method as in claim 21, wherein the energy is selected from the group consisting of heat, radiofrequency, ultrasound, and laser.

23. A method as in claim 10, wherein inducing clotting comprises releasing a clotting factor into the blood pool.