Methods and apparatus for hemostasis following arterial catheterization

• US 20040153060A1
• Filed: 07/10/2003
• Published: 08/05/2004
• Est. Priority Date: 02/04/2003
• Status: Active Grant

• Current Assignee: Cardiodex, Ltd.
• Original Assignee: Cardiodex, Ltd.
• Inventors: Eckhouse, Shimon, Lindenbaum, Hayim
• Granted Patent: US 7,223,266 B2
• Time in Patent Office: Days
• US Class Current: 606/49
• 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 18/08 by means of electrically-heated probes
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• 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 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00601 Implements entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00422 Angioplasty
• CPC Class Codes: A61B 2018/00589 Coagulation
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/00898 Alarms or notifications created in response to an abnormal condition

Abstract

A method for producing hemostasis of an artery of a patient having a puncture following arterial catheterization including introducing a hemostasis device including at least one electrode into the vicinity of the puncture, supplying an electric current to the at least one electrode, thereby heating blood in the vicinity of the puncture and causing coagulation of the blood and subsequently removing the hemostasis device from the patient.

Claims

1. A method for producing hemostasis of an artery of a patient having a puncture following arterial catheterization comprising:

introducing a hemostasis device comprising at least one electrode into the vicinity of said puncture;

supplying an electric current to said at least one electrode, thereby heating a volume of blood in the vicinity of said puncture, causing coagulation of said blood and causing closure of said puncture; and

subsequently removing said hemostasis device from the patient.

2. A method according to claim 1 and wherein said at least one electrode comprises a pair of electrodes.

3. A method according to claim 1 and wherein said introducing comprises introducing via a catheter introducer.

4. A method according to claim 1 and wherein said introducing also comprises inflating an anchor balloon attached to an end of said hemostasis device.

5. A method according to claim 1 and wherein said introducing also comprises inflating a peripheral balloon.

6. A method according to claim 5 and wherein said removing said hemostasis device comprises deflating said peripheral balloon.

7. A method according to claim 1 and wherein said introducing also comprises positioning said at least one electrode in close proximity to said volume of blood.

8. A method according to claim 1 and wherein said supplying comprises supplying electrical power at RF frequencies.

9. A method according to claim 8 and wherein said electrical power comprises electrical power in the range of 0.1-10 watts at up to 25 volts.

10. A method according to claim 1 and wherein said supplying also comprises adjusting said electric current based on a feedback measurement.

11. A hemostasis device comprising:

a main shaft;

at least one balloon; and

at least one electrode, operable to supply an electric current and to thereby heat a volume blood adjacent to said at least one electrode and to cause coagulation of said blood and closure of the puncture.

12. A hemostasis device according to claim 11 and wherein said at least one balloon comprises:

at least one anchor balloon, disposed at an end of said main shaft; and

at least one peripheral balloon, disposed at a location along said main shaft exterior to a wall of said main shaft.

13. A hemostasis device according to claim 12 and wherein said volume of blood is delimited by said peripheral balloon and a wall of said artery.

14. A hemostasis device according to claim 11 and also comprising an electrical power source and control module.

15. A hemostasis device according to claim 14 and wherein said electrical power source and control module comprises:

a power supply, operative to supply power to said at least one electrode;

feedback measurement means; and

a processor.

16. A hemostasis device according to claim 15 and wherein said power supply is an RF power supply.

17. A hemostasis device according to claim 16 and wherein said RF power supply is operative to supply electrical power at RF frequencies within a range of 0.1-10 watts at up to 25 volts.

18. A hemostasis device according to claim 15 and wherein said feedback measurement means is operative to measure at least one of electrical current, blood resistance and blood temperature.

19. A hemostasis device according to claim 15 and wherein said processor is operative to adjust said power based on an output from said feedback measurement means.

20. A hemostasis device according to claim 11 and wherein said at least one electrode comprises a pair of electrodes.

21. A method for producing hemostasis of an artery of a patient having a puncture following arterial catheterization comprising:

introducing a hemostasis device comprising at least one electrode into the vicinity of said puncture;

positioning said at least one electrode in proximity with said puncture;

supplying an electric current to said at least one electrode, thereby heating a volume of blood in the vicinity of said puncture, causing coagulation of said blood and causing closure of said puncture; and

subsequently removing said hemostasis device from the patient.

22. A method according to claim 21 and wherein said positioning comprises:

inflating an anchor balloon attached to an end of said hemostasis device;

inflating a peripheral balloon; and

subsequently deflating said anchor balloon.

23. A method according to claim 22 and wherein said volume of blood is delimited by said peripheral balloon and a wall of said artery.

24. A method according to claim 21 and wherein said at least one electrode comprises a pair of electrodes.

25. A method according to claim 21 and wherein said supplying comprises supplying electrical power at RF frequencies.

26. A method according to claim 25 and wherein said electrical power comprises electrical power in the range of 0.1-10 watts at up to 25 volts.

27. A method according to claim 21 and wherein said supplying also comprises adjusting said electric current based on a feedback measurement.