Methods and apparatus for hemostasis following arterial catheterization

• US 8,372,072 B2
• Filed: 11/22/2011
• Issued: 02/12/2013
• Est. Priority Date: 02/04/2003
• Status: Expired due to Fees

• Current Assignee: Cardiodex, Ltd.
• Original Assignee: Cardiodex, Ltd.
• Inventors: Lindenbaum, Hayim, Eckhouse, Shimon
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): GOOD, SAMANTHA M
• Application Number:
  US13/302,662
• Publication Number:
  US 20120065637A1
• Time in Patent Office: 448 Days
• Field of Search: 606/27, 606 40- 41, 606 49- 50, 606/192, 606/194, 606/213, 604 9601-104
• 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 into a vicinity of the puncture, the hemostasis device comprising;

a main shaft;

an expandable member disposed on the main shaft; and

at least one electrode coupled to the main shaft;

expanding the expandable member to form a region delimited by engagement of the expandable member against an outside of an artery wall;

allowing a limited volume of blood to collect outside the artery wall and within the region;

supplying an electric current to said at least one electrode, thereby heating the region causing coagulation of the limited volume of blood in the region 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 4, further comprising deflating the anchor balloon.

6. A method according to claim 1 and wherein said removing of said hemostasis device comprises deflating said expandable member.

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

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 feedback measurement.

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

introducing a hemostasis device into a vicinity of the puncture, the hemostasis device comprising;

a main shaft;

an expandable member disposed on the main shaft; and

at least one electrode coupled to the main shaft;

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

expanding the expandable member to form a region delimited by engagement of the expandable member against an outside of an artery wall;

allowing a limited volume of blood to collect outside the artery wall and within the region;

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

subsequently removing said hemostasis device from the patient.

12. A method according to claim 11 and wherein said positioning comprises:

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

and subsequently deflating said anchor balloon.

13. A method according to claim 11 and wherein said at least one electrode comprises a pair of electrodes.

14. A method according to claim 11 and wherein said supplying comprises supplying electrical power at RF frequencies.

15. A method according to claim 14 and wherein said electrical power comprises electrical power in the range of 0.1-10 watts at up to 25 volts.

16. A method according to claim 11 and wherein said supplying also comprises adjusting said electric current based on a feedback measurement.