Methods and apparatus for hemostasis following arterial catheterization

• US 7,223,266 B2
• Filed: 07/10/2003
• Issued: 05/29/2007
• Est. Priority Date: 02/04/2003
• Status: Expired due to Fees

• Current Assignee: Cardiodex, Ltd.
• Original Assignee: Cardiodex, Ltd.
• Inventors: Eckhouse, Shimon, Lindenbaum, Hayim
• Primary Examiner(s): Gibson; Roy D.
• Assistant Examiner(s): VRETTAKOS, PETER J
• Application Number:
  US10/616,887
• Publication Number:
  US 20040153060A1
• Time in Patent Office: 1,419 Days
• Field of Search: 606 27- 52, 606/213
• 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 hemostasis device for closing a puncture in an artery wall, comprising:

a main shaft;

at least one expandable member disposed on the main shaft, wherein the expandable member in one configuration is adapted to delimit a blood coagulation volume by the engagement of the expandable member against an outside of an artery wall; and

at least one electrode, operable to supply an electric current, coupled to the main shaft in the vicinity of the blood coagulation volume, wherein upon activation of the electrode, the electrode is adapted to cause blood disposed in the blood coagulation volume to coagulate thereby causing a closure of the puncture.

2. A hemostasis device according to claim 1 and wherein the at least one expandable member comprises:

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

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

3. A hemostasis device according to claim 2 and wherein the blood coagulation volume is delimited by the peripheral balloon and the artery wall.

4. A hemostasis device according to claim 1 and also comprising an electrical power source and control module connected to the electrode.

5. A hemostasis device according to claim 4 and wherein the electrical power source and control module comprises:

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

feedback measurement means for supplying feedback measurements; and

a processor.

6. A hemostasis device according to claim 5 and wherein the power supply is an RF power supply.

7. A hemostasis device according to claim 6 and wherein the 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.

8. A hemostasis device according to claim 5 and wherein the feedback measurement means is operative to measure at least one of electrical current, blood resistance end blood temperature.

9. A hemostasis device according to claim 5 and wherein the processor is operative to adjust the power based on an output from the feedback measurement means.

10. A hemostasis device according to claim 1 and wherein the at least one electrode is disposed at a distal end of the device.

11. A hemostasis device according to claim 1, where the electrode is disposed at a distal tip of the main shaft.