Endovascular embolic device detachment detection method

• US 5,643,254 A
• Filed: 11/21/1995
• Issued: 07/01/1997
• Est. Priority Date: 03/03/1994
• Status: Expired due to Term

• Current Assignee: Stryker European Operations Holdings, LLC (Stryker Corporation)
• Original Assignee: Target Therapeutics, Inc. (Boston Scientific Corporation)
• Inventors: Schaller, Laurent B., Scheldrup, Ronald W.
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): HUANG, STEPHEN D
• Application Number:
  US08/561,169
• Time in Patent Office: 588 Days
• Field of Search: 204/114, 204/129.35, 204/111, 204/153.1, 205/103, 320/43, 604/286, 606/32, 606/191, 606/200
• US Class Current: 606/32
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00123 and automatic shutdown
• CPC Class Codes: A61B 2017/12063 electrolytically detachable

Abstract

This invention is a method for ensuring for endovascular occlusion through the formation of thrombi in arteries, veins, aneurysms, vascular malformations, and arteriovenous fistulas. In particular, it deals with a method to predictably determine the instant of electrolytic detachment of an embolic device which is introduced to and is intended to remain at the desired thrombus formation site. The invention further includes a method for delivering an embolic device and detecting its electrolytic separation.

Claims

1. A method for detecting electrolytic separation of an occlusion device comprising the steps of:

(a) providing a delivery member and an occlusion device coupled to the delivery member via a linking member;

(b) delivering the occlusion device to a desired site in a mammal via the delivery member;

(c) supplying DC power with a superposed AC signal to the linking member; and

(d) monitoring the superposed AC signal to detect a change in said signal.

2. The method of claim 1 wherein step (a) includes selecting the occlusion device to be a vasoocclusive coil.

3. The method of claim 2 wherein step (a) includes selecting the vasoocclusive coil to comprise a radiopaque physiologically compatible material.

4. The method of claim 3 wherein step (a) includes selecting the material from the group consisting of platinum, tungsten, gold, iridium and alloys thereof.

5. The method of claim 4 wherein steps (a) includes selecting the material to be platinum.

6. The method of claim 1 wherein step (c) includes selecting the DC power to provide a voltage in a range of about 0.1 to 6 volts.

7. The method of claim 1 wherein step (c) includes selecting the DC power to provide constant current in a range of about 0.1 to 10 milliamps.

8. The method of claim 1 wherein step (a) includes selecting the linking member to be stainless steel.

9. The method of claim 1 further including the step of interrupting the DC power supply to the linking member in response to detecting a sudden change in the superposed AC signal.

10. The method of claim 1 wherein the AC signal includes a voltage amplitude and step (d) comprises monitoring the voltage amplitude of the AC signal and further including the steps of averaging the monitored voltage amplitude over time to obtain an average monitored value and interrupting the DC power supply to the linking member when at least about a 20% change from the average monitored value is detected.

11. The method of claim 1 wherein step (c) includes providing a constant DC current with AC superposition to the linking member.

12. The method of claim 1 wherein step (a) includes selecting the linking member to have a conductivity that differs from that of the occlusion device.

13. The method of claim 1 wherein step (a) includes providing a linking member comprising stainless steel and the occlusion device to comprise a material selected from the group consisting of platinum, tungsten, gold, iridium and alloys thereof.

14. The method of claim 1 wherein step (a) includes selecting the delivery member to be a guidewire.

15. A method for detecting electrolytic separation of an occlusion device comprising the steps of:

(a) delivering an occlusion device, which is coupled to a delivery member via a linking member, to a desired site in a mammal via the delivery member;

(b) forming a circuit path including the linking member and occlusion device;

(c) supplying DC power with a superposed AC signal to said circuit path; and

(d) monitoring the AC impedance of said circuit path to detect a change in said impedance.

16. The method of claim 15 wherein said monitoring step includes monitoring the AC impedance of said circuit path to detect a change in said impedance indicative of separation between the occlusion device and linking member.

17. The method of claim 15 wherein the AC signal includes a voltage amplitude and step (d) comprises monitoring the voltage amplitude of the AC signal and further including the steps of averaging the monitored voltage amplitude over time to obtain an average monitored value and interrupting the DC power supply to the linking member when at least about a 20% change from the average monitored value is detected.

18. The method of claim 15 wherein the AC signal includes a voltage amplitude and said step (d) comprises monitoring the voltage amplitude of the AC signal and further including the step of interrupting the DC power supply to the linking member in response to detecting a predetermined change in the AC signal amplitude.

19. A method for detecting electrolytic separation of an occlusion device comprising the steps of:

(a) delivering an occlusion device, which is coupled to a delivery member via a linking member, to a desired site in a mammal via the delivery member;

(b) supplying DC power with a superposed AC signal to the linking member; and

(c) monitoring the superposed AC signal to detect a change therein indicative of separation between the occlusion device and delivery member.

20. The method of claim 19 wherein the AC signal includes a voltage amplitude and step (c) comprises monitoring the voltage amplitude of the AC signal and further including the step of interrupting the DC power supply to the linking member in response to detecting a predetermined change in the AC signal amplitude.

21. The method of claim 19 wherein the AC signal includes a voltage amplitude and step (d) comprises monitoring the voltage amplitude of the AC signal and further including the steps of averaging the monitored voltage amplitude over time to obtain an average monitored value and interrupting the DC power supply to the linking member when at least about a 20% change from the average monitored value is detected.