Long term wear electrode for defibrillation system

• US 6,546,285 B1
• Filed: 08/31/2000
• Issued: 04/08/2003
• Est. Priority Date: 03/07/1997
• Status: Expired due to Term

• Current Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Original Assignee: Cardiac Science Operating Company (Cardica Incorporated)
• Inventors: Owen, James M., Totman, Mark H., Fincke, Randall W., OʼLeary, James P.
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US09/652,054
• Time in Patent Office: 950 Days
• Field of Search: 607/5, 607/6, 607/8, 607/142, 607/153
• US Class Current: 607/5
• CPC Class Codes: A61N 1/0452 Specially adapted for transcutaneous muscle stimulation [TMS]
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/046 Specially adapted for shock therapy, e.g. defibrillation
• CPC Class Codes: A61N 1/0468 Specially adapted for promoting wound healing
• CPC Class Codes: A61N 1/0472 Structure-related aspects
• CPC Class Codes: A61N 1/0476 Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/0496 characterised by using specific chemical compositions, e.g. hydrogel compositions, adhesives
• CPC Class Codes: A61N 1/3904 External heart defibrillators [EHD]
• CPC Class Codes: A61N 1/3918 characterised by shock pathway, e.g. by electrode configuration
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting
• CPC Class Codes: A61N 1/3937 Monitoring output parameters
• CPC Class Codes: A61N 1/3987 characterised by the timing or triggering of the shock
• CPC Class Codes: A61N 1/3993 User interfaces for automatic external defibrillators

Abstract

A method of treating a patient for ventricular tachycardia using a wearable defibrillator includes monitoring the patient for a predetermined condition via one or more electrodes on the defibrillator, sending a message to the patient in response to the predetermined condition, activating the defibrillator so that the defibrillator delivers defibrillation energy to the patient, and storing at least one of the results of the monitoring, sending and activating steps in a memory on the defibrillator. The method also includes downloading information stored in the memory of the defibrillator to a base station having an external interface, and transmitting the information downloaded from the memory of the base station to an external location via the external interface of the base station.

Claims

1. A wearable defibrillator adapted to deliver defibrillation energy to a patient, the wearable defibrillator comprising:

at least one electrode having a conductive surface in contact with the patient'"'"'s skin, the at least one electrode being adapted for long-term wear on the patient;

wherein the at least one electrode includes electrically-conductive hydrogel at a surface thereof with contacts to the patient'"'"'s skin, the electrically-conductive hydrogel having a predetermined ion concentration; and

wherein the electrically-conductive hydrogel includes a therapeutic agent which promotes skin health.

2. A wearable defibrillator according to claim 1, wherein the at least one electrode comprises one or more of the following types of electrodes:

a segmented electrode, a low-surface area electrode, a traditional defibrillation electrode, and a subcutaneous electrode.

3. A wearable defibrillator according to claim 1, wherein the at least one electrode is wearable for a period of greater than one week.

4. A wearable defibrillator according to claim 1, wherein the at least one electrode includes a mesh at a surface thereof which contacts to the patient'"'"'s skin.

5. A wearable defibrillator according to claim 1, wherein the at least one electrode is periodically movable to different positions on the patient.

6. A wearable defibrillator according to claim 1, wherein the at least one electrode is wearable for a period of greater than a day.

7. A wearable defibrillator according to claim 1, wherein the at least one electrode is wearable for a period of 2-7 days.

8. A wearable defibrillator adapted to deliver defibrillation energy to a patient, the wearable defibrillator comprising:

at least one electrode having a conductive surface in contact with the patient'"'"'s skin, the at least one electrode being adapted for long-term wear on the patient, wherein said conductive surface is a material selected from the group consisting of moisturizers, emollients, protective agents and antibacterial agents.

9. A wearable defibrillator adapted to deliver defibrillation energy to a patient, the wearable defibrillator comprising:

at least one electrode having a conductive surface in contact with the patient'"'"'s skin, the at least one electrode being adapted for long-term wear on the patient, said at least one electrode including an adhesive portion adapted to hold said at least one electrode with said conductive surface in contact with the skin of the patient;

wherein said portion includes an adhesive layer selected to minimize irritation of the skin, and includes a high moisture vapor transmission material.

10. A wearable defibrillator according to claim 9 wherein said material has a moisture vapor transmission rate of approximately 300 to 1500 g/m²/day.

11. A wearable defibrillator according to claim 9 wherein said adhesive has a peel strength of less than approximately 500 g/cm.

12. A wearable defibrillator according to claim 9 wherein said conductive surface is made of a material having a low salt concentration.

13. A wearable defibrillator comprising:

at least one electrode having a conductive surface in contact with the patient'"'"'s skin, the at least one electrode being adapted for long-term wear on the patient, said at least one electrode including an adhesive portion adapted to hold said at least one electrode with said conductive surface in contact with the skin of the patient; and

a monitor adapted to sense the environment at the interface between said one electrode and the skin of the patient.

14. A wearable defibrillator according to claim 13 wherein said monitor comprises a pH monitor adapted to sense and adjust the pH at said interface to maintain said interface neutral.

15. A wearable defibrillator according to claim 13 wherein said monitor comprises an ion flow control monitor adapted to minimize the ion flow at said interface, except during the application of a therapeutic pulse.

16. A wearable defibrillator adapted to deliver defibrillation energy to a patient, the wearable defibrillator comprising:

at least one electrode having a conductive surface in continuous contact with the patient'"'"'s skin after said one electrode is attached to the patient'"'"'s skin, the at least one electrode being adapted for long-term wear on the patient;

wherein said conductive surface is continuously coated with an electrically-conductive hydrogel,

wherein the electrically-conductive hydrogel includes a therapeutic agent which promotes skin health.

17. A wearable defibrillator according to claim 16, wherein the at least one electrode comprises one or more of the following types of electrodes:

a segmented electrode, a low-surface area electrode, a traditional defibrillation electrode, and a subcutaneous electrode.

18. A wearable defibrillator according to claim 16, wherein the at least one electrode is wearable for a period of greater than one week.

19. A wearable defibrillator according to claim 16, wherein the at least one electrode includes a mesh at a surface thereof which contacts to the patient'"'"'s skin.

20. A wearable defibrillator according to claim 16, wherein the at least one electrode is periodically movable to different positions on the patient.

21. A wearable defibrillator according to claim 16, wherein the at least one electrode is wearable for a period of greater than a day.

22. A wearable defibrillator according to claim 16, wherein the at least one electrode is wearable for a period of 2-7 days.