Cochlear prosthesis test system

• US 4,522,209 A
• Filed: 04/11/1983
• Issued: 06/11/1985
• Est. Priority Date: 04/11/1983
• Status: Expired due to Term

• Current Assignee: Commonwealth of Australia
• Original Assignee: Commonwealth of Australia
• Inventors: Patrick, James F., Money, David K., Kuzma, Janusz A., Crosby, Peter A.
• Primary Examiner(s): Cohen, Lee S.
• Assistant Examiner(s): Falk, Steven
• Application Number:
  US06/483,862
• Time in Patent Office: 792 Days
• Field of Search: 128/419 P, 128/419 R, 128/419 PT, 128/303.1, 128/783-786, 128/419 F, 128/419 B, 206/328, 206/363, 206/438, 179/107 R, 179/107 E, 179/107 BC
• US Class Current: 607/57
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61N 1/37 Monitoring; Protecting
• CPC Class Codes: A61N 2001/37294 Means for testing medical devices within the package prior to implantation

Abstract

A test system for a sealed, sterile package containing a cochlear prosthesis electrode. A light-emitting diode has its two leads in contact with at least two different conducting bands on the electrode. The prosthesis, which is externally-powered, is operated so as to supply a stimulus current between the two bands. If the light-emitting diode is illuminated, proper operation of the prosthesis can be verified without unsealing the package.

Claims

1. A test system comprising a sealed sterile package, said package containing a medical device whose proper operation is to be verified prior to opening of the package;

means in said package, not forming part of said medical device, for indicating the status of said medical device when said medical device is operated;

means for connecting said indicating means to said medical device; and

means for enabling operation of said medical device while it is in said package prior to the opening thereof.

2. A test system in accordance with claim 1 wherein said indicating means generates a light signal and said package is sufficiently transparent in the vicinity of said indicating means to permit viewing thereof while said package is still sealed.

3. A test system in accordance with claim 2 wherein said indicating means is powered from said medical device.

4. A test system in accordance with claim 3 wherein said medical device is normally powered from a disconnected source by means of electromagnetic radiation coupled thereto, and said package allows the transmission therethrough of electromagnetic radiation for powering said medical device.

5. A test system in accordance with claim 4 wherein said medical device is a tissue-stimulating prosthesis.

6. A test system in accordance with claim 4 wherein said connecting means includes a support member having at least three grooves disposed on the exterior thereof, said medical device being contained in the first of said grooves, said indicating means having a pair of wires each contained in a respective one of the second and third grooves, and a pair of means extended through said support member each for contacting both said medical device in said first groove and a wire in a respective one of said second and third grooves.

7. A test system in accordance with claim 6 further including an elastic tube surrounding said support member for applying pressure to said medical device and said pair of wires in their respective grooves, whereby electrical contact is maintained between said medical device and both of said contacting means and between each of said wires and its respective contacting means.

8. A test system in accordance with claim 7 wherein said support member has a fourth groove surrounded by said elastic tube which facilitates cutting of said elastic tube remote from said medical device and removal of said medical device from said support member.

9. A test system in accordance with claim 7 wherein said package includes a tray and said tube is glued to said tray.

10. A test system in accordance with claim 6 wherein each of said contacting means is made of a biocompatible metal.

11. A test system in accordance with claim 6 wherein said medical device is a cochlear prosthesis with an electrode array having a plurality of conducting bands therearound, and each of said contacting means contacts at least one conducting band which is not contacted by the other contacting means.

12. A test system in accordance with claim 1 wherein said indicating means is powered from said medical device.

13. A test system in accordance with claim 12 wherein said medical device is normally powered from a disconnected source by means of electromagnetic radiation coupled thereto, and said package allows the transmission therethrough of electromagnetic radiation for powering said medical device.

14. A test system in accordance with claim 1 wherein said medical device is a tissue-stimulating prosthesis.

15. A test system in accordance with claim 1 wherein said connecting means includes a support member having at least three grooves disposed on the exterior thereof, said medical device being contained in the first of said grooves, said indicating means having a pair of wires each contained in a respective one of the second and third grooves, and a pair of means extended through said support member each for contacting both said medical device in said first groove and a wire in a respective one of said second and third grooves.

16. A test system in accordance with claim 15 further including an elastic tube surrounding said support member for applying pressure to said medical device and said pair of wires in their respective grooves, whereby electrical contact is maintained between said medical device and both of said contacting means and between each of said wires and its respective contacting means.

17. A test system in accordance with claim 16 wherein said support member has a fourth groove surrounded by said elastic tube which facilitates cutting of said elastic tube remote from said medical device and removal of said medical device from said support member.

18. A test system in accordance with claim 16 wherein said package includes a tray and said tube is glued to said tray.

19. A test system in accordance with claim 15 wherein each of said contacting means is made of a biocompatible metal.

20. A test system in accordance with claim 15 wherein said medical device is a cochlear prosthesis with an electrode array having a plurality of conducting bands therearound, and each of said contacting means contacts at least one conducting band which is not contacted by the other contacting means.