Protection apparatus for implantable medical device

• US 20070005111A1
• Filed: 09/08/2006
• Published: 01/04/2007
• Est. Priority Date: 04/26/2001
• Status: Active Grant

• Current Assignee: Alfred E. Mann Foundation For Scientific Research
• Original Assignee: Alfred E. Mann Foundation For Scientific Research
• Inventors: Chu, Lung-Hsi, Schulman, Joseph, Mandell, Lee, Nelson, Richard, Firth, Robert, Vogel, Martin, Vogel, Adam, Falco, Anthony
• Granted Patent: US 7,670,363 B2
• Time in Patent Office: Days
• US Class Current: 607/1
• CPC Class Codes: A61N 1/14 Leading-off electric charges, e.g. by earthing carrying-off electrostatic charges, in general H05F3/00
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 2001/37294 Means for testing medical devices within the package prior to implantation
• CPC Class Codes: H05K 3/301 by means of a mounting structure H05K3/325 takes precedence
• CPC Class Codes: H05K 3/325 by abutting or pinching, i.e. without alloying process; mechanical auxiliary parts therefor adaptations of leads inserted in holes for press-fit connections H05K3/308

Abstract

A method and apparatus for protecting an electronic implantable medical device prior to it being implanted in a patient'"'"'s body. The apparatus affords protection against electronic component damage due to electrostatic discharge and/or physical damage due to improper handling. The apparatus is comprised of a circuit board having conductive surface means for receiving and releasably grasping the electrodes of the medical device to support the device'"'"'s housing proximate to the surface of the circuit board. First and second conductive paths are formed on the circuit board extending between the first and second conductive surfaces for shunting electrostatic discharge currents to prevent such currents from passing through the device'"'"'s electronic circuitry. The respective shunt paths include oppositely oriented diodes, preferably comprising diodes which emit light (i.e., LEDs) when current passes therethrough. Additionally, means are provided to enable functional testing of the medical device.

Claims

1. In combination with a medical device configured to be implanted in a patient'"'"'s body and an external monitor/generator for functionally testing the medical device, the medical device including a housing containing electronic circuitry having output and input capability connected to first and second electrodes extending exteriorly from the housing, an apparatus for use with the medical device prior to it being implanted, said apparatus comprising:

a dielectric substrate carrying spaced first and second connective surfaces, each of said connective surfaces being configured to electrically contact one of the electrodes of the medical device;

at least one connection element comprising at least one O-ring for retaining the first and second electrodes of the medical device in physical and electrical contact with said first and second connective surfaces;

a test/protection circuit carried by said substrate electrically connected between said first and second connective surfaces, wherein said test/protection circuit is selected from the group of;

(a) a current loop suitable for inductively radiating a variable magnetic field corresponding to current flowing between the first and second electrodes of the medical device, wherein said magnetic field is detectable by the external monitor/generator to thereby functionally test the output capability of the electronic circuitry of the medical device;

(b) at least one diode to emit light corresponding to current flowing between the first and second electrodes of the medical device, wherein the light is detectable by the external monitor generator to thereby functionally test the output capability of the electronic circuitry medical device;

(c) a current loop suitable for inductively receiving a variable magnetic field generated by the external monitor/generator to thereby functionally test the input capability of the electronic circuitry of the medical device; and

(d) oppositely directed first and second diodes to thereby serve to protect the medical device from electrostatic discharge prior to implantation;

and wherein said apparatus is configured to be separated from the medical device before implantation.

2. The apparatus of claim 1 wherein said at least one connection element comprises first and second conductive clips mounted on said dielectric substrate for capturing and retaining the first and second electrodes of the medical device.

3. The apparatus of claim 1 wherein said at least one O-ring is formed of medical grade silicone.

4. The apparatus of claim 1 wherein said at least one connection element comprises a single O-ring and said dielectric substrate comprises a circuit board that includes a pair of retaining lips for capturing the single O-ring and wherein the medical device is retainable between the single O-ring and said circuit board.

5. The apparatus of claim 1 wherein said dielectric substrate is a circuit board is formed of polyimide.

6. The apparatus of claim 1 wherein said diode is a photodiode suitable for emitting nonvisual light in response to current therethrough.

7. The apparatus of claim 1 wherein said dielectric substrate has a substrate cutout surrounded by said current loop to enable an externally provided inductive pickup loop to pass through said cutout.

8. The apparatus of claim 7 additionally comprising a sterilization pouch wherein said sterilization pouch includes a pouch cutout conforming to said substrate cutout to enable an externally provided inductive pickup loop to pass through said substrate and pouch cutouts.

9. The apparatus of claim 1 additionally comprising selection means for selecting and/or deselecting a desired test/protection circuit.

10. The apparatus of claim 1 wherein said first and second connective surfaces are formed to minimize eddy currents.

11. The apparatus of claim 10 wherein said first and second connective surfaces are comb-shaped.

12. The apparatus of claim 10 wherein said first and second connective surfaces are formed from serpentine paths.

13. A method of functionally testing an implantable medical device prior to implantation, the device comprising a housing containing electronic circuitry connected between first and second electrodes extending exteriorly from the housing, said method comprising:

providing first and second contacts on a substrate for electrically contacting the first and second electrodes;

providing at least one connection element for retaining the first and second electrodes of the medical device in physical and electrical contact with said first and second contacts;

providing a current loop path between said first and second contacts suitable for emitting a remotely detectable signal corresponding to current flowing between the first and second electrodes of the medical device; and

wherein

said apparatus is configured to be separated from the medical device before implantation.

14. The method of claim 13 wherein the step of providing a current loop path between said first and second contacts is selected from the group of:

(a) providing a current loop between said first and second contacts suitable for inductively radiating a variable magnetic field corresponding to current flowing between the first and second electrodes of the medical device, wherein said magnetic field is detectable by an external monitor/generator to thereby functionally test the output capability of the electronic circuitry of the medical device;

(b) providing at least one diode electrically connected between said first and second contacts to emit light corresponding to current flowing between the first and second electrodes of the medical device, wherein the light is detectable by an external monitor generator to thereby functionally test the output capability of the electronic circuitry medical device; and

(c) providing a receiving current loop between said first and second contacts suitable for inductively receiving a variable magnetic field generated by an external monitor/generator to thereby functionally test the input capability of the electronic circuitry of the medical device.

15. The method of claim 13 further including the steps of:

providing a sterilization pouch;

placing the device within the sterilization pouch; and

sterilizing the device while in said sterilization pouch.

16. The method of claim 15 further including the steps of:

forming said current loop path on said substrate having an inner cutout;

providing a sterilization pouch having an outer cutout conforming to said inner cutout;

placing the device within the sterilization pouch;

wherein said conforming inner and outer cutouts enable an externally provided inductive pickup loop to pass therein and provide a signal to an externally provided monitor; and

sterilizing the device while in said sterilization pouch.

17. The method of claim 13 further including:

applying an activation signal to the device while in said shipping container; and

monitoring the emissions corresponding to the medical device in response to the application of said activation signal wherein the monitoring step is selected from the group of;

monitoring inductively coupled magnetic emissions;

monitoring visual light emissions;

monitoring nonvisual light emissions;

monitoring electrostatic emissions;

monitoring electromagnetic emissions; and

monitoring capacitive changes.

18. The method of claim 17 wherein said step of applying an activation signal comprises providing wireless communicating energy to the electronic circuitry in the housing.

19. The method of claim 17 wherein said step of monitoring the emissions in response to the application of said activation signal comprises use of a negative capacity preamp to pick up a signal from the medical device.

20. The method of claim 13 wherein the step of providing first and second contacts includes forming said contacts to minimize eddy currents.

21. The method of claim 20 wherein the step of forming said contacts to minimize eddy currents comprises forming said contacts in a comb-shaped manner.

22. The method of claim 20 wherein the step of forming said contacts to minimize eddy currents comprises forming said contacts in a serpentine manner.