Protection apparatus for implantable medical device

• US 20030195566A1
• Filed: 04/18/2003
• Published: 10/16/2003
• 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: Schulman, Joseph H., Mandell, Lee J., Nelson, Richard J., Vogel, Martin J., Falco, Anthony D., Firth, Robert A., Chu, Lung-Hsi
• Granted Patent: US 7,108,711 B2
• Time in Patent Office: Days
• US Class Current: 607/2
• 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 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. An apparatus for physically and electrically protecting an electronic medical device having first and second electrodes prior to it being implanted in a patient'"'"'s body, said apparatus comprising:

first and second connective surfaces for respectively electrically contacting the first and second electrodes on the medical device;

at least one elastic element for retaining the first and second electrodes of the medical device in physical and electrical contact with said first and second connective surfaces;

first and second circuit paths connected between said first and second connective surfaces, said first and second circuit paths respectively including oppositely oriented first and second unidirectional current devices 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 further including:

a circuit board;

said connective surfaces being formed on said circuit board for contacting the electrodes and supporting the medical device; and

wherein

said first and second circuit paths are formed on said circuit board.

3. The apparatus of claim 2 wherein said circuit board is formed of polyimide.

4. The apparatus of claim 1 wherein said first and second unidirectional current devices comprise light emitting diodes.

5. The apparatus of claim 1 additionally comprising:

a protection network electrically connected across said first and second connective surfaces to suppress electrostatic discharge; and

wherein

said protection network comprises a pair of unidirectional current devices serially connected in opposing polarities.

6. The apparatus of claim 1 additionally comprising a photodiode coupled between said first and second connective surfaces for emitting radiation capable of being remotely sensed corresponding to current flow between the first and second electrodes of the medical device.

7. The apparatus of claim 1 additionally comprising a current loop coupled between said first and second connective surfaces for inductively emitting a field capable of being remotely sensed corresponding to current flow between the first and second electrodes of the medical device.

8. The apparatus of claim 1 wherein said at least one elastic element comprises an O-ring.

9. The apparatus of claim 8 wherein said O-ring is formed of medical grade silicone.

10. The apparatus of claim 1 wherein said at least one elastic element comprises a single O-ring.

11. The apparatus of claim 10 further comprising:

a circuit board, wherein said circuit board includes a pair of retaining lips for capturing said single O-ring; and

wherein

said medical device is retainable between said O-ring and said circuit board.

12. In combination with a medical device configured to be implanted in a patient'"'"'s body, the device including a housing containing electronic circuitry 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 elastic element for retaining the first and second electrodes of the medical device in physical and electrical contact with said first and second connective surfaces;

a first shunt circuit carried by said substrate electrically connected between said first and second connective surfaces;

a second shunt circuit carried by said substrate electrically connected between said first and second connective surfaces;

wherein

said first and second shunt circuits respectively include oppositely directed first and second diodes to thereby serve to protect the medical device from electrostatic discharge prior to implantation 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.

13. The apparatus of claim 12 wherein said dielectric substrate is a circuit board is formed of polyimide.

14. The apparatus of claim 12 wherein said first and second diodes each include means for emitting light in response to current therethrough.

15. The apparatus of claim 14 further including an external monitor for externally sensing the response of said diodes to an externally provided activation signal supplied to the electronic circuitry.

16. The apparatus of claim 15 wherein said externally provided activation signal is wirelessly supplied to the electronic circuitry within the medical device.

17. The apparatus of claim 14 additionally comprising:

a shipping container defining a transparent window; and

wherein

said apparatus is accommodated in said shipping container with said diodes visible through said window.

18. The apparatus of claim 12 additionally comprising:

a protection network electrically connected across said first and second connective surfaces to suppress electrostatic discharge; and

wherein

said protection network comprises a pair of unidirectional current devices serially connected in opposing polarities.

19. The apparatus of claim 12 additionally comprising a photodiode coupled between said first and second connective surfaces for emitting radiation capable of being remotely sensed corresponding to current flow between the first and second electrodes of the medical device.

20. The apparatus of claim 12 additionally comprising a current loop coupled between said first and second connective surfaces for inductively emitting a field capable of being remotely sensed corresponding to current flow between the first and second electrodes of the medical device.

21. The apparatus of claim 12 wherein said dielectric substrate includes a cutout located within said current loop to enable an externally provided inductive pickup loop to pass through said current loop and to inductively pick up a signal corresponding to current flow between the first and second electrodes of the medical device.

22. The apparatus of claim 12 wherein said at least one elastic element comprises an O-ring.

23. The apparatus of claim 22 wherein said O-ring is formed of medical grade silicone.

24. The apparatus of claim 12 wherein said at least one elastic element comprises a single O-ring.

25. The apparatus of claim 24 wherein said dielectric substrate is a circuit-board that includes a pair of retaining lips for capturing said single O-ring and wherein the medical device is retainable between said O-ring and said circuit board.

26. A method of protecting 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 for electrically contacting the first and second electrodes;

providing at least one elastic 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 first shunt path between said first and second contacts including a first current device oriented to permit current therethrough only from said first to said second contact; and

providing a second shunt path between said first and second contacts including a second current device oriented to permit current therethrough only from said second to said first contact, whereby said first and second shunt paths serve to protect the medical device from electrostatic discharge prior to implantation 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.

27. The method of claim 26 additionally comprising the steps of:

providing a substantially rigid substrate for supporting said first and second contacts, said first shunt path, and said second shunt path; and

configuring said first and second contacts for physically retaining the housing relative to said substrate.

28. The method of claim 26 additionally comprising the step of providing an indicator in at least one of said shunt paths to indicate current therethrough.

29. The method of claim 26 additionally comprising the steps of:

emitting light in said first shunt path to indicate current therethrough; and

emitting light in said second shunt path to indicate current therethrough.

30. The method of claim 29 further including:

providing a shipping container defining a transparent window; and

placing the device in said shipping container oriented so that light emissions from said first and second shunt paths are visible through said window.

31. The method of claim 30 further including sterilizing the device while in said shipping container.

32. The method of claim 30 further including:

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

monitoring the light emissions from said shunt paths in response to the application of said activation signal.

33. The method of claim 32 wherein said step of applying an activation signal comprises providing wirelessly communicating energy to the electronic circuitry in the housing.

34. 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 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.

35. The apparatus of claim 34 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.

36. The apparatus of claim 34 wherein said at least one connection element comprises an O-ring.

37. The apparatus of claim 36 wherein said O-ring is formed of medical grade silicone.

38. The apparatus of claim 34 wherein said at least one elastic element comprises a single O-ring and said dielectric substrate is a circuit board that includes a pair of retaining lips for capturing said single O-ring and wherein the medical device is retainable between said O-ring and said circuit board.

39. The apparatus of claim 34 wherein said dielectric substrate is a circuit board is formed of polyimide.

40. The apparatus of claim 34 wherein said diode is a photodiode suitable for emitting nonvisual light in response to current therethrough.

41. The apparatus of claim 34 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.

42. The apparatus of claim 41 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.

43. The apparatus of claim 34 additionally comprising selection means for selecting and/or deselecting a desired test/protection circuit.

44. 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.

45. The method of claim 44 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.

46. The method of claim 44 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.

47. The method of claim 44 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.

48. The method of claim 44 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;

(a) monitoring inductively coupled magnetic emissions;

(b) monitoring visual light emissions;

(c) monitoring nonvisual light emissions;

(d) monitoring electrostatic emissions;

(e) monitoring electromagnetic emissions; and

(f) monitoring capacitive changes.

49. The method of claim 48 wherein said step of applying an activation signal comprises providing wireless communicating energy to the electronic circuitry in the housing.