Disposable in-package load test element for pacemakers

• US 4,830,005 A
• Filed: 07/23/1987
• Issued: 05/16/1989
• Est. Priority Date: 07/23/1987
• Status: Expired due to Term

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Original Assignee: Siemens Pacesetter, Inc. (Abbott Laboratories)
• Inventors: Woskow, Robert M.
• Primary Examiner(s): Jaworski, Francis
• Assistant Examiner(s): Manuel, George
• Application Number:
  US07/076,952
• Time in Patent Office: 663 Days
• Field of Search: 128/419 PT, 128/419 PG, 128/419 P, 128/1 R, 206/328, 206/330, 206/331, 206/333
• US Class Current: 607/27
• 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 device for use with a pacemaker to simulate the load of a heart. The device is designed for telemetering control and includes in its circuit a magnetic reed switch which opens and closes a load circuit in response to a remotely applied magnetic field. The device is intended to be disposable and is installed in circuit with the pacemaker terminals which normally connect to the heart leads. The device as thus installed is packaged in the sterile shipping package with the pacemaker and both permit the final checking of the pacemaker within its sterile pack prior to shipment and testing of the pacemaker in preparation for implantation without the necessity of opening the sterile package to conduct the test.

Claims

1. A test device for use in association with a pacemaker to test the integrity of pacemaker terminal circuitry and connectors to which heart leads may be coupled comprising:

an electrical component for simulating a heart load;

a switch element connected electrically in a first series circuit with said electrical component for selectively switching said component into and out of the terminal circuitry of the pacemaker, said switch element being capable of responding to a magnetic field, wherein said switch element responds to said magnetic field within a sterile pacemaker shipping package from a magnetic means located outside of said sterile pacemaker shipping package;

first and second contact elements connected in series with said first series circuit, said first and second contact elements adapted to mate with terminal circuitry of the pacemaker; and

support means for mounting said first and second contact elements in a physical configuration to align with terminal circuit contacts of the pacemaker.

2. The device of claim 1 wherein the electrical component is a resistor having a value in a range to simulate a heart as a load on the pacemaker.

3. The device of claim 2 wherein said resistor value is in the range of 300 to 500 ohms.

4. The device of claim 1 further comprising a body including said support means, said support means comprising extended mounting portions of said body, said body encapsulating said electrical component and said switch element, said body and extended mounting portions being formed of plastic.

5. The device of claim 1 further including a third contact element, a second electrical component for simulating a heart load, and a second switch element connected in series with said second electrical component to form a second series circuit, said second series circuit being adapted to electrically connect to a pacer output terminal in series with said second contact element, said second series circuit having a common connection point with said first series circuit, said common connection point being directly connected to said third contact element adapted to contact the pacemaker case to simulate a pacemaker return contact.

12. The device of claim 1 further comprising a light emitting diode, wherein said diode is utilized for providing a visible indicator of the integrity of the terminal circuitry of the pacemaker.

13. The device of claim 1 wherein said switch element is a magnetically sensitive Hall effect semiconductor switch.

14. The device of claim 1 wherein said switch element is a magnetically actuable reed switch.

16. The device of claim 14 further comprising a body encapsulating said first and second series circuits, said support means extending from said body and said support means being formed of plastic.

6. In combination, a pacemaker, a test device installed in association with the pacemaker, and a package enclosing the pacemaker and test device in a sealed sterile environment, said device comprising:

an electrical component for simulating a heart load;

a switch element connected electrically in a first series circuit with said electrical component for selectively switching said component into and out of the terminal circuitry of the pacemaker, said switch element being remotely actuable;

a pair of contact elements connected in series with said component and said switch element for coupling said component and switch element in circuit with terminal circuitry of the pacemaker; and

support means mounting said contact elements in a physical configuration to mate with terminal circuit contacts of the pacemaker.

7. The device of claim 6 wherein the electrical component is a resistor having a value in a range to simulate a heart as a load on the pacemaker.

9. The device of claim 6 wherein said switch element is capable of responding to a magnetic field within a sterile pacemaker shipping package from magnetic field generating means located outside of said sterile pacemaker shipping package.

10. The device of claim 9 wherein said switch element is a magnetic reed switch.

11. The device of claim 6 further comprising a body including said support means, said support means comprising extended mounting portions of said body, said body encapsulating said electrical component and said switch element, said body and extended mounting portions being formed of plastic.

8. The device of claim 8 wherein said resistor value is in the range of 300 to 500 ohms.

15. A test device for use in association with a pacemaker having a pacer output terminal and a pacer return terminal to which heart leads may be coupled, said test device comprising:

first and second series circuits each including a resistor and a magnetic reed switch;

first and second contact element, said first contact element connected in series with said first series circuit, said second contact element connected in series with said second series circuit, said first and second contact elements adapted to electrically mate to said pacer output terminal;

third and fourth elements, said third contact element connected in series with said first series circuit, said fourth contact element connected in series with said second series circuit, said third and fourth contact elements adapted to electrically mate to said pacer return terminal to simulate a pacemaker return contact; and

support means for mounting said first, second, third, and fourth contact elements in a physical configuration to align with said pacer output and pacer return terminals of the pacemaker, whereby said test device may be used to test the integrity of said pacer output terminal and said pacer return terminal.