Implantable medical device with dummy load for pre-implant testing in sterile package and facilitating electrical lead connection

• US 5,237,991 A
• Filed: 11/19/1991
• Issued: 08/24/1993
• Est. Priority Date: 11/19/1991
• Status: Expired due to Term

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Baker, Ross G. Jr., Terry, Reese S. Jr.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US07/794,990
• Time in Patent Office: 644 Days
• Field of Search: 128/419 PT, 128/419 P
• US Class Current: 607/27
• CPC Class Codes: A61N 1/3706 Pacemaker parameters stimulation threshold A61N1/371
• 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

Abstract

An implantable medical device is provided with a removable dummy load across its connector output terminals to allow the device to be tested without removal from the sterile disposable package in which it is shipped and stored. The dummy load is confined with the device entirely within the sterile package to simulate the electrical impedance across the output terminals when the device is implanted in a patient and connected to an electrical lead for tissue stimulation. Testing is performed using a conventional external programmer normally provided for programming and monitoring output functions and parameters of the device. The programmer communicates by telemetry with the device confined within the package, to test selected functions and parameters. The dummy load has posts adapted to mate with the receptacles of the electrical connector of the device, and to be secured mechanically and electrically in the receptacles by set screws. The posts are dimensioned to provide a mechanical stop for the set screws when tightened down, and, when the set screws are backed off slightly from the posts to allow removal of the dummy load, to permit the proximal terminals of the replacing lead to be fully inserted into the receptacles without obstruction by the set screws.

Claims

1. A sterile packaged implantable programmable medical device having operating functions for electrically stimulating selected excitable tissue in a patient'"'"'s body when the device is implanted after removal from its sterile package, comprising:

a medical device adapted to be implanted in a patient;

package means for encapsulating the device in a sterile environment for transport and storage in preparation for implantation;

the device including;

electrical circuit means responsive to predetermined signals generated external to the package means for programming electrical output parameters of the device included within said operating functions, the electrical circuit means including;

battery means for powering the device, and

telemetry means for sending and receiving telemetry signals including at least some of the externally generated predetermined signals to and from the device, whereby to enable communication between the device and a telemetry system external to the package means adapted to program and monitor electrical output parameters of the device,

a case housing the electrical circuit means, and

an electrical connector including output terminals connected to the electrical circuit means, adapted to deliver the electrical output parameters of the device to a load presented when the device is implanted in the patient and connected by the output terminals to proximal terminals of an electrical lead for electrical interaction with the tissue to be stimulated; and

dummy load means contained entirely within the package means for simulating the approximate electrical impedance of said load, the dummy load means including load terminals connected to the output terminals of the connector;

the connector further including fastener means for securely fastening the load terminals of the dummy load means mechanically and electrically to the output terminals of the connector within the package means, and for disconnection therefrom after the device is removed from the package means and before implantation in the patient, whereby at least some of said operating functions of the device may be tested and test measurements monitored by means of the telemetry signals as though the device were implanted in the patient, before removal of the device from its sterile package, and the load terminals of the dummy load means providing a mechanical stop for the fastener means when the load terminals are securely fastened to the output terminals of the device, to assure reliable connection of the proximal terminals of the electrical lead to the output terminals when the dummy load means is replaced by the electrical lead.

2. The invention of claim 1, wherein the electrical circuit means further including reference means for detecting drift in the values of the output parameters over time when test measurements are monitored.

3. The invention of claim 1, wherein said electrical circuit means in combination with the dummy load means comprises means for detecting and communicating to the telemetry means, for external monitoring by the telemetry system, the current drain at preselected locations of the electrical circuit means in response to certain ones of the telemetry signals received by the telemetry means.

4. The invention of claim 1, wherein said electrical circuit means further includes:

measuring means for monitoring at least some of the electrical output parameters of the device.

5. The invention of claim 1, wherein the output terminals of the connector comprise receptacles, the load terminals of the dummy load means comprise posts adapted to be received within and mate with the receptacles, and the fastener means comprise set screws mating with threaded holes into the receptacles to be tightened down on the posts, the posts thereby forming said mechanical stop and being dimensioned so that when the set screws are backed away from the posts but retained in the threaded holes for removal of the dummy load means from the connector, the proximal terminals of the electrical lead are insertable fully into the receptacles without interference from the set screws which may then be tightened down on the proximal terminals.