Testing sterile packaged components of an implantable medical device prior to chronic implantation

• US 6,292,697 B1
• Filed: 02/15/2000
• Issued: 09/18/2001
• Est. Priority Date: 02/15/2000
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Roberts, Jonathan P.
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US09/504,596
• Time in Patent Office: 581 Days
• Field of Search: 607/27, 206/328, 206/438, 206/210, 206/701
• 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

Apparatus, systems and methods for coupling components of an implantable medical device that are contained within separate sterile packages together and testing operation thereof prior to chronic implantation are disclosed. In particular, testing of the integrity of the lead conductors and other electrical components coupled therewith and the testing and calibration of an implantable sensor, e.g., an implantable pressure sensor, coupled to a programmable, implantable hemodynamic monitor (IHM) or implantable pulse generator (IPG) while in respective sterile packages are disclosed. The lead and IPG/IHM sterile packages are provided with package connectors that couple the terminals of the IPG/IHM and lead to external package connector arrays. The package connector arrays are coupled together, and a programmer is employed to downlink telemetered commands to the IPG or IHM to test the sensor and/or lead conductors and uplink via telemetery the results to the programmer for display. When a lead borne pressure sensor is under test, the uplink telemetered pressure readings are compared to a reference pressure reading. A correction factor is determined if the uplink telemetered and reference pressure readings differ, and the correction factor is downlink telemetered from the programmer into memory of the IPG or IHM for use in adjusting the sensor pressure readings. The pressure test may be conducted both at atmospheric pressure and at elevated pressures correlated to typical systolic blood pressures, and the correction factor may be derived from all tests.

Claims

1. A method of coupling first and second components of an implantable medical device that are contained within separate sterile packages together and testing functions, characteristics and operations thereof prior to chronic implantation comprising:

providing a first component sterile package having a first component sterile package connector array on an external surface thereof;

placing the first component having first component terminals in the first component sterile package;

coupling the first component terminals with the first component sterile package connector array through a first component sterile package connector;

enclosing the first component and first component sterile package connector coupled therewith within the first component sterile package;

providing a second component sterile package having a second component sterile package connector array on an external surface thereof;

placing the second component having second component terminals in the second component sterile package;

coupling the second component terminals with the second component sterile package connector array through a second component sterile package connector;

enclosing the second component and second component sterile package connector coupled therewith within the second component sterile package;

coupling the first component sterile package connector array with the second component sterile package connector array to assemble the first and second components in as the operative implantable medical device; and

testing at least one of the functions, characteristics and operations of the implantable medical device.

2. The method of claim 1, wherein the first component comprises an implantable monitor or therapy delivery device and the second component further comprises an elongated lead having lead conductors formed therein coupled with electrical lead components, and the testing method further comprises:

operating the implantable monitor or therapy delivery device to effect a test of the integrity of the lead conductors and electrical lead components coupled therewith; and

communicating the results of the test from the implantable monitor or therapy delivery device to enable determination if lead integrity criteria are achieved.

3. The method of claim 1, wherein the first component comprises an implantable monitor or therapy delivery device and the second component further comprises a physiologic sensor that provides a sensor reading of a physiologic condition of a patient when implanted in the patient, and the testing method further comprises:

operating the implantable monitor or therapy delivery device to obtain a sensor reading from the physiologic sensor;

providing a reference sensor reading; and

communicating the sensor reading from the implantable monitor or therapy delivery device to enable comparison of the reading from the physiologic sensor to the reference sensor reading.

4. The method of claim 3, wherein the physiologic sensor comprises an implantable blood pressure sensor, and wherein:

the reference sensor reading providing method comprises obtaining an atmospheric pressure reading taken by a calibrated ambient pressure measuring instrument; and

the operating method further comprises the step of exposing the pressure sensor to atmospheric pressure applied through the second component sterile package while obtaining the sensor reading.

5. The method of claim 3, wherein the physiologic sensor comprises an implantable blood pressure sensor, and wherein:

the operating method further comprises the step of exposing the pressure sensor to a pressure applied through the second component sterile package and correlated with a blood pressure of a patient while obtaining the sensor reading; and

the reference sensor reading providing step comprises measuring the applied pressure with a calibrated applied pressure measuring instrument.

6. The method of claim 1, wherein the first component comprises a remotely programmable, implantable monitor or therapy delivery device and the second component comprises a physiologic sensor that provides a sensor reading of a physiologic condition of a patient when implanted in the patient, and the testing method further comprises:

programming the implantable monitor or therapy delivery device to obtain a sensor reading from the physiologic sensor;

providing a reference sensor reading;

communicating the sensor reading from the implantable monitor or therapy delivery device to a remote programmer;

comparing the reading from the physiologic sensor to the reference sensor reading to determine if they differ;

determining a correction factor from any determined difference between the reference and physiologic sensor readings; and

programming the implantable monitor or therapy delivery device to employ the correction factor to adjust a sensor reading obtained from the physiologic sensor to a true sensor reading.

7. The method of claim 6, wherein the physiologic sensor comprises an implantable blood pressure sensor, and wherein:

the reference sensor reading providing method comprises obtaining an atmospheric pressure reading taken by a calibrated ambient pressure measuring instrument; and

the operating step further comprises the method of exposing the pressure sensor to atmospheric pressure applied through the second component sterile package while obtaining the sensor reading.

8. The method of claim 6, wherein the physiologic sensor comprises an implantable blood pressure sensor, and wherein:

the operating method further comprises the step of exposing the pressure sensor to a pressure applied through the second component sterile package and correlated with a blood pressure of a patient while obtaining the sensor reading; and

the reference sensor reading providing method comprises measuring the applied pressure with a calibrated applied pressure measuring instrument.

9. A system for coupling first and second components of an implantable medical device that are contained within separate sterile packages together and testing functions, characteristics and operations thereof prior to chronic implantation comprising:

a first component sterile package containing the first component within a first sterile chamber and having a first component sterile package connector array on an external surface thereof;

a first component sterile package connector within the first sterile chamber coupled between electrical terminals of the first component and the first component sterile package connector array;

a second component sterile package containing the second component within a second sterile chamber and having a second component sterile package connector array on an external surface thereof;

a second component sterile package connector within the second sterile chamber coupled between electrical terminals of the second component and the second component sterile package connector array;

a cable to couple the first component sterile package connector array with the second component sterile package connector array to assemble the first and second components in as the operative implantable medical device; and

means for testing at least one of the functions, characteristics and operations of the implantable medical device.

10. The system of claim 9, wherein:

the first component comprises an implantable monitor or therapy delivery device;

the second component further comprises an elongated lead having lead conductors formed therein coupled with electrical lead components; and

the testing means further comprises;

means for operating the implantable monitor or therapy delivery device to effect a test of the integrity of the lead conductors and electrical lead components coupled therewith; and

means for communicating the results of the test from the implantable monitor or therapy delivery device to enable determination if lead integrity criteria are achieved.

11. The system of claim 9, wherein

the first component comprises an implantable monitor or therapy delivery device within the first component sterile package;

the second component further comprises a physiologic sensor within the second component sterile package that provides a sensor reading of a physiologic condition of a patient when implanted in the patient; and

the testing means further comprises;

means for operating the implantable monitor or therapy delivery device to obtain a sensor reading from the physiologic sensor;

means for providing a reference sensor reading; and

means for communicating the sensor reading from the implantable monitor or therapy delivery device to enable comparison of the reading from the physiologic sensor to the reference sensor reading.

12. The system of claim 11, wherein

the physiologic sensor comprises an implantable blood pressure sensor exposed to atmospheric pressure transmitted through the second component sterile package;

and

the reference sensor reading providing means comprises a calibrated ambient pressure measuring instrument that provides a reference atmospheric pressure reading.

13. The system of claim 11, further comprising:

a pressure chamber having a pressure chamber cavity in which the second component sterile package is located; and

wherein;

the physiologic sensor comprises an implantable blood pressure sensor exposed to pressure transmitted through the second component sterile package;

the operating means further comprises means for applying a pressure correlated with a blood pressure of a patient to the pressure chamber cavity to expose the pressure sensor to the applied pressure transmitted through the second component sterile package; and

the reference sensor reading providing means comprises a calibrated applied pressure measuring instrument measuring the applied pressure within the pressure chamber cavity.

14. The system of claim 9, wherein

the first component comprises a remotely programmable, implantable monitor or therapy delivery device;

the second component comprises a physiologic sensor that provides a sensor reading of a physiologic condition of a patient when implanted in the patient; and

the testing means further comprises;

means for providing a reference sensor reading;

a programmer to program the implantable monitor or therapy delivery device to obtain a sensor reading from the physiologic sensor, to communicate the sensor reading from the implantable monitor or therapy delivery device to the programmer, and to program the implantable monitor or therapy delivery device to employ a correction factor to adjust a sensor reading obtained from the physiologic sensor to a true sensor reading, wherein the correction factor is determined from any difference between the reference and physiologic sensor readings.

15. The system of claim 14, wherein

the physiologic sensor comprises an implantable blood pressure sensor exposed to atmospheric pressure transmitted through the second component sterile package;

and

the reference sensor reading providing means comprises a calibrated ambient pressure measuring instrument that provides a reference atmospheric pressure reading.

16. The system of claim 14, further comprising:

a pressure chamber having a pressure chamber cavity in which the second component sterile package is located; and

wherein;

the physiologic sensor comprises an implantable blood pressure sensor exposed to pressure transmitted through the second component sterile package;

the operating means further comprises means for applying a pressure correlated with a blood pressure of a patient to the pressure chamber cavity to expose the pressure sensor to the applied pressure transmitted through the second component sterile package; and

the reference sensor reading providing means comprises a calibrated applied pressure measuring instrument measuring the applied pressure within the pressure chamber cavity.

17. Apparatus for coupling first and second components of an implantable medical device that are contained within separate sterile packages together and testing functions, characteristics and operations thereof prior to chronic implantation comprising:

a first component sterile package containing the first component within a first sterile chamber and having a first component sterile package connector array on an external surface thereof;

a first component sterile package connector within the first sterile chamber coupled between electrical terminals of the first component and the first component sterile package connector array;

a second component sterile package containing the second component within a second sterile chamber and having a second component sterile package connector array on an external surface thereof;

a second component sterile package connector within the second sterile chamber coupled between electrical terminals of the second component and the second component sterile package connector array;

means for coupling the first component sterile package connector array with the second component sterile package connector array to assemble the first and second components in as the operative implantable medical device; and

means for testing at least one of the functions, characteristics and operations of the implantable medical device.

18. The apparatus of claim 17, wherein

the first component comprises a remotely programmable, implantable monitor or therapy delivery device;

the second component comprises a physiologic sensor that provides a sensor reading of a physiologic condition of a patient when implanted in the patient; and

the testing means further comprises;

means for providing a reference sensor reading;

a programmer to program the implantable monitor or therapy delivery device to obtain a sensor reading from the physiologic sensor, to communicate the sensor reading from the implantable monitor or therapy delivery device to the programmer, and to program the implantable monitor or therapy delivery device to employ a correction factor to adjust a sensor reading obtained from the physiologic sensor to a true sensor reading, wherein the correction factor is determined from any difference between the reference and physiologic sensor readings.

19. The system of claim 18, wherein

the physiologic sensor comprises an implantable blood pressure sensor exposed to atmospheric pressure transmitted through the second component sterile package;

and

the reference sensor reading providing means comprises a calibrated ambient pressure measuring instrument that provides a reference atmospheric pressure reading.

20. The apparatus of claim 17, wherein

the first component comprises an implantable monitor or therapy delivery device;

is the second component further comprises an elongated lead having lead conductors formed therein coupled with electrical lead components; and

the testing means further comprises;

means for operating the implantable monitor or therapy delivery device to effect a test of the integrity of the lead conductors and electrical lead components coupled therewith; and

means for communicating the results of the test from the implantable monitor or therapy delivery device to enable determination if lead integrity criteria are achieved.