Interface devices for instruments in communication with implantable medical devices

• US 6,580,948 B2
• Filed: 04/19/2001
• Issued: 06/17/2003
• Est. Priority Date: 04/25/2000
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Haupert, David J., Levan, Charles R., Winkler, Thomas J., Kruse, John M.
• Primary Examiner(s): Layno, Carl
• Application Number:
  US09/838,696
• Publication Number:
  US 20020007198A1
• Time in Patent Office: 789 Days
• Field of Search: 607/27, 607/32, 607/37, 607/57, 607/60, 607/61, 607/5, 607/9, 607/30, 128/903, 600/509, 600/513
• US Class Current: 607/60
• CPC Class Codes: A61N 1/37 Monitoring; Protecting
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer

Abstract

External medical instruments that are in physical contact with a patient'"'"'s body to communicate with or test the function of implantable medical devices (IMDs) implanted in the patient'"'"'s body or to measure a physiologic condition of the patient'"'"'s body and capable of communicating with other medical instruments or systems located at a distance from the patient, and, particularly, safety systems for protecting the patient from harm due to hazardous electrical signals or potentials. The external medical instrument operates pursuant to an instrument operating system that processes and generates electrical signals. A patient cable is coupled to a patient'"'"'s body for transmitting electrical signals from the instrument operating system to the patient'"'"'s body and for receiving electrical signals from the patient'"'"'s body. A data cable extends to a remote instrument or a network, e.g., through a modem and Internet network connection, for communicating signals between the instrument operating system and the remote instrument or network. A first electrical isolation circuit between the instrument operating system and the data cable blocks conduction of hazardous electrical signals imposed upon the data cable from being conducted through the instrument operating system to the patient cable. A further electrical isolation circuit between the patient cable and the instrument operating system blocks conduction to the patient cable of hazardous signals conducted from the data cable through the instrument operating system.

Claims

1. In an external medical instrument to communicate with implantable medical devices (IMDs) implanted in the patient'"'"'s body and capable of communicating with other medical instruments located at a distance from the patient, a safety system for protecting the patient from harm due to hazardous electrical signals comprising:

an expansion bay of the external medical instrument adapted to receive a module expanding the capabilities of the external medical instrument, the expansion bay further comprising an expansion bay interface connector;

a module fitted into the expansion bay and connected with the expansion bay interface connector having a module operating system;

a cable coupling the module operating system with the patient'"'"'s body for conducting electrical signals to and from the patient'"'"'s body;

an instrument operating system that creates and transmits module control data through the expansion bay interface connector in a transmission data path to the module operating system and receives module test data through the expansion bay interface connector in a reception data path from the module operating system; and

an opto-isolator within the module and in the transmission data path and the reception data path for isolating the instrument operating system from the module operating system to block passage of hazardous electrical signals through the cable to the patient'"'"'s body.

2. The safety system of claim 1, further comprising:

an electrical power supply within the instrument coupled with an external power line that provides electrical power to the instrument operating system through an electrically isolated power transformer for blocking passage of hazardous electrical signals conducted through the external power line to the instrument operating system; and

means for providing electrical power to the module operating system through the expansion bay interface connector including an electrically isolated power transformer that isolates the module operating system from hazardous electrical signals.

3. The safety system of claim 1, further comprising:

an analog signal cable interface connector coupled with the instrument operating system adapted to pass analog data to a remote instrument through an analog data transmission cable;

an elongated analog data transmission cable having a first end coupled with the analog signal cable interface connector and a second end coupled with a remote instrument; and

analog signal interface circuitry including an opto-isolator for conducting analog signals between the analog signal cable interface connector and the instrument operating system and for blocking hazardous electrical signals passing through the analog data transmission cable from the remote instrument.

4. The safety system of claim 1, further comprising:

an ECG cable interface connector coupled with the instrument operating system adapted to be coupled with an ECG cable to pass ECG data to the instrument operating system;

an elongated ECG cable having a first end coupled with the ECG cable interface connector and a second end coupled with a plurality of ECG electrodes adapted to be applied to the skin of a patient'"'"'s body; and

ECG signal interface circuitry including an opto-isolator for conducting ECG analog signals between the ECG cable interface connector and the instrument operating system and for blocking the conduction of hazardous electrical signals through the ECG cable interface connector.

5. In an external medical instrument in physical contact with a patient'"'"'s body to communicate with or test the function of imptantable medical devices (IMDs) implanted in the patient'"'"'s body or to measure a physiologic condition of the patient'"'"'s body and capable of communicating with other medical instruments or systems located at a distance from the patient, a safety system) for protecting the patient from harm due to hazardous electrical signals comprising:

an expansion bay of the external medical instrument adapted to receive a module expanding the capabilities of the external medical instrument, the expansion bay further comprising an expansion bay interface connector;

a module fitted into the expansion bay and connected with the expansion bay interface connector having a module operating system;

a cable coupling the module operating system with the patient'"'"'s body for conducting electrical signals to and from the patient'"'"'s body;

an instrument operating system that creates and transmits module control data through the expansion bay interface connector in a transmission data path to the module operating system and receives module test data through the expansion bay interface connector in a reception data path from the module operating system; and

an opto-isolator within the module and in the transmission data path and the reception data path for isolating the instrument operating system from the module operating system to block passage of hazardous electrical signals through the cable to the patient'"'"'s body;

wherein the external medical instrument is an external programmer for receiving information-encoded, telemetry uplink signals transmitted from a IMD telemetry antenna and transmitter circuit in the IMD in a telemetry uplink transmission and for transmitting information-encoded telemetry downlink signals from a programmer telemetry antenna in a telemetry downlink transmission.

6. The safety system of claim 5, further comprising:

an electrical power supply within the instrument coupled with an external power line that provides electrical power to the instrument operating system through an electrically isolated power transformer for blocking passage of hazardous electrical signals conducted through the external power line to the instrument operating system; and

means for providing electrical power to the module operating system through the expansion bay interface connector including an electrically isolated power transformer that isolates the module operating system from hazardous electrical signals.

7. The safety system of claim 5, further comprising:

an analog signal cable interface connector coupled with the instrument operating system adapted to pass analog data to a remote instrument through an analog data transmission cable;

an elongated analog data transmission cable having a first end coupled with the analog signal cable interface connector and a second end coupled with a remote instrument; and

analog signal interface circuitry including an opto-isolator for conducting analog signals between the analog signal cable interface connector and the instrument operating system and for blocking hazardous electrical signals passing through the analog data transmission cable from the remote instrument.

8. The safety system of claim 5, further comprising:

an ECG cable interface connector coupled with the instrument operating system adapted to be coupled with an ECG cable to pass ECG data to the instrument operating system;

an elongated ECG cable having a first end coupled with the ECG cable interface connector and a second end coupled with a plurality of ECG electrodes adapted to be applied to the skin of a patient'"'"'s body; and

ECG signal interface circuitry including an opto-isolator for conducting ECG analog signals between the ECG cable interface connector and the instrument operating system and for blocking the conduction of hazardous electrical signals through the ECG cable interface connector.

9. In an external medical instrument to communicate with implantable medical devices (IMDs) implanted in the patient'"'"'s body and capable of communicating with other medical instruments located at a distance from the patient, a safety system for protecting the patient from harm due to hazardous electrical signals comprising:

an expansion bay of the external medical instrument adapted to receive a module expanding the capabilities of the external medical instrument, the expansion bay further comprising an expansion bay interface connector;

a module fitted into the expansion bay and connected with the expansion bay interface connector having a module operating system;

a cable coupling the module operating system with the patient'"'"'s body for conducting electrical signals to and from the patient'"'"'s body;

a modem interface connector of the external medical instrument adapted to receive a modem;

a modem connected with the modem interface connector and with a data transmission network through a modem data cable, the modem adapted to transmit patient and IMD data to and from a remote location of a network;

an instrument operating system that creates and transmits module control data through the expansion bay interface connector in a transmission data path to the module operating system and receives module test data through the expansion bay interface connector in a reception data path from the module operating system and that creates and transmits patient and IMD data through the modem to the remote location;

an opto-isolator within the module and in the transmission data path and the reception data path for isolating the instrument operating system from the module operating system to block passage of hazardous electrical signals through the cable to the patient'"'"'s body including hazardous signals conducted through the modem interface connector to the instrument operating system and through the modem and modem data cable from the network.

10. The safety system of claim 9, further comprising:

an electrical power supply within the instrument coupled with an external power line that provides electrical power to the instrument operating system through an electrically isolated power transformer for blocking passage of hazardous electrical signals conducted through the external power line to the instrument operating system; and

means for providing electrical power to the module operating system through the expansion bay interface connector including an electrically isolated power transformer that isolates the module operating system from hazardous electrical signals.

11. The safety system of claim 9, further comprising:

an analog signal cable interface connector coupled with the instrument operating system adapted to pass analog data to a remote instrument through an analog data transmission cable;

an elongated analog data transmission cable having a first end coupled with the analog signal cable interface connector and a second end coupled with a remote instrument; and

analog signal interface circuitry including an opto-isolator for conducting analog signals between the analog signal cable interface connector and the instrument operating system and for blocking hazardous electrical signals passing through the analog data transmission cable from the remote instrument.

12. The safety system of claim 9, further comprising:

an ECG cable interface connector coupled with the instrument operating system adapted to be coupled with an ECG cable to pass ECG data to the instrument operating system;

an elongated ECG cable having a first end coupled with the ECG cable interface connector and a second end coupled with a plurality of ECG electrodes adapted to be applied to the skin of a patient'"'"'s body; and

ECG signal interface circuitry including an opto-isolator for conducting ECG analog signals between the ECG cable interface connector and the instrument operating system and for blocking the conduction of hazardous electrical signals through the ECG cable interface connector.

13. In an external medical instrument in physical contact with a patient'"'"'s body to communicate with or test the function of implantable medical devices (IMDs) implanted in the patient'"'"'s body or to measure a physiologic condition of the patient'"'"'s body and capable of communicating with other medical instruments or systems located at a distance from the patient, a safety system for protecting the patient from harm due to hazardous electrical signals comprising:

an expansion bay of the external medical instrument adapted to receive a module expanding the capabilities of the external medical instrument, the expansion bay further comprising an expansion bay interface connector;

a module fitted into the expansion bay and connected with the expansion bay interface connector having a module operating system;

a cable coupling the module operating system with the patient'"'"'s body for conducting electrical signals to and from the patients body;

a modem interface connector of the external medical instrument adapted to receive a modem;

a modem connected with the modem interface connector and with a data transmission network through a modem data cable, the modem adapted to transmit patient and IMD data to and from a remote location of a network;

an instrument operating system that creates and transmits module control data through the expansion bay interface connector in a transmission data path to the module operating system and receives module test data through the expansion bay interface connector in a reception data path from the module operating system and that creates and transmits patient and IMD data through the modem to the remote location; and

an opto-isolator within the module and in the transmission data path and the reception data path for isolating the instrument operating system from the module operating system to block passage of hazardous electrical signals through the cable to the patient'"'"'s body including hazardous signals conducted through the modem interface connector to the instrument operating system and through the modem and modem data cable from the network;

wherein the external medical instrument is an external programmer for receiving information-encoded, telemetry uplink signals transmitted from a IMD telemetry antenna and transmitter circuit in the IMD in a telemetry uplink transmission and for transmitting information-encoded telemetry downlink signals from a programmer telemetry antenna in a telemetry downlink transmission.

14. The safety system of claim 13, further comprising:

an electrical power supply within the instrument coupled with an external power line that provides electrical power to the instrument operating system through an electrically isolated power transformer for blocking passage of hazardous electrical signals conducted through the external power line to the instrument operating system; and

means for providing electrical power to the module operating system through the expansion bay interface connector including an electrically isolated power transformer that isolates the module operating system from hazardous electrical signals.

15. The safety system of claim 13, further comprising:

an analog signal cable interface connector coupled with the instrument operating system adapted to pass analog data to a remote instrument through an analog data transmission cable;

an elongated analog data transmission cable having a first end coupled with the analog signal cable interface connector and a second end coupled with a remote instrument; and

analog signal interface circuitry including an opto-isolator for conducting analog signals between the analog signal cable interface connector and the instrument operating system and for blocking hazardous electrical signals passing through the analog data transmission cable from the remote instrument.

16. The safety system of claim 13, further comprising:

an ECG cable interface connector coupled with the instrument operating system adapted to be coupled with an ECG cable to pass ECG data to the instrument operating system;

an elongated ECG cable having a first end coupled with the ECG cable interface connector and a second end coupled with a plurality of ECG electrodes adapted to be applied to the skin of a patient'"'"'s body; and

ECG signal interface circuitry including an opto-isolator for conducting ECG analog signals between the ECG cable interface connector and the instrument operating system and for blocking the conduction of hazardous electrical signals through the ECG cable interface connector.

17. In an external instrument adapted to be coupled with a patient'"'"'s body to communicate with or test the function of implantable medical devices (IMDS) implanted in the patient'"'"'s body or to measure a physiologic condition of the patient'"'"'s body and capable of communicating with other medical instruments or systems located at a distance from the patient, a safety system for protecting the patient from harm due to hazardous electrical signals comprising:

a instrument operating system that processes and generates electrical signals;

a patient cable adapted to be coupled to a patient'"'"'s body for transmitting electrical signals from the instrument operating system to the patient'"'"'s body and for receiving electrical signals from the patient'"'"'s body;

a data cable extending to a remote instrument or a network for communicating signals between the instrument operating system and the remote instrument or network;

first electrical isolation circuit means between the instrument operating system and the data cable for blocking conduction of hazardous electrical signals imposed upon the data cable from being conducted through the instrument operating system to the patient cable; and

second electrical isolation circuit means between the patient cable and the instrument operating system for blocking conduction to the patient cable of hazardous signals conducted from the data cable through the instrument operating system.

18. The safety system of claim 17, wherein the external medical instrument is an external programmer for receiving information-encoded, telemetry uplink signals transmitted from a IMD telemetry antenna and transmitter circuit in the IMD in a telemetry uplink transmission and for transmitting information-encoded telemetry downlink signals from a programmer telemetry antenna in a telemetry downlink transmission.