Trial neuro stimulator with lead diagnostics

• US 7,493,159 B2
• Filed: 08/06/2003
• Issued: 02/17/2009
• Est. Priority Date: 06/19/2000
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Skime, Robert M., Hrdlicka, Gregory A.
• Primary Examiner(s): Schaetzle; Kennedy J
• Application Number:
  US10/636,487
• Publication Number:
  US 20040111130A1
• Time in Patent Office: 2,022 Days
• Field of Search: 607/27, 607/2, 607/37, 607/10, 607/57, 607/62, 607/63, 607/28, 600/547
• US Class Current: 607/2
• CPC Class Codes: A61N 1/36014 External stimulators, e.g. with patch electrodes external pacemakers A61N1/3625
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/37241 providing test stimulations
• CPC Class Codes: A61N 2001/083 Monitoring integrity of contacts, e.g. by impedance measurement

Abstract

A medical device known as a trial neuro stimulator with a diagnostics module to determine whether the therapy lead is operational for delivering stimulation therapy to improve operation in areas such as reliability and patient comfort is disclosed. The trial neuro stimulator is typically used to test the efficacy of neuro stimulation before implanting an implantable neuro stimulator in a patient. The trial neuro stimulator has a processor, memory, system reset, telemetry module, recharge module, power management module, power source, therapy module, therapy measurement module, and diagnostics module. The diagnostics module can be a lead sensor, a software detector using therapy lead measurements from the therapy measurement module, or, a combination of both the lead sensor and software detector to detect whether the therapy lead is operational. A method for diagnosing whether a therapy lead is operational is also disclosed.

Claims

1. A trial neuro stimulator with diagnostics for screening a patient to evaluate the efficacy of neuro stimulation comprising:

a processor;

a memory coupled to the processor containing a therapy program;

a therapy module operated according to the therapy program to produce stimulation signals, the therapy module having a therapy module connector that includes at least one therapy connector plug;

a therapy lead having a distal end for implantation in the patient and a proximal end that includes a therapy lead connector, the therapy lead connector configured to couple with the therapy module connector outside of the patient and including at least one lead connector pin that is received by the therapy connector plug;

a lead diagnostic module configured for detecting at least one of an operational disconnection of the therapy lead from the therapy module, degradation of a conductor of the therapy lead, or discontinuity of the conductor of the therapy lead, and determining that the therapy lead is not operational to deliver stimulation signals based on the detection; and

a switch, wherein the lead connector pin actuates the switch, and the lead diagnostic module detects an operational disconnection of the therapy lead from the therapy module by detecting whether the therapy lead connector is operationally connected to the therapy module connector based on actuation of the switch, and

wherein the trial neuro stimulator is configured for ambulatory operation.

2. The trial neuro stimulator of claim 1, further comprising a therapy measurement module, wherein the lead diagnostic module includes a software detector that receives therapy lead measurement data from the therapy measurement module and detects the at least one of the operational disconnection of the therapy lead from the therapy module, degradation of the conductor of the therapy lead, or discontinuity of the conductor of the therapy lead by comparing the therapy lead measurement data to predetermined data.

3. The trial neuro stimulator of claim 2, wherein the therapy measurement module is configured to measure a therapy lead impedance.

4. The trial neuro stimulator of claim 1, further comprising an annunciator to annunciate when the at least one of the operational disconnection of the therapy lead from the therapy module, degradation of the conductor of the therapy lead, or discontinuity of the conductor of the therapy lead is detected.

5. The trial neuro stimulator of claim 1, wherein the therapy lead comprises one of an implanted lead coupled to a percutaneous extension and a percutaneous lead.

6. The trial neuro stimulator of claim 1, wherein the therapy lead includes a screening cable, and a proximal end of the screening cable includes the therapy lead connector.

7. A trial neuro stimulator with diagnostics for screening a patient to evaluate the efficacy of neuro stimulation comprising:

a processor;

a memory coupled to the processor containing a therapy program;

a therapy module operated according to the therapy program to produce stimulation signals, the therapy module having a therapy module connector that includes at least one therapy connector plug;

a therapy lead having a distal end for implantation in the patient and a proximal end that includes a therapy lead connector, the therapy lead connector configured to couple with the therapy module connector outside of the patient and including at least one lead connector pin that is received by the therapy connector plug;

a lead diagnostic module configured for determining whether the therapy lead is operational to deliver stimulation signals; and

a switch, wherein the lead connector pin actuates the switch and the lead diagnostic module determines whether the therapy lead is not operationally connected to the therapy module by detecting whether the therapy lead connector is operationally connected to the therapy module connector based on actuation of the switch.

8. The trial neuro stimulator of claim 7, further comprising a therapy measurement module, wherein the lead diagnostic module includes a software detector that receives therapy lead measurement data from the therapy measurement module, compares the therapy lead measurement data to predetermined data, and determines whether the therapy lead is not operationally connected to the therapy module based on the comparison.

9. A trial neuro stimulator with diagnostics for screening a patient to evaluate the efficacy of neuro stimulation comprising:

a processor;

a memory coupled to the processor containing a therapy program;

a therapy module operated according to the therapy program to produce stimulation signals, the therapy module having a therapy module connector that includes at least one therapy connector plug;

a therapy lead having a distal end for implantation in the patient and a proximal end that includes a therapy lead connector, the therapy lead connector configured to couple with the therapy module connector outside of the patient and including at least one lead connector pin that is received by the therapy connector plug;

a lead diagnostic module configured for detecting at least one of an operational disconnection of the therapy lead from the therapy module, degradation of a conductor of the therapy lead, or discontinuity of the conductor of the therapy lead, and determining that the therapy lead is not operational to deliver stimulation signals based on the detection; and

a circuit, wherein the lead connector pin completes the circuit, and the lead diagnostic module detects an operational disconnection of the therapy lead from the therapy module by determining whether the therapy lead connector is operationally connected to the therapy module connector based on completion of the circuit, and

wherein the trial neuro stimulator is configured for ambulatory operation.

10. A trial neuro stimulator with diagnostics for screening a patient to evaluate the efficacy of neuro stimulation comprising:

a processor;

a memory coupled to the processor containing a therapy program;

a therapy module operated according to the therapy program to produce stimulation signals, the therapy module having a therapy module connector that includes at least one therapy connector plug;

a therapy lead having a distal end for implantation in the patient and a proximal end that includes a therapy lead connector, the therapy lead connector configured to couple with the therapy module connector outside of the patient and including at least one lead connector pin that is received by the therapy connector plug;

a lead diagnostic module configured for determining whether the therapy lead is operational to deliver stimulation signals; and

a circuit, wherein the lead connector pin completes the circuit and the lead diagnostic module determines whether the therapy lead is not operationally connected to the therapy module by detecting whether the therapy lead connector is operationally connected to the therapy module connector based on completion of the circuit.

11. A medical device comprising:

a processor;

a memory coupled to the processor containing a therapy program;

a therapy module operated according to the therapy program to produce stimulation signals, the therapy module having a therapy module connector that includes at least one therapy connector plug;

a therapy lead having a distal end for implantation in the patient and a proximal end that includes a therapy lead connector, the therapy lead connector configured to couple with the therapy module connector outside of the patient and including at least one lead connector pin that is received by the therapy connector plug;

a lead diagnostic module configured for detecting at least one of an operational disconnection of the therapy lead from the therapy module, degradation of a conductor of the therapy lead, or discontinuity of the conductor of the therapy lead, and determining that the therapy lead is not operational to deliver stimulation signals based on the detection; and

a switch, wherein the lead connector pin actuates the switch and the lead diagnostic module detects an operational disconnection of the therapy lead from the therapy module by detecting whether the therapy lead connector is operationally connected to the therapy module connector based on actuation of the switch.

12. A medical device comprising:

a processor;

a memory coupled to the processor containing a therapy program;

a therapy module operated according to the therapy program to produce stimulation signals, the therapy module having a therapy module connector that includes at least one therapy connector plug;

a therapy lead having a distal end for implantation in the patient and a proximal end that includes a therapy lead connector, the therapy lead connector configured to couple with the therapy module connector outside of the patient and including at least one lead connector pin that is received by the therapy connector plug;

a lead diagnostic module configured for detecting at least one of an operational disconnection of the therapy lead from the therapy module, degradation of a conductor of the therapy lead, or discontinuity of the conductor of the therapy lead, and determining that the therapy lead is not operational to deliver stimulation signals based on the detection; and

a circuit, wherein the lead connector pin completes the circuit and the lead diagnostic module detects an operational disconnection of the therapy lead from the therapy module by determining whether the therapy lead connector is operationally connected to the therapy module connector based on completion of the circuit.