Trial neuro stimulator with lead diagnostics

• US 20040111130A1
• Filed: 08/06/2003
• Published: 06/10/2004
• Est. Priority Date: 06/19/2000
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Skime, Robert M., Hrdlicka, Gregory A.
• Granted Patent: US 7,493,159 B2
• Time in Patent Office: Days
• US Class Current: 607/48
• 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 operation. 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 proximal end with a therapy lead connector, the therapy lead connector configured to couple with the therapy module connector and including at least one lead connector pin that is received by the therapy connector plug;

a lead diagnostic module coupled to the therapy module connector and coupleable to the therapy lead connector, the 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,

the lead diagnostic module determines whether the therapy lead is operational to deliver stimulation signals by detecting whether the therapy lead connector is operationally connected to the therapy module connector based on actuation of the switch, and

the trial neuro stimulator is not suitable for implantation into the patient.

2. The trial neuro stimulator as in claim 1, further comprising an annunciator to annunciate when the therapy lead in not operational to deliver stimulation signal.

3. 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 proximal end with a therapy lead connector, the therapy lead connector configured to couple with the therapy module connector and including at least one lead connector pin that is received by the therapy connector plug;

a lead diagnostic module coupled to the therapy module connector and coupleable to the therapy lead connector, the 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,

the lead diagnostic module determines whether the therapy lead is operational to deliver stimulation signals by detecting whether the therapy lead connector is operationally connected to the therapy module connector based on completion of the circuit, and

the trial neuro stimulator is not suitable for implantation into the patient.

4. The trial neuro stimulator as in claim 3, further comprising an annunciator to annunciate when the therapy lead in not operational to deliver stimulation signal.

5. 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;

a therapy lead having a proximal end with a therapy lead connector, the therapy lead connector configured to couple with the therapy module connector, and the therapy lead further including a screening cable and an implanted lead;

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

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 determines whether the therapy lead is operational to deliver stimulation signals by determining whether the screening cable is operationally connected to the implanted lead based on the therapy lead measurement data, and

the trial neuro stimulator is not suitable for implantation into the patient.

6. The trial neuro stimulator as in claim 5, further comprising an annunciator to annunciate when the therapy lead in not operational to deliver stimulation signal.

7. The trial neuro stimulator as in claim 5, wherein the therapy measurement module is configured to measure therapy lead impedance.

8. A method of diagnosing whether a therapy lead is operationally connected to a trial neuro stimulator, comprising:

connecting a therapy lead to a therapy connector;

sensing the integrity of the connection between the therapy lead and the therapy connector;

deciding whether the integrity of the connection between the therapy lead and the therapy connector is adequate; and

annunciating an inadequate connection between the therapy lead and the therapy connector.

9. The method as in claim 8, wherein sensing the integrity of the connection between the therapy lead and the therapy connector is accomplished with a lead sensor coupled to the therapy connector and the therapy lead.

10. The method as in claim 8, wherein sensing the integrity of the connection between the therapy lead and the therapy connector is accomplished with a therapy measurement module and deciding whether the integrity of the connection between the therapy lead and the therapy connector is adequate is accomplished with a software detector.

11. The method as in claim 8, further comprising modifying a therapy after deciding that the integrity of the connection between the therapy lead and the therapy connector is inadequate.