Systems and methods for delivering neural therapy correlated with patient status

• US 8,355,797 B2
• Filed: 02/10/2010
• Issued: 01/15/2013
• Est. Priority Date: 02/10/2009
• Status: Active Grant

• Current Assignee: Nevro Corporation
• Original Assignee: Nevro Corporation
• Inventors: Caparso, Anthony V., Parker, Jon, Walker, Andre B., Chitre, Yougandh
• Primary Examiner(s): Schaetzle, Kennedy
• Application Number:
  US12/703,683
• Publication Number:
  US 20100211135A1
• Time in Patent Office: 1,070 Days
• Field of Search: None
• US Class Current: 607/62
• CPC Class Codes: A61N 1/025 Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36062 Spinal stimulation
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 20/70 relating to mental therapies, e.g. psychological therapy or autogenous training
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

Therapy systems for treating a patient are disclosed. Representative therapy systems include an implantable pulse generator, a signal delivery device electrically coupled to the pulse generator, and a remote control in electrical communication with the implantable pulse generator. The pulse generator can have a computer-readable medium containing instructions for performing a process that comprises collecting the patient status and stimulation parameter; analyzing the collected patient status and stimulation parameter; and establishing a preference baseline containing a preferred stimulation parameter corresponding to a particular patient status.

Claims

1. A method for treating a patient, comprising:

collecting a data set containing values of a patient status and values of a spinal cord stimulation parameter at an implantable pulse generator;

analyzing the collected values of the patient status and the values of the stimulation parameter in the data set;

establishing a preference baseline containing individual preference stimulation parameters paired with corresponding individual values of the patient status;

receiving an indication of the patient status; and

in response to receiving the indication of the patient status, automatically adjusting operating parameters of the implantable pulse generator to generate an electrical stimulation signal and apply the generated stimulation signal to a spinal cord region of the patient,

wherein the stimulation parameter includes an amplitude of the stimulation signal, and wherein the patient status includes a first value corresponding to the patient standing and a second value corresponding to the patient lying down, and further wherein establishing a preference baseline includes;

recording the values of the amplitude of the stimulation signal and the values of the patient status at the implantable pulse generator;

determining the patient status to be one of the first value and the second value, wherein a first set of values of the amplitude corresponds to the first value of the patient status, and wherein a second set of values of the amplitude corresponds to the second value of the patient status;

calculating a first arithmetic mean of the first set of values of the amplitude corresponding to the first value of the patient status and a second arithmetic mean of the second set of values of the amplitude corresponding to the second value of the patient status;

setting a first preference amplitude of the preference baseline equal to the calculated first arithmetic mean, the first preference amplitude corresponding to the first value of the patient status; and

setting a second preference amplitude of the preference baseline equal to the calculated second arithmetic mean, the second preference amplitude corresponding to the second value of the patient status.

2. A method for treating a patient, comprising:

collecting a data set containing values of a patient status and values of a spinal cord stimulation parameter at an implantable pulse generator;

analyzing the collected values of the patient status and the values of the stimulation parameter in the data set;

establishing a preference baseline containing individual preference stimulation parameters paired with corresponding individual values of the patient status;

receiving an indication of the patient status; and

in response to receiving the indication of the patient status, automatically adjusting operating parameters of the implantable pulse generator to generate an electrical stimulation signal and apply the generated stimulation signal to a spinal cord region of the patient,

wherein the values of the stimulation parameter and the values of the patient status are measured with a sensing element embedded in the implantable pulse generator, and wherein the values of the stimulation parameter and the values of the patient status are periodically stored in the implantable pulse generator as the data set, and wherein establishing a preference baseline includes correlating the values of the measured stimulation parameter to the individual values of the patient status in the data set to establish the preference baseline.

3. A method for treating a patient, comprising:

collecting a data set containing values of a patient status and values of a spinal cord stimulation parameter at an implantable pulse generator;

analyzing the collected values of the patient status and the values of the stimulation parameter in the data set;

establishing a preference baseline containing individual preference stimulation parameters paired with corresponding individual values of the patient status;

receiving an indication of the patient status; and

in response to receiving the indication of the patient status, automatically adjusting operating parameters of the implantable pulse generator to generate an electrical stimulation signal and apply the generated stimulation signal to a spinal cord region of the patient,

wherein the values of the stimulation parameter include values of a stimulation parameter input from the patient, and wherein the values of the stimulation parameter and the values of the patient status are measured with a sensing element embedded in the implantable pulse generator, and wherein the values of the stimulation parameter and the values of the patient status are periodically stored in the implantable pulse generator as the data set, and wherein establishing a preference baseline includes correlating the measured values of the stimulation parameter input from the patient to the individual values of the patient status in the data set to establish the preference baseline.

4. A method for treating a patient, comprising:

collecting a data set containing values of a patient status and values of a spinal cord stimulation parameter at an implantable pulse generator;

analyzing the collected values of the patient status and the values of the stimulation parameter in the data set;

establishing a preference baseline containing individual preference stimulation parameters paired with corresponding individual values of the patient status;

receiving an indication of the patient status; and

in response to receiving the indication of the patient status, automatically adjusting operating parameters of the implantable pulse generator to generate an electrical stimulation signal and apply the generated stimulation signal to a spinal cord region of the patient,

wherein the values of the stimulation parameter and the values of the patient status are measured with a sensing element embedded in the implantable pulse generator during an initial period, and wherein the values of the stimulation parameter and the values of the patient status are periodically stored in the implantable pulse generator as the data set, and wherein establishing a preference baseline includes correlating the measured stimulation parameter to the individual values of the patient status in the data set to establish the preference baseline when the initial period expires.

5. A method for treating a patient, comprising:

collecting a data set containing values of a patient status and values of a spinal cord stimulation parameter at an implantable pulse generator;

analyzing the collected values of the patient status and the values of the stimulation parameter in the data set;

establishing a preference baseline containing individual preference stimulation parameters paired with corresponding individual values of the patient status;

receiving an indication of the patient status; and

in response to receiving the indication of the patient status, automatically adjusting operating parameters of the implantable pulse generator to generate an electrical stimulation signal and apply the generated stimulation signal to a spinal cord region of the patient,

wherein the values of the stimulation parameter and the values of the patient status are measured with a sensing element embedded in the implantable pulse generator during an initial period, and wherein the values of the stimulation parameter and the values of the patient status are periodically stored in the implantable pulse generator as the data set, and wherein establishing a preference baseline includes;

correlating the measured values of the stimulation parameter to the values of the patient status in the data set to establish the preference baseline when;

the initial period exceeds a preselected duration;

the correlation of the values of the stimulation parameter to the individual values of the patient status has a confidence parameter greater than a preselected threshold;

or

the patient indicates an end of the initial period.

6. A method for treating a patient, comprising:

collecting a data set containing values of a patient status and values of a spinal cord stimulation parameter at an implantable pulse generator;

analyzing the collected values of the patient status and the values of the stimulation parameter in the data set;

establishing a preference baseline containing individual preference stimulation parameters paired with corresponding individual values of the patient status;

receiving an indication of the patient status; and

in response to receiving the indication of the patient status, automatically adjusting operating parameters of the implantable pulse generator to generate an electrical stimulation signal and apply the generated stimulation signal to a spinal cord region of the patient,

wherein the stimulation parameter includes an amplitude of the stimulation signal, and wherein the values of the stimulation parameter and the values of the patient status are measured with a sensing element embedded in the implantable pulse generator, and wherein the values of the stimulation parameter and the values of the patient status are periodically stored in the implantable pulse generator as the data set, and wherein establishing a preference baseline includes;

calculating a first arithmetic mean of the values of the amplitude corresponding to a first value of the patient status and calculating a second arithmetic mean of the values of the amplitude corresponding to a second value of the patient status based on the stored data set; and

setting a first preference amplitude for the preference baseline based on the calculated first arithmetic mean and a second preference amplitude for the preference baseline based on the calculated second arithmetic mean.

7. A method for treating a patient, comprising:

collecting a data set containing values of a patient status and values of a spinal cord stimulation parameter at an implantable pulse generator;

analyzing the collected values of the patient status and the values of the stimulation parameter in the data set;

establishing a preference baseline containing individual preference stimulation parameters paired with corresponding individual values of the patient status;

receiving an indication of the patient status; and

in response to receiving the indication of the patient status, automatically adjusting operating parameters of the implantable pulse generator to generate an electrical stimulation signal and apply the generated stimulation signal to a spinal cord region of the patient,

wherein the stimulation parameter includes a frequency of the stimulation signal, and wherein the values of the stimulation parameter and the values of the patient status are measured with a sensing element carried by the implantable pulse generator, and wherein the values of the stimulation parameter and the values of the patient status are periodically stored in the implantable pulse generator as the data set, and wherein establishing a preference baseline includes;

calculating a first arithmetic mean of the values of the frequency corresponding to a first value of the patient status and calculating a second arithmetic mean of the values of the frequency corresponding to a second value of the patient status based on the stored data set; and

setting a first preference frequency for the preference baseline based on the calculated first arithmetic mean and a second preference frequency for the preference baseline based on the calculated second arithmetic mean.

8. A method for treating a patient, comprising:

collecting a data set containing values of a patient status and values of a spinal cord stimulation parameter at an implantable pulse generator;

analyzing the collected values of the patient status and the values of the stimulation parameter in the data set;

establishing a preference baseline containing individual preference stimulation parameters paired with corresponding individual values of the patient status;

receiving an indication of the patient status;

in response to receiving the indication of the patient status, automatically adjusting operating parameters of the implantable pulse generator to generate an electrical stimulation signal and apply the generated stimulation signal to a spinal cord region of the patient;

recording additional values of the stimulation parameter and the patient status; and

indicating an alarm if the measured values of the stimulation parameter and/or the patient status exceed a corresponding threshold.

9. A method for treating a patient, comprising:

collecting a data set containing values of a patient status and values of a spinal cord stimulation parameter at an implantable pulse generator;

analyzing the collected values of the patient status and the values of the stimulation parameter in the data set;

establishing a preference baseline containing individual preference stimulation parameters paired with corresponding individual values of the patient status;

receiving an indication of the patient status; and

in response to receiving the indication of the patient status, automatically adjusting operating parameters of the implantable pulse generator to generate an electrical stimulation signal and apply the generated stimulation signal to a spinal cord region of the patient,

wherein collecting a data set includes collecting impedance data, and

wherein collecting impedance data includes distinguishing a capacitive component of the impedance data from a resistive component of the impedance data.

10. The method of claim 9, further comprising establishing a value for the patient status that depends at least in part on distinguishing the capacitive component of the impedance data from the resistive component of the impedance data.

11. A computer-implemented method for treating a patient, comprising:

automatically collecting a data set containing values of a patient status and values of a spinal cord stimulation parameter;

automatically establishing a preference baseline containing individual preference stimulation parameter values paired with corresponding individual values of the patient status based on the data set; and

automatically generating an electrical stimulation signal and applying the generated stimulation signal to a spinal cord region of the patient based on a value of the patient status,

wherein the values of the stimulation parameter and the values of the patient status are measured with a sensing element carried by an implantable pulse generator, and wherein the values of the stimulation parameter and the values of the patient status are periodically stored in the implantable pulse generator as the data set, and wherein establishing a preference baseline includes correlating the values of the measured stimulation parameter to the individual values of the patient status in the data set to establish the preference baseline.

12. The method of claim 11, further comprising:

collecting additional values of the stimulation parameter and the patient status; and

updating the established preference baseline with the additional values of the stimulation parameter and the patient status.

13. A computer-implemented method for treating a patient, comprising:

automatically collecting a data set containing values of a patient status and values of a spinal cord stimulation parameter;

automatically establishing a preference baseline containing individual preference stimulation parameter values paired with corresponding individual values of the patient status based on the data set;

automatically generating an electrical stimulation signal and applying the generated stimulation signal to a spinal cord region of the patient based on a value of the patient status;

collecting additional values of the stimulation parameter and the patient status; and

indicating an alarm if the measured values of the stimulation parameter and/or the patient status exceed a corresponding threshold.

14. A therapy system for treating a patient, comprising:

an implantable pulse generator coupled to a sensing element to detect a patient status and a stimulation parameter of the patient, the implantable pulse generator having a memory to store the detected values of the patient status and the stimulation parameter;

a signal delivery device electrically coupled to the pulse generator to apply a stimulation signal to a spinal cord region of the patient; and

wherein the implantable pulse generator has a computer-readable medium containing instructions for performing a process comprising;

analyzing the stored values of the patient status and the stimulation parameter; and

establishing a preference baseline containing a preference stimulation parameter corresponding to a particular value of the patient status.

15. The therapy system of claim 14 wherein the process further includes transmitting an instruction signal from a remote control to the pulse generator, wherein the instruction signal is configured to adjust an operating parameter of the pulse generator according to the established preference baseline.

16. The therapy system of claim 14 wherein the process further includes establishing the preference baseline containing the preference stimulation parameter corresponding to the particular value of the patient status during an initial period and updating the established preference baseline after the initial period.

17. The therapy system of claim 14 wherein the sensing element is carried by the implantable pulse generator.

18. The therapy system of claim 14 wherein the signal delivery device includes a lead having a plurality of contacts, and wherein the computer-readable medium contains instructions for establishing a patient status value based at least in part on an impedance of a circuit that includes at least one of the contacts.

19. The therapy system of claim 18 wherein the computer-readable medium contains instructions for establishing a patient status value based at least in part on a profile of impedance measurements obtained from multiple contacts of the lead.

20. The therapy system of claim 18 wherein the computer-readable medium contains instructions for distinguishing a capacitive component of the impedance from a resistive component of the impedance.

21. The therapy system of claim 18 wherein the computer-readable medium contains instructions for establishing a value for the patient status that depends at least in part on distinguishing the capacitive component of the impedance from the resistive component of the impedance.

22. The therapy system of claim 18 wherein the computer-readable medium contains instructions for establishing different patient status values depending on a rate at which the impedance changes as a function of time.

23. The therapy system of claim 18 wherein the computer-readable medium contains instructions for establishing a patient status value based on the impedance and corresponding to a patient posture.

24. The therapy system of claim 18 wherein the computer-readable medium contains instructions for establishing a patient status value based on the impedance and corresponding to a patient activity.

25. An implantable pulse generator for treating a spinal cord region of a patient, the implantable pulse generator comprising:

a database module programmed to organize and store records containing values of a patient status and a stimulation parameter; and

a processing module programmed to analyze the stored records of the patient status and the stimulation parameter and establish a preference baseline containing a preference stimulation parameter corresponding to a particular value of the patient status.

26. The implantable pulse generator of claim 25 wherein the values of the stimulation parameter and the patient status are measured with a sensing element embedded in the implantable pulse generator, and wherein the values of the stimulation parameter and the patient status are periodically stored in the implantable pulse generator as a data set, and wherein the processing module is also configured to correlate the measured values of the stimulation parameter to the values of the patient status in the data set to establish the preference baseline.

27. The implantable pulse generator of claim 25 wherein the stimulation parameter includes a stimulation parameter input from the patient, and wherein the values of the stimulation parameter and the patient status are measured with a sensing element embedded in the implantable pulse generator, and wherein the values of the stimulation parameter and the patient status are periodically stored in the implantable pulse generator as a data set, and wherein the processing module is also configured to correlate the measured values of the stimulation parameter input from the patient to the values of the patient status in the data set to establish the preference baseline.