System and method of establishing a protocol for providing electrical stimulation with a stimulation system to treat a patient

• US 9,827,424 B2
• Filed: 09/24/2015
• Issued: 11/28/2017
• Est. Priority Date: 05/31/2011
• Status: Active Grant

• Current Assignee: Cirtec Medical Corp.
• Original Assignee: Nuvectra Corporation
• Inventors: Kaula, Norbert, Iyassu, Yohannes
• Primary Examiner(s): LEVICKY, WILLIAM J
• Application Number:
  US14/863,469
• Publication Number:
  US 20160022996A1
• Time in Patent Office: 796 Days
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 40/60 for the operation of medical equipment or devices
• CPC Class Codes: G16H 40/63 for local operation

Abstract

A computer-assisted stimulation programming of an implantable medical device is performed. A perception threshold is determined for a plurality of contacts on a lead configured to be implanted inside a patient. The perception threshold is determined by automatically performing a first sweep of the plurality of contacts and automatically performing a second sweep of a stimulation parameter. A paresthesia coverage provided by the plurality of contacts is determined by automatically performing a third sweep of the plurality of contacts and automatically performing a fourth sweep of the stimulation parameter. The fourth sweep is performed based on the determined perception thresholds. The first sweep, the second sweep, the third sweep, and the fourth sweep are performed without needing a manual input from a human user. A subset of the contacts corresponding to the paresthesia coverage is selected. In response to user input, stimulation programming is performed using the subset of contacts.

Claims

1. An electronic apparatus for performing a computer-assisted stimulation programming of an implantable medical device, the electronic apparatus comprising:

an electronic patient feedback device configured to generate signals in response to a voluntary tactile or visual engagement from a patient;

a first programming device configured to offer a first set of programming options for programming the implantable medical device; and

a second programming device configured to offer a second set of programming options for programming the implantable medical device, wherein the second set of programming options is greater than the first set of programming options, and wherein the second programming device includes;

a user interface configured to receive user input;

a memory storage component configured to store programming code; and

a computer processor configured to execute the programming code to perform the following operations;

determining a perception threshold for each of a plurality of contacts on a lead that is configured to be implanted inside the patient, wherein the determining comprises, determining, for each of the contacts, a respective minimum stimulation parameter that causes the patient to sense an electrical stimulation;

thereafter determining a paresthesia coverage for each of the plurality of contacts by automatically and steadily incrementing, for each of the contacts, a stimulation parameter from a respective starting value that is set to the perception threshold for said contact;

identifying, based on the determining of the paresthesia coverage, a subset of the contacts that offer paresthesia coverage for a pain area of the patient; and

performing, in response to the user input received through the user interface, stimulation programming using the subset of the contacts;

wherein the determining the perception threshold or the determining the paresthesia coverage is performed at least in part based on the signals generated by the electronic patient feedback device.

2. The electronic apparatus of claim 1, wherein the operations further comprise, before the determining the perception threshold:

measuring an impedance for each of the plurality of contacts; and

determining which contacts have connections problems based on the measured impedance.

3. The electronic apparatus of claim 1, wherein:

the determining of the perception threshold and the determining the paresthesia coverage each comprises executing a respective sweep using a nested loop structure.

4. The electronic apparatus of claim 1, wherein:

the determining of the perception threshold comprises automatically incrementing a value of the stimulation parameter by one predetermined step size at a time until a patient feedback indicating perceived stimulation by the patient is received via the electronic patient feedback device.

5. The electronic apparatus of claim 1, wherein:

the determining of the paresthesia coverage comprises automatically incrementing a value of the stimulation parameter by one predetermined step size at a time until a patient feedback indicating perceived paresthesia by the patient is received via the electronic patient feedback device.

6. The electronic apparatus of claim 1, wherein the electronic patient feedback device generates the signals in response to a squeezing of a housing of the electronic patient feedback device.

7. A medical system, comprising:

a lead configured to deliver electrical stimulation to a patient via one or more of a plurality of contacts located on the lead;

a pulse generator to which the lead is coupled, wherein the pulse generator is configured to generate the electrical stimulation;

a patient programmer device configured to program the pulse generator;

an electronic patient feedback device that includes one or more sensors, wherein the electronic patient feedback device is configured to produce an electronic patient feedback signal in response to a voluntary tactile or visual engagement by the patient, the electronic patient feedback device being different from the patient programmer device; and

a clinician programmer device different from the patient programmer device, the clinician programmer being coupled to the pulse generator and to the electronic patient feedback device, wherein the clinician programmer device is configured to program the pulse generator to generate the electrical stimulation, and wherein the clinician programmer device includes;

a memory storage component configured to store computer instructions; and

a processor component configured to execute the computer instructions;

wherein the computer instructions, when executed by the processor component, perform the following operations;

determining a perception threshold for each of the plurality of contacts, wherein the determining comprises determining, for each of the contacts, a respective minimum stimulation parameter that causes the patient to sense an electrical stimulation;

thereafter determining a paresthesia coverage for each of the plurality of contacts by automatically and steadily incrementing, for each of the contacts, a stimulation parameter from a respective starting value that is set to the perception threshold for said contact;

identifying, based on the determining of the paresthesia coverage, a subset of the contacts that offer paresthesia coverage for a pain area of the patient; and

performing, in response to user input, stimulation programming using the subset of the contacts.

8. The medical system of claim 7, wherein the operations further comprise, before the determining the perception threshold:

measuring an impedance for each of the plurality of contacts; and

determining which contacts have connections problems based on the measured impedance.

9. The medical system of claim 7, wherein:

the determining of the perception threshold and the determining the paresthesia coverage each comprises executing a respective sweep using a nested loop structure.

10. The medical system of claim 7, wherein:

the determining of the perception threshold comprises automatically incrementing a value of the stimulation parameter by one predetermined step size at a time until a patient feedback indicating perceived stimulation by the patient is received via the electronic patient feedback device.

11. The medical system of claim 7, wherein:

the determining of the paresthesia coverage comprises automatically incrementing a value of the stimulation parameter by one predetermined step size at a time until a patient feedback indicating perceived paresthesia by the patient is received via the electronic patient feedback device.

12. The medical system of claim 7, wherein the electronic patient feedback device is configured to produce the electronic patient feedback signal in response to a pressure applied by the patient on a housing of the electronic patient feedback device.

13. The medical system of claim 7, wherein the electronic patient feedback device produces the electronic patient feedback signal in response to a squeezing of a housing of the electronic patient feedback device.

14. A method of performing a computer-assisted stimulation programming of an implantable medical device, the method comprising:

determining, via a clinician programming device, a perception threshold for each of a plurality of contacts on a lead that is configured to be implanted inside a patient, wherein the determining comprises, determining, for each of the contacts, a respective minimum stimulation parameter that causes the patient to sense an electrical stimulation, and wherein the clinician programming device is different from, and offers more programming options than, a patient programming device;

thereafter determining, via a clinician programming device, a paresthesia coverage for each of the plurality of contacts by automatically and steadily incrementing, for each of the contacts, a stimulation parameter from a respective starting value that is set to the perception threshold for said contact;

identifying, via a clinician programming device and based on the determining the paresthesia coverage, a subset of the contacts that offer paresthesia coverage for a pain area of the patient; and

performing, via a clinician programming device and in response to user input, stimulation programming using the subset of the contacts;

wherein the determining the perception threshold or the determining the paresthesia coverage is performed at least in part based on signals generated by an electronic patient feedback device in response to a voluntary tactile or visual engagement from the patient, the electronic patient feedback device being different from the patient programming device and the clinician programming device and including a pressure sensor to sense a variable force applied by the patient as the voluntary tactile engagement.

15. The method of claim 14, further comprising, before the determining the perception threshold:

measuring an impedance for each of the plurality of contacts; and

determining which contacts have connections problems based on the measured impedance.

16. The method of claim 14, wherein:

determining of the perception threshold and the determining the paresthesia coverage each comprises executing a respective sweep using a nested loop structure.

17. The method of claim 14, wherein:

the determining of the perception threshold comprises automatically incrementing a value of the stimulation parameter by one predetermined step size at a time, until a patient feedback indicating perceived stimulation by the patient is received via the electronic patient feedback device; and

the determining of the paresthesia coverage comprises automatically incrementing a value of the stimulation parameter by one predetermined step size at a time until a patient feedback indicating perceived paresthesia by the patient is received via the electronic patient feedback device.

18. The method of claim 14, wherein:

the signals generated by the electronic patient feedback device comprise an analog signal, and wherein the method further comprises converting the analog signal into a digital signal.

19. The method of claim 14, wherein the determining the perception threshold and the determining the paresthesia coverage are performed during a surgical setting where the patient is woken up from anesthesia.

20. The method of claim 14, wherein the pressure sensor includes a strain gauge, and wherein the variable force is applied by a squeezing of a housing of the electronic patient feedback device.