SYSTEM AND METHOD OF ESTABLISHING A PROTOCOL FOR PROVIDING ELECTRICAL STIMULATION WITH A STIMULATION SYSTEM TO TREAT A PATIENT

• US 20160022996A1
• Filed: 09/24/2015
• Published: 01/28/2016
• Est. Priority Date: 05/31/2011
• Status: Active Grant

• Current Assignee: Cirtec Medical Corp.
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Kaula, Norbert, Iyassu, Yohannes
• Granted Patent: US 9,827,424 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 device for performing a computer-assisted stimulation programming of an implantable medical device, the electronic device comprising:

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 a patient, wherein the determining comprises automatically performing a first sweep of the plurality of contacts and automatically performing a second sweep of a stimulation parameter;

thereafter determining a paresthesia coverage provided by the plurality of contacts by automatically performing a third sweep of the plurality of contacts and automatically performing a fourth sweep of the stimulation parameter, wherein the fourth sweep is performed based on the determined perception thresholds, and wherein the automatically performing the first sweep, the second sweep, the third sweep, and the fourth sweep are performed without needing a manual input from a human user;

identifying a subset of the contacts that correspond to the paresthesia coverage; and

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

2. The electronic device 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 device of claim 1, wherein:

the first sweep and the second sweep are performed using a nested loop structure; and

the third sweep and the fourth sweep are performed using the nested loop structure.

4. The electronic device of claim 1, wherein:

the automatically performing the first sweep comprises automatically selecting each of the plurality of contacts to deliver electrical stimulation to the patient; and

the automatically performing the second sweep comprises automatically incrementing a value of the stimulation parameter by one predetermined step size at a time, the second sweep being performed until a patient feedback indicating perceived stimulation is received via an electronic patient feedback device.

5. The electronic device of claim 1, wherein:

the automatically performing the third sweep comprises automatically selecting each of the plurality of contacts to deliver electrical stimulation to the patient; and

the automatically performing the fourth sweep comprises automatically incrementing a value of the stimulation parameter by one predetermined step size at a time, the fourth sweep being performed until a patient feedback indicating perceived paresthesia is received via an electronic patient feedback device.

6. The electronic device of claim 1, wherein the automatically performing the fourth sweep comprises assigning, as a starting value for the fourth sweep, a value of the stimulation parameter that produced the perception threshold.

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;

an electronic patient feedback device configured to produce an electronic patient feedback signal in response to an engagement by the patient; and

an electronic device telecommunicatively coupled to the pulse generator and to the electronic patient feedback device, wherein the electronic device is configured to program the pulse generator to generate the electrical stimulation, and wherein the electronic 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 automatically performing a first sweep of the plurality of contacts and automatically performing a second sweep of a stimulation parameter;

thereafter determining a paresthesia coverage provided by the plurality of contacts by automatically performing a third sweep of the plurality of contacts and automatically performing a fourth sweep of the stimulation parameter, wherein the fourth sweep is performed based on the determined perception thresholds, and wherein the automatically performing the first sweep, the second sweep, the third sweep, and the fourth sweep are performed without needing a manual input from a human user;

identifying a subset of the contacts that correspond to the paresthesia coverage; and

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

8. The medical device 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 device of claim 7, wherein:

the first sweep and the second sweep are performed using a nested loop structure; and

the third sweep and the fourth sweep are performed using the nested loop structure.

10. The medical device of claim 7, wherein:

the automatically performing the first sweep comprises automatically selecting each of the plurality of contacts to deliver electrical stimulation to the patient; and

the automatically performing the second sweep comprises automatically incrementing a value of the stimulation parameter by one predetermined step size at a time, the second sweep being performed until a patient feedback indicating perceived stimulation is received via the electronic patient feedback device.

11. The medical device of claim 7, wherein:

the automatically performing the third sweep comprises automatically selecting each of the plurality of contacts to deliver electrical stimulation to the patient; and

the automatically performing the fourth sweep comprises automatically incrementing a value of the stimulation parameter by one predetermined step size at a time, the fourth sweep being performed until a patient feedback indicating perceived paresthesia is received via the electronic patient feedback device.

12. The medical device of claim 11, wherein the automatically performing the fourth sweep comprises assigning, as a starting value for the fourth sweep, a value of the stimulation parameter that produced the perception threshold.

13. The medical device of claim 7, wherein the electronic patient feedback device comprises one or more sensors configured to detect a tactile engagement or a visual engagement from the patient.

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

determining 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 automatically performing a first sweep of the plurality of contacts and automatically performing a second sweep of a stimulation parameter;

thereafter determining a paresthesia coverage provided by the plurality of contacts by automatically performing a third sweep of the plurality of contacts and automatically performing a fourth sweep of the stimulation parameter, wherein the fourth sweep is performed based on the determined perception thresholds, and wherein the automatically performing the first sweep, the second sweep, the third sweep, and the fourth sweep are performed without needing a manual input from a human user;

identifying a subset of the contacts that correspond to the paresthesia coverage; and

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

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:

the first sweep and the second sweep are performed using a nested loop structure; and

the third sweep and the fourth sweep are performed using the nested loop structure.

17. The method of claim 14, wherein:

the automatically performing the first sweep comprises automatically selecting each of the plurality of contacts to deliver electrical stimulation to the patient; and

the automatically performing the second sweep comprises automatically incrementing a value of the stimulation parameter by one predetermined step size at a time, the second sweep being performed until a patient feedback indicating perceived stimulation is received via an electronic patient feedback device.

18. The method of claim 14, wherein:

the automatically performing the third sweep comprises automatically selecting each of the plurality of contacts to deliver electrical stimulation to the patient; and

the automatically performing the fourth sweep comprises automatically incrementing a value of the stimulation parameter by one predetermined step size at a time, the fourth sweep being performed until a patient feedback indicating perceived paresthesia is received via an electronic patient feedback device.

19. The method of claim 18, wherein the automatically performing the fourth sweep comprises assigning, as a starting value for the fourth sweep, a value of the stimulation parameter that produced the perception threshold.

20. 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 under anesthesia.