IP Library Granted Patent US 11,116,986
Granted Patent B2
US 11,116,986 · App. 16/054,422 · Granted Sep 14, 2021

Systems, methods, and devices for performing electronically controlled test stimulation

Inventors: Norbert Kaula (Arvada, CO); Yohannes Iyassu (Denver, CO)
Assignee: CIRTEC MEDICAL CORPORATION
A61N1/37247A61N1/36007A61N1/36107A61N1/36167A61N1/37241G16H20/40G16H40/63G16H50/50A61N1/0502A61N1/0551A61N1/36017A61N1/36171
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Quick Facts
Patent No.
US 11,116,986
App. No.
16/054,422
Granted
Sep 14, 2021
Kind
B2
Abstract

The present disclosure involves systems and methods of programming electrical stimulation therapy for a patient. A communications link is established with a pulse generator that is configured to generate electrical stimulation pulses. An intermittent electrical coupling between the pulse generator and a diagnostic tool is simulated. This simulation is performed by instructing, for a plurality of cycles, the pulse generator to automatically turn on and off the generation of electrical stimulation pulses. Each cycle includes a first time period and a second time period following the first time period. The simulating includes: instructing the pulse generator to generate the electrical stimulation pulses during the first time period; and instructing the pulse generator to stop generating the electrical stimulation pulses during the second time period.

Claims (51)

1. A system for evaluating placement location of a stimulation device in a patient, the system comprising:

a sacral nerve stimulation generator; and

a programmer for programming the sacral nerve stimulation generator, the programmer comprising:

a graphical user interface configured to receive an input from a user and communicate an output to the user;

an electronic memory storage configured to store programming instructions; and

one or more processors configured to execute the programming instructions to perform operations comprising:

establishing a communications link with a trial stimulator that is configured to generate electrical stimulation pulses, the trial stimulator being located external to the patient;

causing the trial stimulator to generate electrical stimulation pulses at a therapeutic frequency of 12 hz or greater;

simultaneously displaying, via the graphical user interface, a plurality of patient sedation states and a plurality of types of physical responses the patient could exhibit in response to being stimulated by the electrical stimulation pulses at the therapeutic frequency, wherein the plurality of types of physical responses includes: motor responses of foot, heel, legs, bellows, great toe, or bottom foot, or sensory responses of genitals, perineum, tailbone, rectal, low extremity, or butt cheek;

associating, in response to user input received via the graphical user interface, each of the patient sedation states with a respective subset of the physical responses; and

simulating an intermittent electrical coupling between the trial stimulator and a percutaneous nerve evaluation (PNE) needle inserted inside a body of the patient, wherein the simulating comprises:

instructing the trial stimulator to interrupt the therapeutic frequency and set to a non-therapeutic frequency; and

instructing the trial stimulator to interrupt the non-therapeutic frequency and set to the therapeutic frequency.

2. The system of claim 1 , wherein the non-therapeutic frequency is substantially zero, and wherein the simulating is activated in response to an engagement of a virtual control mechanism displayed by the graphical user interface.

3. The system of claim 1 , wherein the simulating is performed such that the trial stimulator generates the electrical stimulation pulses at the therapeutic frequency for an X amount of time and at the non-therapeutic frequency for a Y amount of time, where X and Y are user-programmable values entered via the graphical user interface.

4. The system of claim 1 , further comprising: a feedback mechanism configured to communicate a first feedback signal to the user while the trial stimulator is set to the therapeutic frequency and a second feedback signal to the user while the trial stimulator is set to the non-therapeutic frequency.

5. The system of claim 4 , wherein the plurality of types of physical responses further includes a user-defined response inputted via the graphical user interface.

6. The system of claim 1 , further comprising: the trial stimulator, wherein the trial stimulator is configured to simulate the intermittent electrical coupling by interrupting the therapeutic frequency and setting to the non-therapeutic frequency and interrupting the non-therapeutic frequency and setting to the therapeutic frequency.

7. The system of claim 4 , wherein the first feedback signal and the second feedback signal are different types of feedback signals.

8. An electronic programmer, comprising:

a graphical user interface configured to receive an input from a user and communicate an output to the user;

an electronic memory storage configured to store programming instructions; and

one or more processors configured to execute the programming instructions to perform operations comprising:

establishing a communications link with a trial stimulator that is located external to a patient;

causing the trial stimulator to generate electrical stimulation pulses of a sacral nerve stimulation therapy at a therapeutic frequency of 12 hz or greater;

displaying, via the graphical user interface, a plurality of types of physical responses the patient could exhibit in response to being stimulated by the electrical stimulation pulses at the therapeutic frequency, wherein the plurality of types of physical responses includes: motor responses of foot, heel, leg, bellows, great toe, or bottom foot, or sensory responses of genitals, perineum, tailbone, rectal, low extremity, or butt cheek;

displaying, via the graphical user interface, a virtual lead having a plurality of virtual contacts;

associating, for each of the virtual contacts of at least a subset of the plurality of virtual contacts, a respective subset of the physical responses entered by the user via an engagement of the virtual contacts via the graphical user interface; and

simulating an intermittent electrical coupling between the trial stimulator and a percutaneous nerve evaluation (PNE) needle inserted inside a body of the patient, wherein the simulating comprises:

instructing the trial stimulator to interrupt the therapeutic frequency and set to a non-therapeutic frequency; and

instructing the trial stimulator to interrupt the non-therapeutic frequency and set to the therapeutic frequency.

9. The electronic programmer of claim 8 , wherein the non-therapeutic frequency is substantially zero, and wherein the stimulating is activated in response to an engagement of a virtual control mechanism displayed by the graphical user interface.

10. The electronic programmer of claim 8 , wherein the simulating is performed such that the trial stimulator generates the electrical stimulation pulses at the therapeutic frequency for an X amount of time and at the non-therapeutic frequency for a Y amount of time, where X and Y are user-programmable values entered via the graphical user interface.

11. The electronic programmer of claim 8 , further comprising: a feedback mechanism configured to communicate a first feedback signal to the user while the trial stimulator is set to the therapeutic frequency and a second feedback signal to the user while the trial stimulator is set to the non-therapeutic frequency.

12. The electronic programmer of claim 11 , wherein the feedback mechanism is implemented as a visual or audible component on the programmer.

13. The electronic programmer of claim 11 , wherein the first feedback signal and the second feedback signal are different types of feedback signals.

14. A method, comprising:

receiving an input from a user and communicating an output to the user via an electronic user interface;

establishing, via a radio component, a communications link with a trial stimulator that is located external to a patient;

sending instructions to the trial stimulator via the radio component to cause the trial stimulator to generate electrical stimulation pulses for a sacral nerve stimulation therapy at a therapeutic frequency of 12 hz or greater;

simultaneously displaying, via the electronic user interface, a plurality of patient sedation states and a plurality of types of physical responses the patient could exhibit in response to being stimulated by the electrical stimulation pulses at the therapeutic frequency, wherein the plurality of types of physical responses includes: motor responses of foot, heel, leg, bellows, great toe, or bottom foot, or sensory responses of genitals, perineum, tailbone, rectal, low extremity, or butt cheek;

associating, in response to user input received via the electronic user interface, each of the patient sedation states with a respective subset of the physical responses; and

in response to input received from the user via the electronic user interface, performing a simulation of an intermittent electrical coupling between the trial stimulator and a percutaneous nerve evaluation (PNE) needle inserted inside a body of the patient, wherein the simulation comprises:

instructing the trial stimulator to interrupt the therapeutic frequency and set to a non-therapeutic frequency; and

instructing the trial stimulator to interrupt the non-therapeutic frequency and set to the therapeutic frequency.

15. The method of claim 14 , wherein the non-therapeutic frequency is substantially zero, and wherein the stimulating is activated in response to an engagement of a virtual control mechanism displayed by the electronic user interface.

16. The method of claim 14 , wherein the simulation is performed such that the trial stimulator generates the electrical stimulation pulses at the therapeutic frequency for an X amount of time and at the non-therapeutic frequency for a Y amount of time, where X and Y are user-programmable values entered via the electronic user interface.

17. The method of claim 14 , further comprising: communicating a first feedback signal to the user while the trial stimulator is set to the therapeutic frequency and a second feedback signal to the user while the trial stimulator is set to the non-therapeutic frequency.

18. The method of claim 17 , wherein the communicating comprises playing a visual signal or an audible signal as the first feedback signal or as the second feedback signal.

19. The method of claim 14 , wherein the instructing the trial stimulator to interrupt the therapeutic frequency and set to the non-therapeutic frequency and the instructing the trial stimulator to interrupt the non-therapeutic frequency and set to the therapeutic frequency are performed automatically without user input.

20. The method of claim 17 , wherein the first feedback signal and the second feedback signal are different types of feedback signals.

Assignments (6)
PATENT SECURITY AGREEMENT Recorded Jan 30, 2023
From: CIRTEC MEDICAL CORP.
To: BMO HARRIS BANK N.A., AS COLLATERAL AGENT
Reel/Frame 062559/0098 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 18, 2020
From: NUVECTRA CORPORATION
To: CIRTEC MEDICAL CORP.
Reel/Frame 052185/0680 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 14, 2018
From: RODENBECK, ROBERT W.; NOBLE, JOHN; SPANGLER, ANTHONY G.; SAWASKI, JOEL D.; RAMASAMY, JAYASHANGER GOUNDIAH; JONTE, PATRICK B.; MARTY, GARRY R.
To: DELTA FAUCET COMPANY
Reel/Frame 047494/0212 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 3, 2018
From: KAULA, NORBERT; IYASSU, YOHANNES
To: GREATBATCH, LTD
Reel/Frame 046551/0902 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 3, 2018
From: GREATBATCH, LTD
To: QIG GROUP, LLC
Reel/Frame 046551/0970 →
CHANGE OF NAME Recorded Aug 3, 2018
From: QIG GROUP, LLC
To: NUVECTRA CORPORATION
Reel/Frame 046713/0359 →