IP Library Granted Patent US 8,914,128
Granted Patent B2
US 8,914,128 · App. 13/558,271 · Granted Dec 16, 2014

Methods, devices and systems for programming neurostimulation

Inventors: Mir A. Imran (Los Altos, CA); Brian J. Mossop (San Francisco, CA); Eyad Kishawi (San Carlos, CA)
Assignee: Spinal Modulation, Inc.
A61N1/37247A61N1/3605A61N1/0551A61N1/36185A61N1/36071A61N1/36146
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Quick Facts
Patent No.
US 8,914,128
App. No.
13/558,271
Granted
Dec 16, 2014
Kind
B2
Abstract

Methods, devices and systems are provided to efficiently identify, from among a plurality of possible neurostimulation parameter sets, one or more preferred neurostimulation parameter sets that treat a targeted pain of a patient. A plurality of different neurostimulation parameter sets are tested on the patient to thereby identify those tested neurostimulation parameter sets that treat the targeted pain. Each of the tested neurostimulation parameter sets defines an electrode configuration that differs from the other tested neurostimulation parameter sets. If more than one of the tested neurostimulation parameter sets are identified as treating the targeted pain, then neurostimulation parameter sets identified as treating the targeted pain are retested, with the value for a specific neurostimulation signal parameter reduced by a same amount for each of the retested neurostimulation parameter sets, to thereby identify those neurostimulation parameter sets that treat the targeted pain at the reduced power consumption level.

Claims (114)

1. A method for efficiently identifying, from among a plurality of possible neurostimulation parameter sets, a preferred neurostimulation parameter set that an implantable neurostimulation device can use to treat a targeted pain of a patient,

wherein each neurostimulation parameter set defines electrode parameters and neurostimulation signal parameters,

wherein the electrode parameters of each neurostimulation parameter set define which electrodes are used to provide neurostimulation, and

wherein the neurostimulation signal parameters of each neurostimulation parameter set define a pulse width and a pulse amplitude,

the method comprising:

(a) testing on the patient a plurality of different initial neurostimulation parameter sets,

wherein each of the initial tested neurostimulation parameter sets defines an electrode configuration that differs from the other initial tested neurostimulation parameter sets, and

wherein all of the initial tested neurostimulation parameter sets comprise a same starting value for pulse amplitude and a same starting value for pulse width;

(b) when none of the neurostimulation parameter sets tested at step (a) treat the targeted pain,

(b.1) increasing the value of the pulse amplitude by a same amount for each of the plurality of neurostimulation parameter sets,

(b.2) retesting on the patient the plurality of neurostimulation parameter sets with the same increased value for the pulse amplitude for each of the retested neurostimulation parameter sets, and

(b.3) wherein steps (b.1) and (b.2) are repeated until at least one neurostimulation parameter set that treats the targeted pain is identified, wherein each time step (b.1) is repeated the value for the pulse amplitude is again increased; and

(c) when more than one of the neurostimulation parameter sets tested at step (a) or (b) treated the targeted pain,

(c.1) reducing the value of the pulse width by a same amount for each of the plurality of neurostimulation parameter sets tested at step (a) or (b) that treated the targeted pain, wherein the same amount by which the value of the pulse width is reduced is based on the number of neurostimulation parameter sets that treated the targeted pain at the most recently tested value of the pulse width;

(c.2) retesting on the patient the plurality of neurostimulation parameter sets that treated the targeted pain, with the same reduced value for the pulse width for each of the retested neurostimulation parameter sets, to thereby identify those neurostimulation parameter sets that treat the targeted pain with the reduced pulse width, and

(c.3) wherein steps (c.1) and (c.2) are repeated until only one neurostimulation parameter set that treats the targeted pain is identified, wherein each time step (c.1) is repeated the value for the pulse width is again decreased.

2. The method of claim 1 , wherein a maximum value for pulse width is specified, and wherein at step (a), the same starting value for pulse width, included in all of the neurostimulation parameter sets tested at step (a), comprises the maximum value specified.

3. The method of claim 1 , wherein a minimum value for pulse amplitude is specified, and wherein at step (a), the same starting value for pulse amplitude, included in all of the neurostimulation parameter sets tested at step (a), comprises the minimum value specified.

4. The method of claim 1 , further comprising:

(d) once there is only one of the neurostimulation parameter sets tested at step (a), (b) or (c) that treats the targeted pain, then identifying that one of the neurostimulation parameter sets as the preferred neurostimulation parameter set.

5. The method of claim 1 , wherein:

the electrode parameters of each neurostimulation parameter set define which one or more electrodes used to provide neurostimulation are connected as a cathode, and which one or more electrodes used to provide neurostimulation are connected as an anode.

6. A method for efficiently identifying, from among a plurality of possible neurostimulation parameter sets, a preferred neurostimulation parameter set that an implantable neurostimulation device can use to treat a targeted pain of a patient,

wherein each neurostimulation parameter set defines electrode parameters and neurostimulation signal parameters,

wherein the electrode parameters of each neurostimulation parameter set define which electrodes are used to provide neurostimulation, and

wherein the neurostimulation signal parameters of each neurostimulation parameter set define a pulse width, a pulse amplitude and a pulse repetition rate,

the method comprising:

(a) testing on the patient a plurality of different initial neurostimulation parameter sets,

wherein each of the initial tested neurostimulation parameter sets defines an electrode configuration that differs from the other initial tested neurostimulation parameter sets, and

wherein all of the initial tested neurostimulation parameter sets comprise a same starting value for pulse amplitude, a same starting value for pulse width, and a same starting value for pulse repetition rate;

(b) when none of the neurostimulation parameter sets tested at step (a) treat the targeted pain,

(b.1) increasing the value of the pulse amplitude by a same amount for each of the plurality of neurostimulation parameter sets,

(b.2) retesting on the patient the plurality of neurostimulation parameter sets with the same increased value for the pulse amplitude for each of the retested neurostimulation parameter sets, and

(b.3) wherein steps (b.1) and (b.2) are repeated until at least one neurostimulation parameter set that treats the targeted pain is identified, wherein each time step (b.1) is repeated the value for the pulse amplitude is again increased;

(c) when more than one of the neurostimulation parameter sets tested at step (a) or (b) treated the targeted pain,

(c.1) reducing the value of the pulse width by a same amount for each of the plurality of neurostimulation parameter sets tested at step (a) or (b) that treated the targeted pain, wherein the same amount by which the value of the pulse width is reduced is proportional to the number of neurostimulation parameter sets that treated the targeted pain at the most recently tested value of the pulse width;

(c.2) retesting on the patient the plurality of neurostimulation parameter sets that treated the targeted pain, with the same reduced value for the pulse width for each of the retested neurostimulation parameter sets, to thereby identify those neurostimulation parameter sets that treat the targeted pain with the reduced pulse width, and

(c.3) wherein steps (c.1) and (c.2) are repeated until only one neurostimulation parameter set that treats the targeted pain is identified, wherein each time step (c.1) is repeated the value for the pulse width is again decreased; and

(d) once there is only one of the neurostimulation parameter sets tested at step (a), (b) or (c) that treated the targeted pain, then iteratively reducing the pulse repetition rate for that one of the neurostimulation parameter sets until a lowest pulse repetition rate that treats the targeted pain is identified.

7. The method of claim 6 , further comprising:

(e) identifying the one of the neurostimulation parameter sets including the lowest pulse repetition rate that treats the targeted pain as the preferred neurostimulation parameter set.

8. An external programmer configured to efficiently identify, from among a plurality of possible neurostimulation parameter sets, a preferred neurostimulation parameter set that treats a targeted pain of a patient,

wherein each neurostimulation parameter set defines electrode parameters and neurostimulation signal parameters,

wherein the electrode parameters of each neurostimulation parameter set define which electrodes are used to provide neurostimulation, and

wherein the neurostimulation signal parameters of each neurostimulation parameter set define a pulse width and a pulse amplitude,

the external programmer including:

memory to store a plurality of different initial neurostimulation parameter sets to be tested on the patient, wherein each of the initial neurostimulation parameter sets to be tested defines an electrode configuration that differs from the other initial neurostimulation parameter sets, and wherein all of the initial neurostimulation parameter sets comprise a same starting value for pulse amplitude and a same starting value for pulse width;

a controller configured to provide initial test instructions that instruct an implantable pulse generator (IPG), implanted within the patient, to test on the patient the plurality of different initial neurostimulation parameter sets;

telemetry circuitry configured to transmit the test instructions to the IPG implanted within the patient; and

a user interface configured to accept feedback that identifies which tested neurostimulation parameter sets treat the targeted pain;

wherein the controller is also configured to

provide first retest instructions, when none of the initial neurostimulation parameter sets tested treat the targeted pain, wherein the first retest instructions instruct the IPG to increase the value of the pulse amplitude by a same amount for each of the plurality of neurostimulation parameter sets, and retest on the patient the plurality of neurostimulation parameter sets with the same increased value for the pulse amplitude for each of the retested neurostimulation parameter sets, to thereby identify those neurostimulation parameter sets, if any, that treat the targeted pain with the increased pulse amplitude value, and

provide second retest instructions, when more than one of the neurostimulation parameter sets tested treated the targeted pain, wherein the second retest instructions instruct the IPG to reduce the value of the pulse width by a same amount for each of the plurality of neurostimulation parameter sets previously tested that treated the targeted pain, and retest on the patient the plurality of neurostimulation parameter sets that treated the targeted pain, with the same reduced value for the pulse width for each of the retested neurostimulation parameter sets, to thereby identify those neurostimulation parameter sets that treat the target pain with the reduced pulse width;

wherein each time the controller provides the second retest instructions, the amount by which the value of the pulse width is reduced for each of the retested neurostimulation parameter sets is based on the number of neurostimulation parameter sets that treated the targeted pain at the most recently tested value of the pulse width;

wherein the telemetry circuit is also configured to transmit the first and second retest instructions to the IPG; and

wherein the user interface is also configured to accept feedback that identifies those retested neurostimulation parameter sets that treat the targeted pain.

9. The external programmer of claim 8 , wherein the external programmer comprises a patient programmer.

10. The external programmer of claim 8 , wherein the external programmer comprises a clinician programmer.

11. The external programmer of claim 8 , wherein a maximum value for pulse width is specified, and the same starting value for pulse width, included in all of the initial neurostimulation parameter sets, comprises the maximum value for pulse width specified.

12. The external programmer of claim 11 , wherein a minimum value for pulse amplitude is specified, and the same starting value for pulse amplitude, included in all of the initial neurostimulation parameter sets, comprises the minimum value for pulse amplitude specified.

13. The external programmer of claim 8 , wherein the controller is also configured to provide the first and/or second retest instructions until only one neurostimulation parameter set that treats the targeted pain is identified.

14. The external programmer of claim 13 , wherein once there is only one of the neurostimulation parameter sets tested that treats the targeted pain, the controller is configured to identify that one of the neurostimulation parameter sets as the preferred neurostimulation parameter set.

15. An external programmer configured to efficiently identify, from among a plurality of possible neurostimulation parameter sets, a preferred neurostimulation parameter set that treats a targeted pain of a patient,

wherein each neurostimulation parameter set defines electrode parameters and neurostimulation signal parameters,

wherein the electrode parameters of each neurostimulation parameter set define which electrodes are used to provide neurostimulation, and

wherein the neurostimulation signal parameters of each neurostimulation parameter set define a pulse width, a pulse amplitude and a pulse repetition rate,

the external programmer including:

memory to store a plurality of different initial neurostimulation parameter sets to be tested on the patient, wherein each of the initial neurostimulation parameter sets to be tested defines an electrode configuration that differs from the other initial neurostimulation parameter sets, and wherein all of the initial neurostimulation parameter sets comprise a same starting value for pulse amplitude, a same starting value for pulse width and a same starting value for pulse repetition rate;

a controller configured to provide initial test instructions that instruct an implantable pulse generator (IPG), implanted within the patient, to test on the patient the plurality of different initial neurostimulation parameter sets;

telemetry circuitry configured to transmit the test instructions to the IPG implanted within the patient; and

a user interface configured to accept feedback that identifies which tested neurostimulation parameter sets treat the targeted pain;

wherein the controller is also configured to

provide first retest instructions, when none of the initial neurostimulation parameter sets tested treat the targeted pain, wherein the first retest instructions instruct the IPG to increase the value of the pulse amplitude by a same amount for each of the plurality of neurostimulation parameter sets, and retest on the patient the plurality of neurostimulation parameter sets with the same increased value for the pulse amplitude for each of the retested neurostimulation parameter sets, to thereby identify those neurostimulation parameter sets, if any, that treat the targeted pain with the increased pulse amplitude value, and

provide second retest instructions, when more than one of the neurostimulation parameter sets tested treated the targeted pain, wherein the second retest instructions instruct the IPG to reduce the value of the pulse width by a same amount for each of the plurality of neurostimulation parameter sets previously tested that treated the targeted pain, and retest on the patient the plurality of neurostimulation parameter sets that treated the targeted pain, with the same reduced value for the pulse width for each of the retested neurostimulation parameter sets, to thereby identify those neurostimulation parameter sets that treat the target pain with the reduced pulse width;

wherein each time the controller provides the second retest instructions, the amount by which the value of the pulse width is reduced for each of the retested neurostimulation parameter sets is proportional to the number of neurostimulation parameter sets that treated the targeted pain at the most recently tested value of the pulse width;

wherein once there is only one of the neurostimulation parameter sets tested at that treated the targeted pain, then the controller is configured to iteratively reduce the pulse repetition rate for that one of the neurostimulation parameter sets until a lowest pulse repetition rate that treats the targeted pain is identified;

wherein the telemetry circuit is also configured to transmit the first and second retest instructions to the IPG; and

wherein the user interface is also configured to accept feedback that identifies those retested neurostimulation parameter sets that treat the targeted pain.

16. The external programmer of claim 15 , wherein the controller is configured to identify the one of the neurostimulation parameter sets including the lowest pulse repetition rate that treats the targeted pain as the preferred neurostimulation parameter set.

17. The external programmer of claim 16 , wherein:

the electrode parameters of each neurostimulation parameter set define which one or more electrodes used to provide neurostimulation are connected as a cathode, and which one or more electrodes used to provide neurostimulation are connected as an anode.

18. A method for efficiently identifying, from among a plurality of possible neurostimulation parameter sets, a preferred neurostimulation parameter set that an implantable neurostimulation device can use to treat a targeted pain of a patient,

wherein each neurostimulation parameter set defines electrode parameters and neurostimulation signal parameters,

wherein the electrode parameters of each neurostimulation parameter set define which electrodes are used to provide neurostimulation, and

wherein the neurostimulation signal parameters of each neurostimulation parameter set define a pulse width and a pulse amplitude,

the method comprising:

(a) testing on the patient a plurality of different initial neurostimulation parameter sets,

wherein each of the initial tested neurostimulation parameter sets defines an electrode configuration that differs from the other initial tested neurostimulation parameter sets, and

wherein all of the initial tested neurostimulation parameter sets comprise a same specified minimum value for pulse amplitude and a same specified maximum value for pulse width;

(b) when none of the neurostimulation parameter sets tested at step (a) treat the targeted pain, then

(b.1) increasing the value of the pulse amplitude by a same amount for each of the plurality of neurostimulation parameter sets,

(b.2) retesting on the patient the plurality of neurostimulation parameter sets with the same increased value for the pulse amplitude for each of the retested neurostimulation parameter sets, and

(b.3) wherein steps (b.1) and (b.2) are repeated until at least one neurostimulation parameter set that treats the targeted pain is identified, wherein each time step (b.1) is repeated the value for the pulse amplitude is again increased; and

(c) when more than one of the neurostimulation parameter sets tested at step (a) or (b) treated the targeted pain, then

(c.1) reducing the value of the pulse width by a same amount for each of the plurality of neurostimulation parameter sets tested at step (a) or (b) that treated the targeted pain, wherein the same amount by which the value of the pulse width is reduced is based on the number of neurostimulation parameter sets that treated the targeted pain at the most recently tested value of the pulse width,

(c.2) retesting on the patient the plurality of neurostimulation parameter sets that treated the targeted pain, with the same reduced value for the pulse width for each of the retested neurostimulation parameter sets, to thereby identify those neurostimulation parameter sets that treat the target pain with the reduced pulse width, and

(c.3) wherein steps (c.1) and (c.2) are repeated until only one neurostimulation parameter set that treats the targeted pain is identified, wherein each time step (c.1) is repeated the value for the pulse width is again decreased.

19. A method for efficiently identifying, from among a plurality of possible neurostimulation parameter sets, a preferred neurostimulation parameter set that an implantable neurostimulation device can use to treat a targeted pain of a patient,

wherein each neurostimulation parameter set defines electrode parameters and neurostimulation signal parameters,

wherein the electrode parameters of each neurostimulation parameter set define which electrodes are used to provide neurostimulation, and

wherein the neurostimulation signal parameters of each neurostimulation parameter set define a pulse width, a pulse amplitude and a pulse repetition rate,

the method comprising:

(a) testing on the patient a plurality of different initial neurostimulation parameter sets,

wherein each of the initial tested neurostimulation parameter sets defines an electrode configuration that differs from the other initial tested neurostimulation parameter sets, and

wherein all of the initial tested neurostimulation parameter sets comprise a same specified minimum value for pulse amplitude and a same specified maximum value for pulse width;

(b) when none of the neurostimulation parameter sets tested at step (a) treat the targeted pain, then

(b.1) increasing the value of the pulse amplitude by a same amount for each of the plurality of neurostimulation parameter sets,

(b.2) retesting on the patient the plurality of neurostimulation parameter sets with the same increased value for the pulse amplitude for each of the retested neurostimulation parameter sets, and

(b.3) wherein steps (b.1) and (b.2) are repeated until at least one neurostimulation parameter set that treats the targeted pain is identified, wherein each time step (b.1) is repeated the value for the pulse amplitude is again increased;

(c) when more than one of the neurostimulation parameter sets tested at step (a) or (b) treated the targeted pain, then

(c.1) reducing the value of the pulse width by a same amount for each of the plurality of neurostimulation parameter sets tested at step (a) or (b) that treated the targeted pain, wherein at step (c.1), the amount by which the value of the pulse width is reduced for each of the retested neurostimulation parameter sets is proportional to the number of neurostimulation parameter sets that treated the targeted pain at the most recently tested value of the pulse width;

(c.2) retesting on the patient the plurality of neurostimulation parameter sets that treated the targeted pain, with the same reduced value for the pulse width for each of the retested neurostimulation parameter sets, to thereby identify those neurostimulation parameter sets that treat the target pain with the reduced pulse width, and

(c.3) wherein steps (c.1) and (c.2) are repeated until only one neurostimulation parameter set that treats the targeted pain is identified, wherein each time step (c.1) is repeated the value for the pulse width is again decreased; and

(d) once there is only one of the neurostimulation parameter sets tested at step (a), (b) or (c) that treated the targeted pain, then iteratively reducing the pulse repetition rate for that one of the neurostimulation parameter sets until a lowest pulse repetition rate that treats the targeted pain is identified.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 14, 2023
From: ST. JUDE MEDICAL LUXEMBOURG HOLDINGS SMI S.A.R.L. ("SJM LUX SMI")
To: TC1 LLC
Reel/Frame 064903/0680 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 13, 2023
From: IMRAN, MIR A.; MOSSOP, BRIAN J.; KISHAWI, EYAD
To: SPINAL MODULATION, INC.
Reel/Frame 064896/0850 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 3, 2015
From: SPINAL MODULATION LLC
To: ST. JUDE MEDICAL LUXEMBOURG HOLDINGS SMI S.A.R.L. ("SJM LUX SMI")
Reel/Frame 037199/0142 →
CHANGE OF NAME Recorded Nov 20, 2015
From: SPINAL MODULATION, INC.
To: SPINAL MODULATION LLC
Reel/Frame 037150/0872 →
Continuity (3)
Continuation 12579179 · Oct 14, 2009
Provisional Application 61105547 · Oct 15, 2008
Related Publication 20120290042A1 · Nov 15, 2012