IP Library Granted Patent US 12,722,011
Granted Patent B2
US 12,722,011 · App. 18/152,636 · Granted Sep 1, 2026

Algorithm for adjusting a compliance voltage in a stimulator device having neural sensing capability

Inventors: Pujitha Weerakoon (Valencia, CA); Goran N. Marnfeldt (Valencia, CA)
Assignee: Boston Scientific Neuromodulation Corporation
A61N1/36139A61N1/36153A61N1/36157
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,722,011
App. No.
18/152,636
Granted
Sep 1, 2026
Kind
B2
Abstract

An optimization algorithm is disclosed for optimizing an implantable pulse generator. The algorithm is particularly useful when one or more of the electrodes (e.g., the case electrode) is used to provide a common mode voltage (Vcm) to the tissue, which assists in sensing neural responses to the stimulation. The algorithm preferably optimizes both the compliance voltage VH used to power the simulation circuitry, and the strength of tissue driver circuitry used to provide Vcm to the tissue. The algorithm preferably considers information determined by VH measurement circuitry (which informs as to the ability to form prescribed stimulation pulses without loading), sensing monitoring circuitry (which informs as to the magnitude of the inputs of the sensing circuitry), and/or tissue monitoring circuitry (which informs as to adequacy of the strength of the tissue driver circuitry).

Claims (41)

1 . A method for operating a stimulator device having a plurality of electrodes comprising at least one sensing electrode, at least two stimulation electrodes, and at least one common mode electrode, the method comprising:

receiving signals from a patient's tissue at the at least one sensing electrode, and providing the received signal to at least one input of a sense amp circuit;

providing a common mode voltage to the tissue at the at least one common mode electrode, wherein a tissue current at the common mode electrode is limited to a programmable first magnitude;

executing a stimulation program to provide a stimulation current of a prescribed amplitude between the at least two stimulation electrodes and through the patient's tissue using stimulation circuitry powered by a compliance voltage;

generating at least one first control signal indicating whether the tissue current has reached the first magnitude;

generating at least one second control signal indicating whether a second magnitude at the at least one input is appropriate for sensing the signals from the patient's tissue;

generating at least one third control signal indicating whether the stimulation current is provided by the stimulation circuitry at the prescribed amplitude without loading; and

executing an algorithm in the stimulator device, wherein the algorithm is configured to use the at least one first control signal, the at least one second control signal, and the at least one third control signal to adjust the compliance voltage.

2 . The method of claim 1 , wherein the algorithm is configured to adjust the compliance voltage to a lowest value at which

the stimulation current is provided by the stimulation circuitry at the prescribed amplitude without loading; and

either or both of the following occurs:

the tissue current has not reached the first magnitude, or

the second magnitude at the at least one input is appropriate for sensing the signals from the patient's tissue.

3 . The method of claim 2 , wherein the algorithm is configured to initially set the compliance voltage to a maximum voltage.

4 . The method of claim 1 , wherein the algorithm is further configured to use either or both of the at least one first control signal and the at least one second control signal to adjust the first magnitude.

5 . The method of claim 4 , wherein the algorithm is configured to adjust the first magnitude to a lowest value at which either or both of the following occurs:

the tissue current has not reached the first magnitude, or

the second magnitude at the at least one input is appropriate for sensing the signals from the patient's tissue.

6 . The method of claim 4 , wherein the algorithm is configured to adjust the compliance voltage before adjusting the first magnitude.

7 . The method of claim 4 , wherein the algorithm is configured to adjust the first magnitude using the at least one first control signal.

8 . The method of claim 4 , wherein the algorithm is configured to adjust the first magnitude using the at least one second control signal.

9 . The method of claim 4 , wherein the algorithm is configured to adjust the first magnitude using the at least one first control signal and the at least one second control signal.

10 . The method of claim 4 , wherein the algorithm is configured to initially set the first magnitude to a maximum value.

11 . The method of claim 10 , wherein the algorithm is configured to use either or both of the at least one first control signal and the at least one second control signal to reduce the first magnitude to a lowest value.

12 . The method of claim 1 , wherein the algorithm is further configured to select at least one of the electrodes as the at least one sensing electrode.

13 . The method of claim 12 , wherein the algorithm is further configured to select at least one of the electrodes as the at least one sensing electrode prior to adjusting the compliance voltage.

14 . The method of claim 13 , wherein the algorithm selects the at least one sensing electrode upon determining that either or both of the following occurs:

the tissue current has not reached the first magnitude, or

the second magnitude at the at least one input is appropriate for sensing the signals from the patient's tissue.

15 . The method of claim 1 , wherein the algorithm is further configured to modify or suggest a modification to the stimulation program.

16 . The method of claim 15 , wherein the algorithm is configured to continue modifying or suggesting the modification to the stimulation program until determining that either or both of the following occurs:

the tissue current has not reached the first magnitude, or

the second magnitude at the at least one input is appropriate for sensing the signals from the patient's tissue.

17 . A stimulator device having a plurality of electrodes comprising at least one sensing electrode, at least two stimulation electrodes, and at least one common mode electrode, the device comprising:

a sense amp circuit configured to receive at at least one input signals from a patient's tissue at the at least one sensing electrode;

tissue driver circuitry configured to provide a common mode voltage to the tissue at the at least one common mode electrode, wherein a tissue current at the common mode electrode is limited to a programmable first magnitude;

stimulation circuitry configured to execute a stimulation program to provide a stimulation current of a prescribed amplitude between the at least two stimulation electrodes and through the patient's tissue, wherein the stimulation circuitry is powered by a compliance voltage;

first measurement circuitry configured to generate at least one first control signal indicating whether the tissue current has reached the first magnitude;

second measurement circuitry configured to generate at least one second control signal indicating whether a second magnitude at the at least one input is appropriate for sensing the signals from the patient's tissue;

third measurement circuitry configured to generate at least one third control signal indicating whether the stimulation current is provided by the stimulation circuitry at the prescribed amplitude without loading; and

control circuitry programmed with an algorithm, wherein the algorithm is configured to use the at least one first control signal, the at least one second control signal, and the at least one third control signal to adjust the compliance voltage.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 10, 2023
From: WEERAKOON, PUJITHA; MARNFELDT, GORAN N.
To: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
Reel/Frame 062332/0896 →
Continuity (2)
Provisional Application 63266806 · Jan 14, 2022
Related Publication 20230248978A1 · Aug 10, 2023
References Cited (126)
US 4811738A · Economides et al. · 1989 [cited by applicant]
US 5697958A · Paul et al. · 1997 [cited by applicant]
US 5702429A · King · 1997 [cited by applicant]
US 5902236A · Iversen · 1999 [cited by applicant]
US 5902249A · Lyster · 1999 [cited by applicant]
US 5913882A · King · 1999 [cited by applicant]
US 6181969B1 · Gord · 2001 [cited by applicant]
US 6516227B1 · Meadows et al. · 2003 [cited by applicant]
US 6560490B2 · Grill et al. · 2003 [cited by applicant]
US 7024247B2 · Gliner et al. · 2006 [cited by applicant]
US 7424322B2 · Lombardi et al. · 2008 [cited by applicant]
US 7444181B2 · Shi et al. · 2008 [cited by applicant]
US 7450992B1 · Cameron · 2008 [cited by applicant]
US 8255057B2 · Fang et al. · 2012 [cited by applicant]
US 8335664B2 · Eberle · 2012 [cited by applicant]
US 8352030B2 · Denison · 2013 [cited by applicant]
US 8606362B2 · He et al. · 2013 [cited by applicant]
US 8620436B2 · Parramon et al. · 2013 [cited by applicant]
US 9044155B2 · Strahl · 2015 [cited by applicant]
US 9061140B2 · Shi et al. · 2015 [cited by applicant]
US 9155891B2 · Archer · 2015 [cited by applicant]
US 9155892B2 · Parker et al. · 2015 [cited by applicant]
US 9174051B2 · Marnfeldt et al. · 2015 [cited by applicant]
US 9248274B2 · Troosters et al. · 2016 [cited by applicant]
US 9248279B2 · Chen · 2016 [cited by examiner]
US 9259574B2 · Aghassian et al. · 2016 [cited by applicant]
US 9265431B2 · Hincapie Ordonez et al. · 2016 [cited by applicant]
US 9302112B2 · Bornzin et al. · 2016 [cited by applicant]
US 9314632B2 · Marnfeldt et al. · 2016 [cited by applicant]
US 9381356B2 · Parker et al. · 2016 [cited by applicant]
US 9386934B2 · Parker et al. · 2016 [cited by applicant]
US 9403013B2 · Walker et al. · 2016 [cited by applicant]
US 9409020B2 · Parker · 2016 [cited by applicant]
US 9468765B2 · Archer · 2016 [cited by applicant]
US 9526897B2 · Chen et al. · 2016 [cited by applicant]
US 9533148B2 · Carcieri et al. · 2017 [cited by applicant]
US 9604061B2 · Archer · 2017 [cited by applicant]
US 9724508B2 · Lamont et al. · 2017 [cited by applicant]
US 9731116B2 · Chen · 2017 [cited by applicant]
US 9872990B2 · Parker et al. · 2018 [cited by applicant]
US 9974455B2 · Parker et al. · 2018 [cited by applicant]
US 10076667B2 · Kaula et al. · 2018 [cited by applicant]
US 10525252B2 · Feldman · 2020 [cited by examiner]
US 10632300B2 · Wagenbach et al. · 2020 [cited by applicant]
US 10716937B2 · Feldman et al. · 2020 [cited by applicant]
US 10792491B2 · Feldman et al. · 2020 [cited by applicant]
US 10912942B2 · Weerkoon et al. · 2021 [cited by applicant]
US 11040192B2 · Weerakoon et al. · 2021 [cited by applicant]
US 11040202B2 · Marnfeldt · 2021 [cited by applicant]
US 20020156513A1 · Borkan · 2002 [cited by applicant]
US 20050090756A1 · Wolf et al. · 2005 [cited by applicant]
US 20050246004A1 · Cameron et al. · 2005 [cited by applicant]
US 20060271118A1 · Libbus et al. · 2006 [cited by applicant]
US 20080146894A1 · Bulkes et al. · 2008 [cited by applicant]
US 20120092031A1 · Shi et al. · 2012 [cited by applicant]
US 20120095519A1 · Parramon et al. · 2012 [cited by applicant]
US 20120095529A1 · Parramon et al. · 2012 [cited by applicant]
US 20130289665A1 · Marnfeldt · 2013 [cited by examiner]
US 20140194772A1 · Single et al. · 2014 [cited by applicant]
US 20140236042A1 · Parker et al. · 2014 [cited by applicant]
US 20140296737A1 · Parker et al. · 2014 [cited by applicant]
US 20150080982A1 · Funderburk · 2015 [cited by applicant]
US 20150157861A1 · Aghassian · 2015 [cited by applicant]
US 20150231402A1 · Aghassian · 2015 [cited by applicant]
US 20150282725A1 · Single et al. · 2015 [cited by applicant]
US 20150313487A1 · Single et al. · 2015 [cited by applicant]
US 20150360038A1 · Zottola et al. · 2015 [cited by applicant]
US 20160166164A1 · Obradovic et al. · 2016 [cited by applicant]
US 20160287126A1 · Parker et al. · 2016 [cited by applicant]
US 20160287182A1 · Single et al. · 2016 [cited by applicant]
US 20170001003A1 · Pivonka · 2017 [cited by examiner]
US 20170049345A1 · Single et al. · 2017 [cited by applicant]
US 20170071490A1 · Parker et al. · 2017 [cited by applicant]
US 20170135624A1 · Parker et al. · 2017 [cited by applicant]
US 20170216587A1 · Parker et al. · 2017 [cited by applicant]
US 20170216600A1 · Feldman et al. · 2017 [cited by applicant]
US 20170296823A1 · Hershey et al. · 2017 [cited by applicant]
US 20170361101A1 · Single et al. · 2017 [cited by applicant]
US 20180071520A1 · Weerakoon et al. · 2018 [cited by applicant]
US 20180071527A1 · Feldman et al. · 2018 [cited by applicant]
US 20180110987A1 · Parker et al. · 2018 [cited by applicant]
US 20180117335A1 · Parker et al. · 2018 [cited by applicant]
US 20180132747A1 · Parker et al. · 2018 [cited by applicant]
US 20180132760A1 · Parker et al. · 2018 [cited by applicant]
US 20180133459A1 · Parker et al. · 2018 [cited by applicant]
US 20180140831A1 · Feldman et al. · 2018 [cited by applicant]
US 20180228391A1 · Parker et al. · 2018 [cited by applicant]
US 20180228547A1 · Parker et al. · 2018 [cited by applicant]
US 20180256052A1 · Parker et al. · 2018 [cited by applicant]
US 20190083796A1 · Weerakoon · 2019 [cited by examiner]
US 20190099602A1 · Esteller · 2019 [cited by examiner]
US 20190175915A1 · Brill et al. · 2019 [cited by applicant]
US 20190209844A1 · Esteller et al. · 2019 [cited by applicant]
US 20190275331A1 · Zhu et al. · 2019 [cited by applicant]
US 20190290900A1 · Esteller et al. · 2019 [cited by applicant]
US 20190299006A1 · Marnfeldt · 2019 [cited by examiner]
US 20190366094A1 · Esteller et al. · 2019 [cited by applicant]
US 20200009394A1 · Huertas Fernandez · 2020 [cited by examiner]
US 20200155019A1 · Esteller et al. · 2020 [cited by applicant]
US 20200251899A1 · Parks et al. · 2020 [cited by applicant]
US 20200305744A1 · Weerakoon · 2020 [cited by examiner]
US 20200305745A1 · Wagenbach · 2020 [cited by examiner]
US 20210008373A1 · Single · 2021 [cited by examiner]
US 20210023374A1 · Block · 2021 [cited by examiner]
US 20210236829A1 · Zhang et al. · 2021 [cited by applicant]
US 20220040486A1 · Moffitt · 2022 [cited by applicant]
WO 9507114 · 1995 [cited by applicant]
WO 2013109603 · 2013 [cited by applicant]
WO 2015077362 · 2015 [cited by applicant]
WO 2017100866 · 2017 [cited by applicant]
WO 2017173493 · 2017 [cited by applicant]
WO 2017210352 · 2017 [cited by applicant]
WO 2017219096 · 2017 [cited by applicant]
WO 2021046120 · 2021 [cited by applicant]
U.S. Appl. No. 63/264,281, filed Dec. 2, 2021. [cited by applicant]
U.S. Appl. No. 18/049,525, filed Oct. 25, 2022, Marnfeldt. [cited by applicant]
H. Mino & J. Rubenstein, “Effects of Neural Refractoriness on Spatio-Temporal Variability in Spike Initiations with Electrical Stimulation,” IEEE Trans. On Neural Sys. & Rehabilitation Eng., vol. 14, No. 3, pp. 273-280 … [cited by applicant]
M. Moffit et al., A Novel 3-Dimensional Algorithm for Model-Based Programming in Spinal Cord Stimulation (SCS): Illumina-3D™, presentation (2013). [cited by applicant]
M. Hughes, “Fundamentals of Clinical ECAP Measures in Cochlear Implants: Part 1: Use of the ECAP in Speech Processor Programming (2nd Ed.),” Audiology Online (Nov. 8, 2010) (http:// www.audiologyonline.com/ articles/ fu… [cited by applicant]
I. Akhoun et al., “Electrically evoked compound action potential artifact rejection by independent component analysis: Technique validation,” Hearing Research 302, pp. 60-73 (2013). [cited by applicant]
J. Rubinstein et al., “Pseudospontaneous activity: stochastic independence of auditory nerve fibers with electrical stimulation,” Hear Res., 127(1-2), pp. 108-118 (1999) (abstract only). [cited by applicant]
J. Paz, “Physiological Midline Mapping Based on Spinal Cord Stimulation (SCS) Response Using the 32-Contact Paddle Lead,” 19 [cited by applicant]
E.L. Air et al., “Electrophysiologic Monitoring for Placement of Laminectomy Leads for Spinal Cord Stimulation Under General Anesthesia,” Neuromodulation: Technology at the Neural Interface, vol. 15(6), pp. 573-580 (201… [cited by applicant]
J.L. Shils et al., “Intraoperative Neurophysiologic Methods for Spinal Cord Stimulator Placement Under General Anesthesia,” Neuromodulation: Technology at the Neural Interface, vol. 15(6), pp. 560-572 (2012). [cited by applicant]
A. Taghva et al., “Intraoperative Electromyography as an Adjunct to Sacral Neuromodulation for Chronic Pelvic Pain,” Neuromodulation: Technology at the Neural Interface, vol. 18(1), pp. 62-66 (2015). [cited by applicant]
International Search Report and Written Opinion regarding corresponding PCT Application No. PCT/US2023/060412, mailed Apr. 3, 2023. [cited by applicant]