IP Library › Granted Patent US 12,642,971
Granted Patent B2
US 12,642,971 · App. 18/263,178 · Granted Jun 2, 2026

Feedback control of electrical stimulation therapy based on electric field imaging

Inventors: Jerel K. Mueller (St. Paul, MN); Leonid M. Litvak (Bet Shemesh, IL); Vinod Sharma (Maple Grove, MN); Katelynn M. Johnson (New Brighton, MN); Jiashu Li (Mounds View, MN)
Assignee: Medtronic, Inc.
A61N1/36139A61B5/388A61B5/4836A61N1/3615
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Quick Facts
Patent No.
US 12,642,971
App. No.
18/263,178
Granted
Jun 2, 2026
Kind
B2
Abstract

Devices, systems, and techniques are described that use electric field imaging (often referred to as the sensed stimulation artifact representative of a delivered stimulus) as an informative feedback signal to provide closed loop control of electrical stimulation therapy. In some examples, the electric field imaging may be used in combination with other feedback signals, such as ECAP do monitor and adjust the delivered electrical stimulation therapy.

Claims (78)

1 . A medical device comprising:

stimulation generation circuitry configured to deliver electrical stimulation to a patient;

sensing circuitry configured to sense the delivered electrical stimulation; and

processing circuitry operatively coupled to a memory, the processing circuitry configured to:

determine a value of one or more characteristics of the sensed delivered stimulation; and

based on the value of the one or more characteristics of the sensed delivered stimulation, adjust a value of a stimulation parameter that at least partially defines subsequent stimulation to be delivered to the patient,

wherein the stimulation generation circuitry is configured to output a stimulation pulse to a first set of electrodes,

wherein the sensing circuitry configured to sense the stimulation pulse via a second set of electrodes and sense the stimulation pulse via a third set of electrodes, and

wherein the processing circuitry is configured to select one of the second set of electrodes or the third set of electrodes as a default set of sensing electrodes, based on:

a value of one or more characteristics of the sensed stimulation pulse received from the second set of electrodes; and

a value of one or more characteristics of the sensed stimulation pulse received from the third set of electrodes.

2 . The medical device of claim 1 , wherein the electrical stimulation comprises an electrical current pulse.

3 . The medical device of claim 1 , wherein the processing circuitry is configured to sense an event impacting therapy (EIT) based on the value of the one or more characteristics of the sensed delivered stimulation.

4 . The medical device of claim 3 , wherein the event impacting therapy comprises one or more types, the types comprising an acute event, a periodic event, or other event.

5 . The medical device of claim 4 , wherein:

the acute event comprises: a cough, a patient, and a laugh of the patient;

the periodic event comprises: breathing and/or sleeping;

the other event comprises: a posture change of the patient, a blood chemistry change; an electrode environment change and a longitudinal lead movement.

6 . The medical device of claim 1 , wherein the delivered electrical stimulation comprises a first stimulation pulse and a second stimulation pulse,

wherein a magnitude of the second stimulation pulse is greater than a magnitude of the first stimulation pulse, and

wherein sensing circuitry of the medical device is configured to sense the first stimulation pulse and to block sensing for the second stimulation pulse.

7 . The medical device of claim 1 , wherein the value of the stimulation parameter comprises one or more of: a magnitude of current, a value of a pulse width, or a value of a pulse shape.

8 . The medical device of claim 1 , wherein the stimulation generation circuitry is configured to deliver a plurality of stimulation pulses and wherein the sensing circuitry is further configured to:

detect a plurality of evoked compound action potentials (ECAPs), wherein each ECAP of the plurality of ECAPs is elicited by a respective pulse of the plurality of pulses, and wherein a number of ECAPs of the plurality of ECAPs is lower than a number of stimulation pulses of the plurality of stimulation pulses.

9 . The medical device of claim 6 , wherein the processing circuitry is further configured to determine whether the plurality of stimulation pulses elicit greater than a threshold ratio of detectable ECAPs per stimulation pulse.

10 . The medical device of claim 9 , wherein to determine whether the plurality of stimulation pulses elicit greater than the threshold ratio of detectable ECAPs per stimulation pulse, the processing circuitry is configured to:

identify a set of ECAPs elicited by a sequence of consecutive stimulation pulses of the plurality of stimulation pulses;

calculate a ratio of a number of the set of ECAPs to a number of the sequence of consecutive stimulation pulses; and

determine whether the ratio is greater than the threshold ratio.

11 . The medical device of claim 9 , wherein the processing circuitry is further configured to:

responsive to determining that the plurality of stimulation pulses elicit greater than the threshold ratio of detectible ECAPs:

change, based on the value of the characteristic of the sensed delivered stimulation and a value of a characteristic of an ECAP corresponding to the sensed delivered stimulation, the value of the parameter that at least partially defines the second stimulation pulse.

12 . The medical device of claim 8 , wherein the processing circuitry is configured to trigger the respective pulse of the plurality of pulses to elicit a first ECAP of the plurality of ECAPS.

13 . The medical device of claim 3 ,

wherein the event impacting therapy comprises a longitudinal lead migration,

wherein to determine the longitudinal lead migration, the processing circuitry is configured to:

determine a first value of one or more characteristics of the sensed delivered stimulation at a first time;

determine a second value of one or more characteristics of a second sensed delivered stimulation at a second time;

compare the first value to the second value; and

based on the comparison, determine whether a longitudinal lead migration has occurred.

14 . The medical device of claim 1 , wherein the medical device is configured to:

deliver the electrical stimulation to the patient via an electrode mounted to a housing of the medical device; and

sense a bioelectrical signal of the patient via the electrode mounted to the housing of the medical device.

15 . The medical device of claim 1 , wherein the processing circuitry is further configured to:

communicate with an external computing device,

output the one or more characteristics of the sensed delivered stimulation received from the second set of electrodes to the external computing device;

output the one or more characteristics of the sensed delivered stimulation received from the third set of electrodes to the external computing device, and

receive, from the external computing device, a selection of the default sensing electrodes.

16 . A method comprising:

causing, by processing circuitry of a medical device, stimulation generation circuitry of the medical device to deliver electrical stimulation to a patient, wherein the processing circuitry is operatively coupled to a memory;

receiving, by the processing circuitry, an indication of the delivered electrical stimulation from sensing circuitry of the medical device that is configured to sense the delivered electrical stimulation;

determining, by the processing circuitry, a value of one or more characteristics of the sensed delivered stimulation;

based on the value of the one or more characteristics of the sensed delivered stimulation, adjusting, by the processing circuitry, a value of a stimulation parameter that at least partially defines subsequent stimulation to be delivered to the patient

outputting, by the stimulation generation circuitry, stimulation pulse to a first set of electrodes;

sensing, by the sensing circuitry, the stimulation pulse via a second set of electrodes;

sensing, by the sensing circuitry, the stimulation pulse via a third set of electrodes;

selecting, by the processing circuitry, one of the second set of electrodes or the third set of electrodes as a default set of sensing electrodes, based on:

a value of one or more characteristics of the sensed stimulation pulse received from the second set of electrodes; and

a value of one or more characteristics of the sensed stimulation pulse received from the third set of electrodes.

17 . The method of claim 16 , further comprising, detecting an event impacting therapy (EIT) based on the value of the one or more characteristics of the sensed delivered stimulation.

18 . The method of claim 17 , further comprising:

responsive to detecting the event impacting therapy, determining to take an action based on the event impacting therapy; and

responsive to determining to take the action, performing the action by one or more of: storing information regarding the event impacting therapy at a location of the memory, outputting an alert, or controlling the stimulation generation circuitry to change one or more parameters of stimulation pulses of a plurality of stimulation pulses.

19 . The method of claim 16 , further comprising:

delivering, by the stimulation generation circuitry, a plurality of stimulation pulses;

detecting, by the sensing circuitry, a plurality of evoked compound action potentials (ECAPs), wherein each ECAP of the plurality of ECAPs is elicited by a respective pulse of the plurality of pulses, and wherein a number of ECAPs of the plurality of ECAPs is lower than a number of stimulation pulses of the plurality of stimulation pulses;

determining that the plurality of stimulation pulses elicit greater than a threshold ratio of detectable ECAPs per stimulation pulse; and

responsive to determining that the plurality of stimulation pulses elicit greater than the threshold ratio of detectible ECAPs, changing, based on the value of the characteristic of the sensed delivered stimulation and a value of a characteristic of an ECAP corresponding to the sensed delivered stimulation, the value of the parameter that at least partially defines the second stimulation pulse.

20 . A non-transitory computer-readable storage medium comprising instructions that, when executed, causes processing circuitry:

control stimulation generation circuitry of a medical device to deliver electrical stimulation to a patient, wherein the processing circuitry is operatively coupled to a memory;

receive an indication of the delivered electrical stimulation sensed by from sensing circuitry of the medical device that is configured to sense the delivered electrical stimulation;

determine a value of one or more characteristics of the sensed delivered stimulation;

adjust, based on the value of the one or more characteristics of the sensed delivered stimulation, a value of a stimulation parameter that at least partially defines subsequent stimulation to be delivered to the patient;

control the stimulation generation circuitry to output a stimulation pulse to a first set of electrodes,

control sensing circuitry to sense the stimulation pulse via a second set of electrodes and sense the stimulation pulse via a third set of electrodes, and

select one of the second set of electrodes or the third set of electrodes as a default set of sensing electrodes, based on:

a value of one or more characteristics of the sensed stimulation pulse received from the second set of electrodes; and

a value of one or more characteristics of the sensed stimulation pulse received from the third set of electrodes.

Assignments (2)
CORRECTIVE ASSIGNMENT TO CORRECT THE 1ST ASSIGNOR'S DOC DATE PREVIOUSLY RECORDED ON REEL 064401 FRAME 0034. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Aug 8, 2023
From: MUELLER, JEREL K.; LITVAK, LEONID M.; SHARMA, VINOD; JOHNSON, KATELYNN M.; LI, JIASHU
To: MEDTRONIC, INC.
Reel/Frame 064529/0112 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 27, 2023
From: MUELLER, JEREL K.; LITVAK, LEONID M.; SHARMA, VINOD; JOHNSON, KATELYNN M.; LI, JIASHU
To: MEDTRONIC, INC.
Reel/Frame 064401/0034 →
Continuity (2)
Provisional Application 63153092 · Feb 24, 2021
Related Publication 20240100342A1 · Mar 28, 2024
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