# US 11,304,633 B2 · System and method for providing glucose control therapy

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 11,304,633 B2
- Document ID: US11304633B2
- Status: Granted
- Kind: B2
- Application number: 16/178,872
- Filed: 2018-11-02
- Published: 2019-05-02
- Granted: 2022-04-19
- Earliest claimed: 2017-11-02
- Assignees: Boston Scientific Scimed, Inc.
- Applicants: Boston Scientific Scimed, Inc.
- Inventors: Vijay Koya; Bryan Allen Clark; Kyle Harish Srivastava; Michael X. Govea; Elizabeth Mary Annoni
- Web page: https://patentgrep.com/patent/US11304633B2

## CPC

- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 5/14865: {invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors}
- A61B 5/4839: {combined with drug delivery}
- A61M 5/14248: {of the skin patch type}
- A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure}
- A61N 1/36017: {with leads or electrodes penetrating the skin}
- A61N 1/3606: {adapted for a particular treatment}
- A61N 1/36135: {using physiological parameters}
- A61B 5/0093: {Detecting, measuring or recording by applying one single type of energy and measuring its conversion into another type of energy}
- A61B 5/1495: Calibrating or testing of in-vivo probes
- A61M 2005/14208: {with a programmable infusion control system, characterised by the infusion program}
- A61M 2230/201: Glucose concentration
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

A system may include an implantable structure with a plurality of electrodes attached thereto, where the implantable structure is configured to be implanted proximate to a nerve that innervates and is proximate to an organ involved with glucose control. The system may further include a controller configured for use to control which of the plurality of electrodes are modulation electrodes and which of the plurality of electrodes are sense electrodes, a modulation energy generator configured to deliver modulation energy using one or more of the modulation electrodes, and a nerve traffic sensor configured to sense nerve traffic in the nerve using one or more of the sense electrodes. The controller may be configured to determine if the delivered modulation energy captures the nerves based on the sensed neural activity.

## Claims

### Claim 1

A method for providing a glucose control therapy using a lead with multiple electrodes operably positioned proximate to nerves that innervate and are proximate to an organ involved with glucose control, the method comprising:
selecting one or more modulation electrodes from the multiple electrodes for use to deliver modulation energy and selecting one or more sense electrodes from the multiple electrodes for use to sense neural activity in the nerves;
delivering modulation energy using the selected one or more modulation electrodes;
sensing neural activity in the nerves using the selected one or more sense electrodes, and
determining if the delivered modulation energy captures the nerves based on the sensed neural activity,
wherein the lead includes at least one distal patch configured to wrap at least partially around tissue including the nerves, the multiple electrodes being on the at least one distal patch, and the lead is configured to be intravascularly fed into position proximate to the nerves,
wherein delivering modulation energy includes using multiple independent current sources to independently deliver current to two or more of the modulation electrodes, and
wherein each of the multiple independent current sources is configured to source or sink current, each of the multiple independent current sources including a PDAC configured for use to source current and an NDAC configured for use to sink current.

### Claim 2 (depends on 1)

The method of claim 1, further comprising controlling current contributions of each of the modulation electrodes to form at least one target pole within a tissue region that includes the nerves, and implementing a mapping process that includes:
modifying the current contributions from each of the modulation electrodes to move the at least one target pole through different positions in the tissue region,
sensing neural activity in the nerves using the one or more sensed electrodes when the at least one target pole is in each of the different positions, and
determining if the delivered modulation energy using the at least one target pole at each of the different positions captures the nerves based on the sensed activity in the nerves.

### Claim 3 (depends on 1)

The method of claim 1, wherein the mapping process further includes sensing a physiological response, and using the sensed physiological response to determine if the modulation energy is capturing a sympathetic nerve or a parasympathetic nerve.

### Claim 4 (depends on 1)

The method of claim 1, wherein the mapping process further includes implementing a capture threshold detection process when the at least one target pole is in each of the different positions, the capture threshold detection process including testing different values for a modulation parameter and sensing neural activity for each of the different values to determine a threshold modulation parameter value for causing neural activity in the nerves.

### Claim 5 (depends on 4)

The method of claim 4, further comprising using the threshold modulation parameter value to set a modulation parameter value for a graded neuromodulation therapy.

### Claim 6 (depends on 4)

The method of claim 4, wherein the threshold modulation parameter value controls current contribution amplitudes of the modulation electrodes.

### Claim 7 (depends on 1)

The method of claim 1, wherein the mapping process further includes:
sensing a physiological response, and using the sensed physiological response to determine if the modulation energy is capturing a sympathetic nerve or a parasympathetic nerve;
implementing a capture threshold detection process when the target pole is in each of the different positions, the capture threshold detection process including testing different values for a modulation parameter and sensing neural activity for each of the different values to determine a threshold modulation parameter value for causing neural activity in the nerves; and
recording, for each of the different positions of the target pole, whether the modulation energy is capturing the sympathetic nerve or the parasympathetic nerve, and the threshold modulation parameter value.

### Claim 8 (depends on 1)

The method of claim 1, wherein the nerves include a hepatic nerve that innervates and is proximate to a liver.

### Claim 9 (depends on 1)

The method of claim 1, wherein the nerves include a pancreatic nerve that innervates and is proximate to a pancreas.

### Claim 10 (depends on 1)

The method of claim 1, wherein the lead includes at least one distal patch configured to wrap at least partially around tissue including the nerves, the multiple electrodes being on the at least one distal patch.

### Claim 11 (depends on 10)

The method of claim 10, further comprising wrapping the at least one distal patch around a hepatic vessel and hepatic nerves.

### Claim 12 (depends on 10)

The method of claim 10, wherein the lead includes two or more patches.

### Claim 13 (depends on 10)

The method of claim 10, wherein the multiple electrodes on the at least one patch are arranged in an electrode array of at least two rows of electrodes and at least two columns of electrodes.

### Claim 14 (depends on 10)

The method of claim 10, wherein the lead is configured to be intravascularly fed into position proximate to the nerves.

### Claim 15 (depends on 14)

The method of claim 14, wherein the lead is configured to be intravascularly fed through an aorta into a hepatic artery to position the lead proximate to a hepatic nerves.

### Claim 16 (depends on 14)

The method of claim 14, wherein a distal portion of the intravascularly-fed lead is configured to puncture through the hepatic artery and at least partially wrap around the hepatic artery.

### Claim 17 (depends on 14)

The method of claim 14, wherein a distal portion of the intravascularly-fed lead is configured to expand to abut against a wall of the hepatic artery.

### Claim 18 (depends on 14)

The method of claim 14, further comprising laparoscopically, percutaneously, or surgically positioning the lead proximate to the nerve.