# US 2025/0152811 A1 · Implantable medical devices that detect inadvertent delivery of drug to a subcutaneous pocket

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- Number: US 2025/0152811 A1
- Document ID: US20250152811A1
- Status: Published application
- Kind: A1
- Application number: 19/021,470
- Filed: 2025-01-15
- Published: 2025-05-15
- Earliest claimed: 2020-12-16
- Applicants: Medtronic, Inc.
- Inventors: Jeffrey P. Bodner
- Web page: https://patentgrep.com/patent/US20250152811A1

## CPC

- A61M 5/14276: {specially adapted for implantation}
- A61M 5/16809: {by repeated filling and emptying of an intermediate volume}
- A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure}
- A61M 2205/02: characterised by a particular materials
- A61M 2205/3324: PH measuring means
- A61M 2205/3368: Temperature
- A61M 2205/3553: remote, e.g. between patient's home and doctor's office
- 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)}

## Abstract

An implantable medical device configured to monitor fluid in proximity to an implantable medical device for an inadvertent introduction of infusate into a pocket of tissue surrounding the implantable medical device during a refill procedure, the implantable medical device including one or more sensors configured to monitor fluid in proximity to an exterior of the implantable medical device during a procedure to refill the device with infusate, and a processor configured to monitor the one or more sensors during an infusate refill procedure and to activate one or more notification, alert or alarm features to notify a user that a pocket fill may be occurring.

## Claims

### Claim 1

An implantable medical device, comprising:
a refillable infusate delivery system, the refillable infusate delivery system comprising a reservoir in fluid communication with an access port; and
one or more sensors configured to monitor fluid in proximity to an exterior of the implantable medical device for an injection of infusate into a pocket of tissue surrounding the implantable medical device during a procedure to refill the reservoir with infusate; and
a processor configured to monitor the one or more sensors during an infusate refill procedure and to activate one or more notification, alert or alarm features to notify a user that a pocket fill may be occurring.

### Claim 2 (depends on 1)

The implantable medical device of claim 1, wherein the processor is configured to obtain a baseline measurement from the one or more sensors, establish a triggering threshold value, and activate the one or more notification, alert or alarm features upon a measurement sensed by the one or more sensors meeting or exceeding the triggering threshold value.

### Claim 3 (depends on 1)

The implantable medical device of claim 1, wherein the processor is configured to selectively activate the one or more sensors during an infusate refill procedure.

### Claim 4 (depends on 1)

The implantable medical device of claim 1, wherein the one or more sensors comprise one or more electrodes, one or more pH sensors, one or more temperature sensors, or a combination thereof.

### Claim 5 (depends on 1)

The implantable medical device of claim 1, wherein the one or more sensors comprise at least one electrode positioned on the exterior of the implantable medical device.

### Claim 6 (depends on 1)

The implantable medical device of claim 1, wherein the one or more sensors sense salinity in fluid and tissue surrounding the implantable medical device.

### Claim 7 (depends on 1)

The implantable medical device of claim 1, wherein the one or more sensors detect a change in a condition of fluid in proximity to the one or more sensors.

### Claim 8 (depends on 1)

The implantable medical device of claim 1, wherein the implantable medical device is at least one of an implantable infusion pump or an implantable port.

### Claim 9 (depends on 1)

The implantable medical device of claim 1, wherein the implantable medical device further comprises at least one of an access port marker to improve identification of the access port, a needle detector to confirm proper placement of a refilling apparatus within the access port, or a reservoir fill sensor to aid in positioning of a refilling device relative to the implantable medical device.

### Claim 10 (depends on 1)

The implantable medical device of claim 1, wherein the implantable medical device comprises an optical sensor.

### Claim 11 (depends on 1)

The implantable medical device of claim 1, wherein the implantable medical device comprises an acoustic sensor.

### Claim 12 (depends on 1)

The implantable medical device of claim 1, further comprising a physiological sensor configured to provide a confirmation of an introduction of infusate into a pocket of tissue surrounding the implantable medical device through a monitoring of one or more physiological conditions of a patient into which the implantable medical device is implanted.

### Claim 13

A medical system, comprising:
an implantable medical device comprising an infusate delivery system and one or more sensors configured to monitor fluid in proximity to an exterior of the implantable medical device for an injection of infusate into a pocket of tissue surrounding the implantable medical device during a procedure to refill the device with infusate; and
a processor configured to monitor the one or more sensors during an infusate refill procedure and to activate one or more notification, alert or alarm features to notify a user that a pocket fill may be occurring.

### Claim 14 (depends on 13)

The medical system of claim 13, wherein the processor is configured to obtain a baseline measurement from the one or more sensors, establish a triggering threshold value, and activate the one or more notification, alert or alarm features upon a measurement sensed by the one or more sensors meeting or exceeding the triggering threshold value.

### Claim 15 (depends on 13)

The medical system of claim 13, wherein the processor is configured to selectively activate the one or more sensors during an infusate refill procedure.

### Claim 16 (depends on 13)

The medical system of claim 13, wherein the one or more sensors comprise one or more electrodes, one or more pH sensors, one or more temperature sensors, or a combination thereof.

### Claim 17 (depends on 13)

The medical system of claim 13, wherein the implantable medical device is at least one of an implantable infusion pump or an implantable port.

### Claim 18 (depends on 13)

The medical system of claim 13, further comprising an external programmer in wireless communication with the implantable medical device.

### Claim 19 (depends on 18)

The medical system of claim 18, wherein the external programmer is configured to activate the one or more sensors from an inactive state.

### Claim 20 (depends on 18)

The medical system of claim 18, further comprising an external physiological sensor in wireless communication with at least one of the external programmer or implantable medical device, the external physiological sensor configured to provide a confirmation of an introduction of infusate into a pocket of tissue surrounding the implantable medical device through a monitoring of one or more physiological conditions of a patient into which the implantable medical device is implanted.
