# US 2023/0067652 A1 · Systems and methods for detecting disruptions in fluid delivery devices

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- Number: US 2023/0067652 A1
- Document ID: US20230067652A1
- Status: Published application
- Kind: A1
- Application number: 17/985,638
- Filed: 2022-11-11
- Published: 2023-03-02
- Earliest claimed: 2018-04-12
- Assignees: Diatech Diabetes, Inc.
- Applicants: Diatech Diabetes, Inc.
- Inventors: Luis E. Blanco; John H. Wilcox; Nicholas R. Cooper; John Clark Gray
- Web page: https://patentgrep.com/patent/US20230067652A1

## CPC

- A61M 5/16859: {Evaluation of pressure response, e.g. to an applied pulse}
- A61M 5/14244: {adapted to be carried by the patient, e.g. portable on the body}
- A61M 5/14248: {of the skin patch type}
- A61M 5/172: electrical or electronic
- A61M 5/5086: {for indicating if defective, used, tampered with or unsterile}
- A61M 5/16863: {Occlusion detection}
- A61M 2005/2474: {with movable piercing means, e.g. ampoule remains fixed or steady}
- A61M 2205/15: Detection of leaks
- A61M 2205/18: with alarm
- A61M 2205/3553: remote, e.g. between patient's home and doctor's office
- A61M 2205/3569: sublocal, e.g. between console and disposable
- A61M 2205/581: by audible feedback
- A61M 2205/582: by tactile feedback
- 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

A sensor system capable of detecting tissue counter pressure from patients that utilize infusion pumps to administer their medication is provided. Embodiments include a retrofitted piece that is placed between the user's infusion set and pump, as well as a “smart” infusion set configured for measuring characteristics of a fluid traveling therethrough. Hardware is provided that couples with the sensor to store, analyze, and compare data to distinguish between normal and non-normal injection/infusion profiles. An alert system notifies the user of a malfunction within the pump, within the infusion set, or at the injection/infusion site.

## Claims

### Claim at position 1

1-20. (canceled)

### Claim 21

A system for monitoring characteristics of a fluid being delivered from a fluid medication delivery device to an infusion site associated with a user, the system comprising:
at least one sensor configured to generate output signals corresponding to at least one fluid characteristic;
one or more processors in communication with the at least one sensor, and configured to:
detect one or more symptoms corresponding to partial or total failure in delivery of the fluid based on the output signals from the at least one sensor;
generate outputs corresponding to at least one of the detected one or more symptoms, the generated outputs comprising at least one alert to the user; and
responsive to at least one type of detected symptom to generate an output identifying a different infusion site and/or a different fluid medication delivery device for the user based at least in part on historical data relating to one or more of the user, the infusion site, and the fluid delivery device.

### Claim 22 (depends on 21)

The system of claim 21, wherein the one or more processors are further configured to:
predict abnormalities in delivery of the fluid based on the output signals from the at least one sensor, further in view of historical data relating to the one or more of the user, the infusion site, and the fluid delivery device; and
generate outputs corresponding to the predicted abnormalities and identifying a different infusion site and/or a different fluid medication delivery device for the user based at least in part on historical data relating to one or more of the user, the infusion site, and the fluid delivery device.

### Claim 23 (depends on 21)

The system of claim 21, wherein the one or more processors are configured to detect the one or more symptoms further in view of at least one predetermined tolerance and/or threshold.

### Claim 24 (depends on 21)

The system of claim 21, wherein the one or more processors are configured to detect the one or more symptoms based on detected changing conditions along a flow path indicative of fluid delivery failure.

### Claim 25 (depends on 21)

The system of claim 21, wherein the at least one sensor is configured to generate output signals corresponding to an absorption rate of the fluid at the infusion site.

### Claim 26 (depends on 21)

The system of claim 21, wherein the fluid delivery device comprises an infusion pump, and at least one of the at least one sensor is integrated with the infusion pump.

### Claim 27 (depends on 26)

The system of claim 26, wherein the fluid delivery device comprises an infusion set coupled to the infusion pump and terminating at the infusion site, and at least one of the at least one sensor is associated with the infusion set.

### Claim 28 (depends on 27)

The system of claim 27, wherein the infusion set is associated with a continuous glucose monitor at the same infusion site.

### Claim 29 (depends on 21)

The system of claim 21, wherein a first processor of the one or more processors is associated with an infusion pump and further in communication with a computing device comprising a second processor of the one or more processors via a communications network, and wherein the outputs generated by the second processor are provided as alerts for display on the computing device, the alerts at least identifying the different infusion site and/or different fluid medication delivery device for the user.

### Claim 30 (depends on 29)

The system of claim 29, wherein the second processor is configured upon receiving an alert from the first processor to identify a current injection site for the user, record the alert as corresponding to detected abnormalities with respect to the current injection site, and update accordingly a map comprising suitable and unsuitable injection sites for the user.

### Claim 31 (depends on 21)

The system of claim 21, further comprising the fluid delivery device having an infusion pump, an infusion set, and the sensor selectively coupled there between, the sensor residing in a sensor housing comprising:
a first connector portion configured for connecting the sensor housing to the infusion set;
a second connector portion configured for connecting the sensor housing to the infusion pump;
a sampling cavity positioned between the first connector portion and the second connector portion, the sampling cavity in fluid communication with the first and second connector portions via first and second channels, respectively; and
a sensor chamber in fluid communication with the sampling chamber, said sensor chamber configured for receiving the sensor.

### Claim 32 (depends on 31)

The system of claim 31, wherein the sensor chamber extends orthogonally to a flow path of fluid through the first and second channels.

### Claim 33 (depends on 31)

The system of claim 31, wherein the sensor is configured for at least one of collecting and transmitting data pertaining to at least one fluid characteristic of a fluid in the sampling cavity.

### Claim 34 (depends on 31)

The system of claim 31, wherein a portion of the sampling cavity is defined by the sensor.

### Claim 35 (depends on 31)

The system of claim 31, wherein the sampling cavity defines an aperture configured for receiving a portion of the sensor.

### Claim 36 (depends on 21)

The system of claim 21, further comprising the fluid delivery device, wherein the fluid delivery device includes an infusion set comprising:
an interface configured for being removably attached to the user's skin and delivering a fluid to the user; and
a sensor housing in fluid communication with the interface, said sensor housing comprising:
a first connector portion configured for connecting the sensor housing to the interface via a tube;
a second connector portion configured for connecting the sensor housing to a pump;
a sampling cavity positioned between the first connector portion and the second connector portions, the sampling cavity in fluid communication with the first and second connector portions via first and second channels, respectively; and
a sensor chamber in fluid communication with the sampling chamber, said sensor chamber configured for receiving a sensor.

### Claim 37 (depends on 36)

The system of claim 36, wherein the sampling cavity defines an aperture configured for receiving a portion of the sensor.

### Claim 38 (depends on 36)

The system of claim 36, further comprising a needle extending from the second channel, wherein connecting the second connector portion to the pump results in the needle piercing a fluid reservoir in the pump, thereby enabling a flow of fluid from the reservoir to the infusion set.

### Claim 39

A method for monitoring characteristics of a fluid being delivered from a fluid medication delivery device to an infusion site associated with a user, the method comprising:
receiving output signals from at least one sensor disposed along a fluid path, wherein the output signals correspond to at least one fluid characteristic;
detecting in real time and/or predicting one or more symptoms corresponding to partial or total failure in delivery of the fluid based on the output signals from the at least one sensor;
generating outputs corresponding to at least one of the detected and/or predicted one or more symptoms, the generated outputs comprising at least one alert to the user; and
responsive to at least one type of detected and/or predicted symptom, generating an output identifying a different infusion site and/or a different fluid medication delivery device for the user based at least in part on historical data relating to one or more of the user, the infusion site, and the fluid delivery device.

### Claim 40 (depends on 39)

The method of claim 39, comprising detecting and/or predicting the one or more symptoms further in view of at least one predetermined tolerance and/or threshold.
