# US 12,311,158 B2 · Patient line air detection and reuse prevention

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- Number: US 12,311,158 B2
- Document ID: US12311158B2
- Status: Granted
- Kind: B2
- Application number: 17/639,641
- Filed: 2020-09-02
- Published: 2022-09-15
- Granted: 2025-05-27
- Earliest claimed: 2019-09-03
- Assignees: Bayer HealthCare LLC
- Applicants: Bayer Healthcare LLC
- Inventors: John Volkar
- Web page: https://patentgrep.com/patent/US12311158B2

## CPC

- A61M 5/50: having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile {(retractable needles or needle protectors with means for preventing re-use A61M5/321)}
- A61M 5/5086: {for indicating if defective, used, tampered with or unsterile}
- A61M 5/007: {for contrast media}
- A61M 5/1407: {Infusion of two or more substances}
- A61M 5/1452: {pressurised by means of pistons}
- A61M 5/14212: {Pumping with an aspiration and an expulsion action}
- A61M 5/14546: {Front-loading type injectors}
- A61M 2005/1402: {Priming}
- A61M 2005/1403: {Flushing or purging}
- A61M 2039/0027: {for mixing several substances from different containers}
- A61M 2205/12: with interchangeable cassettes forming partially or totally the fluid circuit
- A61M 2205/14: Detection of the presence or absence of a tube, a connector or a container in an apparatus
- A61M 2205/273: preventing reuse, e.g. of disposables
- A61M 2205/3569: sublocal, e.g. between console and disposable
- A61M 2205/583: by visual feedback
- A61M 2205/584: having a color code
- A61M 2205/587: Lighting arrangements
- A61M 2205/6018: providing set-up signals for the apparatus configuration
- A61M 2205/6027: Electric-conductive bridges closing detection circuits, with or without identifying elements, e.g. resistances, zener-diodes
- A61M 2205/6072: Bar codes
- 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 administration line for use with a fluid injector system includes a fluid verification module configured to be in operative communication with a housing of the fluid injector system such that the fluid injector system can determine a status of the administration line. The fluid verification module includes a body defining an inlet port, an outlet port, and a fluid channel extending from the inlet port to the outlet port; a first tubing section connected to the inlet port; and a second tubing section connected to the outlet port.

## Claims

### Claim 1

An administration line for use with a fluid injector system, the administration line comprising:
a fluid verification module configured to be in operative communication with a housing of the fluid injector system such that the fluid injector system can determine a status of the administration line, the fluid verification module comprising:
a body defining an inlet port, an outlet port, a fluid channel extending from the inlet port to the outlet port, and a priming port in fluid communication with a priming cavity;
a first tubing section connected to the inlet port; and
a second tubing section connected to the outlet port, wherein the second tubing section comprises an outlet fitting configured to connect to the priming port during storage or shipment of the administration line, and wherein the priming cavity is configured to receive and hold priming fluid from the outlet fitting during a priming operation of the administration line.

### Claim 2 (depends on 1)

The administration line of claim 1, wherein the first tubing section comprises:
a first inlet fitting configured for connection to a first fluid reservoir of the fluid injector system; and
a second inlet fitting configured for connection to a second fluid reservoir of the fluid injector system,
wherein the first inlet fitting is configured to connect to the second inlet fitting during storage or shipment of the administration line.

### Claim 3 (depends on 1)

The administration line of claim 1, wherein the first tubing section comprises:
an inlet fitting configured for connection to an intermediate tubing set in fluid communication with at least one fluid reservoir of the fluid injector system,
wherein the inlet fitting is configured to connect to the body of the fluid verification module during storage or shipment of the administration line.

### Claim 4 (depends on 1)

The administration line of claim 1, further comprising at least one sheet material disposed within the priming cavity, the at least one sheet material comprising:
a first sheet material having indicia; and
a second sheet material which transitions from an opaque state to an at least partially translucent state when the second sheet material is contacted by the priming fluid,
wherein the indicia on the first sheet material is obstructed by the second sheet material when the second sheet material is in the opaque state, and
wherein the indicia on the first sheet material is visible via a window in the body when the second sheet material is in the translucent state.

### Claim 5 (depends on 1)

The administration line of claim 1, further comprising at least one sheet material disposed within the priming cavity,
wherein the at least one sheet material is configured to change in electrical resistance when contacted by the priming fluid, and
wherein, when the fluid verification module is mounted to the housing of the fluid injector system, the at least one sheet material is configured to interface with at least one probe of the fluid injector system for measuring electrical resistance of the at least one sheet material.

### Claim 6 (depends on 1)

The administration line of claim 1, wherein the body of the fluid verification module further comprises a capillary channel in fluid communication with the priming cavity and configured to take up at least a portion of the priming fluid via capillary action.

### Claim 7 (depends on 1)

The administration line of claim 1, wherein at least a portion of the body of the fluid verification module is configured to act as a lens to display light emitted from a light source of the fluid injector system.

### Claim 8 (depends on 1)

The administration line of claim 1, wherein the body of the fluid verification module comprises one or more engagement features configured for securing the fluid verification module to the housing of the fluid injector system.

### Claim 9 (depends on 1)

The administration line of claim 1, wherein the fluid channel is at least partially transparent such that an imaging device of the housing can determine the presence or absence of fluid in the fluid channel.

### Claim 10 (depends on 1)

The administration line of claim 1, wherein the fluid channel is flexible and configured to interface with a strain gauge of the housing such that the strain gauge can determine fluid pressure in the administration line.

### Claim 11 (depends on 1)

The administration line of claim 1, further comprising at least one of:
an inlet one-way valve associated with the inlet port; and
an outlet one-way valve associated with the outlet port,
wherein at least one of the inlet one-way valve and the outlet one-way valve prohibit fluid flow in an upstream direction from the second tubing section toward the first tubing section.

### Claim 12

A fluid injector system configured to perform an injection procedure in connection with a diagnostic imaging procedure, the fluid injector system comprising:
an administration line comprising:
a fluid verification module, the fluid verification module comprising a body defining an inlet port, an outlet port, a fluid channel extending from the inlet port to the outlet port, and a priming port in fluid communication with a priming cavity;
a first tubing section connected to the inlet port; and
a second tubing section connected to the outlet port, wherein the second tubing section comprises an outlet fitting configured to connect to the priming port during storage or shipment of the administration line, and wherein the priming cavity is configured to receive and hold priming fluid from the outlet fitting during a priming operation of the administration line; and
a controller programmed or configured to determine a status of the administration line.

### Claim 13 (depends on 12)

The fluid injector system of claim 12, wherein the first tubing section comprises:
a first inlet fitting configured for connection to a first fluid reservoir of the fluid injector system; and
a second inlet fitting configured for connection to a second fluid reservoir of the fluid injector system,
wherein the first inlet fitting is configured to connect to the second inlet fitting during storage or shipment of the administration line.

### Claim 14 (depends on 12)

The fluid injector system of claim 12, wherein the first tubing section comprises:
an inlet fitting configured for connection to an intermediate tubing set in fluid communication with at least one fluid reservoir of the fluid injector system,
wherein the inlet fitting is configured to connect to the body of the fluid verification module during storage or shipment of the administration line.

### Claim 15 (depends on 12)

The fluid injector system of claim 12, further comprising:
at least one probe for measuring electrical resistance in communication with the controller; and
at least one sheet material disposed within the priming cavity,
wherein the at least one sheet material is configured to change in electrical resistance when contacted by the priming fluid, and
wherein the controller is programmed or configured to prohibit performance of an injection procedure in response to determining, via the at least one probe, that the at least one sheet material has been previously contacted by the priming fluid.

### Claim 16 (depends on 12)

The fluid injector system of claim 12, further comprising an imaging device in communication with the controller,
wherein the fluid channel is at least partially transparent such that the controller can determine the presence or absence of fluid in the fluid channel via the imaging device; and
wherein the controller is programmed or configured to halt performance of a fluid injection procedure in response to detecting air in the fluid channel via the imaging device.
