# US 2025/0152931 A1 · Single-use disposable set connector

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- Number: US 2025/0152931 A1
- Document ID: US20250152931A1
- Status: Published application
- Kind: A1
- Application number: 19/021,985
- Filed: 2025-01-15
- Published: 2025-05-15
- Earliest claimed: 2014-01-10
- Assignees: Bayer HealthCare LLC
- Applicants: Bayer Healthcare LLC
- Inventors: Richard Sokolov; Alison Ruth Von Moger; Benjamin James Cullen; Ernesto Hueso Monis; Kamman Law; Mark Silvio Profaca; John A. Haury; Michael Swantner
- Web page: https://patentgrep.com/patent/US20250152931A1

## CPC

- A61M 39/1011: {Locking means for securing connection; Additional tamper safeties (A61M39/16 takes precedence)}
- A61M 5/007: {for contrast media}
- A61M 5/5086: {for indicating if defective, used, tampered with or unsterile}
- A61M 39/1033: {Swivel nut connectors, e.g. threaded connectors or bayonet-connectors}
- A61M 2005/1402: {Priming}
- A61M 2039/1027: {Quick-acting type connectors}
- A61M 2039/1044: {Verifying the connection, e.g. audible feedback, tactile feedback, visual feedback, using external light sources}
- A61M 2039/1094: {at least partly incompatible with standard connectors, e.g. to prevent fatal mistakes in connection}
- 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 2205/3306: Optical measuring means
- A61M 2205/3584: using modem, internet or Bluetooth®
- A61M 2205/50: with microprocessors or computers
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- 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 medical connector for providing a sterile connection between a multi-use portion and a single-use portion of a fluid delivery system is provided. The medical connector includes a fluid inlet port configured for removable engagement with a connection port of a multi-use disposable set (MUDS) to establish a fluid connection therewith and a waste outlet port configured for removable engagement with a waste inlet port of the MUDS to establish a fluid connection therewith. A patient fluid line is connected, at a first end, to the fluid inlet port and connected, at a second end, to the waste outlet port. Fluid flow through the patient fluid line is unidirectional from the first end to the second end. The patient fluid line is configured for being disconnected from the waste outlet port for delivering fluid to a patient. A multi-fluid delivery system having the medical connector and MUDS is also provided.

## Claims

### Claim 1

A sensing element for sensing engagement of a medical connector with a connection port of a disposable fluid delivery set, the sensing element comprising:
at least one sensing fin extending vertically from an upper surface of a flexible tab of a locking mechanism of the medical connector, wherein the locking mechanism is configured for reversibly locking the medical connector with the connection port of the disposable fluid delivery set to establish fluid connection between the medical connector with the disposable fluid delivery set and wherein the flexible tab is deflectable between an engaged position and an disengaged position by deflecting at least a portion of the flexible tab;
one or more reflective surfaces on at least one side of the at least one sensing fin for reflecting visible or infrared light, wherein the one or more reflective surfaces of the at least one sensing fin is configured to interact with at least one sensor of a fluid injector system when the locking mechanism is locked in the engaged position, the medical connector is securely connected to the connection port of the disposable set, and a fluid inlet port of the medical connector is in fluid connection with the connection port of the disposable fluid delivery set,
wherein the at least one sensing element is configured to indicate that the medical connector has been inserted or installed into the connection port when the at least one sensing fin is detected by the at least one sensor of the fluid injector system.

### Claim 2 (depends on 1)

The sensing element of claim 1, wherein the one or more reflective surfaces are configured to reflect the visible or infrared light to be detected by the at least one sensor.

### Claim 3 (depends on 1)

The sensing element of claim 1, wherein the at least one sensing element is formed on the flexible tab.

### Claim 4 (depends on 1)

The sensing element of claim 1, wherein the flexible tab of the locking mechanism is on an upper side of medical connector.

### Claim 5 (depends on 4)

The sensing element of claim 4, wherein the wherein the flexible tab forms a releasable locking engagement with a receiving slot on the connection port of the disposable fluid delivery set when in the engaged position.

### Claim 6 (depends on 1)

The sensing element of claim 1, wherein the medical connector further comprises a patient fluid line connected, at a first end, to the fluid inlet port and having a fluid line connector at a second end configured for connection to a patient catheter to establish a fluid connection between the connection port and the patient catheter.

### Claim 7 (depends on 6)

The sensing element of claim 6, wherein the at least one sensing element is configured such that detection of the at least one sensing fin by the at least one sensor initiates an automatic priming sequence to prime the patient fluid line with a fluid.

### Claim 8

A method of preparing a fluid injector for delivery of a medical fluid to a patient, the method comprising:
fluidly connecting a fluid inlet port of a medical connector with a connection port of a disposable fluid delivery set;
engaging a flexible tab of a locking mechanism of the medical connector with a receiving slot on the connection port of the disposable fluid delivery set;
establishing fluid communication through a patient fluid line of the medical connector between the fluid inlet port of the medical connector at a first end of the patient fluid line and a fluid line connector at a second end of the patient fluid line;
detecting, by at least one sensor on a fluid injector system, the presence or absence of at least one sensing element in the form of a sensing fin extending vertically from an upper surface of the flexible tab of the locking mechanism of the medical connector;
if the presence of the sensing fin is detected by the at least one sensor, automatically priming the medical connector by delivering fluid from the fluid inlet port to the fluid line connector through the patient fluid line;
connecting the fluid line connector at the second end of the patient fluid line to an access to a patient's vasculature system; and
initiating a fluid injection procedure to deliver the medical fluid to the patient.

### Claim 9 (depends on 8)

The method of claim 8, wherein detecting the presence of absence of the at least one sensing element comprises detecting reflection of visible or infrared light due to one or more reflective surfaces on the sensing fin to indicate that the medical connector has been properly inserted or installed in the connection port.

### Claim 10 (depends on 8)

The method of claim 8, further comprising if the presence of the sensing element is not detected by the at least one sensor, sending a signal from the at least one sensor to a controller indicating that the medical connector has not been properly inserted or installed in the connection port.

### Claim 11 (depends on 10)

The method of claim 10, further comprising alerting a user of the fluid injector system that the medical connector is not properly inserted or installed in the connection port.

### Claim 12

A controller for a fluid injector system, the controller comprising a processor programmed or configured to:
receive a signal from at least one sensor on the fluid injector system that a sensing element on a flexible locking tab of a medical connector has been detected in an engaged position;
initiate an auto-prime sequence comprising activating at least one piston of one or more of a plurality of syringes of a disposable fluid delivery set to flow a sufficient volume of a medical fluid through a patient fluid line of a medical connector to ensure a complete fluid fill of the patient fluid line;
detect by at least one air detector on the fluid injector that no air is detected in an output of the patient fluid line; and
stop the auto-prime sequence and indicate to a user that the fluid injector system is primed and ready for an injection procedure.

### Claim 13 (depends on 12)

The controller of claim 12, wherein the sensing element comprises at least one sensing fin extending vertically from an upper surface of a flexible tab of a locking mechanism of the medical connector and the signal from the at least one sensor is sent to the controller when one or more reflective surfaces on the sensing fin are detected by the at least one sensor.

### Claim 14 (depends on 12)

The controller of claim 12, wherein the signal from the at least one sensor is sent to the controller when a mechanical interaction is detected between the sensing element and the at least one sensor.

### Claim 15 (depends on 12)

The controller of claim 12, wherein the processor is programmed or configured to:
initiate the auto-prime sequence by drawing fluid into one or more of the plurality of syringes of a disposable fluid delivery set from one or more bulk fluid sources followed by activating the at least one piston to flow the sufficient volume of the medical fluid through the patient line of the medical connector.

### Claim 16 (depends on 15)

The controller of claim 15, wherein the processor is programmed or configured to:
initiate the auto-prime sequence after the processor receives the signal from the at least one sensor that the medical connector has been detected in the engaged position.