# US 10,307,533 B2 · Medical fluid-flow regulating devices with blocking unit

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- Number: US 10,307,533 B2
- Document ID: US10307533B2
- Status: Granted
- Kind: B2
- Application number: 15/253,952
- Filed: 2016-09-01
- Published: 2017-03-02
- Granted: 2019-06-04
- Earliest claimed: 2015-09-01
- Assignees: Medirio S.A.
- Applicants: Medirio S.A.
- Inventors: Irio Giuseppe Calasso; Einar Petersen; Tobias Von Cappelen; Klaus Dietrich; Matteo De Donatis
- Web page: https://patentgrep.com/patent/US10307533B2

## CPC

- A61M 5/16804: {Active flow controllers}
- A61M 5/1413: {Modular systems comprising interconnecting elements}
- A61M 5/14216: {Reciprocating piston type}
- A61M 5/14248: {of the skin patch type}
- A61M 5/16831: {Monitoring, detecting, signalling or eliminating infusion flow anomalies (low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066)}
- A61M 2005/14268: {with a reusable and a disposable component}
- A61M 2039/226: {Spindles or actuating means}
- A61M 2205/18: with alarm
- A61M 2205/332: Force measuring means
- A61M 2205/3341: stabilising pressure or flow to avoid excessive variation
- 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

Medical fluid-flow regulating devices are provided. Such medical fluid-flow regulating devices typically include a rotor and a flow-regulator element engaged or engageable with each other via a coupling that below a torque and/or fluidic-pressure threshold value allows the flow-regulator element to move upon rotation of the rotor and thereby regulate fluid flow. The medical fluid-flow regulating devices also include a blocking unit that above the torque and/or fluidic-pressure threshold value irreversibly blocks the rotor or the flow-regulator element or the coupling between the rotor and the flow-regulator element resulting in irreversible inactivation of the medical fluid-flow regulating device. Systems incorporating such medical fluid-flow regulating devices are also provided. Methods for detecting inactivation of such devices are also provided.

## Claims

### Claim 1

A medical fluid-flow regulating device comprising a rotor and a flow-regulator element engaged or engageable with each other via a coupling that below a torque and/or fluidic-pressure threshold value allows the flow-regulator element to move upon rotation of the rotor and thereby regulate fluid flow and also comprising a blocking unit that above the torque and/or fluidic-pressure threshold value irreversibly blocks the rotor or the flow-regulator element or the coupling between the rotor and the flow-regulator element.

### Claim 2 (depends on 1)

The medical fluid-flow regulating device of claim 1 wherein above the torque and/or the fluidic pressure threshold value, any one or more of the rotor, the flow-regulator element, the coupling, the blocking unit or any elements thereof are displaceable with respect to each other resulting in irreversible engagement with the blocking unit and in permanent inactivation of the medical fluid-flow regulating device.

### Claim 3 (depends on 2)

The medical fluid-flow regulating device of claim 2 wherein the rotor is displaceable with respect to the blocking unit above the torque and/or fluidic-pressure threshold value thereby irreversibly engaging with the blocking unit, and preventing the rotor from rotating.

### Claim 4 (depends on 2)

The medical fluid-flow regulating device of claim 2 wherein the blocking unit or any element thereof is displaceable with respect to the rotor above the torque and/or fluidic-pressure threshold value thereby irreversibly engaging with the rotor and preventing the rotor from rotating.

### Claim 5 (depends on 4)

The medical fluid-flow regulating device of claim 4 wherein the blocking unit comprises a membrane that above the fluidic-pressure threshold value is expanded such as to directly or indirectly block the rotor and prevent the rotor from rotating.

### Claim 6 (depends on 2)

The medical fluid-flow regulating device of claim 2 wherein the flow-regulator element or the coupling between the rotor and the flow-regulator element is displaceable with respect to the rotor or is deformable above the torque and/or fluidic-pressure threshold value thereby functioning as a blocking unit for the rotor or is adapted to move the blocking unit into engagement with the rotor.

### Claim 7 (depends on 1)

The medical fluid-flow regulating device of claim 1 wherein the coupling is a gear coupling.

### Claim 8 (depends on 1)

The medical fluid-flow regulating device of claim 1 wherein the flow-regulator element is an axial pump element.

### Claim 9 (depends on 8)

The medical fluid-flow regulating device of claim 8 wherein the axial pump element is a push or pull element or is coupled to a plunger or piston that is coupled or couplable to a syringe-like or cartridge-like fluid reservoir.

### Claim 10 (depends on 1)

The medical fluid-flow regulating device of claim 1, wherein the blocking unit comprises an irreversible stop element that impedes the rotor from rotating again after the blocking unit has blocked it.

### Claim 11 (depends on 1)

A system comprising a medical fluid-flow regulating device of claim 1 and a hand-held activation device separate from the medical fluid-flow regulating device, the activation device comprising a drive unit for magnetically or inductively rotating the rotor of the medical fluid-flow regulating device and a sensor for detecting rotation of the rotor.

### Claim 12 (depends on 11)

The system of claim 11 wherein the hand-held activation device further comprises a controller programmed to control, based on information from the sensor, if rotation of the rotor fails despite operation of the drive unit for rotating the rotor and/or if operation of the drive unit corresponds to intended rotation of the rotor.

### Claim 13 (depends on 12)

The system of claim 12 wherein the controller is programmed to interpret failure of detection of rotation of the rotor as an increase of the torque and or/force and/or of the fluidic pressure above the threshold value and to associate it to a condition of irreversible inactivation of the medical fluid-flow regulating device.

### Claim 14 (depends on 12)

The system of claim 12 wherein the controller is programmed to warn and/or to stop or prevent operation of the drive unit and/or prevent further use of the medical fluid-flow regulating device if detection of rotation of the rotor fails.

### Claim 15 (depends on 1)

A method of detecting irreversible inactivation of a medical fluid-flow regulating device of claim 1 comprising detecting if the rotor fails to rotate despite operation of a drive unit for rotating the rotor in an energy-transfer position.

### Claim 16 (depends on 15)

The method of claim 15 further comprising warning and/or stopping operation of the drive unit and/or preventing further use of the fluid-flow regulating device if detection of rotation of the rotor fails.
