Medical fluid-flow regulating devices with blocking unit

• US 10,307,533 B2
• Filed: 09/01/2016
• Issued: 06/04/2019
• Est. Priority Date: 09/01/2015
• Status: Active Grant

• Current Assignee: Nuova Ompi S.R.L. (Stevanato Holding Srl)
• Original Assignee: Medirio S.A.
• Inventors: Calasso, Irio Giuseppe, Petersen, Einar, Von Cappelen, Tobias, Dietrich, Klaus, De Donatis, Matteo
• Primary Examiner(s): Bouchelle, Laura A
• Application Number:
  US15/253,952
• Publication Number:
  US 20170056587A1
• Time in Patent Office: 1,006 Days
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2039/226 Spindles or actuating means
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/332 Force measuring means
• CPC Class Codes: A61M 2205/3341 stabilising pressure or flow to avoid excessive variation
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/14216 Reciprocating piston type
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/16804 Flow controllers
• CPC Class Codes: 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

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

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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

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

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

9. 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.

10. 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.

11. 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.

12. 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.

13. 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.

14. 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.

15. 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.

16. 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.