DEVICE FOR ADMINISTERING A FLUID PRODUCT

• US 20160361494A1
• Filed: 08/25/2016
• Published: 12/15/2016
• Est. Priority Date: 02/26/2014
• Status: Active Grant

• Current Assignee: Ypsomed AG (Ypsomed Holding AG)
• Original Assignee: TecPharma Licensing AG (Ypsomed Holding AG)
• Inventors: Jrg, STECK, Jan, BAUMERT, Christoph, LAUSTER, Thomas, GURTNER, Rne, MATHYS, Patrick, HOSTETTLER, Nicolas, BINGGELI, Thomas, BURI
• Granted Patent: US 10,850,032 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/16863 Occlusion detection
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/332 Force measuring means
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/702 automatically during use
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 5/14216 Reciprocating piston type
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• 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
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence

Abstract

An infusion apparatus for delivering medication includes a housing, a drive mechanism, a force sensor, and a transfer element. The drive mechanism comprises first and second conveying elements, the second conveying element for advancing a plug in a reservoir in the distal direction, the first conveying element with limited axial movement relative to the housing but rotatable to cause an ejecting or resetting movement of the second conveying element. The force sensor is arranged along a central axis between the housing and the proximal end of the drive mechanism. The transfer element is axially arranged between the force sensor and the first conveying element and the force sensor bears axial forces exerted by the ejection movement. The second conveying element moves the transfer element away from the first conveying element against the bias of a restoring force such that the force sensor bears axial forces exerted by the resetting movement.

Claims

1. An infusion apparatus for the administration of a medication from a reservoir with a plug moveable along a central axis in a distal direction for ejection, the apparatus comprising:

a housing;

a drive mechanism comprising a first conveying element and a second conveying element, the second conveying element configured for advancing the plug in the reservoir in the distal direction, the first conveying element configured for limited axial movement relative to the housing and being rotatable, wherein rotation of the first conveying element causes an ejection movement or a resetting movement of the second conveying element;

a force sensor arranged along the central axis between the housing and a proximal end of the drive mechanism; and

a transfer element axially arranged between the force sensor and the first conveying element such that the force sensor bears axial forces exerted by the ejection movement,

wherein the second conveying element moves the transfer element away from the first conveying element against the bias of a restoring force such that the force sensor bears axial forces exerted by the resetting movement.

2. The infusion apparatus according to claim 1, wherein a resilient element exerts the restoring force on the transfer element.

3. The infusion apparatus according to claim 2, wherein the resilient element is one or more of an elastomeric part or a spring.

4. The infusion apparatus according to claim 2, wherein the resilient element is one or more of a magnetic or an electromagnetic arrangement.

5. The infusion apparatus according to claim 3, wherein the resilient element operatively couples the transfer element and the first conveying element.

6. The infusion apparatus according to claim 5, wherein the resilient element comprises an O-ring arranged in a groove formed on one or more of the transfer element or the first conveying element.

7. The infusion apparatus according to claim 1, wherein:

the transfer element comprises a force transmitting element and a restricting element,

the force sensor comprises a cantilever beam coupled to a base plate,

the axial forces are measured by deflection of the cantilever beam versus the base plate, and are transmitted from the drive mechanism to the cantilever beam via the force transmitting element, and

a maximum deflection of the cantilever beam is limited by the restricting element.

8. The infusion apparatus according to claim 7, wherein the force transmitting element and the restricting element protrude from the transfer element;

9. The infusion apparatus of claim 8, wherein a ratio of protrusion distances of the force transmitting element and restricting element is above unity.

10. The infusion apparatus according to claim 7, wherein the maximum deflection of the cantilever beam is limited by the restricting element touching the base plate of the force sensor.

11. A method for resetting of an infusion apparatus, comprising the steps of:

providing the infusion apparatus, the infusion apparatus comprising;

a housing,

a drive mechanism comprising a first conveying element and a second conveying element,

a force sensor arranged along the central axis between the housing and a proximal end of the drive mechanism, and

a transfer element axially arranged between the force sensor and the first conveying element such that the force sensor bears axial forces exerted by the second conveying element;

rotating the first conveying element for bringing the second conveying element in a resetting movement;

displacing the transfer element in the proximal direction against the bias of a restoring force;

measuring, by the force sensor, the axial forces exerted by the resetting movement of the second conveying element;

stopping the rotation of the first conveying element once a threshold force is measured; and

rotating the first conveying element in a direction opposite from causing the resetting movement, wherein such rotation advances the second conveying element in the distal direction until the transfer element is returned to a predefined position.

12. The method of claim 11, wherein the predefined position is a position the transfer element assumes before the resetting movement.

13. The method of claim 11, wherein the force sensor is calibrated after the transfer element has returned to the predefined position.

14. The method of claim 11, wherein the infusion apparatus further comprises an electronic control module and the transfer element of the infusion apparatus further comprises a restricting element, the method further comprising:

stopping the rotation of the first conveying element in response to the restricting element limiting further increase of the measured force, corresponding to the threshold force;

recording the threshold force in the electronic control module;

comparing the threshold force with a preset force limit; and

rendering an alarm to the user of the device if the threshold force recorded is below the preset force limit.

15. The method of claim 14, wherein the force sensor comprises a base plate and a cantilever beam and the transfer element further comprises a transmitting element, wherein the restricting element loads the base plate and restricts a maximum displacement of the transmitting element, thereby restricting deflection of the cantilever beam by the transmitting element.

16. The method of claim 15, wherein prior to the restricting element loading the base plate, the transmitting element deflects the cantilever beam such that the sensor measures the axial forces with increasing beam deflection.

17. An infusion apparatus for the administration of a medication from a reservoir with a plug moveable along a central axis in a distal direction for ejection, the apparatus comprising:

a housing;

a drive mechanism configured for advancing the plug in the reservoir in the distal direction in an ejection movement, wherein the drive mechanism is resettable in a resetting movement;

a force sensor comprising a cantilever beam coupled to a base plate, the force sensor arranged along the central axis between the housing and a proximal end of the drive mechanism and configured to bear axial forces exerted during the ejection and resetting movements of the drive mechanism; and

a transfer element comprising a force transmitting element and a restricting element, the transfer element operable between the force sensor and the drive mechanism,

wherein the force sensor measures the axial forces by a deflection of the cantilever beam versus the base plate, the axial forces being transmitted from the drive mechanism to the cantilever beam via the force transmitting element, and

wherein a maximum deflection of the cantilever beam is limited by the restricting element.

18. The infusion apparatus according to claim 17, wherein the force transmitting element and the restricting element protrude from the transfer element;

19. The infusion apparatus according to claim 17, wherein the maximum deflection of the cantilever beam is limited by the restricting element touching the base plate of the force sensor.

20. The infusion apparatus according to claim 17, further comprising a resilient element operatively coupling the transfer element and the drive mechanism.