Medicament infusion device

• US 20130338592A1
• Filed: 06/05/2013
• Published: 12/19/2013
• Est. Priority Date: 06/14/2012
• Status: Active Grant

• Current Assignee: Nuova Ompi S.R.L. (Stevanato Holding Srl)
• Original Assignee: Medirio S.A.
• Inventors: Calasso, Irio Giuseppe
• Granted Patent: US 10,413,657 B2
• Time in Patent Office: Days
• US Class Current: 604/151
• CPC Class Codes: A61M 2005/1402 Priming
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2205/6054 Magnetic identification systems
• CPC Class Codes: A61M 2205/8287 operated by an external magnetic or electromagnetic field
• CPC Class Codes: A61M 5/14232 Roller pumps
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/145 using pressurised reservoirs, e.g. pressurised by means of pistons
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons

Abstract

The present invention refers to a medical device for trans-dermal infusion of a medicament comprising a reservoir for holding a medicament to be infused, a pump for pumping medicament from the reservoir, wherein the device is assembled or adapted to be assembled in at least one pre-operational arrangement with or without the reservoir and is adapted to be rearranged from the at least one pre-operational arrangement into an operational arrangement comprising the reservoir. In particular, in the pre-operational arrangement without reservoir the pump is in a mechanically distressed condition preventing functional operation of the pump, and in the pre-operational arrangement comprising the reservoir the pump is in a mechanically distressed condition preventing functional operation of the pump and/or the reservoir is fluidically disconnected from the pump. In the operational arrangement the pump is in a mechanically stressed condition enabling functional operation of the pump and the reservoir is fluidically connected to the pump.

Claims

1. Medical device for trans-dermal infusion of a medicament, comprising

a reservoir for holding a medicament to be infused,

a pump for pumping medicament from the reservoir,

wherein the device is assembled or adapted to be assembled in at least one pre-operational arrangement with or without the reservoir and is adapted to be rearranged from the at least one pre-operational arrangement into an operational arrangement comprising the reservoir,

wherein in the pre-operational arrangement without reservoir the pump is in a mechanically distressed condition preventing functional operation of the pump, and wherein in the pre-operational arrangement comprising the reservoir at least one of the following pre-operational conditions is met

the pump is in a mechanically distressed condition preventing functional operation of the pump,

the reservoir is fluidically disconnected from the pump,

and wherein in the operational arrangement the pump is in a mechanically stressed condition enabling functional operation of the pump and the reservoir is fluidically connected to the pump.

2. Device according to claim 1 wherein the device comprises an infusion element or is adapted to be fluidically connected to an infusion element, the infusion element being adapted for trans-dermal infusion of the medicament.

3. Device according to claim 2 wherein the pump comprises a tubing for transporting the medicament from the reservoir to the infusion element.

4. Device according to claim 3 wherein in the at least one pre-operational arrangement the tubing is mechanically distressed and wherein in the operational arrangement the tubing is mechanically stressed.

5. Device according to claim 4 wherein the pump is a peristaltic pump adapted to exercise peristaltic pumping when the tubing is mechanically stressed.

6. Device according to claim 5 wherein the pump comprises an epicyclic gear system comprising a plurality of planet gears and a central gear.

7. Device according to claim 5 wherein the pump comprises a ratchet pump system comprising a wrench comprising a ratchet gear functionally coupled to a peristaltic wheel holder via a pawl.

8. Device according to claims 3 wherein the device comprises a clamp movable from an open status, in which the tubing is mechanically distressed, to a closed status in which the tubing is mechanically stressed.

9. Device according to claims 3 wherein in the pre-operational arrangement comprising the reservoir the tubing is fluidically disconnected from the reservoir and/or from the infusion element and wherein in the operational arrangement the tubing is fluidically connected to the reservoir and to the infusion element.

10. Device according to claim 1 wherein in the pre-operational arrangement comprising the reservoir, the reservoir is fluidically accessible from the outside of the device via a filling port so that medicament can be introduced into the reservoir through the port and wherein in the operational arrangement the reservoir is inaccessible from the outside of the device so that medicament is prevented from being introduced into the reservoir.

11. Device according to claim 1 wherein the device comprises a reservoir push element adapted to push a volume of medicament out of the reservoir, which fills at least a part of the inner volume of the tubing when the device is rearranged from a first pre-operational arrangement into a second pre-operational arrangement or into the operational arrangement.

12. Device according to claim 2 wherein the infusion element is displaceable such as to penetrate the skin as a result of the rearrangement from a pre-operational arrangement to the operational arrangement while the device is in contact with the skin.

13. Device according to claim 1 wherein the rearrangement from the at least one pre-operational arrangement to the operational arrangement is irreversible.

14. Kit comprising a plurality of components adapted to be assembled together such as to form a device in a pre-operational arrangement according to claim 1.

15. Method of manufacturing a device according to claim 1 comprising assembling the device into at least one pre-operational arrangement and/or manufacturing device components adapted to be assembled into at least one pre-operational arrangement.