Medical skin mountable device

• US 9,592,336 B2
• Filed: 02/14/2011
• Issued: 03/14/2017
• Est. Priority Date: 10/27/2003
• Status: Active Grant

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Nielsen, Ole Christian, Radmer, Jim, Preuthun, Jan Harald
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): Zhang, Jenna
• Application Number:
  US13/026,691
• Publication Number:
  US 20110137255A1
• Time in Patent Office: 2,220 Days
• Field of Search: 604/173, 604/174, 604/890.1, 604131-133
• US Class Current: 1/1
• 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 2005/14506 mechanically driven, e.g. spring or clockwork
• CPC Class Codes: A61M 2005/14513 with secondary fluid driving or regulating the infusion
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 5/14216 Reciprocating piston type
• CPC Class Codes: A61M 5/14224 Diaphragm type
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/14526 the piston being actuated by fluid pressure
• CPC Class Codes: A61M 5/1486 the bags being substantially completely surrounded by fluid
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A medical device is provided comprising a transcutaneous device unit and a reservoir unit. The transcutaneous device unit comprises a transcutaneous device for transporting a fluid through a skin portion of a subject, and a mounting surface adapted for application to the skin of the subject. The reservoir unit comprises a reservoir adapted to contain a fluid drug, the reservoir comprising an outlet means allowing the transcutaneous device to be arranged in fluid communication with an interior of the reservoir, and an expelling assembly for expelling a fluid drug out of the reservoir and through the skin of the subject via the transcutaneous device. The transcutaneous device unit and the reservoir unit further comprise coupling means allowing the reservoir unit to be secured to the transcutaneous device unit in the situation of use. By this arrangement a two-unit system is provided which can be used in a convenient and cost-effective manner.

Claims

1. A medical device, comprising a first unit and a second unit configured to be secured to each other in a situation of use,

the first unit being in the form of a transcutaneous device unit comprising:

a transcutaneous device having a mounting surface comprising an adhesive allowing the mounting surface to be attached to a skin surface of a subject,

the second unit being in the form of a removable and re-usable reservoir unit comprising;

a unitary housing enclosing a reservoir configured to contain a fluid drug and an expelling assembly, and the expelling assembly being configured to cooperate with the reservoir to expel fluid drug out of the reservoir and through the skin of the subject via the transcutaneous device, the expelling assembly comprising a mechanical pump in combination with an electronically controlled actuator, an electrical energy source and a processor configured to control the mechanical pump, the removable and re-usable reservoir unit being without an adhesive for mounting to the skin surface of the subject.

2. A medical device as in claim 1, wherein the first unit and second unit are disposable and have a first and second operation life respectively, the second operational life being longer than the first operational life.

3. A medical device as in claim 1, wherein fluid communication between the transcutaneous device and the reservoir is established when the transcutaneous device unit and the reservoir unit are secured to each other.

4. A medical device as in claim 1, wherein the expelling assembly is configured to be activated when the transcutaneous device unit and the reservoir unit are secured to each other and de-activated when the units are released from each other.

5. A medical device as in claim 1, wherein the pump has an inlet configured for fluid communication with the reservoir, and an outlet configured for fluid communication with the transcutaneous device, allowing the transcutaneous device to be in fluid communication with the interior of the reservoir.

6. A medical device as in claim 5, wherein the pump comprises an internal flow path arranged between the inlet and the outlet, the inlet and the outlet sealing the interior of the pump and thereby the flow path in an initial sterile state.

7. A medical device as in claim 6, wherein the reservoir unit is transformable from an initial condition in which there is no fluid communication between the pump and the reservoir to a non-reversible operating condition in which fluid communication is established between the inlet of the pump and the reservoir when the pump unit is secured to the transcutaneous device unit for the first time.

8. A medical device as in claim 7, wherein a fluid connector is configured within the interior of the pump in the initial condition, the fluid connector comprising an inlet and an outlet, wherein the fluid connector is configured to be operated from the initial condition and to an operating condition in which fluid communication is established between the interior of the reservoir and the interior of the pump via the fluid connector and with the outlet of the fluid connector being arranged in the flow path of the pump.

9. A medical device as in claim 8, wherein the outlet of the fluid connector comprises a pointed inlet end, the reservoir comprising a penetrable portion configured for penetration by the pointed inlet end.

10. A medical device as in claim 1, wherein the transcutaneous device comprises a pointed end configured to penetrate the skin of a subject, the pointed end being moveable between an initial position in which the pointed end is retracted relative to the mounting surface, and an extended position in which the pointed end projects relative to the mounting surface.

11. A medical device as in claim 10, wherein the transcutaneous device unit comprises a transcutaneous device actuator configured to move the pointed end of the transcutaneous device between the initial and the extended positions.

12. A medical device as in claim 10, wherein the transcutaneous device unit comprises a blocking device configured to block the transcutaneous device actuator, the blocking device being released when the transcutaneous device unit and the reservoir unit are secured to each other, allowing the transcutaneous device actuator to be actuated.

13. A medical device as in claim 12, wherein the expelling assembly is activated when the electronically controlled actuator is actuated.

14. A medical device as in claim 10, wherein the pointed end of the transcutaneous device is moveable between the extended position in which the pointed end projects relative to the mounting surface, and a retracted position in which the pointed end is retracted relative to the mounting surface.

15. A medical device as in claim 14, further comprising a retraction device configured to move the pointed end of the transcutaneous device between the extended and the retracted position when the retraction device is actuated.

16. A medical device as in claim 15, wherein the expelling assembly is deactivated when the retraction device is actuated.

17. A medical device as in claim 1, wherein the transcutaneous device comprises a first portion having a pointed end and a second portion having a second end, the second portion being in fluid communication with the first portion.

18. A medical device as in claim 17, wherein the second end comprises a pointed needle end, the pump having an outlet comprising a needle-penetrable septum allowing a fluid communication to be established between the second end of the transcutaneous device and the pump.

19. A medical device as in claim 1, further comprising a releasable mating coupling for securing the transcutaneous device unit and the reservoir unit to each other.

20. A medical device as in claim 19, wherein the expelling assembly is deactivated when the two units are released from each other.

21. A medical device as in claim 1, wherein the reservoir is prefilled with a liquid drug.

22. A medical device as in claim 1, wherein the reservoir, in a situation of use, comprises a liquid drug but substantially no enclosed free gas.

23. A medical device as in claim 1, in combination with a plurality of removable and re-usable reservoir units, the transcutaneous device unit and the plurality of removable and re-usable reservoir units forming a system,

wherein each of the plurality of removable and re-usable reservoir unit has different capabilities,

wherein the transcutaneous device unit and the plurality of removable and re-usable reservoir units each comprise a mating coupling allowing each of the plurality of removable and re-usable reservoir unit to be secured to the transcutaneous device unit to provide fluid communication between each of the respective reservoirs and the transcutaneous device, and

wherein each combination of the transcutaneous device unit and one of the plurality of removable and re-usable reservoir unit provides an assembly having different capabilities.

24. A medical device as in claim 23, wherein a first reservoir unit of the plurality of removable and re-usable reservoirs comprises a first amount of a drug and a second reservoir unit of the plurality of removable and re-usable reservoirs comprises a second amount of the drug.

25. A medical device as in claim 23, wherein a first reservoir unit of the plurality of removable and re-usable reservoirs comprises a first drug and a second reservoir unit of the plurality of removable and re-usable reservoirs comprises a second drug.

26. A medical device as in claim 23, wherein a first reservoir unit of the plurality of removable and re-usable reservoirs is configured to expel drug at a first pre-set rate and a second reservoir unit of the plurality of removable and re-usable reservoirs is configured to expel drug at a second pre-set rate.

27. A medical device as in claim 23, wherein a first reservoir unit of the plurality of removable and re-usable reservoirs is configured to expel drug at a pre-set rate and a second reservoir unit of the plurality of removable and re-usable reservoirs is configured to expel drug at a selectable rate.

28. A medical device as in claim 23, wherein a first reservoir unit of the plurality of removable and re-usable reservoirs is configured to cause expelling of fluid from the reservoir based upon flow instructions, and a receiver configured to receive flow instructions from a separate control device and deliver the flow instructions to the processor, wherein a second reservoir unit of the plurality of removable and re-usable reservoirs is not configured to receive flow instructions from a separate control device.

29. A medical device as in claim 28, wherein the receiver is a wireless receiver.

30. A medical device as in claim 1, in combination with a plurality of transcutaneous device units, the plurality of transcutaneous device units and the reservoir unit forming a system,

wherein each of the plurality of transcutaneous device units and the reservoir unit comprise a mating coupling allowing the reservoir unit to be secured to each of the plurality of transcutaneous device units to provide fluid communication between the reservoir and the respective transcutaneous device unit,

wherein each combination of one of the plurality of transcutaneous device unit and the reservoir unit provides an assembly having different capabilities.

31. A medical device as in claim 30, wherein a first transcutaneous device unit of the plurality of transcutaneous device units comprises a hollow subcutaneous needle, and a second transcutaneous device unit of the plurality of transcutaneous device units comprises a transcutaneous device selected from a group consisting of a cannula and insertion needle assembly, and a micro needle array.