Medical skin mountable device

• US 20060264835A1
• Filed: 04/25/2006
• Published: 11/23/2006
• Est. Priority Date: 10/21/2003
• Status: Active Grant

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Radmer, Jim, Preuthun, Jan Harald, Nielsen, Ole Christian
• Granted Patent: US 8,062,253 B2
• Time in Patent Office: Days
• US Class Current: 604/174
• 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

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 (1, 100, 500), comprising a transcutaneous device unit (502) and a reservoir unit (505), the transcutaneous device unit comprising:

a transcutaneous device (530),

a mounting surface adapted for application to the skin of the subject, the reservoir unit comprising;

a reservoir (760) adapted to contain a fluid drug,

an expelling assembly (300, 580) adapted for cooperation with the reservoir to expel fluid drug out of the reservoir and through the skin of the subject via the transcutaneous device,

wherein the transcutaneous device unit and the reservoir unit are adapted to be secured to each other in a situation of use.

2. A medical device as defined 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.

3. A medical device as in claim 1, wherein the expelling assembly is activated or allowed 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.

4. A medical device as defined in claim 1, wherein the expelling assembly comprises a pump having an inlet (321) adapted to be arranged in fluid communication with-the reservoir, and an outlet (322) adapted to be arranged in fluid communication with the transcutaneous device, thereby allowing the transcutaneous device to be arranged in fluid communication with the interior of the reservoir.

5. A medical device as defined in claim 4, 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.

6. A medical device as defined in claim 5, 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 a transcutaneous device unit for the first time.

7. A medical device as defined in claim 6, wherein a fluid connector (350) is arranged within the interior of the pump in the initial condition, the fluid connector comprising an inlet (351) and an outlet (353), wherein the fluid connector is arranged 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.

8. A medical device as defined in claim 7, wherein the fluid connector comprises a pointed inlet end, the reservoir comprising a penetratable portion (761) allowing the pointed fluid connector inlet end to be inserted there through.

9. A medical device of claim 1, wherein the transcutaneous device comprises a pointed end adapted 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.

10. A medical device as defined in claim 9, wherein the transcutaneous device unit comprises actuation means (540) for moving the pointed end of the transcutaneous device between the initial and the extended position when the actuation means is actuated.

11. A medical device as defined in claim 10, wherein the transcutaneous device unit comprises means for blocking the actuation means, the blocking means being released when the transcutaneous device unit and the reservoir unit are secured to each other, thereby allowing the actuation means to be actuated.

12. A medical device as defined in claim 10, wherein the expelling assembly is activated when the actuation means is actuated.

13. A medical device as defined in claim 12, 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.

14. A medical device as defined in claim 13, further comprising retraction means (550) for moving the pointed end of the transcutaneous device between the extended and the retracted position when the retraction means is actuated.

15. A medical device as defined in claim 14, wherein the actuation means in an initial condition covers the retraction means, actuation of the actuation means uncovering the retraction means.

16. A medical device as defined in claim 14, wherein the expelling assembly is deactivated when the retraction means is actuated.

17. A medical device as defined in claim 1, wherein the transcutaneous device comprises a first portion (531) having a/the pointed end, and a second portion (532) in fluid communication with the first portion and having a second end.

18. A medical device as defined in claim 17, wherein the second end comprises a pointed needle end, the outlet of the pump comprising a needle-penetratable septum (332) allowing a fluid communication to be established between the second end of the transcutaneous device and the interior of the pump.

19. A medical device as defined in claim 1, wherein the mounting surface comprises adhesive means (571) allowing the medical device to be attached to a skin surface of the subject.

20. A medical device as defined in claim 19 when dependent upon claim 14, wherein operation of the retraction means (550) from a first to an intermediate condition causes the transcutaneous device to be moved from the extended position to the retracted position, and operation of the retraction means from the intermediate to a second condition causes release of the device from the skin surface.

21. A medical device as defined claim 1, comprising releasable mating coupling means (506, 511) for securing the transcutaneous device unit and the reservoir unit to each other.

22. A medical device as defined in claim 21, wherein the expelling assembly is deactivated when the two units are released from each other.

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

24. 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.

25. A medical device (502), comprising:

a transcutaneous device (530, 650) comprising a distal end with an outlet opening and being adapted to penetrate the skin of a subject, and a proximal end (532) with an inlet opening forming a fluid inlet, the fluid inlet being adapted to be arranged in fluid communication with a fluid supply, the transcutaneous device providing a hydraulically stiff fluid communication between the inlet and outlet openings,

a coupling (511) allowing an external fluid supply to be connected to the fluid inlet, and

a mounting surface adapted for application to the skin of the subject.

26. A medical device as defined in claim 25, wherein the distal end of the transcutaneous device is moveable between an initial position in which the distal end is retracted relative to the mounting surface, and an extended position in which the distal end projects relative to the mounting surface, wherein the medical device optionally comprises actuation means for moving the distal end of the transcutaneous device between the initial and the extended position when the actuation means is actuated.

27. A medical device as defined in claim 25, wherein the transcutaneous device is in the form of a hollow subcutaneous needle.

28. A system comprising:

a transcutaneous device unit (502) comprising a transcutaneous device and a mounting surface adapted for application to the skin of a subject,

a plurality of reservoir units (505), each comprising a reservoir containing a fluid drug and an expelling assembly (300) for expelling fluid drug from the reservoir, and each having different capabilities,

the transcutaneous device unit and the reservoir units comprising mating coupling means (511, 506) allowing a reservoir unit to be secured to the transcutaneous device unit to provide fluid communication between the reservoir and the transcutaneous device,

whereby each combination of a transcutaneous device unit and a reservoir unit provides an assembly having different capabilities.

29. A system as in claim 28, wherein a first reservoir unit comprises a first amount of a drug and a second reservoir unit comprises a second amount of the drug.

30. A system as in claim 28, wherein a first reservoir unit comprises a first drug and a second reservoir unit comprises a second drug.

31. A system as in claim 28, wherein a first reservoir unit is adapted to expel drug at a first preset rate and a second reservoir unit is adapted to expel drug at a second preset rate.

32. A system as in claim 28, wherein a first reservoir unit is adapted to expel drug at a preset rate and a second reservoir unit is adapted to expel drug at a selectable rate.

33. A system as in claim 28, wherein a first reservoir unit comprises a processor operatively connected to the expelling assembly to cause expelling of fluid from the reservoir based upon flow instructions, and a receiver operatable coupled to the controller for receiving flow instructions from a separate control device and delivering the flow instructions to the processor, wherein a second reservoir unit is not adapted to receive flow instructions from a separate control device.

34. A system as in claim 33, wherein the receiver is a wireless receiver.

35. A system comprising:

a plurality of transcutaneous device units (502), each comprising a transcutaneous device and a mounting surface adapted for application to the skin of a subject, and each having different capabilities,

a reservoir unit (505) comprising a reservoir containing a fluid drug, and an expelling assembly (300) for expelling fluid drug from the reservoir,

the transcutaneous device units and the reservoir unit comprising mating coupling means (511, 506) allowing the reservoir unit to be secured to a transcutaneous device unit to provide fluid communication between the reservoir and the transcutaneous device,

whereby each combination of a transcutaneous device unit and a reservoir unit provides an assembly having different capabilities.

36. A system as in claim 35, wherein a first transcutaneous device unit comprises a hollow subcutaneous needle, and a second transcutaneous device unit comprises a transcutaneous device selected from a group consisting of a cannula and insertion needle assembly, and a micro needle array.

37. A method comprising the steps of:

providing a transcutaneous device unit (502) comprising a transcutaneous device and a mounting surface,

providing a reservoir unit (505) comprising a reservoir (760) adapted to contain a fluid drug, and an expelling assembly (300) for expelling fluid drug from the reservoir,

assembling the transcutaneous device unit and the reservoir unit to provide a fluid communication between the reservoir and the transcutaneous device.

38. A method as in claim 37, comprising the further step of:

mounting the mounting surface to a skin surface of a subject.

39. A method as in claim 38, comprising the further step of:

after mounting the mounting surface to the skin surface of the subject, actuating the transcutaneous device to establish a fluid communication between the reservoir and the subject.

40. A method of providing a drug delivery device dispensing a drug at a preset rate, comprising the steps of:

providing a system comprising a transcutaneous device unit (502) comprising a transcutaneous device and a mounting surface adapted for application to the skin of a subject, the system further comprising a plurality of reservoir units (505), each comprising a reservoir (760) containing a fluid drug, and an expelling assembly (300) for expelling fluid drug from the reservoir at a preset rate,

selecting a reservoir unit having a desired preset rate, and

assembling the transcutaneous device unit and the selected reservoir unit to provide a fluid communication between the reservoir and the transcutaneous device.

41. A system comprising:

a transcutaneous device unit (930) comprising a transcutaneous device and a mounting surface adapted for application to the skin of a subject,

a reservoir unit (920) comprising a reservoir containing a fluid drug, and at least a portion of an expelling assembly (300) for expelling fluid drug from the reservoir,

a plurality of control units (911, 912, 913, 914), each comprising a controller for controlling an expelling assembly, each having different capabilities,

the transcutaneous device unit and the reservoir unit comprising mating coupling means (931) allowing the reservoir unit to be secured to the transcutaneous device unit to provide fluid communication between the reservoir and the transcutaneous device, and

the controller units and the reservoir unit comprising mating coupling means (917, 921) allowing a controller unit to be secured to the reservoir unit to control the expelling assembly,

whereby each combination of a transcutaneous device unit, a reservoir unit and a control unit provides an assembly having different capabilities.

42. A system as in claim 41, comprising a first reservoir unit comprising a first amount of a drug and a second reservoir unit comprising a second amount of the drug.

43. A system as in claim 41, comprising a first reservoir unit comprising a first drug and a second reservoir unit comprising a second drug.

44. A system as in claim 41, wherein a first control unit is adapted to expel drug at a first preset rate and a second control unit is adapted to expel drug at a second preset rate.

45. A system as in claim 41, wherein a first control unit is adapted to expel drug at a preset rate and a second control unit is adapted to expel drug at a selectable rate.

46. A system as in claim 41, wherein a first control unit comprises a processor operatively adapted to cause expelling of fluid from the reservoir based upon flow instructions, and a receiver operatable coupled to the controller for receiving flow instructions from a separate control device and delivering the flow instructions to the processor, wherein the second control unit is not adapted to receive flow instructions from a separate control device.

47. A system as in claim 46, wherein the receiver is a wireless receiver.