Medical skin mountable device

• US 8,062,253 B2
• Filed: 04/25/2006
• Issued: 11/22/2011
• Est. Priority Date: 10/21/2003
• Status: Expired due to Fees

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Radmer, Jim, Preuthun, Jan Harald, Nielsen, Ole Christian
• Primary Examiner(s): KOHARSKI, CHRISTOPHER
• Application Number:
  US11/411,081
• Publication Number:
  US 20060264835A1
• Time in Patent Office: 2,037 Days
• Field of Search: 604/890.1, 604131-133, 604 65- 67, 604/141, 604/156, 604/180, 604/181
• US Class Current: 604/131
• 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, comprising a transcutaneous device unit and a separate reservoir unit, the transcutaneous device unit comprising:

a transcutaneous device, and

a mounting surface comprising a skin adhering adhesive, wherein the reservoir unit comprises;

a reservoir adapted to contain a fluid drug, and

an expelling assembly 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 secured to each other in a situation of use,

wherein the expelling assembly is activated or allowed to be activated to deliver fluid from the reservoir when the transcutaneous device unit and the reservoir unit are secured to each other and de-activated to stop fluid flow from the reservoir when the units are released from each other, and

wherein the activation occurs by engaging an actuator on the transcutaneous device unit and deactivation occurs by disengaging the actuator.

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 adapted to be arranged in fluid communication with the reservoir, and an outlet 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 is arranged within the interior of the pump in the initial condition, the fluid connector comprising an inlet and an outlet, 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 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 a further actuator for moving the pointed end of the transcutaneous device between the initial and the extended position when the actuator is actuated.

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

12. A medical device as defined in claim 10, wherein the expelling assembly is activated when the actuator 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 a retraction component for moving the pointed end of the transcutaneous device between the extended and the retracted position when the retraction components is actuated.

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

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

17. A medical device as defined in claim 1, wherein the transcutaneous device comprises a first portion having a/the pointed end, and a second portion 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 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 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 component 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 component 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 coupling 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.