Reconstituting infusion device

• US 20060106346A1
• Filed: 09/08/2005
• Published: 05/18/2006
• Est. Priority Date: 09/10/2004
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Kinsey, P. Spencer, Sullivan, Vincent J., Polidoro, John M., Sahi, Carl R., Powell, Kenneth G., Jiang, Ge, Ferriter, Matthew S.
• Granted Patent: US 7,981,076 B2
• Time in Patent Office: Days
• US Class Current: 604/134
• CPC Class Codes: A61M 2005/14256 with means for preventing access to the needle after use
• CPC Class Codes: A61M 5/1407 Infusion of two or more substances
• CPC Class Codes: A61M 5/1409 in series, e.g. first substance passing through container holding second substance, e.g. reconstitution systems needle sets A61M5/162
• 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 5/14566 with a replaceable reservoir for receiving a piston rod of the pump
• CPC Class Codes: A61M 5/14586 pressurised by means of a flexible diaphragm

Abstract

A system and method for a patch-like, self-contained multi-component substance infusion device which provides one or more substantially hidden patient needles which can be placed in fluid communication with a fluid reservoir assembly that includes a rigid bladder portion used in conjunction with a non-distensible bladder film, such as a metallized film. The device can be attached to a skin surface via an adhesive contact and a pressurization system provides a pressure to the contents of a fluid reservoir assembly. Improvements to dry powdered formulations for reconstitution for preferred use in the device are also disclosed.

Claims

1. A device for mixing and delivering a medicament into the body of a patient by injection into or through the skin of a patient, comprising:

a housing having a bottom surface adapted to contact the skin of a patient, and a top surface wherein said housing has a body opening having a longitudinal axis, a reservoir end and a body end;

an injection needle adapted for penetration of tissue, said needle having a lumen;

a first reservoir disposed within said housing forming a first chamber for containing a first substance, and said first reservoir is in selective fluid communication to the lumen of the injection needle;

a pressurizing system for pressurizing said first chamber when the device is activated;

a second reservoir insertable into said body opening along said longitudinal axis said second reservoir having

a barrel having a first and second end wherein at least said first end is open;

a stopper disposed in within said barrel open end adapted for sealing said first end, and translatable within said barrel, having a first position substantially at said first end and having a second position substantially at said second end;

wherein said barrel and stopper form a second chamber for containing a second substance;

a selective fluid communication valve disposed in said body opening wherein the selective fluid communication valve is adapted for selective fluidic communication between said first chamber and said second chamber;

wherein when said stopper is in said first position said second substance is substantially within said second chamber, and when said stopper is in said second position, said second substance is substantially within said first chamber and co-mingled with said first substance for form said medicament for infusion into the patient.

2. A device according to claim 1 wherein said stopper is pierceable and said selective fluid communication valve further comprises an access needle disposed in said body opening wherein the access needle is adapted for selective fluidic communication between said first chamber and said second chamber.

3. A device according to claim 1 wherein said first chamber has a first initial pressure, and said second chamber has a second initial pressure and prior to fluidic communication between said first chamber and said second chamber, said first initial pressure is greater than said second initial pressure.

4. A device according to claim 1 wherein said first chamber has a first initial pressure, and said second chamber has a second initial pressure and prior to fluidic communication between said first chamber and said second chamber, said first initial pressure is less than said second initial pressure.

5. A patch-like infusion device, comprising:

a first reservoir having at least one movable wall containing a first substance at a first pressure;

at least one patient needle in selective fluid communication with said first reservoir;

a second reservoir having at least one movable wall containing a second substance at a second pressure wherein said first and second pressures form a differential pressure;

a selective fluid communication conduit between said first reservoir and said second reservoir, wherein when selective fluid communication conduit between said first reservoir and said second reservoir is enabled said first substance and said second substance are intermingled to form a medicament and whereby said intermingling is caused by said differential pressure;

a spring having a central aperture for applying pressure to said movable wall of said first reservoir to cause fluid to flow from said first reservoir to said patient needle; and

,

a pin engageable with said central aperture and disengageable therefrom for causing said spring to begin applying said a third pressure to said first reservoir when said infusion device is placed into operation.

6. A patch-like infusion device as claimed in claim 5, further comprising an activation means wherein said movable wall of said second reservoir is moved by said activation means, thereby reducing a volume of said second reservoir whereby said volume reduction results in movement of said medicament from said second camber into said first chamber.

7. A patch-like infusion device as claimed in claim 5, wherein disengagement of said pin from said aperture occurs automatically when the user performs another operation on said infusion device.

8. A patch-like infusion device as claimed in claim 7, wherein said operation comprises operating a pushbutton.

9. A patch-like infusion device as claimed in claim 7, wherein said operation comprises removing a pushbutton guard or interlock.

10. A patch-like infusion device as claimed in claim 7, wherein said spring is a disk spring.

11. A method for preparing a medicament prior to delivery into the body of a patient by injection into or through the skin of a patient, comprising:

providing a first reservoir containing a liquid at a pre-determined pressure;

providing a needle in selective communication to said first reservoir;

providing a second reservoir having a chamber with at least one collapsible wall, said chamber containing a substance, said chamber having a pressure less than said pre-determined pressure;

causing fluid communication to occur between said chamber and said reservoir whereby said fluid communication allows said liquid to flow between said first reservoir and said chamber and co-mingling of said liquid and said substance to form said medicament; and

,

collapsing said at least one collapsible wall of said chamber whereby said collapsing forces said medicament to flow from said chamber into said first reservoir, whereby said medicament is prepared for injection.

12. A method according to claim 11 further comprising pressurizing said first reservoir and infusing the medicament into the body of the patient through the needle from said first reservoir.

13. A method according to claim 11 further comprising pressurizing said first reservoir and injecting the medicament into the body of the patient through the needle from said first reservoir.

15. A method according to claim 11 further comprising pressurizing said first reservoir and infusing the medicament into the body of the patient through the needle from said first reservoir.

16. A method according to claim 11 further comprising pressurizing said first reservoir and injecting the medicament into the body of the patient through the needle from said first reservoir.

14. A method for preparing a medicament prior to delivery into the body of a patient by injection into or through the skin of a patient, comprising:

providing a first reservoir containing a substance at a pre-determined pressure;

providing a needle in selective communication to said first reservoir;

providing a second reservoir having a chamber with at least one collapsible wall, said chamber containing a fluid, said chamber having a pressure greater than said pre-determined pressure;

causing fluid communication to occur between said chamber and said reservoir whereby said fluid communication allows said fluid to flow between said first reservoir and said chamber and co-mingling of said liquid and said substance to form said medicament; and

,

collapsing said at least one collapsible wall of said chamber whereby said collapsing forces said medicament to flow from said chamber into said first reservoir, whereby said medicament is prepared for injection.

17. A method for reducing the formation of bubbles in a reconstituted formulation comprising:

providing a pre-determined amount of medicament formulation within a container at a pre-determined first pressure, wherein said pre-determined pressure is less than atmospheric pressure.

adding a pre-determined volume of liquid diluent to said container wherein when said diluent is added to said container said container has a pre-determined second pressure; and

,

mixing said medicament formulation and said liquid diluent at said second pressure within said container to form said reconstituted formulation.

18. A method according to claim 17 wherein said second pressure is less than atmospheric pressure.

19. A method according to claim 17 wherein said first pressure is greater than 2000 mT of vacuum.

20. A method according to claim 18 wherein said second pressure is between 2000 mT of vacuum, and atmospheric pressure.

21. A method according to claim 17 wherein said medicament is a lyophilized powder.

22. A method according to claim 17 wherein said medicament is a spray freeze-dried powder.

23. A method according to claim 18 wherein said medicament is a lyophilized powder.

24. A method according to claim 18 wherein said medicament is a spray freeze-dried powder.

25. A method according to claim 19 wherein said medicament is a lyophilized powder.

26. A method according to claim 19 wherein said medicament is a spray freeze-dried powder.

27. A method according to claim 17 wherein said medicament is a liposome.

28. A method according to claim 17 wherein said medicament is a substantially dry powder.

29. A method according to claim 18 wherein said medicament is a liposome.

30. A method according to claim 18 wherein said medicament is a substantially dry powder.

31. A method according to claim 19 wherein said medicament is a liposome.

32. A method according to claim 19 wherein said medicament is a substantially dry powder.

33. A method according to claim 17 further comprising mixing said reconstituted formulation in an atmosphere substantially comprised of an inert gas.