Reconstituting infusion device

• US 9,044,536 B2
• Filed: 07/18/2011
• Issued: 06/02/2015
• Est. Priority Date: 07/22/2003
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Sullivan, Vincent J., Jiang, Ge, Ferriter, Matthew S., Powell, Kenneth G., Kinsey, P. Spencer, Sahi, Carl R., Polidoro, John M.
• Primary Examiner(s): SCHMIDT, EMILY LOUISE
• Application Number:
  US13/185,495
• Publication Number:
  US 20110276021A1
• Time in Patent Office: 1,415 Days
• Field of Search: 604/82, 604 86- 88, 604/91, 604/131, 604/134, 604/191
• US Class Current: 1/1
• 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 method for reducing the formation of bubbles in reconstituting a formulation for delivery to a patient, comprising:

providing a pre-determined amount of medicament formulation within a container at less than atmospheric pressure;

adding a pre-determined volume of liquid diluent from a reservoir having a flexible, non-distensible membrane to said container, wherein said pre-determined volume of liquid diluent is added to said container while continuously maintaining said diluent below atmospheric pressure;

mixing said medicament formulation and said liquid diluent within said container in an atmosphere substantially comprised of an inert gas to form said reconstituted formulation;

moving a movable wall of said container to force said reconstituted formulation into said reservoir;

delaying pressurization of said reservoir until substantially all of said reconstituted formulation has been forced into said reservoir; and

pressurizing said reservoir and delivering the reconstituted formulation to the patient while said container is connected to said reservoir.

2. A method according to claim 1 wherein said reconstituted formulation is below atmospheric pressure.

3. A method according to claim 1 wherein said less than atmospheric pressure of said container is greater than 2000 mT of vacuum.

4. A method according to claim 2 wherein said reconstituted formulation is between 2000 mT of vacuum, and atmospheric pressure.

5. A method according to claim 1 wherein said medicament is a lyophilized powder.

6. A method according to claim 1 wherein said medicament is a spray freeze-dried powder.

7. A method according to claim 2 wherein said medicament is a lyophilized powder.

8. A method according to claim 2 wherein said medicament is a spray freeze-dried powder.

9. A method according to claim 3 wherein said medicament is a lyophilized powder.

10. A method according to claim 3 wherein said medicament is a spray freeze-dried powder.

11. A method according to claim 1 wherein said medicament is a liposome.

12. A method according to claim 1 wherein said medicament is a substantially dry powder.

13. A method according to claim 2 wherein said medicament is a liposome.

14. A method according to claim 2 wherein said medicament is a substantially dry powder.

15. A method according to claim 3 wherein said medicament is a liposome.

16. A method according to claim 3 wherein said medicament is a substantially dry powder.

17. A method according to claim 1 wherein said inert gas is selected from the group consisting of argon and helium.

18. A method for reducing the formation of bubbles in reconstituting a formulation for delivery to a patient, comprising:

providing a pre-determined amount of medicament formulation within a container at less than atmospheric pressure;

adding a pre-determined volume of liquid diluent from a reservoir having a flexible, non-distensible membrane to said container, wherein said predetermined volume of liquid diluent is added to said container while continuously maintaining said diluent below atmospheric pressure;

mixing said medicament formulation and said liquid diluent within said container to form said reconstituted formulation;

moving a movable wall of said container to force said reconstituted formulation into said reservoir;

delaying pressurization of said reservoir until substantially all of said reconstituted formulation has been forced into said reservoir; and

pressurizing said reservoir and delivering the reconstituted formulation to the patient while said container is connected to said reservoir.

19. The method according to claim 18, wherein said reconstituted formulation is less than atmospheric pressure.

20. A method for reducing the formation of bubbles in reconstituting a formulation for delivery to a patient, comprising:

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

at least partially evacuating a reservoir with a flexible, non-distensible membrane prior to introducing a liquid diluent into the reservoir;

adding a pre-determined volume of liquid diluent to said container from said reservoir while continuously maintaining said diluent below atmospheric pressure, wherein when said diluent is added to said container said container has a pre-determined second pressure;

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

moving a movable wall of said container relative to a remainder of said container to force said reconstituted formulation into said reservoir;

delaying pressurization of said reservoir until substantially all of said reconstituted formulation has been forced into said reservoir; and

pressurizing said reservoir and delivering the reconstituted formulation to the patient.