Reconstituting infusion device

• US 7,981,076 B2
• Filed: 09/08/2005
• Issued: 07/19/2011
• Est. Priority Date: 09/10/2004
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Kinsey, P. Spencer, Sahi, Carl R., Powell, Kenneth G., Jiang, Ge, Sullivan, Vincent J., Polidoro, John M., Ferriter, Matthew S.
• Primary Examiner(s): Stigell; Theodore J
• Assistant Examiner(s): SCHMIDT, EMILY LOUISE
• Application Number:
  US11/222,204
• Publication Number:
  US 20060106346A1
• Time in Patent Office: 2,140 Days
• Field of Search: 604/82, 604 86- 88, 604/131, 604/134, 604/191, 604/198, 604/268
• US Class Current: 604/82
• 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 at an injection site, 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 extendible from said bottom surface and adapted for penetration of tissue at said injection site, said needle having a lumen;

a first reservoir disposed within said housing forming a first chamber for containing a first substance, said first reservoir being in selective fluid communication with the lumen of the injection needle, and said first reservoir comprising a flexible, non-distending film;

a pressurizing system for pressurizing said first chamber when the device is activated, wherein the activation begins delivery to the patient;

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; and

a stopper disposed 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, wherein said second chamber has an internal pressure less than atmospheric pressure when said stopper is in said first position, thereby facilitating unassisted fluid transfer between said first chamber and said second chamber via pressure gradient between said first chamber and said second chamber to draw said first substance into said second chamber to co-mingle said first and second substances to form said medicament for infusion into the patient;

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

a removable retaining pin, preventing pressurization of the first chamber until the retaining pin is removed;

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 co-mingled first and second substances are substantially within said first chamber to prepare the device for activation.

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 fluid 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 fluid communication between said first chamber and said second chamber, said first initial pressure is greater than said second initial pressure.

9. A device according to claim 1, wherein the first reservoir is disposed entirely within said housing.

10. A device according to claim 1, wherein said pressurizing system comprises a stored energy pressurizing system.

11. A device according to claim 10, wherein said stored energy pressurizing system comprises a disk spring.

12. A device according to claim 1, further comprising a patient-depressible button slide for activating the device, wherein said injection needle is biased toward the bottom surface and released to extend from said bottom surface as the button slide is depressed.

4. 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 with the lumen of the injection needle via a first fluid path;

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

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

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

wherein said barrel and stopper form a second chamber for containing a second substance, said second chamber having an internal pressure less than atmospheric pressure when said stopper is in said first position, thereby facilitating unassisted fluid transfer between said first chamber and said second chamber via pressure gradient to draw said first substance into said second chamber to co-mingle said first and second substances to form said medicament for infusion into the patient;

a selective fluid communication valve disposed in said body opening for selective fluid communication between said first chamber and said second chamber via a second fluid path separate from said first fluid path, wherein when said stopper is moved to said second position, said co-mingled first and second substances are communicated to said first chamber to prepare the device for activation;

a pressurizing system for selectively commencing pressurization of said first chamber subsequent to communication of said co-mingled first and second substances to said first chamber, wherein the activation begins delivery to the patient; and

a removable retaining pin, preventing pressurization of the first chamber until the retaining pin is removed.

5. A device according to claim 4, wherein the first reservoir is disposed entirely within said housing.

6. A device according to claim 4, wherein said pressurizing system comprises a stored energy pressurizing system.

7. A device according to claim 6, wherein said stored energy pressurizing system comprises a disk spring.

8. A device according to claim 4, further comprising a patient-depressible button slide for activating the device, wherein said injection needle is biased toward the bottom surface and released to extend from said bottom surface as the button slide is depressed.

13. 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 with the lumen of the injection needle, said fluid communication between the first reservoir and the lumen being held in abeyance until the device is activated;

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

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

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

wherein said barrel and stopper form a second chamber for containing a second substance, said second chamber having an internal pressure less than atmospheric pressure when said stopper is in said first position, thereby facilitating unassisted fluid transfer between said first chamber and said second chamber via pressure gradient to draw said first substance into said second chamber to co-mingle said first and second substances to form said medicament for infusion into the patient;

a selective fluid communication valve disposed in said body opening for selective fluid communication between said first chamber and said second chamber, wherein when said stopper is moved to said second position, said co-mingled first and second substances are communicated to said first chamber to prepare the device for activation;

a pressurizing system for selectively commencing pressurization of said first chamber subsequent to communication of said co-mingled first and second substances to said first chamber, wherein the activation begins delivery to the patient; and

a removable retaining pin, preventing pressurization of the first chamber until the retaining pin is removed.

14. A device according to claim 13, wherein the first reservoir is disposed entirely within said housing.

15. A device according to claim 13, wherein said pressurizing system comprises a stored energy pressurizing system.

16. A device according to claim 15, wherein said stored energy pressurizing system comprises a disk spring.

17. A device according to claim 13, further comprising a patient-depressible button slide for activating the device, wherein said injection needle is biased toward the bottom surface and released to extend from said bottom surface as the button slide is depressed.