Ambulatory drug delivery device

• US 4,734,092 A
• Filed: 02/18/1987
• Issued: 03/29/1988
• Est. Priority Date: 02/18/1987
• Status: Expired due to Term

• Current Assignee: ALARIS Medical Systems, Inc. (Becton, Dickinson & Co)
• Original Assignee: Ivax Corporation (Teva Pharmaceutical Industries, Ltd.)
• Inventors: Millerd, Donald L.
• Primary Examiner(s): Pellegrino, Stephen C.
• Application Number:
  US07/015,931
• Time in Patent Office: 405 Days
• Field of Search: 604/131, 604/140, 604/145, 604/151, 604/65, 604/67, 604/890, 604/891, 128/DIG. 12, 128/DIG. 13, 222/389
• US Class Current: 604/67
• CPC Class Codes: A61M 2005/14204 with gas-producing electrochemical cell
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/155 pressurised by gas introduced into the reservoir
• CPC Class Codes: Y10S 128/12 Pressure infusion

Abstract

A device for infusing a drug into an ambulatory patient, the drug being contained in a transparent spiral conduit which is embedded in a disposable flexible casting conformingly adhered to the patient'"'"'s body, includes a reusable micropump module which is detachably mounted in a collar valve on the casting and forces oxygen into the conduit under pressure to expel the drug into a semi-pivoting cannula inserted into the patient'"'"'s body. A colored oil drop between the oxygen and the drug in the conduit provides a visual indication of drug quantity, while a filter with hydrophobic and hydrophylic membranes keeps the oxygen and oil substantially out of the cannula. A test button sounds an alarm when the device is ready for use and a pressure sensitive switch automatically sounds an alarm and shuts off the pump if the drug becomes completely discharged from the conduit or if the drug delivery system becomes occluded and an interlock switch completes the circuit between the pump and a power source when the reusable module and disposable casting are joined.

Claims

1. Ambulatory drug delivery apparatus, comprising:

a housing;

a fluid reservoir in said housing comprising an extended conduit adapted for storing a fluid to be delivered and having an inlet end and an outlet end,

pump means in communication with said inlet end for pressurizing a driving fluid and introducing said pressurized driving fluid into said conduit;

fluid delivery means in communication with said outlet end for delivering fluid from said conduit upon said introduction of pressurized driving fluid;

movable indicator means disposed in said conduit between said driving fluid and said fluid to be delivered; and

attachment means for attaching said housing to a user'"'"'s body.

2. Apparatus as set forth in claim 1, wherein said indicator means comprises an oil slug colored differently from at least one of said fluids.

3. Apparatus as set forth in claim 1, wherein said conduit is sufficiently transparent to permit visual observation of fluids therein.

4. Apparatus as set forth in claim 1, wherein said conduit comprises a spiraled flexible tube.

5. Ambulatory fluid delivery apparatus, comprising:

a housing;

spiral passageway means in said housing for carrying a fluid to be delivered, said passageway means having an inlet and an outlet;

pump means in communication with said inlet for pressurizing a driving fluid and introducing said pressurized driving fluid into said passageway means;

fluid delivery means in communication with said outlet for delivering fluid from said passageway means upon said introduction of pressurized driving fluid; and

attachment means for attaching said housing to a user'"'"'s body.

6. Apparatus as set forth in claim 5, wherein said housing is flexible.

7. Apparatus as set forth in claim 6, wherein said housing comprises a flexible casting and said passageway means comprises a spiraled flexible tube embedded in said casting.

8. Apparatus as set forth in claim 5, wherein said pump means comprises a module detachably mounted on said housing.

9. Apparatus as set forth in claim 8, further comprising a rotatable collar valve mounted on said housing for receiving said module and for selectively opening and closing said communication between said pump means and said inlet.

10. Apparatus as set forth in claim 9, further comprising switch means for selectively activating said pump means, said collar valve being operatively connected to said switch means for operating said switch means upon rotation of said valve.

11. Apparatus as set forth in claim 5, wherein said pump means comprises:

a pump housing;

means for introducing atmospheric oxygen into said housing;

an electrolytic membrane disposed in said housing and having first and second membrane surfaces;

a first material-pervious electrode disposed on said first membrane surface and a second material-pervious electrode disposed on said second membrane surface; and

an electrical power source disposed in said housing for establishing a voltage gradient across said electrolytic membrane to ionize said oxygen at said first material-pervious electrode, transport said ions through said electrolytic membrane to said second material-pervious electrode, and reconvert said ions to molecules of oxygen which are evolved at said second material-pervious electrode as said driving fluid.

12. Apparatus as set forth in claim 11, wherein said electrical power source comprises a zinc-air battery.

13. Apparatus as set forth in claim 12, further comprising at least one port formed in said pump housing to establish communication between said battery and the atmosphere, and wherein removable sealing means are provided for closing said port.

14. Apparatus as set forth in claim 5, wherein said fluid delivery means comprises a cannula pivotably mounted on said housing.

15. Apparatus as set forth in claim 5, wherein said attachment means comprises an adhesive surface on said housing.

16. Ambulatory fluid delivery apparatus, comprising:

a housing;

passageway means in said housing for carrying a fluid to be delivered, said passageway means having an inlet and an outlet;

pump means in communication with said inlet for pressurizing a driving fluid and introducing said pressurized driving fluid into said passageway means;

fluid delivery means in communication with said outlet for delivering fluid from said passageway means upon said introduction of pressurized driving fluid;

attachment means for attaching said housing to a user'"'"'s body; and

filter means in communication with said outlet for preventing gas in said passageway means from entering said fluid delivery means, said filter means comprising;

a fluid chamber in communication with said outlet for receiving fluid from said passageway means upon said introduction of pressurized driving fluid;

a first outlet port establishing communication between said chamber and the atmosphere and a second outlet port establishing communication between said chamber and said fluid deliver means;

a hydrophobic membrane disposed across said first outlet port for venting gas from said chamber into said atmosphere and retaining liquid in said chamber; and

a hydrophylic membrane disposed across said second outlet port for retaining gas in said chamber and venting liquid from said chamber into said fluid delivery means.

17. Apparatus as set forth in claim 16, further comprising an oil slug disposed in said passageway means between said driving fluid and said fluid to be delivered, said oil slug having a different viscosity than said fluid to be delivered, said hydrophylic membrane being substantially impervious to fluid having said different viscosity.

18. Apparatus set forth in claim 16, wherein said fluid to be delivered comprises pharmaceutical material and said driving fluid comprises oxygen.

19. Ambulatory fluid delivery apparatus, comprising;

a housing having a disposable portion and a reusable portion detachably connected thereto;

passageway means in said disposable portion for carrying a fluid to be delivered, said passageway means having an inlet and an outlet;

pump means in said reusable portion in communication with said inlet for pressurizing a driving fluid and introducing said pressurized driving fluid into said passageway means;

fluid delivery means in said disposable portion in communication with said outlet for delivering fluid from said passageway means upon said introduction of pressurized driving fluid;

attachment means for attaching said housing to a user'"'"'s body;

power source means for supplying electrical power to said pump means; and

switch means electrically connected to said power source means and said pump means for selectively establishing electrical communication therebetween, said switch means being mounted on said reusable portion and being configured to establish said electrical communication when said reusable portion is connected to said disposable portion.

20. Apparatus as set forth in claim 19, wherein said pump means is detachably connected to said reusable portion.

21. Ambulatory fluid delivery apparatus, comprising:

a housing;

passageway means in said housing for carrying a fluid to be delivered, said passageway means having an inlet and an outlet;

pump means in communication with said inlet for pressurizing a driving fluid and introducing said pressurized driving fluid into said passageway means;

fluid delivery means in communication with said outlet for delivering fluid from said passageway means upon said introduction of pressurized driving fluid;

attachment means for attaching said housing to a user'"'"'s body; and

pressure sensor means operatively connected to said pump means for inactivating said pump means upon sensing pressure outside predetermined levels, said pressure sensor means being in communication with said passageway means for sensing fluid pressure therein.

22. Apparatus as set forth in claim 21, wherein said pressure sensor means comprises a pressure sensitive switch.

23. Apparatus as set forth in claim 21, further comprising alarm means operatively connected to said pressure sensor means for producing a warning signal upon said sensing of pressure outside predetermined levels.

24. Apparatus as set forth in claim 23, wherein said pump means and said alarm means are powered by a common battery, said battery being drained when said alarm means produces said warning signal, thereby inactivating said pump means.

25. Apparatus as set forth in claim 23, wherein said alarm means comprises a piezo crystal.

26. Apparatus as set forth in claim 21, further comprising pressure sensor means in communication with said passageway means for sensing said fluid pressure therein, alarm means operatively connected to said pressure sensor means for producing a warning signal when said pressure sensor means senses pressure within a predetermined range, and switch means operatively connected to said pressure sensor means for selectively activating said pressure sensor means.