Fluid delivery device with conformable ullage and fill assembly

• US 5,830,187 A
• Filed: 06/18/1996
• Issued: 11/03/1998
• Est. Priority Date: 12/22/1995
• Status: Expired due to Fees

• Current Assignee: Pescadero Beach Holdings Corporation
• Original Assignee: Science Incorporated
• Inventors: Thompson, Thomas, Kriesel, Marshall S., Feng, William W., Kazemzadeh, Farhad, Kriesel, Matthew B.
• Primary Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US08/666,659
• Time in Patent Office: 868 Days
• Field of Search: 604/82, 604/83, 604/86, 604/131, 604/132, 604/151, 604/153, 604/890.1
• US Class Current: 604/132
• CPC Class Codes: A61M 2209/045 for filling, e.g. for filling reservoirs
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/152 pressurised by contraction of elastic reservoirs containers for dispensing contents by contraction of an elastic bag provided therein, in general B65D83/0061
• CPC Class Codes: A61M 5/31525 Dosing burettes, pipettes B01L3/02

Abstract

A fluid delivery apparatus for continuous basal infusion, together with controlled bolus infusion of injectable medicaments, which embodies a stored energy source such as distendable elastomeric membrane which cooperates with a base and a conformable ullage to define a fluid reservoir and one which includes a unique fill assembly for use in controllably filling the fluid reservoir. The novel fill assembly of the invention enables the fluid reservoir of the fluid delivery portion of the apparatus to be aseptically filled in the field with a wide variety of selected medicinal fluids.

Claims

1. A fluid delivery apparatus comprising:

(a) a fluid delivery assembly having an outlet for delivering fluid from the apparatus, said fluid delivery assembly including;

(i) a base;

(ii) a cover assembly connected to said base, one of said cover assembly and said base having a fluid passageway in communication with said outlet and one of said cover assembly and said base having a receiving chamber interconnected with said fluid passageway;

(iii) operating means for urging controlled fluid flow through said outlet, said operating means including drive means carried by said base; and

(iv) a stored energy means cooperating with said base to define a fluid reservoir having a fluid inlet in communication with said fluid passageway, said stored energy means being energized by fluids introduced into said reservoir through said fluid inlet, said forces establishing stresses within said stored energy means, said stresses tending to return said stored energy means toward a less energized configuration; and

(b) a fluid containing subassembly interconnected with said fluid delivery assembly for filling said reservoir, said fluid containing subassembly comprising;

(i) a container assembly for containing fluid; and

(ii) an adapter assembly receivable within said receiving chamber of said fluid delivery assembly, said adapter assembly comprising a housing for telescopically receiving a part of said container assembly, said housing having driven means engageable by said drive means of said operating means of said fluid delivery assembly for advancing said adapter assembly within said receiving chamber.

2. An apparatus as defined in claim 1 in which said drive means of said operating means comprises a drive wheel rotatably carried by one of said base and said cover assembly and in which said driven means comprises a plurality of outwardly extending, longitudinally spaced teeth provided on said housing of said adapter assembly, said teeth being engageable by said drive wheel to impart movement to said housing of said adapter assembly.

3. An apparatus as defined in claim 1 in which said stored energy means comprises a part of a reservoir unit which is detachably connected to said base, said reservoir unit having a fluid outlet in communication with said fluid passageway.

4. An apparatus as defined in claim 3 in which said fluid delivery assembly further includes valve means in communication with said fluid inlet of said reservoir unit for controlling fluid flow toward said fluid inlet of said reservoir unit.

5. An apparatus as defined in claim 4 further including valve operating means operably interconnected with said valve means for closing said valve means in response to advancement of said adapter assembly within said receiving chamber.

6. An apparatus as defined in claim 4 in which said container assembly comprises:

(a) a container having a fluid chamber;

(b) closure means for sealably closing said container; and

(c) a plunger telescopically movable within said fluid chamber of said container from a first location to a second spaced apart location.

7. An apparatus as defined in claim 6 in which said closure means of said container subassembly comprises a pierceable septum and in which said cover assembly includes a pierceable cannula disposed within said receiving chamber, said hollow cannula being in communication with said fluid inlet of said fluid reservoir via said fluid passageway.

8. An apparatus as defined in claim 6 in which said housing further includes pusher means for engagement with said plunger of said container assembly to move said plunger within said container between first and second locations.

9. An apparatus as defined in claim 6 further including a container cover assembly having a container cover provided with a first open end for telescopically receiving a part of said container of said container assembly and a second end, said container cover being removable from said container to expose said closure means.

10. A fluid delivery apparatus for delivering fluid into a patient comprising:

(a) a fluid delivery assembly having an outlet for delivering fluid from the apparatus, said fluid delivery assembly including;

(i) a base having an upper surface, a lower surface, and a fluid passageway formed in said base intermediate said upper and lower surfaces, said fluid passageway being in communication with said outlet and having first and second ends;

(ii) operating means for urging controlled fluid flow through said outlet, said operating means including drive means carried by said base;

(iii) a cover assembly connected to said base, one of said cover assembly and said base having a receiving chamber interconnected with said first end of said fluid passageway formed in said base; and

(iv) a stored energy means comprising at least one distendable membrane superimposed over said upper surface of said base to define a fluid reservoir having a fluid inlet in communication with said fluid passageway in said base, said membrane being distendable by forces imparted thereon by fluids introduced into said reservoir through said fluid inlet, said forces establishing internal stresses within said distendable membrane, said stresses tending to return said distendable membrane toward a less distended configuration; and

(b) a fluid containing subassembly interconnected with said fluid delivery assembly for filling said reservoir, said fluid containing subassembly comprising;

(i) a container assembly for containing fluid; and

(ii) an adapter assembly receivable within said receiving chamber, said adapter assembly comprising a hollow housing having a first open end for telescopically receiving a part of said container of said container assembly and including a second end, said hollow housing having driven means engageable by said drive means of said fluid delivery assembly for advancing said adapter assembly within said receiving chamber.

11. An apparatus as defined in claim 10 in which said drive means of said operating means comprises a drive wheel rotatably carried by said base and in which said driven means comprises a plurality of outwardly extending, longitudinally spaced engagement members provided on said hollow housing of said adapter assembly, said engagement members being engageable by said drive wheel to impart movement to said hollow housing of said adapter assembly.

12. An apparatus as defined in claim 10 in which said fluid reservoir has a fluid outlet in communication with said fluid passageway in said base.

13. An apparatus as defined in claim 12 in which said fluid delivery assembly further includes valve means in communication with said fluid inlet of said fluid reservoir for controlling fluid flow toward said fluid inlet of said fluid reservoir.

14. An apparatus as defined in claim 13 further including valve operating means operably interconnected with said valve means for closing said valve means in response to advancement of said adapter assembly within said receiving chamber.

15. An apparatus as defined in claim 13 in which said container assembly comprises:

(a) a container having a body portion, a fluid chamber, and first and second open ends;

(b) closure means for sealably closing said first open end of said container; and

(c) a plunger telescopically movable within said container from a first location proximate said second open end to a second spaced apart location.

16. An apparatus as defined in claim 15 in which said closure means of said container assembly comprises a pierceable septum and in which said cover assembly includes a pierceable cannula disposed within said receiving chamber, said hollow cannula being in communication with said fluid inlet of said fluid reservoir via said fluid passageway.

17. An apparatus as defined in claim 15 in which said housing further includes pusher means for engagement with said plunger of said container assembly to move said plunger within said container between first and second locations.

18. An apparatus as defined in claim 15 further including a container cover assembly having a container cover provided with a first open end for telescopically receiving a part of said container of said container assembly and a second end, said container cover being removable from said container to expose said closure means.

19. A fluid delivery apparatus for infusion of beneficial agents into a patient comprising:

(a) a fluid delivery assembly having an outlet for delivering fluid from the apparatus, said fluid delivery assembly including;

(i) a base having an upper surface, a lower surface, and a fluid passageway formed in said base intermediate said upper and lower surfaces, said fluid passageway being in communication with said outlet of the apparatus and having first and second ends;

(ii) fluid reservoir defining means including a distendable membrane and a conformable ullage connected to said base for forming in conjunction therewith a reservoir having an inlet port and an outlet port in communication with said passageway formed in said base;

(iii) operating means including a drive wheel carried by said base, said operating means being operable to impart rotational movement to said drive wheel to urge fluid flow through said outlet; and

(iv) a cover assembly connected to said base, one of said cover assembly and said base having a receiving chamber interconnected with said first end of said fluid passageway formed in said base;

(b) a fluid containing subassembly interconnected with said fluid delivery assembly for filling said reservoir thereof, said fluid containing subassembly comprising;

(i) a container assembly including;

a. a container having a body portion, a fluid chamber, and first and second open ends;

b. closure means for sealably closing said first end of said container; and

c. a plunger telescopically movable within said container from a first location proximate said second open end to a second spaced apart location to cause fluid within said fluid chamber to flow toward said closure means; and

(ii) an adapter assembly receivable within said chamber of said cover assembly, said adapter assembly comprising a hollow housing having a first open end for telescopically receiving a part of said body portion of said container of said container assembly and including a second end, said hollow housing having a plurality of longitudinally spaced teeth engageable by said drive wheel of said fluid delivery assembly for controllably advancing said adapter assembly within said receiving chamber.

20. An apparatus as defined in claim 19 in which said fluid reservoir defining means further includes a membrane retaining ring and a clamping ring which cooperate to capture and seal said distendable membrane and said conformable ullage relative to said base.

21. An apparatus as defined in claim 19 in which said distendable membrane is distendable by forces imparted thereon by said conformable ullage in response to fluids introduced into said reservoir, said forces establishing internal stresses within said distendable membrane, said stresses tending to return said distendable membrane toward a less distended configuration.

22. An apparatus as defined in claim 19 in which said delivery assembly further includes valve means in communication with said fluid inlet of said fluid reservoir for controlling fluid flow toward said fluid inlet of said fluid reservoir.

23. An apparatus as defined in claim 19 in which said operating means further includes control means operably interconnected with said drive wheel for controlling rotation of said drive wheel.

24. An apparatus as defined in claim 19 in which said fluid reservoir defining means further includes a barrier member sealably interconnected with said base.

25. An apparatus as defined in claim 19 in which said fluid reservoir defining means is removably connected to said base.

26. An apparatus as defined in claim 19 in which said conformable ullage comprises an elastomer.

27. An apparatus as defined in claim 19 in which said conformable ullage comprises a gel.

28. An apparatus as defined in claim 19 in which said conformable ullage comprises a foam.

29. An apparatus as defined in claim 19 in which said fluid reservoir defining means comprises a cover having a central convex cavity and a circumferential cavity circumscribing said central convex cavity.