Fluid delivery device with conformable ullage and fill assembly

• US 6,045,533 A
• Filed: 10/29/1998
• Issued: 04/04/2000
• Est. Priority Date: 12/22/1995
• Status: Expired due to Fees

• Current Assignee: Pescadero Beach Holdings Corporation
• Original Assignee: Science Incorporated
• Inventors: Feng, William W, Kriesel, Matthew B., Kazemzadeh, Farhad, Thompson, Thomas N, Kriesel, Marshall S
• Primary Examiner(s): Stright, Ronald
• Assistant Examiner(s): Thissell, Jeremy
• Application Number:
  US09/183,328
• Time in Patent Office: 523 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 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, said lower surface of said base including means for connecting said fluid delivery assembly to the patient;

(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.

2. A fluid delivery apparatus for infusion of beneficial agents into a patent 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; and

(v) fluid delivery means for delivering fluid from said outlet of said fluid delivery assembly, said fluid delivery means comprising a quick connect delivery fitting removably connected to 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 said closure means being pierceable by said hollow cannula of said cover overlay; and

c. a plunger telescopically movable within said container from a first location proximate said open end to a second spaced apart location to cause fluid within said fluid chamber to flow into said hollow cannula; 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.

3. An apparatus as defined in claim 2 further including locking means for releasably locking said quick connect delivery fitting to said base.

4. 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 first and second receiving chambers 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 for cooperation with said base to define a fluid reservoir having a fluid inlet in communication with said fluid passageway, said stored energy means being energizable by forces imparted thereon by fluids introduced into said reservoir through said fluid inlet, said forces establishing internal stresses within said stored energy means, said stresses tending to return said stored energy means toward a less energized configuration; and

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

(i) a first container assembly for containing fluid; and

(ii) a first adapter assembly receivable within said first receiving chamber of said fluid delivery assembly, said first adapter assembly comprising a first housing for telescopically receiving a part of said first container assembly;

(c) a second fluid containing subassembly interconnected with said fluid delivery assembly for delivering fluid to said outlet of said second fluid containing subassembly comprising;

(i) a second container assembly for containing fluid; and

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

5. An apparatus as defined in claim 4 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 drive means comprises a plurality of outwardly extending, longitudinally spaced teeth provided on said second housing of said second adapter assembly, said teeth being engageable by said drive wheel to impart movement to said housing of said adapter assembly.

6. An apparatus as defined in claim 4 in which said stored energy means comprises a part of a reservoir unit which is detachably connected to said base, said unit having a fluid outlet in communication with said fluid passageway.

7. An apparatus as defined in claim 4 in which said stored energy means comprises a distendable membrane sealably connected to said base, said distendable membrane being distendable by fluids introduced into said reservoir.

8. An apparatus as defined in claim 4 further including fluid delivery means for delivering fluid from said outlet of said fluid delivery assembly.

9. An apparatus as defined in claim 4 in which said fluid reservoir defining means further includes a barrier member sealably interconnected with said base.

10. An apparatus as defined in claim 4 in which said conformable ullage comprises an elastomer.

11. An apparatus as defined in claim 4 in which said conformable ullage comprises a gel.

12. An apparatus as defined in claim 4 in which said conformable ullage comprises a flowable substance.

13. An apparatus as defined in claim 4 in which said fluid delivery assembly further includes flow control means for controlling fluid flow through said outlet, said flow control means comprising first and second porous members.

14. An apparatus as defined in claim 13 in which said operating means further includes control means for controlling rotation of said drive wheel.

15. An apparatus as defined in claim 13 in which said control means comprises a dosing indicator disc connected to said drive wheel and a safety interlocking means for controlling rotation of said indexing disc.

16. An apparatus as defined in claim 13 further including locking means for locking said first adapter assembly within said receiving chamber.

17. 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 a fluid passageway 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 lease 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 an internal chamber for receiving a part of said container of said container assembly, 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.