Variable rate infusion apparatus with indicator and adjustable rate control

• US 6,231,545 B1
• Filed: 10/02/1998
• Issued: 05/15/2001
• Est. Priority Date: 12/18/1996
• Status: Expired due to Fees

• Current Assignee: Pescadero Beach Holdings Corporation
• Original Assignee: Science Incorporated
• Inventors: Kriesel, Marshall S., Arnold, Steven M., Garrison, James, Kazemzadeh, Farhad
• Primary Examiner(s): Seidel, Richard K
• Assistant Examiner(s): MAYNARD, JENNIFER J
• Application Number:
  US09/165,713
• Time in Patent Office: 956 Days
• Field of Search: 604/132, 604/83, 604/85, 604/88, 604/89, 604/90, 604/406, 604/30
• US Class Current: 604/132
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/585 having magnification means, e.g. magnifying glasses
• CPC Class Codes: A61M 5/141 with capillaries for restricting fluid flow
• 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 5/16877 Adjusting flow; Devices for setting a flow rate

Abstract

An apparatus for accurately infusing medicinal agents into an ambulatory patient at specific rates over extended periods of time. The apparatus is of a compact, low profile, laminate construction and includes an elastic distendable membrane, chamber having a fluid outlet. Disposed within the fluid chamber is a thin fluid permeable member which precisely controls the rate of fluid flow through the fluid outlet. The apparatus also includes a highly novel fluid flow indicator that provides a readily discernible visible indication of fluid flow through the apparatus. Additionally, the apparatus includes a fill assembly comprising a prefilled vial that can be used to fill the fluid reservoir of the device with a selected medicinal fluid.

Claims

1. A fluid delivery apparatus comprising:

(a) a base assembly having a fixedly located fluid outlet, a fluid delivery passageway defining a flow path in communication with said fluid outlet and a receiving chamber interconnected with said fluid passageway;

(b) a stored energy means connected to said base assembly to define a fluid reservoir having a fluid inlet in communication with said fluid passageway, said stored energy means being distendable by fluid introduced into said reservoir through said fluid inlet, said fluid establishing stresses within said stored energy means, said stresses tending to return said stored energy means toward a less distended configuration;

(c) a cover assembly connected to said base assembly to define a housing;

(d) fill means operably associated with said housing and being in communication with said reservoir for filling said reservoir; and

(e) flow rate control means carried by said housing for controlling the rate of fluid flow from said reservoir toward said fluid outlet via said flow path, said flow rate control means comprising a control member carried by said housing, said control member traversing said flow path and having first and second spaced apart flow restrictors selectively movable into alignment with said flow path by movement of said control member from a first position wherein said first flow regulator is aligned with said flow path to a second position wherein said second flow restrictor is aligned with said flow path.

2. The device as defined in claim 1 in which said control member comprises a generally planar member intersecting said flow path and in which said first and second flow restrictors comprise first and second spaced apart, porous frits mounted on said generally planar member.

3. The apparatus as defined in claim 1 in which said control member comprises a generally planar member and in which said first and second flow restrictors comprise spaced apart apertured wafers carried by said generally planar member.

4. The apparatus as defined in claim 1 further including fluid actuated indicator means disposed intermediate said reservoir and said delivery passageway for indicating fluid flow through said delivery passageway.

5. The device as defined in claim 4 in which said fluid indicator means comprises a pair of thin films having edge portions and generally planar body portions disposed in an overlaying relationship, at least one of said thin films having indicating indicia viewable upon relative sliding movement between said body portions of said films.

6. The device as defined in claim 5 in which said fluid indicator means further comprises actuator means communicating with said fluid delivery passageway for yieldably deforming said edge portion of one of said first and second thin films to slidably move said planar portions of first and second films relative to each other in response to fluid pressure being exerted on said actuator means by fluid within said delivery passageway.

7. A fluid delivery apparatus comprising:

(a) a base assembly having a fluid inlet, a fluid outlet, a fixedly located fluid delivery passageway defining a flow path in communication with said fluid outlet and a receiving chamber interconnected with said fluid passageway, said base assembly having a hollow cannula in communication with said fluid inlet;

(b) a stored energy means connected to said base assembly to define a fluid reservoir having a fluid inlet in communication with said fluid passageway, said stored energy means being distendable by fluid introduced into said reservoir through said fluid inlet, said fluid establishing stresses within said stored energy means, said stresses tending to return said store energy means toward a less distended configuration;

(c) a cover assembly connected to said base assembly to define a housing;

(d) fill means operably associated with said housing for filling said reservoir, said fill means comprising a container having a fluid chamber;

(e) flow rate control means carried by said housing for controlling of the rate of fluid flow from said reservoir toward said fluid outlet via said flow path, said flow rate control means comprising a control member rotably carried by said housing, said control member traversing said flow path and having first and second spaced apart flow restrictors, said control member being rotatable from a first position wherein said first flow restrictor is aligned with said flow path to a second position wherein said second flow restrictor is aligned with said flow path; and

(f) fluid actuated indicator means disposed intermediate said reservoir and said delivery passageway for indicating fluid flow through said delivery passageway.

8. The apparatus as defined in claim 7 in which said fill means further includes:

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

(b) pusher means disposed within said container for engagement with said plunger of said container assembly to move said plunger within said container between first and second locations.

9. The apparatus as defined in claim 7 in which said fluid indicator means comprises a pair of thin films having edge portions and generally planar body portions disposed in an overlaying relationship, at least one of said thin films having indicating indicia viewable upon relative sliding movement between said body portions of said films.

10. The apparatus as defined in claim 9 in which said fluid indicator means further comprises actuator means communicating with said fluid delivery passageway for yieldably deforming said edge portion of one of said first and second thin films to slidably move said planar portions of first and second films relative to each other in response to fluid pressure being exerted on said acutator means by fluid within said fluid passageway.

11. The apparatus as defined in claim 9 in which each of said pair of thin films has a fixedly located edge portion and a body portion, at least one of said films being yieldably deformable by said actuating means to cause relative movement between said body portions of said thin films upon fluid pressure being exerted on said actuating means by fluid within said fluid conduit, whereby said indicating indicia becomes viewable.

12. The apparatus as defined in claim 9 further including:

(a) a platform to which said edge portions of said first and second films are affixed, said platform having spaced apart first and second apertures; and

(b) a support plate disposed proximate said platform, said first and second films being disposed between said support plate and said platform said support plate having spaced-apart first and second depressions aligned with said apertures in said base and a viewing aperture disposed intermediate said depression.

13. An apparatus as defined in claim 10 in which said actuator means comprises:

(a) a first actuator element aligned with said first aperture in said platform for moving a portion of said first film into said first depression in response to fluid pressure being exerted on said first actuator element by fluid within said first fluid conduits; and

(b) a second actuator element aligned with said second aperture in said platform for moving a portion of said second film into said second depression in response to fluid pressure being exerted on said second actuator element by fluid within said second fluid conduit.

14. A fluid delivery apparatus comprising:

(a) a base assembly having a fluid outlet, a fluid delivery passagway defining a flow path in communication with said fluid outlet and a receiving chamber interconnected with said fluid passageway;

(b) a stored energy means connected to said base assembly to define a fluid reservoir having a fluid inlet in communication with said fluid passageway, said stored energy means being distendable by fluid introduced into said reservoir through said fluid inlet, said fluid establishing stresses within said stored energy means, said stresses tending to return said stored energy means toward a less distended configuration;

(c) a cover assembly connected to said base assembly to define a housing;

(d) fill means operably associated with said housing and being in communication with said reservoir for filling said reservoir, said fill means including an adapter assembly movable relative to said housing between first and second positions; and

(e) flow rate control means carried by said housing for controlling the rate of fluid flow from said reservoir toward said fluid outlet, said flow rate control means comprising a control member rotatably carried by said housing, said control member traversing said flow path and having first and second spaced apart flow restrictors, said control member being rotatable from a first position wherein said first flow restrictor is aligned with said flow path to a second position wherein said second flow restrictor is aligned with said flow path; and

(f) dose control means carried by said housing in operable association with said fill means for controllably moving said adapter assembly relative to said housing between said first and second positions to effect fluid flow toward said reservoir.

15. The device as defined in claim 14 in which said flow rate control means further includes means carried by said housing for preventing movement of said control member.

16. The device as defined in claim 14 in which said dose control means further includes means carried by said housing for preventing movement of said adapter assembly between said first and second positions.

17. The device as defined in claim 14 in which said control member of said flow rate control means comprises a disk and in which said first and second flow restrictors comprise first and second spaced apart, porous frits on said disk.

18. The apparatus as defined in claim 14 in which said control member of said flow rate control means comprises a disk and in which said first and second flow restrictors comprise circumferentially spaced apart apertured wafers carried by said disk.

19. The apparatus as defined in claim 14 further including fluid actuated indicator means disposed intermediate said reservoir and said delivery passageway for indicating fluid flow through said delivery passageway.

20. The device as defined in claim 14 in which said dose control means comprises:

(a) a knob rotatably carried by said housing, said knob having gear teeth;

(b) an idler gear rotatably carried by said housing said idler gear having gear teeth of said knob;

(c) a drive gear rotatably carried by said housing, said drive gear having gear teeth in engagement with said gear teeth of said idler gear and with said adapter assembly.

21. A fluid delivery apparatus comprising:

(a) a base assembly having a fluid outlet, a fluid delivery passage way in communication with said fluid outlet, said fluid delivery passageway defining a fluid flow path having a fixedly located, generally linearly extending portion;

(b) a stored energy means connected to said base assembly to define a fluid reservoir having a fluid inlet in communication with said fluid passageway and a fluid outlet in communication with said generally linearly extending portion of said flow path, said stored energy means being distedable by fluid introduced into said reservoir through said fluid inlet, said fluid establishing stresses within said stored energy means, said stresses tending to return said stored energy toward a less distended configuration; and

(c) flow rate control means carried by said housing for controlling of the rate of fluid flow from said reservoir toward said fluid outlet via said generally linearly extending portion of said flow path, said flow rate control means comprising a control member rotatably carried by said housing, said control member having a body portion traversing said generally linearly extending portion of said flow path, said body portion having first and second spaced apart flow restrictors and being rotatable from a first position wherein said first flow restrictor is aligned with said generally linearly extending portion of said flow path to a second position wherein said second flow restrictor is aligned with said generally linearly extending portion of said flow path.

22. A fluid delivery apparatus as defined in claim 21 in which said body portion of said control member extends generally perpendicular to said linearly extending portion of said flow path.

23. A fluid delivery apparatus as defined in claim 22 further including fill means operably associated with said housing for filling said reservoir.

24. A fluid delivery apparatus as defined in claim 23 in which said fill means includes an adapter assembly movable relative to said housing between first and second positions.

25. A fluid delivery apparatus as defined in claim 24 further including dose control means carried by said housing in operable association with said fill means for controllably moving said adapter assembly relative to said housing between said first and second positions to effect fluid flow toward said reservoir.