Fluid delivery device with flow indicator and rate control

• US 5,921,962 A
• Filed: 12/16/1997
• Issued: 07/13/1999
• Est. Priority Date: 10/11/1995
• Status: Expired due to Fees

• Current Assignee: Pescadero Beach Holdings Corporation
• Original Assignee: Science Incorporated
• Inventors: Kriesel, Marshall S., Feng, William W., Kazemzadeh, Farhad, Kluck, William J., Kriesel, Matthew B., Barber, Steve C.
• Primary Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US08/991,122
• Time in Patent Office: 574 Days
• Field of Search: 604/131, 604/132, 604/151, 604/153, 604/890.1, 604/246, 128/DIG. 12
• US Class Current: 604/132
• CPC Class Codes: A61M 2005/14513 with secondary fluid driving or regulating the infusion
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2205/197 by the seal material
• CPC Class Codes: A61M 2209/045 for filling, e.g. for filling reservoirs
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• 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 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: Y10S 128/12 Pressure infusion

Abstract

A fluid delivery device for infusing medicinal fluids having a self-contained stored energy membrane for expelling fluids at a precisely controlled rate. The device is of a compact, low profile, laminate construction so that it can conveniently be used for the fluids, such as insulin and the like, into an ambulatory patient at controlled rates over extended periods of time. Included within the device are various fluid flow control elements including a unique hydraulic fluid rate control system for ultra low flow delivery. Also included is a highly novel flow indictor for providing a positive indication of fluid flow from the device and for indicating at any given time the amount of fluid remaining in the device.

Claims

1. A device for infusing medicinal fluid into a patient at a controlled rate comprising:

(a) a base assembly;

(b) a cover assembly superimposed over and sealably connected to said base assembly, said cover assembly having first and second fluid passageways;

(c) a stored energy means comprising a distendable membrane disposed intermediate said base assembly and said cover assembly, said distendable membrane being distendable from a first configuration to a second configuration and, when distended into said second configuration, having a tendency to return to its first configuration, said distendable membrane;

(i) forming in conjunction with said base assembly a medicinal fluid reservoir having an inlet and an indicator fluid reservoir; and

(ii) forming in conjunction with said cover assembly a central ullage reservoir and a peripheral ullage reservoir, said central ullage reservoir and said peripheral ullage reservoir being interconnected by said first and second fluid passageways;

(d) an ullage defining means for providing ullage within said central ullage reservoir and within said peripheral ullage reservoir, said ullage defining means comprising a flowable mass flowable between said central ullage reservoir and said peripheral ullage reservoir via said first and second passageways formed in said cover assembly;

(e) indicator fluid provided within said indicator fluid reservoir;

(f) fill means communicating with said base assembly for filling said medicinal fluid reservoir with the medicinal fluid to be infused into the patient;

(g) infusion means for infusing medicinal fluid from said medicinal fluid reservoir into the patient, said infusion means comprising a hollow cannula connected to said base assembly, said hollow cannula having;

(i) an inlet in communication with said medicinal fluid reservoir; and

(ii) an outlet end provided in the form of a pierceable portion extending outwardly from said base assembly for insertion into the patient; and

(h) indicator means interconnected with said base assembly for indicating the flow of medicinal fluid from said central medicinal fluid reservoir outwardly toward the patient.

2. A device as defined in claim 1 in which said indicator means comprises an indicator lens assembly connected to one of said base assembly and said cover assembly, said indicator lens assembly including:

(a) a body portion having a circuitously shaped indicator fluid flow path; and

(b) pick-up means connected to said body portion, said pick-up means being in communication with said indicator fluid reservoir for causing indicator fluid to flow into and out of said circuitously shaped indicator fluid flow path in response to said flowable mass flowing between said peripheral ullage reservoir and said central ullage reservoir.

3. A device as defined in claim 1 further including first flow control means carried by said cover assembly for permitting said flowable mass to flow in a first direction from said central conformable ullage reservoir toward said peripheral ullage reservoir via said first passageway upon filling of said medicinal fluid reservoir by said fill means, but positively preventing said flowable mass from flowing in an opposite direction.

4. A device as defined in claim 1 further including flow rate control means carried by said cover assembly for controlling the rate of flow of said flowable mass between said peripheral ullage reservoir and said central ullage reservoir via said second passageway.

5. A device as defined in claim 1 further including second flow control means carried by said base assembly for controlling flow of medicinal fluid from said medicinal fluid reservoir toward said inlet of said hollow cannula.

6. A device as defined in claim 1 in which said base assembly comprises:

(a) a base component having a central opening; and

(b) a medicinal fluid reservoir defining housing receivable within said central opening of said base component.

7. A device as defined in claim 1 in which said base assembly further includes a peripheral portion, and a first elastomeric insert disposed in said peripheral portion of said base assembly, said first elastomeric insert having at lease one circumferentially extending groove formed therein.

8. A device as defined in claim 7 in which said cover assembly further includes a peripheral portion, and a second elastomeric insert disposed in said peripheral portion, said second elastomeric insert having at least one circumferentially extending protuberance sealably receivable within said groove formed in said first elastomeric insert.

9. A device as defined in claim 7 in which said fill means comprises a syringe assembly having a piercing cannula and in which said base assembly further includes a septum disposed proximate said inlet of said medicinal fluid reservoir, said septum being pierceable by said piercing cannula of said syringe assembly.

10. A device for use in infusing medicinal fluid into a patient at a controlled rate comprising:

(a) a base assembly having an upper surface and a lower surface, said base assembly including a central portion, a peripheral portion circumscribing said central portion, said peripheral portion having a generally toroidal shaped chamber formed therein;

(b) stored energy means for forming in conjunction with said central portion of said base, a medicinal fluid reservoir having an inlet and an outlet and for forming in conjunction with said toroidal shaped chamber, a generally toroidal shaped indicator fluid reservoir having an inlet and an outlet, said stored energy means comprising at least one distendable membrane superimposed over said upper surface of said base assembly, said membrane having a central portion overlaying said central portion of said base assembly and a peripheral portion overlaying said toroidal shaped chamber, said peripheral portion being distendable from a first configuration to a second configuration to establish internal stresses, said stresses tending to move said membrane toward said first configuration;

(c) a cover assembly sealably interconnected with said base assembly, said cover assembly having a central portion overlaying said central portion of said base assembly and a peripheral portion overlaying said generally toroidal shaped chamber formed in said base assembly for forming in conjunction with said membrane a generally toroidal shaped, conformable ullage reservoir having a first inlet port, said central portion having a central chamber for forming in conjunction with said membrane a central conformable ullage reservoir, having a first inlet port, said central conformable ullage reservoir being in fluid communication with said generally toroidal shaped, conformable ullage reservoir via first and second passageways formed in said cover;

(d) an ullage defining means for providing ullage within said central conformable ullage reservoir and within said generally toroidal shaped conformable ullage reservoir, said ullage defining means comprising a flowable mass flowable between said central conformable ullage reservoir and said generally toroidal shaped, conformable ullage reservoir via said first and second passageways formed in said cover assembly;

(e) indicator fluid provided within said generally toroidal shaped indicator fluid reservoir;

(f) fill means communicating with said base assembly for filling said medicinal fluid reservoir;

(g) infusion means for infusing medicinal fluid from said medicinal fluid reservoir into the patient, said infusion means comprising a hollow cannula connected to said base assembly, said hollow cannula having;

(i) an inlet in communication with said medicinal fluid reservoir; and

(ii) an outlet end provided in the form of a pierceable portion extending outwardly from said base assembly for insertion into the patient; and

(h) indicator means interconnected with said base assembly for indicating the flow of medicinal fluid from said medicinal fluid reservoir toward the patient.

11. A device as defined in claim 10 in which said indicator means comprises an indicator lens assembly having:

(a) a body portion connected to said base assembly, said body portion having circuitously shaped indicator fluid flow path; and

(b) a pick-up means connected to said body portion, said pick-up means being in communication with said generally toroidal shaped indicator fluid reservoir for causing indicator fluid to flow into and out of said circuitously shaped indicator fluid flow path in response to said flowable mass flowing between said generally toroidal shaped, conformable ullage reservoir and said central conformable ullage reservoir.

12. A device as defined in claim 10 further including first flow control means carried by said cover assembly for permitting said flowable mass to flow in a first direction from said central conformable ullage reservoir toward said generally toroidal shaped conformable ullage reservoir via said first passageway upon filling of said medicinal fluid reservoir by said fill means, but positively preventing said flowable mass from flowing in an opposite direction.

13. A device as defined in claim 10 further including flow rate control means carried by said cover assembly for controlling the rate of flow of said flowable mass between said generally toroidal shaped, conformable ullage reservoir and said central conformable ullage reservoir via said second passageway.

14. A device as defined in claim 10 further including second flow control means carried by said base assembly for controlling flow of medicinal fluid from said medicinal fluid reservoir toward said inlet of said hollow cannula.

15. A device for use in infusing medicinal fluid into a patient at a controlled rate comprising:

(a) a base assembly having an upper surface and a lower surface, said base assembly including a central portion, a peripheral portion circumscribing said central portion, said peripheral portion having a generally toroidal shaped chamber formed therein;

(b) stored energy means for forming in conjunction with said central portion of said base, a medicinal fluid reservoir having an inlet and an outlet and for forming in conjunction with said toroidal shaped chamber, a generally toroidal shaped indicator fluid reservoir having an inlet and an outlet, said stored energy means comprising at least one distendable membrane superimposed over said upper surface of said base assembly, said membrane having a central portion overlaying said central portion of said base assembly and a peripheral portion overlaying said toroidal shaped chamber, said peripheral portion being distendable from a first configuration to a second configuration to establish internal stresses, said stresses tending to move said membrane toward said first configuration;

(c) a cover assembly sealably interconnected with said base assembly, said cover assembly having a central portion overlaying said central portion of said base assembly and a peripheral portion overlaying said generally toroidal shaped chamber formed in said base assembly for forming in conjunction with said membrane a generally toroidal shaped, conformable ullage reservoir having a first inlet port, said central portion having a central chamber for forming in conjunction with said membrane a central conformable ullage reservoir, having a first inlet port, said central conformable ullage reservoir being in fluid communication with said generally toroidal shaped, conformable ullage reservoir via first and second passageways formed in said cover;

(d) an ullage defining means for providing ullage within said central conformable ullage reservoir and within said generally toroidal shaped conformable ullage reservoir, said ullage defining means comprising a flowable mass flowable between said central conformable ullage reservoir and said generally toroidal shaped, conformable ullage reservoir via said first and second passageways formed in said cover assembly;

(e) indicator fluid provided within said generally toroidal shaped indicator fluid reservoir;

(f) fill means communicating with said base assembly for filling said medicinal fluid reservoir;

(g) infusion means for infusing medicinal fluid from said medicinal fluid reservoir into the patient, said infusion means comprising a hollow cannula connected to said base assembly, said hollow cannula having;

(i) an inlet in communication with said medicinal fluid reservoir; and

(ii) an outlet end provided in the form of a pierceable portion extending outwardly from said base assembly for insertion into the patient; and

(h) indicator means for indicating the flow of medicinal fluid from said medicinal fluid reservoir toward the patient;

said indicator means comprising an indicator lens assembly having;

(i) a body portion connected to said base assembly, said body portion having circuitously shaped indicator fluid flow path; and

(ii)a pick-up means connected to said body portion, said pick-up means being in communication with said generally toroidal shaped indicator fluid reservoir for causing indicator fluid to flow into and out of said circuitously shaped indicator fluid flow path in response to said flowable mass flowing between said generally toroidal shaped, conformable ullage reservoir and said central conformable ullage reservoir.

16. A device as defined in claim 15 further including first flow control means carried by said cover assembly for permitting said flowable mass to flow in a first direction from said central conformable ullage reservoir toward said generally toroidal shaped conformable ullage reservoir via said first passageway upon filling of said medicinal fluid reservoir by said fill means, but positively preventing said flowable mass from flowing in an opposite direction.

17. A device as defined in claim 15 further including flow rate control means carried by said cover assembly for controlling the rate of flow of said flowable mass between said generally toroidal shaped, conformable ullage reservoir and said central conformable ullage reservoir via said second passageway.

18. A device as defined in claim 15 further including second flow control means carried by said base assembly for controlling flow of medicinal fluid from said medicinal fluid reservoir toward said inlet of said hollow cannula.

19. A device as defined in claim 15 in which said ullage defining means comprises a viscous oil.

20. A device as defined in claim 15 in which said ullage defining means comprises a flourinated oil.

21. A device as defined in claim 15 in which said indicator fluid comprises a colored oil.

22. A device as defined in claim 15 in which said fill means comprises a syringe assembly having a piercing cannula and in which said base assembly further includes a septum disposed proximate said inlet of said medicinal fluid reservoir, said septum being pierceable by said piercing cannula of said syringe assembly.

23. A device as defined in claim 15 in which said base assembly further includes a first elastomeric insert disposed in said peripheral portion of said base assembly, said first elastomeric insert having at least one circumferentially extending groove formed therein.

24. A device as defined in claim 23 in which said cover assembly further includes a second elastomeric insert disposed in said peripheral portion of said cover assembly, said second elastomeric insert having at least one circumferentially extending protuberance sealably receivable within said groove formed in said first elastomeric insert.