Fluid delivery device with flow indicator and rate control
First Claim
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.
5 Assignments
0 Petitions
Accused Products
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.
134 Citations
24 Claims
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1. A device for infusing medicinal fluid into a patient at a controlled rate comprising:
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(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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. A device for use in infusing medicinal fluid into a patient at a controlled rate comprising:
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(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. - View Dependent Claims (11, 12, 13, 14)
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15. A device for use in infusing medicinal fluid into a patient at a controlled rate comprising:
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(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. - View Dependent Claims (16, 17, 18, 19, 20, 21, 22, 23, 24)
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Specification