Fluid delivery apparatus and method of making same
First Claim
1. A method of making a device for infusing medicinal fluid into a patient at a controlled rate, said device having a base provided with an upper surface including a central portion and a peripheral portion circumscribing the central portion, ullage-defining means disposed above said base, a distendable, elastomeric membrane superimposed over the base, a housing engageable with the base, and a cover covering the housing, the method comprising the steps of:
- (a) gripping a peripheral portion of the distendable membrane in a manner to differentially stretch the membrane to produce a prestressed membrane;
(b) subsequent to stretching the membrane placing the prestressed membrane over the ullage-defining means and the upper surface of the base;
(c) emplacing the housing over the base and the prestressed membrane; and
(d) sealably connecting the prestressed membrane and the housing to the base.
5 Assignments
0 Petitions
Accused Products
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, which, in cooperation with a thin planar base defines a fluid 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 visual indication of fluid flow through the apparatus.
86 Citations
30 Claims
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1. A method of making a device for infusing medicinal fluid into a patient at a controlled rate, said device having a base provided with an upper surface including a central portion and a peripheral portion circumscribing the central portion, ullage-defining means disposed above said base, a distendable, elastomeric membrane superimposed over the base, a housing engageable with the base, and a cover covering the housing, the method comprising the steps of:
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(a) gripping a peripheral portion of the distendable membrane in a manner to differentially stretch the membrane to produce a prestressed membrane; (b) subsequent to stretching the membrane placing the prestressed membrane over the ullage-defining means and the upper surface of the base; (c) emplacing the housing over the base and the prestressed membrane; and (d) sealably connecting the prestressed membrane and the housing to the base. - View Dependent Claims (2, 3, 4, 5, 6)
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7. A method of making a fluid delivery device for use in infusing medicinal fluid into a patient at a controlled rate having a generally plate like base provided with a fluid outlet and an upper surface including a central portion, a distendable elastomeric membrane superimposed over the base, a housing engageable with the base, one of said housing and said base having a groove and the other one a tongue receivable within said groove, a fluid rate control assembly for controlling fluid flowing from the fluid outlet of the base, a fluid flow indicator assembly for indicating fluid flow from the fluid outlet, and a cover covering the housing, the method comprising the steps of:
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(a) stretching the distendable membrane to produce a prestressed membrane; (b) subsequent to stretching the membrane placing the prestressed membrane over the upper surface of the base; (c) emplacing the housing over the base and the prestressed membrane such that the membrane is clamped between the tongue and the groove; (d) cutting the prestressed membrane at a location proximate the tongue to provide a cut, prestressed membrane; (e) sealably interconnecting the cut prestressed membrane and the housing with the upper surface of the base to form a base assembly; (f) connecting the cover to said base assembly to form a fluid delivery assembly; (g) connecting the flow rate control assembly to the fluid delivery assembly to form a controlled delivery assembly; and (h) connecting the fluid flow indicator assembly to the controlled delivery assembly.
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8. A method of making a device for infusing medicinal fluid into a patient at a controlled rate, said device having a base provided with an upper surface including a central portion, a distendable, elastomeric membrane superimposed over the base, and a housing engageable with the base, the method comprising the steps of:
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(a) removing a first length of elastomeric membrane from a first roll of elastomeric membrane; (b) stretching said first length of distendable membrane to produce a first prestressed membrane; (c) removing a second length of elastomeric membrane from a second roll of elastomeric membrane; (d) stretching said second length of distendable membrane to produce a second prestressed membrane; (e) placing the said second prestressed membrane over said first prestressed membrane; (f) placing the first and second prestressed membranes over the upper surface of the base; (g) emplacing the housing over the base and the first and second prestressed membranes; and (h) sealably connecting the first and second prestressed membranes and the housing to the base. - View Dependent Claims (9)
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10. A method of making a device for infusing medicinal fluid into a patient at a controlled rate, said device having a base provided with an upper surface including a central portion, a distendable, elastomeric membrane superimposed over the base, and a housing engageable with the base, the method comprising the steps of:
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(a) removing a first length of elastomeric membrane from a first roll of elastomeric membrane; (b) removing a second length of elastomeric membrane from a second roll of elastomeric membrane and placing said second length of elastomeric membrane over said first length of elastomeric membrane to form an elastomeric laminate; (c) stretching said elastomeric laminate to produce a prestressed laminate; (d) placing said prestressed laminate over the upper surface of the base; (e) emplacing the housing over the base and the prestressed laminate; and (f) sealably capturing and connecting the said prestressed laminate and the housing to the base. - View Dependent Claims (11, 12, 13, 14)
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15. A method of making a low profile fluid delivery device for use in infusing medicinal fluid into a patient at a controlled rate having a generally plate like base provided with a fluid outlet and an upper surface including a central portion and an upstanding tongue circumscribing the central portion, a distendable elastomeric membrane superimposed over the base, a housing engageable with the base, said housing having a groove for receiving the tongue of the base, and a cover covering the housing, the method comprising the steps of:
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(a) removing a first length of elastomeric membrane from a first roll of elastomeric membrane; (b) removing a second length of elastomeric membrane from a second roll of elastomeric membrane and placing said second length of elastomeric membrane over said first length of elastomeric membrane to form a first elastomeric laminate; (c) removing third length of elastomeric membrane from a third roll of elastomeric membrane and placing said third length of elastomeric membrane over said first elastomeric laminate to form a second elastomeric laminate; (d) stretching said second elastomeric laminate to produce a prestressed second laminate; (e) placing said second prestressed laminate over the upper surface of the base; (f) emplacing the housing over the base and said second laminate such that said second laminate is captured between the tongue of the base and the groove of the housing; (g) cutting said second laminate at a location proximate the upstanding tongue of the base to provide a cut second laminate; and (h) sealably interconnecting said cut second laminate and the cover with the upper surface of the base. - View Dependent Claims (16, 17, 18)
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19. A method of making a device for infusing medicinal fluid into a patient at a controlled rate, said device having a plate-like base provided with an upper surface including a central portion, and a peripheral portion circumscribing the central portion, a distendable, elastomeric membrane superimposed over the base and a housing engageable with the base, the method comprising the steps of:
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(a) differentially prestressing the membrane; (b) subsequent to stretching the membrane placing the membrane over the upper surface of the base; (c) emplacing the housing over the base and the membrane; and (d) sealably connecting the membrane and the housing to the base. - View Dependent Claims (20, 21)
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22. A method of making a device for infusing medicinal fluid into a patient at a controlled rate, said device having a plate-like base provided with an upper surface including a central portion, an ullage defining member disposed above the base, a distendable, elastomeric membrane superimposed over the base and the ullage defining member and a housing engageable with the base, the method comprising the steps of:
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(a) placing the membrane over the ullage defining member and the upper surface of the base to distend said membrane; (b) emplacing the housing over the base and the membrane; and (c) sealably connecting the membrane and the housing to the base. - View Dependent Claims (23, 24, 25, 26, 27)
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28. A method of making a device for infusing medicinal fluid into a patient at a controlled rate, said device having a base provided with a fluid inlet, a distendable, elastomeric membrane superimposed over the base, said elastomeric membrane being distendable by fluid introduced into said fluid inlet to form a cooperation with said base a fluid reservoir, the method comprising the steps of:
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(a) producing a prestressed membrane from a starting elastomeric membrane by the step of exerting forces on said starting membrane in a manner to produce internal stresses therewithin to form a prestressed membrane; (b) following the step of forming said prestressed membrane, placing the prestressed membrane over the base; and (c) sealably interconnecting the prestressed membrane with the base. - View Dependent Claims (29, 30)
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Specification