Pressure reservoir filling process for an implantable medication infusion pump
First Claim
1. A method of filling a pressure reservoir of an implantable medication infusion pump with a selected pressure fluid, wherein the pressure reservoir is separated from a medication chamber by a movable wall, said method comprising the steps of:
- drawing a vacuum in the pressure reservoir;
connecting the pressure reservoir to a supply of the pressure fluid to vacuum-draw the pressure fluid for flow into and to fill the pressure reservoir;
calibrating the quantity of the pressure fluid within the pressure reservoir by subjecting the pressure reservoir to a predetermined pressure to expel excess pressure fluid therefrom and to calibrate the quantity of pressure fluid therein;
sealing the pressure reservoir; and
performance testing the pressure reservoir under simulated implantation conditions.
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Accused Products
Abstract
An improved process and related apparatus are provided for filling a pressure reservoir of an implantable medication infusion pump with a selected pressure fluid, wherein the pressure reservoir is separated by a movable wall from an adjacent medication chamber. The improved filling process includes vacuum-draw filling of the pressure reservoir with relatively purified pressure fluid in liquid state. The specific quantity of pressure fluid within the pressure reservoir is thereafter calibrated by filling the adjacent medication chamber with a calibration fluid at a predetermined positive pressure, thereby expelling excess pressure fluid from the pressure reservoir. The pressure reservoir is then sealed and the performance characteristics thereof are tested under simulated implantation conditions to confirm the capability of the pressure reservoir to maintain medication within the medication chamber under substantially constant pressure conditions.
319 Citations
23 Claims
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1. A method of filling a pressure reservoir of an implantable medication infusion pump with a selected pressure fluid, wherein the pressure reservoir is separated from a medication chamber by a movable wall, said method comprising the steps of:
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drawing a vacuum in the pressure reservoir; connecting the pressure reservoir to a supply of the pressure fluid to vacuum-draw the pressure fluid for flow into and to fill the pressure reservoir; calibrating the quantity of the pressure fluid within the pressure reservoir by subjecting the pressure reservoir to a predetermined pressure to expel excess pressure fluid therefrom and to calibrate the quantity of pressure fluid therein; sealing the pressure reservoir; and performance testing the pressure reservoir under simulated implantation conditions. - View Dependent Claims (3, 4, 5, 6, 7, 9, 10)
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2. A method as defined in claim further comprising:
the step of retaining the pressure reservoir in a substantially minimum volume configuration during said step of connecting the pressure reservoir to the supply of pressure fluid.
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8. A method as defined in claim wherein said calibrating step comprises:
filling the medication chamber with a selected calibration fluid at a predetermined pressure level.
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11. A method of filling a pressure reservoir of a reservoir subassembly with a selected pressure fluid, said subassembly having the pressure reservoir separated from a medication chamber by a movable wall and being adapted for use in an implantable medication infusion pump, said method comprising the steps of:
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drawing a vacuum in the pressure reservoir; filling the pressure reservoir with the pressure fluid in liquid form by connecting the pressure reservoir to a supply of the pressure fluid for vacuum-drawn flow into and to fill the pressure reservoir, said filling step including retaining the pressure reservoir in a substantially minimum volume configuration; calibrating the quantity of the pressure fluid within the pressure reservoir by filling the medication chamber with a calibration fluid under predetermined pressure to expel excess pressure fluid from the pressure reservoir; closing the pressure reservoir; and performance testing the pressure reservoir under simulated implantation conditions, said performance testing step comprising; immersing the pressure reservoir in a bath of liquid at a temperature generally corresponding to patient body temperature; filling the medication chamber with liquid; withdrawing a small quantity of the liquid from the medication chamber; and monitoring the pressure of the liquid within the medication chamber in relation to the quantity of liquid withdrawn therefrom to determine pressure reservoir performance.
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- 12. A method as defined in claim wherein the pressure fluid is a selected fluorocarbon.
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15. A method of filling a pressure reservoir of an implantable medication infusion pump with a selected pressure fluid, wherein the pressure reservoir is separated from a medication chamber by a movable wall, said method comprising the steps of:
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drawing a vacuum in the pressure reservoir; connecting the pressure reservoir to a supply of the pressure fluid to vacuum-draw the pressure fluid for flow into and to fill the pressure reservoir; calibrating the quantity of the pressure fluid within the pressure reservoir by subjecting the pressure reservoir to a predetermined pressure to expel excess pressure fluid therefrom and to calibrate the quantity of pressure fluid therein; and sealing the pressure reservoir.
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16. Station apparatus for filling a pressure reservoir of an implantable medication infusion pump with a selected pressure fluid, wherein the pressure reservoir is separated from a medication chamber by a movable wall, said station apparatus comprising:
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means for drawing a vacuum in the pressure reservoir; means for connecting the pressure reservoir to a supply of the pressure fluid to vacuum-draw the pressure fluid for flow into and to fill the pressure reservoir; means for calibrating the quantity of the pressure fluid within the pressure reservoir by subjecting the pressure reservoir a predetermined pressure to expel excess pressure fluid therefrom and to calibrate the quantity of pressure; means for sealing the pressure reservoir; and means for performance testing the pressure reservoir under simulated implantation conditions. - View Dependent Claims (17, 18, 19, 20, 21, 22)
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23. Station apparatus for filling a pressure reservoir of an implantable medication infusion pump with a selected pressure fluid, wherein the pressure reservoir is separated from a medication chamber by a movable wall, said station apparatus comprising:
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means for drawing a vacuum in the pressure reservoir; means for connecting the pressure reservoir to a supply of the pressure fluid to vacuum-draw the pressure fluid for flow into and to fill the pressure reservoir; means for calibrating the quantity of the pressure fluid within the pressure reservoir by subjecting the pressure reservoir to a predetermined pressure to expel excess pressure fluid therefrom and to calibrate the quantity of pressure fluid, and means for sealing the pressure reservoir.
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Specification