Packaging system for a sterilizable calbratable medical device
First Claim
1. An improved package for a medical device that includes a hydratable sensor, said package comprising:
- a tray for receiving the medical device;
a chamber provided within the tray for receiving a hydratable sensor of the medical device;
a hydratable sensor of the medical device, said sensor disposed in the chamber;
a gas permeable cover overlying the tray;
a source of hydration fluid external to the tray;
an outer wrap including a gas-impermeable portion and a gasimpermeable portion enclosing the tray; and
plumbing means for controlling fluid flow into and within the outer wrap, said plumbing means being operable to selectively establish, without breaching a portion of the outer wrap surrounding the sensor, fluid communication between;
a. said gas permeable portion of the outer wrap and said sensor of effect sterilization of said sensor with a gaseous sterilant;
b. said chamber and the source of hydration fluid external to the tray to effect hydration of said sensor with the hydration fluid; and
c. said chamber and a source of gas external to the chamber and the hydration fluid therein to effect equilibration of the hydration fluid in order to calibrate the sensor within the chamber.
1 Assignment
0 Petitions
Accused Products
Abstract
An improved package for a medical device includes an inner wrap that envelopes the medical device, the inner wrap including a gas-permeable surface, and a chamber defined in the inner wrap to store a hydratable sensor of the medical device. Plumbing for the package controls fluid flow into and within the inner wrap, to selectively establish, without breaching a portion of the inner wrap surrounding the sensor, fluid communication between the gas-permeable surface and the sensor, to sterilize the sensor and the inner wrap with a gaseous sterilant, or to hydrate the sensor with hydration fluid obtained from a source of hydration fluid connected to the chamber, or to equilibrate the hydration fluid in the chamber with an external source of gas, to calibrate the sensor within the inner wrap.
59 Citations
25 Claims
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1. An improved package for a medical device that includes a hydratable sensor, said package comprising:
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a tray for receiving the medical device; a chamber provided within the tray for receiving a hydratable sensor of the medical device; a hydratable sensor of the medical device, said sensor disposed in the chamber; a gas permeable cover overlying the tray; a source of hydration fluid external to the tray; an outer wrap including a gas-impermeable portion and a gasimpermeable portion enclosing the tray; and plumbing means for controlling fluid flow into and within the outer wrap, said plumbing means being operable to selectively establish, without breaching a portion of the outer wrap surrounding the sensor, fluid communication between; a. said gas permeable portion of the outer wrap and said sensor of effect sterilization of said sensor with a gaseous sterilant; b. said chamber and the source of hydration fluid external to the tray to effect hydration of said sensor with the hydration fluid; and c. said chamber and a source of gas external to the chamber and the hydration fluid therein to effect equilibration of the hydration fluid in order to calibrate the sensor within the chamber. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. In a package for a sterilizable calibratable medical device, a tonometry chamber receiving a sensor component of the medical device, the tonometry chamber comprising:
a small compartment having a curved wall, a fluid inlet port, a gas inlet port and a gas vent;
a baffle disposed between the fluid inlet port and the gas inlet port, the curved wall of the chamber and the baffle combining to promote circulatory flow of the fluid disposed therein.- View Dependent Claims (12, 13, 14, 15)
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16. A method of packaging a medical device that includes a hydratable sensor, the method comprising the steps of:
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providing a tray for receiving the medical device; defining a chamber within the tray for receiving a hydratable sensor of the medical device; providing a hydratable sensor on the medical device, said sensor disposed in the chamber; providing a gas-permeable cover overlying the tray; providing a source of hydration fluid external to the tray; providing an outer wrap including a gas-permeable portion and a gas-impermeable portion enclosing the tray; and providing plumbing means for controlling fluid flow into and within the outer wrap, said plumbing means being operable to selectively establish, without breaching a portion of the outer wrap surrounding the sensor, fluid communication between; a. said gas-permeable portion of the outer wrap and said sensor to effect sterilization of said sensor with a gaseous sterilant; b. said chamber and the source of hydration fluid external to the tray to effect hydration of said sensor with the hydration fluid; and c. said chamber and a source of gas external to the chamber and the hydration fluid therein to effect equilibration of the hydration fluid in order to calibrate the sensor within the chamber. - View Dependent Claims (17, 18, 19, 20, 21, 22, 23, 24, 25)
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Specification