Method and system for packaging of medical devices including shape memory materials

Medical devices may be packaged in order to protect the medical device from physical damage during shipment and/or storage. Medical devices may also be packaged in order to protect the sterility of the medical device. Packaging of medical devices is common because medical devices may be subjected to shock, temperature cycles, contaminated environments and other conditions detrimental to the medical device\'s physical condition and/or sterility during storage and transport prior to use.

Methods and systems are described for packaging medical devices. Packages are described for constraining expansion of medical devices along at least one axis. Removal devices for removing the medical devices from the packages are described. Medical devices stored in and removed from packages can include shape memory materials (e.g., polymers, alloys) which can cause the medical device to expand due to activation of the shape memory material. Medical devices can also expand due to other reasons, such as elastic recoil and/or thermal expansion. The methods and systems described herein may be used to limit the expansion of a medical device along at least one axis while inside a package. The methods and systems described herein may be used to relieve some of the stored strain in the medical device upon the opening of the package. Methods and systems are also described for opening a package which is subject to expansive forces from the medical device.

In one aspect the disclosure describes a package for a medical device containing a shape memory polymer. The package includes at least one intermediate member which has an interior surface capable of mating with a portion of the medical device, a constraining member disposed around the at least one intermediate member, and a compressing member disposed between the at least one intermediate member and the constraining member.

In another aspect, the disclosure describes a method of packaging a shape memory medical device. The method includes packaging a shape memory medical device in a chamber created by interior surfaces of a plurality of sabots, and encompassing a circumference of the plurality of sabots with a constraining member. The method also includes initiating an expansion of the medical device, and limiting the expansion of the medical device via limiting movement of the sabots.

In another aspect, the disclosure describes a removal device for removing a medical device from a package. The removal device includes a housing for containing the package in an unopened state, wherein the housing comprises a handle body and a hinged lid body attached to the handle body. The removal device also includes a chamber defined by an interior surface of the handle body and the hinged lid body, the chamber adapted to contain the package in the unopened state. The removal device also includes a cylinder adapted to engage a constraining member of the package, wherein turning about the axis of the cylinder winds a removed portion of the constraining member of around the cylinder. The removal device also includes an opening shaped to allow the medical device to pass out of the chamber.

In another aspect, the disclosure describes a package for a medical device containing a shape memory polymer. The package includes at least one intermediate member which has an interior surface capable of mating with a portion of the medical device. The package also includes a means for constraining the at least one intermediate member, the means for constraining disposed around the at least one intermediate member. The package may also include a means for compressing the medical device disposed between the at least one intermediate member and the means for constraining the medical device.

A BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows an assembled package comprising three sabots and a constraining member.

FIG. 1B shows a sabot with a detail of an inner surface of the sabot.

FIG. 2 shows three sabots with key elements.

FIG. 3A shows another embodiment of an assembled package comprising sabots, a constraining member, and a compressing member.

FIG. 3B shows a side view of an assembled package with a compressing member partially removed from the assembled package.

FIG. 3C shows a side view of an assembled package and a removed compressing member.

FIG. 4A shows another embodiment of an assembled package comprising sabots and a constraining member, with the package in a heightened compression configuration.

FIG. 4B shows the assembled package in a lessened compression configuration.

FIG. 5 shows an assembled package comprising sabots, a constraining member, and a compressing member.

FIG. 6A shows a package with an elliptical compressing member in a greater compression position.

FIG. 6B shows a package with an elliptical compressing member in a lower compression position.

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