Packaging for medical articles such as a size varying series of orthopedic implants
Packaging which can accommodate medical articles such as a series of orthopedic implants e.g. femoral stem components for prosthetic hip joints which have a dimension which varies minimally across the series but which vary considerably in overall size. The packaging is designed to minimize the travel of any member of the series packaged therein such that all the packaged components in the series can pass the standard handling and shipping tests typically used by the manufacturers of medical articles such as implants and preferably comprises two thermoformed tray components which each carry three types of cavities which are interconnected and designed to be assembled with their cavities facing each other to contain the lower stem, body and angled shaft of the stem component, respectively, with the cavities for the lower stem and the body cooperating to capture a minimally varying dimension of the series.
1. A rigid synthetic polymer package for medical articles comprising:
(A) a rigid base having an interior surface and an exterior surface; and
(B) a cover having at least two compartments including (a) a first compartment having (i) a first interior surface adapted for movement restraining contact with a first portion of a medical article, and (ii) an opposing first exterior surface; and (b) a second compartment having (i) a second interior surface adapted for contact with a second portion of the medical article, and (ii) an opposing second exterior surface; and
wherein the base and cover having closure means, and
wherein the first and second compartments of the cover are attached to each other by a connecting hinge adapted for manual movement of the first compartment relative to the second compartment to rotate the first interior surface away from the second interior surface and which cannot be rotated about the connecting hinge to a position where the first interior surface covers the second interior surface, wherein the first compartment of the cover has first and second cavities and the second compartment of the cover has a third cavity and the base has a first compartment having first and second cavities connected by an integrally formed hinge to a second compartment having a third cavity;
wherein the third cavity of both the cover and the base is a longer hemi-tubular shape generally parallel to a long edge of the package and the second cavity of both the cover and the base is a shorter hemi-tubular shape at an acute angle to a longitudinal axis of the long edge; and the first cavity of the first compartment of both the cover and the base connects the second and third cavities and the first cavity has a significantly greater width parallel to a short edge of the package than the second and third cavities; and
wherein the said base and cover are configured face to face such that the longer and shorter hemi-tubular shape cavities form respective longer and shorter tubular shape cavities; and
wherein the cavities of the cover and the base cooperate to establish a clearance which closely approximates a dimension of the largest member of the series of orthopedic stem components of different sizes.
2. A two piece package thermoformed from a rigid thermoplastic material adapted for the transport and handling of any one of a series of femoral stem components of different sizes for a prosthetic hip joint, the sizes ranging from a smallest component to a largest component, said package comprising two facing generally rectangular tray components, with each tray component having
a. a longer hemi-tubular cavity generally parallel to a long edge of its tray component and having a width and length;
b. a shorter hemi-tubular cavity at an acute angle to the long edge, said shorter section having a width and a length; and
c. a transition cavity in communication with the longer and shorter hemi-tubular sections which has a width parallel to a short edge of its tray, the transition cavity being of significantly greater width than the widths of the longer and shorter hemi-tubular cavities and having a wall in alignment with the longitudinal wall of the longer hemi tubular cavity closer to the periphery of the tray; and
d. a first closure means; and
wherein the tray components are configured in a face to face configuration such that the longer and shorter hemi-tubular cavities form a longer and shorter tubular cavity, and
wherein the tray components cooperate to establish a clearance which closely approximates a dimension of the largest member of the series of femoral stem components of different sizes, and
wherein each of the tray components has a hinge located approximately at the juncture of the longer hemi-tubular cavity and the transition cavity and the hinge runs parallel to the short edge of the tray component and runs the width of the tray component, thus allowing the portion of the tray component containing the transition cavity and the shorter hemi-tubular cavity to rotate out of the plane of the tray component.
3. The two piece package of claim 2 wherein the first closure means is located on the rotatable portion of each of the tray components and the first closure functions independently of a second closure means which holds the portion of each of the tray components carrying the longer hemi-tubular cavity to each other.
4. The two piece package of claim 2 wherein the rigid thermoplastic material of both of the tray components is comprised of an aromatic polyether polyurethane on the surfaces which are adapted to face the femoral components to be packaged.
5. The two piece package of claim 4 wherein the aromatic polyether polyurethane is melt laminated to another thermoplastic resin.
6. The two piece package of claim 5 wherein the other thermoplastic resin is polyethylene terephthalate glycol.