Hinged support collar for mechanical heart valve packaging

Packaging is provided for a heart valve prosthesis. A holder is adapted to grasp the heart valve prosthesis and includes a post. The packaging includes a collar for holding the post of the holder. An inner tray of the packaging receives the collar such that the prosthesis is suspended within the inner tray. An outer tray receives the inner tray. An inner tray lid seals the inner tray and an outer tray lid seals the outer tray.

FIELD OF THE INVENTION 
The present invention relates to packaging and a holder for a heart valve 
prosthesis. More particularly, the present invention relates to packaging 
for a heart valve prosthesis. 
BACKGROUND OF THE INVENTION 
Heart valve prostheses are used to replace the natural heart valve of a 
patient. One type of heart valve prosthesis is shown in U.S. Pat. No. 
4,276,658, issued Jul. 7, 1981, entitled HEART VALVE PROSTHESIS. Following 
manufacture and prior to implantation, the prosthesis must be transported 
in a sterile, sealed package. The package should be designed so that it is 
easily disassembled for removal of the valve during surgery yet provides a 
secure, sterile and protective container during transportation. 
Various packaging designs are shown in the prior art. For example, U.S. 
Pat. No. 4,101,031, issued Jul. 18, 1978 to Cromie, entitled "KAGE FOR 
PROSTHETIC HEART VALVE OR THE LIKE" shows a rigid canister which screws 
together and includes an O-ring. U.S. Pat. No. 4,512,471, issued Apr. 23, 
1985 to Kaster et al., entitled "STORAGE UNIT" also shows a canister which 
screws together. The Cohen et al. reference, U.S. Pat. No. 4,750,619, 
issued Jun. 4, 1988, entitled "KAGE WITH TRAY FOR SECURING AND 
PRESENTING A STERILE PROSTHETIC IMPLANT ELEMENT" shows three containers 
which sit within each other. The Lubock et al. reference, U.S. Pat. No. 
4,801,015, issued Jan. 31, 1989 entitled "RELEASABLE HOLDER AND KAGE 
ASSEMBLY FOR A PROSTHETIC HEART VALVE" also shows a rigid container which 
screws together. 
The heart valve prosthesis is typically suspended in the package by a 
holder. One such holder is described as a hanger in U.S. Pat. No. 
5,443,502, issued Aug. 22, 1995 to Caudillo et al., entitled ROTATABLE 
HEART VALVE HOLDER. The holder should be constructed such that it may be 
held in the packaging. 
SUMMARY OF THE INVENTION 
The present invention provides packaging for a heart valve prosthesis. The 
packaging provides a sterile, sealed container for the heart valve 
prosthesis following manufacture and prior to implantation. The packaging 
includes a tray having a recess formed therein. A heart valve prosthesis 
holder is adapted to carry the heart valve prosthesis. A collar is shaped 
to fit into the inner tray and includes a hinge which pivotably couples a 
first jaw to a second jaw which is moveable between an open position and a 
closed position. The first and second jaws are shaped to clamp about the 
heart valve prosthesis holder when in the closed position to suspend the 
heart valve prosthesis in the tray. In another aspect of the invention, 
the collar includes a plurality of legs which are adapted to couple to leg 
receptacles in the tray.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
FIG. 1 is an exploded top perspective view of assembly 10 in accordance 
with the present invention. Assembly 10 includes packaging 12, valve 
holder 14 and heart valve prosthesis 16. Packaging 12 includes outer tray 
18, inner tray 20, collar 22, inner tray lid 24 and outer tray lid 26. 
As shown in FIG. 1, inner tray 20 fits into cavity or recess 28 of outer 
tray 18. Similarly, collar 22, heart valve prosthesis 16 and valve holder 
14 fit in cavity or recess 30 of inner tray 20. Inner tray lid 24 fits 
over inner tray 20 and seals to inner tray sealing flange 32. Similarly, 
outer tray lid 26 fits over outer tray 18 and inner tray 20 and seals to 
outer tray sealing flange 34. Inner tray sealing flange 32 rests on flange 
shoulder 36 of outer tray 18 thereby supporting inner tray 20. 
FIGS. 2 through 6 describe the preferred embodiment and show how individual 
pieces fit together and advantageously cooperate. FIG. 2 is an exploded 
view of valve holder 14, collar 22 and inner tray 20. Prosthesis 16 
includes suture cuff 50, prosthesis body 52 (not shown in FIG. 2) and an 
occluder(s) or leaflet(s) carried therein (not shown). The occluder is 
supported by pivot guards 56. Valve holder 14 includes body 58 and holder 
post 68. Post 68 includes post head 74 having multiple circumferentially 
spaced finger recesses or grips 76 and provides a generally square shape. 
In one embodiment (not shown) only two opposed grips 76 are provided. 
Other shapes are within the scope of the present invention. A receptacle 
77 extends through the axis of post 68 and is adapted to receive the tip 
of an elongated handle (not shown). Ridges 62 are adapted to receive a 
suture therethrough which is used to secure valve 16 to holder 14. 
Collar 22 includes a first top jaw 80A and a second jaw 80B movably 
attached to jaw 80A at pivot 84 to move between an open position (shown in 
FIG. 2) and a closed position (shown in FIG. 3). Holder post 68 fits into 
post clamp 86 formed in the center of collar 22. Walls 87A and 87B of post 
clamp 86 are configured to conform around post 68. Post clamp 86 also 
includes post head support surfaces 88A and 88B and tip receiving recesses 
90. Tips 92 of post clamp 86 prevent rotational and axial motion of post 
with respect to collar 22, which also prevents top 91 of post head 74 from 
coming in contact with lid 24. Post head support surfaces 88A and 88B are 
recessed from jaws 80A and 80B and are positioned and shaped to support 
holder post head 74. Recesses 90A,90B interface with post tips 92 to 
prevent rotation and prevent post head 74 from contacting inner tray lid 
24. Collar 22 includes leg extensions 93 each having locking tips 94 
positioned at their distal ends. Leg extensions 93 and locking tips 94 are 
used for locking collar 22 into inner tray 20, as explained below. Jaws 
80A, 80B each include abutting surfaces 95A and 95B positioned opposite 
pivot 84 which are in abutting contact when jaws 80A and 80B are in the 
closed position. Additionally, jaws 80A and 80B include upper locking 
members 96A and 96B and lower locking members 97A and 97B, respectively, 
positioned opposite pivot 84. Locking members 96A,B and 97A,B are adapted 
to grasp and lock on opposing locking members when jaws 80A and 80B are in 
the closed position thereby releasably securing jaws 80A and 80B in the 
closed position. Each jaw 80A and 80B also includes a cut away region 98A 
and 98B formed therein which may be grasped by surgical personnel and 
which allows for circulation of sterilization gases and for visibility of 
the product. Rear abutting surfaces 99A and 99B are positioned adjacent 
pivot 84 for abutting contact when jaws 80A and 80B are in a fully open 
position. Additionally, rear abutting surfaces 99A, 99B form a gap between 
them when jaws 80A and 80B are in the closed position. The gap interfaces 
with protrusion 108 formed on the inner rim of inner tray 20. The 
interface prevents collar 22 from rotating with respect to inner tray 20. 
Inner tray 20 includes collar support surfaces or ledges 100. Collar 
support surfaces 100 are generally flat, circumferentially interspersed 
and extend radially inward from wall 102 which forms a shelf for placement 
of lip 82 of collar 22. Shelf 100 supports collar at 82A,82B, 99A,99B and 
97A,97B (four approximately equally spaced points for stability). Collar 
lock protrusions 104 extend radially inward to create bumps protruding 
from wall 102, are circumferentially interspersed, and are positioned near 
the plane created by support ledges 100. Collar lock protrusions 104 
alternate between adjacent collar support surfaces 100. Inner tray 20 also 
includes middle ledge 108 positioned to fit between rear abutting surfaces 
99A, 99B when jaws 80A and 80B are in the closed position. Additionally, 
ledge 108 prevents rotation of collar 22 in tray 20. 
FIG. 3 is a top plan view and FIG. 4 is a side elevational view of assembly 
holder 14, valve 16, collar 22 and inner tray 20 in an assembled 
condition. As shown in the figures, heart valve prosthesis 16 is securely 
held by valve holder 14, and valve holder 14 is suspended in inner tray 
20. Valve holder 14 is carried in collar 22 at post clamp 86 and on post 
head support surface 88, shown in FIG. 2. Recesses 90 prevent rotation of 
valve holder 14 by securing post head tips 92. 
Collar 22 is secured in inner tray 20 by leg extensions 93 and locking tips 
94 which fit in collar lock protrusions 104. Rotation of collar 22 within 
tray 20 is prevented by rear abutting surfaces 99A, 99B which abut ledge 
108 of tray 20. Inner tray 20 is sealed by inner tray lid 24 shown in FIG. 
1. 
FIG. 5 is a top plan view and FIG. 6 is a side elevational view of outer 
tray 18. Outer tray 18 includes finger recesses 40 formed in flange 
shoulder 36 on opposite sides of cavity or recess 28. Recess 28 is formed 
by wall 42. Finger recesses 40 extend downward from shoulder 36 to provide 
means for removal of inner tray 20 (shown in FIG. 1), from cavity 28. 
Finger recesses 40 also provide a passageway for sterilization gases to 
penetrate into cavity 28 when inner tray 20 is nested in place. The 
depression formed by flange shoulder 36 forms lip inner wall 44 which 
extends between sealing flange 34 and flange shoulder 36. A portion of 
flange shoulder 36 forms tab receiving shoulder 46 for receiving tab 48 of 
inner lid 24 (shown in FIG. 1). Flange shoulder 36 is shaped to support 
flange 32 of inner tray 20. With inner lid 24 sealed to flange 32, tab 48 
fits in tab receiving shoulder 46 (shown in FIG. 1). Further, outer tray 
lid 26 seals to sealing flange 34 and tab 118 extends over cut-away 
portion 120 of sealing flange 34 providing a gripping surface on outer lid 
for easy removal, as shown in FIG. 1. In one embodiment, lids 24 and 26 
are heat sealed using a platen during manufacture. 
Inner tray 20 fits in outer tray 18 and is positioned such that tab 48 lies 
over tab receiving shoulder 46. Outer tray lid 26 seals outer tray 18 and 
maintains assembly 10 together during shipping. 
During surgery, prosthesis 16 is removed in accordance with the following 
steps. Outer tray lid 26 is removed by pulling on tab 118 which overhangs 
portion 120 of sealing flange 34. This exposes inner tray lid 24. Inner 
tray 20 is removed by placing, for example, a thumb and forefinger in 
finger recesses 40 such that sealing flange 32 of tray 20 is grasped 
without breaking the sterile barrier. Alternatively, outer tray 18 can be 
tipped from inner tray 20. Furthermore, a tab 130 shown in FIG. 1 can be 
attached to lid 24 such that the surgical personnel can grasp tab 130 and 
lift inner container 20 from outer container 18. Inner tray 20 is then 
withdrawn from outer tray 18 and outer tray 18 is discarded. Inner tray 
lid 24 is removed by pulling on tab 48 which extends over flange 32. This 
exposes post head 74. An elongated handle (not shown) may be inserted into 
receptacle 77 while grasping tray 20. The convex shape of the top of 
collar 22 tends to distribute a downward force in an outward, radial 
direction such that a force may be applied while inserting the handle into 
receptacle 77, without causing the collar 22 to collapse. Torsional load 
may also be applied to receptacle 77 such as that which would be applied 
if the receptacle were threaded. As described above, rotation of post 68 
is prevented by rotation stop walls 90 which lock post 68 in place and by 
middle ledge 108 and rear abutting surfaces 99A, 99B which prevent 
rotation of collar 22 within tray 20. After the handle is secured to valve 
holder 14, collar 22 and valve holder 14 may be pulled out of inner tray 
20. This snap removal occurs because the tray and collar are preferably 
made of a polymeric material which allows for moderate deformation. 
Removal of collar 22 from inner tray 20 releases the constraint on shelf 
placement lip 82 of collar 22 and allows for easy removal of valve holder 
14 in the surgical setting. Valve holder 14 is removed from collar 22 by 
opening jaws 80A and 80B as shown in FIG. 2. Prosthesis 16 is removed from 
valve holder 14 by cutting a suture (not shown). 
During implantation, a surgical personnel may use finger recesses 76 of 
post head 74 to grasp valve holder 14 and thereby rotate valve body 52. 
For example, valve body 52 may rotate within suture cuff 50 after suture 
cuff 50 is attached to the heart tissue annulus. Typically, a surgical 
personnel will hold finger recesses 76 between a thumb and opposing 
forefinger. 
In a preferred embodiment, trays 18 and 20 and collar 22 are made of a 
thermally formed polymer, such as polycarbonate which is clear and which 
may be steam sterilized. In a preferred embodiment, trays 18 and 20 are 
formed by thermoform molding techniques. Collar 22 is formed by injecting 
molding. Lids 24 and 26 are preferably made from a porous, steam 
penetrable spun bonded polyolefin material having sterile barrier 
properties, such as Tyvek.RTM. 1073B available from Dupont de Nemours 
having an adhesive coating. This allows the assembly 10 to be sterilized 
while in an assembled condition by forcing sterilization gases through 
lids 24 and 26 and across surfaces of the interior of trays 18 and 20 and 
prosthesis 16. Other polymers may be used which better withstand other 
sterilization techniques such as ethylene oxide gas or gamma radiation. 
General manufacture and usage would remain unchanged from the steps 
outlined herein. The finger recesses 40 allows pressure to equilibrate 
between inner tray 20 and outer tray 18 during vacuum sterilization 
cycles. 
The packaging is advantageous because the prosthesis 16 is suspended within 
the packaging and does not contact the sides of the packaging. Further, 
the packaging is easily disassembled during surgery because the trays are 
not locked together. Using a clear packaging provides visibility which 
allows easy identification of the product. The flexible nature of the tray 
containers is advantageous because the lips of the containers allow some 
limited bending of the Bpackaging when a vacuum is applied to the 
containers during the sterilization process. The locking nature of the 
components is useful because a rotational torque can be applied without 
causing the components to slip within each other. The particular packaging 
is also well suited for low cost, reliable and easy manufacture and 
provides reduced costs over prior art packaging. The packaging is designed 
to withstand vacuum steam sterilization, and the pressure differentials 
imposed during the steam sterilization cycle. In addition, the packaging 
of the present invention provides dual sterile barriers in a recyclable 
container. Further, the packaging does not require additional external 
shock absorbing material such as open or closed cell foam which allows 
overall package size reduction. 
In the present invention, the product is suspended in the inner tray using 
a locking mechanism which is held in a closed position by the inner tray. 
The configuration of the collar and the inner tray prevent upward or 
downward rotative movement of the collar. The locking mechanism which is 
utilized to suspend the product within the package functions without any 
input from the outer tray. This allows the outer tray to function as a 
shock absorber without effecting the contained product. The design is 
robust and well suited for transportation and storage. The ability to open 
the package and present it to the sterile field without breaking the 
sterile field is considerably easier than in prior art techniques due to 
the finger recess in the outer package and the fact that the inner tray is 
not "locked" within the outer tray. 
Although the present invention has been described with reference to 
preferred embodiments, workers skilled in the art will recognize that 
changes may be made in form and detail without departing from the spirit 
and scope of the invention. For example, the holder may be of any desired 
shape to fit within the collar. Furthermore, other post head 
configurations may be used in which rotation of the post is prevented. 
Additionally, other types of heart valves and holders and heart valve 
prostheses of any design from any manufacturer other than those 
specifically shown may also be used with the present invention. Holder 14 
and prosthesis 16 are provided as example configurations. Further, the 
specific locking members 96A,B and 97A,B are one preferred embodiment of a 
locking mechanism which is used to releasably secure the jaws in a closed 
position. However, any other type or configuration of a locking mechanism 
may be employed. Similarly, any type of hinge mechanism may be used to 
couple the two jaws together.