Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Heart valve – Combined with surgical tool
Reexamination Certificate
2000-09-20
2002-07-09
Willse, David H. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Heart valve
Combined with surgical tool
C206S438000
Reexamination Certificate
active
06416547
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to carriers for holding heart valves during storage and transportation and, more particularly, to carriers for holding heart valves made from natural tissue (known as bioprosthetic heart valves).
2. Description of the Related Art
To minimize the possibility of damage to a relatively delicate medical device, bioprosthetic heart valves are packaged in jars filled with preserving solution for shipping and storage prior to use in the operating theater. In doing so, the valves are stabilized to prevent the valves from striking the inside of the jar.
Prior to implantation in a patient, residual traces of the preserving solution need to be washed from the valve. This washing is accomplished by first removing the valve from the jar and then rinsing the valve in a shower. Alternatively, the valve may be immersed and agitated in a bath. First, the medical personnel removes the valve from its jar by grasping a valve holder with a gloved hand. The valve holder is typically centrally located with respect to, and sutured to, the valve sewing ring. A surgical handle is then threaded into a socket provided in the valve holder. The valve is then rinsed in the bath or shower while being held at the end of the handle. After rinsing, the handle is used to position the valve in the appropriate implantation site. This conventional process leaves the valve susceptible to damage if the valve strikes a surface while being manipulated on the end of the surgical handle.
In addition to the susceptibility for damage to the valves in the operating theater, the transportation of the valves to the operating theater also introduces problems. Heart valves are often shipped to customers, that is, hospitals, via aircraft. The valves, packed in jars as described above, are stored in the cargo hold of the aircraft during flight, which is a low-pressure and low-temperature environment. With conventional packaging approaches, there has been the possibility of leakage of the preserving fluid during transport in such environments, which is undesirable. With leakage, the integrity of the sterilization of the valve is suspect.
In view of the foregoing, it is apparent that there is still a need in the art for a carrier for heart valves that enables a medical practitioner to easily and safely remove and rinse a valve, as well as attached a surgical handle thereto. In addition, there is also a need in the art for a carrier for heart valves that does not leak during transportation, even in low-pressure environments.
SUMMARY OF THE INVENTION
The present invention provides a carrier for heart valves that overcomes the disadvantages of conventional approaches to the packaging of heart valves. The carrier of the present invention enables a medical practitioner to first connect the surgical handle to the valve holder while the heart valve remains in its shipping carrier. In addition, the carrier of the present invention is configured to minimize or substantially eliminate leaking of preserving fluid during transportation and storage.
According to one aspect of the invention, a carrier for a heart valve includes a jar, a rinse cage receivable within the jar, and a holder to which a heart valve is attachable, for example, by sewing apparatus. The rinse cage includes a first engagement structure, and the holder includes a second engagement structure complementary to the first engagement structure for releasably engaging therewith. The engagement structures are configured such that when engaged, a heart valve attached to the holder is disposed within the rinse cage.
One of the advantages of the carrier of the present invention is that a heart valve attached to the holder is protected not only when within the jar but also when removed from the jar. More specifically, when the holder is removed from the jar, the rinse cage with the valve suspended therein is also removed because the two components are engaged. Accordingly, the heart valve may be rinsed outside of the jar while still being received within and protected by the rinse cage.
To facilitate the removal of the holder-and-rinse cage combination, the holder preferably has a socket for engaging with a surgical handle. A medical practitioner may attach a surgical handle to the holder to remove the valve from the jar while the valve is still received within the rinse cage in the jar. Accordingly, the practitioner does not need to manually remove and hold the valve to attach a handle.
To facilitate the engagement of the surgical handle, the carrier may include a stop which is configured to limit rotation of the holder relative to the rinse cage, and locking apparatus which is configured to limit rotation of the rinse cage relative to the jar. Accordingly, as a surgical handle is tightened into the socket, frictional forces cause the holder to rotate. However, the stop limits the rotation by engaging with the rinse cage. As the handle is further tightened, frictional forces cause the rinse cage to rotate, which rotation is limited by the locking apparatus. Accordingly, a medical practitioner is able to engage a surgical handle securely and firmly without needing to manually remove the valve from the jar.
According to another aspect of the invention, the carrier includes a lid attachable to the jar. A lid has a gasket that is held rotatable relative to the lid with a flange. To form a seal with integrity, a top surface of the jar is tapered to define an apex. When the lid is attached to the jar, the apex contacts and compresses the gasket as the lid is tightened, without the gasket rotating responsively with the lid. To further increase the integrity of the seal, the flange may include a vent for allowing gases between the gasket and the lid to escape during sterilization processes of the carrier.
Other aspects, features, and advantages of the present invention will become apparent to those skilled in the art from a consideration of the following detailed description taken in conjunction with the accompanying drawings which illustrate, by way of example, the principles of the present invention in the context of a carrier for heart valves, but which are equally relevant to other carriers in which items are stored or transported.
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Erickson Stephen M.
Nguyen Than
Numamoto Michael J.
Pathmanaban Leslie
Condino Debra D.
Cumberbatch Guy L.
Edwards Lifesciences Corporation
James John Christopher
Willse David H.
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