TWO-PART PACKAGE FOR MEDICAL IMPLANT
The invention provides a two-part package and method of use for a pre-attached medical implant and delivery tool system. The package includes a wet compartment and a dry compartment and allows a pre-attached implant and delivery tool system to be at least partially stored immersed in a fluid in the wet compartment and at least partially stored in the dry compartment. In one embodiment the implant comprises a replacement heart valve, and the heart valve is stored inside the wet compartment while the heart valve delivery tool remains dry in the dry compartment.
1 . A medical implant and delivery tool package comprising:
a wet compartment containing a fluid;
a dry compartment; and
a delivery tool connected to a replacement heart valve implant while partially stored in the wet compartment;
wherein the delivery tool and wet compartment are stored in the dry compartment.
2 . The medical implant and delivery tool package of claim 1 , wherein the delivery tool is partially stored in the dry compartment.
3 . The medical implant and delivery tool package of claim 1 , wherein the wet compartment is partially contained within a wet container.
4 . The medical implant and delivery tool package of claim 1 , wherein the wet compartment contains at least two flushing parts.
5 . The medical implant and delivery tool package of claim 1 , wherein an interface is located between the wet compartment and the dry compartment to allow the replacement heart valve to be connected to the delivery tool.
6 . The medical implant and delivery tool package of claim 5 , wherein the interface includes a seal assembly comprised of elastomer diaphragm and plastic support spring.
7 . The medical implant and delivery tool package of claim 6 , wherein an additional seal is created by inflatably expanding and collapsing multi lumens of the replacement heart valve implant against a ring of the outer periphery of the delivery tool.
8 . The medical implant and delivery tool package of claim 1 , wherein the wet container incorporates folded wings on the device packaging.
9 . The medical implant and delivery took package of claim 1 , wherein the wet container comprises an upper housing, lower housing, upper gasket, lower gasket to create a seal between the wet compartment and the dry compartment.
10 . An apparatus for delivering a medical implant and delivery tool package in a dual compartment comprising:
a wet compartment;
a dry compartment; and
a delivery tool connected to the medical implant partially stored in the dry compartment;
wherein the delivery tool is delivered in a dry state and fluid is added to the wet compartment once delivered.
11 . The apparatus of claim 10 wherein, the medical implant is a replacement heart valve.
12 . A method of delivering a medical implant system comprising:
delivering a wet compartment in a dry state;
placing a delivery tool connected to a medical implant into a dry compartment;
placing the wet compartment and delivery tool within a dry compartment; and
filling the water compartment with fluid once the packet has been delivered.
13 . The method of delivering a medical implant system of claim 12 , wherein the medical device is delivered within the wet compartment in an expanded configuration.
14 . The method of delivering a medical implant system of claim 12 , wherein the fluid within the wet compartment is sterilized along with the delivery tool.
15 . The method of delivering a medical implant system of claim 12 , wherein a seal ring is compressed when a seal cap is screwed onto the wet container.
16 . The method of delivering a medical implant system of claim 15 , wherein a seal cap arm pushes an elastomer compression fitting against a V-rib or the wet container.
17 . The method of delivering a medical implant system of claim 12 , wherein the delivery tool includes a driven compression component and an elastomer compressible component.
18 . The method of delivering a medical implant system of claim 17 , wherein the compression component is in a conical shape.
19 . The method of delivering a medical implant system of claim 12 , wherein a balloon is inflated within a catheter and lumen during delivery.
20 . The method of delivering a medical implant system of claim 12 , wherein the medical implant is a replacement heart valve.