Dual sterilization containment vessel
The disclosure pertains to a vessel for holding replacement heart valves and associated positioning and installation apparatus which is configured and adapted to contain a biocidal sterilization fluid during and following exposure of a delivery system for the replacement heart valve to sterilization by ionizing radiation and methods of use therefor. The vessel includes a shield which limits exposure of biologically derived material therein to radiation. The vessel also provides a storage and shipping container for the replacement heart valve in which the biologically derived material is maintained in a sterile fluid environment.
1. A dual sterilization containment vessel for biologically derived medical components, comprising:
a hollow element having a wall, a proximal end, a distal end, and a lumen therebetween, said lumen configured and adapted to contain a biologically derived medical component and at least a portion of an apparatus configured and adapted to implant the biologically derived medical component in a living body;
a removable distal end cap disposed at the distal end;
a removable proximal end cap disposed at the proximal end; and
a radiopaque sleeve disposed about at least a portion of the lumen;
wherein the radiopaque sleeve is removable.
2. The dual sterilization containment vessel of claim 1 , further including a secondary proximal end cap removably coupled to the proximal end cap, the secondary proximal end cap being adapted to reversibly seal the proximal end cap to a delivery catheter passing therethrough.
3. The dual sterilization containment vessel of claim 2 , wherein the combination of the hollow element, the distal end cap, the proximal end cap, the secondary proximal end cap, and the delivery catheter form a fluid tight system providing a continuous fluid connection between the interior of the hollow element and the lumen of the delivery catheter.
4. The dual sterilization containment vessel of claim 1 , wherein the radiopaque sleeve is disposed about the hollow element.
5. The dual sterilization containment vessel of claim 1 , wherein the distal end cap is threadably connected to the hollow element.
6. The dual sterilization containment vessel of claim 1 , wherein the proximal end cap is threadably connected to the hollow element.
7. The dual sterilization containment vessel of claim 1 , wherein at least a portion of an interior of at least one of the hollow element, the distal cap, and the proximal cap includes a polished surface in fluid communication with the lumen of the hollow element.
8. The dual sterilization containment vessel of claim 1 , wherein the radiopaque sleeve is secured to the hollow element by a set screw.
9. The dual sterilization containment vessel of claim 1 , wherein the radiopaque sleeve is secured to the hollow element by a clamping element.
10. The dual sterilization containment vessel of claim 9 , wherein the radiopaque sleeve is formed from several pieces.
11. The dual sterilization containment vessel of claim 1 , wherein a biologically derived medical component contained within the lumen receives no more than 4 gray of ionizing radiation when the dual sterilization containment vessel receives between 30 gray and 50 gray of ionizing radiation.
12. A dual sterilization containment vessel for biologically derived medical components, comprising:
a hollow element having a wall, a proximal end, a distal end, and a lumen therebetween, said lumen configured and adapted to contain a biologically derived medical component and at least a portion of an apparatus configured and adapted to implant the biologically derived medical component in a living body;
a removable distal end cap disposed at the distal end;
a removable proximal end cap disposed at the proximal end; and
a radiopaque sleeve disposed about at least a portion of the lumen;
wherein the hollow element comprises two or more segments sealingly joined together.
13. The dual sterilization containment vessel of claim 12 , wherein the hollow element comprises two half-cylindrical walls joined along a longitudinal seam.
14. The dual sterilization containment vessel of claim 13 , wherein the two half-cylindrical walls are disposed in an abutting relationship.
15. A dual sterilization containment vessel for biologically derived medical components, comprising:
a hollow element having a wall, a proximal end, a distal end, and a lumen therebetween, said lumen configured and adapted to contain a biologically derived medical component and at least a portion of an apparatus configured and adapted to implant the biologically derived medical component in a living body;
a removable distal end cap disposed at the distal end;
a removable proximal end cap disposed at the proximal end; and
a radiopaque sleeve disposed about at least a portion of the lumen;
wherein at least a portion of at least one of the hollow element, the distal cap, and the proximal cap includes a region transparent to visible light.