Dual sterilization containment vessel

• US 9,707,077 B2
• Filed: 09/11/2014
• Issued: 07/18/2017
• Est. Priority Date: 11/15/2011
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Conroy, Michael J., Chang, Robert T., McCollum, Brian K.
• Primary Examiner(s): Stashick, Anthony
• Assistant Examiner(s): Van Buskirk, James M
• Application Number:
  US14/483,598
• Publication Number:
  US 20150005873A1
• Time in Patent Office: 1,041 Days
• Field of Search: 206464, 623 217, 623 211- 212, 623 111, 623 126, 623 236, 606108
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61L 2/0029 Radiation
• CPC Class Codes: A61L 2/0088 Liquid substances
• CPC Class Codes: A61L 2/26 Accessories or devices or components used for biocidal treatment
• CPC Class Codes: A61L 2202/21 Pharmaceuticals, e.g. medicaments, artificial body parts
• CPC Class Codes: A61M 2039/1033 Swivel nut connectors, e.g. threaded connectors, bayonet-connectors
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 39/10 Tube connectors; Tube couplings A61M39/02 takes precedence; connecting needles to syringes or hubs A61M5/34; connecting catheter tubes to hubs A61M25/0014
• CPC Class Codes: A61M 39/12 for joining a flexible tube to a rigid attachment

Abstract

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.

Claims

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.