Method for increasing the leakage resistance in a closed, pressurized system comprising a septum-sealed container

Patent metadata

Field	Value
Publication number	US-9974710-B2
Application number	US-201615195031-A
Country	US
Kind code	B2
Filing date	Jun 28, 2016
Priority date	Jan 30, 2009
Publication date	May 22, 2018
Grant date	May 22, 2018

Abstract

The present invention relates to a method for increasing leakage resistance in a closed, pressurized system. The method involves providing a closed system including a container sealed with a septum having a top surface with an exposed section, which is maintained under a positive pressure of at least about 5 psig. A contact surface of a hard component is fixedly placed adjacent to or in contact with at least a portion of a border section or a central section of the exposed section of the septum, or both, to reduce the size of any bulge or deformation formed in the exposed section of the septum. The present invention also relates to a kit for increasing leakage resistance in a closed, pressurized system, which includes the hard component.

First claim

What is claimed is:

1. An apparatus for infusing a receptacle by increasing leakage resistance in a closed, pressurized system, comprising:
a closed system comprising a container sealed with a septum in contact with the container, the septum having a first surface with a first exposed section and a second surface with a second exposed section generally opposite the first exposed surface, wherein the second exposed section of the septum is exposed to an interior of the container, the system capable of being maintained under a positive pressure of at least about 34.5 kPa (5 psig), and
a contact surface of a hard component fixedly placed in contact with the first exposed section of the septum,
wherein the hard component has at least two passageways to accommodate at least two needles configured to flush and clear the septum sealed container,
wherein the hard component has a hardness greater than a hardness of the septum and a thickness sufficient to have substantially no deflection when pushed by the force of a bulge extending from the septum,
wherein the placement of the contact surface is configured to contact any outward bulge or deformation formed in the septum caused by positive pressure,
and wherein the contact surface is further capable of withstanding positive pressure to prevent leakage resistance from the closed system.

2. The apparatus according to claim 1 , wherein the positive pressure maintained in the closed system is in the range of from about 34.5 kPa (5 psig) to about 2,413 kPa (350 psig).

3. The apparatus according to claim 1 , further comprising a crimp seal sealing the container.

4. The apparatus according to claim 1 , wherein the container contains a particle containing an active drug ingredient, a radioactive ingredient, or mixture thereof.

5. The apparatus according to claim 1 , wherein the contact surface of the hard component is smaller than the area of the exposed section of the septum.

6. The apparatus according to claim 1 , wherein the hard component is thicker than the septum.

7. An apparatus consisting of:
a closed system comprising a container sealed with a septum in contact with the container, the septum having a first surface with a first exposed section and a second surface with a second exposed section generally opposite the first exposed surface, wherein the second exposed section of the septum is exposed to an interior of the container, the system capable of being maintained under a positive pressure of at least about 34.5 kPa (5 psig), and
a contact surface of a hard component fixedly placed in contact with the first exposed section of the septum,
wherein the hard component has at least two passageways to accommodate at least two needles configured to flush and clear the septum sealed container,
wherein the hard component has a hardness greater than a hardness of the septum and a thickness sufficient to have substantially no deflection when pushed by the force of a bulge extending from the septum,
wherein the placement of the contact surface is configured to contact any outward bulge or deformation formed in the septum caused by positive pressure,
and wherein the contact surface is further capable of withstanding positive pressure to prevent leakage resistance from the closed system.

8. The apparatus according to claim 7 , wherein the positive pressure maintained in the closed system is in the range of from about 34.5 kPa (5 psig) to about 2,413 kPa (350 psig).

9. The apparatus according to claim 7 , further comprising a crimp seal sealing the container.

10. The apparatus according to claim 7 , wherein the container contains a particle containing an active drug ingredient, a radioactive ingredient, or mixture thereof.

11. The apparatus according to claim 7 , wherein the contact surface of the hard component is smaller than the area of the exposed section of the septum.

12. The apparatus according to claim 7 , wherein the hard component is thicker than the septum.

13. The apparatus according to claim 1 , further comprising a catheter connected to one of the at least two needles and wherein the catheter is configured to flush or clear contents of the septum sealed container via the catheter.

14. The apparatus according to claim 7 , further comprising a catheter connected to one of the at least two needles and wherein the catheter is configured to flush or clear contents of the septum sealed container via the catheter.

Assignees

• Biocompatibles Uk Ltd

Inventors

• Simpson Thomas J
• Duncan Graham
• Scott Donald

Classifications

• A61J1/1406 Primary

  Septums, pierceable membranes · CPC title

• A61J1/2089 Primary

  Containers or vials which are to be joined to each other in order to mix their contents (combinations of vial and syringe for mixing their contents A61J1/2096) · CPC title

• B65D90/54

  Gates or closures · CPC title

• A61J1/14

  Details; Accessories therefor (A61J7/00 takes precedence; openers B65D, B67B7/00) · CPC title

• A61J1/05 Primary

  for collecting, storing or administering blood, plasma or medical fluids {(multiple bags systems for separating or storing blood components A61M1/0209); Infusion or perfusion containers} · CPC title