Medical liquid container with a toggle film leak tester and method of leak testing with same
AssigneeAmerican Hospital Supply Corporation
InventorCharles J. McPhee
Life of this patent
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Abstract
A parenteral liquid bottle with a sealed leak testing chamber in its closure. This leak testing chamber has an opening sealed off by a protective thermoplastic-metal film with a permanently stretched section extending across the opening. This permanently stretched section of the film maintains either a "concave" or a "convex" shape without a pressure differential across the film. A vacuum source temporarily applied to an external surface of the film causes the film to "toggle" from its concave to its convex position indicating the chamber is properly sealed. Failure to so toggle indicates a leak in the chamber.
Claims13
A medical liquid container with a puncturable tubular connector for joining the container to a fluid transferring device, wherein the improvement comprises:
- a combined connector and toggle leak tester that includes an upstanding thermoplastic tube with a passage and an outer end surface;
- a first thermoplastic barrier integrally formed with the tube and sealing off the tube's passage at a location spaced inwardly from the tube's outer end surface;
- a flexible film bonded at a manually peelable joint to the tube's outer end surface and forming a second barrier, said film being in a deformed state with one convex surface and one concave surface for toggling when a pressure differential is applied across the film, whereby the film can function as a leak tester and also be isolated from contact with the container's contents.
In a thermoplastic medical liquid container having a tubular neck, the improvement of:
- a closure hermetically sealed across the container neck and having a rigid upstanding thermoplastic outlet tube with a dispensing passage therethrough;
- said outlet tube being sealed off by a first puncturable thermoplastic diaphragm integrally formed with the outlet tube;
- a rigid upstanding thermoplastic inlet tube connected to the closure and having an inlet passage therethrough;
- a puncturable resealable rubber diaphragm within the inlet tube and sealing off its passage;
- said outlet tube and inlet tube having outer ends terminating in a common plane;
- a three-layer thermoplastic-metal-thermoplastic laminate sandwich forming a film with inner and outer surfaces and one of the thermoplastic layers is hermetically sealed at a manually peelable joint to the outer ends of the thermoplastic outlet and inlet tubes;
- said deformable film having a visible concavoconvex deformation across the passage of each tube, said deformed film having a diameter to thickness ratio at each tube passage of from 35 to 250 and is capable of maintaining a visible concave or a convex configuration with equal pressure on inner and outer surfaces of the film, said film toggling from a concave configuration to a convex configuration when a temporary vacuum is appled to its outer surface;
- and a removable outer cap fitting over and enclosing the film and tube structure.
Dependencies are inferred from the claim text.