IP Library › Granted Patent US 11,850,320
Granted Patent B2
US 11,850,320 · App. 16/717,735 · Granted Dec 26, 2023

Liquid-chemical sterilization system with biological indicator

Inventors: Yan Fang (Irvine, CA); Prabhakaran Jayabalan (Lake Forest, CA); Benjamin M. Fryer (Lake Forest, CA)
A61L2/18A61L2/186A61L2/28C12M1/34C12M23/12C12M23/34C12M23/38C12M23/40C12M23/48C12M37/06C12Q1/22A61L2202/24
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Quick Facts
Patent No.
US 11,850,320
App. No.
16/717,735
Granted
Dec 26, 2023
Kind
B2
Abstract

A sterilization system includes a vial, a carrier of microorganisms disposed in the vial, and a fluid management system having an output connectable to the vial for delivering a liquid chemical sterilant and a neutralizer thereto. Additionally, a growth medium may be delivered to the vial such that the vial and growth medium may assessed for a change to a visual characteristic indicative of sterilization inefficacy.

Claims (42)

1. A sterilization system, comprising:

a vial;

a carrier disposed in the vial, the carrier being impregnated with a source of microorganisms including spores;

a fluid management system having an output connectable to the vial for delivering liquids thereto, the fluid management system comprising:

a valve;

a first tube;

a source of a liquid-chemical sterilant;

a source of a neutralizer, the source of the neutralizer connected to the output via the valve and the first tube; and

a source of a growth medium, wherein the valve is configured to either allow a flow between a second tube of the fluid management system and the vial or allow a flow between a third tube of the fluid management system and the source of the neutralizer; and

a fixture, the fixture comprising:

a first segment including a needle connected to the output;

a second segment including a cavity containing the vial;

a hinge connecting the first segment to the second segment, said hinge configured such that a rotation of the first segment about the hinge causes the needle to penetrate the vial.

2. The sterilization system of claim 1 , further comprising a medical device having a lumen connected between the needle and the output.

3. The sterilization system of claim 2 , wherein the medical device comprises an endoscope.

4. The sterilization system of claim 1 , further comprising a second cavity containing a second vial containing a growth medium.

5. The sterilization system of claim 1 , wherein the fixture further comprises a heating element disposed adjacent to the cavity.

6. The sterilization system of claim 1 , wherein the liquid-chemical sterilant comprises peracetic acid.

7. The sterilization system of claim 6 , wherein the growth medium comprises α-MUG.

8. The sterilization system of claim 7 , wherein the spores comprise Geobacillus stearothermophilus spores.

9. The sterilization system of claim 1 , wherein the vial includes a cover.

10. A sterilization system, comprising:

a first vial;

a carrier disposed in the first vial, the carrier being impregnated with a source of microorganisms including spores;

a fluid management system having an output connectable to the first vial for delivering liquids thereto, the fluid management system comprising:

a valve;

a tube;

a source of a liquid-chemical sterilant; and

a source of a neutralizer, the source of the neutralizer connected to the output via the valve and the tube; and

a fixture, the fixture comprising:

a first segment including a needle connected to the output;

a second segment including a first cavity containing the first vial, and a second cavity containing a second vial containing a growth medium; and

a hinge connecting the first segment to the second segment, said hinge configured such that a rotation of the first segment about the hinge causes the needle to penetrate the first vial.

11. The sterilization system of claim 10 , further comprising a medical device having a lumen connected between the needle and the output.

12. The sterilization system of claim 11 , wherein the medical device comprises an endoscope.

13. The sterilization system of claim 10 , wherein the fluid management system further comprises a source of a growth medium.

14. The sterilization system of claim 13 , wherein the fixture further comprises a heating element disposed adjacent to the first cavity.

15. The sterilization system of claim 13 , wherein the liquid-chemical sterilant comprises peracetic acid.

16. The sterilization system of claim 15 , wherein the growth medium comprises α-MUG.

17. The sterilization system of claim 16 , wherein the spores comprise Geobacillus stearothermophilus spores.

18. The sterilization system of claim 10 , wherein the first vial includes a cover.

19. The sterilization system of claim 10 , wherein the second vial includes a cover.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 5, 2020
From: FANG, YAN; JAYABALAN, PRABHAKARAN; FRYER, BENJAMIN M.
To: ASP GLOBAL MANUFACTURING GMBH
Reel/Frame 054291/0978 →
Continuity (3)
Provisional Application 62782949 · Dec 20, 2018
Provisional Application 62782931 · Dec 20, 2018
Related Publication 20200199516A1 · Jun 25, 2020