IP Library › Granted Patent US 11,400,175
Granted Patent B2
US 11,400,175 · App. 16/792,475 · Granted Aug 2, 2022

Apparatus and method to measure concentration of disinfectant in medical device reprocessing system

Inventors: Yan Fang (Irvine, CA); Nick N. Nguyen (Silverado, CA); Kaitao Lu (Irvine, CA)
Assignee: ASP Global Manufacturing GmbH
A61L2/18A61B1/00057A61B1/123A61B1/125A61B90/70A61L2/24G01N21/80G01N31/22A61B2090/701A61L2202/11A61L2202/14A61L2202/15A61L2202/17A61L2202/24
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Quick Facts
Patent No.
US 11,400,175
App. No.
16/792,475
Granted
Aug 2, 2022
Kind
B2
Abstract

A medical instrument processor includes an enclosure, a liquid distribution system, and a disinfectant concentration measuring subsystem. The enclosure is configured to hold a medical instrument. The liquid distribution system is configured to deliver a disinfection solution to a medical instrument within the enclosure. The liquid distribution system has a liquid outlet. The disinfectant concentration measuring subsystem includes a first mixing chamber in fluid communication with the liquid outlet, a pump that is configured to simultaneously pump the disinfection solution and the reagent solution into the first mixing chamber, and a concentration analysis assembly that is operable to determine a concentration of disinfectant in a sample solution that is output from the first mixing chamber. The reservoir is in fluid communication with the first mixing chamber.

Claims (55)

1. A method for measuring a concentration of a disinfectant in a disinfection solution of a medical instrument processor, the method comprising:

(a) directing a flow of the disinfection solution into a first mixing chamber;

(b) directing a flow of a reagent solution into the first mixing chamber;

(c) mixing the disinfection solution and the reagent solution in the first mixing chamber to create a sample solution;

(d) directing the sample solution into a sample chamber comprising clear sides;

(e) passing light having a known first intensity and wavelength through the clear sides of the sample chamber and the sample solution in the sample chamber;

(f) measuring a second intensity of the light transmitted through the sample chamber and the sample solution in the sample chamber;

(g) determining a reaction product concentration in the sample solution based upon a difference between the known first intensity and the second intensity of the light; and

(h) determining the disinfectant concentration in the disinfection solution based upon the reaction product concentration;

wherein the reaction product is sodium hydroxide.

2. The method of claim 1 , wherein the disinfectant comprises ortho-phthalaldehyde.

3. The method of claim 1 , wherein the disinfection solution and the reagent solution are mixed in a volume to volume ratio of about 1:1 to create the sample solution.

4. The method of claim 1 , further comprising issuing an alert signal when the disinfectant concentration in the disinfection solution is below a predetermined value.

5. The method of claim 1 , further comprising:

(a) determining that the disinfectant concentration in the disinfection solution is below a predetermined value; and

(b) outputting the disinfectant solution from the medical instrument processor.

6. The method of claim 1 , further comprising:

(a) determining that the disinfectant concentration in the disinfection solution is not below a predetermined value; and

(b) recirculating the disinfectant solution in the medical instrument processor.

7. The method of claim 1 , comprising simultaneously directing the flow of the disinfection solution and the reagent solution into the first mixing chamber.

8. The method of claim 1 , further comprising:

(a) directing the disinfection solution and the reagent solution into a second mixing chamber; and

(b) mixing the disinfection solution and the reagent solution in the second mixing chamber to generate the sample solution.

9. The method of claim 8 , comprising:

(a) mixing the disinfection solution and the reagent solution in the first mixing chamber using a static mixer; and

(b) mixing the disinfection solution and the reagent solution in the second mixing chamber using a static mixer to generate the sample solution.

10. The method of claim 1 , further comprising directing the sample solution into a de-gassing module, prior to directing the sample solution into the sample chamber.

11. The method of claim 1 , further comprising measuring the temperature of the sample solution as it passes from the first mixing chamber into the sample chamber.

12. The method of claim 11 , further comprising making temperature corrections when determining the disinfectant concentration in the disinfection solution based upon the reaction product concentration.

13. The method of claim 8 , further comprising directing the sample solution into a de-gassing module prior to directing the sample solution into the sample chamber.

14. The method of claim 8 , further comprising measuring the temperature of the sample solution as it passes from the second mixing chamber into the sample chamber.

15. The method of claim 14 , further comprising making temperature corrections when determining the disinfectant concentration in the disinfection solution based upon the reaction product concentration.

16. A method for measuring a concentration of a disinfectant in a disinfection solution of a medical instrument processor, the method comprising:

(a) mixing the disinfection solution and a reagent solution in one or more mixing chambers to generate a sample solution;

(b) directing the sample solution into a sample chamber;

(c) passing light having a first intensity and wavelength through the sample chamber and the sample solution in the sample chamber;

(d) measuring a second intensity of the light transmitted through the sample chamber and the sample solution in the sample chamber;

(e) calculating a concentration of sodium hydroxide in the sample solution based upon a difference between the first intensity of the light and the second intensity of the light; and

(f) determining the disinfectant concentration in the disinfection solution based upon the concentration of sodium hydroxide in the sample solution.

17. The method of claim 16 , further comprising:

(a) determining that the disinfectant concentration in the disinfection solution is below a predetermined value; and

(b) outputting the disinfectant solution from the medical instrument processor.

18. The method of claim 16 , further comprising:

(a) determining that the disinfectant concentration in the disinfection solution is not below a predetermined value; and

(b) recirculating the disinfectant solution in the medical instrument processor.

19. A method for determining a concentration of ortho-phthalaldehyde in a disinfection solution of a medical instrument processor, the method comprising:

(a) mixing the disinfection solution and a reagent solution in one or more mixing chambers to generate a sample solution;

(b) directing the sample solution into a sample chamber;

(c) passing light having a first intensity of from about 70 millicandela to about 120 millicandela and a wavelength of from about 500 nanometers to about 600 nanometers through the sample chamber and the sample solution in the sample chamber;

(d) measuring a second intensity of the light transmitted through the sample chamber and the sample solution in the sample chamber;

(e) calculating a concentration of sodium hydroxide in the sample solution based upon a difference between the first intensity of the light and the second intensity of the light; and

(f) determining the concentration of ortho-phthalaldehyde in the disinfection solution based upon the calculated concentration of sodium hydroxide.

20. The method of claim 19 , further comprising either:

(a) determining that the disinfectant concentration in the disinfection solution is below a predetermined value and outputting the disinfectant solution from the medical instrument processor; or

(b) determining that the disinfectant concentration in the disinfection solution is not below a predetermined value and recirculating the disinfectant solution in the medical instrument processor.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 2, 2020
From: FANG, YAN; NGUYEN, NICK N.; LU, KAITAO
To: ETHICON, INC.
Reel/Frame 051974/0659 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 2, 2020
From: ETHICON, INC.
To: ASP GLOBAL MANUFACTURING GMBH
Reel/Frame 052060/0215 →
Continuity (2)
Division 15157952 · May 18, 2016
Related Publication 20200179545A1 · Jun 11, 2020