IP Library › Granted Patent US 12,551,590
Granted Patent B2
US 12,551,590 · App. 17/852,898 · Granted Feb 17, 2026

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 12,551,590
App. No.
17/852,898
Granted
Feb 17, 2026
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 (80)

1 . A reagent solution, comprising:

(a) sodium sulfite;

(b) phenolphthalein, configured to act as a pH indicator;

(c) 37% hydrochloric acid;

(d) isopropanol; and

(e) water;

wherein the reagent solution is configured for use measuring ortho-phthalaldehyde concentration in a liquid sample, and is further configured to react with excess sodium sulfite to quantitatively generate hydroxide, which is neutralized by a controlled amount of acid.

2 . The reagent solution of claim 1 , comprising about 3% of the sodium sulfite.

3 . The reagent solution of claim 1 , comprising about 0.004% of the phenolphthalein.

4 . The reagent solution of claim 1 , comprising about 0.175% of the 37% hydrochloric acid.

5 . The reagent solution of claim 1 , comprising about 15.7% of the isopropanol.

6 . The reagent solution of claim 1 , comprising about 81.1% of the water.

7 . A ready-to-use reagent solution, comprising a mixed reagent solution of claim 1 , wherein the ready-to-use reagent solution comprises by weight percentage of the ready-to-use solution:

(a) from about 1% to about 4.8% of the sodium sulfite;

(b) from about 0.1% to about 0.3% of sodium bisulfite;

(c) from about 0.06% to about 0.12% of sodium chloride;

(d) from about 0.002% to about 0.008% of the phenolphthalein;

(e) from about 10% to about 20% of the isopropanol; and

(f) the balance of the water;

wherein the ready-to-use solution is formulated to react with ortho-phthalaldehyde that is present in the liquid sample to quantitatively generate hydroxide in the liquid sample.

8 . The ready-to-use reagent solution of claim 7 , comprising:

(a) about 2.78% of the sodium sulfite;

(b) about 0.185% of the sodium bisulfite;

(c) about 0.104% of the sodium chloride;

(d) about 0.004% of the phenolphthalein;

(e) about 15.7% of the isopropanol; and

(f) about 81.2% of the water.

9 . A reagent solution comprising raw materials, wherein the raw materials comprise:

(a) a sulfite selected from the group consisting of sodium sulfite, sodium bisulfite and combinations thereof;

(b) a pH indicator/absorbance species selected from the group consisting of phenolphthalein, 0-cresol phthalein, p-naphtholbenzene, and ethyl-bis(2,4-dimethylphenyl)acetate;

(c) an acid selected from the group consisting of hydrochloric acid, sulfuric acid, nitric acid, phosphoric acid, organic carboxylic acids and combinations thereof;

(d) isopropanol as a solvent; and

(e) water;

wherein the reagent solution is configured to be mixed to form a ready-to-use solution that is configured to react with ortho-phthalaldehyde concentration in a liquid sample, and is further configured to react with excess sodium sulfite to quantitatively generate hydroxide, which is neutralized by a controlled amount of acid.

10 . The reagent solution of claim 9 , wherein the sulfite is sodium sulfite.

11 . The reagent solution of claim 10 , wherein the sodium sulfite is present at from about 1% to about 5% by weight percentage of the reagent solution.

12 . The reagent solution of claim 9 , wherein the pH indicator/absorbance species is phenolphthalein.

13 . The reagent solution of claim 12 , wherein the phenolphthalein is present at from about 0.002% to about 0.008% by weight percentage of the reagent solution.

14 . The reagent solution of claim 9 , wherein the acid is 37% hydrochloric acid.

15 . The reagent solution of claim 9 , wherein the isopropanol is present at from about 10% to about 20% by weight percentage of the reagent solution.

16 . The reagent solution of claim 9 , comprising by weight percentage of the total weight of the reagent solution:

(a) from about 1% to about 5% of the sodium sulfite;

(b) from about 0.002% to about 0.008% of the phenolphthalein;

(c) from about 0.1% to about 0.2% of the 37% of hydrochloric acid;

(d) from about 10% to about 20% of the isopropanol; and

(e) the balance of the water.

17 . A ready-to-use reagent solution, comprising a mixed reagent solution of claim 9 , wherein the ready-to-use reagent solution comprises:

(a) from about 1% to about 4.8% of the sodium sulfite;

(b) from about 0.1% to about 0.3% of the sodium bisulfite;

(c) from about 0.06% to about 0.12% of the sodium chloride;

(d) from about 0.002% to about 0.008% of the phenolphthalein;

(e) from about 10% to about 20% of the isopropanol; and

(f) a balance of the water;

wherein the ready-to-use solution is formulated to react with ortho-phthalaldehyde that is present in the liquid sample to quantitatively generate hydroxide in the liquid sample.

18 . A reagent solution, consisting of:

(a) a sulfite selected from the group consisting of sodium sulfite, sodium bisulfite and combinations thereof;

(b) a pH indicator/absorbance species selected from the group consisting of phenolphthalein, O-cresolphthalein, p-naphtholbenzene, and ethyl-bis(2,4-dimethylphenyl)acetate;

(c) an acid selected from the group consisting of hydrochloric acid, sulfuric acid, nitric acid, phosphoric acid, organic carboxylic acids and combinations thereof;

(d) isopropanol as a solvent; and

(e) water;

wherein the reagent solution is configured to be mixed to form a ready-to-use solution configured to react with ortho-phthalaldehyde concentration in a liquid sample, and is further configured to react with excess sodium sulfite to quantitatively generate hydroxide, which is neutralized by a controlled amount of acid.

19 . The reagent solution of claim 18 , wherein:

(a) the sulfite is the sodium sulfite and is present at from about 1% to about 5% by total weight percentage of the reagent solution;

(b) the pH indicator/absorbance species is the phenolphthalein and is present at from about 0.002% to about 0.008% by total weight percentage of the reagent solution;

(c) the acid is the 37% hydrochloric acid and is present at from about 0.1% to about 0.2% of by total weight percentage of the reagent solution; and

(d) the isopropanol is present at from about 10% to about 20% by total weight percentage of the reagent solution.

20 . A ready-to-use reagent solution, consisting of a mixed reagent solution of claim 18 , wherein the ready-to-use reagent solution consists of:

(a) from about 1% to about 4.8% of the sodium sulfite;

(b) from about 0.1% to about 0.3% of the sodium bisulfite;

(c) from about 0.06% to about 0.12% of the sodium chloride;

(d) from about 0.002% to about 0.008% of the phenolphthalein;

(e) from about 10% to about 20% of the isopropanol; and

(f) a balance of the water;

wherein the ready-to-use solution is formulated to react with ortho-phthalaldehyde that is present in the liquid sample to quantitatively generate hydroxide in the liquid sample.

21 . The reagent solution of claim 1 , comprising by weight percentage of the total weight of the reagent solution:

(a) from about 1% to about 5% of the sodium sulfite;

(b) from about 0.002% to about 0.008% of the phenolphthalein;

(c) from about 0.1% to about 0.2% of the 37% hydrochloric acid;

(d) from about 10% to about 20% of the isopropanol; and

(e) a balance of water.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 24, 2025
From: FANG, YAN; NGUYEN, NICK N.; LU, KAITAO
To: ETHICON, INC.
Reel/Frame 070601/0090 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 24, 2025
From: ETHICON, INC.
To: ASP GLOBAL MANUFACTURING GMBH
Reel/Frame 070609/0648 →
Continuity (3)
Division 16792475 · Feb 17, 2020
Division 15157952 · May 18, 2016
Related Publication 20220401603A1 · Dec 22, 2022
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