Clinical examination apparatus and method

• US 9,528,937 B2
• Filed: 03/29/2007
• Issued: 12/27/2016
• Est. Priority Date: 03/30/2006
• Status: Active Grant

• Current Assignee: Sysmex Corporation
• Original Assignee: Sysmex Corporation
• Inventors: Tanaka, Yousuke, Naito, Takamichi, Mizumoto, Toru
• Primary Examiner(s): Skibinsky, Anna
• Application Number:
  US11/729,661
• Publication Number:
  US 20070233518A1
• Time in Patent Office: 3,561 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: G01N 21/64 Fluorescence; Phosphorescence
• CPC Class Codes: G01N 35/00594 Quality control, including calibration or testing of components of the analyser
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 40/63 for local operation

Abstract

A clinical examination apparatus is equipped with a measurement unit which measures a patient'"'"'s clinical specimen, an output unit which outputs the measurement result by this measurement unit and a storage unit which stores determination criteria of the measurement result by the measurement unit according to a medical organization. Moreover, the clinical examination apparatus determines whether or not the measurement result corresponds to a predetermined state based on the measurement result by the measurement unit and the determination criteria stored in the storage unit, for each medical organization, and upon determination that the measurement result corresponds to a predetermined state, allows the output unit to output information indicating the predetermined state.

Claims

1. A urine specimen measuring apparatus located in a medical facility, the apparatus comprising:

a suction pipe having a tip end configured to insert into a test tube containing a urine specimen obtained from a patient, wherein the suction pipe inserted into the test tube is controlled to repeatedly suction and discharge the urine specimen, thereby stirring the urine specimen in the test tube, the suction pipe is further controlled to aspirate an initial portion of the stirred urine specimen and to distribute the aspirated initial portion of the urine sample into a first aliquot and a second aliquot;

a first measurement sample preparation unit configured to contain a first measurement sample that includes a first dyeing reagent and the first aliquot and is used for counting erythrocytes;

a second measurement sample preparation unit configured to contain a second measurement sample that includes a second dyeing reagent and the second aliquot and is used for counting bacteria;

an optical detecting unit comprising a sheath flow cell configured to form a first flow of the first measurement sample and a second flow of the second measurement sample, a semiconductor laser light source configured to irradiate the first and second flows, a scattered light detector configured to detect first scattered light information from particles in the first flow and to detect second scattered light information from particles in the second flow and a fluorescence detector configured to detect first fluorescence information from the particles in the first flow and to detect second fluorescence information from the particles in the second flow;

a memory configured to store a first re-examination determination condition including gender, age range and first determination criteria of the number of erythrocytes and the number of bacteria, and a second re-examination determination condition including gender, age range and second determination criteria of the number of erythrocytes and the number of bacteria;

a specimen information acquirer configured to acquire specimen information for the urine specimen;

a receiver configured to receive patient information indicating gender and age of a patient of the urine specimen and medical specialty information identifying the first and second branch of medical science;

a display; and

a computer configured to determine whether or not a first re-examination for a first branch of medical science is required for a urine specimen, and to determine whether or not a second re-examination for a second branch of medical science is required for the urine specimen by performing operations comprising;

acquiring the specimen information for the urine specimen,

receiving the patient information and the medical specialty information identifying at least one of the first and second branch of medical science on the basis of the specimen information,

preparing a measurement result including at least the number of the erythrocytes and the number of the bacteria from the detected first and second scattered light information by the scattered light detector and the detected first and second fluorescence information by the fluorescence detector;

responsive to receiving the medical specialty information of the first branch of medical science, determining whether or not the first re-examination is required by comparing the measurement result, the gender of the patient and the age of the patient to the first re-examination determination condition of the medical specialty information of the first branch of medical science;

displaying first re-examination information on the display, when the first re-examination is required, the first re-examination information indicating that the first re-examination is required;

responsive to receiving the medical specialty information of the second branch of medical science, determining whether or not the second re-examination is required by comparing the measurement result, the gender of the patient and the age of the patient to the second re-examination determination condition of the medical specialty information of the second branch of medical science; and

displaying second re-examination information on the display, when the second re-examination is required, the second re-examination information indicating that the second re-examination is required.

2. The urine specimen measuring apparatus according to claim 1, wherein the specimen information included a specimen number.

3. The urine specimen measuring apparatus according to claim 1,

wherein the memory stores a first abnormality determination condition determining whether or not the measurement result is in a first abnormal state and a second abnormality determination condition determining whether or not the measurement result is in a second abnormal state,

wherein the computer performs operations comprising:

determining whether or not the measurement result is in the first abnormal state by comparing the measurement result to the first abnormality determination condition when the acquired medical specialty information include the first branch of medical science, and displaying first abnormal information indicating that the measurement result is in the first abnormal state on the display, when the measurement result is in the first abnormal state,

wherein the computer performs operations comprising;

determining whether or not the measurement result is in the second abnormal state by comparing the measurement result to the second abnormality determination condition when the acquired medical specialty information include the second branch of medical science, and

displaying second abnormal information indicating that the measurement result is in the second abnormal state on the display unit, when the measurement result is in the second abnormal state.

4. The urine specimen measuring apparatus according to claim 1, wherein the computer performs operations further comprising:

receiving an input of medical specialty information and re-examination determination condition, the medical specialty information specifying a medical organization; and

storing the input re-examination determination condition in the memory in association with the medical specialty information.

5. The urine specimen measuring apparatus according to claim 4, wherein the computer performs operations further comprising displaying an input screen on the display for receiving the input of the medical specialty information and the re-examination determination condition.

6. The urine specimen measuring apparatus according to claim 4, wherein the computer performs operations further comprising:

receiving an input of a name of the re-examination determination condition, and

storing the inputted name in the storage unit in association with the re-examination determination condition.

7. A urine specimen measuring apparatus located in a medical facility, the apparatus comprising:

a suction pipe having a tip end configured to insert into a test tube containing a urine specimen obtained from a patient, wherein the suction pipe inserted into the test tube is controlled to repeatedly suction and discharge the urine specimen, thereby stirring the urine specimen in the test tube, the suction pipe is further controlled to aspirate an initial portion of the stirred urine specimen and to distribute the aspirated initial portion of the urine sample into a first aliquot and a second aliquot;

a first measurement sample preparation unit that contains a first measurement sample that includes a first dyeing reagent and the first aliquot and is used for counting erythrocytes;

a second measurement sample preparation unit configured to contain a second measurement sample that includes a second dyeing reagent and the second aliquot and is used for counting bacteria;

an optical detecting unit comprising a sheath flow cell configured to form a first flow of the first measurement sample and a second flow of the second measurement sample, a semiconductor laser light source configured to irradiate the first and second flows, a scattered light detector configured to detect first scattered light information from particles in the first flow and to detect second scattered light information from particles in the second flow and a fluorescence detector configured to detect first fluorescence information from the particles in the first flow and to detect second fluorescence information from the particles in the second flow;

a display;

a memory that stores a plurality of urine re-examination determination conditions, wherein each of the re-examination determination conditions is applied by each branch of medical science of the medical facility, includes gender, age range and determination criteria of the number of erythrocytes and the number of bacteria, and determines whether or not a re-examination of a urine specimen for each of the branches of medical science is required;

a receiver for receiving patient information including gender and age of a patient of the urine specimen and medical specialty information identifying at least one of the branches of medical science;

a computer configured to perform operations comprising;

receiving the patient information and the medical specialty information identifying at least one of the branches of medical science on the basis of the urine specimen obtained from the patient,

preparing a measurement result including at least the number of the erythrocytes and the number of the bacteria from the detected first and second scattered light information and the detected first and second fluorescence information from the first and second measurement samples;

determining whether or not the re-examination is required by comparing the measurement result, the gender of the patient and the age of the patient to the re-examination determination condition applied by the at least one branch of medical science; and

displaying re-examination information indicating that the re-examination is required when it is determined that the re-examination is required.

8. The urine specimen measuring apparatus according to claim 7, wherein the receiver comprises an input device that receives medical specialty information and the re-examination determination condition;

and

the computer stores the inputted re-examination determination condition in the memory in association with the medical specialty information.

9. The urine specimen measuring apparatus according to claim 8, wherein the computer performs operations further comprising displaying an input screen that receives the input of the medical specialty information and the re-examination determination condition on the display.

10. The urine specimen measuring apparatus according to claim 8, wherein the receiver is configured for receiving an input of a name of the patient, and the computer stores the inputted name in the memory in association with the re-examination determination condition.

11. A urine examination method performed by a urine specimen measuring apparatus located in a medical facility, the method comprising:

stirring a urine specimen obtained from a patient in a test tube by repeating suction and discharge of the urine specimen by a suction pipe inserted into the test tube;

aspirating an initial portion of the stirred urine specimen by the suction pipe;

distributing the initial portion of the aspirated urine specimen into a first aliquot and a second aliquot;

preparing a first measurement sample for counting erythrocytes from a first dyeing reagent and the first aliquot;

preparing a second measurement sample for counting bacteria from a second dyeing reagent and the second aliquot;

subjecting the first measurement sample to an optical detection unit comprising a sheath flow cell, a semiconductor laser light source, a scattered light detector and a fluorescence detector and detecting first scattered light information from particles in the first measurement sample by the scattered light detector and first fluorescence information from particles in the first measurement sample by the fluorescence detector;

subjecting the second measurement sample to the optical detection unit and detecting second scattered light information from particles in the second measurement sample by the scattered light detector and second fluorescence information from particles in the second measurement sample by the fluorescence detector;

using a computer in electronic communication with the urine specimen measuring apparatus to carry out the following operations;

receiving patient information indicating gender and age of a patient of the urine specimen and medical specialty information identifying at least one of a plurality of branches of medical science;

preparing a measurement result including at least the number of the erythrocytes and the number of the bacteria from the detected first and second scattered light information and the detected first and second fluorescence information;

receiving a urine re-examination determination condition including gender, age range and determination criteria of the number of erythrocytes and the number of bacteria, and applied by the at least one branch of medical science for a urine specimen from a memory that stores a plurality of re-examination determination conditions applied by each branch of medical science of the medical facility to evaluate measurement results;

determining whether or not the re-examination is required by comparing the measurement result, the gender of the patient and the age of the patient with the received re-examination determination condition applied by the at least one branch of medical science; and

displaying re-examination information indicating that the re-examination is required on a display, when it is determined that the re-examination is required.

12. The urine examination method according to claim 11,

wherein the memory stores a plurality of abnormality determination conditions, each of the abnormality determination conditions determining whether or not the measurement result is in an abnormal state,

wherein comparing the measurement result with the re-examination determination condition further comprises comparing the measurement result with the abnormality determination condition, the step of determining whether or not the re-examination is required further comprises determining whether or not the measurement result is in the abnormal state from the comparing result of the measurement result and the abnormality determination condition, and displaying information further comprises displaying the abnormal information on the display.

13. The urine examination method according to claim 11, further comprising:

receiving an input of medical specialty information and re-examination determination condition, the medical specialty information identifying a branch of medical science and the re-examination determination condition assigned by the medical specialty; and

storing the input re-examination determination condition in the memory in association with the medical specialty information.