Blood collection aid and blood collection device and method for reducing blood culture contamination rate

Abstract

The application relates to the technical field of blood culture, in particular to a blood sampling auxiliary device, a blood sampling device and a method for reducing blood culture contamination rate. The blood sampling auxiliary device comprises a pipe body 1, a first interface 2 and a second interface 3; the pipe body 1 is provided with an isolation cavity 4. The blood sampling auxiliary device and the blood sampling device can isolate the blood before venous blood sampling, so that trace skin colonization bacteria are isolated in the cavity, and thus the blood culture contamination rate can be reduced.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of blood culture, in particular to a blood collection auxiliary device, a blood collection device and a method for reducing blood culture contamination rate. BACKGROUND

[0002] In hospital clinics and medical research experiments, automated blood culture is a microbiological examination method for detecting the presence of bacteria in blood samples, which plays a very important role in quickly detecting whether bacteria grow in the blood of patients with sepsis and bacteremia, and thus determining the diagnosis. Therefore, blood culture is one of the most important and most common bacterial examination projects. At present, the instruments and supporting blood culture bottles for blood culture in clinics mainly rely on imports, such as Bactct 9000 series of BD Company of the United States and Bact / Alert 3D of France Merieux. They usually use a silicon rubber sensor coated on the bottom of the culture bottle to observe the change in the amount of CO2 produced by bacteria during growth according to the fluorescence or color sensing method of the bottom sensor to determine whether bacteria grow, which has been recognized by the clinic.

[0003] Blood culture should be collected according to the standard procedure and strict aseptic operation. However, the skin of the patient has resident bacteria, which can cause contamination of the blood culture. That is, the bacteria growing in the blood culture are brought into the culture during sample collection or operation, rather than from the patient's blood.

[0004] At present, most blood cultures are obtained by venipuncture. In order to reduce the contamination of skin resident bacteria, the venipuncture site should be disinfected. In the past 50 years, many disinfection methods have been used in clinics, including external alcohol (70% isopropyl), iodine, povidone-iodine, iodine fluoride, chlorine dioxide and chlorhexidine gluconate. Many studies have compared these disinfectants, and the following conclusions are drawn: iodine, chlorine dioxide and chlorhexidine gluconate are better than povidone-iodine. Iodine and chlorhexidine gluconate are likely to have the same effect.

[0005] The main skin disinfection method currently used is a three-step disinfection method. ① 70% alcohol is used to wipe the venipuncture site. Wait for dry. ② 1%-2% iodine tincture for 30 seconds or 10% latent disinfection for 1.5-2 minutes. Wait for dry. ③ 70% alcohol to remove iodine. After skin disinfection, the number of resident bacteria is greatly reduced, but there may still be incomplete disinfection problems, which can cause trace resident bacteria to enter the culture bottle and cause contamination problems. Under the current detection technology, the acceptable range of contamination in the laboratory is ≤3%, but the positive rate of blood culture detection is only about 10%, which means that contamination has a great interference on the blood culture detection result.

[0006] The link that has greater influence on blood culture contamination rate is the collection process of blood culture sample. First, the disinfection technology has been practiced in many ways, and reliable control measures have been established. In addition, the intravenous puncture process, for intravenous puncture of blood culture, generally has two collection methods. One is to use a syringe to directly puncture and collect on the skin after disinfection, and then transfer to the culture bottle. The other is the current commercial blood culture bottle which is negative pressure inside, can directly use the intravenous butterfly blood collection needle to puncture and collect, so that the blood sample is directly cultured in the culture bottle. The two measures do not have isolation function for trace skin colonizing bacteria, causing blood culture contamination.

[0007] Therefore, the current blood culture collection method has the following shortcomings: high contamination rate, inaccurate blood culture detection results, high difficulty in excluding contamination, and waste of medical resources. SUMMARY

[0008] Therefore, the present application provides a blood collection aid and a blood collection device and a method for reducing blood culture contamination rate. The blood collection aid and the blood collection device can isolate the front segment of the blood before intravenous blood collection, so that the trace skin colonizing bacteria are isolated in the cavity, thereby reducing the blood culture contamination rate.

[0009] In order to achieve the above-mentioned application purposes, the present application provides the following technical solutions:

[0010] The present application provides a blood collection aid, comprising a tube body 1, a first interface 2, a second interface 3, and a isolation cavity 4.

[0011] The technical problem solved by the present application is to provide a blood culture sample collection method which can adapt to the mainstream culture bottles with vacuum negative pressure in the market. Due to blood flow, trace skin colonizing bacteria only exist in the front segment of blood collection, and transferring the front end blood helps to reduce contamination. Through this method, about 0.01-10mL of blood in the front segment of intravenous blood collection can be isolated in the isolation cavity, and at the same time, the trace skin colonizing bacteria are isolated in the cavity, so that they do not enter the culture bottle, reducing the blood culture contamination rate and improving the accuracy of blood culture detection.

[0012] Preferably, the capacity of the isolation cavity is 0.01-10mL.

[0013] Preferably, in a specific embodiment provided by the present application, the tube body 1 is sequentially provided with an isolation cavity 4, a first pipeline 5, a second pipeline 6 and a pushable piston 7.

[0014] The first pipeline 5 is in communication with the first interface 2 and the isolation cavity 4, respectively; the first interface 2 can be connected with a blood collection needle, so that the collected front segment blood is placed in the isolation cavity;

[0015] After the pushable piston 7 is pushed to move to the end of the isolation cavity 4, the second pipeline 6 is connected with the first interface 2 and the second interface 3 respectively, so that the collected blood in the rear section flows into the container connected with the second interface 3.

[0016] As a preferred, the isolation cavity is in a negative pressure state.

[0017] As a preferred, a support is arranged between the pushable piston 7 and the outer wall of the first pipeline 5.

[0018] As a preferred, a support is arranged between the inner walls of the first pipeline 5.

[0019] In another specific embodiment provided by the application, the pipe body 1 is a U-shaped pipe body, one end of the pipe body 1 is respectively provided with the first interface 2 and the second interface 3, and the other end is in a closed state.

[0020] In the application, the inside of the blood sampling auxiliary device is in a sterile state.

[0021] The above arrangement makes the isolation cavity isolate the blood in the front section without affecting the subsequent sample collection.

[0022] The application further provides a blood sampling device, which comprises the above blood sampling auxiliary device and a blood sampling needle.

[0023] As a preferred, the blood sampling needle is a butterfly-shaped blood sampling needle. The general butterfly-shaped blood sampling needle is used for skin puncture, so that the peripheral venous blood can be collected through the puncture point.

[0024] As a preferred, the blood sampling auxiliary device and the blood sampling needle are in an integrated structure or can be detachably connected.

[0025] As a preferred, the blood sampling device further comprises a culture bottle.

[0026] As a preferred, the blood sampling device further comprises a culture bottle puncture head, so that the culture bottle puncture hole is formed, and the collected blood sample enters the culture bottle through the hole.

[0027] The application further provides a method for reducing the blood culture pollution rate, which adopts the above blood sampling auxiliary device for auxiliary blood sampling, or adopts the above blood sampling device for blood sampling, and then carries out blood culture on the collected blood.

[0028] The application provides a blood sampling auxiliary device, a blood sampling device and a method for reducing the blood culture pollution rate. The blood sampling auxiliary device comprises a pipe body 1, a first interface 2 and a second interface 3, and the pipe body 1 is provided with an isolation cavity 4.

[0029] Currently, there is no means to clearly distinguish between contaminated and true positive blood culture results. Therefore, reducing the contamination rate of blood culture is of great significance to blood culture detection. The present application designs a blood collection method and a matching device, which reduces the contamination problem caused by skin colonization bacteria of blood culture through the introduction of an isolation cavity, improves the detection accuracy of blood culture, reduces the waste of medical resources caused by false positive problems of blood culture contamination, and reduces the burden of laboratory personnel. According to statistics, each contaminated false positive problem causes an average increase of 3.4 US dollars per patient. Therefore, the present application is of great significance to improve the accuracy of blood culture results, has important significance for saving the lives of critically ill patients, and also has the effect of reducing the economic burden of medical institutions. BRIEF DESCRIPTION OF DRAWINGS

[0030] Figure 1 、 3 is a front view cross-sectional view of the blood collection aid of embodiment 1;

[0031] Figure 2 、 4 is a top view cross-sectional view of the blood collection aid of embodiment 1;

[0032] Figure 5 is a front view cross-sectional view of the blood collection aid of embodiment 2;

[0033] Wherein, 1-pipe body, 2-first interface, 3-second interface, 4-isolation cavity, 5-first pipeline, 6-second pipeline, 7-pushable piston. DETAILED DESCRIPTION

[0034] The present application discloses a blood collection aid, a blood collection device and a method for reducing blood culture contamination rate. Those skilled in the art can refer to the content of the present application and appropriately improve the process parameters. It should be particularly pointed out that all similar substitutions and changes are obvious to those skilled in the art, and they are considered to be included in the present application. The method and application of the present application have been described by preferred embodiments, and relevant personnel can obviously modify or appropriately change and combine the methods and applications described herein without departing from the content, spirit and scope of the present application, to realize and apply the present application technology.

[0035] TERMS EXPLANATION:

[0036] The blood culture system is to select a suitable culture bottle, and then assist with a suitable culture method and various modern detection techniques to automatically and continuously monitor the changes in the culture bottle after inoculation to determine whether bacteria exist in the culture bottle. It plays a very important role in quickly detecting whether bacteria grow in the blood of patients to determine the diagnosis, and is the key to effective clinical treatment.

[0037] The materials used in the blood collection aid, the blood collection device and the method for reducing blood culture contamination rate of the present application can be purchased from the market.

[0038] The present invention will be further illustrated below with reference to the embodiments:

[0039] Example 1: Piston-type isolation chamber

[0040] In this embodiment, the piston-type isolation chamber structure that can be connected to the blood collection needle is as follows:

[0041] The blood collection aid includes a tube body 1, a first interface 2, and a second interface 3; the tube body 1 is sequentially provided with an isolation cavity 4, a first conduit 5, a second conduit 6, and a pushable piston 7;

[0042] See Figure 1 , 2 The first conduit 5 is connected to the first interface 2 and the isolation cavity 4 respectively; the first interface 2 can be connected to the blood collection needle so that the collected blood is placed in the isolation cavity;

[0043] See Figure 3 , 4 After the piston 7 is pushed to move towards the isolation chamber 4, the second pipe 6 is connected to the first interface 2 and the second interface 3 respectively, so that the collected blood flows into the container that can be connected to the second interface 3.

[0044] The inside of the blood collection aid is sterile.

[0045] Preferably, the capacity of the isolation chamber is 0.01 to 10 mL.

[0046] Preferably, the isolation chamber is under negative pressure.

[0047] Preferably, a support is provided between the pushable piston 7 and the outer wall of the first pipe 5.

[0048] Preferably, a support is provided between the inner walls of the first pipe 5.

[0049] The usage method is as follows:

[0050] 1. Disinfect the patient's skin. Skin disinfection methods are recommended in CLSI documents and blood culture procedure guidelines.

[0051] 2. Use venous blood collection techniques and perform venous puncture using a butterfly needle.

[0052] 3. Assemble the isolation chamber with the blood collection needle and culture bottle. Connect interface 1 to the blood collection needle and interface 2 to the culture bottle.

[0053] 4. The blood sample first flows into the isolation chamber through pipe 1.

[0054] 5. After collecting the required amount of blood from the front end, push the piston inward, and the sample will continue to flow through tube 2 into the culture bottle.

[0055] Example 2: U-shaped tube isolation chamber

[0056] The U-shaped tube isolation chamber structure that can be connected with a blood collection needle in this embodiment is as follows:

[0057] The blood collection aid includes a tube body 1, a first interface 2, and a second interface 3. The tube body 1 is provided with an isolation chamber 4. The tube body 1 is a U-shaped tube body, and the tube body 1 is provided with the first interface 2 and the second interface 3 at one end, and the other end is in a closed state.

[0058] The inside of the blood collection aid is in a sterile state.

[0059] As a preferred, the capacity of the isolation chamber is 0.01-10 mL.

[0060] As a preferred, the inside of the isolation chamber is in a negative pressure state.

[0061] The specific structure is shown in Figure 5 .

[0062] The use method is as follows:

[0063] 1. Disinfect the skin of the patient. The skin disinfection method has been recommended in the CLSI document and the blood culture operation specification document.

[0064] 2. Use the intravenous blood collection technology to perform intravenous puncture with a butterfly blood collection needle.

[0065] 3. Assemble the isolation chamber with the blood collection needle and the culture bottle, connect the interface 1 with the blood collection needle, and connect the interface 2 with the culture bottle.

[0066] 4. The blood sample flows into the U-shaped isolation chamber.

[0067] 5. After the initial blood flow fills the U-shaped isolation chamber, the sample continues to flow into the culture bottle through the interface 2.

[0068] Test Example 1

[0069] The blood collection aids with isolation chambers of Examples 1 and 2 and blood collection needles are used to collect blood from the same individual, and the blood sample enters the culture bottle. At the same time, direct intravenous puncture collection is performed with a butterfly blood collection needle, and the blood sample directly enters the culture bottle as a control. The skin disinfection method is the aforementioned three-step disinfection method.

[0070] The blood culture method is as follows: using Bc120 automatic blood culture system to detect blood culture by matching with blood culture bottle. When the system reports positive bottle, do smear, gram staining and transfer blood agar, chocolate agar and MacConkey agar. And the isolated colonies are identified and standard drug sensitivity test is conducted to make the final blood culture report. The negative bottle is the system report negative detection blood sample contamination rate after 5 days of routine culture, the calculation formula is as follows:

[0071]

[0072] The detection results are as follows:

[0073] Table 1 blood sample contamination rate

[0074] Group Total number of blood culture specimens / each Number of contaminated blood culture specimens / each Contamination rate / % Example 1 400 2 0.50％ Example 2 400 2 0.50％ Control 400 9 2.25％

[0075] The above only describes the preferred embodiments of the present application, and it should be noted that for those skilled in the art, without departing from the principles of the present application, a number of improvements and refinements can be made, and these improvements and refinements should also be considered as the protection scope of the present application.

Claims

1. A blood collection aid, characterized in that, It includes a tube body (1), a first interface (2), and a second interface (3); the tube body (1) is provided with an isolation cavity (4); The tube body (1) is provided with an isolation cavity (4), a first pipe (5), a second pipe (6) and a pushable piston (7) in sequence. The first conduit (5) is connected to the first interface (2) and the isolation cavity (4) respectively; the first interface (2) can be connected to the blood collection needle so that the collected blood is placed in the isolation cavity; After the pushable piston (7) moves to the end of the isolation cavity (4), the second pipe (6) is connected to the first interface (2) and the second interface (3) respectively, so that the collected blood flows into the container that can be connected to the second interface (3); The capacity of the isolation chamber is 0.01~10mL.

2. The blood collection aid according to claim 1, characterized in that, The isolation chamber is under negative pressure.

3. The blood collection aid according to claim 2, characterized in that, A support is provided between the pushable piston (7) and the outer wall of the first pipe (5).

4. The blood collection aid according to claim 2 or 3, characterized in that, A support is provided between the inner walls of the first pipe (5).

5. A blood collection device, characterized in that, Includes the blood collection aid and blood collection needle as described in any one of claims 1 to 4.

6. The blood collection device according to claim 5, characterized in that, The blood collection aid and the blood collection needle are either an integral structure or detachably connected.

7. The blood collection device according to claim 5 or 6, characterized in that, The blood collection device also includes culture bottles.

8. A method for reducing blood culture contamination rate, characterized in that, Blood collection is performed using the blood collection aid described in any one of claims 1 to 4, or by using the blood collection device described in any one of claims 5 to 7, and then the collected blood is cultured.

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