A gynecological uterine cavity fungus sampling device and sampling method

Abstract

The application provides an instrument tube, a sampling swab and a gynecological uterine cavity fungus sampling method. The application comprises an instrument tube body. The instrument tube can be extended into, expanded, attached to and supported the isolated cervical canal wall. After the instrument tube is used to explore and expand the cervix, the closed distal end can be cut off, and the instrument tube is converted into a double-end open instrument tube. The sampling swab can be extended into the channel of the instrument tube, pass through the distal end of the instrument channel supported by the mechanical tube and reach the uterine cavity to sample the uterine cavity fungus, so that the uterine cavity fungus sample is taken out through the sampling instrument tube channel. Compared with the prior art, the application greatly reduces the pollution opportunity of the uterine cavity fungus sample and improves the accuracy of the bacterial sampling result.

Description

[0001] Technical Field: This invention relates to the field of gynecological instrument technology, specifically to a gynecological intrauterine bacterial sampling device and sampling method.

[0002] Background: Significant progress has been made in the application of microbiota in the medical field. In recent years, domestic and international research on microbiota has focused on gut microbiota, while research on intrauterine microbiota is scarce. In fact, intrauterine microbiota is directly located in the endometrium and uterine cavity, and is more closely related to the female reproductive tract environment. We hypothesize that abnormal intrauterine microbiota may directly affect the endometrium through metabolism, inflammatory environment, and immune response, altering endometrial proliferation and migration phenotypes, thereby inducing endometrial dysfunction and leading to disease. Therefore, abnormal intrauterine microbiota may play a greater role in the occurrence, development, diagnosis, and treatment of endometriosis.

[0003] The uterine cavity flora is a low-biomass microbial community. Due to its small initial quantity, it is easily contaminated by exogenous bacterial DNA, such as bacteria or bacterial DNA from the vagina and cervix, laboratory equipment, and reagents unintentionally introduced into the sample during collection, processing, and analysis. Therefore, researchers need to strictly adhere to operating procedures, including maximizing the use of protective equipment to prevent contamination, improving sampling standards, and enhancing the accuracy of test results. Existing sampling methods, such as direct sampling through the vagina and cervix, have a high probability of bacterial contamination and interference; puncture sampling is an invasive procedure and poses a significant risk to patients. Therefore, we propose a uterine cavity flora sampling device and method.

[0004] Summary of the Invention: The purpose of this invention is to provide a gynecological intrauterine bacterial sampling device and sampling method to solve the problems mentioned in the background art.

[0005] To achieve the above objectives, the technical solution adopted by the present invention is as follows: a gynecological uterine cavity bacterial sampling device, comprising an instrument tube, wherein the distal probe of the instrument tube is closed and the proximal end is an open lumen inlet.

[0006] The sampling swab has a nylon short fiber fluff head and an ABS plastic tube for the attached handle.

[0007] As a preferred embodiment of the gynecological intrauterine bacterial sampling device of the present invention, the distal probe of the instrument tube is closed and has a blunt, streamlined shape, which is beneficial for cervical exploration and cervical dilation, and can reduce patient pain and discomfort.

[0008] As a preferred embodiment of the gynecological intrauterine bacterial sampling device described in this invention, the sampling swab head is a nylon short fiber fluff head, with fine and soft fluffs that cause minimal damage to the patient's endometrium.

[0009] As a preferred embodiment of the gynecological intrauterine bacterial sampling device described in this invention, the instrument tube is made of PVC material and the connected hand handle is made of ABS plastic tube, which has moderate hardness and is easy to bend according to the angle of the cervix, reducing secondary damage.

[0010] As a preferred embodiment of the gynecological uterine cavity bacterial sampling device described in this invention, the diameter of the instrument tube in the uterine cavity is moderate, which can dilate the cervix and fit and support the cervical canal wall without causing obvious discomfort or pain to the patient.

[0011] As a preferred embodiment of the gynecological uterine cavity bacterial sampling device of the present invention, the instrument tube is made of PVC material, and the distal closed probe can be cut to transform it into a double-ended open instrument tube that runs through the uterine cavity and the vaginal portion of the cervix.

[0012] As a preferred embodiment of the gynecological uterine cavity bacterial sampling device of the present invention, the sampling swab can be inserted into and pass through the instrument tube, so that the sampling villi of the swab can reach the uterine cavity area directly; after sampling is completed, it can be withdrawn into the instrument tube lumen and withdrawn from the cervix and vagina with the instrument tube, thereby reducing vaginal and cervical bacterial contamination.

[0013] As a preferred embodiment of the gynecological intrauterine bacterial sampling device of the present invention, the swab can be broken off at the handle after sampling and placed in a cryopreservation tube for freezing, thereby reducing sample contamination during the sample handling process by the operator.

[0014] A sampling method for a gynecological intrauterine bacterial sampling device specifically includes the following steps:

[0015] Step 1: Hold the instrument tube with large forceps and insert the distal probe of the instrument tube into the patient's cervix to extend and dilate the cervical canal.

[0016] Step 2: The instrument tube is withdrawn from the cervix and vagina. The distal closed probe is cut off with medical scissors, transforming the instrument tube into a double-ended open instrument tube that connects the uterine cavity and the cervix and vagina.

[0017] Step 3: Insert the double-ended open instrument tube through the dilated cervical canal, and attach it to and support the cervical canal wall.

[0018] Step 4: Hold the ABS handheld swab and insert the nylon short fiber flocculent tip of the swab into the open inlet of the instrument tube (1) through the tube lumen. The swab tip will then reach the uterine cavity. The swab tip will rotate and remain in the uterine cavity to collect the bacterial sample.

[0019] Step 5: After the sampling swab has completed the sampling, it is retracted into the lumen of the instrument tube and withdrawn from the cervix and vagina along with the instrument tube.

[0020] Step 6: After sampling, the swab can be pushed out from the distal end of the instrument tube (1), broken off at the hand handle, placed in a cryopreservation tube, quick-frozen with liquid nitrogen, and stored in a -80°C refrigerator.

[0021] Compared with the prior art, the beneficial effects of the present invention are:

[0022] 1. Compared with existing technologies, this application provides new methods and technologies for the detection of intrauterine flora, laying a certain technical foundation for the emerging and still early-stage research on intrauterine flora.

[0023] 2. Compared to existing sampling methods that directly sample through the vagina and cervix, which have a high chance of bacterial contamination and interference, the device and method of this invention isolate the vagina and cervix through an instrument cannula, reducing the problem of sample contamination. On the other hand, compared to invasive puncture sampling methods, the device and method of this invention samples through the natural vaginal cavity and cervix, reducing harm to the patient. Attached Figure Description

[0024] Figure 1 The instrument tube described in this invention is a gynecological uterine cavity bacterial sampling device and sampling method.

[0025] Figure 2 The sampling swab described in this invention is for a gynecological intrauterine bacterial sampling device and sampling method. Detailed Implementation

[0026] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0027] The criteria for recruiting patients for this application include:

[0028] Inclusion criteria:

[0029] (1) Patients aged ≥18 years and ≤50 years, and who are premenopausal women;

[0030] (2) The menstrual cycle is normal (28±7 days), and the sampling was not taken during menstruation, pregnancy, or lactation.

[0031] (3) No oral contraceptives, contraceptive injections, subdermal implants or intrauterine devices have been used within at least 3 months prior to sampling;

[0032] (4) No sexual activity for at least 3 days prior to sampling;

[0033] (5) No antibiotics or probiotics, hormone replacement therapy, or GnRH-a drugs have been used within at least 8 weeks prior to sampling;

[0034] (6) No vaginal irrigation, medication application, or cervical treatment was performed within 7 days prior to sampling;

[0035] Exclusion criteria

[0036] (1) Patients aged <18 years or >50 years;

[0037] (2) The patient is menstruating, pregnant, or breastfeeding;

[0038] (3) Postmenopausal status;

[0039] (4) The control group should exclude those with clinical manifestations of endometriosis, such as dysmenorrhea, pelvic pain, dyspareunia and / or infertility (having 12 months of regular unprotected intercourse but failing to conceive).

[0040] (5) Had taken antibiotics or probiotics within 8 weeks prior to sampling;

[0041] (6) Patients with a history of inflammatory bowel disease, functional bowel disease, gastrointestinal tumors or surgery, acute or severe gastrointestinal symptoms requiring drug treatment, gastrointestinal infection, bacterial vaginosis, cervicitis, pelvic inflammatory disease, urinary tract infection, thyroid disease, diabetes, any acute inflammation, any malignant tumor, fever of any cause, infectious disease, or autoimmune disease.

[0042] (7) Abnormal TCT and / or HPV results in the past three years;

[0043] Example 1

[0044] Reference Figure 1 , Figure 2 A gynecological intrauterine bacterial sampling device includes an instrument tube (1), the distal probe of the instrument tube is closed, and the proximal end of the instrument tube (1) is an open lumen inlet (3).

[0045] The sampling swab (4) has a nylon short fiber fluff head (5) and an ABS plastic tube (6) connected to the hand handle.

[0046] 2. The gynecological intrauterine bacterial sampling device according to claim 1, characterized in that: the instrument tube (1) can be inserted into the cervix from the closed probe end (2), expand the cervix, and adhere to and support the cervical canal wall.

[0047] 3. The gynecological uterine cavity bacterial sampling device according to claim 2, characterized in that: the instrument tube is made of PVC material, and the distal closed probe (2) can be cut to transform it into a double-ended open instrument tube that connects the uterine cavity and the vaginal part of the cervix.

[0048] 4. A gynecological uterine cavity bacterial sampling device according to claim 3, characterized in that: the sampling swab (4) can be inserted into and pass through the instrument tube (1) so that the swab sampling villous head (5) can directly reach the uterine cavity area.

[0049] 5. A gynecological intrauterine bacterial sampling device according to claim 4, characterized in that: after the sampling swab (4) completes sampling, it can be returned to the lumen of the instrument tube (1) and withdrawn from the cervix and vagina along with the instrument tube.

[0050] 6. A gynecological intrauterine bacterial sampling device according to claim 5, characterized in that: the swab after sampling can be pushed out from the distal end of the instrument tube (1) and broken off at the hand handle (6).

[0051] Example 2

[0052] Reference Figure 1 , Figure 2 All specimens in this application were collected before treatment. Disposable samplers (1, 4) were used to collect uterine cavity samples. If there was discharge from the external cervical os, it was first wiped with a dry cotton ball, and the swab was inserted deep into the uterine cavity. A sampling method for a gynecological tumor sampling device, using a gynecological uterine cavity bacterial sampling device as described in Example 1, specifically includes the following steps:

[0053] Step 1: Hold the instrument tube (1) with large forceps, insert the distal probe (2) of the instrument tube (1) into the patient's cervix, and extend it to dilate the cervical canal.

[0054] Step 2: The instrument tube is withdrawn from the cervix and vagina. The distal closed probe (2) is cut off with medical scissors, and the instrument tube is converted into a double-ended open instrument tube that connects the uterine cavity and the cervix and vagina.

[0055] Step 3: Insert the double-ended open instrument tube through the dilated cervical canal, and attach it to and support the cervical canal wall.

[0056] Step 4: Hold the ABS handle of the sampling swab and insert the nylon short fiber flocculent tip (5) into the uterine cavity through the open lumen inlet (3) of the instrument tube (1). Rotate the swab tip 5-10 times in the uterine cavity and hold it for about 10 seconds.

[0057] Step 5: After the sampling swab (4) completes the sampling, it is returned to the lumen of the instrument tube (1) and withdrawn from the cervix and vagina along with the instrument tube.

[0058] Step Six: After sampling, the swab can be pushed out from the distal end of the instrument tube (1) and broken off at the hand handle (6). Two swabs are collected from each patient. After collection, the swabs are placed in a sterile cryopreservation tube and quickly placed in a liquid nitrogen tank for rapid freezing for at least 15 minutes. Then, they are transferred to a -80°C freezer for storage as soon as possible. Record the patient's clinical information.

[0059] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A gynecological intrauterine bacterial sampling device, characterized in that: It includes an instrument tube (1), the distal end of which is closed, and the proximal end of which is an open lumen inlet (3). The sampling swab (4) has a nylon short fiber fluff head (5) and an ABS plastic tube (6) connected to the hand handle.

2. The instrument tube (1) can be inserted into the cervix through the closed probe end (2), dilate the cervix, and adhere to and support the cervical canal wall.

3. The instrument tube is made of PVC material, and the distal closed probe (2) can be cut to transform it into a double-ended open instrument tube that connects the uterine cavity and the vaginal part of the cervix.

4. The sampling swab (4) can be inserted into and pass through the instrument tube (1) so that the sampling villous head (5) of the swab can reach the uterine cavity area directly.

5. After the sampling swab (4) has completed the sampling, it can be returned to the lumen of the instrument tube (1) and withdrawn from the cervix and vagina along with the instrument tube.

6. After sampling, the swab can be pushed out from the distal end of the instrument tube (1), broken off at the hand handle (6), placed in a cryopreservation tube for freezing, and sent for testing.

7. The sampling method of the gynecological intrauterine bacterial sampling device according to any one of claims 1-6, characterized in that: The method includes the following steps: Step 1: Hold the instrument tube (1) with large forceps, insert the distal probe (2) of the instrument tube (1) into the patient's cervix, and extend it to dilate the cervical canal. Step 2: The instrument tube is withdrawn from the cervix and vagina. The distal closed probe (2) is cut off with medical scissors, and the instrument tube is converted into a double-ended open instrument tube that connects the uterine cavity and the cervix and vagina. Step 3: Insert the double-ended open instrument tube through the dilated cervical canal, and attach it to and support the cervical canal wall. Step 4: Hold the ABS handheld swab and insert the nylon short fiber flocculent tip (5) into the uterine cavity through the open lumen inlet (3) of the instrument tube (1). The swab tip rotates and stays in the uterine cavity to collect bacterial samples. Step 5: After the sampling swab (4) completes the sampling, it is returned to the lumen of the instrument tube (1) and withdrawn from the cervix and vagina along with the instrument tube. Step 6: After sampling, the swab can be pushed out from the distal end of the instrument tube (1), broken off at the hand handle (6), placed in a cryopreservation tube, flash-frozen with liquid nitrogen, and stored in a -80°C refrigerator.

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