Sampling device for acquiring excrement sample

Abstract

The invention relates to a sampling device, and discloses a sampling device for acquiring an excrement sample, the sampling device comprises a sleeve body, a heating expansion layer and a sheath; a sample storage cavity and a groove are formed in the side wall of the sleeve body along the axial direction; the sample storage cavity is provided with a sampling channel, the sampling channel extends out of the side wall of the sleeve body, and the end part of the sampling channel is provided with a sealing film; the groove is provided with a sampling area and a finger detection area, the bottom of the sampling area is provided with a flow guide inclined plane, and the finger detection area is provided with an arc-shaped bottom wall; the heating expansion layer is arranged on the outer side wall of the sleeve body; lubricating liquid is filled between the sheath and the sheath body, and two bonding parts are symmetrically arranged at the other end of the sheath in the axial direction of the sheath. The sampling device for acquiring the excrement sample can directly touch a rectum wall and an anal canal, can sample excrement in vivo, avoids the problem that the excrement is easily polluted during sampling, improves the accuracy of a detection result, and improves the sampling efficiency.

Description

Technical Field

[0001] This invention relates to a sampling device, and more particularly to a sampling device for obtaining fecal samples. Background Technology

[0002] In my country's field of malignant tumor diagnosis and treatment, colorectal cancer ranks second in incidence and fourth in mortality, respectively, presenting a very serious situation and severely impacting the health of Chinese residents. According to domestic expert consensus, colorectal cancer screening for residents can begin with fecal occult blood testing or fecal DNA testing; if abnormalities are found, colonoscopy is then performed. Digital rectal examination (DRE) is a common clinical examination method, primarily used to examine the anus, rectum, and surrounding tissues for lesions. The sampling personnel use their fingers to palpate the rectal wall and anal canal to make a preliminary assessment of the presence of rectal and anal canal lesions. However, the scope of examination possible with DRE is very limited. Therefore, during community screening, after performing a DRE, medical personnel still need to collect stool samples for further testing. However, residents' compliance with self-collecting stool samples is often poor, and the collected samples are easily contaminated.

[0003] In the prior art, US patent application US20030120180A1 discloses a method and apparatus for collecting and testing biological samples. The apparatus includes a generally tubular body with an inner surface defining a pocket. The pocket has a distal end and a proximal end, the distal end being normally closed while the proximal end remains open to allow fingers to enter the pocket from the proximal end. Additionally, the body has a generally tubular outer surface, located radially outside the inner surface, with a portion specifically designed to adsorb target substances. This device is made of a nonwoven outer layer or other injectable meltblown elastic material, enabling efficient collection and subsequent release of bodily fluids or samples. An internal protective barrier material, which can be made of a plastic film, hygienically protects the user from contamination by these fluids or samples. However, the patent does not include a structure for sampling feces. The sampling method still involves using equipment to collect samples from the surface of the human body or object by smearing or wiping. The entire sampling process is cumbersome and outdated, and the sampling effect and efficiency are very unstable. The open sampling process also makes the samples easy to be contaminated.

[0004] US Patent Application US4473079A discloses a simple, compact, and self-contained method for detecting occult blood. This patent discloses a surgical glove coated with a reagent material for detecting occult blood. One aluminum foil ring is fixed to the upper surface of the inside of the thumb with rubber adhesive. A small amount of petrolatum mixture containing a dispersed peroxide compound is then applied to the center of the aluminum foil ring. Another aluminum foil ring is also glued to the base of the thumb, and a circular filter paper, pre-soaked in a solution of a mildly acidic substance and an indicator, is attached to its center. Finally, it is firmly fixed to the center of the aluminum foil ring with adhesive. However, this solution only discloses a technical approach for detecting fecal samples and does not disclose the specific sampling structure. It still uses a traditional scraping method and does not address how to achieve stable sampling or avoid sample contamination.

[0005] US patent application US4991592A discloses a device for obtaining tissue samples in a biopsy, such as... Figure 1 As shown, the device incorporates a flexible conduit 50 inside the finger cot 20 of the glove. The tip of the conduit 50 is close to the fingertip, and the other end extends to the palm area. After a doctor locates a lesion through finger palpation, the conduit 50 guides a biopsy needle 57 precisely to that location to obtain a tissue sample. While this approach optimizes the sampling process, its application in digital rectal examinations presents significant safety risks. The biopsy needle can easily cause rectal damage during insertion and movement, posing a risk of scratching or even puncturing the rectal mucosa, potentially leading to bleeding or serious complications. Furthermore, the needle struggles to collect solid fecal particles, making it difficult to guarantee a sufficient sample volume. Summary of the Invention

[0006] The purpose of this invention is to provide a sampling device for obtaining fecal samples. When the sampling personnel wear this sampling device, they can collect fecal samples from the body at the same time as a digital rectal examination. This solves the problem that fecal samples are easily contaminated during sampling, improves the accuracy of the test results, and does not cause rectal damage during the sampling process, thus avoiding safety hazards.

[0007] To achieve the above objectives, the present invention provides a sampling device for obtaining fecal samples, comprising a sleeve, a heat-expanding layer, and a protective sleeve; One end of the sleeve is provided with an opening, and the side wall of the sleeve is provided with a sample storage cavity and a groove in sequence along the axial direction. A sample inlet is provided at the junction of the sample storage cavity and the groove, and a detachable diaphragm is provided at the sample inlet. The sample storage cavity is provided with a sampling channel at one end away from the groove, and the sampling channel extends to the outside of the side wall of the sleeve and is provided with a sealing film at the end; The groove is provided with a sampling area and a finger inspection area in sequence along the axial direction of the sleeve and away from the sample storage cavity. The bottom of the sampling area is provided with a guide slope. The finger inspection area has an arc-shaped bottom wall. One end of the guide slope is connected to the arc-shaped bottom wall and the other end extends to the diaphragm. The guide slope is inclined from the arc-shaped bottom wall toward the sample storage cavity in the axial direction close to the sleeve. The thermal expansion layer is disposed on the outer side wall of the sleeve and surrounds the sampling area; The sheath is fitted over the body of the sleeve, and the space between the sheath and the body of the sleeve is filled with lubricant. One end of the sheath near the opening is fixedly connected to the body of the sleeve, and the other end of the sheath is provided with two adhesive portions symmetrically along its axial direction.

[0008] Furthermore, the inner wall of the sample storage cavity is provided with one or more supporting ribs axially around the sleeve.

[0009] Furthermore, the inner wall of the sample storage chamber is provided with an absorbent layer, and a filter screen is provided on the side of the sample inlet near the diaphragm.

[0010] Furthermore, a unidirectional flow-guiding membrane is provided, which is located on the side of the diaphragm near the sample storage chamber.

[0011] Furthermore, the sidewall thickness of the sleeve is Centimeters, the thickness of the arc-shaped bottom wall is centimeter, : .

[0012] Furthermore, the top of the thermal expansion layer is provided with expansion protrusions.

[0013] Furthermore, the adhesive portion includes an arc-shaped segment and a planar segment. One end of the arc-shaped segment is connected to the sheath, and the other end is connected to the planar segment. An adhesive layer is provided on the opposite sides of the two adhesive portions.

[0014] Furthermore, the thickness of the end of the sleeve furthest from the opening is greater than the thickness of the sidewall of the sleeve.

[0015] Compared with existing technologies, the sampling device for obtaining fecal samples according to an embodiment of the present invention has the following advantages: When a digital rectal examination is required, the finger is inserted into the opening, and the fingertip is pressed against the arc-shaped bottom wall. The two adhesive parts are torn off, and the end of the sheath near the adhesive part is pushed to the opening. The sealing film is then torn off, and the sheath is inserted into the rectum. The arc-shaped bottom wall contacts the rectum, and the presence of lesions in the rectal wall and anal canal is initially determined by touching with the fingertip. During insertion and fingertip touching, the heated expansion layer of the sheath expands upon contact with the rectal wall, making it easier for feces to enter the groove. Furthermore, due to the design of the guide slope, feces easily accumulate in the sampling area, meaning solid feces are directly distributed in the sampling area. If the feces are watery, the watery feces easily enter the storage cavity under the action of the guide slope, thus completing the sampling of either solid or watery feces. Subsequently, the finger and sheath are withdrawn from the rectum, and the end of the sheath near the adhesive part is repositioned and adhesively bonded to complete the sealing of the fecal sample. This allows for fecal sampling within the body, avoiding the problem of feces being easily contaminated during sampling, improving the accuracy of test results, and enabling simultaneous sampling during digital rectal examination, thereby improving sampling efficiency. Attached Figure Description

[0016] Figure 1 The figures are from US patent application US4991592A in the background art; Figure 2 This is a schematic diagram of the sampling device according to an embodiment of the present invention; Figure 3 This is a schematic diagram of the structure of the sleeve of the sampling device according to an embodiment of the present invention; Figure 4 This is a structural schematic diagram of the sleeve of the sampling device according to an embodiment of the present invention from another perspective; Figure 5 This is a cross-sectional view of the sampling device according to an embodiment of the present invention; Figure 6 yes Figure 5 A magnified view of a section at point A in the middle; Figure 7 This is a cross-sectional view of the sample storage chamber of the sampling device according to an embodiment of the present invention; Figure 8 This is a reference schematic diagram of the sampling device for solid fecal sampling according to an embodiment of the present invention; Figure 9 This is a reference schematic diagram of the water and fecal sampling device according to an embodiment of the present invention; Figure 10 This is a physical sample image of the present application.

[0017] In the diagram, 1. Sleeve body; 11. Opening; 12. Sample storage chamber; 121. Sample inlet; 122. Sampling channel; 123. Sealing membrane; 124. Supporting ribs; 125. Absorbent layer; 126. Filter screen; 13. Groove; 131. Sampling area; 132. Finger examination area; 1311. Guide slope; 1321. Arc-shaped bottom wall; 14. Diaphragm; 2. Thermal expansion layer; 21. Expansion protrusion; 3. Sheath; 31. Adhesive part; 311. Arc-shaped section; 312. Planar section; 20. Finger sleeve; 50. Guide tube; 57. Biopsy needle. Detailed Implementation

[0018] The specific embodiments of the present invention will be described in further detail below with reference to the accompanying drawings and examples. The following examples are for illustrative purposes only and are not intended to limit the scope of the invention.

[0019] In the description of this invention, it should be understood that the terms "first," "second," etc., are used to describe various types of information, but these terms are not limited to them; they are only used to distinguish information of the same type from one another. For example, without departing from the scope of this invention, "first" information can also be referred to as "second" information, and similarly, "second" information can also be referred to as "first" information. Wherein, i refers to solid feces, p refers to watery feces, and z refers to the rectal wall.

[0020] like Figures 2 to 10 As shown, a sampling device for obtaining fecal samples according to a preferred embodiment of the present invention includes a sleeve 1, a heat-expanding layer 2, and a protective sleeve 3. The sleeve 1 is used to insert into the rectum for digital rectal examination and sampling. Specifically, one end of the sleeve 1 is provided with an opening 11 for wearing the sampling device on the finger during digital rectal examination. The sidewall of the sleeve 1 is provided with a sample storage cavity 12 and a groove 13 in sequence along the axial direction. A sample inlet 121 is provided at the junction of the sample storage cavity 12 and the groove 13. A detachable diaphragm 14 is provided at the sample inlet 121. The groove 13 facilitates the collection of solid feces or watery feces, reducing the difficulty of sampling. At the same time, it is easy to reduce the local sidewall thickness of the sleeve 1, which helps to improve the sensitivity during digital rectal examination. The sample storage chamber 12 is used to store watery fecal samples. A sampling channel 122 is provided at the end of the sample storage chamber 12 away from the groove 13. The sampling channel 122 extends to the outside of the side wall of the sleeve 1 and is provided with a sealing membrane 123 at the end. If it is necessary to remove the watery fecal samples, the sealing membrane 123 is pierced by an auxiliary instrument such as a syringe and the watery fecal samples are taken out from the sample storage chamber 12 through the sampling channel 122. For solid fecal samples, they are mainly left in the groove 13, while for watery fecal samples, they are safely stored in the sample storage chamber 12, ensuring that both types of samples can be effectively obtained and kept in their original state in one operation, ensuring the integrity of the samples taken.

[0021] like Figures 3 to 6As shown, the groove 13 is provided with a sampling area 131 and a finger inspection area 132 in sequence along the axial direction of the sleeve 1 and away from the sample storage cavity 12. The bottom of the sampling area 131 is provided with a guide slope 1311. The finger inspection area 132 has an arc-shaped bottom wall 1321. One end of the guide slope 1311 is connected to the arc-shaped bottom wall 1321, and the other end extends to the diaphragm 14. The guide slope 1311 is inclined from the arc-shaped bottom wall 1321 toward the axial direction of the sample storage cavity 12 near the sleeve 1. The sampling area 131 is mainly used to store solid feces. The guide slope 1311 can facilitate the collection of solid feces or facilitate the introduction of watery feces into the sample storage cavity 12. The digital rectal examination area 132 is equipped with an arc-shaped bottom wall 1321. When the sampling personnel wear gloves, their fingertips will naturally fit in this area, which plays a role in precise positioning. At the same time, it is easy to reduce the thickness and reduce the interference of glove material on tactile sensation. This allows the sampling personnel to obtain clearer and more realistic feedback when performing sampling, improving the sensitivity of the fingertips when touching the intestinal wall during digital rectal examination, the accuracy of diagnosis, and the stability and reliability of sampling. Sampling devices typically used to obtain fecal samples are made of relatively flexible materials, resulting in a variable sampling volume in the sampling area 131. Sampling personnel can actively adjust the size of the sampling area 131 by slightly bending their fingers, as needed, causing it to tilt upwards. This creates a larger space between the sampling area 131 and the rectal wall, effectively increasing the sampling volume. When a large sample size is required for testing, or when the stool characteristics are difficult to collect, this action ensures that a sufficient amount of fecal sample is obtained in one go. Furthermore, this action allows the sampling area 131 to form a relatively large-arc groove, better accommodating solid feces and avoiding the need for secondary operations due to insufficient sample size, thus reducing additional pain for the patient and improving the success rate of a single sampling.

[0022] It should be noted that in this invention, solid stool samples can be used for relevant fecal tests. Sampling is completed during digital rectal examination of the patient, eliminating the need for the patient to collect samples themselves. This increases sampling efficiency while ensuring standardized sampling and avoiding fecal sample contamination. Watery stool samples, on the other hand, are more difficult to collect and are prone to contamination. The sampling device in this invention can directly collect watery stool samples, avoiding sample contamination. The collected samples can be used for rapid pathogen screening, inflammatory marker testing, fecal occult blood testing, and bacterial culture. Solid and watery stool samples can be used for different examinations, thus making it suitable for assessing and determining various gastrointestinal conditions.

[0023] To prevent the bottom wall of the groove 13 from contacting the intestinal wall, which would prevent feces from accumulating in the sampling area 131 or seal the sampling port, a heat-expanding layer 2 is provided on the outer wall of the sleeve 1 and surrounds the sampling area 131. That is, after the sleeve 1 is inserted into the rectum, the heat-expanding layer 2 expands due to heat, creating a gap between the sampling area 131 and the intestinal wall. Simultaneously, feces located in front of the heat-expanding layer 2 are easily drawn into the groove 13 as the sleeve 1 is inserted. Specifically, the heat-expanding layer 2 can be made of expandable microsphere material, capable of expanding when heated to 35℃-40℃. The volume expansion coefficient of the heat-expanding layer 2 ranges from 1.2 to 2, meaning the volume of the heat-expanding layer 2 increases by 20% to 100%. Furthermore, when the finger is withdrawn from the anus, the heat-expanding layer 2 prevents feces from easily detaching from the sampling area 131, ensuring that the amount of feces collected meets the examination requirements.

[0024] In existing technologies, during finger-finger examinations, the sleeve 1 needs to be sprayed with lubricant to reduce the difficulty of the examination, requiring an additional lubricant spraying operation. To further simplify the finger-finger examination process, the sampling device for obtaining fecal samples in this invention has a sheath 3 fitted over the sleeve 1, with lubricant filling the space between the sheath 3 and the sleeve 1. One end of the sheath 3 near the opening 11 is fixedly connected to the sleeve 1, and the other end of the sheath 3 has two symmetrically arranged adhesive portions 31 along its axial direction. Both adhesive portions 31 are fixedly connected to the end of the sheath 3 away from the opening 11, and the two adhesive portions 31 can be bonded to each other. In this invention, the sheath 3 not only cooperates with the sleeve 1 to store lubricant but also serves to seal the fecal sample after sampling, preventing contamination.

[0025] Specifically, when a digital rectal examination is required, the finger is inserted into the opening 11 on the sheath 1, with the fingertip against the arc-shaped bottom wall 1321. The two adhesive portions 31 are torn open, and the end of the sheath 3 closest to the adhesive portion 31 is pushed towards the opening 11. The diaphragm 14 is to prevent lubricant from entering the sample storage cavity 12, which would prevent the sampling of watery feces. Therefore, before the digital rectal examination, the diaphragm 14 must be torn open. The surface of the sheath 1 is coated with lubricant and inserted into the rectum. The arc-shaped bottom wall 1321 contacts the rectum. The fingertip is used to palpate and preliminarily determine whether there are lesions in the rectal wall and anal canal. During insertion and fingertip contact, the heated expansion layer 2 expands upon contact with the rectal wall, allowing feces to enter the groove 13. Due to the guide slope 1311, the feces easily converge in the sampling area 131, meaning solid feces are directly distributed in the sampling area 131. If the feces are watery, they easily enter the storage cavity 12 under the action of the guide slope 1311, thus completing the sampling of either solid or watery feces. Subsequently, the finger and sheath 1 are withdrawn from the rectum, and the end of the sheath 3 near the adhesive part 31 is reattached to seal the fecal sample. After sampling, during subsequent testing, the two adhesive parts 31 are torn open, and the end of the sheath 3 near the adhesive part 31 is pushed to the opening 11. Solid feces are directly extracted in the sampling area 131, while watery feces are extracted by piercing the sealing film 123 with an auxiliary instrument such as a syringe and inserting it into the storage cavity 12 through the sampling channel 122.

[0026] Furthermore, in some embodiments, to prevent the inlet 121 of the sample storage chamber 12 from being squeezed, deformed, and closed, thus preventing watery fecal samples from entering the sample storage chamber 12, therefore, as Figure 4 , Figure 7 As shown, the inner wall of the sample storage cavity 12 is provided with one or more supporting ribs 124 axially surrounding the sleeve 1. The number of supporting ribs 124 can be adjusted according to actual use.

[0027] Furthermore, when taking watery fecal samples, the sample size should be no less than 5 ml.

[0028] Furthermore, in some embodiments, to facilitate the removal of larger particles from the watery fecal sample, such as undigested food and impurities, and to facilitate the adsorption of the watery fecal sample within the sample storage cavity 12 to prevent overflow, therefore, as Figure 6As shown, the inner wall of the sample storage chamber 12 is provided with a water-absorbing layer 125, and a filter screen 126 is provided on the side of the sample inlet 121 near the diaphragm 14. It should be noted that the water-absorbing layer 125 in this invention comprises a layered hydrophilic base layer and a hydrophobic base layer. The hydrophobic base layer is attached to the inner wall of the sample storage chamber 12, while the hydrophilic base layer is disposed away from the inner wall of the sample storage chamber 12 to absorb the water-based fecal sample within the sample storage chamber 12 and prevent overflow. It should also be noted that the hydrophilic base layer of the water-absorbing layer 125 in this application is a titanium dioxide film, which can adsorb water on its surface without permeating it, thereby providing adsorption force to adsorb the water-based fecal sample into the sample storage chamber 12.

[0029] Furthermore, in some other embodiments, for patients with diarrhea, whose stools are generally watery, to reduce centrifugation time and improve detection efficiency, the filter 126 in the figure can be replaced with a one-way flow membrane (not shown in the figure). The one-way flow membrane is located on the side of the diaphragm 14 near the sample storage chamber 12. The one-way flow membrane can directly separate the liquid in the watery stool into the sample storage chamber 12 for rapid pathogen screening or inflammatory marker testing.

[0030] Furthermore, in some embodiments, the sleeve 1 is made of silicone, rubber, or latex. To ensure the sleeve 1 has sufficient support strength and prevent deformation of the sample storage cavity 12 due to excessive softness, which would affect sampling efficiency, the sleeve 1 should not be too thick, as this would increase the difficulty of digital rectal examination. Since digital rectal examination primarily relies on the fingertip contacting the arc-shaped bottom wall 1321 against the rectal wall, the sidewall thickness of the sleeve 1 is designed to improve the sensitivity of touch during examination. The thickness of the curved bottom wall 1321 is [number] centimeters. centimeter, : Specifically, the thickness of the sleeve 1 is between 1 mm and 1.5 mm. The thickness of the arc-shaped bottom wall 1321 is determined according to... : Adaptive settings were implemented to meet the structural strength requirements of sleeve 1, as well as the touch sensitivity requirements during finger inspection.

[0031] In some embodiments, in order to further improve the efficiency of fecal sampling, the top of the heat-expanding layer 2 is provided with an expansion protrusion 21. After the expansion protrusion 21 expands due to heat, it contacts the intestinal wall, increasing the gap between the groove 13 and the intestinal wall, which is conducive to the sampling operation.

[0032] In some embodiments, to facilitate the design of the adhesive portion 31, it is easy to separate and bond two oppositely arranged adhesive portions 31, such as... Figure 1As shown, the adhesive portion 31 includes an arc-shaped segment 311 and a flat segment 312. One end of the arc-shaped segment 311 is fixedly connected to the sheath 3, and the other end is connected to the flat segment 312. Adhesive layers are provided on the opposite sides of the two adhesive portions 31. The flat segment 312 facilitates the bonding and separation of the two adhesive portions 31, and the arc-shaped segment 311 is easy to splice with the sheath 3, simplifying the overall structure of the sheath 3.

[0033] Furthermore, in some embodiments, in order to prevent the fingertip from puncturing the sleeve 1 during finger inspection and sampling after the fingertip is inserted into the end of the sleeve 1, the thickness of the end of the sleeve 1 away from the opening 11 is greater than the thickness of the side wall of the sleeve 1, and the side wall of the sleeve 1 is locally thickened to improve the safety and reliability of the sleeve 1 during use.

[0034] Furthermore, during finger-test sampling, such as Figure 8 As shown, the digital rectal exam device is placed on the index finger and inserted into the rectum. The heated expansion layer 2 expands and adheres to the rectal wall, causing solid feces to accumulate in the sampling area 131. After the digital rectal exam, the sampling device needs to be withdrawn from the rectum. To prevent the fecal sample from slipping out of the sampling area 131, the index fingertip presses against the arc-shaped bottom wall 1321 against the rectal wall, ensuring the solid feces are contained within the depression formed by the heated expansion layer 2 and the arc-shaped bottom wall 1321, thus preventing the sample from slipping out. Similarly, when sampling watery feces, as... Figure 9 As shown, the watery fecal sample can be located in the depression formed by the thermal expansion layer 2 and the arc-shaped bottom wall 1321, which facilitates the watery fecal sample to enter the sample storage cavity 12 through the inlet 121 to obtain a sufficient amount of watery fecal sample.

[0035] See Figure 5 , Figure 7 To prevent excessive deformation of the bottom wall of the sampling area 131, which could cause fecal sample leakage, when the finger is withdrawn after the finger examination, some embodiments have a bottom wall thickness greater than the thickness of the arc-shaped bottom wall 1321. To avoid excessive deformation of the bottom wall of the sampling area 131 under stress. In some other embodiments, the bottom wall of the sampling area 131 is made of a material that is harder than other areas of the sampling device, thereby avoiding excessive deformation of the bottom wall of the sampling area 131.

[0036] The sampling device of this invention can be manufactured in various ways, such as blow molding or injection molding. For example, in a specific embodiment, inserts corresponding to the shapes of the sample storage cavity 12, groove 13, and sampling channel 122 are first installed in the mold cavity. Liquid raw materials are injected into the mold cavity to cool and solidify the sleeve 1. For example, an STM-120 manual injection molding and sealing equipment or a WINTEC t-win injection molding machine can be used. By designing the mold cavity and the corresponding inserts, mass production of the sleeve 1 can be achieved. Alternatively, other blow molding equipment can be used in conjunction with the mold to achieve blow molding production of the sleeve 1. Subsequently, the inserts are removed from the sleeve, and a diaphragm 14 is attached to the sample inlet 121, a sealing film 123 is attached to the sampling channel 122, and the heat-expanding layer 2 is attached to the outer wall of the sleeve 1. The outer sheath can be produced using blow molding or casting processes. The produced sheath 3 is placed over the outer part of the sleeve body 1, and then the sheath 3 is fixed to the sleeve body 1 using a heat sealing process. Lubricant is then injected into the sheath 3 through the opening at the other end. Finally, the two adhesive parts 31 are bonded and fixed to seal the sheath 3, thus completing the production of the entire product. In some other embodiments, the filter screen 126 or the absorbent layer 125 and the one-way flow membrane can be installed before the diaphragm 14 is attached.

[0037] In summary, this invention provides a sampling device for obtaining fecal samples. When a digital rectal examination is required, the finger is inserted into the opening 11, and the fingertip is pressed against the arc-shaped bottom wall 1321. The two adhesive parts are torn open, and the end of the sheath 3 near the adhesive part is pushed to the opening 11. The sealing film 123 is then torn open, and the sheath 1 is inserted into the rectum. The arc-shaped bottom wall 1321 contacts the rectum. By touching with the fingertip, a preliminary judgment is made as to whether there are lesions in the rectal wall and anal canal. During the insertion and fingertip touching process, the heated expansion layer 2 of the sheath 1 expands upon contact with the rectal wall, making it easier for feces to enter the groove 13. The inclined flow surface 1311 facilitates the collection of feces in the sampling area 131, meaning solid feces are directly distributed in the sampling area 131. If the feces are watery, the watery feces easily enter the storage cavity 12 under the action of the inclined flow surface 1311, thus completing the sampling of solid or watery feces. Subsequently, the finger and sheath 1 are withdrawn from the rectum, and the end of the sheath 3 near the adhesive part is repositioned and adhesively bonded to complete the sealing of the fecal sample. This allows for fecal sampling within the body, avoiding the problem of feces being easily contaminated during sampling, improving the accuracy of the test results, and enabling simultaneous sampling during digital rectal examination, thereby improving sampling efficiency.

[0038] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and substitutions can be made without departing from the technical principles of the present invention, and these improvements and substitutions should also be considered within the scope of protection of the present invention.

Claims

1. A sampling device for obtaining fecal samples, characterized in that: It includes a sleeve (1), a thermal expansion layer (2), and a sheath (3); One end of the sleeve (1) is provided with an opening (11). The side wall of the sleeve (1) is provided with a sample storage cavity (12) and a groove (13) in sequence along the axial direction. The junction of the sample storage cavity (12) and the groove (13) is provided with a sample inlet (121). A detachable diaphragm (14) is provided at the sample inlet (121). The sample storage cavity (12) is provided with a sampling channel (122) at one end away from the groove (13). The sampling channel (122) extends to the outside of the side wall of the sleeve (1) and is provided with a sealing film (123) at the end. The groove (13) is provided with a sampling area (131) and a finger inspection area (132) in sequence along the axial direction of the sleeve (1) and away from the sample storage cavity (12). The bottom of the sampling area (131) is provided with a guide slope (1311). The finger inspection area (132) has an arc-shaped bottom wall (1321). One end of the guide slope (1311) is connected to the arc-shaped bottom wall (1321), and the other end extends to the diaphragm (14). The guide slope (1311) is inclined from the arc-shaped bottom wall (1321) toward the sample storage cavity (12) in the axial direction close to the sleeve (1). The thermal expansion layer (2) is provided on the outer side wall of the sleeve (1) and surrounds the sampling area (131); The sheath (3) is fitted over the sleeve (1), and the space between the sheath (3) and the sleeve (1) is filled with lubricant. The end of the sheath (3) near the opening (11) is fixedly connected to the sleeve (1), and the other end of the sheath (3) is symmetrically provided with two adhesive parts (31) along its axial direction.

2. The sampling device for obtaining fecal samples as described in claim 1, characterized in that: The inner wall of the sample storage cavity (12) is provided with one or more supporting ribs (124) around the sleeve (1) in the axial direction.

3. The sampling device for obtaining fecal samples as described in claim 1, characterized in that: The inner wall of the sample storage chamber (12) is provided with a water-absorbing layer (125), and the sample inlet (121) is provided with a filter screen (126) on the side near the diaphragm (14).

4. The sampling device for obtaining fecal samples as described in claim 1, characterized in that: It is also provided with a one-way flow membrane, which is located on the side of the diaphragm (14) near the sample storage chamber (12).

5. The sampling device for obtaining fecal samples as described in claim 1, characterized in that: The sidewall thickness of the sleeve (1) is The thickness of the arc-shaped bottom wall (1321) is [cm]. centimeter, : .

6. The sampling device for obtaining fecal samples as described in claim 1, characterized in that: The top of the thermal expansion layer (2) is provided with an expansion protrusion (21).

7. The sampling device for obtaining fecal samples as described in claim 1, characterized in that: The adhesive portion (31) includes an arc-shaped segment (311) and a planar segment (312). One end of the arc-shaped segment (311) is connected to the sheath (3), and the other end is connected to the planar segment (312). An adhesive layer is provided on the opposite sides of the two adhesive portions (31).

8. The sampling device for obtaining fecal samples as described in claim 1, characterized in that: The thickness of the end of the sleeve (1) away from the opening (11) is greater than the thickness of the side wall of the sleeve (1).

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