A fluid sample sampling head and its application
By designing a fluid sample sampling head with a porous fiber structure, and taking advantage of the fact that the hardening property of the peripheral wall in the circumferential direction is less than that in the axial direction, the problem of insufficient sample volume in existing saliva sampling heads when saliva secretion is low is solved. This achieves efficient saliva adsorption and extrusion, making it suitable for fluid sample sampling head applications.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- GUANGZHOU WONDFO BIOTECH
- Filing Date
- 2023-05-22
- Publication Date
- 2026-06-30
Smart Images
Figure CN118986417B_ABST
Abstract
Description
Technical Field
[0001] This invention belongs to the technical field of sample collection devices, specifically relating to a fluid sample sampling head and its application. Background Technology
[0002] In the field of medical testing, it is often necessary to collect bodily fluid samples from the human body. For example, in drug or substance abuse testing, saliva samples are frequently collected for immediate testing. A sampling element is typically used to collect saliva samples. This element generally includes a sampling rod, a grip at one end of the rod, and a sampling head at the other end. The sampling head is made of absorbable material; when placed in the mouth, it absorbs saliva. When squeezed or expelled, the saliva sample contained within the head is released without altering the composition of the saliva.
[0003] Drug or substance abuse testing generally requires a sufficient amount of saliva sample to achieve the desired detection result. Existing saliva sampling heads are as follows: Figure 1 As shown, its structure is cylindrical and made of capillary material. It absorbs saliva or urine through wicking at the tip. However, when using this saliva sampling head to collect saliva, for individuals with low saliva production or those whose oral saliva production is reduced due to drug abuse, the existing sampling head often results in insufficient sample volume. Especially with the current trend towards multi-sample testing for immediate drug use or abuse, the requirement for larger sample volumes is increasing, and therefore, the existing sampling head can no longer meet the demand. Summary of the Invention
[0004] The purpose of this invention is to provide a fluid sample sampling head that can increase the amount of fluid sample adsorbed and the amount of adsorbed sample squeezed out when adsorbing fluid samples.
[0005] The following technical solutions are used to achieve the above objectives.
[0006] The first aspect of the present invention provides a fluid sample sampling head, wherein the fluid sample sampling head has a porous fiber structure, the hardening of the peripheral wall of the fluid sample sampling head along its circumferential direction is less than the hardening of the two ends along its axial direction, the fluid sample sampling head exhibits linear expansion and contraction deformation during external force compression, and the peripheral wall of the fluid sample sampling head along its circumferential direction is used to collect body fluids.
[0007] In some embodiments, the porous fiber structure is a layered interconnected structure stacked along the axial direction of the fluid sample sampling head.
[0008] In some embodiments, the fluid sample sampling head is made of a product with Porex Fiberwick product code S017919.
[0009] In some embodiments, the fluid sample sampling head has a cylindrical structure.
[0010] In some embodiments, the diameter of the fluid sample sampling head is 10-15 mm and the height is 25-35 mm.
[0011] A second aspect of the present invention provides an application of the fluid sample sampling head described above in the collection of body fluids.
[0012] In some embodiments, the bodily fluid is human saliva.
[0013] In some embodiments, the fluid sampler is used to collect samples from individuals with low saliva production.
[0014] A third aspect of the present invention provides a saliva sampling method, employing a fluid sample sampling head as described above, comprising the following steps:
[0015] Place the fluid sample sampling head in the mouth and collect saliva through the circumferential wall of the fluid sample sampling head for 6 to 8 minutes.
[0016] After collection, the fluid sample sampling head is removed and squeezed forcefully. During the external force squeezing, the fluid sample sampling head undergoes linear expansion and contraction deformation, squeezing saliva out of the sampling head and collecting it.
[0017] In a fourth aspect, the present invention provides a fluid sample sampling rod, the fluid sample sampling rod comprising a sampling rod and a fluid sample sampling head as described above, the sampling rod being connected to the fluid sample sampling head.
[0018] In some embodiments, the sampling rod includes a rod body, a connector, and a handle; the rod body is a cavity structure with one open end for accommodating test strips; the connector is disposed at the open end of the rod body and has a plug-in hole communicating with the cavity structure; the fluid sample sampling head is plugged into the plug-in hole.
[0019] In this invention, through long-term sampling practice, technicians have discovered that the sampling head contacts and absorbs the saliva sample through its top surface, while the absorption amount on its peripheral surface is very small, or even negligible when saliva secretion is low. Furthermore, because the peripheral wall of the sampling head is a hardened surface along the circumferential direction, the sampling head will bend and deform when squeezed (e.g., ...). Figure 1 , Figure 2 and Figure 5 As shown in the image, this causes a large amount of saliva to accumulate inside the sampling head and cannot be squeezed out, which further makes it difficult to collect a suitable sample volume when saliva secretion is low.
[0020] Therefore, after extensive experimentation, this invention utilizes a porous fiber structure for the fluid sample sampling head. This head collects bodily fluids by using its circumferential wall, thereby increasing the surface area in contact with bodily fluids such as saliva. This allows for better saliva adsorption and increases the amount of saliva adsorbed. Furthermore, the circumferential wall of this fluid sample sampling head has less hardening properties than its axial ends, enabling it to undergo linear expansion and contraction deformation during external pressure. Thus, when bodily fluid is squeezed out of the fluid sample sampling head, it undergoes linear expansion and contraction deformation under external force without bending deformation, allowing for better expulsion of the absorbed saliva sample and increasing the amount of saliva collected. Attached Figure Description
[0021] Figure 1 This is a schematic diagram of the existing sampling head in its normal state, as described in the background technology and Comparative Example 1;
[0022] Figure 2 yes Figure 1 A schematic diagram of the deformation of the sampling head under external force.
[0023] Figure 3 This is a schematic diagram of the structure of the fluid sample sampling head in normal state according to Embodiment 1 of the present invention;
[0024] Figure 4 yes Figure 3 A schematic diagram of the deformation of a fluid sample sampling head under external force.
[0025] Figure 5 yes Figure 1 A magnified structural diagram of the side view of an existing sampling head under a microscope;
[0026] Figure 6 yes Figure 3 A magnified structural image of the side view of the fluid sample sampling head under a microscope;
[0027] Figure 7 This is a schematic diagram of the structure of the fluid sample sampling rod according to an embodiment of the present invention.
[0028] Explanation of reference numerals in the attached figures:
[0029] 10. Fluid sample sampling head; 20. Rod; 30. Connector; 40. Handle; 50. Test paper. Detailed Implementation
[0030] To facilitate understanding of the present invention, a more complete description will be provided below. The present invention can be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided to provide a thorough and complete understanding of the disclosure of the present invention.
[0031] Unless otherwise specified, experimental methods in the following examples are generally performed under standard conditions or as recommended by the manufacturer. All commonly used chemical reagents used in the examples are commercially available products.
[0032] Unless otherwise defined, all technical and scientific terms used in this invention have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used in this specification is for the purpose of describing particular embodiments only and is not intended to limit the invention. The term "and / or" as used in this invention includes any and all combinations of one or more of the associated listed items.
[0033] This invention provides a fluid sample sampling head 10, such as... Figure 3 , Figure 4 , Figure 6 and Figure 7 As shown, the fluid sample sampling head 10 has a porous fiber structure. The hardening of the peripheral wall of the fluid sample sampling head 10 along its circumferential direction is less than that at both ends along its axial direction. Here, hardening refers to the strength of the structure. The stronger hardening at the corresponding structural position will have stronger strength and hardness to resist deformation. The fluid sample sampling head 10 exhibits linear expansion and contraction deformation during external force compression, and the peripheral wall of the fluid sample sampling head 10 along its circumferential direction is used to collect body fluids.
[0034] The fluid sample sampling head 10 employs a porous fiber structure. This head collects body fluids through its circumferential wall, increasing the surface area in contact with fluids such as saliva for better saliva adsorption and higher adsorption capacity. Furthermore, the circumferential wall of the fluid sample sampling head 10 has less hardening properties than its axial ends, allowing it to undergo linear expansion and contraction during external pressure. Therefore, when extruding body fluid from the fluid sample sampling head 10, the following occurs: Figure 4 As shown, under the action of external force, the fluid sample sampling head 10 exhibits linear expansion and contraction deformation without bending deformation, which can better squeeze out the absorbed saliva sample and increase the saliva collection volume.
[0035] In some of these embodiments, such as Figure 6 As shown, the porous fiber structure is an approximately stacked layered structure along the axial direction of the fluid sample sampling head 10. This layered structure makes it easier for the fluid sample sampling head 10 to absorb body fluid through the circumferential wall, and also ensures that the fluid sample sampling head 10 undergoes linear expansion and contraction deformation under pressure, so that the absorbed saliva sample can be squeezed out in the largest possible amount.
[0036] Furthermore, it should be noted that the hardening property of the peripheral wall of the fluid sample sampling head 10 is less than that of its two ends along its axial direction. The hardening property is set such that the peripheral wall of the fluid sample sampling head 10 can adsorb a large amount of body fluid, while the two ends along the axial direction cannot adsorb body fluid or adsorb less body fluid than the peripheral wall. Preferably, the peripheral wall of the fluid sample sampling head 10 can adsorb a large amount of body fluid, while the two ends along the axial direction can adsorb virtually no body fluid.
[0037] In some embodiments, the fluid sample sampling head 10 is made of Porex Fiberwick product code S017919. Specifically, in this embodiment, the fluid sample sampling head 10 is made of Porex Fiberwick product code S017919 and is cut to size using a circular hole cutting die. Of course, in other embodiments, the fluid sample sampling head 10 can also be cut from other porous fiber materials. There are no particular limitations, as long as the hardening of the peripheral wall along its circumferential direction is less than the hardening of the two ends along its axial direction, and it exhibits linear expansion and contraction deformation during external pressure, and can be used to collect body fluids through its peripheral wall in the circumferential direction.
[0038] In some of these embodiments, such as Figure 3 As shown, the fluid sample sampling head 10 has a cylindrical structure. The cylindrical structure is easy to manufacture and convenient to place in the oral cavity to absorb saliva. Specifically, the diameter of the fluid sample sampling head 10 is 10-15 mm, and the height is 25-35 mm, which can adapt to the oral cavity of various people and improve the comfort of use. Of course, in other embodiments, the cross-section of the fluid sample sampling head 10 can be elliptical, square, rectangular, triangular, star-shaped, pentagonal, hexagonal, or have any other suitable number of sides or perimeter; no particular limitation is made here.
[0039] The present invention also provides the application of the fluid sample sampling head 10 as described above in the collection of body fluids.
[0040] In some embodiments, the bodily fluid is human saliva.
[0041] In some embodiments, the fluid sample sampling head 10 is used to collect samples from individuals with low saliva production.
[0042] This invention also provides a fluid sample sampling rod, which includes a sampling rod and a fluid sample sampling head 10 as described above. The sampling rod is connected to the fluid sample sampling head 10. The sampling rod is easy to hold; by holding the sampling rod and placing the fluid sample sampling head 10 in the mouth, saliva can be collected.
[0043] In some embodiments, such as Figure 7 As shown, the sampling rod includes a rod body 20, a connector 30, and a handle 40. The rod body 20 is a cavity structure with one open end, which is used to accommodate the test strip 50. The connector 30 is disposed at the open end of the rod body 20 and has an insertion hole communicating with the cavity structure. The fluid sample sampling head 10 is inserted into the insertion hole, and when the fluid sample sampling head 10 is inserted into the insertion hole, it can contact the test strip 50. The sampling rod allows the test strip 50 for detection to be placed, and allows the test strip 50 and the fluid sample sampling head 10 to be integrated and in contact with each other. The sample collected by the fluid sample sampling head 10 can directly enter the test strip 50, which contains a control line. After the collected saliva enters the test strip 50, it is chromatographyd to the control line for display, indicating that the amount of absorbed saliva is sufficient.
[0044] This invention also provides a saliva sampling method, using the fluid sample sampling head 10 as described above, comprising the following steps:
[0045] Place the fluid sample sampling head 10 in the oral cavity and collect saliva through the peripheral wall of the fluid sample sampling head 10 in its circumferential direction for 6 to 8 minutes;
[0046] After collection, the fluid sample sampling head 10 is removed and squeezed forcefully. During the external force squeezing process, the fluid sample sampling head 10 undergoes linear expansion and contraction deformation, squeezing saliva from the sampling head into the tube body.
[0047] Example 1
[0048] This embodiment provides a fluid sample sampling head 10, which is obtained by punching and cutting a 13mm diameter die on a Porex Fiberwick product (product code S017919) to obtain a cylindrical sampling head with a diameter of 13mm and a height of 30mm. The resulting fluid sample sampling head 10 is as follows: Figure 3 As shown, its deformation state under pressure is as follows: Figure 4 As shown, a magnified schematic diagram under a microscope is as follows: Figure 6 As shown.
[0049] Comparative Example 1
[0050] Comparative Example 1 provides a fluid sample sampling head, which is an existing product (https: / / www.porex.com / zh-hans / markets / in-vitro-diagnostics / sample-collection / #SalivaUrineCollection). This existing fluid sample sampling head is a cylinder with a diameter of 13 mm and a height of 30 mm. The hardening of the circumferential surface of this saliva sampling head is greater than that of the top surface, and the fiber structure of this saliva sampling head is vertically arranged along the axial direction. The resulting fluid sample sampling head is as follows... Figure 1 As shown, its deformation state under pressure is as follows: Figure 2 As shown, a magnified schematic diagram under a microscope is as follows: Figure 5 As shown.
[0051] Using the fluid sample sampling head obtained in Comparative Example 1, saliva samples were collected from 273 randomly selected clinical subjects after being held in their mouths for 7 minutes. These 273 subjects were divided into three batches for testing. The saliva collection data are shown in Tables 1 to 3 below.
[0052] Using the fluid sample sampling head obtained in Example 1, saliva was collected from 112 randomly selected clinical subjects after they held the sample in their mouths for 7 minutes. These 112 subjects were divided into two batches for testing. The saliva collection data are shown in Tables 4 and 5 below.
[0053] Table 1 shows the saliva collection volume of the first batch of subjects in Comparative Example 1 using the fluid sample sampling head.
[0054]
[0055]
[0056] Table 2 shows the saliva collection volume of the second batch of subjects in Comparative Example 1 using the fluid sample sampling head.
[0057]
[0058] Table 3 shows the saliva collection volume of the third batch of subjects in Comparative Example 1 using the fluid sample sampling head.
[0059]
[0060] Table 4. Saliva collection volume of the first batch of subjects using the fluid sample sampling head in Example 1.
[0061]
[0062] Table 5. Saliva collection volume of the second batch of subjects using the fluid sample sampling head in Example 1.
[0063]
[0064] As shown in Tables 1 to 3 above, using the fluid sample sampling head of Comparative Example 1, the proportion of saliva samples with a volume higher than 1.3 ml was approximately 70%, and the proportion with a volume higher than 2.0 ml was approximately 50%. However, some individuals had saliva samples with a volume less than 1.3 ml due to low saliva production. Tables 4 and 5 above show that using the fluid sample sampling head of Example 1, the proportion of saliva samples with a volume higher than 2.0 ml was approximately 93%. Therefore, compared to existing fluid sample sampling heads, the fluid sample sampling head of this invention can better adsorb saliva, increase the amount of saliva adsorbed, and can maximize the expulsion of absorbed saliva samples, thereby increasing the saliva collection volume.
[0065] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.
[0066] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.
Claims
1. A fluid sample sampling head, characterized in that, The fluid sample sampling head has a porous fiber structure. The hardening of the peripheral wall of the fluid sample sampling head along its circumferential direction is less than that at both ends along its axial direction. The fluid sample sampling head exhibits linear expansion and contraction deformation during external force compression, and the peripheral wall of the fluid sample sampling head along its circumferential direction is used to collect body fluids. The porous fiber structure is a layered, interconnected structure stacked along the axial direction of the fluid sample sampling head.
2. The fluid sample sampling head as described in claim 1, characterized in that, The fluid sample sampling head has a cylindrical structure.
3. The fluid sample sampling head as described in claim 2, characterized in that, The diameter of the fluid sample sampling head is 10~15mm and the height is 25~35mm.
4. The application of the fluid sample sampling head according to any one of claims 1 to 3 in the collection of body fluids.
5. The application as described in claim 4, characterized in that, The bodily fluid in question is human saliva.
6. A saliva sampling method, characterized in that, The fluid sample sampling head according to any one of claims 1 to 3 includes the following steps: Place the fluid sample sampling head in your mouth and collect saliva through the circumferential wall of the fluid sample sampling head for 6 to 8 minutes. After collection, the fluid sample sampling head is removed and squeezed forcefully. During the external force squeezing, the fluid sample sampling head undergoes linear expansion and contraction deformation, squeezing saliva out of the sampling head and collecting it.
7. A fluid sample sampling rod, characterized in that, The fluid sample sampling rod includes a sampling rod and a fluid sample sampling head as described in any one of claims 1 to 3, wherein the sampling rod is connected to the fluid sample sampling head.
8. The fluid sample sampling rod as described in claim 7, characterized in that, The sampling rod includes a rod body, a connector, and a handle; the rod body is a cavity structure with one open end, the cavity structure is used to accommodate test strips, the connector is disposed at the open end of the rod body, the connector has a plug hole communicating with the cavity structure, and the fluid sample sampling head is plugged into the plug hole.