CN114460298A - Biomarker screening system for early diagnosis of lung tumor - Google Patents
Biomarker screening system for early diagnosis of lung tumor Download PDFInfo
- Publication number
- CN114460298A CN114460298A CN202210136546.4A CN202210136546A CN114460298A CN 114460298 A CN114460298 A CN 114460298A CN 202210136546 A CN202210136546 A CN 202210136546A CN 114460298 A CN114460298 A CN 114460298A
- Authority
- CN
- China
- Prior art keywords
- user
- sampling
- analysis
- sampling unit
- skin
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Withdrawn
Links
Images
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/574—Immunoassay; Biospecific binding assay; Materials therefor for cancer
- G01N33/57484—Immunoassay; Biospecific binding assay; Materials therefor for cancer involving compounds serving as markers for tumor, cancer, neoplasia, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides, metabolites
- G01N33/57488—Immunoassay; Biospecific binding assay; Materials therefor for cancer involving compounds serving as markers for tumor, cancer, neoplasia, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides, metabolites involving compounds identifable in body fluids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15101—Details
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/5302—Apparatus specially adapted for immunological test procedures
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
- G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
- G01N2333/46—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans from vertebrates
- G01N2333/47—Assays involving proteins of known structure or function as defined in the subgroups
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
- G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
- G01N2333/46—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans from vertebrates
- G01N2333/47—Assays involving proteins of known structure or function as defined in the subgroups
- G01N2333/4701—Details
- G01N2333/4742—Keratin; Cytokeratin
Abstract
The invention relates to a biomarker screening system for early diagnosis of lung tumor, which comprises a detection kit, an installer and a detection server; the detection kit is worn by a user and is used for collecting a blood sample of the user for tumor marker analysis; the installer is used for assisting a user in correctly fixing the sampling unit in the detection kit to the skin surface of a sampling position and carrying out biomarker analysis on a collected blood sample; the detection server is in communication connection with the installer and is used for receiving detection data of blood samples of the user and uploading the data to relevant departments for recording; the detection kit comprises a sampling unit, a microneedle array mode is adopted to collect a blood sample of a user, a plurality of immunosensors are used for carrying out biological reaction on the blood sample, and the analysis unit arranged in the installer is used for carrying out analysis on the concentration of the marker based on immunosensor signals.
Description
Technical Field
The invention relates to the technical field of tumor diagnosis. In particular to a biomarker screening system for early diagnosis of lung tumors.
Background
Lung cancer is a major tumor disease at present, has high hiding power, can be easily overlooked in early stage, generally, if the lung cancer is diagnosed, the lung cancer is in late stage after more than 8 years, and the lung cancer often loses the optimal treatment time. By screening lung tumor markers in advance, the lung lesion can be found as soon as possible, so that related treatment means can be arranged earlier.
The lung tumor marker refers to various antigens formed in the development process of tumors or special proteins secreted by the tumors, such as carcinoembryonic antigen, NSE neuron specific enolase, CA153, CA125 and the like, and abnormal change of the tumor marker can indicate the possibility of tumors to a certain extent and remind patients of further examination as soon as possible. The tumor marker is characterized in malignant tumor cells, or substances produced by malignant tumor cells in an abnormal way or substances produced by host stimulation response to tumors, and can reflect the occurrence and development of tumors and monitor the response of the tumors to treatment.
According to the related disclosed technical scheme, the blood tumor marker analysis device disclosed by the publication number CN209167322(U) can detect various tumor markers by putting different types of tumor marker detection cards into a plurality of detection boxes, so that certain detection efficiency is improved; the disclosure of publication No. US2021404021(a1) discloses a method for determining characteristics of a tumor cell population, comprising culturing a tumor cell population with lipid particles containing a lipid membrane and a first nucleic acid contained in the lipid membrane, detecting the content of a target protein substance in the tumor cell population, and counting the number of tumor cells having characteristics determined based on the detection result from among tumor cells expressed with a reporter gene; the solution of publication number WO2021222340(a1) proposes a biopsy marker that emits near infrared fluorescence to locate the biopsy site; biopsy markers have a body formed of a polymer and an amount of near-infrared fluorescent dye, such as indocyanine green, embedded in the polymer, and any and all biopsy markers within the field of view can be easily identified and located, thus confirming the tissue sample's risk of cancerous tissue.
Disclosure of Invention
The invention aims to provide a biomarker detection and screening system which can be operated by a patient, so that the patient can correctly and automatically collect blood samples through the auxiliary function of an installer, and the patient can be helped to timely find tumor lesions in an early stage or continuously monitor the lesions of the patient in a tumor recovery stage through a quick detection output result based on an immunosensor.
The invention adopts the following technical scheme:
a biomarker screening system for early diagnosis of lung tumors, the screening system comprising a detection suite, an installer, and a detection server; the detection kit is worn by a user for collecting a blood sample of the user for marker analysis; the installer is used for assisting a user to fix the sampling unit in the detection kit to the skin surface of a sampling position; the detection server is in communication connection with the installer and is used for receiving detection data of a user and further analyzing the data;
wherein the detection kit comprises:
a wearing assembly for fixing the sampling unit to a body part of a user;
the sampling unit is used for collecting blood samples of a user;
the installer includes:
the installation component is used for assisting a user in installing the sampling unit;
an analysis unit for performing a biomarker determination on a blood sample of a user;
the communication unit is used for carrying out data communication exchange with the detection server;
wherein the sampling unit comprises a plurality of groups of microneedle sampling arrays; the base surface of the microneedle sampling array is made of a soft material which is skin-friendly and sticky, so that the microneedle sampling array is attached to the skin surface of a user, and the needle head of the microneedle sampling array is kept at the specified depth of the dermis layer of the user in the sampling process; the user correctly presses the sampling unit to the skin surface through the installer;
wherein the mounting assembly in the mounter comprises a plurality of sensors for detecting the skin surface property of a user and the posture and strength of the user for fixing the microneedle sampling array, so as to determine the impact strength and the impact angle when the mounting assembly presses and attaches the sampling unit to the skin of the user;
the installer comprises a group of adjustable resistance handles for setting a proper pre-pressure when the sampling unit is pressed on the skin of the sampling part;
the mounting device comprises a positioning cavity; the positioning cavity is used for fixing the preset position of the sampling unit and guiding the sampling unit in the process that the installer pushes and presses the sampling unit; the top end of the positioning cavity is in contact with the skin surface of a user when being installed, and the top end comprises a plurality of pressure-sensitive sensors for measuring pressure values when a plurality of positions of the top end are in contact with the skin of the user;
the surface of the sampling unit, which is in contact with the skin of a user, is a working surface; the side opposite to the working surface is an analysis surface; the micro needle of the micro needle sampling array is positioned on one side of the working surface of the sampling unit; the micro-needle sampling array comprises a capillary structure and is used for guiding the collected blood sample to the analysis surface;
the analysis unit comprises a cover slip; a plurality of groups of immunosensors are arranged on the first surface of the cover glass; the first surface of the cover glass is closely contacted with the analysis surface, and the immunosensor is fully contacted with the blood sample in the analysis surface;
the immunosensor adopts a photoelectric immunosensor; the immunosensor detects lung tumor markers of the user blood samples acquired by the sampling unit;
the target markers of the immunosensor comprise at least one of: carcinoembryonic antigen (CEA), neuron-specific enolase (NSE), cytokeratin 19 fragment (CYFRA21-1), carbohydrate antigen CA125, carbohydrate antigen CAl5-3, squamous cell carcinoma antigen (SCC);
the analysis unit further comprises at least one optical sensor for detecting an optical reaction of the photo-electric immunosensor on the analysis face; the analysis unit converts the marker concentration of the acquired optical analysis data and submits the analysis data to the detection server through the communication unit;
the communication unit is connected with the detection server in a wired communication or wireless communication mode.
The beneficial effects obtained by the invention are as follows:
1. the screening system of the invention detects the tumor marker by using various selectable immunosensors, and the implementation mode is simple and quick;
2. the sampling unit of the screening system provided by the invention uses the microneedle sampling array to perform blood sampling operation on a patient, so that the discomfort of the patient is reduced as much as possible, and meanwhile, the self-contained viscous material is also beneficial to keeping the sampling unit on the blood sampling position of the patient;
3. the screening system of the invention uses an installer to assist the patient to fix the sampling unit to the blood sampling part, and controls the pre-pressure and pre-pressing angle of the sampling unit by the installer, thereby facilitating the self-posture adjustment of the patient and being suitable for the patient with dyskinesia to carry out the sampling operation;
4. the software and hardware design requirements of the invention are based on modular design, and the invention can be conveniently switched and upgraded in the technical updating and modifying stage, thereby being beneficial to the optimization and upgrading of the technical scheme in the future.
Drawings
The invention will be further understood from the following description in conjunction with the accompanying drawings. The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the embodiments. Like reference numerals designate corresponding parts throughout the different views.
Fig. 1 is a schematic structural diagram of the mounter;
FIG. 2 is an enlarged view of a part of the structure of the mounter;
FIG. 3 is a schematic view of the appearance of a set of the microneedle sampling arrays;
FIG. 4 is a schematic distribution diagram of a plurality of groups of the microneedle sampling arrays;
FIG. 5 is a schematic structural diagram of the sampling unit;
FIG. 6 is a schematic view of a plurality of pressure sensitive sensors in the positioning chamber;
FIG. 7 is an enlarged side sectional view of the positioning chamber in the embodiment.
Description of the figure numbering: 101-a movable handle; 102-a stationary handle; 103-a positioning block; 104-a resilient element; 105-a switching electromagnet; 106-a compression bar; 107-positioning cavity; 108-a magnetic element; 109-a slider; 110-a guide lumen; 111-coverslip; 200-a sampling unit; 201-microneedle sampling array; 202-a needle head; 203-a liquid collecting tank; 204-base plane; 205-a capillary tube; 206-liquid absorption layer; 207-a filter layer; 208-a layer to be detected; 209-base; 301-a pressure sensitive sensor; 302-a contact layer; 303-buffer layer.
Detailed Description
In order to make the technical solution and advantages of the present invention more apparent, the present invention is further described in detail below with reference to the embodiments thereof; it should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention. Other systems, methods, and/or features of the present embodiments will become apparent to those skilled in the art upon review of the following detailed description. It is intended that all such additional systems, methods, features and advantages be included within this description, be within the scope of the invention, and be protected by the accompanying claims. Additional features of the disclosed embodiments are described in, and will be apparent from, the detailed description that follows.
The same or similar reference numerals in the drawings of the embodiments of the present invention correspond to the same or similar components; in the description of the present invention, it is to be understood that if there is an orientation or positional relationship indicated by the terms "upper", "lower", "left", "right", etc. based on the orientation or positional relationship shown in the drawings, it is only for convenience of description and simplification of description, but it is not intended to indicate or imply that the device or assembly referred to must have a specific orientation.
The first embodiment is as follows:
a biomarker screening system for early diagnosis of lung tumors, the screening system comprising a detection suite, an installer, and a detection server; the detection kit is worn by a user for collecting a blood sample of the user for marker analysis; the installer is used for assisting a user to fix the sampling unit 200 in the detection kit to the skin surface of a sampling position; the detection server is in communication connection with the installer and is used for receiving detection data of a user and further analyzing the data;
wherein the detection kit comprises:
a wearing assembly for fixing the sampling unit 200 to a body part of a user;
a sampling unit 200 for collecting a blood sample of a user;
the installer includes:
a mounting component for assisting a user in mounting the sampling unit 200;
an analysis unit for performing a biomarker determination on a blood sample of a user;
the communication unit is used for carrying out data communication exchange with the detection server;
wherein the sampling unit 200 comprises a plurality of groups of microneedle sampling arrays 201; the base surface 204 of the microneedle sampling array 201 is made of a soft material which is skin-friendly and sticky, and is used for enabling the microneedle sampling array 201 to be attached to the skin surface of a user, and enabling the microneedle sampling array 201 to keep the needle head 202 to reach the specified depth of the dermis layer of the user in the sampling process; the user correctly presses the sampling unit to the skin surface through the installer;
wherein the mounting assembly in the mounter comprises various sensors for detecting the skin surface property of the user and the posture and strength of the user fixing the microneedle sampling array 201, thereby determining the impact strength and impact angle when the mounting assembly presses and attaches the sampling unit to the skin of the user;
the mounting device comprises a set of adjustable resistance handles for setting a suitable pre-pressure when the sampling unit 200 is pressed against the skin of the sampling site;
the installer includes a positioning cavity 107; the positioning cavity 107 is used for fixing the preset position of the sampling unit 200 and guiding the sampling unit 200 in the process that the installer pushes and presses the sampling unit 200; the top end of the positioning cavity 107 is contacted with the skin surface of a user when being installed, the top end comprises a plurality of pressure-sensitive sensors 301 for measuring the pressure values when the top end is contacted with the skin of the user at a plurality of positions in a circle;
the surface of the sampling unit 200, which is in contact with the skin of the user, is a working surface; the side opposite to the working surface is an analysis surface; the needle 202 of the microneedle sampling array 201 is positioned on one side of the working surface of the sampling unit 200; the microneedle sampling array 201 comprises a capillary tube 205 structure therein for guiding the collected blood sample to the analysis surface;
the analysis unit comprises a cover slip 111; a plurality of groups of immunosensors are arranged on the first surface of the cover glass 111; the first side of the cover slip 111 is in intimate contact with the analysis side and the immunosensor is brought into intimate contact with the blood sample in the analysis side;
the immunosensor adopts a photoelectric immunosensor; the immunosensor detects lung tumor markers of user blood samples acquired by the sampling unit 200;
the target markers of the immunosensor comprise at least one of: carcinoembryonic antigen (CEA), neuron-specific enolase (NSE), cytokeratin 19 fragment (CYFRA21-1), carbohydrate antigen CA125, carbohydrate antigen CAl5-3, squamous cell carcinoma antigen (SCC);
the analysis unit further comprises at least one optical sensor for detecting an optical reaction of the photo-electric immunosensor on the analysis face; the analysis unit converts the marker concentration of the acquired optical analysis data and submits the analysis data to the detection server through the communication unit;
the communication unit is connected with the detection server in a wired communication or wireless communication mode;
turning to fig. 1, a schematic diagram of the mounter is shown; the installer comprises a movable handle 101 and a fixed handle 102; the fixed handle 102 is connected with the movable handle 101 through a rotating shaft; the movable handle 101 and the fixed handle 102 both comprise a handle part with anti-skid textures, a user clamps the handle part of the movable handle 101 at the tiger mouth part, the other four fingers except the thumb hold the handle part of the fixed handle 102, and the movable handle 101 rotates around the rotating shaft by expanding and contracting the palm;
further, as shown in fig. 1 and 2, a fixing hole is included at the other end of the handle portion of the movable handle 101; the fixing hole is provided with and fixed with an elastic element 104; the elastic element 104 may be made of a material such as a spring, rubber, or silicone, and is used to generate a restoring force for restoring the movable handle 101; the other end of the elastic element 104 is connected with a positioning block 103; the positioning block 103 can move forward and backward along a first direction in a movable cavity in the middle of the fixed handle 102, and the two side walls of the movable cavity limit the displacement of the positioning block 103 in a second direction and a third direction perpendicular to the first direction; the middle of the positioning block 103 comprises a threaded hole; the threaded hole is in threaded fit with the pressure lever 106, so that the relative position of the pressure lever 106 of the positioning block 103 is fixed; the first end of the plunger 106 includes a magnetic element 108; the magnetic element 108 cooperates with a switching electromagnet 105 located at the rearmost end of the movable chamber in the first direction; the switching electromagnet 105 is configured to turn on a switching circuit, and the magnetic force and the magnetic field direction generated by the switching electromagnet 105 are controlled by the potential and the on/off of the switching circuit, so that the magnetic element 108 is attracted or repelled along a first direction; further, by changing the current and voltage of the switching circuit, the switching electromagnet 105 generates an attractive force or a repulsive force which can be quantitatively controlled to the magnetic element 108;
on the other hand, a slider 109 is included at the second end of the strut 106; the slide block 109 and the cover glass 111 are connected and fixed through a connecting mechanism, so that the positioning cavity 107 and the cover glass 111 move synchronously; further, a guide cavity 110 on the fixing handle 102 is used for limiting the movement of the sliding block 109 in the first direction; optionally, the optical sensor on the analysis unit is mounted on a side of the guide cavity 110 facing the cover glass 111;
fig. 3 shows an embodiment of the microneedle sampling array 201 according to one embodiment; a set of such microneedle sampling arrays 201 is shown; the base 209 is made of flexible material, optionally medical silica gel; the base 209 may alternatively be circular, quadrilateral or other geometric shape suitable for injection molding; the base 209 comprises a sump 203 centrally recessed in the work surface; a micro needle group 202 is fixed in the center of the liquid collecting pool 203; the contact surface of the base 209 and the skin of the user is a base surface 204;
wherein, a plurality of groups of microneedle sampling arrays 201 can be arranged on the sampling unit 200, as shown in fig. 4; preferably, the groups of microneedle sampling arrays 201 are uniformly distributed on the working surface with a central point;
wherein the micro-needle set 203 comprises a plurality of needles 202; as shown in fig. 5, the needle 202 protrudes from the base surface 204 by a certain height h; preferably, the protrusion height h of the needle 202 is between 200 and 2000 microns; the protruding height h is selectable and is selected according to the blood sampling part of the user; for example, the blood sampling device is suitable for blood sampling of finger parts, and the protruding height h can be 300 micrometers; for blood sampling of an arm part, the protruding height h can be 1500 micrometers or more; the bottom maximum diameter of the needle 202 is 250 microns, and the tip minimum diameter is 100 to 120 microns;
during blood collection, the needle 202 punctures the stratum corneum and epidermis of the user's skin, allowing blood to seep out of the sides of the needle 202 and pool into the sump 203 as the needle 202 is deployed; at the same time, blood is effectively retained in the reservoir 203 due to the base 204 being pressed against the user's skin;
further, the schematic structure of the microneedle sampling array 201 shown in fig. 5; wherein a first end of the capillary tubes 205 is connected to the liquid collecting tank 203; the blood in the reservoir 203 will flow from the reservoir 203 into the capillary 205 due to capillary effect; a liquid absorbing layer 206 is arranged at the second end, opposite to the first end, of the capillary tube 205; the liquid absorbent layer 206 is in close contact with the second end of the capillary tube 205 for enhancing the suction force of the capillary tube 205; the liquid absorbing layer 206 is made of polypropylene optionally;
further, the other side of the liquid absorption cotton comprises a filter layer 207; the filter layer 207 is used for filtering blood, so that serum in the blood can permeate the filter layer 207 to intercept blood cells in the blood; the filter layer 207 is preferably a biochemical filter screen with 0.22 micron filtration pores to achieve effective separation of serum and blood cells;
as configured above, after the blood in the liquid collecting tank 203 passes through the capillary tube 205, the blood is absorbed and filled in the liquid absorbing layer 206 by the liquid absorbing layer 206, and further due to the filtration of the filter layer 207 by the pressure difference, the serum in the blood enters the layer to be tested 208 in the sampling unit 200; the microneedle sampling array 201 can penetrate through the stratum corneum of the skin without touching the pain nerve, and the needle head 202 forms a dermal notch on the surface of the skin to ensure that blood can sufficiently flow out of the dermal layer without causing obvious pain and skin injury, so that the blood sampling process is easier to accept, and the blood sampling operation can be performed more frequently without causing the user to feel disgusting;
further, the side surface of the sampling unit 200 includes at least one positioning groove; the positioning groove enables the sampling unit 200 to keep a fixed position or a fixed positioning angle after being pressed into the positioning cavity 107 each time; meanwhile, the positioning groove is also used for fixedly matching with the wearing component;
the wearing component has various implementation forms according to different parts of the user attached to the sampling unit 200; in one embodiment, the user attaches the sampling unit 200 to the surface of a finger and attaches the sampling unit 200 to the finger using the wearing assembly in the shape of a finger sleeve, so as to further ensure that the sampling unit 200 is closely attached to the skin of the finger of the user, obtain a sufficient blood sample, and avoid the pricking feeling of the skin of the user caused by the displacement of the sampling unit 200; in other embodiments, the sampling unit 200 is fixed on the forearm or the big arm, and the wearing component matched with the forearm or the big arm is an elastic fabric component or a soft rubber component sleeved on the forearm or the big arm;
returning to fig. 2, the analysis unit includes a piece of cover glass 111; the cover glass 111 is made of a high-definition transparent material, such as high-transparency epoxy resin or transparent toughened glass; the cover glass 111 includes multiple sets of immunosensors on a first side thereof; in one embodiment, each set of the immunosensors is correspondingly contacted with the to-be-detected layer 208 of one set of the microneedle sampling array 201, so that the immunosensors can closely react with serum in the to-be-detected layer 208;
further, opposite to the first face of the cover glass 111 is a second face of the cover glass 111; in one embodiment, the method comprises reacting with serum using an optical immunosensor, and analyzing an optical signal of the optical immunosensor by the optical immunosensor; because the cover glass 111 is a transparent structure, the optical sensor detects the optical reaction of the optical immunosensor after penetrating through the second surface, and analyzes the concentration of the target marker after converting the optical reaction into a corresponding electric signal;
the optical immunosensor comprises an interlayer optical fiber sensor, a displacement optical fiber sensor or a grating biosensor; after the sensor reacts with the serum in the layer to be detected 208 through the reagent in the sensor, corresponding optical signals including light intensity, spectral frequency, refraction angle and the like are generated; selecting suitable optical sensors for detection corresponding to different optical immunosensors; the technical scheme is not limited, and the selection can be performed by related technicians; optionally, a group of immunosensors is positioned corresponding to the analysis layer of one microneedle sampling array 201, and only blood samples in the analysis layer of the one microneedle sampling array 201 are detected, so that an independent analysis can be performed on one blood sample, and confusion of detection results caused by a plurality of blood samples or a plurality of sensors is avoided;
wherein, the sampling unit 200 is a disposable component, is stored in a sealed package form, and is used as medical waste to be correspondingly treated after one-time blood collection;
the immunosensor can be reused for 8 to 10 times; after each use, thoroughly cleaning with cleaning solution or pure water, and fully airing for later use;
further, the installer is adaptively designed to adapt to the use conditions of different users;
the purpose of the mounting device is to ensure that the sampling unit 200 is correctly attached to the skin surface of the user, achieve sufficient puncturing effect to obtain sufficient blood sample detection, and for users with poor hand strength, the mounting device can also assist in completing the attachment of the sampling unit 200;
with the above settings, the mounter includes the following usage steps:
a preparation stage:
cleaning the cover glass 111, including cleaning with pure water or a cleaning agent; and fully drying after cleaning;
unsealing the entire sampling unit 200 and aligning the analysis side with the first side of the coverslip 111;
after the second surface of the cover glass 111 is connected and fixed with the slide block 109, the cover glass is pressed into the positioning cavity 107;
pressing the slider 109 into the guide cavity 110;
resetting the plurality of groups of sensors in the mounting assembly;
after the preparation stage is finished, a sampling stage is carried out:
the user aligns the installer of the properly prepared sampling unit 200 to a sampling site, such as a finger, arm, or other body part;
after the user presses the positioning cavity 107 of the installer to a sampling part, a plurality of sensors work cooperatively, at least comprising measuring the pressure when the user presses the installer to a body part, and further calculating a plurality of pressure values of a plurality of positions where the positioning cavity 107 is in contact with the user when pressing, so as to judge whether the positioning cavity 107 is uniformly and sufficiently in contact with the skin surface of the user;
the user makes the elastic element 104 elongate by gripping the movable handle 101, and pulls the touch-release magnetic element 108 to approach the switch electromagnet 105 until the touch-release magnetic element and the switch electromagnet contact and trigger the mounter to prepare for impact;
the user releases the movable handle 101, and along with the return of the elastic element 104 and the repulsion force generated by the switch electromagnet 105 to the magnetic element 108, the sampling unit 200 together with the cover glass 111 is impacted and pressed on the sampling position of the user;
the slide 109 is detached from the cover slip 111, leaving the sampling unit 200 with the cover slip 111 on the user's sampling site;
the user wears the wearable assembly as required, and further fixes the sampling unit 200 and the cover glass 111 to wait for the blood sampling to be completed;
after sampling is finished, a recovery detection stage is carried out;
the user aligns the positioning cavity 107 with the sampling unit 200, and the slide block 109 is connected with the cover glass 111 and fixed with each other;
the user pulls back the sliding block 109 by gripping the movable handle 101 and cooperating with the switch electromagnet 105, so as to further pull the sampling unit 200 into the positioning cavity 107 and fix the sampling unit;
starting the analysis unit to carry out marker concentration detection on the blood sample;
and uploading the detection data to a detection server through the communication unit for further processing.
Example two:
this embodiment should be understood to include at least all of the features of any of the foregoing embodiments and further modifications thereon;
in order to facilitate the user to press the sampling unit 200 onto the skin surface by himself, and ensure that the groups of microneedle sampling arrays 201 on the working surface can penetrate into the skin of the user to a sufficient depth during the pressing process of the sampling unit 200 by the mounting device, the pressing action is detected by using a plurality of sensors arranged in the mounting device;
in one embodiment, as shown in fig. 6, 12 pressure-sensitive sensors 301 are arranged around the top end of the positioning cavity 107; the pressure values measured by the 12 pressure-sensitive sensors 301 are respectively p1、p2……p12(ii) a By calculating the average value and the dispersion degree of a plurality of pressure values, whether the user completely and sufficiently presses the opening part of the positioning cavity 107 on the skin surface to be sampled is judged:
including, calculating an overall variance of the plurality of pressure values:
where n-12 in the present embodiment,
is the average of a plurality of pressure values, SpThe overall variance of the pressure values is used for evaluating the deviation degree of the pressure values from the mean value, namely, the contact uniformity degree of the positioning cavity 107 and the skin of the user is evaluated; spThe uniformity of the skin puncture that is the lowest required by the sampling unit 200 can be set according to the laboratory; when S ispThe mounting device is configured to disable the activation of the actuation step when the minimum release threshold is not met, wherein in one embodiment, the polarity of the switching electromagnet 105 is set to generate an attractive force F on the magnetic element 1080Adsorbing the magnetic substanceAn element 108 keeping the sampling unit 200 staying in the positioning chamber 107;
further, at SpWhen the value of (a) satisfies the release threshold, the force for driving the sampling unit 200 to move rapidly towards the skin of the user comprises a force F of the switching electromagnet 105 to the magnetic element 108 in a first directionαAnd FβActing force on the positioning block 103 in a first direction after the elastic element 104 is deformed, and enabling:
-Fα+Fβ＞k·F1equation 2;
wherein FαTaking a positive value as an attractive force and taking a negative value as a repulsive force; fβThe acting force after the stretching deformation of the elastic element 104 is released; k is a skin attribute correction coefficient, different values are made according to the age of the user and the difference of sampling positions, and the aim is to control the impact force not to be too large to cause the excessive pain of the skin of the user; f1Is a preset value of the impact force;
further, FβThe magnitude of the value is related to the degree of deformation of the resilient element 104; the elastic element 104 is configured to supplement FαA driving force after the distance between the switching electromagnet 105 and the magnetic element 108 is increased and greatly decreased; the user deforms the elastic element 104 by gripping the movable handle 101; in practical use, the different hand holding forces of the user can cause the movable handle 101 to reach different positions, thereby generating different FβA value; therefore, further, by providing an angle sensor at the connection position of the movable handle 101 and the fixed handle 102, measuring the angle θ from the initial position to the final stop position of the user gripping the movable handle 101, so that the deformation amount of the elastic member 104 can be calculated based on the angle θ, F can be further calculatedβThe value is obtained.
Example three:
this embodiment should be understood to include at least all of the features of any of the foregoing embodiments and further modifications thereon;
in the process of puncturing the surface of the skin by using the microneedle sampling array 201, because the needle head 202 is small, the phenomenon of insufficient penetrating force can exist when the dermis is punctured; therefore, the skin of the sampling site is pre-tensioned by the positioning cavity 107, so that the skin of the sampling site is smoother and the microneedle sampling array 201 is easier to penetrate through;
as shown in fig. 7, the front end of the positioning cavity 107, which contacts with the skin, includes a bevel with an angle; the groove position comprises a contact layer 302 covered by a soft material; the material of the contact layer 302 is preferably a high-density organic material, such as medical silica gel, medical rubber, etc.; the physical properties of the material of the contact layer 302 include that the shore hardness is 45 to 50 degrees, the contact layer can recover 100% after being compressed, and the Poisson ratio is 0.45 to 0.5;
further, between the contact layer 302 and the groove, a buffer layer 303 is included; the volume of the buffer layer 303 is about 15% of the total volume of the contact layer 302;
when a user presses the positioning cavity 107 to the skin surface of the sampling site, the contact layer 302 deforms under the action of pressure, and the contact layer 302 deforms further to the position of the buffer layer 303 along with the increase of the pressure; by the fact that the epidermis drawn to the contact position is stretched radially outwards due to the greater friction of the organic material used for the contact layer 302 with the skin, the overall effect is that the epidermis covered in the positioning chamber 107 is tightened radially outwards, and the dermal penetration of the sampling unit 200 is thus made even better.
In the above embodiments, the descriptions of the respective embodiments have respective emphasis, and reference may be made to the related descriptions of other embodiments for parts that are not described or illustrated in a certain embodiment.
Although the invention has been described above with reference to various embodiments, it should be understood that many changes and modifications may be made without departing from the scope of the invention. That is, the methods, systems, and devices discussed above are examples. Various configurations may omit, substitute, or add various procedures or components as appropriate. For example, in alternative configurations, the methods may be performed in an order different than described, and/or various components may be added, omitted, and/or combined. Moreover, features described with respect to certain configurations may be combined in various other configurations, as different aspects and elements of the configurations may be combined in a similar manner. Further, elements therein may be updated as technology evolves, i.e., many of the elements are examples and do not limit the scope of the disclosure or claims.
Specific details are given in the description to provide a thorough understanding of the exemplary configurations including implementations. However, configurations may be practiced without these specific details, for example, well-known circuits, processes, algorithms, structures, and techniques have been shown without unnecessary detail in order to avoid obscuring the configurations. This description provides example configurations only, and does not limit the scope, applicability, or configuration of the claims. Rather, the foregoing description of the configurations will provide those skilled in the art with an enabling description for implementing the described techniques. Various changes may be made in the function and arrangement of elements without departing from the spirit or scope of the disclosure.
In conclusion, it is intended that the foregoing detailed description be regarded as illustrative rather than limiting, and that it be understood that these examples are illustrative only and are not intended to limit the scope of the invention. After reading the description of the invention, the skilled person can make various changes or modifications to the invention, and these equivalent changes and modifications also fall into the scope of the invention defined by the claims.
Claims (9)
1. A biomarker screening system for early diagnosis of lung tumors, the screening system comprising a detection suite, an installer, and a detection server; the detection kit is worn by a user for collecting a blood sample of the user for marker analysis; the installer is used for assisting a user to fix the sampling unit in the detection kit to the skin surface of a sampling position; the detection server is in communication connection with the installer and is used for receiving detection data of a user and further analyzing the data;
wherein, the detection kit includes:
a wearing assembly for fixing the sampling unit to a body part of a user;
the sampling unit is used for collecting blood samples of a user;
the installer includes:
the installation component is used for assisting a user in installing the sampling unit;
an analysis unit for performing a biomarker determination on a blood sample of a user;
the communication unit is used for carrying out data communication exchange with the detection server;
wherein the sampling unit comprises a plurality of groups of microneedle sampling arrays; the base surface of the microneedle sampling array is made of a soft material which is skin-friendly and sticky, so that the microneedle sampling array is attached to the skin surface of a user, and the needle head of the microneedle sampling array is kept at the specified depth of the dermis layer of the user in the sampling process; the user correctly presses the sampling unit to the skin surface through the installer;
wherein the mounting assembly in the mounter comprises a plurality of sensors for detecting the surface property of the skin of the user and the posture and strength of the user for fixing the microneedle sampling array, thereby determining the impact strength and the impact angle when the mounting assembly presses and attaches the sampling unit to the skin of the user.
2. The biomarker screening system for early diagnosis of lung tumors of claim 1, wherein the mounting device comprises a set of adjustable resistance handles for setting a suitable pre-pressure when pressing the sampling unit against the skin of the sampling site.
3. The biomarker screening system for early diagnosis of lung tumors of claim 2, wherein the installer comprises a positioning cavity; the positioning cavity is used for fixing the preset position of the sampling unit and guiding the sampling unit in the process that the installer pushes and presses the sampling unit; the top end of the positioning cavity is in contact with the skin surface of a user when being installed, and the top end comprises a plurality of pressure-sensitive sensors around the circumference for measuring the pressure values when a plurality of positions of the top end are in contact with the skin of the user.
4. The system of claim 3, wherein the sampling unit is a working surface in contact with the skin of the user; the side opposite to the working surface is an analysis surface; the micro needle of the micro needle sampling array is positioned on one side of the working surface of the sampling unit; the microneedle sampling array comprises a capillary structure therein for directing a collected blood sample to the analysis face.
5. The biomarker screening system for early diagnosis of lung tumor according to claim 4, wherein the analysis unit comprises a cover glass; a plurality of groups of immunosensors are arranged on the first surface of the cover glass; the first side of the cover slip is in intimate contact with the analysis side and the immunosensor is placed in intimate contact with a blood sample in the analysis side.
6. The system of claim 5, wherein the immunosensor is a photoelectric immunosensor; and the immunosensor is used for detecting lung tumor markers of the user blood samples acquired by the sampling unit.
7. The biomarker screening system for early diagnosis of lung tumor according to claim 6, wherein the target markers of the immunosensor comprise at least one of: carcinoembryonic antigen (CEA), neuron-specific enolase (NSE), cytokeratin 19 fragment (CYFRA21-1), carbohydrate antigen CA125, carbohydrate antigen CAl5-3, squamous cell carcinoma antigen (SCC).
8. The system of claim 7, wherein the analysis unit further comprises at least one optical sensor for detecting an optical response of the photo-electric immunosensor on the analysis surface; and the analysis unit converts the marker concentration of the acquired optical analysis data and submits the analysis data to the detection server through the communication unit.
9. The system of claim 8, wherein the communication unit is configured to connect to the detection server via wired or wireless communication.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210136546.4A CN114460298A (en) | 2022-02-15 | 2022-02-15 | Biomarker screening system for early diagnosis of lung tumor |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210136546.4A CN114460298A (en) | 2022-02-15 | 2022-02-15 | Biomarker screening system for early diagnosis of lung tumor |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN114460298A true CN114460298A (en) | 2022-05-10 |
Family
ID=81413100
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202210136546.4A Withdrawn CN114460298A (en) | 2022-02-15 | 2022-02-15 | Biomarker screening system for early diagnosis of lung tumor |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN114460298A (en) |
-
2022
- 2022-02-15 CN CN202210136546.4A patent/CN114460298A/en not_active Withdrawn
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CA2412401C (en) | Cap for a lancing device | |
| JP4035047B2 (en) | Method and apparatus for collecting blood for diagnostic tests | |
| TW592665B (en) | Method and device for sampling and analyzing interstitial fluid and whole blood samples | |
| KR100586210B1 (en) | System for removing body fluid, especially blood | |
| US6783502B2 (en) | Integrated lancing and analytic device | |
| US7766845B2 (en) | Disposable lancet and lancing cap combination for increased hygiene | |
| US6352514B1 (en) | Methods and apparatus for sampling and analyzing body fluid | |
| US6099484A (en) | Methods and apparatus for sampling and analyzing body fluid | |
| ES2318846T3 (en) | SYSTEM FOR THE EXTRACTION OF BODY LIQUIDS. | |
| US20070016103A1 (en) | Body fluid sampling device | |
| EP2727531A2 (en) | Body fluid sampling device | |
| AU2001266766A1 (en) | Cap for a lancing device | |
| JP2011101826A (en) | Lancing device of sample collection | |
| JP2009509679A (en) | Body fluid collection promotion means | |
| US7896819B2 (en) | Method of determining the concentration of an analyte in a body fluid and system in therefor | |
| CN114460298A (en) | Biomarker screening system for early diagnosis of lung tumor | |
| AU777826B2 (en) | Method and apparatus for obtaining blood for diagnostic tests | |
| CN114041831A (en) | Device for detecting osteoporosis treatment effect and preparation method thereof | |
| CA2733803A1 (en) | Cap for a lancing device | |
| MXPA06010039A (en) | Body fluid sampling device |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| WW01 | Invention patent application withdrawn after publication |
Application publication date: 20220510 |
|
| WW01 | Invention patent application withdrawn after publication |