CN109394236B - Blood sampling device and control equipment thereof - Google Patents

Blood sampling device and control equipment thereof Download PDF

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Publication number
CN109394236B
CN109394236B CN201710707945.0A CN201710707945A CN109394236B CN 109394236 B CN109394236 B CN 109394236B CN 201710707945 A CN201710707945 A CN 201710707945A CN 109394236 B CN109394236 B CN 109394236B
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blood
microneedle
anesthetic
lancing
microneedle assembly
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CN109394236A (en
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李泉
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150015Source of blood
    • A61B5/150022Source of blood for capillary blood or interstitial fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150015Source of blood
    • A61B5/15003Source of blood for venous or arterial blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150053Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
    • A61B5/150106Means for reducing pain or discomfort applied before puncturing; desensitising the skin at the location where body is to be pierced
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150175Adjustment of penetration depth
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150977Arrays of piercing elements for simultaneous piercing
    • A61B5/150984Microneedles or microblades
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M19/00Local anaesthesia; Hypothermia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/003Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles having a lumen

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Medical Informatics (AREA)
  • Biophysics (AREA)
  • Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Anesthesiology (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

The invention is suitable for the field of medical apparatus and instruments, has provided a blood sampling device and its control equipment, the blood sampling device includes: a first microneedle assembly having an anesthetic release channel; a second microneedle assembly having a blood collection channel; a first motion structure driving the first microneedle assembly to inject an anesthetic into the epidermal layer; a second motion structure for driving the second microneedle assembly to collect blood from the skin; and a blood storage structure in communication with the second microneedle assembly for storing the collected blood. The blood sampling device provided by the invention is characterized in that a plurality of micro-needles with tiny diameters are orderly arranged into a micro-needle array, and a wound formed by pricking the skin with the needles is tiny; and the puncturing depth of the micro-needle can be accurately controlled in the blood sampling process, the anesthetic is released when the micro-needle is punctured into the epidermis layer of the skin, the micro-needle is punctured into the dermis layer for blood sampling after the anesthesia is finished, and the patient does not feel pain in the whole process, so that painless blood sampling can be achieved.

Description

Blood sampling device and control equipment thereof
Technical Field
The invention belongs to the field of medical instruments, and particularly relates to a blood sampling device and control equipment thereof.
Background
The collection of blood to provide a test sample is one of the routine testing means in clinical testing. In the prior art, the commonly used blood sampling method is to puncture a vein and sample blood, or prick the tip of a finger with a needle, and then squeeze out the blood and collect the blood, and the method is mainly used for periodically detecting the blood sugar level of a diabetic patient.
However, during the research and practice of the prior art, the applicant of the present application found that the following disadvantages exist in the prior art: venipuncture blood collection is usually painful and generally requires professional medical personnel to perform so as to reduce injury; and the blood volume of taking a blood sample of the mode of acupuncture finger tip is less and also relatively painful, moreover to children, because children have fear to the acupuncture, and do not want to take a blood sample, this can increase the degree of difficulty of blood sampling work undoubtedly, so the demand of modern medical treatment can not be satisfied to above-mentioned blood sampling mode.
Disclosure of Invention
The embodiment of the invention provides a blood sampling device and control equipment thereof, aiming at solving the problem that a person to be sampled is still painful due to the blood sampling modes such as venipuncture or needle-pricked finger tip in the prior art.
The embodiment of the present invention is achieved as follows, a blood sampling device including:
a first microneedle assembly having an anesthetic release channel;
a second microneedle assembly having a blood collection channel;
a first motion structure driving the first microneedle assembly to inject an anesthetic into the epidermal layer;
a second motion structure for driving the second microneedle assembly to collect blood from the skin; and
a blood storage structure in communication with the second microneedle assembly for storing the collected blood.
The embodiment of the present invention further provides another blood sampling device, including:
the micro-pinhole array is arranged on a bottom plate of the shell;
placed in the casing:
a first microneedle assembly having an anesthetic release channel;
a second microneedle assembly having a blood collection channel;
a first motion structure driving the first microneedle assembly to inject an anesthetic into the epidermal layer;
a second motion structure for driving the second microneedle assembly to collect blood from the skin;
the upper part of the shell is provided with a cover for packaging the first microneedle assembly, the second microneedle assembly, the first motion structure, the second motion structure and the blood storage structure into the shell;
the cover is provided with:
the pressing holes correspond to the first motion structure and the second motion structure;
a blood storage structure in communication with the second microneedle assembly for storing the collected blood.
The embodiment of the invention also provides blood sampling control equipment, which comprises:
a control panel;
the power supply is connected with the control panel;
the first driving component is connected with the control board and can drive the first motion structure to move;
the second driving component is connected with the control board and can drive the second motion structure to move;
the vacuum pump is connected with the control panel;
a mounting position for mounting a disposable blood sampling device.
The blood sampling device provided by the invention has the advantages that the micro needles with tiny diameters are orderly arranged into the micro needle array, when the blood is sampled and the micro needles invade the skin tissue of a blood-sampled person, the micro needles are accurately controlled to be inserted into the epidermis layer and not to contact pain nerves, drugs such as anesthetic and the like are quickly released at the depth, the skin wound is tiny, and after the anesthesia is completed, the micro needles are controlled to be inserted into the capillary vessels of the dermis layer again to draw blood, so that a patient can not feel pain, and the painless blood sampling is realized.
Drawings
FIG. 1 is a schematic structural view of a blood collection device provided in an embodiment of the present invention;
fig. 2 is a schematic partial structural view of a first microneedle assembly and a second microneedle assembly provided in an embodiment of the present invention;
fig. 3 is a schematic diagram of an arrangement of microneedles provided in an embodiment of the present invention;
FIG. 4 is a schematic view of a sealing structure of a blood collection device provided by an embodiment of the present invention;
FIG. 5 is a schematic view of a release mechanism of a lancing device according to an embodiment of the present invention;
FIG. 6 is a cross-sectional view taken along plane B-B of a blood collection device provided by an embodiment of the present invention;
FIG. 7 is an enlarged partial schematic view of a cross-sectional view taken along plane B-B of a blood collection device according to an embodiment of the present invention;
FIG. 8 is a schematic view of a first baffle of a blood collection device according to an embodiment of the present invention;
FIG. 9 is a schematic view of a second baffle of a blood collection device according to an embodiment of the present invention;
FIG. 10 is an assembly view of a closure and blood storage structure of a blood drawing device according to an embodiment of the present invention;
FIG. 11 is a schematic view of a closure of a lancing device according to an embodiment of the present invention;
FIG. 12 is an assembled view of the internal structure of a blood-drawing device according to an embodiment of the present invention;
FIG. 13 is a schematic view of a base plate structure of a blood collection device according to an embodiment of the present invention;
FIG. 14 is a schematic view of the overall structure of another blood collection device provided in accordance with the present invention;
fig. 15 is a schematic structural module diagram of a blood collection control device provided by an embodiment of the invention.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is described in further detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.
The blood sampling device provided by the embodiment of the invention is characterized in that a plurality of micro-needles with tiny diameters are orderly arranged into a micro-needle array, wherein the diameter of the micro-needles is tiny and can reach a nanometer level, so that skin wounds formed by the micro-needles are tiny when the micro-needles invade skin tissues of a blood-sampled person, the blood-sampled person basically does not feel pain, in the blood sampling process, the first micro-needle assembly can be accurately controlled to move downwards, the micro-needles are penetrated into the epidermis layer of a pain-free nerve, an anesthetic is injected into the skin tissues of the blood-sampled person, then the second micro-needle assembly is controlled to move downwards, so that the micro-needles are penetrated into the dermis layer and blood is pumped under the action of anticoagulant and other medicaments, and the pain-free blood sampling can be further achieved.
The following detailed description of specific embodiments of the present invention is provided for the purpose of illustrating the invention.
In an embodiment of the present invention, with reference to fig. 1 to 15, the blood collection device includes: a first microneedle assembly 1 having an anesthetic release channel; a second microneedle assembly 2 having a blood collection channel; a first motion structure 3 driving the first microneedle assembly 1 to inject an anesthetic into the epidermis layer; the second motion structure 4 drives the second microneedle component 2 to collect blood from the skin; and a blood storage structure 5 in communication with the second microneedle assembly 2 for storing the collected blood.
In the embodiment of the invention, during the blood collection process, the blood collection device can precisely control the movement of the first motion structure 3 and the second motion structure 4, so that the first microneedle assembly 1 of the blood collection device is driven by the first motion structure 3 to invade the skin epidermis layer of the blood-collected person, and the anesthetic is injected into the skin epidermis layer of the blood-collected person through the anesthetic release channel; after anesthesia is completed, the second moving structure 4 is controlled to move, so that the second microneedle assembly 2 continues to penetrate into the dermis of the person to be sampled, so as to puncture the capillary vessels or vein vessels in the dermis, make blood flow out, collect blood through the blood collecting channel in the second microneedle assembly 2, and then store the collected blood in the blood storage structure 5 communicated with the second microneedle assembly 2.
During the whole blood sampling process, the blood-sampled person can not feel pain basically because the first microneedle assembly 1 invades into the skin epidermal layer of the blood-sampled person and is not sensitive to the pain; further, since the anesthetic is injected into the epidermal layer of the skin of the subject when the first microneedle assembly 1 penetrates into the epidermal layer, and the local nerve of the site to be sampled loses sensation, particularly pain, temporarily, the site to be sampled is anesthetized when the second microneedle assembly 2 continues to penetrate into the dermal layer of the subject to be sampled and the subject is sampled, and therefore, the subject does not feel pain, and thus painless blood sampling can be realized.
In an embodiment of the present invention, the first microneedle assembly 1 comprises: a hollow microneedle array 11; an anesthetic storage device 12; and injecting an anesthetic into the channel 13 of the microneedle array. The anesthetic storage device 12 includes: an anesthetic storage cavity 121; an anesthetic release 122 located on the storage chamber; and a sealing structure 123 enclosing the anesthetic in the storage chamber.
As an embodiment of the present invention, the hollow microneedle array 11 may be a microneedle array fixedly disposed on the first microneedle substrate 14, the microneedle array 11 may be composed of 100 single-channel microneedles 111, and the single-channel microneedles 111 may be arranged at a predetermined distance to form a 10-row and 10-column square array, which may be used for injecting anesthetic. However, one row or one column of through-holes 141 are also provided between the single-via microneedles 111 every two rows or columns. Further, a through hole 141 is formed in the center of the small square array of 4 adjacent single-channel microneedles 111, so that a structure similar to a gobang is formed. That is, a total of 9 × 9 — 81 through holes 141 are provided, and the through holes 141 may form a 9 × 9 square array.
As a preferred embodiment of the present invention, the single-channel microneedle 111 may be fixedly disposed in a protrusion 142 of the first microneedle substrate 14, and a tip portion of the single-channel microneedle 111 protrudes from a convex bottom surface of the protrusion. However, the depth of protrusion of the tip portion of the single-access microneedle 111 may be set according to the depth of the epidermis layer of the skin tissue of the subject, for example, the thickness of the epidermis layer of the human body is generally about 200um, and thus, the tip portion of the single-access microneedle 111 may be set to protrude to a depth of 200um or less, so that it can invade and release the anesthetic to a depth of about 200um or less at the epidermis layer of the human body, but not to reach the capillary-containing dermis layer of 200um to 1000um, so as not to puncture the capillary or vein in the skin tissue. Further, the diameter of the needle hole of the single-channel microneedle 111 is very small, and can be on the order of nanometers, and the wound formed when the microneedle penetrates the skin is very small, and the skin of the epidermis of the subject, which is not sensitive to pain, is penetrated, so that the subject hardly feels pain at the stage of releasing the anesthetic. The protrusion 142 can play a limiting role when the single-path microneedle 111 invades skin tissues, namely, the invasion depth of the single-path microneedle 111 is limited, and the purpose of accurate control is favorably achieved.
In the embodiment of the present invention, a first flow guiding plate 15 is disposed on the back surface of the first microneedle substrate 14 opposite to the surface where the needle tip of the single-channel microneedle 111 protrudes, the first flow guiding plate 15 is disposed with holes 151 corresponding to the through holes 141 of the first microneedle substrate 14, and an anesthetic guiding groove 152 corresponding to the single-channel microneedle 111 is disposed between each row of the holes 151. The first flow guide plate 15 and the first microneedle substrate 14 may be bonded by various welding methods such as ultrasonic welding, thermal welding, plasma welding, and bonding.
In the blood sampling process, the anesthetic can be released into the anesthetic guiding groove 152 from the anesthetic releasing device 122 on the anesthetic storage cavity 121, and then is injected into the channel 13 of the corresponding single-channel microneedle 111 through the anesthetic guiding groove 152, and is released into the epidermis layer of the skin tissue of the blood-sampled person through the needle tip of the single-channel microneedle 111, so as to play an anesthetic role before blood sampling, and provide a precondition guarantee for painless blood sampling.
In the embodiment of the present invention, the anesthetic storage device 12 includes anesthetic storage cavities 121 respectively disposed on two sides of the first flow guiding plate 15 in a balanced manner, and a volume of each anesthetic storage cavity 121 is 5 to 150uL, which is used for storing anesthetic, i.e. the two anesthetic storage cavities 121 can store about 10 to 300uL of anesthetic at a time. The anesthetic dosage stored in the anesthetic storage cavity 121 can completely meet the dosage requirement of anesthesia before blood drawing, and a precondition guarantee is provided for painless blood collection. In addition, the two anesthetic storage cavities 121 which are arranged in a balanced manner can relatively balance the stress action, so that the first microneedle substrate 14 can be ensured to move downwards in a relatively horizontal state, the time and the depth of the single-path microneedle 111 invading the skin tissue of the blood-sampled person are basically in a synchronous state, and the release effect of the anesthetic can be ensured.
In an embodiment of the present invention, the shape of the anesthetic storage cavity 121 may be a square, a cylinder, or the like, and may be set according to practical situations, which is not limited herein.
In one embodiment of the present invention, the anesthetic releasing means 122 may be a one-way valve structure 1221 provided at the bottom of the anesthetic storage chamber 121, for example, the one-way valve structure 1221 may be a plastic diaphragm type one-way valve. When the anesthetic storage device 12 is pressed down to the skin tissue of the blood-sampled person by an external force, the one-way valve structure 1221 may be elastically deformed, and a gap may occur at a joint portion of the anesthetic storage device and the anesthetic storage cavity 121, at this time, the anesthetic stored in the anesthetic storage cavity 121 may flow into the anesthetic guiding groove 152 of the first guiding plate 15 along the gap, and may be injected into the skin tissue of the blood-sampled person through the channel of the single-channel microneedle 111.
In another embodiment of the present invention, the anesthetic releasing device 122 may be composed of a soft film 1222 and a lancet 1223 disposed at the bottom of the anesthetic storage chamber 121, and the tip portion of the lancet 1223 is opposite to the soft film 1222. The lancet 1223 can be formed on a substrate 124 by injection molding, which is a simple process. When the blood collection device is pressed down, the puncture needle 1223 can puncture the flexible membrane 1222, so that the anesthetic in the anesthetic storage chamber 121 can be released and flow into the anesthetic guide groove 152, and then released into the epidermis layer of the skin of the subject through the needle tip portion of the single-channel microneedle 111.
In a preferred embodiment of the present invention, the flexible membrane 1222 and the lancet 1223 can be disposed at a safe distance, and when the anesthetic is injected into the anesthetic storage cavity 121, the flexible membrane 1222 is protruded downward due to the pressure, so that the safe distance can prevent the lancet 1223 from directly puncturing the flexible membrane 1222 to cause leakage, thereby keeping the blood sampling device clean and safe.
As an embodiment of the present invention, the blood sampling device can be manufactured by injecting anesthetic into the anesthetic storage cavity 121 in advance, and then sealing the anesthetic storage cavity with the sealing structure 123 adapted to the anesthetic storage cavity, so as to prevent the sealed anesthetic from being contaminated or overflowing by dust and other contaminants during transportation or storage.
In a preferred embodiment of the present invention, taking the anesthetic storage cavity 121 as a cylinder as an example, the sealing structure 123 may be a sealing cover fitted with the anesthetic storage cavity 121 and having an opening 1231 at the center, and after injecting anesthetic into the anesthetic storage cavity 121 and sealing, the opening 1231 may be kept in an open state, so that the air pressure in the anesthetic storage cavity 121 is kept relatively balanced with the air pressure in the outside, so as to prevent the soft membrane 1222 from being protruded downwards due to the pressure difference between the inside and the outside of the anesthetic storage cavity 121 and being punctured by the puncturing needle 1223 when injecting anesthetic, so that the anesthetic in the anesthetic storage cavity 121 is released in advance and wasted.
In another preferred embodiment of the present invention, the sealing structure 123 may be configured as a boss structure with a central extending protrusion, the opening 1231 is located on the boss, and the opening 1231 may be configured as a funnel shape to facilitate the injection of the anesthetic and to observe whether the anesthetic overflows. In addition, the edge of the boss structure is an annular groove 1232, so that in the production process, if the anesthetic overflows due to overfilling, the anesthetic can firstly flow into the annular groove 1232, and the overflowing anesthetic can be blown off by a spray gun, so that the overflowing anesthetic can be prevented from directly flowing into the blood sampling device, and the whole sanitary and clean state of the blood sampling device is maintained.
In the embodiment of the present invention, a sealing cover/sealing plug/sealing film (not shown) or the like can be disposed on the opening 1231 of the sealing structure 123 to seal the opening 1231, so as to keep the anesthetic agent from overflowing during storage, transportation and use and keep it clean and safe.
In the embodiment of the present invention, when it is required to release the anesthetic in the anesthetic storage cavity 121 for anesthesia, the anesthetic storage cavity 121 can be moved downward by manual operation or mechanical control (e.g., motor driving), and the one-way valve structure is elastically deformed or the puncturing needle 1223 can puncture the soft membrane 1222, so that the anesthetic in the anesthetic storage cavity 121 can flow to the hollow microneedle array 11 through the channel of the anesthetic release device 122 and can be injected into the epidermis layer of the skin tissue of the human body through the channel 13 of the microneedle array 11, so as to achieve the anesthetic effect.
In an embodiment of the present invention, the second microneedle assembly 2 comprises: a microneedle array 21 composed of double-pathway microneedles 211; a medicament storage device 22 that can store a medicament; the double-channel microneedle 211 includes: an agent channel 212 through which an agent can be injected into the microneedle array 21; a blood collection channel 213 for collecting blood from the skin.
In an embodiment of the present invention, the dual-channel microneedle 211 may be a microneedle having two hollow channels, or a microneedle set composed of two microneedles each having a hollow channel. One of the channels is a drug channel 212 for injecting a drug into the microneedle array 21, and the other is a blood collection channel 213 for collecting blood from the skin. The microneedle array 21 may be a microneedle array fixedly disposed on the second microneedle substrate 23, and the microneedle array 23 may be composed of 81-port dual-channel microneedles 211, and is sequentially arranged at a predetermined distance to form a 9-row and 9-column square array. And each of the dual-channel microneedles 211 is arranged in one-to-one correspondence with the through holes 141 on the first microneedle substrate 14 and the holes 151 on the first flow guide plate 15.
The single-channel microneedles 11 and the double-channel microneedles 211 may be arranged in other arrangements or numbers. For example, the arrangement may be arranged as a circular ring type array distributed at intervals, and the like, and may be specifically set according to actual needs, and is not limited herein.
As a preferred embodiment of the present invention, the microneedles of the first microneedle assembly 1 and the second microneedle assembly 2 may be made of degradable materials with good toughness or biocompatibility, so as to improve the toughness of the microneedles with small pore size, and prevent the microneedles from being broken due to poor toughness and remaining in the body of the blood-sampled subject to damage the body of the blood-sampled subject during the blood sampling process. Or even if residual, can avoid the body of the blood-sampled person from causing damage due to the biocompatibility and the rapid degradation.
In an embodiment of the present invention, the dual-channel microneedle 211 may be fixedly built in the protruding structure 231 of the second microneedle substrate 23, and the tip portion of the dual-channel microneedle 211 protrudes from the bottom surface of the protruding structure 231. A height difference is formed between the height of the protrusion 231 extending out of the surface of the first microneedle substrate 14 and the height of the protrusion 142 disposed on the first microneedle substrate 14, wherein the height difference can be set according to the distribution rule from the epidermis layer to the dermis layer of the skin of the human body, and if the depth from the epidermis layer to the dermis layer of the human body is 200um to 1000um, the height difference can be set to 200um to 1000 um. The protruding structure 231 can play a limiting role when the double-channel microneedle 211 pricks into the skin tissue of a human body, so that the pricking depth of the double-channel microneedle 211 can be limited, and the purpose of accurate control is favorably achieved.
In an embodiment of the present invention, a second flow guiding plate 24 is bonded to the back surface of the protruding structure 231 of the second microneedle substrate 23, and the second flow guiding plate 24 is provided with a medicament guiding groove 241 and a blood guiding groove 242 corresponding to the medicament channel 212 and the blood sampling channel 213 in the dual-channel microneedle 211, respectively. The second guide plate 24 and the second microneedle substrate 23 may be bonded by various welding methods such as ultrasonic welding, thermal welding, plasma welding, and bonding.
In the embodiment of the present invention, the two sides of the second diversion plate 24 are provided with a medicament storage cavity 221 and a blood storage cavity 224; the medicament storage cavity 221 may be used to store a medicament for assisting blood collection, such as a vasodilator, an anticoagulant, and the like. During blood collection, blood at the skin wound is easy to agglomerate or the micro needle is easy to block due to the action of the platelet or the blood coagulation factor, which influences the blood collection process; however, when the auxiliary medicament is injected at the same time of blood collection, the normal blood collection can be ensured.
In one embodiment of the present invention, the blood storage chamber 224 may also contain an amount of anticoagulant and/or vasodilator to prevent blood from becoming blocked too quickly during storage.
In the embodiment of the present invention, when blood is collected through the blood collecting channel 213, the drug releasing device 222 disposed on the bottom of the drug storage cavity 221 may be a one-way valve structure 2211, for example, a plastic diaphragm type one-way valve, and after being elastically deformed by a force, a gap is formed at a joint portion of the one-way valve structure 2211 and the bottom of the drug storage cavity 221, and the drug therein may flow out from the gap and be injected into the skin tissue of the blood-collected subject through the drug channel 212. The bottom of the blood storage cavity 224 is provided with a reverse one-way valve structure 2241, which is opposite to the flow guiding direction of the one-way valve structure 2211, and the reverse one-way valve structure 2241 allows only blood to enter the blood storage cavity 221 during blood collection without flowing backwards, so that the normal blood collection can be ensured.
In an embodiment of the present invention, the medicament storage device 22 further includes a sealing structure 223 capable of enclosing the medicament in the medicament storage cavity 221, wherein the arrangement manner of the sealing structure 223 may refer to the arrangement manner of the sealing structure 123, and is not described herein again.
In the embodiment of the invention, the first microneedle assembly 1 and the second microneedle assembly 2 are arranged in a staggered and stacked manner, so that the movement of the first microneedle assembly 1 and the movement of the second microneedle assembly 2 can be conveniently and respectively controlled, and the precise control of the penetration depth of the microneedles into the skin tissue is facilitated.
In an embodiment of the present invention, the blood collection device further comprises an elastic suspension holder 7 disposed at the bottom of the housing 6, supporting the first and second microneedle assemblies 1 and 2. Wherein the elastic suspension support 7: a frame body 71 composed of a resiliently deformable arm; a positioning structure (not shown) located at the bottom of the frame 71 for extending the microneedles of the first microneedle assembly 1 and the second microneedle device 2 from the microneedle holes; a first group of hangers 73 disposed on both sides of the frame body 71 for suspending the first microneedle assembly 1; the elastic hangers 74 are disposed on the frame 71 and used for hanging the second microneedle assembly 2, and the elastic hangers 74 are disposed on the other two sides of the frame 71, staggered with the first group of hangers 73, and have a set height difference with the first group of hangers 73. The set height difference can be set according to the distribution of the epidermis layer to the dermis layer of the human skin, for example, the thickness of the epidermis layer of the human skin is generally within 200um, so the set height difference can be set within 200um, so that the blood sampling device can accurately control the depth of the first group of hanging pieces 73 and the elastic hanging pieces 74 on the frame body 71 pressing against the skin tissue.
In the embodiment of the present invention, when the first group of hanging members 73 on the two sides of the frame 71 are pressed, the first group of hanging members 73 can elastically deform to drive the first microneedle assembly 1 hung therein to press against the skin tissue of the human body, so that the single-channel microneedles 111 in the first microneedle assembly 1 are inserted into the epidermis layer of the skin of the human body. When the elastic hanging pieces 74 on the other two sides of the frame body 71 are pressed, the elastic hanging pieces 74 can elastically deform to drive the second microneedle assembly 2 suspended therein to press against the skin tissue of the human body, so that the double-channel microneedles 211 in the second microneedle assembly 2 are inserted into the dermis layer of the skin of the human body. When the pressure for pressing the first group hanging piece 73 and/or the elastic hanging piece 74 is released, the first group hanging piece 73 and/or the elastic hanging piece 74 can restore to the original position before pressing through the elastic restoring force generated by the first group hanging piece and/or the elastic hanging piece, and the first microneedle assembly 1 and/or the second microneedle assembly 2 are driven to leave the skin tissue of the blood-sampled person.
In the embodiment of the present invention, the bottom plate 61 of the housing 6 of the blood sampling device is provided with a micro-needle hole array 611, through which the micro-needles of the first micro-needle assembly 1 and the second micro-needle assembly 2 can pass; and a cover 8 for enclosing the first microneedle assembly 1 and the second microneedle assembly 2 in the housing 6. The cover 8 has hanging means (not shown) for hanging the first microneedle assembly 1 and the second microneedle assembly 2, respectively. The cover 8 can protect the interior of the blood sampling device from being polluted by external pollutants, and keep the blood sampling device sanitary and clean.
The present invention also provides a blood sampling device comprising: a housing 6, wherein a bottom plate 61 of the housing 6 is provided with a micro-pinhole array 611; inside this housing 6 are placed: a first microneedle assembly 1 having an anesthetic release channel; a second microneedle assembly 2 having a blood collection channel; a first motion structure 3 driving the first microneedle assembly 1 to inject an anesthetic into the epidermis layer; the second motion structure 4 drives the second microneedle component 2 to collect blood from the skin; a blood storage structure 5 communicating with the second microneedle assembly 2 for storing the collected blood; the upper part of the shell 6 is provided with a cover 8 for enclosing the first microneedle assembly 1, the second microneedle assembly 2, the first motion structure 3, the second motion structure 4 and the blood storage structure 5 into the shell 6; the cover 8 has thereon: and a pressing hole 81 corresponding to the first moving structure 3 and the second moving structure 4.
In the embodiment of the present invention, the cover 8 further has a positioning pin/positioning hole 82, so that it can be fixed on the housing 6 through the positioning hole/positioning pin 82, so as to prevent the cover 8 from sliding off and falling out of the housing 6 during transportation, storage, or sale, and to prevent the components inside the housing 6 from being contaminated by external dust and other contaminants.
In the embodiment of the present invention, a protective film (not shown) is further attached to the side of the bottom plate 61 of the housing 6 contacting the skin, so that contaminants such as dust can be prevented from adhering to the bottom plate 61 of the blood sampling device or entering the blood sampling device through the microneedle array hole 611 on the bottom plate 61, and the contaminants such as dust can infect the human body from the contact part with the human body during blood sampling, thereby further ensuring the use hygiene and safety of the blood sampling device.
In an embodiment of the present invention, the blood storage structure 5 comprises: a blood storage chamber 51; a first tube connector 511 and a second tube connector 512 which are arranged at one side of the blood storage cavity 51 and communicated with the second group of microneedle assemblies 2 through a catheter (not shown in the figure); a first check valve (not shown) and a second check valve (not shown) connected to the first pipe connection 511 and the second pipe connection 512, respectively; a reverse one-way valve (not shown) is arranged at the opposite side of the blood storage cavity 51 and corresponds to the second one-way valve; a blood drawing hole 513 is arranged at the opposite side of the blood storage cavity 51 corresponding to the first one-way valve, and a breathable and watertight part 514 is arranged on the blood drawing hole; the air-permeable and water-impermeable part 514 can be connected to a vacuum pump 13 of an external device; a blood discharge hole 515 communicated with the reverse check valve is arranged at a position corresponding to the reverse check valve on the opposite side of the blood storage cavity 51; the open end of the blood storage chamber 51 is sealed by a flexible film (not shown); a rigid sheet (not shown) is attached to the outside of the flexible film.
In the embodiment of the present invention, the air-permeable and water-impermeable part 514 installed on the blood drawing hole 513 can allow air to pass but not moisture to pass, the external device vacuum pump 13 of the blood drawing device can draw air in the blood storage chamber 51 through the air-permeable and water-impermeable part 514 so as to make it in a negative pressure/vacuum environment, and blood of the human body flows to the blood storage chamber 51 due to the pressure difference, thereby achieving rapid blood drawing, shortening the blood drawing time and reducing the pain of the human body. The air-permeable and water-impermeable part 514 can prevent external moisture from entering the blood storage cavity 51, and can dilute or contaminate the collected blood sample. The air-permeable and water-impermeable part 514 can be an air-permeable and water-impermeable film.
In the embodiment of the present invention, the open end of the blood storage chamber 51 is sealed with a flexible film, and a rigid sheet is attached to the outside of the flexible film. The rigid sheet can further prevent the blood sample in the blood storage cavity 51 from splashing due to external impact in the blood collection process. The flexible film is used for sealing between the rigid thin plate and the blood storage cavity 51, so that the blood storage cavity 51 can be separated from the rigid thin plate, the open end of the blood storage cavity 51 can be completely sealed, and pollutants are prevented from entering the blood storage cavity 51 from the edge gap of the rigid thin plate, so that the collected blood sample can be further prevented from being polluted.
In the embodiment of the invention, the sealing cover 8 of the blood sampling device is provided with the sliding groove 83 connected with external equipment, so that the blood sampling device can be in sliding push-pull fit with the external equipment through the sliding groove 83, and the use convenience of the blood sampling device is improved due to the drawer-type structure.
An embodiment of the present invention further provides a blood collection control apparatus, including: a control panel 9; a power supply 10 connected to the control board 9; a first driving component 11 which is connected with the control board 9 and can drive the first motion structure 3 to move; a second driving component 12 connected with the control board 9 and capable of driving the second motion structure 4 to move; a vacuum pump 13 connected to the control board 9; a mounting position for mounting a disposable blood sampling device. The first driving assembly 11 and the second driving assembly 12 are respectively composed of a linear motor and an attachment mechanism capable of performing linear pressing motion.
In the embodiment of the invention, the linear motor can directly convert the electric energy into the mechanical energy of linear motion without a transmission device of other intermediate conversion mechanisms, and has the advantages of high positioning precision, simple structure, stable motion, low noise, low friction of moving parts and the like.
In the embodiment of the present invention, the device further includes a display screen 14 connected to the control board 9, and the display screen 14 can display a current blood sampling process, for example, data such as a current anesthetic dosage, a retention time of an anesthetic for injection, a blood sampling volume, a blood sampling position, a needle puncture depth, and the like can be displayed on the display screen 14, so as to remind a blood sampling worker to adjust or end blood sampling, and improve blood sampling efficiency and accuracy.
In an embodiment of the present invention, the apparatus further includes a sound playing device 15 connected to the control board 9, and the sound playing device can be used to play the blood sampling process data during the blood sampling period, for example, play the sound data such as the injection time of anesthetic, the injection dosage of anesthetic, the depth of the microneedle invading the skin, and the blood flow volume, so as to prompt the blood sampling worker to adjust the abnormal condition of blood sampling in time and end the blood sampling operation, or can instruct the non-professional blood sampling worker to perform the correct blood sampling operation step, for example, the sugar friend can perform the blood sampling operation and detect the blood sugar level at home according to the blood sampling operation step played by the blood sampling device. The universality and the convenience of the use of the blood sampling device can be further improved.
In the embodiment of the invention, the device further comprises a starting switch 16 connected with the control board 9, and when blood sampling is required, the control board 9 can control the starting switch 16 to be turned on and off to drive the blood sampling device to perform blood sampling or stop the blood sampling operation.
In the embodiment of the invention, the mounting position of the device is provided with a positioning pin/positioning hole 612 corresponding to the positioning hole/positioning pin on the blood sampling device, so that the blood sampling device can be fixedly mounted on the mounting position, and the skin tissue of a blood sampler is prevented from being pulled by the movement of the blood sampling device during blood sampling to cause pain; or the blood sampling device is not installed in place and normal blood sampling operation cannot be performed.
In the embodiment of the invention, the device further comprises a release switch (not shown in the figure) of the blood sampling device, when abnormal conditions occur after blood sampling or in the blood sampling process, a blood sampling worker can press the release switch to separate the positioning pin/positioning hole of the blood sampling device from the positioning hole/positioning pin of the blood sampling device, so that the blood sampling operation can be stopped, the safety of blood sampling is ensured, and the blood sampling worker can conveniently adjust the abnormal conditions occurring in the blood sampling process in time.
In an embodiment of the invention, the apparatus further comprises a fixation structure (not shown) for fixing the apparatus to the arm. Wherein, the fixing structure can be a bandage, a magic tape, a buckle structure and other structures. When blood is collected, the blood collecting device can be fixed on the arm of a blood-sampled person through the fixing structure, and the blood collecting device can be prevented from shifting and dragging skin tissues of the blood-sampled person in the blood collecting process, so that the pain is increased, and the convenience in use of the blood collecting device can be further improved.
In the embodiment of the invention, the device can be set to be a watch-type structure, the size of the device is small, the size of a USB flash disk with the length multiplied by the width of 50 multiplied by 18 can be manufactured, the whole device is very small and exquisite, and the device can be worn on hands to take blood and is very convenient; the blood sampling device adopting the watch type structure is used for sampling blood, the micro needle arranged in the device cannot be seen in the whole process, the fear of a blood-sampled person to the needle (especially children) can be reduced, and therefore the difficulty of blood sampling can be increased to a certain extent due to the resistance of the blood-sampled person and the like of the blood-sampled person. In addition, in the blood sampling process, the blood sampling device does not see blood in the blood sampling process, so that blood sampling can be easily completed for some blood-sick blood-sampled persons.
In the embodiment of the invention, the device also comprises an attention transfer device 17 connected with the control board 9, the attention transfer device 17 can be a video/music player, a picture displayer, a game machine, a fragrance releasing device and the like, and when blood is taken, some videos/music, pictures, games and the like can be played at the same time to attract the attention of a blood-taken person, so that the blood-taken person (especially a child) can easily complete blood drawing without crying during the process of watching videos, pictures or playing games, and the trouble of blood drawing of the blood-taken person is reduced.
The blood sampling device provided by the invention is characterized in that a microneedle array is formed by orderly arranging a plurality of microneedles with tiny diameters (nanometer level), when the microneedles invade the skin tissues of a blood-sampled person, the formed skin wounds are tiny, and the blood-sampled person basically does not feel pain; during blood sampling, the anesthetic can be released into the epidermal layer of the skin tissue of a blood-sampled person through the anesthetic releasing device, and blood is drawn after anesthesia is completed, so that painless blood sampling can be further achieved; when blood is drawn, medicaments such as anticoagulant and the like are injected into skin tissues of a human body to assist in blood drawing so as to ensure the normal blood drawing. In addition, the blood sampling device is of a disposable and detachable structure, is convenient to install and use, effectively ensures that cross contamination of blood among blood-sampled persons due to sharing of blood sampling needles and the like can not occur, and simultaneously ensures that collected blood samples are not polluted to influence final detection result judgment.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents and improvements made within the spirit and principle of the present invention are intended to be included within the scope of the present invention.

Claims (26)

1. A lancing device, comprising:
a first microneedle assembly having an anesthetic release channel;
a second microneedle assembly having a blood collection channel;
a first motion structure driving the first microneedle assembly to inject an anesthetic into the epidermal layer;
a second motion structure for driving the second microneedle assembly to collect blood from the skin; and
a blood storage structure in communication with the second microneedle assembly for storing the collected blood;
an elastic suspension mount comprising:
a frame body composed of elastic arms which can be pressed and deformed;
the first group of hangers are arranged on two sides of the frame body and used for hanging the first microneedle assembly;
the elastic hanging pieces are arranged on the other two sides of the frame body, are arranged in a staggered mode with the first group of hanging pieces, and have set height difference with the first group of hanging pieces.
2. The blood collection device of claim 1, wherein the first microneedle assembly comprises:
a hollow microneedle array;
an anesthetic storage device; and
injecting an anesthetic into the channel of the microneedle array.
3. The lancing device of claim 2, wherein the anesthetic storage device comprises:
an anesthetic storage cavity;
an anesthetic release positioned on the storage chamber; and
a sealing structure enclosing the anesthetic within the storage cavity.
4. The blood collection device of claim 1, wherein the second microneedle assembly comprises:
a microneedle array consisting of dual-pathway microneedles;
a medicament storage device capable of storing a medicament;
the dual-channel microneedle includes:
an agent channel into which the agent can be injected into the microneedle array;
a blood collection channel for collecting blood from the skin.
5. The lancing device of claim 4, wherein the medicament storage device comprises:
a medicament storage chamber;
and the medicament release device is positioned on the medicament storage cavity and can release the medicament.
6. The lancing device of claim 5, wherein the medicament storage device further comprises:
a sealing structure capable of sealing the drug in the drug storage chamber.
7. The lancing device according to claim 4, wherein the double-pathway microneedle is a microneedle having two hollow channels or a microneedle set consisting of two microneedles each having a hollow channel.
8. The blood collection device of claim 1, wherein the first microneedle assembly is in a staggered, stacked arrangement with the second microneedle assembly.
9. The lancing device of claim 1, wherein the resilient suspension mount is disposed at a bottom of the housing and supports the first and second microneedle assemblies.
10. The lancing device of claim 9, wherein the resilient suspension mount comprises:
and the positioning structure is positioned at the bottom of the frame body and enables the microneedles in the first microneedle assembly and the second microneedle assembly to extend out of the microneedle hole.
11. The lancing device of claim 1, further comprising a housing having a base plate with an array of microneedle holes disposed thereon, and a cover enclosing the first and second microneedle assemblies in the housing.
12. A lancing device, comprising:
the micro-pinhole array is arranged on a bottom plate of the shell;
placed in the casing:
a first microneedle assembly having an anesthetic release channel;
a second microneedle assembly having a blood collection channel;
a first motion structure driving the first microneedle assembly to inject an anesthetic into the epidermal layer;
a second motion structure for driving the second microneedle assembly to collect blood from the skin;
a blood storage structure in communication with the second microneedle assembly for storing the collected blood; the upper part of the shell is provided with a cover for packaging the first microneedle assembly, the second microneedle assembly, the first motion structure, the second motion structure and the blood storage structure into the shell;
the cover is provided with:
the pressing holes correspond to the first motion structure and the second motion structure;
the blood collection device further comprises an elastic suspension bracket, comprising:
a frame body composed of elastic arms which can be pressed and deformed;
the first group of hangers are arranged on two sides of the frame body and used for hanging the first microneedle assembly;
the elastic hanging pieces are arranged on the other two sides of the frame body, are arranged in a staggered mode with the first group of hanging pieces, and have set height difference with the first group of hanging pieces.
13. The lancing device of claim 12, wherein the cover further comprises a locating pin/hole.
14. The lancing device of claim 12, wherein a protective membrane is attached to the skin contacting side of the base of the housing.
15. The lancing device of claim 12, wherein the blood storage structure comprises:
a blood storage cavity;
the first pipe joint and the second pipe joint are arranged on one side of the blood storage cavity and are communicated with the second group of microneedle assemblies through a conduit;
the first one-way valve and the second one-way valve are respectively connected with the first pipe joint and the second pipe joint;
a reverse one-way valve is arranged at the opposite side of the blood storage cavity and at the position corresponding to the second one-way valve;
a blood drawing hole is formed in the opposite side of the blood storage cavity and corresponds to the first one-way valve, and a breathable and watertight part is arranged on the blood drawing hole;
the air-permeable and water-impermeable part can be connected with a vacuum pump of external equipment;
a blood discharge hole communicated with the reverse one-way valve is formed in the opposite side of the blood storage cavity and in the position corresponding to the reverse one-way valve;
the open end of the blood storage cavity is sealed by a flexible film;
and a rigid thin plate is attached to the outer side of the flexible thin film.
16. The lancing device of claim 12, wherein the cover has a chute for connection to an external device.
17. A blood collection control apparatus, characterized in that the apparatus comprises:
a control panel;
the power supply is connected with the control panel;
the first driving component is connected with the control board and can drive the first motion structure to move;
the second driving component is connected with the control board and can drive the second motion structure to move;
the vacuum pump is connected with the control panel;
a mounting station to which a disposable lancing device can be mounted, said lancing device being according to any one of claims 1 to 16.
18. The blood collection control device of claim 17, wherein the first drive assembly and the second drive assembly are respectively composed of a linear motor and an attachment mechanism capable of performing linear pressing motion.
19. The lancing control device of claim 17, further comprising a display screen coupled to the control panel.
20. The lancing control device of claim 17, further comprising a sound player connected to the control panel.
21. The lancing control device of claim 17, further comprising an activation switch coupled to the control panel.
22. The blood collection control apparatus of claim 17, wherein the mounting location is provided with a locating pin/locating hole corresponding to the locating hole/locating pin of the blood collection device.
23. The lancing control device of claim 22, further comprising a lancing device release switch on the device, wherein the alignment pin/alignment aperture disengages the alignment pin/alignment aperture of the lancing device when the release switch is depressed.
24. The lancing control device of claim 17, further comprising a securing structure on the lancing control device for securing the device to an arm.
25. The lancing control device of claim 17, wherein the lancing control device is a watch-type structure.
26. The lancing control device of claim 17, further comprising an attention transfer device coupled to the control panel.
CN201710707945.0A 2017-08-17 2017-08-17 Blood sampling device and control equipment thereof Active CN109394236B (en)

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