WO2019033362A1

WO2019033362A1 - Blood collection device and control apparatus therefor

Info

Publication number: WO2019033362A1
Application number: PCT/CN2017/097928
Authority: WO
Inventors: 李泉
Original assignee: 深圳华迈兴微医疗科技有限公司; 李泉
Priority date: 2017-08-17
Filing date: 2017-08-17
Publication date: 2019-02-21

Abstract

Disclosed are a blood collection device and a control apparatus therefor, wherein same are applicable in the field of medical instruments. The blood collection device comprises: a first microneedle assembly (1) having an anesthetic releasing channel; a second microneedle assembly (2) having a blood collection channel; a first movement structure (3) for driving the first microneedle assembly (1) to inject anesthetic into the epidermis; a second movement structure (4) for driving the second microneedle assembly (2) to collect blood from the skin; and a blood storage structure (5) in communication with the second microneedle assembly (2) and used for storing the collected blood. In the blood collection device, a microneedle array is formed of a plurality of microneedles with a micro diameter distributed in an orderly manner, such that a wound caused by the microneedles punching of the skin is micro in scale; and during the process of blood collection, the punched depth of the microneedles can be precisely controlled. When the microneedles punch the epidermis of the skin, the anesthetic is released, and after anesthesia is completed, the microneedles punch the dermis for drawing the blood. During the whole process, a patient will not feel pain, thereby realizing painless blood collection.

Description

Blood stasis device and control device thereof

Technical field

[0001] The invention belongs to the field of medical instruments, and in particular relates to a blood collection device and a control device thereof.

Background technique

[0002] Collecting blood to provide a test sample is one of the conventional detection means in clinical tests. In the prior art, the commonly used blood collection method is to puncture the vein and collect blood, or to acupuncture the tip of the finger, and then extrude the blood and collect it. This method is mostly used for the regular detection of blood sugar level in diabetic patients.

[0003] However, in the research and practice of the prior art, the applicant of the present application found that the prior art has the following defects: venous puncture blood collection is usually more painful, and generally requires professional medical personnel to carry out Reduce the damage; the way of acupuncture the tip of the finger is less bloody and more painful, and for children, because the child has a fear of acupuncture, and is not willing to take blood, this will undoubtedly increase the blood collection work. Difficulty, so the above blood collection methods can no longer meet the needs of modern medical care.

technical problem

Embodiments of the present invention provide a blood collection device and a control device thereof, which are directed to solving the problem that a blood collection method such as a vein puncture or a needle tip of a finger in the prior art still causes a pain in a person to be blood-sucked.

Problem solution

Technical solution

[0005] The embodiment of the present invention is implemented as follows, a blood collection device, the blood collection device comprising:

a first microneedle assembly having an anesthetic release channel;

a second microneedle assembly having a blood collection channel;

[0008] driving the first microneedle assembly to inject a first moving structure of an anesthetic into the epidermal layer;

[0009] a second moving structure that drives the second microneedle assembly to collect blood from the skin;

[0010] in communication with the second microneedle assembly for storing a blood storage structure of the collected blood.

[0011] Another embodiment of the present invention provides another blood collection device, the blood collection device comprising:

[0012] a housing, the bottom plate of the housing is provided with an array of micro pinholes;

[0013] the housing is placed with: [0014] a first microneedle assembly having an anesthetic release channel;

[0015] a second microneedle assembly having a blood collection channel;

[0016] driving the first microneedle assembly to inject a first moving structure of an anesthetic into the epidermal layer;

[0017] driving the second microneedle assembly to collect blood from the skin, a second moving structure;

[0018] the upper portion of the housing has a cover enclosing the first microneedle assembly, the second microneedle assembly, the first motion structure, the second motion structure, and the blood storage structure into the housing;

[0019] the cover has:

[0020] a pressing hole corresponding to the first motion structure and the second motion structure;

[0021] in communication with the second microneedle assembly for storing a blood storage structure of the collected blood.

[0022] The embodiment of the invention further provides a blood collection control device, the device comprising:

[0023] a control panel;

[0024] a power source connected to the control board;

[0025] connected to the control board, the first driving component capable of driving the movement of the first moving structure;

[0026] coupled to the control board, the second driving component that can drive the movement of the second moving structure;

[0027] a vacuum pump connected to the control panel;

[0028] The mounting position of the disposable blood collection device can be installed.

Advantageous effects of the invention

Beneficial effect

[0029] The blood collection device provided by the invention is arranged in an array of micro-needle arrays by a plurality of micro-needle micro-needle arrays. In the blood collection, the micro-needle invades the skin tissue of the blood-collected person, because the micro-needle penetration depth is precisely controlled. In the epidermis, without contact with the painful nerves, the drug such as anesthetic is quickly released at this depth, and the skin wound is small. When the anesthesia is completed, the micro-needle is again controlled to enter the capillaries of the dermis to draw blood, and the patient does not feel pain. Achieve painless blood collection.

Brief description of the drawing

DRAWINGS

1 is a schematic structural view of a blood collection device according to an embodiment of the present invention;

2 is a partial structural schematic view of a first microneedle assembly and a second microneedle assembly according to an embodiment of the present invention;

3 is a schematic diagram of a microneedle array arrangement according to an embodiment of the present invention; 4 is a schematic view showing a sealing structure of a blood collection device according to an embodiment of the present invention;

5 is a schematic structural view of a release device of a blood collection device according to an embodiment of the present invention;

6 is a cross-sectional view of a B-B surface of a blood collection device according to an embodiment of the present invention;

7 is an enlarged schematic partial structural view of a B-B cross-sectional view of a blood collection device according to an embodiment of the present invention;

8 is a schematic structural view of a first baffle of a blood collection device according to an embodiment of the present invention;

9 is a schematic structural view of a second deflector of a blood collection device according to an embodiment of the present invention;

10 is an assembled view of a cap and a blood storage structure of a blood collection device according to an embodiment of the present invention;

11 is a schematic view showing a cover structure of a blood collection device according to an embodiment of the present invention;

[0041] FIG. 12 is an assembled view of the internal structure of a blood collection device according to an embodiment of the present invention;

FIG. 13 is a schematic structural diagram of a bottom plate of a blood collection device according to an embodiment of the present invention; FIG.

FIG. 14 is a schematic diagram of an overall structure of another blood collection device according to an embodiment of the present invention; FIG.

15 is a schematic structural diagram of a blood collection control device according to an embodiment of the present invention.

Embodiments of the invention

The present invention will be further described in detail below with reference to the accompanying drawings and embodiments. It is understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

[0046] The blood collection device provided by the embodiment of the invention is arranged in an array of micro-needle arrays with a plurality of tiny micro-needle arrays, wherein the micro-needle has a small diameter and can reach a nanometer level, so that it invades the skin tissue of the blood-collected person. The skin wound formed is very small, so the blood-collecting person does not feel pain at all. In the process of blood collection, the first micro-needle assembly can be precisely controlled to move downward, and the depth of the micro-needle into the skin is painless. The epidermis of the nerve, and the anesthetic is injected into the skin tissue of the blood-collected person, and then the second micro-needle assembly is controlled to move downward, so that the micro-needle is inserted into the dermis layer and blood is drawn under the action of anticoagulant and the like. Therefore, painless blood collection can be further achieved.

[0047] The specific implementation of the present invention will be described in detail below with reference to specific embodiments.

1 to 15, in an embodiment of the present invention, 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 microneedle assembly 1 a first moving structure 3 for injecting an anesthetic into the epidermis; a second moving structure 4 for driving the second microneedle assembly 2 to collect blood from the skin; and communicating with the second microneedle assembly 2 for storing the collected blood Blood storage structure 5.

[0049] In the embodiment of the present invention, during the blood collection, the blood collection device can precisely control the movement of the first movement structure 3 and the second movement structure 4, so that the blood collection device is driven by the first movement structure 3. Next, the first microneedle assembly 1 invades the skin epidermis of the blood-collected person, and injects the anesthetic into the skin epidermis of the blood-collected person through the anesthetic release channel; after the anesthesia is completed, the second motion structure is controlled. Movement, causing the second microneedle assembly 2 to continue deep into the dermis layer of the blood donor to puncture the capillaries or venous blood vessels in the dermis layer, allowing blood to flow out, and collecting blood through the second microneedle assembly 2 The channel performs blood collection and then stores the collected blood in a blood storage structure 5 in communication with the second microneedle assembly 2.

[0050] During the whole blood collection process, since the first microneedle assembly 1 invades the skin epidermis of the blood collector to be insensitive to pain, the blood sampler does not substantially feel pain; and in the first microneedle assembly 1 Invading the epidermis, the anesthetic is injected into the epidermal layer of the blood donor's skin, causing the local nerves in the blood-sucking site to temporarily lose their sensation, especially pain, so that the second micro-needle assembly 2 continues to invade the blood-collected person. The dermis layer is used for blood collection, and the blood collection site is under anesthesia, so that the blood-collected person does not feel pain, and painless blood collection can be achieved.

[0051] In an embodiment of the invention, the first microneedle assembly 1 comprises: a hollow microneedle array 11; an anesthetic storage device 12; and a channel 13 for injecting an anesthetic into the microneedle array. The anesthetic storage device 12 includes: an anesthetic storage chamber 121; an anesthetic release device 122 on the storage chamber; and a sealing structure 123 enclosing the anesthetic in the storage chamber.

[0052] As an embodiment of the present invention, the hollow microneedle array 11 may be a microneedle array fixed on the first microneedle substrate 14, and the microneedle array 11 may be composed of a 100-port single-channel microneedle 111. And these single-channel microneedles 111 can be arranged in a square array of 10 rows and 10 columns according to a preset distance, and can be used for injecting an anesthetic. However, a row or a row of through holes 141 is provided between every two rows or two columns of single-channel microneedles 111. Further, a through hole 141 is formed at a center position of a small square array composed of every four adjacent single-pass micro-needles 111 to form a structure similar to Gomoku. That is, a total of 9*9=81 through holes 14 1 are provided, and the through holes 141 can form a 9*9 square array. [0053] As a preferred embodiment of the present invention, the single-channel microneedle 111 can be fixedly disposed on the protrusion 142 of the first microneedle substrate 14 and the tip end portion of the single-pass microneedle 111 protrudes from the protrusion. Protruding the bottom surface. However, the depth at which the tip portion of the single-pass microneedle 111 protrudes may be set according to the depth of the skin layer of the skin tissue of the blood sampler. For example, the thickness of the epidermis layer of the human body is about 200 μm. Therefore, the single-channel microneedle 11 The depth of the tip portion of 1 can be set to within 200 um so that it can invade and release the anesthetic to a depth of about 200 um at the human epidermal layer, but does not reach the 200 _U m-1000 um capillary-containing dermis layer. Do not pierce the capillaries or venous blood vessels in the skin tissue. Furthermore, the single-channel microneedle 111 has a pinhole diameter which is very small, up to the nanometer level, and the wound formed by the invading skin is very small, and it invades the epidermal layer skin which is insensitive to the pain of the blood collector, so At the stage of releasing the anesthetic, the blood-collected person does not substantially feel the pain. The protrusion 142 can invade the skin tissue in the single-channel microneedle 111, and has a limit function, that is, restricting the depth of penetration of the single-channel microneedle 111, which is advantageous for achieving precise control.

In the embodiment of the present invention, the first microneedle substrate 14 is disposed on the back surface opposite to the needle tip extending surface of the single-pass microneedle 111, and a first deflector 15 is engaged with the first deflector. An aperture 151 corresponding to the through hole 141 of the first microneedle substrate 14 is provided on the 15th, and an anesthetic guide groove 152 corresponding to the single passage microneedle 111 is provided between each row of the holes 151. The first deflector 15 and the first microneedle substrate 14 may be joined by various welding methods such as ultrasonic/hot-melt welding/plasma welding/bonding.

[0055] During the blood collection, the anesthetic can be released from the anesthetic release device 122 on the anesthetic storage chamber 121 into the anesthetic guide trough 152, and then injected through the anesthetic guide trough 152 into its corresponding single-pass microneedle. In the channel 13 of the 111, the needle tip portion of the single-channel microneedle 111 is released into the epidermal layer of the skin tissue of the blood donor to provide an anesthetic effect before blood drawing, and provides a prerequisite for painless blood collection.

[0056] In an embodiment of the present invention, the anesthetic storage device 12 includes an anesthetic storage cavity 121 that is balanced on both sides of the first baffle 15, and the volume of each anesthetic storage cavity 121 is 5-150 uL. Both are used to store anesthetic, that is, the two anesthetic storage chambers 121 can store about 10-300 uL of anesthetic at a time. The dosage of the anesthetic stored in the anesthetic storage chamber 121 is sufficient to meet the requirement of anesthesia before blood drawing, and provides a prerequisite for painless blood collection. In addition, the two balanced anesthetic storage chambers 1 21 can balance the force, thereby ensuring that the first microneedle substrate 14 can be kept moving in a relative horizontal state, and the single-channel microneedles 111 Invading the skin of the blood donor's skin and The depth is basically in a synchronized state, which ensures the release of the anesthetic.

In the embodiment of the present invention, the shape of the anesthetic storage chamber 121 may be a square body, a cylinder or the like, and may be set according to actual conditions, which is not limited herein.

In one embodiment of the present invention, the anesthetic release device 122 may be a one-way valve structure 1221 disposed at the bottom of the anesthetic storage chamber 121. For example, the one-way valve structure 1221 may be a plastic diaphragm type. Check valve. When the anesthetic storage device 12 is pressed by the external force to the skin tissue of the blood sampled person, the one-way valve structure 1221 can be elastically deformed, and a gap occurs at a joint portion with the anesthetic storage chamber 121, and then stored in the anesthetic storage. The anesthetic agent in the cavity 121 can flow into the anesthesia guiding groove 152 of the first baffle 15 along the slit, and is injected into the skin tissue of the blood donor by the passage of the single-pass microneedle 111.

In another embodiment of the present invention, the anesthetic release device 122 may be composed of a soft membrane 1222 and a puncturing needle 1223 disposed at the bottom of the anesthetic storage chamber 121, and the needle tip portion of the puncturing needle 1223 is directly opposite Soft film 1 222. Wherein, the puncturing needle 1223 can be formed on a substrate 124 by injection molding, and the molding process is simple. When the blood collection device is pressed under pressure, the puncturing needle 1223 can pierce the soft membrane 1222, so that the anesthetic agent in the anesthetic storage chamber 121 can be released and flow into the anesthetic guide groove 152, and then The needle tip portion of the single-pass microneedle 111 is released into the skin epidermis of the blood donor.

In a preferred embodiment of the present invention, a safe distance may be set between the soft film 1222 and the puncturing needle 1223, and an anesthetic agent 注入 is injected into the anesthetic storage cavity 121, and the soft film 1222 is subjected to pressure. The function protrudes downward, and the safety distance can prevent the puncture needle 1223 from directly piercing the soft film 1222, thereby causing liquid leakage, and keeping the blood collection device clean and safe.

[0061] As an embodiment of the present invention, after the blood collection device is manufactured, the anesthetic agent may be injected into the anesthetic storage cavity 121 in advance, and then sealed by the sealing structure 123 adapted thereto, so as to avoid The sealed anesthetic is contaminated or spilled by contaminants such as dust during transportation or storage.

[0062] In a preferred embodiment of the present invention, the anesthetic storage chamber 121 is provided as a cylinder. The sealing structure 123 may be a central crucible provided with a mouthpiece 1231 and the anesthetic storage cavity 121. After the anesthetic is injected into the anesthetic storage chamber 121 and sealed, the mouthpiece 1231 can be kept in a state of being released, so that the air pressure in the anesthetic storage chamber 121 is relatively balanced with the external air pressure. In order to avoid the injection of an anesthetic agent, the soft film 1222 is pressed by the inside and outside of the anesthetic storage chamber 121. Poorly protruding downward and being punctured by the punctured needle 1223, the anesthetic agent in the anesthetic storage chamber 121 is released in advance, resulting in waste.

[0063] In another preferred embodiment of the present invention, the sealing structure 123 may be disposed as a centrally extending protruding boss structure, the opening 1231 is located on the boss, and the opening 1231 may be configured as a It is funnel shaped to facilitate the injection of anesthetic and to see if it is spilled. In addition, the edge of the boss structure is an annular groove 1232. During the production process, if the anesthetic is overfilled, it may first flow into the annular groove 1232, and the overflowing anesthetic may be blown off by a spray gun. The anesthetic that avoids spillage directly flows into the interior of the blood collection device, maintaining the overall hygienic state of the blood collection device.

[0064] In the embodiment of the present invention, a sealing cover/seal plug/seal film (not shown) or the like adapted thereto may be disposed on the opening 1231 of the sealing structure 123 to The mouth 1231 is sealed so as to keep the anesthetic from overflowing during storage, transportation and use and to keep it clean and safe.

[0065] In an embodiment of the present invention, when it is necessary to release the anesthetic in the anesthetic storage chamber 121 for anesthesia, the anesthesia storage chamber 121 may be moved downward by manual operation or mechanical control (eg, motor drive). The one-way valve structure is elastically deformed or the piercing needle 1223 can pierce the soft membrane 122 2 such that the anesthetic in the anesthetic storage chamber 121 can flow through the passage in the anesthetic release device 122 to the hollow microneedle array 11 And through the channel 13 of the microneedle array 11 into the epidermal layer of the skin tissue of the human body to achieve anesthesia.

In the embodiment of the present invention, the second microneedle assembly 2 includes: a microneedle array IJ21 composed of a two-channel microneedle 211; a drug storage device 22 that can store a medicament; the dual-channel microneedle 211 includes : The drug can be injected into the drug channel 212 of the microneedle array 21; the blood collection tube 213 can collect blood from the skin.

In an embodiment of the invention, the two-pass microneedle 211 may be a microneedle having two hollow channels, or a microneedle set consisting of two microneedles each having a hollow channel. Among them, one channel can inject the drug into the drug channel 212 of the microneedle array 21, and the other channel is a blood sampling channel 21 that can collect blood from the skin. The microneedle array 21 can be a microneedle array fixed on the second microneedle substrate 23. The microneedle array 23 can be composed of 81-port dual-channel microneedles 211, and arranged in a sequence according to a preset distance. A square array of 9 columns. Further, each of the two-channel microneedles 211 is aligned with the through holes 141 of the first microneedle substrate 14 and the holes 151 of the first deflector 15.

[0068] It should be noted that the arrangement or the number of the single-channel microneedles 11 and the two-channel microneedles 211 may also be Is the other way to set up. For example, the arrangement may be set to a ring-shaped array with a distributed distribution, etc., and may be set according to actual needs, and is not limited herein.

[0069] As a preferred embodiment of the present invention, the microneedle on the first microneedle assembly 1 and the second microneedle assembly 2 can be made of a degradable material with good toughness or good biocompatibility to improve The toughness of the microneedle having a small pore diameter prevents the microneedle from being broken due to poor toughness during the blood collection process, and remains in the blood donor body, thereby causing damage to the body of the blood sampled person. Or even if it remains, it is biocompatible and can be quickly degraded to avoid damage to the body of the blood donor.

In the embodiment of the present invention, the two-channel microneedle 211 can be fixed in the convex structure 231 disposed on the second microneedle substrate 23, and the tip end portion of the two-channel microneedle 211 protrudes from the convex portion. The bottom surface of the structure 231. Wherein, a height difference is formed between a height of the protruding structure 231 extending from the surface of the first microneedle substrate 14 and a height of the protrusion 142 disposed on the first microneedle substrate 14, wherein the height difference is according to the human body. The distribution of the skin epidermis to the dermis is set such that the depth between the epidermis and the dermis of the human body is 200 um to 1000 u m, and the height difference can be set to 200 _U m - 1000 um. The convex structure 231 can be inserted into the human skin tissue 双 in the double-channel microneedle 211 to play a limit position, thereby limiting the depth of the double-channel micro-needle 211 to be inserted, which is convenient for precise control.

[0071] In an embodiment of the present invention, a second baffle 24 is coupled to the back surface of the protruding structure 231 of the second microneedle substrate 23, and the second baffle 24 is provided with the dual path. The drug channel 212 and the blood collection channel 213 in the microneedle 211 correspond to the drug guiding groove 241 and the blood guiding groove 242, respectively. The second deflector 24 and the second microneedle substrate 23 may be joined by various welding methods such as ultrasonic/hot-melt welding/plasma welding/healing.

[0072] In the embodiment of the present invention, the two sides of the second baffle 24 are provided with a drug storage cavity 221 and a blood storage cavity 224; wherein the drug storage cavity 221 can be used for storing blood for assisting blood collection. Agents, for example, vasodilators, anticoagulants, and the like. In the blood collection, due to the action of platelets or coagulation factors, it is easy to cause the blood at the wound of the skin to coagulate or block the microneedle - affecting the progress of blood collection; however, injecting the auxiliary agent at the same time of blood collection can ensure the normal blood collection. get on.

[0073] In one embodiment of the invention, an appropriate amount of anticoagulant and/or vasodilator may also be added to the blood storage chamber 224 so that the blood does not clog too quickly during storage.

[0074] In the embodiment of the present invention, the blood collected by the blood collection channel 213 can be stored in the medicament. The drug release device 222 on the bottom of the reservoir body 221 can be a one-way valve structure 2211, for example, a plastic diaphragm type one-way valve. After the force is elastically deformed, the check valve structure 2211 and the bottom of the drug storage cavity 221 The joint portion forms a slit in which the medicament can flow out of the slit and is injected into the skin tissue of the blood donor through the drug channel 212. Wherein, the bottom of the blood storage chamber 224 is provided with a reverse check valve structure 2241 opposite to the direction of the flow of the check valve structure 2211. The reverse check valve structure 2241 allows only blood to enter the blood storage during blood collection. In the cavity 221, the flow cannot be reversed, and the blood collection can be ensured normally.

In the embodiment of the present invention, the drug storage device 22 further includes a sealing structure 223 for sealing the drug into the drug storage cavity 221, wherein the sealing structure 223 can be disposed by referring to the sealing structure 123. The way of setting up is not repeated here.

[0076] In the embodiment of the present invention, the first microneedle assembly 1 and the second microneedle assembly 2 are alternately stacked, and the staggered stacking manner can facilitate the control of the first microneedle assembly 1 and the second microneedle, respectively. The movement of the component 2 facilitates precise control of the depth of penetration of the microneedles into the skin tissue.

In an embodiment of the invention, the blood collection device further includes an elastic suspension bracket 7 disposed at a bottom of the housing 6 to support the first microneedle assembly 1 and the second microneedle assembly 2. Wherein, the elastic suspension bracket 7:

[0078] a frame 71 composed of a press-deformable elastic arm; a positioning of the micro-needle in the first micro-needle assembly 1 and the second micro-needle member 2 protruding from the micro-needle hole at the bottom of the frame 71 a structure (not shown); a first set of hangers 73 for hanging the first microneedle assembly 1 on both sides of the frame 71; and a frame 71 for hanging the second microneedle assembly The elastic hanging members 74 are disposed on the other sides of the frame body 71, are staggered with the first group of hanging members 73, and have a set height difference from the first group of hanging members 73. Wherein, the set height difference can be set according to the distribution of the skin layer of the human skin to the dermis layer. For example, the skin skin layer thickness of the human body is generally within 200 um, so the set height difference can be set within 200 um. In order to enable the blood collection device to accurately control the depth at which the first set of hangers 73 and the elastic hangers 7 on the frame 71 are pressed against the skin tissue.

In the embodiment of the present invention, when the first set of hangers 73 两侧 on both sides of the frame 71 are pressed, the first set of hangers 73 can be elastically deformed to drive the first microneedle assembly 1 suspended therein. The skin of the human body is organized such that the single-pass microneedle 111 in the first microneedle assembly 1 is inserted into the epidermal layer of the human skin. When the elastic hanging members 74 另 on the other sides of the frame body 7 1 are pressed, the elastic hanging members 74 can be elastically deformed to drive the suspensions suspended therein. The second microneedle assembly 2 is pressed against the skin tissue of the human body, and the two-pass microneedle 211 in the second microneedle assembly 2 is inserted into the dermis layer of the human skin. When the pressure 按压 pressing the first set of hangers 73 and/or the elastic hangers 74 is released, they can return to the position before the initial pressing by the elastic restoring force generated by themselves, and drive the first microneedle assembly 1 and/or the second micro. The needle assembly 2 is placed away from the skin tissue of the blood donor.

[0080] In the embodiment of the present invention, the bottom plate 61 of the housing 6 of the blood collection device is provided with a micro pinhole array 611, so that the micro needles on the first microneedle assembly 1 and the second microneedle assembly 2 can pass. And encapsulating the first microneedle assembly 1 and the second microneedle assembly 2 into the cover 8 of the housing 6. The cover 8 has suspension means (not shown) for suspending the first microneedle assembly 1 and the second microneedle assembly 2, respectively. The cover 8 protects the interior of the blood collection device from external contaminants and maintains the sanitation and cleanliness of the blood collection device.

[0081] The present invention further provides a blood collection device, the blood collection device comprising: a housing 6, the bottom plate 61 of the housing 6 is provided with a micro pinhole array 611; the housing 6 is placed with: an anesthetic release channel a first microneedle assembly 1; a second microneedle assembly 2 having a blood collection channel; a first moving structure 3 for driving the first microneedle assembly 1 to inject an anesthetic into the epidermal layer; and driving the second microneedle assembly 2 from the skin a second moving structure 4 for collecting blood; a blood storage structure 5 for storing the collected blood in communication with the second microneedle assembly 2; an upper portion of the housing 6 having the first microneedle assembly 1 and the second microneedle The assembly 2, the first moving structure 3, the second moving structure 4 and the blood storage structure 5 are enclosed in the cover 8 of the housing 6; the cover 8 has: and the first moving structure 3, the second moving structure 4 Corresponding pressing hole 81.

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 to avoid the cover 8 The casing 6 is slid and dropped during transportation, storage, or sales, and the components inside the casing 6 are contaminated by external dust and the like.

In the embodiment of the present invention, the side of the bottom plate 61 of the casing 6 that is in contact with the skin is also attached with a protective film (not shown) to prevent dust and the like from adhering to the bottom plate of the blood collection device. 61, or the contaminants enter the inside of the blood collection device through the microneedle array hole 611 on the bottom plate 61, and in the blood collection, dust and the like infect the human body from the contact with the human body, so that the use of the blood collection device can be further ensured. And security.

[0084] In an embodiment of the present invention, the blood storage storage structure 5 comprises: a blood storage cavity 51; disposed on the side of the blood storage cavity 51, through a catheter (not shown) and a second set of microneedles a first pipe joint 51 1 and a second pipe joint 512 connected to the assembly 2; a first one-way connected to the first pipe joint 511 and the second pipe joint 512 respectively a valve (not shown), a second check valve (not shown); on a side opposite to the blood storage chamber 51, a reverse check valve is disposed at a position corresponding to the second check valve (not shown in the figure); on the opposite side of the blood storage chamber 51, a position corresponding to the first check valve is provided with a blood drawing hole 513, and the blood drawing hole is provided with a gas permeable impervious portion 514; The venting portion 514 can be connected to the vacuum pump 13 of the external device; on the opposite side of the blood storage chamber 51, a position corresponding to the reverse check valve is provided with a blood discharge hole 515 communicating with the reverse one-way valve; The mouth end of the blood reservoir chamber 51 is sealed with a flexible film (not shown); the outer side of the flexible film is attached with a rigid sheet (not shown).

[0085] In an embodiment of the present invention, the gas permeable, water-impermeable portion 514 mounted on the blood-sucking hole 513 may allow gas to pass through without allowing moisture to pass therethrough, and the external device vacuum pump 13 of the blood collection device may pass through the gas-permeable, water-impermeable portion 5 14 The air in the blood storage chamber 51 is extracted to be in a negative pressure/vacuum environment, and the blood of the human body flows to the blood storage chamber 51 due to the pressure difference, thereby achieving rapid blood collection, shortening the blood sampling time and reducing The pain of the human body. The permeable, water-impermeable portion 514 blocks outside moisture from entering the blood-storing chamber 51, diluting or contaminating the blood sample taken. The gas permeable, water impermeable portion 514 can be a gas permeable, water impermeable film.

In an embodiment of the invention, a flexible film seal is applied to the mouth end of the blood reservoir cavity 51, and a rigid thin plate is attached to the outer side of the flexible film. The rigid sheet can further prevent the blood sample inside the blood reservoir chamber 51 from splashing due to an external force impact during blood collection. The flexible film seal is used 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, and the mouth end of the blood storage cavity 51 can be completely sealed to prevent pollution. The object enters the inside of the blood reservoir cavity 51 from the edge gap of the rigid sheet, thereby further ensuring that the collected blood sample is not contaminated.

[0087] In the embodiment of the present invention, the cover 8 of the blood collection device is provided with a sliding slot 83 connected to the external device, so that the blood collection device can be slidingly pushed and pulled with the external device through the sliding slot 83, similarly The drawer type structure improves the convenience of use of the blood collection device.

[0088] An embodiment of the present invention further provides a blood collection control device, the device comprising: a control board 9; a power source 10 connected to the control board 9; and a control board 9 connected to drive the movement of the first motion structure 3 a first drive assembly 11; a second drive assembly 12 coupled to the control panel 9 for driving movement of the second motion structure 4; a vacuum pump 13 coupled to the control panel 9; a mounting location for the disposable blood collection device. The first driving component 11 and the second driving component 12 are respectively composed of a linear motor and an auxiliary mechanism capable of linear pressing motion. [0089] Wherein, in the embodiment of the present invention, the linear motor can directly convert electrical energy into mechanical motion of linear motion without requiring other intermediate conversion mechanism transmission devices, and has high positioning accuracy, simple structure, and stable motion. , low noise, small friction of moving parts and so on.

[0090] In an embodiment of the invention, the device further comprises a display screen 14 connected to the control panel 9, by which the current blood collection process can be displayed, for example, the current anesthetic can be displayed on the display screen 14. Use the dose, the interval of injection of anesthesia, the volume of blood collection, the location of blood collection, the depth of acupuncture, etc., in order to remind the blood collection staff to adjust or end the blood collection, and improve the efficiency and accuracy of blood collection.

[0091] In an embodiment of the invention, the device further comprises a sound playing device 15 connected to the control panel 9, which can be used to play the process data of the blood collection during the blood collection, for example, the injection of the anesthetic injection, the injection of the anesthetic Dose, microneedle intrusion into the skin, blood flow and other sound data to prompt the blood collection worker to adjust and end the abnormal blood collection, or to instruct the non-professional blood collection worker to perform the correct blood collection procedure For example, the sugar friends can perform blood collection operations and detect blood sugar levels at home according to the blood collection operation steps played by the blood collection device. That is, the versatility and convenience of use of the blood collection device can be further improved.

In the embodiment of the present invention, the device further includes an activation switch 16 connected to the control panel 9. When the blood collection is required, the control panel 9 can control the opening and closing of the activation switch 16 to drive the blood collection device. Perform blood collection or stop blood collection.

[0093] In the embodiment of the present 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 collection device, so that the blood collection device can be fixedly mounted on the mounting position. The blood collection device is avoided, and the blood collection device moves to pull the skin tissue of the blood collector to cause pain; or the blood collection device is not installed in place, and the normal blood collection operation cannot be performed.

[0094] In an embodiment of the present invention, the device further includes a blood collection device releasing a switch (not shown), and when an abnormality occurs during the blood collection or during the blood collection, the blood collection worker can press The release is closed, and the positioning pin/positioning hole is separated from the positioning hole/positioning pin of the blood collection device, so that the blood collection operation can be stopped, thereby ensuring the safety of blood collection and facilitating the abnormality of the blood collection worker during the blood collection process. Adjustment.

[0095] In an embodiment of the invention, the device further includes a fixed structure that can fix the device to the arm ( Not shown in the figure). The fixing structure may be a structure such as a bandage, a Velcro, a buckle structure or the like. In the blood collection, the blood collection device can be fixed to the blood donor's arm through the fixed structure, and the blood collection device can be prevented from being displaced during the blood collection process and involved in the skin tissue of the blood-collected person, thereby increasing the pain. Further improving the convenience of use of the blood collection device.

[0096] In the embodiment of the present invention, the device can be configured as a watch type structure, and the device is small in size, and can be made into a U disk having a length X of 50×18, and the whole device is very compact and can be worn on the hand. It is very convenient to carry out blood collection. Moreover, the blood collection device of the watch type structure is used for blood collection, and the microneedle provided inside the device is not seen in the whole process, which can reduce the fear of the blood collection person (especially a child), so This can, to a certain extent, reduce the difficulty of the blood collection worker to increase blood collection because of the resistance of the blood collector. In addition, during the blood collection process, the blood collection device does not see blood during the blood drawing, which can be easily performed for some blood-sucking blood collectors.

[0097] In an embodiment of the invention, the device further comprises an attention transfer device 17 coupled to the control panel 9, the attention transfer device 17 may be a video/music player, a picture display, a game machine, aroma Release the device, in the blood collection, you can play some videos/music, pictures, games, etc. to attract the attention of the blood collector, so that the blood collector (especially the child) can watch videos, pictures or play games. In the process of easily completing the blood draw, without crying, reducing the trouble of blood collection workers to collect blood.

[0098] The blood collection device provided by the present invention comprises a microneedle array composed of a plurality of micro-needle (nano-scale) microneedles arranged in an orderly manner, and the micro-needle invades the skin tissue of the blood-collected person, and the skin wound formed by the micro-needle is very small. The blood-collected person does not feel pain at all; and in the blood collection, the anesthetic can be released into the epidermal layer of the skin tissue of the blood-collected person through the anesthetic release device, and blood is drawn after the anesthesia is completed, so that the pain can be further achieved. Blood collection; blood-sucking colleagues inject anticoagulant and other drugs into the skin tissue of the human body to assist blood collection to ensure the normal blood collection. In addition, the blood collection device is a disposable detachable structure, which is convenient to install and use, and effectively ensures that blood is not cross-contaminated due to sharing of a blood collection needle, etc., and the collected blood is also ensured. The sample is not contaminated and affects the final test result judgment.

The above description is only the preferred embodiment of the present invention, and is not intended to limit the present invention, and any modifications, equivalents, and improvements made within the spirit and scope of the present invention should be included in the present invention. Within the scope of protection of the invention.

Claims

Claim

A blood collection device, characterized in that: the blood collection device comprises: a first microneedle assembly having an anesthetic release channel;

a second microneedle assembly having a blood collection channel;

a first moving structure for driving the first microneedle assembly to inject an anesthetic into the epidermal layer; a second moving structure for driving the second microneedle assembly to collect blood from the skin; and communicating with the second microneedle assembly for A blood storage structure that stores the collected blood. The blood collection set according to claim 1, wherein said first microneedle assembly comprises a hollow microneedle array;

Anesthetic storage device;

An anesthetic is injected into the channel of the microneedle array.

The blood collection set according to claim 2, wherein said anesthetic storage device comprises:

Anesthetic storage chamber;

An anesthetic release device located on the storage cavity;

The anesthetic is enclosed in a sealed structure of the storage cavity.

The blood collection set according to claim 1, wherein said second microneedle assembly comprises a microneedle array consisting of two-channel microneedles;

a drug storage device that can store a medicament;

The dual channel microneedles include:

The agent can be injected into the drug channel of the microneedle array;

A blood collection channel that collects blood from the skin.

[Claim 5] The blood collection device according to claim 4, wherein the drug storage device comprises a drug storage cavity;

An agent release device that is positioned on the drug storage cavity to release the agent. [Claim 6] The blood collection device according to claim 5, wherein the drug storage device further comprises:

The medicament can be enclosed in a sealed structure of the medicament storage cavity.

[Claim 7] The blood collection device according to claim 4, wherein the two-channel microneedle is a microneedle having two hollow passages, or a microneedle composed of two microneedles each having a hollow passage group.

[Claim 8] The blood collection set according to claim 1, wherein the first microneedle assembly and the second microneedle assembly are alternately stacked.

[Claim 9] The blood collection device according to claim 1, wherein the blood collection device further comprises an elastic suspension disposed at a bottom of the housing to support the first microneedle assembly and the second microneedle assembly support.

[Claim 10] The blood collection device according to claim 9, wherein the elastic suspension bracket comprises a frame body composed of a press-deformable elastic arm;

a positioning structure located at a bottom of the frame body for extending micro needles in the first microneedle assembly and the second microneedle assembly from the microneedle hole;

a first set of hanging members for hanging the first microneedle assembly on the two sides of the frame; a resilient hanging member for hanging the second microneedle assembly, the elastic hanging member And disposed on the other sides of the frame body, staggered with the first group of pendants, and having a set height difference from the first group of pendants.

[Claim 11] The blood collection device according to claim 1, wherein the blood collection device further includes a housing, the housing bottom plate is provided with an array of micro pinholes, and the first microneedle assembly And a second microneedle assembly is encapsulated into the cover of the housing.

[Claim 12] A blood collection device, wherein the blood collection device comprises:

a housing, the bottom plate of the housing is provided with an array of micro pinholes;

The housing is placed with:

a first microneedle assembly having an anesthetic release channel;

a second microneedle assembly having a blood collection channel; Driving the first microneedle assembly to inject a first moving structure of an anesthetic into the epidermal layer;

Driving a second movement structure of the second microneedle assembly to collect blood from the skin;

a blood storage structure for storing the collected blood in communication with the second microneedle assembly; the upper portion of the housing having the first microneedle assembly, the second microneedle assembly, the first motion structure, and the second a moving structure and a blood storage structure encapsulating the cover of the housing; the cover having:

a pressing hole corresponding to the first moving structure and the second moving structure.

[Claim 13] The blood collection device according to claim 12, wherein the cover further has a fixed pin/positioning hole.

[Claim 14] The blood collection device according to claim 12, wherein a protective film is attached to a side of the bottom plate of the casing that is in contact with the skin.

[Claim 15] The blood collection device according to claim 2, wherein the blood storage structure comprises

Blood storage chamber;

a first tube joint and a second tube joint disposed on one side of the blood storage chamber and communicating with the second group of microneedle assemblies through a conduit;

a first check valve and a second check valve respectively connected to the first pipe joint and the second pipe joint

a reverse check valve is disposed at a position corresponding to the second one-way valve on a side opposite to the blood storage chamber;

a blood-sucking hole is disposed at a position corresponding to the first one-way valve on a side opposite to the blood-storing cavity, and the blood-sucking hole is provided with a gas-permeable and impervious portion;

The permeable water-impermeable portion may be connected to a vacuum pump of an external device; on a side opposite to the blood-storing chamber, a position corresponding to the reverse one-way valve is provided with blood venting in communication with the reverse one-way valve a hole; the mouth end of the blood storage cavity is sealed with a flexible film;

A rigid sheet is attached to the outer side of the flexible film.

[Claim 16] The blood collection device according to claim 12, wherein the cover is provided with an outer The chute to which the device is connected.

A blood collection control device, characterized in that the device comprises:

Control panel

a power source connected to the control board;

a first driving component coupled to the control panel to drive movement of the first moving structure; a second driving component coupled to the control panel to drive movement of the second moving structure; a vacuum pump coupled to the control panel;

A mounting position for a disposable blood collection device can be installed.

The blood collection control apparatus according to claim 17, wherein said first drive unit and said second drive unit are each composed of a linear motor and an auxiliary mechanism that can perform linear pressing motion.

A blood collection control apparatus according to claim 17, wherein said blood collection control apparatus further comprises a display screen connected to said control panel.

A blood collection control apparatus according to claim 17, wherein said blood collection control apparatus further comprises a sound playback apparatus connected to said control board.

A blood collection control apparatus according to claim 17, wherein said blood collection control apparatus further comprises an activation switch connected to said control panel.

A blood collection control apparatus according to claim 17, wherein said mounting position is provided with a positioning pin/positioning hole corresponding to a positioning hole/positioning pin on the blood collection device.

The blood collection control device according to claim 17, wherein the device further comprises a blood collection device release switch, the release pin is pressed, the positioning pin/positioning hole and the positioning hole of the blood collection device/ The locating pin is detached.

The blood collection control apparatus according to claim 17, wherein said blood collection control device further comprises a fixing structure for fixing said device to the arm.

A blood collection control apparatus according to claim 17, wherein said blood collection control device is a watch type structure.

A blood collection control apparatus according to claim 17, wherein said blood collection control apparatus further comprises an attention transfer means connected to said control board. 81

Z6L60/LlOZ l3/13d Z9CCC0/6T0Z OAV