CN116585606A - Self-adjustable microneedle patch for local anesthesia - Google Patents

Self-adjustable microneedle patch for local anesthesia Download PDF

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Publication number
CN116585606A
CN116585606A CN202310711709.1A CN202310711709A CN116585606A CN 116585606 A CN116585606 A CN 116585606A CN 202310711709 A CN202310711709 A CN 202310711709A CN 116585606 A CN116585606 A CN 116585606A
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China
Prior art keywords
module
drug delivery
drug
microneedle
medicine
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CN202310711709.1A
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Chinese (zh)
Inventor
赵婉晴
刘庆冬
王志龙
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Laixiong Health Technology Weihai Co ltd
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Laixiong Health Technology Weihai Co ltd
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Priority to CN202310711709.1A priority Critical patent/CN116585606A/en
Publication of CN116585606A publication Critical patent/CN116585606A/en
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    • 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
    • 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
    • A61M2037/0023Drug applicators 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
    • 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
    • A61M2037/0046Solid microneedles

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Informatics (AREA)
  • Dermatology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

The invention discloses a self-adjustable local anesthetic microneedle patch, which comprises a plurality of microneedle heads, a base part, a drug delivery assembly and a control system, wherein a fine needle hole is formed at the needle tip of each microneedle head, a cavity for containing drugs is formed inside each microneedle head, the base part is a thin plate, the drug delivery assembly is in a convex arch shape, the drug delivery assembly is adhered to the upper surface of the base part and extends from one end to the other end of the base part, and the control system is connected with a drug storage device and/or a drug delivery pump and is used for controlling and adjusting the flow rate of the drugs. The invention improves the regulation and control capability and comprehensive applicability of the microneedle patch, realizes the controllable regulation of the drug release rate and the release dosage, has more compact and reasonable structural layout and wider application, and greatly meets the higher and more comprehensive personalized requirements of people on the microneedle patch for anesthesia.

Description

Self-adjustable microneedle patch for local anesthesia
Technical Field
The invention relates to the technical field of medical equipment, in particular to a self-adjustable microneedle patch for local anesthesia, which is suitable for local anesthesia before operation, pain treatment, chronic disease treatment and the like, and an application object is local skin, tissue or organ.
Background
Along with the continuous development of medical technology, the anesthesia technology is continuously updated and improved, and the traditional anesthesia mode has a plurality of problems such as the need of operation of a professional doctor, difficult control of medicine dosage, larger side effects of medicines and the like. Therefore, research and development of a self-adjustable microneedle patch for anesthesia becomes a current hot research direction. The microneedle patch for anesthesia is a novel local anesthesia technology based on microneedle technology, and the technology has been widely applied to operations and treatments of parts of the oral cavity, nose, ears, eyes and the like. In the oral cavity field, the microneedle patch for anesthesia can be used for operations such as tooth cosmetology, tooth restoration, tooth implantation and the like, and in the nose field, the microneedle patch for anesthesia can be used for operations such as nasosinusitis, nasal polyp and the like; in the ear field, the microneedle patch for anesthesia can be used for operations such as earring manufacturing, ear hole filling and the like; in the field of eyes, the microneedle patch for anesthesia can be used for myopia, hyperopia, astigmatism and other operations. In general, microneedle patches consist of a series of microneedles, each of a few millimeters in diameter, that stimulate the skin to produce a local anesthetic effect. The microneedle patch can control the anesthetic effect by adjustable dosage and frequency, and can also be adapted to different skin types and operation types by changing the microneedle patch. It is easy to see that the self-adjustable micro-needle patch for anesthesia is a novel anesthesia mode, and the micro-needle patch is used for directly conveying medicines into subcutaneous tissues, so that the accurate control of the medicines is realized, and the side effects of the medicines are reduced. Meanwhile, the self-adjustable microneedle patch for anesthesia has the advantages of being simple in operation, free of operation of a professional doctor, controllable in drug release time and the like, and therefore attention is paid.
According to the shape of the microneedle patch and the property of the medicine, the self-adjustable microneedle patch for anesthesia can be divided into different types, such as needle-shaped microneedle patch, sheet-shaped microneedle patch, spherical microneedle patch and the like, however, when the existing microneedle patch for anesthesia is generally used, the release rate and the release amount of the medicine cannot be adjusted according to the specific condition of a patient, and the release time and the release mode of the medicine cannot be adjusted according to the specific condition of the patient, so that a more reasonable adjusting and controlling mode of the structure needs to be researched, the adjusting capability of the microneedle patch in terms of dosage, frequency and the like is improved, the drug effect and the safety of the anesthetic medicine are ensured, the persistence and the stability of the anesthetic effect are ensured, and the operability and the convenience in clinical application are ensured. And the method can be widely applied and expanded in the application field, and the applicability is improved.
Therefore, on the premise of comprehensively considering factors such as stability, biocompatibility, drug release control, operation convenience and the like, how to better regulate the release rate and the release dosage of the microneedle patch drug, obtain a more reasonable regulation control mode, ensure the persistence and the stability of an anesthesia effect and become the problem to be solved urgently at present, so the invention provides a self-adjustable microneedle patch for local anesthesia, and the regulation control capability and the comprehensive applicability of the microneedle patch are improved.
Disclosure of Invention
The invention aims to provide a self-adjustable local anesthetic microneedle patch, which solves the problems in the prior art, has better controllability, safety stability and operation convenience, can adjust the drug release rate and release dosage in real time and perform sustainable control, has more compact and reasonable structural layout and wider application, and greatly meets the higher and more comprehensive personalized requirements of people on the anesthetic microneedle patch.
In order to achieve the above object, the present invention provides a self-adjustable microneedle patch for local anesthesia, comprising a plurality of microneedles, a base portion, a drug delivery assembly and a control system, wherein the tips of the microneedles are provided with a fine needle hole, a cavity for accommodating a drug is formed inside the microneedles, the fine needle hole penetrates through the cavity in the longitudinal direction of the microneedles, the plurality of microneedles are arranged on the lower surface of the base portion, and a through hole communicating with the fine needle hole is formed in the base portion, the drug delivery assembly is in a convex arch shape in the middle, the drug delivery assembly is adhered or movably connected to the upper surface of the base portion and extends from one end to the other end of the base portion, the drug delivery assembly comprises an elastic shrinkage film, a drug storage cavity, a connection protrusion member, a filtering film and a protective barrier, the drug delivery assembly is connected to a drug storage and/or a drug delivery pump through a delivery catheter, the drug storage cavity or the drug delivery pump is used for delivering a drug (e.g. an anesthetic) to the drug delivery assembly, and further through the filtering film is formed to the internal cavity of the microneedles, the drug delivery assembly is connected to local anesthetic and the drug delivery system is realized by regulating the flow rate of the drug to the local anesthetic and/or the drug delivery system.
Further, the middle of the elastic shrink film is convex and is in a nearly semicircular shape, the elastic shrink films are connected with each other through a connecting convex component, each elastic shrink film covers a group of micro needles, and the number of the micro needles in each group is preferably 5-16; the elastic shrink film is made of an elastic polymeric material.
Furthermore, the medicine storage cavity of the medicine conveying component is internally provided with a water absorbing material (such as sponge), the water absorbing material is matched with a filtering membrane to play a role in buffering medicines, the dosage caused by abrupt excessive conveying or just starting conveying of the medicines is avoided from being suddenly increased, the medicine quantity is conveyed to be more moderate and uniform, meanwhile, the filtering membrane can also slowly release the medicines, and meanwhile, other substances in the medicine storage cavity are prevented from entering the inner cavity of the micro needle head, so that the medicine use safety is ensured.
Further, the plurality of micro needles have sharp ends to facilitate penetration of the stratum corneum of the skin and penetration into local tissues of the human body, preferably have a conical or polygonal shape including rectangular pyramid, pentagonal pyramid, hexagonal pyramid, and the like.
Further, in order to avoid the skin penetration to cause a strong pain of the patient, an elastic spacer may be disposed between each adjacent microneedle, and the elastic spacer occupies 40-60% of the length of the microneedle in a natural state, thereby enabling the free end surface of the elastic spacer to form an effective surface of the microneedle patch, and the tip of the microneedle protrudes out of the effective surface, so that the elastic spacer may play a role in buffering the penetration after the microneedle is inserted into the local tissue of the human body. Preferably, the resilient spacer may be integrally formed with the microneedle, such as by being integrally formed of the same polymeric material during compression molding, or may be a unitary structure of different materials secured by bonding.
Preferably, the microneedle patch can be rectangular, square, round, pea-shaped, etc. according to the application position, so as to adapt to local anesthesia.
Preferably, for drug treatment and intervention with the above microneedle patch, the microneedle patch of the present invention can be applied to other mammals (e.g., monkey, sheep, horse, dog, cat, rabbit, rat, mouse, etc.) in addition to human.
Further, the control system comprises a first processor, a timing module, a drug delivery module, a display, a man-machine interaction module, a first wireless transceiver module, a liquid measurement assembly, a mechanical compression module or a delivery pump, a first calculation module and a storage module. The device comprises a timing module, a drug delivery module, a display, a man-machine interaction module, a first wireless transceiver module, a liquid measurement assembly, a mechanical compression module, a first calculation module and a storage module, wherein the timing module, the drug delivery module, the display, the man-machine interaction module, the first wireless transceiver module, the liquid measurement assembly, the mechanical compression module, the first calculation module and the storage module are all connected with a first processor. The drug delivery module may be a drug delivery assembly comprising the drug reservoir and/or a drug delivery pump.
The mechanical compression module may be a compression plate or other suitable pressure accumulating member for generating a continuous squeezing force on the drug delivery assembly or reservoir, and during a particular operation, medical personnel may issue a squeezing drug delivery command via the man-machine interaction module, and the first processor receives the drug delivery command and controls the mechanical compression module to squeeze the drug delivery assembly or reservoir.
The liquid measurement assembly comprises a second processor, a hydraulic detector, a second wireless transceiver module and a second calculation module; the second wireless transceiver module, the hydraulic detector and the second calculation module are all connected with the second processor. The hydraulic pressure detector is used for detecting the dosage of the liquid medicine in the medicine storage cavity of the medicine conveying component and sending a dosage detection signal to the second processor, and the hydraulic pressure detection signal is the pressure of the liquid medicine in the medicine storage cavity of the medicine conveying component. The second processor receives the liquid medicine detection signal and sends the liquid medicine detection signal to the second calculation module, and the second calculation module is used for calculating the dosage of the liquid medicine in the medicine storage cavity of the medicine conveying assembly. The specific calculation process is that a first pressure threshold value of a medicine storage cavity of the medicine conveying assembly is preset in the second calculation module, and the dosage of the liquid medicine is calculated through the first pressure threshold value and the actual hydraulic pressure.
Medical staff controls the first processor to send a calibration signal through the man-machine interaction module; the first processor receives the calibration signal and sends out the calibration signal, the timing module receives the calibration signal and starts timing, at this moment, the display time starts timing from 0", the delivery pump in the drug delivery module receives the calibration signal and delivers the liquid medicine in the drug storage device to the drug storage cavity of the drug delivery assembly, the hydraulic detector (for example, a pressure sensor) detects the liquid pressure of the liquid medicine in the drug storage cavity of the drug delivery assembly and sends out a hydraulic detection signal to the second processor, the second processor receives the hydraulic detection signal and sends out the hydraulic detection signal to the second calculation module, the second calculation module receives the hydraulic detection signal and calculates the residual quantity of the liquid medicine in the drug storage cavity of the drug delivery assembly, when the liquid medicine dosage in the drug storage cavity of the drug delivery assembly reaches a preset first pressure threshold, the second calculation module sends out a stop signal, and the second processor receives the stop signal and controls the second wireless transceiver module to send out the stop signal; the first wireless receiving and transmitting module receives the stop signal and transmits the stop signal to the first processor, and the first processor receives the stop signal and controls the conveying pump to stop working and simultaneously controls the timing module to continue timing. If the dosage of the liquid medicine in the medicine storage cavity of the medicine conveying component is lower than a second preset value, the second calculating module sends out a starting signal, and the second processor receives the starting signal and controls the second wireless receiving and transmitting module to send out the starting signal; the first wireless receiving and transmitting module receives the starting signal and transmits the starting signal to the first processor, and the first processor receives the starting signal and controls the conveying pump to start working and simultaneously controls the timing module to continue timing. The first threshold is the highest value of the dosage of the liquid medicine, and when the first threshold exceeds the highest value, the flow rate of the liquid medicine is excessively high, so that potential safety hazards are caused; the second preset value is the lowest value of the liquid medicine dosage, and when the second preset value is lower than the lowest value, the liquid medicine dosage in the medicine storage cavity of the medicine conveying assembly is too small, and the delivery, slow release and normal exertion of the medicine effect can be affected.
The method comprises the steps that when the dosage of liquid medicine in a medicine storage cavity of a medicine delivery assembly changes (the liquid medicine is delivered to an inner cavity of a micro needle through a filtering membrane and is delivered to local tissues of a human body through a fine needle hole), a hydraulic detector sends a hydraulic detection signal to a second processor, the second processor receives the hydraulic detection signal and sends the hydraulic detection signal to a second calculation module, the second calculation module receives the hydraulic detection signal and calculates the dosage of the liquid medicine in the medicine storage cavity of the medicine delivery assembly, a first dosage signal is sent, the second processor receives the first dosage signal and controls a second wireless transceiver module to send the first dosage signal, the first wireless transceiver module receives the first dosage signal and sends the first dosage signal to the first processor, the first processor receives the first dosage signal and sends the first calculation module, the first time period signal corresponds to the first dosage signal, the first processor receives the first time period signal and sends the first calculation module, and the first calculation module receives the first dosage signal and the first time period signal, and calculates the flow of the liquid medicine in the medicine storage cavity of the medicine delivery assembly; the first computing module sends out a flow signal; the first processor receives the flow signal, controls the display to display the number contained in the flow signal, and controls the storage module to store the flow signal. From this, through the operating time of timing module record medicine delivery module, measure the liquid medicine volume that the medicine delivery module carried the liquid medicine to the survey in the liquid component through survey liquid component, calculate the liquid medicine volume that the medicine delivery module carried the liquid medicine to survey liquid component and the operating time of medicine delivery module and obtain the flow or the velocity of flow of liquid medicine to the flow of accurate demarcation liquid medicine to a certain extent through first calculation module.
In addition, as a preference, in order to facilitate storage and use, the invention also provides a storage box for storing the microneedle patch, the storage box consists of a main shell, an auxiliary shell and a connecting piece, one end of the connecting piece is fixed with the auxiliary shell, the other end of the connecting piece is hinged with the main shell, the auxiliary shell rotates around the main shell through the connecting piece, the two ends of the main shell are respectively provided with a microneedle storage end and a plug end, the main shell is provided with a slot for inserting the microneedle storage end and the plug end, the main shell and the auxiliary shell are both made of hard materials, and can be used as a small operation table when the main shell and the auxiliary shell are connected into a whole through the plug end, for example, the storage box is used for placing medicines, surgical instruments or pathological sections.
Compared with the prior art, the invention has the following beneficial technical effects:
by adopting the technical scheme, the technical problems of the microneedle patch in the aspects of dosage, frequency adjustment, lack of continuity and stability of anesthetic effect, safety of anesthetic medication and the like in the prior art are solved, the invention creatively provides the microneedle patch for local anesthesia, which comprises a plurality of microneedles, a base part, a drug delivery assembly, a control system and the like, wherein the drug delivery assembly comprises an elastic contraction film, a drug storage cavity, a connecting bulge member, a filtering film and a protective blocking sheet, is connected to a drug storage device and/or a drug delivery pump through a delivery catheter so as to deliver anesthetic to the drug storage cavity of the drug delivery assembly, and further is delivered to the internal cavity of the microneedles through the filtering film, and the drug liquid is delivered into local tissues of a human body through a fine needle hole, so that local anesthetic administration is realized; the flow rate of the medicine is controlled and regulated through the control system, and the carrying and the operation are more convenient through the setting of the storage box. The adjusting and controlling capability and the comprehensive applicability of the microneedle patch are improved through the synergistic effect of the structures and the details thereof, the controllable adjustment of the drug release rate and the release dosage is realized, the structural layout is more compact and reasonable, the application is wider, and the higher and more comprehensive personalized requirements of people on the microneedle patch for anesthesia are greatly met. The structure and the system of the invention are reasonably matched to form an organic whole, the defects existing in the prior art are overcome by the synergistic effect, and the good sustainable regulation effect of the microneedle patch is realized.
Drawings
FIG. 1 is a schematic view showing the structure of a microneedle patch for local anesthesia according to example 1 of the present invention;
FIG. 2 is a schematic diagram showing the structure of a microneedle patch according to example 1 of the present invention for injecting a drug into the skin;
FIG. 3 is a schematic view of a partial structure of a microneedle patch according to an embodiment of the present invention coupled to a drug reservoir and/or drug delivery pump;
FIG. 4 is a system schematic diagram of a microneedle patch control system of the present invention;
FIG. 5 is a schematic illustration of the structure of different microneedles in a microneedle patch of the present invention;
FIG. 6 is a lateral side view of an alternative microneedle patch of the present invention;
fig. 7 is a schematic view of the structure of a pea-like microneedle patch of the present invention;
FIG. 8 is a schematic view of a microneedle patch container of the present invention;
fig. 9 is a schematic structural view of a drug delivery assembly having an intermediate recess in another embodiment of the present invention.
Detailed Description
The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. All other related embodiments, which can be made by those skilled in the art without inventive effort, are intended to be within the scope of the present invention, based on the embodiments of the present invention.
Example 1
Referring to fig. 1-4, the self-adjustable local anesthetic microneedle patch 200 provided by the present invention comprises a plurality of microneedles 210, a base portion 220, a drug delivery assembly 230, a control system 240, and the like, wherein a fine needle hole 212 is formed at the tip of the microneedle 210, a cavity for accommodating a drug is formed inside the microneedle 210, the fine needle hole 212 penetrates through the cavity along the longitudinal direction of the microneedle 210, the plurality of microneedles 210 are arranged on the lower surface of the base portion 220, a through hole communicating with the fine needle hole 212 is formed in the base portion 220, the base portion 220 is a thin plate, the drug delivery assembly 230 is in a convex arch shape in the middle, the drug delivery assembly 230 is adhered or movably connected to the upper surface of the base portion 220, and extends from one end of the base portion 220 to the other end, the drug delivery assembly 230 includes an elastic contractile membrane 231, a drug storage cavity 233, a connection protrusion member 234, a filter membrane 235, and a protective barrier 236, the drug delivery assembly 230 is connected to a drug storage and/or a drug delivery pump 70 through a delivery catheter, the drug storage or drug delivery pump 70 is used for delivering a drug (e.g., an anesthetic) to the drug storage cavity 233 of the drug delivery assembly 230, and further is delivered to the interior cavity of the microneedle 210 through the filter membrane 235, the drug solution is delivered into the local tissue (e.g., skin) 222 of the human body via the fine needle hole 212, local anesthetic administration is achieved, and the control system 240 is connected to the drug storage and/or the drug delivery pump 70 for controlling and adjusting the flow rate of the drug.
Further, in this embodiment, the elastic shrink film 231 is centrally protruded and has a nearly semicircular shape, and the plurality of elastic shrink films 231 are connected to each other by the connection protrusion member 234, and each elastic shrink film 231 covers one set of micro needles 210, and the number of each set of micro needles 210 is preferably 5-16; the elastic shrink film 231 is made of an elastic polymeric material.
Further, the medicine storage cavity 233 of the medicine delivery assembly 230 is provided with a water absorbing material (such as sponge), which cooperates with the filtering membrane 235 to play a role in buffering the medicine, so as to avoid abrupt increase of dosage caused by abrupt excessive delivery or just starting delivery of the medicine, and to make the medicine delivery become more gentle and uniform, and meanwhile, the filtering membrane 235 can also prevent other substances in the medicine storage cavity 233 from entering the inner cavity of the micro needle 210 while slowly releasing the medicine, thereby ensuring the medication safety.
In this embodiment, an interface is provided on one end side wall of the drug delivery assembly 230, to which the reservoir and/or drug delivery pump 70 is connected via a delivery conduit, thereby enabling communication of the drug delivery assembly 230 with the reservoir and/or drug delivery pump 70.
Further, as shown in connection with fig. 5, the plurality of micro needles 210 have sharp ends to facilitate penetration of the stratum corneum of the skin and penetration into the local tissue 222 of the human body, and preferably have a conical or polygonal shape including rectangular pyramid, pentagonal pyramid, hexagonal pyramid, etc.
Further, as shown in fig. 6, in order to avoid the skin penetration to cause a strong pain to the patient, an elastic spacer 30 may be disposed between each adjacent microneedle 210, and the elastic spacer 30 occupies 40-60% of the length of the microneedle 210 in a natural state, so that the free end surface of the elastic spacer 30 forms an effective surface 32 of the microneedle patch 200, and the tip of the microneedle 210 protrudes from the effective surface 32, so that the elastic spacer 30 can play a role of buffering the penetration after the microneedle 210 is inserted into the local tissue 222 of the human body. Preferably, the resilient spacer 30 may be integrally formed with the microneedle 210, such as by being integrally formed of the same polymeric material during compression molding, or may be a unitary structure with different materials secured by bonding.
Preferably, the microneedle patch 200 may be configured in a rectangular, square, round, pea-like shape, etc. according to the application site, so as to be suitable for local anesthesia, and as shown in fig. 7, the microneedle patch 200 is pea-like for local anesthesia of the tongue, eyes, nose, joints, etc.
Further, as shown in fig. 3, the application of a squeezing force to the reservoir 70 to contract the volume of the reservoir 70 and force the drug solution from the reservoir 70 through the delivery catheter and into the drug storage chamber 233 in the direction of flow indicated by arrow 74 is indicated by the thick arrow 72.
Preferably, for drug treatment and intervention with the above microneedle patch, the microneedle patch of the present invention can be applied to other mammals (e.g., monkey, sheep, horse, dog, cat, rabbit, rat, mouse, etc.) in addition to human.
Further, as shown in fig. 4, the control system 240 includes a first processor 1, a timing module 2, a drug delivery module 3, a display 4, a man-machine interaction module 5, a first wireless transceiver module 6, a liquid measurement assembly 7, a mechanical compression module or delivery pump 8, a first calculation module 9, and a storage module 10. The timing module 2, the drug delivery module 3, the display 4, the man-machine interaction module 5, the first wireless transceiver module 6, the liquid measurement assembly 7, the mechanical compression module 8, the first calculation module 9 and the storage module 10 are all connected with the first processor 1. The drug delivery module 3 may be a drug delivery assembly 230 comprising the drug reservoir and/or drug delivery pump 70.
The mechanical compression module 8 may be a compression plate or other suitable extrusion for generating a continuous extrusion force against the drug delivery assembly 230 or the drug reservoir 70, and during a particular operation, medical personnel may issue extrusion drug delivery commands via the human-machine interaction module 5, and the first processor 1 receives the drug delivery commands and controls the mechanical compression module 8 to extrude the drug delivery assembly 230 or the drug reservoir 70.
The liquid measuring assembly 7 comprises a second processor, a hydraulic detector, a second wireless transceiver module and a second calculation module; the second wireless transceiver module, the hydraulic detector and the second calculation module are all connected with the second processor. The hydraulic pressure detector is used for detecting the dosage of the liquid medicine in the medicine storage cavity 233 of the medicine delivery assembly 230 and sending a dosage detection signal to the second processor, wherein the hydraulic pressure detection signal is the pressure of the liquid medicine in the medicine storage cavity 233 of the medicine delivery assembly. The second processor receives the liquid medicine detection signal and sends the liquid medicine detection signal to a second calculation module, and the second calculation module is used for calculating the dosage of the liquid medicine in the medicine storage cavity 233 of the medicine delivery assembly. The specific calculation process is that a first pressure threshold value of a medicine storage cavity of the medicine conveying assembly is preset in the second calculation module, and the dosage of the liquid medicine is calculated through the first pressure threshold value and the actual hydraulic pressure.
Medical staff controls the first processor 1 to send out a calibration signal through the man-machine interaction module 5; the first processor 1 receives the calibration signal and sends the calibration signal, the timing module 2 receives the calibration signal and starts timing, at this time, the display time starts timing from 0, the delivery pump in the drug delivery module 3 receives the calibration signal and delivers the drug solution in the drug storage 70 to the drug delivery component drug storage cavity 233, the hydraulic detector (for example, a pressure sensor) detects the hydraulic pressure of the drug solution in the drug delivery component drug storage cavity 233 and sends a hydraulic pressure detection signal to the second processor, the second processor receives the hydraulic pressure detection signal and sends the hydraulic pressure detection signal to the second computing module, the second computing module receives the hydraulic pressure detection signal and computes the residual amount of the drug solution in the drug delivery component drug storage cavity 233, and when the drug solution dosage in the drug delivery component drug storage cavity 233 reaches the preset first pressure threshold, the second computing module sends a stop signal, and the second processor receives the stop signal and controls the second wireless transceiver module to send the stop signal; the first wireless transceiver module receives the stop signal and sends the stop signal to the first processor 1, and the first processor 1 receives the stop signal and controls the conveying pump to stop working and simultaneously controls the timing module 2 to continue timing. If the dosage of the liquid medicine in the medicine storage cavity 233 of the medicine conveying component is lower than a second preset value, the second calculating module sends out a starting signal, and the second processor receives the starting signal and controls the second wireless receiving and transmitting module to send out the starting signal; the first wireless transceiver module 6 receives the start signal and sends the start signal to the first processor 1, and the first processor 1 receives the start signal and controls the start of the delivery pump and controls the timing module 2 to continue timing. The first threshold is the highest value of the dosage of the liquid medicine, and when the first threshold exceeds the highest value, the flow rate of the liquid medicine is excessively high, so that potential safety hazards are caused; the second preset value is the lowest value of the liquid medicine dosage, and when the second preset value is lower than the lowest value, the liquid medicine dosage in the medicine storage cavity of the medicine conveying assembly is too small, and the delivery, slow release and normal exertion of the medicine effect can be affected.
To change the dosage of the liquid medicine in the medicine storage cavity 233 of the medicine delivery component (the liquid medicine is delivered to the inner cavity of the micro needle through the filtering membrane and is delivered to the local tissue of the human body through the fine needle hole), the hydraulic detector sends a hydraulic detection signal to the second processor, the second processor receives the hydraulic detection signal and sends the hydraulic detection signal to the second calculating module, the second calculating module receives the hydraulic detection signal and calculates the dosage of the liquid medicine in the medicine storage cavity of the medicine delivery component, a first dosage signal is sent, the second processor receives the first dosage signal and controls the second wireless transceiver module to send the first dosage signal, the first wireless transceiver module 6 receives the first dosage signal and sends the first dosage signal to the first processor 1, the first processor 1 receives the first dosage signal and sends the first calculating module 9, the first time period signal corresponds to the first dosage signal, the first processor 1 receives the first time period signal and sends the first calculating module 9, the first calculating module 9 receives the first dosage signal and the first time period signal, and calculates the flow of the liquid medicine in the medicine storage cavity 233 of the medicine delivery component; the first calculation module 9 sends out a flow signal; the first processor 1 receives the flow signal, controls the display 4 to display the number contained in the flow signal, and controls the storage module 10 to store the flow signal. Therefore, the working time of the drug delivery module 3 is recorded through the timing module 2, the liquid medicine amount of the drug delivery module 3 delivering the liquid medicine into the liquid measurement module 7 is measured through the liquid measurement module 7, the liquid medicine amount of the drug delivery module 3 delivering the liquid medicine into the liquid measurement module 7 and the working time of the drug delivery module 3 are calculated through the first calculation module 9, and the flow rate or the flow velocity of the liquid medicine is obtained, so that the flow rate of the liquid medicine is accurately calibrated to a certain extent.
Example 2
As shown in fig. 8, the structure of this embodiment is substantially the same as that of embodiment 1, except that in this embodiment, for convenience in storage and use, a storage box for storing the microneedle patch 200 is provided, the storage box is composed of a main casing 11, an auxiliary casing 12 and a connecting piece 13, one end of the connecting piece 13 is fixed with the auxiliary casing 12, the other end of the connecting piece is hinged with the main casing 11, the auxiliary casing 12 rotates around the main casing 11 through the connecting piece 13, the two ends of the main casing 11 are respectively provided with a microneedle storage end 101 and a plug end 102, slots for inserting the microneedle storage end 101 and the plug end 102 are provided on the main casing 11, the main casing 11 and the auxiliary casing 12 are made of hard materials, and when the main casing 11 and the auxiliary casing 12 are integrally connected through the plug end 102, the storage box can be used as a small operation console, for example, for placing medicines, surgical instruments or pathological sections, and the storage box has the functions of simple structure, small size, convenience in carrying and opening, and convenience in arrangement and cleaning.
Further, the connecting piece 13 is composed of two U-shaped steel frames and a slideway on the main shell 11. Before the receiver is unopened, microneedle storage end 101 of main casing 11 inserts and establishes in the slot, makes main casing 11 and auxiliary casing 12 constitute a complete flat plane, take out auxiliary casing 12 through connecting piece 13, microneedle storage end 101 exposes, microneedle storage end 101 is equipped with a plurality of grooves and is used for placing microneedle paster 200, the leakproofness and the convenience of microneedle paster have been guaranteed before unopened, auxiliary casing 12 passes through connecting piece 13 and winds main casing 11 rotation, make auxiliary casing 12 insert and establish at plug end 102, and main casing 11 and auxiliary casing 12 reform into a complete flat plane, do not influence the size of receiver, still can place medicine, surgical instrument or pathological section on the box body simultaneously, it is more convenient to use.
Example 3
As shown in fig. 9, this embodiment has substantially the same structure as embodiment 1, except that in this embodiment, as an alternative solution, the drug delivery assembly 230 has a middle concave shape, and accordingly, the elastic shrink film 231 and the protective barrier 236 each have a middle concave shape. In this embodiment, the top of the drug delivery assembly 230 is provided with an interface to which the drug reservoir and/or drug delivery pump 70 is connected via a delivery conduit, whereby communication of the drug delivery assembly 230 with the drug reservoir and/or drug delivery pump 70 is achieved, the interfaces being provided in number, and the delivery conduit being affixed to the top of the protective barrier 236 and in communication with each interface separately, in this embodiment the delivery tube is cylindrical or flat.
Further, as those skilled in the art will appreciate, other control mechanisms, driving mechanisms, power sources and/or auxiliary structures may be additionally provided to perform the necessary control and operation without departing from the spirit of the invention and without structural interference between the structures, as may be implemented by those skilled in the art. The division of the modules or units is merely a logical function division, and there may be another division manner when actually implemented, for example, a plurality of units or components may be combined or may be integrated into another system, or some features may be omitted or not performed. The functional units in the embodiments may be integrated in one processing unit, or each unit may exist alone physically, or two or more units may be integrated in one unit. The integrated units may be implemented in hardware or in software functional units. The coupling or direct coupling or communication connection between the illustrated or discussed embodiments may be through some interface, device or unit indirect coupling or communication connection, which may be in electrical, mechanical, or other form.
It will be evident to those skilled in the art that the invention is not limited to the details of the foregoing illustrative embodiments, and that the present invention may be embodied in other specific forms or combinations thereof without departing from the spirit or essential characteristics thereof. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.
Furthermore, it should be understood that although the present disclosure describes embodiments, not every embodiment is provided with a separate embodiment, and that this description is provided for clarity only, and that the disclosure is not limited to the embodiments described in detail below, and that the embodiments described in the examples may be combined as appropriate to form other embodiments that will be apparent to those skilled in the art.

Claims (10)

1. A self-adjustable microneedle patch for local anesthesia, comprising a plurality of microneedles, a base portion, a drug delivery assembly and a control system, wherein a fine needle hole is formed at a tip of the microneedle, a cavity for accommodating a drug is formed inside the microneedle, the fine needle hole penetrates through the cavity in a longitudinal direction of the microneedle, the plurality of microneedles are arranged on a lower surface of the base portion, and a through hole communicated with the fine needle hole is formed in the base portion, the base portion is a thin plate, the drug delivery assembly is in a convex arch shape in the middle, the drug delivery assembly is adhered to an upper surface of the base portion and extends from one end to the other end of the base portion, the drug delivery assembly comprises an elastic shrink film, a drug storage cavity, a connecting protrusion member, a filter membrane and a protective barrier sheet, the drug delivery assembly is connected to a drug storage and/or a drug delivery pump through a delivery catheter, the drug storage or the drug delivery pump is used for delivering the drug to the drug cavity of the drug delivery assembly, and further through the internal cavity of the microneedle, and the control system is connected to the drug storage and/or the drug delivery pump for controlling a flow rate of the drug.
2. The microneedle patch for local anesthesia according to claim 1, wherein the elastic shrink film is convex in the middle and has a nearly semicircular shape, and a plurality of elastic shrink films are connected with each other through a connection convex member, each elastic shrink film covers one group of microneedles, and the number of the microneedles in each group is 5-16.
3. The local anesthetic microneedle patch of claim 1, wherein a water-absorbing material is disposed in a drug storage cavity of the drug delivery assembly, a port is disposed on a sidewall of one end of the drug delivery assembly, and the drug storage and/or drug delivery pump is connected to the port via a delivery catheter.
4. The local anesthetic microneedle patch of claim 1, the plurality of microneedles having sharp tips to facilitate penetration of the stratum corneum of the skin and penetration into local tissues of the human body, the sharp tips of the microneedles having a conical or polygonal shape including rectangular pyramid, pentagonal pyramid, hexagonal pyramid.
5. The microneedle patch for local anesthesia of claim 1, wherein an elastic spacer is provided between each adjacent microneedle, the elastic spacer occupies 40-60% of the length of the microneedle in a natural state, and the elastic spacer is integrally formed with the microneedle.
6. The microneedle patch for local anesthesia according to any one of claims 1 to 5, which is pea-shaped for local anesthesia of the tongue, eyes, nose, joints.
7. The microneedle patch for local anesthesia according to any one of claims 1-5, the control system comprising a first processor, a timing module, a drug delivery module, a display, a human-computer interaction module, a first wireless transceiver module, a liquid measurement assembly, a mechanical compression module or delivery pump, a first calculation module, and a storage module; the timing module, the drug delivery module, the display, the man-machine interaction module, the first wireless transceiver module, the liquid measuring assembly, the mechanical compression module, the first calculation module and the storage module are all connected with the first processor.
8. The local anesthetic microneedle patch of claim 7, the liquid measurement assembly comprising a second processor, a hydraulic detector, a second wireless transceiver module, and a second computing module; the second wireless transceiver module, the hydraulic detector and the second calculation module are all connected with the second processor, the hydraulic detector is used for detecting the dosage of the liquid medicine in the medicine storage cavity of the medicine conveying component and sending a dosage detection signal to the second processor, the hydraulic detection signal is the pressure of the liquid medicine in the medicine storage cavity of the medicine conveying component, the second processor receives the liquid medicine detection signal and sends the liquid medicine detection signal to the second calculation module, and the second calculation module is used for calculating the dosage of the liquid medicine in the medicine storage cavity of the medicine conveying component.
9. The microneedle patch for local anesthesia according to any one of claims 1 to 5, which is housed with a dedicated housing box at the time of storage.
10. The microneedle patch for local anesthesia according to any one of claims 1 to 5, which is suitable for mammals such as humans, monkeys, sheep, horses, dogs, cats, rabbits, rats, mice, etc.
CN202310711709.1A 2023-06-15 2023-06-15 Self-adjustable microneedle patch for local anesthesia Pending CN116585606A (en)

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