WO2015103891A1 - 手持式高频超声雾化全呼吸道药物导入装置 - Google Patents

手持式高频超声雾化全呼吸道药物导入装置 Download PDF

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Publication number
WO2015103891A1
WO2015103891A1 PCT/CN2014/087366 CN2014087366W WO2015103891A1 WO 2015103891 A1 WO2015103891 A1 WO 2015103891A1 CN 2014087366 W CN2014087366 W CN 2014087366W WO 2015103891 A1 WO2015103891 A1 WO 2015103891A1
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WO
WIPO (PCT)
Prior art keywords
piezoelectric ceramic
atomization
cup
cover
atomizing
Prior art date
Application number
PCT/CN2014/087366
Other languages
English (en)
French (fr)
Inventor
王成
陆阳
陆春天
江松林
唐盛高
袁涛
Original Assignee
常州正元医疗科技有限公司
广州纳泰生物医药技术有限公司
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Filing date
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Application filed by 常州正元医疗科技有限公司, 广州纳泰生物医药技术有限公司 filed Critical 常州正元医疗科技有限公司
Priority to US14/891,890 priority Critical patent/US10195368B2/en
Publication of WO2015103891A1 publication Critical patent/WO2015103891A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/005—Sprayers or atomisers specially adapted for therapeutic purposes using ultrasonics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/001—Particle size control
    • A61M11/003—Particle size control by passing the aerosol trough sieves or filters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M15/00—Inhalators
    • A61M15/0085—Inhalators using ultrasonics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M15/00—Inhalators
    • A61M15/0001—Details of inhalators; Constructional features thereof
    • A61M15/0021—Mouthpieces therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0057—Pumps therefor
    • A61M16/0066—Blowers or centrifugal pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3379—Masses, volumes, levels of fluids in reservoirs, flow rates
    • A61M2205/3386—Low level detectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8206—Internal energy supply devices battery-operated

Definitions

  • the invention relates to a medicine introduction device, and more particularly to a hand-held high frequency ultrasonic atomization full respiratory medicine introduction device.
  • the ultrasonic atomizer is a process of converting liquid into fine droplets by using electric energy.
  • the resonance of the piezoelectric ceramic sheet drives the liquid to be transported, and forms air pockets on the surface of the specific interface, thereby continuously generating small droplets of a specific size range.
  • the existing high-frequency ultrasonic atomizing spray system due to the limitation of the piezoelectric ceramic sheet, must use a relatively high voltage, and therefore generally supplies power through a socket to an alternating current connection, or a high-voltage direct current using a large number of batteries. Higher power consumption leads to the heat generation of the whole system. On the one hand, it is difficult to maintain the stability of the system, and it may also cause the activity of the drug molecules in the solution to be affected, and denaturation or other changes may cause the drug to fail.
  • the existing ultrasonic atomizer places the liquid medicine in a specific part inside the atomizer, and is generally non-removable, which is not conducive to the aseptic storage of the medicine, and does not utilize the disinfection treatment of the entire chamber to clean the cleaning belt. Many inconveniences have caused the opportunity for pollution to increase greatly.
  • the present invention provides a hand-held high-frequency ultrasonic atomizing full-breath drug introduction device, which uses a piezoelectric ceramic atomization sheet made of a low-power material, thereby power consumption.
  • a hand-held high-frequency ultrasonic atomizing full-breath drug introduction device which uses a piezoelectric ceramic atomization sheet made of a low-power material, thereby power consumption.
  • Small, small, low cost, easy to operate can be used for total respiratory administration, can effectively deliver most of the drug to the lower respiratory tract and through the lower respiratory tract into the blood to reach the whole body.
  • a hand-held high-frequency ultrasonic atomizing full-breath drug introduction device comprising a housing having an open space with an air inlet at the bottom and a cover disposed on the opening of the open space of the housing
  • the cover body is provided with a mist outlet
  • the open space of the shell is provided with an open cup for placing the liquid medicine and a mist mask for collecting the mist above the medicine cup, and the bottom of the mist mask is located in the medicine cup.
  • the piezoelectric ceramic atomizing sheet comprises a piezoelectric ceramic body, an upper electrode layer and a lower electrode layer respectively covering the upper surface of the ceramic body, and the upper electrode layer includes a covering portion covering the upper surface of the piezoelectric ceramic body and Extending from an edge of the cover portion to an extension formed by a lower surface of the piezoelectric ceramic body to enclose an edge of the piezoelectric ceramic body, the lower electrode layer covering the lower surface of the piezoelectric ceramic body and respectively at the edge Separating from the extension of the upper electrode layer, the surface of the cover portion of the upper electrode layer away from the piezoelectric ceramic body is further covered with an upper electrode protection layer, and the piezoelectric ceramic body is made of a low-power piezoelectric ceramic material.
  • Power piezoelectric ceramic material comprising a main material component are as follows:
  • the weight percentage is 63.3 ⁇ 68.3% of lead tetraoxide ( Pb 3 O 4 );
  • the weight percentage is 14.2 ⁇ 15.3% of zirconium dioxide ( ZrO 2 );
  • titanium dioxide TiO 2
  • the weight percentage is 4.6 ⁇ 5.2% of strontium oxide (SrO);
  • Manganese dioxide (0.3% to 1.1% by weight) MnO 2 );
  • antimony trioxide Ce 2 O 3
  • the above ingredients are designed according to the weight percentage to the total weight. Before the ingredients, the ingredients are added, and then the main material is added.
  • the calculation principle is that the components with smaller weight percentage are added as much as possible according to the upper limit of the percentage. The large components are calculated and added to the lower limit by the percentage range to make the total weight reasonably distributed.
  • the piezoelectric ceramic atomized sheet of the invention adopts a special low-power material, including a specific proportion of the main material and the additive component, so as to be driven by a low voltage and generate high-frequency ultrasound, so that the atomized particles of the liquid medicine are smaller and atomized. better result.
  • cerium oxide in the main material SrO
  • the surface of the piezoelectric ceramic body is provided with a plurality of recessed holes.
  • the recessed hole is a combination of one or a combination of a circular hole, an elliptical hole, a square hole, a rectangular hole, a prismatic hole or a triangular hole.
  • the shape of the recess may be a circle, an ellipse, a square, a rectangle, a diamond or a triangle, and various other regular or irregular polygons.
  • the concave holes on the surface of the atomizing sheet may be recessed holes having only one shape on the same atomizing sheet, and may also include concave holes having different shapes.
  • the number of concave holes on the surface of the atomizing sheet may be any value determined by the size of the atomizing sheet and the use requirement, and the density of the concave holes may be uniformly distributed or unevenly distributed.
  • the number of recessed holes of one shape may be any appropriate amount.
  • the depth of the recess can be any value that can be obtained using a particular processing method, primarily determined by the specific requirements of the processing method and spray system.
  • the plurality of mist vents are evenly arranged along the circumferential interval of the top of the atomizing hood.
  • the larger atomized particles can be blocked in the chamber, and the smaller atomized particles are discharged from the mist discharge port and discharged through the mist outlet for the user to inhale, so that the medicinal rate is higher, of course, more
  • the vents can also be arranged unevenly and set according to actual needs.
  • the longitudinal section of the piezoelectric ceramic atomized sheet extends substantially along an arc.
  • the arc of the above arc is 0 to ⁇ . That is, the piezoelectric ceramic atomized sheet has a curvature of 0 ⁇ The arc of ⁇ .
  • the above-mentioned piezoelectric ceramic atomizing sheet may have a planar configuration or a curved surface structure, and may be square or rectangular (other shapes may be used) in the case of flattening.
  • the curvature of the atomized sheet can be set according to the demand of the drug introduction. 0 ⁇ Any radians between ⁇ .
  • a part of the atomizing sheet can be set as a curved surface structure, and the remaining part retains the planar structure.
  • Discontinuous surface structures can be set in several areas, and other areas are flat structures. Here, those skilled in the art can adjust according to actual needs.
  • the piezoelectric ceramic atomizing sheet generates an ultrasonic wave having a frequency of 1.0 to 10 MHz (MHz). ).
  • the atomized sheet made of the special low-power piezoelectric ceramic material of the invention can achieve high-frequency atomization effect, so that the atomization degree is high, the mist particles are small, and most of the particles can effectively enter the lower respiratory tract, and the whole respiratory tract can be realized. Inhalation.
  • the piezoelectric ceramic atomizing sheet generates an ultrasonic wave having a frequency of 3 to 6 MHz.
  • the atomized particles of the liquid chemical formed by the piezoelectric ceramic atomized sheet have a diameter of 0.1 to 5 ⁇ m and a median diameter of 2.5 to 3. Micron.
  • the atomized particles of the liquid chemical formed by the piezoelectric ceramic atomized sheet have a diameter of 2 to 4 ⁇ m and a median diameter of 2.5 to 3 Micron.
  • the upper electrode layer and the lower electrode layer of the piezoelectric ceramic atomizing sheet are respectively a gold electrode layer or a silver electrode layer, and the upper electrode protective layer is an alloy plating layer or a glaze protective layer.
  • the upper electrode protective layer protects the upper electrode layer.
  • the handheld high frequency ultrasonic atomizing full respiratory drug introduction device further comprises a control circuit board for atomization and/or Or a battery pack powered by a blower.
  • the voltage of the battery pack is 1.5v ⁇ 10v, and further preferably, the voltage of the battery pack is 1.5v ⁇ 4.5v .
  • the invention adopts the special material design of the low-power piezoelectric ceramic atomizing sheet and the structural design of the curved surface structure and the surface concave hole, so that the piezoelectric ceramic atomizing sheet can be driven by the low pressure and generate high-frequency ultrasonic waves, so that the liquid atom atomizing particles Smaller and consume less energy.
  • the atomization control circuit board of the present invention is further provided with a liquid level detecting function.
  • the atomization control circuit board actively cuts off the circuit and stops the system. And give a warning of insufficient liquid.
  • the atomization control circuit board of the present invention has a dosing function, and the user can independently set the amount of atomization to be administered according to the amount of administration.
  • the atomization control circuit board can modulate a certain range of frequency and peak voltage. Further, the atomization circuit board can realize the active matching of the output frequency and the natural frequency of the piezoelectric ceramic atomization piece, that is, the atomization control circuit board can automatically frequency-modulate The peak voltage of the output can be adjusted to adjust the resonance of the piezoelectric ceramic atomizer.
  • the atomization control circuit board is disposed in the housing, and the housing is further provided with an atomization control circuit board and/or Or the power outlet of the power supply connected to the air blower. That is to say, the whole respiratory drug introduction device of the present invention can be driven by a battery pack provided by itself or by an external power source, which is more convenient to use and can be selected according to actual conditions.
  • the housing is provided with a dosing port for externally connecting the medicine bottle or the filling liquid
  • the cavity of the atomizing cover is provided with an opening at a position corresponding to the medicine feeding port of the housing.
  • the dosing port can be used as a filling solution, and can also be seamlessly joined with a standard vial device.
  • the interface can be either a spiral type or a bayonet type, and the connection commonly used in the prior art. Means can be.
  • the hand-held high frequency ultrasonic atomized full respiratory drug introduction device of the present invention further includes a mouthpiece or an inhalation mask for matingly coupled to the mist outlet. In this way, the user can easily inhale the drug.
  • the atomization control board when the battery pack or external direct current supplies power to the atomization control circuit board, the atomization control board outputs an electrical signal of a certain frequency and falls within the working peak voltage range required for the piezoelectric ceramic atomization sheet, and the piezoelectric ceramic The atomizing sheet produces a better resonant oscillation, causing the liquid in the cup to oscillate at a high frequency and form a mist above the liquid.
  • the atomization control circuit board drives the piezoelectric ceramic atomization sheet to perform high-frequency resonance oscillation, the liquid in the medicine cup above the piezoelectric ceramic atomization sheet generates high-frequency resonance and forms an atomization area in the atomization chamber, and the air blowing device is simultaneously provided.
  • the fan may be) the external air is continuously driven from the air inlet by the battery pack or the external power source, and the air continuously enters the atomization cavity through the air passage, so that the pressure in the atomization chamber increases.
  • the atomized particles formed by the liquid are ejected through the mist outlet.
  • the hand-held high-frequency ultrasonic atomized total respiratory drug introduction device of the invention can be continuously sprayed, and the spray is characterized in that a specific volume can be uniformly sprayed in a specific time, and the liquid volume in the medicine bottle is larger than the dead volume. Underneath, atomization can be achieved uniformly.
  • Hand-held high-frequency ultrasonic atomization full-breath drug introduction device can be used for various aqueous solutions of drugs, organic solutions for water-soluble drugs to promote drug introduction (such as an appropriate ratio of alcohol solution), and local atomization administration of suspensions and systemic diseases.
  • Atomized administration preferably, is mainly used for atomization of an aqueous solution or suspension of a drug, preferably, mainly for aerosol administration of a respiratory system, and further preferably, for the treatment of highly pathogenic influenza virus infectious diseases Administration of the treatment.
  • the aqueous solution for atomization administration may be a small interfering nucleic acid drug, a chemical small molecule drug, a protein drug, an antibody drug, a refined Chinese patent medicine, and other drugs.
  • the hand-held high-frequency ultrasonic atomized full-respiratory drug introduction device of the invention breaks and atomizes the solution structure containing the drug molecules to form extremely fine liquid particles through the high-frequency resonance of the piezoelectric ceramic atomized sheet, thereby realizing low power consumption.
  • Hand-held portable, small atomized particles able to reach the lower respiratory tract / Alveolar and achieve full respiratory administration.
  • the piezoelectric ceramic atomized sheet of the invention and the auxiliary structure, the medicine cup, the atomization cavity and the like can be disassembled, and can be conveniently cleaned and disinfected after use.
  • the present invention Compared with the prior art, the present invention has the following advantages: the present invention provides a hand-held high-frequency ultrasonic atomizing full-respiration drug introduction device, which is made of a special low-power piezoelectric ceramic material. Frequency ultrasonic atomization effectively reduces energy consumption, and the overall volume of the device is greatly reduced. It is a portable and portable full-respiration drug introduction device, and the manufacturing cost is greatly reduced, and has a wide and good application prospect.
  • the atomized droplets produced by the low-power high-frequency ultrasonic atomized drug introduction device of the present invention are much smaller than the existing atomizing device, and can be used for the lower respiratory tract / Alveolar-based full-breathing mode drug introduction, while existing nebulizers produce larger particles and therefore can only be administered to the upper respiratory tract.
  • the setting of the external medicine bottle and the medicine cup can not only inject the liquid into the medicine cup, but also conveniently use the external medicine bottle to conveniently change the medicine bottle, which is beneficial to the aseptic storage of the medicine and the disinfection treatment of the sprayer.
  • the system adopts high-frequency ultrasonic technology, making full use of unique materials to make piezoelectric ceramic atomizing sheet, atomizing sheet curved structure and surface concave hole structure, effectively reducing system power consumption, the whole system can be 2.5W power, 1.5 ⁇ 10v, even 1.5 ⁇ 4.5V Under the condition of voltage, the high-efficiency atomization of the liquid drug solution is continuously and uniformly realized, and the diameter of the atomized particles is smaller than that of the existing ultrasonic atomizer, which is more favorable for the introduction of the lower respiratory tract drug.
  • the introduction device of the invention can control the size distribution of the atomized particles of the aqueous solution or suspension of the drug to make the specific proportion of the drug enter the lower respiratory tract separately / Alveolar, middle and upper respiratory tract, for full respiratory administration.
  • FIG. 1 is a partial cross-sectional view showing the handheld high-frequency ultrasonic atomizing full-respiratory drug introduction device of the present invention
  • Figure 2 is a schematic view of the mouthpiece of the present invention.
  • Figure 3 is a schematic view of the inhalation mask of the present invention.
  • Figure 4 is a bottom view of the piezoelectric ceramic atomizing sheet of the present invention.
  • Figure 5 is a top plan view of a piezoelectric ceramic atomizing sheet of the present invention.
  • Figure 6 is a cross-sectional view showing the piezoelectric ceramic atomizing sheet of the present invention.
  • Figure 7 is a schematic diagram showing the distribution of atomized particles of different sizes in the respiratory tract after drug introduction
  • Figure 8 is a schematic diagram (LD) of the atomization effect of the drug introduction device of the present invention and the prior art atomization device;
  • the invention provides a hand-held high-frequency ultrasonic atomizing full-respiration drug introduction device, as shown in FIG. 1 Illustrated, a preferred embodiment of the full respiratory drug delivery device of the present invention is shown in the figure, the device comprising a housing 1 having an open space at the bottom with an air inlet 2 and a housing 1 disposed therein The cover body on the opening of the open space, the cover body is provided with a mist outlet 3 (the housing 1 and the cover body are two parts, which are more convenient to be disassembled, and may of course be provided as one body). Housing 1 The open space is provided with an open cup 4 for placing a liquid medicine and a mist mask 9 for collecting fog above the medicine cup 4.
  • the bottom of the mist mask 9 is located in the opening of the medicine cup 4, and is in the medicine Cup 4
  • a first chamber 19 is formed between the outer wall and the inner wall of the casing 1.
  • a second chamber 20 is formed between the outer wall of the mist cover 9 and the inner wall of the casing 1.
  • the ceramic cup 4 is provided with a piezoelectric ceramic atomizer.
  • the piezoelectric ceramic atomizing sheet 5 is located below the preset highest liquid level in the medicine cup 4, and the cup wall of the medicine cup 4 is connected to the housing 1 through the connecting member, and is connected to the housing and/or at the preset Medicine cup above the highest liquid level
  • a vent hole 12 is formed in the wall of the cup for connecting the first chamber 19 and the second chamber 20.
  • the top of the atomizing cover 9 is provided with a venting port 11, a venting port 11 and a venting port 3
  • the fluid phase is connected, and a blowing device 6 for blowing air toward the mist outlet 13 is disposed in the air inlet 2 of the casing 1.
  • the drug introducing device further includes a piezoelectric ceramic atomizing sheet 5 Phase-connected atomization control circuit board 7 .
  • Piezoelectric ceramic body 13 is made of low-power piezoelectric ceramic material, and the low-power piezoelectric ceramic material includes the following main material components: weight percentage is 63.3 ⁇ 68.3% The lead tetraoxide; the weight percentage is 14.2 ⁇ 15.3% of zirconium dioxide; the weight percentage is 8.1 ⁇ 9.5% of titanium dioxide; the weight percentage is 4.6 ⁇ 5.2% Cerium oxide; 1.5 to 1.8% by weight of ferric oxide; 1.0 to 1.4% by weight of tin dioxide; and the following added components: 0.3 to 1.1% by weight Manganese dioxide; 0.5-0.8% by weight of antimony trioxide; 0.4-0.8% by weight of antimony pentoxide; 0.3% to 0.7% by weight of zinc oxide.
  • the bottom of the medicine cup 4 is provided with a piezoelectric ceramic atomizing sheet 5, so that the liquid medicine is located in the piezoelectric ceramic atomizing sheet.
  • the medicine cup 4 can resonate with the bottom piezoelectric ceramic atomizing sheet 5 to generate ultrasonic waves for atomizing the medicine cup 4
  • the liquid inside may be disposed on the side wall or at other locations, and the preferred embodiment is not intended to be a limitation of the present invention, but is merely an example.
  • the upper portion of the cup wall of the medicine cup 4 is connected to the housing 1 through a connecting member, and the connecting member is opened for communicating with the first chamber. 19 and the venting opening 12 of the second chamber 20.
  • the venting opening 12 here mainly serves to connect the two chambers, and the wind generated by the ventilating device 6 is taken from the first chamber 19 Flowing into the second chamber 20, and entering the atomizing cover 9 from the gap between the outer wall of the bottom of the atomizing cover 9 and the inner wall of the medicine cup 1, and driving the mist to flow upward from the liquid level of the medicine cup 4, and From the venting port 11 Discharge.
  • a venting hole is provided in the wall of the cup.
  • the venting hole should be placed above the preset maximum liquid level in the cup so that the wind can also enter directly from the venting hole.
  • the above two types of holes or the like may be provided.
  • Atomizing cover The upper part of the 9 is hermetically connected to the housing 1 and is provided with a mist outlet 11 on the top (the top of the atomizing cover 9 can be an atomizing cover 9
  • the tops are arranged circumferentially spaced to better discharge smaller atomized particles from the mist outlet 3, while larger atomized particles are blocked.
  • the drug introduction device of the present invention further includes an atomization control circuit board electrically connected to the piezoelectric ceramic atomizing sheet 5 A battery pack 8 for powering the atomization control circuit board and/or the blower unit 8 .
  • the piezoelectric ceramic atomizing sheet 5 includes a piezoelectric ceramic body 13 having a concave hole provided on the surface thereof, respectively covering the ceramic body 13
  • the upper electrode layer 14 and the lower electrode layer 15 on the upper and lower surfaces, the upper electrode layer 14 includes a covering portion covering the upper surface of the piezoelectric ceramic body 13 and extending downward from the edge of the covering portion to the piezoelectric ceramic body An extension formed by the lower surface of the 13 is wrapped around the edge of the piezoelectric ceramic body 13, and the lower electrode layer 15 is covered on the lower surface of the piezoelectric ceramic body 13 at the edge and the upper electrode layer, respectively.
  • the extension portion is spaced apart by a distance, and the surface of the cover portion of the upper electrode layer 14 away from the piezoelectric ceramic body 13 is further covered with an upper electrode protection layer 16 for the piezoelectric ceramic body 13 Made of low power piezoelectric ceramic material.
  • the liquid medicine in the medicine cup 4 generates an atomization area due to high frequency resonance, and the atomization area communicates with the cavity in the atomizing cover 9, thereby passing through the atomizing cover 9 and the mist discharge port at the top thereof. 11 , and the fog outlet 3 The mist is discharged for the user to use.
  • the blowing device 6 is a fan
  • the first chamber 19 is formed between the outer wall of the medicine cup 4 and the atomizing cover 9 and the inner wall of the casing 1 respectively.
  • the second chamber 20 to form a passage that allows fluid to circulate.
  • the fan 6 blows air into the interior of the device through the air inlet 2, and the wind passes through the first chamber between the cup 4 and the outer wall of the casing 1 19 Flowing in the direction of the mist outlet, entering the second chamber 14 between the outer wall of the atomizing cover 9 and the casing 1 through the vent hole 12 in the connecting piece of the medicine cup 4 and the casing 1, due to the upper portion of the atomizing cover 9 And housing 1 sealingly connected, and the lower part is located in the opening of the medicine cup 4, and here, there is a gap between the outer wall of the atomizing cover 9 and the inner wall of the casing 1, from which the wind enters the inner bottom of the atomizing cover 9, and Atomized hood 9
  • the upward flow causes the atomized particles formed by the liquid medicine in the medicine cup 4 to flow upward, is discharged through the mist discharge port 11 at the top of the atomizing cover 9 and the mist outlet port 3 on the cover body, and is matched with the mist outlet 3 Connected mouthpiece 17 Or inhale the mask
  • the upper electrode layer 13 and the lower electrode layer 14 of the piezoelectric ceramic atomizing sheet 5 are respectively a gold electrode layer and an upper electrode protective layer.
  • 15 is a glaze protective layer.
  • the casing 1 is provided with a dosing port 10 for an external medicine bottle or a filling liquid, and an opening of the atomizing cover 9 corresponding to the dosing port 10 of the casing 1 is opened. Dosing port 10 The opening is used to install an external vial or to fill the vial 4.
  • the drug introduction device of the present embodiment further includes a battery pack 8 for supplying power to the atomization control circuit board 7 and/or the air blowing device 6
  • the voltage of the battery pack is 1.5v ⁇ 4.5 v
  • the atomization control circuit board 7 can drive the piezoelectric ceramic atomization sheet 5 through the battery pack 8, or can be directly connected to the power source through the power connection port to drive the piezoelectric ceramic atomization sheet. 5, but only need 1.5 ⁇ 10v voltage, and further need only 1.5 ⁇ 4.5v
  • the voltage is OK. That is, a curved-shaped atomized sheet made of a low-power piezoelectric material provided with a concave hole on the surface of the present application can be driven only by a voltage of several volts, and an ordinary battery pack can be used.
  • Atomization control circuit board 7 is set in the housing Inside the housing 1, there is also a power port for powering the atomization control circuit board 7 and/or the blower unit 6.
  • the device is also provided with a mouthpiece 17 for mating with the mist outlet 3 Or inhaling the mask 18, as shown in Figures 2 and 3, respectively, the mist outlet 3 is connected to the suction mask 18 or the mouthpiece 17, and the suction mask 18 or the mouthpiece 17 is included for use with the mist outlet 3
  • the connecting portion, the shape and size of the connecting portion are exactly matched with the mist outlet 3, and can be directly engaged, forming a tight connection by the frictional force of the contact surface, ensuring that the atomized particles are all from the mouthpiece 17 or the suction mask 18 Spray at a uniform speed.
  • Piezoelectric ceramic body 13 The surface is provided with a plurality of recessed holes, and the recessed holes are a combination of several of a circular hole, an elliptical hole, a square hole, a rectangular hole, a prismatic hole or a triangular hole.
  • the longitudinal section of the piezoelectric ceramic atomizing sheet 5 is generally curved, Figure 4 A bottom view of the piezoelectric ceramic atomizing sheet 5 is shown, Fig. 5 shows a plan view of the piezoelectric ceramic atomizing sheet 5, and Fig. 6 shows a longitudinal sectional view of the piezoelectric ceramic atomizing sheet 5 of the present embodiment.
  • the piezoelectric ceramic atomizing sheet of the present embodiment 5 The shape is a circular curved structure, or it can be a partial curved structure, or a discontinuous multiple curved structure.
  • the curvature of the surface can be any arc between 0 and ⁇ .
  • the atomizer can be about ⁇ /8 as shown.
  • the curvature of the curved surface that is, the 45 ° center angle corresponds to the arc.
  • the atomizing sheet may be a partial curved surface structure with a flat structure at both ends and a semi-circular arc in the middle.
  • the piezoelectric ceramic body of the piezoelectric ceramic atomizing sheet 5 of the present invention 13 contains concave holes of a specific size and shape, and its shape, number, density, and depth include, but are not limited to, any one of the following: the concave holes on the surface of one piece of the atomizing sheet may be all circular, and the number may be any suitable.
  • a recessed surface on the surface of a piece of atomized sheet may also be partially (appropriate number) circular, part (appropriate number) of squares; the recessed surface of a piece of atomized sheet may be part (appropriate number) elliptical, part (appropriate number ) Diamond, part (appropriate number) of irregular polygons.
  • the recessed holes on the surface of a piece of atomized sheet may be evenly distributed, or the density in a local area may be larger than in other areas. The depth of the above various recessed holes can be determined to be any suitable value according to the preparation process and the use requirements.
  • the low-energy high-frequency ultrasonic atomized full-respiration drug introduction device of the invention is characterized in that very fine atomized particles are generated by high-frequency ultrasound, and most of the particles are in the range of 2 to 4 micrometers, and can effectively enter the lower respiratory tract /
  • a small portion of the relatively large atomized particles can be distributed in the upper and middle respiratory tract.
  • Figure 7 It shows the relationship between the size of the atomized particles and the resting position when the respiratory tract is administered. It can be seen that the larger the diameter of the atomized particles, the more likely it is to stop in the upper respiratory tract, and the atomized particles become smaller and will enter the lower respiratory tract more. / Alveolar.
  • the whole respiratory drug introduction device provided by the invention produces relatively small particles and more can enter the respiratory tract.
  • Figure 8 As shown, the laser diffraction particle size measurement by the new generation of real-time high-speed spray particle sizer Spraytec LD method analysis, through D50
  • the atomized particle size of the high-frequency ultrasonic atomizer and the OMRON atomizer of the embodiment of the present invention is distributed: the median diameter of the atomized particles of the handheld high-frequency ultrasonic atomized total respiratory drug introduction device of the present invention is 5.13 micron (figure 8 upper), while the control ohmon nebulizer atomized particles have a median particle size of 10.14 microns (bottom of Figure 8).
  • the hand-held high-frequency ultrasonic atomized full-respiration drug introducing device of the invention not only has the advantages of low power consumption, convenient carrying, low cost, but also can generate smaller atomized particles, and is suitable for total respiratory drug introduction, and has very Good and broad application prospects.

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Abstract

一种手持式高频超声雾化全呼吸道药物导入装置，包括具有进风口（2）的壳体（1）和具有出雾口（3）的盖体，壳体（1）内设置有带有雾化片的药杯（4）以及位于其上方的顶部具有排雾口（11）的雾化罩（9），在进风口（2）、出雾口（3）及排雾口（11）之间形成流体流通的通道，进风口（2）附近还设置有风扇，压电陶瓷雾化片（5）的本体由如下组分的材料制成(以重量百分比计)：63.3～68.3％的四氧化三铅；14.2～15.3％的二氧化锆；8.1～9.5％的二氧化钛；4.6～5.2％的氧化锶；1.5～1.8％的三氧化二铁；1.0～1.4％的二氧化锡；0.3～1.1％的二氧化锰；0.5～0.8％的三氧化二铈；0.4～0.8％的五氧化二铌；0.3～0.7％的氧化锌。该装置功耗和体积较小，方便携带，成本较低，且雾化颗粒小，适用于全呼吸道药物导入以及下呼吸道肺泡集中给药。

Description

手持式高频超声雾化全呼吸道药物导入装置
技术领域
本发明涉及一种药物导入装置，更特别涉及一种手持式高频超声雾化全呼吸道药物导入装置。
背景技术
针对特定药物的给药系统长期以来一直是与医药研究相伴随发展的一个领域，而许多药物需要通过特定的手段，形成特定大小的雾化颗粒，才能被有效吸收和利用。超声雾化器是采用电能将液体转化为细小液滴的过程，通过压电陶瓷片的谐振带动液体传输，并在特定界面的表面形成气穴，从而不断产生特定大小范围的小液滴。
现有的高频超声雾化喷雾系统，由于压电陶瓷片的限制，必须要采用较高的电压，因此一般都通过插座与交流电连接提供电力，或者采用大量的电池的高电压直流电提供电力。较高的功耗导致整个系统容易产生热量，一方面使得系统难以维持稳定，同时也可能导致溶液中的药物分子活性受到影响，发生变性或者其他变化而使药物失效。
另一方面，由于功耗高，所需要的配件相应增加，体积也变得相对较大，无法实现便携式操作，只能固定在特定的有交流电源的场所，或者由于体积大变得笨重而不方便移动。同时，高功耗也导致了整个雾化给药系统的高成本，不利于在广大疾病患者推广使用。
此外，现有的超声雾化器将液体药物置于雾化器内部特定的部位，且一般不可拆卸，不利于药物的无菌保存，也不利用对整个腔室实施消毒处理，给清理清洁带来诸多不便，使污染的机会大大增加。
发明内容
为克服现有技术中的上述问题，本发明提供了一种手持式高频超声雾化全呼吸道药物导入装置，该装置采用了低功耗材料制成的压电陶瓷雾化片，因而功耗小，体积小，且成本低廉，操作方便，可用于全呼吸道给药治疗，可有效将大部分药物输送到下呼吸道部位及经过下呼吸道进入血液从而到达全身。
本发明采用的技术方案是：一种手持式高频超声雾化全呼吸道药物导入装置，包括底部设置有进风口的具有开放空间的壳体和设置在壳体的开放空间的开口上的盖体，盖体上设置有出雾口，壳体的开放空间设置有用于放置药液的具有开口的药杯和位于药杯上方用于聚集雾的聚雾罩，聚雾罩的底部位于药杯的开口内，且在药杯内的雾化罩的外壁与药杯的内壁之间存在间隙，聚雾罩的上部与壳体的内壁之间密封连接，药杯的外壁与壳体的内壁之间形成第一腔室，聚雾罩的外壁与壳体的内壁之间形成第二腔室，药杯上设置有压电陶瓷雾化片，压电陶瓷雾化片位于药杯内的预设最高药液液面之下，药杯的杯壁通过连接件与壳体相连接，且在连接件和 / 或位于预设最高药液液面之上的药杯的的杯壁上开设有用于连通第一腔室和第二腔室的通风孔，雾化罩的顶部上设置有排雾口，排雾口与出雾口相流体连通，壳体内在其进风口处设置有用于朝向出雾口方向吹风的一吹风装置，药物导入装置还包括与压电陶瓷雾化片相电连接的雾化控制线路板，压电陶瓷雾化片包括压电陶瓷本体、分别覆盖在陶瓷本体上、下表面上的上电极层和下电极层，上电极层包括覆盖在压电陶瓷本体上表面上的覆盖部以及自覆盖部的边缘向下弯折延伸至压电陶瓷本体的下表面形成的延伸部，以包住压电陶瓷本体的边缘，下电极层覆盖在压电陶瓷本体的下表面上且边缘处分别与上电极层的延伸部间隔一段距离，上电极层的覆盖部的远离压电陶瓷本体的表面上还覆盖有一上电极保护层，压电陶瓷本体由低功耗压电陶瓷材料制成，低功耗压电陶瓷材料包括如下主材料组分：
重量百分比为 63.3~68.3% 的四氧化三铅（ Pb 3 O 4 ）；
重量百分比为 14.2~15.3% 的二氧化锆（ ZrO 2 ）；
重量百分比为 8.1~9.5% 的二氧化钛（ TiO 2 ）；
重量百分比为 4.6~5.2% 的氧化锶（ SrO ）；
重量百分比为 1.5~1.8% 的三氧化二铁（ Fe 2 O 3 ）；
重量百分比为 1.0~1.4% 的二氧化锡（ SnO 2 ）；
以及如下的添加组分
重量百分比为 0.3~1.1% 的二氧化锰（ MnO 2 ）；
重量百分比为 0.5~0.8% 的三氧化二铈（ Ce 2 O 3 ）；
重量百分比为 0.4~0.8% 的五氧化二铌（ Nb 2 O 5 ）；
重量百分比为 0.3~0.7% 的氧化锌（ ZnO 2 ）。
在实际使用中，以上所述各成分按照重量百分比来设计总重量，配料前先配添加成分，再配主材料，计算原则是占重量百分比较小的成分尽量按照百分比上限来添加，重量百分比较大的成分后计算，并按照百分比范围靠下限添加，使其总重量合理分配。
本发明的压电陶瓷雾化片采用特有的低功耗材料，包括特定比例的主材料和添加成分，达到可通过低压驱动且产生高频超声，从而使得药液雾化颗粒更小，雾化效果更好。其中主材料中的氧化锶（ SrO ）能够增强陶瓷材料的整体稳定性，使得雾化片的使用寿命更长，质量更稳定；而特定比例的四种添加成分的使用，大幅提高了此压电陶瓷的性能，压电常数 d33 可以达到 328 ～ 391pC/N ，机电耦合系数 kp 可以达到 57.6% ～ 69.1% ，机械品质因数 Qm 可以达到 1 519 ～ 1654 。从而使压电陶瓷更容易被激励而产生超声震荡。
优选地，压电陶瓷本体的表面设置有多个凹孔。
更优选地，凹孔为圆形孔、椭圆形孔、正方形孔、长方形孔、棱形孔或三角形孔中的一种或几种的组合。凹孔的形状可以是圆形、椭圆形、正方形、长方形、菱形或三角形以及其他各种规则或不规则的多边形。雾化片表面的凹孔，在同一片雾化片上，可以是只含有一种形状的凹孔，也可以包括形状不同的凹孔。雾化片表面凹孔的数量可以是由雾化片大小和使用需求确定的任意值，凹孔的密度可以均匀分布，也可以不均匀分布。在同一片雾化片上，一种形状的凹孔数量可以为任意适量的数值。凹孔的深度可以为采用特定加工方法所能获得的任意值，主要由加工方法和喷雾系统的特定需求决定。
优选地，排雾口为多个，多个排雾口沿着雾化罩的顶部周向间隔均匀排列。这样，较大的雾化颗粒可被阻挡在腔室内，而较小的雾化颗粒则从排雾口排出，并经由出雾口排出供使用者吸入，使得药用率更高，当然，多个排雾口也可以不均匀排列，根据实际需求来设置。
优选地，压电陶瓷雾化片的纵截面基本沿弧线延伸。
更优选地，上述弧线的弧度为 0~ π。即，压电陶瓷雾化片大体呈弧度为 0~ π的弧形。上述的压电陶瓷雾化片可以是平面构型，也可以是一种曲面型的结构，在摊平的情况下为正方形或长方形（也可以是其他形状）。雾化片弯曲的弧度根据药物导入的需求，可以设置为 0~ π之间的任意弧度值。同时，可以根据特定的雾化需求，雾化片的一部分设置为曲面结构，其余部分保留平面结构，如果是部分为弧形则要求最好为整体对称结构，对称地分布在压电陶瓷雾化片中心的两侧。可以在若干区域设置不连续的曲面结构，其他区域为平面结构。在此，本领域技术人员可根据实际需要调整。
进一步地，压电陶瓷雾化片所产生的超声波频率为 1.0~10 兆赫兹（ MHz ）。本发明的特殊低功耗的压电陶瓷材料制成的雾化片可达到高频雾化效果，使得雾化度高，雾颗粒小，大部分颗粒可以有效进入下呼吸道部位，能够实现全呼吸道吸入。
更进一步地，压电陶瓷雾化片所产生的超声波频率为 3~6 兆赫兹。
进一步地，压电陶瓷雾化片所形成的药液的雾化颗粒的直径为 0.1~5 微米，中位粒径为 2.5~3 微米。
更进一步地，压电陶瓷雾化片所形成的药液的雾化颗粒的直径为 2~4 微米，中位粒径为 2.5~3 微米。
优选地，压电陶瓷雾化片的上电极层、下电极层分别为金电极层或银电极层，上电极保护层为合金镀层或釉保护层。上电极保护层对上电极层起到保护作用。
优选地，手持式高频超声雾化全呼吸道药物导入装置还包括用于为雾化控制线路板和 / 或吹风装置供电的电池组。
更优选地，电池组的电压为 1.5v~10 v ，进一步优选地，电池组的电压为 1.5v~4.5 v 。本发明通过低功耗压电陶瓷雾化片的特殊材料设计以及曲面结构和表面凹孔的结构设计，使得压电陶瓷雾化片可通过低压带动并产生高频超声波，使得药液雾化颗粒更小，能耗更小。
进一步地看，本发明的雾化控制线路板还设置有液位检测功能，当药杯中的药液下降到一定高度或者无液体时，雾化控制线路板会主动切断电路，使系统停机，并给出液体不足的警告。
此外，本发明的雾化控制线路板具有定量给药功能，使用者可根据用药量自主设定给药的雾化量。
雾化控制线路板可以调制一定范围的频率和峰值电压，更近一步，该雾化线路板可实现输出频率与压电陶瓷雾化片的固有频率主动匹配，即雾化控制线路板可以自动调频，输出的峰值电压可以调整，从而调整压电陶瓷雾化片谐振。
进一步地，雾化控制线路板设置在壳体内，壳体上还开设有用于为雾化控制线路板和 / 或吹风装置接通电源的接电口。也就是说，本发明的全呼吸道药物导入装置可通过自身设置的电池组驱动，也可以通过外接电源来驱动，这样使用起来更方便，可根据实际情况来选择。
进一步地，壳体上开设有用于外接药瓶或加注药液的加药口，雾化罩的腔璧在对应于壳体加药口的位置处开设有开口。加药口可做为加注药液用，也可以与标准的药瓶装置通过接口做无缝接合，其接口可以是螺旋式的，也可以是卡口式的，现有技术中常用的连接手段都可以。
更进一步地，本发明的手持式高频超声雾化全呼吸道药物导入装置还包括用于与出雾口相配合连接的咬嘴或吸入面罩。这样，使用者就可以便捷地吸入药物。
在本发明中，当电池组或者外部直流电给雾化控制线路板供电时，雾化控制板输出一定频率的电信号并落在压电陶瓷雾化片需要的工作峰值电压范围内，压电陶瓷雾化片就会产生较好的谐振振荡，使得药杯内的液体产生高频振荡，并在液体的上方形成雾。当雾化控制线路板驱动压电陶瓷雾化片做高频谐振振荡，使压电陶瓷雾化片上方药杯中的液体产生高频谐振并在雾化腔体内形成雾化区，同时吹风装置（在具体实施例中，可为风扇）在电池组或者外接电源的驱动下使外部空气从进风口不断进入，空气持续经过通风道进入雾化腔体，使得雾化腔体内的压强增大，液体形成的雾化颗粒就会经过出雾口喷出。
本发明的手持式高频超声雾化全呼吸道药物导入装置可以持续喷雾给药，喷雾的特征是能够在特定时间内均匀地喷出特定的体积，且在药瓶中液体体积大于死体积的情况下，都可以均匀的实现雾化。
手持式高频超声雾化全呼吸道药物导入装置可以用于各种药物水溶液、水溶性药物促进药物导入的有机溶液（如适当比率的酒精溶液）及悬浮液的局部雾化给药及全身性疾病雾化给药，优选的，主要用于药物水溶液或悬浮液的雾化，优选的，主要用于呼吸系统雾化给药，进一步优选的，主要用于治疗高致病性流感病毒感染性疾病治疗的给药。雾化给药的水溶液可以是小干扰核酸药物，化学小分子药物，蛋白药物，抗体药物，精制的中成药药物，以及其他药物。
本发明的手持式高频超声雾化全呼吸道药物导入装置通过压电陶瓷雾化片的高频率的谐振，将含有药物分子的溶液结构打散雾化形成极细小的液体颗粒，实现低功耗、手持便携、雾化颗粒小、能到达下呼吸道 / 肺泡并实现全呼吸道给药。本发明的压电陶瓷雾化片及其附属结构、药杯、雾化腔体等结构件都可以拆卸，方便使用后清洗消毒。
与现有技术相比，本发明具有下列优点：本发明提供了一种手持式高频超声雾化全呼吸道药物导入装置，采用特殊的低功耗压电陶瓷材料制成的雾化片在高频超声雾化的同时有效降低能耗，装置整体体积大大减小，是一种方便携带的手持式全呼吸道药物导入装置，且制造成本大幅降低，具有广泛而良好的应用前景。
其次，本发明的低功耗高频超声雾化药物导入装置所产生的雾化液滴比现有的雾化装置要小很多，可以用于下呼吸道 / 肺泡为主的全呼吸道模式的药物导入，而现有的雾化器所产生的颗粒较大，因此只能对上呼吸道给药。此外，外接药瓶处和药杯的设置，既可以将药液注入药杯，也可以方便地采用外接药瓶，方便地更换药瓶，有利于药物的无菌保存和喷雾器的消毒处理。该系统采用高频超声技术，充分利用独特材料制成压电陶瓷雾化片、雾化片曲面结构和表面凹孔结构，有效降低系统功耗，整个系统可以在 2.5W 功率、 1.5~10v ，甚至是 1.5~4.5V 电压条件下，持续均匀的实现液体药物溶液的高效雾化，雾化颗粒直径大小比现有的超声雾化器更小，更有利于下呼吸道药物导入。本发明的导入装置，可通过控制药物水溶液或悬浮液雾化颗粒的大小分布，使特定比例的药物分别进入下呼吸道 / 肺泡、中呼吸道和上呼吸道，实现全呼吸道给药。
附图说明
图 1 为本发明的手持式高频超声雾化全呼吸道药物导入装置的局部剖视示意图；
图 2 为本发明的咬嘴的示意图；
图 3 为本发明的吸入面罩的示意图；
图 4 为本发明的压电陶瓷雾化片的仰视示意图；
图 5 为本发明的压电陶瓷雾化片的俯视示意图；
图 6 为本发明的压电陶瓷雾化片的剖视示意图；
图 7 为药物导入后不同大小的雾化颗粒在呼吸道的分布示意图；
图 8 为本发明的药物导入装置与现有技术的雾化装置的雾化效果对比示意图（ LD ）法；
图 9 为本发明的药物导入装置与现有技术的雾化装置的雾化效果另一对比示意图（ TOF ）法。
图中： 1 、壳体； 2 、进风口； 3 、出雾口； 4 、药杯； 5 、压电陶瓷雾化片； 6 、吹风装置； 7 、雾化控制线路板； 8 、电池组； 9 、雾化罩； 10 、加药口； 11 、排雾口； 12 、通风孔； 13 、压电陶瓷本体； 14 、上电极层； 15 、下电极层； 16 、上电极保护层； 17 、咬嘴； 18 、吸入面罩； 19 、第一腔室； 20 、第二腔室。
具体实施方式
下面结合附图对本发明的较佳实施例进行详细阐述，以使本发明的优点和特征更易于被本领域技术人员理解，从而对本发明的保护范围作出更为清楚明确的界定。
本发明提供了一种手持式高频超声雾化全呼吸道药物导入装置，如图 1 所示，该图中展示了本发明的全呼吸道药物导入装置的一优选实施例，该装置包括底部设置有进风口 2 的具有开放空间的壳体 1 和设置在壳体 1 的开放空间的开口上的盖体，盖体上设置有出雾口 3 （壳体 1 和盖体为两个部件，更方便拆卸，当然也可以设置为一体）。壳体 1 的开放空间内设置有用于放置药液的具有开口的药杯 4 和位于药杯 4 上方用于聚集雾的聚雾罩 9 ，聚雾罩 9 的底部位于药杯 4 的开口内，且在药杯 4 内的雾化罩 9 的外壁与药杯 4 的内壁之间存在间隙，聚雾罩 9 的上部（当然，在实际应用中也可以为中部）与壳体 1 的内壁之间密封连接，药杯 4 的外壁与壳体 1 的内壁之间形成第一腔室 19 ，聚雾罩 9 的外壁与壳体 1 的内壁之间形成第二腔室 20 ，药杯 4 上设置有压电陶瓷雾化片 5 ，压电陶瓷雾化片 5 位于药杯 4 内的预设最高药液液面之下，药杯 4 的杯壁通过连接件与壳体 1 相连接，且在连接件和 / 或位于预设最高药液液面之上的药杯 4 的的杯壁上开设有用于连通第一腔室 19 和第二腔室 20 的通风孔 12 ，雾化罩 9 的顶部上设置有排雾口 11 ，排雾口 11 与出雾口 3 相流体连通，壳体 1 内在其进风口 2 处设置有用于朝向出雾口 13 方向吹风的一吹风装置 6 ，药物导入装置还包括与压电陶瓷雾化片 5 相电连接的雾化控制线路板 7 。压电陶瓷本体 13 由低功耗压电陶瓷材料制成，低功耗压电陶瓷材料包括如下主材料组分：重量百分比为 63.3~68.3% 的四氧化三铅； 重量百分比为 14.2~15.3% 的二氧化锆；重量百分比为 8.1~9.5% 的二氧化钛； 重量百分比为 4.6~5.2% 的氧化锶；重量百分比为 1.5~1.8% 的三氧化二铁； 重量百分比为 1.0~1.4% 的二氧化锡；以及如下的添加组分：重量百分比为 0.3~1.1% 的二氧化锰；重量百分比为 0.5~0.8% 的三氧化二铈；重量百分比为 0.4~0.8% 的五氧化二铌；重量百分比为 0.3~0.7% 的氧化锌。
在本发明的该优选实施例中，药杯 4 的底部设置有压电陶瓷雾化片 5 ，这样，药液位于压电陶瓷雾化片 5 的正上方，雾化效果更好，药杯 4 可以随着底部压电陶瓷雾化片 5 一起谐振，以产生超声波以便雾化药杯 4 内的药液。当然，在具体应用中，也可以设置在侧壁上或其他位置处，本优选实施例不作为本发明的限制，而只是作为一种举例。
在本实施例中，药杯 4 的杯壁上部与壳体 1 通过连接件相连接，且在连接件上开设有用于连通第一腔室 19 和第二腔室 20 的通风孔 12 。本领域技术人员应了解，此处通风孔 12 主要起到连通两个腔室，将通风装置 6 产生的风从第一腔室 19 流动到第二腔室 20 ，并从雾化罩 9 的底部外壁与药杯 1 的内壁之间的间隙进入雾化罩 9 内，并带动雾从药杯 4 液面的上方向上流动，并从排雾口 11 排出。因而，只要能起到这个作用的通风孔设置方式均应涵盖在本发明的保护范围之内，比如，可以在药杯 4 的杯壁上设置通风孔，当然在这种情况下，通风孔应该设置在药杯内的预设的最高药液液面之上，这样，风也可以直接从通风孔进入。或者，可以设置有上述两种类型的孔等。雾化罩 9 的上部与壳体 1 相密封连接且在顶部上设置有排雾口 11 （雾化罩 9 的顶部可为雾化罩 9 的一部分，也可以是另外设置罩子，并在罩子上开设排雾口），排雾口 11 与出雾口 3 相流体连通。在本实施例中，排雾口 11 有多个，且在雾化罩 9 的顶部沿周向间隔排列，以更好地将较小的雾化颗粒从出雾口 3 排出，而较大的雾化颗粒则被挡住。
本发明的药物导入装置还包括与压电陶瓷雾化片 5 相电连接的雾化控制线路板 7 ，用于为雾化控制线路板和 / 吹风装置 6 供电的电池组 8 。压电陶瓷雾化片 5 包括表面设置有凹孔的压电陶瓷本体 13 、分别覆盖在陶瓷本体 13 上、下表面上的上电极层 14 和下电极层 15 ，上电极层 14 包括覆盖在压电陶瓷本体 13 上表面上的覆盖部以及自覆盖部的边缘向下弯折延伸至压电陶瓷本体 13 的下表面形成的延伸部，以包住压电陶瓷本体 13 的边缘，下电极层 15 覆盖在压电陶瓷本体 13 的下表面上且边缘处分别与上电极层 14 的延伸部间隔一段距离，上电极层 14 的覆盖部的远离压电陶瓷本体 13 的表面上还覆盖有一上电极保护层 16 ，压电陶瓷本体 13 由低功耗压电陶瓷材料制成。在本发明中，药杯 4 内的药液因高频谐振产生雾化区，该雾化区与雾化罩 9 内的空腔相连通，从而通过雾化罩 9 及其顶部的排雾口 11 ，和出雾口 3 将雾排出供使用者使用。在本实施例中，该吹风装置 6 为风扇，药杯 4 、雾化罩 9 的外壁与壳体 1 内壁之间分别形成第一腔室 19 和第二腔室 20 ，以形成允许流体流通的通道。风扇 6 通过进风口 2 向装置内部吹风，风通过药杯 4 与壳体 1 外壁之间的第一腔室 19 向出雾口方向流动，经由药杯 4 与壳体 1 的连接件上的通风孔 12 进入雾化罩 9 外壁与壳体 1 之间的第二腔室 14 内，由于雾化罩 9 的上部与壳体 1 密封连接，而下部位于药杯 4 的开口内，并且在此处，雾化罩 9 的外壁与壳体 1 的内壁之间存在空隙，风从该间隙进入雾化罩 9 的内底部，并沿着雾化罩 9 向上流动，从而带动药杯 4 内的药液形成的雾化颗粒向上流动，经过雾化罩 9 顶部的排雾口 11 和盖体上的出雾口 3 排出，并经与出雾口 3 配合连接的咬嘴 17 或吸入面罩 18 进入人体。即，自进风口 2 至通风孔 12 ，以及第一腔室 19 、第二腔室 20 ，以及排雾口 11 和出雾口 3 形成气体流通的通道，使得气流带动由压电陶瓷雾化片 5 谐振导致的药液形成的雾化颗粒从出雾口 3 排出，供使用者使用。
本实施例中的低功耗压电陶瓷材料包括如下主材料组分：
重量百分比为 66.3% 的四氧化三铅；
重量百分比为 14.7% 的二氧化锆；
重量百分比为 8.7% 的二氧化钛；
重量百分比为 4.9% 的氧化锶；
重量百分比为 1.7% 的三氧化二铁；
重量百分比为 1.2% 的二氧化锡；
以及如下的添加组分
重量百分比为 0.7% 的二氧化锰；
重量百分比为 0.6% 的三氧化二铈；
重量百分比为 0.7% 的五氧化二铌；
重量百分比为 0.5% 的氧化锌。
在本实施例中，压电陶瓷雾化片 5 的上电极层 13 、下电极层 14 分别为金电极层，上电极保护层 15 为釉保护层。壳体 1 上开设有用于外接药瓶或加注药液的加药口 10 ，雾化罩 9 的对应于壳体 1 的加药口 10 的位置处开设有开口。加药口 10 和上述开口用于安装外接药瓶或向药杯 4 内加注药液。
本实施例的药物导入装置还包括用于为雾化控制线路板 7 和 / 或吹风装置 6 供电的电池组 8 ，电池组的电压为 1.5v~4.5 v ，雾化控制线路板 7 可通过电池组 8 驱动压电陶瓷雾化片 5 ，也可以由接电口与电源直接连接从而驱动压电陶瓷雾化片 5 ，但是只需要 1.5~10v 的电压，更进一步只需要 1.5~4.5v 电压即可。即，通过本申请的表面设置有凹孔的由低功耗压电材料制成的曲面形状的雾化片，只需要几伏的电压即可驱动，可使用普通的电池组。雾化控制线路板 7 设置在壳体 1 内，壳体 1 上还开设有用于为雾化控制线路板 7 和 / 或吹风装置 6 接通电源的接电口。该装置还配置有用于与出雾口 3 相配合连接的咬嘴 17 或吸入面罩 18 ，分别如图 2 和图 3 所示，出雾口 3 与吸入面罩 18 或咬嘴 17 相连，吸入面罩 18 或咬嘴 17 包括用于与出雾口 3 相连接的连接部，连接部的形状和大小与出雾口 3 正好匹配，可以直接卡入，通过接触表面的摩擦力形成紧密连接，保证雾化颗粒全部从咬嘴 17 或吸入面罩 18 中匀速喷出。
压电陶瓷本体 13 的表面设置有多个凹孔，凹孔为圆形孔、椭圆形孔、正方形孔、长方形孔、棱形孔或三角形孔中的几种的组合。压电陶瓷雾化片 5 的纵截面大体呈弧形，图 4 图示了压电陶瓷雾化片 5 的仰视图，图 5 展示了压电陶瓷雾化片 5 的俯视图，图 6 展示了本实施例的压电陶瓷雾化片 5 的纵切剖视示意图。
如图 5 所示，本实施例的压电陶瓷雾化片 5 的形状是圆形曲面结构，或者也可以是部分曲面结构，或者是不连续多处曲面结构。曲面的弧度可以是 0 到π之间的任意弧度。例如，雾化片可以是如图所示的约π /8 的弧度的曲面，即 45 °的圆心角多对应的圆弧。又如，雾化片可以是两端为平面结构，中间为半圆弧的部分曲面结构。
如图所示，本发明中的压电陶瓷雾化片 5 的压电陶瓷本体 13 表面含有特定大小、形状的凹孔，其形状、数量、密度、深度包含但不限于下述的任意一种：一片雾化片表面的凹孔可以是全部为圆形，数量可以是合适的任意值（例如 100 或者 200 个）；一片雾化片表面的凹孔也可以部分（适当数量）圆形，部分（适当数量）正方形；一片雾化片表面的凹孔可以是部分（适当数量）椭圆形，部分（适当数量）菱形，部分（适当数量）不规则多边形。一片雾化片表面的凹孔可以均匀分布，也可以在局部区域密度大于另外一些区域。上述各种凹孔的深度根据制备工艺和使用需求，可以确定为合适的任意数值。
本发明的低能耗高频超声雾化全呼吸道药物导入装置，其特点是通过高频超声产生极细小的雾化颗粒，大部分颗粒在 2~4 微米范围，可以有效进入下呼吸道 / 肺泡部位，小部分相对较大的雾化颗粒可以分布在上呼吸道和中呼吸道。图 7 显示了呼吸道给药时，雾化颗粒大小与停留位置的关系，从中可以看出，雾化颗粒直径越大，越倾向于停在上呼吸道，雾化颗粒变小时，将更多的进入下呼吸道 / 肺泡。
本发明所提供的全呼吸道药物导入装置，产生的颗粒相对较小，更多的可以进入系呼吸道。如图 8 所示，采用新一代实时高速喷雾粒度仪 Spraytec 进行激光衍射气雾粒径测定 LD 法分析，通过 D50 分布来对比本发明的实施例的高频超声雾化器与欧姆龙雾化器的雾化颗粒大小：本发明的手持式高频超声雾化全呼吸道药物导入装置雾化颗粒的中位粒径为 5.13 微米（图 8 上部），而对照的欧姆龙雾化器雾化颗粒的中位粒径为 10.14 微米（图 8 下部）。如图 9 所示，采用 TSI 公司 3321 型 APS 进行飞行时间空气动力学气雾粒径测定 TOF 法分析，过质量平均值分布来对比本发明的手持式高频超声雾化全呼吸道药物导入装置与欧姆龙雾化器的雾化颗粒大小：本发明的低能耗高频超声雾化器的雾化颗粒的中位粒为 1.43 微米（图 9 上部），而对照的欧姆龙雾化器的雾化颗粒的中位粒径为 2.63 微米（图 9 下部）。以上两种检测方法均表明，本发明的手持式高频超声雾化全呼吸道药物导入装置所产生的雾化颗粒大小只有欧姆龙雾化器颗粒的 50% 左右。
因而，本发明的手持式高频超声雾化全呼吸道药物导入装置不仅具有低功耗，携带方便，成本低廉的优点，而且能够产生更小的雾化颗粒，适用于全呼吸道药物导入，具有非常良好而广泛的应用前景。
以上对本发明的特定实施例进行了说明，但本发明的保护内容不仅仅限定于以上实施例，在本发明的所属技术领域中，只要掌握通常知识，就可以在其技术要旨范围内进行多种多样的变更。

Claims (12)

1. 一种手持式高频超声雾化全呼吸道药物导入装置，包括底部设置有进风口（ 2 ）的具有开放空间的壳体（ 1 ）和设置在所述壳体（ 1 ）的开放空间的开口上的盖体，所述盖体上设置有出雾口（ 3 ），壳体（ 1 ）的开放空间设置有用于放置药液的具有开口的药杯（ 4 ）和位于所述药杯（ 4 ）上方用于聚集雾的聚雾罩（ 9 ），所述聚雾罩（ 9 ）的底部位于所述药杯（ 4 ）的开口内，且在所述药杯（ 4 ）内的所述雾化罩（ 9 ）的外壁与所述药杯（ 4 ）的内壁之间存在间隙，所述聚雾罩（ 9 ）的上部与所述壳体（ 1 ）的内壁之间密封连接，所述药杯（ 4 ）的外壁与所述壳体（ 1 ）的内壁之间形成第一腔室（ 19 ），所述聚雾罩（ 9 ）的外壁与所述壳体（ 1 ）的内壁之间形成第二腔室（ 20 ），所述药杯（ 4 ）上设置有压电陶瓷雾化片（ 5 ），所述压电陶瓷雾化片（ 5 ）位于所述药杯（ 4 ）内的预设最高药液液面之下，所述药杯（ 4 ）的杯壁通过连接件与所述壳体（ 1 ）相连接，且在连接件和 / 或位于预设最高药液液面之上的药杯（ 4 ）的的杯壁上开设有用于连通第一腔室（ 19 ）和第二腔室（ 20 ）的通风孔（ 12 ），雾化罩（ 9 ）的顶部上设置有排雾口（ 11 ），所述排雾口（ 11 ）与所述出雾口（ 3 ）相流体连通，所述壳体（ 1 ）内在其进风口（ 2 ）处设置有用于朝向所述出雾口（ 13 ）方向吹风的一吹风装置（ 6 ），所述药物导入装置还包括与所述压电陶瓷雾化片（ 5 ）相电连接的雾化控制线路板（ 7 ），其特征在于：所述压电陶瓷雾化片（ 5 ）包括压电陶瓷本体（ 13 ）、分别覆盖在所述陶瓷本体（ 13 ）上、下表面上的上电极层（ 14 ）和下电极层（ 15 ），所述上电极层（ 14 ）包括覆盖在所述压电陶瓷本体（ 13 ）上表面上的覆盖部以及自所述覆盖部的边缘向下弯折延伸至所述压电陶瓷本体（ 13 ）的下表面形成的延伸部，以包住所述压电陶瓷本体（ 13 ）的边缘，所述下电极层（ 15 ）覆盖在所述压电陶瓷本体（ 13 ）的下表面上且边缘处分别与所述上电极层（ 14 ）的延伸部间隔一段距离，所述上电极层（ 14 ）的覆盖部的远离所述压电陶瓷本体（ 13 ）的表面上还覆盖有一上电极保护层（ 16 ），所述压电陶瓷本体（ 13 ）由低功耗压电陶瓷材料制成，所述低功耗压电陶瓷材料包括如下主材料组分：
重量百分比为 63.3~68.3% 的四氧化三铅；
重量百分比为 14.2~15.3% 的二氧化锆；
重量百分比为 8.1~9.5% 的二氧化钛；
重量百分比为 4.6~5.2% 的氧化锶；
重量百分比为 1.5~1.8% 的三氧化二铁；
重量百分比为 1.0~1.4% 的二氧化锡；
以及如下的添加组分
重量百分比为 0.3~1.1% 的二氧化锰；
重量百分比为 0.5~0.8% 的三氧化二铈；
重量百分比为 0.4~0.8% 的五氧化二铌；
重量百分比为 0.3~0.7% 的氧化锌。
2. 根据权利要求 1 所述的手持式高频超声雾化全呼吸道药物导入装置，其特征在于：所述压电陶瓷本体（ 13 ）的表面设置有多个凹孔，凹孔为圆形孔、椭圆形孔、正方形孔、长方形孔、棱形孔或三角形孔中的一种或几种的组合。
3. 根据权利要求 1 所述的手持式高频超声雾化全呼吸道药物导入装置，其特征在于：所述排雾口（ 11 ）为多个，多个排雾口（ 11 ）沿着雾化罩（ 9 ）的顶部周向间隔均匀排列。
4. 根据权利要求 1 所述的手持式高频超声雾化全呼吸道药物导入装置，其特征在于：所述压电陶瓷雾化片（ 5 ）的纵截面基本沿弧线延伸，所述弧线的弧度为 0~ π。
5. 根据权利要求 1 所述的手持式高频超声雾化全呼吸道药物导入装置，其特征在于：所述压电陶瓷雾化片（ 5 ）所产生的超声波频率为 1.0~10 兆赫兹。
6. 根据权利要求 1 所述的手持式高频超声雾化全呼吸道药物导入装置，其特征在于：所述压电陶瓷雾化片（ 5 ）所产生的药液的雾化颗粒的直径为 0.1~5 微米。
7. 根据权利要求 1 所述的手持式高频超声雾化全呼吸道药物导入装置，其特征在于：所述压电陶瓷雾化片（ 5 ）的上电极层（ 14 ）、下电极层（ 15 ）分别为金电极层或银电极层，上电极保护层（ 16 ）为合金镀层或釉保护层。
8. 根据权利要求 1 所述的手持式高频超声雾化全呼吸道药物导入装置，其特征在于：还包括用于为所述雾化控制线路板（ 7 ）和 / 或所述吹风装置（ 6 ）供电的电池组（ 8 ）。
9. 根据权利要求 1 所述的手持式高频超声雾化全呼吸道药物导入装置，其特征在于：所述电池组（ 8 ）的电压为 1.5v~10 v 。
10. 根据权利要求 1 所述的手持式高频超声雾化全呼吸道药物导入装置，其特征在于：所述雾化控制线路板（ 7 ）设置在所述壳体（ 1 ）内，所述壳体（ 1 ）上还开设有用于为所述雾化控制线路板（ 7 ）和 / 或吹风装置（ 6 ）接通电源的接电口。
11. 根据权利要求 1 所述的手持式高频超声雾化全呼吸道药物导入装置，其特征在于：所述壳体（ 1 ）上开设有用于外接药瓶或加注药液的加药口（ 10 ），所述雾化罩（ 9 ）的腔璧上在对应于壳体（ 1 ）的加药口（ 10 ）的位置处开设有开口。
12. 根据权利要求 1 所述的手持式高频超声雾化全呼吸道药物导入装置，其特征在于：还包括用于与所述出雾口（ 3 ）相配合连接的咬嘴（ 17 ）或吸入面罩（ 18 ）。
PCT/CN2014/087366 2014-01-13 2014-09-25 手持式高频超声雾化全呼吸道药物导入装置 WO2015103891A1 (zh)

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