CN114768012A - Synchronous nasal cavity autonomous quantitative medicine delivery device with expiration - Google Patents
Synchronous nasal cavity autonomous quantitative medicine delivery device with expiration Download PDFInfo
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- CN114768012A CN114768012A CN202210063868.0A CN202210063868A CN114768012A CN 114768012 A CN114768012 A CN 114768012A CN 202210063868 A CN202210063868 A CN 202210063868A CN 114768012 A CN114768012 A CN 114768012A
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- 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
- A61M15/0091—Inhalators mechanically breath-triggered
-
- 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
- A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
-
- 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
- A61M2210/00—Anatomical parts of the body
- A61M2210/06—Head
- A61M2210/0618—Nose
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pulmonology (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
The synchronous nasal cavity autonomous quantitative drug delivery device of expiration of the invention includes: the quantitative medicine conveying device comprises a quantitative chamber, a device outer wall structure, pistons at two sides, piston push-pull rods, adjustable tension springs, spring tension adjusting knobs, piston clamps, piston clamp adjusting knobs, butt-joint pipes, one-way circulation ports, two-way circulation ports and middle-way nose plugs, and is characterized in that the medicine conveying device is integrally connected with all components into a whole by adopting an integrated wearable design, and all components are combined in a modularized mode and can be detached and replaced. The synchronous expiration nasal cavity autonomous quantitative drug delivery device overcomes the defects and shortcomings of the existing drug delivery device, has autonomous operation, safety and high efficiency, realizes a constant dose long-time nasal cavity drug delivery effect similar to an intravenous drip mode, and meets the urgent need of clinical drug treatment of patients who are not suitable for intravenous injection.
Description
Technical Field
The invention relates to a nasal cavity drug delivery device, in particular to a synchronous expiration nasal cavity autonomous quantitative drug delivery device.
Background
The respiratory area of the nasal cavity is the largest part of the nasal cavity, blood vessels under the mucous membrane are rich, and the venules, the arterioles, the capillaries and the lymphatic vessels are interwoven into a net, so that the medicine can be quickly absorbed, the medicine is absorbed to enter the whole blood circulation, the bioavailability of the medicine can be improved, and the first pass effect of the oral medicine is avoided. In addition, the medicine which is not easy to be absorbed in the gastrointestinal tract and is easy to be damaged by gastric acid can be effectively absorbed by the nasal mucosa, thereby improving the treatment effect of the medicine.
The submucosal blood vessels of the nasal cavity are very rich, the arteries, the veins and the capillaries are interwoven into a net shape, the liquid medicine can be quickly absorbed and enters the systemic circulation, and the absorption speed and the absorption degree of the liquid medicine can be equivalent to those of intravenous injection sometimes. However, the existing nasal preparations have the following defects:
1. the patient needs to be trained to master the administration operation method. Although nasal formulations can be self-administered to patients, there are not many patients who need to be able to properly handle them.
2. When the medicine is needed to be inhaled, the medicine is beneficial to enter the nasal cavity, but the medicine cannot be controlled to further enter the lung through the oropharynx, so that the medicine is lost.
3. The retention time in nasal cavity is short, and in order to prolong the retention time, adhesive is usually added, but the adhesive has serious influence on ciliary activity in nose, and has a problem of toxicity to nasal cilia.
4. Most nasal preparations are manually administered in a single dose, and cannot realize administration in a constant dose and a long-term mode similar to intravenous drip.
At present, the incidence of chronic diseases is more and more, some chronic disease patients need to be treated by multiple injections, repeated needle insertion not only causes great psychological burden to the patients, but also causes problems of venous sinus, phlebitis and the like, and the limb veins of the patients can be inserted everywhere. In addition, since the administration of the drug by injection requires a nurse in charge and the administration of the drug by the patient himself/herself is impossible, it is highly desirable to develop a nasal drug administration device which is capable of autonomous operation, is safe and efficient, and realizes a constant dose for a long period of time, and which is similar to the "intravenous drip" mode. At present, the reports of the devices are not seen, so that the urgent need of clinical drug treatment of intravenous injection patients is not met.
Disclosure of Invention
The invention aims to provide a breath synchronous nasal cavity autonomous quantitative drug delivery device which is safe, efficient, quantitative and capable of delivering drugs for a long time.
The synchronous expiration nasal cavity autonomous quantitative drug delivery device has the following advantages that the device is different from the existing nasal cavity drug delivery device:
1. the safety is high: the medicine does not need to add additives such as adhesive with cilia toxicity (inhibiting cilia from falling off caused by cilia swinging), mucosal absorption promoter with potential safety and the like, has no influence on the physiological microenvironment and cilia movement of the nasal cavity, has no side effects such as stimulation and the like, and has high safety.
2. Accurate positioning and high drug utilization rate: the medicine does not need to be prepared into a special dosage form or a special carrier is applied; the drug is only prepared into solution, emulsion and suspension, so that the positioned and high-efficiency delivery can be realized, the drug cannot enter the trachea and the lung, and the utilization rate is high.
3. Quick-acting: the medicine has high dispersibility in solution, small surface tension, high affinity with nasal mucosa, maximally accelerated absorption, and rapid action.
4. Self-administration, convenient operation: the user adjusts the spring tension regulation knob and the piston card regulation knob according to the self condition and the dosage of the medicine, and the quantitative delivery of the medicine to the nasal cavity can be completed through normal inspiration and expiration. As shown in figures 3-4, the application principle of the breath synchronous nasal cavity autonomous quantitative drug delivery device is as follows: (1) when the oral cavity starts to inhale, under the combined action of inhaling and tension spring, the pistons at both sides move downwards, the medicine flows into the quantitative chamber through the medicine butt-joint pipe, and meanwhile, because the one-way circulation port of the nasal cavity butt-joint pipe is closed, no medicine enters the nasal cavity. (2) When the oral cavity inhales at the tail end, the piston in the quantitative chamber is blocked by the piston to stop moving, and meanwhile, air enters from the outside through the air passage of the piston on the other side, so that the subsequent inhalation of a user is ensured. (3) When the oral cavity exhales and begins, under the expiration impetus effect, two side pistons shift up, and the medicine is passed through one-way circulation mouth by the ration room and is flowed to the nasal cavity and connect the pipe, simultaneously because the one-way circulation mouth of medicine to the pipe is closed, can not have the medicine to get into the ration room (4) when the indoor piston of ration removes the ration room bottom, the stop removal, the exhaling in oral cavity is through the air duct of opposite side piston to the external outflow, guarantees the smooth and easy of exhaling. And (5) repeating the processes (1) to (4) when the oral cavity inhales again.
5. The nasal administration purpose of a similar intravenous drip mode with constant dose for a long time is realized: by applying the synchronous nasal cavity autonomous quantitative drug delivery device for expiration, the drug enters the nasal cavity in a small-dose multi-time drug delivery mode, the sufficient contact and absorption of the nasal cavity mucous membrane are ensured, the bioavailability of the drug is high, and the purpose of nasal cavity drug delivery similar to an intravenous drip mode with constant dose for a long time can be realized.
6. The patient does not need special operation requirements, and the applicable crowd is wider: the drug delivery device disclosed by the invention is easy to realize autonomous drug delivery, free of pain and stimulation, suitable for patients who are not suitable for long-term intravenous injection, and also suitable for children, the old, patients with mental retardation and the like.
Drawings
Fig. 1 is a schematic diagram of the components of the breath-synchronized nasal autonomous metered dose device of the present invention.
Fig. 2 is a schematic structural diagram of the design of the synchronous nasal cavity autonomous quantitative drug delivery device of the invention.
Fig. 3 is a working principle diagram of the nasal cavity autonomous quantitative drug delivery device with synchronous expiration during oral inhalation.
Fig. 4 is a working principle diagram of the nasal cavity autonomous quantitative drug delivery device synchronously with expiration during oral cavity expiration.
Detailed Description
Hereinafter, specific embodiments of the present invention will be described in detail. It should be noted that technical features or combinations of technical features described in the following embodiments should not be considered in isolation, and they may be combined with each other to achieve better technical effects.
As shown in fig. 1 to 4, the synchronous expiration nasal autonomous quantitative drug delivery device of the present invention comprises: the quantitative chamber 10, the outer wall structure 11 of the device, the pistons 20 at two sides, the piston push-pull rod 21, the adjustable tension spring 30, the spring tension adjusting knob 31, the piston clamp 40, the piston clamp adjusting knob 41, the butt joint pipe 50, the one-way flow port 60, the two-way flow port 61 and the middle-way nasal plug 70 are integrally connected into a whole by applying an integrated wearable design, the components are combined in a modularized mode and can be detached and replaced, and the drug delivery device is used for delivering liquid, solid or gaseous drugs.
The docking pipe 50 includes: a drug interface tube 51, a nasal interface tube 52, and an oral interface tube 53 for delivery of drugs or air flow.
The quantitative chamber 10 is connected with two one-way communication ports 60, and then is respectively connected with the drug butt joint pipe 51 and the nasal cavity butt joint pipe 52, so that the drug is controlled to be conveyed from the drug butt joint pipe 51 to the quantitative chamber 10, and then conveyed from the quantitative chamber 10 to the nasal cavity butt joint pipe 52.
Device outer wall structure 11 connect a one-way circulation opening 60 and two-way circulation openings 61, a two-way circulation opening 61 is located device outer wall structure 11 top, for the piston removal in the device outer wall structure 11 provides the air current business turn over route, another two-way circulation opening 61 connects oral cavity butt joint pipe 53, for the oral cavity is breathed airflow and is passed in and out device outer wall structure 11 and provide the route, a one-way circulation opening 60 is located device outer wall structure 11 middle part, for breathing in the in-process piston removal provides the air current and gets into the route when 40 positions of piston card.
The piston push-pull rod 21 is connected with the pistons 20 at the two sides, so that the synchronous movement of the pistons 20 at the two sides is ensured; the piston 20 on one side is located inside the quantitative chamber 10 for controlling the medicine to flow in and out of the quantitative chamber 10, and the piston on the other side is located in the outer wall structure 11, and the piston contains a ventilation channel inside, and is combined with the one-way flow port 60 and the two-way flow port 61 on the outer wall structure 11 for regulating and controlling the process of the piston 20 on both sides during the inhalation and exhalation of the oral cavity.
The adjustable tension spring 30 is connected with the piston push-pull rod 21 to provide auxiliary power for the piston in the quantitative chamber 10 to move downwards to the position of the piston clamp 40 in the air suction process; the spring tension adjusting knob 31 is connected with the adjustable tension spring 30 and is used for adjusting the tension of the adjustable tension spring 30.
The plunger card 40 is connected to a plunger card adjustment knob 41 for controlling the volume of the medication in the dosing chamber 10.
The hollow channel in the middle-through nasal plug 70 is used for connecting the nasal cavity butt-joint pipe 52 and delivering the medicine into the nasal cavity.
The middle-through nasal plug 70 is connected with a sprayer nozzle of an atomizer to disperse the medicine into fine liquid drops, particles or aerosol, so that the surface area of the medicine is increased, and the absorption efficiency of the nasal cavity is improved.
An application method of a synchronous expiration nasal cavity autonomous quantitative drug delivery device comprises the following steps:
(1) according to the self condition and the dosage of the medicine, the spring tension regulating knob 31 and the piston card regulating knob 41 are regulated, the middle through nasal plug 70 is plugged into the nasal cavity of the user, and the position is regulated until the air inlet and the air outlet of the nasal cavity are completely plugged after the hollow channel of the middle through nasal plug 70 is closed;
(2) the user remains still and performs normal inhalation and exhalation through the oral docking tube 53 to accomplish the quantitative delivery of the drug to the nasal cavity.
Example 1 test grouping for a breath-synchronized nasal autonomous metered dose device
The breath-synchronized nasal autonomous quantitative drug delivery device of the present invention was used in the following tests.
The testing personnel: the nose cavity disease does not exist between the ages of 20-50 years, and the nature is not limited.
The test method comprises the following steps: the design of the table 1 is divided into an experimental group and a control group, each group has 6 names, and berberine is taken as a drug representative to prepare 5mL of berberine aqueous solution (10 mg/mL). According to the self condition of a tester, the spring tension regulation knob and the piston card regulation knob are adjusted, so that the effective use of the nasal cavity autonomous quantitative drug delivery device with synchronous expiration is ensured.
The experimental group was administered according to the application method of the present invention according to the design scheme of table 1, and the body position was kept for 10min after the administration. The control group was administered intranasally according to the design scheme of table 1 while referring to the experimental group method.
Example 2 test results of a nasal autonomous quantitative drug delivery device with synchronous expiration
After nasal administration according to the design of table 1, each group of drugs was evaluated for retention degree in nasal cavity, nasal feeling and acceptability of the testers, bitter taste in oropharynx, berberine concentration in plasma, and the like.
Oropharyngeal feeling: whether the medicine entering the nasal cavity enters the oropharynx or not is evaluated through the feeling of bitter taste of the oropharynx.
And (3) detecting the concentration of berberine in plasma: reference method [ Qiu Row, Li Jiachuan, Bengzhili, methodological research for measuring the concentrations of 5 berberine type alkaloids in blood plasma by HPLC method, the third International science and technology Association for Chinese medicine ], wherein HPLC measurement is carried out after deproteinization of blood plasma samples by acetonitrile, and the concentration of berberine in blood plasma of each group of testers is compared at 5min after administration.
The test results of each group are shown in table 2, the effect of each index in the table is represented by 1-100 (the higher the numerical value is, the better the representative effect is), the overall evaluation is given by integrating each index, and the overall evaluation is divided into 4 grades: excellent, good, medium and poor.
TABLE 1 test grouping for synchronous nasal cavity autonomous quantitative drug delivery device with exhalation
Note that: means without the feature or structure; indicates that the modules are significantly different from the experimental group.
TABLE 2 test results of nasal autonomous quantitative drug delivery device with synchronous expiration
The results in table 2 show that the effect of each aspect of the breath synchronous nasal cavity autonomous quantitative drug delivery device in the experimental group is obviously higher than that of the control group, and the device has the advantages of high retention degree of the drug in the nasal cavity, good nasal feeling, no bitter taste in the oropharynx and high berberine concentration in blood plasma, and good overall evaluation, wherein the evaluation of the experimental group 2 is better.
Compared with an experimental group, the control group has poor effect, the berberine concentration in blood plasma of the control groups 1, 2, 7, 9-11 is very low or none, the administration effect is the worst, various problems exist when the control groups 3-5 are applied, and the medicine entering the nasal cavity of the control group 8 overflows, so that the berberine concentration in the blood plasma is influenced.
The results in table 2 prove that any component and parameter in the technical protection scheme of the synchronous expiration nasal cavity autonomous quantitative drug delivery device are mutually synergistic and can not be deleted, and the absence of any component and parameter in the technical protection scheme can have great influence on the absorption and blood absorption effects of the drugs. The synchronous expiration nasal cavity autonomous quantitative drug delivery device has the characteristics of safety, high efficiency and convenience in application, and has a good application prospect.
The above detailed description is specific to possible embodiments of the invention, and the embodiments are not intended to limit the scope of the invention, and all equivalent implementations or modifications that do not depart from the scope of the invention should be construed as being included within the scope of the invention. In addition, various modifications, additions and substitutions in other forms and details may occur to those skilled in the art within the scope and spirit of the invention as disclosed in the claims. It is understood that various modifications, additions, substitutions and the like can be made without departing from the spirit of the invention as disclosed in the accompanying claims.
Claims (10)
1. Synchronous nasal cavity of exhaling is from moving ration infusion device, its characterized in that, the infusion device include: the quantitative chamber and device outer wall structure, two side pistons and piston push-and-pull rods, adjustable tension springs and spring tension regulation knobs, piston clamps and piston clamp regulation knobs, butt-joint pipes, one-way circulation ports, two-way circulation ports and middle-way nose plugs.
2. The breath-synchronized nasal autonomous metered dose delivery apparatus of claim 1 wherein said docking tube comprises: a drug interface tube, a nasal interface tube and an oral interface tube for delivery of drugs or air flow.
3. The breath-synchronized autonomous nasal metered dose delivery device of claim 1 wherein said metering chamber is connected to two one-way flow ports and then to a drug docking station and a nasal docking station, respectively, to control the delivery of drug from the drug docking station to the metering chamber and then from the metering chamber to the nasal docking station.
4. The breath-synchronized nasal cavity autonomous metered dose delivery device of claim 1 wherein said outer wall structure is connected to a one-way flow port and two-way flow ports, one of the two-way flow ports being located at a top portion of the outer wall structure to provide an air flow path for movement of the piston within the outer wall structure, the other of the two-way flow ports being connected to the oral cavity interface tube to provide an air flow path for flow of oral breathing air into and out of the outer wall structure, and one of the two-way flow ports being located at a middle portion of the outer wall structure to provide an air flow path for movement of the piston into the piston position during inspiration.
5. The device for synchronous nasal autonomous quantitative drug delivery with expiratory synchronization of claim 1, wherein the piston push-pull rod is connected with the bilateral pistons to ensure the synchronous movement of the bilateral pistons; the piston at one side of the bilateral pistons is positioned in the quantitative chamber and used for controlling the medicine in and out of the quantitative chamber, the piston at the other side of the bilateral pistons is positioned in the outer wall structure of the device, and the piston internally contains a ventilation channel and is combined with a one-way flow port and a two-way flow port on the outer wall structure of the device and used for regulating and controlling the bilateral piston processes during the inspiration and expiration of the oral cavity.
6. The device for the synchronous nasal autonomous quantitative drug delivery with expiration as claimed in claim 1, wherein the adjustable tension spring is connected with the piston push-pull rod to provide an auxiliary power for the piston in the quantitative chamber to move down to the piston position during inspiration; the spring tension adjusting knob is connected with the adjustable tension spring and used for adjusting the tension of the adjustable tension spring.
7. The device as claimed in claim 1, wherein the piston card is connected to a piston card control knob for controlling the volume of the drug in the dosing chamber.
8. The breath-synchronized nasal autonomous metered dose delivery device of claim 1 wherein said hollow passageway is formed in said hollow nasal plug for connection to a nasal interface tube for delivering the drug into the nasal cavity.
9. The device for the synchronous nasal autonomous quantitative drug delivery with exhalation as claimed in claim 1, wherein said middle opening nasal plug is connected to an atomizer nozzle for dispersing the drug into fine droplets, particles or aerosol, increasing the surface area of the drug and improving the absorption efficiency of the nasal cavity.
10. A method of use of the breath-synchronized nasal autonomous metered dose device according to any of claims 1 to 9, comprising the steps of:
(1) according to the self condition of a user and the dosage of the medicine, the spring tension regulating knob and the piston card regulating knob are regulated, the middle-through nasal plug is plugged into the nasal cavity of the user, and the position is regulated until the air inlet and the air outlet of the nasal cavity are completely blocked after the hollow channel of the middle-through nasal plug is closed;
(2) the user keeps a static state, and the oral cavity butt joint pipe of the nasal cavity autonomous quantitative drug delivery device synchronously exhales air to normally inhale and exhale air so as to finish the quantitative delivery of the drug to the nasal cavity.
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| CN202210063868.0A CN114768012B (en) | 2022-01-14 | 2022-01-14 | Automatic quantitative drug delivery device for synchronous nasal cavity during exhalation |
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| US6752147B1 (en) * | 1998-01-30 | 2004-06-22 | Hagepharm Gmbh | Inhalation apparatus for powder medications |
| CN1524001A (en) * | 2001-02-26 | 2004-08-25 | ���յ�ŵ˹��˾ | Nasal devices |
| US20060289006A1 (en) * | 2005-06-27 | 2006-12-28 | Kos Life Sciences, Inc. | Breath actuated nasal drug delivery system |
| US20100199984A1 (en) * | 2007-04-02 | 2010-08-12 | Abbott Laboratories | Breath actuated nasal pump |
| CN110464922A (en) * | 2019-08-19 | 2019-11-19 | 丁瑞芬 | A kind of vaporizer dose control equipment |
| WO2021150883A1 (en) * | 2020-01-22 | 2021-07-29 | Virginia Commonwealth University | Air-jet dry power inhaler for rapid delivery of pharmaceutical aerosols to infants |
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