WO1997002062A1 - Vaporisateur pour les cavites nasales et procede d'utilisation dudit vaporisateur - Google Patents
Vaporisateur pour les cavites nasales et procede d'utilisation dudit vaporisateur Download PDFInfo
- Publication number
- WO1997002062A1 WO1997002062A1 PCT/JP1996/001798 JP9601798W WO9702062A1 WO 1997002062 A1 WO1997002062 A1 WO 1997002062A1 JP 9601798 W JP9601798 W JP 9601798W WO 9702062 A1 WO9702062 A1 WO 9702062A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- medicine
- nozzle
- nasal
- passage
- patient
- Prior art date
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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
- A61M15/00—Inhalators
- A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
-
- 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
- A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
- A61M15/003—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using capsules, e.g. to be perforated or broken-up
- A61M15/0033—Details of the piercing or cutting means
-
- 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
- A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
- A61M15/0045—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters
-
- 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
- A61M15/08—Inhaling devices inserted into the nose
-
- 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
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/06—Solids
- A61M2202/064—Powder
-
- 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
- A61M2205/07—General characteristics of the apparatus having air pumping means
- A61M2205/071—General characteristics of the apparatus having air pumping means hand operated
- A61M2205/075—Bulb type
Definitions
- the present invention relates to a nasal administration device suitable for administering a powdery medicine filled in a medicine accommodating chamber to a nasal cavity and a method of using the same.
- a method of treating the patient by administering a powdered drug through the nasal cavity is adopted. Also, in this treatment method, a powdery medicine filled in a medicine storage chamber such as a capsule is administered into the nasal cavity using a special atomizer.
- a sprayer disclosed in Japanese Patent Application Laid-Open No. 59-324267 is known as a sprayer used for this treatment method.
- a pump section is provided on the air inflow side of the cylindrical member, a concave portion into which a capsule is inserted is formed on the air outflow side of the cylindrical member, and a chemical agent is formed on the tip side of the cylindrical member.
- a tip portion having an opening serving as a spray port is detachably provided, and a capsule housing portion is formed inside by fitting the tip portion to the cylindrical member.
- the capsule further comprises a cap which is detachably fitted to the cylindrical member at the distal end thereof.
- a needle extending in the axial direction is provided in the capsule, and the distal end is fitted to the cylindrical member.
- the medication to the nasal cavity is performed alternately to the left and right nasal cavities, a gap is provided between the capsule receiving part and the capsule so that all the medicine in the capsule is not administered by one pressing operation of the pump part. A prescribed amount of the drug is administered by pressing the pump unit about four times in one nasal cavity.
- the left and right nasal cavities are provided one by one. Since the medicine is being administered, it is necessary to repeatedly press the pump unit and insert the cylindrical member into the nasal cavity several times in order to supply the medicine to the left and right nasal cavities evenly. There is a problem that it becomes something.
- the tip When a hole is formed in the capsule in preparation for administration, the tip is removed from the cylindrical member to accommodate the capsule, and in this state, a cap is inserted into the cylindrical member and the tip to perform the hole. When spraying chemicals, the cap is removed again, and then the pump is pressed to spray the nasal passages. The problem is that it is bothersome and the cap may be lost.o
- the present invention has been made in view of the above-described problems of the prior art, and allows a medicine in a medicine holding chamber to be simultaneously administered to the left and right nasal cavities of a patient with a simple operation, and is widely applicable to children and adults. It is intended to provide a nasal administration device. Disclosure of the invention
- the nasal administration device of the present invention basically comprises a medicine storage chamber in which a powdered medicine is accommodated, and the left and right nozzles are used to insert the medicine in the left and right nasal cavity of the patient into the medicine accommodation chamber.
- the distance between the nozzles in the left and right directions can be adjusted according to the distance between the nasal cavities of the patient.
- the distance between the left and right nozzles is adjusted according to the distance between the nasal cavities of the patient.
- the left and right nozzles can be inserted at desired positions in the nasal cavity.
- the present invention provides a medicine storage chamber for storing a powdery medicine, air supply means for supplying air to the medicine storage chamber, and air supplied from the air supply means.
- a passage means having left and right medicine passages for supplying the medicine into the left and right nasal cavities of the patient; and a medicine in the passage means for spraying the medicine while inserted into the left and right nasal cavities of the patient. It is composed of distance adjustment nozzle means provided on the passage ejection side so as to be adjustable according to the distance between the nasal cavities of the patient.
- the medicine in the medicine storage chamber forms the passage means while being agitated by the air from the air supply means. It is simultaneously sprayed into the left and right nasal cavities of the patient from the left and right drug passages. Further, when the distance adjusting nozzle means is inserted into the left and right nasal cavities of the patient, the distance adjusting nozzle means can be inserted into the nasal cavity by adjusting the distance adjusting nozzle means in accordance with the distance between the left and right nasal cavities of the patient. Can be reliably inserted into a desired site.
- the present invention provides a medicine storage chamber for accommodating a powdery medicine, air supply means for supplying air to the medicine storage chamber, and a medicine in the medicine storage chamber by air supplied from the air supply means.
- a passage means having left and right medicine passages for supplying into the left and right nasal cavities of the patient, and a medicine passage ejection of the passage means for spraying the medicine in a state of being inserted into the left and right nasal cavities of the patient.
- the medicine in the medicine storage chamber forms the passage means while being agitated by the air from the air supply means. It is simultaneously sprayed into the left and right nasal cavities of the patient from the left and right drug passages. Further, when the rotatable nozzle of the left and right nozzles constituting the distance adjusting nozzle means is rotated, the nozzle turns with the eccentric amount as a radius. By adjusting the distance between the left and right nozzles, the distance between the nasal cavity of the patient can be adjusted.
- At least one of the left and right nozzles constituting the distance adjusting nozzle means is detachably provided in the passage means.
- the nozzles and the chemical passage can be easily cleaned to every corner.
- the spray ports of the nozzles constituting the distance adjusting nozzle means are formed in a substantially linear shape.
- the medicine in the medicine storage room is sprayed into the left and right nasal cavity of the patient, the air containing the medicine flows linearly from the left and right medicine passages toward the spray port, and the rectification and straightness are improved. It is sprayed into the nasal cavity as given.
- the spray ports of the nozzles constituting the distance adjusting nozzle means are formed eccentrically.
- the eccentric spray port rotates with the nozzles.
- the spray ports are moved to the center of the nasal cavity. The medicine can be uniformly sprayed into the nasal cavity from the spray opening.
- a medicine storage chamber for accommodating a powdered medicine; air supply means for supplying air to the medicine storage chamber; and a medicine in the medicine storage chamber by air supplied from the air supply means.
- distance adjusting nozzle means comprising left and right nozzles provided on the side of the nozzle. At least one of the left and right nozzles that make up the stage is provided movably to the left and right with respect to the other nozzle.
- the medicine in the medicine storage chamber forms the passage means while being agitated by the air from the air supply means. It is simultaneously sprayed into the left and right nasal cavities of the patient from the left and right drug passages.
- the distance between the left and right nozzles is adjusted to the patient's nasal cavity by moving the movably provided nozzles of the left and right nozzles that constitute the distance adjustment nozzle means in the left and right directions. be able to.
- the distance adjusting nozzle means includes: a left and right direction guide portion for guiding at least one of the left and right nozzles in the left and right directions; And a nozzle holding unit for holding the nozzle.
- the left and right separation distance from the other nozzle can be adjusted in accordance with the nasal cavity distance, and
- the nozzle holding portion can prevent the nozzle from falling off.
- the adjustable nozzle and the passage means of the left and right nozzles constituting the distance adjusting nozzle means are connected by a flexible connection pipe.
- the nozzle and the passage means are connected by the flexible connecting pipe, so that the connecting pipe is deformed according to the amount of movement of the nozzle. This allows the nozzle to always communicate with the chemical passage of the passage means while allowing the movement of the nozzle.
- the medicine storage chamber is configured to supply the medicine by a capsule or a separate supply device.
- the medicine is supplied to the medicine storage chamber using a capsule or a separate supply device, so that a predetermined amount of the medicine is supplied to the medicine storage chamber every time the medicine powder is administered to the patient. Can supply.
- the air supply means is a means for supplying air by a pump. Therefore, when air is discharged from the pump, the discharged air is supplied toward the chemical storage chamber.
- FIG. 1 is a side view showing a nasal administration device according to a first embodiment of the present invention
- FIG. 2 is a cross-sectional view showing a nasal administration device according to the first embodiment of the present invention
- FIG. 3 is a distance in a maximum separated state.
- FIG. 4 is an enlarged cross-sectional view of a main part showing an adjustment nozzle mechanism
- FIG. 4 is a plan view showing a distance adjustment nozzle mechanism in a maximum distance state
- FIG. 5 is an enlarged cross-sectional view of a main part showing a distance adjustment nozzle mechanism in a minimum close state
- FIG. Fig. 7 is a plan view showing the distance adjustment nozzle mechanism in the minimum approach state.
- FIG. 7 is a cross-sectional view showing a state in which the passage member is assembled to the capsule holder after the air inflow hole is formed in the force capsule with the first drilling pin.
- FIG. 8 is a cross-sectional view from the same position as in FIG. 1 showing a state in which the medicine in the capsule is sprayed by pressing the pump portion, and
- FIG. 9 shows a nasal dispenser according to a second embodiment of the present invention.
- Fig. 10 is a cross-sectional view.
- FIG. 11 is an enlarged cross-sectional view of a main part showing a distance adjustment nozzle mechanism in a minimum approach state.
- FIG. 12 is a cross-sectional view showing a distance adjustment nozzle mechanism according to a modification of the first embodiment of the present invention.
- FIG. 13 is a cross-sectional view showing a distance adjusting nozzle mechanism according to a modification of the second embodiment of the present invention
- FIG. 14 is a cross-sectional view showing a nasal administration device according to the third embodiment of the present invention
- FIG. FIG. 16 is a plan view showing a nasal dispenser according to a third embodiment of the present invention.
- FIG. 16 does not show a state in which an adjustable nozzle is attached to left and right guide grooves and a nozzle holding projection, and is indicated by an arrow in FIG. XVI-Cross-sectional view from XVI direction.
- Fig. 17 is an enlarged cross-sectional view of the main part showing the adjustable nozzle left and right with maximum separation.
- Fig. 18 is the minimum adjustable nozzle left and right.
- FIG. 19 is an enlarged cross-sectional view of a main part showing a state in which the distance adjustment nozzle is brought closer, and FIG. 19 is a cross-sectional view showing a distance adjustment nozzle mechanism according to a modification of the third embodiment of the present invention. It is. BEST MODE FOR CARRYING OUT THE INVENTION
- FIGS. 1 to 18 a nasal administration device according to an embodiment of the present invention will be described with reference to FIGS. 1 to 18.
- FIGS. 1 to 8 show a first embodiment of the present invention.
- reference numeral 1 denotes a nasal administration device according to the present embodiment.
- the nasal administration device 1 has a capsule holder 2, a pump unit 14, a chemical passage 20, and a distance adjusting nozzle mechanism to be described later. It is roughly composed of 25.
- the capsule holder 2 holds a capsule, and includes a fixing member 3 described below formed in a double cylindrical shape, and an axial direction with respect to the fixing member 3 which is located on an inner peripheral side of the fixing member 3. And a movable member 8 provided so as to be movable in the vehicle.
- the fixing member 3 includes an outer cylindrical portion 3A formed in a stepped cylindrical shape, an inner cylindrical portion 3B provided in the outer cylindrical portion 3A, and a lower end side of the outer cylindrical portion 3A closed.
- the flange portion 3E prevents the movable member 8 that moves in the axial direction on the inner peripheral surface of the outer cylindrical portion 3A from coming off, and the pump portion 14 provided to cover the fixed member 3 from the outer peripheral side. Positioning is performed.
- the opening of the inner cylindrical portion 3B is connected to the outer cylindrical portion 3A and the inner cylindrical portion 3B at the axial center of the outer cylindrical portion 3A, and the cylindrical portions 3A and 3B are connected to each other.
- An air inflow chamber 4 is formed between them.
- an air supply passage 5 communicating with the air inflow chamber 4 is formed in the bottom 3C of the fixing member 3, and a medicine trapping portion 3D serving as a bottom of the inner cylindrical portion 3B has a first portion to be described later.
- the hole 16 is formed so as to protrude toward the one-side capsule hole 11 side.
- communication holes 6 and 6 are formed in the inner cylinder portion 3B to communicate the inner peripheral side and the air inflow chamber 4, and a locking pin 10 described later is formed on the inner peripheral surface of the outer cylinder portion 3A.
- the engaging groove 7 to be engaged is formed to extend in the axial direction.
- the movable member 8 is provided so as to be movable in the axial direction inside the outer cylindrical portion 3A of the fixed member 3, and is provided at a lower end of the cylindrical portion 8A and the outer cylindrical portion 3A.
- A is formed of a large-diameter bottom portion 8B held movably in the axial direction within A, and a small-diameter projection 8C extending from the center of the bottom portion 8B into the inner cylindrical portion 3B.
- a pin insertion hole 9 is formed in the axial direction, penetrating through the bottom portion 8B, communicating with the inside of the cylindrical portion 8A, and through which the first drilling pin 16 is inserted.
- a locking pin 10 is formed so as to protrude radially outward, and the locking pin 10 is engaged with the engaging groove 7 of the fixing member 3 so that Movable with fixed member 3 The rotation of the movable member 8 with respect to the fixed member 3 is restricted while allowing the member 8 to move in the axial direction.
- the inner peripheral side of the cylindrical portion 8 A of the movable member 8 is a one-side capsule hole 11, and the one-side capsule hole 11 is integrated with the other-side capsule hole 19, which will be described later.
- the capsule receiving hole 12 is formed.
- the movable member 8 is movable in the axial direction along the outer cylindrical portion 3A of the fixed member 3, and the male screw 8D of the movable member 8 is replaced with a female screw described later.
- the rotation of the movable member 8 with respect to the fixed member 3 is regulated by the detent pin 10, so that the movable member 8 is automatically pulled up to the passage member 17 side.
- Reference numeral 13 denotes a supply valve provided in the air inflow chamber 4.
- the supply valve 13 opens and closes an air supply passage 5 formed in the fixed member 3, and air is supplied from the pump section 14. When the valve is opened, the air supply passage 5 is closed when air is sucked into the pump section 14.
- Numeral 14 denotes a pump portion as an air supply means formed in a cylindrical shape with a bottom made of a rubber material.
- the pump portion 14 has a thick opening portion 14A, a bottom portion 14B and the opening portion. It comprises a pressing portion 14C between the portion 14A and the bottom portion 14B, and the opening portion 14A is hermetically attached to the outer cylindrical portion 3A of the fixing member 3. Also, the pump section
- Most of the capsule holder 2 is accommodated in 14, thereby reducing the size of the nasal administration device 1 in the axial direction.
- Reference numeral 15 denotes a suction valve provided at a bottom portion 14B of the pump portion 14.
- the suction valve 15 is located at a central portion and communicates with the inside of the pump portion 14 and a suction passage 15A.
- a valve body 15B that opens and closes the suction passage 15A is generally configured. The valve body 15B opens when air is supplied from the pump section 14, and the pump section 1 The valve opens when air is sucked into 4.
- Reference numeral 16 denotes a first drilling pin provided in the fixing member 3.
- the first drilling pin 16 has a base end fixed to the drug capturing section 3D and a distal end formed through a pin through hole 9.
- the protruding portion is formed so as to protrude toward the one-side capsule hole 11 side, and the tip is a sharp needle tip 16A.
- the needle tip 16 A of the first drilling pin 16 has a one-side cap.
- the needle tip 16 A is retracted into the pin insertion hole 9, so that the needle tip 16 A is removed from the air inlet hole H 1. It will be in a state where it was lost.
- reference numeral 17 denotes a passage member as passage means screwed to the movable member 8 of the capsule holder 2, and the passage member 17 has a small-diameter portion 17A on one side which is the capsule holder 2 side.
- the other side has a large diameter portion 17B.
- the large diameter portion 17B is provided with left and right distance adjusting nozzle mechanisms 25.
- a movable member screw hole 18 is formed in the small-diameter portion 17 A, and an inner thread 8 D of the movable member 8 is screwed to the inner periphery of the opening of the movable member screw hole 18.
- Female thread 18 A is formed.
- another capsule hole 19 which forms the capsule accommodation hole 12 together with the one capsule hole 11 is formed.
- Reference numerals 20 and 20 denote left and right chemical passages formed in the passage member 17, respectively.
- Each of the chemical passages 20 is branched while communicating with the capsule hole 19 on the other side as shown in FIG.
- Branch passage 2OA and a straight passage portion 20B extending linearly in the axial direction from the branch passage 20A, and is formed in a substantially U-shape. It is a tapered spray port 28 described later.
- 2 1 is a second drilling pin provided in the passage member 17 so as to face the first drilling pin 16, and the base end side of the second drilling pin 21 is slidable in the axial direction. It is fixed to a slide block 22 provided, and its tip side extends so as to penetrate the seal rubber 23, and its tip is a sharp needle tip 21 A.
- the sliding block 2 is connected to an operation plate 24 (see FIG. 1) provided outside the passage member 17 for operating the second drilling pin 21.
- the second drilling pin 21 is moved in the direction of arrow A through the sliding block 22 by moving the operation plate 24 in the direction of arrow A in FIG.
- An air outflow hole H2 is formed in the capsule K by 21A.
- Reference numeral 25 denotes a distance adjusting nozzle mechanism provided on the passage member 17.
- the distance adjusting nozzle mechanism 25 is provided with a left and right fitting, which will be described later, provided on the passage member 17 side.
- the convex portions 26, 26, the left and right adjustable nozzles 27.27 rotatably mounted on the respective fitting convex portions 26, and the respective adjustable nozzles 27 and the respective fitting projections.
- a tapered spray port 28, 28 provided over the section 26.
- Reference numerals 26 and 26 denote left and right fitting projections provided on the upper end face side of the passage member 17, respectively.
- the fitting projections 26 are straight passages of the left and right chemical passages 20.
- the portion 20B is formed in a cylindrical shape integrally projecting from the passage member 17 so as to cover the ejection side.
- Reference numerals 27 and 27 denote left and right adjustable nozzles removably attached to the left and right fitting projections 26 and 26, respectively, and each of the adjustable nozzles 27 is inserted into the nasal cavity of the patient.
- c is formed in a truncated cone shape gradually reduced in diameter toward the distal end side which is inserted also, the base end side inner periphery of each adjustable nozzle 2 7, or rotatable to each fitting convex portions 2 6 It has a fitting hole 27 A that can be detachably fitted.
- Each adjustable nozzle 27 is rotated with respect to each fitting projection 26 so that the nozzle pitch can be adjusted according to the distance between the nasal cavities of the patient for the reason described later. ing.
- Numerals 28 and 28 are provided from the inner periphery of each fitting projection 26 to the inner periphery of each adjustable nozzle 27, and are tapered spray ports that gradually expand toward the distal end side.
- the spray ports 28 are arranged on the same axis as the straight passage portion 20 # of each chemical passage 20. Then, when the air containing the chemical is supplied from each chemical passage 20, the tapered spray ports 28 gradually diffuse the air containing the chemical along the tapered inner wall surface. The drug is diffused into the nasal cavity and distributed for distribution.
- the distance adjusting nozzle mechanism 25 configured as described above is configured such that each of the adjustable nozzles 27 has a linear passage portion 20 ⁇ of the chemical passage 20 and an axis C of the tapered spray port 28.
- the adjustable nozzle 27 is eccentric with an eccentric amount d 1 from an axis C 1 serving as a center of rotation. Therefore, by rotating each adjustable nozzle 27, the nozzle pitch of each adjustable nozzle 27 becomes L1 in the maximum separation state shown in FIGS. 3 and 4, and in the minimum approach state shown in FIGS. 5 and 6.
- the nozzle pitch of each adjustable nozzle 27 is L2.
- the amount of rotation of each adjustable nozzle 27 By making appropriate adjustments, the nozzle pitch can be adjusted to the internasal distance of the patient.
- the nasal administration device 1 has the above-described configuration. Next, the use operation will be described.
- the female screw 18A of the passage member 17 is screwed to the male screw 8D of the capsule holder 2 side.
- the movable member 8 of the capsule holder 2 is moved toward the passage member 17 by screwing the passage member 17, so that the capsule K is held in the capsule receiving hole 12 while being slightly pressed in the axial direction. Is done.
- the needle tip 16A of the first drilling pin 16 having the air inlet hole H1 formed in the capsule K is removed, and the capsule K has an air inlet hole H1, a pin insertion hole 9 and It communicates with the air inflow chamber 4 through each communication hole 6.
- the second drilling pin 21 is moved toward the capsule K by moving the operation plate 24 in the direction of arrow A, and Drill an air outflow hole H2 in capsule K with 21A needle tip. After that, return the operation plate 24 to the original position and remove the needle tip 21 A from the capsule K. This means that a hole was prepared in preparation for medication. Next, a medication operation for spraying the drug in the perforated capsule K into the nasal cavity of the patient will be described.
- each adjustable nozzle 27 is inserted into both nasal cavities of the patient, and as shown in FIG. 8, air pressure is generated from the pump section 14 by crushing the pressing section 14 C of the pump section 14.
- This air acts on the air supply passage 5 to push the supply valve 13 against the chemical trapping part 3D of the inner cylinder part 3B to open the valve, and the air inflow chamber 4, the communication holes 6, the pin holes 9 And into the capsule K through the air inlet hole H1.
- the air flowing into the capsule K stirs the medicine and mixes the medicine.
- the air containing this chemical is sprayed from the left and right tapered spray ports 28, 28 through the air outlet hole H2 and the left and right chemical passages 20, 20.
- the medicine can be simultaneously administered to the left and right nasal cavities of the patient.
- the respective adjustable nozzles 27 are appropriately rotated to rotate the respective nozzles.
- the nozzle pitch of each of the adjustable nozzles 27 is adjusted by appropriately adjusting the nozzle pitch of the adjustable nozzles 27 between L 1, the nozzle pitch for the maximum separation and protruding state, and L 2, the nozzle pitch for the minimum approach state. Can be adjusted to the distance between the patient's nasal cavities, and the respective adjustable nozzles 27 can be reliably and smoothly inserted into desired positions in the patient's nasal cavity.
- the operation of attaching the capsule K to the movable member 8 and the operation of reciprocating the second piercing pin 21 in the axial direction make the air inflow hole in the axial direction of the capsule K.
- H1 and the air outflow hole H2 can be easily formed, the preparation operation up to the administration operation can be greatly simplified, and the medicine in the capsule K can pass through the left and right medicine passages 20
- the medicine in the capsule K can pass through the left and right medicine passages 20
- each adjustable nozzle 27 when each adjustable nozzle 27 is inserted into the nasal cavity of a patient, by rotating each adjustable nozzle 27, the nozzle pitch at which the maximum separation state is at L1 and the nozzle pitch at which the minimum approach state is at minimum approach is H
- the nozzle pitch between the adjustable nozzles 27 can be adjusted to the distance between the nasal cavities extremely easily between the two, so that each adjustable nozzle 27 can be reliably inserted into a desired part in the nasal cavity.
- each adjustable nozzle 27 can be smoothly and smoothly inserted into the nasal cavity without discomfort.
- a single type of nasal medication device 1 is used for children and adults with different internasal distances.
- the application range of the nasal administration device 1 can be greatly expanded.
- the adjustable nozzles 27 and 27 are provided on the left and right sides, so that the adjustment range of the nozzle pitch can be enlarged, and the applicable range can be further expanded.
- each adjustable nozzle 27 is detachable from the passage member 17, by removing each adjustable nozzle 27 after administration, each adjustable nozzle 27, the chemical passage 20, etc. It can be easily washed to every corner, and workability and hygiene in washing can be improved.
- each chemical passage 20 and the tape-shaped spray port 28 are arranged on the same axis, and the air containing the chemical is passed through each chemical passage 20.
- the air containing this drug can be given a rectifying property and a straight-forward property and accelerated, so that the drug can reach the inner part of the nasal cavity. It can be supplied effectively.
- each tapered ejection port 28 is provided on the ejection side of each chemical passage 20, and the air containing the medicine is diffused by each tapered ejection port 28, so that each tapered ejection port is provided.
- the medicine can be uniformly administered over a wide area in the patient's nasal cavity from the outlet 28, and the efficiency of the medicine can be enhanced by promoting the absorption of the medicine into the human body by improving the spray efficiency of the medicine.
- the dispensing operation can be performed without removing them at all. Not only can it be omitted, but there is no risk that the drilling tool will be lost, and handling can be done more safely.
- the medicine falling from the air inflow hole H1 of the capsule K can be captured by the drug capturing section 3D of the fixing member 3, and the drug captured by the drug capturing section 3D can be transferred from the pump section 14 during the dispensing operation.
- the prescribed amount of the medicine can be reliably administered to the patient, and the frequency of cleaning the nasal administration device 1 can be reduced.
- FIGS. 9 to 11 show a second embodiment of the present invention.
- the feature is that the spray nozzle of the adjustable nozzle is arranged eccentrically from the center of rotation.
- the same components as those in the above-described first embodiment are denoted by the same reference numerals, and description thereof will be omitted.
- 31 is a nasal administration device according to the present embodiment
- 32 is a passage member of the nasal administration device 31
- the passage member 32 is the passage member described in the first embodiment. It is composed of a small-diameter portion 32A and a large-diameter portion 32B almost in the same manner as 17.
- the passage member 32 differs from that of the first embodiment in that fitting concave portions 34, 34 described later are formed on the upper surface side of the large diameter portion 32B. .
- Reference numeral 33 denotes a distance adjustment nozzle mechanism provided in the passage member 32 according to the present embodiment.
- the distance adjustment nozzle mechanism 33 includes left and right fitting recesses provided on the passage member 32 side, which will be described later. 3 4, 3 4, left and right adjustable nozzles 35, 35, which are rotatably mounted in the respective fitting recesses 34, and sprays provided in the respective adjustable nozzles 35 Mouth 36, 36.
- Reference numerals 34 and 34 denote left and right fitting recesses provided on the upper end face side of the passage member 32.
- the fitting recesses 34 are located at positions corresponding to the left and right chemical passages 20, respectively. It is formed in a circular hole shape.
- Reference numerals 35 and 35 denote left and right adjustable nozzles according to the present embodiment attached to the left and right fitting recesses 34 and 34, respectively.
- a nasal cavity insertion portion 35A whose distal end side is gradually reduced in diameter so as to be inserted into the nasal cavity insertion portion 35A, and is detachably and rotatably fitted into the fitting concave portion 34.
- a fitting portion 35B a fitting portion 35B.
- the nasal cavity insertion portion 35A rotates around the axis C3 of the fitting portion 35B, and the axis C4 of the nasal cavity insertion portion 35A becomes the rotation center. It is eccentric with the displacement d2 from the axis C3.
- the nozzle pitch of each nasal cavity insertion portion 35A becomes L3 in the maximum separation state shown in FIG. 10 and each nozzle in the minimum proximity state shown in FIG.
- the nozzle pitch of the nasal cavity insertion section 35 A is L 4.
- the nozzle pitch can be adjusted to the distance between the nasal cavities of the patient by appropriately adjusting the amount of rotation of each adjustable nozzle 35.
- Numerals 36 and 36 are provided in each of the adjustable nozzles 35 and are spray ports formed by being bent in a substantially "U" shape.
- Each of the spray ports 36 is a straight passage portion of each chemical passage 20.
- each spray port 36 is disposed at the center of the nasal cavity, so that the medicine can be uniformly sprayed into the nasal cavity.
- each of the spray ports 36 gradually moves the air containing the chemical along the inner wall surface of the tapered portion 36 B. Drugs are diffused into the nasal cavity and distributed for distribution.
- each spray port 3 The taper portion 36 B is arranged by arranging the tapered portion 36 B of the adjustable nozzle 35 inserted into the nasal cavity of the patient at the center (on the same axis) of the nasal cavity 35 A of the adjustable nozzle 35.
- the drug can be uniformly sprayed into the nasal cavity through the, so that the absorption of the drug in the nasal cavity can be further promoted and the efficacy of the drug can be enhanced.
- the tapered spray port 28 is formed directly on each fitting projection 26 and the adjustable nozzle 27.
- the spray cylinders 42, 42 are provided on the upper end surface of the passage member 17, and the adjustable nozzles 43, 43 are rotatable and detachable on the outer peripheral side of each of the spray cylinders 42.
- tapered spray ports 44, 44 are formed on the inner peripheral side of each spray cylinder 42.
- a spray port 36 ′ may be formed to extend linearly to each adjustable nozzle 35. Good.
- the left and right adjustable nozzles 27, 35, 43 are provided, and the adjustable nozzles 27, 35, 43 are rotated. Although the pitch is adjusted, one of the left and right nozzles is fixed and the other is adjustable so that the nozzle pitch is adjusted. May be.
- the adjustable nozzles 27, 35, and 43 are detachable, but the adjustable nozzles may be rotatably fixed. Therefore, loss of each adjustable nozzle can be prevented.
- FIGS. 14 to 18 show a third embodiment of the present invention.
- the feature of this embodiment is that the nozzle is provided so as to be movable left and right.
- the same components as those in the above-described first embodiment are denoted by the same reference numerals, and description thereof will be omitted.
- 51 is a nasal administration device according to the present embodiment
- 52 is a passage member as a passage means of the nasal administration device 51
- the passage member 52 is the same as that of the first embodiment. It is composed of a small-diameter portion 52A and a large-diameter portion 52B almost in the same manner as the passage member 17 described above.
- the passage member 52 according to the present embodiment is different from the first prior art in that a distance adjustment nozzle mechanism 56 described later is provided instead of the distance adjustment nozzle mechanism 25 according to the first embodiment. Are different.
- Reference numerals 53 and 54 denote left and right medicine passages formed in the passage member 52 according to the present embodiment.
- the left and right medicine passages 53 and 54 communicate with the other-side capsule hole 19.
- the ejection side of the straight passage portion 53B on the left side is formed as a spray port 55 in a fixed nozzle 57 described later.
- the right straight passage portion 54B is shorter than the left straight passage portion 53B, and a connection pipe 63 described later is connected to the ejection side thereof.
- Reference numeral 56 denotes a distance adjusting nozzle mechanism provided in the large diameter portion 52B of the passage member 52 according to the present embodiment.
- the distance adjusting nozzle mechanism 56 includes a fixed nozzle 57, which will be described later, in the left and right directions. It comprises a guide groove 58, a nozzle holding projection 59, an adjustable nozzle 61, a connection pipe 63, and the like.
- Reference numeral 57 denotes a fixed nozzle protruding from the large-diameter portion 52B of the passage member 52 located on the left side of the medicine passage 53 on the left side, and the fixed nozzle 57 is inserted into the nasal cavity of the patient. It is formed in a truncated conical shape whose diameter gradually decreases toward the distal end.
- Reference numeral 58 denotes a left and right opening formed on the other end surface of the large diameter portion 52B of the passage member 52.
- the left and right guide grooves 58 which serve as direction guides, are located on the straight line portion 54B extension line of the right chemical passage 54, as shown in FIG. And is formed in an elliptical shape extending in the radial direction.
- the width dimension (diameter dimension of the arc portion) of the left and right plan inner grooves 58 is set slightly larger than the diameter dimension of the adjustable nozzle 61, whereby the left and right guide grooves 58 are formed.
- the adjustable nozzle 61 is supported so that it can move in the left and right directions (arrows B and C).
- Reference numeral 59 denotes a nozzle holding projection as a nozzle holding portion provided in the left and right guide grooves 58, and the nozzle holding projection 59 is, as shown in FIG.
- the guide groove 58 protrudes inward from the inner peripheral surface to form an annular shape.
- the nozzle holding projection 59 engages with the annular groove 61A of the adjustable nozzle 61, while allowing the adjustable nozzle 61 to move in the left and right guide grooves 58.
- the adjustable nozzle 61 is prevented from falling off.
- Reference numeral 60 denotes a connecting pipe moving space formed between the straight passage section 54B of the right chemical passage 54 and the left and right guide grooves 58.
- the connecting pipe moving space 60 is an adjustable nozzle. This allows the connecting pipe 63 to move left and right in response to the movement of 61.
- Reference numeral 1 denotes an adjustable nozzle protruding from the large-diameter portion 52B of the passage member 52.
- the adjustable nozzle 61 is a pair with the fixed nozzle 57, and the adjustable nozzle 61 is a pair. It is formed in the shape of a truncated cone whose diameter gradually decreases toward the distal end side in almost the same manner as 7.
- an annular groove 61A is formed over the entire outer circumference of the base end side of the adjustable nozzle 61, and the adjustable nozzle 61 is provided with a nozzle holding projection through the annular groove 61A.
- 59 is engaged movably left and right.
- Numeral 62 denotes a spray port formed in the adjustable nozzle 61.
- the spray port 62 is located at the center of the adjustable nozzle 61 and is formed so as to penetrate the adjustable nozzle in the axial direction. I have. Further, the spray port 62 communicates with the chemical passage 54 on the right side via the connection pipe 63.
- Reference numeral 63 denotes a connecting pipe provided in the connecting pipe moving space 60.
- the connecting pipe 63 is formed on the passage member 17 such that one end thereof communicates with the straight passage portion 54B of the right chemical passage 54.
- Adjustable nozzle 6 1 connected so that the other end communicates with spray port 6 2 It is connected to the.
- the connection pipe 63 is made of a sufficiently flexible resin material or the like, and when the adjustable nozzle 61 is moved by this, it is deformed according to the amount of movement, and the chemical passage 54 and the spray port are formed. It is possible to always communicate with 6 2 ⁇
- the distance adjusting nozzle mechanism 56 configured as described above moves the adjustable nozzle 61 in the direction of arrow B, thereby adjusting the adjustable nozzle 61 and the fixed nozzle.
- the left and right separation distance (nozzle pitch) from 5 7 can be set to L5, which is the maximum separation state.
- the nozzle pitch Can be defined as L 6 which is the minimum approach state.
- the adjustable nozzle 61 by moving the adjustable nozzle 61 in the directions of arrows B and C to adjust the nozzle pitch appropriately between L5 in the maximum separation state and L6 in the minimum approach state, the fixed nozzle 57
- the nozzle pitch with the adjustable nozzle 61 can be adjusted to the distance between the nasal cavities of the patient. Further, since the adjustable nozzle 61 is mounted in the left and right direction inner groove 58 so that the annular groove 61A is engaged with the nozzle holding projection 59, the nozzle holding projection 5 9 prevents the dropout from the passage member 17.
- the adjustable nozzle 61 is moved left and right.
- nozzle pitch By moving the adjustable nozzle 61 and the fixed nozzle 57 in the left and right directions (nozzle pitch) by moving the nozzle in the left and right directions along the direction guide groove 58, the distance between the adjustable nozzle 61 and the fixed nozzle 57 in the maximum separation state
- the nozzle pitch can be adjusted more easily-because it can be adjusted to the nasal distance of the patient between 5 and L 6 in the minimum approach state.
- a nozzle holding projection 59 is provided in the direction guide groove 58, and the nozzle holding projection 59 is engaged with the annular groove 61A of the adjustable nozzle 61. 6 1 can be smoothly moved along the nozzle holding projection 59, and the adjustable nozzle 61 can be prevented from falling off from the passage member 52.
- the chemical passage 54 on the right side and the spray port 62 are connected by a connecting pipe 63 made of a flexible material, even when the adjustable nozzle 61 is moved, the chemical passage 54 and the spray port 62 are moved. 2 can be always communicated, and from the spray port 62 into the nasal cavity Chemicals can be sprayed reliably.
- the left side is the fixed nozzle 57
- the right side is the adjustable nozzle 61, so that the adjustable nozzle 61 is fixed to the fixed nozzle 57.
- the distance adjustment nozzle mechanism 56 for adjusting the nozzle pitch by approaching and separating has been illustrated.
- Nozzle holding projections 73, 73 and connecting pipe moving space 74, 74 are provided on the left and right
- adjustable nozzles 75, 75 are provided in the left and right holding guide grooves 72, 72.
- the adjustable nozzles 75, 75 may be connected to the chemical channels 77, 77 via the connecting pipes 76, 76.
- the nozzle pitch can be appropriately adjusted as in the third embodiment.
- the nozzle pitch is L7 in the maximum separation state and the nozzle pitch is L8 in the minimum proximity state by moving the adjustable nozzles 75 relatively close to or away from each other.
- the nozzle pitch can be adjusted with an adjustment range twice as large as that of the third embodiment, and the applicable range can be widened.
- the taper-shaped spray ports 28, 44 are illustrated as spray ports, and in the second embodiment, a spray port 36 having a tapered portion 36B is illustrated.
- the spray ports 56 and 62 are illustrated as straight shapes having the same diameter in the axial direction.However, the shape is not limited to this, and the shape of the spray ports may be appropriately changed according to the chemical spray conditions. It is desirable.
- an oval left and right guide groove 58 is formed as a left and right guide portion, and an adjustable nozzle 61 is provided in the left and right guide groove 58.
- the left and right guide projections are provided as the left and right guides, and the adjustable nozzle is slidably attached to the left and right guide projections. Is also good.
- the nozzle holding projection 59 is formed
- the adjustable nozzle 61 is formed with the annular groove 61A
- the nozzle holding projection 59 and the annular groove 61A are connected to each other.
- the capsule accommodation hole 12 is provided as the medicine accommodation room, and the capsule K containing the medicine is introduced into the capsule accommodation hole 12.
- the chemicals may be directly injected from outside using a separate supply device or the like. In this case, capsule K is not required o Industrial availability
- the nasal administration device and the method for using the same according to the present invention can be applied to a device that sucks fine powder or granules filled in a capsule by breaking the capsule.
Description
Claims
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/793,337 US5899202A (en) | 1995-06-30 | 1996-06-28 | Medicine administering device for nasal cavities and method of using same |
EP96921116A EP0779078A4 (en) | 1995-06-30 | 1996-06-28 | DEVICE FOR ADMINISTERING MEDICINES INTO THE NASAL CAVE AND METHOD FOR USE THEREOF |
KR1019970701238A KR100236431B1 (ko) | 1995-06-30 | 1996-06-28 | 비강용 투약기 |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP18853495 | 1995-06-30 | ||
JP7/188534 | 1995-06-30 | ||
JP7/227265 | 1995-08-11 | ||
JP22726595A JP3434396B2 (ja) | 1995-06-30 | 1995-08-11 | 鼻腔用投薬器 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1997002062A1 true WO1997002062A1 (fr) | 1997-01-23 |
Family
ID=26504993
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/JP1996/001798 WO1997002062A1 (fr) | 1995-06-30 | 1996-06-28 | Vaporisateur pour les cavites nasales et procede d'utilisation dudit vaporisateur |
Country Status (6)
Country | Link |
---|---|
US (1) | US5899202A (ja) |
EP (1) | EP0779078A4 (ja) |
JP (1) | JP3434396B2 (ja) |
KR (1) | KR100236431B1 (ja) |
CN (1) | CN1156968A (ja) |
WO (1) | WO1997002062A1 (ja) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6186141B1 (en) | 1996-05-10 | 2001-02-13 | Glaxo Wellcome Inc. | Unit dose dispensing device |
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JP3317823B2 (ja) * | 1995-08-11 | 2002-08-26 | 株式会社ユニシアジェックス | 投薬器 |
US6298846B1 (en) | 1997-01-30 | 2001-10-09 | Unisia Jecs Corporation | Suction type medicator |
IL135774A0 (en) * | 1997-10-22 | 2001-05-20 | Ponikau Jens | Use of antinfungal agents for the topical treatment of fungus-induced mucositis |
FR2771012B1 (fr) * | 1997-11-17 | 2000-03-10 | Sofab | Pulverisateur nasal |
JP3488620B2 (ja) | 1998-02-05 | 2004-01-19 | 株式会社日立ユニシアオートモティブ | 吸入式投薬器 |
TW523414B (en) * | 1999-01-14 | 2003-03-11 | Teijin Ltd | Apparatus and method for administrating certain amount of powdered material |
JP2000217917A (ja) | 1999-01-27 | 2000-08-08 | Unisia Jecs Corp | 吸入式投薬器 |
CN1217712C (zh) * | 1999-03-03 | 2005-09-07 | 奥普蒂诺斯公司 | 鼻传送装置 |
FR2798068B1 (fr) * | 1999-09-02 | 2002-04-26 | Valois Sa | Tete de distribution nasale de produit fluide |
DE10006026A1 (de) * | 2000-02-10 | 2001-08-23 | Birgit Vaassen | Applikator mit zwei Schaften |
US6644305B2 (en) * | 2000-04-14 | 2003-11-11 | Trudell Medical International | Nasal inhaler |
ZA200306564B (en) * | 2001-02-26 | 2004-10-15 | Optinose As | Nasal devices. |
US20030041860A1 (en) * | 2001-08-29 | 2003-03-06 | Verona Steven N. | Particulate dispenser |
JP3950738B2 (ja) * | 2002-05-14 | 2007-08-01 | 株式会社 バイオアクティス | 鼻腔用粉状薬剤施薬装置 |
GB0215270D0 (en) * | 2002-07-02 | 2002-08-14 | Optinose As | Nasal devices |
GB0300008D0 (en) * | 2003-01-02 | 2003-02-05 | Optinose As | Delivery devices |
EP1671667A4 (en) * | 2003-10-09 | 2013-05-01 | Shin Nippon Biomedical Lab Ltd | NASAL PULVERULENT DRUG DELIVERY DEVICE |
EP1694393A1 (en) * | 2003-12-15 | 2006-08-30 | Bespak plc | Nasal drug delivery |
GB0420513D0 (en) * | 2004-09-15 | 2004-10-20 | Optinose As | Powder delivery devices |
JP2006087797A (ja) * | 2004-09-27 | 2006-04-06 | Hitachi Ltd | 鼻腔用投薬器 |
WO2006037636A2 (en) * | 2004-10-06 | 2006-04-13 | Boehringer Ingelheim International Gmbh | Dispensing device, storage device and method for dispensing powder |
US20060207596A1 (en) * | 2005-03-18 | 2006-09-21 | Fairfield Clinical Trials, Llc | Device and method for delivery of combination nasal medication |
US8360056B2 (en) * | 2006-08-31 | 2013-01-29 | Hitachi, Ltd. | Medicine sprayer |
US20090198199A1 (en) * | 2008-02-01 | 2009-08-06 | Drug Enhancement Company Of America, Llc | Inert container and dispenser |
WO2010025276A1 (en) * | 2008-08-27 | 2010-03-04 | Drug Enhancement Company Of America, Llc | Container and dispenser |
US8191552B2 (en) * | 2008-11-15 | 2012-06-05 | Cfd Research Corporation | Negative pressure, bi-directional nasal aerosol delivery |
US20110092922A1 (en) | 2009-10-19 | 2011-04-21 | Trompen Mick A | Transdermal dispensing apparatus and methods |
JP2012115376A (ja) * | 2010-11-30 | 2012-06-21 | Metoran:Kk | 鼻用気体供給装置 |
SI2701611T1 (sl) * | 2011-04-27 | 2015-11-30 | Biom'up | Razdeljevalnik biomedicinskega hemostatskega praška |
JP5815396B2 (ja) * | 2011-12-26 | 2015-11-17 | 株式会社吉野工業所 | 吐出器 |
JP5815398B2 (ja) * | 2011-12-27 | 2015-11-17 | 株式会社吉野工業所 | 吐出器 |
JP5869873B2 (ja) * | 2011-12-27 | 2016-02-24 | 株式会社吉野工業所 | 吐出器 |
USD755367S1 (en) | 2014-03-10 | 2016-05-03 | Civitas Therapeutics, Inc. | Indicator for an inhaler |
USD752734S1 (en) | 2014-03-10 | 2016-03-29 | Civitas Therapeutics, Inc. | Inhaler grip |
USD752204S1 (en) | 2014-03-10 | 2016-03-22 | Civitas Therapeutics, Inc. | Indicator for an inhaler |
FR3066921B1 (fr) * | 2017-06-06 | 2022-06-03 | Aptar France Sas | Dispositif de distribution de produit fluide ou pulverulent. |
USD828543S1 (en) * | 2017-08-01 | 2018-09-11 | Khanquer Pharma, Inc. | Dual nostril nasal spray device |
CN108939225A (zh) * | 2018-06-12 | 2018-12-07 | 陈新 | 一次性鼻吸式通用型喉嘴 |
CN110354355A (zh) * | 2019-07-31 | 2019-10-22 | 杭州超德斯实业有限公司 | 一种双模鼻吸管 |
WO2022126624A1 (zh) * | 2020-12-18 | 2022-06-23 | 江苏奇力康皮肤药业有限公司 | 一种鼻喷瓶的联动喷盖 |
WO2022126626A1 (zh) * | 2020-12-18 | 2022-06-23 | 江苏奇力康皮肤药业有限公司 | 可独立喷射的双孔鼻腔喷瓶 |
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-
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- 1996-06-28 EP EP96921116A patent/EP0779078A4/en not_active Withdrawn
- 1996-06-28 WO PCT/JP1996/001798 patent/WO1997002062A1/ja not_active Application Discontinuation
- 1996-06-28 CN CN96190682A patent/CN1156968A/zh active Pending
- 1996-06-28 KR KR1019970701238A patent/KR100236431B1/ko not_active IP Right Cessation
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US6186141B1 (en) | 1996-05-10 | 2001-02-13 | Glaxo Wellcome Inc. | Unit dose dispensing device |
Also Published As
Publication number | Publication date |
---|---|
JP3434396B2 (ja) | 2003-08-04 |
EP0779078A1 (en) | 1997-06-18 |
EP0779078A4 (en) | 1999-12-22 |
JPH0970433A (ja) | 1997-03-18 |
KR970705418A (ko) | 1997-10-09 |
US5899202A (en) | 1999-05-04 |
CN1156968A (zh) | 1997-08-13 |
KR100236431B1 (ko) | 1999-12-15 |
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