CN1250384A - Improved inhalation apparatus - Google Patents

Abstract

An inhalation device (1) for dispensing a product, comprising a seat (2) for a dispensing container (3) and comprising a valve stem (9) for receiving a pressurized dispensing container, the air inlet of said seat and A part (8) of an interface (7). The device further comprises a conduit means and an air flow controller in the shape of an annular membrane (12) adjacent to the valve stem receiving portion, the conduit means being in communication with the seat for delivering product towards the port. The air flow controller (12) is biased to a first position corresponding to no or minimal air flow from the air inlet to the port, and in use is movable by the pressure dispense container to a position corresponding to the flow from the air inlet to the port. The mouthpiece has a second position corresponding to the maximum air flow, continuing to move the pressure dispensing container so that a dose of product is dispensed into the maximum air flow generated by the user applying suction to the mouthpiece.

Description

Improved inhalation device

The present invention relates to an inhalation device for dispensing substances for inhalation, in particular, but not exclusively, for dispensing pharmaceutical products in aerosol form from a pressurized dispensing container.

It is known to provide a sensor in an inhalation device to detect the user's inhalation in order to synchronize the release of the inhaled substance into the inhaled air stream with the inhalation. For example in the administration of aerosol products for the relief of asthma, it is important that the timing of the dispensing operations be carefully controlled for maximum deposition of the material in the user's lungs.

It is known from GB 2266466 to provide an electrically operated dispensing device which reacts to a signal sent by a sensor which in turn reacts to the air flow passing through the passage. The disadvantage of this solution is that the device is expensive.

It is an object of the present invention to provide a dispensing device in which mechanical means are employed to coordinate the release of the substance with the inhalation.

Accordingly, the present invention provides an inhalation device for dispensing a product comprising a seat for a pressurized dispensing container and comprising a valve stem for receiving a pressurized dispensing container, an air inlet of said seat and parts of a mouthpiece, said The apparatus further includes a conduit means and an air flow controller adjacent to the stem receiving portion, the conduit means being in communication with the seat for delivering product towards the port, said air flow controller being biased to a a first position corresponding to no or minimal air flow and, in use, movable by the pressure dispensing container to a second position corresponding to maximum air flow from the air inlet to the port, continuing to move the pressure dispensing container, A dose of product is dispensed into the maximum air flow created by the user applying suction to the mouthpiece.

An advantage of the present invention is that the dispensing of the drug is synchronized with the inhalation by the user using an inexpensive inhalation device. Another advantage is that the air flow present allows a minimal air volume flow through the seat inlet interface and into the user's mouth, even when the air flow control is in the first, sealing position. This has the advantage that it helps to prevent the danger of the user panicking due to not being able to inhale any amount of air.

The volume flow of the minimum air flow is preferably smaller than the volume flow of the maximum air flow.

The maximum volume flow rate is preferably 8 to 12 times the minimum volume flow rate.

An advantage of the increased second volume flow rate, which is greater than the first volume flow rate, is that a sufficient air flow is established prior to discharge of product from the pressurized dispensing container to allow maximum deposition of the drug particles in the user's lungs.

The air flow controller preferably includes a portion accessible to the front end of the pressure dispensing container.

An advantage of the present invention is that the operation of the air flow controller is performed by contact of the front end of the pressure dispensing container with the air flow controller. It has been found that the change in height of the pressure dispensing container, calculated from the tip of the valve stem to the bottom of the container, can vary by a few millimetres. An advantage of the present invention is that this change in the height of the pressure dispensing container does not affect the operation of the air flow controller and the timing of product discharge as the second air flow is established because the air flow controller is derived from Front-driven of the pressure dispensing vessel.

In a first embodiment, the air flow controller comprises an annular membrane comprising one or more raised ribs and an outer periphery, the ribs being located on the upper surface of the annular membrane for pressure distribution in use. The front end of the container is in contact and the outer perimeter engages the seat so that there is no or minimal air flow therebetween; the outer perimeter responds to movement of the raised ribs by moving out of contact with the seat to allow maximum air flow therebetween flow through.

An advantage of the first embodiment is that the installation of the device is straightforward and that the operation of the device is independent of height changes of the pressure dispensing container. Another advantage is that the air flow controller is hidden from the user and thus less prone to damage.

The raised ribs are preferably raised radial ribs extending substantially from the central portion of the annular membrane substantially to the outer periphery.

Alternatively, the raised ribs are one or more raised concentric circular ribs spaced radially from each other from the central portion of the annular membrane to substantially the outer periphery.

In a second embodiment, the air flow controller includes a generally cylindrical sleeve receivable in a seat, the sleeve being open at an upper end for receiving a pressure dispensing container, and having a transverse membrane at its lower end, the transverse membrane The first section of the transverse membrane includes a first portion of the air flow controller that is capable of contacting and moving with the front end of the pressure dispensing container, and the second section of the transverse membrane includes a second portion of the air flow controller that is in contact with the first The segments are engaged together with the air flow controller in a first position so that there is no or minimal air flow therebetween; deflection of the first segment relative to the second segment allows maximum air flow through the first segment of the transverse membrane thus The gap formed between the first and second segments.

The advantage of the second embodiment is that the installation of the device is straightforward and the operation of the device is independent of height changes of the pressure dispensing container.

In a third embodiment, the air flow controller includes a plunger valve having an actuator biased to an extended position, the actuator being contactable and movable with the front end of the pressure dispensing container; The downward deflection of the actuator opens the plunger valve and allows maximum air flow to be established therebetween.

An advantage of this embodiment is that the second air inlet does not open gradually, but allows the second air flow to build up quickly. Another advantage is that the operation of the device is independent of height changes of the dispensing container and the components are hidden from the user and are therefore less likely to be damaged.

The plunger valve preferably includes a damper cartridge assembly for retarding upward movement of the actuator after the actuator is depressed, said damper cartridge delaying closure of the plunger valve.

An advantage of using a buffer cartridge assembly is that the closing of the second air inlet can be delayed for several seconds after the user releases the pressurized dispensing container. This has the advantage that it allows the user of the device to continue inhaling the dispensed medicament even if they mistakenly release the pressurized dispensing container before stopping inhalation. This allows a greater proportion of the drug to be deposited in the user's lungs and helps prevent improper operation of the device.

In a fourth embodiment, the air flow controller includes a skirt for contacting the front end of the pressure dispensing container, the skirt including one or more keys for engaging the longitudinal slot in the seat and one or more A plurality of downwardly extending flanges; said flanges include one or more raised protrusions for engaging with openings in the partition wall of the seat when the air flow controller is in the first position; The portion receiving the pressure dispensing container is separated from the port; the skirt moves down to the second position of the air flow controller, leaving the protrusion unsealed against the opening to allow maximum air flow to be established therethrough.

An advantage of the fourth embodiment is that the air flow controller does not have to seal a large surface area so that a more reliable seal can be established.

Minimal air flow is best through the discharge holes.

The device preferably also includes a pressure dispensing container.

A preferred embodiment of the invention will now be described, by way of example only, with reference to the accompanying drawings.

Fig. 1 is the sectional view of the first embodiment of the present invention;

Figure 2 is an exploded perspective view of the first embodiment of the present invention;

Fig. 3 is the sectional view of the second embodiment of the present invention;

4 is an exploded perspective view of a second embodiment of the present invention;

Figure 5a is a cross-sectional view of a third embodiment of the present invention;

Figure 5b is a perspective view of a detail of the present invention;

6 is an exploded perspective view of a third embodiment of the present invention;

Figure 7a is a sectional view of a fourth embodiment of the present invention;

Figure 7b is a perspective view of a detail of the present invention;

Fig. 8 is an exploded perspective view of a fourth embodiment of the present invention.

Referring to Fig. 1 and 2, the first embodiment of the present invention comprises a device 1, and this device comprises a base 2, and base 2 is made up of a cylindrical part 6 and a mouthpiece 7, and cylindrical part 6 is open at its upper end, so that Air can enter the device 1 and receive a cylindrical pressure dispensing container 3 with a port 7 protruding from the lower end of the cylindrical part 6 . The port 7 may protrude laterally from the cylindrical portion 6 of the seat, or alternatively protrude from the cylindrical portion 6 at a slightly downward angle. When the container 3 is inserted into the cylindrical portion 6, there is a gap 5 between the container 3 and the inner surface of the cylindrical portion 6 for allowing air to flow therethrough.

The seat 2 also includes a stem seat 8 for receiving the valve stem 9 of the pressure-dispensing container 3 . Stem seat 8 is of conventional construction and comprises a hole communicating with an opening in the side wall of the seat block by a conduit to direct the aerosol spray as it discharges through valve stem 9 in direction towards outlet 11 of mouthpiece 7 .

An annular membrane 12 is sealingly engaged with the uppermost end of the stem seat 8 . The annular membrane 12 is generally planar in cross-section and includes a central hole 13 . The cross-sectional shape of the central hole 13 is preferably the same as the cross-sectional shape of the rod seat 8 . When the device 1 is assembled, the annular membrane 12 is sealingly engaged with the rod seat 8 by pushing the rod seat 8 partially or completely through the central hole 13 . The annular membrane 12 is held in place by the outer diameter of the stem seat 8, while the inner diameter of the central bore 13 of the annular membrane 12 is an interference fit. The diameter of the annular membrane 12 is such that the outer periphery 18 of the membrane 12 engages the inner surface of the cylindrical portion 6 of the seat 2 in a first position by means of an interference fit. In this way, the annular membrane 12 functions to substantially block the air passage, so that air does not enter the port 7 from the cylindrical portion 6 of the seat 2 . A vent hole may be provided in the annular membrane 12 to allow a minimum flow of air from the open end of the seat 2 into the port 7 . Alternatively, the seal between the annular membrane 12 and the seat 2 can be designed to allow a very small amount of air to pass therethrough. The annular membrane 12 together with the inner surface of the seat 2 acts like an air flow controller controlling the time and flow of air passing through the inhalation device 1 . Membrane 12 can be made of polypropylene with good sealing properties or a soft elastic glue.

The annular membrane 12 further includes a plurality of raised ribs 14 on the upper surface of the annular membrane 12 . The radial ribs 14 act like a means to bend the membrane 12 into the second position when the device 1 is in use and also provide structural strength to the membrane 12 in the sealing position. The raised ribs 14 can be radial or, alternatively, concentric. The raised rib 14 may be triangular in shape in the vertical plane and has an apex 15 positioned towards the central hole 13 so as to contact the front end 16 of the pressure dispensing container 3 in use. The ribs 14 can have various shapes that do not affect the operation of the air flow controller. Where the end of the pressure dispensing container 3 is close to the valve stem 9 , the front end 16 of the pressure dispensing container 3 includes the collar and other surfaces of the pressure dispensing container 3 . If concentric ribs are used, the ribs closest to the central hole 13 will be more raised than the ribs closest to the periphery 18 .

In use, the user places the mouthpiece 7 in his mouth and inhales. With the annular membrane 12 engaged with the seat 2 in the first position, it is possible not to have much air flow through the air flow controller. Thereafter, the user presses down on the pressure dispensing container 3 . The downward movement of the container 3 brings the front end 16 of the container 3 into contact with the apex 15 of the raised rib as the valve stem 9 begins to slide. Further downward deflection of the pressure vessel 3 causes the raised ribs 14 to bend the annular membrane 12 from the first position to the second position. Since the central portion of the annular membrane 12 is hermetically fixed to the uppermost end of the rod seat 8, the central region of the annular membrane 12 is less curved than the outer peripheral portion 17 of the annular membrane 12. When the outer periphery 18 moves downward, allowing air to flow from the open upper end of the seat 2 through the gap between the outer periphery 18 and the seat 2 into the interface 7 and out of the outlet 11, the bending of the membrane 12 causes the outer periphery 18 to align with the cylinder of the seat 2. The inside diameter of part 6 is not sealed.

Further depressing the dispensing container 3 further depresses the valve stem 9 causing the membrane 12 to bend to a third position and a dose of medicine is discharged through the valve stem 9 and the valve stem seat 8 . The dispensing container 3 can be moved beyond the third position, but this does not affect the operation of the device 1 . After the air flow through the inhaler has been established, the drug is expelled and the drug particles are thus entrained in the air flow and inhaled. It should be recognized that in this embodiment and in the embodiments to be described later, the required stroke of the valve stem 9 for actuating the pressure dispensing container 3 must be long enough to allow the air flow controller to discharge a A dose of drug previously moved from the first location to the third location.

In the first position where the annular membrane 12 seals against the inner surface of the cylindrical portion 6, it is desirable to have a minimum flow of air through the inhaler into the mouth of the user when suction is applied to the mouthpiece 7. This minimum flow of air helps to prevent any sense of panic that the inhaler user may experience if they cannot inhale a certain amount of air. This minimum air volume flow can be produced by incorporating a discharge hole in the annular membrane 12 . Alternatively, a minimum air volume flow can be ensured by designing the annular membrane (12) to have a minimum amount of leakage air through the outer periphery 18 in the sealed state. Thus, the inhaler has a minimum air volume flow through the inhaler in the inactive state (membrane in the first position) and a maximum air volume flow through the inhaler when the annular membrane 12 has been bent to the second position. The ratio between the maximum and minimum air volume flow can vary widely and can be adjusted by varying the size of the discharge orifice and/or the nature of the sealing contact of the annular membrane 12 . The ratio between the maximum and minimum air volume flow is preferably in the range of 8-12, and the ratio between the maximum and minimum air volume flow is preferably about 10.

Another embodiment of the present invention is now described. Parts of the other embodiment in common with the first embodiment are designated by the same reference numerals.

As shown in Figures 3 and 4, in a second embodiment of the present invention, the air flow controller 20 comprises a deformable member 21 comprising a cylindrical sleeve 22 open at its upper end , for receiving the pressure distribution container 3, closed at its lower end with a transverse membrane 23. A cylindrical sleeve 22 is sealingly mounted on the seat 2 at its uppermost end. This sealing is preferably made at the uppermost end of the cylindrical portion 6 . However, the sealing can also be made at any point on the cylindrical portion 6 of the seat 2 above the transverse membrane 23 . The transverse membrane 23 comprises a central hole 13 through which the valve stem 9 of the dispensing container 3 passes when the dispensing container 3 is inserted into the device 1 . The transverse membrane 23 further comprises a first portion 25 joined to an annular member 26 surrounding the central hole 13 and a second portion 27 separated from the first portion 25 by a plurality of slits 28 in the transverse membrane 23 . In the inactive position, the first and second portions 25 , 27 engage each other to prevent any large air flow over the transverse membrane 23 . When the dispensing container 3 is pressed down, the front end 16 of the dispensing container 3 contacts the ring member 26 and bends the ring member 26 and first portion 25 downward from the first position to the second position. Thus, the second portion 27 of the transverse membrane 23 is separated from the first portion 25, and when the first portion 25 and the annular member 26 are bent down to the second position, the slit 28 opens allowing maximum air when the user applies suction to the interface 7. The flow passes through the slot 28 .

Further downward pressure on the dispensing container 3 depresses the valve stem 9 further, bending the transverse membrane 23 to the third position and expelling a dose of medicament through the valve stem 9 and the valve stem seat 8 . After the maximum air flow through the inhaler has been established, the drug is discharged and the drug particles are thus entrained in the air flow and inhaled.

The transverse membrane 23 preferably has an upwardly extending dome-like configuration in the first position. This configuration biases the transverse membrane 23 into contact with the front end 16 of the dispensing container 3 . This biasing action also ensures that the slit 28 closes again when the dispensing container 3 is released. The deformable member 21 is preferably made of a polymer such as polypropylene.

Vent holes may be made in either the first or second part 27, or alternatively the interface between the first and second parts 25, 27 may be designed to allow a minimum air volume flow therethrough .

A third embodiment of the invention is shown in FIGS. 5 a , 5 b and 6 . A plunger valve 30 of conventional construction is arranged near the rod seat 8 . The plunger valve 30 includes an actuator 31 extending upwardly from the plunger valve 30 towards the front end 16 of the dispensing container 3 . In the first position of the plunger valve 30, the actuator is biased to an upwardly extended position. The seat 2 further comprises a wall 32 at the lowermost end of the cylindrical portion 6 which seals the cylindrical portion 6 relative to the port 7 . When in use, when the user applies suction to the interface 7 and presses down on the dispensing container 3, the actuating rod 31 of the plunger valve 30 is pushed down by the front end 16, and the plunger is moved from the first position to the second position. The valve 30 opens and allows maximum air flow from the upper open end of the seat 2, through the plunger valve 30, through the slots 33 on either side of the rod seat 8, into the port 7.

Further downward pressure on the dispensing container 3 further depresses the plunger valve 30 to the third position and causes a dose of medicament to be expelled through the valve stem 9 and the valve stem seat 8 . After the maximum air flow through the inhaler has been established, the medicament is discharged and the medicament particles are thus entrained in the air flow and inhaled.

The plunger valve 30 may be of a non-conventional type and includes a damper cartridge assembly which retards the upward extension of the actuator 31 after the actuator rod 31 is depressed with the dispensing container 3 . Like this, the closure of plunger valve 30 and the cessation of air flow all can delay a known time after releasing dispensing container 3, and the benefit of this is, if the user of inhalation device mistakenly releases dispensing before completing the inhalation cycle container 3, the air flow through the inhalation device does not stop for a few seconds, thereby allowing the user to complete the inhalation of the discharged medicament.

A fourth embodiment of the invention is shown in FIGS. 7 a , 7 b and 8 . A deformable skirt 40 is provided for receiving the front end 16 of the dispensing container 3 . The skirt 40 includes a central bore 13 through which the stem 9 protrudes and engages the stem seat 8 . The skirt 40 further comprises one or more keys 47 received in grooves 48 on the inner surface of the cylindrical portion 6 . Key 47 prevents rotation of skirt 40 when engaged with slot 48 . The skirt 40 further includes a downwardly extending flange 42 having a protrusion 43 on a vertical surface. The protrusion 43 may be in the shape of a raised bump. In the first position of the skirt 40 the protrusion 43 is sealingly engaged with the opening 44 in the intermediate wall 50 of the seat 2 . A partition 50 separates the interface 7 from the cylindrical part 6 . Skirt 40 may be fabricated from a polymer or other deformable material.

In use, the dispensing container 3 is depressed, causing the skirt 40 to move downwards to a second position while the protrusion 43 steps out of the opening 44 . This movement is provided by the flange 42 bent away from the partition 50 . The gap created between the protrusion 43 and the opening 44 allows minimal air flow through the inhalation device into the mouthpiece 7 when the user applies suction to the mouthpiece 7 .

Further downward pressure on the dispensing container 3 moves the skirt 40 to the third position and allows a dose of medicament to be expelled through the valve stem 9 and valve stem seat 8 . After the maximum air flow through the inhaler has been established, the medicament is discharged and the medicament particles are thus entrained in the air flow and inhaled.

Above the level of the skirt 40 a limiting constraint 49 is provided on the inner surface of the seat 2 . The restraint 49 prevents the skirt 40 from being pulled out of the seat 2 when the pressure dispensing container 3 is removed for cleaning or replacement. The force required to separate the skirt 40 from the front end 16 of the pressure dispensing container 3 is less than the force required to move the skirt 40 past the limiting constraint 49 .

Vent holes 45 may be provided in the skirt 40 to allow minimal air flow through the inhaler when the inhaler is in the rest position.

It should be appreciated that various modifications may be made to the structure of the device 1 without departing from the scope of the present invention.

An advantage of all these embodiments is that the air flow controller is in contact with the front end 16 of the pressure dispensing container 3 in use. Thus, the operation of the inhaler is independent of height changes of the dispensing container body. Rather, it is related to the distance between the tip of the valve stem 9 and the front end 16 of the container 3, which height variation has been found to vary by approximately the same amount as the stroke length of the valve stem 9, which has been found to be larger than the entire container 3 has much less height variation. In this way, the timing of the dispensing of a dose of drug relative to the onset of maximum air flow is much more reliable.

Claims (14)

1. suction apparatus that is used for allocated product, it comprises that one is used for the seat of pressurised dispenser container and comprises that one is used to admit the valve rod of pressurised dispenser container, the air intake of above-mentioned seat and the part of an interface, said apparatus further comprises a pipe guide and an air flow controller adjacent with the valve rod receiving portion, pipe guide is communicated with seat, be used for towards the interface conveying products, above-mentioned air flow controller be biased to one with do not have air flow from air intake to interface or minimum air flow corresponding first location arranged, and in use can by pressurised dispenser container move to one with the maximum corresponding second position of air flow is arranged from air intake to interface, continue the movement pressure dispense container, the product of a dosage is assigned in the maximum air flow, and air flow is produced by the user that applies suction to interface.

2. as the desired suction apparatus of claim 1, it is characterized by, the volume flow of minimum air flow is less than the volume flow of maximum air flow.

3. as the desired suction apparatus of claim 2, it is characterized by, maximum volume flow is 8～12 times of minimum volume flow.

4. each desired suction apparatus of claim as described above is characterized by, air flow controller comprise one can with the part of the preceding end in contact of pressurised dispenser container.

5. each desired suction apparatus of claim as described above, it is characterized by, air flow controller comprises a circular membrane, the latter comprises the rib and a neighboring of one or more protuberances, rib is positioned on the upper surface of circular membrane, be used in use the preceding end in contact with pressurised dispenser container, neighboring and seated connection close, so that do not have air flow betwixt or minimum air flow is arranged; The neighboring is to the mobile response of rib of protuberance, moves into seat to disengage, to allow that maximum air flow process is arranged betwixt.

6. as the desired suction apparatus of claim 5, it is characterized by, the rib of protuberance is the radial rib of protuberance, and it extends from the core of circular membrane basically, arrives the neighboring substantially always.

7. as the desired suction apparatus of claim 5, it is characterized by, the rib of protuberance is the concentric round rib of one or more protuberance, and it radially separates each other from the core of circular membrane, arrives the neighboring substantially always.

8. as each desired suction apparatus of claim 1 to 4, it is characterized by, air flow controller comprises that one can shelter the columniform sleeve that is roughly in present, sleeve is uncovered in the upper end, to be used to admit pressurised dispenser container, one horizontal film is arranged in its lower end, first section first that comprises air flow controller of horizontal film, it can be with the preceding end in contact of pressurised dispenser container and therewith moves, second section second portion that comprises air flow controller of horizontal film, above-mentioned second section engages in primary importance with air flow controller with first section, so that do not have air flow betwixt or minimum air flow is arranged; First section deflection with respect to second section allows the slit of maximum air flow through so forming between first and second sections of horizontal film.

9. as each desired suction apparatus of claim 1 to 4, it is characterized by, air flow controller comprises a plunger valve, and it has an actuator that is biased to extended position, and above-mentioned actuator can be with the preceding end in contact of pressurised dispenser container and therewith moved; Offseting downward of actuator opened plunger valve and allowed to set up betwixt maximum air flow.

10. as the desired suction apparatus of claim 9, it is characterized by, plunger valve comprises a dsah-pot assembly, and to be used for delaying moving up of actuator later at hydraulic actuator down, above-mentioned dsah-pot postpones closing of plunger valve.

11. each desired suction apparatus as claim 1 to 4, it is characterized by, air flow controller comprises that one is used for the skirt section with the preceding end in contact of pressurised dispenser container, and this skirt section comprises the one or more edges of a wing that are used for the key that engages with the cannelure of seat and one or more downward extension; The above-mentioned edge of a wing comprises the projection of one or more protuberances, and the opening that it is used for when air flow controller is in primary importance on the partition with seat engages; Partition with seat be used to admit the part of pressurised dispenser container and interface to separate; The skirt section is moved downward to the second position of air flow controller, makes projection not to the opening sealing, to allow to set up the air flow from the maximum of its process.

12. the desired suction apparatus of each claim is characterized by as described above, minimum air flow is through discharge orifice.

13. the desired suction apparatus of each claim also comprises a pressurised dispenser container as described above.

14. one kind basically as preceding with reference to the accompanying drawings as described in and the suction apparatus that illustrates in the drawings.

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