CN105903111B - Dose counter, inhalator and its axis for inhalator - Google Patents

Abstract

The dose inhaler (12) of manual operation measurement includes: dose counter room (66), the dose counter room includes dosage display band (112), the dosage shows that band is driven by ratchet (94), and the ratchet is driven by actuating pawl (80), which is activated by the movement of tank (20)；Two step ribs (144,146), the two steps rib are set to prevent the swing of tank (20)；Tap (194), the tap are set to prevent hazing for display window (118)；With friction surface (132,134), which is arranged on the axis (108) with storage spool (110) to prevent stop-band skidding；Rotary regulator, the rotary regulator is arranged for storage spool and including wavy engagement surface (300), the wavy engagement surface has recess (302), the recess is bonded on the control element (128 with projection form on the elasticity fork of split pin (108), 130) on, therefore allow to store the increment unwinding of spool, but if inhalator, which drops into, still resists excessively rotation on hard surface.

Description

Dose counter, inhalator and its axis for inhalator

The application is that international application no is PCT/EP2011/002462, national application number 201180024350.6, applies Day is the Chinese patent application on May 18th, 2011, entitled " dose counter, inhalator and its axis for inhalator " Divisional application.

Technical field

The present invention relates to for the dose counter of inhalator, inhalator and its axis and its assemble method.It is of the invention special It not can be applied to the dose inhaler of metering, the dose inhaler of the metering includes dry powder pharmaceutical inhalator, breath actuated suction Enter the dosing dose inhaler of device and manual operation.

Background technique

The dose inhaler of metering may include the tank for accommodating the pressurization of medicament, which accommodates active medicine and propellant Mixture.This tank is usually by deep drawn aluminium cupuliform at the deep drawn aluminium cup has the lid of curling, and the lid of the curling is with metering Valve module.Metering valve assemblies are provided with valve rod outstanding, which is inserted into as promotion matching piece with medicine in use In valve rod base in the actuator body of the inhalator of object conveying outlet.In order to activate manually operable inhalator, user With the end of the closure of hand application compressing force to tank, the internal part of metering valve assemblies is spring-loaded, so that in some allusion quotations The compressing force of approximation 15 to 30N is needed to start the device in the case where type.In response to this compressing force, tank is relative to stem shaft To movement, and the axial movement is enough to activate metering valve and the drug for the amount measured and propellant is caused to be pushed over valve rod. This nozzle then passed through in valve rod base is released in the ozzle of inhalator, so that the use of the outlet sucking by inhalator Person will receive the drug of dosing.

The shortcomings that self administration of medication of inhalator is, it is difficult to determine that how many active medicine and/or propellant stay in inhalator (such as If fruit has, active medicine in particular), and this is potentially dangerous for user, this is because dosage becomes Unreliable and stand-by provision is not always available.

Therefore, the inhalator including dose counter has become known.

WO 98/280733 discloses a kind of inhalator with ratchet mechanism, which is used to drive band carminative Batching counter.Tape wrapping has friction clutch or spring to axis thereon to prevent axis from reversely rotating.

EP-A-1486227 discloses a kind of inhalator for dry powder pharmaceutical, which has for band dose counter Ratchet mechanism, when close inhalator ozzle when operate the ratchet mechanism.Due to opening and closing the mode of ozzle, it is mounted on The actuating pawl of the device on yoke is advanced the long stroke of known consistent length when opening and closing ozzle.

WO 2008/119552 discloses a kind of dose inhaler of metering, and the dose inhaler of the metering is suitable for respiratory exercise Work application and operated with known and constant 3.04mm+/- 0.255mm tank stroke length.Band is unwound from it The storage spool of counter rotates on the axis with split pin, which is intended to keep storage spool to be to tense.

Recently, become to wish to be further improved dose counter, and particularly feel usefully, to be hand The dose inhaler of the pot type metering of dynamic operation provides split-hair dose counter.Regrettably, mistake of the invention is being made In journey it has been found that in these inhalators, the stroke length of the tank in use is largely by making on each dosage The operation of user controls.Therefore, stroke length is alterable height, and it was found that, it is extremely difficult to it is provided for these applications highly reliable Dose counter.When tank does not discharge, dose counter must dosage without counting, since this may falsely indicate that use Person's dosage has been applied, and if repeatedly done so, and user will lose before the actual time for replacing the device Tank or whole device.In addition, tank must not be discharged in the case where no dose counter counts, because user may think that Tank discharges not yet and then applies another dosage, and if repeatedly done so, and active medicine and/or propellant may Use up, and user according to counter think the device be still adapted to using.It has also been discovered that, assembles some known inhalators Device and be extremely difficult for its dose counter.In addition, feeling it is desirable that by making them use water quilt It can easily be used after washing and improve inhalator.Some dose counters may not keep particularly reliable counting, example Such as, if they are dropped on hard surface.

Summary of the invention

The present invention is directed to mitigate one or more problems of the prior art at least to a certain extent.

According to the first aspect of the invention, a kind of dose counter of dose inhaler for metering, the sucking are provided Device has ontology, which is arranged to that the pharmacy jar of pre-determined configurations is kept to move so as to the pharmacy jar relative to ontology；Described dose Batching counter includes:

For counting the incremental count system of dosage, the incremental count system has main body；Actuator, the actuator It is arranged to respond to move in tank and driven and move in response to tank and drive increment output link, the actuator and increment Output link is configured with the release of the scheduled tank in tank release sequence construction and counts construction, and the tank release construction is by institute The position that actuator is stated relative to benchmark determines that the tank discharges construction release medicament in the tank, and the counting constructs Position by the actuator relative to the benchmark determines that the incremental count system makes increment meter in counting construction Number, wherein the actuator arrangement is at reaching the meter at the position of the actuator in tank release construction or later The position of the actuator in number construction.

It has been found that this arrangement is highly advantageous, this is because it provides point-device dose counter, the agent Batching counter is suitable for the dose inhaler of the metering of manual operation.It has been found that the dose counting utensil with these features There is the failure rate for being less than every million complete tank starting 50 fail counts of pressure.During making the present invention unexpectedly Ground discovery, being counted at the point that tank discharges or shortly after that by dose counter may be implemented highly reliable counting.This hair Bright people, which has been found that, discharges momentum and movement involved in the tank, and in some embodiments, in tank release in user On tank back pressure in be slightly reduced, can highly reliably cause the other further movement by timing point.

Actuator and incremental count system may be disposed so that actuator count and discharge construction in its position it Between relative to ontology displacement be less than 1mm, typically 0.25 arrive 0.75mm, more preferably about 0.4 arrive 0.6mm, about 0.48mm It is preferred.The tank that substantially can be consistently moved with actuator can reliably move this it is other at a distance to realize It is very reliable to count.

The incremental count system may include ratchet mechanism, and the increment output link may include ratchet, institute Ratchet is stated with multiple circumferentially spaced teeth, the tooth is arranged to engage the actuator.

The actuator may include actuating pawl, and the actuating pawl is arranged to engage on the tooth of the ratchet.Activate pawl It can be arranged attached to actuator pin or integral with actuator pin, which is arranged to engage pharmacy jar bottom flange simultaneously And it is depressed by pharmacy jar bottom flange.Actuating pawl can be substantially U-shaped, and there are two parallel arm, the arm is arranged to draw tool On the center claw component for being substantially perpendicular to the arm arrangement.This provides very that reliably actuating pawl, the actuating pawl can The tooth of ratchet is pulled by ground.

The incremental count system may include tape counter, and the tape counter has band, and increment dosage label is located at Described to take, the band is arranged on band storage spool and is arranged to unwind from it.

Actuator and increment output link can be arranged to provide: starting to construct, start to construct described, the actuator It is spaced apart with the ratchet output link；Resetting construction constructs in the resetting, the actuator is made during tank release sequence It is engaged with the increment output link；With terminate construct, ends construction, during tank release sequence the actuator from The ratchet output link is detached from.

In described start in construction, the actuator can be arranged to big away from its position in the release construction About 1.5 to 2.0mm and position, about 1.80mm is preferred.

When in resetting construction, the actuator can be arranged to big away from its position in the release construction About 1.0 to 1.2mm and position, about 1.11mm is preferred.

When in end construction, the actuator can be arranged to big away from its position in the release construction About 1.1 to 1.3mm and position, about 1.18mm is preferred.

These arrangements provide very reliable dose counting, the dose inhaler particularly measured in the pot type of manual operation In the case where.

The main body may include a structure, and the structure is used to force when the actuator is constructed by the end The actuator is detached from the increment output link.The structure may include the protrusion on otherwise substantially straight surface, cause Dynamic device engages on a surface and is arranged to slide during tank release sequence along the surface.

The dose counter may include counting pawl, and the counting pawl has tooth, and the tooth is arranged to engage the increasing Output link is measured, the tooth and increment output link are arranged to only allow the unidirectional increment between the tooth and increment output link Relative motion.When increment output link includes ratchet, therefore tooth may be used as the anti-return sliding tooth for ratchet, therefore only Ratchet one-way is allowed to move or rotate.

Counting pawl can substantially stationary be mounted in the main body of incremental count system, and counts pawl and can be arranged to The equally spaced tooth that increment output link is repeatedly engaged in interlocking structure can be driven in anti-return in operational counter.Meter Number pawl can be positioned so that: when actuator and increment output link, which are in it, terminates construction, increment output link is to be located at Midway or the mode for being located substantially on midway move to next anti-return driving interlocking from an anti-return driving interlocking structure Construction.This is highly advantageous, because it minimizes dose counter double count or danger without counting.

Another aspect according to the present invention provides a kind of inhalator, which includes: main body, and the main body is arranged to Keep the pharmacy jar of pre-determined configurations；And dose counter, the dose counter are mounted in main body, the dose counter such as this hair Described in bright at least one other aspect.

Inhalator main body may include tank receiving portion and the counter dial housing that is mutually separated, and dose counter is located at its main body Interior, in counter dial housing, the main body of inhalator, which has, separates tank receiving portion and counter for increment output link and its actuator The wall surface of room, the wall surface are provided with intercommunicating pore, and actuating component extends through the intercommunicating pore so that tank movement is transmitted to actuating Device.

Another aspect according to the present invention provides a kind of inhalator for dosing sucking, which includes: master Body, the main body have tank shell, and the tank shell is arranged to the movement for keeping pharmacy jar so as to pharmacy jar in tank shell；With Dose counter, the dose counter have actuating component, and at least part of the actuating component is located at the tank shell In operated with will pass through the movement of pharmacy jar, wherein the tank shell there is inner wall and positioned close to the actuating component the One inner wall tank support construction.This is highly advantageous, because the first inner wall tank support construction can prevent tank relative to inhalator Main body excessively swing.Since the tank can operate the actuating component of dose counter, this significantly improves dose counting and is avoided Counters error.

The tank shell can have longitudinal axis, and outlet port, the center go out the longitudinal axis through its center Mouthful port arrangements at the cooperation of the outer pot release lever of pharmacy jar, the inner wall tank support construction, the actuating component and described Outlet port be located at in the common plane of the longitudinal axes coincident.Therefore, this construction can prevent tank towards dosimeter The position of number device actuating component is swung, therefore minimizes the mistake in counting.

The tank shell can have other inside tank skin support construction, the other inside tank skin support construction position In on the inner wall opposite or substantially opposite with the actuating component.Therefore, tank, which can be supported for resisting, leaves actuating The pendulum motion of component is to minimize miscount.

The tank shell can be substantially straight and tubulose, and can have a kind of arrangement, in this arrangement, often A inner wall support construction includes the rail longitudinally extended along the inner wall.

Each rail can be step-like, and wherein it can have: towards the medicine outlet end of the tank shell Or the first part of valve rod base positioning, the first part extend internally first distance from the main surface of the inner wall；With towards The tank room opposed end positioning second part, the second part from the main surface of the inner wall extend internally second compared with Small distance.Therefore, this can enable tank be easily inserted into tank shell to make tank can when it is inserted into tank shell To be gradually aligned in stepwise fashion.

The inhalator may include other tank supporting rail, inner wall of the other tank supporting rail around the tank shell Inner peripheral interval and along its longitudinally extend.

At least one of described other rail can extend internally constant distance from the main surface of the inner wall.

Other at least one of the rail could be formed with the construction similar with the first inner wall tank support construction.

In addition to described at least part of the actuating component, the dose counter can be located at and the tank shell In the counter dial housing of separation, the actuating component includes pin, and the pin, which extends through, separates the counter dial housing and tank shell Hole in wall.

Another aspect according to the present invention, provides a kind of inhalator for sucking medicament, which includes

For keeping the ontology of formulation reservoir；The ontology includes dose counter, and the dose counter has can The actuator of movement and reset spring for the actuator, the reset spring have substantially cylindrical and annular End；The ontology has the support construction for the end for being used to support the reset spring, the support construction in it The groove below shelf and the shelf thereon can be joined to including the end.

This shelf and groove arrangement are highly advantageous, this is because it allows tool (such as manually or mechanically tweezers) For the reset spring of actuator to be placed into shelf, which is then withdrawn at least partially through the groove.

The shelf can be U-shaped.

The support construction may include the U-shaped upstanding wall extended around U-shaped frame, the shelf and upstanding wall because This forms the step riser portions of step-like arrangement.

Groove below shelf is also possible to U-shaped.

The surface of at least one beveling can be arranged on the inlet of shelf.This can contribute to actuator and reset Spring is inserted into appropriate location.

Additional aspects of the present invention provide a kind of assemble method of inhalator, the assemble method the following steps are included: by The end of the spring is located on the shelf and then at least partly removes via the groove by assembling tool Return the assembling tool.Compared with art methods, this assemble method be it is highly advantageous, in prior art approaches, Spring insertion is difficult, and recalling for tool surprisingly recalls spring again sometimes.

The cylindrical and annular end of the spring can be while being located on the shelf transversely It is moved in the shelf in the direction that its cylinder extends.

Another aspect according to the present invention, provides a kind of inhalator for sucking medicament, which includes for protecting Hold the ontology of formulation reservoir；And dose counter, the dose counter have movable actuator and are mounted on described Chassis on ontology；The chassis is thermally fixed in position on the body.

This is highly advantageous, because chassis highly precisely can be arranged and be held firmly in place, by This, further increases counting precision compared with prior art arrangement, in prior art arrangement, can allow in snapping connection Some movements of the chassis relative to ontology.

The chassis can have heat fixation to the ontology corresponding hole or pin pin or hole at least one.

The chassis can have ratchet counter output link mounted thereto.

The ratchet counter output link may include ratchet, and the ratchet is arranged to incrementally be involved in dosage measuring Band, dosage indicia are located on the dosage measuring band.

Another aspect according to the present invention provides the method for assembling foregoing aspects of inhalator according to the present invention, the party Method is the following steps are included: by the chassis heat fixation to the ontology.The step of heat fixation, is highly advantageous for fixing chassis Ground is arranged into the dose counting for realizing high precision on ontology in the inhalator of assembling.

The assemble method may include causing spring reset ratchet before the chassis heat fixation is in place Dynamic device is mounted in the ontology.

The method may include before by chassis heat fixation step in place by the chassis and agent Meter amount band is pre-assembled.

The method may include dosage measuring covering is attached on the ontology after the heat fixation step. The covering can be soldered on the ontology, or in some embodiments can be glued or be attached in another manner suitable Work as position.

Another aspect according to the present invention provides a kind of for sucking medicament and with the inhalator of ontology, the ontology Include its major part for keeping formulation reservoir；And dose counter, the dose counter are located at the ontology In dose counter room, the major part of the dose counter room and the ontology separates, the dose counter of the ontology Room has dose display and is perforated so as to allow water or hydrous matter in the dose counter room to be evaporated to greatly In gas.

This is highly advantageous, because it enables, inhalator is thoroughly washed and dose counting room hereafter can be abundant It is dry.

The display device may include the indoor mechanical counter display device of the dose counter and for observing The window of mechanical counter display device.Mechanical counter display device may include band.The dose counter room of perforation is therefore The reliable washing (if desired, being washed by user) of inhalator may be implemented, and therefore can display device window not It is dry in the case where hazing.

The dose counter room can be perforated by tap, and the tap is formed through the outer wall of the ontology. At the bottom part for the ontology that tap can be located at inhalator, therefore realize after wash when making inhalator be in orthostatic position Promote the abundant discharge of inhalator when setting.

Another aspect according to the present invention, provides a kind of dose counter for inhalator, which includes It shows that band, the display band are arranged to drive with being incremented from band storage spool to increment band and pick up in drive shaft, there is inner hole The spool by support shaft support and be used to around the support shaft rotate, at least one of the hole and support shaft have Protrusion, the protrusion are resiliently biased into another with the hole and support shaft by the phase mutual friction that longitudinally extends interaction One frictional engagement.

This arrangement can provide good friction for spool, therefore improve tape counter display device precision and prevent Spool undesirably unwinds (for example, if inhalator surprisingly falls).

The support shaft can be it is fork and elastic, so that the support shaft and hole are resiliently biased to rub Engagement.

The support shaft can have two forks, or have more forks in some cases, and each fork has radial direction The protrusion of extension, the protrusion have is parallel to the friction edges that the longitudinal axis of the support shaft extends along, so as to The hole of the friction interaction frictional engagement support shaft longitudinally extended between protrusion and the hole of the support shaft.

The hole can be smooth cylinder or substantially cylindrical hole.

Each of above-mentioned inhalator of various aspects according to the present invention can have the pharmacy jar being mounted thereto.

The tank may include the dosage facility measuring tank of pressurization, and the dosage facility measuring tank of the pressurization has and can move back and forth Bar, the bar extends from tank and can move in its main tank part, to discharge the medicament (example of dosing under stress Such as, by operating the intrinsic metered dose valve of tank).The tank can be operated by being pressed on the main tank body with hand.

In the case where being provided with one or more supporting rails or inner wall support construction, tank can begin when in tank room There is the gap that 0.35mm is arrived away from the first inner wall support construction about 0.25 eventually.The gap can nearly exactly be 0.3mm.One Denier label be applied can be applied to tank ontology itself or tank the gap be enough to allow tank in inhalator it is steady Movement, and the significant swing of tank is prevented simultaneously, which can lead to the inaccurate counting of the dose counter of inhalator, When the actuating component of the dose counter especially when the lower surface arrangement of tank at engagement for counting purpose.

Additional aspects of the present invention provide a kind of method for assembling the dose counter for inhalator, this method comprises: Band is provided, the band has dosage indicia on it；Band telltale mark is provided on the belt；With described in sensor monitoring The band is loaded while band telltale mark.

This method advantageouslys allow for for example through the high efficiency of the band of winding and accurate loading.

The method may include the dosage indicia is provided as number.The method may include position the band Label is provided as one or more lines across the band.

The loading may include will be on the tape wrapping to spool or axis.

The method may include stop winding when the telltale mark is in predetermined position.

The method may include providing pixel along the band and the position of the telltale mark separately for the band Change label.

The method may include provide starting point for the band.

Additional aspects of the present invention provide the band system for being used for dose counter, which is used for inhalator, should There is mainly elongated band structure and the dosage indicia on the band structure with system and with telltale mark.

It is described with telltale mark may include across the band structure extend at least one line.

The band system may include pixelation label, pixelation label be located on the band structure and with it is described Telltale mark is separately.

The band system may include starting point, which is located on the band structure.

The telltale mark can be located between timing point and pixelation label.

The main elongated band structure can have its at least one end on spool or axis.

Additional aspects of the present invention provide a kind of method of increment dose counter designed for inhalator, this method packet It includes:

Calculate the nominal tank releasing position and dose counter position of the dose counter actuator for the inhalator； The failure of the dose counter of each release that calculating is constructed according to tolerance levels, for counting the inhalator/at The actuator of power, the dose counter can be applied in the inhalator；With selection tolerance levels so that the mistake It loses/success rate at or below/and is higher than predetermined value.

This is highly advantageous, because it allows a series of reliability of inhalator counters according to the design and manufacture High efficiency and accurate prediction.

The method may include the failure/success rate is selected as the failure rate no more than 5000 a ten thousandths.

The method may include setting average counter positions, so that the dose counter that is constructed according to the tolerance is in tank In its average releasing position or later during released movement.

The method may include the average counter position is set as about 0.4 after the average releasing position To 0.6mm, the about 0.48mm such as after the average releasing position.

The method may include the standards of the releasing position in the dose counter that will be constructed according to the tolerance The tolerance settings of deviation are about 0.12 to 0.16mm, such as about 0.141mm.

The method may include the standards of the counting position in the dose counter that will be constructed according to the tolerance The tolerance settings of deviation are about 0.07 to 0.09mm, such as about 0.08mm.

Additional aspects of the present invention include the computer implemented method of the increment dose counter designed for inhalator, This method includes the method as described in last aforementioned aspects of the invention.On the computer implemented method may include Any feature for the optional feature that face illustrates.

Additional aspects of the present invention include a series of a kind of increment dosimeters of the manufacture for inhalator in production run The method of number devices, this method comprises: according to such as the design method system described at least one aforementioned aspects of the invention above Make the dose counter of the series.

Additional aspects of the present invention include a kind of method for manufacturing a series of increment dose counters for inhalator, institute Stating method includes manufacturing the dose counter, and the dose counter has dose counter actuator relative to dose counting The nominal tank release of device chassis (or inhalator main body) and dose counting position；And the method includes constructing the dosimeter Device is counted, average tank releasing position of mean dose counting position during tank discharges in the series in the series Or later.

The method may include the dose counter is constructed, the mean dose counting position in the series is described About 0.4 arrives 0.6mm, such as about 0.48mm after average releasing position in series.

The method may include construct the dose counter, the standard deviation of the releasing position in the series 0.16mm, such as about 0.14mm are arrived in about 0.12.

The method may include construct the dose counter, the standard of the dose counting position in the series Deviation is in about 0.07 and arrives 0.09mm, such as about 0.08mm.

Additional aspects of the present invention include a series of a kind of method for manufacturing inhalators, this method comprises: executing such as this hair Method described at least one bright aforementioned aspects；With by each dose counting in the increment dose counter of the series Device is assembled to the corresponding main body of inhalator.

These aspects are advantageously a series of inhalators and the production run of dose counter is prepared, the dose counter It reliably counts in operation.

Additional aspects of the present invention provide a kind of increment dose counter of dose inhaler for metering, the metering Dose inhaler have ontology, the ontology be arranged to keep tank so that the tank is moved relative to the ontology, the increasing Amount dose counter includes main body；Actuator, the actuator arrangement are driven at the movement in response to tank and along countings Direction drives increment output link, and the actuator is configured to limitation output link along the direction opposite with the counting direction Movement.This advantageously makes the dose counter of inhalator be able to maintain the reliable counting of doses remaining, even if falling or with other Mode is also such in the case where shaking.

The output link may include ratchet.

The actuator may include pawl, and the ratchet and pawl can be arranged to only allow the wheel relative to institute State the single direction ratchet movement of pawl.

The dose counter may include the anti-return drive member fixed to the main body.

When in the resting position in the dose counter, the ratchet can be at a construction, in the structure In making, the rear surface of a tooth of ratchet engages the anti-return drive member, and is not just driving between the pawl and wheel The pawl is spaced apart with the adjacent rear surface of another tooth of the ratchet in the case where dynamic/obstruction engagement.

The incremental count system can be arranged to respond to input in actuating at least one aforementioned aspects of the invention And counter display is incrementally moved from first stop to second station along first direction, it is provided with adjuster, the tune Section device is arranged to act on the counter display in the first stop, to show the counter in the first stop The motor adjustment of showing device is to incremental motion.

According to another aspect of the present invention, the dose counter for inhalator is provided, which includes counting Device display device, the counter display, which is arranged to, to be used to refer to show dosage information；Drive system, the drive system It is arranged to for being inputted in response to actuating and incrementally moves the counter display from first stop along first direction To second station, it is provided with adjuster, the adjuster is arranged to act on the counter display dress in the first stop Set, in the first stop by the motor adjustment of the counter display to incremental motion.

The adjuster is advantageous in that, in the case where counter falls, it helps prevent counter display Undesired movement.

Preferably, which includes band.

Preferably, the band shows dose counter label on it.First stop may include the agent for keeping the band The region of batching counter, the region are located at before the display area for such as display window of counter label.

The first stop may include first axle, and the band is disposed in the first axle and shows in the counter Showing device is unwound when moving from first axle described in its.

The first axle can be installed into for fixed substantially in terms of rotation relative to the dose counter Element rotation.

The adjuster may include at least one protrusion, at least one protrusion be arranged in first axle and it is described substantially On one in terms of the rotation in fixed element, and incrementally engage first axle and described fixed substantially in terms of rotation Element another on one or more structures.

At least two protrusions can be set.Protrusion described in exactly two can be set.

Each protrusion may include the surface of rounding.

At least one described protrusion can be located on the substantially fixed element, and the substantially fixed element can To include the fixing axle for being fixed to the main body of the dose counter, the first axle is rotatably mounted to the fixing axle.

Preferably, the fixing axle has at least two flexibly leg flexible (or forks).Each leg can have along court At least one being formed on the leg to external direction is described raised, and one or more structure is formed in described the On engagement surface inside the direction of one axis, at least one described protrusion is arranged to flexibly engage one or more knot Structure.Preferably, a series of structures are set.And structure described in even number can be set.8 to 12 knots can be set Structure.In one embodiment, ten structures are set.

Each structure may include the recess being formed on engagement surface.Each recess may include the surface of rounding Wall part, the surface wall portions of the rounding are preferably incorporated into plain wall section surface at least one side thereof.The engagement Surface may include a series of recess, and the convex wall part of the engagement surface can be formed in per two adjacent institutes It states between recess, each convex wall part includes protrusion rounding wall part.

Each protrusion rounding wall part of each projecting wall portion point can be connected to each phase by the plain wall section surface Neighbour's recess.

The fixing axle may include have fork leg split pin and each protrusion can be located at the fork leg on.

The first axle may include substantially hollow spool.

At least one described structure can be located on the inner surface of spool.In other embodiments, it can be located at outside it On surface.The engagement surface can partly extend along the spool, corresponding inner surface or outer surface remaining or it is another Part has substantially smooth necked part along its at least part.

The drive system may include toothed ratchet, and the toothed ratchet is arranged to act on positioned at described second On the second axis stood, second axis is rotatable with will be on the tape wrapping to second axis.

Second axis can be located at the dosimeter that the first axle is spaced apart and be parallel to the first axle In the main body of number device.

Ratchet can be fixed to the second axis and be arranged to rotate together with the second axis.Ratchet can be fixed to the second axis It end and is coaxially aligned with the second axis.

Dose counter may include anti-return drive system, and the anti-drive system arrangements that return are at the fortune of the second axis of limitation It is dynamic.Anti- return drive system may include substantially fixed tooth, which is arranged to act on the tooth of ratchet.

Another aspect according to the present invention provides a kind of axis, which is used to for counter tape being maintained to be used for inhalator In dose counter, which has engagement surface, which includes the structure being incrementally spaced around its periphery, the structure Including a series of curved concave and convex portions.

The axis may include hollow spool.

The engagement surface can be the substantially cylindrical surface being directed inwardly toward.

The engagement surface may include flat surfaces wall part, each recess of flat surfaces wall part connection and convex Wall part out.

Each recess may include rounding wall part.

Each projecting wall portion point may include rounding wall part.

The recess can be regularly spaced around the longitudinal axis of the axis.

The projecting wall portion point can be regularly spaced around the longitudinal axis of the axis.

In some embodiments, 8 to 12 be regularly spaced around its longitudinal axis the recess and/or convex can be equipped with Wall part out.

One embodiment includes ten recess being regularly spaced apart around the longitudinal axis of the axis and/or protrusion wall Part.

Another aspect according to the present invention provides a kind of axis for dose counter and counter tape component, the dosage Counter is used for inhalator, which includes rotatable axis and counter tape, the counter tape wound around the axis and It is suitable for unwinding from the axis when inhalator activates, which has engagement surface, which includes the increasing around the positioning of its periphery The structure being spaced apart to amount.

Another aspect according to the present invention provides a kind of inhalator of sucking for medicament and the like, the inhalator The dose counter in aforementioned aspects including such as of the invention second to the end.

Preferred construction is made of the dose inhaler for the metering being manually operated, and the dose inhaler of the metering includes dosage Counter dial housing, the dose counter room include that dosage shows band, which shows that band is driven by ratchet, and the ratchet is by actuating pawl Driving, the actuating pawl is by the motion actuation of tank, and during the use of inhalator, the band is adjusted from storage spool unwinding, rotation Device is arranged for storing spool and the wavy engagement surface including having recess, which is bonded on the elasticity of split pin On the control element with projection form on fork, therefore allow to store the increment unwinding of spool, but drop into firmly in inhalator Surface in the case where still prevent excessively rotation.

Detailed description of the invention

The present invention can be performed in various ways, and describe dose counter, axis, inhalator with reference to the drawings With assemble method, the preferred embodiment designed and manufactured, in which:

Fig. 1 is the isometric view of the main body of the preferred embodiment of inhalator according to the present invention, the main body with for its Nozzle cover is together；

Fig. 2 is the top plan view of component as shown in Figure 1；

Fig. 3 A is the section on the plane 3A-3A in Fig. 2；

Fig. 3 B corresponds to the view of Fig. 3 A, but dose counter is assembled to the main body of inhalator；

Fig. 4 A be inhalator main body, nozzle cover, dose counter and dose counter window decomposition view；

Fig. 4 B is the view of the direction 4B in Fig. 4 C of the spring retainer of dose counter；

Fig. 4 C is the top view of the spring retainer of Fig. 4 B；

Fig. 5 be assembling inhalator main body, nozzle cover, dose counter and dose counter window bottom view；

Fig. 6 A, 6B, 6C, 6D, 6E, 6F, 6G and 6H are each views of the dose counter components of inhalator；

Fig. 7 A and 7B are the cross-sectional views for showing the intracorporal ullage gap of master of inhalator；

Fig. 7 C is analogous to the other cross-sectional view of the cross-sectional view of Fig. 7 B, but tank is removed；

Fig. 7 D is the top plan view of inhalator main body；

Fig. 8 A, 8B, 8C and 8D show inhalator main body and dose counter components during assembly；

Fig. 9 shows the sectional side view of the reference line of the actuating pawl for dose counter；

Figure 10 A, 10B, 10C, 10D, 10E and 10F show actuating pawl, the various sides of the position and construction of ratchet and counting pawl View；

Figure 11 shows the tolerance distribution of the beginning of the actuator of dose counter, resetting, release, counting and end position；

Figure 12 is the enlarged view of the part of Fig. 4 A；

Figure 13 shows the end sections of the band of dose counter；

Figure 14 shows the computer system for designing dose counter；

Figure 15 is the isometric view of follow-on storage spool of the inhalator for Fig. 1 to 14；

Figure 16 shows the end-view of the storage spool of Figure 15；

Figure 17 is the section of the longitudinal axis of the storage spool across Figure 15 and 16；

Figure 18 A to 18C is mounted in the view of the storage spool of Figure 15 to 17 in the dose counter chassis of Fig. 1 to 14 Figure, the profile of the control element of the fork of the second axis (or split pin) are slightly different to the profile in Fig. 6 F, which is in compression structure It makes；

Figure 19 A to 19C is the same as the view of Figure 18 A to 18C, but the different rotary position due to storing spool, at fork In the construction more extended；

Figure 20 is the isometric view of assembling and the chassis of the storage spool including Figure 15 to 17, but for the sake of clarity not Including band；

Figure 21 is the view of the preferred embodiment of Diskus according to the present invention；

Figure 22 is the decomposition view of the inhalator of Figure 21；

Figure 23 is the view of the dose counter of the inhalator of Figure 21；

Figure 24 is the decomposition view of dose counter shown in Figure 23；

Figure 25 is the decomposition view of the various pieces of the inhalator of Figure 21；And

Figure 26 is the view of the yoke of the inhalator of Figure 21.

Specific embodiment

It is that Fig. 1 shows preferred embodiment in accordance with the present invention and there is the nozzle cover that can be fixed on the ozzle 16 of main body The main body 10 of the dose inhaler 12 of the metering of 14 manual operation.

Main body has tank room 18, and tank 20 (Fig. 7 A) may slide into the tank room.Tank 20 has substantially cylindrical master Side wall 24, the major side wall are connected to head portion 28 by conical section 26, which has substantially flat lower surface 30, which has outer annular driving surface 32, which is arranged to engage the actuating pin in dose counter 36 On 34 and the actuating pin 34 of dose counter 36 is driven, as will be described.Medially and axially extend from lower surface 30 Be valve rod 38, which is arranged in the valve rod base 40 for being sealingly engaged at the main body 10 of inhalator 12.Valve rod base 40 has Lead to the access 42 of nozzle 44, which is used to guide the content of tank 20, i.e. active medicine and propellant into inhalator main body 12 air outlet slit 46.It will be understood that due to the gap 48 between the inner wall 50 of the main body 10 of tank 20 and inhalator 12, main body 10 Open-top 52 forms the air intake led in inhalator 12, which is connected by air flue 54 and air outlet slit 46 It is logical, so that the content for leaving the tank of nozzle 44 is mixed with the air being inhaled by the user by air flue 54, so as to together Across air outlet slit and the mouth (not shown) of entrance user.

Dose counter 36 will now be described.Dose counter 36 includes actuating pin 34, once actuating pin is mounted on main body In 10, which is just reset the bias from bottom to top of spring 56.As being best shown in Fig. 4 A, 6H and 8A, pin 34 is included Side surface 58,60, the side surface be arranged to be located at main body 10 dose counting room 66 in corresponding guiding surface 62,64 it Between slide；And end stop surface 68, the correspondence which is formed in dose counting room 66 at engagement The moving upwards with banking pin 34 of end stop 70.Pin 34 has a top section 72, the top section be it is cylindrical and And via hole 74 is extended through, which is formed through partition wall 76, which separates dose counting room 66 and tank room 18.Pin 34 Top section 72 there is flat top surface 78, which is arranged to engage the outer annular driving surface of tank 20 32。

Actuating pin 34 is integrally formed with driving or actuating pawl 80.It activates pawl 80 to construct with substantially inverted U-shape, the base Inverted U-shape is constructed with two arms 82,84 being spaced apart from each other and parallel extended from the base portion of actuating pin 34 in sheet, each Arm keeps the opposed end of blade tooth component 90 at its respective distal portion 88, the blade tooth component in a direction substantially perpendicular to arm 82, 84 direction extends, and in order to provide the device that can become " saddle " driving device, which is used to pull dose counter 36 Each of increment drive system 96 or 11 sliding tooths 92 of ratchet 94 of ratchet mechanism 96.As shown in such as Figure 10 B , blade tooth component 90 has sharp lower vertical side of the edge 98, which is arranged to engage sliding tooth 92, by this The edge that engagement provides is contacted with surface provides the very accurately rotation of positioning and ratchet 94 as a result of actuating pawl 80 Positioning.

Dose counter 36 also has chassis pre-assembled module 100, as shown in Fig. 4 A and 6A, the chassis pre-assembled module packet Chassis 102 is included, which includes first axle 104, which receives the ratchet 94 for being fixed to reel shaft 106；With the second axis (or split pin) 108, second axis are parallel to first axle 104 and are spaced apart with first axle 104, and second axis is can slide It moves and rotatably receives band storage spool 110.

As shown in Fig. 6 B, when inhalator be not used at all it is out-of-date, band 112 it is most of wound on band storage volume On axis 110, and band 112 has along the series of rules of its display number 114 spaced apart with the residual developing agent in index pot 20 The quantity of amount.When inhalator is used repeatedly, since actuating pin 34 is operated by tank 20, ratchet 94 is activated the rotation of pawl 80, And band 112 incrementally and is gradually wound up on reel shaft 106 from the second axis 108.With 112 chassis 102 band guiding piece Pass through around 116, number 114 is enable to show by the window 118 in dose counter room covering 120, the belt is tangible At on it or being otherwise positioned within dosage indicia 122 thereon.

As shown in Fig. 6 A and 6D, there are two forks 124,126 for the formation of the second axis 108.Fork 124,126 is offset with one another out. These forks have the position being diametrically opposed, friction disposed thereon or control element 128 on the second axis 108, 130, each pitch one described in friction or control element.Each control element is longitudinal along its respective fork 124,126 Ground extends and has the friction surface 132,134 longitudinally extended, which is arranged essentially parallel to the longitudinal axis of the second axis Line extends and is adapted to engage in in the substantially cylindrical hole 136 in storage spool 110.Setting is in hole 136 and control This control between element 128,130 is arranged as band storage spool 110 and provides good rotation control, so that it will not the phase Hope ground unwinding (such as when inhalator falls).Unwinding is with storage spool 10 and band power needed for overcoming this frictional force is about 0.1N。

As in Fig. 6 D and Fig. 6 G and 10A to 10F it can be seen that, chassis 102 be provided with anti-return sliding tooth 138 or Pawl 138 is counted, which flexibly and is substantially stationary mounted thereto.As will be described below and as Figure 10 A is arrived In 10F it can be seen that, when activating pin 34 and being depressed sufficiently so as to metering valve (not shown) in toilet-cleaning jar 20, activate pawl 80 Pull down one in the tooth 92 of ratchet 94 and as shown in figure 6d rotating wheel 94 counterclockwise to make a tooth 92 skip counting Pawl 138, therefore 112 1 distance of band is incrementally wound relative to the dosage indicia 122 on dose counting room 120, to indicate one A dosage is used.

With reference to Figure 10 B, the tooth of ratchet 94 has end 143, and the end is between flat surfaces 140,142 with 0.1mm half Diameter is rounded.Ratchet 94 has central axis 145, central axis 0.11mm above datum plane 220 (Fig. 9).Anti- return The top of sliding tooth 138/nose surface 147 is located at 220 top 0.36mm of datum plane.It is anti-return sliding tooth top nose surface 147 with Vertical (that is, transverse to datum plane 220- Fig. 9) distance between the central axis 145 of wheel 94 is 0.25mm.Protruding portion surface 144 amounts of being laterally extended with 0.20mm, the vertical length of flat 145 ' is 1mm, and the width on protruding portion surface is 1.22mm (along the direction of axis 145), the top 149 on protruding portion surface 144 are put down in the 3.02mm vertically below of axis 145 Smooth part 145 ' is spaced at a distance from 2.48mm with 145 side of axis to (that is, being parallel to datum plane 220).When actuating pawl 80 and pin 34 in when starting construction, and the top surface 78 (Fig. 6 H) of pin 34 is in datum plane 220 (Fig. 9) top 11.20mm.The length of valve rod 22 Degree is 11.39mm, and when tank is static and waiting is activated, the driving surface 32 of tank 20 is above datum plane 220 11.39mm, so that there are the gaps of 0.19mm between tank 20 and pin 34 in such configuration.

Figure 10 A and 10B show actuating pawl 80, ratchet 94 and counting pawl 138 in starting position, and wherein pin 34 is flat Smooth top 78 is engaged with the outer annular driving surface 32 of tank 20 not yet, or there are no pushed away at least during tank pressure Under.

In this " beginning " position, the non-return rear surface that pawl 138 is bonded on a tooth in the tooth 92 of ratchet 94 is counted On 140.The lower edge 98 of actuating pawl distance " D " (Fig. 9) 1.33mm, the datum plane above datum plane 220 pass through The bottom surface or shoulder 41 of valve rod base 40, main shaft " X " of the datum plane 220 perpendicular to the main body 10 of inhalator 12, the master The central coaxial of axis and valve rod bore 43 and it is parallel to cunning of the tank 20 in the main body 10 of inhalator 12 when tank is released Dynamic direction.

As shown in Figure 10 B, the favorable characteristics of the construction are, when inhalator 12 is not used in sucking, blade tooth/actuating Device 90 serves as the anti-return drive member of supplement.Particularly, fall if inhalator 12 is unexpected, dose counter 36 is caused to shake It is dynamic, then, if wheel 94 will attempt as shown in Figure 10 B rotation (backward) clockwise, the rear surface 140 of tooth is by engaging claw 80 Tooth component 90 and by the tooth component block.Therefore, though anti-138 temporary bend of return sliding tooth or by it is this vibration gram Clothes are taken turns 94 undesirable back rotation and are prevented from, and in next tank release sequence, pawl 90 will force wheel 94 to catch up with it Correct position, so that dose counter 36 continues to provide correct dosage instruction.

Figure 10 C shows a kind of construction, and in this configuration, actuating pawl 80 is pressed down to blade tooth component by pin 34 by tank 20 The 90 side edge 98 just position with an indented joint in tooth 92, and therefore any further pressure of pin 34 will start Rotating wheel 94.This referred to as " resets " position or construction.In such configuration, the lower edge 98 of actuator 80 is in datum plane 220 top 0.64mm.

Figure 10 D shows a kind of construction, wherein actuating pawl 80 is moved into the position lower than position shown in Figure 10 C, And wherein the metered dose valve (not shown) in tank is released to be discharged by nozzle 44 in this lucky position Active medicine and propellant.It will be noted that in such configuration, counting pawl 138 and once being connect in the construction of Figure 10 D with the counting pawl The rear surface 140 of the tooth 92 closed is spaced apart very slightly.Referred to as " release " construction is constructed shown in Figure 10 D.At this In kind construction, the lower edge 98 of actuator 80 0.47mm below datum plane 220.

Figure 10 E shows the other step in the sequence, referred to as " counts " position, wherein actuating pawl 80 revolves ratchet 94 The circumferential angular distance between two teeth in tooth 92 is turned over, so that counting pawl 138 just completes one in tooth 92 forward Surface 142 is advanced and elasticity skips the tooth and the engagement with the rear surface of next tooth 140.Therefore, in this " counting " In construction, have occurred and that the sufficiently long stroke motion of pin 34 makes the band 112 of dose counter 36 that will just count down one Dosage.In such configuration, the lower edge 98 of actuator 0.95mm below datum plane 220.Therefore, in this position In, actuator 80 (including edge 98) is usually than the low 0.48mm in release construction.Construction is counted than release although having been found that Construction further occur, but count be it is highly reliable, be less than every 1/1000050th fail count.This is at least partly Ground due to momentum effect, and due in some embodiments inside it metering valve discharge when tank by some back pressures release make On user.

In the construction of Figure 10 F, pawl 80 is depressed further into it just from one in tooth 92 by pin 34 by tank 20 The position of a disengaging, and it is auxiliary with the engagement on the protruding portion surface 144 on chassis 102 by one in arm 84 to activate pawl 80 This disengaging (see Fig. 6 G) is helped, and (referred to as " end " constructs) will be seen that at this dispersal point, counts pawl 138 and be positioned in It is placed exactly on the way or is located substantially on the way between two teeth in sliding tooth 92.Therefore, this advantageously means that, exists and appoints What double count or minimum possibility without counting, the double count or will be undesirable without counting.Terminate in construction at this, The side edge 98 of actuator 1.65mm below datum plane 220.It will be appreciated that any further pressure of actuating pawl 80 and pin 34 The position of the band 112 shown by dose counter 36 will not influenced by crossing " end " construction shown in Figure 10 F, this is because actuating It is detached from when pawl 80 is below the position that it shows in figure 10f with ratchet 94.

As shown in Fig. 7 C and 7D, the inner wall 50 of main body 10 is provided with two step supporting rails 144, and the supporting rail is in main body Interior longitudinal direction extends and is located immediately adjacent hole 74.As shown in Fig. 7 B, the two steps support being diametrically opposed is also set up Rail 146, and this is diametrically opposed means that perpendicular (not shown) can substantially immediately pass through the first rail 144, hole 74, valve rod base 40 centre bore 148 (tank bar 25 is located in the centre bore 148) and second liang of step supporting rail 146.Such as Schematically shown shown in Fig. 7 A and in Fig. 7 B, rail 144,146 provide between tank 20 and rail 144,146, almost The maximum interspace radially of accurate 0.3mm, about 0.25 to 0.35mm is typical range.This in this plane is empty Gap means that tank 20 only can forwardly and rearwardly be swung in this plane away from actuating 34 direction of pin.Relatively small Distance and it is above-mentioned thus prevent tank from rocking and prevent change actuating pin 34 height so that undesirably change dose counter 36 Precision.Therefore, this is highly advantageous.

The inner wall 50 of main body 10 be provided with from inner wall 50 extend internally different constant radius amounts two pairs of rails 152,154 and Two other two step rails 150, thus the institute rail spaced apart for the periphery around inner wall 50 144,146,150,152, 154, the maximum interspace of almost accurate 0.3mm is realized substantially around tank 20, to prevent unsuitable swing, while still Allow tank free movement in inhalator 12.It will can be clearly seen from Fig. 7 C, for example, two step rails include the outlet of tank room 18 First part near end 156, the width which has substantially constant radial direction or extend internally；Lead to rail The first step 160 of second part 162；Second part 102, the second part have the radial direction smaller than first part 156 or to The elongation of interior extension；With last second step 164, rail is incorporated into main 50 main surface of inner wall in the second step.

The method that assembling inhalator 12 will now be described.

With reference to Fig. 8 A, the main body 10 of inhalator 12 is formed by two or more improved plastics structural shapes, this two or more Improved plastics structural shape, which has linked together, becomes the construction shown.

As shown in Fig. 8 B, activates pawl 80 and pin 34 translates forward the pin reception area into dose counter room 66 In the position in domain 166, and pin 34 and actuator 80 can then be increased until 34 through hole 74 of pin occurs.

Next, reset spring 56 is inserted into 34 lower section of pin, and under the substantially cylindrical annular of spring 56 End 168 can be moved to by pliers or pliers shape assembling tool (not shown) to be protected with the spring in dose counter room 66 The shelf 170 of holder 172 engages.Spring retainer 172 is U-shaped, and shelf 170 is that U-shaped and having is formed under it The groove 174 of side.As shown in Fig. 4 B, 4C and 12, shelf 170 includes three beveled surfaces 176,178,180, the beveling table Face, which is arranged with, helps that the lower end 168 of spring is moved in the position on shelf by using assembling tool (not shown). Once the lower end 168 of spring is in appropriate location, assembling tool (not shown) can be at least partially through spring 56 The groove 174 of the lower section of lower end 168 and be easily removed.

Band 112 is attached to band storage spool 110 at an end (not shown) and is wound up by motor 200 (Figure 13) On spool, which has hexagon output shaft 202, which is bonded on (the figure of hexagon slot 204 of spool In 6B).During winding, band is monitored by sensor 206, which can be in the form of camera or laser scanner, should Sensor supplies data to the computer control 205 for motor 200.The identification of controller 205 is in the line across band 112 Three telltale marks 210 of form, and stop motor 202 when band 112 is almost wound up on spool 110, so that band 112 distal portion 212 for example can be fixed to reel shaft 106 by adhesive.Controller 205 is also identified by sensor 206 The pixelation of observation with dimension mark 214 and by the particulars of band 112 (quantity of the number 114 such as, taken, it is all 114) number such as 120 or 200 is recorded in memory system data memory 217.Next, disk winding axis until The appropriate location of line 210, in the appropriate location, once spool 110 and reel shaft 106 slide into the second axis 108 and first axle 104 On, starting point 216 just will be in a position to be located in window 118 when inhalator 12 assembles completely.In this embodiment, Before band 112 is fixed to reel shaft 106, spool 110 and reel shaft 106 be may slide on axis 108,104, and tep reel Axis can then be winding to the position of starting point 216.

Next, being passed through by pin 182,184,186 in dose counter room 66, being formed in main body 10 Hole or slit 188,190,192 on chassis 102 and make pin 182,184,186 extend through (or at least entering) hole or slit 188,190, the dose counter components of the assembling of chassis pre-assembled module 100 shown in 192, Fig. 6 B can be as seen in fig. 8 c It is inserted into dose counter room 66.Relatively firmly pushed to main body 10 by chassis 102, pin 182,184,186 is subsequent Be thermally fixed, and therefore chassis 102 be hereafter firmly held in very much it is in the position in main body and immovable, therefore Help to provide big precision for dose counter 36.Next, as shown in Fig. 8 D, dose counter room covering 120 It can be assemblied on dose counter room 66 and can such as be fixed by welding in appropriate location, starting point 216 passes through window Mouth is shown.

When preparation inhalator 12 is so as to for the first time in use, user can be ready to suck three times by depressing tank 20 Device, this shows that the first number 114 taken by window 118 in the position of starting point 216, number shown in Fig. 8 D 114 be " 200 ", thereby indicate that remaining 200 dosage will be assigned from tank 20 and inhalator 12.

As in Fig. 8 D and shown in Fig. 5, opened wide in lower surface 198 of the tap 194 by the main body 10 of inhalator Substantially semicircular notch or groove structure 196 and the bottom for being arranged on dose counter room 66.Therefore, if user (not shown) will determine the main body 10 of washing inhalator (for example, after meeting with unhygienic situation or as just a kind of choosing Select), tap 194 allows that water is initially discharged out of dose counter room 66, and hereafter also evaporates in dose counter room 66 Water or any hydrous matter so that window 118 will not undesirably mist over.

Figure 14 shows computer system 230, which is used to design dose counter 36, and particularly uses Come calculate distribution, the distribution represent actuator lower edge 98 relative to the beginning of datum plane 220 (Fig. 9), resetting, release, Mean place and standard deviation in the product line of the inhalator of counting and end position, and it is big therefore to represent actuating pawl 80 On body relative to ratchet 94, the beginning of main body 10 of chassis 102 and (when inhalator 12 assembles completely) inhalator 12, resetting, Mean place and standard deviation in the product line of the inhalator of release, counting and end position.Computer system 230 includes Data storage 232, CPU 234, input unit 236 (such as keyboard or communication port) and 238 (such as communication ends of output device Mouth, display screen and/or printer).User can be by 236 input data of input unit, when various dose counters want structure Cause to have dose counter position collection it is a series of when, which can be used to predict to count in mathematical computations by CPU 234 Number failure rate, the position collection have given average and standard deviation, and consider that any momentum/inertia effect and metering valve are used Family back pressure reduces effect (this will occur when the tank of the tank of given type discharges).Therefore, computer system 230 is mathematically used In the design distribution.For the inhalator described herein 12 with dose counter 36 and tank 20, the distribution be designed to as Shown in Figure 11.X-axis shows the distance of the downside surface 98 of the actuator 80 above datum plane 220, and y-axis represents Distribution.Therefore, curve 240, which is shown, starts to construct the average value 1.33mm with the top of datum plane 200 (standard deviation is 0.1mm), curve 242 shows resetting and constructs the average value with 220 top 0.64mm of datum plane (standard deviation is 0.082mm), curve 244 shows release and constructs the average value 0.47mm with the lower section of datum plane 220 (standard deviation is 0.141mm), curve 246 shows to count and constructs the average value 0.95mm with the lower section of datum plane 220 (standard deviation is 0.080mm), and curve 248 shows and terminates to construct the average value with 220 lower section 1.65mm of datum plane (standard deviation is 0.144mm)。

Figure 15 to 20 shows preferred embodiment in accordance with the present invention, and the preferred embodiment is referring to figs. 1 to 14 descriptions The improvement type of embodiment.In these figures, identical appended drawing reference those of has been used in the figure of front, equivalent to indicate Component.Other than following modification, inhalator 12 is identical as the inhalator in Fig. 1 to 14.

It is possible, firstly, to see, existing modification is that the sliding tooth 92 of ratchet 94 has the wheel with sliding tooth in Fig. 1 to 14 Wide different profile.In this embodiment, there are only 9 ratchets 94 rather than 11.

In addition, the control element 128,130 on the fork 124,126 of the second axis 108 has cone as shown in Figure 18 C and 19C Shape profile, the tapered profiles are different from the profile of control element 128,130 shown in Fig. 6 F.However, in both profiles Any profile can be used for the embodiment of Figure 15 to 20.

In addition, as shown in Figure 15, there is the substantially cylindrical engagement surface being facing inwardly toward with storage spool 110 300, which has the wave shape along engageable surface portions extended.Engagement surface 300 has perpendicular to constant Store the cross section 301 of the longitudinal length of spool 110.This cross section 301 can be seen in Figure 16 and by a series of ten A regular spaced recess 302 and ten convex wall parts 304 form.Convex wall part 304 be recess 302 between at equal intervals 's.Each radius of recess 302 with 0.2mm.Each convex wall part 304 is also with the radius of 0.2mm.Finally, transversal Face 301 also includes plain wall section 306 between recess 302 and all rounding wall parts of convex wall part 304.Cross section 301 Geometry is therefore by defined below: recess 302 and the radius of convex wall part 304, plain wall section 306 and there are 10 recess 302 and the fact that convex wall part 304.

The minor diameter (that is, between end of opposite convex wall part 304) of engagement surface 300 is 2.46mm.Engagement surface 300 major diameter (that is, between outermost portion of recess 302) is 2.70mm.The fork 124,126 of split pin (the second axis) 108 Undeformed end is to end maximum gauge (that is, in region of the maximum radial ductility of control element 128,130) 3.1mm, and it will be understood accordingly that storage spool 110 relative to split pin 108 it is all it is rotary configured in, once storage volume Axis 110 has been assembled in split pin 108, and fork 124,126 is just elastically compressed.It is inserted when split pin 108 is in undeformed It is 1mm in the minimum clearance in the plane of the cross section of Figure 18 C and 19C between fork 124,126 when before entering in state.Work as opening When pin 108 is in maximum compression, as shown in Figure 18 A to 18C, when control element 128,130 is shown as being bonded on convex wall portion When dividing on 304 top, the gap 308 between the end 310,312 of fork 124,126 is 0.36mm.On the other hand, as schemed Shown in 19A to 19C, when split pin 108 is in minimal compression (once be inserted into storage spool in), when control element 128, 130 be shelved on recess 302 in when, fork 124,126 end 310,312 between gap be 0.6mm.Control element 128,130 To be also the radius of 0.2mm to external radiation, they are just shelved in recess 302 with the contact of full surface and (is at least existed Axial position in split pin, at the axial direction position, taper control element is in their maximum radial range), without thump Thump enter recess 302, be locked in recess 302 or fail to be assemblied in recess 302.Therefore, control element 128,130 Radius is preferably substantially identical as the radius of recess 302.

It will be understood that although Figure 18 B and 19B are the end-views of the coaxial axis along storage spool 110 and split pin 108, Figure 18 A and 19A are cross sections.Figure 19 A is the section on the plane A-A ' in Figure 19 C, and Figure 18 A is cutting at same level Face, but storage spool 110 is rotated relative to split pin 108 certainly.

Using inhalator 12 and ratchet 94 rotation use dosage to count when, store spool incrementally rotate through to The rotation position of anti-rotation (that is, due to increased compression of the split pin 108 in the rotation position) and promote rotation (that is, by In the reduced compression of the split pin 108 in this rotation position) rotation position, and this may relate to storage spool 110 With issuing click forward to the next position for the position being equal in Figure 19 A to 19C, in the next position, split pin Control element 128,130 is located in recess 302.This functionality initially allows for storage spool to unwind as needed during use, But it is also prevented from band 112 and unclamps (if inhalator 12 such as drops on hard surface) during carrying.This be it is very favorable, Because band 11 be prevented from moving to it will be given for dosage in tank quantity incorrect reading position.

During the compression and extension of fork between two constructions shown in Figure 18 C and 19C radially, fork 124,126 Point 316 in split pin rotates, and fork 124,126 merges in the point.This turning effort means in fork 124,126 and engagement There are cam effects between surface 300 without significantly rubbing, although in this way, by by engagement surface 300 and fork 124, the elastic force that 126 adjusters formed provide can adjust the unwinding of band, so that during transportation or in inhalator 12 The unwinding of band is less likely to occur in the case where falling.Dduring test it has been found that 0.3 to 0.4N power needs to be applied to band 112 to overcome the adjuster at storage spool 110.0.32N by the control element 128 with profile shown in Figure 19 C come Realize, and 0.38N by be changed to as with reference to Fig. 6 F show and described in the profile of control element 128 realize.These power Noticeably greater than above-mentioned 0.1N power and the undesirable movement for substantially avoiding band, even if being dropped into inhalator on hard surface In the case where be also such.The improved arrangement of Figure 15 to 20 does not provide this power " consistently ", so that passing through dosimeter in band The undesirably high frictional force of band 112 is generally not present when other components of number device, this is because due at adjuster Elastic force incremental property, when band slips over static chassis component, band 112 can incrementally loosen.

Substitution has ten recess 302 and convex wall parts 304, can be used other quantity, and such as 8 or 12.It is preferable, however, that , there are even number (especially due to two control elements 128,130 of setting), so that all control elements 128,130 Simultaneously it will extend and shrink.However, it is possible to conceive other arrangements with 3 or more forks, and/convex wall the part that is recessed Quantity can be maintained the integer that the quantity that can be pitched eliminates, with maintain have simultaneously expansion/contraction system.For example, Conception uses 9,12 or 15 recess/convex wall parts in the case where 3 forks.

Substitute has engagement surface 300 on the inside of storage spool 110, which can be placed on storage spool So as to by outer legs/pawl flexible or the like engagement on 110 outside.

It will be noted that not being only to allow depositing in one direction by the adjuster that engagement surface 300 and fork 124,126 provide Store up the rotation (the case where such as ratchet 94) of spool.Rotation in both directions (that is, forwardly and rearwardly) is possible.This meaning , during assembly, if it is desired to, storage spool 110 can be assembled on balladeur train 102 by spool 100, axis 106 and band 112 During or after wind backward.

Storage spool 110 and the balladeur train 102 including split pin 108 are all moulded by polypropylene material.

It will see from Figure 16, cross-sectional shape 301 is not symmetrical in hexagon slot 204.This has made hexagon Slot 204 can be maintained at useful size and meanwhile still allow for cross section 301 desired size and geometry and do not have Have and interferingly cooperate with the hexagonal shape of hexagon slot 204, and also allows to mould to carry out during manufacture.

As shown in Figure 17, storage spool 110 has a series of four circumferential ribs 330, and four circumferential ribs are in storage volume Inside axis and edge is separated by.During molding, storage spool 110 is maintained at the correct side of mould by these ribs On.

Figure 21 and 22 is shown for the inhalator 510 that is sucked with the dosage dispensing dry powder shape medicament of metering so as to patient Preferred embodiment in accordance with the present invention.It is disclosed in such as Fig. 1 to 16 of EP-A-1330280 of inhalator 510, EP-A-1330280 Content pass through reference herein and be entirely incorporated into here, but the storage spool 110 of dose counter 516 and the second axis 108 are modified So as to as in Figure 15 to 20.Therefore, the component that Diskus 510 generally includes shell 518 and is contained in the shell 512 (see Figure 21).Shell 518 includes: shell 520, which has open end 522 and ozzle 524 (Figure 25) so as to patient Sucking；Lid 526, the lid are fixed to and close the open end 522 of shell 520；With covering 528, the covering is with can It is installed to shell 520 pivotably to cover ozzle 524.As shown in Figure 22, inhalator 510 further include: actuation spring 569；The first yoke 566 with opening 572；Bellows 540 with bizet 574；Storage 514；Second yoke 568, accumulator 542 Second yoke is installed to dose counter 516；The shell 520 has transparent window 5130 on it to observe dose counting Device tape label 5128.Dosing system further includes two cams 570, which is mounted on ozzle covering 528 simultaneously And it can be moved between the open and closed positions with the covering 528.Each cam 570 includes opening 580, the opening For allowing the outwardly extending hinge 582 of shell 520 to extend therethrough and being accommodated in the first groove of covering 528 In 584.Cam 570 further includes boss 586, which extends outwardly and be accommodated in the second groove 588 of covering 528 In, so that 528 around hinge 582 of covering pivots and cam 570 is as 528 around hinge 582 of covering moves.Such as EP-A- Described in 1330280, cam 570 is acted on cam follower 578, to move up and down the second yoke 568, and is therefore passed through The engagement of pawl 5138 on second yoke 568 and tooth 5136 and operate dose counter.The remainder of inhalator such as EP-A- It is set in 1330280 and is operated as described in EP-A-1330280 like that.

Therefore dose counting system 516 includes web or band 5128 (Figure 23 and 24), continuous digital or other suitable marks Note is imprinted on the web or takes, and is aligned with the transparent window 5130 being arranged in shell 18 (see Figure 22).Dose counting system 516 It include: rotatable storage spool 110 (as described above)；It can be along the indexing spool 5134 that single direction rotates；With web 5128, The web is rolled-up and receives on spool 110 and first end 5127 is fixed to spool 5134, and wherein web 5128 is from volume Axis 110 is unwound, so that continuously showing the label when spool 5134 rotates or advances.In Figure 23 and 24, in order to clear The wavy engagement surface 300 of spool 110 is not shown in purpose.

Spool 134 is arranged to the rotation when yoke 566,568 moves, and one medicament is conveyed from storage 514 to realize, so that item Number on material 5128 is advanced to indicate that another dosage has been inhaled into device 510 and distribute.Web 5128 may be disposed so that institute It states number or other suitable markers is increasedd or decreased when spool 5134 rotates.For example, web 5128 may be disposed so that number Word or other suitable markers reduce the quantity to indicate remaining dosage in inhalator 510 when spool 5134 rotates.Alternatively, Web 5128 may be disposed so that number or other suitable markers increase when spool 5134 rotates to indicate by inhalator 10 The quantity of the dosage of distribution.

Indexing spool 5134 includes the tooth 5136 that radially extends, the tooth when yoke is moved with the cam from the second yoke 568 from The pawl 5138 that moving part 578 extends engages, so that the rotation of indexing spool 5134 or advance.More particularly, pawl 5138 is shaped and cloth It is set to so that its only soldered tooth when ozzle covering 528 is closed and the lid 526 of yoke 566,568 towards shell 518 is retracted 5136 and make index spool 5134 advance.

Dose counting system 516 further includes chassis 5140, which is fixed to accumulator 542 for dose counting system, and And including axis 108,5144, which is used to receive spool 110 and indexing spool 5134.As above with reference to described in Figure 15 to 20, Spool 108 is that have fork and including radially projecting convex block 5146, the convex block by with the wavy engagement surface in spool 110 300 engage to generate the elastic resistance of the rotation of the spool 110 on axis 108.Clutch spring 5148 is received in indexing spool On 5134 end and it is locked into chassis 5140, to allow spool 5134 only to rotate along single direction.

Can to it is illustrated above and description embodiment various modification can be adapted without departing from as according to Patent Law by explaining The scope of the present invention defined in the appended claims.

Claims (7)

1. a kind of inhalator for sucking medicament, the inhalator include

For keeping the ontology of formulation reservoir；The ontology includes dose counter, and the dose counter has movable Actuator and reset spring for the actuator, the reset spring there is substantially cylindrical and annular end Portion；The ontology has the support construction for the end for being used to support the reset spring, the support construction packet in it Include the groove that the end can be joined to below shelf and the shelf thereon.

2. inhalator as described in claim 1, wherein the shelf is U-shaped.

3. inhalator as described in claim 2, wherein the support construction includes the U extended around the shelf of U-shaped Therefore the upstanding wall of shape, the shelf and upstanding wall form the step riser portions of step-like arrangement.

4. the inhalator as described in claim 1 or claim 2 or claim 3, wherein described below the shelf Groove is also U-shaped.

5. the inhalator as described in any one of claims 1 to 3, the inhalator is wrapped in the inlet for leading to the shelf Include at least one beveled surface.

6. a kind of method of inhalator of assembling as described in any one of claims 1 to 5, the assemble method includes following The end of the reset spring: being located on the shelf by step by assembling tool and then via the groove It is at least partially withdrawn the assembling tool.

7. method as described in claim 6, wherein the cylindrical and annular end of the reset spring can The direction extended while being located on the shelf transverse to its cylinder moves in the shelf.