FI58076C - ANORDNING FOER ORAL INHALATION AV FINFOERDELADE FASTA CEILINGS - Google Patents

Description

2,58076 Patent No. 764,576) or a source of compressed gas (see British Patent No. 1,305,172). In such devices, it is difficult to synchronize the patient's inhalation with the operation of the auxiliary power source. Other inhalation devices that operate solely by user inhalation are described in British Patents Nos. 1,118,341, 1,182,779, 1,122,284, 1,295,081 and 1,301,856, U.S. Patent No. 3,635,219 and Belgian Patent No. 3,635,219. No. 781 102.

According to the present invention there is provided an apparatus for oral inhalation of finely divided solid medicaments, the apparatus having a hollow housing and a capsule holder, said housing comprising air inlets and vents through which air can flow through the housing, the outlet or openings being adaptable or orally. The main features of the invention appear from the appended claim 1.

When using the device of the present invention, it is first loaded by placing a capsule containing a fine drug in a capsule holder. As the patient inhales through the outlet or openings, the sensitive vibrating member vibrates in the turbulent air flow provided to the hollow housing, and the capsule holder and the capsule therein vibrate with the vibrating member. Provided that the capsule is punctured, the vibratory motion shakes the fine drug out of the capsule inside the housing. In this case, the air flow grips it, passing it through the outlet or openings down to the user's lungs. Thus, it is clear that the drug capsule must either be punctured before the capsule is placed in the holder or it must be punctured while it is in place. The latter method is the most convenient, and thus the device according to the present invention may be provided with means for puncturing the medicament capsule when it is inserted into the device.

The capsule can be punctured at any point on its surface, and the most suitable puncture site depends on the specific features of the embodiment of the invention, as will be explained later.

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In order to easily access the inside of the housing for charging the device with a medicament capsule, part of the housing can be detached 3,58076, e.g. by means of screw threads or a snap-on locking mechanism. The hollow housing may be suitably elongate and narrow, with the sensitive vibrating member mounted longitudinally inside the housing. Using such an embodiment, the shape of a pleasantly slim housing is achieved.

The elongate vibrating member may be in the form of a long narrow flat strip made of a suitable material, e.g. metal or plastic, so that the main component of the vibration is in one plane, the vibration corresponding to an approximately harmonic movement. Alternatively, the oscillating member may be in the form of a rod, i.e. a spindle, which may oscillate in any direction perpendicular to its longitudinal axis. The rod is preferably round in cross section.

The capsule holder is attached to one end of the sensitive vibrating member. Preferably, the capsule holder is located close to the vent vent or vents. The capsule holder may be in the form of a simple cup to which the capsule fits tightly. In addition, it is preferred to place the capsule holder in a tapered location in the hollow housing, e.g., such as a Venturi funnel, to provide a minimum pressure zone around the capsule when the patient inhales through the vent or vents. Alternatively, the capsule-holder cup may have a passage through which air may flow from inside the hollow housing to the other end of the main axis of the capsule.

The device according to the invention also comprises at least one air outlet and one or more air inlets. Preferably, the device has only one air vent and one or more air inlets. In the event that the device has only one air inlet, it may be located at the end of the device or on one side. In addition, other air inlets can be placed at the end or sides of the device, for example there may be one main opening at the end of the housing and one or more auxiliary openings, e.g. on the sides of the device.

If the sensitive oscillating member is in the form of a strip-like tongue, it is preferred that the cross-sectional area of the air outlet is approximately of the same order of magnitude as the total cross-sectional areas of the inlet openings.

The interior parts of the housing of the device are constructed and arranged in such a way that inhalation of the user of the device through the outlet causes a turbulent air flow propagating inside the housing, which in turn causes said member to vibrate. The structure of the inner parts depends on the method to be used to disperse the drug in the air stream. When the sensitive oscillating member is tongue-shaped, a turbulent air flow can be obtained by providing the inner part of the housing and / or the sensitive oscillating member itself with guide plates. Another possible method of achieving the desired vortex, preferably when the sensitive oscillating member is rod-shaped, is to place a plurality of air inlets in the side wall of the device at the capsule holder. Preferably, these inlets are obliquely oriented or are located close to internal guide plates directed at a certain angle so that the incoming air becomes directed to a circular path.

The exit and dispersion of the drug from the capsule can be further facilitated and the vortex enhanced by providing the capsule holder with, for example, a disc-shaped projection which can strike the side walls of the housing as the member vibrates.

Suitably, a device for puncturing the drug capsule is also an integral part of the device. In embodiments where the capsule holder is in the form of a simple cup, the capsule is preferably punctured on opposite sides of its major axis. If the capsule holder has an air duct, it is most convenient to puncture the capsule at the main axis so that a centrally located through hole is provided at each end.

It is usually best to install a protective grille in the air vent to prevent the patient from inhaling the entire capsule if it is accidentally detached from the capsule holder.

In the event that it is difficult for patients to inhale sufficiently vigorously, the airflow through the housing can be amplified by using an additional source of force, such as a compressible rubber ball that is compressed while the patient inhales. In such an embodiment, the rubber ball is connected to one air inlet of the housing, leaving the second air inlet free for inhalation by the user of the device.

The invention will now be described in the following with the aid of some embodiments characteristic of the invention with reference to the accompanying drawings, in which:

Figure 1 is a cross-sectional view of an inhaler according to the present invention; Figure 2 is a cross-sectional view of another device according to the present invention; Fig. 3 is a section along the line A-A in Fig. 2; Fig. 4 is a cross-sectional view of a third device according to the present invention; Fig. 5 is a cross-sectional view of a fourth device according to the present invention; Figure 6 is a cross-sectional view of a further device according to the present invention; Fig. 7 is a section along the line B-B in Fig. 6; Fig. 8 is a section along the line C-C in Fig. 6; Fig. 9 is a cross-sectional view of a further device according to the present invention; Fig. 10 is a section along the line D-D in Fig. 9; Fig. 11 is a section along the line E-E in Fig. 9; Figures 12 and 13 are cross-sections of two further preferred devices according to the present invention.

Figure 1 shows a capsule holder 2 inside a hollow housing 1, in which a capsule 3 containing fine medicine is placed. · The capsule holder 2 is mounted at the end of a tongue-shaped member 4 sensitive to vibration, the member being attached at one end to an inlet protrusion 6 and air outlets 6. to allow airflow through the housing. The air outlets 7 are intended to be placed in the mouth, and for this purpose the housing is shaped to fit close to the air outlets. The guide plates 8 project inwards from the wall of the housing perpendicular to the longitudinal axis of the housing, and the guide plate 9 cooperating therewith is mounted on the vibrating member. The dimensions and position of the cooperating plate 9 are chosen so that a small clearance 11 is left between the plates 8 and the cooperating plate 9. The throttling pieces 10 form a constriction at the capsule and the capsule holder.

When using the device, the patient pushes the housing part around the air vents 7 into the mouth after first loading the device with the capsule 3. The capsule can be punctured either before filling or only when the capsule is in place, using a mechanism not shown in Figure 1. , which can be detached from each other by means of screw threads at points X (threads not shown). The patient then inhales through the air vents 7, thus sucking air through the inlets 6 and further through the housing 1. As the air flow passes the baffles 8 and 9 through the clearance 11, an aerodynamically unstable situation is created in the clearance 11. The fragile vibrating organ begins to vibrate in the plane of the drawing, and the drug is shaken out of the perforated capsule inside the housing. In this case, the air stream adheres to the drug particles, transporting them down to the patient's lungs as he inhales. The constriction formed by the choke cap 6 58076 provides a minimum pressure zone around the capsule, which is likely to aid in drug dispersion.

Figures 2 and 3 show a device similar to Figure 1. Also in this case there is a capsule holder 102 inside the hollow housing 101 in which a capsule 103 containing a fine drug is placed. · A member in the form of a tongue 104 sensitive to oscillating movement is fixed inwards from the capsule holder 102 protruding 105 · In this case, too, the housing can be divided into two parts from point Y, and the capsule can be punctured either before charging or while it is in place. The housing has air inlets 106 and air outlets 107. The sensitive vibrating member is supported by baffles 109 located near the inlets 106, with a small clearance between the plates 109 and the walls 108 of the inlets 106.

As the patient operates the device by inhaling through the outlets 107, air flows into the device through the inlets 106. As the air flow passes the clearance between the plates 109 and the walls 108, an unstable aerodynamic situation is again created, and the sensitive vibrating member begins to vibrate in the plane of the drawing.

Figure 4 shows another device according to the present invention. Also in this case, the housing 201 includes a capsule holder 202 in which the capsule 203 is placed, the capsule holder being mounted on a sensitive vibrating member formed by a tongue 204 attached to a protrusion 205. Air inlets 206 on the side of the housing and air outlets 207 at its ends. guide plates 209 are mounted on the oscillating member, the leading edges 212 of which are located near and parallel to the longitudinal slots 213.

As air is sucked in through the inlets 206 and further through the slots 213, the air flow oscillates at the leading edges 212 of the plates 209, causing the sensitive vibrating member to vibrate completely.

Figure 5 shows another device according to the present invention. Also in this case, the housing 301 includes a capsule holder 302 with a capsule 303 mounted on a vibrating member formed by a tongue 304, which in turn is attached to the housing end 305. The housing has one air inlet 306 on one side and an outlet 307 at the other end. and open the annular clearance 314. A plug 315 having a hole 316 drilled in the end of the housing is fitted near the outlet opening 307. The cross-sectional area of the hole 316 is approximately 7,58076 equal to the area of the annular clearance 314 when the tongue 304 is in its most deflected position. For example, when using a device with a tongue about 12 mm wide covering an 8 mm diameter circular air inlet 306, it is possible to provide a tongue deviation of about 0.5 mm at the center of the inlet 306.

Thus, with the tongue in its most deviated position, the area of the open annular clearance is somewhat more than 12 mm. The area 2 of 12 mm also corresponds to the area of a round hole with a diameter of about 4 mm. Thus, the plug 313 is provided with a hole 316 with a diameter of 4 mm.

When the device is in use, the air impulse passes through the inlet 306, raising the tongue 304 somewhat and continuing its journey towards the outlet 307. When air reaches the plug 315 »this restricts its movement, and as a result, the air inflow rate decreases and the tongue 304 closes the inlet. The air contained in the housing exits through the outlet 307 so that the internal pressure decreases and the external air pressure reopens the inlet 306. Continuation of this sequence causes the tongue to move back and forth up and down, and the speed of movement tends to match the natural resonant frequency of the tongue.

Figures 6-8 further show a device according to the present invention. Inside the hollow housing 401 is a capsule holder 402 into which a capsule 403 containing a fine drug is placed.

A sensitive oscillating member formed by the rod 404 is attached to the end of the housing. In this case, too, the housing is in two parts, and at Z the parts are detachable from each other. The housing has air inlets 406 and a vent 407. Inlets 406 are holes drilled approximately tangentially to the housing wall at the capsule holder 402, as shown in Figure 7. The housing further has one air inlet 406a near the end of the housing to which the rod 404 is attached. The capsule holder has an internal channel 417 and a circular disc 418 larger in diameter than the capsule holder 402. The sharp-tipped piercing member 421 is concentrically disposed within the housing by a sliding grid means 420.

The nozzle of the outlet 407 extends somewhat into the housing, thereby forming an annular trough 422.

When using the device, the housing parts are first detached from each other at point Z, the device is charged with a capsule 403 and the housing halves are reconnected. The capsule is then punctured at both ends of its major axis by inserting the puncturing member 421 through the capsule 8 58076 and retracting it again. As the patient now inhales through the outlet 407, he or she sucks air through the tangential holes 406, creating a vortex at the capsule holder 402. Provided that the flow rate is sufficient, the capsule holder then undergoes a circular rotation, whereby the disc 418 will face a series of light impacts on the inner surface of the housing. The rotational motion and the associated knocking effect cause the powder inside the capsule to float so that the agglomerates disintegrate. At the same time, air is sucked in through the inlet 406a, with air still passing through the device towards the end of the device comprising the outlet 407. When the air flow reaches the capsule holder 402, a part of it passes through the duct 417 and further through the perforated capsule 403. The rapid vibration of the capsule 403 ensures that the powdered medicament can escape freely from the hole at the end of the capsule closest to the outlet 407. The remaining portion of the air flow from the inlet 406a reaches the disc 418, further enhancing the vortex around the capsule. When the powder comes out of the capsule, a stream of air adheres to it, transporting it towards the outlet 407. As the circulating particles flow through the housing, the centrifugal force holds particles larger than a certain size near the housing wall and begins to circulate in the trough 422, while instead the airflow transports the finer particles to the outlet 407 and down to the patient's lungs.

As it circulates in the trough 422, the coarse particles have to rub against the walls of the housing, so that more and more material is constantly converted into small particles which exit through the outlet 407.

In particular, an important advantage of this embodiment is the ease of construction and assembly of the device. The moving part does not have to be precisely matched to the fixed part, and thus it is possible to assemble the device from injection molded products made with cheap molds. Minor variations in the shape and size of the cast parts are not particularly significant, and the device operates without the need for precise installation of the parts.

An important feature of the preferred device described with reference to Figures 6-8 is that no oscillation occurs below a certain critical intensity level of the air flow; thus, the effective release of a powdered drug is always associated with a certain minimum amount of airflow to the lungs, and this ensures the efficient transfer of the powder to the lungs. Said critical flow level will generally be about 30-35 l / min, but the speed is predetermined by the number and location of the 9 58076 holes through which air flows into the device due to suction.

It is possible to cover one of said holes with a finger, whereby the powder is released at a lower flow rate than normal. This procedure can be used, for example, when adults administer the drug to infants with relatively small lung volumes.

Figures 9-H show a preferred embodiment of the device according to the present invention. Inside the hollow housing 501 is a capsule holder 502 into which a capsule containing a fine drug (not shown in the drawing) can be placed. The sensitive vibrating member formed by the plastic rod 504 is attached at one end to a capsule holder 502 and at the other end to a push button 505 slidably mounted to the end of the housing 501.

A return spring 524 is positioned between the push button 505 and the annular shoulder 525.

The housing is in two parts and the parts can be detached from each other by means of a screw thread 523. The housing has air inlets 506 and an air outlet 507. Inlets 506 are holes drilled approximately tangentially to the housing wall at the capsule holder 502, as shown in Figure 10. The capsule holder 502 has a hollow piercing member 517 having a tapered end extending through the capsule . The capsule holder 502 also has a circular disc 518 that is larger in diameter than the capsule holder 502. The second sharp-tipped piercing member is mounted concentrically inside the housing near the outlet 507 by a lattice means 520. A plug 515 is fitted in the housing near the outlet 507, into which a hole 516 is drilled.

When using the device, the housing parts are first detached from each other by unscrewing the screw thread 523, and the capsule holder 502 is loaded with the capsule by inserting it into the hollow piercing member 517 and thus piercing the other end of the capsule. The housing halves are then reconnected. The push button 505 is then pressed by hand against the pressure of the spring 524, thereby moving the capsule against the second piercing member 521 and piercing the other end of the capsule. Spring 524 returns the capsule holder to its original position. The patient inhales through the outlet 507 while sucking air through the tangential holes 506, creating a vortex at the capsule holder 502. The capsule holder 502 is subjected to a circular rotation by its action, so that the disc 518 will face a series of light impacts on the inner surface of the housing. Also in this case, the rotational movement and the associated knocking effect cause the powder to float inside the capsule. At the same time, part of the air drawn in through the inlets 506 passes behind the disc 518, further into the projecting channel 517 and through the capsule pierced therefrom. When the powder comes out of the capsule, an air vortex grips it and transports it towards the outlet 507. As in the embodiment shown in Figure 6, the finer particles in the air stream pass through the hole 516 to the outlet 507 and further into the patient's lungs. The annular plug 515 retains the coarser particles until they are sufficiently reduced by abrasion to exit through the central hole 516.

Figures 12 and 13 show embodiments of the device which are otherwise substantially similar to those shown in Figure 9, except that the capsule burst method has been modified.

In Fig. 12, the end of the sensitive vibrating member formed by the rod 604 is attached to a knob 605 which is integral with the sleeve 626 of the outer surface of the housing 601. Also in this case, the spring 624 returns the knob and the sleeve to their original position after the knob is pressurized during the puncturing phase. Alternatively, the housing end 627 comprising the knob 605 may be provided with a steeply pitched screw thread that cooperates with a similar thread (not shown in the drawing) on the outer surface 628 of the knob. In such an embodiment, when the sleeve 626 is pressed, it also rotates, and at the same time causes the capsule in the capsule holder 602 to rotate as the capsule encounters the fixed piercing member 621. This rotational movement during the piercing provides an easier and more secure puncture.

A similar arrangement is shown in Figure 13. Also in this case, the fixed end of the rod 704 is attached to a knob 705 which is integral with the sleeve 726 which fits on the outer surface of the housing 701. The outer surface of the knob 705 is provided with a screw thread 728 that mates with corresponding threads 727 at the end of the housing. A coil spring 724 is located in the annular space between the knob 705 and the sleeve 726 with one end of the spring attached to the housing and the other end sleeve. To puncture the capsule, the sleeve is rotated inward, whereby the capsule contained in the capsule holder 702 rotates upon encountering the fixed piercing member 721. When the sleeve is released, the coil spring returns the sleeve to its original position as the capsule disengages from the piercing member 721.

Claims (9)

11 58076 An apparatus for oral inhalation of finely divided solid medicaments, the apparatus comprising a hollow housing and a capsule holder, said housing comprising air inlet and vent openings through which air can flow through the housing, the outlet or openings being adaptable to the mouth or orally, characterized in that the capsule holder (2, 102-702) is attached to one end of an elongate sensitive oscillating member (4, 104-70 * 0), the other end of said member being fixed inside the housing (1, 101-701), remote from the capsule holder and that the internal parts of the housing (1, 101 to 701) (8, 9, 106, 108, 109, 206, 208, 213, 306, 308, 406, 506, 606, 706) are constructed and fitted so that inhalation of the user of the device through the air vent or openings (7, 107-507) causes a swirling air flow advancing inside the housing (1, 101-701), which in turn causes said member (4, 104-704) to vibrate. Device according to Claim 1, characterized in that the device has only one air outlet (307, 407, 507). Device according to claim 1 or 2, characterized in that the elongate vibrating member is formed by a rod (404, 504, 604, 704) which can oscillate in any direction perpendicular to its longitudinal axis. Device according to Claim 3, characterized in that the cross section of the rod (404, 504, 604, 704) is circular. Device according to claim 1 or 2, characterized in that the sensitive vibrating member is in the form of an elongate narrow flat strip (4, 104, 204, 304) so that the main component of the vibration is in one plane. Device according to Claim 3 or 4, characterized in that the housing is provided with a plurality of air inlets (406, 506, 606, 706) located at the capsule holder. Device according to claim 6, characterized in that the air inlets (406, 506) are located transversely and form an angle with respect to the circumference of the housing in order to direct the incoming air to a circular path. Device according to Claim 6, characterized in that the cross-sectional area of the air outlet is of the same order of magnitude as the total cross-sectional areas of the air inlet openings. Device according to one of Claims 1 to 8, characterized in