KR100494283B1 - Unit dose dispensing device - Google Patents

Abstract

The device for administering a unit amount of substance consists of a nozzle assembly 2 comprising a container 24 for receiving a unit amount of substance and an outer body 4 to which the nozzle assembly 2 is detachably attached. The body 4 comprises a system capable of carrying out the release of the substance from the nozzle assembly 2 and operating means operable by the user to carry out the release. Preferably, the release system consists of a spring-loaded air piston that is operable to inject air into the vessel 24 to cause the release of material. In one embodiment, the drive spring for the air piston is loaded with spring energy by the action of mounting the nozzle assembly on the body, after which the drive spring is manipulated by the user to perform release of the spring energy to cause release. The cock is held until the operation of the means.

Description

Unit dosage unit {UNIT DOSE DISPENSING DEVICE}

The present invention relates to a device for administering a unit dose of a substance such as a pharmaceutical, drug, or therapeutic drug. In particular, the present invention relates to an apparatus for administering a unit dose of such substance into the body cavity. Particularly preferred forms of the invention are intended for intranasal administration.

International patent application PCT / EP94 / 01859 (WO94 / 28956) discloses a device for the administration of a pharmaceutical from a capsule containing a substance. The capsule is compressed to a pressure sufficient to explode the capsule and eject the contents in a spray form through the outlet. While the previously proposed device works satisfactorily, the device is relatively bulky, making it difficult for a person to carry it, for example in a shirt or jacket pocket. In addition, the device is configured to be reloaded with a new capsule of material after use, but due to the nature of the instrument in the device, some difficulties are encountered during the reloading process.

A unit dose dispenser has been proposed in which a pharmaceutical agent sealed in an internal chamber of the device is ejected by the operation of a piston that is manually operated by a user. These already proposed devices are intended for one-time use and once the unit quantity has been ejected, the entire device must be discarded. Because of the relatively high cost of the entire device that must be discarded after each use, this limits the potential application of the device.

1 is a side view of a first embodiment of a unit dose device according to the present invention comprising a nozzle assembly detachably attached to the main body of the device.

FIG. 2 is a cross-sectional view of a nozzle assembly including a capsule of a unit amount of material prior to discharge with the nozzle assembly capable of attaching to the main body. FIG.

FIG. 3 is a cross sectional view similar to FIG. 2 showing the nozzle assembly being removed from the main body after discharge of the unit amount.

4 is a cross-sectional view showing the main body of the apparatus in a state before attachment of the nozzle assembly.

Fig. 5 is a sectional view of the apparatus showing a state before the operation when the nozzle assembly is attached to the main body.

Fig. 6 is a sectional view similar to Fig. 5, showing the state during operation.

Fig. 7 is a sectional view similar to Fig. 5 showing the completion state of the operation.

Figure 8 is a side view of a second embodiment of a unit dose device according to the present invention showing the main body of the device and a nozzle assembly for insertion into the main body.

FIG. 9 shows a nozzle assembly and lid when inserted into the main body but is similar to FIG.

FIG. 10 shows the main body with a lid adapted to cover the nozzle assembly and operation button. FIG.

Figure 11 is an enlarged cross sectional view showing the detailed structure of the nozzle assembly before insertion into the main body.

12-14 illustrate nozzle assemblies that cooperate with an air cylinder / piston assembly during various stages of operation of the apparatus.

Figures 15-18 illustrate the cooperation between the nozzle assembly and the air piston / cylinder assembly during various stages in the insertion and shipment of the nozzle assembly into the device causing the shipment of the device.

19-21 are perspective views illustrating the cooperation between a fastening and actuation ring and a resistor ring in contact with the piston of the air piston / cylinder assembly at various stages during shipping and operation of the device.

According to the invention, there is provided a nozzle assembly for administering a unit amount of a substance, said nozzle assembly being adapted to detachably attach to a body having a system capable of discharging said substance, said nozzle assembly being said A container for storing a unit amount of material, means for removably attaching the nozzle assembly to the body, and means for cooperating with the release system, wherein administration of the material from the container is performed in response to manipulation of the release system by the user. do.

Preferably, the release system comprises a ram and the administration of material from the container occurs in response to the movement of the ram.

Advantageously, the nozzle assembly comprises means for puncturing the vessel in response to the movement of the ram.

Advantageously, the nozzle assembly includes a passageway to receive the ram when the nozzle assembly is mounted on or after the body.

In a preferred embodiment of the present invention, the container is in the form of a capsule mounted in the chamber of the nozzle assembly, and the puncturing means is a first hollow needle mounted at the outer end of the chamber and the agent carried by the piston in the inner end of the chamber. It consists of two hollow needles and the capsule is placed in a chamber between the first and second needles. The inner end of the chamber is in communication with the ram receiving passage and the structure is displaceable in the chamber such that the second needle is displaced towards the first needle so that the two needles puncture both ends of the capsule by movement of the ram along the passage. Is made. In this embodiment, the release system also includes means for injecting a gas, for example air, into the capsule via the second needle, so that the substance is encapsulated via the first needle under the influence of the gas injected via the second needle. Is administered from. The first needle may be guided directly to the discharge orifice of the nozzle assembly or, preferably, the first needle may be guided upstream of the vortex chamber of the discharge orifice. Preferably the ram comprises a passageway through which air or other gas is injected into the capsule via the second needle.

In a particularly preferred embodiment, the means for attaching the nozzle assembly to the body comprises a protruding tubular portion insertable into an opening in the body. The tubular portion includes a fastening formation detachably engageable with the fastening means of the body adjacent the opening, the tubular portion also comprising a passageway for receiving the ram of the discharge system.

According to another feature of the invention, there is provided a body for use in cooperation with the nozzle assembly described above, the body being adapted to detachably retain the nozzle assembly relative to the body and a system for effecting release of the material from the nozzle assembly. Means for cooperating with attachment means of the nozzle assembly and operating means operable by the user to effect ejection.

In a preferred embodiment, the release system comprises a ram that cooperates with the nozzle assembly to effect the administration of the substance upon operation of the operating means.

The main body is preferably made of a structure that can be held in the user's hand, and the operation means of the main body is composed of at least one operation member such as a button that can be operated by a finger.

In one embodiment, the displacement of the operating member by the user operates to cause displacement of the ram along the passage of the nozzle assembly. The displacement of the ram can be used to effect perforation of the container to allow material to be released. When the administration is performed by injecting air into the container in the nozzle assembly, the displacement of the operating member is also effective to drive the air piston to charge the air into the container. Preferably, the air piston is spring loaded and the initial displacement of the operating member acts to force the drive spring with spring energy that is released continuously to drive the piston to inject air into the container. Preferably, the system includes an air reservoir in communication with the air passage through the ram and the air piston is operative to flow air from the air chamber to the vessel through the air passage in the ram.

In another embodiment of the present invention, mounting of the nozzle assembly to the body induces loading and cocking of the spring driven air piston and displacement of the operating member releases the piston to inject air into the container. Release of the piston also induces drive of the ram to effect puncture of the vessel.

Embodiments of the present invention will be described by way of example with reference to the accompanying drawings.

The unit dose administering device shown in FIG. 1 of the accompanying drawings includes a nozzle assembly 2 carrying a unit dose of a substance to be administered, the nozzle assembly 2 comprising a mechanism operated by a user to eject a unit dose. It is detachably fitted to the main body 4 which receives it. After use, the spent nozzle assembly 2 is removed from the body 4 and discarded and replaced with a new nozzle assembly.

With particular reference to FIG. 2, the nozzle assembly 2 consists of an outer casing 6 with an outlet orifice 8 at its outer end. The illustrated nozzle assembly 2 is particularly intended for nasal administration of the material so that the outer casing 6 is of a size suitable for its use. The inner sleeve 12 fixedly mounted within the outer casing 6 extends beyond the lower end of the outer casing 6 to form a fixing portion 16 which is inserted into the main body of the device, so that the nozzle assembly as described in detail below. (2) is attached to the main body (4). The fastening portion 16 terminates at an outer fastening ring 18 which is intended to cooperate with the fastening finger in the main body 4. The annular shoulder 20 at the bottom of the outer casing 6 is configured to seat firmly against the annular support surface on the main body 4 when the nozzle assembly 2 is fitted on the main body 4. .

The inner sleeve 12 of the nozzle assembly 2 defines a chamber or cylinder 22 containing a capsule 24 containing a unit dose of the substance to be administered. The substance may be in liquid or powder form. The upper end wall 12a of the inner sleeve 12 carries a hollow needle 26 that projects to the upper end of the cylinder 22. The lower end of the cylinder 22 houses a piston 30 carrying a hollow needle 32. Accordingly, it can be seen from FIG. 2 that the capsule 24 is positioned in the cylinder 22 with both ends of the capsule 24 proximate the points of the upper and lower needles 26, 32. The nozzle assembly 2 is provided to the user in this state before use. As will be explained later, when the nozzle assembly 2 is inserted into the main body 4 and the device is operated by the user, the piston 30 carrying the lower needle 32 is directed towards the upper needle 26. It is driven along the cylinder 22. This action causes the capsule 24 to be perforated by the two needles and pushed by the piston 30 so that its upper end is firmly seated against the upper end wall 12a of the cylinder 22, with the upper needle 26 ) Protrudes into the interior of the capsule 24 and the face of the piston 30 is firmly seated against the lower end of the capsule 24 so that the lower needle 32 protrudes into the lower end of the capsule. Is shown in FIG. In this state, a substantial seal is formed between the capsule 24 and the upper end wall 12a of the cylinder 22 and is also formed between the face of the piston 30 and the lower end of the capsule 24 and the piston 30 The silver is preferably made of a semi-soft material which ensures that a seal is formed. As described, air injected into the capsule 24 through the lower needle 32 causes the contents of the capsule 24 to be released through the upper needle 26. When the contents of the capsule 24 are in a liquid state, the upper needle 26 discharges into the vortex chamber 40 defined between the upper end wall 12a of the cylinder 22 and the outer casing 6, and the vortex chamber ( 40 discharges to the outer casing 6 via the discharge orifice 8. Vortex chamber 40 enhances droplet formation and facilitates ejection in spray form from orifice 8.

As is apparent, the capsule 24 is made of a material that can be perforated by the needles 26, 32 and is preferably made of a suitable plastic material. Capsule 24 may be manufactured by a blow fill seal molding method which is well known per se.

Referring to FIG. 4, the main body 4 of the device comprising a mechanism operable to cause the administration of the substance from the capsule 24 includes a central passage 50 which opens onto the upper end of the main body 4. do. The central passage 50 is intended to receive the fixing portion 16 at the lower end of the inner sleeve 12 of the nozzle assembly 2. The central passage 50 is defined by a fixed inner sleeve 52, the upper edge of which defines an annular support surface which is joined by the shoulder 20 on the nozzle assembly 2. The inner sleeve 52 forms an integral structure with the outer sleeve 53. The part 56 mounted on the main body 4 under the sleeve 52 snaps over the fastening ring 18 on the fixing part 16 to detachably fasten the nozzle assembly 2 to the main body 4. It entails opposing elastic fingers 58 that engage (see Figure 5). The component 56 defines an axial guide for the ram 60 that engages the lower end of the cylinder 22 such that the upper end 60a lies adjacent to the lower end face of the piston 30 carrying the lower needle 32. It is supported by the fixing structure 59 which is also described below. The ram 60 also defines an air tube and the upper end is in communication with the passageway through the lower needle 32 and the lower end is defined between the fixed structure 59 and the air piston 68 mounted in the lower part of the main body 4. It has an internal passageway 62 in communication with the air reservoir 66. The air piston 68 is biased by the compression spring 70 to an upper position adjacent the lower end of the fixed structure 59 and corresponding to the minimum volume of the air reservoir 66. The air piston 68 is shown in FIGS. 4 and 5 in this state. The air chamber 72 is defined between the air piston 68 and the base of the main body 4 and communicates with the air reservoir 66 via the one-way valve 74 in the crown of the air piston 68 so that the air is Upon movement of the air piston 68 toward the base of the main body 4, it is charged from the air chamber 72 to the air reservoir 66 via one valve 74.

The main body 4 carries a button assembly composed of opposing buttons 80 on both sides of the fixing sleeve 52. The button assembly consisting of two buttons 80 has an outer position (see FIGS. 4 and 5) and an inner position where the outer ends of the two buttons 80 are substantially flush with the outer ends of the fixing sleeve 52. 7 is suitably mounted for axial movement in the main body 4 therebetween. The main body 4 is of a size that can be easily gripped by the user's hand with the thumb and forefinger coupled to each button 80. It should be appreciated that the two buttons 80 of the button assembly move simultaneously even though they are configured to be joined by the other finger of the user. The button assembly is spring biased to an external position by a compression spring 82 interposed between the button assembly and the fixing structure 59. The button assembly forms a means for manipulating the device, which will now be described.

The button assembly is linked to the ram 60 by a pivoting lever 84 in a structure formed by the sleeves 52, 53 so that the pressing of the button 80 toward the inner position causes the lever 84 to compress the compression spring 86. Causes the ram 60 to be driven upwards against the bias of. As a result, the upper end 60a of the ram 60 displaces the piston 30 and the lower needle 32 upward of the nozzle assembly so that the upper end and the lower end of the capsule 24 are drilled by the two needles 26 and 32. And also move the capsule 24 upwards to engage the upper end wall 12a of the cylinder 22 as previously described. This state is shown in FIG. The button assembly also has a subordinate resilient leg 90 that engages an actuating stem extending upward from the air piston 68 such that the compression of the button 80 causes the bias of the compression spring 70 to be biased. The air piston 68 is shipped as the air piston 68 is displaced by inducing the movement of the air piston 68 toward the base of the main body 4, and this condition is similar to that shown in FIG. The displacement of the air piston 68 toward the base of the main body 4 is such that the air in the air chamber 72 passes through the one-way valve 74 in the crown of the air piston 68 so that the air piston 68 is connected to the main body. As it is driven towards the base of 4), it causes it to be released into the air reservoir 66, which increases in capacity.

The button assembly is formed with an inner surface 94 that spans the same space as the fixed sleeve 52 when the button assembly is in the outer position. This is usually the "rest" of the button assembly and the nozzle assembly 2 is inserted into the main body 4 when the button assembly is in this state. When the button assembly is compressed, the inner surface 94 moves downward with the button assembly to release the finger 58 from engagement with the engagement ring 18 and thus the nozzle assembly 2 (see FIG. 6). To move along the outside of the elastic fastening finger (58). Thus, the resilient fastening finger 58 can detachably engage the fastening ring 18 of the nozzle assembly in a snap operation allowing the insertion of the nozzle assembly 2 before use and its removal after use. When the button assembly is pressed by the operation of the device, the inner surface 94 of the button assembly prevents detachment of the nozzle assembly 2 so as to avoid the risk of accidental removal of the nozzle assembly 2 during operation of the device. Acts as a fastening surface for temporarily holding 58).

When the button assembly reaches the minimum range of its travel, the subordinate elastic legs 90 engage with the cam cylinder 100 carried by the fixing structure 59 so that the cam cylinder 100 has a leg air piston 68. Leg 90 is deflected inward to separate it from engaging with stem 68a. 6 shows the condition that the lower end of the leg 90 approaches the cam cylinder 100 just before the release of the leg 90 from the piston stem 68a. Thus, if the air piston 68 is released from the suppression that occurs at the lower end of the displacement of the air piston 68 and the compression spring 70 is at maximum loading, the air piston 68 will allow air from the air reservoir 66 to air. It is operated upwards by the force in the compression spring 70 to pass through the lower needle 32 through the tube 62 and release it into the capsule 24 so that the contents of the capsule 24 are in the upper needle 26, the vortex chamber. Release through 40 and release orifice 8. This state is shown in FIG. Upon release of the button 80 of the button assembly, the button assembly is returned to the external position by the compression spring 82 to release the restraining inhibition of the inner surface 94 on the fastening finger 58 and the nozzle assembly 2 The ram 60 will also be returned to its lower position by the lever 84 and the compression spring 86, allowing it to be removed and replaced with a new assembly for subsequent use (see FIG. 4).

The device also includes a detachable protective cap (not shown) that fits over the outer sleeve 53 and surrounds the nozzle assembly 2 and the button 80. The cap prevents entry of dust into the apparatus and prevents accidental operation.

The fixing portion 16 of the nozzle assembly is transparent so that the user can easily determine whether the nozzle assembly is new or used and the piston 30 is observable. After use of the nozzle assembly, the upward displacement of the piston 30 can be observed by the user.

In the mentioned embodiment, pressing the button assembly has the effect of puncturing the capsule in preparation for release of the material and 'caking' the air piston triggered by the release of the leg from the piston stem at the lower end of the run of the button assembly, which is It is released by injecting air into the capsule.

In the second embodiment, caulking of the air piston can be accomplished by inserting the nozzle assembly into the main body such that triggering for effective release of the caulked air piston is performed by manipulation of a button assembly or other trigger. In this embodiment, the ram is connected to the air piston such that the ram does not drive upwards to cause perforation of the capsule until the device is triggered. Thus, in the present embodiment the device can be stored in a loading state that is activated as soon as the trigger is operated. This embodiment will be described in detail with reference to Figs.

The unit dose administration device of the second embodiment consists of a nozzle assembly 110 carrying a unit dose of a substance to be administered, the nozzle assembly 110 containing a main body for receiving a mechanism operated by a user to discharge a unit dose ( 112 is detachably fitted. After use, the spent nozzle assembly 110 is removed from the body 112, discarded and replaced with a new nozzle assembly. As described, the insertion of the nozzle assembly into the main body 112 acts to caulk the instrument such that the instrument is released to eject the dose by manipulation of a trigger in the form of a button 114. After insertion of the nozzle assembly 110, the device with the caulked instrument in preparation for subsequent use may be conveniently stored by the user, for example in a pocket, purse or purse. In this storage mode, the detachable cap 116 is applied to the body 112 to surround the operation button 114 and the nozzle assembly 110.

The nozzle assembly 110 is generally similar to the nozzle assembly of the previous embodiment and is shown in detail in FIG. The nozzle assembly 110 consists of an outer casing 118 having a discharge orifice 120 at its outer end. The nozzle assembly 110 shown is particularly intended for nasal administration of material and therefore the size of the outer casing 118 is suitable for its use. The inner sleeve 122 mounted in the outer casing 118 extends beyond the lower end of the outer casing 118 to form a fixing portion 124 which is inserted into the main body 112 of the device, as described in detail below. Mount the assembly to the main body. The fastening portion 124 terminates in an external fastening groove 126 that cooperates with a retainer system in the main body 112 as described below.

The inner sleeve 122 of the nozzle assembly 110 defines a chamber or cylinder that houses a capsule 24 containing a unit dose of a substance to be administered as described in connection with the above embodiment. The upper end wall of the inner sleeve 122 carries a hollow needle 128 that protrudes to the upper end of the cylinder via the seal 130. The lower end of the cylinder receives the piston 132 carrying the hollow needle 134. Therefore, the capsule 24 is positioned in the cylinder with both ends of the capsule 24 adjacent to the tips of the upper and lower needles 128, 134 and the nozzle assembly 110 is provided to the user in this state before use (FIG. 11). The upper needle 128 is in communication with the discharge orifice 120 via the vortex chamber 136 which enhances droplet formation as described in connection with the above embodiment. The lower surface of the piston 132 communicates with the air cylinder 144 of the air cylinder / piston assembly 146 of the instrument within the main body 112 when the nozzle assembly 110 is inserted into the main body 112. A passage 132a is formed to receive the ram 140 having the passage 142 (see FIGS. 12-14). When the nozzle assembly 110 is inserted into the main body 112, the ram 140 is located in the passage 132a in the lower piston 132 and the lower needle 134 is shown in FIGS. 12-14. The outer surface of the ram 140 in the passage 132a of the lower piston 132 is in hermetic communication with the air passage 142 in the ram 140.

Ram 140 is integrally formed as an extension of air cylinder 144 of air cylinder / piston assembly 146. The air piston 148 of the air cylinder / piston assembly 146 is of tubular form with an upper end with a seal 150 that seals against the inner wall of the cylinder 144. The air piston 148 also includes a pair of opposing elastic arms 152 that can be removably fastened to the fastening groove 154 at the outer wall of the cylinder 144 so that the piston at the lower end position in the air cylinder 144 ( 148) separably. The air piston 148 has a resistor ring 160 at the lower end, which plays an important role in caulking and operating the instrument as described below. Register ring 160 is applied to the lower end of air piston 148 such that register ring 160 moves axially with piston 148 but can rotate about piston 148 about the axis of the piston. The air piston 148 is subjected to an upward spring bias provided by a compression spring 162 interposed between the resistor ring 160 and the lower end of the main body 112 of the apparatus (see Figures 15-18).

The basic series of operations or operations of the apparatus is shown in FIGS. 12-14. 12 shows the shape of the nozzle assembly 110 and the air cylinder / piston assembly 146 after the nozzle assembly 110 is inserted into the main body 112, and the instrument is in the shipping state of the resistor ring 160. And a compression spring 162 acting on the air piston 148. The manner in which the instrument remains caulked arises from its cooperation between the resistor ring 160 and the other components described, as will be described below. In this state, the ram 140 is seated in the lower piston 132 with the capsule 24 positioned between them although not perforated by the upper and lower needles 128, 134. The air piston 148 is at the lowest position with respect to the air cylinder 144 and is detachably fastened there by the fastening finger 152. When the operation button 114 is pressed by the user, the register ring 160 is displaced to release the instrument from its caulking state such that the force of the compression spring 162 forces the main air cylinder / piston assembly 146 as a unit. Releasing to drive upwards, ram 140 travels upwards within inner sleeve 122 of nozzle assembly 110 to displace lower piston 132 and capsule 24 thereby allowing upper and lower needles ( 128 and 134 cause the capsule 24 to perforate (see FIG. 13). The continuous upward movement of the ram 140 and the air cylinder 144 ends as a result of the sealing engagement of the lower piston 132 opposite the lower end of the capsule 24 and the continuous upward loading of the compression spring 162 is registered. The detachable fastening finger 152 under the action on the air piston 148 via the ring 160 is separated from the fastening groove 154 on the air cylinder 144 and the air piston 148 is the air cylinder 144. Is driven upwards to force air into the capsule 24 via the air passage 142 and the lower needle 134 of the ram 140, thereby administering the contents in the manner described in connection with the above embodiment. Let's do it. Figure 14 shows the shape of the air cylinder / piston assembly 146 in the ejecting or terminating stage.

The manner in which the new nozzle assembly 110 is inserted and retained in the main body 112 as a result of the shipping and caulking of the instrument will be described with reference to FIGS. 15 and 16 illustrate the shape of removal of the nozzle assembly that is contiguous with the shape after the ejection or end of operation of the nozzle assembly with the air piston 148 at the top position in the air cylinder 144. 15 and 16, the lower end of the fixing part 124 of the nozzle assembly 110 is mounted 170 in the shuttle 172, which is mounted for vertical movement within the upper end of the main body 112. ), The shuttle 172 consists of means for supporting the nozzle assembly 110 in the main body 112. Shuttle 172 is associated with retainer 174 which acts to engage nozzle assembly within seat 170 and also performs other functions as described. Retainer 174 is mounted to move vertically with shuttle 172 but is also laterally displaceable with respect to shuttle 172 under the action of a relatively light spring bias provided by a spring (not shown). This lateral movement, which occurs at the end of the insertion and caulking step, causes the fastening of the rib on the retainer 174 to engage in the peripheral fastening groove 126 on the fastening portion 124 of the nozzle assembly 110 and thereby the shuttle ( 172, fastening the fixing part 124 in the seating position (this is shown in Figure 18). Retainer 174, which additionally has the function of fastening nozzle assembly 110 to shuttle 172, also has air piston 148 downward during insertion of nozzle assembly 110 against the bias of compression spring 162. And thereby compress the compression spring 162. For this purpose the retainer 174 has a dependency, indicated by reference numeral 174a, which engages the junction 180 on the structure of the air piston 148 out of the cylinder 144. When the nozzle assembly 110 is inserted into the shuttle 172 at the top of the main body and pressed downward, the retainer 174 also moves downward with the shuttle and the subordinate portion 174a of the retainer 174 is compressed with a spring. The piston 148 is pushed downward against the bias of 162 such that the fastening finger 152 along the air cylinder 144 recombines in the groove 154 at the lower end of the air cylinder 144. Is displaced downward to the lower position (see FIG. 17). If the fastening finger 152 on the air piston 148 continues to move downwards only a few millimeters beyond the tip that engages in the fastening groove 154 of the air cylinder 144, the resistor ring 160 is divided into the fastening position (described later). The instrument remains caulked against the force of the compressed compression spring 162. With the shipment of the compression spring 162 taken by the resistor ring 160 to hold the instrument in the caulking state, the retainer 174 is held against the shuttle 172 under the influence of the lightweight lateral spring bias applied to the retainer 174. It is possible to displace laterally, thereby fastening the nozzle assembly 110 in the shuttle 172 by engaging the fastening ribs in the fastening groove 126 of the fixing portion 124 of the nozzle assembly 110. In addition, this lateral movement of the retainer 174 allows the retainer's subordinate portion 174a to displace the air piston 148 to allow the air piston 148 to continuously displace upwards when the mechanism is operated by button 114 operation. ) Causes lateral displacement away from the junction 180, and additionally lateral displacement causes retainer 174 and shuttle 172 and nozzle assembly 110 to engage opposite upward displacement. This is the shape shown in FIG.

15-18 illustrate an elastic fastening lip 181 at the upper end of the main body. The fastening lip 181 provides a lightweight support and positioning for the upper end of the nozzle assembly 110 during insertion, and in the inserted position of the nozzle assembly 110 the lip 181 is the inner sleeve of the nozzle assembly 110. 122 into the annular groove 182 on. The fastening lip 181 is also connected to the nozzle assembly during shipment and before the fastening 124 is fastened into the seat 170 of the shuttle 172 by lateral displacement of the retainer 174 at the end of the insertion stroke as described above. Prevent accidental separation of 110.

As described above, the resistor ring 160 mounted at the lower end of the air piston 148 maintains the mechanism in a caulking state against the bias of the compression spring 162 and then disengages the unit amount as described above. It plays an important role in allowing separation or operation. The operation of the register ring 160 will be described with reference to FIGS. 19 to 21. Mounted in the main body 112 is a fixed lock 200 which is generally cylindrical in shape. This is shown in Figures 19-21 but has been omitted in the other figures for simplicity. Air cylinder / piston assembly 146 lies in lock 200. The lock 200 has a plurality of axial slots 202 (three slots shown) spaced upwardly from the bottom of the lock 200 and spaced at equal intervals around the axis of the lock 200. The register ring 160, also shown in Figures 19-21, has a corresponding number of radial lugs 160a (lug) spaced at equal intervals around the axis of the ring 160. Also mounted within the interior of the lock 200 is an operating ring 204 having a generally cylindrical shape. The operation ring 204 interacts with the button 114 such that the operation ring 204 is displaced downward within the lock 200 when the button 114 is pressed by the user. The operating ring 204 is comprised of a series of corresponding legs 204a each associated with one of the slots 202 in the lock 200. Each dependent leg 204a of the operating ring 204 has a radial lug on the register ring 160 such that its radial lug 160a aligns with each slot 210 when the register ring 160 is angularly divided. Each one of 160a defines an associated slot 202, an axial slot 210, in a lock 200 that can be moved.

19 shows the shape into which the nozzle assembly 110 is inserted and the caulking mechanism (equivalent to FIGS. 12 and 18). In this condition, each radial lug 160a is coupled by engagement at a small step 212 defined between the end face of the associated leg 204a of the operation ring 204 and the corner of the slot 202 in the lock 200. Fastening is opposed to the movement in the upper axial direction and the rotation direction. When the operating ring 204 is displaced downward by the manipulation of the button 114, the downward displacement of the legs 204a of the operating ring 204 causes the compression spring 2 2 to move from the fastening step 212. Displace the register ring 160 downward against the bias of 162. When so separated, the inclined cooperating cam surface defined by the top surface of the radial lug 160a and the end surface of the associated leg 204a of the operation ring 204 is affected by the compression spring bias acting on the resistor ring 160. Causing a slight rotation of the register ring 160 underneath so that the top surface of each radial lug 160a moves on the inclined cam surface 220 formed at the bottom of the lock 200 between adjacent slots 202. do. As a result of the axial bias applied by the compression spring 162, the radial lug 160a is adjacent to the next lug 160a defined between the slot 202 in the lower lock and the leg 204a in the operation ring 204. Is caused to move along the cam surface 220 with axial and rotational displacement until reaching axial slot 210 (see FIG. 20) and when entering the slot, register ring 160 is slot 210 Can be axially displaced to the upper end of the valve, thereby generating displacement of the air cylinder piston assembly 146 and displacement of the air piston 148 to effect puncture and release of the capsule as previously described. . This mode is shown in FIG.

Figure 21 shows the shape at the end of the operating action, in particular it is identical to the shape present after removal of the nozzle assembly 110 with ejection. When the new nozzle assembly 110 is inserted as already described with reference to Figures 15-18, the downward of the air piston 148 as a result of the interaction between the retainer 174 and the piston 148 during insertion The displacement induces downward movement of the register ring 160. When the radial lug 160a of the register ring 160 moves downward along the slot 210 and beyond the slot 210 to a sufficient extent to clarify the bottom edge of the adjacent leg 204a of the operation ring 204, The camming action between the resistor ring 160 and the air piston 148 under the influence of the axial bias applied by the now compressed compression spring 162 until the next operation of the operation ring 204 by pressing the button 114. Rotation of register ring 160 such that lug 160a is angularly displaced from slot 210 on the end face of leg 204a held at fastening step 212 against continuous axial and rotational displacements. Generates. This is again the shape shown in FIG. 19, and despite the continuous action described, the register ring 160 experiences a series of axial and rotational movements during operation and subsequent caulking action and thereby within each complete operating cycle. It is divided into 120 ㅀ steps. As just mentioned, it should be appreciated that the camming action between the resistor ring 160 and the air piston 148 is provided below the surface of the air piston 148 by an inclined cooperating cam surface on the top surface of the register ring 160. do.

It will be recalled that during the action of insertion of nozzle assembly 110, shuttle 172 and retainer 174 are displaced downward by nozzle assembly 110, leading to downward displacement of air piston 148. During this action the retainer 174 moves downward along the vertical guide groove in the main body 112. At the end of the insertion action that induces lateral displacement of retainer 174 (FIG. 18) to engage nozzle assembly 110 in shuttle 172, retainer 174 moves from the vertical guide groove to retain retainer 174, shuttle. The 172 and the nozzle assembly 11 are fastened in the main body 112 to face upward axial displacement. At the end of the acting action, slight pressure on the nozzle assembly 110 by the user will induce a continuous lateral displacement of the retainer 174 under the applied lateral spring bias, thereby retaining the retainer 174 into another vertical guide groove. The retainer 174, shuttle 172 and nozzle assembly 110 can then be pulled upwards. When the shuttle 172 is adjacent to the upper end of the main body 112, the groove in which the retainer 174 is mounted toward the end of the upward movement causes the lateral displacement of the retainer 174 in the opposite direction to lock the shuttle 172. Allow separation of the nozzle assembly 110 from the engagement, whereby the nozzle assembly may be recovered. After removal of the nozzle assembly 110, the second lateral spring action on the retainer 174 indicates that the retainer 174 is laterally displaced such that the shuttle 172 returns to a position where it can accommodate the new nozzle assembly 110. Secure.

The device of the second embodiment can be configured in an overall size similar to that of the container for lipstick and can be conveniently carried by the user, for example in a pocket, purse or purse.

The devices mentioned are suitable for intranasal administration of the drug sumatriptan, for example for use in the treatment of migraine headaches. However, the device may also be used for intranasal administration of other substances such as fluticasone propionate and beclomethasone dipropionate, which are suitable for the treatment of respiratory diseases such as allergic rhinitis. . The device may also be used for oral administration of the substance or for administration of the substance to other body openings and lungs.

In the above-described apparatus, the nozzle assembly consists of a capsule which is perforated at both ends by a hollow needle and the discharge is carried out by injecting air into the capsule, but in another form the substance to be administered can be contained in the cylinder in the nozzle assembly so that the body or cylinder of the cylinder The piston inside is displaced by the operation of the ram and causes the release of the contents by the effect of the displacement without air injection. However, the use of capsules in conjunction with releasing air injection is desirable to provide an effective means of ensuring the release of a predetermined unit amount in the form of spraying without requiring excessive operating forces that can be applied by the user. In addition, the capsule itself can be made inexpensively with existing equipment.

In the devices mentioned herein, most parts can be molded from a suitable plastic material. The nozzle assembly comprising the substance to be administered is a single use consumable item. The nozzle assembly is a relatively simple structure and can be produced quite inexpensively. The main body of the device containing the main part of the dosing device is of course retained for repeated reuse with a new nozzle assembly. Although the parts of the main body need to be made of a relatively strong structure in order to use more than a few times, the relative price of the main body may nevertheless be accepted as not a single use item. Attachment and detachment of the nozzle assembly is very simple and the force required to be performed by the user to operate the device is relatively low and suitable within the physical range of the user's physical ability, including the elderly and the physically handicapped.

The embodiments are described by way of example and modifications may be made within the scope of the invention.

Claims (23)

Nozzle assembly (2; 110) for administering a unit amount of a substance, The nozzle assembly is configured to detachably attach to a body (4; 112) having a system operable to effect release of the material, The nozzle assembly includes a container 24 for receiving a unit amount of the substance, means 16 and 124 for removably attaching the nozzle assembly to the body, and in cooperation with the discharge system for operation of the discharge system by the user. Dosing means 26, 30, 32; 128, 132, 134 in response to administering the substance from the container, The discharge system of the body includes a ram (60; 140) arranged to interact with the dispensing means of the nozzle assembly, wherein the dispensing means comprises a nozzle assembly configured to cause dispensing of material from the container in response to movement of the ram. In And the dispensing means of said nozzle assembly comprises means (26; 32) for puncturing the vessel in response to movement of the ram. 2. The nozzle assembly of claim 1, wherein the nozzle assembly comprises a passageway (22; 132a) for receiving a ram when the nozzle assembly is mounted on the body or thereafter. 3. The container according to claim 1 or 2, wherein the container is in the form of a capsule mounted in the chamber 22 of the nozzle assembly and the puncturing means comprises hollow needles 26; 128 mounted to the outer end of the chamber. And the capsule is displaceable by actuation of the ram towards the outer end of the chamber to cause perforation by the needle. The method of claim 1, wherein the discharge system of the body comprises means for injecting gas into the container, wherein the container in the nozzle assembly is in the form of a capsule mounted within the chamber of the nozzle assembly, and the puncturing means is outside the chamber. A first hollow needle (26; 128) mounted at an end and a second hollow needle (32; 134) carried by a piston (30; 132) in the inner end of the chamber; The material is placed in the chamber between the second needles and displaces the second needle toward the first needle such that the piston is displaceable in the chamber under the action of the ram such that the two needles puncture both ends of the capsule. And the administration gas is injected into the capsule via the second needle from the release system of the body so that it is administered from the capsule via the first needle under influence. 5. The nozzle assembly of claim 4, wherein the first needle runs upstream of the vortex chamber (40; 136) of the discharge orifice (8; 120) of the nozzle assembly. 3. The device of claim 1 or 2, wherein the means for removably attaching the nozzle assembly to the body comprises a protruding tubular portion of the nozzle assembly insertable into an opening in the body, the tubular portion being coupled with the fastening means 58; 174 of the body. Nozzle assembly, characterized in that it comprises a separable coupling formation (18; 126). 3. The apparatus of claim 2, wherein the means for removably attaching the nozzle assembly to the body comprises a protruding tubular portion of the nozzle assembly insertable into an opening in the body, the tubular portion being detachably coupled with the fastening means 58; 174 of the body. Possible fastening formations (18; 126), And the tubular portion comprises a passage for receiving a ram of the discharge system. 3. The nozzle assembly of claim 1 or 2, wherein the nozzle assembly is sized such that an outer end of the nozzle assembly to which the substance is administered can be inserted into the body cavity. 9. The nozzle assembly of claim 8, wherein the outer end of the nozzle assembly is sized to be inserted into the nasal cavity. An apparatus for administering a unit dose of a substance comprising a nozzle assembly according to claim 1 or a body (4; 112) for use with the nozzle assembly, The body includes a system (60; 140) for executing release of the material from the nozzle assembly and cooperating with the nozzle assembly, and means for cooperating with attachment means of the nozzle assembly to detachably retain the nozzle assembly relative to the body. And operating means (80; 114) operable by the user to effect the ejection. An apparatus for administering a unit dose of a substance comprising a nozzle assembly according to claim 4 and a body (4; 112) for use with the nozzle assembly, The body includes a system (60; 140) for executing release of the material from the nozzle assembly and cooperating with the nozzle assembly, and means for cooperating with attachment means of the nozzle assembly to detachably retain the nozzle assembly relative to the body. And operating means (80; 114) operable by the user to effect the ejection, The release system further comprises means (18; 146) for injecting air into the capsule via a second needle, causing the release of the substance to pass through the first needle. 12. The device according to claim 11, wherein the ram comprises an air passage (62; 142) in communication with the second needle for injection of air into the capsule. 13. The device of claim 12, wherein the means for injecting air comprises a spring loaded air piston for injecting air into the capsule via an air passage in the ram by the user during operation of the operating means. Device. 14. A method according to claim 13, characterized in that the operating means is initially driven to apply a load to the driving spring of the air piston with spring energy and thereafter release the spring energy so that the air piston injects air. Device. 14. The apparatus of claim 13, wherein the means for detachably retaining the nozzle assembly comprises support means for the nozzle assembly 174, and means for retaining the drive spring under load 160; The support means are displaceable by the nozzle assembly when mounting the nozzle assembly to the body, the movement of the support means serving to load the drive spring 162 of the air piston 148 with spring energy, and the retaining And the means are detachable in response to the operation of the operating means by the user such that the air piston is driven by a drive spring to effect the release of the material. An apparatus for administering a unit dose of a substance comprising a nozzle assembly according to claim 6 and a body (4; 112) for use with the nozzle assembly, The body includes a system (60; 140) for executing release of the material from the nozzle assembly and cooperating with the nozzle assembly, and means for cooperating with attachment means of the nozzle assembly to detachably retain the nozzle assembly relative to the body. And operating means (80; 114) operable by the user to effect the ejection, The release system further comprises means (18; 146) for injecting air into the capsule via a second needle causing the release of the substance to pass through the first needle, The ram includes air passages 62 and 142 in communication with the second needle for injecting air into the capsule, The means for injecting air comprises a spring-loaded air piston for injecting air into the capsule via an air passage in the ram by the user during operation of the operating means, Means for separably retaining the nozzle assembly include support means for nozzle assembly 174 and means (160; 200) for retaining the drive spring under load, the support means being nozzles to the body. Displaceable by the nozzle assembly when mounting the assembly, the movement of the support means serves to load the drive spring 162 of the air piston 148 with spring energy, the retaining means being operated by a user Detachable in response to the actuation of the means such that the air piston is driven by a drive spring to effect the release of the material, The support means being configured to cooperate with the inner end of the protruding tubular portion of the nozzle when the tubular portion is inserted into the body, the support means being displaceable within the body as a result of the insertion movement of the tubular portion of the nozzle assembly in the direction of the axis of the tubular portion. Device. 17. The apparatus of claim 16, wherein the means for detachably retaining the nozzle assembly further comprises means for removably fastening the tubular portion of the nozzle assembly to the support means to prevent separation of the nozzle assembly during ejection. Device. 14. The apparatus of claim 13, wherein the manipulating means is associated with the ram such that initial actuation of the manipulating means causes perforation of the capsule before displacing the ram to release the spring energy of the drive spring of the air piston. 14. The device according to claim 13, wherein the ram is subject to the action of the actuating spring of the air piston such that the release of spring energy upon operation of the operating means performs the actuating movement of the ram to effect perforation of the capsule. . The apparatus according to claim 10, wherein the main body has a structure that can be held in a user's hand and the operation means includes at least one operation member that can be operated by a finger of the same hand. The apparatus of claim 10, wherein the release system comprises a spring loaded air piston operable to inject air into the vessel to permit release of the substance. 22. The drive spring 162 for the air piston 148 is loaded with spring energy by the action of mounting the nozzle assembly on the body, the drive spring subsequently causing release. And the caulking state is maintained until the operating means is operated by the user to perform the release of the spring energy. A device for administering a unit dose of a substance comprising a nozzle assembly according to claim 5 and a body (4; 112) for use with the nozzle assembly, The body includes a system (60; 140) for executing release of the material from the nozzle assembly and cooperating with the nozzle assembly, and means for cooperating with attachment means of the nozzle assembly to detachably retain the nozzle assembly relative to the body. And operation means (80; 114) operable by the user to effect the discharge The release system further comprises means (18; 146) for injecting air into the capsule via a second needle, causing the release of the substance to pass through the first needle.