This invention relates to devices for delivering at least one dose of a composition to the nasal cavity.
Nasal spray inhalers are known in the prior art. A nasal spray inhaler may include an elongated discharge member formed for insertion into a nasal cavity. A reservoir is coupled to the discharge member with spray actuation being achieved by squeezing the discharge member towards the reservoir. Such devices suffer from several deficiencies. First, the discharge member has a substantially long length due to the necessity for sufficient insertion into the nasal cavity and accommodation of a user's fingers thereabout. In addition, it is difficult to consistently locate the tip of the discharge member, having the spray orifice, at a position within the nostril where it is at an appropriate distance and is in axial alignment with the nasal valve to ensure delivery of the drug to the posterior nasal cavity when a patients fingers are placed atop of the gripping surface of the discharge member and beneath their nose. During squeezing motion necessary to actuate the device, the tip of the discharge member may move in reaction to the patient input motion which can result in misalignment and less efficient dose administration. Additionally, these designs can be difficult and unsanitary to use when administering a drug to others, such as in the case when a parent administers a spray to a child.
Thus, there is a need for a new nasal spray device that overcomes these shortcomings.
Several embodiments of the present invention provide for a delivery device for the delivery of at least one dose of a composition into a nasal cavity. The composition may be a liquid or powder composition. The delivery device includes a discharge member formed for insertion into a nasal cavity, a discharge aperture being formed therethrough. The delivery device may further include a body containing a reservoir of at least one dose of a composition, such as a liquid or powder composition. The body is elongated and generally extending along a longitudinal axis. Further, the discharge member extends along a secondary axis. The secondary axis intersects with, and is disposed transversely to, the longitudinal axis.
Advantageously, a delivery device is provided having a discharge member which is not axially aligned with the body of the delivery device. In this manner, the body may be maintained away from the face of a user during dose administration. In addition, a relatively short discharge member may be provided.
Other embodiments provide a delivery device for the delivery of at least one dose of a composition into a nasal cavity, the device including a discharge member formed for insertion into a nasal cavity, a discharge aperture being formed therethrough; a stop surface defined at least partially about the discharge member, the stop surface extending radially outwardly from the discharge member, the stop surface limiting the extent the discharge member may be inserted into a nasal cavity; and, a body containing a reservoir of at least one dose, the body being elongated and generally extending along a longitudinal axis, wherein the discharge member extends along a secondary axis, the secondary axis intersecting with, and being disposed transversely to, the longitudinal axis.
Various embodiments of the present invention provide a delivery device for the delivery of at least one dose of a composition into a nasal cavity, the device including a discharge member formed for insertion into a nasal cavity, a discharge aperture being formed therethrough; and, a body containing a reservoir of at least one dose, the body being elongated and generally extending along a longitudinal axis, wherein the discharge member extends along a secondary axis, the secondary axis intersecting with, and being disposed transversely to, the longitudinal axis; wherein the reservoir is elongated and extends along the longitudinal axis, and; wherein a portion of the reservoir extends transversely away from the longitudinal axis to define a well for collecting a liquid or powder composition gravitationally below the longitudinal axis, during use of the delivery device.
Other embodiments of the present invention provide for a drug product comprising a delivery device and a composition comprising at least one active pharmaceutical agent. Suitable active pharmaceutical agents include but are not limited to mometasone furoate, such as mometasone furoate monohydrate or mometasone furoate anhydrous, fluticasone furoate, fluticasone propionate, budesonide, triamcinolone, ciclesonide, oxymetazoline, azelastine, olopatadine, montelukast and combinations thereof or pharmaceutically acceptable salts thereof.
Various embodiments of the present invention provide a delivery device for the delivery of at least one dose of a composition into a nasal cavity, the device including a discharge member formed for insertion into a nasal cavity, a discharge aperture being formed therethrough; and, a body containing a reservoir of at least one dose, the body being elongated and generally extending along a longitudinal axis; a trigger for causing delivery of at least one dose from the reservoir through the discharge aperture, the trigger being located on the body and spaced from the discharge member; wherein the discharge member extends along a secondary axis, the secondary axis intersecting with, and being disposed transversely to, the longitudinal axis; and wherein the trigger is configured to have a force applied thereto for actuation, the force being applied in a direction generally oblique to the longitudinal axis. The secondary axis may subtend an acute angle with the longitudinal axis. The acute angle may be in the range from about 15° to about 45°. The force for actuation may be applied to the trigger in a direction generally parallel to the secondary axis. The discharge member may terminate at a free end with the discharge aperture being formed through the free end. The discharge aperture may be formed at the furthest most location on the discharge member from the body. A pump for delivering the at least one dose from the reservoir and through the discharge aperture may be included. The trigger may be pivotally attached to the body. The trigger may extend along a central axis, the central axis subtends an acute angle with the longitudinal axis. The acute angle may be in the range from about 15° to about 45°. The force for actuation may be applied to the trigger in a direction generally perpendicular to the central axis. Other embodiments provide a drug product with the device and a composition comprising at least one active pharmaceutical agent. Suitable at least active pharmaceutical agents include mometasone furoate, such as mometasone furoate monohydrate or mometasone furoate anhydrous.
These and other features of the invention will be better understood through a study of the following detailed description and accompanying drawings.
As shown generally in the figures, several embodiments of the present invention provide a delivery device 10 for the delivery of at least one dose of a composition, such as a liquid or powder composition, into a nasal cavity of a user. The delivery device 10 generally includes a discharge member 12 and a body 14. With reference to
The discharge member 12 is formed for insertion into a nasal cavity. In several embodiments, the discharge member 12 is generally bullet-shaped. The discharge member 12 may have a maximum length of 0.75″ and a maximum diameter of 0.5″. A discharge aperture 20 is formed through the discharge member 12 to permit at least one dose of a composition, such as a liquid or powder composition, to be administered from the delivery device 10. The discharge member 12 extends from the body 14 to have a free end 22. The discharge aperture 20 may be formed through the free end 22 (e.g., centrally through the free end 22), or the discharge aperture 20 may be formed at the furthestmost location on the discharge member 12 from the body 14. The discharge member 12 may be formed of various materials suitable for insertion into a nasal cavity.
The discharge member 12 may be immovably fixed to the body 14. The discharge member 12 may be unitarily formed with the body 14 or attached thereto using any known technique.
The body 14 contains a reservoir 24 (best shown in
With reference to
With reference to
In addition, the front end 32, may be flattened or truncated or provided with little curvature adjacent to the stop surface 33 to provide a stable alignment surface for acting against the upper lip 28 in angularly aligning the nasal valve of device 10 with the nose 34 of the user. The front end 32 minimizes rocking or other angular or rotational variation, including during application of actuation force to the trigger 26.
The angled discharge member 12 relative to the body 14 of the delivery device 10 locates a patient's hands, during placement and actuation, away from their face. This locates a patient's hands away from their nose where it can come into contact with nasal discharge. The discharge member 12 is designed to be placed against the face above the upper lip 28 and beneath the nasal cavity 30, with the nose as a reference surface to assist in axially locating the spray orifice of the discharge member with the nasal valve when placed within the nasal cavity 30. Accordingly, the underside of the nose provides a depth locator when the discharge member 12 is placed upward within the nasal cavity 30. The length of the discharge member 12 is short as compared to the prior art, to place the discharge aperture 20 at a proper distance from the nasal valve when placed within the nasal cavity 30. Furthermore, the trigger 26 and the body 14 of the device 10 have been designed to generally align the forces and reaction forces in opposing fashion during actuation, minimizing any reaction moments moving the discharge member 12 during actuation. The combination of these three features (hands-away actuation; depth location; general orientation of actuation and counter forces) increases the likelihood of proper placement during administration and allows for easier administration to users.
With reference to
As will be recognized by those skilled in the art, the delivery device 10 may be self-administered or administered by a third party to a user. For example, a parent or medical practitioner may administer at least one dose of a composition by the delivery device 10 to a child or elderly patient.
Any configuration for delivering a dose of a composition from the reservoir 24 through the discharge aperture 20 may be utilized, particularly a trigger-activated configuration. By way of non-limiting example, a pump 36 may be provided to deliver a dose of a composition from the reservoir 24 through the discharge aperture 20. The pump 36 may be provided with a discharge tube 38, as best shown in
To permit delivery of at least one dose of a composition from the discharge tube 38 through the discharge aperture 20, a change of direction element 48 is provided having a channel 50 formed therethrough to register with the aperture 44. The channel 50, in turn, is in registration with the discharge aperture 20 to permit delivery of the fluid. The channel 50 includes first and second sections 50A, 50B angularly off-set from one another. The sections 50A, 50B may be angularly off-set the angle α as described above. The stop block 40 and the change of direction element 48 may be formed separately and joined or formed unitarily as a single component. A nozzle 52 may be disposed along the fluid path between the stop block 40 and the discharge aperture 20 to control the resulting spray pattern of the administered dose. The nozzle 52 may be disposed to define the discharge aperture 20.
With the arrangement described above, the trigger 26 may be coupled to the reservoir 24 to cause forward translation thereof upon the trigger 26 being actuated as shown in
With reference to
An actuator 66 is provided to transmit force from the trigger 26 to the reservoir 24 to cause forward translation thereof. The actuator 66 includes at least one mounting block 68 or two of the mounting blocks 68, each having an aperture 70 formed therethrough. The aperture(s) 70 are formed to receive the pin 58. The actuator 66 is mounted into the body 14 with the one or more mounting blocks 68 extending through an opening 72 formed in the body 14 with the pin 58 passing through the one or more apertures 70. The passage 64 of the trigger 26 is defined in an end member 74. The one or more mounting blocks 68 are positioned to be adjacent to one or both ends of the end member 74.
The actuator 66 also includes one or more actuating arms 76 formed and positioned to engage against corresponding actuating surfaces 78 on the reservoir 24. The actuator may 66 have a yoke shape with two of the actuating arms 76 being provided, the actuating arms 76 being spaced apart to straddle the reservoir 24. With the actuating arm(s) 76 being forced forwardly, force is applied against the actuating surface(s) 78 resulting in forward translation of the reservoir 24.
To transmit force from the trigger 26 to the actuator 66, one or both ends of the end member 74 is provided with a protrusion 80 of limited circumferential length. Also, a notch 82 is formed in each of the mounting blocks 68 configured to be engaged by one of the protrusions 80.
With reference to
With reference to
To cause actuation, force is applied, to the trigger 26, as shown in
With force being removed from the trigger 26 after dose administration, return force from the pump 36 urges the reservoir 24 rearwardly to the inactive state, such as that shown in
A cap 84 may be provided to cover the discharge aperture 20 (
With reference to
The descriptions of the embodiments of the invention have been presented for purpose of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise forms disclosed, and obviously many modifications and variations are possible in light of the above teaching.
Filing Document | Filing Date | Country | Kind | 371c Date |
---|---|---|---|---|
PCT/US09/63071 | 11/3/2009 | WO | 00 | 10/11/2011 |
Number | Date | Country | |
---|---|---|---|
61110906 | Nov 2008 | US | |
61110912 | Nov 2008 | US |