Patent Application
20230031735
A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction of the patent document or the patent disclosure, as it appears in the Patent and Trademark Office patent file or records, but otherwise reserves all copyright rights whatsoever.
The application of a local anesthetic, such as lidocaine, to portions of the nasal sinus cavity, especially the sphenopalatine ganglion (SPG), can be effective in reducing the pain associated with migraines. This has been historically accomplished through the use of a cotton swab applicator saturated in viscous local anesthetic and applied intranasally while the migraine sufferer lies in a supine position. However, this method requires the assistance or supervision of a trained medical professional.
Certain illustrative embodiments illustrating organization and method of operation, together with objects and advantages may be best understood by reference to the detailed description that follows taken in conjunction with the accompanying drawings in which:
While this invention is susceptible of embodiment in many different forms, there is shown in the drawings and will herein be described in detail specific embodiments, with the understanding that the present disclosure of such embodiments is to be considered as an example of the principles and not intended to limit the invention to the specific embodiments shown and described. In the description below, like reference numerals are used to describe the same, similar or corresponding parts in the several views of the drawings.
The terms “a” or “an”, as used herein, are defined as one or more than one. The term “plurality”, as used herein, is defined as two or more than two. The term “another”, as used herein, is defined as at least a second or more. The terms “including” and/or “having”, as used herein, are defined as comprising (i.e., open language). The term “coupled”, as used herein, is defined as connected, although not necessarily directly, and not necessarily mechanically. The terms ‘activation’ and ‘action of the user’, as used herein, may refer to application of the dispensing force to the actuation button.
Reference throughout this document to “one embodiment”, “certain embodiments”, “an embodiment” or similar terms means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, the appearances of such phrases or in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments without limitation.
The medication dispensing device with angled tip may dispense medication for pain relief and treatment of conditions that may be effectively treated by the introduction of medications to the sinus cavity. The device may comprise a medication applicator and an activator. In a non-limiting example, a treatment for migraine relief may consist of the introduction of a pain relief medication to the sphenopalatine ganglion (SPG). However, this should in no way be considered the only condition that may be treated through the introduction of medication to the posterior sinus cavity and various physical structures contained therein.
The medication applicator may store a medication and may dispense the medication as an aerosol mist. The medication applicator may be adapted to dispense the medication through an orifice of the user. The orifice may be the first or second nostril of a user directed at a pre-determined position within the posterior nasal cavity. In a non-limiting example, the novel combination product may deliver medication doses to the effective sphenopalatine ganglion (SPG), which efficiently blocks activation of the trigeminovascular system associated with headache disorders and permits the user to self-administer the medication for relief from pain. As noted, additional conditions may be treated through introduction of medication to the posterior nasal cavity through the operation of the medication applicator.
In a non-limiting example, the medication applicator may be adapted to dispense the medication through a nostril of a user directed at a sphenopalatine ganglion to treat pain such as that occurring during a migraine episode.
The activator may be operable to release the medication in multiple doses. In a non-limiting example where the applicator is operable to dispense two doses of medication, a first dose may be dispensed upon a first activation of an actuation button and a second dose may be dispensed upon a second activation of the actuation button.
Each dose dispensed by the medication applicator may comprise a predetermined volume of the medication. A safety interlock may prevent premature dispensing of the medication. The invention may be adapted for the user to self-administer the medication. The invention may be adapted to dispense the medication while the user is upright. As non-limiting examples, the user may be sitting, standing, or lying down while using the invention to self-administer a medication, without requiring the assistance of another person.
Throughout this document, proximal refers to a direction that is closer to the user orifice such as, in a non-limiting example, a nostril and distal refers to a direction that is opposite proximal.
The medication applicator may comprise a cartridge, a nozzle, a seal, and a plunger. The medication applicator may dispense the aerosol mist comprising the medication through the nozzle when the plunger pushes the seal towards a proximal end of the cartridge. The nozzle may be designed to deliver medication in a specific pattern and to a specific location as required for the treatment of a particular condition.
The cartridge may be a tubular container for the medication, however, this should not be considered limiting as other geometries may be considered as advantageous for the packaging of the medication in the container. The cartridge may comprise a nozzle interface, a proximal cartridge aperture, and a distal cartridge aperture. The nozzle interface may be a coupler for accepting the nozzle and may be located on the proximal end of the cartridge. The medication may be forced from within the cartridge through the proximal cartridge aperture which may be located at the center of the nozzle interface. The distal cartridge aperture may be located at a distal end of the cartridge. The seal may slidably interface with the distal cartridge aperture.
In a non-limiting example of medication types to be dispensed, the medication may be a liquid anesthetic. In a preferred embodiment, the medication may be any pre-established formulation or medication. It may be understood, however, that the device may be adapted to dispense numerous medications based upon the fluidity and specification of the medication to be dispensed.
In a non-limiting example, the nozzle may be adapted to direct the medication from the cartridge into the nostril of the user. The nozzle may comprise an atomizer, an insertion limiter, and a cartridge interface. The atomizer may be located at the proximal end of the nozzle and may be configured to dispense medication in particular patterns or quantities necessary to the course of treatment required by the user. The atomizer may convert the medication into the aerosol mist as the medication is forced through one or more apertures under pressure. The pressure may result from proximal movement of the seal within the cartridge during activation. The atomizer may comprise a blunt nasal tip that is to be inserted into the nasal passages to avert nasal trauma to the user. The insertion limiter may be a flange located at the proximal end of the nozzle and axially surrounding the nozzle. The insertion limiter may limit the insertion distance of the nozzle into each nostril. The cartridge interface may mate with the nozzle interface on the cartridge. The medication forced from the cartridge may enter the nozzle via a nozzle aperture in the cartridge interface. The nozzle may bend between the cartridge interface and the atomizer to form an obtuse angle. Additionally, the nozzle may be removed and exchanged for a nozzle with a different angle, nozzle aperture, or configuration that may be suitable for a change in medication or dosage level.
Efficacy is predicated upon accurately delivering a sprayable material such as a medication to a desired location within a cavity, such as, in a non-limiting example, the SPG within the nasal cavity of a user. To address the need for accuracy in delivery of a medication or other sprayable material without the use of catheter routing, an anatomically optimized nozzle geometry (length, nozzle angle, and cone angle) comfortably positions the spray-tip deep inside the frontal nasal cavity of a user. This accuracy in positioning provides for a faster clearance rate of the sprayed material from the delivery device while targeting between the middle and inferior turbinates of a user. In a non-limiting example, a compliant nozzle shroud may deform under pressure to fit into the user’s nasal passage, regardless of individual variation in nasal opening or nasal cavity dimensions. The compliant nozzle shroud may also increase comfort. In this non-limiting example, upon actuation, the customized orifice pattern within the spray-tip of the delivery device provides a narrow and targeted plume of medication that effectively allows it to pass through the nasal valve of the user to target the SPG and promote direct-nerve absorption of the sprayed material, such as a medication or other treatment material, at the SPG.
As non-limiting examples, the semi-rigid, silicone-cast nozzle may be 4.0 +/-0.5 cm in length. The nozzle may comprise a bend angle of 15 to 30 degrees and a cone angle of 30.0 +/- 10.0 degrees. The nozzle may comprise a silicon-plate spray tip comprising customized features designed to achieve target droplet size, dispersion, and cavity and surface deposition characteristics. These customized features may comprise up to 60 apertures of 6 µm +/- 1.0 µm diameter arranged in a circular pattern with a central inner aperture oriented 0 degrees from center and outer apertures oriented radially 15 degrees +/- 5 degrees from center. In a preferred embodiment, there may be 40 apertures. In this context, 0 degrees is defined to be a direction that is perpendicular to the surface of the silicon-plate spray tip
The seal may be a semi-rigid plug that slidably couples to the interior of the cartridge at the distal end of the cartridge. The outer diameter of the seal may match the inner diameter of the cartridge such that the medication is prevent from escaping the cartridge via the distal end of the cartridge. Forward motion of the seal within the cartridge may pressurize the medication and may force the medication out of the cartridge via the proximal cartridge aperture. The seal may be moved proximally in steps such that the medication is dispensed in multiple doses.
The plunger may move the seal in a proximal direction when a dispensing force is applied to the plunger. The plunger may comprise a seal interface at the proximal end of the plunger. The seal interface may mate with the seal such that movement of the plunger is conveyed to the seal. A dispensing spring may be a compression spring. The dispensing spring may apply the dispensing force to the plunger by pressing against the distal end of the plunger. The plunger may be limited by a housing to longitudinal movement within the invention.
The activator may be operable to apply the dispensing force to the plunger such that the plunger may move in a proximal direction to dispense the medication through the nozzle in two or more separate doses. The distance that the plunger moves for each dose may determine the volume of the medication that is dispensed in that dose. The first dose may be dispensed upon the first activation of the actuation button as the plunger moves from a first plunger position to a second plunger position. The first activation may comprise pressing and releasing the actuation button or pressing and holding the actuation button. A subsequent dose of a medication or formulation that has been loaded into the cartridge may be dispensed upon the second activation of the actuation button as the plunger moves from the second plunger position to a third plunger position. In an embodiment, additional doses may be dispensed when the device is configured to dispense multiple doses of a medication or formulation.
The activator may comprise the dispensing spring, the actuation button, a sliding lock, and a lock channel located within the plunger. The actuation button may be a mechanical pushbutton that is accessible through an upper housing. The actuation button may comprise one or more pivot arms that may enable the actuation button to pivot when an actuation force is applied to the actuation button from outside of the upper housing. When pressed inward, the actuation button may convey the actuation force to the sliding lock that is located adjacent to the actuation button such that the sliding lock may slide if the sliding lock is unlocked. The sliding lock may be springloaded by one or more lock springs and may apply an opposing force to the actuation button such that the actuation button may move outward to its original position when the actuation force is removed.
The sliding lock may be an armature that is adjacent to the plunger. The sliding lock may be limited by the housing to sliding perpendicularly to the direction of motion of the plunger unless restrained from moving. The sliding lock may be further limited by the housing to sliding in a direction that is oriented towards or away from the actuation button. The sliding lock may comprise a plunger pin which may pass through the lock channel of the plunger and which may prevent proximal motion of the plunger unless features of the lock channel are aligned with the plunger pin.
The lock channel may be a cut-out within the plunger. Proximal movement of the plunger may be limited by mechanical interference between the lock channel and the plunger pin. The features of the lock channel that may control proximal movement of the plunger may be a first offset, a plunger lever, a second offset, and a pin capture channel. The first offset may be a notch located at the proximal end of the lock channel and extending towards the actuation button. The plunger lever may be a semi-rigid hook at a midpoint of the lock channel. The tip of the hook may be pointed towards the actuation button. The plunger lever may be positioned such that a continuous path through the lock channel from proximal end of the lock channel to distal end of the lock channel would exist if not interrupted by the tip of the hook of the plunger lever. The second offset may be a notch located at the midpoint of the lock channel adjacent to the tip of the hook of the plunger lever and extending towards the actuation button. The pin capture channel may comprise the distal end of the lock channel.
Initially, the plunger pin may reside at a first stop position within the first offset and may prevent proximal movement of the plunger. When the actuation force is applied to the actuation button, the sliding lock may be forced to slide and the plunger pin may move out of the first offset. The plunger may then move proximally until the plunger pin is pressed against the plunger lever at a second stop position. The first dose may be dispensed during the proximal movement of the plunger. The actuation button may be released or held without further dispensing of the medication. When the actuation button is released, the one or more lock springs may force the sliding lock to slide such that the plunger pin moves to a third stop position within the second offset. With the plunger pin at the third stop position, proximal motion of the plunger is prevented.
When the actuation force is applied to the actuation button for a second time, the sliding lock may be forced to slide and the plunger pin may move out of the second offset. The plunger pin may press against the top of the hook of the plunger lever and may cause the plunger lever to flex away from the actuation button until the plunger pin aligns with the pin capture channel and the plunger may move proximally. A second dose of the medication stored within the device may be dispensed during the proximal movement of the plunger. Once the plunger pin is within the pin capture channel, the plunger pin may prevent the sliding lock from sliding. The actuation button may remain in the depressed position, indicating that the medication has been completely dispensed and the invention is no longer usable.
The upper housing and a lower housing may comprise the housing that encloses the medication applicator and the activator. A nozzle cap may removably couple to the proximal end of the housing to cover the nozzle. The nozzle cap may comprise a locking extension. When the nozzle cap is in place, the locking extension may penetrate the housing via a locking aperture in the lower housing and may press against the sliding lock such that the sliding lock is prevented from moving. Thus, when the nozzle cap is in place, the actuation button may be prevented from dispensing the medication if pressed unintentionally.
Although the preferred embodiment is described as dispensing two doses, those skilled in the art will recognize that more than two doses may be dispensed by modifications to the invention as described herein. As a non-limiting example, the lock channel may be modified to include additional offsets and plunger levers which define additional stopping positions for the plunger pin.
A first travel distance, defined to be the distance that the plunger travels between the first stop position and the second stop position, may determine the volume of the medication contained in the first dose. A second travel distance, defined to be the distance that the plunger travels between the third stop position and a fourth stop position, may determine the volume of the medication contained in a second dose. In a preferred embodiment, the first travel distance and the second travel distance may be substantially the same such that the first dose and the second dose are the same volume. However, those skilled in the art will recognize that the lock channel may be modified such that the first travel distance and the second travel distance are unequal and therefore a different volume of the medication is dispensed at each activation. Equally, the lock channel may be modified for additional travel distances of either equal or unequal distances to provide different volumes of a medication at each activation for which the device is configured.
In some embodiments, the housing may be configured to allow a spring cap located at the distal end of the housing to be removed for access to the interior of the housing. The spring cap may retain the dispensing spring against the plunger.
In a non-limiting example, for dispensing medication into the nasal passages of a user a first dose may be dispensed with the nozzle inserted into a first nostril and the second dose may be dispensed with the nozzle inserted into a second nostril. As a non-limiting example, the first nostril may be the left nostril and the second nostril may be the right nostril, or vice versa. The capacity of the cartridge may be selected such that both doses may be dispensed into a single nostril without harm. As a non-limiting example, the cartridge may have a capacity of 0.6 ml. The invention may dispense 0.3 ml upon the first activation of the actuation button. The invention may dispense 0.3 ml upon the second activation of the actuation button. Equally, the invention may be configured to deliver different volumes of a medication upon each activation, as well as increasing or decreasing the number of activations that are available to a user in a single cartridge. In a non-limiting example, an alternative dispensing regimen might involve dispensing 0.2 ml on a first actuation of the actuation button and 0.4 ml of a medication on a second actuation of the actuation button.
In use, the invention may be preloaded with the medication. The locking extension on the nozzle cap may prevent the medication from being dispensed if the actuation button is unintentionally pressed. The first dose and the second dose may comprise predetermined dosages of the medication that have been preloaded into the cartridge. The medication may be self-administered by the user once the nozzle cap has been removed. The first dose and the second dose may be individually dispensed by the user via the activator. The medication may be dispensed while the user is in an upright position by placing the nozzle into a nostril and pressing the actuation button to administer the first dose. The actuation button may be pressed and released or pressed, held, and released. The medication may be dispensed into the nostril as an aerosol mist and the aerosol mist may reach the nasal cavity adj acent to the sphenopalatine ganglion. The nozzle may be moved to the other nostril, inserted, and the actuation button pressed a second time to administer the second dose. The actuation button may be left in the depressed position after the second dose as an indication that the invention has been used and no further doses remain.
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The plunger 224 may move proximally (up in this figure) to dispense the medication. The sliding lock 320 may slide laterally under the influence of the actuation button 300 and the one or more lock springs 322. As the sliding lock 320 slides it may reposition the plunger pin 324 within the lock channel 330. The plunger 224 may move if there is no mechanical interference between the plunger pin 324 and the lock channel 330 or may be prevented from moving if there is mechanical interference between the plunger pin 324 and the lock channel 330. The actuation button 300 may comprise the one or more pivot arms 302 allowing the actuation button 300 to pivot when pressed. The spring cap 296 may removably couple to the upper housing 292 and the lower housing 294 via a threaded interface.
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The lock channel 330 may be a cut-out within the plunger 224. The lock channel 330 may comprise the first offset 332, the second offset 334, the plunger lever 336, and the pin capture channel 338. Initially, the plunger 224 will align with the plunger pin 324 at the first plunger position 280. Specifically, the plunger pin 324 will be located at the first stop position 350 within the first offset 332. As the dispensing spring pushes the plunger 224 to the left, the plunger pin 324 at the first stop position 350 may prevent the plunger 224 from moving.
When the actuation button is pressed for a first time, the sliding lock may be pushed down and the plunger pin 324 may drop. The plunger 224 may then be free to slide to the left such that the plunger pin 324 is relocated to a subsequent second stop position 352. Movement of the plunger 224 may be stopped when the plunger pin 324 encounters the plunger lever 336. The actuation button may be held down or released immediately. When the actuation button is released, the one or more lock springs may push the sliding lock up, moving the plunger pin 324 to the third stop position 354. Movement of the plunger 224 may be blocked by the plunger pin 324 when the plunger pin 324 is at the third stop position 354. In moving between the first plunger position 280 and the second plunger position 282, the plunger 224 may have caused the first dose to be dispensed.
When the actuation button is pressed for a second time, the sliding lock may be pushed down and the plunger pin 324 may drop. The plunger 224 may press down on the plunger lever 336, causing the plunger lever 336 to flex downward. When the plunger pin 324 is aligned with the pin capture channel 338, the plunger 224 may move to the left again. As the plunger 224 moves to the left, the plunger pin 324 may enter the pin capture channel 338 and may move to the fourth stop position 356. When the plunger pin 324 is within the pin capture channel 338, the plunger pin 324 may be prevented from moving upwards when the actuation button is released. Having the actuation button stuck in the pressed position is an indication that the device is spent. In moving between the second plunger position 282 and the third plunger position 284, the plunger 224 may have caused the second dose to be dispensed. In an alternative embodiment, additional doses may be configured to be dispensed by the addition of additional plunger positions.
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While certain illustrative embodiments have been described, it is evident that many alternatives, modifications, permutations and variations will become apparent to those skilled in the art in light of the foregoing description.
