Patent Description:
Certain types of pain associated with headaches and facial aches are known to respond to treatment by the direct application of anesthetic to the sphenopalatine ganglion or its surrounding region. The sphenopalatine ganglion (SPG) is a nerve bundle located toward the center of the head. The SPG is bilateral, and one is located behind each side of the nose. The SPG plays a unique role in headache disorders as a key structure responsible for the expression of cranial autonomic symptoms, most commonly seen in trigeminal autonomic cephalalgia. Cluster headache, which is one type of trigeminal autonomic cephalalgia, is a severe headache characterized by recurrent episodes of excruciating pain, often on one side of the head.

Conventional methods for treating pain associated with headaches and facial aches have many safety and efficacy problems, and patients experiencing severe pain are typically unable to travel to a physician's office for treatment before the pain intensifies. It is especially difficult to mitigate a full-blown cluster headache attack if the pain is not treated when the headache begins.

Although the anatomical position of the SPG makes it difficult to treat with a local anesthetic, a nerve block of the SPG has been known to provide effective relief in a variety of pain conditions. With this approach, anesthetic is applied to the SPG or its surrounding area by a trained medical professional, who typically inserts a cotton-tipped applicator soaked in the anesthetic into the nostril of the patient. Nasal catheter devices have also been used by physicians to administer medicament to the SPG or its surrounding area. The success of these methods depends heavily on the skill and experience of the physician, and patients experiencing severe pain are typically unable to receive treatment from a physician before the pain escalates.

Therefore, there is a need for improved nasal delivery devices and methods that enable patients to apply medicament on-demand for fast relief from head or facial pain, and to lessen or prevent reoccurrence. Document <CIT> discloses an example of nasal delivery devices and methods that enable patients to apply medicament on-demand.

Painful episodes associated with facial aches and headaches, such as cluster headaches and migraines, occur at varying frequencies from patient to patient. When a cluster headache occurs, it often takes too long for a patient to travel to a physician in order to receive local administration of medicament to the SPG, or its surrounding area, in order to prevent or mitigate a full-blown cluster headache attack. Therefore, it is desirable for a patient to be able to self-administer the medicament locally to the SPG or surrounding area using a compact and portable device for treating the cluster headache in a home setting, without the need of a physician or other trained medical professional.

A challenge for self-administered intranasal delivery devices is to ensure a safe and substantially pain-free insertion without having a trained professional position the delivery device and administer the medicament. There are several aspects of the present invention that help ensure proper positioning and medicament delivery, including, for example: a device capable of (<NUM>) sensing, via integrated sensors, a clear sinus passageway and autonomously steering itself into position; and/or (<NUM>) providing an external datum and direction-finding system to guide the patient in positioning the device so that insertion may be effected without the additional need for steering the catheter; and/or (<NUM>) steering itself automatically, and storing all motions during a training session performed by, and controlled by, a trained medical professional such that the device can subsequently "replay" the motions automatically when needed during self-administration.

In an aspect of the present invention, there is provided an intranasal device for the self-administration of medicament includes a body, a catheter, a feedback mechanism, and a delivery system. The body has a chamber to store the medicament. The catheter is configured to extend from the body and is in fluid communication with the chamber. A distal end of the catheter is configured for entry into a nasal passage of a patient. The feedback mechanism is configured to indicate a position of the distal end of the catheter within the nasal passage. The delivery system is configured to deliver the medicament from the chamber into the nasal passage via the catheter, wherein the delivery system comprises a centrifugal pump, a peristaltic pump, a piezoelectric pump, a motorized syringe, a pneumatically controlled syringe, a hydraulically controlled syringe, a pressurized reservoir using a software controlled valve arrangement or combinations thereof.

As used herein, delivery or administration of medicament "toward the SPG" and similar such phrases are intended to include the SPG itself and/or the surrounding region in proximity to the SPG, e.g., the pterygopalatine fossa which houses the SPG, which may include nearby tissue or mucous membranes.

All manner of medicaments suitable for introduction at or in the vicinity of the SPG are contemplated for use in accordance with the present invention. The term medicament is used herein to refer to a pharmaceutical formulation comprising one or more pharmaceutically active compound(s). Examples of suitable medicaments in accordance with the present invention include those that alleviate or eliminate pain associated with a facial ache or headache (e.g., cluster headache or migraine), such as anesthetics. Suitable medicaments may comprise one or more pharmaceutically active compound(s) selected from the group comprising or consisting of lidocaine, zolmitriptan, sumatriptan, ambucaine, amolanone, amylocaine, benoxinate, betoxycaine, biphenamine, bupivacaine, butacaine, butamben, butanilicicaine, butethamine, butoxycaine, carticaine, cocaethylene, cocaine, cyclomethycaine, dibucaine, dimethisoquin, dimethocaine, diperodon, dyclonine, ecgonidine, ecgonine, ethyl aminobenzoate, ethyl chloride, etidocaine, eucaine, euprocin, fenalcomine, fomocaine, hexylcaine, hydroxyprocaine, hydroxytetracaine, isobutyl p-aminobenzoate, leucinocaine mesylate, levoxadrol, meperidine, mepivacaine, meprylcaine, metabutoxycaine, methyl chloride, myrtecaine, naepaine, octacaine, orthocaine, oxethazaine, parethoxycaine, phenacaine, phenol, a pipecoloxylidide, piperocaine, piridocaine, polidocanol, pramoxine, sameridine, prilocaine, propanocaine, proparacaine, propipocaine, propoxycaine, pseudococaine, pyrrocaine, quinine urea, risocaine, ropivacaine, salicyl alcohol, tetracaine, tolycaine, trimecaine, veratridine, zolamine, all pharmaceutically acceptable salts thereof, and combinations thereof.

According to an exemplary embodiment, the medicament comprises lidocaine or a pharmaceutically acceptable salt thereof, wherein the medicament is used to treat, for example, pain associated with cluster headache.

Non-limiting examples of pain that may be treated by methods of the present invention include: cluster headache, sphenopalatine neuralgia, migraine headache, atypical facial pain, cancer pain of the head and/or neck, tongue and/or mouth pain, temporomandibular joint (TMJ) pain, Sluder's neuralgia, paroxysmal hemicranias, herpes zoster, postherpetic neuralgia, vasomotor rhinitis, complex regional pain syndrome (CRPS), reflex sympathetic dystrophy (RSD), lower back pain, post-traumatic headache, fibromyalgia and postdural puncture headache.

As used herein, the term therapeutically effective amount may refer to an amount that, when administered to a particular subject, achieves a therapeutic effect by inhibiting, alleviating or curing a disease, disorder or symptom(s) in the subject or by prophylactically inhibiting, preventing or delaying the onset of a disease, disorder or symptom(s). A therapeutically effective amount may be an amount which relieves to some extent one or more symptoms of a disease or disorder in a subject; and/or returns to normal either partially or completely one or more physiological or biochemical parameters associated with or causative of the disease or disorder; and/or reduces the likelihood of the onset of the disease, disorder or symptom(s). According to one embodiment, a therapeutically effective amount is an amount which achieves a therapeutic effect by alleviating or eliminating pain associated with a facial ache or headache, such as a cluster headache or migraine headache, e.g., by administering a medicament comprising lidocaine or a pharmaceutically acceptable salt thereof.

Furthermore, the claimed subject matter is not constrained to limitations that solve any or all disadvantages noted in any part of this disclosure.

A more detailed understanding may be had from the following description, given by way of example in conjunction with the accompanying drawings, wherein:.

Intranasal devices for insertion into a nasal passage for treating pain in a patient, such as pain associated with a cluster headache, are described. Unlike prior intranasal devices, the devices described herein may be used to self-administer a medicament in a home setting by a patient. The intranasal devices may be patient operated, and may be configured (programmed) based on the anatomy of the patient. The devices preferably include feedback mechanisms and controls to help the patient position the device within their nasal passage (e.g. nasal cavity).

Certain terminology is used in the description for convenience only and is not limiting. The words "proximal" and "distal" generally refer to positions or directions toward and away from, respectively, an individual or patient operating an intranasal device. The words "axial," "vertical," "transverse," "left," "right," "above," and "below" designate directions in the drawings to which reference is made. The term "substantially" is intended to mean considerable in extent or largely but not necessarily wholly that which is specified. The terminology includes the above-listed words, derivatives thereof and words of similar import.

<FIG> and <FIG> provide a front perspective view and a back perspective view, respectively, of an intranasal delivery device <NUM>, according to a first aspect of this disclosure. The intranasal delivery device <NUM> includes a body <NUM> and a position controller <NUM>. The body <NUM> has an upper portion <NUM> and a lower portion <NUM> (e.g. grip portion or handle portion). The upper portion <NUM> preferably extends at an angle from the lower portion <NUM>. The upper portion <NUM> includes a nostril insertion tip <NUM> configured for entry into a nostril of the patient. While not expressly illustrated in <FIG> and <FIG>, the upper portion <NUM> is preferably a replaceable medicament cartridge that comprises the medicament reservoir, and preferably both the catheter and medicament reservoir. The nostril insertion tip <NUM> defines a channel <NUM> that extends from an interior of the body <NUM> to an exterior of the body <NUM>. The channel <NUM> is configured to receive a tube (not shown) within. The tube may be, for example, a thin flexible tube such as a catheter. The catheter may be rigid, flexible, or a combination of rigid and flexible, such that the balance between rigidity and flexibility allows for advancement of the catheter into a nasal cavity without turning or getting caught. The catheter is also configured to minimize pain, discomfort, and injury during insertion. The configuration of the catheter may depend on, for example, the configuration of the delivery device to which the catheter is coupled, the method of treatment being performed, or other factors to facilitate positioning of the catheter. It will be appreciated that the embodiments of delivery devices described herein may include one or more configurations of the catheters.

The nostril insertion tip <NUM> may be coupled to a stopper surface <NUM> of the upper portion <NUM>. The nostril insertion tip <NUM> may be removable, washable, replaceable, and sanitizeable. The upper surface <NUM> may be a substantially flat surface, and the nostril insertion tip <NUM> may extend substantially perpendicular from the upper surface <NUM>. The nostril insertion tip <NUM> may include a single unit through which the catheter passes, or alternatively, the nostril insertion tip <NUM> may be telescopic and include two or more pieces which advance into the nasal cavity. The single unit insertion tip <NUM> may include a more rigid form so as to allow advancement of a more flexible catheter. The telescopic insertion tip <NUM> may include a series of one or more units which extend telescopically from the upper surface <NUM>. The one or more units may be rigid to allow for guidance of a flexible catheter inside the nasal cavity to a desired location. In an aspect, the telescopic insertion tip <NUM> may be stored within the delivery device <NUM>, such that the insertion tip <NUM> does not extend beyond the upper surface <NUM> until the device <NUM> is activated.

The lower portion <NUM> of the body <NUM> is configured to be gripped or held by a patient. In an aspect, the lower portion <NUM> is agnostic as to which hand or side the patient is using to grip the lower portion <NUM>. The lower portion <NUM> includes the position controller <NUM>, a medicament delivery control <NUM> (e.g. actuator), and a chamber (not visible in the figures). The position controller <NUM> is configured to control the movement of the catheter through the channel <NUM>. The movement includes advancing and retracting the catheter from the body <NUM>. In an aspect, the position controller <NUM> includes a thumbwheel that can be rotated by the patient to advance and retract the catheter. In an alternative aspect, the position controller <NUM> may also include a linear actuator, such as a motorized rack, piezoelectric motor (e.g. squiggle motor), pneumatic or hydraulic piston, or another controller configured to advance and retract a catheter. In another alternative aspect, the position controller <NUM> may include a small motor, such as a direct current (DC) brush or stepper motor, along with a pinch roller mechanism configured to grip the catheter to advance and retract the catheter with precision position control. The position controller <NUM> is preferably sized to at least partially fit within the body <NUM> of the device <NUM>.

The chamber is configured to store a medicament within. The chamber may be defined by the body <NUM>, or may be defined by a replaceable cartridge <NUM>, the replaceable cartridge being removable from the body <NUM>. The catheter is coupled, removably or non-removably, to the replaceable cartridge such that the catheter is in fluid communication with the chamber. In an aspect, the catheter may be attached to the replaceable cartridge such that the replaceable cartridge and the catheter are removable from the body <NUM> as a single unit.

The device <NUM> also preferably includes a feedback mechanism (not shown), a delivery system (not shown), and a power source (not shown). The feedback mechanism is configured to indicate a position of a distal end of the catheter within the nasal passage of the patient, as discussed in more detail below. The power source, such as a battery, is configured to provide power to either or all of the position controller <NUM>, the feedback mechanism, and the delivery system.

The delivery system is operatively coupled to the chamber, and is configured to deliver the medicament from the chamber into the nasal passage via the catheter. The delivery system may include a centrifugal pump, peristaltic pump, piezoelectric pump, motorized syringe, pneumatically controlled syringe, hydraulically controlled syringe, spring or memory metal controlled syringe, a pressurized reservoir using a software controlled-valve arrangement, combinations thereof, or other delivery system configured to deliver medicament.

A method for using the intranasal delivery device <NUM> for administering the medicament comprises the patient aligning the nostril insertion tip <NUM> with one of their nostrils. The nostril insertion tip <NUM> may be inserted into the nostril as far it can comfortably go or up until the nostril contacts the upper surface <NUM> of the upper portion <NUM>. The nostril insertion tip <NUM> may be made of a soft, conforming material or a material that is custom molded to the specific shape of the nostril for each patient. After inserting the tip <NUM>, the catheter may be advanced through the channel <NUM> of the tip <NUM> and inserted into the nostril and the nasal cavity. The catheter may be advanced by a first actuation of the position controller <NUM>, such as manually rotating the position controller <NUM>. Alternatively, the catheter may be advanced by pressing a button or an on/off switch to activate, for example, a motor operatively coupled to the catheter. The catheter may then be positioned adjacent to or in close proximity to the sphenopalatine ganglion (SPG). The positioning of the catheter is aided by the feedback mechanism, which provides feedback to the patient indicating whether the catheter is in position or needs adjustment. For example, the feedback mechanism could indicate the position of the distal end of the catheter by using visual or audible indicators, such as light indicators, textual information, audible feedback such as tone patterns and/or synthesized speech, vibration, combinations thereof, or other indicators to inform the patient of the position of the catheter. According to an embodiment, the device is programmed with instructions from a prior training session with a trained medical professional to guide the distal end of the catheter toward the SPG.

After the catheter is positioned within the nasal cavity, the medicament is delivered from the chamber toward the SPG region. The patient may deliver the medicament through the catheter using the delivery system. The delivery system may be activated by actuating the medicament delivery control <NUM> (e.g. second actuation). The medicament delivery control <NUM> may include a button or an on/off switch that activates, for example, a motor. Alternatively, the medicament delivery control <NUM> may include a pump, which may be manually operated to pump the medicament into the nasal cavity. The delivery energy could also be supplied by way of a pre-pressurized drug reservoir wherein the user controls a valve to release the medicament allowing the drug to be delivered by the stored pressure. The medicament delivery control <NUM> may also be activated based on catheter advancement. For example, after the catheter advances a predetermined distance (e.g. minimal distance) into the nasal cavity, the delivery control <NUM> may be automatically activated.

After the delivery of the medicament toward the SPG, the catheter is retracted from the nasal cavity. The catheter may be retracted by the patient by manually rotating the position controller <NUM> in a direction opposite to the rotation for advancement. Alternatively, if the catheter is advanced by pressing a button or an on/off switch to activate, a reverse or retract button or switch may be activated by the patient to retract the catheter. Once the catheter has retracted, the nostril insertion tip <NUM> is removed from the nostril of the patient. The nostril insertion tip <NUM>, the catheter, the replaceable cartridge, and any remaining medicament may be removed from the intranasal delivery device <NUM> and discarded.

<FIG> and <FIG> illustrate an alternate aspect of an intranasal delivery device. Portions of the aspect disclosed in <FIG> and <FIG> are similar to aspects described above in <FIG> and <FIG> and those portions function similarly to those described above unless specified otherwise.

<FIG> and <FIG> provide a front perspective view and a back perspective view, respectively, of an intranasal delivery device <NUM>, according to an aspect of this disclosure. The intranasal delivery device <NUM> includes a body <NUM>, a catheter <NUM>, and a stopper <NUM>. The body <NUM> includes an upper portion <NUM>, a middle portion <NUM> (e.g. grip portion or handle portion), and a lower portion <NUM>. The upper portion <NUM> defines a channel (not visible in the figures) that extends from an interior of the body <NUM> to an exterior of the body <NUM>. The channel is configured to receive the catheter <NUM> within. The middle portion <NUM> is positioned proximal to the upper portion <NUM>. The middle portion <NUM> may be shaped or configured to be easily held by the patient. A diameter of the center of the middle portion <NUM> may be less than a diameter of upper and lower ends of the middle portion <NUM>, forming a curvature that may be gripped, for example, between a thumb and index finger. In an aspect, the middle portion <NUM> is substantially hollow and comprises a flexible material that is compressible and expandable. The lower portion <NUM> of the body <NUM> is positioned proximal to the middle portion <NUM> and defines a chamber <NUM>.

According to a first embodiment, the medicament is stored within a medicament chamber in the upper portion <NUM>, wherein the chamber <NUM> is a bulb containing air that can pressurize the contents of the reservoir when the patient squeezes it. The upper portion <NUM> and the catheter may comprise a disposable portion that is fitted to the reusable portion (<NUM> and <NUM>), which may contain medicament delivery sensing and user feedback electronics. The catheter <NUM> is coupled, removably or non-removably, to the upper portion <NUM> such that the catheter <NUM> is in fluid communication with the medicament chamber contained within the upper portion <NUM>.

According to a second embodiment, the chamber <NUM> may be configured to store the medicament within. In this embodiment, the lower portion <NUM> is a replaceable cartridge that may be removed from the intranasal delivery device <NUM> and replaced with another cartridge. The catheter <NUM> is coupled, removably or non-removably, to the lower portion <NUM> such that the catheter <NUM> is in fluid communication with the chamber <NUM>. The catheter <NUM> extends through the upper portion <NUM> and the middle portion <NUM> of the body <NUM>. The catheter <NUM> may be attached to the lower portion <NUM> such that the lower portion <NUM> and the catheter <NUM> are removable from the body <NUM> as a single unit. In an aspect, the catheter <NUM> may be axially fixed to the body <NUM>, such that translation of the catheter <NUM> in and out of the body <NUM> through the channel is substantially prevented.

In other alternative embodiments, the middle portion <NUM> is only rigid in one plane, and flexible in the other plane. This allows pressure/squeezing in the flexible plane, and does not require the lower portion <NUM> to be flexible. The complete delivery device <NUM> may be disposable.

In accordance with the aforementioned embodiments described in connection with <FIG> and <FIG>, the stopper <NUM> is slidably attached to the catheter <NUM>. The position of the stopper <NUM> may be adjusted by translating the stopper <NUM> along the catheter <NUM> to a desired position, and may be configured based on the left or right nostril. When the desired position is achieved, the stopper <NUM> may be fixed or locked to the catheter <NUM> at that position. The desired position may be based on the anatomy of the patient, and may be determined by the prescribing physician. For example, the desired position of the stopper <NUM> may be based on the length and/or size of the nostril and the nasal cavity of the patient. The stopper <NUM> is sized to substantially prevent entry of the stopper <NUM> into the nasal passage.

The device <NUM> may also include a delivery system (not shown), a power source (not shown), and a sensor <NUM>. The delivery system and the power source may be configured substantially similarly as the delivery system and the power source of the intranasal delivery device <NUM>.

The stopper <NUM> and the sensor <NUM> may each compose a feedback mechanism configured to indicate a position of a distal end <NUM> of the catheter <NUM> within the nasal passage of the patient. It will be appreciated that the intranasal delivery device <NUM> may include either one of the stopper <NUM> or the sensor <NUM>, or both the stopper <NUM> and the sensor <NUM>. The stopper <NUM> may provide the patient with a tactile feedback. For example, the desired position of the stopper <NUM> on the catheter <NUM> may be at a position that defines a distal length (D) of the catheter <NUM> that is substantially the same as a distance from an opening of the nostril to the SPG region. When the patient inserts the catheter <NUM> into the nasal cavity, the patient will receive a tactile feedback when the stopper <NUM> contacts the nostril of the patient.

<FIG> illustrates a schematic of a feedback mechanism <NUM> that includes the sensor <NUM>. The feedback mechanism <NUM> includes a controller, such as an electronic control unit, which may facilitate the positioning of the catheter <NUM>. The feedback mechanism <NUM> further includes a processor <NUM>, a memory <NUM>, a display <NUM>, and an actuator <NUM>. While the feedback mechanism <NUM> is represented as a single unit, in other aspects the feedback mechanism <NUM> may be distributed as a plurality of distinct but interoperating units, incorporated into another component, or located at different locations on or off the intranasal delivery device <NUM>.

The sensor <NUM> is coupled to the distal end <NUM> of the catheter <NUM>. The sensor <NUM> may sense the position and orientation of the distal end <NUM> and provide feedback to the processor <NUM>. The sensor <NUM> may include, for example, an Inertial Measurement Unit (IMU), which is an electronic device that integrates the functions of both a 3D accelerometer and a 3D gyroscope. The processor <NUM> may be configured to output signals to the actuator <NUM> in response to signals received from the sensor <NUM>. The actuator <NUM> may include one or more actuators configured to actuate, for example, the delivery system and/or the position controller. The display <NUM> may also be coupled to the processor <NUM> to display various data to the patient relating to, for example, the position of the catheter <NUM> within the nasal cavity. Action may be taken in response to the data, including advancing or retracting the catheter <NUM>. In addition to feedback during use, the processor <NUM> may record usage information in memory <NUM> and provide the usage information to a mobile device (not shown) via, for example, a wireless link over a cloud network. The usage information may also be transferred to a healthcare provider for adherence, compliance, and/or emergency use information.

The method of operating the intranasal delivery device <NUM> may be substantially similar to the method of operating the intranasal delivery device <NUM>. Alternatively, a method for using the intranasal delivery device <NUM> for administering the medicament comprises positioning the stopper <NUM> on the catheter <NUM> at the desired position. The stopper <NUM> is then locked to the catheter <NUM> at the desired position. After the stopper <NUM> is locked, the patient aligns the distal end <NUM> of the catheter <NUM> with one of their nostrils, and inserts the catheter <NUM> into the nostril. In an aspect, the catheter <NUM> is axially fixed to the body <NUM>, such that insertion of the catheter <NUM> involves the patient moving the entire body <NUM> of the intranasal delivery device <NUM> towards the nasal cavity so that the catheter <NUM> is pushed into the nasal cavity. Alternatively, the catheter <NUM> may be inserted using a position controller as described above. The catheter <NUM> is inserted into the nasal cavity until the stopper <NUM> contacts the nostril.

After the stopper <NUM> contacts the nostril, the patient may then deliver the medicament toward the SPG. Delivery of the medicament toward the SPG may be performed using a delivery system as described above. Alternatively, delivery of the medicament may be performed manually by squeezing the lower portion <NUM>, which acts as a squeeze bulb, so that medicament is pumped out of the upper portion <NUM> and through the catheter <NUM>. In this embodiment, as described above, the medicament is stored in the upper portion <NUM>, wherein the chamber <NUM> is a bulb containing air that can pressurize the contents of the reservoir when the patient squeezes it.

Alternatively, the medicament may be pumped out of the chamber <NUM> by squeezing the middle portion <NUM> causing the medicament to be pushed through the catheter <NUM>. In this aspect, the middle portion <NUM> functions as a squeeze bulb. In this instance, the lower portion <NUM> may be formed of a rigid material, such that squeezing the middle portion <NUM> increases the pressure within the lower portion <NUM> causing the medicament to be pushed out of the chamber <NUM>. Alternatively, the lower portion <NUM> may be formed of a flexible material, and the medicament may be pumped through the catheter <NUM> by squeezing the lower portion <NUM>. The delivery device <NUM> provides for consistent delivery of a medicament to a desired location regardless of variable individual application of pressure.

After the delivery of the medicament toward the SPG, the catheter <NUM> is retracted from the nasal cavity. The catheter may be retracted by the patient using the position controller as described above. Alternatively, the patient may manually retract the catheter <NUM> by pulling the body <NUM> of the intranasal delivery device <NUM> away from the nasal cavity. Once the catheter has retracted, the catheter <NUM> and the replaceable cartridge <NUM> may be removed from the body <NUM> and discarded. Alternatively, the entire intranasal delivery device <NUM> may be discarded.

<FIG> illustrates another alternate aspect of an intranasal delivery device. Portions of the aspect disclosed in <FIG> are similar to aspects described above in <FIG> and those portions function similarly to those described above unless specified otherwise.

<FIG> provides a front perspective view of an intranasal delivery device <NUM>, according to an aspect of this disclosure. The intranasal delivery device <NUM> includes a body <NUM> and a position controller <NUM>. The body <NUM> has an upper portion <NUM> and a lower portion <NUM> (e.g. grip portion or handle portion). The upper portion <NUM> includes a nostril insertion tip <NUM> and an interlock switch <NUM>. Preferably, the upper portion <NUM> is a replaceable cartridge that also contains the medicament chamber and catheter. The nostril insertion tip <NUM> is configured for entry into a nostril of the patient. The nostril insertion tip <NUM> defines a channel <NUM> that extends from an interior of the body <NUM> to an exterior of the body <NUM>. The channel <NUM> is configured to receive a catheter (not shown) within. In an aspect, the nostril insertion tip <NUM> of the intranasal delivery device <NUM> may be configured substantially similarly to the nostril insertion tip <NUM> of the intranasal delivery device <NUM>.

The lower portion <NUM> of the body <NUM> is configured to be gripped or held by the patient. The lower portion <NUM> includes the position controller <NUM> and a medicament delivery control <NUM> (not visible in the figures). The medicament chamber of the upper portion <NUM> (not visible in the figures) is preferably disposed within the lower portion <NUM>. The position controller <NUM>, the medicament delivery control <NUM>, and the chamber of the intranasal delivery device <NUM> may be configured substantially similarly to the position controller <NUM>, the medicament delivery control <NUM>, and the chamber of the intranasal delivery device <NUM>, respectively.

The device <NUM> may also include a feedback mechanism (not shown) and a power source (not shown) configured substantially similarly to the feedback mechanisms and power sources of intranasal delivery devices <NUM>, <NUM>, <NUM>, and <NUM> described above.

The method of operating the intranasal delivery device <NUM> may be substantially similar to the method of operating either of the intranasal delivery devices <NUM> and <NUM> described above. Additionally, during the insertion of the nostril insertion tip <NUM> into the nostril of the patient, the interlock switch <NUM> may provide an indication to the patient that the intranasal delivery device <NUM> has been inserted fully into the nostril. In an aspect, the interlock switch <NUM> may be locked, and released only when the catheter is in the desired location. The interlock switch <NUM> may be spring loaded, and configured to compress against the upper lip of the patient.

<FIG> and <FIG> illustrate another alternate aspect of an intranasal delivery device. Portions of the aspect disclosed in <FIG> and <FIG> are similar to aspects described above in <FIG> and those portions function similarly to those described above unless specified otherwise.

<FIG> and <FIG> provide a front perspective view and a back perspective view, respectively, of an intranasal delivery device <NUM>, according to an aspect of this disclosure. The intranasal delivery device <NUM> includes a body <NUM> and a controller <NUM>. The body <NUM> has an upper portion <NUM> and a lower portion <NUM> (e.g. grip portion or handle portion). The upper portion <NUM> is preferably a replaceable cartridge comprising the medicament chamber and catheter(s). The upper portion <NUM> includes a pair of insertion tips <NUM>, an advance/retract switch <NUM>, a mouth member <NUM> (e.g. bite block), and a power control <NUM>. The mouth member <NUM> is configured to contact a mouth of the patient operating the device <NUM>, and may include a breathing window <NUM>, a teeth shelf <NUM>, or other features to facilitate positioning of the delivery device <NUM>. The mouth member <NUM> may be adjustable based on the anatomy of the patient. The mouth member <NUM> may be custom molded to the patient and preferably remains as part of the reusable body. The mouth member <NUM> may be configured to be removed and sanitized. The power control <NUM> is configured to actuate a power source of the device <NUM> between an "on" position and an "off' position.

The insertion tips <NUM> are configured to align with each nostril of the patient. The insertion tips <NUM> define channels <NUM> that extend from an interior of the body <NUM> to an exterior of the body <NUM>. The channels <NUM> are each configured to receive a catheter (not shown) within. In an aspect, each of the insertion tips <NUM> of the intranasal delivery device <NUM> may be configured substantially similarly to the nostril insertion tips <NUM> and <NUM> of the intranasal delivery devices <NUM> and <NUM>.

The lower portion <NUM> of the body <NUM> is configured to be gripped or held by the patient. The lower portion <NUM> includes the controller <NUM>. The medicament chamber contained in the upper portion <NUM> is preferably disposed within the lower portion <NUM>. The chamber is configured to store a medicament within, as described above. One or two catheters may be coupled to the chamber, such that each catheter is in fluid communication with a medicament stored within the chamber. Each of the one or two catheters extend from the chamber and through a respective channel <NUM>.

The controller <NUM> is configured to control a position controller to move the catheters through the channels <NUM>, and further configured to control a delivery system to deliver the medicament from the chamber into the nasal cavity via the one or two catheters. The position controller and the delivery system may be configured substantially similarly to the position controllers and delivery systems of the intranasal delivery devices <NUM>, <NUM>, and <NUM>. The controller <NUM> may comprise a "trigger," that may be actuated by the patient while holding the lower portion <NUM> of the body <NUM>. Switch <NUM> is used to select which side (left or right) is treated. Advancement and retraction of a single catheter along with dispensing of the medicament are preferably automatic in this embodiment once the patient presses and holds the trigger switch. Treatment is preferably applied one side at a time.

The device <NUM> may also include a feedback mechanism (not shown) and a power source (not shown) configured substantially similarly to the feedback mechanisms and power sources of intranasal delivery devices <NUM> and <NUM> described above.

The method of operating the intranasal delivery device <NUM> may be substantially similar to the methods of operating any of the intranasal delivery devices <NUM>, <NUM>, and <NUM> described above. Additionally, during alignment of the insertion tips <NUM> with each respective nostril, the patient also aligns the mouth member <NUM> with their mouth. In alternative aspects, the mouth member <NUM> may be aligned with, for example, the patient's teeth and/or chin. The patient may grip the mouth member <NUM> with their teeth. After alignment of the insertion tips <NUM> and the mouth member <NUM>, the intranasal delivery device <NUM> may be operated as discussed above.

<FIG> illustrate another alternate aspect of an intranasal delivery device. Portions of the aspect disclosed in <FIG> are similar to aspects described above in <FIG> and those portions function similarly to those described above unless specified otherwise.

<FIG> provides a front perspective view, <FIG> provides a back perspective view with a medicament cartridge attached, and <FIG> provides a back perspective view with a training cartridge attached, respectively, of an intranasal delivery device <NUM>, according to an aspect of this disclosure. The intranasal delivery device <NUM> includes a body <NUM> and a replaceable medicament cartridge 504a or training cartridge 504b. The body <NUM> has an upper portion <NUM> and a lower portion <NUM> (e.g. grip portion or handle portion). The upper portion <NUM> may extend at an angle from the lower portion <NUM> and/or be rotatable relative to the lower portion <NUM>. The upper portion <NUM> includes a nostril insertion tip <NUM> and a nose stop <NUM>. The nostril insertion tip <NUM> is configured for entry into a nostril of the patient, and may be rotatable (e.g. ball joint) to align with a respective nostril. The nostril insertion tip <NUM> defines a channel <NUM> that extends from an interior of the body <NUM> to an exterior of the body <NUM>. The channel <NUM> is configured to receive a catheter <NUM> within. In an aspect, the nostril insertion tip <NUM> of the intranasal delivery device <NUM> may be configured substantially similarly to the nostril insertion tips <NUM> and <NUM> of the intranasal delivery devices <NUM> and <NUM>.

The nose stop <NUM> includes at least one light emitting diode (LED) <NUM>. The nose stop <NUM> is configured to provide feedback to the patient during use of the intranasal delivery device <NUM> regarding the position and/or path of the catheter within the nasal cavity. For example, the at least one LED <NUM> may include different colored lights. One light may light when inserting the catheter, and once the catheter reaches a desired position, the light may turn off and another light may turn on, indicating to the patient that the catheter is positioned properly.

The lower portion <NUM> of the body <NUM> is configured to be gripped or held by the patient. The lower portion <NUM> includes the replacement medicament cartridge 504a (<FIG>) or the training cartridge 504b (<FIG>), a mouth member <NUM> (e.g. bite block), an liquid crystal display (LCD) display <NUM>, a lip recess <NUM>, a power control <NUM>, and a grip recess <NUM>. The mouth member <NUM> and the power control <NUM> may be configured substantially similarly to the mouth member <NUM> and the power control <NUM> of the intranasal delivery device <NUM>, respectively. The LCD display <NUM> may be configured substantially similarly to the display <NUM> of the intranasal delivery device <NUM>. The lip recess <NUM> is configured to contact a lip of the patient when the mouth member <NUM> is positioned proximate to the mouth of the patient. The grip recess <NUM> is configured for ambidextrous gripping of the lower portion <NUM>.

The replaceable medicament cartridge 504a and the training cartridge 504b are removable from the intranasal delivery device <NUM>. The replaceable medicament cartridge 504a includes a chamber (not visible in the figures), and the training cartridge 504b may include a chamber, a position controller <NUM> and a medicament delivery control <NUM>. The position controller <NUM>, the medicament delivery control <NUM>, and the chamber of the intranasal delivery device <NUM> may be configured substantially similarly to the position controllers <NUM>, <NUM>, and <NUM>, the medicament delivery control <NUM>, <NUM>, and the chambers of the intranasal delivery device <NUM>, <NUM>, and <NUM>, respectively. <FIG> shows an embodiment of a device that may be used during a training session by a physician, which includes a display <NUM>.

The device <NUM> may also include a feedback mechanism (not shown), a delivery system (not shown), and a power source (not shown) configured substantially similarly to the feedback mechanisms, delivery systems, and power sources of intranasal delivery devices <NUM>, <NUM>, <NUM>, and <NUM> described above.

It will be appreciated that the embodiments of delivery devices <NUM>, <NUM>, <NUM>, <NUM>, and <NUM> described herein may include one or more configurations of catheters. For example, each delivery device <NUM>, <NUM>, <NUM>, <NUM>, and <NUM> may include a catheter that is either rigid, flexible, or a combination of rigid and flexible, such that the balance between rigidity and flexibility allows for advancement of the catheter into a nasal cavity without turning or getting caught, as described in detail above.

The method of operating the intranasal delivery device <NUM> may be substantially similar to the methods of operating any of the intranasal delivery devices <NUM>, <NUM>, <NUM>, and <NUM> described above. <FIG> illustrates the intranasal delivery device <NUM> in an inserted position with the catheter <NUM> extended within the nasal cavity.

The intranasal delivery devices described herein are ergonomically designed so that the patient can comfortably hold and maintain a position of the device at the nostril during self-administration of a medicament. The patient does not have to know how far or how hard to insert and push the catheter to reach the desired position, which prevents injury. An advantage of a motorized intranasal delivery device is safety. The possibility of injury is greatly reduced with speed, position, and force feedback provided by a feedback mechanism in real time. For example, if excessive insertion force is detected, the device may be configured to stop advancement of the catheter and/or retract the catheter. The device may then provide information to the patient regarding a corrective action. Speed of inserting the catheter may also be controlled to avoid tissue injury.

An additional embodiment of the present invention is a kit comprising: (a) an intranasal device as described herein (optionally without the medicament chamber attached to the device) and (b) one or more replaceable cartridges, each replaceable cartridge comprising the chamber comprising the medicament. According to another embodiment, a kit comprises (a) an intranasal device as described herein (optionally without the medicament chamber and catheter attached to the device) and (b) one or more replaceable cartridges, each replaceable cartridge comprising the catheter and the chamber comprising the medicament. According to another embodiment, a kit comprises (a) an intranasal device as described herein (optionally without the medicament chamber and catheter attached to the device), (b) one or more replaceable cartridges, each replaceable cartridge comprising the chamber comprising the medicament, and (c) one or more catheters. The patient then assembles components of the kit before self-administering medicament; for example, by attaching the replaceable cartridge to the intranasal device. Each kit may include one or more replaceable cartridges comprising the medicament chamber and optionally one or more catheters (if the catheter is not included as part of the replaceable cartridge) to be used with the device for multiple dosing sessions. Each kit may also include one or more sanitizing wipes in a single package or individually packed.

Claim 1:
An intranasal device (<NUM>) for self-administration of a therapeutically effective amount of medicament toward the SPG, the intranasal device comprising:
a body (<NUM>) having a chamber configured to store the medicament;
a catheter (<NUM>) configured to extend from the body, a distal end of the catheter being configured for entry into a nasal passage of a patient, the catheter being in fluid communication with the chamber;
a feedback mechanism (<NUM>) configured to indicate a position of the distal end of the catheter within the nasal passage; and
a delivery system configured to deliver the medicament from the chamber into the nasal passage via the catheter,
wherein the delivery system comprises a centrifugal pump, a peristaltic pump, a piezoelectric pump, a motorized syringe, a pneumatically controlled syringe, a hydraulically controlled syringe, a pressurized reservoir using a software controlled-valve arrangement or combinations thereof.