Delivery device and method for intranasal administration of topical therapeutic agents

The present invention provides a delivery device for intranasal administration of topical therapeutic agents to a desired site within a nasal cavity. The delivery device, in some embodiments, comprises a housing defining an interior and adapted to contain a supply of at least one therapeutic agent. The delivery device further includes a flexible connector, which is in fluid communication with the supply in the housing. A distributor, which is also integrally formed with the connector, is also provided. The distributor includes a proximal end that is in fluid communication with a distal end of the connector, and is adapted to receive the supply of the at least one therapeutic agent delivered by way of a conduit. The distributor further includes a distal end defining an outlet configured to diffuse the therapeutic agent when delivered to the treatment site.

FIELD OF THE INVENTION

This invention relates to a device and method for delivering a topical therapeutic agent in a nasal passage. It is particularly directed to medical devices and methods for delivery of diffused and predetermined amounts of therapeutic agents at a particular location in a nasal passage.

BACKGROUND

Migraines are a common type of headache that the American Headache Society (AHS) estimates to be suffered by approximately 28 million Americans aged 12 years and older. Migraine symptoms include a pounding headache, nausea, vomiting, and light sensitivity. These symptoms are traditionally treated with antinausea drugs and abortive or preventive medications. Headache remedies include pain relievers. A recent procedure that attempts to alleviate pain delivers an anesthetic, such as lidocaine, directly to nerves in the back of the nasal cavity to a nerve center known as the sphenopalatine ganglion.

A device that has been used for such a procedure includes a conventional syringe, an atomizer, and a connector. The connector is disclosed in U.S. Pat. No. 6,112,743. A shortcoming with such a system is that it is not suitable for home use for a number of reasons. First, the amount of therapeutic agent that is to be delivered to a site would need to be measured and carefully delivered by the user. Next, the rate of delivery of the therapeutic agent requires training and experience. Lastly, proper positioning of the atomizer at a treatment site is not within the knowledge of home users.

The present invention provides a device and method that overcomes such shortcomings. Other objects and advantages of the present invention will be made more apparent hereinafter.

SUMMARY OF THE INVENTION

The present invention provides a delivery device for intranasal administration of topical therapeutic agents to a desired site within a nasal cavity. For example, an anesthetic agent may be delivered with a device in accordance with the present invention to the sphenopalatine ganglion to produce desensitization thereof for the treatment of migraine headaches. The delivery device, in some embodiments, comprises a housing defining an interior and adapted to contain a supply of at least one therapeutic agent. In some embodiments, the housing may be fully enclosed with the supply contained therein. In other embodiments, the housing may include a closable opening into which a pre-measured supply of therapeutic agent may be received. The delivery device further includes a flexible connector. The connector is integrally formed with the housing and defines conduit and a proximal end, which is in fluid communication with the supply in the housing. In some embodiments the connector may be malleable such that it may be bent into a desired form that maintains its shape. In other embodiments, the connector may be relatively pliable and malleable such that no specific shape is maintained. A distributor, which is also integrally formed with the connector, is also provided. The distributor includes a proximal end that is in fluid communication with a distal end of the connector, and is adapted to receive the supply of the at least one therapeutic agent delivered by way of the conduit. The distributor further includes a distal end defining an outlet. The outlet is configured to diffuse the at least one therapeutic agent when delivered to the treatment site. Operatively connected to the supply in the housing is an actuator that causes the supply of the at least one therapeutic agent to be released from the housing through the conduit, through the distributor, and out of the outlet. In some embodiments, an indicator is provided on the connector. The indicator will provide the user with a guide so the user is able to determine how far to insert the distributor into the nasal cavity. This indicator my include markings. In a preferred embodiment, the indicator may comprise a hub adapted to contact the nostril when at the desired position.

One possible use for the present invention is to deliver a topical anesthetic agent, such as 0.5% Marcaine, to the sphenopalatine ganglion, i.e., SPG blocks, to produce desensitization of the ganglion for the treatment of migraine headaches. Another use for the present invention is to delivery topical anti-inflammatory and decongestant agents, such as Oxymetazoline, for the treatment of nasal congestion and sinusitis. The present invention may also be used to delivery variety of topical steroid agents, such as triamcinolone acetonide, for the treatment of seasonal allergies and hay fever.

There has thus been outlined, rather broadly, the more important features of the invention in order that the detailed description thereof that follows may be better understood, and in order that the present contribution to the art may be better appreciated. There are, of course, additional features of the invention that will be described hereinafter and which will form the subject matter of the claims appended hereto. Those skilled in the art will appreciate that the conception, upon which this disclosure is based, may readily be utilized as a basis for the designing of other structures, methods and systems for carrying out the several purposes of the present invention. It is important, therefore, that the claims be regarded as including such equivalent constructions insofar as they do not depart from the spirit and scope of the present invention.

It should be noted that the drawings of the invention are not to scale. The drawings are merely schematic representations, not intended to portray specific parameters of the invention. The drawings are intended to depict only typical embodiments of the invention, and therefore should not be considered as limiting the scope of the invention. The invention will be described with additional specificity and detail through the use of the accompanying drawings. In the drawings like numbering represents like elements between the drawings.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

There is shown inFIG.1of the drawings, a preferred embodiment of the present invention. The delivery device10comprises a housing12, which defines an interior14. The interior14is adapted to contain a supply16of at least one therapeutic agent. The supply16may be a liquid agent contained solely by the interior14. Alternatively, the supply may be an encapsulated aliquot of the therapeutic agent, discussed below. In the present embodiment, the housing is fully enclosed with the supply contained therein. The housing may be filled with a desired amount of the agent and then sealed. As such, there is no need for the user to measure the therapeutic agent to be delivered since the device is self-contained and ready-for-use.

A flexible connector18is provided. The connector18defines a distal end20and a proximal end22. The connector further defines an internal conduit through which the therapeutic agent may pass. The proximal end22of the connector is in fluid communication with the housing12, and more particularly, the supply16in the interior14of the housing. In order to maintain a sterile environment, the connector18is integrally formed with the housing12. By providing a self-contained unit, and not requiring a user to connect various parts of the device, the risk of introduction of contaminants is reduced or eliminated. The connector is preferably of a malleable material that enables it to be bent into a desired shape for use, as will be discussed in greater detail below. Use of a malleable material, while not required, allows for greater ease of use. This hub may provide the user with tactile feedback

The proximal end22of the connector18is connected, and preferably integrally formed with, and in fluid communication with a proximal end26of a distributor24. The distal end28of the distributor defines an outlet30. The outlet30is configured to diffuse, and preferably atomize, the supply16of therapeutic agent as it is urged out of the outlet30.

In some embodiments, the connector18may include an indicator such as markings33, and may further include a hub34. The indicator provides the user with an indication to allow proper positioning of the distributor24within the nasal cavity. For example, when used to deliver a topical anesthetic agent, such as 0.5% Marcaine, to the sphenopalatine ganglion, so as to provide relief from migraine headaches, the indicator, such as hub34, will be positioned on the connector18, such that when the hub contacts the user's nostril (FIG.2), the outlet30will be positioned approximately 3.5 to 4 cm from the nasal sill so the anesthetic is delivered to the sphenopalatine ganglion. When delivering other types of therapeutic agents where the desired location of delivery is a different distance from the nasal sill, the hub34would be positioned to accommodate such a delivery site. In so doing, the user need not make any decisions regarding proper delivery of the therapeutic agent.

Shown schematically inFIGS.1and2is an actuator36. The actuator36is operatively connected to the supply16in the housing12so that activation of the actuator will cause the supply to be transmitted from the housing12, through the connector18, through the distributor24and its outlet30. A variety of actuators may be utilized for this purpose, as will be understood by those skilled in the art. The actuator, utilizing a spring mechanism, would, when activated by depression of a button release mechanism, cause the contents of the supply chamber to be forced through the connector toward and through the distal atomizer for delivery at the target site.

Referring toFIG.2, a method of using the embodiment ofFIG.1is explained. A user will insert the distributor24into the nasal passage. In a preferred embodiment, the distributor may include a lubricant to make insertion easier. The distributor24and connector18are guided up into the nasal cavity until the hub34contacts the nasal sill. The user then activates the actuator36so that the supply16is urged through device10out of outlet30to the desired treatment site37. In this single-use embodiment, the device is then discarded.

In one example, delivery of 0.5% Marcaine to the sphenopalatine ganglion (SPG) for the purpose of desensitizing the SPG for the management of migraine headaches, the shield would be positioned at 3.5-4 cm from the atomizer to allow the atomizer to be advanced that distance within the nasal passage where the SPG is anatomically located. The arc of the connector would be curved approximately 45 degrees prior to insertion into the nasal passage and the atomizer distal end would be directed toward the ear on the same side. Such positioning would maximize the delivery of the agent to the SPG. Once sufficiently positioned, the activator button on the medication chamber is depressed and the treatment agent is released and transferred from the chamber, down the connector, and through the atomizer to reach its preferred target. Such a simple and effective mechanism can be performed by either a health care provider or as a home use device for self-administration by a patient. The predetermined aliquot of 0.5% Marcaine contained within the chamber ensures delivery of the proper dosage of the therapeutic agent.

While the previous embodiment depicted a single-use device, in other embodiments, the device may be reloaded. Referring toFIGS.3A-3C, a multi-use device110is shown. In many respects, this embodiment is similar to the previous embodiment. A difference, however, is that the interior114of the housing112may be accessed by the user by way of a closeable opening, such as lid116. Sealed supplies, such as supply118may be inserted by the user into the housing112. In this embodiment, the interior114of the housing112, may include, at its distal end120, a piercing structure122that is adapted to puncture the supply118so the therapeutic agent therein is connected to the connector124. In a preferred embodiment, the piercing structure122is configured to both pierce the supply118, while also creating a seal with the exterior of the supply so prevent loss of the therapeutic agent. In order to make the insertion of the supply even more user friendly, the supply118may include one or more slots126that are guided into cooperating guides128formed with the interior114of the housing112so the supply118is properly aligned. In a preferred embodiment, the closing of the lid116will cause the supply118to be urged against the piercing structure with sufficient force to connect the connector124to the therapeutic agent. Once the closeable opening is re-closed, device110is operated in the same manner as previously discussed.

Yet another version of a multi-use embodiment is shown discussed in conjunction withFIGS.4A-4B. In this embodiment, a multi-use device210is shown. In many respects, this embodiment is similar toFIGS.3A-3C. Similar toFIGS.3A-3C, the interior214of the housing212may be accessed by the user by way of a closeable opening, such as lid216. Sealed supplies, such as supply218and supply219may be inserted by the user into the housing212. In this embodiment, the interior214of the housing212, may include, at its distal end220, a pair of piercing structures222, which are adapted to puncture each of supply218and219so the therapeutic agent in each supply is connected to the connector224. The supplies218and219may be guided by cooperating guide228formed with the interior214of the housing212so each of supplies218and219is properly aligned. In a preferred embodiment, the closing of the lid216will cause supply218and219to be urged against the piercing structure with sufficient force to connect the connector224to the therapeutic agent. Such an embodiment is particularly useful where a therapeutic agent is to be delivered in separate nasal passages. The housing212, in this embodiment, includes two separate actuators236and237, which are shown schematically. It should be understood that a single actuator may be used to actuate delivery of each supply. In this preferred embodiment, the supplies are loaded by the device supplier, and the lid, when closed, is not re-openable without damaging the housing. This minimizes the possibility of tampering of the therapeutic agent, as well as greater control over the supplies loaded into the device. In this embodiment, the device210would allow for a separate delivery of therapeutic agent in separate nasal passages to complete a single treatment cycle with a single device.

In some situations, however, it may be desired that the supplies218and219may be reloaded. In such a circumstance, the lid216would include a latching mechanism, not shown, which would allow it to be selectably opened and closed.

While a presently preferred embodiment of the present invention has been shown and described, it will be apparent that modifications may be made without departing from the scope of the invention as defined in the attached claims.