Title:  Methods and kits for maxillary dental anesthesia by means of a nasal deliverable anesthetic

United States Patent:  6,413,499

Inventors:  Clay; Bryan M. (302 Oakmont Trail, Ridgeland, MS 39157)

Appl. No.:  567635

Filed:  May 9, 2000

Methods and systems for anesthetizing a portion or all of a patient's maxillary dental arch using a nasal delivered anesthetizing composition. The process generates anesthesia sufficient for facilitation of operative dentistry, endodontics, periodontics or oral surgery for teeth of the maxillary arch. The dental nasal spray process consists of inserting one or more dispensing devices through the patient's nostril and delivering metered dosages of anesthetic solution or gel into the nasal cavity. The process may utilize a single solution which is a mixture of anesthetic agents, vasoconstricting agents and other physiological inert agents or two separate solutions, wherein one solution contains the vasoconstricting agents and the other solution contains the anesthetic agents. Anesthetic diffusion through the thin walls of the nasal cavity allows for the blocking of nerve impulses originating from the maxillary dentition and surrounding tissues. Anesthesia of specific oral regions such as right versus left sides of the dental arch, anterior versus posterior teeth, and soft tissue anesthesia may be controlled through modification of the dosage volume and the selection of right or left nostril insertion and agent delivery.

SUMMARY AND OBJECTS OF THE INVENTION

The present invention relates to methods and systems for anesthetizing a patient's teeth and surrounding palatal tissues within the maxillary dental arch by means of a nasal deliverable anaesthetic. Such methods and systems eliminate altogether the need for painful needle injected local anesthetics when preparing a patient for dental work on the maxillary, or upper, dental arch. By this means, patients will have less fear and anxiety when visiting a dentist and will experience greatly decreased pain associated with the application of the local anesthetic preparatory to carrying out the actual dental procedure. Moreover, because the nasal delivered anesthesia is total, complete and more easily administered compared to needle injected anesthetics, there is less danger of the anesthetic not taking effect or prematurely losing its anesthetizing effect compared to needle delivered anesthetics. The delivery of the anesthetics through topical absorption in the nasal cavity also eliminates the potential for accidental intervascular administration of anesthetics, as can occur during the administration of local, needle-delivered nerve blocks.

The nasal deliverable anesthetizing composition comprises one or more anesthetizing agents, such as lidocaine, tetracaine, or benzocaine, together with an appropriate liquid or gel carrier. The anesthetic composition may also include one or more vasoconstrictors in order to ensure more rapid uptake of the anesthetizing agent and also to help maintain the anesthetic localized in the desired area. The carrier may include any appropriate liquid or gel which yields an anesthetic composition having a desired rheology, pH, absorbability, and the like. Any other active agent or passive constituent may be added in order to provide any desired benefit to the patient, manufacturer, or person administering the anesthetic.

The nasal deliverable anesthetizing method may be employed through delivery of a single mixture of one or more an anesthetic agents, one or more vasoconstricting agents and associated carriers, or through delivery of multiple solutions. Ideally, the sequence of multiple solution delivery would be delivery of the vasoconstricting composition, followed by delivery of the anesthetic composition. A time period of one to ten minutes between administration of the two components may be beneficial in order to allow for maximum vasoconstriction and opening of the nasal canals prior to administration of the anesthetic composition.

The anesthetic composition may be introduced into a patient's nasal cavity by means of any appropriate delivery system known in the art for delivering a nasal spray or nasal anesthetic. Examples include hand-held spray bottles, single dosage pump sprayers, pressurized aerosol canisters, pneumatically actuated sprayers, syringes or squeeze bottles equipped with tubular extensions, and the like. The delivery systems may be modified to provide for set dosages to be delivered. Atomizers or other means for providing a fine mist or spray are presently preferred, although the anaesthetic composition may certainly be applied as an non-atomized liquid, gel or even a solid, such as a powder. Delivery systems that better control the range or area of application may be better suited in anesthetizing only a portion of the patient's teeth rather than the entire maxillary dental arch.

The inventor, who is an ear, nose and throat specialist by trade, found that, after anesthetizing a patient's nasal cavity using a nasal delivered anesthesia preparatory to nasal procedures, the patient complained of extensive numbing of the upper dental arch, which the patient considered to be an undesirable side effect. Upon further analysis and inquiry, this unintended and undesired side effect of tooth numbing resulted from accidental application and absorption of the anesthetic in the region of the maxillary nerve and the pterygopalatine ganglion, a concentrated bundle of nerves located at the extreme rear upper end of the nasal cavity. The maxillary nerve is where the posterior, middle and anterior superior alveolar nerves collect, which are responsible for initially transmitting pain, temperature and pressure impulses generated by the nerves of the maxillary dentition and surrounding maxillary bone. After the impulses pass through the maxillary nerve and the main trunk of the trigeminal nerve, they are transmitted to the brain for processing and recognition.

The nasal deliverable anesthetizing compositions of the present invention are therefore believed to work by anesthetizing at least a portion of the branches of the maxillary nerve. Depending on the extent of anesthetization of the maxillary nerve and its associated branches, it is possible to numb the pain of part or all of the teeth and surrounding tissues of the maxillary arch. Moreover, introducing the nasal deliverable anesthesia into the left or right nasal cavities affects whether the left or right halves of the maxillary dental arch are anesthetized. This is fortunate, because it so happens that the teeth and surrounding tissue of the maxillary arch are the most painful and difficult parts of the mouth to properly anesthetize. By this means the dentist can more carefully control the location and extent of the anesthesia.

The surrounding facial gingival tissue (that which lies between the teeth and the lips) is not entirely anesthetized by the foregoing procedure, but may be readily and easily anesthetized by any desired means, such as by applying a topical anesthesia or a shallow and less painful injection of a local anesthesia.

The nasal deliverable anesthetic compositions of the present invention are unique in the field of dentistry. They offer the dentist, and more importantly the patient, a convenient and far less traumatizing method for obtaining profound anesthesia of the maxillary dentition, hard palate and soft palate. In particular, they offer complete elimination of patient fear of needle injections, as well as complete elimination of the pain associated with needle injections. The methods and systems of the present invention are far less technique-sensitive compared to needle injections. They eliminate, or at least reduce, the incidence of sharp biohazard wastes associated with used syringe needles. They eliminate the risk of accidental I.V. administration of local anesthetic/vasoconstricting solutions. They are completely effective in anesthetizing teeth with active infections that can render local, needle-delivered anesthetics ineffective due to inflammation and associated low pH. They provide partial or complete anesthesia of the maxillary dental arch without anesthetizing the lips. Finally, by alleviating the pain and fear associated with needle delivered anesthetics, they may encourage more people to seek help from a dentist in correcting health threatening dental maladies.

Accordingly, it is an object of the invention to provide improved methods and systems for delivering a local anesthetic in connection with painful dental procedures, which is less painful to administer compared to conventional needle delivered anesthetics.

It is an additional object and feature of the invention to provide methods and systems for delivering a local anesthetic in connection with painful dental procedures which eliminate the use of needle delivered anesthetics altogether, at least with respect to a portion of a patient's teeth, particularly at least a portion of the patient's maxillary dental arch, which is the most painful to anesthetize using a needle.

It is a further object and feature of the invention to provide methods and systems for painlessly anesthetizing a patient's teeth without the use of a needle, which further allows for the painless anesthetization of surrounding gingival tissues.

Claim 1 of 32 Claims

What is claimed and desired to be secured by United States Letters Patent is:

1. A method for selectively targeting and anesthetizing at least a portion of a patient's maxillary dental arch comprising:

(a) providing a nasally deliverable anesthetizing composition which includes a pharmaceutically effective amount of an anesthetizing agent; and

(b) selectively delivering a quantity of the anesthetizing composition into the rear of the patient's nasal cavity in order for at least a portion of the anesthetizing composition to be absorbed by nasal tissue located at the rear of the nasal cavity in the vicinity of at least one nerve responsible for transmitting pain impulses from at least a portion of the maxillary dental arch to the patient's brain in order to thereby selectively and remotely anesthetize at least that portion of the patient's maxillary dental arch.
 

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