Drug – bio-affecting and body treating compositions – Dentifrices
Reexamination Certificate
2000-05-09
2002-07-02
Krass, Frederick (Department: 1614)
Drug, bio-affecting and body treating compositions
Dentifrices
C514S535000, C514S537000, C424S450000, C433S215000
Reexamination Certificate
active
06413499
ABSTRACT:
BACKGROUND OF THE INVENTION
1. The Field of the Invention
The invention disclosed herein is in the field of anesthesia, more particularly the field of dental anesthesia. More particularly, the invention is in the field of nasal deliverable anesthesias that are sprayed or otherwise placed in the nasal cavity in order to numb the nerves associated with pain sensations generated by teeth and surrounding tissue within the maxillary dental arch.
2. The Relevant Technology
Most people fear going to the dentist. They equate visiting the dentist with pain. The most excruciating pain is typically caused by the drilling of cavities, root canal procedures, the pulling of teeth, crown and bridge work, and other procedures which disrupt, damage or otherwise put pressure on the pulp of a tooth and/or the surrounding maxillary bone and gingiva.
Various techniques have been employed to reduce the pain associated with the aforementioned dental procedures. The most common procedure to relieve or reduce dental pain is the application of a local anesthetic into the surrounding gingival tissue adjacent to the tooth. Alternatively, some dentists have found it useful to inject the anesthetic directly into the alveolar bone adjacent to the operative area. In many cases, application of the local anaesthetic by needle injection is itself very painful. The fear of needles is so great in some individuals that the injection can be more traumatic than the dental procedure itself. As between the upper and lower dental arches, most people believe that the pain associated with injecting a local anaesthetic to the upper dental arch is greater than with the lower dental arch.
Another source of fear is the possibility of failure of the anesthesia, which may result from incorrect placement of the anaesthetic. The duration of operative anesthesia may be unexpectedly short due to incorrect placement, the failure providing the correct dosage, or premature destruction of the anesthesia due to inflammation and associated low tissue pH. The proper dosage of anesthesia can vary greatly from one patient to the next, and can vary in the same patient due to biological variation, anxiety, fear, or infection in the area. The fear and anxiety associated with painful injections may actually deter some people from seeking dental work, even badly needed dental work required to relieve immediate pain and to correct serious acute or chronic conditions.
Complications can also occur with local injections. Locally, infections can occur and be transmitted through a contaminated needle. Improper placement of the needle can result in tearing or ripping of local tissue and nerves, as can delivering too large a volume of anesthetic to an area. Blood vessels can be lacerated when making regional blocks which may result in hematoma formation. In view of the foregoing, there has been a long-felt need to find alternatives to needle administered anesthesia.
One attempt at helping patients to overcome their fear of dental injections is the preliminary application of topical anesthetics in the form of gels, liquids, sprays, or patches to the gingival area where it is desired to insert the needle with the local anaesthetic. A topical anesthetic having a liquid or gel consistency and containing lidocaine, tetracaine, and adrenaline or epinephrine is described in U.S. Pat. No. 5,942,543 to Ernst. Another topical anesthetic gel composition, which purportedly aids in wound repair and hemostasis, is described in U.S. Pat. No. 5,563,153 to Mueller et al. The problem with topical anesthesia is at least two-fold: (1) patients still fear the needle and (2) the needle is still very painful once injected beyond the numbed gingival surface. In reality, topical anesthetics are only truly effective in relieving pain associated with superficial procedures such as suturing a laceration. Topical anesthetics do not effectively alleviate dental pain involving a tooth or the surrounding bone.
Yet another attempt at delivering a pain-free injection is disclosed in U.S. Pat. No. 5,180,371 to Spinello, which describes an aspirating hypodermic syringe capable of automatically injecting the dental anesthetic independent of squeezing by the dentists fingers. Spinello claims that the local anesthetic can be delivered even while the needle enters the tissue and then at different flow rates. The problem with the Spinello device is that it still involves an injection by a painful needle and, in view of the varying set flow rates intended to reduce pain, the length of time of the injection process is actually longer than manually performed injections. There is also the additional high cost of the device, both for the dentist and the patient. Attempts at improving the dental anesthetic pump are disclosed in U.S. Pat. No. 6,022,337 to Walter et al. and U.S. Pat. No. 5,368,572 to Shirota.
An attempt to alleviate a patient's fear and anxiety of a needle by eliminating the needle altogether is described in U.S. Pat. Nos. 5,366,489 and 5,496,363 to Burgio. The Burgio patents claim to provide a needleless method for relieving pain by means of electrical impulses applied to local tissues in an attempt to temporarily block nerve sensations. This method is referred to as “transcutaneous electrical nerve stimulation”, or “TENS”. In practice, the TENS method may actually provide enough blockage of sensation to allow for minor dental procedures, or to facilitate less painful injections for more involved dental procedures. However, this method has failed to save patients from having to endure painful injections when more intrusive and, hence, more painful, dental procedures are involved. Moreover, the TENS method has been associated with unpredictable results and has been generally ignored by the dental market. It is far more costly than simply providing topical anesthetics prior to dental injections.
One of the problems with anesthetizing teeth is the problem of accessing the nerves responsible for dental pain sensations. Because of the location of dental nerves, finding and numbing the nerves responsible for the pain sensation is not a very simple task. The same is not true for internal nasal tissues. Since internal nasal tissues include a large area of very thin mucous membrane tissue, topical anesthetics would be expected to be quite effective in immediately numbing pain for purposes of nasal surgery, such as the removal of polyps. This is in sharp contrast to teeth, which are completely immune to topical anesthetics applied thereto.
Accordingly, other interesting medical developments have been in the field of topical anesthetic sprays and aerosols used to deliver local anesthesia to the area of the larynx and respiratory system. For example, U.S. Pat. No. 5,571,071 to Shapiro discloses an improved laryngoscope blade having an attached anesthetic-containing reservoir for providing an anesthetic spray at one end of the blade. In addition, a fluid delivery means is included for providing anesthetic to other surfaces of the blade. U.S. Pat. No. 5,593,661 to Henry discloses the delivery of a selected dosage of lidocaine in an aerosolized form from a canister. The anesthetic so delivered is said to be useful in delivering anesthesia to a patient's respiratory system, either directly or by way of an airway.
In view of the foregoing, it would be an improvement in the art to provide improved methods and systems for delivering a local anesthetic in connection with painful dental procedures, which was less painful to administer compared to conventional needle delivered anesthetics.
It would be an additional improvement in the art to provide methods and systems for delivering a local anesthetic in connection with painful dental procedures which eliminated 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 upper dental arch, which is the most painful to anesthetize using a needle.
It would be a tremendous improvement in the art if such methods and systems for painlessly de
Jagoe Donna
Krass Frederick
Workman & Nydegger & Seeley
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