Abstract:
Apparatus and methods for providing a dental appliance that functions as an aspirator and tongue deflector. The aspirator has a proximal end and a distal end configured to be positioned at near a treatment location in the mouth of the patient. A tongue deflector is disposed on the distal end of the aspirator for controlling movement of the patient&#39;s tongue at the location. An elongate aspiration tube emanates at the proximal end of the aspirator and terminates at the tongue deflector for aspirating liquids at or near the treatment location. The aspirator tube has an aspiration channel running concentrically along the aspiration tube from the proximal end to a collection recess in the tongue deflector. The dental appliance may be fabricated such that the tongue deflector and aspirator are formed as one contiguous unitary piece.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    Not Applicable 
       STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0002]    Not Applicable 
       INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISC 
       [0003]    Not Applicable 
       NOTICE OF MATERIAL SUBJECT TO COPYRIGHT PROTECTION 
       [0004]    A portion of the material in this patent document is subject to copyright protection under the copyright laws of the United States and of other countries. The owner of the copyright rights has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the United States Patent and Trademark Office publicly available file or records, but otherwise reserves all copyright rights whatsoever. The copyright owner does not hereby waive any of its rights to have this patent document maintained in secrecy, including without limitation its rights pursuant to 37 C.F.R. §1.14. 
       BACKGROUND OF THE INVENTION 
       [0005]    1. Field of the Invention 
         [0006]    This invention pertains generally to dental appliances, and more particularly to an apparatus for deflecting the tongue, aspirating liquids, and maintaining the patient&#39;s mouth in an open position during oral surgery and other dental procedures. 
         [0007]    2. Description of Related Art 
         [0008]    A common problem for dentists and dental hygienists performing surgery and other dental procedures is the removal of saliva generated by the patient, removal of water used to cool high speed drills, and removal of water and other liquids used in connection with certain procedures. During most of these procedures, the dentist, dental assistant, or hygienist must manually place a suction tube in the patient&#39;s mouth for aspiration of liquids. And, in order to achieve proper and efficient aspiration, it is often necessary to hold the suction tube in place or to move it around in a vacuuming motion. 
         [0009]    In addition, it is often necessary for the dentist or dental assistant to deflect the patient&#39;s tongue away from the area in which work is being performed. And, during the time that the procedure is being performed, the patient undergoes stress in an effort to keep his or her mouth in an open position. 
         [0010]    As a result, the work space inside the mouth is reduced or otherwise encumbered by the various dental appliances being used by the dentist and the dental assistant. In addition, the patient&#39;s jaw muscles become tense and it be difficult for the patient to maintain the mouth in an open position. 
         [0011]    Various devices have been developed to assist the dentist while performing dental procedures. For example, U.S. Pat. No. 4,975,057 issued to Dyfvermark on Dec. 4, 1990, discloses a bite block having an aperture for insertion of a suction nozzle associated with an aspiration device. However, this particular device is not suited for use by patients who are missing teeth and cannot effectively clamp the bite block in place and, furthermore, does not provide for deflecting the tongue away from the work area. U.S. Pat. No. 4,024,642 issued to Zorovich on May 24, 1977, discloses a bite block coupled to an hour-glass shaped shield having a system of suction channels. This device, however, does not deflect the tongue, greatly restricts the dentist&#39;s work area, and requires external control of the level of suction. U.S. Pat. No. 3,924,333 issued to Erickson on Dec. 9, 1975, discloses a bite block with left and right tongue guards and a series of channels which communicate with an evacuation tube. This device, however, cannot be held in place where a patient has several missing teeth, cannot be easily installed and removed in the mouth, and is difficult to use. U.S. Pat. No. 3,090,122 issued to Erickson on May 21, 1963, discloses a receptacle for placement in one side of the mouth, and has apertures and drains for aspirating fluids. This device, however, is best suited for a reclining patient and severely limits the dentist&#39;s work space. 
         [0012]    Thus described have been devices which are independent of the handpiece used by the dentist. However, various tongue deflectors and shields can be found as attachments for a handpiece. For example, U.S. Pat. No. 1,004,118 issued to Waters on Sep. 26, 1911, discloses a handpiece mounted shield having slotted receptacles to allow the position of the shield to be changed for working on either side of the mouth. U.S. Pat. No. 1,067,571 issued to Abbott on Jul. 15, 1913, discloses a handpiece mounted shield which can be rotated from side to side. U.S. Pat. No. 2,671,269 issued to Francis on Mar. 9, 1954, discloses a tongue deflector for mounting to the head of a dental handpiece. U.S. Pat. No. 2,731,722 issued Wilen on Jan. 24, 1956, discloses a spoon-shaped tongue deflector and shield for attachment to a dental handpiece which has a tube for carrying a water spray. U.S. Pat. No. 2,924,013 issued to Wowra on Feb. 9, 1990; U.S. Pat. No. 1,516,933 issued to Terranova on Nov. 25, 1924; U.S. Pat. No. 1,152,122 issued to Samphere on Aug. 31, 1915; and U.S. Pat. No. 594,952 issued to Hoyer on Dec. 7, 1987, all disclose variously styled tongue and cheek shields for attachment to a dental handpiece. 
         [0013]    In addition to the deficiencies previously described, none of these devices provides a viable solution to deflecting the tongue, aspirating liquids, and maintaining the mouth in an open position while, at the same time, maximizing the unencumbered work area for the dentist. Ideally, a single, uniform dental appliance would provide for deflecting the tongue, aspirating liquids with variable suction level, and maintaining the patient&#39;s mouth in an open position. None of the devices heretofore developed, however, meets the existing need for such a device. The present invention satisfies that need. 
       BRIEF SUMMARY OF THE INVENTION 
       [0014]    An aspect of the invention is an apparatus for performing dental work on a patient. The apparatus comprises an aspirator having a proximal end and a distal end configured to be positioned at near a treatment location in the mouth of the patient. A tongue deflector is disposed on the distal end of the aspirator for controlling movement of the patient&#39;s tongue at said location. An elongate aspiration tube emanates at the proximal end of the aspirator and terminates at the tongue deflector for aspirating liquids at or near the treatment location. The aspirator tube has an aspiration channel running concentrically along the aspiration tube from the proximal end to the tongue deflector. The aspirator consists of a single, contiguous material such that the tongue deflector and aspiration tube form a unitary member. 
         [0015]    Generally, the aspirator comprises a rigid material (e.g. a hard thermoplastic) such that the tongue deflector is restricted from motion with respect to the aspiration tube. However, other materials known in the art may also be used. 
         [0016]    In one embodiment, the tongue deflector comprises a first (e.g. upper) surface having a recess, wherein the recess has a floor configured to facilitate collection of fluids at the location. The floor of the recess has a vacuum opening in communication with the aspiration channel to allow fluids to be directed from the recess of the tongue deflector, through the aspiration channel, to exit out the proximal end of the aspirator. 
         [0017]    In a preferred embodiment, the vacuum opening is disposed below the first surface to minimize contact of soft tissue with the vacuum opening. The vacuum opening is disposed normal to the aspiration channel such that fluids are drawn downward into the channel from the recess. 
         [0018]    In another embodiment, a bite tube is releasably and slideably attached to the aspirator. The bite tube is configured to support and stabilize aspirator in the patient&#39;s mouth, and to be positioned a varying points along the aspiration tube. The bite tube may comprise an open first end and an open second end, said first and second ends forming first and second tooth receptacles, whereby said bite tube is secured in the mouth by placing a tooth in at least one of said tooth receptacles and biting down on the bite tube. 
         [0019]    In one mode, at least a portion of the bite tube comprises a compliant material, e.g. Styrofoam or the like. 
         [0020]    In another embodiment, the tongue deflector comprises a second surface opposite the first surface, wherein the second surface has a tooling hole used to fabricate the aspirator as a unitary plastic injection mold. 
         [0021]    Another aspect is a method of fabricating a dental appliance for deflecting the tongue and aspirating liquids in the mouth of a patient undergoing dental work. The method includes the steps of disposing a core pin inside a mold cavity shaped to form an aspirator from a unitary piece of plastic, wherein the aspirator comprises a tongue deflector on its distal end and an aspirator tube on its proximal end, and an aspiration channel spanning along the aspirator tube from the proximal end to a location at the tongue deflector. The aspiration channel is formed by the core pin. The method further includes the steps of supporting the core pin inside the mold cavity with a support pin, and injecting plastic in the mold cavity to form the unitary aspirator around the core pin. Generally, the support pin creates a tooling hole in the aspirator. 
         [0022]    In one embodiment, the tooling hole is located within the tongue deflector. In another embodiment, the mold is configured to create a recess in the tongue deflector, wherein the recess is in fluid communication with the aspiration channel. 
         [0023]    Another aspect is a dental apparatus comprising an aspirator having an aspiration tube portion at its proximal end and a tongue deflector portion at its distal end, wherein tongue deflector portion is configured to be positioned at near a treatment location in a patient&#39;s mouth and extends laterally from an axis of the aspiration tube portion to control movement of the patient&#39;s tongue at the location. The aspiration tube section comprises an aspiration channel extending from the proximal end to the tongue deflector for aspirating liquids at or near the treatment location. The tongue deflector portion and the aspirator tube portion are formed from a single, contiguous, unitary member. 
         [0024]    In a preferred embodiment, the tongue deflector portion comprises a first surface having a recess with a floor configured to facilitate collection of fluids at the location. The floor has a vacuum opening in communication with the aspiration channel to allow fluids to be directed from the recess of the tongue deflector and through the aspiration channel to the proximal end of the aspirator. 
         [0025]    A bite tube may also be used, wherein the bite tube is configured to releasably and slideably attach to the aspirator tube portion; wherein the bite tube is configured to support and stabilize aspirator in the patient&#39;s mouth. 
         [0026]    Further aspects of the invention will be brought out in the following portions of the specification, wherein the detailed description is for the purpose of fully disclosing preferred embodiments of the invention without placing limitations thereon. 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S) 
         [0027]    The invention will be more fully understood by reference to the following drawings which are for illustrative purposes only: 
           [0028]      FIG. 1  illustrates a perspective view of the aspiration device of the present invention. 
           [0029]      FIG. 2  is a top view of the aspiration device of  FIG. 1 . 
           [0030]      FIG. 3  is a bottom view of the aspiration device of  FIG. 1  with the bite tube removed. 
           [0031]      FIG. 4  is a perspective view of the distal end of the aspiration device of  FIG. 1 . 
           [0032]      FIG. 5  shows a side view of the bite tube of the present invention removed from the aspiration device. 
           [0033]      FIG. 6  shows a front view of the bite tube of  FIG. 5   
           [0034]      FIG. 7  illustrates a side view of the aspiration device of  FIG. 1 . 
           [0035]      FIG. 8  illustrates an exemplary manufacturing setup for the aspiration device of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0036]    Referring more specifically to the drawings, for illustrative purposes the present invention is embodied in the apparatus generally shown in  FIG. 1  through  FIG. 8 . It will be appreciated that the apparatus may vary as to configuration and as to details of the parts, and that the method may vary as to the specific steps and sequence, without departing from the basic concepts as disclosed herein. 
         [0037]    Referring to  FIG. 1  through  FIG. 3 , the dental appliance  10  in accordance with the present invention includes an aspirator  12  having a tongue deflector  14  at its distal end  24 . The aspirator  12  tapers inward from the distal end  24  to form a generally cylindrical aspiration tube  16  that terminates at a proximal end  22 . 
         [0038]    The tongue deflector  14  and aspirator tube  16  form a unitary, contiguous member (aspirator  12 ) that is preferably constructed from the same material. Preferably, the aspirator  12  is fabricated from plastic or the like material that can be plastic injection molded as a unitary piece (described in further detail below). Preferably, aspirator  12  is either disposable or suitable for sterilization after use. 
         [0039]    The aspirator is generally sized to accommodate the anatomical features of the patient&#39;s mouth. Thus, dimensions may be varied to fit smaller or larger patients, or be sized to fit all patients. While, other dimensions can be used, it is generally preferred that tongue deflector  14  portion be approximately one inch (2.54 cm) wide or less, and approximately one inch (2.54 cm) in length. The aspirator tube  16  is sized to have a profile smaller than the tongue deflector  14 , e.g. having a diameter of approximately 0.25 inches. 
         [0040]    A tubular channel  18  extends generally concentric along the aspirator tube  16 , emanating at the proximal end  22  and terminating at opening  30 , which is located prior to the distal extreme  24  of the tongue deflector  14 . The outer diameter of the aspirator tube  16  is generally slightly larger than the diameter of channel  18 . 
         [0041]    Aspirator tube  16  extends beyond the proximal end of tongue deflector  14  in an elongate fashion to allow the proximal end  22  to extend out the patients mouth and accessible for coupling to a vacuum pump, e.g. by using a flexible hose or the like. By positioning the distal end  28  of aspiration tube  24  such that it is spaced apart from wall  20  in tongue deflector  12 , a vacuum gap  30  is formed through which liquids and small particles can be aspirated. 
         [0042]    The buccal (i.e. upper) surface  32  of tongue deflector  14  has a recess  26  forming a bowl or cup-like shape. Toward the distal end of the recess, and in between end  30  of the aspirator tube  16 , the floor of recess  26  is further recessed to form a vacuum opening  28 . Vacuum opening  28  allows vertical communication to the aspirator channel  18  from the recess  26 . The recess  26  allows fluids in the mouth to collect and be directed toward vacuum opening  28  and removed through channel  18  and out proximal end  22 . In addition, amalgam shavings can be placed directly into vacuum opening  28  and removed, thus decreasing any amounts of mercury that would otherwise be deposited in the mouth. 
         [0043]    The size of the vacuum opening  28  is sized to provide the proper amount of suction (i.e. strong enough suction to pull in fluids and other debris, and yet weak enough so not to pull in tissue from the patient&#39;s mouth). Generally, the dimensions of the opening  28  are sized to correspond to the vacuum pressure provided by most vacuum pumps used in the art. For example, the vacuum opening of the device shown in  FIG. 1  is generally rectangular, having sides of approximately 0.17″×0.17″. It is appreciated that the dimensions of the opening  28  may vary depending on the diameter of the aspirator tube channel  18  or vacuum pump. An exemplary range of side dimensions of the opening  28  may be from 0.12″ to 0.23.″ It is also appreciated that the opening  28  may comprise a non-rectangular shape, e.g. a circular shape. 
         [0044]    The device  10  of the present invention also acts as a defogging device, pulling moisture vapor out of the treatment region (e.g. where a mirror may be placed) of the patient&#39;s mouth and into to vacuum opening  28 . Thus, physician time is saved by use of the device because fogging of mirrors or like instruments is minimized or removed. 
         [0045]    The pre-set opening size of the vacuum opening  28  provides a number of advantages over existing devices. In the configuration shown in  FIGS. 1-3 , the vacuum pressure during operation is constant (unless varied externally by vacuum pump or other instrument), and can&#39;t be accidentally shut off or varied from any manipulation of the aspirator  12  in the treatment region of the patient&#39;s mouth. In addition, the one piece structure of the aspirator  12  (e.g. integral, contiguous aspirator tube  16  and tongue deflector  14 ) provides a more rigid interface, preventing motion of the aspirator tube  16  with respect to the tongue deflector  14 . In addition, the one-piece construction allows for a larger diameter aspiration channel  18 , without increasing the dimensions of the tongue deflector  14 . 
         [0046]    The recess  26  in buccal surface  32  also serves as a spacer to position vacuum opening  28  away from soft tissue in the mouth against which the buccal surface  32  and vacuum opening  28  would otherwise rest. This prevents soft tissue from being drawn into vacuum opening  28  and stopping the suction. This is particularly advantageous when used on periodontal patients who have surgery and have exposed cementum on the root surface. The exposed cementum is an area which is highly sensitive to vacuum or air and, therefore, it is important to be able to minimize suction. Even at times when very soft sublingual tissue might be drawn into vacuum opening  28 , due to the low vacuum level employed, no damage will result to the soft tissue that is drawn into opening  28 . 
         [0047]    As shown in  FIG. 7  the lingual (i.e. lower) surface  34  of tongue deflector  14  portion is generally flat, or slight convex curvature. The geometry of the lingual surface  34  gently holds the tongue away from the teeth and toward the mid area of the mouth, thereby limiting movement of the tongue and providing sufficient room for the dentist or hygienist to perform the required dental procedure. 
         [0048]    Referring to  FIGS. 1 ,  2 ,  5  and  6 , aspiration tube  24  is coupled to a bite tube  20 , which is configured to support and stabilize aspirator  12  in the patient&#39;s mouth. In a preferred embodiment, bite tube  20  is an elongate tubular member having an upper tooth receptacle  52  and a lower tooth receptacle  54 . It is appreciated, however, that bite tube  20  may comprise a number of shapes including cylindrical-shaped, triangular-shaped, and rectangular or like shapes. It will also be appreciated that bite tube  20  could be hollow or, alternatively, it could be a solid member with hollowed ends to form upper tooth receptacle  52  and lower tooth receptacle  54 . 
         [0049]    In one embodiment, bite tube  20  is fabricated from a lightweight rigid material such as plastic or the like. Alternatively, all or a portion (e.g. upper and lower ends) of the bite tube  20  may comprise a deformable material (e.g. Styrofoam, or the like) that allows the patient to sink their teeth into the bite tube 20 . 
         [0050]    The bite tube  20  is configured to be detachably received on the aspirator  12 . Bite tube  20  has a bore  36  that runs through the side of the bite tube  20  to form an anterior opening  38  and posterior opening  40 . This allows the proximal end  18  of the aspirator  12  to be extended through anterior opening  38  and posterior opening  40  for support. 
         [0051]    Referring now to  FIG. 7 , anterior opening  38  and posterior opening  40  are preferably displaced by an angle θ, so that aspiration tube  20  slants downward relative to a horizontal position. As shown in  FIG. 7 , angle θ is shown to be approximately 60 degrees. While an angle of 60 degrees is generally preferred, any angle (e.g. within a range of approximately 45 degrees through 90 degrees) could be employed. 
         [0052]    The bite tube  20  is secured in the patient&#39;s mouth by having the patient gently bite down to insert opposing (one upper and one lower) teeth in upper receptacle  52  and lower receptacle  54 , respectively. Alternatively, one tooth (either upper or lower) could be engaged in a receptacle and the other end of the bite tube supported by a cotton roll or the like between the bite tube and the gum tissue where an opposing tooth is missing. Note that the use of bite tube  20  is distinctly advantageous in that conventional bite blocks must be secured in place with several upper and lower teeth. The present invention, however, can be secured in place even though a patient is missing teeth. 
         [0053]    In one embodiment, a portion of a cotton roll or the like may be positioned to be retained in the upper and lower receptacles  52 ,  54 , thus providing extra stability and grip. 
         [0054]    In general, bite tube  20  is secured on the side of the mouth opposite from the side of the mouth on which the dental procedure will be performed so that the tongue is retracted away from the work area. Referring also to  FIG. 7 , it can be seen that different sizes of the mouth, as well as work area positions, can be accommodated by sliding aspiration tube  16  back and forth in bite tube  20  until tongue deflector  14  is in the desired position. For example, the device may be fit to an adult, or person with a wide arch, by sliding the bite tube  20  toward the proximal end  22  of the aspirator tube  16 . Accordingly, the bite may be fit to a child, or person with a narrow arch, by sliding the bite tube  20  toward the distal end  24  or tongue deflector portion  14 . 
         [0055]    Generally, the bore  36  has a diameter that is equal or slightly less than the outside diameter of the aspirator tube  16  so that a snug fit secures the bite tube  20  on the aspirator  12 , while allowing the aspirator tube  16  to rotate or translate within bore  36  with slight manual pressure. 
         [0056]    It should also be noted that aspirator  12  can be rotated 360 degrees about bite tube  20  so that the position of the tongue deflector portion  14  can be adjusted in the mouth while maintaining a constant suction level. This feature also permits the device to be used on either side of the mouth with ease. 
         [0057]    According to one embodiment of the invention, it is contemplated to use the aspirator  12  without the bite tube  20 . Referring to  FIG. 7 , there may be occasions where it is desirable to dispense with the bite tube  20  (e.g. sliding it off of the proximal end  22  of aspirator  12  (shown in phantom)) and to use a conventional dental handpiece or other dental instrument for support. In one embodiment, a standoff bracket or the like piece (such as that shown in U.S. Pat. No. 5,232,362, herein incorporated by reference in its entirety) could be used to couple aspirator  12  to the handpiece. In this configuration, the dentist or hygienist can reposition the tongue deflector  14  portion (and vacuum gap  30 ) as the handpiece is moved. 
         [0058]    Referring back to  FIG. 4 , the aspirator  12  also comprises a tooling hole,  50  located at the lingual surface  34  of the tongue deflector  14 . The tooling hole  50  allows the aspirator  12  to be manufactured as a one-piece construction. Although it is contemplated that the aspirator tube section  16  and tongue deflector  14  could be manufactured as separate pieces (i.e. extrusion) and then fused or bonded, it is much more preferable (from both a manufacturing cost standpoint, and from a functional standpoint as described above) to have the aspirator injection-molded as one piece. 
         [0059]      FIG. 8  illustrates an exemplary method for manufacturing the aspirator  12  of the present invention. As shown in  FIG. 8 , the aspirator  12  may be fabricated as a unitary plastic structure by plastic mold injection. To facilitate fabrication, a center core pin  70  is positioned in the mold cavity to construct the aspiration channel  18  of the aspirator  12 . To support the distal end  74  in its proper concentric position along aspirator tube  16 , a support pin  72  runs generally normal from the bottom surface  34  of the tongue deflector portion  14  (defined by the lower wall of the mold (not shown)). The support pin  72  accordingly creates tooling hole  50  that runs from bottom surface  34  into the aspiration chamber  18 . To minimize effect of the tooling hole  50  with the suction properties of the aspirator  12 , the support pin  72  can be sized to have a small diameter, e.g. 0.050 inches or less. Tooling hole  50  allows fabrication of a unitary aspirator structure  12  having a tongue deflector portion  14  and a aspirator tube portion  16 . 
         [0060]    Accordingly, it will be seen that the present invention provides for stabilization of the patient&#39;s mouth in an open position as well as deflecting the tongue while removing liquid which would otherwise accumulate in the mouth. Therefore, difficult dental procedures can be performed with minimal discomfort to the patient and with less distraction to the dentist which would otherwise occur where multiple dental appliances are required to serve the same function. For example, lower molar crown preparations or fillings on the opposite side of the mouth generally require retraction of the tongue by the dentist and use of a mouth mirror while trying to work on the lingual side of the tooth and trying to keep the area from filling up with saliva and debris. The present invention will serve to retract the tongue and keep the work area free of liquid at the same time, as well as to reduce back strain to the dentist or hygienist who would otherwise be using several dental appliances to accomplish the same task as the present invention. As a result, the dentist and hygienist can work more efficiently, thereby reducing the cost of the procedure. At the same time, the patient is made more comfortable while undergoing treatment. 
         [0061]    The aspirator of the present invention is uniquely configured so that the elongate aspirator tube and tongue deflector can be fabricated as a unitary piece through a single manufacturing step, thus decreasing manufacturing costs, and improving the functionality of the device. 
         [0062]    Although the description above contains many details, these should not be construed as limiting the scope of the invention but as merely providing illustrations of some of the presently preferred embodiments of this invention. Therefore, it will be appreciated that the scope of the present invention fully encompasses other embodiments which may become obvious to those skilled in the art, and that the scope of the present invention is accordingly to be limited by nothing other than the appended claims, in which reference to an element in the singular is not intended to mean “one and only one” unless explicitly so stated, but rather “one or more.” All structural, chemical, and functional equivalents to the elements of the above-described preferred embodiment that are known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the present claims. Moreover, it is not necessary for a device or method to address each and every problem sought to be solved by the present invention, for it to be encompassed by the present claims. Furthermore, no element, component, or method step in the present disclosure is intended to be dedicated to the public regardless of whether the element, component, or method step is explicitly recited in the claims. No claim element herein is to be construed under the provisions of 35 U.S.C. 112, sixth paragraph, unless the element is expressly recited using the phrase “means for.”