Patent Publication Number: US-2016220340-A1

Title: Device for obtaining a bite registration impression

Description:
FIELD OF THE INVENTION 
     This invention relates generally to dental devices, and more particularly, but not by way of limitation, to a device for obtaining a bite registration impression which can be used in the manufacture of a variety of intraoral appliances, such as an appliance for treating sleep apnea. 
     BACKGROUND OF THE INVENTION 
     Obstructive sleep apnea is a relatively common disorder which can produce morbidity and mortality. The disorder arises during sleep when the victim undergoes repeated cessation of breathing. This cessation results from an obstruction of the throat air passage (i.e., pharynx) due to severe narrowing or a collapse of the throat air passage. Without enough oxygen, the brain has to wake up the patient enough to start breathing again. The patient may or may not be aware that they have stopped breathing. A sleep mate will often hear the patient gasp or choke when they are able to breathe again. People with mild sleep apnea may stop breathing only a few times an hour. People with severe sleep apnea can stop breathing as many as 80 times an hour. Repeated cessation of breathing reduces blood oxygen and disturbs sleep. Reduction in blood oxygen can cause hypertension, heart attacks and strokes. Additionally, sleep disturbances can produce excessive daytime sleepiness, headache, depression, irritability and cognitive impairments. 
     Various oral appliances and methods have been proposed for the treatment of sleep disorders. Many such appliances place the mandible in a protruded position that maintains an open air way by preventing the lower jaw from falling back and collapsing the airway. This in turn will allow patients to inhale more air per breath leading to a better night&#39;s sleep. Such appliances treat sleep disorders such as sleep apnea without the need for surgery, a mask, or medication. Oral appliances are typically fabricated by dental laboratories and are dependent on a dentist providing impressions taken from the patient&#39;s upper and lower teeth as well as the bite registration for aligning the upper and lower teeth in the final appliance. 
     Often, the first step in the construction of such oral appliances is the determination of a bite registration that protrudes the mandible between a natural biting position and maximum protrusive position. Conventional practice is to advance the mandible between 60% to 80% of maximum voluntary protrusion. This step may be accomplished with a George Gauge™. The George Gauge™ is an intraoral device that allows the clinician to register the correct jaw position, e.g., protrusive jaw position, for mandibular repositioning appliances. The George Gauge™ measures the protrusion and retrusion of the mandible. A fast setting material is then used to obtain the bite registration based upon the desired protrusive jaw position. 
     The second step is determining the vertical dimension of occlusion that can be incorporated into the oral appliance. Although the George Gauge™ enables the clinician to determine the correct position of the mandible in the protrusive, retrusive directions, it only provides limited assistance in determining the vertical dimension, which is critical for maintaining an open airway. Consequently, the dental appliance created for the patient can sometimes need to be created several times before the appliance works correctly. And, in some cases, the patient becomes dissatisfied with the overall lack of good results and gives up. Thus, there is a need for a device for obtaining a bite registration impression that enables the dental clinician to position the dentition of the mandible in relation to the dentition of the maxilla in three dimensions. 
     SUMMARY OF THE INVENTION 
     A device for obtaining a bite registration impression which may be used to manufacture an intraoral appliance is disclosed. The device includes a support platform arranged to fit within a patient&#39;s mouth. The support platform includes upper and lower planar surfaces for retaining thereon an impression making material configured to be imprinted with an impression of the patient&#39;s teeth. A positioning block fits within a slot of the support platform and includes a plurality of upward facing bite grooves arranged for engaging dentition of the maxilla, and a plurality of downward facing bite grooves arranged for engaging dentition of the mandible. The positioning block is provided to position the mandible with respect to the maxilla, such as in a protruded position for creating an impression used in the manufacture a sleep apnea appliance. 
    
    
     
       DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is an isometric view of the device for obtaining a bite registration impression which can be used in the manufacture of an appliance for treating sleep apnea; 
         FIG. 2  is an exploded isometric view of the device for obtaining a bite registration impression illustrating its two components including the support platform and the positioning block; 
         FIG. 2A  is an elevational view of alternative embodiments of the positioning block of the present invention, each positioning block varying in height from the others; 
         FIG. 3  is an isometric view of the device for obtaining a bite registration impression with impression making material placed thereover; 
         FIG. 4  is a sectional view taken along line  4 - 4  of  FIG. 3 ; 
         FIG. 5  is a side view of a mouth of a patient illustrating teeth of the maxilla and teeth of the mandible, with the mandible positioned in its natural biting position prior to insertion of the device of the present invention; 
         FIG. 6  is a side view, partially in section, of a mouth of a patient with the device of the present invention inserted therein to illustrate use of the device for creating a bite registration impression; 
         FIG. 7  is a side view, partially in section, of a mouth of a patient with the device of the present invention inserted therein to illustrate use of the device for creating a bite registration impression; and, 
         FIG. 8  is a top view of a resulting bite registration impression created by use of the device of the present invention. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     Referring now to  FIGS. 1 and 2 , wherein like numbers indicate like parts and components throughout the drawings, there is shown at  10  a preferred embodiment of the device for obtaining a bite registration impression of the present invention. The device  10  includes a support platform  14  and a positioning block  18 . All parts may be made of plastic and/or metal. The support platform includes an internal end including a generally U-shaped mandibular arch  22  formed of opposed forks  26   a  and  26   b.  (In this description, the term “internal” refers to inside the mouth or toward the inside of the mouth, and “external” refers to outside the mouth or toward the outside of the mouth.) As best shown in  FIG. 2 , the forks  26   a  and  26   b  are spaced apart by a predetermined distance to define an elongated slot  30  located therebetween, the slot extending distally to a keyhole opening indicated at  34 . The U-shaped mandibular arch  22  includes upper and lower planar surfaces on which a plurality of retention holes  36  are located to help secure an impression making material  38  onto the support platform  14 . At the external end of the support platform  14 , a handle  42  is provided which extends from the U-shaped mandibular arch  22 . The handle  42  may be integral with the U-shaped mandibular arch  22  or connected thereto. As shown in  FIGS. 1 and 2 , the handle  42  may include a scalloped surface to facilitate placement of the device  10  into the mouth of a patient and removal of the device  10  therefrom. The impression making material  38  is used in the casting of dental impressions ( FIG. 8 ) for use in creating an appliance for treating sleep apnea, and other uses. As should be apparent to someone skilled in the art, any thermoplastic, alginate or vinylpolysiloxine-based dental impression putty would be suitable for this purpose. 
     Referring again to  FIGS. 1 and 2 , the positioning block  18  may be a solid structure and may include a rounded end  46  arranged to fit through the keyhole opening  34  located at the distal end of the elongated slot  30  of the support platform  14 . The positioning block  18  is arranged to be inserted into and frictionally engage with the elongated slot  30 . The positioning block  18  is formed of an upper registration surface  50  which includes a plurality of bite grooves  54  and a lower registration surface  58 , also including a plurality of bite grooves  62 . Referring now to  FIG. 2A , the positioning block  18  could be provided as a set of positioning blocks  18  of varying height. That is, the distance between the upper registration surface  50  and the lower registration surface  58  of the positioning block  18  could be varied for each positioning block  18  in the set for the purpose of controlling the vertical dimension of occlusion to be incorporated into the oral appliance. 
     Referring now to  FIG. 7 , the bite grooves  54  are arranged for receiving one or more incisors  66  of the maxilla, while the bite grooves  62  are arranged for receiving one or more incisors of the mandible of a patient. The number of bite grooves  54 ,  62  located on the upper and lower registration surfaces  50 ,  58  in the figures is merely exemplary, and it is contemplated that a greater or fewer number of bite grooves  54 ,  62  could be utilized without departing from the scope of the invention. However, by providing numerous bite grooves in the upper and lower registration surfaces, a dental practitioner can precisely select an appropriate bite groove for placement of the incisors of the maxilla and mandible to obtain a suitable protruded position for obtaining a registration impression for use in creating an appliance for treating sleep apnea. 
     The series of steps which comprise the method of the present invention for obtaining a bite registration impression will now be discussed. First, as shown in  FIGS. 1 and 2 , a positioning block  18  of suitable height is selected and frictionally fitted into the slot  30  of the support platform with the rounded end  46  of the positioning block  18  inserted through the key hole  34  of the elongated slot  30  to obtain a proper positioning of the positioning block  18  within the slot  30 . Referring now to  FIG. 3 , the next step in the procedure is to cover all surfaces of the internal portion of the support platform  14  as well as all surfaces of the positioning block  18  positioned therein with a supply of pliable impression making material  38 . The impression making material can be formed of any suitable material commonly utilized for this purpose in the dental profession, e.g., an alginate or polyvinyl silaxane (PVS). 
       FIG. 5  illustrates the patient&#39;s mouth prior to insertion of the device  10  of the present invention, the patient&#39;s mouth including dentition  66  of the maxilla  70  and dentition  74  of the mandible  78 , the mandible  78  being shown in the natural biting position. Referring now to  FIG. 6 , the dental clinician then grips the handle  42  of the support platform  14  and, while holding the handle  42 , asks the patient to open his mouth and inserts the device  10  into the patient&#39;s mouth between the maxilla  70  and the mandible  78 . 
     The device  10  is then seated in the patient&#39;s mouth and pressed against the dentition  66  of the maxilla  70  in the direction of arrow  79  so that the impression making material  38  contacts and conforms to the dentition  66  of the patient&#39;s maxilla  70  only (i.e. the incisors, cuspids, and molars) while the handle  42  extends externally to the patient&#39;s mouth. As best shown in  FIG. 6 , one or more incisors  82  of the maxilla  70  contact the impression making material  38  and extends into one of the plurality of bite grooves  54  located on the upper registration surface  50 . Still referring to  FIG. 6 , the mandible  78  is shown therein in its natural biting position. As this stage, the dentition  74  of the mandible  78  has not yet contacted the impression making material  38  of the device  10 . 
     A recommended amount of mandible protrusion is then determined, or has previously been determined. As discussed above, the conventional practice for determining a recommended amount of mandible protrusion is to advance the mandible between 60% to 80% of maximum voluntary protrusion. Once that recommended amount has been determined, the dental clinician advances the mandible  78  to that position of protrusion (as indicated by arrow  81 ) and the patient is then instructed to bite firmly on the impression making material  38  and into the bite groove  62  of the positioning block  18 . Referring now to  FIG. 7 , as the patient bites (as indicated by arrow  87 ), the incisors  86  of patient&#39;s mandible  78  make contact with the impression making material  38  and extend into one of the plurality of bite grooves  62  of the lower registration surface  58  corresponding with the recommended amount of mandible protrusion. Likewise, the dentition  74  of the mandible  78  contacts the impression making material  38  which conforms to the dentition  74  of the patient&#39;s mandible  78 , thus creating a bite registration impression  90  ( FIG. 8 ) which can be used to manufacture an appliance for treating sleep apnea or any other device for mandibular positioning. 
     The device  10  should be left in the patient&#39;s mouth long enough to allow the impression making material  38  to set. After the impression making material  38  has set sufficiently to hold its own shape, utilizing the handle  42 , the dentist may remove the device  10  from the mouth of the patient. 
     The use of the terms “a” and “an” and “the” and similar referents in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein, is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention. 
     Preferred embodiments of this invention are described herein, including the best mode known to the inventors for carrying out the invention. It should be understood that the illustrated embodiments are exemplary only, and should not be taken as limiting the scope of the invention.