Abstract:
A sensor positioning and stabilizing device is provided. The sensor positioning and stabilizing device holds and stabilizes dental x-ray film or digital sensors during implant surgery with requiring a patient to bite down or manually hold it in position in order to take an x-ray.

Description:
RELATED APPLICATION DATA 
     This application is a continuation in part of U.S. application Ser. No. 13/359,152 filed Jan. 26, 2012, which claims the benefit of U.S. Provisional Patent Application Ser. No. 61/436,463, filed Jan. 26, 2011, the entireties of which are hereby incorporated by reference. 
    
    
     FIELD OF THE INVENTION 
     This invention relates generally to positioning devices for positioning, holding and stabilizing dental x-ray film or digital sensors during implant surgery. More particularly the invention relates to an improved dental positioning and stabilizing device that does not require a patient to bite down or manually hold it in position in order to take an x-ray. 
     BACKGROUND OF THE INVENTION 
     Dentists typically use intra-oral radiographs (“x-rays”) to obtain images of their patients&#39; teeth to aid in diagnosis and treatment. In traditional oral and dental radiography, an electronic sensor is placed in the patient&#39;s mouth behind the tooth to be examined. The electronic sensor or film is secured to a positioning device or is contained within a cartridge, typically cardboard or plastic. The sensor is placed behind the tooth while the holder extends through the bite area and the patient bites down on the holder to hold the sensor in place. The x-rays pass through the tooth and imprint on the sensor, which converts the x-rays into an electrical signal. The electrical signal is transmitted over a wire connected to a computer, either directly or though a module containing intermediate processing circuitry. The computer then processes the signal to produce an image on an associated output device, such as a monitor or a printer. Similarly, x-ray film can be exposed and developed to offer the same or similar view of the desired area 
     Numerous sensor holders have been marketed but in most conventional cases the patient must either bite down or use a finger to hold the sensor in place while the dentist or staff takes the x-ray. 
     Intra-oral x-rays are also required in dental implant surgery. Dental implant surgery is a procedure that replaces damaged or missing teeth with artificial teeth that look and function like real teeth. Dental implants are surgically placed in the jawbone, where they serve as the roots of missing teeth. To place the implant, the surgeon uses a dental drill including a driver and bit to drill through the patients&#39; tissue and bone. The titanium implant includes a threaded outer portion that is screwed into the bone by the driver. An abutment portion is coupled to the titanium implant and extends out of the patient&#39;s gum and into the oral cavity. A cosmetic tooth is then attached to the abutment portion. Dental implants are often placed close to adjacent teeth and drilling into the roots of adjacent teeth while placing implants can cause irreparable harm. Consequently, it is critical for the implant to be placed as substantially parallel as possible to the roots of the adjacent teeth. It would be ideal for the dentist to take an x-ray prior to removing the drill and drill bit from the patient&#39;s jaw/bone so that she could ascertain correct and substantially parallel placement of the drilled hole. However, this task is complicated by several factors. First, the drill bit being x-rayed is high above the occlusal plane. Therefore, if a bite block sensor holder were used and a patient had to bite down in an attempt to stabilize the sensor/film holder, the drill bit would interfere with the biting action thus preventing stabilization. Second, if the patient is sedated, they are unable to follow commands to bite down or hold the sensor with their finger. Finally, asking the patient to hold the sensor/film holder may introduce bacteria into the surgical field, resulting in possible contamination of the implant and associated bone graft products. 
     Thus, there is a need for an x-ray positioning device that departs from the conventional methodology of having a patient bite down on or hold the sensor/film cartridge or holder in place (referred to herein as “patient interference”). There is also a need for an x-ray positioning device that improves patient comfort. 
     BRIEF SUMMARY OF THE INVENTION 
     Accordingly, this invention provides a sensor positioning and stabilizing device which overcomes the above-mentioned problems. More specifically, the invention provides a sensor/film positioning and stabilizing device wherein the device is operably coupled to the drill bit or implant driver shank after the dentist drills through the patient&#39;s jaw bone. 
     The invention also provides a sensor positioning and stabilizing device which does not require a patient to exert any force on the device to hold it in place. 
     The invention also provides a sensor positioning and stabilizing device that eliminates the need for a bite holder. 
     The invention also provides a sensor positioning and stabilizing device that allows for easy removal of the sensor. 
     The invention also provides a sensor positioning and stabilizing device that may be used with sensors of any width, length or size. 
     The invention includes a finger positioning tab that provides the surgeon with greater freedom in orienting the sensor. 
     Still further, the invention is relatively thin, which also contributes to the improved ergonomics of the sensor positioning and stabilizing device, and enables the sensor to get closer to the target area, thereby improving the image data transmitted by the sensor to the computer. 
     Still further, the positioning and stabilizing system includes an elongate receiving channel having a longitudinal axis, said elongate receiving channel configured to slidably receive a drill bit or a shank of an implant driver; and a dental sensor operably coupled to said elongate receiving channel such that said dental sensor is substantially parallel to the longitudinal axis of said elongate receiving channel. 
     Moreover, the invention includes a dental sensor operably coupled to a positioning and stabilizing system comprising an elongate receiving channel for receiving an implant drill bit or shank of an implant driver wherein the dental sensor is substantially parallel to said elongate receiving channel. 
     Further features of the present invention will become apparent from the following detailed description taken with reference to the accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       For a better understanding of the invention, and to show how the same may be carried into effect, reference will now be made, by way of example, to the accompanying drawings, in which: 
         FIG. 1A  shows a drill bit extending from the gums of a patient into the oral cavity. 
         FIG. 1B  is an x-ray of the misaligned drill bit of  FIG. 1A . 
         FIG. 2  is a perspective view of the dental sensor positioning and stabilizing device in accordance with the invention. 
         FIG. 3  is a perspective view of a first alternative embodiment of the dental sensor positioning and stabilizing device in accordance with the invention. 
         FIG. 4  is a side view of the dental sensor positioning and stabilizing device in accordance with the invention. 
         FIG. 5  is a top view of the dental sensor positioning and stabilizing device in accordance with the invention. 
         FIG. 6A  is a top view of the dental sensor positioning and stabilizing device in accordance with the invention attached to an implant driver with the sensor placed behind the dental arch. 
         FIG. 6B  is a side view of the dental sensor positioning and stabilizing device in accordance with the invention with the device attached to a drill bit with the sensor place behind the dental arch. 
         FIG. 7A  is a perspective view of a second embodiment of a dental sensor positioning and stabilizing device in accordance with the invention. 
         FIG. 7B  is a top view of the embodiment of  FIG. 7A . 
         FIG. 8  is an x-ray of an implant that is correctly aligned in relation to adjacent teeth. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     As described above, the invention comprises a dental sensor positioning and stabilizing device for positioning, stabilizing and aligning dental x-ray sensors. The positioning device does not require a bite holder, block or other mechanism or any patient interference such as the patient biting down on the device or holding the device in place. As used herein, we refer to a “sensor” as encompassing both sensors and film. 
       FIG. 1A  shows the oral cavity of a sedated patient after the hole for the implant has been drilled. The shank portion of the drill bit can be seen extending into the oral cavity out from the gums by 1 to 2 centimeters and ostensibly appears parallel with adjacent teeth. As can be seen in  FIG. 1B , however, the drill bit is not parallel with the roots of adjacent teeth.  FIG. 1B  is an x-ray of a misaligned drill bit during implant surgery and highlights the problem that the present invention is designed to solve. In this case, if the drill bit was removed and an implant permanently placed the adjacent tooth root would be damaged irreparably resulting in possible tooth loss. In addition, if the implant is placed to close to an adjacent tooth at the most coronal aspect (near the crown) excessive bone loss can occur resulting in a poor aesthetic outcome. 
     Referring now to  FIGS. 2 through 5  an exemplary dental positioning and stabilizing device in accordance with an embodiment of the present invention is shown. Positioning and stabilizing device  10  includes integrally formed elongate arms  14 ,  16 , body  18  having first  30  and second  32  sides thereof and finger tab portion  20 . Body  18  comprises an elongate receiving channel  19  having a longitudinal axis and includes aperture  21 . Aperture  21  is sized to receive the shank portion of the drill bit (as best seen in  FIG. 1A ) that extends from the patient&#39;s gums and into the oral cavity after the implant hole has been drilled. Aperture  21  forms elongate receiving channel  19 . In an embodiment of the invention aperture  21  is sized such that the inner diameter is from approximately 2.45 mm to about 2.25 mm. Elongate receiving channel  19  is designed to slidably accommodate the shank portion of a dental drill bit or implant driver shank; however, elongate receiving channel is also designed to frictionally engage the shank portion of a dental drill bit or implant driver such that after the dental positioning and stabilizing device is in position on the drill bit, the device is securedly fixed on the drill bit. 
     Arms  14 ,  16  each include resilient flanges  22 ,  24 , respectively. Flanges  22 ,  24  act to operably and resiliently connect elongate arms to cylindrical-shaped body  18 . Those of skill in the art will appreciate that while body  18  is depicted as being circular or cylindrical-shaped many other shapes are contemplated and fall within the scope of the invention. Elongate arms  14 ,  16  are C-shaped in cross section and include sensor channels  26  which form clamps that are designed to grip the sensor and stabilize it in position. When stabilized in position, the sensor is substantially parallel to the longitudinal axis of elongate receiving channel  19 . By substantially parallel we mean that the sensor can be moved from being precisely parallel to the longitudinal axis of the elongate receiving channel to an acute angle off from the longitudinal axis of the elongate receiving channel  19 . In other words, the sensor can be positioned at an acute angle from the longitudinal axis of the elongate receiving channel, the acute angle being from 0.1 degrees to about 45 degrees. 
     Positioning device is formed from a resilient or flexible material such as polypropylene or the like such that flanges  22 ,  24  resiliently and easily pivot elongate arms  14 ,  16  from an initial position (shown) to a second open position. While in the second position, sensor channels  26  accommodate the dental sensor and then resiliently return to the initial position in which channels  26  snuggly surround the sensor so that it is stabilized within channels  26 . Arms  14 ,  16  are integrally formed with flanges  22 ,  24 . Flanges  22 ,  24  are integrally formed with and extend laterally from first side  30  of elongate channel  18 . Resilient flanges  22 ,  24  accommodate the resilient and flexible movement of arms  14 ,  16  from the initial position to a second position, as noted above. Those of skill in the art will appreciate that numerous embodiments that are within the scope of the invention are possible. For example, flanges  22  and  24  need not be integrally formed with body  18  but rather may be operably connected by adhesive, connecting tabs and other such means without departing from the scope of the invention. Similarly, one flange may extend laterally from a central body. Such one flange may include two resilient arms having channels which receive the sensor or film. Further, those of skill in the art will appreciate that any system designed to hold a dental sensor substantially parallel to the longitudinal axis of the elongate receiving channel and which does not require patient interference is within the scope of the invention. 
     Finger tab portion  20  is operably connected to and integrally formed with the second side  32  of body  18 . Those of skill in the art will appreciate that finger tab portion need not be integrally formed with circumferential body  18  but rather may be operably connected by adhesive, connecting tabs and other such means without departing from the scope of the invention. Finger tab portion  20  extends generally radially outward and slightly downward from said circumferential body  19 . Finger tab portion and includes upper  36  and lower  38  elements and tab portion  44 . Upper element  36  includes a first generally straight portion  34  that extends radially outward from second side  32  of circumferential body  18 . Lower element  38  includes curvilinear portion  40  and extends radially outward and downward from second side  32  of circumferential body  18 . Tab portion  44  extends laterally from upper and lower elements  36 ,  38 . Upper and lower elements  36 ,  38  and tab portion  44  are ergonomically designed so that the surgeon can easily grasp and precisely position the sensor positioning and stabilizing device  10  behind the teeth and an x-ray of the drill bit in the drilled hole can be taken (as best seen in  FIG. 1B ). 
       FIG. 3  depicts an embodiment of a sensor positioning and stabilizing device  300  in accordance with the invention in which the elongate receiving channel  319  is substantially longer in length than the embodiment depicted in  FIG. 2  and finger tab portion  320  extends radially outward and is substantially perpendicular to elongate arms  314 ,  316 . Those of skill in the art will appreciate however that elongate receiving channel  319  may be of any length to accommodate varying drill bit lengths and patient dental profiles. Positioning device  300  includes integrally formed elongate arms  314 ,  316 , body  318  having first  330  and second  332  sides thereof and finger tab portion  320 . Body  318  comprises an elongate receiving channel  319  with aperture  321 . Aperture  319  is sized to receive a drill bit or shank portion of an implant driver (as best seen in  FIG. 1A ) that extends from the patient&#39;s gums and into the oral cavity after the implant hole has been drilled. Elongate receiving channel  319  is designed to slidably accommodate the shank portion of a dental drill bit. 
     Arms  314 ,  316  each include resilient flanges  322 ,  324 , respectively. Flanges  322 ,  324  act to operably and resiliently connect elongate arms to circumferential body  318 . Elongate arms  314 ,  316  are C-shaped in cross section and include sensor channels  326  which form clamps that are designed to grip the sensor and stabilize it in position. Positioning device is formed from a resilient or flexible material such as polypropylene or the like such that flanges  322 ,  324  resiliently and easily pivot elongate arms  314 ,  316  from an initial position (shown) to a second open position. While the arms are in the open position, sensor channels  326  accommodate the dental sensor or film and then resiliently return to the initial position in which channels  326  snuggly surround the sensor so that it is stabilized within channels  26 . Arms  314 ,  316  may be integrally formed with flanges  322 ,  324 . Flanges  322 ,  324  in turn are integrally formed with and extend laterally from first side  330  of elongate channel  318 . Resilient flanges  322 ,  324  accommodate the resilient and flexible movement of arms  314 ,  316  from the initial position to a second position, as noted above. Those of skill in the art will appreciate that numerous embodiments that are within the scope of the invention are possible. For example, flanges  322  and  324  need not be integrally formed with body  318  but rather may be operably connected by adhesive, connecting tabs and other such means without departing from the scope of the invention. Similarly as described above, one flange may extend laterally from a central body. Such one flange may include two resilient arms having channels which receive the sensor or film. 
     As depicted in  FIG. 3 , finger tab portion  320  is operably connected to and integrally formed with the second side of body  318 . Finger tab portion  320  extends radially outward from circumferential body  318 . Finger tab portion includes tab portion  344 . Tab portion  344  extends laterally from straight portion  334  and is designed so that the surgeon can easily grasp and precisely position the sensor positioning and stabilizing device  300  behind the teeth and an x-ray of the drill bit in the drilled hole can be taken (as best seen in  FIG. 1B ). 
       FIG. 4  is a side view of the dental sensor positioning and stabilizing device  10  in accordance with the invention with detail regarding finger tab portion  20 . Finger tab portion  20  includes tab body  40 . Finger tab portion  20  extends generally radially outward and slightly downward from said circumferential body  19 . Finger tab portion and includes upper  36  and lower  38  elements and tab portion  44 . Upper element  36  includes a first generally straight portion  34  that extends radially outward from second side  32  of circumferential body  18 . Lower element  38  includes curvilinear portion  40  and extends radially outward and downward from second side  32  of circumferential body  18 . Tab portion  44  extends laterally from upper and lower elements  36 ,  38 . Upper and lower elements  36 ,  38  and tab portion  44  are ergonomically designed so that the surgeon can easily grasp and precisely position the sensor positioning and stabilizing device  10  behind the teeth and an x-ray of the drill bit in the drilled hole can be taken (as best seen in  FIG. 1B ). Finger tab portion  20  and thus dental sensor position and stabilizing device  10  may be oriented upwards or downwards depending on where the implant will be located, i.e. upper or lower gum line. Optional raised ridge  46  surrounds tab portion  44  and is designed to allow the surgeon to securedly grip finger tab portion  20 . 
       FIG. 5  depicts a top view of the sensor positioning and stabilizing device  10  in accordance with the invention showing detail regarding aperture flanges  22 ,  24  and C-shaped in cross section sensor channels  26 . 
       FIG. 6A  is a top view of the dental sensor positioning and stabilizing device  10  in use in accordance with one aspect of the invention. As can be seen, the positioning and stabilizing device  10  has been slidably received by an implant drill bit  60  through aperture  21  and into elongate receiving channel  19 . Sensor  62  is received within and held by sensor channels  26  thus allowing it to be easily positioned behind the dental arch  64  above the occlusal plane  66 . 
       FIG. 6B  is a side view of the dental sensor positioning and stabilizing device  10  in accordance the invention in operation. The dental surgeon first drills a hole through the patient&#39;s mucosa  70  and bone  68  as close as possible to a parallel position next to adjacent teeth. As can be seen, the positioning and stabilizing device  10  is then slidably received by the implant drill bit  60  as also seen in  FIG. 6A . Sensor  62  is positioned within sensor channels  26  and is moveably positioned from left to right by the finger tab portion  20  behind the dental arch  64  above the occlusal plane  66  into the correct position for taking an x-ray of the drill bit. With the drill bit in position, the dental surgeon next takes an x-ray and views it on a computer screen. If the drill bit is positioned parallel to adjacent tooth structure, the dental sensor positioning device is removed from the drill bit  60  and a second, larger drill bit is used to enlarge the pre-existing hole. The process of taking an x-ray may be repeated as many times as the surgeon desires to ensure that the hole into which the dental implant will be secured is parallel to adjacent tooth structure. If the x-ray shows that the initial drilling of the drill bit is not parallel then the sensor positioning device is removed and a second, larger drill bit is used to drill through the pre-existing hole to correct the path of the hole. The sensor positioning device is then place on the drill bit (with the drill removed) and another x-ray is taken to verify position. The dental surgeon may repeat the process as many times as desired to verify that the drill bit is correctly positioned and substantially parallel to the adjacent teeth. The drill bit is then removed and replaced with implant  72  as best seen in  FIG. 8 . 
     Referring now to  FIGS. 7A and 7B  an alternative embodiment of the dental sensor positioning and stabilizing device  710  in accordance with the invention is shown. Dental sensor positioning and stabilizing device  710  broadly includes sensor holder  712  having sensor face  713 ; body  714  defining a plurality of elongate receiving channels positioned perpendicular to a longitudinal axis  719  thereof, and actuator portion  719  defining first and second resilient arms  720 ,  722 . Body  714  may be integrally formed with sensor holder  712 , however, those of skill in the art will appreciate that body  714  can also be adhesively joined or snap fitted with sensor holder  712 . 
     In preferred constructions, sensor holder  712 , body  714  and actuator portion  719  may be integrally-formed as a single component. For example, in one construction, sensor holder  712 , body  714  and actuator portion  719  are injection molded as a single part in one manufacturing step. By integrally-molding the dental sensor positioning and stabilizing device  710 , the overall cost of the device is reduced. If the dental sensor positioning and stabilizing device  710  is integrally formed, a single material may be used in a single injection molding step. Alternatively, two different materials or any number of materials could be used to form the device. For example, a co-molding or two step injection molding process may also be employed. 
     Sensor face  713  preferably includes a sheath (not shown) that will be adhesively and removably coupled to sensor face  713  for holding a dental sensor (not shown). A plurality of elongate receiving channels  716 ,  717 ,  718  are positioned in body  714  perpendicular to a longitudinal axis  719  thereof and are structured to accommodate a drill bit. Drill bit may be positioned in first, second or third receiving channel depending on the particular patient anatomy involved. 
     Apertures  724 ,  725  and  726  are sized to receive the shank portion of a drill bit (as best seen in  FIG. 1A ) that extends from the patient&#39;s gums and into the oral cavity after the implant hole has been drilled. Apertures  724 ,  725 ,  726  form elongate receiving channels  716 ,  717 ,  718 . In an embodiment of the invention, apertures  724 ,  725 ,  726  are sized such that the inner diameter is from approximately 2.45 mm to about 2.25 mm. Elongate receiving channels  716 ,  717 ,  718  are structured to slidably accommodate the shank portion of a dental drill bit or implant driver shank; however, elongate receiving channels  716 ,  717 ,  718  are also designed to frictionally engage the shank portion of a dental drill bit or implant driver such that after the dental positioning and stabilizing device is in position on the drill bit, the device is securedly fixed on the drill bit. 
     Arms  720 ,  722  may be integrally formed with body  714 , however, those of skill in the art will appreciated that any structure that operably coupled arms  720 ,  722  to body  714  may be employed. Arms  720 ,  722  act to operably and resiliently couple with body  714 . Positioning device  710  is formed from a resilient or flexible material such as polypropylene or the like such that arms  720 ,  722  resiliently and easily move from an initial non-actuated position (shown) to a second actuated position  728  as shown by arrows as best seen in  FIG. 7B . When the surgeon pinches the arms to actuate the device to the second position, elongate receiving channels  716 ,  717 ,  718  open in response thereof allowing easy placement of the dental positioning and stabilizing device  710  over the dental drill bit or implant driver dental and then resiliently return to the initial non-actuated position in which elongate receiving channels  716 ,  717 ,  718  snuggly surround the sensor so that it is stabilized within channels  716 ,  717 ,  718 . As can best be seen in  FIG. 7B , coupling mechanism  730  transmits the actuation of arms  720 ,  722  from the initial non-actuated position to the second actuated position to elongated receiving channels  716 ,  717 ,  718 . 
     Those of skill in the art will appreciate that numerous embodiments that are within the scope of the invention are possible. For example, arms  720 ,  722  and sensor holder  712  need not be integrally formed with body  714  but rather may be operably connected by adhesive, connecting tabs and other such means without departing from the scope of the invention. 
     In operation the dental positioning and stabilizing device of  FIGS. 7A and 7B  are used as follows. The dental surgeon first drills a hole through the patient&#39;s mucosa  70  and bone  68  as close as possible to a parallel position next to adjacent teeth. The surgeon grasps actuator portion  720  and pinches it inwardly to move it from the non-actuated initial position to the actuated position which causes elongate channels to open so that the positioning and stabilizing device  710  may then slidably be received by an implant drill bit received through one of elongate receiving channels  716 ,  717 ,  718  depending on the particular patient anatomy. A sensor (not shown) is positioned within a sheath (not shown) that is operably coupled to the face  713  of the sensor holder  712  and may be moveably positioned from left to right by the actuator portion  719  behind the dental arch  64  above the occlusal plane  66  into the correct position for taking an x-ray of the drill bit. With the drill bit in position, the dental surgeon next takes an x-ray and views it on a computer screen. If the drill bit is positioned parallel to adjacent tooth structure, the dental sensor positioning device is removed from the drill bit and a second, larger drill bit is used to enlarge the pre-existing hole. The process of taking an x-ray may be repeated as many times as the surgeon desires to ensure that the hole into which the dental implant will be secured is parallel to adjacent tooth structure. If the x-ray shows that the initial drilling of the drill bit is not parallel then the sensor positioning device is removed and a second, larger drill bit is used to drill through the pre-existing hole to correct the path of the hole. The sensor positioning device is then place on the drill bit (with the drill removed) and another x-ray is taken to verify position. The dental surgeon may repeat the process as many times as desired to verify that the drill bit is correctly positioned and substantially parallel to the adjacent teeth. The drill bit is then removed and replaced with implant  72  as best seen in  FIG. 8 . 
       FIG. 8  depicts an x-ray taken with the sensor positioning and stabilizing device  10 ,  710  in accordance with the invention. As can be seen and compared to the angled drill bit depicted in  FIG. 1B  the implant  72  can be seen to be correctly positioned and substantially parallel to the adjacent teeth. 
     Advantageously, the sensor positioning and stabilizing device in accordance with the invention is supported by a drill bit thus eliminating the need to have a patient bite down on, manually hold the sensor/film cartridge or holder in place, or otherwise stabilize the device. The sensor positioning and stabilizing device in accordance requires no patient interference. 
     While the invention has been particularly shown and describe with respect to exemplary embodiments thereof, those of ordinary skill in the art will appreciate and understand that changes in form and details may be made without departing from the scope and spirit of the invention.