Abstract:
A device for use at least in conjunction with powdered, time-released, periodontal medication, with a view to improving at least upon problems associated with conditional applicators for such medications. Such a device may be in the shape of a hollow, half-cone with a tubular holding element attached to the top of the cone for rotational adjustments. The thin conical shape at the apex of the assisting device penetrates under the gum-line (into the gingival crevice) naturally. The device expands and maintains a sub-gingival space between the gingiva (gum-line) and the tooth. This allows the syringe tip to expulse the medication into the gingival crevice via at least three techniques.

Description:
FIELD OF THE INVENTION 
   The present invention relates generally to dental equipment and, more particularly, to dental implements that are configured for accessing gingival crevices. 
   BACKGROUND OF THE INVENTION 
   Periodontal disease and its treatment require an anatomic understanding of an important dental structure (i.e., physiological feature) known as the gingival crevice. This “gingival crevice” can be likened to how a turtleneck sweater fits around a person&#39;s neck. If one places a hand between one&#39;s neck and the turtleneck sweater, the intervening space could be likened to a gingival crevice. On one side of the hand, the neck could represent the white outer (enamel) surface of a tooth, or even the lower yellow part of the tooth&#39;s root surface. On the other side of the hand, the inside collar of the turtleneck sweater could represent the inside lining of the gum tissue surrounding a tooth. Again, the intervening space between the neck and turtleneck sweater would correspond to a gingival crevice. 
   It is well known that, immediately upon the completion of a dental cleaning, a distinct biological process begins. Saliva in the mouth coats the clean tooth, providing a sticky coating that attaches to the tooth structure. Bacteria in the mouth are then able to attach to the sticky coating and begin multiplying exponentially. During the bacterial lifecycle, the bacteria produce enzymes and toxins that are capable of entering the gingival crevice. Once inside the crevice, the bacteria release these enzymes and toxins which are able to create microscopic ulcers on the inside tissue wall of the gingival crevice. This can result in bleeding inside the gingival crevice, thus eventually allowing the bacteria to enter the microscopic holes created in the tissues of the gingival crevice. Once inside the gum tissue, the bacteria can destroy deeper structures such as connective tissues and blood vessels and could progress even deeper, perhaps eventually reaching and even destroying the bone that holds the teeth in place. 
   In the past, dental treatment has relied on the use of mechanical instruments to scrape the root and tooth structures that lie inside the gingival crevice in order to control the aforementioned disease process. There have even been attempts in the past to assist in the control of periodontal disease by using liquid or gel medications that are applied by thin metal or plastic syringe tips placed into the gingival crevice. Recently, however, the first “new generation” of time released sub-gingival powdered medications has been released commercially, as of the year 2001 (namely, the “ARESTIN” medication developed by Orapharma, Inc., of Warminster, Pa.). It is recognized that the administration of these and future medications will likely be dependent upon a syringe-like cartridge for application. 
   A current, conventional syringe tip is 1.5 mm wide on its outside tip diameter and will not easily begin to submerge into the gingival crevice; gingival crevices generally allow for the safe sub-gingival passage of structures that are, at a maximum, ½ mm wide. Another difficulty with this type of syringe/cartridge applicator is that it is rigid and cannot easily be angulated or rotated to reach many areas of the mouth. Therefore, a need has been recognized in connection with assisting in the application of medications to be placed inside the gingival crevice. 
   It is typical for the cell lining of the gingival crevice to adhere to the tooth&#39;s enamel or root surface. Ideally, then, the gingival crevice should be opened at its entry along the gum-line and then penetrated and expanded with deeper progression into the crevice. Maintaining this newly opened space is crucial in order to allow the medication to be applied in proper bulk and dosage. This means that the medication will easily enter the gingival crevice and fill up the potential space created by the assisting device. 
   Therefore, a need has been recognized in connection with providing an assisting device that may be reliably placed by a dentist. The device should preferably be constructed with enough strength and rigidity to withstand the biological resistances found in the tissue wall making up the gingival crevice. The device should also be readily adaptable to the medication applicator and yet be adjustable for individual patients. The device, also should not cause injury to the gingival crevice and should be comfortable for the patient. 
   A large need has thus been recognized in connection with providing an optimized, applicator-assisted device for delivering powdered medication. 
   In the context described hereinabove, the emergence of a time-released powdered medication since 2001 has increased the use of non-surgical treatment for periodontal diseases. Conventional plastic syringe tips used for the application of this (and future) medications is fraught with the following technical and biological problems:
         1. The syringe tip is too large to enter the gingival crevice comfortably and safely.   2. The medications are unable to reach the bottom of the crevice in a consistent manner.   3. The syringe tip is unable to carefully maintain an open space in the gingival crevice that is large enough to hold a full dosage of the medication.   4. The application tip of the syringe is not adjustable enough to alter angulations in a way that allows the syringe tip to enter the gingival crevice.   5. The application tip of the syringe is not adjustable at all for rotational movement in a way that allows the syringe tip to enter the gingival crevice.       

   Needs have thus also been recognized in connection with overcoming the above-listed problems and with providing a medication-assisting device that can be used in conjunction with an application syringe tip (or future applicator tips) of current and future medications. 
   SUMMARY OF THE INVENTION 
   It is believed that the items broadly contemplated herein can play a significant role in the future application of medications, time-released powdered or otherwise, that are placed locally into the gingival crevice. The newer time-released medications will most likely continue to be packaged and applied by a cartridge/syringe applicator similar to one mentioned heretofore. Therefore, it is believed that embodiments of the present invention will be well-suited to overcome the existing problems discussed heretofore. 
   In this vein, broadly contemplated herein is a device for assisting in the placement of sub-gingival, locally placed dental medications. It allows for locating and aligning a medication applicator during the initial entry into the gingival crevice. The assisting device then allows for the complete passage of dental medications into the deeper regions of the gingival crevice. This is followed by the safe removal of the assisting device upon completion of the applied medication. 
   In summary, there is broadly contemplated, in accordance with at least one presently preferred embodiment of the present invention, instrumentation for assisting in the administration of dental medication, the instrumentation comprising: a forward portion adapted for insertion into a gingival crevice; and a control portion adapted for facilitating maneuverability of the forward portion. 
   Further, there is broadly contemplated, in accordance with at least one presently preferred embodiment of the present invention, a method of administering dental medication, the method comprising the steps of: providing at least one cartridge adapted to administer medication to a gingival crevice; and providing instrumentation comprising: a forward portion adapted for insertion into a gingival crevice; and a control portion adapted for facilitating maneuverability of the forward portion; the forward portion being adapted to accommodate the at least one cartridge. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
     The present invention and its presently preferred embodiments will be better understood by way of reference to the detailed disclosure herebelow and to the accompanying drawings, wherein: 
       FIG. 1.0  is a perspective view of a hollow cone. 
       FIG. 1.A  is a perspective view of a cone with a plane cutting it in half. 
       FIG. 1.B  is a perspective view of one half of a cone 
       FIG. 1.C  is a perspective view of a half-cone and of parallel cuts to be made. 
       FIG. 1.D  is a perspective view of a completed base of an assisting device. 
       FIG. 2.0  is a perspective view of a hollow tubular structure for making up the holding element of the base of an assisting device. 
       FIG. 2.A  is a perspective view of a unified assisting device formed from a tubular holding element and assisting base. 
       FIG. 3.0  is a perspective view of a conventional hollow dental instrument handle. 
       FIG. 3.A  is a perspective view of a solid rod for fitting into a dental handle. 
       FIG. 3.B  is a perspective view of solid rod inserted into a dental handle. 
       FIG. 3.C  is a perspective view of a handle assembly incorporated into an assisting device. 
       FIG. 4.0  is a schematic side view which relates the size of a conventional medication applicator syringe tip to a gingival crevice. 
       FIG. 4.A  is a schematic side view similar to  FIG. 4.0  but showing an inventive assisting device. 
       FIG. 4.B  is substantially the same view as  FIG. 4.A  but additionally illustrating a manner by which an assisting device may open and maintain space in a gingival crevice. 
       FIG. 4.C  is substantially the same view as  FIG. 4.B  but showing full placement of an assisting device in a gingival crevice. 
       FIG. 5.0  is a bottom view of an assisting device with a medication syringe tip in place. 
       FIG. 5.A  is a schematic side view of an assisting device and medication syringe tip placed in a gingival crevice. 
       FIG. 6.0  is a side view of an assisting device illustrating a rotational fulcrum. 
       FIG. 6.A  is a schematic side view of an assisting device subsequent to rotation of the same towards a tooth while opening an apex of the assisting device. 
       FIG. 7.0  is a top schematic view showing the base of an assisting device in place. 
       FIG. 7.A  is substantially the same view as  FIG. 7.0 , but showing lateral and fulcrum movements of an assisting device. 
       FIG. 7.B  is substantially the same view as  FIG. 7.0 , but showing the simultaneous removal of an assisting device and placement of a syringe tip into a gingival crevice. 
       FIG. 7.C  is substantially the same view as  FIG. 7.0 , but showing the application of medication into a gingival crevice. 
       FIG. 8.0  is a top schematic view of an assisting device in a crevice. 
       FIG. 8.A  is substantially the same view as  FIG. 8.0 , but showing lateral and fulcrum movements of an assisting device. 
       FIG. 8.B  is substantially the same view as  FIG. 8.0 , but showing syringe tip placement into a crevice. 
       FIG. 8.C  is a side schematic view of an assisting device and syringe tip inside a gingival crevice. 
       FIG. 8.D  is substantially the same view as  FIG. 8.C , but showing a syringe tip inside a gingival crevice. 
       FIGS. 9.A  through  9 .E show, in perspective view, various ends and end portions that can be utilized in connection with, or associated with, syringe tips. 
   

   DESCRIPTION OF THE PREFERRED EMBODIMENTS 
   With reference to FIGS.  1 .A– 1 .D, an assisting device in accordance with at least one embodiment of the present invention can best be visualized by starting with the structure of a hollow geometric cone  100 . If such a cone  100  is then cut in half from top to bottom as seen in  FIGS. 1.A  and  1 .B, and then further cuts are made as shown in  FIGS. 1.C  and  1 .D, then a minimum diameter or radius of the modified structure  100  will be towards what was the apex of the cone. Preferably, the larger semi-circular portion at the top of the modified cone structure  100  will have a point Z that will serve as a locus of connection to a hollow tubular structure. The lowermost portion of the modified cone structure  100 , as shown in  FIG. 1.D  will preferably be thin enough and small enough to enter the 0.5 mm (or so) natural opening of a human gingival crevice. The problem  1  discussed previously is thus solved. 
   On the other hand, a hollow tubular structure  102 , as shown in  FIG. 2.0 , will preferably serve as a holding element for the basic body ( 100 ) of an assisting device having the previously described “modified cone” shape, with the result being a unified structure  104  as shown in  FIG. 2.A . This will further permit rotation of the assisting device  100 , thereby achieving easier entry into the gingival crevice at any position of the mouth. This thus solves problems  4  and  5  discussed previously. 
   Once the assisting device  104  enters a gingival crevice it will preferably serve to penetrate, expand and maintain the newly opened space. This thus solves problem  3  discussed previously. 
   Once inside a gingival crevice, assisting device  104  will preferably be operable via any conceivably suitable technique (three of which are explained herebelow) for applying medication to a fully opened gingival crevice. This solves problem  2  discussed previously. 
   In a “leveraged opening” technique, as illustrated in FIGS.  4 .A– 6 .A, that portion of the assisting device  104  that is concave preferably faces the tooth as it enters the gingival crevice. This can be seen clearly in  FIGS. 5.0  and  5 .A. As shown there, obtuse angle DFH forms a fulcrum at point F. This fulcrum permits the assisting device  104  to be pushed as a lever toward the tooth via the hollow tubular holding portion of the assisting device. In turn, the apex of the assisting device  104  is preferably moved in an opposite direction away from the root of the tooth, as seen in  FIGS. 6.0  and  6 .A. The rotational movement around the fulcrum points F and G allows the medication syringe tip to enter further past and reaching near the end of the assisting device,  FIG. 6.A . This allows a syringe tip to apply the medication past the assisting device and into the opened apex of the gingival crevice. 
   In a “shoehorn technique” (see FIGS.  7 . 0 – 7 .C), the assisting device  104  is made to slide easily into a gingival crevice and travel to the bottom of the crevice. The assisting device  104  is again preferably rocked back and forth at the fulcrum Points, F and G, stretching the gingival crevice away from the tooth and root. The assisting device  104  is then preferably removed from the crevice until only about 20% of the device remains in the crevice. At this point, the syringe tip applicator slides easily between the assisting device and the tooth, carefully entering the crevice. Once the syringe tip is about 1.5 mm inside the crevice it is possible to remove the assisting device. The syringe tip is now free to penetrate further into the gingival crevice and to apply the medication. 
   In a “time retraction” technique, the assisting device  104  is preferably placed fully into a gingival crevice. The device  104  is then preferably allowed to remain in the gingival crevice for 15 to 20 seconds while rocking the device periodically at the fulcrum Points F and G. This will stretch the inner walls of the gingival crevice away from the tooth. At the appropriate time, the assisting device is removed and the syringe tip applicator is placed into the space created by the assisting device. The syringe tip applicator can now penetrate further and the medication can be applied. 
   The disclosure now turns to a more detailed discussion of the functioning of an assisting device and handle assembly as a unified, functional unit and of the three prior discussed techniques for applying medications into local sites of the sub-gingival crevice that lie around teeth. 
     FIG. 1.0  shows a cone  100  upright with its wide mouth facing up and the sharp apex facing downward. 
   As shown in FIG  1 .A, by utilizing the plane ABC, one can visualize where the cone will be cut in half from top to bottom. 
     FIG. 1.B  shows the results of cutting the cone  100  in half from top to bottom. An additional point Z is shown as the mid-point of the remaining top of the cone. 
     FIG. 1.C  shows additional points placed on the cone. A single cut will preferably be made at line D-F, which will parallel the cut made at line E-G. The purpose of this cut is to create two obtuse angles, angle DFH, and angle EGI. These angles will act as a fulcrum against the tooth structure that they contact via. points F and G. An additional cut is preferably made beneath arc H-I, eliminating the apex of the cone entirely. 
     FIG. 1.D  shows the final result of the alterations discussed above. 
     FIG. 2.0  shows a hollowed out cylindrical tube  102  that is oriented vertically. The top part of the cylindrical tube is marked as point K. The bottom part of the cylindrical tube is marked as point J. 
     FIG. 2.A  shows the manner by which point J of the vertically oriented cylindrical tube  102  preferably attaches to point Z of the basic body of the assisting device  100 . The hollow tube  102  and basic body  100  make up a unified structure that can be referred to as the “assisting device”  104 . 
     FIG. 3.0  shows a conventional dental instrument handle, which may preferably be used here as a finger-grip. 
     FIG. 3.A  shows a cylindrical solid rod  108  having two separate angles, acute angle LMN and obtuse angle MNO. The cylindrical solid rod  108  also presents two attachment ends referred as point O and point L. 
     FIG. 3.B . shows point O of the cylindrical solid rod  108  connecting into point P of the hollow dental instrument handle  106 . The connection of these two pieces is preferably through a press fit that is non-movable and non-rotational. Once joined, these two pieces can be referred to as the “handle assembly,”  110 . 
     FIG. 3.C . shows how the handle assembly  110  and the assisting device  104  are preferably pressure fit together. This pressure fit at point L of the cylindrical solid rod to point K of the hollowed tube, however, allow for manual rotation between the handle assembly, and the assisting device  104 . The unified structure will henceforth be indicated at  111 . 
     FIG. 4.O . shows how a conventional medication applicator syringe-tip ( 112 ) will not fit passively into the gingival crevice  114 . The syringe tip here ( 112 ) is 1.5 mm wide, while the crevice  114 , as well-known, will typically only accept objects with a maximum width of 0.5 mm. Also shown, for a better understanding of this and other concepts, are tooth  116 , gums  118  and bone  120 . 
   In accordance with a “leveraged opening technique”,  FIG. 4.A . shows the assisting device  104  entering the gingival crevice  114  at an angle that allows parallel surfaces F-H and G-I (see  FIG. 1.D ), to contact the tooth structure ( 116 ) and begin sliding into the crevice  114 . The width of the tip on the assisting device  104  may preferably be around 0.5 mm, thus allowing gentle hand pressure to guide the device  104  easily into the crevice  114 . This begins the process of separating the internal wall of the gingival crevice  114  from the root, or enamel surface, of tooth  116 . It is recognized that patients find this easy to tolerate without local anesthesia. 
     FIG. 4.B . shows the continued separation of the gingival crevice  114  as the assisting device  104  penetrates halfway into the crevice  114 . The separation is maintained due to the gradual widening of the conical assisting device  104 . 
     FIG. 4.C . shows the full penetration of the assisting device  104  into the gingival crevice  114  while maintaining separation of the inner surface of the crevice from the tooth  116 . 
     FIG. 5.O . shows how the assisting device and a medication syringe tip  122  (containing powdered medication  124 ) appear when viewed from the vantage point of the root of the tooth. Points F and G represent the fulcrum of the assisting device  104  as it rests against the root of the tooth. A preferred 0.5 mm internal diameter of the syringe  122  is seen as it relates to the preferred circular shape of the assisting device tip. Once full penetration of the assisting device  104  into the crevice has occurred, the rocking of the fulcrum will open up (0.5 mm.), thus providing enough space for the medication to be expelled into the gingival crevice. 
     FIG. 5.A . shows the full penetration of the assisting device  104  into the crevice  114 . Point H is the most apical (i.e., bottom) portion of the assisting device  104  and rests against the root of the tooth at point T. (Though a slight separation is shown between points H and T in the drawing, this is merely for illustrative purposes; it should be understood that essentially no such separation is preferably involved.) Due to this tight juncture, it will essentially be impossible at this stage to release the medication  124  from the syringe tip  122  into the crevice. During this time, though, the assisting device  104  continues to maintain the separation of the inner surface of the crevice  114  from the root surface of the tooth  116 . The medication syringe tip  122  can be seen in place between the assisting device  104  and the root of the tooth  116 . Preferably, the syringe tip  122  will only be able to penetrate about halfway into the assisting device  104  at this moment. 
     FIG. 6.O . schematically shows a side view of the assisting device  104  as it rests next to the root of the tooth  116  during full penetration into the gingival crevice  114 . Shown is the manner in which the dental handle assembly  110  (see  FIG. 3.C .) can apply a force on the hollowed-out cylindrical tube  102  that makes up the superior portion of the assisting device  104 . The force from the dental handle allows the assisting device  104  to rock at a fulcrum formed by point F. The resultant action is to create a greater force (due to leverage) at the bottom of the assisting device  104 . The force at the bottom of the assisting device tip is in the opposite direction as the force applied to the superior portion of the assisting device  104 . This opposite force pressures the bottom of the gingival crevice  114  away from the tooth, allowing the medication syringe tip  122  (see  FIG. 5.A ) to slide deeper into the crevice and to consummately open a wider space between the assisting device  104  and the root surface of the tooth  116 . This allows for complete expulsion of the medication inside the syringe tip (see  FIG. 5.A ) into the gingival crevice  114 . The medication is thence compelled to migrate to the deepest portion of the crevice  114 . 
     FIG. 6.A . shows the assisting device  104  completely penetrating into the gingival crevice  114 . The dental handle or handle assembly (not shown) has placed an apical and rotational force on the upper portion of the assisting device  104 . This has caused pivoting about Fulcrum F of line F-D, toward the root of the tooth  116 . As a consequence of this pivotal movement about point F, the space between points H and T has increased. A change has thus occurred from essentially no opening (as seen in  FIG. 5.A ), to about a 1.5 mm opening here. The expansion of this space between points H and T thus allows the syringe tip  122  to freely release the medication into the bottom of the gingival crevice  114 . 
   In accordance with a “shoehorn technique”,  FIG. 7.O . first shows assisting device  104  in place with gingival crevice  114  open. Also shown are tooth  116  and gums  118 . 
     FIG. 7.A . illustrates a lateral and forward rocking motion of assisting device  104  to stretch the gingival crevice  114 . 
     FIG. 7.B . shows the assisting device  104  pulled out of the crevice  116  until only about 20% of it actually remains inside the crevice  114 . At this point in time the medication syringe  122  is preferably placed into the crevice  114  while in contact with the assisting device  104 . Once syringe tip  122  is inside crevice  114 , the assisting device is pulled out. 
     FIG. 7.C . shows the medication syringe tip  122  placing the medication into the crevice  114 . Preferably, medication will be expelled by positive pressure on a plunger attached to the syringe tip  122 . 
   In accordance with a “timed retraction technique”,  FIG. 8.0 . first shows the assisting device  104  in place, as in  FIG. 7.0 . 
     FIG. 8.A . shows lateral and forward rocking of the assisting device  104  in the crevice  114 . This is preferably followed by a 15–20 second holding period of the device  104  in place, so as to stretch a gingival crevice entry area. 
     FIG. 8.B . shows the space that may be left open by the 15–20 second holding of the device  104  in place. The medication syringe tip  122  can now easily enter the gingival crevice  114  and proceed to the base of the crevice  114  for the administration of the medication. 
     FIG. 8.C . shows a side view of the assisting device  104  (with syringe top  122 ) opening the gingival crevice  114 . 
     FIG. 8.D . shows the medication syringe  122  easily entering the gingival crevice  114  and passing further into the crevice to administer medication. 
   In both  FIGS. 8.B . and  8 .D., dotted lines show the maximum expansion of the gums  118  defining gingival crevice  114  before they start to relapse towards a “normal” position. The solid lines depicting gums  118  thus illustrate that there is still a sufficient opening for syringe tip  122  to be placed into crevice  114 . 
   Though particular embodiments of various components have been described hereinabove, it should be understood that a large variety of similar components, performing similar functions, are also broadly contemplated in accordance with the present invention. For instance, standard syringe tips, which are generally hollow and generally present no particular structural embellishments at the exit portion where medication is expelled, are generally contemplated in accordance with the embodiments of the present invention. However, a wide range of other possible syringe tips is broadly contemplated herein, or even other types of “ends” or “end portions” for delivering medication into a gingival crevice and even for providing functions similar to an assisting device as described heretofore. 
     FIGS. 9.A . through  9 .E. show, in illustrative and non-restrictive fashion, different “ends” or “end portions” for delivering medication into a gingival crevice. For example,  FIG. 9.A . shows a simple projection  302  integral with a syringe tip  122 ′. 
     FIG. 9.B . shows a single projection  304  on a syringe tip  122 ′. The projection  304  could be attached in essentially any suitable manner to syringe tip  122 ′ (e.g., via a snap-on connection), or could even be integral with it. 
     FIG. 9.C  shows an end portion  306  that can be freely attachable to a syringe tip, e.g. via a clamp-on connection, a screw connection, glue connection, friction fit, etc. 
     FIG. 9.D . shows a double projection  308  on a syringe tip  122 ′. The projection  308  could be attached in essentially any suitable manner to syringe tip  122 ′ (e.g., via a snap-on connection), or could even be integral with it. 
     FIG. 9.E . shows an end portion  310  that can be freely attachable to a syringe tip  122 ′ via a snap-on connection. To this end, syringe tip  122 ′ may include a suitable annular protrusion  312  or the like for being accommodated in a corresponding groove  314  or the like on end portion  310 . 
   It should be appreciated that the arrangements shown in  FIGS. 9.A . through  9 .E. are but representative of a wide variety of types of solitary instrumentation or add-on instrumentation that could be utilized for facilitating the delivery of medication to a gingival crevice and/or to “mimic” the functions of an assisting device as described heretofore (e.g., to assist in teasing open, retracting, prying or gaining entry into a gingival crevice). Thus, arrangements such as those shown in  FIGS. 9.A  through  9 .E could be used in conjunction with or instead of an assisting device as described heretofore. 
   If not otherwise stated herein, it may be assumed that all components and/or processes described heretofore may, if appropriate, be considered to be interchangeable with similar components and/or processes disclosed elsewhere in the specification, unless an express indication is made to the contrary. 
   If not otherwise stated herein, any and all patents, patent publications, articles and other printed publications discussed or mentioned herein are hereby incorporated by reference as if set forth in their entirety herein. 
   It should be appreciated that the apparatus and method of the present invention may be configured and conducted as appropriate for any context at hand. The embodiments described above are to be considered in all respects only as illustrative and not restrictive. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.