Abstract:
An improved orthodontic tensioning device having an elastomeric resilient body portion and first and second connectors which are securely attached to the elastomeric resilient body portion and have elements for connecting with a connecting structure. 
     The orthodontic tensioning device preferably is applied by the orthodontist thus eliminating any dependency on the patient to faithfully wear his elastics. This provides control by the dental professional, and generally may improve results by reducing or eliminating tendencies of those who fail to replace or use elastics. It&#39;s all controlled by the dentist!

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation-in-part of, and claims priority to, U.S. patent application Ser. No. 61/207,258 filed on Feb. 10, 2009, and U.S. patent application Ser. No. 61/260,082 filed on Nov. 11, 2009, the disclosures of which are incorporated herein by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    The present invention relates to orthodontic devices, and more particularly to orthodontic tensioning devices. 
         [0004]    2. Brief Description of the Related Art 
         [0005]    Orthodontic treatment began years ago, one of the most notable developments coming from Edward Angle, who in the early 1900&#39;s classified certain malocclusions into three categories, malocclusions being the relationship with the molars and the upper and lower teeth to each other. A class I malocclusion, by definition, is when the upper first molar has its mesio-buccal cusp in the groove, the buccal groove of the lower first molar. That is a class I definition of the relationships of the molars. If the molars are in that position, all the other teeth in the arches, upper and lower, may be crowded, and there may also be an overlapping of teeth. So it was this relationship that was defined as a class I malocclusion. 
         [0006]    The second category, class II malocclusions is where the mesio-buccal cusp of the upper first molar is not in that lower buccal groove of the first molar, but is one half step forward. All the other teeth, therefore, are forward, and, therefore, the upper front teeth are correspondingly forward. The class II malocclusion also involved the fact that the lower jaw in 25% of these malocclusions really was at fault because it was retrusive or recessive, so that really brought not the upper teeth forward, but it in essence the lower jaw brought all the lower teeth backward. So that created the same situation with the molar relationships, which is called class II. Generally, the class II malocclusion is characterized by the lower dental arch being located excessively rearward relative to the direction of the upper dental arch when the jaws are closed. 
         [0007]    A class III malocclusion is where the lower molar and all the teeth anterior, or forward of the lower molar, generally are forward of the upper mesial cusp of the first molar. It is the reverse situation to that of class II. The class III malocclusion is where the lower dental arch is located forwardly from its location relative to the position of the upper dental arch when the jaws are closed. 
         [0008]    Treatment of class II and class III malocclusions generally involves the movement of the teeth to orthodontically correct positions. Edward Angle was awarded U.S. Pat. No. 678,453 for a rigid archwire attached to teeth to draw the teeth together. Orthodontists utilize orthodontic appliances, which may, for example, include brackets, buccal tubes, archwires, and other items which are attached to the teeth. Brackets generally have a slot to hold the archwire, and buccal tubes, which are generally attached to the patient&#39;s molars, retain the ends of the wire. For example, the archwire may span from a buccal tube attached to a molar, and continue medially to the midline through the brackets attached to each of the teeth of the dental arch, and from the midline, distally to the other end of the dental arch where the archwire is secured to a buccal tube. It is generally common to refer to such orthodontic appliances of the type mentioned collectively, as braces. 
         [0009]    Also used in conjunction with the brackets and wires are elastomeric tensioning elements. Rubber or elastic bands have been customarily used in the field of orthodontics to provide a force application to the teeth and jaws in connection with wires and brackets. Generally, the elastomeric bands are used in pairs and are connected between the upper and lower dental arches to the respective braces. The elastomeric bands generally facilitate the application of a directional force to move the teeth over time to their desired positions. The elastomeric bands are sometimes referred to as intraoral bands, and may, for example, be connected within the patient&#39;s mouth at one end over a hook on a cuspid bracket supporting an upper archwire, and at the other end to a hook on a molar tube supporting a lower archwire. There may be a band and a molar tube and hook applied on the opposite side of the dental arch in the same manner. Patients are required to remove and replace the intraoral bands frequently in order to facilitate and maximize the directional force being applied. If the patient complies, and replaces the bands (e.g., once a day), as instructed, then the tension is maximized and the treatment time is minimized. A person is supposed to put an elastic on the hook on the front or the anterior and stretch it to the hook on the molar, either upper or lower, depending on whether the patient is being treated for a class II malocclusion or a class III malocclusion. However, a problem is that the use of the elastomeric bands has been voluntary and often, many patients fail to wear their elastomeric bands, or fail to change them, or both, as instructed. Therefore, cases where treatment takes perhaps two years to complete, may have been completed in one year, had the patient worn the elastomeric bands consistently, as instructed. 
         [0010]    Prior attempts to address the situation involve the use of a mechanism which is placed on the wires and on the teeth so that the patient cannot take it off, and then, the result presumes that the patient&#39;s treatment moves along much more quickly. One prior mechanism is generally referred to as the Herbst appliance, and another is the Forsus appliance. These mechanisms are constructed having an outside cylinder and, inside the cylinder, is a compressible coil spring which, once compressed, wants to open, which is the driving force. One type of Herbst appliance has a telescoping rod and sleeve assembly for its force transmission member. 
         [0011]    Other attempts have been made incorporating springs for force transmission. One example is U.S. Pat. No. 4,708,646 issued on Nov. 24, 1987 to James J. Jasper for an “Orthodontic Device for Correcting the Bite” which discloses a spring with caps that are provided to slide along a wire. U.S. Pat. No. 5,352,116 issued on Oct. 4, 1994 to Richard P. West for an “Adjustable Bite Corrector” which shows the use of a coil spring in an adjustable length device for applying a force. While these devices have attempted to provide a way to ensure that the patient wears the device, these devices are not without their own problems. For example, when the spring is covered by an outer sheath, the breaking of the spring, which may from time to time occur, may be masked. 
         [0012]    Another coil spring is shown in U.S. Pat. No. 5,545,037 issued on Aug. 13, 1996 to Watanabe Takeshi for an “Interarch Orthodontic Coil Spring”. U.S. Pat. No. 5,651,672 issued on Jul. 29, 1997 to James D. Cleary et al. discloses an “Orthodontic Force Module” which refers to an elongated body made of an elastomeric material with couplings at each end for connection to selected orthodontic appliances. U.S. Pat. No. 5,897,313 issued on Apr. 27, 1999 to James D. Cleary et al. also discloses an “Orthodontic Force Module”; and U.S. Pat. No. 6,053,730 issued on Apr. 25, 2000 to James D. Cleary discloses an “Orthodontic Force Module With Fracture Resistant Coupling”. U.S. Pat. No. 6,120,289 issued on Sep. 19, 2000 to James D. Cleary et al. for an “Orthodontic Attachment Device for Interarch Appliances”, discloses a wire segment which permits the orthodontic device to move more freely. These devices have been proposed to provide a device which is not removable in order to attempt to alleviate the problems of the patient failing to replace or use traditional bands in the manner recommended by the orthodontist. 
         [0013]    A need exists for an orthodontic device which provides the application of force to orthodontic appliances, such as, for example the brackets, buccal tubes, archwires, or attachments connected to the archwires, brackets, or tubes, and which facilitates consistent use of the device by the patient. 
       SUMMARY OF THE INVENTION 
       [0014]    The present invention provides an improved orthodontic device for applying a directional force to facilitate the correction of the alignment of teeth. The device is provided for use in conjunction with orthodontic appliances, including with orthodontic members, such as, for example, brackets, tubes, hooks and wires, and orthodontic members attached thereto. The device is particularly useful in conjunction with orthodontic interarch appliances and intraarch devices. The orthodontic device of the present invention may be used intraorally to apply tension between an upper orthodontic appliance and a lower orthodontic appliance. For example, the orthodontic device of the present invention may provide tensioning between an upper interarch wire and a lower interarch wire. The present orthodontic device may be connected to hardware structures, such as, for example, hooks, brackets or other structures which are applied to, or carried on, the teeth. The orthodontic device may be used, for example, intraorally by attaching one end of the device to a hook on a cuspid bracket supporting an upper archwire, and attaching the other end of the orthodontic device to a hook on a molar tube supporting a to lower archwire. The device has an elastomeric component and connectors for connecting the device to an orthodontic appliance. In a preferred form, the device, in accordance with the invention, may be connected at each end thereof to an orthodontic appliance, such as, for example, on a hook of a bracket, or wire. 
         [0015]    It is an object of the present invention to provide a novel orthodontic device for applying a directional force to teeth to facilitate correction of an orthodontic condition or problem. 
         [0016]    It is a further object of the present invention to provide an orthodontic device which may be attached to an orthodontic appliance to facilitate tensioning teeth. 
         [0017]    It is a further object of the present invention to provide an orthodontic device which facilitates orthodontic treatment by minimizing the treatment time for a patient. 
         [0018]    It is a further object of the present invention to facilitate the minimizing of the treatment time by providing a device which requires no effort on the part of the patient to use in that the device may be installed during an orthodontic visit, as opposed to repeated reinstalls at home by the patient. 
         [0019]    It is another object of the present invention to provide an elastomeric interarch device which may be attached to orthodontic appliances by crimping. 
     
    
     
       BRIEF DESCRIPTION OF THE PREFERRED EMBODIMENTS 
         [0020]      FIG. 1  is a front elevation view of an orthodontic tensioning device according to the present invention. 
           [0021]      FIG. 2  is a sectional view of the device of  FIG. 1 . 
           [0022]      FIG. 3  is a partial sectional view taken in the area  3  of  FIG. 2 . 
           [0023]      FIG. 4  is an enlarged partial view of a first alternate embodiment of the leg portion of the first connector. 
           [0024]      FIG. 5  is a view of the tensioning device of  FIG. 1  installed on an orthodontic appliance mounted to a patient&#39;s teeth. 
           [0025]      FIG. 6  is a sectional view of a second alternate embodiment of an orthodontic tensioning device according to the present invention, showing the first connector and a partial view of the elastomeric body portion. 
           [0026]      FIG. 7  is an enlarged partial view of a third alternate embodiment of the leg portion of the first connector. 
           [0027]      FIG. 8  is an elevation view of a fourth alternate embodiment of an orthodontic tensioning device according to the present invention, illustrated with a split tube connector. 
           [0028]      FIG. 9  is a bottom plan view of the device of  FIG. 8 . 
           [0029]      FIG. 10  is a schematic illustration of a method for producing a tensioning device according to the invention. 
           [0030]      FIG. 11  is a sectional view of a fifth alternate embodiment of an orthodontic tensioning device according to the invention. 
           [0031]      FIGS. 11   a  through  11   g  illustrate alternate configurations of the fifth alternate embodiment shown in  FIG. 11 . 
           [0032]      FIGS. 11   h  through  11   j  illustrate alternate configurations of the fifth alternate embodiment shown in  FIG. 11 , but having a closed end loop configuration. 
           [0033]      FIG. 11   k  is a graph of a plot of force (in psi) on the y-axis versus time (in seconds) on the x-axis for an exemplary proposed stretching profile of the embodiment illustrated in  FIGS. 11   a  through  11   g.    
           [0034]      FIGS. 11   l  through  11   p  illustrate alternate configurations of the fifth alternate embodiment shown in  FIG. 11 . 
           [0035]      FIG. 12  is a front elevation view of a tensioning device according to the present invention. 
           [0036]      FIG. 13  illustrates a schematic embodiment of a partial view of a device according to the present invention showing the wire member and the retaining element in separate view. 
           [0037]      FIGS. 14-16  illustrate examples of embodiments of orthodontic tensioning devices according to the invention. 
           [0038]      FIG. 17  is a sectional view of an alternate embodiment of an orthodontic tensioning device shown in an exemplary environment where the device is installed on the pins of brackets. 
           [0039]      FIGS. 17   a  through  17   g  are alternate illustrations of the alternate embodiment of the tensioning device shown in  FIG. 17 . 
           [0040]      FIG. 17   i  is a graph of a plot of force (in psi) on the y-axis versus time (in seconds) on the x-axis for an exemplary proposed stretching profile of the embodiment illustrated in  FIGS. 17   a  through  17   g , where  FIG. 17   h  is shown with corresponding force profile data. 
           [0041]      FIG. 17   j  is a graph of a plot of force (in psi) on the y-axis versus time (in seconds) on the x-axis for an exemplary proposed stretching profile of the engaging end of the embodiment illustrated in  FIGS. 17   a  through  17   g , where  FIG. 17   k  is shown with corresponding force profile data. 
           [0042]      FIG. 18  is a top plan view of the device of  FIG. 17 , shown separate from the bracket and pins. 
           [0043]      FIG. 19  is a sectional view of the retaining element of the device of  FIG. 17 , shown separate from the other components. 
           [0044]      FIG. 20  is a separate view of an example of a bracket with a pin that the device of  FIG. 17  may be used in connection with. 
           [0045]      FIGS. 21-24  illustrate an alternate embodiment of an orthodontic tensioning device constructed with a grommet at the ends for connecting to an orthodontic structure, such as a hook using a split washer retainer. 
           [0046]      FIGS. 25-28  show an alternate embodiment of a tensioning device with a retaining cap attachment mechanism. 
           [0047]      FIG. 29  shows an alternative embodiment of an orthodontic tensioning device with a linkage attachment mechanism. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0048]    Preferred embodiments are disclosed in the drawing figures and described herein. The orthodontic devices are constructed with an elastomeric component that exhibits resiliency when stretched and provides a force that encourages the return of the component from its stretched condition to its unstretched condition. In use, the tensioning devices of the invention may be installed in an orthodontic application where the tensioning device is stretched from a slightly stretched condition or from an unstretched condition. The activity of the patient&#39;s muscle movement, for example, when opening and closing one&#39;s mouth or jaw, may cause a tensioning device that is installed on orthodontic hardware in the patient&#39;s mouth to stretch and release the tension that the elastomeric component provides. 
         [0049]    Referring to  FIGS. 1-3 , there is illustrated an orthodontic device  10  having a resilient body portion  11  with a first connector  12  and a second connector  13 . The resilient body portion  11  preferably carries the first connector  12  at one end thereof and the second connector  13  at the other end thereof. The first connector  12  is mounted to the resilient body portion  11  and has means for attaching the first connector  12  to an orthodontic appliance. The second connector  13  is mounted to the resilient body portion  11  and has means for attaching the second connector  13  to an orthodontic appliance. Preferably, the resilient body portion  11  is comprised of a material which is not readily prone to corrosion when exposed to the environment of a patient&#39;s mouth. The resilient body portion  11  may be comprised of other orally suitable elastomers, such as natural and synthetic rubbers, thermoplastic elastomers, and blends of these materials. Preferred materials include those selected from the group of materials including: SBC&#39;s (styrene-block-copolymers), such as, SEBS (styrene ethylbutylene styrene), SEPS (styrene ethylene propylene styrene), SBS (styrene butadiene styrene), SIS (styrene isoprene styrene), and EPDM (ethylene-propylene-diene-monomer), thermoplastic polyurethane, cross linked polyurethane, silicone, natural rubber, and copolyester. As illustrated in  FIGS. 1-3 , the device  10  is shown having a resilient body portion  11  which comprises an elastomeric tube. 
         [0050]    In a first preferred embodiment, the first connector  12  comprises a crimpable metal material, and is configured having securing means for securing the first connector  12  to an orthodontic appliance. Preferably, as shown in  FIG. 1 , the connecting means may comprise a hook  14 . The orthodontic appliance, to which the first connector  12  may be secured, for example, may be a hook of a bracket, an archwire, or other orthodontic appliance or part thereof. Mounting means is provided for mounting the first connector  12  to the body portion  11 . The mounting means is shown in the first preferred embodiment device  10  comprising a mounting leg  16  which mounts the first connector  12  to the body portion  11 . The mounting leg  16  preferably is disposed within the resilient body portion  11 , and preferably has holding means  18  to facilitate retention of the first connecting element  12  on the body portion  11 . The hook  14  is configured for connection to a connecting structure, such as, for example, an archwire, bracket, hook or other orthodontic appliance. The first connector hook  14  preferably is comprised of a crimpable material to facilitate connection of the first connector  12  to another structure. As illustrated in  FIG. 5 , the connecting structure is shown comprising a receiving hook  21  of an archwire  22 . The first connector  12  is placed on the receiving hook  21  by positioning the hook  14  of the first connector  12  over the receiving hook  21 , and when the aperture  14  is positioned on the receiving hook  21 , a force is applied to the hook  14  to crimp it in attaching engagement with the receiving hook  21 . 
         [0051]    The second connector  13  of the device  10  may then be connected to another archwire, bracket, hook or other orthodontic appliance. In the illustration shown in  FIG. 1 , the second connector  13  of the device  10  of the first embodiment preferably may be the same as the first connector  12 , but is attached at the opposite end of the body portion  11 . The second connector  13  is shown having a hook  24  for securing the second connector  13  to an orthodontic appliance. The hook  24  of second connector  13  preferably is comprised of a crimpable material. Mounting means is provided for mounting the second connector  13  to the body portion  11 , and preferably may comprise a mounting leg  26  which mounts the second connector  13  to the body portion  11 . The mounting leg  26  preferably is disposed in the resilient body portion  11 , with adhesive as described herein, and preferably has raised bumps  27  to facilitate retention of the second connector  13  on the body portion  11 . 
         [0052]    Referring to  FIG. 5 , the device  10  is shown illustrating an example of the application of a crimping force to the first connector  12 . The hook  14  is shown in a crimped condition. The crimping may take place with the use of pliers or other force applying tool to apply force to hook  14  to reshape the hook  14  for engagement with an orthodontic structure to which the device  10  is to be attached. Preferably this is accomplished by closing the hook  14 . The crimping of the first connector  12  facilitates the securing of the connector  12  to an orthodontic appliance. Preferably, the second connector  13  is also secured to an orthodontic appliance, and may be done in the same manner, by crimping the hook  24 . 
         [0053]    In  FIG. 5 , the device  10  is shown installed on an orthodontic appliance  90 , such as, for example, an upper appliance  100  and lower appliance  101 . In  FIG. 5 , the right side of the patient&#39;s teeth is shown, and generally, although not shown, the left side may be similar with the appliances being installed on the teeth in the same manner. In the example illustrated in  FIG. 5 , the appliance  90  is what has been generally referred to as braces, which, in this example, includes an upper archwire  103 , a lower archwire  104 , and a plurality of brackets  105  affixed to a patient&#39;s teeth. The brackets  105  may be attached to the teeth with a suitable adhesive. The bracket  106  is shown having a post  107  attached thereto, and is attached to an upper canine tooth  109 . A bracket  110  is shown having a post  111  attached thereto and mounted on a lower canine tooth  112 . A bracket  113  with a hook  114  is attached to an upper molar  115 . A lower molar band  116  with a receiving hook  117  is attached to a lower molar  118 . A band  120  with a tube  121  is provided on the upper molar  122  at the distal end of the upper dental arch. The upper archwire  103  is secured at the tube  121  on the upper molar  122 , and is bent to form an end  123  which retains the archwire  103 . The upper archwire  103  is shown spanning the brackets attached to the upper teeth. Similarly, the lower archwire  104  has an end  124  which is secured at the tube  125  (which may include a hook) which is carried by a band  126  attached to the lower molar  127  at the distal end of the lower dental arch. In the illustration shown in  FIG. 6 , the orthodontic appliance components are being applied to a patient&#39;s teeth to correct a class II malocclusion. The device  10  is positioned on the orthodontic appliance  90 . As illustrated, the first connector  12  of the device  10  is positioned on the hook  117  of the lower molar band  116 . The hook  14  is positioned on the receiving hook  117  and is received on the hook shaft  130 . The hook  14  preferably is crimped or closed to remain secured on the receiving hook  117  (which also may be crimped or locked). The device  10  is then stretched to position the second connector  13  on the post  107  of the bracket  106  on the upper canine  109 . When installed on the orthodontic appliance  90 , the device  10  supplies a force to the upper and lower archwires, respectively  103  and  104 , to facilitate the treatment which is designed to bring the teeth to an orthodontically desired alignment. 
         [0054]    The device  10  may be attached to the orthodontic appliance  90  by crimping the first connector  12  and the second connector  13  to secure the device  10  to the respective points of connection on the orthodontic appliance. As shown in  FIG. 5 , the hook  14  of the first connector  12  is crimped for securing engagement with the receiving hook  117 . The hook  24  of the second connector  13  is crimped for securing engagement with the post  107 . The hook  117  and post  107  are provided for illustration, and the orthodontic appliance may have other components by which the device  10  may connect to provide a force to the patient&#39;s jaw or teeth being treated. For example the device  10  may be connected to a wire, tube, or other component. 
         [0055]    In a second preferred embodiment illustrated in  FIG. 6 , the device  210  is shown having a resilient body portion  211  and a first connector  212  with a leg  216  and a hook  214 . The leg  216  is illustrated with holding means comprising a loop  217 . The leg  216  has a first leg portion  218  which is spaced from a second leg portion  219 , to define a loop  217 . An adhesive  221  is applied to secure the second connector  213  to the body portion  211 , and preferably coats the leg  216  and loop  217 . The second connector  213  preferably may be formed with a leg with holding means also having a loop. The device  210  preferably is constructed and may be used in accordance with the embodiment of the device  10  described herein and shown in  FIGS. 1-5 . 
         [0056]    In a third preferred embodiment, an orthodontic device  310  is illustrated in  FIG. 7 . The device  310  preferably is similar to the device  10 , having a resilient body portion (not shown) and a first connector  312  with a leg  316  and a hook  314 . The leg  316  is provided with an outer uneven surface  317 . Preferably, as illustrated in  FIG. 7 , the outer surface  317  of the leg  316  has a plurality of cross cuts  325  formed therein. The second connector (not shown) preferably may be formed with a leg which also has an uneven surface. The leg  316  is attached to a body portion with an adhesive. The device  310  preferably is constructed and may be used as in accordance with the embodiment of the device  10  described herein and shown in  FIGS. 1-6 . 
         [0057]    Referring to  FIGS. 8 and 9 , another preferred embodiment of the present invention comprises an orthodontic device  410  with an elastomeric body portion  411 , and having a first connector  412  with a hook  420 . The first connector  412  preferably may be constructed and attached to the elastomeric body portion in the same manner as the first connectors  12 ,  212 , and/or  312  shown and described herein. The second connector  413  comprises a split tube  414  having a leg  416 . The leg  416  preferably has holding means and is preferably connected to the body portion  411  with adhesive. The holding means, for example, may comprise raised bumps, a loop or an uneven surface portion such as for example a cross cut, or a combination of thereof. The split tube  414  facilitates connection of the orthodontic device  410  to an archwire. The split tube  414  has a lateral opening  415  disposed therein, and an interior space  417 . The second connector  413  of the device  410  may be installed on an archwire by placing the split tube lateral opening over the wire and positioning the tube  414  so the archwire is in the interior space  417 . The tube  414  may then be crimped to engage the archwire. The first connector  412  preferably is connected to another suitable structure, such as, for example, a receiving hook of a bracket, by crimping the hook  420  of the first connector  412 . 
         [0058]    The composition used for the elastomeric material preferably is an elastomer which is durable and may be adherable to a wire element. According to preferred embodiments, thermoplastic elastomers (TPE&#39;s) are used. One example of thermoplastic elastomers (TPE&#39;s) useful to form the elastomeric member may be those block copolymer types, including TPE&#39;s of styrene-ethylene/butylene-styrene block copolymers. The material possesses rubber-like characteristics but at temperatures above the melting point, melts and is flowable. The elastomeric material, when flowable, such as the TPE&#39;s, may be formed into a desired shape, and permitted to cool to the elongated configuration of the tensioning device. 
         [0059]    A retaining element applied to the end of the wire member facilitates retention of the tensioning device assembly. A retaining element is provided in the preferred embodiments, and preferably is formed from a material which is rigid and onto which the elastomeric material, such as, for example a TPE, may be attached. According to the preferred embodiments, the elastomeric material is attached to the retaining element through a molding process. 
         [0060]    The retaining element preferably is compatible with the elastomeric material so that there is suitable bond strength so that the bond may be sustained during tensioning conditions that the tensioning device is to repeatedly encounter when in use in a patients&#39; mouth. Examples of compounds that may be used to form the retaining element include rigid materials, such as, polypropylene (PP), polyethylene (PE), amorphous polar plastics such as polycarbonate (PC), polymethylmethacrylate (PMMA), polystyrene (PS), high impact polystyrene (HIPS), polyphenylene oxide (PPO), glycol modified polyethylene terephthalate (PETG), acrylonitrile butadiene styrene (ABS), semicrystalline polar plastics such as polyester (PET, PBT) and polyamide (Nylon 6, Nylon 66). Preferably, the material, such as, for example, a TPE, used for the elastomeric member and the material used for the retaining element are provided to be compatible to afford the retention of the tensioning device components. The retaining element and the elastomeric portion of the tensioning device are secured together so the wire which has an end carrying the retaining element also is secured at that end to the elastomeric member. For example, the elastomeric material and the retaining element material may be formed for connection with a first connector, such as the steel wire, using molding steps, including for example two-shot molding or insert molding. According to preferred embodiments, the elastomeric body of the tensioning device may be constructed from a composition of an ESTANE® material (Lubrizol). According to preferred embodiments, the retaining element may be formed from a composition of an ISOPLAST® material (Lubrizol). 
       Example 1 
       [0061]    An orthodontic tensioning device was constructed using a 0.020 mm diameter stainless steel wire (outer diameter, o.d.=0.020 mm). The length of the wire was approximately 12 mm. The wire was bent at one end thereof to form a kink or loop. To the wire end where the loop was formed, a plastic material was installed thereon. The plastic material was applied by placing the wire in a mold and flowing molten plastic into the mold and onto the wire end. After the molten plastic cooled, the wire end contained a secure plastic element. A second wire was prepared and treated with a plastic element in the same manner as the first wire. Next, the treated wires were attached to an elastomeric member. The elastomeric member, in this example, was a latex composition and was molded onto each wire by molding over the treated end of the wire. The latex composition was formed from a thermoplastic elastomer compound based on styrene-ethylene/butylene-styrene block copolymer, and is commercially available from a number of manufacturers, including one TPE sold under the name UNISOFT TPE. One particular elastomeric TPE used in this Example has the following mechanical properties (see Table 1): 
         [0000]    
       
         
               
               
               
               
             
           
               
                 TABLE 1 
               
               
                   
               
               
                 Mechanical Properties 
                 Test Method 
                 English-Units 
                 SI-Units 
               
               
                   
               
             
             
               
                 Shore Hardness 
                 ASTM D-2240 
                   29 A 
                   29 A 
               
               
                 Specific Gravity 
                 ASTM D-792 
                 0.93 (g/cc) 
                 0.93 (g/cc) 
               
               
                 Tensile Strength 
                 ASTM D-412 
                  850 (psi) 
                  5.9 (Mpa) 
               
               
                 Elongation at Break 
                 ASTM D-412 
                  650 (%) 
                  650 (%) 
               
               
                 Compression Set 
                 ASTM D 395 B 
                   10 (%) 
                   10 (%) 
               
               
                 22 hrs@RT 
               
               
                   
               
             
          
         
       
     
         [0062]    The thermoplastic elastomer was heated to about 310 to 410 degrees F. and was flowable. The mold may be heated, or preheated to facilitate flow of the TPE. 
         [0063]    The latex elastomeric member was constructed to be about 4 to 5 mm (measured at its outer diameter (o.d.), and was elongate. The elastomeric member was formed by placing the treated wire ends on opposite locations of a mold for molding the latex elongated member. Each treated wire end was placed at an end of the mold so that the latex elongate member would attach to the treated wire ends at each end thereof. The device formed was strong and water and saliva resistant, and exhibited resiliency when stretched. 
         [0064]      FIG. 10  illustrates a schematic diagram showing a preferred embodiment of the molding steps used to form a tensioning device according to the invention. Accordingly, the molding may be accomplished by techniques, such as, for example multi-component injection molding of the elastomeric member and the retaining member, overmolding or insert type molding. 
         [0065]      FIG. 11  shows a sectional view of a preferred embodiment of a tensioning device  510  formed according to the present invention. The tensioning device  510  has a resilient body portion  511  with a first connector  512  and a second connector  513 . Retaining elements  520 ,  521 , respectively, are provided on the first connector  512  and second connector  513 . The first connector  512  is illustrated having an end configuration which is illustrated in a preferred embodiment as a loop  522 . 
         [0066]    The resilient body portion  511  preferably carries the first connector  512  at one end thereof and the second connector  513  at the other end thereof. The first connector  512  and retaining element  520  are secured to the resilient body portion  511 . The first connector  512  has means for attaching the first connector  512  to an orthodontic appliance. The second connector  513  is secured to the resilient body portion  511  and also has means for attaching the second connector  513  to an orthodontic appliance. The attachment means preferably may comprise a preformed end configuration or alternately, or in addition, may be a crimpable first connector  512 . The second connector  513  may be similarly configured for connection with an orthodontic appliance. 
         [0067]      FIGS. 11   a  through  11   g ,  11   h  through  11   j , and  11   l  though  11   p , illustrate further embodiments of the tensioning device shown in  FIG. 11 . According to the illustrations, a preferred exemplary embodiment is shown with examples of preferred dimensions for the tensioning device. Though the wire ends are illustrated in a preferred configuration having an open hook portion that is surrounded by a retaining element, the wire hook end may be alternately configured such as for example as a ring, or bar, so that the wire portion of the device may be suitably held by the retaining element. Though preferred dimensions are provided, the tensioning device according to the invention may be constructed with dimensions other than those shown and referred to in  FIGS. 11   a  through  11   g ,  11   h  through  11   j , and  11   l  through  p.    
         [0068]    According to the preferred embodiments of the process, a tensioning device may be produced by providing the first wire member and second wire member, which for example may be steel wires that are crimpable. On an end of each wire segment, a retaining element is formed to leave at least a portion of the wire segment uncovered. The process includes forming a connecting structure between the first wire member and the second wire member. The connecting structure forms a resilient body portion. The connecting structure preferably is formed over the retaining element. This may be done by a first step wherein the retaining element is formed on the wire prior to the installation of the connecting structure, or alternately, the retaining elements and connecting structure may be formed together. The resultant device includes the connecting structure that forms a resilient body portion with wire ends projecting from each end thereof. The retaining element may be surrounded by the connecting structure in totality or in substantial part so as to secure the wire members and the connecting structure together. The process may be used to produce the embodiments of the tensioning devices illustrated in  FIGS. 11 ,  11   a - 11   g ,  11   h - 11   j ,  11   l - 11   p ,  12 ,  13 , as well as those shown in  FIGS. 14-16 . 
         [0069]      FIGS. 14 ,  15  and  16  show examples of orthodontic tensioning devices which include wire end connecting portions attached to an elastomeric body. Though measurements of the devices may be of various sizes to accommodate various patients and tensions, examples of some preferred dimensions are illustrated in  FIGS. 14 and 15 . For example, one preferred length of the elastomeric body may be about 1.66 inches. 
         [0070]    According to  FIG. 17 , there is illustrated a preferred embodiment of an orthodontic tensioning device  610  that includes a resilient body portion  611  with a first connector  612  and a second connector  613 . The resilient body portion  611  preferably carries the first connector  612  at one end thereof and the second connector  613  at the other end thereof. According to a preferred embodiment, the first connector  612  and the second connector  613  may be identical connectors, but they do not have to be. The first connector  612  is mounted on the resilient body portion  611  and has means for attaching the first connector  612  to an orthodontic appliance. The second connector  613  is mounted to the resilient body portion  611  and has means for attaching the second connector  613  to an orthodontic appliance. Preferably, the resilient body portion  611  is comprised of a material which is not readily prone to corrosion when exposed to the environment of a patient&#39;s mouth. The resilient body portion  611  may be comprised of other orally suitable elastomers, such as natural and synthetic rubbers, thermoplastic elastomers, and blends of these materials, including any of those elastomeric materials described herein. Examples of preferred materials include those selected from the group of materials including: SBC&#39;s (styrene-block-copolymers), such as, SEBS (styrene ethylbutylene styrene), SEPS (styrene ethylene propylene styrene), SBS (styrene butadiene styrene), SIS (styrene isoprene styrene), and EPDM (ethylene-propylene-diene-monomer), thermoplastic polyurethane, cross linked polyurethane, silicone, natural rubber, and copolyester. 
         [0071]    The first connector  612  and a second connector  613  may be configured to facilitate mounting of the device  610  onto an orthodontic structure, such as, for example, a pin  300  of a bracket  301 . The first connector  612  is shown having a bore  615  therethrough that is preferably dimensioned to receive the bracket pin  300  therethrough. As illustrated in  FIG. 17 , the bore  615  preferably includes a first bore portion  616  and a second bore portion  617 . According to a preferred configuration, the first bore portion  616  preferably has a length that will permit the head  302  of the pin  300  to pass through when the device  610  is installed on a bracket  301 . The bore  615  is illustrated having a second bore portion  617  that has a larger dimension, which may, for example, be a larger width or diameter, than the first bore portion  616 . The second bore portion  617  is shown configured to receive the pin head  302  of the bracket pin  300 . An example of a bracket  301  and pin  300  is shown in  FIG. 20 . 
         [0072]    The first connector  612  preferably may be constructed from a suitable material which is durable and resistant to moisture and the conditions present in a human mouth. According to a preferred embodiment, the first connector  612  has a key, such as, for example, the circumferential flange  620 , which is configured to connect with the mounting end  621  of the device  610 . The first mounting end  621  preferably is constructed having an aperture  622  disposed therein that includes a wider portion  623  that is designed to receive the flange  620  of the first connector  612 . Preferably, a press-fit mounting may be used to install the first connector  612  on the resilient body portion  611 , and in particular on the first mounting end  621 . The first connector  612  preferably is constructed from a material which is capable of engaging with an orthodontic structure, such as, for example, the bracket pin  300 . According to preferred embodiments, the first connector  612  may comprise a grommet which may be constructed from an acrylic or metal so as to provide durability to the device  610  when the device  610  attached to orthodontic hardware structures and when the device  610  is in use where it is subjected to forces from stretching. 
         [0073]    The second connector  613  may be constructed and attached to the second mounting end  631  of the device  610  in the same manner as described in connection with the first connector  612 . The second mounting end  631  may be configured the same as that shown and described in connection with the first mounting end  621 , and the second connector  613  may be constructed as described herein in connection with the first connector  612 . 
         [0074]      FIG. 18  illustrates a top plan view of the tensioning device  610  shown in an uninstalled condition, where the ends are not connected to the bracket  301 .  FIG. 19  illustrates the first connector  612  in an exploded separate sectional view that shows the first connector  612  separate from the elastomeric body portion  611  and the second connector  613 . The connector flange  620  of the first connector  612  preferably is configured to facilitate mounting in the first mounting end  621  of the elastomeric body portion  611 . 
         [0075]      FIGS. 17   a  through  17   g  illustrate alternate views of the tensioning device  610  and bracket  301  and shown in  FIGS. 17-20 . An exemplary proposed force profile for a stretching condition is represented by the graphs in  FIGS. 17   i  and  17   j , with respective illustrations shown in  FIGS. 17   h  and  17   k.    
         [0076]    Referring to  FIGS. 21-24 , there is illustrated an alternate embodiment of an orthodontic tensioning device  710  which includes an elastomeric body portion  711   a  first connecting end portion  712  and a second connecting end portion  713 . The first connecting end portion  712  preferably is formed with an aperture  714  therein that is configured to be positioned on a bracket. For example, according to a preferred installation, the device  710  may be installed on the pin  300  of a bracket  301  by sliding the first connecting end portion  712  over the pin  300  so that the aperture  714  is positioned on the pin shaft  303 . For example, as shown in  FIG. 23 , the device  710  is illustrated connected to a hook  306  of a molar tube  307 , the hook  306  having a shaft  308  and head  309 , the molar tube  307  being secured on a molar  305 . According to a preferred embodiment, the second connecting end portion  713  of the device  710  may be configured the same as the first connecting end portion  712 , with an aperture  716 . According to a preferred installation, a retaining element, such as, for example, a split washer  720 , shown in  FIG. 24 , may be used to secure the first connecting end portion  712  to the bracket pin  300 . Other suitable retaining elements may be used, such as split rings and the like. The split washer  720  may be installed by placing it on the pin shaft  303  in a location above the first connecting end portion  712  and then configuring the split washer  720  by crimping it or shaping it to a position or configuration where it is secured on the pin  300 . For example, preferably, the pin head  302  acts as a stop relative to the split washer  720 , so that once the split washer  720  is secured on the pin shaft  303 , it does not slip past the pin head  302 . The removal of the device  710  may be accomplished by expanding the split washer  720  and then removing the split washer  720  and removing the connecting end portion  712  from the pin  300 . 
         [0077]    Referring to  FIGS. 25-28 , there is illustrated an alternate embodiment of a tensioning device  810  which includes an elastomeric body portion  811   a  first connecting end portion  812  and a second connecting end portion  813 . The first connecting end portion  812  preferably is formed with a retaining element shown comprising a cap  825  that is configured to be mounted onto a bracket, such as, for example, the bracket  805 . The bracket  805  is illustrated comprising an upper flange  806  and a lower flange  807  and has a groove therein  808  for receiving an archwire  103 ′. The cap  825  preferably is configured having a first or upper flange  826  and a second or lower flange  826  that connect with the cap structure  827 . The cap structure  827  preferably includes a groove  828  provided therein so that when the tensioning device  810  is installed on a bracket  805  and press fit onto the bracket upper and lower flanges  806 ,  807 , an archwire that may be present (which, for example, may be passing through the bracket groove  808 ) may be accommodated. 
         [0078]    As illustrated in  FIGS. 25-27 , the archwire  103 ′ is shown in a sectional view passing through the bracket groove  308 . The cap  825  of the tensioning device  810  preferably is constructed so that it may be installed on the bracket flanges  806 ,  807  and may be retained thereby without interfering with the archwire  103 ′. According to a preferred configuration, the cap element  825  of the device  810  may include a groove  828  which is illustrated receiving the archwire  103 ′. For example, according to a preferred installation, the device  810  may be installed on the bracket  805  by aligning one of the connecting end portions  812 ,  813  over the bracket flanges  806 ,  807 , and pressing the connecting end  812 ,  813  onto the bracket  805  so that the retaining cap  825  securingly engages with the bracket flanges  806 ,  807 . Similarly, removal of the device  810  may be accomplished by exerting a pressure on the end portion  812  of the device  810  to maneuver the cap  825  so that it may be disengaged from the bracket  805 . 
         [0079]    According to a preferred embodiment, the device  810  may be constructed by the methods disclosed herein, including the molding method, where the retaining cap  825  is molded with the elastomeric body  811  ( FIG. 27 ) so that the end portion  812  of the device  810  is formed with the cap  825  held thereby. In addition, an alternate method is to provide a retaining cap  825  having a flanged configuration similar to the configuration disclosed herein for example in  FIGS. 17-20  where the first connector  612  is secured at the elastomeric first end portion  621 . The device  810  may be constructed having an end portion  812  with an aperture therein that may receive and secure a cap element  825 . For example, as with the device  610 , the tensioning device  810  may be constructed so that it has a mating configuration at the end portion  812  that is dimensioned to receive a flange (not shown) or other retaining portion of the cap element  825 . 
         [0080]    As shown in  FIG. 27 , with a retaining cap  825  provided at each end of the elastomeric body  811 , the tensioning device  810  may be installed by pressing the end of the device  10  onto a bracket, such as the bracket  805  shown and described. In addition, alternate embodiments may be constructed where the tensioning device  810  includes at least one retaining cap  825  at one end thereof and has an alternate securing element at the other end, such as, for example, a crimpable member or wire, or any other suitable connecting mechanisms, including any of those described herein. The retaining cap  825  portion of the device  810 , preferably, is constructed from a material, e.g., plastic, steel or other suitable material, that can be sturdy yet resilient so as to allow a press fit installation onto the bracket flanges  806 ,  807 . 
         [0081]    An alternate embodiment of an orthodontic tensioning device  910  is shown in  FIG. 29 . Preferably, the device  910  is constructed from an elastomeric material, such as, for example, those discussed herein, and includes a plurality of engaging elements  905 ,  906  that may be positioned to engage an orthodontic appliance, such as, for example, the pin of a bracket or hook on a molar band. The device  910  may be attached to structures used for orthodontic treatments, and particularly, those structures installed in the mouth of a patient, such as brackets, bands and the like. According to a preferred configuration, the engaging elements  905 ,  906  are provided to include a plurality of outer engaging elements  905   a ,  905   b ,  905   c ,  905   d ,  905   e ,  905   f  and a plurality of inner engaging elements  906 . The outer engaging elements  905  may be linked together, for example, with a plurality of elements  905  forming a linkage of a suitable length. The linkage length, for example, formed from the outer engaging elements  905   a ,  905   b ,  905   c  may be adjusted by cutting or removing links or elements  905  to form linkages of different lengths. Though, in the exemplary embodiment shown in  FIG. 29 , three outer engaging elements  905  are shown on each end of the device  910 , other numbers and configurations of engaging elements may be linked together (or removed therefrom) to form longer or shorter lengths. 
         [0082]    The engaging elements  905 ,  906  preferably are retained on the elastomeric body portion  911  of the device  910 . The engaging elements  905  and  906  may be held on the elastomeric body portion  911  with a suitable mounting means or method, such as, for example, by forming the elastomeric body  911  over the engaging elements  905 ,  906 , or by providing a mounting flange or flanges (not shown) on the engaging elements  905 ,  906  that are designed to be held by the elastomeric material of the body  911 . In addition, or alternately, a suitable retaining component may be used to attach the engaging elements  905 ,  906  to the elastomeric material. According to a preferred embodiment, the engaging elements  905 ,  906  may be attached using the overmolding method or compositions, or both, described herein. For example, the engaging elements  905 ,  906  may be secured to the elastomeric end portions  912 ,  913  using a retaining element such as those  520 ,  521  shown and described in connection with the embodiment of  FIG. 11 , and those shown in  FIGS. 11   c  through  11   f . Preferably, the engaging element  905   a  proximate to the elastomeric first end  912  may be secured to the elastomeric body portion  911  of the device  910 , and the additional engaging elements  905   b ,  905   c , may be attached through their respective linkages. In addition, though the inner engaging elements  906  are shown disposed over the elastomeric end portion  912 , this represents one preferred arrangement, with another preferred arrangement being providing the inner engaging elements  906  within the elastomeric portion, so they are not as visible and may be protected. The engaging elements  905 ,  906  preferably are crimpable so that they may be attached to a structure, such as a hook or pin of a bracket or band, and may be crimped to secure thereto. 
         [0083]    The engaging elements  905 ,  906  may be constructed from a suitable composition, such as metal (e.g., stainless steel). Though not shown, the device  910  may be constructed with alternate configurations for the engaging elements, such as, for example, a molded component, such as, nylon or other suitable durable and flexible material that may be formed to include linkages that may be cut or removed to adjust the length of the device. 
         [0084]    According to preferred embodiments, the tensioning devices according to the invention may be constructed to have a desirable force tension so that a desired force may be provided for treatment when the device is installed in a patient. When the tensioning device is installed, it is designed to provide a force to facilitate treatment of an orthodontic condition. For example, some preferred force levels for the tensioning devices may be 100, 200 and 300 grams of force. Considering an application in a patient, for example, a tensioning device may be installed at the hook on the cuspid and stretch to a molar hook, where when installed, the tensioning device preferably is stretched from its original length or condition to a stretched length or condition. The strength of force for the stretching, according to preferred embodiments, may range between from about several grams up to a few hundred grams of force, with preferred force levels being from about 100 to 300 grams. The tensioning devices according to the invention may be provided in different lengths so that a suitable tensioning device can be used for patients according to that patient&#39;s physiology and needs, so that the patient&#39;s need is matched to a desired force characteristic. 
         [0085]    Preferred embodiments of the tensioning devices according to the invention may regulate the elastomeric composition by controlling the components of the elastomer composition and/or the process for forming the elastomeric portion of the tensioning device to provide different force levels, such as, for example, by providing different levels of stretchability to the elastomeric component of the tensioning device. Therefore, according to some preferred embodiments, tensioning devices may be provided in a kit with differing force characteristics so that a tensioning device that is desired for a particular patient may be selected for use. 
         [0086]    Various modifications may be made within the spirit and scope of the invention. For example, though the embodiments illustrated in the figures, including the exemplary embodiments of  FIGS. 11-16  show crimpable end portions, a track end portion, such as that shown in  FIG. 8  may be used. Alternately, a retaining cap may be used as a connector for connecting one or both ends of the tensioning device to a bracket flange. Connectors may comprise wire lengths which may be cut and crimped as required. In addition, as illustrated in  FIGS. 14 ,  15  and  16 , the elastomeric material may be provided in different lengths and thicknesses to accommodate different needs of tension. The devices illustrated and described herein may be used with intraarch applications, such as, for example, from a molar hook to a hook on the cuspid bracket of the same dental arch. Although the invention is described in relation to several embodiments, various modifications and changes may occur to those skilled in the art without departing from the spirit and scope of the invention described herein and as defined by the appended claims.