Methods, devices, systems, assemblies, and kits for tissue retraction in an oral cavity

CROSS-REFERENCE

0001This application claims the benefit of <patcit id="pcit0001" dnum="US97538707P"><text>U.S. Provisional Application No. 60/975,387, filed September 26, 2007</text></patcit>, <patcit id="pcit0002" dnum="US61026989A"><text>U.S. Provisional Application No. 61/026,989, filed February 7, 2008</text></patcit>, and <patcit id="pcit0003" dnum="US61081908A"><text>U.S. Provisional Application No. 61/081,908, filed July 18, 2008</text></patcit>, which are incorporated herein by reference in their entireties.

BACKGROUND OF THE INVENTION

0002The mouth or oral cavity <b><i>10</i></b> of a human is illustrated in <figref idref="f0001"><b>FIG. 1A</b></figref> to provide context for the invention. The mouth, or oral cavity, is bounded by muscles and bones: anteriorly by the lips <b><i>12</i></b>, posteriorly continuous with the oropharynx, laterally by the muscles of the cheeks <b><i>14</i></b>, superiorly by the body hard palate and muscular soft palate <b><i>16</i></b>; and inferiorly by the muscular tongue <b><i>18</i></b> and the soft tissues of the floor of the mouth. The tongue is a voluntary muscular structure that occupies the floor of the mouth. Teeth <b><i>20</i></b> are embedded in the alveoli or sockets of alveolar ridges of the mandible <b><i>30</i></b> which forms a mandibular arch <b><i>32</i></b>, or alveolar process, which contain the lower (caudad) set of teeth and maxilla <b><i>40</i></b> which forms a maxillary arch <b><i>42</i></b>, or alveolar process, which contains the upper (cephalad) set of teeth. Each of the alveolar arch <b><i>32</i></b>, <b><i>42</i></b>, has an external surface <i><b>34</b>, <b>44</b></i> which is adjacent the cheeks and lips and an internal surface <b><i>36, 46</i></b> adjacent the tongue and palate. The teeth <b><i>20</i></b> engage the gingival tissue <b><i>22</i></b>.

0003The mouth <b><i>10</i></b> has salivary glands that secrete about 1.5L of fluid daily into the mouth. Secretion of saliva is controlled by the autonomic nervous system. Parasympathetic stimulation causes vasodilation and secretion of water saliva with low enzyme content, whereas sympathetic stimulation cases vasoconstriction and secretion of smaller amounts of saliva that are richer in organic materials. Reflex secretion occurs when, for example, there is food in the mouth.

0004Devices and systems currently known and used in the dental arts include those disclosed in: <patcit id="pcit0004" dnum="US4695253A"><text>U.S. Patent Nos. 4,695,253 to Tysse</text></patcit> for Oral Evacuation Device and Method; <patcit id="pcit0005" dnum="US6981870A"><text>6,981,870 to Heasley</text></patcit> for Rubber Dam Clamps Retained by Adhesion and Improved Frictional Forces; <patcit id="pcit0006" dnum="US6022214A"><text>6,022,214 to Hirsch et al.</text></patcit> for Intraoral Illumination Device and Method of Using Same; <patcit id="pcit0007" dnum="US5931673A"><text>5,931,673 to Bobolan </text></patcit>for Intraoral Dental Dam; <patcit id="pcit0008" dnum="US5890899A"><text>5,890,899 to Sclafani </text></patcit>for Dental Isolator; <patcit id="pcit0009" dnum="US5516286A"><text>5,516,286 to Kushner </text></patcit>for Dental Isolation Tray Particularly Suited for Use When Applying Dental Sealants and Method for Its Use; <patcit id="pcit0010" dnum="US5460524A"><text>5,460,524 to Anderson </text></patcit>for Device and Method for Saliva Suction with Tongue Retractor and Bit Handle; <patcit id="pcit0011" dnum="US5078604A"><text>5,078,604 to Malmin </text></patcit>for Dental Barrier Drape Devices and Retainer Apparatus Therefor; <patcit id="pcit0012" dnum="US5037298A"><text>5,037,298 to Hickham </text></patcit>for Apparatus and Improves Process for Removing Saliva While Retracting Cheeks and Lips; <patcit id="pcit0013" dnum="US4899490A"><text>4,899,490 to Jenkinson </text></patcit>for Dental Mask; <patcit id="pcit0014" dnum="US4215477A"><text>4,215,477 to Shanel </text></patcit>for Holder for Rubber Dental Dam; <patcit id="pcit0015" dnum="US3772790A"><text>3,772,790 to Swan-Gett et al.</text></patcit> for Tooth Isolating Shield; U.S. Patent Publication <patcit id="pcit0016" dnum="US20040170945A"><text>US 2004/0170945 to Heasley</text></patcit> for General Field Isolation Rubber Dams without Operative Inserts Which Isolate the Dental Alveolar Arch for Dental Treatment; and <patcit id="pcit0017" dnum="US20070231773A"><text>US 2007/0231773 to Pontynen et al.</text></patcit> for Methods, Devices, Systems, and Kits for Isolating Teeth.

0005Commercially available devices include, for example, Isolite i2 by Isolyte Systems (Santa Barbara, California), described at <b>www.isolitesystems.com;</b> OptiDam by KerrHawe SA (Switzerland), described at <b>www.kerrhawe.com;</b> and OptraGate and OptraDam by IvoClar Vivident Ltd. (New Zealand), described at <b>www.ivoclar.co.nz.</b>

0006It would be beneficial to have a device, system, assembly, kit and method that enables dental practitioners to quickly retract tissue and isolate one or more teeth and/or gingival tissue in the oral cavity from surrounding tissue to generate a working field and which maintains a dry working field for performing the dental procedure.

SUMMARY OF THE INVENTION

0007Provided herein is a retraction device comprising a topology conformable structure adaptable to be in a constrained shape that can be delivered into an oral cavity and further adaptable to be in an unconstrained shape to create a useable working field in the oral cavity, the useable working field providing increased accessibility and increased visibility within the oral cavity. In some embodiments, the conformable structure is a frame. Additionally, the frame can further comprise a membrane. The frame can also comprise a light source. The frame can also comprise an evacuation component. The device can be adaptable to be deployed in under 1 minute. In some embodiments, the device can be adaptable to create a working field in under 1 minute. The device can be deployed in under 20 seconds. The device can further comprise a tongue retractor wherein the tongue retractor can be adaptable to deflect the tongue without passing over either arch of teeth. The tongue retractor can contain and confine the tongue in a restricted space. In some embodiments, the device can further comprise at least one evacuation component. The evacuation component can be used to remove saliva or other bodily fluids from the oral cavity. Additionally, the evacuation component can be used to remove moist air or breath from the oral cavity. The device can be adaptable to retract soft tissue surrounding at least one arch of teeth. Additionally, the device can be adaptable to retract the soft tissue surrounding both the upper and lower arches of teeth in the oral cavity. The device can also be used in some cases to isolate at least a portion of gum tissue in the oral cavity. In isolating the teeth of gum tissue, the device can be used to create a barrier that can be efficiently separate dental surfaces from any influence by saliva or other body fluids. Furthermore, the device can comprise at least one aperture to facilitate the ability to breathe through the device. The device can facilitate the scanning of the dental surfaces by providing increased accessibility to the oral cavity and increased visibility within the structures within the oral cavity. The device can facilitate scanning or imaging of the oral cavity, wherein the scanning or imaging comprises at least one of digital scanning/imaging or optical scanning/imaging. Furthermore, the device can be adaptable to isolate both arches of teeth is less then 20 seconds. In some embodiments, the device can be adaptable to be positioned without interfering with access to dental surfaces, while also being further adaptable to prevent interference with access to dental surfaces by the tongue, cheeks or lips and further adaptable to provide maximum patient comfort.

0008Further provided herein is a retraction device comprising a topology conformable structure adaptable to create a working field in an oral cavity of a patient, wherein the working field is at least 10% larger than a working field created in the oral cavity of the patient without use of the device. The device can be used to provide at least 10% more access to an area of interest in the oral cavity. In some embodiments, the area of interest is one arch of teeth. Alternatively, the area of interest can be both arches of teeth. The device can be adaptable to provide at least 10% more visibility within the oral cavity. The device can be adaptable to provide at least 10% less contamination of structures located in the oral cavity by fluid. The fluid can be saliva, blood, or any other suitable bodily fluid. In some embodiments, the device can be adaptable to provide at least 10% less interference by soft tissue in accessing structures in the oral cavity. The conformable structure can be a frame. The device can be adaptable to evacuate bodily fluids from a protected side of the oral cavity and also any fluid used to rinse the oral cavity on the working field side of the membrane during a procedure. In some embodiments, the device can comprise a full membrane that can isolate the oral cavity from harmful debris or undesirable chemicals and tastes. In some embodiments, the frame is a wire frame. In some embodiments, the device further comprises a membrane. Additionally, the device can comprise a light source. The light source can be used to illuminate the oral cavity. The light source can be used to cure materials placed in the oral cavity. Alternatively, the device can comprise light sources that can either illuminate or cure material. The device can be adaptable to isolate at least one arch located within the oral cavity or create a barrier that can efficiently separate dental surfaces from any influence by saliva or other bodily fluid. The device can be adaptable to isolate the upper arch and the lower arch in the oral cavity. In some embodiments, the device can be adaptable to isolate at least a portion of gum tissue in the oral cavity. The device can be used to isolate the entire gum tissue. Furthermore, the device can be adaptable to be deployed in under 1 minute. The device can also be adaptable to create a working field in under 1 minute. In some embodiments, the device can be deployed in under 20 seconds. Additionally, no further adjustment of the device can be needed after the device has been deployed. In some embodiments, the device can further comprise a tongue retractor. The tongue retractor can contain and confine the tongue in a restricted space. The tongue retractor and the elements which attach it to the rest of the device can be adaptable to allow a first occlusal surface of a tooth in the upper arch of teeth and a second occlusal surface of a tooth in the lower arch of teeth to touch. The tongue retractor can be adaptable to compress at least one side of the tongue or both sides of the tongue. The device can be adaptable to apply suction to the oral cavity. The device can be adaptable to apply suction to the oral cavity through at least one aperture. The device can also be adaptable to facilitate the ability to breathe through the device. The device can be adaptable to isolate at least one dental arch or create a barrier around the at least one dental arch in less than 20 seconds. The device can further be adaptable to be positioned without interfering with access to dental surfaces and further adaptable to provide maximum patient comfort.

0009Additionally, provided herein is a retraction device comprising a malleable frame adaptable to be in a constrained shape that can be delivered into an oral cavity and further adaptable to be in an unconstrained shape to isolate at least one arch of teeth from saliva and soft tissue surrounding the arch. The malleable frame can be a wire frame, including but not limited to a metal wire. Alternatively, the wire frame can be a polymer frame or a combination or metal and polymer frame. The malleable frame can further comprise a membrane. Additionally, the device can further comprise a light source. In some embodiments, the device can be adaptable to be deployed in under 1 minute. The device can be adaptable to be deployed in under 20 seconds, in some embodiments. The device can also be adaptable to create a working field in under 1 minute. Furthermore, the device can comprise a tongue retractor. The tongue retractor can contain and confine the tongue. The tongue retractor and the elements which attach it to the rest of the device can be adaptable to allow a first occlusal surface of a tooth in the upper arch of teeth and a second occlusal surface in the lower arch of teeth to touch. The device can also comprise at least one evacuation component. The device can be adaptable to retract soft tissue surrounding at least one arch of teeth or in some cases, retract the soft tissue surrounding the upper and lower arches of teeth. The device can be adaptable to isolate at least a portion of gum tissue located in the oral cavity. In some embodiments, the device further comprises at least one aperture to facilitate the ability to breathe through at least one aperture in the device. The device can be further adaptable to facilitate the application of a substance to at least one tooth surface. The substance can be a powder. In some embodiments, the powder is a reflective powder. The powder can be an imaging powder for pattering the dental surfaces. The substance can be a dental restorative material or medication. The device can also be adaptable to facilitate the application of hardware (orthodontic brackets) to at least one tooth surface. The device can be further adaptable to facilitate treatment of at least one periodontal pocket using including, but not limited to, a laser device, an ultrasonic or sonic frequency scaler device, treatment with hand scalers and curettes, periodontal surgery, or dental implant placement, or any suitable combination thereof. The device can also be adaptable to isolate at least one dental arch in less than 20 seconds. The device can be adaptable to create a working field without interfering with access to dental surfaces. The device can be further adaptable to be positioned in the mouth to provide for maximum patient comfort.

0010Further provided herein are methods of use of the invention described herein. Provided herein is a method of retracting tissue in an oral cavity comprising: inserting a retraction device comprising a topology conformable structure adaptable to be in a constrained shape that can be delivered into an oral cavity and further adaptable to be in an unconstrained shape to create a useable working field in the oral cavity, the useable working field providing increased accessibility to and increased visibility within the oral cavity; and positioning the retraction device in the oral cavity to create the useable working field. The positioning step can be performed in less than 1 minute. In some embodiments, the positioning step can be performed in less than 20 seconds.

0011Yet another method for retracting tissue in an oral cavity comprises: inserting a retraction device comprising a topology conformable structure adaptable to create a useable working field in an oral cavity of a patient, wherein the working field is at least 10% larger than a working field in oral cavity of the patient without use of the device; and positioning the retraction device in the oral cavity to create the working field.

0012Another method provided herein is a method of facilitating the creation of an oral cavity model comprising: inserting a retraction device comprising a topology conformable structure adaptable to be in a constrained shape that can be delivered into an oral cavity and further adaptable to be in an unconstrained shape to create a useable working field in the oral cavity, the usable working field providing increased accessibility to and increased visibility within the oral cavity; and positioning the retraction device in the oral cavity to create the useable working field in the oral cavity. In some embodiments, the method can further comprise the step of illuminating the oral cavity with the retraction device. Additionally, the method can comprise the step of applying an imaging powder to the at least one dry tooth surface.

0013Further provided herein are kits for retracting tissue in an oral cavity. Provided herein are kits for retracting tissue in an oral cavity comprising: a topology conformable structure adaptable to be in a constrained shape that can be delivered into an oral cavity and further adaptable to be in an unconstrained shape to create a useable working field in the oral cavity, the useable working field providing increased accessibility to and increased visibility within the oral cavity. In some embodiments, the kit can further comprise a tongue retractor. Additionally, the kit can further comprise a light ring. Furthermore, the kit can comprise an evacuation component. The kit can further comprise a membrane adaptable to be fitted over the frame. In some embodiments, the kit can further comprise a gum protection cover. The kit can also further comprise a lip ring.

0014Furthermore, additionally provided herein is a kit for retracting tissue in an oral cavity comprising: a retraction device comprising a topology conformable structure adaptable to be in a constrained shape that can be delivered into an oral cavity and further adaptable to be in an unconstrained shape to create a useable working field in the oral cavity, the useable working field providing increased accessibility to and increased visibility within the oral cavity; and a kit of secondary dental products wherein tissue retraction in the oral cavity is necessary. In some embodiments, the kit can further comprise an illumination source. Additionally, the kit can comprise at least one optical scanner or digital scanner. Furthermore, the kit can further comprise a powder for facilitate scanning of the dental surfaces. In some embodiments, the kit can further comprise a whitening or bleaching kit.

INCORPORATION BY REFERENCE

0015All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

0016The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which: <ul id="ul0001" list-style="none" compact="compact"><li><figref idref="f0001"><b>FIG. 1A</b></figref> depicts an anterior view of an oral cavity with the mouth open and the teeth exposed illustrating the structures of the oral cavity; <figref idref="f0001"><b>FIG. 1B</b></figref> is an illustration of a human body with the anatomical planes of the body identified;</li><li><figref idref="f0002 f0003"><b>FIGS. 2A-2E</b></figref> illustrate one embodiment of a retraction device positioned in the oral cavity of a patient; <figref idref="f0002"><b>FIG. 2A</b></figref> is a perspective view of the device positioned in the oral cavity; <figref idref="f0002"><b>FIG. 2B</b></figref> is a side view of the retraction device positioned within the oral cavity; <figref idref="f0002"><b>FIG. 2c</b></figref> depicts a portion of the retraction device positioned over the caudad portion of the oral cavity as viewed along the line <b>B-B in</b><figref idref="f0002"><b>FIG. 2B; FIG. 2D</b></figref> depicts a portion of the retraction device positioned over the caudad portion of the oral cavity as viewed along the line <b>B-B</b> in <figref idref="f0002"><b>FIG. 2B</b></figref>, without surrounding tissue structures; <figref idref="f0003"><b>FIG. 2E</b></figref> depicts a portion of the retraction device positioned over the cephalad portion of the oral cavity as viewed along the line <b>B-B</b> in <figref idref="f0002"><b>FIG. 2B</b></figref>; <figref idref="f0003"><b>FIG. 2F</b></figref> depicts an anterior view of the device positioned in the oral cavity; <figref idref="f0003"><b>FIG. 2G</b></figref> depicts a cross-sectional view of the device, and surrounding tissue structures, along the sagittal plane;</li><li><figref idref="f0004"><b>FIGS. 3A-3D</b></figref> illustrate one embodiment of a retraction device; <figref idref="f0004"><b>FIG. 3A</b></figref> is perspective view of the retraction device as viewed from the distal end of the device; <figref idref="f0004"><b>FIG. 3B</b></figref> is a top view of the retraction device; <figref idref="f0004"><b>FIG. 3C</b></figref> is a side view of retraction device; <figref idref="f0004"><b>FIG. 3D</b></figref> is a posterior view of the retraction device;</li><li><figref idref="f0005"><b>FIGS. 4A-4D</b></figref> illustrate the tongue and gum protection cover isolated from the retraction device; <figref idref="f0005"><b>FIG. 4A</b></figref> is a perspective view of the tongue and gum protection cover of the retraction device as viewed from the distal end of the device; <figref idref="f0005"><b>FIG. 4B</b></figref> is a top view of the tongue and gum protection cover of the retraction device; <figref idref="f0005"><b>FIG. 4C</b></figref> is a side view of the tongue and gum protection cover of the retraction device; <figref idref="f0005"><b>FIG. 4D</b></figref> is a posterior view of the tongue and gum protection cover of the retraction device;</li><li><figref idref="f0006"><b>FIGS. 5A-5D</b></figref> illustrate the frame covering both the upper and lower arches of the retraction device, isolated from the membrane of the retraction device; <figref idref="f0006"><b>FIG. 5A</b></figref> is a perspective view of the frame as viewed from the distal end of the device; <figref idref="f0006"><b>FIG. 5B</b></figref> is a top view of the frame of the retraction device; <figref idref="f0006"><b>FIG. 5C</b></figref> is a side view of the frame of the retraction device; <figref idref="f0006"><b>FIG. 5D</b></figref> is a posterior view of the frame of the retraction device;</li><li><figref idref="f0007"><b>FIGS. 6A-6D</b></figref> illustrate the light ring portion of the retraction device isolated from the retraction device; <figref idref="f0007"><b>FIG. 6A</b></figref> illustrates a perspective view of the light ring as viewed from the posterior side; <figref idref="f0007"><b>FIG. 6B</b></figref> illustrates a top view of the light ring; <figref idref="f0007"><b>FIG. 6C</b></figref> illustrates a side view of the isolated light ring; <figref idref="f0007"><b>FIG. 6D</b></figref> illustrates a posterior view of the light ring;</li><li><figref idref="f0008"><b>FIGS. 7A-7D</b></figref> illustrate an alternative embodiment of a retraction device without a tongue or gum protection component; <figref idref="f0008"><b>FIG. 7A</b></figref> illustrates the retraction device as viewed from the distal end of the device; <figref idref="f0008"><b>FIG. 7B</b></figref> illustrates a top view of the retraction device; <figref idref="f0008"><b>FIG. 7C</b></figref> illustrates a side view of the retraction device; <figref idref="f0008"><b>FIG. 7D</b></figref> illustrates a posterior view of the retraction device;</li><li><figref idref="f0009"><b>FIGS. 8A-8D</b></figref> illustrate an alternative embodiments of a retraction device having a frame covered by a membrane; <figref idref="f0009"><b>FIG. 8A</b></figref> illustrates a perspective view of the isolation/retraction device; <figref idref="f0009"><b>FIG. 8B</b></figref> illustrates a top view of the isolation/retraction device; <figref idref="f0009"><b>FIG. 8C</b></figref> illustrates a side view of the isolation/retraction device; <figref idref="f0009"><b>FIG. 8D</b></figref> illustrates a posterior view of the isolation/retraction device;</li><li><figref idref="f0010"><b>FIGS. 9A-9D</b></figref> illustrate the isolation membrane or cover of the retraction device isolated from the retraction device; <figref idref="f0010"><b>FIG. 9A</b></figref> illustrates a perspective view of the isolation membrane of the retraction device; <figref idref="f0010"><b>FIG. 9B</b></figref> illustrates a top view of the isolation membrane of the retraction device; <figref idref="f0010"><b>FIG. 9C</b></figref> illustrates a side view of the isolation membrane/cover of the retraction device; <figref idref="f0010"><b>FIG. 9D</b></figref> illustrates a posterior view of the isolation membrane/cover of the retraction device;</li><li><figref idref="f0011"><b>FIGS. 10A-10D</b></figref> illustrate an alternative embodiment of a light ring and lip and cheek retractor isolated from a retraction device; <figref idref="f0011"><b>FIG. 10A</b></figref> illustrates a perspective view of the light ring; <figref idref="f0011"><b>FIG. 10B</b></figref> illustrates a top view of the isolated light ring; <figref idref="f0011"><b>FIG. 10C</b></figref> illustrates a side view of the isolated light ring; <figref idref="f0011"><b>FIG. 10D</b></figref> illustrates a posterior view of the isolated light ring;</li><li><figref idref="f0012"><b>FIGS. 11A-11D</b></figref> illustrate an alternate embodiment of a light ring comprising a flexible electrical circuit membrane; <figref idref="f0012"><b>FIG. 11A</b></figref> illustrates a perspective view of the light ring; <figref idref="f0012"><b>FIG. 11B</b></figref> illustrates a top view of the isolated light ring; <figref idref="f0012"><b>FIG. 11C</b></figref> illustrates a side view of the isolated light ring; <figref idref="f0012"><b>FIG. 11D</b></figref> illustrates a posterior view of the isolated light ring;</li><li><figref idref="f0013"><b>FIGS. 12A-12D</b></figref> illustrate an alternate embodiment of an isolated frame of a retraction device, including tongue cover, and lip and cheek retraction ring; <figref idref="f0013"><b>FIG. 12A</b></figref> illustrates a perspective view of the frame; <figref idref="f0013"><b>FIG. 12B</b></figref> illustrates a top view of an isolated frame; <figref idref="f0013"><b>FIG. 12C</b></figref> illustrates a side view of an isolated frame; <figref idref="f0013"><b>FIG. 12D</b></figref> illustrates a posterior view of the isolated frame;</li><li><figref idref="f0014"><b>FIGS. 13A-13D</b></figref> illustrate an alternate embodiment of an isolated frame of a retraction device; <figref idref="f0014"><b>FIG. 13A</b></figref> illustrates a perspective view of the frame; <figref idref="f0014"><b>FIG.13B</b></figref> illustrates a top view of an isolated frame of the retraction device; <figref idref="f0014"><b>FIG. 13C</b></figref> illustrates a side of the frame; <figref idref="f0014"><b>FIG. 13D</b></figref> illustrates a posterior view of the isolated frame;</li><li><figref idref="f0015"><b>FIGS. 14A-14D</b></figref> illustrate an isolated view an alternative embodiment of a frame; <figref idref="f0015"><b>FIG. 14A</b></figref> illustrates a perspective view of the frame; <figref idref="f0015"><b>FIG. 14B</b></figref> illustrates a top view of the frame; <figref idref="f0015"><b>FIG.14C</b></figref> illustrates a side view of the frame; <figref idref="f0015"><b>FIG. 14D</b></figref> illustrates an posterior view of the frame;</li><li><figref idref="f0016"><b>FIGS. 15A-15D</b></figref> illustrate an alternate embodiment of a frame comprising an evacuation component; <figref idref="f0016"><b>FIG. 15A</b></figref> illustrates a perspective view of the frame; <figref idref="f0016"><b>FIG. 15B</b></figref> illustrates a top view of the frame; <figref idref="f0016"><b>FIG. 15C</b></figref> illustrates a side view of the frame; <figref idref="f0016"><b>FIG. 15D</b></figref> illustrates an posterior view of the frame;</li><li><figref idref="f0017"><b>FIGS. 16A-16D</b></figref> illustrate an alternative embodiment of an isolated lip ring; <figref idref="f0017"><b>FIG. 16A</b></figref> illustrates a perspective view of the lip ring as viewed from the distal side; <figref idref="f0017"><b>FIG. 16B</b></figref> illustrates a top view of the lip ring; <figref idref="f0017"><b>FIG. 16C</b></figref> illustrates a side view of the lip ring; <figref idref="f0017"><b>FIG. 16D</b></figref> illustrates a posterior view of the lip ring;</li><li><figref idref="f0018"><b>FIGS. 17A-17D</b></figref> illustrate an embodiment of an isolated tongue cover; <figref idref="f0018"><b>FIG. 17A</b></figref> illustrates a perspective view of the tongue cover; <figref idref="f0018"><b>FIG. 17B</b></figref> illustrates a top view of a tongue cover; <figref idref="f0018"><b>FIG. 17C</b></figref> illustrates a side view of a tongue cover; <figref idref="f0018"><b>FIG. 17D</b></figref> illustrates a posterior view of a tongue cover;</li><li><figref idref="f0019"><b>FIGS. 18A-18D</b></figref> illustrates an alternate embodiment of an frame adaptable to be folded; <figref idref="f0019"><b>FIG. 18A</b></figref> illustrates a perspective view of the frame as viewed from the distal end; <figref idref="f0019"><b>FIG. 18B</b></figref> illustrates a top view of the frame; <figref idref="f0019"><b>FIG. 18c</b></figref> illustrates a side view of the frame; <figref idref="f0019"><b>FIG. 18D</b></figref> illustrates a posterior view of the frame;</li><li><figref idref="f0020"><b>FIGS. 19A-19D</b></figref> illustrates an alternative embodiment of a foldable frame without a tongue cover; <figref idref="f0020"><b>FIG. 19A</b></figref> illustrates a perspective view of the frame as viewed from the distal end; <figref idref="f0020"><b>FIG. 19B</b></figref> illustrates a top view of the frame; <figref idref="f0020"><b>FIG. 19C</b></figref> illustrates a side view of the frame; <figref idref="f0020"><b>FIG. 19D</b></figref> illustrates a posterior view of the frame;</li><li><figref idref="f0021"><b>FIGS. 20A-20D</b></figref> illustrate isolated cheek retractors from a foldable frame; <figref idref="f0021"><b>FIG. 20A</b></figref> illustrates a perspective view of the cheek retractors; <figref idref="f0021"><b>FIG. 20B</b></figref> illustrates a top view of the cheek retractors; <figref idref="f0021"><b>FIG. 20C</b></figref> illustrates a side view of the cheek retractors; <figref idref="f0021"><b>FIG. 20D</b></figref> illustrates a posterior view of the cheek retractors;</li><li><figref idref="f0022"><b>FIGS. 21A-21D</b></figref> illustrate a retraction device for retracting tissue surrounding the lower arch, tongue, cheeks, and lips, including lighting and suction; <figref idref="f0022"><b>FIG. 21A</b></figref> illustrates a perspective view of the retraction device as viewed from the distal side; <figref idref="f0022"><b>FIG. 21B</b></figref> illustrates the retraction device as viewed from top; <figref idref="f0022"><b>FIG. 21C</b></figref> illustrates a side view of the retraction device; <figref idref="f0022"><b>FIG. 21D</b></figref> illustrates a posterior view of the retraction device;</li><li><figref idref="f0023"><b>FIGS. 22A-22D</b></figref> illustrates an alternative embodiment of a retraction device comprising a frame with gum protector and tongue cover; <figref idref="f0023"><b>FIG. 22A</b></figref> illustrates a perspective view of the retraction device as viewed from the distal side; <figref idref="f0023"><b>FIG. 22B</b></figref> illustrates a top view of the retraction device; <figref idref="f0023"><b>FIG. 22C</b></figref> illustrates a side view of a retraction device; <figref idref="f0023"><b>FIG. 22D</b></figref> illustrates a posterior view of a retraction device;</li><li><figref idref="f0024"><b>FIGS. 23A-23D</b></figref> illustrate an alternative embodiment of a membrane isolated from the retraction device comprising a gum protector, a tongue cover and evacuation component; <figref idref="f0024"><b>FIG. 23A</b></figref> illustrates a perspective view of the retraction device as viewed from the distal end; <figref idref="f0024"><b>FIG. 23B</b></figref> illustrates a top view of the retraction device; <figref idref="f0024"><b>FIG. 23C</b></figref> illustrates a side view of the retraction device; <figref idref="f0024"><b>FIG. 23D</b></figref> illustrates a posterior view of the retraction device;</li><li><figref idref="f0025"><b>FIGS. 24A-24D</b></figref> illustrate an isolated view of an alternate embodiment of a frame comprising an evacuation component; <figref idref="f0025"><b>FIG. 24A</b></figref> illustrates a perspective view of the frame as viewed from the distal end; <figref idref="f0025"><b>FIG. 24B</b></figref> illustrates a top view of the frame; <figref idref="f0025"><b>FIG. 24C</b></figref> illustrates a side view of the frame; <figref idref="f0025"><b>FIG. 24D</b></figref> illustrates a posterior view of the frame;</li><li><figref idref="f0026"><b>FIGS. 25A-25D</b></figref> illustrate an alternate embodiment of a retraction device comprising a lower frame and gum protector and light lip ring; <figref idref="f0026"><b>FIG. 25A</b></figref> illustrates a perspective view of the retraction device as viewed from the distal end; <figref idref="f0026"><b>FIG. 25B</b></figref> illustrates a top view of the frame; <figref idref="f0026"><b>FIG. 25c</b></figref> illustrates a side view of the frame; <figref idref="f0026"><b>FIG. 25D</b></figref> illustrates a posterior view of the frame;</li><li><figref idref="f0027"><b>FIGS. 26A-26D</b></figref> illustrate an alternate embodiment of a retraction device comprising a lower arch frame and a tongue cover; <figref idref="f0027"><b>FIG. 26A</b></figref> illustrates a perspective view of the retraction device; <figref idref="f0027"><b>FIG. 26B</b></figref> illustrates a top view of the retraction device; <figref idref="f0027"><b>FIG. 26C</b></figref> illustrates a side view of the retraction device; <figref idref="f0027"><b>FIG. 26D</b></figref> illustrates a posterior view of the retraction device;</li><li><figref idref="f0028"><b>FIGS. 27A-27D</b></figref> illustrates an alternative embodiment of retraction device comprising an upper and lower arch frame and tongue cover; <figref idref="f0028"><b>FIG. 27A</b></figref> is a perspective view of the frame as viewed from the front; <figref idref="f0028"><b>FIG. 27B</b></figref> illustrates a top view of the retraction device; <figref idref="f0028"><b>FIG. 27c</b></figref> illustrates a side view of the retraction device; <figref idref="f0028"><b>FIG. 27D</b></figref> illustrates a view of the retraction device as viewed from the top;</li><li><figref idref="f0029"><b>FIGS. 28A-28D</b></figref> illustrate an alternate embodiment of an isolated frame comprising a evacuation component; <figref idref="f0029"><b>FIG. 28A</b></figref> illustrates a perspective view of the frame as viewed from the distal side; <figref idref="f0029"><b>FIG. 28B</b></figref> illustrates a top view of the frame; <figref idref="f0029"><b>FIG. 28C</b></figref> illustrates a side view of the frame; <figref idref="f0029"><b>FIG. 28D</b></figref> illustrates a posterior view of the frame;</li><li><figref idref="f0030"><b>FIGS. 29A-29D</b></figref> illustrate an isolated tongue cover; <figref idref="f0030"><b>FIG. 29A</b></figref> illustrates a perspective view of the tongue cover as viewed from the distal side; <figref idref="f0029"><b>FIG. 28B</b></figref> illustrates a top view of the tongue cover; <figref idref="f0030"><b>FIG. 29C</b></figref> illustrates a side view of the tongue cover; <figref idref="f0030"><b>FIG. 29D</b></figref> illustrates a posterior view of the tongue cover;</li><li><figref idref="f0031"><b>FIGS. 30A-30D</b></figref> illustrates an isolated upper arch frame; <figref idref="f0031"><b>FIG. 30A</b></figref> illustrates a perspective view of the frame; <figref idref="f0031"><b>FIG. 30B</b></figref> illustrates a top view of frame; <figref idref="f0031"><b>FIG. 30C</b></figref> illustrates a side view of the frame; <figref idref="f0031"><b>FIG. 30D</b></figref> illustrates a posterior view of the frame;</li><li><figref idref="f0032"><b>FIGS. 31A-31D</b></figref> illustrates an alternative embodiment of an isolated upper and lower arch frame; <figref idref="f0032"><b>FIG. 31A</b></figref> illustrates a perspective view of the frame; <figref idref="f0032"><b>FIG. 31B</b></figref> illustrates a top view of frame; <figref idref="f0032"><b>FIG. 31C</b></figref> illustrates a side view of the frame; <figref idref="f0032"><b>FIG. 31D</b></figref> illustrates a frontal view of the frame; and</li><li><figref idref="f0033"><b>FIGS. 32A-32D</b></figref> illustrates an alternative embodiment of a retraction device frame; <figref idref="f0033"><b>FIG. 32A</b></figref> illustrates a perspective view of the frame; <figref idref="f0033"><b>FIG. 32B</b></figref> illustrates a top view of frame; <figref idref="f0033"><b>FIG. 32C</b></figref> illustrates a side view of the frame; <figref idref="f0033"><b>FIG. 32D</b></figref> illustrates a frontal view of the frame.</li></ul>

DETAILED DESCRIPTION OF THE INVENTION

0017In order to understand the configurability, adaptability and operational aspects of the invention, it is helpful to understand the anatomical references of the body <b><i>50</i></b> with respect to which the position and operation of the device, and components thereof, are described. There are three anatomical planes generally used in anatomy to describe the human body and structure within the human body: the axial plane <b><i>52</i></b>, the sagittal plane <b><i>54</i></b> and the coronal plane <b><i>56</i></b> (see <figref idref="f0001"><b>FIG. 1B</b></figref>). Additionally, devices and the operation of devices are better understood with respect to the caudad <b><i>60</i></b> direction and/or the cephalad direction <b><i>62</i></b>. Devices positioned within the body can be positioned dorsally <b><i>70</i></b> (or posteriorly) such that the placement or operation of the device is toward the back or rear of the body. Alternatively, devices can be positioned ventrally <b><i>72</i></b> (or anteriorly) such that the placement or operation of the device is toward the front of the body. Various embodiments of the device for isolating teeth, systems and kits of the present invention may be configurable and variable with respect to a single anatomical plane or with respect to two or more anatomic. Similarly, the various components can incorporate differing sizes and/or shapes in order to accommodate differing patient oral cavity sizes.

0018Provided herein is a retraction device for isolating the lower and upper arches of teeth located in the oral cavity. The retraction device can isolate the lower and upper arches of teeth. Additionally, the retraction device can isolate gum tissue located adjacent to the lower and upper arches. By isolating the dental surfaces, the device can be used to create a barrier that can efficiently separate the dental surfaces from any influence by saliva or other body fluids. A portion of the gum tissue can be isolated or the entire gum tissue can be isolated. The present invention contemplates devices adapted and configured to retract tissue in the oral cavity away from one or more dental arches or from one or more teeth. By retracting the tissue, teeth are set apart or kept away from other tissue, saliva, and debris to create a site within the oral cavity suitable to perform a dental procedure, such as dental imaging. As will be appreciated by those skilled in the art, because the teeth are embedded in the jaw bone, a target tooth is not per se "isolated" from a neighboring tooth. However, the devices, can be configured such that the target tooth is isolated from a neighboring tooth such that the neighboring tooth is not impacted by the use of dental materials during a procedure on the target tooth. Isolation of one or more target teeth can also include exposing those teeth to create a surgical sit, or site for performing a procedure. Isolation of one or more target teeth can also include creating a barrier that can efficiently separate dental surfaces from any influence by saliva or other body fluids.

0019The devices are further configured such that they are rapidly deployable. The devices are able to quickly achieve a dry working field and substantially maintain the working field condition during the procedure without the need for interaction. The device can isolate at least one arch of teeth in seconds. In some embodiments, the device can be deployed to isolate the upper and lower arches of teeth in less than about 60 seconds or 1 minute. In some embodiments, the device can be deployed to isolate the upper and lower arches of teeth in less than about 1 minute. In some embodiments, the device can be deployed to isolate the upper and lower arches of teeth in less than about 20 seconds.

0020In some embodiments, a device of the present invention is a single unit apparatus that can be positioned within a patient's mouth to isolate one or more of the patient's teeth by retracting tissue, including the tongue. The ability to retract the tongue provides considerable advantage for accessing the oral cavity. For example, a device can be a single arch that isolates only the upper teeth or a portion thereof or a single arch that isolates only the lower teeth or a portion thereof. Such single-arch devices which isolate only lower or upper teeth can be used independently or in combination with one another to form a two piece device. In some embodiments, a single arch (e.g., lower arch) device is coupled to a paddle that isolates the other half of the mouth and tongue (e.g., the upper teeth) and/or keeps the mouth open. Since the device herein is shaped like the mouth, the device can be inserted into a patient's mouth accurately in about one minute or less or about 20 seconds or less.

0021The devices herein include one or more retractors. A retractor is an element that deflects, retracts, or displaces soft tissue, such as lips, tongue and/or cheek(s), away from teeth and/or alveolar surfaces. In some embodiments, a device comprises one retractor. In some embodiments, a device comprises two retractors. The tongue can be deflected by an open tongue retractor structure, such as a wire tongue retractor. Alternatively, the tongue retractor can include a cover for containing the tongue from the sides. The tongue can be entirely confined within the tongue retractor so that the tongue is confined within a restricted space and thereby prevented from filling the oral cavity. Additional retractors can be used, especially when each retractor uniquely retracts a different portion of the cheek(s) and/or lip(s).

0022Devices can further be adapted and configured to provide one or more apertures that correspond with one or more upper and/or lower teeth. A lower retractor may be provided adjacent an aperture for the lower teeth such that it is adapted and configured to extend or protrude the lower lip and cheeks away from the lower teeth, or at least a target lower tooth, e.g. where only one tooth is exposed through the lower tooth aperture. Similarly, an upper retractor may be positioned adjacent an aperture corresponding to one or more upper teeth, wherein the retractor is adapted and configured to extend or protrude the upper lip and cheeks away from the upper teeth, or at least a target upper tooth. The upper and/or lower teeth can be inserted into such tooth receiving apertures without impinging on the patient's teeth and without forceful contact with the alveolar process or gingiva. In some embodiments, additional regions of interest (e.g., gums) may be exposed by using a more minimal device or by removing (such as by cutting) one or more parts of the device as necessary.

0023The retractor can have various dimensions to achieve suitable to achieve creation of a working field around a target tooth or teeth. Thus, the length, height, curvature, and width can be adjusted to take into account the size of the mouth and/or the facial features of the patient. For example, in some embodiments, retractors can be configured to increase in size as the retractor extends away from the alveolar arch to allow for retraction of more cheek muscle. In some embodiments, a lower retractor and/or an upper retractor is between about 1 mm to about 10 cm in height. Retractors for children, adults, and animals can have different lengths, widths, curvatures, etc.

0024The lower and upper retractors can be adapted to extend to the back of the mouth where the retractors interconnect. For example, the lower and upper retractors may be connected on both the right and left back (posterior) sides of the mouth, e.g. immediately posterior the most posteriorly positioned tooth, via a flexible bridge that permits the patient to open and close their mouth with the device fully deployed therein. Such a bridge can include, for example, one or more features adapted to increase flexibility or rigidity. In some embodiments, the bridges comprise folds, bellows or ribs which increase its elasticity. In some devices, the bridges are made of a different material than the retractors. Additionally, the lower and upper retractors can be connected via an inflexible bridge forcing a patient to keep their mouth open at a specified angle. In some embodiments, the bridges are designed to help keep a patient's mouth open but also provide flexibility to permit closing of the mouth.

0025A flange or bridge (such as "webbing") can also be provided that connects the anterior portion of the lower retractor prevents the tongue from dislodging the device by positioning the tongue over the top of the webbed portion described.

0026The bridges in the back of the mouth can be coupled to or extend into a shield that prevents debris and other components from entering the throat during a dental procedure. The shield can have a proximal curvature to allow extra room for the tongue. In some embodiments, the shield curvature is such that the apex of curvature is in the center of the mouth. In some embodiments, the shield can further act as a tongue containment device, tongue retractor, tongue deflector, tongue suppressor, tongue elevator, tongue support, etc. In some embodiments, the shield comprises an aperture or apertures (mesh) in its center to permit a patient to breathe using their mouth. The aperture allows the patient to breath through the mouth. Additionally, the aperture may be large enough such that the patient can put their tongue into and/or through the aperture. The aperture can also be used to provide access to the back of the mouth e.g. to visualize debris or saliva build-up, as well as to give access to high volume suction.

0027Some configurations of the shield are configured to function as a tongue retractor comprises a surface that is a u-shaped flange extending from the inside of the mouth toward the outside. The bottom surface of the tongue retractor can have an internal surface with side surfaces extending from top to bottom forming a barrier between the mouth and the throat. The throat barrier is below the breathing aperture, which permits the patient to breathe through the mouth during the procedure.

0028In some embodiments, a shield can be used to maintain the patient's mouth in an open state. Such shield has a support mechanism above the breathing cavity. The support mechanism may be a u-shaped flange that extends upwardly and externally above the breathing cavity. The support mechanism is adapted to maintain the mouth cavity open. The support mechanism is especially useful for dental surgery, when the patient is unconscious or sedated.

0029Devices of the invention can also be adapted and configured to integrate with a saliva ejection or suction/evacuation element. A saliva suction element includes, for example, one or more suction inlets, one or more suction channels, and one or more suction outlets. A suction channel can extend from a region inside the mouth (e.g. posteriorly and then forward in and around the alveolar process under the tongue) to a region near or at the mouth opening (e.g. anteriorly). A suction channel can be integrated into the frame of the device. For example, a suction inlet can be at a region abutting the internal cheek or back of the mouth when the device is deployed. In some embodiment multiple suction inlets align the bottom lower retractors. Such suction inlets are coupled to a single channel leading to an outlet or port in the front of the patient's mouth. A suction channel can extend from the suction inlet within the frame of the device, or external to the device, to a suction outlet or port located at the proximal end of the device herein or proximal to the device herein (external to the mouth). The suction port can be coupled to a suction device external to the patient to draw saliva from the back of the mouth outside the patient. A saliva ejection or suction element enhances the seal around the teeth. In some embodiments, suction channels(s) and outlet(s) are located on the underside (meaning the "tissue side") of the "sealing mechanism" such that the device attaches itself firmly to the alveolar process or upper and lower alveolar processes when suction is applied. The suction actuated sealing mechanism can also consists of a suction channel within the "windshield wiper blade" or retractor element, with perforations positioned in two rows on the tissue side ("underside") of the seal. In the case of the upper arch portion of the device, the perforations are on the superior surface of the seal. When suction is applied to the channel or channels, via a port or ports near the proximal end of the device, the seal(s) adhere(s) to the alveolar process or processes. The suction is also capable of evacuating saliva on the tissue side of the barrier while evacuating debris and other contaminates on the working field side of the barrier.

0030The devices herein can also be integrated with a lighting element. As with other components of the invention, the integrated light can be formed integrally, such that it is a constituent piece of the device, or such that the device ultimately forms a single unit, one component of which is the light fixture. Such devices are composed of a translucent material capable of illuminating once it is inserted into the patient's mouth. In some embodiments, the device comprises LED light source or a fiber optic light source, or an effervescent light source either of which can, for example, be embedded in the device or coated on the device. The lighting device can also be configured such that it is powered by an external power source or a power source that is not external. Light sources can be located along the sides of the device, or along the top or the device or along the bottom of the device or all over the device.

0031The devices herein can be manufactured using an elastic but somewhat stiff wire to form the upper and lower retractors. The wire can be encapsulated in silicone and then encapsulated by a soft polymeric material, for example. In some embodiments, the wire is a polymer wire. Alternatively, the wire can be a metal wire. In some embodiments, the wire is used by itself without a soft membrane or coating. In some embodiments, a nickel/titanium alloy wire is used for the frame to optimize the collapsibility of the device for insertion purposes and compliance with mouth shape while providing the forces necessary to accomplish retraction of cheeks and tongue and to position the sealing mechanism. The heat in the oral cavity can activate property changes in the metal springing it into its designed shape making it less intrusive to insert. In some embodiments, a nylon or other plastic material is used for this "wire frame" that may be effected by the body heat also.

0032The devices described herein are particularly useful in aiding the imaging or scanning of the dental surfaces located within the oral cavity. The device can be used to create a larger working field, wherein the working field comprises the dental surfaces of interest and the area surrounding the dental surfaces of interest. The devices described herein can be used to create a larger working field to facilitate imaging the oral cavity. The oral cavity can be imaged using radiology equipment, such as X-rays, or to scan the dental surfaces by enabling a better insertion of the scanning device into the oral cavity. Additionally, the larger working field, together with the dry dental surfaces created by the devices, further facilitate the scanning of the dental surfaces by allowing for the placement of a powder on the dental surfaces, wherein the power aids in the ability to scan the dental surfaces. The devices can also be used to facilitate the generation of dental impressions by ensuring proper placement of dental trays within in the oral cavity since the devices can embody a design with minimal material, thereby taking up less space in the oral cavity. This provides for less interference by both the devices and the soft tissue with the materials and kits needed to create the dental tray. The ability to make a dental impression, utilizing the established, well controlled, full arch working field provided by the device provides a major advantage to the dentist. The dentist can transition directly from procedures involving the teeth or periodontal structures to making an impression of the area or an entire arch of teeth without removing the device or ever compromising the working field required for a complete and accurate impression.

0033The remainder of the devices herein can be made from one or more polymeric materials including, but not limited, to c-Flex-thermal plastic elastomer (TPE), silicon, slow recovery foam (SRF), and polypropylene (PP). Preferably, a clear polymer is used to manufacture the devices herein. The material can be embossed or pre-molded into the shape of the inside of the mouth which provides extra comfort to the patient. The device can be composed of one or more materials or of a single material having two or more durometers. In one embodiment, a first material conforms to the shape of the alveolar process(es) and creates a seal around one or more of the teeth while the second material provides a structure that retracts the cheek(s) and tongue, providing a clear working field for the dental practitioner and comfort and safety for the patient. In any of the embodiments herein, a material can optionally contain a lubricant or flavored lubricant to facilitate insertion and removal. In some embodiments, the device is molded in the practitioner's office to fit the individual patient. In some embodiments, a practitioner can measure a patient's mouth, using a sterilizable and reusable "tri-in" device, as an aid in selecting the best size of device for the patient. Overall, the device herein can be made in different sizes to fit different size mouths. In some embodiments, a device herein can be used in veterinary dental procedures. Such devices can be adapted to fit an animal being treated (e.g., dog, cat, horse, etc.). The sealing portion of the device can be formed from any suitable hydrophilic material, hydrophobic material, or a putty (e.g., Van-R reversible hydrocolloid, available from Dux Dental, and vinyl polysiloxane, available from 3M Express).

0034Prior to inserting the devices described herein into a patient's mouth, the devices have a circular circumference as provided by the upper and lower retractors. The devices can have at least one, two, or three apertures - e.g., one for one or more of the lower teeth, and/or one for one or more of the upper teeth, and/or one for the tongue and/or airway and/or the largest (proximal or posteriorly positioned) aperture which is used for access to the working field. The apertures for the target teeth (either upper or lower) can be formed by implanting the device and punching one or more target teeth through a perforated ridge. In some embodiments, a first aperture is designed to expose/isolate all of the target teeth and is c-shaped; a second aperture is designed to expose/isolate all of the target teeth. The first and second apertures border on their exterior end with retractors adapted to retract the lips and cheeks away from all teeth. The upper and lower retractors are coupled in the back of the mouth using flexible bridges that permit the patient to open their mouth at various angles. The bridges are also coupled to a shield with an aperture large enough to allow at least a portion of the patient's tongue to protrude through it.

0035As will be appreciated by those skilled in the art, the devices can be adapted and configured to completely isolate both full arches of teeth and is adapted to permit closing of the mouth. This may allow the upper and lower teeth to come together and permits a dental practitioner to make a judgment about the interaction(s) of upper and lower teeth (e.g., bite). The ability to look at all arch of teeth also permits judgment based on features of other teeth whether they are being worked on or not (e.g., comparing teeth coloration, etc.). Furthermore, exposing a plurality of teeth permits a dental practitioner to work on more than 1, 2, 3, 4, 5, 6 etc., teeth each of which may be located in a different part of the mouth without having to re-adjust the device.

0036The devices are adapted and configured for use in a procedure requiring a dry environment, such as performing restoration (e.g., crown and filling work) or creating molds of the oral cavity. Absence of saliva can impact the quality of a tooth impression, especially when making impressions of teeth prepared for laboratory fabricated dental restorations or prostheses. The devices of this invention enable a practitioner to insert the device, optionally perform suction on any saliva that remains in the patient's mouth or perform any other step to facilitate a dry working field, and then insert impression material onto a tooth, remove that impression material and optionally insert a filling material. The devices permit an impression to be taken and filling added without removing the device so that no impression or filling material goes down the patient's throat. The devices also helps prevent saliva from getting onto the teeth during the entire period it is placed in the mouth.

0037For surgical procedures, the devices can be used to isolate one or more teeth of interest while preventing blood, disposables, implantable parts, implanted related parts, or instruments from getting into the patient's throat. The device can be used to create a barrier that can efficiently prevent inhalation or ingestion of

0038The retraction devices described herein can comprise a topology conformable structure adaptable to be in a constrained shape that can be delivered into an oral cavity and further adaptable to be in an unconstrained shape to create a useable working field in the oral cavity, the useable working field providing increased accessibility to and increased visibility within the oral cavity. In some embodiments, the conformable structure is a frame. Additionally, the frame can further comprise a membrane. The frame can also comprise a light source. The device can be adaptable to be deployed in under 1 minute. In some embodiments, the device can be adaptable to create a working field in under 1 minute. The device can be deployed in under 20 seconds. The device can further comprise a tongue retractor wherein the tongue retractor can be adaptable to deflect the tongue without passing over either arch of teeth. The tongue retractor can contain and confine the tongue in a restricted space. In some embodiments, the device can further comprise at least one evacuation element. The device can be adaptable to retract soft tissue surrounding at least one arch of teeth. Additionally, the device can be adaptable to retract the upper and lower arches of teeth in the oral cavity. The device can also be used in some cases to isolate at least a portion of gum tissue in the oral cavity. Furthermore, the device can comprise at least one aperture to facilitate the ability to breathe through the device. The device can facilitate the scanning of the dental surfaces wherein the scanning comprises at least one of digital scanning or optical scanning. Furthermore, the device can be adaptable to isolate both arches of teeth is less than 20 seconds. In some embodiments, the device can be adaptable to be positioned without interfering with access to dental surfaces and further adaptable to provide maximum patient comfort.

0039Further provided herein is a retraction device comprising a topology conformable structure adaptable to create a working field in an oral cavity of a patient, wherein the working field is at least 10% larger than a working field created in the oral cavity of the patient without use of the device. The device can be used to provide at least 10% more access to an area of interest in the oral cavity. In some embodiments, the area of interest is one arch of teeth. Alternatively, the area of interest can be both arches of teeth. The device can be adaptable to provide at least 10% more visibility within the oral cavity. The device can be adaptable to provide at least 10% less contamination of structures located in the oral cavity by fluid. The fluid can be saliva, blood, or any other bodily fluid. In some embodiments, the device can be adaptable to provide at least 10% less interference between soft tissue and instruments accessing the oral cavity. The conformable structure can be a frame. In some embodiments, the frame is a wire frame. In some embodiments, the device further comprises a membrane. Additionally, the device can comprise a light source. The device can be adaptable to isolate at least one arch located within the oral cavity. The device can be adaptable to isolate the upper arch and the lower arch in the oral cavity. In some embodiments, the device can be adaptable to isolate at least a portion of gum tissue in the oral cavity. The device can be used to isolate the entire gum tissue. Furthermore, the device can be adaptable to be deployed in under 1 minute. The device can also be adaptable to create a working field in under 1 minute. In some embodiments, the device can be deployed in under 20 seconds. Additionally, no further adjustment of the device can be needed after the device has been deployed. In some embodiments, the device can further comprise a tongue retractor. The tongue retractor can contain and confine the tongue in a restricted space. The tongue retractor can be adaptable to allow a first occlusal surface and a second occlusal surface to touch. The tongue retractor can be adaptable to compress at least one side of the tongue or both sides of the tongue. The device can be adaptable to apply suction to the oral cavity. The device can be used to evacuate the oral cavity. The device can be adaptable to apply suction to the oral cavity through at least one aperture adaptable to facilitate the ability to breathe through the device. The device can be adaptable to isolate at least one dental arch in less than 20 seconds. The device can further be adaptable to be positioned without interfering with access to dental surfaces and further adaptable to provide maximum patient comfort.

0040Additionally, provided herein is a retraction device comprising a malleable frame adaptable to be in a constrained shape that can be delivered into an oral cavity and further adaptable to be in an unconstrained shape to isolate at least one arch of teeth from saliva and soft tissue surrounding the arch. The malleable frame can be a wire frame. The malleable frame can further comprise a membrane. Additionally, the device can further comprise a light source. In some embodiments, the device can be adaptable to be deployed in under 1 minute. The device can be adaptable to be deployed in under 20 seconds, in some embodiments. The device can also be adaptable to create a working field in under 1 minute. Furthermore, the device can comprise a tongue retractor. The tongue retractor can contain and confine the tongue. The tongue retractor can be adaptable to allow a first occlusal surface and a second occlusal surface to touch. The device can also comprise at least one evacuation element. The device can be adaptable to retract soft tissue surrounding at least one arch of teeth or in some cases, retract the soft tissue surrounding the upper and lower arches of teeth. The device can be adaptable to isolate at least a portion of gum tissue located in the oral cavity. In some embodiments, the device further comprises at least one aperture to facilitate the ability to breathe through the device. The device can be further adaptable to facilitate the application of a substance to at least one tooth surface. The substance can be a powder. In some embodiments, the power is a reflective powder. The powder can help create a pattering on the surface the teeth. The device can also be adaptable to isolate at least one dental arch in less than 20 seconds. The device can be adaptable to create a working field without interfering with access to dental surfaces. The device can be further adaptable to be positioned in the mouth to provide for maximum patient comfort.

0041As described above, <figref idref="f0001"><b>Fig. 1A</b></figref> depicts an oral cavity <b><i>10</i></b> from an anterior <b><i>72</i></b> view with the mouth <b><i>10</i></b> open and the teeth exposed <b><i>20</i></b> and <figref idref="f0001"><b>Fig. 1B</b></figref> illustrates a human body with the anatomical planes of the body identified.

I. <u>DEVICES</u>

0042<figref idref="f0002"><b>Fig. 2A</b></figref> illustrates a perspective view of one embodiment of a retraction device <i><b>200</b>,</i> as viewed from the front and at an above angle as positioned within the oral cavity <b><i>10</i></b>. The device <b><i>200</i></b> can comprise a cheek or soft tissue retraction frame <b><i>202</i></b>. The device can further comprise a lip ring <b><i>208</i></b> for retracting at least one lip. Additionally, the device can comprise an evacuation component capable of suctioning fluid from the oral cavity. The evacuation component can be in communication, preferably fluid communication, with the oral cavity <b><i>10</i></b> through at least one inlet <b><i>212</i></b> in the frame <b><i>202</i></b>. <figref idref="f0002"><b>Fig. 2B</b></figref> is a side view of the device <b><i>200</i></b> as positioned within the oral cavity <b><i>10</i></b>. The frame can be comprised of an upper frame <b><i>204</i></b> and a lower frame <b><i>206</i></b>. In some embodiments, inlets <b><i>212</i></b> for evacuating the oral cavity <b><i>10</i></b> can be located in the upper frame <b><i>204</i></b> and the lower frame <b><i>202</i></b>. <figref idref="f0002"><b>Fig. 2B</b></figref> also illustrates how the lip ring <b><i>208</i></b> can be used to retract the lips <b><i>12</i></b>, <i><b>12'</b>.</i> In some embodiments, the device can further comprise a tongue retractor <i><b>210</b>.</i><figref idref="f0002"><b>Fig. 2C</b></figref> illustrates a cross-sectional view of the oral cavity along the line <b>B-B</b> in <figref idref="f0002"><b>Fig. 2B. Fig. 2C</b></figref> is a cross-sectional view of the caudal side of the oral cavity. <figref idref="f0002"><b>Fig. 2C</b></figref> illustrates the positioning of the upper frame <b><i>204</i></b> of the device <b><i>200</i></b> around the gums of the upper dental arch <b><i>42</i></b>, retracting the cheek tissue <b><i>14</i></b> away from the gums. <figref idref="f0002"><b>Fig. 2C</b></figref> also illustrates how the upper portion of the lip ring <b><i>208</i></b> can retract the upper lip <b><i>12</i></b>. <figref idref="f0002"><b>Fig. 2D</b></figref> illustrates the complete frame viewed from the top of the device in position around the upper dental arch and the upper portion of the lip ring <b><i>208</i></b> without any surrounding soft tissue. The gum protection cover <b><i>220</i></b> is covering the upper frame in <figref idref="f0002"><b>Fig. 2D</b></figref><b>.</b><figref idref="f0003"><b>Fig. 2E</b></figref> illustrates a cross-sectional view of the oral cavity along the line <b>B-B</b> in <figref idref="f0002"><b>Fig. 2B</b></figref>, viewing the cephalic portion of the oral cavity. <figref idref="f0003"><b>Fig. 2E</b></figref> illustrates how the lower frame <b><i>206</i></b> of the device isolates the gums of the lower dental arch from the cheeks tissue <b><i>14'</i></b>. <figref idref="f0003"><b>Fig. 2E</b></figref> also illustrates the retraction of the lower lip <b><i>12</i></b>' by the lip ring <b><i>208</i></b>. <figref idref="f0003"><b>Fig. 2E</b></figref> also shows inlets <b><i>212</i></b> in the frame for evacuating fluid from the oral cavity. <figref idref="f0003"><b>Fig. 2F</b></figref> illustrates a frontal view of the device <b><i>200</i></b> in position in the oral cavity <i><b>10</b>.</i><figref idref="f0003"><b>Fig. 2F</b></figref> illustrates the upper frame <b><i>204</i></b> and the lower frame <b><i>206</i></b> and a lip ring <b><i>208</i></b>. The lower frame <b><i>206</i></b> has inlets <b><i>212</i></b> for providing suction. <figref idref="f0003"><b>Fig. 2F</b></figref> also illustrates a device <b><i>200</i></b> with a tongue retractor <b><i>210</i></b> as viewed from the front. <figref idref="f0003"><b>Fig. 2G</b></figref> illustrates a cross-sectional view of the device <b><i>200</i></b> shown in <figref idref="f0003"><b>Fig. 2G</b></figref> along the line <b>C-C</b>.

0043<figref idref="f0004"><b>Figs. 3A-3D</b></figref> illustrates one embodiment of an isolated retraction device. <figref idref="f0004"><b>Fig. 3A</b></figref> illustrates a perspective view of the device as viewed from the distal end of the device <i><b>300</b>.</i><figref idref="f0004"><b>Fig. 3A</b></figref> illustrates an upper frame <i><b>304</b>,</i> a lower frame <i><b>306</b>,</i> and a lip ring <b><i>308</i></b>. The lower frame comprises inlets <b><i>312</i></b> for evacuating the oral cavity. <figref idref="f0004"><b>Fig. 3A</b></figref> also illustrates a device <b><i>300</i></b> comprising a lip ring <b><i>308</i></b> further comprising a light ring <b><i>314</i></b>. The device in <figref idref="f0004"><b>Fig. 3A</b></figref> also comprises a tongue retractor <i><b>310</b>.</i><figref idref="f0004"><b>Fig. 3B</b></figref> is a top view of the retraction device <b><i>300</i></b>. <figref idref="f0004"><b>Fig. 3B</b></figref> illustrates the upper frame with gum protection cover <b><i>320</i></b>, the top portion of the lip ring <i>308,</i> and the light sources <i><b>316</b>, <b>316'</b></i> for providing light to the light ring portion of the lip ring <i>308.</i> The light source can either be isolated power sources for light, such as self-contained batteries, or alternatively, the light sources can be connectors which can be used to plug in an external power source. The light ring can be used to illuminate the oral cavity. The light ring can comprise any suitable feature for generating light to illuminate the oral cavity including, but not limited to, light emitting diodes (LEDs), fiberoptic wires, light bulbs, fluorescent or chemiluminescent light sources, or any other suitable light source. The light sources <b><i>316</i></b>, <b><i>316'</i></b> can be connected to an external power supply. Alternatively, the light sources can comprise batteries. <figref idref="f0004"><b>Fig. 3C</b></figref> illustrates a side view of the isolated retraction device <i><b>300</b>.</i> In addition to the upper frame <b><i>304</i></b>, the lower frame <b><i>306</i></b>, the tongue retractor <b><i>310</i></b>, lip ring <b><i>308</i></b>, light ring <b><i>314</i></b>, and light sources <b><i>316</i></b>, the device <b><i>300</i></b> can further comprise a lip rest <b><i>318</i></b> for providing further retraction of the lip and to facilitate placement of the device. <figref idref="f0004"><b>Fig. 3D</b></figref> illustrates a posterior view of the device <b><i>300</i></b> illustrating the upper frame <b><i>304</i></b> with gum protection cover <b><i>320</i></b>, the lower frame <b><i>306</i></b> with gum protection cover <b><i>320</i></b>, portions of the lip ring <b><i>308</i></b>, and the posterior side of the tongue retractor <i><b>310</b>.</i>

0044<figref idref="f0005"><b>Figs. 4A-4D</b></figref> illustrate the upper gum protection cover <b><i>420</i></b> and the lower gum protection cover <b><i>422</i></b> isolated from the retraction device. <figref idref="f0005"><b>Fig. 4A</b></figref> is a perspective view of the gum protection covers <b><i>420</i></b>, <b><i>422</i></b>, and the tongue retractor <i><b>410</b>.</i> Inlet <b><i>412</i></b> can be seen in the lower gum protection cover <b><i>422</i></b>. The inlets <b><i>412</i></b> can provide communication, preferably fluid communication, between the oral cavity and the retraction device. The upper and lower gum protection covers can be rigid. Alternatively, the gum protectors can be soft, pliable membranes. The gum protectors can be made out any suitable material including, but not limited to, rubber, wax, foam, or any other suitable material or combination thereof. <figref idref="f0005"><b>Fig. 4B</b></figref> is a top view of a retraction device <b><i>400</i></b>, illustrating the upper gum protector <b><i>420</i></b> and the tongue retractor <i><b>410</b>.</i><figref idref="f0005"><b>Fig. 4C</b></figref> illustrates a side view of the gum protection covers, both the upper gum protection cover <b><i>420</i></b> and the lower gum protection cover <b><i>422</i></b>. <figref idref="f0005"><b>Fig. 4C</b></figref> also shows the tongue retractor <b><i>410.</i></b><figref idref="f0005"><b>Fig. 4D</b></figref> illustrates a posterior view of the retraction device <b><i>400</i></b>, illustrating the upper gum protection cover <b><i>420</i></b> and the lower gum protection cover <b><i>422</i></b>. Inlets <b><i>412</i></b> for evacuating the oral cavity can be seen in the lower gum protection cover <b><i>422</i></b>.

0045In some embodiments, the retraction device <b><i>500</i></b> is comprised of a frame <b><i>502</i></b>, as shown in <figref idref="f0006"><b>Figs. 5A-5D</b></figref>. The frame <b><i>502</i></b> can be further comprised of an upper frame <b><i>504</i></b> and a lower frame <b><i>506</i></b>. The frame can be a malleable frame. It can be shaped to conform to the topology of the patient's oral cavity. In some embodiments, the frame is a wire frame. In some embodiments, the frame is made of a moldable plastic or wax. The frame can be made out of any suitable material for making the frame. Inlets <b><i>512</i></b> for evacuating the oral cavity can be seen in the lower frame <i><b>506</b>.</i> A suction port located on the bottom frame <b><i>524</i></b> can be used to introduce suction through the inlets <b><i>512</i></b> in the lower frame <b><i>506</i></b>. <figref idref="f0006"><b>Fig. 5A</b></figref> also illustrates a tongue retractor <i><b>510</b>.</i><figref idref="f0006"><b>Fig. 5B</b></figref> is a view of the retraction device <b><i>500</i></b> from the top showing the top frame <b><i>504</i></b>, the bottom frame <b><i>506</i></b>, inlets <b><i>512</i></b> in the bottom frame, and the tongue retractor <b><i>510.</i></b><figref idref="f0006"><b>Fig. 5C</b></figref> illustrates a side view of the frame <b><i>502</i></b>, illustrating the top and bottom frames, <b><i>504</i></b>, <b><i>506</i></b>, respectively, and a tongue retractor <i><b>510</b>.</i><figref idref="f0006"><b>Fig. 5D</b></figref> illustrates a posterior view of the frame <b><i>502</i></b>, showing the top frame <b><i>504</i></b>, the bottom frame <b><i>506</i></b>, and inlets <b><i>512</i></b> in the bottom frame <b><i>506</i></b>.

0046<figref idref="f0007"><b>Figs. 6A-6D</b></figref> illustrate a light ring <b><i>614</i></b> isolated from the retraction device. The lip ring can be used to retract the cheeks, and lips. <figref idref="f0007"><b>Fig. 6A</b></figref> illustrates a posterior perspective view of the light ring. The light ring <b><i>614</i></b> can have at least one light source <b><i>616</i>,</b><i><b>616'</b>.</i> In some embodiments, the light ring can be a single unit with the lip ring. Alternatively, the light ring can be attached to the lip ring if necessary. The light ring <b><i>614</i></b> can have at least one opening <b><i>625</i></b> though which the oral cavity can be illuminated. <figref idref="f0007"><b>Fig. 6B</b></figref> is a top view of the light ring <b><i>614</i></b>, showing the light sources <b><i>616</i>, <i>616'</i></b>. <figref idref="f0007"><b>Fig. 6C</b></figref> is a side view of the lip ring <b><i>614</i></b> showing the lip rest <b><i>618</i></b> and the light source <b><i>616</i></b>. <figref idref="f0007"><b>Fig. 6D</b></figref> is a posterior view of the light ring <b><i>614</i></b>. <figref idref="f0007"><b>Fig. 6D</b></figref> also shows a lip rest <b><i>618</i></b>, openings <b><i>625</i></b>, <b><i>625'</i></b> in the lip ring for illuminating the oral cavity, and light sources <b><i>616</i></b>, <b><i>616'</i></b>.

0047<figref idref="f0008"><b>Figs. 7A-7D</b></figref> illustrate an alternative embodiment of a retraction device <b><i>700</i></b>, wherein the retraction device does not comprise a tongue retractor or gum protection covers. <figref idref="f0008"><b>Fig. 7A</b></figref> illustrates a perspective view of a minimalistic retraction device <b><i>700</i></b> comprising a frame <b><i>702</i></b>, a lip ring <b><i>708</i></b> with a light ring <b><i>714</i></b>. <figref idref="f0008"><b>Fig. 7B</b></figref> is a top view of the retraction device <b><i>700</i></b> illustrating the upper frame <b><i>704</i></b>, the lower frame <b><i>704</i></b> comprising at least one inlet <b><i>712</i></b> for evacuating the oral cavity. The device can comprise more than one inlet. <figref idref="f0008"><b>Fig. 7B</b></figref> also illustrates a top view of the lip ring <b><i>708</i></b> with a light ring <b><i>714</i></b>, lip rest <b><i>718</i></b>, and light sources <b><i>716</i></b>, <i><b>716'</b>.</i><figref idref="f0008"><b>Fig. 7C</b></figref> is a side view of the retraction device <b><i>700</i></b> illustrating the upper frame <i><b>704</b>,</i> lower frame <b><i>706</i></b> with at least one inlet <b><i>712</i></b>, lip ring <i><b>708</b>,</i> light ring <b><i>714</i></b> with lip rest <b><i>718</i></b>, and light source <b><i>716</i></b>. <figref idref="f0008"><b>Fig. 7D</b></figref> is a posterior view of the retraction device <b><i>700</i></b>.

0048<figref idref="f0009"><b>Figs. 8A-8D</b></figref> illustrate an alternative embodiment of a retraction device <b><i>800</i></b> in which the frame is covered by a cover <b><i>826</i></b>. The frame cover <b><i>826</i></b> can be a soft membrane material. The frame cover can be made of any suitable material including, but not limited to, rubber, or corn polymers, or "green" or environmentally friendly sustainable materials, or any of the materials previously mentioned. <figref idref="f0009"><b>Fig. 8A</b></figref> is a perspective view of the device <b><i>800</i></b> with a cover <b><i>826</i></b> covering the entire device. In some embodiments, the cover can cover a portion of the device. The cover can have openings <b><i>825</i></b> which can fit around the dental surfaces in the oral cavity of the patient. In some embodiments, the opening <b><i>825</i></b> is a slit. In some embodiments, the opening has a shape similar to the dental arch. <figref idref="f0009"><b>Fig. 8B</b></figref> illustrates a top view of the device <b><i>800</i></b> showing the cover <b><i>826</i></b> and an opening <b><i>825</i></b> in the cover <b><i>826</i></b>. <figref idref="f0009"><b>Fig. 8C</b></figref> is a side view of the device <b><i>800</i></b>. The cover can cover the upper and lower frames of the device, with the space between the upper and lower frames remaining uncovered. Alternatively, the cover can cover the space in between the upper and lower frames as shown in <figref idref="f0009"><b>Fig. 8C. Fig. 8D</b></figref> is a posterior view of the device.

0049<figref idref="f0010"><b>Figs. 9A-9D</b></figref> illustrate a cover <b><i>926</i></b> isolated from the retraction device. <figref idref="f0010"><b>Figs. 9A-9D</b></figref> show an isolated cover <b><i>926</i></b> for both the upper and lower frames.

0050<figref idref="f0011"><b>Figs. 10A-10D</b></figref> illustrate a light ring <b><i>1014</i></b> isolated from the retraction device. <figref idref="f0011"><b>Fig. 10A</b></figref> illustrates a front perspective view of an isolated light ring <b><i>1014</i></b> illustrating the light sources <b><i>1016</i></b>, <b><i>1016'</i></b> and the outputs <b><i>1015</i></b> from the light ring <b><i>1014</i></b> which can be used to illuminate the oral cavity. The light ring <b><i>1014</i></b> can also have a lip rest <b><i>1018</i></b> as shown in <figref idref="f0011"><b>Fig. 10A. Fig. 10B</b></figref> is a top view of the light ring <b><i>1014</i></b>. <figref idref="f0011"><b>Fig. 10C</b></figref> is a side view of the light ring <b><i>1014</i></b>. <figref idref="f0011"><b>Fig. 10D</b></figref> is a posterior view of the light ring <b><i>1014</i></b>. The outputs <b><i>1015</i></b> from the light ring <b><i>1014</i></b> can be located in the upper part of the light ring, the lower part of the light ring, and on the sides of the light ring, as shown in <figref idref="f0011"><b>Fig. 10D</b></figref>. Alternatively, the outputs <b><i>1015</i></b> from the light ring <b><i>1014</i></b> can be located in only the upper portion of the light ring. The light outputs can be located only in the lower portion of the light ring. The light outputs can be located in the sides of the light ring. The light outputs can be grouped together or the light outputs can be uniformly spaced throughout the light ring. The light outputs can be any suitable output for illuminating the oral cavity including, but not limited to, light bulbs, LEDs, fiber optics, or any combination thereof or any other suitable light output.

0051<figref idref="f0012"><b>Figs. 11A-11D</b></figref> illustrate an alternate form of a light ring <b><i>1114</i></b>. In some embodiments, the light ring can be made of a flexible material, as shown in <figref idref="f0012"><b>Figs. 11A-11D</b></figref>. The flexible material allows the light ring to be flexed without damage to the circuit.

0052<figref idref="f0013"><b>Figs. 12A-12D</b></figref> illustrate an alternate embodiment of an isolated frame of the retraction device <b><i>1200</i></b>. The frame design of the invention can provide better access to the palette area for scanning, as previously described. The upper and lower frames also facilitate insertion of a scanning device along the side of the frame. The tissue can be kept away from the teeth so that a powder coating can be applied to the dental surfaces. The mouth can be scanned in its entirety without stopping. <figref idref="f0013"><b>Fig. 12A</b></figref> is a perspective view of the device as viewed from the posterior side of the device <b><i>1200</i></b>. The lip ring <b><i>1208</i></b>, the upper and lower frames, <b><i>1204</i></b>, <b><i>1206</i></b>, respectively, and tongue retractor <b><i>1210</i></b> can be seen. <figref idref="f0013"><b>Fig. 12B</b></figref> is a top view of the device <b><i>1200</i></b>. <figref idref="f0013"><b>Fig. 12C</b></figref> is a side view of the device <b><i>1200</i></b>. <figref idref="f0013"><b>Fig. 12D</b></figref> is a posterior view of the device.

0053<figref idref="f0014"><b>Figs. 13A-13D</b></figref> illustrate an alternate embodiment of a retraction device <b><i>1300</i></b> without a tongue retractor.

0054<figref idref="f0015"><b>Figs. 14A-14D</b></figref> illustrate a frame <b><i>1402</i></b> isolated from a retraction device. The frame can be used alone to retract soft tissue. Alternatively, the frame can be used with other features or components, such as a soft cover for the frame, a light ring, or lip ring. <figref idref="f0015"><b>Fig. 14A</b></figref> is perspective view of the frame <i><b>1402</b>.</i><figref idref="f0015"><b>Fig. 14B</b></figref> is a top view of the frame. <figref idref="f0015"><b>Fig. 14C</b></figref> is a side view of the frame. <figref idref="f0015"><b>Fig. 14D</b></figref> is a view of the posterior side of the frame.

0055<figref idref="f0016"><b>Figs. 15A-15D</b></figref> illustrate the frame shown in <figref idref="f0015"><b>Figs. 14A-14D</b></figref> together with an evacuation component. <figref idref="f0016"><b>Fig. 15A</b></figref> illustrates the frame <b><i>1502</i></b> comprising a lip ring <b><i>1508</i></b>, and upper frame <b><i>1504</i></b> and a lower frame <b><i>1506</i></b>, wherein the lower frame has evacuation inlets <i><b>1512</b>.</i><figref idref="f0016"><b>Fig. 15B</b></figref> illustrates a top view of the upper and lower frame, <b><i>1504</i></b>, <b><i>1506</i></b>, respectively, the lip ring <b><i>1508</i></b>, and inlets <b><i>1512</i></b> in the bottom frame <i><b>1506</b>.</i><figref idref="f0016"><b>Fig. 15C</b></figref> is a side view of the frame <b><i>1502</i></b> of the device <b><i>1500</i></b> including upper and lower frames <b><i>1504</i></b>, <b><i>1506</i></b>, lip ring <b><i>1508</i></b>, and inlets located in the lower frame <i><b>1506</b>.</i><figref idref="f0016"><b>Fig. 15D</b></figref> is a posterior view of the retraction device <b><i>1500</i></b> including upper and lower frame <b><i>1504</i></b>, <b><i>1506</i></b>, lip ring <b><i>1508</i></b>, and inlets <b><i>1512</i></b> from the evacuation component of the device.

0056<figref idref="f0017"><b>Figs. 16A-16D</b></figref> are views of an isolated lip ring. <figref idref="f0017"><b>Fig. 16A</b></figref> is a perspective view of the lip ring <b><i>1608</i></b> from the posterior side of the lip ring. The lip ring can have attachment fittings <b><i>1609</i></b> for attaching the lip ring <b><i>1608</i></b> to the frame of the retraction device. <figref idref="f0017"><b>Fig. 16B</b></figref> is a top view of the lip ring <b><i>1608</i></b>. <figref idref="f0017"><b>Fig. 16C</b></figref> is a side view of the lip ring <b><i>1608</i></b>; <figref idref="f0017"><b>Fig. 16D</b></figref> is a posterior view of the lip ring <b><i>1608</i>.</b>

0057<figref idref="f0018"><b>Figs. 17A-17</b></figref> are isolated views of a tongue retractor. The tongue retractor can be a wire structure. Alternatively, the tongue retractor can comprise a structure that extends into a volume of space forward from the wire structure. The tongue can occupy the space underneath the tongue retractor cover. The tongue retractor can serve to contain and confine the tongue in a restricted space, thereby preventing the tongue from filling the oral cavity. <figref idref="f0018"><b>Fig. 17A</b></figref> is a perspective view of a tongue retractor <b><i>1710</i>.</b> The tongue retractor <b><i>1710</i></b> can be a simple structure consisting of a wire frame. Alternatively, the tongue retractor <b><i>1710</i></b> can comprise a cover <b><i>1711</i></b> for encasing the tongue retractor <i><b>1710</b>.</i> The tongue retractor can contain the tongue from at least one side of the tongue. Alternatively, the tongue retractor can contain the tongue from both sides of the tongue. In some embodiments, the tongue retractor can confine the tongue in its entirety. The tongue retractor can confine the tongue to a restricted space, thereby preventing the tongue from filling the oral cavity. <figref idref="f0018"><b>Fig. 17B</b></figref> is a top view of the tongue retractor <b><i>1710</i></b>. <figref idref="f0018"><b>Fig. 17C</b></figref> is a side view of a tongue retractor <b><i>1710</i></b>. <figref idref="f0018"><b>Fig. 17D</b></figref> is a posterior view of the tongue retractor <b><i>1710</i></b>.

0058In some embodiments, the retraction device can be of the embodiments shown in <figref idref="f0019"><b>Figs. 18A-18D</b></figref>. The retraction device <b><i>1800</i></b> can further comprise a hinge <b><i>1828</i></b> that can be used to further alter the shape of the retraction device <i><b>1800</b>.</i> In some embodiments, the hinge can be a flexible material hinge. As shown in <figref idref="f0019"><b>Fig. 18A</b></figref>, the retraction device <b><i>1800</i></b> can comprise an upper frame <b><i>1804</i></b>, and a lower frame <b><i>1806</i></b>, and a tongue retractor <i><b>1810</b>.</i> The upper and lower frames <b><i>1804</i></b>, <b><i>1806</i></b>, respectively can be in mechanical communication through at least one support <b><i>1830</i></b>. The support can comprise a hinge <b><i>1828</i></b> for collapsing the upper frame <b><i>1804</i></b> toward the lower frame <b><i>1806</i></b>. The hinge <b><i>1828</i></b> can facilitate the compression of the device <b><i>1800</i></b> to undertake a more compact structure for ease in inserting into the oral cavity. In some embodiments, the hinge can be located in the side supports. In some embodiments, a hinge can be located in the upper frame <b><i>1804</i></b> or the lower frame <b><i>1806</i></b> or both the upper and lower frames <b><i>1804</i></b>, <i><b>1806</b>.</i> The support can be rigidly affixed to the upper and lower frames. Alternatively, the support <b><i>1830</i></b> can be a swiveling support <b><i>1830</i></b> as shown in <figref idref="f0019"><b>Fig. 18A</b>. <b>Fig. 18B</b></figref> is a top view of the retraction device <b><i>1800</i></b>, illustrating the top frame <b><i>1804</i></b>, the bottom frame <b><i>1806</i></b>, the tongue retractor <b><i>1810</i></b>, and the side supports <b><i>1830</i></b>. <figref idref="f0019"><b>Fig. 18C</b></figref> is a side view of a retraction device <b><i>1800</i></b>, illustrating the top frame <b><i>1804</i></b>, the bottom frame <b><i>1806</i></b>, tongue retractor <i><b>1810</b>,</i> side support <b><i>1830</i></b>, and hinge <i><b>1828</b>.</i><figref idref="f0019"><b>Fig. 18D</b></figref> is a posterior view of the retraction device <b><i>1800</i></b>.

0059<figref idref="f0020"><b>Figs. 19A-19D</b></figref> show an embodiment of the retraction device having a hinge and swivel supports but without a tongue retractor.

0060Isolated supports <b><i>2030</i></b>, <b><i>2030'</i></b> are shown in <figref idref="f0021"><b>Figs. 20A-20D</b></figref>. In some embodiments, the supports <i><b>2030</b>, <b>2030'</b></i> have at least one hinge <b><i>2028</i></b>, <i><b>2028'</b>.</i> In some embodiments, the supports comprise multiple hinges. <figref idref="f0021"><b>Fig. 20A</b></figref> is a perspective view of the isolated supports <b><i>2030</i></b>, <i><b>2030'</b>.</i><figref idref="f0021"><b>Fig. 20B</b></figref> is a top view of the isolated supports <b><i>2030</i></b>, <b><i>2030'</i></b>. <figref idref="f0021"><b>Fig. 20C</b></figref> is a side view of one of the supports <b><i>2030</i></b> with a hinge <i><b>2028</b>.</i><figref idref="f0021"><b>Fig. 20D</b></figref> is a posterior view of two isolated supports <b><i>2030</i></b>, <b><i>2030'</i></b> and their respective hinges <b><i>2028</i></b>, <i><b>2028'</b>.</i>

0061<figref idref="f0022"><b>Figs. 21A-21D</b></figref> illustrate a lower arch retraction device <b><i>2100</i></b> with lip ring <b><i>2108</i></b> with light ring <b><i>2114</i></b>, and tongue retractor <i><b>2110</b>.</i> The tongue retractor is braced between the upper palate and below the tongue area. The lip ring connects to the bottom of the frame. When present, an evacuation component is then positioned over the top of the lip ring to form a single unit. The lip ring <b><i>2118</i></b> is held in place by the upper lip in conjunction with the lip rest <b><i>2118</i></b> and the lower soft tissue anatomy surrounding the area. The device can have a frame covered with a soft membrane cover as shown in <figref idref="f0022"><b>Fig. 21A</b></figref>. In some embodiments, suction can be administered to the oral cavity through inlets <b><i>2112</i></b> in the soft membrane. <figref idref="f0022"><b>Fig. 21B</b></figref> is a top view of the retraction device <b><i>2100</i></b>, illustrating the lower frame <b><i>2106</i></b> with lower gum protection cover <b><i>2122</i></b>, inlets in the lower frame <b><i>2106</i></b> and lower gum protection cover <b><i>2122</i></b>, and lip ring <b><i>2108</i></b> with light ring <b><i>2114</i></b> and light sources <b><i>2116</i></b>, <i><b>2116'</b>.</i><figref idref="f0022"><b>Fig. 21C</b></figref> is a side view of the retraction device <b><i>2100</i></b>. <figref idref="f0022"><b>Fig. 21D</b></figref> is a posterior view of the retraction device <b><i>2100</i></b>.

0062<figref idref="f0023"><b>Figs. 22A-22D</b></figref> illustrate an alternative embodiment of a retraction device <b><i>2200</i></b> comprising a frame <b><i>2206</i></b> with gum protector <b><i>2222</i></b> without a lip ring. <figref idref="f0023"><b>Fig. 22A</b></figref> is a perspective view of a retraction device <b><i>2200</i></b>. <figref idref="f0023"><b>Fig. 22B</b></figref> is a top view of a retraction device <b><i>2200</i></b> illustrating a lower frame <b><i>2206</i></b> with gum protector <b><i>2222</i></b> with inlets <b><i>2212</i></b> along the lower frame <b><i>2206</i></b>, and tongue retractor <i><b>2210</b>.</i><figref idref="f0023"><b>Fig. 22C</b></figref> is a side view of the retraction device <b><i>2200</i></b>. <figref idref="f0023"><b>Fig. 22D</b></figref> is a posterior view of the retraction device <b><i>2200</i></b>.

0063<figref idref="f0024"><b>Figs. 23A-23D</b></figref> illustrate a tongue retractor membrane or cover <b><i>2311</i></b> configuration. <figref idref="f0024"><b>Fig. 23A</b></figref> illustrates a perspective view of the tongue retractor <b><i>2310</i></b> as viewed from the posterior side of the device. <figref idref="f0024"><b>Fig. 23B</b></figref> illustrates a top view of the tongue retractor <b><i>2311</i></b> with cover <b><i>2311</i></b>. <figref idref="f0024"><b>Fig. 23C</b></figref> illustrates a side view of the tongue retractor <i><b>2310</b>.</i><figref idref="f0024"><b>Fig. 23D</b></figref> is a posterior view of the tongue retractor cover <i><b>2310</b>.</i>

0064<figref idref="f0025"><b>Figs. 24A-24D</b></figref> illustrate a view of an isolated lower frame <b><i>2406</i></b> from a lower arch retraction device. In some embodiments, the lower frame comprises at least one inlet <b><i>2412</i></b> for evacuating the oral cavity. <figref idref="f0025"><b>Fig. 24A</b></figref> illustrates a perspective view of the frame <b><i>2406.</i></b><figref idref="f0025"><b>Fig. 24B</b></figref> is a top view of the lower frame <b><i>2406</i></b>. <figref idref="f0025"><b>Fig. 24C</b></figref> is a side view of the frame <b><i>2406</i></b>. <figref idref="f0025"><b>Fig. 24D</b></figref> is a posterior view of the frame <i><b>2406</b>.</i>

0065<figref idref="f0026"><b>Figs. 25A-25D</b></figref> illustrate an alternative embodiment of a lower frame retraction device <b><i>2500</i></b>. The device shown in <figref idref="f0026"><b>Figs. 25A-25D</b></figref> illustrate a device that has leverage once positioned in the mouth to hole the bottom arch in position, thereby preventing the tongue from lifting the bottom arch out of position. <figref idref="f0026"><b>Fig. 25A</b></figref> is a perspective view of the lower frame retraction device <b><i>2500</i></b>. The retraction device <b><i>2500</i></b> shown in <figref idref="f0026"><b>Fig. 25A</b></figref> does not rely upon the upper palette and the tongue retractor <b><i>2510</i></b> to stabilize the device <b><i>2500</i></b>. Therefore, the device is less intrusive than other devices and can further facilitate scanning the oral cavity. <figref idref="f0026"><b>Fig. 25A</b></figref> also illustrates a device <b><i>2500</i></b> having a lower frame <b><i>2506</i></b> with gum protection cover <b><i>2522</i></b> with an opening <b><i>2525</i></b> for the dental arch. The device can also have a lip ring <b><i>2508</i></b> with a light ring <b><i>2514</i></b> and lip rest <b><i>2518</i></b>. <figref idref="f0026"><b>Fig. 25B</b></figref> illustrates a top view of the device <b><i>2500</i></b>. <figref idref="f0026"><b>Fig. 25C</b></figref> illustrates a side view of the device <b><i>2500</i></b>. <figref idref="f0026"><b>Fig. 25D</b></figref> illustrates a posterior view of the device <b><i>2500</i></b>.

0066An alternate embodiment of a lower arch retraction device <b><i>2600</i></b> is shown in <figref idref="f0027"><b>Figs. 26A-</b></figref><b>26D</b>. <figref idref="f0027"><b>Fig. 26A</b></figref> illustrates a lower frame <b><i>2606</i></b> with a gum cover <b><i>2622</i></b>, and a tongue retractor <b><i>2610</i></b>. An opening <b><i>2625</i></b> for the dental arch is shown in <figref idref="f0027"><b>Fig. 26A</b></figref>. Furthermore, a suction port <b><i>2624</i></b> can connect the retraction device <b><i>2600</i></b> to a source of suction to evacuate the oral cavity through at least one inlet <b><i>2612</i></b> located in the frame or gum protector or both. <figref idref="f0027"><b>Fig. 26B</b></figref> is a top view of the retraction device showing the suction port <b><i>2624</i></b> and inlets <b><i>2612</i></b> in communication, preferably fluid communication, with the suction port <b><i>2624</i></b>, the lower frame <b><i>2606</i></b> and gum protection cover <b><i>2622</i></b>, tongue retractor <b><i>2610</i></b>, and the opening <b><i>2625</i></b> for the dental arch in the retraction device <b><i>2600</i></b>. <figref idref="f0027"><b>Fig. 26C</b></figref> is a side view of a retraction device <b><i>2600</i></b> illustrating the frame <b><i>2606</i></b>, the gum protection cover <b><i>2622</i></b>, the tongue retractor <b><i>2610</i></b>, and suction port <b><i>2624</i></b>. <figref idref="f0027"><b>Fig. 26D</b></figref> is a posterior view of the retraction device <b><i>2600</i></b>.

0067<figref idref="f0028"><b>Figs. 27A-27D</b></figref> illustrate an alternate embodiment of an isolated lower arch retraction device <b><i>2700</i></b>. <figref idref="f0028"><b>Fig. 27A</b></figref> illustrates a retraction device <b><i>2700</i></b> comprising an alternate embodiment of a lip ring <b><i>2708</i></b>, an upper frame <i><b>2704</b>,</i> a lower frame <b><i>2706</i></b>, and a tongue retractor <b><i>2710</i></b>. The retraction device <b><i>2700</i></b> also has a posterior balancing positional support <b><i>2732</i></b> which aids in the insertion of the device into the oral cavity and provides posterior balancing positional support. The posterior balancing positional supports <b><i>2732</i></b> contact the back of the cheeks to balance forces from the front of the cheeks in order to properly center the device along the posterior/anterior axis. <figref idref="f0028"><b>Fig. 27B</b></figref> is a top view of the retraction device <b><i>2700</i></b> illustrating the lip ring, <b><i>2708</i></b>, lower frame <b><i>2706</i></b>, tongue retractor <b><i>2710</i></b>, and posterior supports <b><i>2732</i></b>. <figref idref="f0028"><b>Fig. 27C</b></figref> is a side view of the retraction device, showing the lip ring <b><i>2708</i></b>, lower frame <b><i>2706</i></b>, tongue retractor <b><i>2710</i></b>, and posterior supports <b><i>2732</i></b>. <figref idref="f0028"><b>Fig. 27D</b></figref> is a frontal view of the retraction device <b><i>2700</i></b> illustrating the lip ring <b><i>2708</i></b>, lower arch frame <b><i>2706</i></b>, tongue retractor <b><i>2710</i></b>, and posterior supports <b><i>2732</i></b>.

0068<figref idref="f0029"><b>Figs. 28A-28D</b></figref> illustrate an isolated evacuation element <b><i>2834</i></b>. <figref idref="f0029"><b>Fig. 28A</b></figref> is a perspective view of an evacuation element <b><i>2834</i></b> as viewed from the posterior side. The evacuation element can be in communication with a suction source through the suction port <b><i>2824</i></b>. The evacuation element <b><i>2834</i></b> can be used to evacuate the oral cavity through at least one inlet <b><i>2812</i></b> located in the evacuation element <b><i>2834</i></b>. In some embodiments, multiple evacuation elements <b><i>2812</i></b> can be located along the length of the evacuation element, as shown in <figref idref="f0029"><b>Fig. 28A</b></figref>. In some embodiments, inlets <b><i>2812</i></b> can be located along the interior of the cheeks. In some embodiments, inlets <b><i>2812</i></b> can be located around the tongue. Inlets <b><i>2812</i></b> can be located along both the cheeks and the tongue. <figref idref="f0029"><b>Fig. 28B</b></figref> is a top view of the evacuation element. <figref idref="f0029"><b>Fig. 28C</b></figref> is a side view of the evacuation element <b><i>2834</i></b>. <figref idref="f0029"><b>Fig. 28D</b></figref> is a posterior view of the evacuation element <b><i>2834</i></b>.

0069<figref idref="f0030"><b>Figs. 29A- 29D</b></figref> illustrate an isolated tongue deflection cover <b><i>2911</i></b>. The tongue deflection cover can be used to deflect the tongue out of the working space to facilitate scanning the dental surfaces. <figref idref="f0030"><b>Fig. 29A</b></figref> illustrates a perspective view of the tongue deflection cover <b><i>2911</i></b> as viewed from the posterior side. <figref idref="f0030"><b>Fig. 29B</b></figref> illustrates a top view of the tongue deflection cover <b>2911</b>. <figref idref="f0030"><b>Fig. 29C</b></figref> illustrates a side view of a tongue deflection cover. <figref idref="f0030"><b>Fig. 29D</b></figref> illustrates a posterior view of the tongue deflection cover.

0070<figref idref="f0031"><b>Figs. 30A-30D</b></figref> illustrate an isolated upper arch frame <b><i>3004</i></b>. The upper arch frame <b><i>3004</i></b> can be used in conjunction with a lower arch retraction device. The upper arch frame <b><i>3004</i></b> can be used to provide optional support for upper retraction of the soft tissue in the oral cavity. <figref idref="f0031"><b>Fig. 30A</b></figref> illustrates one embodiment of an upper arch frame <b><i>3004</i></b>. The arch support can comprise connectors <b><i>3036</i></b> to connect the upper arch frame <b><i>3004</i></b> to the retraction device. The upper arch frame <b><i>3004</i></b> can be connected to the lower retraction device by snapping the upper arch frame <b><i>3004</i></b> and the lower retraction device together. Alternatively, the upper arch frame <b><i>3004</i></b> can connected to the lower retraction device by screwing the pieces together. Alternatively, the upper arch frame can be adhered to the lower retraction device by any suitable adhesive or mechanism for adhering the two units together including but not limited to, glue, tape, rubber bands, or any combination thereof. <figref idref="f0031"><b>Fig. 30B</b></figref> is a top view of an isolated upper arch frame <b><i>3004</i></b>. <figref idref="f0031"><b>Fig. 30C</b></figref> is a side view of an upper arch frame. <figref idref="f0031"><b>Fig. 30D</b></figref> is a posterior view of an upper arch frame.

0071<figref idref="f0032"><b>Figs. 31A-31D</b></figref> illustrate an alternative embodiments of an isolated upper arch retraction device <b><i>3100</i></b> including a lip ring <i><b>3108</b>.</i> In some embodiments, the retraction device is a single piece. In some embodiments, the retraction device <b><i>3100</i></b> can be more than one piece, where the pieces are assembled prior to inserting the device into the oral cavity. The lip ring can be attached to the frame at the posterior end of the device <b><i>3100</i></b>. <figref idref="f0032"><b>Fig. 31A</b></figref> is a perspective view of upper arch retraction device <b><i>3100</i></b> having a lip ring <b><i>3108</i></b>, upper arch frame <b><i>3104</i></b>, and tongue retractor <i><b>3110</b>.</i> In some embodiments, the device <b><i>3100</i></b> further comprises a tongue cover for containing the tongue. <figref idref="f0032"><b>Fig. 31B</b></figref> is a top view of the retraction device <b><i>3100</i></b>, illustrating the upper arch frame <b><i>3104</i></b>, lip ring <b><i>3108</i></b>, and tongue retractor <b><i>3110</i></b>. <figref idref="f0032"><b>Fig. 31C</b></figref> is a side view of the retraction device <b><i>3100</i></b>. <figref idref="f0032"><b>Fig. 31D</b></figref> is a frontal view of the retraction device <b><i>3100</i></b>.

0072<figref idref="f0033"><b>Figs. 32A-32D</b></figref> illustrate an alternative embodiment of a retraction device <b><i>3200</i></b>. In this embodiment, the upper retraction frame <b><i>3204</i></b> is separated by a gap <b><i>3238</i></b>. In some embodiments, the lip ring can have a gap <b><i>3238</i></b>. In some embodiments, both the upper frame <b><i>3204</i></b> and the lip ring <b><i>3208</i></b> have a gap <b><i>3238</i></b>, as shown in <figref idref="f0033"><b>Fig. 32A</b></figref>. The device can have a tongue retractor <i><b>3210</b>.</i><figref idref="f0033"><b>Fig. 32B</b></figref> is a top view of a retraction device <b><i>3200</i></b> with a gap <i><b>3238</b>.</i><figref idref="f0033"><b>Fig. 32C</b></figref> illustrates a side view of a retraction device <b><i>3200</i></b>. <figref idref="f0033"><b>Fig. 32D</b></figref> illustrates a front view of the retraction device <b><i>3200</i></b>.

II. <u>METHODS</u>

0073Further provided herein are methods of use of the invention described herein. Provided herein is a method of retracting tissue in an oral cavity comprising: inserting a retraction device comprising a topology conformable structure adaptable to be in a constrained shape that can be delivered into an oral cavity and further adaptable to be in an unconstrained shape to create a useable working field in the oral cavity, the useable working field providing increased accessibility to and increased visibility within the oral cavity; and positioning the retraction device in the oral cavity to create an isolated working field. The positioning step can be performed in less than 1 minute. In some embodiments, the positioning step can be performed in less than 20 seconds.

0074Yet another method for retracting tissue in an oral cavity comprises: inserting a retraction device comprising a topology conformable structure adaptable to create a working field in an oral cavity of a patient, wherein the working field is at least 10% larger than a working field in oral cavity of the patient without use of the device; and positioning the retraction device in the oral cavity to create an isolated working field.

0075Another method provided herein is a method of facilitating the creation of an oral cavity model comprising: inserting a retraction device comprising a topology conformable structure adaptable to be in a constrained shape that can be delivered into an oral cavity and further adaptable to be in an unconstrained shape to create a useable working field in the oral cavity, the usable working field providing increased accessibility to and increased visibility within the oral cavity; and positioning the retraction device in the oral cavity to create the useable working field in the oral cavity. In some embodiments, the method can further comprise the step of illuminating the oral cavity with the retraction device. Additionally, the method can comprise the step of applying a powder to the at least one dry tooth surface.

III. <u>MATERIALS OF MANUFACTURE</u>

0076As will be appreciated by those skilled in the art, the devices described herein, and other device designs that can be employed under the invention based on the teachings herein, and their components can be made from a variety of materials known in the art. Candidate materials for the devices and components would be known by persons skilled in the art and include, for example, the materials described above as well as suitable biocompatible materials such as metals (e.g. stainless steel, shape memory alloys, such a nickel titanium alloy nitinol) and engineering plastics (e.g. polycarbonate). See, for example <patcit id="pcit0018" dnum="US5190546A"><text>US Patent Nos. 5,190,546 to Jervis</text></patcit> for Medical Devices Incorporating SIM Memory Alloy Elements and <patcit id="pcit0019" dnum="US5964770A"><text>5,964,770 to Flomenblit</text></patcit> for High Strength Medical Devices of Shape Memory Alloy. For example, a device frame may be made of materials such as titanium, cobalt chrome stainless steel. Alternatively, a sheath or outer layer covering a frame can be made of biocompatible polymers such as polyetheretherketone (PEEK), polyarylamide, polyethylene, and polysulphone. See, for example <patcit id="pcit0020" dnum="US5190546A"><text>US Patent Nos. 5,190,546 to Jervis </text></patcit>for Medical Devices Incorporating SIM Memory Alloy Elements and <patcit id="pcit0021" dnum="US5964770A"><text>5,964,770 to Flomenblit </text></patcit>for High Strength Medical Devices of Shape Memory Alloy. Other materials may be appropriate for some or all of the components, such as biocompatible polymers, including polyetheretherketone (PEEK), polyarylamide, polyethylene, and polysulphone. <patcit id="pcit0022" dnum="US5964770A"><text>5,964,770 to Flomenblit </text></patcit>for High Strength Medical Devices of Shape Memory Alloy.

0077A variety of hydrophillic materials, hydrophobic materials, or putties can also be used, e.g. to form seals. Such materials would be known to a person skilled in the art and include, for example, hydrophilic material or a putty (e.g., Van-R reversible hydrocolloid, available from Dux Dental, and vinyl polysiloxane, available from 3M Express), as discussed above. Other materials that might also be used include, for example, poly(vinyl alcohol) (PVA) hydrogels, hydrophillic, medical grade foam, polysaccharides, glucosaminoglycans. Additional materials can include, silicons, thermal plastic elastiomers (TPE), thermal plastic urethanes (TPU), nylons and material, epoxys, corn polymers or other environmentally friendly materials, or any combination thereof. The material can also be any suitable biocompatible material.

0078In some embodiments, the device can be constructed from materials having different properties. In some embodiments, the devices described herein can be created from single property membrane transformed into multiple properties. The material can harden through additional processes, such as by changing the molecular structure of the material. In some embodiments, the material can be placed over a frame or device. The material can then undergo a process that can change the material properties of the material. In some embodiments the material property of the device is the same throughout. Alternatively, the device can be comprised of material having different properties. For example, the material of the device can be harder or stiffer in some areas and softer in other areas. The properties of the material can be changed using a laser. Alternatively, the properties of the material can be changed using light. The properties of the material can be changed using any suitable method for altering the material characteristics of the material including, but not limited to, temperature and pH, laser curing, stereolithographic laser polymerization and crosslinking, optical post manufacturing processing, and chemical post manufacturing processing, or any combination thereof.

IV. <u>KITS</u>

0079The invention also contemplates a kit comprising one or more devices with one or more device products associated with a particular dental treatment. For example, lasers are currently used in dentistry for various applications including but not limited to: cavity removal, cutting or hardening bonding material, whitening teeth, and re-contouring, reshaping, or removing gum tissue. The device herein can be used in combination with laser therapy to act as a shield and tongue and cheek retractor, preventing other regions of the mouth from being affected by the laser. Thus compounds used with the laser procedure could be provided in the kit with the devices or devices, as well as equipment adaptors, etc.

0080Additionally, a kit comprising one or more devices with one or more complementary automatic impression tray system(s) or implant specific impression tray(s), which are designed to fit over the upper and/or lower arches of teeth, to capture a detailed and accurate impression of each full arch of teeth and the surrounding alveolar process and gingiva, which the device is in place. This prevents any contamination of the impression(s) with saliva and prevents any escape of impression materials into the mouth cavity or the patient's throat.

0081Further provided herein are kits for retracting tissue in an oral cavity. Provided herein are kits for retracting tissue in an oral cavity comprising: a topology conformable structure adaptable to be in a constrained shape that can be delivered into an oral cavity and further adaptable to be in an unconstrained shape to create a useable working field in the oral cavity, the useable working field providing increased accessibility to and increased visibility within the oral cavity. In some embodiments, the kit can further comprise a tongue retractor. Additionally, the kit can further comprise a light ring. Furthermore, the kit can comprise an evacuation component. The kit can further comprise a membrane adaptable to be fitted over the frame. In some embodiments, the kit can further comprise a gum protection cover. The kit can also further comprise a lip ring.

0082Furthermore, additionally provided herein is a kit for retracting tissue in an oral cavity comprising: a retraction device comprising a topology conformable structure adaptable to be in a constrained shape that can be delivered into an oral cavity and further adaptable to be in an unconstrained shape to create a useable working field in the oral cavity, the useable working field providing increased accessibility to and increased visibility within the oral cavity; and a kit of secondary dental products wherein tissue retraction in the oral cavity is necessary. In some embodiments, the kit can further comprise an illumination source. Additionally, the kit can comprise at least one optical scanner or digital scanner. Furthermore, the kit can further comprise a powder for facilitate scanning of the dental surfaces. In some embodiments, the kit can further comprise a whitening or bleaching kit.

0083While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.

0084For completeness, claims 1 to 80 of the parent application are recited on the following pages. For the avoidance of doubt, these form part of the description of the present application and do not define the scope of the present invention.

<u>ASPECTS OF THE INVENTION</u>

0085<ol id="ol0001" compact="compact"><li>1. A retraction device comprising a topology conformable structure adaptable to be in a constrained shape that can be delivered into an oral cavity and further adaptable to be in an unconstrained shape to create a useable working field in the oral cavity, the useable working field providing increased accessibility and increased visibility within the oral cavity.</li><li>2. The device of aspect 1 wherein the conformable structure is a frame.</li><li>3. The device of aspect 2 wherein the conformable structure further comprises a membrane.</li><li>4. The device of aspect 1 further comprising a light source.</li><li>5. The device of aspect 1 wherein the device is adaptable to be deployed in under 1 minute.</li><li>6. The device of aspect 1 wherein the device is adaptable to create a working field in under 1 minute.</li><li>7. The device of aspect 1 wherein the device is adaptable to be deployed in less than 20 seconds.</li><li>8. The device of aspect 1 further comprising a tongue retractor.</li><li>9. The device of aspect 8 wherein the tongue retractor is further adaptable to contain and confine the tongue.</li><li>10. The device of aspect 8 wherein the tongue retractor is adaptable to deflect the tongue without passing over either arch of teeth.</li><li>11. The device of aspect 1 further comprising at least one evacuation component.</li><li>12. The device of aspect 1 wherein the device is adaptable to retract soft tissue surrounding at least one arch of teeth.</li><li>13. The device of aspect 1 wherein the device is adaptable to retract soft tissue surrounding an upper arch of teeth and a lower arch of teeth.</li><li>14. The device of aspect 1 wherein the device is further adaptable to isolate at least a portion of gum tissue located in the oral cavity.</li><li>15. The device of aspect 1 further comprising at least one aperture to facilitate the ability to breathe through the device.</li><li>16. The device of aspect 1 wherein the scanning comprises at least one of digital scanning or optical scanning.</li><li>17. The device of aspect 1 wherein the device is adaptable to isolate both arches of teeth is less then 20 seconds.</li><li>18. The device of aspect 1 wherein the device is adaptable to be positioned without interfering with access to dental surfaces and further adaptable to provide maximum patient comfort.</li><li>19. A retraction device comprising a topology conformable structure adaptable to create a working field in an oral cavity of a patient, wherein the working field is at least 10% larger than a working field created in the oral cavity of the patient without use of the device.</li><li>20. The device of aspect 19 wherein the device is adaptable to provide at least 10% more access to an area of interest in the oral cavity.</li><li>21. The device of aspect 19 wherein the device is adaptable to provide at least 10% more visibility within the oral cavity.</li><li>22. The device of aspect 19 wherein the device is adaptable to provide at least 10% less contamination of structures located in the oral cavity by fluid.</li><li>23. The device of aspect 19 wherein the device is adaptable to provide at least 10% less interference by soft tissue located in the oral cavity.</li><li>24. The device of aspect 19 wherein the conformable structure is a frame.</li><li>25. The device of aspect 19 further comprising a membrane.</li><li>26. The device of aspect 19 further comprising a light source.</li><li>27. The device of aspect 19 wherein the device is adaptable to isolate at least one arch located in the oral cavity.</li><li>28. The device of aspect 19 wherein the device is adaptable to isolate an upper arch and a lower arch located in the oral cavity.</li><li>29. The device of aspect 19 wherein the device is adaptable to isolate at least a portion of gum tissue in the oral cavity.</li><li>30. The device of aspect 19 wherein the device is adaptable to be deployed in under 1 minute.</li><li>31. The device of aspect 30 wherein the device is adaptable to create a working field in under 1 minute.</li><li>32. The device of aspect 30 wherein the device is adaptable to be deployed in under 20 seconds.</li><li>33. The device of aspect 30 wherein the device requires no further adjustment after being deployed.</li><li>34. The device of aspect 19 further comprising a tongue retractor.</li><li>35. The device of aspect 34 wherein the tongue retractor is adaptable to contain and confine the tongue.</li><li>36. The device of aspect 34 wherein the tongue retractor is adaptable to allow a first occlusal surface and a second occlusal surface to touch.</li><li>37. The device of aspect 34 wherein the tongue retractor is adaptable to compress at least one side of the tongue.</li><li>38. The device of aspect 34 wherein the tongue retractor is adaptable to compress both sides of the tongue.</li><li>39. The device of aspect 19 further adaptable to apply suction to the oral cavity.</li><li>40. The device of aspect 19 further comprising at least one aperture adaptable to facilitate the ability to breathe through the device.</li><li>41. The device of aspect 19 wherein the device is adaptable to at least one dental arch in less than 20 seconds.</li><li>42. The device of aspect 19 wherein the device is adaptable to be positioned without interfering with access to dental surfaces and further adaptable to provide maximum patient comfort.</li><li>43. A retraction device comprising a malleable frame adaptable to be in a constrained shape that can be delivered into an oral cavity and further adaptable to be in an unconstrained shape to isolate at least one arch of teeth from saliva and soft tissue surrounding the arch.</li><li>44. The device of aspect 43 wherein the malleable frame is a wire frame.</li><li>45. The device of aspect 44 wherein the malleable frame further comprises a membrane.</li><li>46. The device of aspect 43 further comprising a light source.</li><li>47. The device of aspect 43 wherein the device is adaptable to be deployed in under 1 minute.</li><li>48. The device of aspect 43 wherein the device is adaptable to be deployed in under 20 seconds.</li><li>49. The device of aspect 43 wherein the device is adaptable to create a working field in under 1 minute.</li><li>50. The device of aspect 43 further comprising a tongue retractor.</li><li>51. The device of aspect 50 wherein the tongue retractor is further adaptable to contain and confine the tongue.</li><li>52. The device of aspect 50 wherein the tongue retractor is adaptable to allow a first occlusal surface and a second occlusal surface to touch.</li><li>53. The device of aspect 43 further comprising at least one evacuation component.</li><li>54. The device of aspect 43 wherein the device is adaptable to retract soft tissue surrounding at least one arch of teeth.</li><li>55. The device of aspect 43 wherein the device is adaptable to retract soft tissue surrounding an upper arch of teeth and a lower arch of teeth.</li><li>56. The device of aspect 43 wherein the device is further adaptable to isolate at least a portion of gum tissue located in the oral cavity.</li><li>57. The device of aspect 43 further comprising at least one aperture to facilitate the ability to breathe through the device.</li><li>58. The device of aspect 43 wherein the device is further adaptable to facilitate the application of a substance to at least one tooth surface.</li><li>59. The device of aspect 43 wherein the substance is a powder.</li><li>60. The device of aspect 43 wherein the device is adaptable to isolate at least one dental arch in less than 20 seconds.</li><li>61. The device of aspect 43 wherein the device is adaptable to create a working field without interfering with access to dental surfaces.</li><li>62. The device of aspect 43 wherein the device is adaptable to be positioned in the mouth with maximum patient comfort.</li><li>63. A method of retracting tissue in an oral cavity comprising: <ul id="ul0002" list-style="none" compact="compact"><li>inserting a retraction device comprising a topology conformable structure adaptable to be in a constrained shape that can be delivered into an oral cavity and further adaptable to be in an unconstrained shape to create a useable working field in the oral cavity, the useable working field providing increased accessibility and increased visibility within the oral cavity; and</li><li>positioning the retraction device in the oral cavity to create the working field.</li></ul></li><li>64. The method of aspect 63 wherein the positioning step is performed in less than 1 minutes.</li><li>65. The method of aspect 63 wherein the positioning step is performed in less than 20 seconds.</li><li>66. A method of retracting tissue in an oral cavity comprising: inserting a retraction device comprising a topology conformable structure adaptable to create a working field in an oral cavity of a patient, wherein the working field is at least 10% larger than a working field in oral cavity of the patient without use of the device; and positioning the retraction device in the oral cavity to create an isolated working field.</li><li>67. A method of facilitating the creation of an oral cavity model comprising: inserting a retraction device comprising a topology conformable structure adaptable to be in a constrained shape that can be delivered into an oral cavity and further adaptable to be in an unconstrained shape to create a useable working field in the oral cavity, the useable working field providing increased accessibility and increased visibility within the oral cavity; and positioning the retraction device in the oral cavity to create the useable working field in the oral cavity.</li><li>68. The method of aspect 67 further comprising the step of illuminating the oral cavity with the retraction device.</li><li>69. The method of aspect 67 further comprising the step of applying a powder to the at least one dry tooth surface.</li><li>70. A kit for retracting tissue in an oral cavity comprising: a topology conformable structure adaptable to be in a constrained shape that can be delivered into an oral cavity and further adaptable to be in an unconstrained shape to create a useable working field in the oral cavity} the useable working field providing increased accessibility and increased visibility within the oral cavity.</li><li>71. The kit of aspect 70 further comprising a tongue retractor.</li><li>72. The kit of aspect 70 further comprising a light ring.</li><li>73. The kit of aspect 70 further comprising an evacuation component.</li><li>74. The kit of aspect 70 further comprising a membrane adaptable to be fitted over the frame.</li><li>75. The kit of aspect 70 further comprising a gum protection cover.</li><li>76. The kit of aspect 70 further comprising a lip ring.</li><li>77. A kit for retracting tissue in an oral cavity comprising: a topology conformable structure adaptable to be in a constrained shape that can be delivered into an oral cavity and further adaptable to be in an unconstrained shape to create a useable working field in the oral cavity, the useable working field providing increased accessibility and increased visibility within the oral cavity; and a kit of secondary dental products wherein tissue retraction in the oral cavity is necessary.</li><li>78. The kit of aspect 77 further comprising an illumination source.</li><li>79. The kit of aspect 77 further comprising at least one of an optical scanner or digital scanner.</li><li>80. The kit of aspect 77 further comprising a powder.</li><li>81. The kit of aspect 77 further comprising a whitening or bleaching kit.</li></ol>