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

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

This application claims the benefit of U.S. Provisional Application No. 60/975,387, filed Sep. 26, 2007, U.S. Provisional Application No. 61/026,989, filed Feb. 7, 2008, and U.S. Provisional Application No. 61/081,908, filed Jul. 18, 2008, which are incorporated herein by reference in their entireties.

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

The mouth 10 has salivary glands that secrete about 1.5 L 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.

Devices and systems currently known and used in the dental arts include those disclosed in: U.S. Pat. No. 4,695,253 to Tysse for Oral Evacuation Device and Method; U.S. Pat. No. 6,981,870 to Heasley for Rubber Dam Clamps Retained by Adhesion and Improved Frictional Forces; U.S. Pat. No. 6,022,214 to Hirsch et al. for Intraoral Illumination Device and Method of Using Same; U.S. Pat. No. 5,931,673 to Bobolan for Intraoral Dental Dam; U.S. Pat. No. 5,890,899 to Sclafani for Dental Isolator; U.S. Pat. No. 5,516,286 to Kushner for Dental Isolation Tray Particularly Suited for Use When Applying Dental Sealants and Method for Its Use; U.S. Pat. No. 5,460,524 to Anderson for Device and Method for Saliva Suction with Tongue Retractor and Bit Handle; U.S. Pat. No. 5,078,604 to Malmin for Dental Barrier Drape Devices and Retainer Apparatus Therefor; U.S. Pat. No. 5,037,298 to Hickham for Apparatus and Improves Process for Removing Saliva While Retracting Cheeks and Lips; U.S. Pat. No. 4,899,490 to Jenkinson for Dental Mask; U.S. Pat. No. 4,215,477 to Shanel for Holder for Rubber Dental Dam; U.S. Pat. No. 3,772,790 to Swan-Gett et al. for Tooth Isolating Shield; U.S. Patent Publication US 2004/0170945 to Heasley for General Field Isolation Rubber Dams without Operative Inserts Which Isolate the Dental Alveolar Arch for Dental Treatment; and US 2007/0231773 to Pontynen et al. for Methods, Devices, Systems, and Kits for Isolating Teeth.

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

It 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.

Provided 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.

Further 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.

Additionally, 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.

Further 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.

Yet 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.

Another 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.

Further 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.

Furthermore, 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.

All 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.

• Provisional Patent
• Utility Patent

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