Patent Application
20160100913
Oral devices and systems for use after oral surgery and, more specifically, oral shields that help prevent dry socket, decrease pain during post-operative healing, and improve oral hygiene.
Even the most successful and painless mouth surgery, e.g., tooth extractions, implants, bone grafts, hard tissue surgery, soft tissue surgery, gum surgery, and so forth, can be followed by days or weeks of discomfort for patients recovering from that surgery. Historically, patients are provided with a pain killer and some gauze pads and sent on their way to deal with their recovery. Between 5 and 8 percent of patients become afflicted with alveolar osteitis, i.e., “dry socket”, and between 8 and 15 percent of patients develop a mild infection requiring another visit to the dentist's office. The problem centers around the need for continued oral hygiene, e.g., brushing and flossing one's teeth, in a post-surgical condition. Indeed, continued good oral hygiene decreases bacteria in the mouth, aiding the overall healing process and reduces the potential chances of swelling. In contrast, infrequent or no oral hygiene at all increases the likelihood of post-surgery infections. However, even when performing daily oral hygiene properly and carefully, contacting an area recently subjected to surgery or an extraction can be excruciatingly painful, if the toothbrush bristles or the toothbrush handle make contact with the area, which, as a result, reduces the chances the patient will keep up with hygiene following mouth surgery.
Consequently, there is a need for an oral device that acts as a barrier to protect the site of an implant, extraction, bone graft, and the like. More specifically, there is a need for such an oral barrier device that avoids inadvertent contact with the site during oral hygiene activity, e.g., brushing and flossing one's teeth.
In a first aspect, an oral shield device for protecting an area in a patient's mouth is disclosed. In various embodiments, the device is manufactured from at least one of a low durometer thermoplastic, a biocompatible material, silicone, fabric, a polymer, and any combination thereof.
In some embodiments, the device includes a molded body forming a contoured surface, e.g., concave, arcuate, arched, or hemispherical, and a pair of wings extending from the body. In one variation of the embodiment, during use, the contoured surface of the molded body is disposed on a lower surface of the body, proximate to the extraction area. Further, each wing of the pair of wings extends from the body proximate the contoured surface on the lower surface of the body. In another variation, the contoured surface forms an aperture through the body. In other variations, the pair of wings may be structured and arranged to oppose one another in use and each of the pair of wings may be substantially planar.
In another embodiment, the device further includes at least one detent or surface that is structured and arranged to be accommodated between adjacent teeth. In a variation of the embodiment, the at least one detent includes a pair of detents or surfaces and each detent of the pair of detents is adapted to releasably attach to a discrete tooth.
In other embodiments, the device may include an elongate handle having at a distal end thereof a connector that is structured and arranged to releasably attach to the molded body. In a variation of the embodiment, the connector forms an aperture adapted to mate with a projection disposed on the molded body or, alternatively, the connector includes a projection adapted to mate with an aperture formed on or in the molded body.
In a second aspect, an oral shield system for protecting an area in a patient's mouth is disclosed. In some embodiments, the oral shield system includes an oral shield device and an elongate handle having at a distal end thereof a connector attached to the device. The oral shield device may include a molded body forming a contoured surface, e.g., concave, arcuate, arched, or hemispherical, and a pair of wings extending from the body. In one variation of the embodiment, during use, the contoured surface of the molded body is disposed on a lower surface of the body, proximate to the extraction area. Further, each wing of the pair of wings extends from the body proximate the contoured surface on the lower surface of the body. In another variation, the contoured surface forms an aperture through the body. In other variations, the pair of wings may be structured and arranged to oppose one another in use and each of the pair of wings may be substantially planar.
In another embodiment, the device further includes at least one detent or surface that is structured and arranged to be accommodated between adjacent teeth. In a variation of the embodiment, the at least one detent includes a pair of detents.
In a variation of the embodiment, the connector forms an aperture adapted to mate with a projection disposed on the molded body or, alternatively, the connector comprises a projection adapted to mate with an aperture formed on the molded body.
In yet another embodiment, the elongate handle includes a flexible portion that can provide rotation and six degree of freedom. In one variation of some embodiments, the flexible portion can be rotated to provide a “gooseneck” orientation.
In a third aspect, a method of protecting an area in a patient's mouth is disclosed. In some embodiments, the method includes providing an oral shield device having a molded body forming a contoured surface and a pair of wings extending from the body and positioning the device over the area in the patient's mouth. In variations of the embodiment, providing an oral shield may include providing a molded body whose contoured surface is structured and arranged to retain the molded body at a distance from the area, so as not to contact the area.
In the drawings, like reference characters generally refer to the same or similar parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention. In the following description, various embodiments of the present invention are described with reference to the following schematic drawings, in which:
Referring to
The elongate handle 6 may be structured and arranged to include an elongate portion having a proximal end 21 and a distal end 31. The handle 12 may be shaped like a toothbrush handle and may be made of a material or materials that are flexible and bendable. Handle 6 may be cast or molded from a hard plastic, e.g., a high durometer thermoplastic, but also may include side grips 8 and/or a marque grip 7 to improve hand grip function for comfort and ease of use. For that purpose and to further improve gripping, side grips 8 and the marque grip 7 may be cast or molded from a low durometer thermoplastic. Optionally, for children, the handle 6 or the marque grip 7 may be cast in a smaller size and may include cartoon characters, favorite puppets, or comic book super heroes. Larger handles for older children and young adults can be cast as sports items, e.g., baseball bats, lacrosse sticks, hockey sticks and the like, and/or include a football, a soccer ball, a basketball, and the like.
The distal end 31 of the handle 6 may be configured to include a flexible plastically deformable portion 5 and a shield retainer assembly 9. The shield retainer assembly 9 provides a mechanism for releasably connecting the elongate handle 6 to the oral shield device 4, e.g., to the flexible portion 5 of the oral shield device 4. The flexible portion 5 is structured and arranged to enable a user to vary the orientation, attitude, and distance of the oral shield device 4 relative to the handle 6. For example, as shown in
As shown in
Although the shield retainer assembly 9 shown in
Alternatively, in another embodiment, a retainer portion may be incorporated into the oral shield device 4 while a shield retainer socket may be incorporated at the distal end 31 of the elongate handle 6 such that the oral shield device 4 is retained within the shield retainer socket of the elongate handle 6 rather than vice versa. As above, a shield retainer socket incorporated into the elongate handle 6 may be structured and arranged to grab and releasably retain the retainer portion of the oral shield device 4. In yet another embodiment, the retainer portion and retainer socket interface can be positioned between the wire 10 and the handle 6. In all of these embodiments, any suitable mating interconnection can be employed, as long as the oral shield device 4 is reliably retained by the handle 6 during use and is not inadvertently released.
The oral shield device 4 may be designed of a material, as discussed below, that permits application over an extraction site in a patient's mouth for a longer period of time, e.g., hours, days, and so forth, before requiring removal. For longer term applications, an aperture 35 (
Referring to
The oral shield device 4 may be structured and arranged to include a molded body 20 and a pair of opposing wings or flaps 29. The molded body 20 may be configured to provide a contoured surface 32, e.g., a surface having a shape that is recessed, concave, arcuate, arched, hemispherical, and so forth, while the wings or flaps 29 may be similarly shaped or planar or substantially planar. For example, the contoured surface 32 of the molded body 20 may be provided on a lower surface of the molded body 20, which is the surface proximate an extraction or surgical area to be covered and protected, and the wings or flaps 29 may extend from the molded body 20 proximate the contoured surface 32 on the lower surface of the molded body 20. The molded body 20 may be adapted to include the shield retainer socket 13 described above. Optionally, the vent hole 35 or other aperture or relief may be provided through the molded body 20 of the oral shield device 4. One purpose of the vent hole 35 is to break any suction, i.e., negative pressure, that may form after application of the oral shield device 4. Another purpose of the vent hole 35 is to allow air into the affected area, e.g., to allow air exchange with the extraction site.
The wings or flaps 29 may be designed to extend downward from the molded body 20, generally away from the shield retainer socket 13. The wings or flaps 29 are structured and arranged to be applied to lingual and buccal sides of the gum adjacent the socket or affected area, i.e., the extraction site. The wings or flaps 29 are configured to oppose and may be biased toward one another in use. The length of the wings or flaps 29 should be long enough to completely cover the extraction site, e.g., on the buccal and lingual sides of the gums, to ensure that the bristles of a tooth brush do not disturb the underlying thrombus or cause undue pain or discomfort to the patient. For example, the length of each wing of flap measured from a tangent to the inside radius of the bottom of the contoured surface 32, typically, may be between 2 mm and 6 mm. However, in some applications, wing or flap lengths could be shorter than 2 mm and longer than 6 mm. In some variations of the embodiment, the contoured surface 32 forms an arched portion that is structured and arranged to minimize any contact between the molded body 20 of the oral shield device 4 and the affected area that it spans and covers. Thus, the wings or flaps 29—and hence the gums—support the oral shield device 4 and provide a snug fit.
Texturing may be added to the contoured surface 32 to, inter alia, provide an irregular surface that reduces the total surface area in contact with the gingiva and that provides pressure relief channels. A standard commercial texture, e.g., MT-11260 manufactured by Mold-Tech, Inc. of Albertville, Minn., which includes a random pattern texture that is about 0.004 inches deep, may be used. However, those of ordinary skill in the art realize that any of a variety of commercially-available textures or custom textures can be added to or included with the contoured surface 32. Exemplary texturing to the contoured surface 32 is shown in
The features of an oral shield device 4 may be modified for a specific application. For example, referring to
For the wisdom tooth extraction shield 19 depicted in
Having described certain embodiments of the elongate handle 6 and oral shield device 4 of the oral shield system 1, a method of using the oral shield system 1, for example during performance of personal oral hygiene, is now described.
Preferably, the user may center the molded body 20 and, more particularly, the contoured surface 32 so that the one of the opposing flaps or wings 29 is positioned on the lingual side of the user's gingiva (gums) 18 and the other of the opposing flaps or wings 29 is positioned on the buccal side of the user's gingiva 18. As the oral shield device 4 is lowered or raised into position as the case may be, each of the tooth detents 16 accommodates the distal 22 or mesial 23 of the adjacent teeth 17. The distance between the detents 16 and the contoured surface 32 of the molded body 20 are sized and configured to prevent the oral shield device 4 from contacting the thrombus or exposed bone, which would be the source of great discomfort and also may cause other complications. The wings of flaps 29 extend along the gingiva 18 to seal off the extraction site from the sides.
Once the extraction site 14 or 15 has been covered by the oral shield device 4, the user inserts her toothbrush 2 and begins to brush her teeth as she normally would. The wings or flaps 29 and the molded body 20 cover the extraction site 14 or 15, preventing the bristles of the tooth brush 2 from disturbing the healing process. This prevents discomfort or pain and avoids possibly infecting the extraction site 14 or 15.
The foregoing description of various embodiments of the invention has been provided for the purposes of illustration and description. It is not intended to be exhaustive or to limit the claimed subject matter to the precise forms disclosed. Many modifications and variations will be apparent to the practitioner skilled in the art.
For example, more or less of the handle may be plastically deformable, up to an entire length of the handle or none at all. In the latter case, the handle may include a substantially rigid gooseneck or other non-linear configuration. Alternatively or additionally, the shield retainer assembly may be a ball-and-socket or multi-axis swivel connection, allowing further adjustability of the oral shield device relative to the handle. In certain embodiments, the oral shield device may be manufactured integrally with the handle, eliminating the need for the shield retainer assembly. In other embodiments, once the oral shield device is attached to the handle with the shield retainer assembly, the combination may form an inseparable assembly.
Embodiments were chosen and described in order to best describe the principles of the invention and its practical application, thereby enabling others skilled in the relevant art to understand the claimed subject matter, the various embodiments and with various modifications that are suited to the particular use contemplated. All combinations and permutations of structures, methods, and materials disclosed herein are considered to be part of the invention, as well as all equivalents. The scope of the invention is to be defined by the following claims and not limited to any particular embodiment.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 14137188 | Dec 2013 | US |
| Child | 14739775 | US |
