TISSUE

PRIORITY

This application claims priority to U.S. Provisional Application No. 61/645,934, filed with the United States Patent and Trademark Office on May 1 1, 2012, the entire contents of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field _ of the _ I yen tion :

The present invention relates generally to bone and soft tissue growt stimulation and, more particularly, to electromagnetic devices for stimulating growth of intra-oral hone and soft tissue.

2. Description of the Related Art:

A substantial percentage of the world's older populations axe dental implant recipients. Many denial implant patients are aging baby-boomers and senior citizens. Older dental patients often have medical maladies suc as diabetes, heart disease, and rheumatoid arthritis. Such diseases complicate and slow bone and soft tissue growth around dental implants. In addition, many older patients take blood thinning medications and aspirins, which also result in slower bone and soft tissue healing. Slow healing of oral bone and soft tissue can also be caused by smoking and alcohol use. Poor healing of bone and soft tissue surrounding a dental implant can lead to complications including failure of the dental implant.

Conventional devices used for bone and soft tissue growth stimulation are based on application of Sow electrical current, pulsating electromagnetic field or ultrasound and the like. An example of such a device is provided by U.S. Patent No. 5,743,844 to Tepper et ah, the entire contents of which are incorporaied herein by reference. However, such devices are not designed for stimulating growth of intra-oral bone and soft tissue around dental implants, i.e., such devices are not designed for intra-oral insertion. Further, use of conventional bone and soft tissue growth stimulating devices in a home or office setting is hindered since these devices are not designed for dental treatment settings. Use of conventional bone tissue growth stimulating devices typically requires visits to the doctor office or a similar medical facility. The difficulties of using such devices in a home or office are increased due to the fact that such medical devices were not designed to he used for dental treatments.

SUMMARY OF THE INVENTION

According to an embodiment of the present invention, a device for stimulating growt of intra-oral bone and soft tissue is provided. ^' Fhe device includes a housing adapted to fit within a user's mouth and an electromagnetic field emitter disposed within the housing providing an electromagnetic pulse to an interior of the user's month. The device also includes a control unit for controlling intensity and frequenc of the electromagneiic pulse emitted from the e lectromagnetic field emitter and for controlling durati on of treatment.

According to an embodiment of the present invention, a method for stimulati ng growth of intra-oral bone and soft tissue using a device is provided. The method includes positioning a housing within a user's mouth and providing an electromagnetic field emitter for emitting an electromagneiic pulse to an interior of the user's mouth. The method also includes controlling intensity and frequency of the electromagnetic pulse using a control unit, setting duration of treatment using the control unit, and producing the electromagnetic pulse.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and other objects, features and advantages of certain embodiments of the present invention will be more apparent from the following detailed description taken in conjunction with the accompanying drawings, in which:

FIG. 1 il lustrates a diagram of a device for stimulating growth of intra-oral bone and soft tissue, according to an embodiment of the present invention;

FIG. 2 illustrates a front view of a housing of a device for stimulating growth, of intra-oral bone and soft tissue, according to an embodiment of the present invention: FIG. 3 illustrates a front view of a housing of a device for stimulating erowth of intra-oral bone and soft tissue having a convex outer surface, according to an embodiment of the present invention;

FIG. 4 illustrates a top view of a housing of a device for growth of intraoral bone and soft tissue having a plurality of arcuate indentations, according to an. embodiment of the present invention:

FIG . 5 illustrates a top view of a housing of a device for stimulating growth of t ra-otal. bone and soft tissue having a variable thickness from a proximal end to a distal end, according to a embodiment of the present invention;

FIG. 6 illustrates a side view of a connection member and a support structure of a device for stimulating growth of intra-oral bone and soft tissue, according to an embodiment of the present invention;

FIG. 7 illustrates a segmented magnetic field emitter of a device for stimulating growth of intra-oral bone and soft tissue, according to an embodi ment of the present invention; and

FIG. 8 illustrates a schematic of a method for stimulating growth of intra-oral bone and soft tissue using a device, according to an embodiment of the present invention.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

The following detailed description of embodiments of the invention will be made in reference to the accompanying drawings. In describing the invention, explanation about related functions or constructions known in the art are omitted for the sake of clearness in understanding the concept of the invention to avoid obscuring the invention with unnecessary detail.

Prior to receiving a dental implant, an area of a patient's jaw bone and soft tissue is removed, i.e. drilled into, in preparation for implantation. The dental implant is most commonly shaped like a screw with a hollow center. The dental implant is screwed into the maxillary or mandible jawbone and is rigidly affixed thereto. A successful implantation requires surrounding bone and soft tissue to grow around the dental implant, securing the dental implant to the jawbone in the patient ^' s mouth. However, patient populations requiting dental, implants are often slow-healers due to advanced age, a history of smoking, alcohol consumption, disease, and use of blood thinning medications, etc. Embodiments of the present invention provide a device for stimulating intra-oral bone and soft tissue growth. Accordingly, the device for stimulating growth of intra-oral bone and soft tissue provided herein promotes improved recovery outcomes for patients receiving dental implants implanted in maxillary and mandible jawbone areas.

FIG. 1 illustrates a diagram of a device for stimulating growth of intra-oral bone and soft tissue, according to an embodiment of the present invention. The device 100 includes a housing 1 10 adapted to fit within a user's mouth. An electromagnetic field emitter 120 is disposed within the housing 1 10, The electromagnetic field emitter 120 provides an electromagnetic pulse to an interior of the user's mouth. The device 100 also includes a control unit 130 for controlling control information. The control information includes intensity, frequency and shape of the electromagnetic pulse emitted from the electromagnetic field emitter 120. The shape of the electromagnetic pulse refers to the shape of the electromagnetic field emitted from the electromagnetic field emitter 120. The shape of the magnetic field includes any geometric shape, such as a circle, oval etc., as well as azimuthal, meridional, dipoie, quadropole, solenoidal, toroidal, poloida!, and radial magnetic field shapes. The control information also includes duration of treatment. The duration of treatment may be from one second to 60 minutes. According to an embodiment of the present invention, the duration of treatment is at least one minute.

The housing 1 10 includes a proximal end 150, a distal end 160, an outer surface 170, and an inner surface ISO. The housing 1 1.0 may be a probe that is inserted into the user's mouth and may be constructed out of a flexible material that adapts to contours of the inteoor of the user's mouth. The outer surface 170 contacts the user's cheek. The inner surface 180 contacts the user's gum, i.e., gingival tissue. An exterior surface of the housing 1 0 also includes a fastener (not shown) for attaching a removable sterile sleeve. The removable sterile sleeve includes medical gauze, cotton, and/or flexible plastic. By changing the removable sterile sleeve afte each user, the housing 1 10 remains sterile, limiting transfer of bacteria and disease between users.

A solid metal core wrapped by a wire is disposed within the electromagnetic field emitter 120. The wire may be made of solid copper. The wire is insulated by a non-conductive material. The control unit 130 modifies electrical current transmitted to the electromagnetic field emitter 120 to provide a desired intensity, frequency, shape and duration of a pulsating electromagnetic field to the user's mouth. The control unit 130 provides the electrical current in a range of 3- ΙΟΟΟΗζ, and modifies the electrical current to provide the pulsating electromagnetic field with a frequency of 0.05-25 Hz. The control unit J 30 provides the electrical current sufficient for the electromagnetic field emitter 120 to generate an electromagnetic field, in the range of 0.1 -50 mXesla.

The control, unit 130 includes components necessary to control the electromagnetic field emitter 120, i.e., a power cable for plugging into an electrical outlet, a rechargeable battery for portable use, a transformer, a processor, a display, intensity, frequency, shape and duration controls for the electromagnetic field emitter 120, etc. The electromagnetic field emitter 120 provides the pulsating electromagnetic field to the interior of the user's mouth, stimulating jawbone and soft tissue growth.

The control unit 130 includes an electrical cable 140 connecting the control unit 130 to the electromagnetic field emitter 120. The electrical cable 140 enters at the proximal end 150 of the housing 1 10, According to an embodimem of the present invention, the control unit 130 controls the electromagnetic field emitter 120 wirelessly. In a wireless configuration, the control unit 130 and the electromagnetic field emitter 120 include wireless transmitters (not shown) for transmitting the control information. The housing .1 10 includes components for receiving and processing the control nformation transmitted by the control unit 130. The housing 1 30 also includes a rechargeable battery to power the electromagnetic field emitter 120. The control unit 130 may he configured to wirelessly control a plurality of housings simultaneously.

FIG. 2 illustrates a front view of a housin of a device for stimulating growth of infra-oral bone and soft tissue, according to an embodiment of the present invention. The housing 1.10 includes a housing base 200 and an upper surface 210. The inner surface 1 80 and the outer surface 170 of the housing 1 10 extend from the housing base 200 to meet the upper surface 210. FIG. 2 illustrates the housing 1 10 as being triangular in shape, however, the housing 1 10 can be any shape.

FIG. 3 illustrates a front view of a housin of device for stimulating growth of intra-oral bone and soft tissue having a convex outer surface, according to an embodiment of the present invention. The outer surface 170 is embodied as a convex surface. The convex, surface provides additional bulge to the housing 1 10 to keep the housing 1 10 wedged between the user's cheek and gum. FIG. 4 illustrates a top view of a housing of a device for stimulating growth of intra-oraS bone and soft tissue having a plurality of arcuate indentations, according to an embodiment of the present invention. The inner surface 180 includes a plurality of arcuate indentations 400. The arcuate indentations 400 are configured to fit around the user's teeth. The arcuate indentations 400 provide an ergonomic fit for the housing HO within the user's mouth, allowing a more comfortable experience during treatment, as well as keeping the housing 1 10 wedged between the user's cheek and gam.. Farther, the housing Π0 may be embodied as a crescent moon-shape corresponding to the contours of the user's mouth.

The plurality of indentations 400 in the housing 1 10 are illustrated for fitting within upper (maxillary) and lower (mandible) left quadrants of the user's mouth. However, according to an embodiment of the present invention, the plurality of indentations 400 are configured to fit around upper and lo wer right quadrants of the user's mouth.

FIG. 5 illustrates a top view of a housing of a device for stimulating growth of intra-oral bone and soft tissue having a variable thickness from a proximal end to a distal end, according to an embodiment of the present invention, A thickness of the housing 1 10 increases from the proximal end 150 extending towards a middle portion 500 of the housing 1 10. The thickness of the housing 110 decreases from the middle portion 500 extending towards the distal end 1.60 of the housing 110. Thus, the middle portion 500 is the thickest point of the housing. A variable thickness of the housing 1 10 provides an ergonomic fit for the housing 1 10 within the user's mouth, allowing a more comfortable experience during treatment, as well as keeping the housing .1 10 wedged between the user's cheek and gum.

FIG. 6 illustrates a side view of a connection member and a support structure of a device for stimulating growth of intra-oral bone and soft tissue, according to an embodiment of the present invention. A connection member 600 includes a first end 610 and a second end 620, The first end 610 is flexibly attached to an exterior surface of the housing 1 10. A support, structure 630 is flexibly attached to the second end 620 of the connection member 600, The support structure 630 fits between die user's gum and teeth opposite to the housing 1 10 such that the support structure 630 secures the housing 110 between the user's cheek and gum. The support structure 630 includes a supporting inner surface 640 contacting the user's gum, and a supporting outer surface 650 contacting the user's cheek. The supporting inner surface 640 and the supporting outer surface 650 extend from a support structure base 660 to meet a support upper surface 670 of the support structure 630.

According to embodiments of the present invention, the connection member 600 is made of a flexible material and is removable from the housing 1 10 and the support structure 630. The connection member 600 may be adjustable, and/or come in a variety of sizes, to accommodate various sizes of users ⁵ mouths. Further, the connection member 600 may be rotatably attached to the exterior surface of the housing 3 10 and or an exterior surface of the support structure 630. Flexibility and rotatabiSity of the connection member 600 enables insertion of the housing 1 10 and the support structure 630 into the user's mouth. Thus, the user avoids the discomfort of having to open their mouth greater than a fully extended height of the connection member 600 and the housing I S O while inserting the connection member 600 and the housing 1 10 into their mouth.

According to an embodiment of the present invention, the support structure 600 may be a second housing, including all functionality of the housing 1 .10, with the housing 1 1 being a first housing. Accordingly, third and fourth housings may be provided to fit within each quadrant of the user's mouth simultaneously. That is, the first housing may be provided in the lower left quadrant of the user's mouth attached by a first connection member to a second housing in the tipper left quadrant of the user's mouth, and third housing may be provided in the lower right quadrant of the user's mouth attached by a second connection member to a fourth housing in the upper right quadrant of the user's mouth. Thus, the first housing includes a first electromagnetic field emitter for emitting a first electromagnetic pulse, the second housing includes a second electromagnetic field emitter for emitting a second electromagnetic pulse, the third housing includes a third electromagnetic field emitter for emitting a third electromagnetic pulse, and the fourth housing includes a fourth electromagnetic field emitter for emitting a fourth electromagnetic pulse.

FIG. 7 illustrates a segmented electromagnetic field emitter of a device for growth of mtra-oral bone and soft tissue, according to an embodiment of the present invention. The electromagnetic field emitter 320 is segmented into a plurality individually controllable electromagnetic emission regions 700 providing the electromagnetic pulse to a target region of the user's mouth. The control unit 130 controls each of the electromagnetic emission regions 700 of the electromagnetic field emitter 120. Where the user has a dental implant at a single tooth. the target region is the gum below the tooth where the dental impiaot is located. For example, region A of FIG. ? illustrates an electromagnetic field when a third region of a total of seven regions is turned on. In this example, turning on the elec tromagnetic field of only the third region of the electromagnetic field emitter 120 provides targeted electromagnetic therapy.

FIG. 8 illustrates a schematic of a method for stimulating growth of intraoral bone and soft tissue using a device, according to an embodiment of the present invention. In step 800, the method includes positioning a housing within a user's month. In step 810, an electromagnetic field emitter is provided within the housing for emitting an electromagnetic pulse to an interior of the user's mouth. In step 820, a control unit controls intensity and frequency of the electromagnetic pulse. In step 830, the control unit sets duration of treatment. The method includes producing the electromagnetic pulse. The electromagnetic pulse may be emitted to an affected quadrant of the user's mouth, such as to the user's gum where a dental implant is located. The electromagnetic pulse may target the affected quadrant of the user's mouth using a segmented electromagnetic field emitter.

While the invention has been shown and described with reference to certain embodiments of the present invention thereof, it will be understood by those skilled in the art that various changes in details may be made therein without departing from the spirit and scope of the present invention as defined by the appended claims and equivalents thereof