Patent ID: 12233283

DETAILED DESCRIPTION OF THE INVENTION

Embodiments of the present invention are described herein with reference to the drawing figures.FIGS.1-7depict various views of example intraoral positioning device (IPD)100that is used to position a patient's (user's) jaw, mouth and soft tissue (e.g., tongue) for intensity-modulated radiation therapy (IMRT) planning and treatment). IPD100is a device that positions oral structures and displaces soft tissue (thereby sparing such tissue unnecessary exposure to radiation) by creating separation between a patient's anatomical structures (e.g., the patient's upper and lower arches). In addition, IPD100may also be used for other planning and treatment procedures involving radiation therapy including for example intensity modulated proton therapy—IMPT, CT imaging, X-ray imaging and MRI imaging. IPD100is configured or manufactured as one-piece (integral), but those skilled in the art know that IPD100may be made in two or more pieces that are combined to form IPD100.

As shown, IPD100comprises an engagement member101that is configured to engage anatomical structures in a patient's mouth including tissue, tongue and/or teeth as described below. Specifically, engagement member101includes upper section102, middle section104and lower section106. Upper section102is an arc shaped wall of a single diameter that includes an annular indentation or channel102a(as a positioning aid) positioned toward the rear of upper section102for the maxilla or teeth to engage. Channel102ais defined by a single curved wall that is configured into a trough or groove. However, channel102amay be defined by two, three or more walls that create the groove. A wall may be linear or rounded to a degree. For example, channel102amay be configured as a rectangular groove.

Upper section102alternatively may incorporate other positioning aids to create positive engagement of the maxilla or upper teeth. However, upper section102may be configured without any indention or channel for a patient who is denture-less. Channel102ais one form of a positioning aid. Other possible positioning aids may include channels, grooves, indentations, recessions, thermo-molded pieces or other structures, sections or positioning aids known to those skilled in the arts. Middle section104is configured as a wall that is vertically positioned in the rear (defining the opening or cavity as described below). Lower section106is configured as a flat wall. However, those skilled in the art know that the upper, middle and/or lower section may be configured to any shape or size to achieve desired results as known to those skilled in the art.)

Upper section102, middle section104and lower section106(i.e., these walls) together form a bite block and define an opening108(cavity) for receiving and positioning a tongue. As part of bite block configuration, middle section104extends vertically from and functions as a back/rear wall between upper and lower sections or walls102and106that define opening108. The opening108or cavity enables a patient's tongue to be extended forward over the lower incisor and within IPD100. Upper section102extends beyond the length of lower section106as shown (similar to an awning or overhang). This extended portion102bacts as a displacement stent for the tongue, thereby limiting movement of the patient's tongue. The stent (overhang or extended portion102b) is configured as an arc (curved shape) as shown inFIGS.1-6, but the stent may be configured in any other shape to achieve desired results as known to those skilled in the art. In this example inFIGS.1-6, tongue displacement stent102bacts a ceiling, thereby preventing a patient's tongue from rising (i.e., moving vertically) above. The opening108(cavity) in the structure may also be configured in various shapes and sizes to accommodate the size of different patient (user) anatomic structures. Larger mouths generally have larger tongues as well.

Upper section102, middle section104and/or lower section106may incorporate additional positioning aids or elements to create positive engagement of the mandible and associated dental structures. These positioning aids may include channels, grooves, indentations or recessions, thermo-molded pieces or sections, and other positioning aids known to those skilled in the arts.

IPD100also includes handle or bar110extending from middle section or wall104, axially with respect to engagement member101, to enable a user to grasp IPD100. Handle110may have various shapes to achieve desired results. Handle110may incorporate ladder steps or ledges to add in grasping. Alternatively, handle110may be fully open, solid or any other configuration to achieve desired results.

FIGS.7-12depict views of another example IPD700(intraoral positioning device). IPD700is similar to IPD100in that IPD700comprises an engagement member701that is configured to engage a patient's anatomical structures (e.g., tissue, tongue and teeth). Specifically, engagement member701includes an upper section or wall comprising segments702a,702b,702c(described below), middle section or wall704and lower section or wall706.

As mentioned, in this example, upper section is divided into three segments: inner segment702a, outer segment702band transition segment702c. Both inner and outer segments702aand702bare configured as arc or concave shape, but having different diameters from one another. In this example, segment702ahas a larger diameter than segment702b. Segment702atransitions into segment702bgradually through a transition segment or section702c. That is, segment section702cfunctions as a transition between inner segment702aand outer segment702b, and transition segment is shown (e.g.,FIG.10) as a curve wall, in reverse to the curvature of upper section702a, with a gradually decreasing diameter, thereby transitioning between inner and outer segments. However, those skilled in the art know that any number of segments (curved or linear) may be used to achieve desired results. Segment702bextends outwardly from segment702avia segment702c.

Segment702aincludes an annular indentation or channel702a1(as a positioning aid) positioned toward the rear of upper section702for the maxilla or teeth to engage as described above. As described above, channel702a1is defined by a single wall that is configured as a trough. However, channel702a1may be defined by two, three or more segments or walls that create a groove or other engagement point. A wall may be linear or rounded to a degree. For example, channel702a1may be configured as a rectangular groove.

As described above, upper section alternatively may incorporate other positioning aids to create positive engagement of the maxilla or upper teeth. However, upper section702may be configured without any indention or channel for a patient who is denture-less. Channel702a1is one form of a positioning aid. Other possible positioning aids may include channels, grooves, indentations, recessions, thermo-molded pieces or other structures, sections or positioning aids known to those skilled in the arts.

Similar to middle section104above, middle section704is configured as a wall that is vertically positioned in the rear (defining the opening or cavity as described below). Lower section706is configured as a flat wall. However, those skilled in the art know that the upper, middle and/or lower section may be configured to any shape or size to achieve desired results as known to those skilled in the art.)

Segment702aof the upper section, middle section704and lower section706(i.e., these walls) together form a bite block and define an opening708(cavity) for receiving and positioning a tongue. Segment702bof upper section702extends beyond the length of lower section706as shown. This extended portion702bacts as a displacement stent for the tongue, thereby limiting movement of the patient's tongue. The stent (extended portion702b) is configured as an arc (curved shape) as shown inFIGS.7-12, but the stent may be configured in any other shape to achieve desired results as known to those skilled in the art. In this example, tongue displacement stent702bacts a ceiling, thereby preventing a patient's tongue from rising (i.e., moving vertically) above. The opening708(cavity) in the structure may also be configured in various shapes and sizes to accommodate the size of different patient (user) anatomic structures. Larger mouths generally have larger tongues as well.

Upper section702, middle section704and/or lower section706may incorporate additional positioning aids or elements to create positive engagement of the mandible and associated dental structures. These positioning aids may include channels, grooves, indentations or recessions, thermo-molded pieces or sections, and other positioning aids known to those skilled in the arts.

IPD700also includes handle or bar710extending from middle section704to enable a user to grasp IPD700. Handle710may have various shapes to achieve desired results. Handle710may incorporate ladder steps or ledges to add in grasping. Alternatively, handle710may be open, solid or any other configuration to achieve desired results.

FIG.13-18depict views of another example IPD1300(intraoral positioning device). This IPD1300is similar to IPD700inFIGS.7-12. IPD1300comprises an engagement member1301that incorporates an upper section1302with an inner segment1302a, lower segment1302band transition segment or section1302c.

The diameter of the inner segment1302aof the upper section1302is significantly greater than lower segment1302b. Therefore, the transition segment1302ctransitions at a greater slope than the transition segment shown inFIGS.7-12.FIG.16depicts this clearly. IPD1300includes a middle section or wall1304and lower section or wall1306. Upper section1302, middle section1304and lower section1306(i.e., these walls) together form a bite block and define an opening1308(cavity) for receiving and positioning a tongue similar to the example inFIGS.1-6above. IPD1300further includes handle1310for grasping as described above.

In short, as seen inFIGS.13-18, example IPD1300varies in overall sizing and form from the example IPD100inFIGS.1-6, but functions similarly to the example inFIGS.1-6.

FIGS.19-22depict views of another example intraoral positioning device1900. As shown, the bite block of the IPD1900has upper and lower sections or walls1902,1904and middle wall1906extending from and between upper and lower walls192,1904. Upper wall1902, lower wall1904and middle wall1906together define the bite block of IPD1900having and opening to receive a patient's tongue. However, IPD1900does not include vertical side sections or walls or an extended tongue displacement stent as shown in the other examples. Upper and lower sections1902and1904or walls include indentations1902a,1904aas positioning aids as described above. This may also be used as shown for a simple bite block without tongue stent but maintaining the open center for tongue positioning. IPD1900also includes handle or bar1910extending from middle section1904to enable a user to grasp IPD1900. Handle1910may have various shapes to achieve desired results. Handle1910may incorporate ladder steps or ledges to add in grasping. Alternatively, handle1910may be open, solid or any other configuration to achieve desired results.

FIG.23-27depict views of another example IPD2300(intraoral positioning device). This IPD2300is similar to IPD700inFIGS.7-12(and other examples) in design and functionality. In that, IPD2300enables proper separation between the upper and lower arches of patient's mouth during treatment sessions. In this example, IPD2300includes a set of lower index ridges2310on the lower (bottom) section or wall which enable a patient to position his/her lower jaw to a finite position, i.e., to improve repeatability from planning through full treatment.

FIGS.28-32depict views of another example IPD2800. IPD2800is configured to position and maintain a patient's tongue against the base of his/her mouth while creating separation between the upper and lower arches (jaws) of the patient's mouth. IPD2800comprises an engagement member2801that is configured to engage a patient's anatomical structures in his/her mouth including tissue, tongue and teeth as described below. Specifically, engagement member2801includes an (1) upper section or wall comprising inner segment2802a, outer segment2802band transition segment2802cbetween the inner and outer segments, (2) middle or side section or wall2804and a lower section or wall2806.

Inner segment2802ais constructed with a diameter sufficient to enable a patient to bite down for a treatment session. Outer segment2802bhas an arc shaped wall of generally singular diameter and it extends outwardly from the bottom of inner segment2802avia a transition segment2802c. However, outer segment2802bcurvature is opposite to the curvature of segment2802aas shown. Because of this construction, transition segment2802chas a steep slope from inner segment2802ato outer segment2802b, thereby essentially forming a wall of ninety-degrees in angle. Outer segment2802beffectively extends directly from lower segment laterally. In this example, the tangential plane at the vertex (at the axis of symmetry) of the curvature of outer segment2802bis parallel to the plane of handle2810. Outer segment2802bfunctions as a stent, thereby depressing a patient's tongue below IPD2800. In other examples, outer segment2802bmay be constructed as flat or other shape to achieve desired results.

Inner segment2802aincludes an annular indentation or channel2802a1(as a positioning aid) positioned toward the rear of upper section2802for the maxilla or teeth to engage. Channel2802ais defined by an annular shaped wall that is configured as a trough or groove. However, channel2802a1may be defined by two, three or more walls that create a groove. A wall may be linear or rounded to a degree. For example, channel2802a1may be configured as a rectangular groove. IPD2800further includes index ridges2808as describe above with respect to example IPD2300. IPD2800further includes handle2810for grasping as described above.

FIGS.33-37depict views of another example IPD3300. IPD3300is configured to position and maintain a patient's tongue laterally within his/her mouth while creating separation between the upper and lower arches (jaws) of the patient's mouth. IPD3300comprises engagement member3301for engaging anatomical structure in a patient's mouth including patient's tissue, tongue and teeth as described below. Engagement member3301includes a bite block that is defined by upper and lower sections or walls3302,3304, side sections or walls3306,3308and front and back sections or walls3310,3312, respectively as shown. Upper and lower sections or walls3302,3304are configured in an arc shape (concave) while side sections or walls3302,3304and front and back sections or walls extend vertically to define shape of the bite block.

As part of front section or wall3310, the bite block includes opening3318to the right of stent3314. Similar to the embodiments herein, opening3318is configured to receive a patient's tongue (i.e., a portion thereof) to stabilize the position of the patient's tongue.FIG.36best depicts wall3310including opening3318.

Upper and lower sections3302and3304incorporate annular indentations or channels3302aand3304a, respectively (as positioning aids) for the maxilla, mandible or teeth (upper and lower) to engage. Engagement member3301further includes lateral displacement stent3314extending from front section3310of the bite block. Stent3306is configured vertically with respect to the axis of IPD3300and offset from the center of section3310as best shown inFIG.36. Stent3306is configured to displace (move) a patient's tongue (left or right), i.e., cause the tongue to deviate in a desired direction. Stent3306is curved (diameter) to improve the patient's comfort during treatment.

As indicated, this stent (extended portion)3314acts as a displacement stent for the tongue, thereby limiting movement of the patient's tongue. Stent3314is configured as an arc (curved shape) as shown, but stent3314may be configured in any other shape to achieve desired results as known to those skilled in the art. A plane tangent at the vertex of the curvature shape of stent3314is vertical with respect to the plane of handle3316(as described below). In this example, the height of stent3314is greater than the height of front wall3314as shown. However, the dimensions of stent3314may vary as desired. Stent3314is offset from center of wall3310as shown, but it may be located at any position and angle to achieve desired results as known to those skilled in the art.

In this example, stent3314, as best shown inFIG.36, is configured to cause a patient's tongue to deviate to the right. However, IPD3300may be rotated 180 degrees to enable a practitioner to deploy IPD3300in a patient's mouth and cause a patient's tongue to deviate in the opposite direction (i.e., to the left).

IPD3300further includes handle3316extending from and attached to the engagement member3301. The handle functions similar to those handles described above with respect to the other example IPDs.

For any example in this disclosure, an IPD may be constructed as an integral part or several parts constructed together (e.g., molding etc.). In addition, the material used to create the IPD may be plastic, photopolymer cured resins, composite plastics, ABS, ceramic, composite ceramic or any other suitable materials as known to those skilled in the arts. In addition, the material that the device is made of, as well as the general design may allow for radiation shielding/attenuation. Further, the IPD in these examples may be produced in different sizes to achieve a desired effect, typically a certain incisal opening or separation between the maxilla and mandible. The tongue positioning stent in the example inFIGS.1-6including the hollow cavity in the bite block (i.e., main body of the device) allow for the tongue to be positioned in a forward or elongated position with the main body of the tongue covered by the stent. The patient's tongue may be positioned differently as described above with the other examples in the figures.

It is to be understood that the disclosure teaches examples of the illustrative embodiments and that many variations of the invention can easily be devised by those skilled in the art after reading this disclosure and that the scope of the present invention is to be determined by the claim(s) below.