WO2019108946A1

WO2019108946A1 - Mouth guard with embedded detection system

Info

Publication number: WO2019108946A1
Application number: PCT/US2018/063330
Authority: WO
Inventors: Timothy Huang; Jan Anders AKERVALL; Johann Walter SCHWANK
Original assignee: Akervall Technologies, Inc.
Priority date: 2017-11-30
Filing date: 2018-11-30
Publication date: 2019-06-06

Abstract

A mouth guard is provided with embedded features that assist in detecting biological markers in saliva or breath as well as acceleration that may be associated with head trauma. The mouth guard may have an accelerometer, a power source and an electronic chip embedded within its unitary structure. The electronic chip can transmit data from the accelerometer to a receiver where it can be determined if the data exceeds a predetermined value for potential head trauma.

Description

TITLE

MOUTH GUARD WITH EMBEDDED DETECTION SYSTEM

FIELD OF THE DEVICE

Disclosed herein is a novel mouth guard with embedded features associated with detecting biological markers in saliva or breath and/or detecting acceleration that may be associated with head trauma.

BACKGROUND

Head trauma, such as concussions, are common in many sports and often result from a hit to the head. The head impact creates a rotation of the head, which in turn results in a rapid acceleration and deceleration of the brain. In this sudden movement, the brain crashes into the inside of the skull resulting in trauma to the brain tissue during which a cascade of biological responses occurs. These biological responses (protein releases, etc.) create a rapid biochemical imbalance that can damage the brain tissue.

The diagnosis of concussions is still purely clinical (headaches, disorientation, nausea, etc.) and there is currently no available device that can assist players, parents and coaches to quickly determine if head acceleration has occurred that could potentially cause traumatic brain injury. This creates a significant danger to players since the clinical symptoms often appear later and subsequent, additional head trauma can occur before the player is taken off the field. The long term effects on traumatic head injuries can be significant, including learning difficulties and mental status changes that can affect players throughout their lives.

The prior art includes mouth guards with sensors, and sports equipment, such as helmets, equipped with sensors that are designed to detect unsafe accelerations of a user’s head. The guards, however, are not comfortable and are heavy/bulky for users to wear because they are not custom fit to the user’s teeth and do not have their electronics smoothly integrated into the guards.

The weight and bulk associated with the prior art guards is also due, in part, because of the power needed to operate the electronics. Guards that use“onboard” power sources locate the power sources on portions of the guards that extend outside of the mouth, which adds to their bulk and cause the guards to be unbalanced. The mouth guard prior art does not locate a battery in the portion of the guard held in the user’s mouth because this would increase the bulk of the guard. Further, the prior art guards do not encase the battery so if the battery leaks, the leaked material could come in contact with the wearer. The leaked material can be corrosive and/or toxic so failing to encase it can be dangerous for the wearer.

Some prior art guards also do not promptly communicate, or signal, an unsafe acceleration. Instead, they may store the sensed data for future review or, even if timely communicated, they may not have done so in an easily readable or

understandable format.

What is needed is an inexpensive, but effective, custom fitted mouth guard with safely embedded electronics and a power source that can be conformably fitted to a user’s dentition. This guard also needs to provide a rapid, clean and easily understood indication of a potentially unsafe acceleration so that remedial action can be immediately taken.

SUMMARY

In one embodiment, a mouthguard may have a first side and a second side opposite the first side, a first front flap and a second front flap separated by a forward cusp, an outer side flap separated from the second front flap by a side cusp, a first inner side flap and a second inner side flap, an electronics lobe forming a U-shape with the first front flap. The electronics lobe may have a forward wall, an upper wall transverse the forward wall, and a rear wall parallel the forward wall. The forward wall, the upper wall and the rear wall may be co-planar. An arc-shaped bite line may extend across the first side, where the bite line divides the first side into an inner portion and an outer portion. A plurality of open spaces may extend from the first side to the second side. The bite line and the electronics lobe are free from the plurality of open spaces.

In another aspect, the electronic lobe may be unitary, one piece and integrally formed with the first hemispherical front flap and the first inner side flap.

In another aspect, where the electronics lobe comprises the first side the electronics lobe and the first side are coplanar, and on the second side the electronics lobe has a step to a surface that is not coplanar with the second side. In another aspect, the electronics lobe may entirely encase both a non- replaceable accelerometer, a non-replaceable wireless transmitter connected to the accelerometer and a non-replaceable battery connected to the accelerometer and the transmitter.

In another aspect, the electronics lobe may have a ramp-like shape that thickens from a forward portion to a rear portion of the lobe.

In another aspect, a chemical sensor may be in contact with a chemically sensitive material embedded between the first side and the second side.

In another aspect, a temperature sensor may be embedded between the first side and the second side, wherein the temperature sensor and/or the accelerometer signals an electronics chip in the electronics lobe to power up or power down, wherein the power up signal is based on a sensed temperature from the temperature sensor of at least 95- 105 degrees F and the power down signal is based on a sensed temperature from the temperature sensor below 90 degrees F.

A method of forming a mouthguard may include the step of providing a first state with a first front flap, a second front flap, an outer side flap, a first inner side flap, a second inner side flap and a bite line. Each of the flaps and the bite line have first and second sides, where all of the first sides of the flaps and the bite line are coplanar with one another in a first plane and all of the second sides of the flaps and the bite line are coplanar with one another in a second plane. An electronics lobe may be connected to the first front flap, wherein a portion of the electronics lobe is not coplanar with either the first or the second sides. The method may also include locating the first and second sides of each of the first front flap, the second front flap, the outer side flap, the first inner side flap, the second inner side flap and the electronics lobe in a second state where each of the flaps and the lobe are angled with respect to the first and second planes.

In another aspect, the flaps and the lobe are moved from the first state, which is a flattened state, to the second state where the flaps and lobe are angled with respect to the bite line.

In another aspect, upper edges of the first front flap and the second front flap are located above an upper edge of the first inner side flap and the second inner side flap in the second state. In another aspect, the inner surfaces of the first front flap, the second front flap, the outer side flap and the lobe may conform, and hold their shape to, contours of outer surfaces of dentitions.

In another aspect, inner surfaces of the first inner side flap and the second inner side flap may conform to, and hold their shape to, contours of inner surfaces of dentitions.

In another aspect, an inner surface of the bite line may conform to, and holds it shape to, incisal edges and/or occluding surfaces of dentitions.

BRIEF DESCRIPTION OF THE DRAWINGS

The features of the device described herein will be better understood in the context of the detailed description in conjunction with the drawings.

Fig. 1 depicts one embodiment of a plan view of an appliance in a first state; Fig. 2 A depicts a cross-sectional side view of the appliance of Fig. 1 along lines

2A-2A;

Fig. 2B depicts a cross-sectional side view of the appliance of Fig. 1 along lines

2B-2B;

Fig. 2C depicts a cross-sectional side view of the appliance of Fig. 1 along lines

2C-2C;

Fig. 3 depicts one embodiment of a plan view of another appliance in a first state;

Fig. 4 depicts a cross-sectional side view of the appliance of Fig. 3 along lines 4-4;

Fig. 5 is a schematic perspective view of the appliance of Fig. 1 in a second state;

Fig. 6 is a schematic perspective view of the appliance of Fig. 3 in a second state;

Fig. 7 is a schematic perspective view of the appliance of Fig. 3 in the second state but with a combined, conformed battery and electronic chip lobe;

Fig. 8 is a schematic perspective view of one embodiment of an open space in an appliance;

Fig. 9 is a schematic perspective view of another embodiment of an open space in an appliance; Fig. 10A is a schematic perspective view of two open spaces in an appliance in a first state;

Fig. 10B is a schematic perspective view of two open spaces in an appliance in a second state;

Fig. 11 is a schematic depiction of the appliance of Fig. 3 in a second state on the dentition of a user;

Fig. 12 is a schematic depiction of the appliance of Fig. 1 is a second state on the dentition of a user;

Fig. 13 is a schematic plan view of another embodiment of an appliance in a first state;

Fig. 14 is a schematic plan view of an opposite side of the appliance of Fig. 13 in the first state;

Fig. 15 is a schematic perspective view of the appliance of Fig. 13 in a second state;

Fig. 16 is a schematic perspective view of the appliance of Fig. 13 in the second state;

Fig. 17 is a schematic plan view of the appliance of Fig. 13 in the second state;

Fig. 18 is a schematic perspective view of the appliance of Fig. 13 in the second state on schematic dentitions of a user; and

Fig. 19 is a schematic plan view of the appliance of Fig. 13 in the second state on schematic dentitions of a user.

DETAILED DESCRIPTION OF THE PREFERRED EMODIMENTS

It is to be understood that the device and method described herein may assume various alternative orientations and step sequences, except where expressly specified to the contrary. It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification are simply exemplary embodiments. Hence, specific dimensions, directions or other physical characteristics relating to the embodiments disclosed are not to be considered as limiting, unless expressly stated otherwise.

Turning now to Fig. 1, one embodiment of a dental appliance 10, also referred to a mouth guard herein, is depicted. A preferred embodiment of the dental appliance 10 is shown in a flattened, first state. The appliance 10 is a one-piece, unitary and integrally formed sheet of material. In one embodiment, the appliance 10 may be .25 mm to 2 mm thick and fabricated from a thermoplastic polymer matrix material. Such a material is widely available, inexpensive and readily disposable when the appliance 10 is exhausted. In the first state, the appliance 10 is rigid, inflexible and resides in a single plane.

The appliance 10 may be produced by injection molding, but other production methods are permissible. In one embodiment, the appliance 10 may be produced by 3- D printing. Alternatively, a portion of the appliance 10 may be injection molded and another portion produced by 3-D printing.

The appliance 10 comprises a first front flap 12 and a second front flap 14, which together are called a maxillary flap. A forward cusp 16 is located between the two flaps 12, 14. The cusp 16 extends inwardly into the appliance 10 at least partially dividing the first front flap 12 and the second front flap 14. The cusp 16 extends inwardly toward, but preferably does not reach, a bite line 18.

The bite line 18 is the line on the appliance 10 along which the incisal edges 20 of the incisors 22 and the tips of the occluding surfaces 24 of the posterior teeth 26 come in contact with the appliance 10, as shown in Fig. 12. Together, these edges 20 and surfaces 24 are called crowns herein. The bite line 18 is generally arch-shaped to be complementary to the arrangement of teeth in a wearer’s mouth.

A first side cusp 28 further defines the first front flap 12. The first side cusp 28 is located between the first front flap 12 and a first outer side flap 30. The first side cusp 28 extends inwardly into the appliance 10 toward the bite line 18. The first side cusp 28 may extend inwardly into the appliance 10 at the same depth as the forward cusp 16 or to a greater or lesser extent.

A second side cusp 32 further defines the second front flap 14. The second side cusp 32 is located between the second front flap 14 and a second outer side flap 34.

The second side cusp 32 extends inwardly into the appliance 10 toward the bite line 18. The second side cusp 32 may extend inwardly into the appliance 10 at the same depth as the forward cusp 16 or to a greater or lesser extent.

In the embodiment depicted in Fig. 1, a line of symmetry 36 extends from the forward cusp 16 to equally divide the appliance 10 into a first half 38 and a second half 40, which are symmetric with one another. More particularly, the line of symmetry 36 results in a mirror image between the first half 38 and the second half 40. A perimeter 42 defines the first front flap 12, the second front flap 14, and the side flaps 30, 34. The perimeter 42 is preferably rounded, or curvilinear. This curved design is envisioned to impose the least, if any, discomfort to the wearer of the dental appliance 10 since it has no sharp comers or edges to embed into the soft gum tissue.

As best seen in Figs. 2A, 2B and 2C, the appliance 10 has a first planar side 44 and a second planar side 46 in the first state. The second planar side 46 is opposite the first planar side 44. The second planar side 46 may be parallel to the first planar side 44. Therefore, in the depicted embodiment, the appliance 10 has a substantially constant uniform thickness, except as noted below.

The appliance 10 depicted in Fig. 1 has a plurality of open spaces 48 on an inner portion 50 and an outer portion 52 of the appliance 10, wherein the portions are defined by the bite line 18. The open spaces 48 may extend continuously, without interruption through the appliance 10 from the first side 44 to the second side 46, as can be appreciated in Figs. 1, 2B, and 2C.

In one embodiment, the opens spaces 48 have a cylindrical cross-section 48A, as shown in Figs. 8 and 10 A. In another embodiment, the open spaces 48 have a conical cross-section 48B, as shown in Fig. 9. In the conical embodiment, the open spaces 48B have circular cross-sections going from large to small from the first planar side 44 toward the second planar side 46. In Figs. 8 and 10A, the circular cross- sections include the openings at the sides 44, 46. The open spaces 48 in Fig. 1 are in the condition where a force has not been applied to the appliance 10.

The open spaces 48 are located in a preferred pattern as shown in Fig. 1.

Beginning with the area of the outer portion 52 of the first outer side flap 30, there is a first set of open spaces 54. Preferably, there is a first unperforated area 56 between the perimeter 42 of the appliance 10 and the first set of open spaces 54. The first unperforated area 56 extends between the first set of open spaces 54 and a rearmost portion 58 of the first half 38 of the appliance 10. The first unperforated area 56 extends from the outer portion 52 across the bite line 18 to the inner portion 50 of the appliance 10.

The first set of open spaces 54 comprise a single open space. The first set of open spaces 54 are located outboard of the bite line 18 in the outer portion 52 of the appliance 10 and on the first half 38 of the appliance 10. Moving forward from the rearmost portion 58 of the first half 38 the appliance 10 along the perimeter 42 beyond the first set of open spaces 54, a second unperforated area 60 is provided. The second unperforated area 60 extends between the first set of open spaces 54 and a second set of open spaces 62.

The second set of open spaces 62 comprises two open spaces. The two open spaces are aligned with one another. An imaginary line 64 extending through the centers of the two open spaces extends outward through the outer portion 52 and the perimeter 42. The second set of open spaces 62 are located outboard of the bite line 18 in the outer portion 52 of the appliance 10 and on the first half 38 of the appliance 10.

Moving forward from the second set of two open spaces 62 along the perimeter 42 beyond the second set of open spaces 62, a third unperforated area 66 is provided. The third unperforated area 66 extends between the second set of open spaces 62 and a third set of open spaces 68. The third unperforated area 66 is located outboard of the bite line 18 in the outer portion 54 of the appliance 10 and on the first half 38 of the appliance 10.

The third set of open spaces 68 is comprised of an array of three open spaces arranged in a line. An imaginary line 70 extending through the centers of the open spaces of the third set of open spaces 68 and the imaginary line 64 extending through the second set of open spaces 62 intersects at a point 72 outside of the perimeter 42 of the appliance 10. The imaginary lines 64, 70 are therefore not parallel with one another.

The third set of open spaces 68 are located outboard of the bite line 18 in the outer portion 54 of the appliance 10 and on the first half 38 of the appliance 10.

Moving forward from the third set of open spaces 68 along the perimeter 42, a fourth unperforated area 74 is provided. The fourth unperforated area 74 extends from the third set of open spaces 68 to a fourth set of open spaces 76.

The fourth set of open spaces 76 comprises two open spaces. The two open spaces are aligned with one another. An imaginary line 78 extending through the centers of the two open spaces extends outward through the outer portion 52 and the perimeter 42. The imaginary line 78 extending through the two open spaces is a parallel the imaginary line 64 extending through the second set of open spaces 62. The fourth set of open spaces 76 are located outboard of the bite line 18 in the outer portion 52 of the appliance 10 and on the first half 38 of the appliance 10. Moving forward from the fourth set of open spaces 76 along the perimeter 42, a fifth unperforated area 80 is provided. The fifth unperforated area 80 extends from the fourth set of open spaces 76 to a fifth set of open spaces 82.

The fifth set of open spaces 82 is comprised of two open spaces. An imaginary line 84 extending through the two open spaces of the fifth set 82 is parallel to the imaginary line 78 extending through the fourth set of open spaces 76.

The fifth set of open spaces 82 are located outboard of the bite line 18 in the outer portion 52 of the appliance 10 and on the first half 38 of the appliance 10. More particularly, the fifth set of open spaces 82 is located in the first front flap 12.

Moving from the fifth set of open spaces 82 along the perimeter 42, a sixth unperforated area 86 is provided. The sixth unperforated area 86 extends between the fifth set of open spaces 82 and a sixth set of open spaces 88. The sixth unperforated area 86 is located radially inward from the forward cusp 16 and between the forward cusp 16 and the bite line 18.

The sixth set of open spaces 88 is comprised of three arrays of open spaces arranged in a triangular pattern. A first array 90 comprises a base of the triangle. The first array 90 is located adjacent the perimeter 42 and generally parallel the perimeter 42. A second and third array 92, 94 comprises the sides of the triangle. The second and third arrays 92, 94 are positioned at acute angles with respect to the first array 90. The acute angle may be such as approximately 60 degrees.

Imaginary lines 96, 98 extending through the centers of the open spaces of the second and third arrays 92, 94 diverge from one another as they extend outwardly through the outer portion 52 and the perimeter 42.

The sixth set of open spaces 88 are located outboard of the bite line 18 in the outer portion 52 of the appliance 10 and on the second half 40 of the appliance 10.

Each of the arrays 90, 92, 94 of the sixth set of open spaces 88 is comprised of three individual open spaces.

The second array 92 of the sixth set of open spaces 88 is oriented parallel to the fourth and fifth sets of open spaces 76, 82.

Located between the sixth set of open spaces 88 and a seventh set of open spaces 100, an seventh unperforated area 102 is provided. The seventh unperforated area 102 is between the forward cusp 16 and the bite line 18 in the outer portion 52 of the appliance 10. The seventh set of open spaces 100 is comprised of three arrays of open spaces arranged in a triangular pattern. A first array 104 comprises a base of the triangle. The first array 104 is located adjacent the perimeter 42 and generally parallel the perimeter 42. A second and third array 106, 108 comprise the sides of the triangle. The second and third arrays 106, 108 are positioned at acute angles with respect to the first array 104. The acute angle may be such as approximately 60 degrees.

Imaginary lines 110, 112 extending through the centers of the open spaces of the second and third arrays 106, 108 diverge from one another as they extend outwardly through the outer portion 52 and the perimeter 42.

The seventh set of open spaces 100 is located outboard of the bite line 18 in the outer portion 52 of the appliance 10 and on the second half 40 of the appliance 10.

Each of the arrays 104, 106, 108 of the seventh set of open spaces 100 is comprised of three individual open spaces.

The second array 106 of the seventh set of open spaces 106 is oriented parallel to the second array 92 in the sixth set of open spaces 88. The third array 108 of the seventh set of open spaces 100 is oriented parallel the third array 94 in the sixth set of open spaces 88.

Moving downwardly from the seventh set of open spaces 100 along the perimeter 42, an eighth unperforated area 114 is provided. The eighth unperforated area 114 extends between the seventh set of open spaces 100 and an eighth set of open spaces 116. The eighth unperforated area 114 is located radially inward from the perimeter 42 and between the perimeter and the bite line 18.

The eighth set of open spaces 116 comprises two open spaces. The two open spaces are aligned with one another. An imaginary line 118 extending through the centers of the two open spaces extends outward through the outer portion 52 and the perimeter 42. The imaginary line 118 is parallel to the imaginary line 70 extending through the third array of open spaces 108 in the seventh set of open spaces 104. The eighth set of open spaces 116 are located outboard of the bite line 18 in the outer portion 52 of the appliance 10 and on the second half 40 of the appliance 10.

Moving downward from the eighth set of open spaces 116 along the perimeter 42, a ninth unperforated area 120 is provided. The ninth unperforated area 120 extends between the eighth set of open spaces 116 and a ninth set of open spaces 122. The ninth set of open spaces 122 comprise two open spaces. The two open spaces are aligned with one another. An imaginary line 124 extending through the centers of the two open spaces extends outward through the outer portion 52 and the perimeter 42. The imaginary line extending through ninth set of open spaces 122 is parallel the imaginary line 118 extending through the eighth set of open spaces 116. The ninth set of open spaces 122 are located outboard of the bite line 18 in the outer portion 52 of the appliance 10 and on the second half 40 of the appliance 10.

Moving rearward from the ninth set of open spaces 122 along the perimeter 42, a tenth unperforated area 126 is provided. The tenth unperforated area 126 extends between the ninth set of open spaces 122 and a tenth set of open spaces 128.

The tenth set of open spaces 128 comprises three open spaces. The three open spaces are aligned with one another. An imaginary line 130 extending through the centers of the three open spaces extends outward through the outer portion 52 and the perimeter 42. The imaginary line 130 is not parallel to the imaginary lines 118, 124 extending through the eighth or ninth sets of open spaces 116, 122. The tenth set of open spaces 128 are located outboard of the bite line 18 in the outer portion 52 of the appliance 10 and on the second half 40 of the appliance 10.

Moving rearward from the tenth set of open spaces 128 along the perimeter 42, an eleventh unperforated area 132 is provided. The eleventh unperforated area 132 extends between the tenth set of open spaces 128 and an eleventh set of open spaces 134.

The eleventh set of open spaces 134 comprises two open spaces. The two open spaces are aligned with one another. An imaginary line 136 extending through the centers of the two open spaces extends outward through the outer portion 52 and the perimeter 42. The imaginary line 136 is parallel to the imaginary lines 118, 124 extending through the eighth and ninth sets of open spaces 116, 122. The eleventh set of open spaces 134 are located outboard of the bite line 18 in the outer portion 52 of the appliance 10 and on the second half 40 of the appliance 10.

The imaginary line 126 and the imaginary line 130 intersect at a point 137 outside of the perimeter of the appliance. The lines 136, 130 are therefore not parallel one another.

Moving rearward from the eleventh set of open spaces 134 along the perimeter 42, a twelfth unperforated area 138 is provided. The twelfth unperforated area 138 extends between the eleventh set of open spaces 134 and a twelfth set of open spaces 140.

The twelfth set of open spaces 140 comprises a single open space. The single open space is located outboard of the bite line 18 in the outer portion 52 of the appliance 10 and on the second half 40 of the appliance 10.

Moving downward from the twelfth set of open spaces 140 along the perimeter 42, a thirteenth unperforated area 142 is provided. The thirteenth unperforated area 142 extends from the twelfth set of open spaces 140 to a rearmost portion 144 of the second half 40 of the appliance 10. The thirteenth unperforated area 142 extends from the outer portion 52 across the bite line 18 to the inner portion 52 of the appliance 10.

Inboard of the bite line 18, a thirteenth set of open spaces 146 are provided in the inner portion 52 of the appliance 10. The thirteenth set of open spaces 146 are located in a triangular pattern.

The thirteenth set of open spaces 146 are located on a rearward side 148 of a battery lobe 150. On a forward side 152 of the battery lobe 150, a fourteenth set of open spaces 154 is provided. The fourteenth set of open spaces 154 are located in a triangular pattern. The fourteenth set of open spaces 154 are provided in the inner portion 50 of the appliance 10 on the second half 40 of the appliance 10. There are no open spaces between the thirteenth set of open spaces 146 and the fourteenth set of open spaces 154 on the inner portion 50 of the second half 40 of the appliance 10.

Moving toward the symmetry line 36 from the fourteenth set of open spaces 154 is a fourteenth unperforated area 156. The fourteenth unperforated area 156 extends from the bite line 18 to the perimeter 42 in the inner portion 50 of the second half 40 of the appliance 10.

Moving toward the symmetry line 36 from the fourteenth unperforated area 156, a fifteenth set of perforations 158 is provided. The fifteenth set of perforations 158 comprises an inner row 160 and an outer row 162 of individual open spaces. The inner row 160 is closest to the bite line 18 while the outer row 162 is closest to the perimeter 42. Both rows 160, 162 are in the inner portion 50 but they span the symmetry line 36 and are equally divided by the symmetry line 36. The inner and outer rows 160, 162 are parallel one another, but the inner row 160 is advanced forward of the outer row 162. In the depicted embodiment, the inner row 160 is advanced at least the diameter of one individual open space beyond the outer row 162 in the forward direction. The inner row 160 has two more open spaces than the outer row 162, but otherwise the individual open spaces are aligned so that imaginary lines 164, 166 extending through the aligned open spaces of the two rows 160, 162 are parallel the symmetry line 36.

Moving backwards along the perimeter 42 from the fifteenth set of open spaces 158, a fifteenth unperforated area 168 is provided. The fifteenth unperforated area 168 is located between the perimeter 42 and the bite line 18 in the inner portion 50 of the appliance 10 on the first half 38 of the appliance 10. Further, the fifteenth unperforated area 168 is located between the fifteenth set of open spaces 158 and a sixteenth set of open spaces 170.

The sixteenth set of open spaces 170 are located on a forward side 172 of a chip lobe 174. The sixteenth set of open spaces 170 are located in a triangular pattern. The sixteenth set of open spaces 170 are provided in the inner portion 50 of the appliance 10 on the first half 38 of the appliance 10.

A seventeenth set of open spaces 176 are located on a rearward side 178 of the chip lobe 174. The seventeenth set of open spaces 176 are located in a triangular pattern. There are no open spaces between the sixteenth set of open spaces 170 and the seventeenth set of open spaces 176 on the inner portion 50 of the first half 38 of the appliance 10.

As made clear by the above description, the appliance 10 is symmetrical about the line of symmetry 36. Thus, the first, second, third, fourth, fifth, sixth, sixteenth and seventeenth, sets of open spaces 54, 62, 68, 76, 82, 88, 170, 176 are symmetrical with the twelfth, eleventh, tenth, ninth, eighth, seventh, fourteenth and thirteenth sets of open spaces, 140, 134, 128, 122, 116, 100, 154, 146 respectively. The fifteenth set of open spaces 158 is symmetrical about itself along the line of symmetry 36.

In the embodiment depicted in Fig. 1, the bite line 18 is free of open spaces.

The appliance 10 depicted in Fig. 1 and described above has been found to have a superior force absorbing design. It has been found that arrays of open spaces comprised of three open spaces where the arrays are arranged in a triangular pattern is particularly effective in absorbing and dissipating force. Thus, it is a preferred part of the design for the sixth and seventh sets of open spaces 88, 100 to be arranged in the first front flap 12 and the second front flap 14, where a force impact is likely to be experienced. It is also a preferred part of the design that sets of open spaces are located parallel one another. It has been found by locating the sets of open spaces in these orientations that force absorption and dissipation is increased compared with prior art designs.

The sets of open spaces, their orientation and their location, assist in fitting the appliance, saliva flow and unhindered breathing and talking.

Fig. 10B depicts two of the open spaces 48 A of Fig. 1 but subject to a force.

The force deforms the open spaces 48A resulting in dissipation of the force. In Fig.

10B, the open spaces 48B are deformed as a result of one kind of force from a circular cross-section to an oval cross-section. The shape change of the open spaces 48A expends some or all of the energy of the force traveling through the appliance 10.

In one example, because the appliance 10 maintains a constant volume, when a force encounters an open space 48, the deformed open space 48 compresses the adjacent open spaces 48. The combination of deformation and compression of the open spaces 48 results in force dissipation.

One kind of force, such as caused by a shearing action, may travel through the appliance 10 in a wave or waves. The waves may travel along an outer surface of the appliance 10 and/or through the appliance 10.

Another kind of force is a force that is normal to the appliance 10. The normal force can be applied substantially at once, it can be repeated, and/or it can increase or decrease in intensity.

While Fig. 10B depicts the two open spaces 48 A both deformed to dissipate a force, it can be appreciated that only one or the other might be deformed. Further, while Fig. 10B depicts the open spaces 48 A deformed into oval cross-sections, they may be deformed into other shapes and/or the shapes do not have to match one another.

The open spaces 48 are located in the appliance 10 to maximize tensile strength of the appliance 10 without exposing any of the protected dental surfaces to the unprotected teeth on the opposite jaw. The locations of the open spaces 48 also optimize saliva flow around the dentitions, which improves comfort. More particularly, saliva can be sucked through the open spaces 48. The open spaces 48 also function to improve breathing by allowing the appliance 10 to be thinner and thus take up less space in the mouth. Based on the foregoing, it can be appreciated that the appliance material, the location of that material on the wearer’s dentition as described herein, the open spaces, and/or plastic and/or elastic deformation effectively diminishes forces transmitted in the axial (normal) direction, as well as in the horizontal direction, with respect to the dental surfaces.

With reference back to Fig. 1, the chip lobe 174 houses an embedded electronic chip 180. The chip 180 may comprise the embedded detection system. The electronic chip 180 may be entirely encased within the lobe 174. Being encased, there is no portion of the chip 180 that is exposed to the user’s dentitions or mouth. In other words, the same unitary, integrally formed and one-piece polymeric material of the appliance 10 encases the electronic chip 180.

As can be appreciated in Figs. 2A, 2B and 2C, the chip lobe 174 maintains the first planar side 44 and the second planar side 46 so that the appliance 10 maintains its constant thickness.

The chip lobe 174 laterally expands the perimeter 42 of the appliance 10 in its first state. More particularly, the chip lobe 174 extends the inner portion 50 of the first half 38 of the perimeter 42 inwardly. The chip lobe 174 extends toward the battery lobe 150

Figs. 3 and 4 depict an alternative embodiment of an appliance 182 with only a single lobe 184. The appliance 182 has the features of appliance 10 except as noted herein. For example, the appliance 182 is symmetrical except for the lobe 184 While the single lobe 184 is shown on one side of the appliance 182, the lobe 184 can instead be on the other side. Preferably, the single lobe 184 is in the same location as either the chip lobe 174 or the battery lobe 150 of the appliance of Figs. 1 and 2. In the case of a single lobe 184, the electronic chip 180 and a battery 188 are stacked on one another. More particularly, the chip 180 and battery 188 are in direct touching stacked contact with one another. The chip 180 and battery 188 may be individual components, or they may be unitarily and integrally formed with one another.

Additional polymeric material 190 may be added above and/or below the combined chip/battery 180, 188 to provide additional cushioning between the appliance 182 and the soft mouth tissues of the user. The additional material 190 may also be added to the chip and/or battery lobes depicted in Figs. 1 and 2. By way of example, a dome of polymeric material 190 is located on the first planar side 44 above the combined battery and chip 180, 188. The dome 190 is thickest radially outward from the center of the combined battery and chip 180, 188 and the dome 190 tapers to the edges of the combined battery and chip 180, 188. As can be appreciated in Fig. 11, the dome 190 is in contact with the lingual side 192 of the gums adjacent the molars when it is in a second state and the appliance 182 is conformed to the dentitions of a user.

In one example, the entire thickness of the appliance 10, 182 may be increased, or it may be increased in certain areas, as noted above. 3-D printing may be used to increase the thickness of the appliance 10, 182 to 1.6 - 3 mm by depositing a thermoplastic polymer matrix on top of an existing layer.

The appliance 182 in the embodiment depicted in Figs. 3 and 4 has the same features described for Figs, 1 and 2A-C except as noted above. Additionally, the appliance 182 in Figs. 3 and 4 has a modified pattern of open spaces. Namely, as shown in Fig. 3, the patterns of open spaces between the perimeter 42 and the bite line 18 in the inner portion 50 are modified. In this embodiment, beginning from the thirteenth unperforated area 142 at the rearmost portion 144 and moving forward two rows of open spaces are provided. The first row of open spaces 194 is adjacent the perimeter 42 while the second row 196 is adjacent the bite line 18. The individual open spaces of the rows 194, 196 are offset from one another so that the open spaces of the first row 194 are located between the open spaces of the second row 196.

Continuing to move forward about the perimeter 42 of the inner portion 50, three rows of open spaces are provided in the inner portion 50. The three rows are divided between the first half 38 and the second half 40 of the appliance 182. A first row 198 is provided adjacent the perimeter 42. The first row 198 has the fewest open spaces compared to the other rows.

A second middle row 200 is located between the first row 198 and a third row 202. The individual open spaces of the first row 198 are positioned between the individual open spaces of the second row 200. The second row 200 has one additional open space compared with the first row 198.

The third row 202 is the row nearest of the three rows to the bite line 18. The third row 202 has an additional open space compared with the second row 200. The individual open spaces of the second row 200 are located between the individual open spaces of the third row 202.

In the first state of the appliance 182, imaginary lines 204, 206, 208 extending through each of the rows 198, 200, 202 are parallel one another.

Continuing rearwardly from the three rows of open spaces 198, 200, 202, a grouping of four open spaces 210 is provided in the inner portion 50 on the first half 38.

The combined battery and electronic chip 188, 180 separates the grouping of four open spaces 210 with a grouping of five open spaces 212 in the inner portion 50 of the first half 38. The area 214 separating the four open spaces 210 with the grouping of five open spaces 212 is free of open spaces and comprises an unperforated area. In addition, the areas between the open spaces noted above are unperforated areas.

Regardless of the embodiment of the appliance, the electronic chip 180 may be comprised of several elements. The elements may include a three axis accelerometer, a transmitter, a temperature sensor, and associated circuitry. An accelerometer 216, a transmitter 218 and a temperature sensor 220 are schematically depicted on the chip 180 in the appliance 10. These same items can be located in the chip of any other appliance described herein.

The accelerometer 216 may be used to monitor acceleration as experienced by the wearer in the x, y and z planes. Data from the accelerometer 216 may be sent to the transmitter 218. The transmitter 218 may use a wireless technology standard for exchanging data over short distances, such as a Bluetooth enabled device. The transmitter 218 preferably immediately transmits the sensed acceleration data without delay.

At least one receiver that is physically separate from the transmitter 218 can be provided that promptly receives the transmitted acceleration data. A receiver 222 is schematically depicted in Fig. 1. It is expected that coaches, medical personnel, the wearer and/or parents can have a receiver 222. The receiver 222 can present the data in real time/contemporaneously of the sensed acceleration experienced by the wearer to determine if the acceleration has exceeded a preset threshold value. The value may be one that is set below where potential head trauma may occur. If the value is reached, the receiver 222 can provide a notification that the wearer has reached the preset value and that the wearer should be examined for injury. In addition, the receiver 222 can provide information on when the preset value was reached, such as with a date and time stamp. It can be appreciated that a single receiver 222 can receive signals from one or more transmitters 218 so that an entire team can be individually or simultaneously monitored. Multiple receivers may also be used to receive individual transmitted signals or a plurality of signals. The chip 180 can also do the comparison step with the preset value.

The receiver 222 can be adapted to control the data provided by the appliance 10. Namely, through the receiver 222, the threshold values for accelerations can be modified and the timing for when the data is received by the receiver 222 can be modified.

An embedded chemical/electrical sensor 224 can be included with the chip 180, as shown in Fig. 1, or it can be physically separate from the chip 180. The sensor 224 may comprise an embedded detection system. In either case, the sensor 224 can be used to process electrical signals from chemically sensitive, electrically conductive polymer materials located inside one or more of the open spaces 48. The materials may be such as patches 226 of chemically sensitive materials entirely circumferentially extending, such as a ring, about an inner diameter of one or more open spaces 48. As shown in Fig. 8, the patch 226 is a continuous circumferentially extending ring located approximately midway through the open space 48. The patches 226 may also extend only about a portion of the inner diameter of one or more open spaces 48. The patches 226 may be located along the entire length of the open space 48, just at one end, at both ends or just in a portion of the open space 48.

Preferably, as shown in Fig. 8, the open space 48 extends from the first side 38 of the appliance 10 to the second side 40 of the appliance 10 so that air and/or saliva can enter from either end and be detected by the patch 226. In this embodiment, the open space 48A is depicted as cylindrical.

However, as shown in Fig. 9, one or more open spaces 48B, containing a patch 226 or not containing a patch, may not extend from the first side 38 of the appliance 10 to the second side 40 of the appliance 10. Instead, the open spaces 48B may have an end 228 that is closed, or at least restricted. In these cases, the air and/or saliva becomes at least temporarily trapped in the open space 48B. These open spaces 48B with closed/restricted ends 228 may be used where patches 226 need additional time to process the air and/or saliva. The patch 226 in Fig. 9 is depicted at the closed/restricted end 228 of the open space 48B, but it may be located as noted above in the discussion of Fig. 8.

In the embodiment where the open spaces 48 A are continuous from the first side 44 to the second side 46, or where the open spaces 48B are closed, the open spaces may also have a conical shape 48B as shown in Fig. 9.

As noted above, the appliance 10, 182 may be constructed of a thermoplastic polymer matrix. The matrix is non-conductive so that it will not interfere with the electrical signals from the chemically sensitive materials.

The chemically sensitive materials change their electrical conductivity when they come in contact with certain molecules that are contained in the mouth, saliva or breath. For example, the chemically sensitive materials could detect glucose or ketones in wearers. Glucose can be helpful to identify or monitor users with diabetes conditions. Other potential detectable molecules include, but are not limited to, nitric oxide, carbon dioxide, and oxygen. In addition, the materials can detect breathing patterns, such as, but not limited to, air exchange frequency and/or quantity of air.

The materials may also detect change in temperature of the saliva or breath.

The temperature detection can be by the materials and/or by the temperature sensor 220. In either case, when the appliance 10 detects a change in temperature of the saliva or breath in the mouth, the data can be sent from the sensor 220, or the materials, to the chip 180 and/or transmitter 218. The transmitter can send it to the receiver 222 for evaluation.

Temperature changes may be helpful in determining if the wearer is

experiencing hyperthermia or hypothermia. For example, normal mouth temperatures ranges from approximately 92 to 101 degrees F. A change in that range from 2-4 degrees F can provide an early indication the wearer should have their core temperature checked, or other tests made.

The appliance 10 can also use the materials and/or temperature sensor 220 to time the device out. Namely, if the sensor detects a temperature below a typical user temperature, such as between 92 and 101 degrees F, then the chip can signal the other components to go into hibernation mode to conserve battery life. Upon the materials and/or sensor detecting the same predetermined range, the chip can wake the appliance back up. The change in electrical conductivity can be detected by the chemical/electrical sensor 224. The sensor 224 transmits the sensed data to the chip 180 where it can be compared to a preset value. When the preset value is met, the transmitter 218 sends a signal to the receiver 222 that the wearer should be examined. The transmission of the signal from the sensor 224 to the chip 180 may be through a wire or an electrically conductive polymer, as schematically depicted in Fig. 1. The comparison step may also be made by the receiver.

The sensor 224 may also be set up to detect potential dehydration issues, or other performance/health related issues of the user.

The electronic chip 180 maybe electrically powered by the battery 188. Like the chip 180, the battery 188 may be housed in the battery lobe 186.

The battery 188 is entirely encased with in the lobe 186. In other words, the same unitary, integrally formed and one-piece polymeric material of the appliance 10 encases the battery 188.

The battery lobe 186 laterally expands the perimeter 42 of the appliance 10. More particularly, the battery lobe 186 extends the inner portion 50 of the second half 40 of the perimeter 42 inwardly when the appliance 10 is in the first state. The battery lobe 186 and the chip lobe 174 may be symmetric with one another. Like the chip lobe 174, the battery lobe 186 does not affect the thickness of the appliance 10.

Both the battery 188 and the electronic chip 180 are hermetically sealed within the polymeric material. By being encased, the battery 188 and the electronic chip 180 cannot come into direct contact with any part of the wearer’s mouth. This protects the battery 188 and the chip 180 from hard surfaces (e.g., teeth) and fluids (e.g., saliva) in the mouth. And, it protects the mouth from the chip 180 and the battery 188 which may have sharp edges, capacitors, resistors, and chemicals.

As can be appreciated at least by Figs. 2A and 2B the battery 188 and the chip 180 have planar upper 232, 236 and lower 234, 238 surfaces that are parallel with the first and second sides 44, 46 of the appliance 10 while it is in the first state.

Based on the above, the battery 188 is not replaceable. It may be rechargeable, however, by placing the appliance 10 on a charging station.

A charging station (not shown) may have a primary coil that induces a current in a secondary coil (not shown) in the appliance 10 to charge the battery 188 in the i

appliance 10 by electromagnetic inductive charging. Whether replaceable or not, the charge state of the battery 188 can be determined by the electronic chip 180 and conveyed to the transmitter 218, where its state can be received by the receiver 222 and displayed.

The battery 188 may be rigid or it may be flexible. A flexible battery can be advantageous as it can be bent and shaped, in some cases repeatedly, as the appliance 10 is shaped to the contours of the mouth of the wearer, which is described in additional detail below. The battery 188, whether rigid or flexible, can be such as oval, circular or it may have an irregular shape so as to conform to the mouth of the user.

Embodiments of a rigid battery 188 are shown in Figs. 5 and 6. In these embodiments, the batteries 188 remain planar despite the fact that they have been moved to the second state. Embodiments of a flexible battery 188 are shown in Figs. 7 and 12. In these embodiments the batteries 188 are curved to have a concave 240 and a convex 242 surface. As shown in Fig. 7, the chip 180 may have complementary concave and convex surfaces.

The electronic chip 180 can be programmed such that when the accelerometer 216 is not sensing accelerations for a predetermined amount of time, the chip 180, accelerometer 216 and sensors 220, 224 can be put into hibernation mode to conserve battery life.

The battery 188 and the electronic chip 180 are electrically connected together through a conduit 244 like a thin wire, such as copper or a copper alloy, and/or through a ribbon of electrically conductive polymer. In any case, it is preferred that the conduit 244 be entirely encased within the appliance 10.

Fig. 1 depicts one embodiment of the conduit 244. The conduit 244 is directed connected to each of the battery 188 and the chip 180. The conduit 244 extends in an arc-shape in the inner portion 50, between the perimeter 42 and the bite line 18. The arc-shape extends in a single plane parallel with the first side 44 and the second side 46, which can be appreciated from the figures, such as Fig. 2C. In the depicted

embodiment, the conduit 244 extends between the inner and outer rows 160, 162 of open spaces of the fifteenth set 158.

The temperature sensor 220 causes the electronic chip 180 to wake up, or energize, once the sensor 220 senses a predetermined temperature. In other words, the chip 180, the sensor 220, accelerometer 214, transmitter 218 and battery 188 can be dormant until woken up. This preserves the battery life to the maximum extent. The predetermined temperature may be such as 60 degrees Celsius, which can be appreciated based on the method of using the appliance 10 described in detail below. The temperature sensor 220 is thus useful for maintaining the battery life such as during shipment or during the time after the appliance 10 has been manufactured but before it is used by the wearer.

Turning now to Figs. 13-19, one embodiment of a dental appliance 260, also referred to a mouth guard herein, is depicted. A preferred embodiment of the dental appliance 260 is shown in a flattened, first state in Figs. 13-14. The appliance 260 is a one-piece, unitary and integrally formed sheet of material. In one embodiment, the appliance 260 may be .25 mm to 2 mm thick and fabricated from a thermoplastic polymer matrix material. Such a material is widely available, inexpensive and readily disposable when the appliance 260 is exhausted.

The appliance 260 may be produced by injection molding, but other production methods are permissible.. In one embodiment, the appliance 260 may be produced by 3-D printing. Alternatively, a portion of the appliance 260 may be injection molded and another portion produced by 3-D printing.

The appliance 260 comprises a first front flap 262 and a second front flap 264, which together are called a maxillary flap. A forward cusp 266 is located between the two flaps 262, 264. The cusp 266 extends inwardly into the appliance 260 at least partially dividing the first front flap 262 and the second front flap 264. The cusp 266 extends inwardly toward, but preferably does not reach, a bite line 268. The cusp 266 may have a Y-shape.

The bite line 268 is the line on the appliance 260 along which the incisal edges 270 of the incisors 272 and the tips of the occluding surfaces 274 of the posterior teeth 276 come in contact with the appliance 260, as shown in Figs 18-19. Together, these edges 270 and surfaces 274 are called crowns herein. The bite line 268 is generally arch-shaped to be complementary to the arrangement of teeth in a wearer’s mouth.

Referring back to Figs. 13-14, a first side cusp 278 further defines the first front flap 262. The first side cusp 278 is located between the first front flap 262 and a first outer side flap 280. The first side cusp 278 may extend at least partially inwardly into the appliance 260 toward the bite line 268, but it does not reach the bite line 268. The first side cusp 278 may extend inwardly into the appliance 260 at the same depth as the forward cusp 266 or to a greater or lesser extent. The first side cusp 278 may also be comprised of a linear portion 280.

The linear portion 280 may transition to an electronics lobe 282. The lobe 282 may also be deemed a first outer side flap for the appliance 260. In the depicted embodiment, the lobe 282 may be generally square in shape. The lobe may have a forward wall 284. The forward wall 284 may extend generally linearly. In the first state of the appliance 260 shown in Figs. 13-14, the forward wall 284 may form a U- shape with the first front flap 262. The first front flap 262 may be curved while the forward wall 284 is linear.

In one embodiment, the forward wall 284 transitions to an upper wall 286. The transition preferably comprises a smooth curve. A smooth curved transition reduces the likelihood that the transition will irritate or interfere with the soft tissues in the mouth of a user. The upper wall 286 extends generally perpendicular to the forward wall 284 in the first state. The upper wall 282 also extends rearwardly in a generally linear fashion.

The depicted embodiment shows the upper wall 286 transitioning to a rear wall. The rear wall 288 extends generally perpendicularly to the upper wall 286, and generally parallel the forward wall 282. The rear wall 288 may be generally linear, however, the transition between the rear wall 288 and the upper wall 286 may be a curved transition for the same reasons mentioned above. In the first state, the forward wall, the upper wall and the rear wall may be co-planar.

The lobe 282 may be unitary, one piece and integrally formed with the appliance 260. In an embodiment, the electronics lobe 282 is unitary, one piece and integrally formed with the first front flap 262 and a first inner side flap 292.

In one embodiment, the lobe 282 may be separately formed from the appliance 260, but then the lobe 282 is welded, such as sonically welded, to the appliance 260. Other methods may be used to connect the lobe 282 to the appliance 260, but regardless of the method selected, it is preferred that the connection results in a seamless connection. The lobe 282 may also be removable with respect to the appliance 260.

The rear wall 288 defines a first end portion 290 of the appliance 260. The first end portion 290 uses a smooth curve (smooth for the reasons stated above) to transition to the first inner side flap 292. The first inner side flap 292 may have a convex shape, bowed away from the batery and chip lobe 282. The first inner side flap 292 extends into the appliance 260 to a central portion 294.

The central portion 294 may have a concave shape that bows into the appliance 260. The central portion 294 may be equally bisected by a line 296 extending through the forward cusp 266. The concave shape is smooth, continuous and without sharp comers/edges so that it does not cause irritation with soft mouth tissues.

The central portion 294 may transition to a second inner side flap 298 via a smooth curve. The second inner side flap 298 may have a convex shape, bowed toward the first inner side flap 292. The second inner side flap 298 extends away from the central portion 294 to a second end portion 300.

The second end portion 300 may comprise a rounded area of the appliance 260. The second end portion 300 results in the tapering down of the second inner side flap 298 and a second outer side flap 302.

The second outer side flap 302 may have a convex shape where it is extending away from the second inner side flap 298 as the second outer side flap 302 extends away from the second end portion 300 of the appliance 260.

The second outer side flap 302 extends to a second side cusp 304. The second side cusp 282 is located between the second front flap 264 and the second outer side flap 302. The second side cusp 304 extends inwardly into the appliance 260 toward the bite line 268, but stops before reaching the bite line 268. The second side cusp 282 may extend inwardly into the appliance 260 at the same depth as the forward cusp 266 or to a greater or lesser extent. The second side cusp 304 may have a V-shape.

The first front flap 262, the first side cusp 278, the lobe 282, the first end portion 290, the first inner side flap 292, the central portion 294, the second inner side flap 298, the second end portion 200, the second outer side flap 302, the second side cusp 304, the second front flap 264 and the forward cusp 266 together form a perimeter 306 of the appliance 260. The perimeter 306 is preferably rounded, or curvilinear. This curved design is envisioned to impose the least, if any, discomfort to the wearer of the dental appliance 260 since it has no sharp comers or edges to embed into the soft gum tissue of the user.

As best seen in Figs. 13 and 14, the appliance 260 has a first planar side 308 and a second side 310 in the first state. The second side 310 is opposite the first planar side 308. The second side 310 may be generally parallel to the first planar side 308. Therefore, in the depicted embodiment, the appliance 260 has a substantially constant uniform thickness, except as noted below.

The appliance 260 has a plurality of open spaces 312 on an inner portion 314 and an outer portion 316 of the appliance 260 where the portions 314 and 316 are defined by the bite line 268. The open spaces 312 extend through the appliance 260 from the first side 308 to the second side 310, as can be appreciated in Figs. 13-14. The open spaces 312 may have the cross-sections discussed above for the open spaces 48,

48 A, 48B. Preferably, the open spaces 312, except as noted herein, extend from the first side 308 to the second side 310 in a continuous, uninterrupted fashion.

The open spaces 312 are located in a preferred pattern as shown in the figures. This pattern includes both areas where there are open spaces 312 as well as where there are no open spaces 312.

Beginning with the lobe 282, on the outer portion 316 of the appliance 260, it is preferred that no open spaces 312 are located in this area. The absence of open spaces 312 extends from the first end portion 290 of the appliance 260 through the lobe 282 to adjacent the first side cusp 278. This area may be designated a first unperforated area 318.

In the outer portion 316 approximately inward from the first side cusp 278, a first set of open spaces 320 is provided. The first set of open spaces 320 comprise two open spaces that are aligned with one another. The first set of open spaces 320 are located outboard of the bite line 268 in the outer portion 316 of the appliance 260. An imaginary line 321 extending through the centers of the two open spaces 320 extends outward through the perimeter 306.

Moving forward from the first set of open spaces 320, a second unperforated area 322 is provided. The second unperforated area 322 extends between the first set of open spaces 320 and a second set of open spaces 324in the outer portion 316 of the appliance 260.

The second set of open spaces 324 comprises two open spaces. The two open spaces 324 are aligned with one another. An imaginary line 326 extending through the centers of the two open spaces extends outward through the perimeter 306. The second set of open spaces 324 are located outboard of the bite line 268. The imaginary lines 321, 326 maybe parallel one another. Moving forward from the second set of two open spaces 324 along the perimeter 306 beyond the second set of open spaces 324, a third unperforated area 328 is provided. The third unperforated area 328 extends between the second set of open spaces 324 and a third set of open spaces 330. The third unperforated area 328 is located outboard of the bite line 258 in the outer portion 316.

The third set of open spaces 330 is comprised of three arrays of open spaces arranged in a triangular pattern. A first array 332 comprises a base of the triangle. The first array 332 is located adjacent the perimeter 306. A second and third array 334, 336 comprises the sides of the triangle. The second and third arrays 334, 336 are positioned at acute angles with respect to the first array 332. The acute angle may be such as approximately 60 degrees.

Imaginary lines 338, 340 extending through the centers of the open spaces of the second and third arrays 334, 336 diverge from one another as they extend outwardly through the perimeter 306. Imaginary line 338 may be parallel imaginary lines 321, 326.

Each of the arrays 332, 334, 336 of the third set of open spaces 330 is comprised of three individual open spaces.

Moving along the perimeter 306, between the third set of open spaces 330 and a fourth set of open spaces 342, and inboard of the forward cusp 266, a fourth

unperforated area 344 is provided. The fourth unperforated area 344 extends from the third set of open spaces 330 to the fourth set of open spaces 342 in the outer portion 316.

The fourth set of open spaces 342 is comprised of three arrays of open spaces arranged in a triangular pattern. A first array 346 comprises a base of the triangle. The first array 346 is located adjacent the perimeter 306. A second and third array 348, 350 comprises the sides of the triangle. The second and third arrays 348, 350 are positioned at acute angles with respect to the first array 346. The acute angle may be such as approximately 60 degrees.

Imaginary lines 338, 340 extending through the centers of the open spaces of the second and third arrays 352, 354 diverge from one another as they extend outwardly through the perimeter 306. Imaginary lines 338, 340, 352, 354 are not parallel one another. Each of the arrays 346, 348, 350 of the fourth set of open spaces 342 are comprised of three individual open spaces.

Moving along the perimeter 306 in the outer portion 316, between the fourth set of open spaces 342 and a fifth set of open spaces 356, a fifth unperforated area 358 is provided. The fifth unperforated area 358 extends from the fourth set of open spaces 342 to the fifth set of open spaces 356.

The fifth set of open spaces 356 comprises two open spaces. The two open spaces are aligned with one another. An imaginary line 360 extending through the centers of the two open spaces extends outward through the perimeter 306. The imaginary line 360 extending through the two open spaces is parallel the imaginary line 354 extending through the open spaces of the third array 350 of the fourth set of open spaces 342 . The fifth set of open spaces 356 is located outboard of the bite line 268.

Moving forward from the fifth set of open spaces 356 along the perimeter 306 in the outer portion 316, a sixth unperforated area 362 is provided. The sixth unperforated area 362 extends from the fifth set of open spaces 356 to a sixth set of open spaces 364.

The sixth set of open spaces 364 is comprised of two open spaces. An imaginary line 366 extending through the two open spaces of the sixth set 364 is parallel to the imaginary line 360 extending through the fifth set of open spaces 360.

The sixth set of open spaces 364 are located outboard of the bite line 268 and inboard of the second side cusp 304.

Moving from the sixth set of open spaces 364 along the perimeter 306 in the outer portion 316, a seventh unperforated area 368 is provided. The seventh

unperforated area 368 extends between the sixth set of open spaces 364 and a seventh set of open spaces 370. The seventh unperforated area 368 is located radially inward from the perimeter 306 and outboard the bite line 268.

The seventh set of open spaces 370 is comprised of three open spaces arranged in a line. An imaginary line 372 extending through the centers of the opens spaces of the seventh set of open spaces 370 is not parallel the imaginary line 366.

Moving downwardly from the seventh set of open spaces 370 along the perimeter 306 in the outer portion 316, an eighth unperforated area 374 is provided.

The eighth unperforated area 374 extends between the seventh set of open spaces 370 and an eighth set of open spaces 376. The eighth unperforated area 374 is located radially inward from the perimeter 306 and between the perimeter 306 and the bite line 268.

The eighth set of open spaces 376 comprises two open spaces. The two open spaces are aligned with one another. An imaginary line 378 extending through the centers of the two open spaces extends outward through the perimeter 306. The imaginary line 378 may be parallel to the imaginary line 366 extending through the sixth array of open spaces 364. The eighth set of open spaces 376 are located outboard of the bite line 268 but inboard of the perimeter 306.

Moving downward from the eighth set of open spaces 376 along the perimeter 306 in the outer portion 316, a ninth unperforated area 380 is provided. The ninth unperforated area 380 extends between the eighth set of open spaces 376 and a ninth set of open spaces 382.

The ninth set of open spaces 382 comprises a single open space. The single open space is located outboard of the bite line 268 but inboard of the perimeter 306.

Moving downward from the ninth set of open spaces 382 along the perimeter 306 in the outer portion 316 a tenth unperforated area 384 is provided in the inner portion 314. The tenth unperforated area 384 extends from the ninth set of open spaces 382 to a second end portion 386 of the appliance 260. The tenth unperforated area 384 extends across the bite line 268 to a tenth set of open spaces 388.

Moving toward the bisecting line 296 from the tenth unperforated area 384, is where the tenth set of open spaces 388 may be provided. The tenth set of open spaces 388 may be comprised of an inner row 390 and an outer row 392 of individual open spaces. The inner row 390 is closest to the bite line 268 while the outer row 392 is closest to the perimeter 306.

The inner and outer rows 390, 392 may be parallel one another, but the inner row 390 is advanced forward of the outer row 392 toward the bite line 268. In the depicted embodiment, the inner row 390 is advanced at least the diameter of one individual open space beyond the outer row 392 in the direction of the bite line 268.

Both rows 390, 392 may have the same number of open spaces, which in the depicted embodiment may be 9. The individual open spaces of the rows 390, 392 may be offset from one another such that the inner row 390 is shifted toward the bisecting line 296 and the outer row 392 is shifted away from the bisecting line 296. Moving toward the bisecting line 296 from the tenth set of open spaces 388, an eleventh unperforated area 394 may be provided. The eleventh unperforated area 394 may be located between the bite line 268 and the perimeter 306.

An eleventh set of open spaces 396 may be provided between the eleventh unperforated area 394 and a twelve unperforated area 398, all inboard of the bite line 268 in the inner portion 314.

The eleventh set of open spaces 396 may be comprised of an inner row 400 and an outer row 402 of individual open spaces. The inner row 400 is closest to the bite line 268 while the outer row 402 is closest to the perimeter 306.

The inner and outer rows 400, 402 may be parallel one another, but the inner row 400 is advanced forward of the outer row 402 toward the bite line 268. In the depicted embodiment, the inner row 400 is advanced at least the diameter of one individual open space beyond the outer row 402 in the direction of the bite line 268.

The rows 400, 402 may have an unequal number of open spaces. In the depicted embodiment, the inner row 400 may have five open spaces while the outer row 402 may have four open spaces. The eleventh set of open spaces 396 may be centered on the bisecting line 296. Thus, one of the open spaces of the inner row 400 may be divided in half by the bisecting line 296, while two open spaces of the outer row 402 are on either side of the bisecting line 296. As can be appreciated from the above, the individual open spaces of the rows 400, 402 are not aligned with one another, but are instead offset from one another.

The twelfth unperforated area 398 is located between the bite line 268 and the perimeter 306 in the inner portion 314.

A twelfth set of open spaces 404 are located adjacent the twelfth unperforated area 398. The twelfth set of open spaces 404 may be comprised of an inner row 406 and an outer row 408 of individual open spaces. The inner row 406 is closest to the bite line 268 while the outer row 408 is closest to the perimeter 306 in the inner portion 314.

The inner and outer rows 406, 408 may be parallel one another, but the inner row 406 is advanced forward of the outer row 408 toward the bite line 268. In the depicted embodiment, the inner row 406 is advanced at least the diameter of one individual open space beyond the outer row 408 in the direction of the bite line 268. Both rows 406, 408 may have the same number of open spaces, which in the depicted embodiment may be 9. The individual open spaces of the rows 406, 408 may be offset from one another such that the inner row 406 is shifted toward the bisecting line 296 and the outer row 408 is shifted away from the bisecting line 296.

A thirteenth unperforated area 410 may be located between the twelfth set of open spaces and the first end portion of the appliance 260 in the inner portion 314.

Preferably, as shown in the depicted embodiment, the bite line 268 is free of open spaces. It is also preferred that the electronics lobe 282 is free of open spaces.

The appliance 260 described and depicted herein has been found to have a superior force absorbing design. It has been found that arrays of open spaces comprised of three open spaces where the arrays are arranged in a triangular pattern is particularly effective in absorbing and dissipating force. Thus, it is an intentional part of the design for the third and fourth sets of open spaces 330, 342 to be arranged in the first front flap 262 and the second front flap 264, where a force impact is likely to be experienced.

It is also an intentional part of the design that certain sets of open spaces are located parallel one another. It has been found by locating the sets of open spaces in these orientations that force absorption and dissipation is increased as a force impact radiates from the point of impact outwardly and the radiating force encounters the regular rows of open spaces. The embodiments depicted in Figs. 10A and 10B of the open spaces 48A subject to a force are equally applicable to the design depicted in Figs 13-19.

The open spaces 312 are located in the appliance 260 to maximize tensile strength of the appliance 260 without exposing any of the protected dental surfaces to the unprotected teeth on the opposite jaw. The locations of the open spaces 312 also optimize saliva flow around the dentitions, which improves comfort. More particularly, saliva can be sucked through the open spaces 312. The open spaces 312 also function to improve breathing by allowing the appliance 260 to be thinner and thus take up less space in the mouth.

Based on the foregoing, it can be appreciated that the appliance material, the location of that material on the wearer’s dentition as described herein, the open spaces, and/or plastic and/or elastic deformation effectively diminishes forces transmitted in the axial (normal) direction, as well as in the horizontal direction, with respect to the dental surfaces.

The sets of open spaces, their orientation and their location, also assist in fitting the appliance, saliva flow and unhindered breathing and talking.

With reference back to Figs 13 and 14, the electronics lobe 282 may house an embedded electronic chip 412. The chip 412 may comprise an embedded detection system 414. The electronic chip 412 may be entirely encased within the lobe 282.

Being encased, there is no portion of the chip 412 that is exposed to the user’s dentitions or mouth; the chip 412 is hermetically sealed within the lobe 282. In other words, the same unitary, integrally formed and one-piece polymeric material of the appliance 260 encases the electronic chip 412, and preferably the embedded detection system 414.

As can be appreciated in Figs. 13-19, the electronics lobe 282, while having the first planar side 308 that is planar, may have a different shape on the second side 310. The electronics lobe 282 on the second side 310 may be thicker than the rest of the appliance 260. In the first state of the appliance 260, the electronics lobe 282 may have a step 416 that extends about the lobe 282. The step 416 locates an outer surface 418 of the lobe 282 a predetermined distance from the second side 310. The predetermined distance of the outer surface 418 from the second side 310 may be fixed, or it may vary. Preferably, the step 416 is formed of smooth edges and gradual transitions so as not to have any surfaces that might irritate, catch or cut the soft tissues of the user’s mouth.

In view of the above, it can be appreciate that where the electronics lobe 282 comprises the first side 308, the electronics lobe 282 and the first side 308 are coplanar, and on the second side 310 the electronics lobe 282 has a step 416 to an outer surface 418 that is not coplanar with the second side 310.

In the depicted embodiment, electronics lobe 282 may have a ramp-like shape that gradually thickens from a forward portion 420 to a rear portion 422. The ramp-like shape may be useful in gradually moving soft mouth tissues away from the appliance 260 so make room for the electronics lobe 282 in the mouth, such as between the teeth/gums and the cheek. The flexibility of the cheek can readily accommodate the slight increase in the thickness of the lobe 282 without discomfort. Additional polymeric material (not shown) may be added to the second side 310 of the lobe 282 to provide additional cushioning between the appliance 260 and the soft mouth tissues of the user.

Figs. 13-19 depict the appliance 260 with only one electronics lobe 282. While the lobe 282 is shown on one side of the appliance 282, the lobe 282 can instead be on the other side. Within the electronics lobe 282, an electronic chip 412 and a battery 426 are preferably stacked on one another. More particularly, the chip 412 and battery 426 are in direct touching contact with one another. The chip 412 and battery 426 may be part of the embedded detection system 414.

The chip 424 and the battery 426 cannot be removed from the appliance 260 without destroying the appliance 260 such that it can no longer effectively function for its intended purpose. The battery 426 may be charged such as through electromagentic inductive charging.

As can be appreciated from the above, in the preferred embodiment, the electronics lobe 282 entirely encases both the non-replaceable accelerometer 428, the non-replaceable wireless transmitter 430 connected to the accelerometer 428 and the non-replaceable battery 426 connected to the accelerometer 428 and the transmitter 430. A temperature sensor 432, a chemical/electrical sensor 434 may be included on the chip 412. Chemical/electrical sensor 224, described above, may also be used. The accelerometer 428, sensors 432, 434 and the transmitter 430 may be part of the embedded detection system 414. The accelerometer 428, transmitter 430, battery 426, and sensors 432, 434 maybe as disclosed herein as parts 216, 218, 220 and 224 and work in the same or similar manner.

The appliance 260 may be constructed of a thermoplastic polymer matrix. The matrix is non-conductive so that it will not interfere with the electrical signals from the chemically sensitive materials.

One method of fitting and/or using the dental appliance 260 described above follows. The appliance 260 is initially in a first planar state, as shown in Figs. 13-14.

In this first state, the appliance 260 has the first front flap 262, the second front flap 264, the outer side flap 302, the first inner side flap 292, the second inner side flap 298 and the bite line 268, each part of the first and second sides 308, 310, where all of the first side 308 portions of flaps 262, 264, 302, 292 and 298 and the bite line 268 are coplanar with one another in a first plane 450, and all of second sides 310 of the flaps 262, 264, 302, 292 and 298 and the bite line 268 are coplanar with one another in a second plane 452.

In the first state, the electronics lobe 282 has an outer surface 418 that is not coplanar with either the first or the second sides 308, 301.

At room temperature, the appliance 260 is rigid. The appliance 260 may be heated such as by convection, conduction and/or radiation until it is pliable. In most cases, when the appliance 260 reaches 60 degrees Celsius (approximately 140 degrees F), it will be pliable. As noted above, the temperature sensor 432 is provided to sense heating of the appliance 260, such as beyond ambient temperature. The temperature sensor 432 can signal the chip 412 that it should wake up/activate upon reaching a preset temperature, such as the temperature at which the appliance 260 becomes pliable.

Once pliable, the appliance 260 is located adjacent the dentition of a user such as in Figs. 15-19. In the preferred embodiment, the appliance 260 is located adjacent the maxilla (upper dentition) into a second, non-planar state. The second, non-planar state is depicted in Figs. 15-19. Alternatively, the appliance 260 may be located adjacent the mandible (lower jaw), or a first appliance can be located adjacent the maxilla and a second appliance can be located adjacent the mandible.

Continuing with the embodiment wherein the appliance 260 is located just adjacent the maxilla, the crowns of the dentition 270, 274 are positioned adjacent the bite line 268 on the appliance 260. The appliance 260 is moved into contact with the dentition 270, 274 and then molded around the dentition. More particularly, the first and second front flaps 262, 264 are molded in front of outward facing surfaces 436 of the dentition.

Inner surfaces 462, 464, 466, 468 of the first front flap 262, the second front flap 264, the outer side flap 392 and lobe 282 conform, and hold their shape to, contours of the outward facing surfaces 436 of dentitions. The outward facing surfaces 436 of dentitions may create pockets 500 in the inner surfaces of the first front flap 462, the second front flap 464, the outer side flap 466 and the lobe 468 that match the shape and size of each tooth. For example, the outward facing surfaces 436 of the incisors 600 may create pockets 500A in the surfaces 462, 464. The outward facing surface 436 of the canine 602 may create a pocket 500B in the surface 436 of the flaps 462, 464, 446 or lobe 468. The outward facing surfaces 436 of the molars 446 may create pockets 500C in the flap 446 or lobe 468.

Inner surfaces 470, 472 of the first inner side flap 292 and the second inner side flap 298 conform to, and hold their shape to, contours of rearward facing surfaces 438 of dentitions. The rearward facing surfaces 438 of dentitions may create pockets 500 in the inner surfaces of the first inner side flap 292 and the second inner side flap 298 that match the shape and size of each tooth. For example, the rearward facing surfaces 438 of the canines 602 may create a pocket 500D in the flaps 292, 298. The rearward facing surfaces 438 of the molars 446 may create pockets 500E in the flaps 292, 298.

An inner surface 474 of the bite line 268 conforms to, and holds it shape to, incisal edges 270 and/or occluding surfaces 274 of dentitions. The incisal edges and the occluding surfaces 274 may create pockets 500F, 500G in the bite line 268.

Preferably, the first and second front flaps 262, 264, and also the electronics lobe 282 and the second outer side flap 302, are located vertically, or with a small angle variance from vertical (e.g. 10 degrees), from the bite line 268. The flaps 262, 264, 302 and lobe 282 are preferably located in this orientation because it encases the dentitions to protect them and it keeps the appliance 260 close to the dentitions so that it is easier for the wearer to speak, drink and breath with the appliance 260 in place. In other words, in the second state, the appliance 260 does not interfere with the lips, tongue or palate of the user.

The above-described position of the flaps 262, 264, 302 and lobe 282 temporarily but largely immovably locks the appliance 260 to the dentitions. This ensures forces experienced by the user are directly and efficiently transferred to the appliance 260. It also ensures that the lobe 282 does not move or end up in a location that may cause user discomfort.

Upper edges 454, 456 of the first front flap 262 and the second front flap 264 are located above upper edges 458, 460 of the first inner side flap 292 and the second inner side flap 298 in the second state. This provides extra space for the user’s tongue and it facilitates saliva flow and breathing.

The first inner side flap 292 and the second inner side flap 298 are molded upwardly so they are positioned behind rearward facing surfaces 438 of the dentition. The flaps 292, 298 (as well as flaps 262, 264, and 302) are located vertically, or within a small angle variance from vertical (e.g. 10 degrees) from the bite line 268. The upward location of the flaps 262, 264, 302, 292, 298 and lobe 282 effectively encases the outward and rearward surfaces 436, 438 of the maxilla dentition in a channel 440, which can be appreciated from Figs. 15-19. The channel 440 is curved along the bite line 268 so as to be complimentary to the wearer’s dentition. The channel 440 protects the outward and rearward facing surfaces 436, 438 as well as the incisal edges 270 and occluding surfaces 274 of many of the wearer’s dentition.

When the appliance 260 is fit onto the dentition of a wearer, the forward cusp 266 falls centrally between the two maxillary central incisor teeth 272. When formed to the dentitions, the first and second front flaps 262, 264 cross over a maxillary teeth- gum intersection line and extend over the soft gum tissue, lt has been found that when the appliance 260 extends over the maxillary teeth-gum intersection line, the appliance 260 more robustly can protect the dentition from being moved during force application. In one embodiment, the flaps 262, 264 extend beyond the teeth-gum intersection line approximately .25 to .35 mm. While one range of extension is mentioned above, it can be appreciated that this dimension can be larger or smaller to cover more or less of the soft gum tissue 442.

The flaps 262, 264, 302, 292, 298 and lobe 282 can be manually manipulated to position them as described above. In addition, the wearer can draw air through the open spaces 312. The vacuum created by the wearer by drawing the air through the spaces 312 pulls the pliable appliance 260 into conformal contact with the dentition.

The manual manipulation and/or the vacuum applied to the appliance 260 causes an interior surface 444 of the appliance 260 to mold into intimate contact with the outward facing surfaces 436, the edges 270, the occluding surfaces 275 and/or rearward facing surfaces 438 of the dentition.

The electronics lobe 282 is moved until it is located on the cheek, or outer, side of the molars 446 of the user. Thus, the electronics lobe 282 is moved from a flat planar state to a state in which it is substantially vertically oriented and transverse to the bite line 268.

As the appliance 260 cools, it may shrink into further contact with the dentition. During cooling, the appliance 260 hardens into a shape that well adheres to the contours of every unique tooth. This adherence ensures the appliance 260 does not become dislodged and provides the advantages noted above for the lobe 282. The open spaces 312 in the appliance 260 provide a conformal fit of the appliance 260 onto any dentition and enable a secure custom fit by changing in size and in shape in all or some when the appliance 260 is in the pliable condition. The secure, custom fits enables the appliance to remain fixed on the dentition. The open spaces 312 allow the softened thermo-polymer material to be formed into a three-dimensional shape without buckling, bunching, creasing, or bulging.

Based on the above-provided description and figures, it can be appreciated that there is no portion of the appliance 260 that spans an upper palate 448 of the user. Instead, the appliance 260 terminates at the flaps 262, 264, 302, 292, 298 and lobe 282 before it extends across the upper palate 448. Thus, there is a gap between the flaps 262, 264, 302, 292, 298 and lobe 282 that leaves the upper plate 448 exposed. It has been found that this facilitates breathing, speaking, swallowing and saliva flow.

If the appliance 260 has to be re-fitted after it has cooled and hardened, it can be warmed to its softening point and the fitting process can be repeated because its second state is only a semi-permanent state.

In accordance with the provisions of the patent statutes, the present invention has been described in what is considered to represent its preferred embodiments.

However, it should be noted that the invention can be practiced otherwise than as specifically illustrated and described without departing from its spirit or scope.

Claims

What is claimed is:

1. A mouthguard, comprising:

a first side and a second side opposite the first side;

a first front flap and a second front flap separated by a forward cusp;

an outer side flap separated from said second front flap by a side cusp;

a first inner side flap and a second inner side flap;

an electronics lobe forming a U-shape with said first front flap, said electronics lobe having a forward wall, an upper wall transverse said forward wall, and a rear wall parallel said forward wall, wherein said forward wall, said upper wall and said rear wall are co-planar;

an arc-shaped bite line extending across said first side, said bite line dividing said first side into an inner portion and an outer portion; and

a plurality of open spaces extending from the first side to the second side;

wherein said bite line and said electronics lobe are free from said plurality of open spaces.

2. The mouthguard of claim 1, wherein said electronic lobe is unitary, one piece and integrally formed with said first front flap and said first inner side flap.

3. The mouthguard of claim 1, wherein where said electronics lobe comprises said first side said electronics lobe and said first side are coplanar, and on said second side said electronics lobe has a step to a surface that is not coplanar with said second side.

4. The mouthguard of claim 1, wherein said electronics lobe entirely encases both a non-replaceable accelerometer, a non-replaceable wireless transmitter connected to the accelerometer and a non-replaceable battery connected to the accelerometer and the transmitter.

5. The mouthguard of claim 1, wherein said electronics lobe has a ramp- like shape that thickens from a forward portion to a rear portion of the lobe.

6. The mouthguard of claim 1, wherein a chemical sensor in contact with a chemically sensitive material is embedded between the first side and the second side.

7. The mouthguard of claim 4, wherein a temperature sensor is embedded between the first side and the second side, wherein the temperature sensor and/or the accelerometer signals an electronics chip in said electronics lobe to power up or power down, wherein the power up signal is based on a sensed temperature from the temperature sensor of at least 95-105 degrees F and the power down signal is based on a sensed temperature from the temperature sensor below 90 degrees F.

8. A method of forming a mouthguard, comprising:

providing a first state with a first front flap, a second front flap, an outer side flap, a first inner side flap, a second inner side flap and a bite line, wherein each of said flaps and said bite line have first and second sides, where all of said first sides of said flaps and said bite line are coplanar with one another in a first plane, and all of said second sides of said flaps and said bite line are coplanar with one another in a second plane;

providing an electronics lobe connected to said first front flap, wherein a portion of the electronics lobe is not coplanar with either said first or said second sides; and

locating said first and second sides of each of said first front flap, said second front flap, said outer side flap, said first inner side flap, said second inner side flap and said electronics lobe in a second state where each of said flaps and said lobe are angled with respect to said first and second planes.

9. The method of forming the mouthguard of claim 8, wherein said flaps and said lobe are moved from the first state, which is a flattened state, to the second state where said flaps and lobe are angled with respect to the bite line.

10. The method of forming the mouthguard of claim 8, wherein upper edges of said first front flap and said second front flap are located above an upper edge of said first inner side flap and said second inner side flap in said second state.

11. The method of forming the mouthguard of claim 8, wherein inner surfaces of said first front flap, said second front flap, said outer side flap and said lobe conform, and hold their shape to, contours of outer surfaces of dentitions.

12. The method of forming the mouthguard of claim 8, wherein inner surfaces of said first inner side flap and said second inner side flap conform to, and hold their shape to, contours of inner surfaces of dentitions.

13. The method of forming the mouthguard of claim 8, wherein an inner surface of said bite line conforms to, and holds it shape to, incisal edges and/or occluding surfaces of dentitions.