POSITIONING STRUCTURE FOR OROPHARYNGEAL EXERCISE DEVICES AND SYSTEMS AND RELATED METHODS

Abstract

A mouthpiece of an oropharyngeal exercise device including a positioning structure used to position a user's mouth on said mouthpiece, and methods for using such a mouthpiece for such exercises. A user's mouth can be positioned such that the apex of a user's tongue is positioned to complete an oropharyngeal exercise. The mouthpiece includes a lip guard. The mouthpiece can be used to guide a user's tongue to a position when completing an oropharyngeal exercise.

Claims

1. A mouthpiece of an oropharyngeal exercise device, comprising: (a) a positioning structure used to position a user's mouth on said mouthpiece such that an apex of a user's tongue is positioned to complete an oropharyngeal exercise; and (b) a lip guard.

2. The mouthpiece of the oropharyngeal exercise device of claim 1, wherein the positioning structure comprises a plurality of outward protrusions.

3. The mouthpiece of the oropharyngeal exercise device of claim 2, wherein the mouthpiece comprises a perimeter and the plurality of outward protrusions are disposed around at least a portion of said perimeter.

4. The mouthpiece of the oropharyngeal exercise device of claim 1, wherein the mouthpiece is a length of about 28.5 mm, wherein the positioning structure is about 8 mm from the lip guard.

5. The mouthpiece of the oropharyngeal exercise device of claim 1, wherein the mouthpiece is a length of about 35 mm, wherein the positioning structure is about 10 mm from the lip guard.

6. The mouthpiece of the oropharyngeal exercise device of claim 1, wherein the positioning structure is about 0.25 inches from an inner edge of a user's front top teeth during use of the device.

7. The mouthpiece of the oropharyngeal exercise device of claim 1, wherein the mouthpiece comprises a mouthpiece width, and wherein the positioning structure comprises at least one ridge having a ridge width less than or equal to the mouthpiece width.

8. The mouthpiece of the oropharyngeal exercise device of claim 7, wherein the positioning structure comprises three ridges.

9. The mouthpiece of the oropharyngeal exercise device of claim 8, wherein the three ridges comprise a length of about 11 mm and a width of about 2 mm, such that the three ridges are about 10 mm from the lip guard of the mouthpiece.

10. The mouthpiece of the oropharyngeal exercise device of claim 1, wherein the positioning structure comprises a groove having a groove depth and groove width, and wherein the mouthpiece comprises a mouthpiece width, and wherein the groove width is less than or equal to the mouthpiece width.

11. The mouthpiece of the oropharyngeal exercise device of claim 1, wherein the positioning structure comprises a convex ridge comprising a depth ranging from about 0.1 mm to about 6 mm.

12. The mouthpiece of the oropharyngeal exercise device of claim 1, further comprising a second positioning structure, wherein the mouthpiece comprises a first side opposite a second side, and wherein the positioning structure is a first positioning structure disposed on the first side and second positioning structure is disposed on the second side.

13. The mouthpiece of the oropharyngeal exercise device of claim 12, wherein the first positioning structure and the second positioning structure are grooves comprising about the same dimensions.

14. The mouthpiece of the oropharyngeal exercise device of claim 13, wherein the second positioning structure is about 3 mm from the first positioning structure.

15. An oropharyngeal exercise device, comprising: (a) a bulb body comprising: (i) a mouthpiece sized and shaped to be insertable into a user's mouth, the mouthpiece including a lip guard and a positioning structure used to position a user's mouth on said mouthpiece such that an apex of a user's tongue is positioned to complete an oropharyngeal exercise; (ii) a proximal extension; and (iii) a central body disposed between the mouthpiece and the proximal extension; (b) a lumen defined within the bulb body such that the lumen is defined within the mouthpiece, the proximal extension and the central body; (c) a proximal opening defined in the proximal extension, wherein the proximal opening is sized to couple with an elongate tube, whereby the proximal opening allows liquid to flow into the lumen; (d) a flow restriction structure associated with the bulb body, wherein the flow restriction structure comprises: (i) a restricted configuration in which the flow restriction structure is configured to restrict a flow of a fluid through the lumen such that the user must apply at least a first amount of negative pressure to create a first flow rate of the fluid; and (ii) a less restricted configuration in which the flow restriction structure is configured to restrict the flow of fluid through the lumen such that the user must apply at least a second amount of negative pressure to create a second flow rate of the fluid, wherein the second amount of negative pressure is greater than the first amount, and wherein the second flow rate is greater than the first flow rate; and (e) at least one distal opening defined in the mouthpiece and in fluidic communication with the lumen, wherein the flow restriction structure can be the at least one distal opening.

16. The mouthpiece of the oropharyngeal exercise device of claim 15, wherein the wherein the mouthpiece is a length of about 28.5 mm, wherein the positioning structure is about 8 mm from the lip guard.

17. The mouthpiece of the oropharyngeal exercise device of claim 15, wherein the mouthpiece is a length of about 35 mm, wherein the positioning structure is about 10 mm from the lip guard.

18. A method of completing an oropharyngeal exercise, comprising: (a) positioning a user's mouth around a mouthpiece of the oropharyngeal exercise device, wherein the mouthpiece comprises: (i) a positioning structure used to position the user's mouth on said mouthpiece such that an apex of a user's tongue is positioned to complete an oropharyngeal exercise; and (ii) a lip guard; (b) positioning the user's tongue on the positioning structure of the mouthpiece; and (c) completing the oropharyngeal exercise using the oropharyngeal exercise device.

19. The method of claim 18, wherein the oropharyngeal exercise comprises at least one of: (a) mimicking a bolus formation of a swallow; and (b) pressing the user's tongue upward such that the bolus formation is pushed rearward in the user's mouth.

20. The method of claim 18, wherein the positioning structure comprises a plurality of outward protrusions.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0031] The following drawings are illustrative of particular examples of the present invention and therefore do not limit the scope of invention. The drawings are not necessarily to scale, though embodiments can include the scale illustrated, and are intended for use in conjunction with the explanations in the following detailed description wherein like reference characters denote like elements. Examples of the present invention will hereinafter be described in conjunction with the appended drawings.

[0032] FIG. 1A is a schematic view of a user performing the suction exercise using an exercise device, according to one embodiment.

[0033] FIG. 1B is a schematic view of a user performing the tongue press exercise using an exercise device, according to one embodiment.

[0034] FIG. 2A is a schematic view of a mouth exercise, according to one embodiment.

[0035] FIG. 2B is a schematic view of another mouth exercise, according to one embodiment.

[0036] FIG. 2C is a schematic view of another mouth exercise, according to one embodiment.

[0037] FIG. 3A is a schematic view of a user inserting an exercise device in the user's mouth, according to one embodiment.

[0038] FIG. 3B is a schematic view of a user performing the suction exercise using an exercise device, according to one embodiment.

[0039] FIG. 3C is a schematic view of a user performing a tongue press exercise using an exercise device, according to one embodiment.

[0040] FIG. 4A is an isometric view of a mouthpiece of an exercise device, according to one embodiment.

[0041] FIG. 4B is a front view of the mouthpiece of FIG. 4A, according to one embodiment.

[0042] FIG. 4C is a side view of the mouthpiece of FIG. 4A, according to one embodiment.

[0043] FIG. 4D is a front view of a mouthpiece of an exercise device, according to another embodiment.

[0044] FIG. 5A is a front view of a mouthpiece of an exercise device, according to one embodiment.

[0045] FIG. 5B is a front view of a mouthpiece of an exercise device, according to another embodiment.

[0046] FIG. 5C is a front view of a mouthpiece of an exercise device, according to another embodiment.

[0047] FIG. 5D is a front view of a mouthpiece of an exercise device, according to one embodiment.

[0048] FIG. 6A is a side view of a mouthpiece of an exercise device, according to one embodiment.

[0049] FIG. 6B is a side view of a mouthpiece of an exercise device, according to one embodiment.

[0050] FIG. 6C is a front view of a mouthpiece of an exercise device, according to another embodiment.

[0051] FIG. 7 is a side view of a groove of a mouthpiece of an exercise device, according to one embodiment.

[0052] FIG. 8 is a side view of a mouthpiece of an exercise device in use, according to one embodiment.

[0053] FIG. 9 is a front view of the mouthpiece of FIG. 4D, according to one embodiment.

[0054] FIG. 10 is a flow diagram of using a mouthpiece of an exercise device, according to one embodiment.

DETAILED DESCRIPTION

[0055] The various embodiments herein relate to devices, systems, and methods for positioning a user's tongue on an oropharyngeal exercise device during use of said device. Certain implementations include a mouthpiece of a device, wherein a structure on the mouthpiece permits a user to position their tongue to ensure that the mouthpiece is positioned correctly with respect to the user's tongue before performing exercises using the device.

[0056] In certain embodiments, the exercise device can be attached to a liquid delivery mechanism that requires a user to perform repeated exercises in order to urge liquid out of the mechanism such that the user can drink it. The device can cause the user to use specific motions to deliver the water, thereby strengthening the various muscles in the mouth (including, for example, tongue, soft palate, and/or pharyngeal dilator muscles) while also providing repetitions, a duration to hold, and/or resistance to enhance the effect.

[0057] Some users may have difficulty positioning the device correctly in their mouth in order to perform the muscle movements required to use the device. Incorporating a positioning structure (also referred to as a positioning body or positioning feature) into the device allows a user to orient the device in relation to their mouth and tongue, thereby allowing them to understand how to perform the necessary muscle movements to use the device. The structure also assists a user in self-correcting their muscle movements.

[0058] The various implementations of the positioning structure on the exercise device as disclosed or contemplated herein can guide a user by providing an indicator of where the apex of a user's tongue should be located while using the device. Further, when a user applies suction to the device, the positioning structure can stabilize the jaw and/or the apex of the tongue. Additionally, the texture of the positioning structure or feature can provide additional proprioceptive stimulation. This stimulation can create a positive reinforcement for a user, which can build neural pathways and reinforce to a user the appropriate muscle movements required to use the device.

[0059] As shown in FIG. 1A, the tongue suction exercise as described above is performed using the container device 12 with the bulb 14 (also referred to as a mouthpiece). In the exercise, the tongue 16 is extended toward the bottom of the mouth, creating space between the tongue 16 and the hard palate 18 and thereby creating negative pressure within the user's mouth such that a suction is applied to the bulb 14. The apex of the tongue can slightly lower or stay anchored to what is referred to as the spot (the optimal location where the user's tongue is typically positioned during rest and initiation of any swallowing activities) about behind the top front teeth.

[0060] Further, as shown in FIG. 1B, the tongue press exercise as described above is performed using the container device 12 and bulb 14. In the exercise, the tongue 16 is pressed upwards towards the hard palate 18 to mimic the swallowing action of urging food or liquid into the pharynx. More specifically, the tip of the tongue 16 is urged into contact with the hard palate 18 behind the front top teeth and the back of the tongue 16 is urged upward in a wave-like motion such that, if food/liquid were present, the tongue 16 would urge the food/liquid towards the back of the throat.

[0061] FIGS. 2A-2C show the exemplary movement of a user's mouth while completing an oropharyngeal exercise. That is, a user's mouth can undergo three different movements that complete such an exercise. The tongue suction exercise as shown in FIG. 2A involves an attempt to mimic the bolus formation of a normal swallow. That is, the tongue 16 creates a bolus by extending towards the bottom of the mouth. This creates a negative pressure, and the edges of the tongue 16 are bowed upward creating a bowl or trough. This targets use of the middle genioglossus muscle, and, without being limited by theory, it may also target the hyoglossus, palatoglossus, and transverse muscles of the tongue 16. Other muscles it may target are the styloglossus and vertical muscles of the tongue 16.

[0062] The tongue press exercise as shown in FIG. 2B is a motion that mimics when the tongue 16 presses upwards during the swallow to push the bolus of food or liquid into the pharynx. The tip of the tongue 16 is pressed up against the hard palate behind the front top teeth and the back of the tongue 16 is pressed up in a wave-like motion pushing the bolus towards the back of the throat. Without being limited by theory, it appears that the superior longitudinal muscle is activated along with the genioglossus, hyoglossus, and palatoglossus muscles.

[0063] The tongue push exercise as shown in FIG. 2C is a movement of the tongue 16 in which the tongue 16 is stuck outside of the mouth in a straight motion. This exercise activates the inferior genioglossus and, if the tongue 16 is pointed, it also activates the transverse tongue muscle. This motion may also have movements to the left, right, up, or down when sticking out to increase range of motion and strengthen additional muscles and/or target specific muscles.

[0064] In use as best shown in FIGS. 3A-3C, the user can place the mouthpiece 14 in the user's mouth (as best shown in FIG. 3A) and perform either the tongue suction exercise (as shown in FIG. 3B) or the tongue press exercise (as shown in FIG. 3C). Further, the user can also perform the tongue push exercise as discussed elsewhere. The various exercises can be performed using the bulb 14 in substantially the same manner as described above, so the performance of those exercises will not be described in additional detail here.

[0065] The various embodiments relating to the positioning structures, bodies, or features as disclosed or contemplated herein are intended to help the user to locate her/his tongue in the optimal location during the exercise as discussed above. For example, FIG. 4A-4C show one embodiment of a positioning structure 32 of an oropharyngeal device mouthpiece 30. In this implementation, the positioning structure 32 is a plurality of small, raised outward protrusions (or bumps) 32 disposed on the outer surface 34 of the mouthpiece 30 at a desired location on the mouthpiece 30. More specifically, the protrusions 32 are disposed at the location where the apex of the user's tongue should be positioned for proper use of the mouthpiece 30. In the specific implementation as shown, there are protrusions 32 disposed around the entire circumference of the mouthpiece 30. Alternatively, the protrusions 32 can be disposed solely in a specific area on one side of the mouthpiece 30 where the tongue apex should be positioned. In one embodiment, each protrusion can have a width ranging from about 0.1 mm to about 16 mm and a height ranging from about 0.1 mm to about 8 mm. Alternatively, in a specific exemplary embodiment, each protrusion can have a width of about 1.5 mm and a height of about 0.75 mm.

[0066] The positioning structure 32 of the mouthpiece 30 can be configured for use in both children and adults. For example, in one exemplary implementation, FIGS. 4A, 4B, and 4C can show a positioning structure 32 of a mouthpiece 30 configured for use by children. The mouthpiece 30 has a lip guard 38 and distal end 46 opposite the lip guard 38. In these embodiments, the mouthpiece 30 is a shorter length than the length of the mouthpiece 30 configured for use by an adult. For use by a child, the positioning structure 32 is located on the mouthpiece 30 about 8 mm from the lip guard 38 of the mouthpiece 30 and is a length of 9.5 mm. In other embodiments, the location of the positioning structure can range from 0 mm to 24 mm from the lip guard 38 and the length of the positioning structure 32 can range from 0.1 mm to the length of the mouthpiece. A user can select a mouthpiece for use from mouthpieces of various sizes in order to accommodate for their size of mouth based on their age. For example, users ages 3-9 can use a mouthpiece 30 with a positioning structure 32 about 8 mm from the lip guard 38. The positioning structure 32 can be closer to the lip guard 38 if the mouthpiece 30 is smaller in size. In some examples, smaller mouthpieces can be configured for use by users 3 years of age or younger. The size of the mouthpiece needed by a user can be determined on a case-by-case basis.

[0067] In contrast, the positioning structure of the mouthpiece configured for use by adults can have different characteristics than the mouthpiece used by children. For example, FIG. 4D shows such a mouthpiece 40. The mouthpiece 40 configured for use by adults has a longer length than the mouthpiece 30 used by children, as can be seen by comparing the device 30 of FIGS. 4A-4C to the device 40 of FIG. 4D. Additionally, the placement of the positioning structure 42 can be at a different location on the mouthpiece 40. For example, the positioning structure 42 in this embodiment is about 10 mm from the lip guard 48 of the mouthpiece 40 and is a length of about 10.5 mm. Like the mouthpiece 30 configured for use by children, the positioning structure 42 can span an area on the outer surface 44 of the mouthpiece 40.

[0068] The position and/or texture of the positioning structures 32, 42 described above, along with the various additional structure embodiments described herein (including structures 52, 62, 72, 82, 92, 102, 112) can help guide proper positioning of the associated mouthpiece in relation to the user's tongue and/or mouth and signal proper use of the device mouthpiece to a user. The texture of the structure (such as structures 32, 42, for example) can also assist the user in guiding the user's mouth muscles, as it can prevent the user's tongue from moving back and forth along the mouthpiece 60 by acting as a barrier to additional movement of the tongue in an incorrect direction. All of the various positioning structures disclosed or contemplated herein can have the same operational benefits.

[0069] Various different types of positioning structures are contemplated herein. For example, FIGS. 5A-5D show different exemplary configurations of the positioning structure according to various embodiments. FIG. 5A shows a positioning structure 52 that is a series of raised ridges 52 protruding outwardly from the surface 54 of the mouthpiece 50. More specifically, in this embodiment, the positioning structure 52 is three ridges 52. Alternatively, the positioning structure 52 can have one, two, four, five, six, seven, eight, or any other number of ridges 52. In certain implementations, the ridges 52 can extend across the entire width of the mouthpiece 50 as shown. Each ridge 52 can have a height ranging from about 0.1 mm to about 5 mm and a width ranging from about 0.1 mm to about 10 mm. Alternatively, the ridges 52 can have a height of about 0.75 mm and a width of about 1.5 mm. In other embodiments, the ridges 52 can extend only a portion of the way across the width of the mouthpiece 50. Similar to the mouthpiece 40 of FIG. 4D, the mouthpiece can have features such as a lip guard 58, outer surface 54, and distal end 56.

[0070] FIG. 5B shows an alternate positioning structure 62 of a mouthpiece 60 including a lip guard 68, outer surface 64, and distal end 66. The positioning structure 62 can be a variety of different textures. For example, in the exemplary embodiment as shown, the structure 62 can be a repeated raised diamond pattern 62. In some embodiments, the structure 62 can have a height ranging from about 0.1 mm to about 5 mm and a width ranging from about 0.1 mm to about 10 mm. Alternatively, the structure 62 can have a height of about 0.75 mm and a width of about 1.5 mm.

[0071] FIG. 5C shows another example of the positioning structure 72 wherein the positioning structure 72 is a groove 72. The groove 72 is formed in the outer surface 74 of the mouthpiece 70 such that it has a depth extending into the outer surface 74. The groove 72 can have a width less than the width of the mouthpiece 70. The depth of the groove 72 can be about 0.75 mm. Alternatively, the groove 72 can have a depth ranging from about 0.1 mm to about 6 mm and a width ranging from about 0.1 mm to about 15 mm. Alternatively, the groove 72 can have a depth of about 1.5 mm and a width of about 6 mm. In some embodiments, the groove can be on both sides of the mouthpiece, as shown in FIG. 6B. Embodiments of the mouthpiece 70 including a groove 72 can include features of the mouthpiece seen in other embodiments (e.g., a lip guard 78, outer surface 74, and distal end 76).

[0072] FIG. 5D shows yet another example of a positioning structure 82 in which the positioning structure 82 is the shape of a mark or logo 82. The mark or logo 82 can be disposed on the outer surface 84 of the mouthpiece between the lip guard 88 and distal end 86. The positioning structure 82 can be a three-dimensional rendering of any mark or logo 82 such that the mark or logo 82 is a structure 82 that protrudes from the surface 84 of the mouthpiece 80 or is formed or otherwise defined within the surface 84 (such as a channel, groove, or other formation carved into or other formed within the surface 84).

[0073] The positioning structure can be a variety of shapes and configurations. For example, the positioning structure can be a plurality of bumps, rounded cylinders, knurl, various polygons, ovals, divots, pyramids, cones, geometric tiles, circles, straight lines, curved or wavy lines, a target-like shape including ovals and/or circular lines, and/or patterning in such a square, oval, line(s), logo shape, or any other known shape or combination of known shapes.

[0074] FIG. 6A shows another exemplary embodiment of the positioning structure 92 wherein the positioning structure 92 can be a convex ridge or protrusion 92 extending from the surface 94 of the mouthpiece 90. The protrusion 92 can have a semi-circular shape, providing a curved slope. Alternatively, the protrusion 92 can have any shape. The protrusion 92 can protrude about 4 mm from the mouthpiece 90. Alternatively, the protrusion 92 can protrude from about 0.1 mm to about 10 mm from the mouthpiece 90.

[0075] FIGS. 6B and 6C show yet another alternative positioning structure 102A: a concave cavity 102A defined in the surface 102 of a side of the outer surface 104 of a mouthpiece 100. A second concave cavity 102B is located on an opposite side of the outer surface 104 of the mouthpiece 100. In such an embodiment, the second concave cavity 102B can be used by a user to sense the location at which a user's lips and/or teeth should be positioned to use the mouthpiece. The second concave cavity 102B can be located on the mouthpiece 100 such that the range from the teeth to locate the beginning of the apex tongue placement is 0 mm to 8 mm. As shown in FIG. 6C, the positioning structure 102A can span a portion of the width of the mouthpiece 100. Alternatively, either or both of the structures 102A, 102B can be channels or any other shape that span the entire width of the mouthpiece 100. FIG. 7 shows the variety of positioning structure 112 depths that such a structure has in various embodiments.

[0076] FIG. 8 shows a mouthpiece 110 in use by a user, according to one embodiment. When the mouthpiece 110 is positioned in the user's mouth, the positioning structure 112 can be positioned about a quarter of an inch from the inner edge of a user's front top teeth. The positioning structure 112 can encompass a broad area of the outer surface 114, which accommodates for variability in a user's mouth. This range can be tailored to different mouth sizes and/or age ranges or encompass a larger range to accommodate most mouth sizes. The apex of the tongue of a user is then about 3 mm to 25 mm from the proximal end of the mouthpiece that contacts lips when in appropriate contact with a positioning structure 112. This variation in position accounts for placement of lips on the lip guard, which can be affected by lip and/or teeth size.

[0077] Returning to the mouthpiece 40 discussed above and depicted in FIG. 4D, FIG. 9 shows additional detail relating to the relative location of the various components of the mouthpiece 40 in accordance with one exemplary implementation. As noted above, the mouthpiece has a lip guard 48 and distal end 46. The outer surface 44 can define the shape of the mouthpiece 40 from the lip guard 48 to the distal end 46. The outer surface 44 can include a positioning structure 42.

[0078] The positioning structure 42 can be disposed on the mouthpiece at a predetermined location. For example, the mouthpiece 40 can have a length A and the positioning structure 42 can have a length C. The positioning structure 42 can be positioned such that it is a distance B from the lip guard 48. The distance B can be any distance that permits a user to complete an oropharyngeal exercise, such as the exercises described herein. The positioning structure length C can be any length that allows a user to dispose their tongue on the positioning structure 42 such that the user's tongue is in position to complete such an exercise. As such, the various distances A, B, C discussed herein can be tailored to accommodate the particular user such that the device 40 (or any other embodiment herein) can operate as discussed herein.

[0079] FIG. 10 is a flow diagram of a method of completing an oropharyngeal exercise (150). The method can include positioning a user's mouth around a mouthpiece of an oropharyngeal exercise device (block 152). The method can include positioning a user's tongue on the positioning structure of the mouthpiece (block 154) and completing the oropharyngeal exercise using the oropharyngeal exercise device (block 156). Such a method can be used with any embodiments of the mouthpiece described herein. That is, the mouthpiece of the oropharyngeal exercise device can include a lip guard and a positioning structure used to position the user's mouth on said mouthpiece such that the apex of a user's tongue is positioned to complete an oropharyngeal exercise.

[0080] The oropharyngeal exercise can include any of the oropharyngeal exercises described above with respect to FIGS. 2A-3C. Some embodiments of the method can include, for example, completing the exercise (block 156) of mimicking a bolus formation of a swallow (as shown in FIG. 2A) and/or pressing a pressing the user's tongue upward such that the bolus formation is pushed rearward in the user's mouth (as shown in FIG. 2B).

[0081] As mentioned above, any of the various positioning structures and/or components described herein with respect to any of the various device embodiments can be incorporated into any of the other device implementations. Further, any of the positioning structure device embodiments herein can be incorporated into or used with any of the container implementations disclosed or contemplated herein.

[0082] While the various systems described above are separate implementations, any of the individual components, mechanisms, or devices, and related features and functionality, within the various system embodiments described in detail above can be incorporated into any of the other system embodiments herein.

[0083] The term about, as used herein, refers to variation in the numerical quantity that can occur, for example, through typical measuring techniques and equipment, with respect to any quantifiable variable, including, but not limited to, mass, volume, time, distance, wavelength, frequency, voltage, current, and electromagnetic field. Further, there is certain inadvertent error and variation in the real world that is likely through differences in the manufacture, source, or precision of the components used to make the various components or carry out the methods and the like. The term about also encompasses these variations. The term about can include any variation of 5% or 10%, or any amountincluding any integerbetween 0% and 10%. Further, whether or not modified by the term about, the claims include equivalents to the quantities or amounts.

[0084] Numeric ranges recited within the specification are inclusive of the numbers defining the range and include each integer within the defined range. Throughout this disclosure, various aspects of this disclosure are presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the disclosure. Accordingly, the description of a range should be considered to have specifically disclosed all the possible sub-ranges, fractions, and individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed sub-ranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6, and decimals and fractions, for example, 1.2, 3.8, 1, and 4 This applies regardless of the breadth of the range. Although the various embodiments have been described with reference to preferred implementations, persons skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope thereof.

[0085] Although the various embodiments have been described with reference to preferred implementations, persons skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope thereof.