DENTAL IMAGING DEVICE

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] The present application claims the benefit of U.S. Provisional Patent Application No. 63/177,982, filed April 22, 2021 and titled, “Dental Imaging Device,” the entire contents of which is incorporated herein by reference in its entirety.

BACKGROUND OF THE DISCLOSURE

[0002] Dental imaging devices are prevalent in the field of dentistry. Generally, dental imaging devices employ external cameras to provide left, right and center buccal views, with the jaws open or closed in a dental office with the assistance of a medical professional operating the cameras or scanning devices. Intra-oral cameras are generally employed to capture images of a particular tooth or multiple teeth and are operated by trained professionals in the dental office setting. These intra-oral cameras can be moved to provide a view of almost any surface of the tooth, including inner view, outer view and chewing surface. Both the traditional camera and the intra-oral cameras, however, have drawbacks.

[0003] Clinicians ( e.g ., dentists, dental assistants, etc.) benefit from the ability to see the full patient arch from what is commonly called the occlusal view. This means being able to see all teeth at once in either the mandibular or maxillary jaw. The occlusal view allows clinicians to see tooth and jaw alignment, tooth rotations, spacing between teeth, the chewing surface of the teeth as well as a lingual view of some-or-all the teeth, gum tissue, including potential concerns related to the patient’s gums, and otherwise assess a patient’s oral health. This view is, however, exceedingly difficult to capture using current techniques and equipment. Neither traditional cameras shooting the images from outside the mouth or intra-oral cameras shooting from inside the mouth are well suited for this task. That is, conventional dental imaging devices do not provide a quick and consistent mechanism, system or method for capturing both external images of the teeth and full arch views captured from within the mouth.

[0004] The difficulties with capturing the occlusal views are a result of several factors, including limited space in a patient’s mouth, odd angles of both the mouth and the image capture device, a lack of lighting and other related factors and difficulties. Additionally, the humidity in the mouth causes fogging of the camera lens, thereby obscuring any images that are taken with the intra-oral cameras. Current techniques to capture these occlusal views involve one of two options, including a) taking the picture using a mirror that is placed on the patient's tongue (or roof of their mouth) and angled such that camera lens is focused on the mirror itself, thus providing a view of the patient’s mouth, or b) simply asking the patient to open their mouth as widely as they can and taking a picture of the arch. Both techniques have significant drawbacks. The first technique (using a mirror) is unwieldy, uncomfortable, mirrors fog-up, inconsistent sizing and angles of the photos make them very susceptible to human error and commercially available medical quality mirrors are expensive. Additionally, the mirrors need to be sterilized after each use. The second technique (asking the patient to “open wide”) has significant limitations, including views that are poorly lit or blurry, odd angles that make it difficult to determine depth of view and a host of human error problems.

[0005] It would, therefore, be desirable to design, develop and implement an improved system and method to capture occlusal and lingual views of the teeth that enables images to be taken from outside the mouth to provide, center, left and right buccal views as well as a panoramic full or partial mouth view. The preferred invention addresses the limitations and difficulties of the prior art systems and methods.

BRIEF SUMMARY OF THE INVENTION

[0006] Briefly stated, the disclosure relates to dental imaging devices that are designed and configured to capture and store images of a patient’s teeth and arches in a relatively simple manner such that the patient collects and transmits the images without assistant from a medical professional.

[0007] In another aspect, the preferred invention is directed to a dental imaging device for collecting images of a patient’s mouth and teeth. The dental imaging device includes a camera holder having a rectangular shape, a proximal portion and a distal portion, a camera mounted to the distal portion of the camera holder, an extension connected to the proximal portion of the cameral holder, and a handle connected to the extension opposite the camera holder. The extension has a curved shape. The handle includes a power source and a transmitter. The camera is configured to collect images of the patient’s mouth and the transmitter is configured to transmit the collected images to a central processor. [0008] In a further aspect, the preferred invention is directed to a dental imaging device for collecting images of a patient’s mouth and teeth. The dental imaging device includes a camera holder having a spoon-like shape, a proximal portion and a distal portion with a depression, a camera mounted in the depression of the distal portion of the camera holder, an extension connected to the proximal portion of the cameral holder, and a handle connected to the extension. The extension has a curved shape. The handle includes a power source and a transmitter. The camera is configured to collect images of the patient’s mouth and the transmitter is configured to transmit the collected images to a central processor

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0009] The following description of preferred embodiments of the disclosure will be better understood when read in conjunction with the appended drawings. It should be understood, however, that the disclosure is not limited to the precise arrangements and instrumentalities shown. In the drawings:

[0010] Fig. 1 illustrates a top perspective view of a dental imaging device according to a first preferred embodiment of the present disclosure, employing a single camera, wherein an exemplary lower jaw or mandible, teeth and tongue or an exemplary lower dental arch are show, but other portions of the patient’s anatomy are transparent for clarity;

[0011] Fig. 2 illustrates a top perspective view of the dental imaging device of Fig. 1, employing first and second cameras, and the exemplary lower dental arch;

[0012] Fig. 2A illustrates a magnified top perspective view of the dental imaging device and particularly the first and second cameras of Fig. 2, as well as an exemplary lower dental arch; [0013] Fig. 3 illustrates a top perspective view of the dental imaging device of Fig. 1, employing first, second and third cameras;

[0014] Fig. 3 A illustrates a magnified top perspective view of the dental imaging device and particularly the first, second and third cameras of Fig. 3;

[0015] Fig. 4A illustrates a top perspective view of a dental imaging device according to a second preferred embodiment of the present disclosure;

[0016] Fig. 4B illustrates a magnified side perspective view of a distal end of the dental imaging device of Fig. 4A, wherein the distal end is positioned in a patient’s mouth; and [0017] Fig. 4C a top perspective view of the dental imaging device of Fig. 4A. DESCRIPTION OF THE DISCLOSURE

[0018] Certain terminology is used in the following description for convenience only and is not limiting. The words “lower,” “bottom,” “upper” and “top” designate directions in the drawings to which reference is made. The words “inwardly,” “outwardly,” “upwardly” and “downwardly” refer to directions toward and away from, respectively, the geometric center of the dental imaging device, and designated parts thereof, in accordance with the present disclosure. Unless specifically set forth herein, the terms “a,” “an” and “the” are not limited to one element, but instead should be read as meaning “at least one.” The terminology includes the words noted above, derivatives thereof and words of similar import.

[0019] It should also be understood that the terms “about,” “approximately,” “generally,” “substantially” and like terms, used herein when referring to a dimension or characteristic of a component of the disclosure, indicate that the described dimension/characteristic is not a strict boundary or parameter and does not exclude minor variations therefrom that are functionally similar. At a minimum, such references that include a numerical parameter would include variations that, using mathematical and industrial principles accepted in the art (e.g., rounding, measurement or other systematic errors, manufacturing tolerances, etc.), would not vary the least significant digit.

[0020] Referring to the drawings in detail, wherein like numerals indicate like elements throughout, there is shown in Figs. 1-3 A a first preferred embodiment of a dental imaging device, generally designated 10. The dental imaging device 10 includes a camera holder 12 that is preferably scallop shaped or generally rectangualar, an extension 14 that places or positions the camera(s) 50 in the mouth 60 relative to a patient’s teeth 62 or other patient anatomy and a handle 16 that is held external to the mouth 60. The dental imaging device 10 preferably defines a longitudinal axis 70 along which the cameral holder 12, extension 14 and handle 16 are positioned in the first preferred embodiment. The camera holder 12 has a proximal portion 12a and a distal portion 12b. The extension 14 has a curved shape or a U-shape in the first preferred embodiment to positioning relative to and engagement with the patient’s teeth, preferably the front teeth, to position the camera 50 for collecting the images. The handle 16 is connected to the extension 14 opposite the camera holder 12 and includes a power source 30 and a transmitter 32. The camera 50 is configured to collect images of the patient’s mouth and the transmitter 32 is configured to transmit the collected images to a central processor 34. The preferred transmitter 32 transmits the collected images to the central processor 34 by a wireless protocol, such as Bluetooth, but is not so limited and may be connected to the central processor 34 by a wired connection or may otherwise transmit the collected images.

[0021] The scallop or rectangular shaped camera holder 12 is advantageous for placing the lens surface of a camera 50 as far as possible from the field of view that is desired when taking intra-oral pictures. The cameral holder 12, specifically the distal portion 12b, is preferably configured to retract the patient’s tongue away from the camera 50 and the field of view 20 during use. The camera 50 is mounted to the distal portion 12b of the camera holder 12 such that the distal portion 12b is not limited to being scallop or rectangularly shaped and may have a thin tubular or cylindrical shape with the camera 50 mounted on the distal end, may be shaped and configured to engage the patient’s anatomy for orienting the camera 50 toward the teeth 62 that are being imaged or may be otherwise sized and shaped based on designer and user preferences. When placed into the roof of the mouth 60 (not shown) the scallop shape nests into the contours of the shape of the mouth 60 and may be designed and configured to conform to the shape of the roof of the patient’s mouth 60 to orient and position the camera 50 relative to the patient’s teeth 62. With the small camera(s) 50 and lens(es) installed into the scalloped holder 12 this provides a preferred mandibular occlusal view. The camera holder 12 can be used in the reversed position and placed against the tongue (Fig. 1) to capture a preferred maxillary occlusal view. The limited surface area contact with the tongue enables the user to apply pressure downwardly to the tongue providing increased field-of-view distance, thus optimizing the quality of the maxillary occlusal view. The camera holder 12, extension 14 and handle 16 are preferably constructed of a strong, resilient, biocompatible material, such as a structural polymeric material, that is able to take on the general size and shape of the dental imaging device 10, withstand the normal operating conditions of the dental imaging device 10 and perform the preferred functions of the dental imaging device 10.

[0022] The extension 14 is preferably shaped such that the camera(s) 50 can be placed without teeth 62 interfering with the positioning of the lens(es) of the camera 50 or without blocking a field of view 20 of the camera 50 from taking images of the patient’s teeth and gums. In one preferred configuration, the extension 14 has a shape that is curved or U-shaped to fit over the patient’s front teeth for positioning the camera 50 in the patient’s mouth to collect images of the patient’s arches. The extension 14 preferably has the U-shape when viewed from the side. Additionally, the shape of the extension 14 can provide a reference point for positioning the camera(s) 50 inside the patient’s mouth 60. In one configuration, the extension may be constructed of a flexible material, enabling shaping specifically to a user’s preference or anatomy, such as over the patient’s front teeth. The extension 14 may, therefore, be constructed of the same or different materials relative to the camera holder 12 and the handle 16 depending on whether the extension 14 is flexible or relatively strong and stiff. The extension 14 is not limited to being constructed of a flexible material and may be constructed of a stiff, strong material that is able to engage the patient’s anatomy to position the camera 50 relative to the patient’s arches for collecting the desired images.

[0023] The handle 16 is designed to be ergonomic such that the images can be taken by the patient themselves or by a clinician. The handle 16 can be used to provide power and electronic components to operate the camera(s) 50 using either batteries or by cord to another power source (not shown). The handle 16 may be electrically connected to a patient’s mobile device that is able to control the camera 50, collect images from the camera 50 and store the images 50 for transmission to a remote central processor, such as to a central processor that is accessible to the patient’s dentist or physician. The handle 16 may also include a wireless transmitter(s) (not shown) that enables wireless connection to a smartphone, computer tablet or personal computer; memory storage to collect images and transfer to a computer - similar to a universal serial bus (“USB”) memory stick or lightweight cable that is connected directly to a computer or other central processor. Accordingly, a live image of the camera images can be viewed by the user so that the camera holder 12 can be adjusted, however slightly or significantly, to obtain better framed images from the camera 50 by modifying the positioning of the camera 50 relative to the patient’s arches.

[0024] The dental imaging device 10 can be customized to the shape of a patient’s mouth or can be offered in multiple sizes to fit a multitude of patient sizes. For example, as shown in a second preferred embodiment of the dental imaging device, generally designated 110, in Figs. 4A-4C, the distal portion 112b of the camera holder 112 has a spoon shape that is designed and configured to retract or confirm to the shape of the patient’s tongue to urge the tongue away from the field of view 20 of the camera 50, 150 and to position and orient the camera 50, 150 for capturing the images of the patient’s upper dental arches or upper teeth 62. The distal portion 112b of the camera holder 112 may alternatively be designed and configured to fit the contours or nest into the roof of the patient’s mouth 60 for appropriate positioning of the camera 50, 150 when taking images of the lower dental arch or the patient’s lower teeth 62. The distal portion 112b may be generally sized and configured to engage portions of the patient’s anatomy within or adjacent to the mouth 60 such that the camera 50, 150 is oriented and spaced appropriately to acquire the desired images of the patient’s teeth 62 and dental arches. The same reference numbers are utilized to identify the similar components of second preferred dental imaging device 110 relative to the first preferred dental imaging device 10 with a “1” reference prior to the reference numbers of the second preferred embodiment to identify the similar features of the second preferred embodiment compared to the first preferred embodiment. The U-shaped hump of the extension 114 may be positioned closer or farther from the position of the camera 150 on the camera holder 112 to adjust the image ultimately collected by the camera 150 of the second preferred embodiment. The handle 116 may also be formed with differing widths and/or lengths. [0025] In the second preferred embodiment, the extension 114 has a generally U-shape with a first leg 114a, a center leg 114b and a second leg 114c, wherein the first leg 114a is attached to the handle 116, the second leg 114c is attached to the camera holder 112 and the center leg 114b spaces the first leg 114a from the second leg 114c. The first and second legs 114a, 114c preferably extend generally perpendicular to a longitudinal axis 170 of the dental imaging device 110 and the center leg 114b preferably extends generally parallel to the longitudinal axis 170. In use, the center let 114b is preferably positioned on an occlusal surface of the patient’s teeth 62, the first leg 114a is positioned proximate a facial or buccal surface of the teeth 62 and the second leg 114c is positioned proximate a lingual surface of the teeth 62. The extension 114 is not limited to this U-shaped configuration and may have a V-shape, a flexible shape, or nearly any shape that conforms to the patient’s anatomy to orient the camera 150 relative to the patient’s dental arches for acquiring the desired images.

[0026] Referring to Figs. 1-4C, the image capture may be accomplished by using a single or first camera 50 with a lens or with multiple cameras, such as first, second and third cameras 50, 150 and lenses. As shown in Fig. 1, for example, a single camera 50 or multiple cameras 50, 150 with a relatively wide field of view 20, which may have a pyramid shape, a cone shape or an alternative shape or exposure to preferably capture the desired portion of the patient’s arches, may be employed, which can capture a view of the entire upper or lower set of teeth 62. Alternatively, when the camera 50, 150 is placed at the roof of the mouth 60, the camera 50, 150 can capture a view of all of the lower set of teeth 62 or the full lower dental arch of the patient. For example, without limitation, a lens with an approximate three centimeter (3 cm) focus, an approximate one hundred degree (100°) horizontal field of view and an approximate seventy degree (70°) vertical field of view may be employed, although these characteristics are exemplary only and may be modified based on designer or user preferences. Alternatively, as shown in Fig. 2, dual cameras or first and second cameras 50 with smaller fields of view may be employed to cover the same or more area for collection or acquisition of the patient’s teeth and arches. This configuration with the first and second cameras 50, 150 may be employed to reduce lens distortion, increase resolution, or use smaller/lower cost cameras. Alternatively, as shown in Fig. 3, first, second and third cameras 50, 150 or more may also be clustered to expand the field of view, increase resolution, reduce lens distortion or a combination thereof. The camera 50, 150 may also capture the upper and lower teeth in a single (composite) image. The camera(s) 50, 150 may be angled in a variety of configurations, ranging from parallel to the flat surface of the camera holder 12, 112 to a ninety degree (90°) angle. In the multi-camera version of the dental imaging device 10, 110, the cameras 50, 150 may be angled in opposite directions such that in the ninety degree (90°) scenario outlined above, the cameras 50, 150 would be oriented “back-to-back". Optionally, the camera(s) 50, 150 may be used in conjunction with cheek retractors (not shown), which may be connected or attached to the image capture devices 10, 110 or may be separate instruments provided for use with the image capture devices 10, 110, for any or all of the desired images.

[0027] The camera(s) 50, 150 may be miniature, cell-phone type cameras, such as three by three millimeters (3 mm x 3 mm x 3 mm) but can be larger or smaller as practical for use and cost. The preferred camera 50, 150 will have a wide field of view, typically ninety degrees (90°) or greater horizontally (HFOV) and seventy degrees (70°) or greater vertical field of view (VFOV). Preferably, the camera(s) 50, 150 will keep the images in focus from about one inch (1”) or less to relatively significant distances for capturing images of the patient’s teeth and arches. Preferably, the camera(s) 50, 150 will have useful fixed focus but could also employ manual or automatic focus as appropriate to the particular patient’s anatomy or situation. Preferably, the camera(s) 50, 150 should have a resolution of one megapixel (1 MP) or greater. Preferably, the camera(s) 50, 150 will output color images, but is not so limited and may collect or acquire black and white images, video images, ultraviolet images or other images or combinations of images that are desired by the designer or clinician.

[0028] Non-limiting examples of suitable camera(s) 50, 150 include those manufactured by KLT or Kai Lap Technology Group, each with a three centimeter (3 cm) to infinity focus, such as, for example: KLT-K7MF 1MX258 V 2.0, featuring low cost, small size, thirteen megapixels (13 MP), HFOV 100, VFOW seventy degrees (70°); KLT-H3MPF-0V 5640 VI.0, featuring five megapixels (5 MP), HFOV 111, VFOW sixty-six degrees (66°); and KLT-E 4 MPF- 0V 9281 V 2.0, featuring one megapixel (1 MP), HFOV 99, VFOW fifty-five degrees (55°).

[0029] For appropriate lighting, the image capture devices 10, 110 may include one or more light emitting diodes (LEDs) or comparable lights (not shown) to illuminate the dark interior of the mouth 60. For connectivity, the device 10, 110 may be connected by cord to a smart phone, computer tablet or personal computer, or the dental imaging device 10, 110 can be connected by wireless means such as Bluetooth and is in communication with a central processor for storage, manipulation and arrangement of the collected images. In one configuration, the user will preferably review images at a screen of a smartphone (not shown) while taking the images. The smartphone will have user prompts to guide the user for capturing desired images.

[0030] For example, the user interface can facilitate the user selecting the shot or image that they want to take and have a specific camera/lens that is used for that shot. For instance, a straight-on camera shot would be taken for the three buccal views of the patient’s arches. Similarly, the user interface can guide the patient through an image capture sequence based on a predetermined sequence. By following either audio and/or written prompts, the user will be instructed as to what images are to be taken in specific sequence and any specific instructions they should follow. As a non-limiting example, the prompt may request that the user place the camera holder 12, 112 into the proper or desired position or to prompt the patient to open their mouth wider. When performed correctly, the user will be notified that the images are acceptable. [0031] The dental imaging device 10, 110, when paired with a smartphone, computer tablet or personal computer, will benefit from image correction and formatting software to ensure that images are of sufficient quality, that the images captured are sized consistently and that they are stored according to image type. Where more than one camera 50, 150 is employed, accompanying software may be configured to splice the multiple images together to provide a single image that appears to have been taken using a single camera 50, 150. Due to panoramic view and depth of field distortions - separately, accompanying software may be configured to automatically, or with user assistance or in “post-production”, correct for any lens distortions, color, brightness, contrast, sharpness corrections, a combination thereof or the like.

[0032] The accompanying software may additionally be configured to analyze the tooth number and size of each tooth’s three surfaces - lingual, front and chewing or occlusal surface. To determine the size of the teeth 62 more accurately, the software may first receive data collected from an intra-oral scanner, such as the camera 50, and compare the measurements for each tooth as determined by the scanner with those determined by the software. The scanner may be attached to the camera holder 12 or may be separately employed as a stand-alone component for manipulation and use by the patient or a clinician. The camera 50, 150 may also be designed and configured for both scanning and for image capture. The software may also be enabled to adjust a particular image to provide a distinct perspective of the teeth. For example, if a view that features the lingual side of the teeth 62 rather than the chewing surface is more advantageous, the software can adjust the view accordingly.

[0033] In a preferred method, the camera or scanner 50, 150 collects the desired images of the patient’s teeth 62 and the dental imaging device 10, 110 transmits the collected images of the patient’s teeth to the central processor 34, 134. The central processor 34, 134 analyzes the collected images to determine a captured number of teeth in the images and compares the captured number of teeth in the images to an expected number of teeth in the images. If the captured number of teeth and the expected number of teeth do not match, the central processor 34, 134 preferably sends a message to the patient’s dentist, orthodontist or physician or the patient regarding the miss-match. The central processor 34, 134 may also compare a captured size of the teeth in the images to an expected size of the teeth in the images to determine any inconsistencies and transmit a message regarding the inconsistencies or matching of the sizes.

The central processor may further save the results of any of the comparisons to the patient’s medical records for subsequent analysis or comparisons. The central processor 34, 134 may further adjust a first image of the collected images to provide a distinct perspective of a portion of the patient’s teeth, such as focusing the first image at a lingual, occlusal or alternative side of the patient’s teeth, focusing the first image on a specific tooth 62 of the patient’s teeth, focusing the first image on the patient’s gums, focusing the first image on a boundary between the patient’s gums and teeth or other adjustments or enhancements that are desirable for analysis, treatment or evaluation of the patient’s teeth, gums, arches or mouth.

[0034] The preferred dental imaging devices 10, 110 also preferably have a length L, 1L and a width W, 1W. The preferred length L, 1L is approximately four inches to fourteen inches (4- 14”) and the width W, 1W is approximately one-quarter to three-quarters of an inch (¼- ¾”) but are not so limited and may be otherwise sized and configured based on designer preferences, clinician preferences, patient anatomy or otherwise designed. The camera 50, 150 is preferably positioned approximately one to two inches (1-2”) distally on the camera holder 12, 112 relative to the extension 14, 114 such that the desired image(s) is collected when the extension 14, 114 is engaged with the patient’s anatomy, such as the front teeth. The extension 114 preferably has a curved shape or a U-shape when viewed from the side. The camera holder 12, 112 includes the proximal portion 12a, 112a and the distal portion 12b, 112b, with the camera 150 mounted in a depression of the spoon-shaped distal portion 112b in the second preferred embodiment. The handle 16, 116 is preferably sized and configured such that the user is able to comfortably grasp the proximal end of the handle 16, 116 to manipulate the camera 50, 150 into the desired location in the patient’s mouth, the extension 14, 114 is engaged with the patient’s anatomy and the patient is able to manipulate the capture of images during operation of the dental imaging devices 10, 110. The extension 14, 114 preferably defines a height H, 1H relative to the camera 50, 150 such that the camera 50, 150 is positioned below the occlusal surfaces of the teeth opposite the dental arch of which the camera 50, 150 is taking the images. The height H, 1H is approximately one-quarter to three-quarters of an inch (¼- ¾”) but is not so limited and may be otherwise sized and configured for desired positioning of the camera 50, 150 relative to the patient’s dental arches.

[0035] Referring to Figs. 4A-4C, the second preferred dental imaging device 110 may include the relatively solid cylindrical and tapered handle 116 of Figs. 4A-4C, the cylindrical shaped handle 116 of Fig. 4A-4C or alternative styles and designs of handles, such as the relatively flat rectangular handle 16 of the first preferred embodiment, that generally do not significantly impact the function or operation of the dental imaging device 110. The handle 116 preferably accommodates the power source 130, a control button 131 and the transmitter 132, wherein the transmitter 132 is configured to transmit the collected images to the central processor 134 and the control button 131 may be designed and configured to power off and on the dental imaging device 110, actuate collection of images from the camera 150, transmit collected images from the dental imaging device 110 to the central processor 134 with the transmitter 132 or otherwise provide control of the dental imaging device 110 and its functions for the user. The dental imaging device 110 is not limited to including the single preferred control button 131 and may be designed and configured with additional or alternative control buttons based on designer and user preferences. The power source 30, 130 may be comprised of a battery, more preferably a rechargeable battery in the preferred embodiments, but is not so limited and may be comprised of nearly any type and variety of power source 30, 130 that is able to provide power to the dental imaging device 110 to perform the preferred functions described herein. The camera holder 12, 112 preferably has a spoon-like shape or configuration with the camera 50, 150 positioned within the depression of the camera holder 12, 112 and the edges configured to retract the patient’s tongue or soft tissue of the mouth while taking the images with the camera 50, 150. The camera holder 12, 112 is not limited to having the spoon-like configuration and may be generally planar, cylindrical or otherwise designed and configured to position the camera 50, 150 for collecting the desired images of the patient’s dental arches and teeth.

[0036] In the preferred embodiments, the dental imaging device 10, 110 may be disposable or may alternatively be reusable. When reusable, the dental imaging device 10, 110 is preferably sterilizable for multiple uses or may be sterilizable for at-home use by a single patient.

[0037] It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concept thereof. It is understood, therefore, that this disclosure is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the present disclosure as defined by the present description.