Reference to Related Applications

[0001] This application claims priority from US Application No. 62/618724 filed 18 January 2018. For purposes of the United States, this application claims the benefit under 35 U.S.C. §1 19 of US Application No. 62/618724 filed 18 January 2018 and entitled BIMAXILLARY IMPLANT-SUPPORTED MANDIBULAR ADVANCEMENT (BIMA) THERAPY which is hereby incorporated herein by reference for all purposes.

Technical Field [0002] The present invention relates to methods and devices for positioning a patient’s lower jaw (mandible). Such methods and devices have example applications in reducing snoring, treatment of Obstructive Sleep Apnea (OSA) and related sleep disorders.

Background [0003] Problems snoring and other sleeping disorders can have significant adverse impacts on quality of life and overall health. Narrowing or collapse of the upper airway is a root cause of such sleeping disorders.

[0004] Snoring can irritate other people. Excessive snoring can strain relationships. Loud snoring is also a symptom of OSA. [0005] OSA is characterized by the repeated collapse of a patient’s upper airway during sleep and the complete or partial obstruction of airflow. During these collapses, patients experience episodes of shallow or paused breathing. These episodes result in repeated awakenings and/or drops in blood oxygen levels. This disordered breathing during sleep can result in daytime symptoms such as sleepiness, cognitive impairment, and a general decrease in quality of life. OSA is also associated with increased risk of motor vehicle accidents, cardiovascular disease, and overall lowered life expectancy, which highlights the need for effective long-term treatment. [0006] Currently the two main non-surgical treatment modalities for OSA are

Continuous Positive Airway Pressure (CPAP) and mandibular advancement devices. CPAP delivers pressurized air to stent the airway open while the patient breathes.

The pressurized air is delivered from a CPAP machine by way of a facial mask worn during sleep. While CPAP is effective in treating OSA symptoms, many patients find CPAP cumbersome as CPAP machines can be loud and CPAP face-masks are typically tight fitting. The feeling of forced air may also not be tolerated by some patients. Accordingly, CPAP suffers from very low patient acceptance and long-term compliance with treatment is poor.

[0007] Mandibular advancement devices are intra-oral appliances which function by pulling the patient’s lower jaw and the associated soft tissues of the throat forward, away from the airway. Such devices can help to keep the airway open during sleep. Most currently-available mandibular advancement devices attach to the teeth as a means of holding the mandible in position. Studies have reported unwanted changes to a patient’s bite, and that long-term treatment using such devices leads to significant changes in occlusion for the majority of patients.

[0008] Some prior art proposes intra-oral dental appliances which hold the mandible forward using mini-implants or bone screws. US Patent Application 2012/0040301 A1 discloses a device that connects directly to implants in the maxilla and mandible to advance the mandible. However, the degree of mandibular advancement that is possible using this device, and therefore, the amount of clinical effectiveness, is limited. Furthermore, the use of mini-implants placed anterior to the canines can lead to discomfort and esthetic concerns. US Patent Application 2009/0032030 A1 discloses a mandibular advancement device that requires the use of mini-implants in conjunction with aligners or similar components that contact the teeth. This device may delay but not eliminate the unwanted movement of teeth.

[0009] There is a general need for new mandibular advancement devices and related methods that may be more acceptable to users. There is a particular need for such devices and methods that facilitate increased compliance with treatments for sleep disorders such as excessive snoring and OSA and address the problem of unwanted tooth displacement. Summary

[0010] The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools and methods which are meant to be exemplary and illustrative, not limiting in scope. In various embodiments, one or more of the above- described problems have been reduced or eliminated, while other embodiments are directed to other improvements.

[0011] This invention has a number of aspects. These include, without limitation:

• appliances for advancing a wearer’s mandible and parts for such appliances;

• kits containing parts and/or tools for installing and/or fitting appliances for advancing a wearer’s mandible;

• methods for manufacturing customized appliances for advancing a wearer’s mandible;

• methods and appliances for coupling to various types of bone implants;

• methods and apparatus for retaining a wearer’s mandible at a desired position;

• methods and apparatus for reducing snoring; and

• methods for treating obstructive sleep apnea.

[0012] One aspect of the invention provides an appliance for advancing a wearer’s mandible. The appliance comprises an anchor member comprising a generally U- shaped member having left-side and right-side arms joined by a curved portion, each arm supporting a first and second fitting spaced apart from each other. The first fitting is adapted to detachably couple the anchor member to a first bone anchor located on an inside of the arm such that the second fitting is cantilevered in an anterior direction relative to the first bone anchor. The appliance further comprises elongate left-side and right-side tension members. Each tension member has a first end coupled to the second fitting on the arm of each respective side. The left-side and right-side tension members comprise a third fitting at a second end opposed to the first end. The third fitting of the left-side and right-side tension members is adapted to respectively detachably couple the second end of the tension member to a left-side and right-side second bone anchor.

[0013] In some embodiments, the tension members are removably coupled to the second fittings. The tension members may be pivotally coupled to the second fittings. In some embodiments, the second fittings each comprise a projecting head and the tension members each comprise a socket engageable with the projecting head of the corresponding second fitting.

[0014] In some embodiments, a center-to-center distance between the first and second fittings of each of the left-side and right-side arms is shorter than a center-to- center distance between the second and third fittings along the corresponding left side or right-side tension member. The distance between the second and third fittings may be in the range of 30 mm to 45 mm. The distance between the first and second fittings along each of the left-side and right-side arms may be at least 3 mm. In some embodiments, when the wearer’s mandible is closed, an angle between the anchor member and each of the left-side and right-side tension members is 50 degrees or less.

[0015] In some embodiments, the first fittings each comprise a socket configured to snap on to a ball-shaped head of the first bone anchor. The third fittings may each comprise a socket configured to snap on to a ball-shaped head of the second bone anchor. In some embodiments, at least one of the left-side and right-side tension members comprises a rigid bar. In other embodiments, the left-side and right-side tension members comprise an elastic belt, a wire, a monofilament line, or a linkage comprising two or more pivotally connected links. At least one of the left-side and right-side tension members may be adjustable in length, for example by way of a screw-type length adjustment mechanism.

[0016] In some embodiments, the anchor member is made of a polyamide plastic which may be a biocompatible polyamide 12 plastic. In some embodiments, the anchor member is thinner in a plane of the anchor member and wider in a direction perpendicular to the plane of the anchor member. In some embodiments, the left-side and right-side tension members have different lengths. The appliance may comprise a set of interchangeable tension members of different lengths. In some embodiments, the bone implants each comprise a bone screw or plate.

[0017] Another aspect of the invention provides an appliance for advancing a wearer’s mandible. The appliance comprises a left-side and right-side part configured for applying traction to a left side and right side of the wearer’s mandible, respectively. Each of the left-side and right-side parts comprises an anchor member comprising a first and second fitting spaced apart from each other. The first fitting is adapted to detachably couple the anchor member to a first bone anchor in the wearer’s maxilla such that the second fitting is cantilevered in an anterior direction relative to the first bone anchor. Each of the left-side and right-side parts further comprises an elongate tension member having a first end coupled to the second fitting of the anchor member. The tension member comprises a third fitting at a second end opposed to the first end adapted to detachably couple the second end of the tension member to a second bone anchor in the wearer’s mandible. In some embodiments, the left-side and right-side parts are coupled together by a joining part that connects front ends of the left-side and right-side anchor members. The joining part may be formed integrally with the left-side and right-side anchor members. The middle portion of the joining part may be narrowed.

[0018] Another aspect of the invention provides an appliance for advancing a wearer’s mandible. The appliance comprises an anchor member comprising a first and second fitting spaced apart from each other, the first fitting adapted to detachably couple the anchor member to a first bone anchor such that the second fitting is cantilevered in an anterior direction relative to the first bone anchor. The appliance further comprises an elongate tension member having a first end coupled to the second fitting of the anchor member and comprising a third fitting at a second end opposed to the first end. The third fitting is adapted to detachably couple the second end of the tension member to a second bone anchor.

[0019] Another aspect of the invention provides a method for manufacturing an appliance for positioning a wearer’s mandible. The method comprises obtaining an intraoral scan of the wearer’s mouth and bone implants in the wearer’s maxilla. The method processes the intraoral scan to determine locations of the bone implants, define a gum-line of the wearer’s maxilla, and define a model path that conforms to and is spaced apart from the gum line by an offset distance. A solid model is generated for an anchor member such that an inner surface of the modelled anchor member follows the model path. Attachment features at locations corresponding to the bone implants are included in the solid model. The method then generates an anchor member according to the solid model by a computer controlled manufacturing process. In some embodiments, the offset distance is in the range of 0.5 mm to 3 mm.

[0020] Another aspect of the invention provides a method for treating a patient afflicted by obstructive sleep apnea. The method comprises installing at least one bone implant into either side of the patient’s maxilla and at least one bone implant into either side of the patient’s mandible. Lengths of tension members are selected for an appliance described herein which will advance the patient’s mandible by a desired projection amount. The appliance, including the selected tension members, is then connected to the bone implants. [0021] In addition to the exemplary aspects and embodiments described above, further aspects and embodiments will become apparent by reference to the drawings and by study of the following detailed descriptions.

Brief Description of the Drawings

[0022] The accompanying drawings illustrate non-limiting example embodiments of the invention.

[0023] FIG. 1 is a schematic drawing illustrating the operation of a mandibular advancement device that uses bone dental implants to couple to a wearer’s maxilla and mandible.

[0024] FIG. 2A is a perspective view of an exemplary mini-implant. [0025] FIG. 2B is a schematic illustration showing the attachment of an installed mini implant to a tension member socket.

[0026] FIG. 2C is a schematic illustration showing the use of miniplates for anchoring an appliance.

[0027] FIG. 3 is a perspective view of a mandibular advancement device according to an example embodiment.

[0028] FIG. 4 is a magnified perspective view of the anchor member of the mandibular advancement device of FIG. 3. [0029] FIG. 5 is a perspective view of a tension member according to an example embodiment.

[0030] FIG. 6 is a plan view of the mandibular advancement device of FIG. 3.

[0031] FIG. 7 is a side elevation view of a model dental anatomy showing example mini-implant locations.

[0032] FIG. 8 is a perspective view of the mandibular advancement device of FIG. 3 installed onto a model dental anatomy.

[0033] FIG. 9A is a block diagram showing an example method for providing a mandibular advancement device customized for a specific wearer’s dental anatomy. [0034] FIG. 9B is a block diagram showing an example algorithm for determining anchor member dimensions customized for a specific wearer’s dental anatomy.

[0035] FIG. 10 is a table illustrating an example set of standard tension member lengths.

[0036] FIGS. 1 1 A - 1 1 B are different views of a tension member according to an example embodiment.

[0037] FIG. 1 1 C is a schematic illustration of an adjustable tension member according to an example embodiment.

[0038] FIG. 12 is a block diagram showing an example method for selecting an appropriate tension member length. Description

[0039] Throughout the following description specific details are set forth in order to provide a more thorough understanding to persons skilled in the art. However, well known elements may not have been shown or described in detail to avoid

unnecessarily obscuring the disclosure. Accordingly, the description and drawings are to be regarded in an illustrative, rather than a restrictive, sense.

[0040] The present invention relates to mandibular advancement devices. An example application of such devices is managing sleep disorders such as excessive snoring or OSA. Example embodiments provide intra-oral appliances that can be anchored to a wearer’s upper jaw (maxilla) and mandible by way of intra-oral implants in the maxilla and mandible. The appliances include members that pull the mandible forward into a position at which obstruction of the upper airways is reduced or eliminated.

[0041] FIG. 1 is a schematic diagram illustrating a system 10 according to an example embodiment. System 10 comprises an anchor member 12 that is attachable to a wearer’s maxilla 20 by way of one or more bone implants. FIG. 1 shows bone implants 18A and 18B. A tension member 14 extends from an anchor point 16 on anchor member 12 and is attachable to the wearer’s maxilla 20 by way of one or more bone implants. FIG. 1 shows bone implant 18C. Tension member 14 is dimensioned to have a length short enough to pull the person’s mandible 22 forwardly into a desired position. Tension member 14 transfers forces 24 to the person’s mandible 22 by way of bone implant 18C. Forces 26 applied to anchor member 12 by tension member 14 are transferred to the wearer’s maxilla by way of bone implants 18A and/or 18B.

[0042] Advantageously, anchor point 16 is cantilevered forward from bone implants 18A and 18B by anchor member 12. The distance between the more anteriorly situated bone implant 18A and anchor point 16 may be represented by d _a . In some embodiments, d _a is in the range of about 3 mm to 10 mm. In some embodiments, anchor point 16 is at least 4 mm or 5 mm forward from bone implants 18A and 78B. Preferably, anchor point 16 is located anteriorly (at or further forward than) from a wearer’s maxillary canine teeth. The angle at which anchor member 12 extends relative to tension member 14, which is the same as the angle that is formed between tension member 14 and the horizontal direction along mandible 22, may be represented by Q. A cantilevered anchor point 16 permits Q to be smaller than would be the case if tension member 14 were attached at the location of bone implant 18A. This allows forces 24 to be directed more nearly parallel to a direction along mandible 22 than would be the case if anchor point 16 were at a more posterior location, while avoiding aesthetic concerns of positioning bone implants too close to the front of the wearer’s maxilla. In some embodiments, Q is 50° or less or 45° or less. [0043] FIG. 1 shows only that part of system 10 on the right hand side of a wearer’s mouth. In most cases system 10 includes parts that act on both the right and left sides of a person’s mandible. These parts may be separate or combined into a single part. It is both convenient and advantageous to provide a single component that provides an anchor member for both sides of a wearer’s mouth. However, this invention may also be practiced with separate anchor members for left and right sides of a wearer’s mouth. It is not necessary for system 10 to be completely symmetrical. The distance the mandible is advanced by system 10, also referred to herein as “protrusion”, will not always be the same for each side.

[0044] Anchor member 12 is preferably shaped to fit inside a wearer’s mouth between the wearer’s maxilla and cheek. Anchor member 12 may take a variety of forms. Anchor member 12 is preferably spaced apart from the wearer’s gums when in use. The cross-section of anchor member 12 may be flattened. Anchor member 12 may have a width in a superior/inferior direction that is greater than a thickness in a direction perpendicular to the wearer’s maxilla. In other words, the anchor member may be thinner in a plane of the anchor member and wider in a direction

perpendicular to the plane of the anchor member. This is advantageous for best withstanding the forces applied by tension member 14 and also for wearer comfort. The closer anchor member 12 is to the occlusal plane, the more anchor member 12 can project anteriorly and/or labially without contacting the inside of the cheeks/lips in a way likely to cause discomfort to a wearer. Preferably, anchor member 12 overlaps with at least a portion of a wearer’s upper teeth.

[0045] In some embodiments, anchor member 12 has the form of an arch or U-shape that is shaped and sized to generally conform to the shape of the wearer’s maxilla. Opposed arms of the U-shape provide an anchor member 12 for each side of the wearer’s mouth. The curved portion of anchor member 12 that extends across the anterior portion of the maxilla helps to stabilize anchor points 16.

[0046] Anchor member 12 may be made of a suitable biocompatible material such as a suitable grade of plastic or metal. For example, anchor member 12 may comprise a suitably shaped rod, bar, or other suitable member. [0047] Tension member 14 may have a variety of forms. Tension member 14 is typically elongated and has a first fitting at a first end for coupling to anchor member 12 at anchor point 16 and a second fitting at a second end for coupling to bone implant 18C. Portions of tension member 14 between the first and second fittings may be stiff (e.g., tension member 14 may comprise a stiff rod or bar) or may be laterally flexible. Portions of tension member 14 between the first and second fittings may be elastically extendable or substantially non-elastic under the forces expected in use. Tension member 14 may be made of any suitable biocompatible material or materials.

[0048] Tension member 14 may be fixed in length or adjustable in length. Where tension member 14 is fixed in length, system 10 may include a set of tension members 14 of different lengths such that the position to which system 10 urges the wearer’s mandible is adjustable by selecting an appropriate one of the set of tension members 14.

[0049] The coupling between tension member 14 and bone implant 18C may take any of a wide variety of forms. It is convenient for the coupling to be a snap-fit type coupling in which the second fitting can be engaged to bone implant 18C by pressing and removed from bone implant 18C by pulling. Especially if tension member 14 is relatively stiff against lateral deflection it is desirable that the coupling allows tension member 14 to pivot with respect to bone implant 18C.

[0050] The coupling of tension member 14 to anchor member 12 at anchor point 16 may permit tension member 14 to be removably attached to anchor member 12. In some embodiments, the coupling is a snap-fit type coupling in which the first fitting can be engaged to anchor member 12 by pressing and removed from anchor member 12 by pulling. Especially if tension member 14 is relatively stiff against lateral deflection it is desirable that the coupling at anchor point 16 allows tension member 14 to pivot with respect to anchor member 12.

[0051] In some embodiments, anchor member 12 and tension member 14 are constructed as a single part having a hinged or flexible connection. For example, in some embodiments, the tension member and anchor member are constructed as a single part or in a way that the tension member is not removable from the anchor member. In such embodiments, one or both of the tension member and anchor member are flexible to provide freedom of movement of the wearer’s mandible laterally.

Design alternatives

[0052] Many interfaces providing a connection of anchor member 12 to tension member 14 at anchor point 16 are possible. As an illustrative example, in some embodiments, the interface at anchor point 16 comprises a revolute joint, a slot joint, a universal joint, a keyhole mechanism (e.g. as described below), or a hook or similar projection that engages a loop. It is also not necessary that the interface extends labially from anchor member 12 as illustrated in FIG. 1 . In other embodiments, the interface for coupling anchor member 12 to tension member 14 may extend interiorly, superiorly, or anteriorly from anchor member 12.

[0053] The selection of an appropriate interface may depend on the design of tension member 14 and/or any attachment features present on tension member 14. The coupling of tension member 14 to mandibular implant 18C may, for example, employ any of the possible interfaces described for coupling anchor member 12 to tension member 14. Preferably, at least one of the two couplings of tension member 14 allow for rotational motion. In some embodiments, both of tension member 14’s couplings allow for rotational motion of tension member 14.

[0054] Many designs for tension members 14 are possible. For example, tension members 14 may be provided by:

• rigid or semi-rigid members (e.g. rods or bars);

• elastic belts, bands or straps;

• lengths of suitable cord such as orthodontic wire, monofilament line or the like;

• linkages comprising two or more links pivotally connected together;

• etc.

• that couple to any appropriate interface at anchor point 16, and to a bone implant 18C in the wearer’s mandible.

[0055] Any practical manner of providing an attachment point located anteriorly to maxillary bone implants and a connector connecting the attachment point to a posteriorly located mandibular bone implant may be applied in practising the present invention.

[0056] Removable attachment of anchor member 12 to bone implants 18A, 18B may be provided by any coupling arrangement which will hold anchor member 12 against the forces exerted at anchor point 16 by tension member 14. For example, anchoring of anchor member 12 to bone implants may be provided by:

• snap-fit type couplings;

• ball and socket couplings;

• hooks that engage loops or other hooks;

• threaded fasteners;

• keyhole mechanisms in which a keyhole shaped aperture having a slot

extending from a larger opening and the aperture receives a member having a wider part extending from a narrower part such that the narrower part can be positioned in the slot with the wider part inside the slot such that the member is securely held; and/or

• keyed joints.

Implant design

[0057] Bone implants (e.g. 18A, 18B, 18C) each comprise a bone anchor portion and a portion formed to couple to anchor member 12 or tension member 14. These bone implants may take a wide variety of forms.

[0058] FIG. 2A is a perspective view of an exemplary mini-implant 30 which may be installed into a wearer’s jaw to anchor mandibular advancement devices as described herein. Mini-implant 30 has a threaded shank 32, a collar 34, and a ball head 36. In some embodiments, threaded shank 32 has a self-tapping thread. When mini-implant is installed into a wearer’s jaw, all threads on shank 32 are preferably subgingival and the start of collar 34 is flush with the top of a wearer’s gingiva.

[0059] Mini-implants such as mini-implant 30 illustrated in FIG. 2A are typically installed so that shank 32 projects between a wearer’s tooth roots. Contact between a tooth root and a mini-implant may cause injury, and thus, root contact of mini-implants employed in the present invention is preferably avoided. [0060] In the illustrated mini-implant 30, ball head 36 extends axially and radially from collar 34 and comprises drive socket 38. Drive socket 38 may comprise a suitably shaped (e.g. hexagonal) cavity in ball head 36 which facilitates mini-implant 30 being rotated and thereby advanced into, or retracted from, a wearer’s jaw.

[0061] FIG. 2B is a schematic cross-sectional view illustrating the attachment of screw 30 to an example anchor member 40 using a snap-fit type coupling. Screw 30 is securely fixed in a wearer’s jaw 46, with the start of collar 34 being flush with the surface of gingiva 48. Ball head 36 is advanced past a tapered hole 42 and is retained in socket 44 of anchor member 40, thereby detachably coupling mini-implant 30 with anchor member 40 and allowing for anchor member 40 to be rotated about ball head 36 absent any other coupling of anchor member 40. Preferably, a gap is provided between anchor member 40 and a wearer’s gingiva 48, the gap distance represented by d _g . In some embodiments, d _g is a few mm or less. For example, d _g may be in the range of about 0.5 mm to 3 mm.

[0062] In some embodiments, mini-implant 30 has an outer thread diameter of a few mm or less. In a preferred embodiment, mini-implant 30 has an outer thread diameter of 1 .6 mm. In some embodiments, mini-implant 30 has a length in the range of about 5 mm to 10 mm measured from the tip of shank 32 to the end of collar 34. In a preferred embodiment, mini-implant 30 has a length of 6 mm. In some embodiments, ball head 36 has a diameter of 3.00 mm +/- 0.05 mm.

[0063] In some embodiments, mini-implant 30 is designed to be easily removable from a wearer’s jaw and is intended for temporary use. In other embodiments, mini implant 30 is designed to be permanently or semi-permanently attached to a wearer’s jaw once implanted. In embodiments where a more permanent attachment to bone is desirable, threads on shank 32 may be coated with a material that enhances osteointegration of the implant. Examples of coatings that may be provided include, but are not limited to, carbon, bisphosphonates, bioactive ceramics, fluoride, hydroxyapatite, and calcium phosphate. In some embodiments, shank 32 may be constructed of a material which enhances osteointegration between mini-implant 30 and the wearer’s jaw, such as titanium. Miniplate design

[0064] Any suitable bone anchors may be used to support a mandibular advancement device as described herein. For example, as an alternative to or in addition to interfacing with individual mini-implants in the alveolus of the maxilla and mandible, a mandibular advancement device may interface with protruding heads or other features supported by miniplates. Use of mini-implants 30 is only an illustrative example.

[0065] In an example embodiment, two mini-plates are placed in the maxilla (one on the right, one on the left), and two miniplates are placed in the mandible (one on the right, one on the left). FIG. 2C shows an example attachment of a mandibular advancement device to various interface features on miniplates 50A and 50B. As illustrated, miniplate 50A may be secured o the wearer’s infra-zygomatic crest of a wearer’s maxillary buttress. Miniplate 50B may be secured to the buccal shelf of the wearer’s mandible. Miniplate 50A is shown to be a 3-hole miniplate whereas miniplate 50B is shown to be a 2-hole miniplate. Other configurations are also possible.

Miniplates 50A and 50B may be fixed to bone by suitable fasteners such as monocortical miniscrews 52. Miniscrews 52 may, for example, have a diameter of 2 mm and a length of 5 mm. Miniscrews 52 and corresponding portions of miniplates 50A and 50B are typically located under gingival tissue once installed.

[0066] Miniplate 50A supports an elongated head 54. Miniplate 50B supports a spherical head 56. Miniplates 50A and 50B and their respective heads 54 and 56 may be positioned in such a way that the part of miniplates 50A and 50B which connect to heads 54 and 56 exits the gingival tissues at or incisal to the mucogingival junction. In the maxilla, head 54 may be located in the region of the second premolar. In the mandible, head 56 may be located in the region of the first molar. Elongated head 54 may be inserted into a correspondingly shaped cavity in anchor member 62 to support anchor member 62 against posterior and inferior rotation and movement. Spherical head 56 may rotationally couple to a mandibular attachment feature on tension member 64 using a snap-fit type coupling, for example. Spherical head 56 may, for example, have a spherical shape, ranging from 2-8mm in diameter, ideally 3mm, as described above. Method of medical treatment

[0067] Some embodiments of the present invention provide a method for medical treatment of patients who experience disorders due to their airways being obstructed during sleep. The method involves installing at least one bone implant into either side of the maxilla and at least one implant into either side of the mandible. The method further involves advancing the patient’s mandible by installing an intra-oral appliance to the bone implants installed into the patient’s jaws. The intra-oral appliance may provide an anteriorly located point near the maxilla for attaching one end of a tension member. Another end of the tension member may be attached to a bone implant located in the mandible, the tension member pulling the mandible forward and thereby moving soft tissue obstructing the patient’s airway away. The intra-oral appliance may, for example be worn while the patient is sleeping to reduce or prevent OSA. In some embodiments of the method a set of progressively shorter tension members is provided. The patient may use the tension members in a sequence such that over a few days or weeks the advancement of the mandible is increased.

Example embodiment

[0068] FIG. 3 illustrates a mandibular advancement device 100 according to an example embodiment of the invention. Device 100 comprises anchor member 1 12 which is installed labially over a wearer’s maxilla and is held in place between the wearer’s maxilla and lips/cheeks while being worn. Anchor member 1 12 comprises side bars 130 which extend from approximately a wearer’s premolar teeth to their molar teeth on both sides of their mouth while device 100 is being worn.

[0069] Anchor member 1 12 further comprises a curved front arch portion 140 which extends between and connects side bars 130. Anchor member 1 12 may comprise a single unitary part. Front arch portion 140 preferably has a curvature and chamfer angle closely matching the curvature of a wearer’s gum line without being in contact with the gums or teeth while being worn. For example, anchor member 1 12 may be dimensioned and shaped to be spaced apart from the wearer’s gums by

approximately 0.5 mm to 3 mm while device 100 is being worn. [0070] Optionally, front arch portion 140 comprises indent 142 at its centre. Indent 142 can be used to indicate the optimal location to hold device 100 during installation into a wearer’s mouth for proper alignment of device 100.

[0071] Device 100 additionally comprises two tension members 1 14, which have a rotational connection to anchor member 1 12 at interfaces 1 16 (components not shown). In this embodiment, each tension member 1 14 is provided by a rigid bar. The degrees of freedom and permitted rotation of tension members 1 14 relative to anchor member 1 12 are not required to be limited. However, when device 100 is in use, tension members 1 14 extend from their points of attachment at interfaces 1 16 inferiorly and posteriorly generally toward the wearer’s mandibular molars.

[0072] FIG. 4 is a magnified view of the left side of anchor member 1 12 detached from tension member 1 14. FIG. 4 shows an example construction for attaching anchor member 1 12 to a wearer’s maxilla. In this example embodiment each side bar 130 of anchor member 1 12 comprises a socket 132 shaped and dimensioned to receive a head of a first bone implant. The heads of the bone implants may, for example, comprise balls. Side bars 130 also comprise recesses 134 located posteriorly from socket 132. Recesses 134 bear against a head of a second bone implant when device 100 is being worn. Abutting engagement of the second bone implants with recesses 134 resists rotations of anchor member 1 12 in a sense that would allow front arch portion 140 to move in an inferior direction.

[0073] FIG. 4 also illustrates an example coupling between anchor member 1 12 and a tension member. In this embodiment the coupling is provided by a ball post 136 with a ball end that extends labially from side bar 30. The ball end of ball post 136 is dimensioned to be received in a corresponding socket in a corresponding tension member 1 14.

[0074] FIG. 5 is a component view of an example tension member 1 14. Tension member 1 14 comprises upper socket 124 for interfacing with a ball post 136 on anchor member 1 12. Tension member 1 14 further comprises a lower socket 126 for attaching to an intra-oral implant in a wearer’s mandible.

[0075] FIG. 6 shows the connection of anchor member 1 12 to tension member 1 14. Ball post 136 and upper socket 124 are dimensioned such that upper socket 124 snaps onto a ball end of ball post 136. The ball end of ball post 136 may, for example, comprise a generally spherical ball having a diameter in the range of about 2 mm to 8 mm. Preferably, the diameter is around 3mm. The illustrated ball and socket design provides an advantage of permitting at least a limited range of movement of tension members 1 14 in all directions, providing wearers with greater comfort and providing clinicians with greater latitude in installing device 100.

[0076] Preferably tension members 1 14 can remain attached to anchor member 1 12 at all times except when a new set of tension members 1 14 is desired to achieve desired positioning of the mandible. Accordingly, in some embodiments, a wearer may periodically replace tension members 1 14 with shorter tension members 1 14 over a period (e.g. of days or weeks) until a desired positioning of the mandible is achieved.

[0077] Device 100 is preferably constructed from a biocompatible material or materials. In some embodiments, the biocompatible material is a durable polymeric substance. According to a more specific embodiment, the polymeric substance is a plastic. In a more specific embodiment, the plastic is a semi-flexible plastic. In yet another embodiment, device 100 is constructed from a polyamide plastic. According to a more specific embodiment, the polyamide plastic is biocompatible polyamide 12. In some embodiments, tension members 1 14 and anchor member 1 12 are

constructed from different materials.

[0078] It is not necessary that ball post 136, when provided, extends labially from anchor member 1 12. In some embodiments, ball post 136 extends interiorly from anchor member 1 12, with upper socket 124 being shaped accordingly to attach to ball post 136 to permit rotational motion. Such embodiments may be desirable in cases where the labial projection of tension member 1 14 causes discomfort to a wearer.

Mode of use of device

[0079] FIG. 7 is a left side perspective view of a wearer’s dental anatomy showing locations at which bone implants are provided for an example mandibular positioning system. In this example the bone implants are mini dental implants 1 18, which are referred to generally herein as mini-implants 1 18. Mini-implants 1 18A and 1 18B are attached to the wearer’s maxilla 120. Mini-implant 1 18C is attached to the wearer’s mandible 122 posteriorly to mini-implants 1 18A and 1 18B. Each mini-implant 1 18 comprises a screw portion for engagement in the wearer’s bone and a projecting portion which may, for example, have the form of a ball for coupling to a mandibular advancement device 100.

[0080] FIG. 8 shows an example method of attaching mandibular advancement device 100 in a wearer’s mouth using the mini-implants 1 18 illustrated in FIG. 7. Anterior socket 132 is shaped to surround and be supported by mini-implant 1 18A in the anterior, inferior, and superior directions. Recess 134 is supported against moving in the superior direction by mini-implant 1 18B.

[0081] The locations and orientations of mini-implants 1 18A and 1 18B in the maxilla will vary from user to user. Anchor member 1 12 may be made to place mini-implant interfaces e.g., socket 132 and recess 134 in alignment with mini-implants 1 18A and 1 18B respectively on each side of the wearer’s mouth. Preferably, the center of each mini-implant 1 18A maps to the center of the corresponding socket 132 and the center of each mini implant 1 18B maps to the center of the corresponding recess 134. Mini implants 1 18A and 1 18B interface with sockets 132 and recesses 134 so as to restrict the posterior and inferior rotation and movement of front arch portion 140 when tension member 1 14 is put in tension.

[0082] Lower socket 126 of tension member 1 14 interfaces with mini-implant 1 18C attached to the wearer’s mandible. Preferably, lower socket 126 is sized so that lower socket 126 snaps firmly onto mini-implant 1 18C. Lower socket 126 is preferably easily removable from mini-implant 1 18C while being attachable to mini-implant 1 18C securely enough that mini-implant 1 18C is retained by lower socket 126 while the wearer sleeps. Mandibular advancement device 100 comprises interface features that permit it to be easily installed into and removed from a wearer’s mouth on a nightly basis. A wearer may put mandibular advancement device 100 on by snapping socket 132 over the corresponding mini-implant 1 18A, rotating anchor member 1 12 until recess 134 comes into contact with and is supported by mini-implant 1 18B, advancing their mandible until lower sockets 126 are aligned with corresponding mini-implants 1 18C and snapping lower sockets into engagement with the corresponding mini implants 1 18C. Installation of device 100 onto a wearer’s mouth may comprise performing the above actions in any alternate order. The reverse of the above actions may be performed to remove mandibular advancement device 100.

Fitting of device

[0083] In some embodiments, a mandibular advancement device (also referred to as an“appliance”) as described herein is custom made to fit a particular wearer’s dental anatomy. FIG. 9A is a flowchart showing a non-limiting example method 200 that may be performed to provide an appliance customized for a specific wearer’s dental anatomy. At step 205, optimal bone implant types, locations and orientations for the wearer are determined. Relevant factors in the determination include, but are not limited to, wearer bone density, number of teeth, and nerve locations. Bone implants are then installed at the determined locations.

[0084] At step 210 an intraoral scan of the wearer’s dental anatomy is obtained using a suitable intraoral scanner. Intraoral scanners are commercially available. Intraoral scanners are devices which are operable to capture digital impressions of wearer’s dental and oral soft tissue anatomy. The intraoral scan includes locations of the bone implants and shapes and dimensions of relevant parts of the wearer’s maxilla and mandible.

[0085] Method 200 continues to step 215 which determines optimal geometry and dimensions of an appliance. Preferably, the determination in step 215 relies at least in part on the intraoral scan obtained in step 210. Step 215 may depend on additional factors including, but not limited to, the curvature and vertical slope of the wearer’s upper gum-line. In some embodiments, step 215 may be performed manually by a clinician. In some embodiments, step 215 may be performed programmatically by an algorithm, such as the one illustrated by method 250 in FIG. 9B. An algorithm employed at step 215 may produce a variety of outputs. For example, in

embodiments where additive manufacturing techniques are utilized, the algorithm may produce a stereolithographic model. Embodiments where step 215 is performed by a human clinician with the aid of a computer algorithm are also possible.

[0086] FIG. 9B is a flowchart showing a non-limiting example method 250 that a computer algorithm may perform to determine anchor member dimensions at step 215 of method 200. Method 250 receives intraoral scan data 255. At step 260, method 250 processes the scan data to determine locations of bone implants and to identify the gum line around the patient’s maxilla. Step 260 may, for example determine a spline curve conforming to a wearer’s maxillary gingival contour based on data 255. In some embodiments, the most labial point of each tooth’s gingival curvature is used to define the spline curve. At step 265, a model path for the anchor member is defined. The model path is offset from the determined gum line. For example, each point used to define the spline curve in step 260 may be offset by an offset distance in the labial direction. The offset distance is preferably between 0.5 mm to 3 mm.

[0087] Step 270 may optionally be performed to smooth the spline curve to produce a more constant curvature. Many line smoothing techniques are possible at optional step 270. For example, the sequence of points forming the spline curve may be fitted to a parametric curve.

[0088] At step 275, a solid model for the anchor member is generated. An inside of the solid model follows the model path. For example, the model path may be expanded in the labial, superior, and inferior directions to produce a volume defining the anchor member. The distance that the spline is extended in the various directions may take into consideration the distance between the wearer’s gingiva and their vestibule, whether the volume will overlap with tooth crowns, the locations of mucogingival junctions , and the dimensions required for achieving a desired strength, rigidity, and/or stiffness of the anchor member based on the material the anchor member will be fabricated from.

[0089] At step 280, attachment features for the anchor member are defined in the solid model. There are two aspects to step 280; one is the attachment feature(s) for attaching the anchor member to heads of bone implants in the maxilla and the other is the attachment feature(s) for attaching a tension member to the anchor member. Step 280 may comprise positioning the attachment feature(s) for coupling the anchor member to the head of a maxillary bone implant at locations corresponding to the locations of the locations of the bone implants determined in step 260. Shapes and dimensions for the attachment features may be based on prior knowledge of the configuration of the bone implants or may be set to match dimensions of bone implants determined by processing the intraoral scan data. [0090] Any appropriate attachment feature discussed herein for coupling an anchor member to a tension member may be defined in the model at step 280. The attachment feature for coupling to a tension member may be positioned anteriorly to the features for coupling to the maxillary bone implants. The determination of the location of the tension member attachment feature may consider whether it is positioned to optimally transfer forces using a tension member.

[0091] Method 250 proceeds optionally to step 285 where the model volume is reduced. The model volume may be reduced to achieve a shape that more comfortably fits inside a wearer’s mouth and/or to further define any attachment features. Additionally, the model volume may be reduced to provide convenience features for the wearer.

[0092] In an example embodiment where method 250 determines anchor member dimensions for a mandibular advancement device 100 attaching to a model dental anatomy as in FIG. 8, step 280 may define sockets in the anchor member model correspondingly located to, and having similar diameters as, the spherical heads of mini-implants 1 18A and 1 18B. Step 280 may also define anteriorly located ball posts 136 in the model. At step 285, the model volume may be reduced to achieve substantially the same shape as side bars 130, comprising attachment features sockets 132 and recesses 134. Also at step 285, the model volume of the front of anchor member 1 12 may be reduced to produce indent 142.

[0093] At step 220 of method 200, an appliance according to any embodiments of the present invention is created based on at least the appliance details determined at step 215. In some embodiments, the device is created using additive manufacturing techniques such as selective laser sintering, 3D printing, and injection molding. In other embodiments, the appliance is created using subtractive manufacturing techniques such as CNC milling.

[0094] After the creation of an appliance at step 220, method 200 proceeds to decision block 225 where an assessment is made whether or not the appliance is properly fitted for the wearer. The assessment may be based on factors including, but not limited to, wearer feedback, wearer comfort, whether or not the appliance produces the desired protrusion, and whether surface imperfections exist. The assessment at decision block 225 may involve a clinician installing the appliance in the wearer’s mouth.

[0095] If the appliance is determined to not be properly fitted, method 200 proceeds to step 230 where the appliance is adjusted to improve the fit of the appliance based on any appropriate criteria. As an illustrative example, where it is desirable to remove surface imperfections on the appliance or to change portions of the appliance geometry, a person fitting the appliance may use a bur or other cutting tool to selectively remove material from areas of the device and/or improve surface finish of the appliance. This step may use dental tools such as a dental handpiece equipped with a suitable bur. Preferably, burs used to modify the appliance are appropriate for the specific material that the appliance produced at step 220 is constructed of.

Following the adjustments made in step 230, method 200 proceeds back to decision block 225. Method 200 ends when a clinician is satisfied at decision block 225 that the fit of the appliance is appropriate for the wearer.

[0096] Some embodiments provide a kit that is usable by a clinician for performing method 200 as described above. The kit may include, for example, some or all of tissue punches, suitable bone-implants, a screwdriver and/or other tools for installing the bone implants into a wearer’s mouth, ordering information for obtaining a custom mandibular advancement device and burs or other tools for adjusting the fit of the appliance.

Tension Members

[0097] In some embodiments, only the anchor member of the mandibular

advancement device is customized for wearers according to method 200. Tension members may be supplied in a range of pre-determined sizes. In general, wearers will have varying anteroposterior distances within which the bone anchors can be implanted. Where the bone anchors are of a type that fit between roots of teeth, there are a wide range of potential root-to-root distances within the mouth. Consequently, the amount of protrusion provided with a certain tension member length (such as tension member 12 in FIG. 1 ) may change on a wearer-to-wearer basis.

[0098] The relationship between tension member length and the resultant protrusion may be explained with reference to FIG. 1 . Where tension member 12 is shorter the mandible is held farther forward. In other words, a wearer’s jaw is forced farther forward compared to its relaxed position if a shorter tension member 12 is used.

[0099] Different wearers may require different protrusion distances. Furthermore, any particular wearer may require a range of different protrusions over the course of treatment. Tension members appropriate for a particular wearer may be selected from a set of tension members having different standard lengths.

[0100] FIG. 10 is a table illustrating an example set of different standard tension member lengths that can be provided to achieve varying amounts of protrusion when used in conjunction with mandibular advancement devices described herein. In this example embodiment, tension members have designated sizes from I to XII, where I is the longest tension member and produces the least protrusion. Conversely, XII is the shortest tension member and produces the most protrusion.

[0101] In the example FIG. 10 embodiment, the largest size tension member (I) has a length of 42.6 mm, and the smallest size tension member (XII) has a length of 31 .6 mm. The tension member lengths in FIG. 10 are only intended to serve as an illustrative example. Additional tension member lengths may be employed to achieve smaller or larger protrusions. Preferably, each incremental step in tension member size produces an incremental protrusion difference of around 1 mm ± 0.5 mm.

[0102] FIG. 1 1 A shows an example tension member 300 that may be provided as a standard length tension member as described above. Tension member 300 is designed with a profile that advantageously keeps its overall thickness small while still allowing a wearer to hold tension member 300 easily. An indent 302 or other indicia may be provided to indicate the correct orientation of the tension member to the wearer. In the illustrated embodiment, end 304 is intended to be attached to an anteriorly located attachment point near the maxilla, and end 306 is intended to be attached to a posteriorly located bone implant in the mandible.

[0103] FIG. 1 1 B shows another view of example tension member 300. Tension member 300 optionally comprises a marking 308 to indicate to the wearer which side of their mouth tension member 300 should be used on. The wearer may require tension members of different lengths on either side of the mouth. In the illustrated embodiment, tension member 300 is labelled with“Ft”, which indicates that tension member 300 corresponds to the right side of a wearer’s mouth. A tension member 300 for use on the left side of a wearer’s mouth may for example be labelled with“L”.

Adjustable tension members

[0104] In some embodiments tension members are adjustable in length. FIG. 1 1 C shows an example adjustable tension member 350. Adjustable tension member 350 comprises mandibular piece 352 having a socket 354 for attaching to a bone implant in a wearer’s mandible. Adjustable tension member 350 also comprises maxillary piece 356 having a socket 358 for attaching to a feature of an anchor member anchored to the wearer’s maxilla. A spacing between mandibular piece 352 and maxillary piece 356 is adjustable. In the illustrated embodiment this adjustment is schematically illustrated by a threaded stud 360. For example, the length of tension member 350 may be adjusted by turning mandibular piece 352 relative to maxillary piece 356. For example, stud 360 may be received in an internally threaded cavity (not shown) in one or both of mandibular piece 352 and maxillary piece 356.

[0105] In some embodiments, an adjustable tension member may comprise indicia which indicate a length to which the tension member is set. In some embodiments, stud 360 has a thread pitch measurement such that one full rotation of either of pieces 352 and 356 lengthens or shortens adjustable tension member 350 by ½ mm,

1 mm or another desired length.

Method for fitting tension members

[0106] Constant advancement of the mandible can create hypertonicity in the lateral pterygoid muscle (the muscle responsible for opening the jaw) by sustaining the muscle in a shortened state. Consequently, the use of tension members which are too short could cause the attachment of the lateral pterygoid to the articular disk to displace the disk anteriorly, potentially leading to disk derangement and other temporomandibular joint (TMJ) disorders. Therefore, it is desirable to select lengths for tension members which are long enough to avoid TMJ complications while being short enough to advance the wearer’s mandible to a desired position.

[0107] FIG. 12 is a flowchart showing a non-limiting example method 400 that may be performed to select appropriate lengths for tension members. In some embodiments, method 400 is performed independently for each side of the wearer’s mouth.

Preferably, method 400 is performed to select suitable tension member lengths for each side, having regard to both sides concurrently. At step 405, a clinician determines a wearer’s maximum mandibular advancement distance. At step 410, a starting tension member length is selected. In some embodiments, the starting tension member length is selected to be in the range of about 2 ^{t0 of the} maximum mandibular advancement distance determined at step 405.

[0108] Method 400 proceeds to step 415 where a trial is conducted to determine the suitability of the selected tension member length. In some embodiments, step 415 comprises the wearer sleeping overnight with an installed mandibular advancement device as described herein having the selected tension member length. Also at step 415, an evaluation to subjectively and/or objectively measure the effectiveness of the appliance at reducing snoring or OSA symptoms is performed to assess the suitability and effectiveness of the selected tension member length.

[0109] In some embodiments, the evaluation at step 415 comprises a nocturnal polysomnography (i.e. a sleep study). In other embodiments, a home diagnostic may be performed using a home sleep apnea test device which measures heart, lung, and brain activity, breathing patterns, arm and leg movements, and blood oxygen levels during sleep.

[0110] At decision block 420, an inquiry is made into whether the selected tension member length is suitable for the wearer. A clinician may determine suitability at decision block 420 by any of a number of suitable factors including, but not limited to, whether the wearer experiences discomfort or pain at the location of their bone implants, whether the wearer experiences tenderness in the jaw, whether the wearer is experiencing any clicking/popping of the jaw, and wearer feedback regarding the comfort of wearing the device overnight.

[0111] If the selected tension member length is deemed acceptable to the wearer without significant adverse effects at decision block 420, method 400 proceeds to decision block 425 which assesses whether goals relating to the wearer’s sleep disorders are met. Such goals can include any of a number of metrics including, but not limited to, a target blood oxygen level, a target breathing interval, and a target neurological arousal. If clinical goals have not been met with the selected tension member length, method 400 proceeds to step 430 where a shorter tension member is selected. In some embodiments, the shorter tension member is incrementally smaller than the tension member tested in step 415.

[0112] Tension members may be made available in a range of standard lengths (see e.g. FIG. 10). An incremental change may involve selecting a tension member having a length that is one or two steps smaller than the tension member tested in step 415 (e.g. from size IV to size V in FIG. 10). The tension members may, for example, be made available in lengths separated by steps that are suitably small (e.g. about ½ mm). The suitability of the new shorter tension member is then re-assessed at steps 415, 420, and 425.

[0113] If treatment with the new shorter tension member is deemed unsuitable for the wearer at decision block 420, step 435 is performed to revert to a longer tension member and method 400 terminates. As mentioned above, method 400 may be performed separately for each side of the wearer’s mouth. In some embodiments, method 400 may terminate for one side of the wearer’s mouth (decision block 420) and method 400 continues until a suitable length for a tension member is found for the other side of the wearer’s mouth.

[0114] Method 400 may end when the result of decision block 425 indicates that clinical goals relating to the treatment of a wearer’s sleep disorders have been achieved.

Interpretation of Terms

[0115] Unless the context clearly requires otherwise, throughout the description and the claims:

• “comprise”,“comprising”, and the like are to be construed in an inclusive

sense, as opposed to an exclusive or exhaustive sense; that is to say, in the sense of “including, but not limited to”;

• “connected”,“coupled”, or any variant thereof, means any connection or

coupling, either direct or indirect, between two or more elements; the coupling or connection between the elements can be physical, logical, or a combination thereof; • “herein”,“above”,“below”, and words of similar import, when used to describe this specification, shall refer to this specification as a whole, and not to any particular portions of this specification;

• “or”, in reference to a list of two or more items, covers all of the following

interpretations of the word: any of the items in the list, all of the items in the list, and any combination of the items in the list;

• the singular forms“a”,“an”, and“the” also include the meaning of any

appropriate plural forms.

• “forward” relative to a person means in an anterior direction.

• “backward” relative to a person means in a posterior direction.

• anatomical directions such as“superior”,“inferior”,“proximal”,“distal”,

“anterior”,“posterior” describe directions relative to a wearer of a device as described herein.

[0116] Words that indicate directions relative to an apparatus device or system such as“vertical”,“transverse”,“horizontal”,“upward ”,“downward”,“forward”,“backward”, “inward”,“outward”,“vertical”,“transverse”,� ��left”,“right”,“front”,“back”,“top”, “bottom”,“below”,“above”,“under”, and the like, used in this description and any accompanying claims (where present), depend on the specific orientation of the apparatus described and illustrated. The subject matter described herein may assume various alternative orientations. Accordingly, these directional terms are not strictly defined and should not be interpreted narrowly.

[0117] While steps or blocks in methods or processes are presented in a given order, alternative examples may perform methods or processes having steps or blocks that are performed in different orders, and/or some processes or blocks may be deleted, moved, added, subdivided, combined, and/or modified to provide alternative or subcombinations. Each of these processes or blocks may be implemented in a variety of different ways. Also, while processes or blocks are at times shown as being performed in series, these processes or blocks may instead be performed in parallel, or may be performed at different times.

[0118] Where a component (e.g. a bar, implant, member, assembly, device, etc.) is referred to above, unless otherwise indicated, reference to that component (including a reference to a“means”) should be interpreted as including as equivalents of that component any component which performs the function of the described component (i.e., that is functionally equivalent), including components which are not structurally equivalent to the disclosed structure which performs the function in the illustrated exemplary embodiments of the invention.

[0119] Specific examples of systems, methods and apparatus have been described herein for purposes of illustration. These are only examples. The technology provided herein can be applied to systems other than the example systems described above. Many alterations, modifications, additions, omissions, and permutations are possible within the practice of this invention. This invention includes variations on described embodiments that would be apparent to the skilled addressee, including variations obtained by: replacing features, elements and/or acts with equivalent features, elements and/or acts; mixing and matching of features, elements and/or acts from different embodiments; combining features, elements and/or acts from embodiments as described herein with features, elements and/or acts of other technology; and/or omitting combining features, elements and/or acts from described embodiments.

[0120] Various features are described herein as being present in“some

embodiments”. Such features are not mandatory and may not be present in all embodiments. Embodiments of the invention may include zero, any one or any combination of two or more of such features. This is limited only to the extent that certain ones of such features are incompatible with other ones of such features in the sense that it would be impossible for a person of ordinary skill in the art to construct a practical embodiment that combines such incompatible features. Consequently, the description that“some embodiments” possess feature A and“some embodiments” possess feature B should be interpreted as an express indication that the inventors also contemplate embodiments which combine features A and B (unless the description states otherwise or features A and B are fundamentally incompatible).

[0121] It is therefore intended that the following appended claims and claims hereafter introduced are interpreted to include all such modifications, permutations, additions, omissions, and sub-combinations as may reasonably be inferred. The scope of the claims should not be limited by the preferred embodiments set forth in the examples, but should be given the broadest interpretation consistent with the description as a whole.

[0122] While a number of exemplary aspects and embodiments have been discussed above, those of skill in the art will recognize certain modifications, permutations, additions and sub-combinations thereof. It is therefore intended that the following appended claims and claims hereafter introduced are interpreted to include all such modifications, permutations, additions and sub-combinations as are consistent with the broadest interpretation of the specification as a whole.