Patent Description:
Medicaments are widely used for various medical procedures. A common medicament used in medical procedures is a topically applied or injected local anaesthetic and when using such anaesthetics, it is important to administer a known dose to the patient to avoid over or under dosing. Further, for topically applied of injected local anaesthetics, it is important to administer the dose in an even manner about the area to be anaesthetised. Uneven dosing may result in localised sensitivity in low dose areas or extended numbness in over-dosed areas. Excess amounts of medicament may also lead to undesirable side effects or complications beyond extended numbness as well.

Reference is made hereafter to the medicament being a local anaesthetic for ease of description. However, it should be appreciated that other medicaments may also be applied using the same devices and methods.

Further, reference is made hereafter to delivery of local anaesthetic to the 'gums' of a patient for ease of description. The term 'gums' or grammatical variations thereof as used in this specification refer to the gingiva and cervical areas of the teeth being the area where the crown meets the tooth. Further, the term 'gums' specifically excludes the tongue and cheeks of the oral cavity.

Intraoral local anaesthetic treatments usually require the administration via either an injection, rubbing of anaesthetic topically, adhesive strips or in some cases, a spray. Each of these art methods has disadvantages.

The use of an injection to the gums is a common method of administration of anaesthetic for dental applications. Injections are accurate in terms of dosing and accurate in terms of where the dose is applied. Injections are however very site specific hence, multiple injections are needed to apply medicament to a wider area of the mouth meaning more time and expense. Injections to the gums are also widely disliked by patients - the insertion of an injection needle may in fact prevent or discourage a patient from the very treatment they require. Injection use also requires a degree of skill from the practitioner, may be costly, may require an extra degree of sterilisation and may have inherent special disposal requirements. Practitioners too prefer not to cause stress or unnecessary pain to their patients hence would prefer not to use an injection if other options were equally useful and of less stress to a patient.

Rubbing of local anaesthetic topically may be completed by the practitioner topically applying anaesthetic from a bulk amount to the patient's gums. This may be completed by, for example, transferring medicament to a cotton bud or cotton swab or roll from the bulk and topically rubbing the transferred anaesthetic onto the area of the gums to be numbed. This method of administration inherently may lead to variations in dose i.e. it is difficult to measure out how much anaesthetic is transferred from the bulk and difficult to evenly distribute the anaesthetic to the gums or other areas. This method of administration also requires care in keeping the bulk amount sterile and stable. The method is also prone to inadvertent application of anaesthetic to non-target areas leading to unnecessary numbing. Transfer to a swab or bud is also not best practice in terms of maintaining medical sterilisation standards as the extra handling may increase the risk of cross-infection.

Adhesive strips may be supplied with a known amount of local anaesthetic thereon which goes part way to addressing dosing and strips may be applied to a wider area than a single injection site. Adhesive strips however are not favoured since, within the mouth, fluids and uneven contours and the like prevent clean adhesion and hence transfer of anaesthetic. Strips may not adhere at all, or not adhere for sufficiently long, leading to uneven dosing or, in worst cases, no dosing. Strips that do not adhere or, not adhere for sufficiently long, may also slip and numb non-target parts of the patient. A further draw back of strips is that they may be difficult to apply to constricted areas like gums as the practitioner may need to at least temporarily hold the strips in place inside the patients mouth using their fingers causing patient discomfort.

Transfer trays may be used in dental practices however they have a variety of problems when used to apply anaesthetic to the gums. One issue is that patients' mouths and teeth are by nature never identical in shape and form. This means that a tray for one patient is seldom a perfect fit for another patient. As a result, bespoke or customised trays must be used for each patient (or at least a group of patients). Poor fit leads to uneven dosing, trays falling out of the patient's mouth during administration, trays causing pain to the patient if too small, use of special materials like memory foams to try and address the varied sizes, insertion of the tray into the patient's mouth may be awkward and uncomfortable, and application of an even force on the area to be administered may be difficult.

It has to be noted that intraoral applicators devices are already known, for example described in <CIT>. In this disclosure, the device includes body interior walls not configured to bear against at last part of the patient's soft tissue adjacent to the teeth. Also, in the embodiments described in this document, neither the body of the applicator nor the holder portion comprise a resilient-memory type material, the latter enabling a better clamping to the walls adjacent to the teeth and less pressure as the walls go upward towards the soft tissue.

As may be appreciated, it may be useful to provide a device and method of administration that topically applies anaesthetic to the gums of a patient in a manner that avoids injections, provides an accurate dose to the target areas and is compliant with the patient's mouth and minimises patient discomfort or at least to provide the public with a choice.

Further aspects and advantages of the intraoral applicator device and related methods of use will become apparent from the ensuing description that is given by way of example only.

An intraoral applicator device according to the claimed invention is defined in claim <NUM> and is described herein that is configured to transfer medicament from the applicator to the gums of a patient. Preferred embodiments of the claimed invention are defined in the dependent claims. Use of the intraoral applicator device is also described but does not form part of the claimed invention.

Selected advantages of the above include one or more of the following:.

As noted above, an intraoral applicator device is described herein that is configured to transfer medicament from the applicator to the gums of a patient. Use of the intraoral applicator device is also described. The device and methods of use may assist in topically applying medicament e.g. a topical anaesthetic to the gums of a patient without the need for or use of needles or syringes.

For the purposes of this specification, the term 'about' or 'approximately' and grammatical variations thereof mean a quantity, level, degree, value, number, frequency, percentage, dimension, size, amount, weight or length that varies by as much as <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM>% to a reference quantity, level, degree, value, number, frequency, percentage, dimension, size, amount, weight or length.

The term 'substantially' or grammatical variations thereof refers to at least about <NUM>%, for example <NUM>%, <NUM>%, <NUM>% or <NUM>%.

The term 'comprise' and grammatical variations thereof shall have an inclusive meaning - i.e. that it will be taken to mean an inclusion of not only the listed components it directly references, but also other non-specified components or elements.

The term 'oral cavity' and grammatical variations thereof refers to a typical mouth comprising a jaw made up of an opposing mandible and maxilla side with teeth and gums whereby there are two opposing side jaw portions and a front jaw portion forming a substantially U shape oriented substantially in a first plane. The teeth and gums comprise an outer side facing away from the throat and an inner side facing the throat.

The term 'mouth' and 'oral cavity' may be used interchangeably herein.

As noted above, reference is made hereafter to delivery of local anaesthetic to the 'gums' of a patient for ease of description. The term 'gums' or grammatical variations thereof as used in this specification refer to the gingiva and cervical areas of the teeth being the area where the crown meets the tooth. Further, the term 'gums' specifically excludes the tongue and cheeks of the oral cavity.

The term 'teeth' or grammatical variations thereof refers to teeth located on the maxilla and/or mandible side of patients jaw.

The term 'patient' or grammatical variations thereof as used herein generally refers to a person requiring or desiring application of medicament to the gums. The patient may alternatively be an animal and the device used for veterinary applications. Reference to the term 'patient' or 'person' herein should not be seen as limiting to either human or veterinary use and the device may be adapted to suit either application.

Further aspects of the intraoral applicator device and related methods of use will become apparent from the following working examples that are given by way of example only and with reference to the accompanying drawings in which:.

The above described intraoral applicator device and related methods of use are now described by reference to specific examples.

In this example, a first embodiment of device is described with reference <FIG>.

As shown in the Figures, an intraoral applicator device <NUM> has a body <NUM> formed in a substantially or similar shape to a U, V or square U shape or channel shape which is said to lie in a first plane <NUM>.

Body <NUM> includes body arm(s) <NUM>, a body base end <NUM> and body space <NUM> there between. Overall the U, or V or channel shape is shaped or formed to be at least similar to the outward and/or inward shape of at least some of the teeth and/or gums of at least one side jaw portion of a patient to be medicated. Each body arm(s) <NUM> is an elongate member portion formed with the body base <NUM> in between and connected or formed with.

The body arm(s) <NUM> and body base <NUM> in this embodiment, each comprise in cross section a channel section being contiguous with each other being spatially connected together as twin walls and base, with each being made up of, in cross section, at least one outer wall <NUM> facing outwardly when in use in a mouth and at least one inner wall <NUM> facing when in use the inside the mouth, separated at one end by a base member <NUM> with an internal channel space <NUM> therein. The outer wall <NUM> is any suitable shape to fit or abut/touch the teeth and gums e.g. curved in shape being oriented as an upright member not necessarily being parallel with the inner wall <NUM> also being oriented as an upright member. The outer wall <NUM> and inner wall <NUM> are oriented in a second plane <NUM> substantially at a first angle <NUM> to the first plane <NUM> occupied by the body <NUM> of the device <NUM> such that the inner and outer walls <NUM>, <NUM> can, when in use, abut and bear on a surface of the teeth. For example, first angle <NUM> can be approximately or near to <NUM> degrees to an angle of the first plane <NUM>.

The outer wall <NUM> has a first outer face surface <NUM> facing, when in use, outwardly of a mouth and, inner wall <NUM> has a second outer face surface <NUM> facing the mouth when in use. Base wall <NUM> has third outer face surface <NUM>. Outer wall <NUM> also has a first inner channel surface <NUM> and inner wall <NUM> has a second inner channel surface <NUM>. Base member <NUM> also has a third inner channel surface <NUM>. First inner channel surface <NUM> faces second inner channel surface <NUM> and third channel surface <NUM> which provide a continuous border surface for the channel space <NUM>.

The outer wall <NUM> is spaced from the inner wall <NUM> by a dimension parallel with the first plane <NUM>, by wall to wall internal width dimension <NUM>. The outer wall <NUM> has a first thickness dimension <NUM>, inner wall <NUM> has a thickness dimension <NUM>, and base wall <NUM> has a third thickness dimension <NUM>.

Outer wall <NUM> comprises a planar member having a first top end edge surface <NUM> and, inner wall <NUM> has a second top edge surface <NUM>. Outer wall <NUM> has an in use first height dimension <NUM> taken from the base wall <NUM> to the first top end edge <NUM> and inner wall <NUM> has a second height dimension <NUM> also taken from its own second top end edge <NUM> to the base wall <NUM>. Height <NUM> is selected to be similar, smaller or greater than height <NUM>. Base wall <NUM> has a width dimension <NUM> oriented parallel within the first plane <NUM>.

As shown in <FIG>, the outer wall <NUM> has a height that varies from the body base <NUM> to an end of the body arms <NUM> and the inner wall <NUM> has a height that is constant, wherein the base of the outer wall <NUM> is non-sloping and level, the outer wall is vertically oriented and inner wall <NUM> is sloped towards body space <NUM>. The top edge of the inner wall <NUM> is outwardly curved and the intersection between the inner wall <NUM> and base wall <NUM> and between the base wall <NUM> and the inner wall are rounded.

The device <NUM> is designed to be retained within the mouth by the device <NUM> at least gripping or holding the teeth and optionally the gums, to allow the medicament to be able to contact and be temporarily held against the gums. The material for the device <NUM> needs to be soft enough to contact the gums but strong enough to at least clamp the teeth and be of a material able to hold a medicament thereon or therein for application to the gums. It was found that the device <NUM> needs to clamp at least the teeth quite firmly to be retained to allow the medicament to be applied as required. It was also found that the device needs to clamp the teeth quite firmly to be retained.

The device has features that enable the device <NUM> to grip, hold or better grip at least the teeth which include at least one of the following features: mixed or different material types and shape differences including ribbing or steps and angles.

The outer wall <NUM> can be formed of a material different to the material type of the inner wall <NUM>. Furthermore the material for the base wall <NUM> can be the same or different to the outer wall and/or the inner wall.

For example, one wall e.g. the outer wall <NUM> (or inner wall <NUM>) can be formed of a rigid material such as injection moulded polypropylene plastic and the other wall, i.e. inner wall <NUM> (or outer wall <NUM>) can be formed of more flexible material such as EVA foam. Co-moulding techniques can be used to form these walls having different material types either as in each wall or as part of each wall.

A holder portion <NUM> is an optional feature of the oral applicator device, which includes any suitable means in the form of a structure that is shaped and configure to hold the device <NUM> to at least some of the teeth.

In particular, holder portion <NUM> is a feature of the walls or applied to any or all of the walls <NUM>, <NUM>, <NUM> of the device <NUM> which assist in the clamping or holding action of the device (i.e. by causing the lower portion of the walls <NUM>, <NUM> to clamp or grip better to the teeth or optionally more clamping at a lower portion of <NUM>, <NUM> and less or graduated or stepped pressure as one goes upward of the walls <NUM>, <NUM> so at the top to assist in allowing the medicament to just touch/bear on the gums).

The clamping includes an action whereby the holder portion is pre-stressed but formed of a material that allows the holder portion to resiliently deflect outwardly over the object (directly to the teeth or indirectly via a lower portion of the body) being clamped, to then deflect back to hold thereon around the teeth or some of the teeth. The holder portion has to be strong enough to hold, grip and capture the holder portion and body to at least the teeth or some teeth without hurting the patient. The holder portion also needs to be strong enough to allow the substance to be applied to the gums, also without hurting the patient. The holder portion further needs to be flexible or resilient enough to allow at least hand operation to grip the teeth and allow simple and easy removal from the teeth.

Holder portion <NUM> includes at least one protuberance e.g. rib or ribs, ridge(s) and steps <NUM> (best seen in <FIG>) or angles mounted or formed on any face of the outer surfaces <NUM>, <NUM>, <NUM> or inner surfaces <NUM>, <NUM> and <NUM>, of any of the walls <NUM>, <NUM>, <NUM>, which can be separately or integrally formed with the body <NUM> or holder portion <NUM> can be a channel shaped member.

Ribs <NUM> as shown in <FIG> are formed as raised protuberances, either as separate members or joined members, which can be separately formed and applied to a lower portion of the outer surface of one or two of or any of the walls <NUM>, <NUM> and to base wall <NUM> or can be integrally formed as part of a moulding or manufacturing process to make the device.

In this example, the ribs <NUM> are shaped as shaped elongate curved or angled planar members which can be rectangular and shaped to overlap or be similar in shape to the outer shape/surface of the outer wall <NUM>, inner wall <NUM> and base wall <NUM>.

The holder portion <NUM> also includes five spaced ribs <NUM> whereby two spaced ribs <NUM> are located on each body arm <NUM> and one rib <NUM> is located centrally on the body base between the body arms <NUM>.

As shown in <FIG>, the rib(s) <NUM> are shown as being housed within optional complementary shaped slots <NUM> (see <FIG> particularly) within the outer surfaces <NUM>, <NUM>, <NUM> of a lower portion of outer and inner walls <NUM>, <NUM> and of base wall <NUM>. The recessed slots <NUM> help align the holder portion <NUM> with the body and also allow the holding to be flush or slightly recessed into the body <NUM> for a more comfortable fit in the mouth.

The holder portion <NUM> is shaped and configured to provide a holding or clamping of the walls <NUM>, <NUM>, <NUM> to at least the teeth, especially outer wall <NUM> and inner wall <NUM> or at least one of outer wall <NUM> or inner wall <NUM> whereby one of the walls <NUM> or <NUM> is caused by its structure or portion thereof to move or flex with respect to the other wall. For example, the outer wall <NUM> is formed to be more rigid than the inner wall <NUM> which is more flexible, thereby causing either the holding and clamping of a portion of the device <NUM> to the teeth and the transfer of the or part of the medicament e.g. a gel, to at least a portion of the immediately adjacent gums.

The holder portion <NUM> can be formed as discrete ribs <NUM> or be formed having a wall section of a continuous length e.g. a channel or a series of shorter lengths either joined together or not joined together. A series of shorter lengths would allow the device <NUM> to expand and contract to fit a variety of jaw sizes.

The holder portion <NUM> in another example best seen in <FIG> includes a continuous length form as a frame like member comprising U shaped curved or channel shaped ribs portions or is of separate U shaped protuberances 62A spaced and joined or connected along a central support spine 62B whereby that the holder portion <NUM> is shaped and configure to clamp the teeth either through a lower section of the body <NUM> or directly to the teeth themselves. The ribs 62A can have a greater width than the width of the spine 62B which is better required to exert pressure on the lower portion of the body <NUM> and gums when required to hold the device <NUM> in place.

The spine 62B being elongate having a main longitudinal axis is located parallel along the main longitudinal length of the base wall <NUM> and the ribs 62A being elongate in shape having a longitudinal axis, are located and oriented extending at right angles to the spine 62B to extend laterally across the width of the base wall and up the outer surfaces <NUM>, <NUM> of outer wall <NUM> and inner wall <NUM>. In this example, spine 62B has a width somewhat less than the width of the ribs 62A.

At least one handle <NUM> is also shown. A handle <NUM> is not essential, but can be useful in assisting in the handling of the device without contaminating the medicament or device <NUM> especially as this device is being put in the mouth of patient and to allow better fitting to the teeth and gums and to ease removal.

The handle <NUM> is usually shaped as a planar tab like member attached to the outer wall <NUM> though it can be attached formed with the holder portion or base wall <NUM> or even the inner wall <NUM>.

In general the device described herein is shaped and configured to enable a medicament from an upper portion of the outer and inner walls <NUM>, <NUM> to be topically applied to a surface of at least the gums which requires at least a lower portion of the device <NUM> to be able to clamp or hold the device to at least the teeth.

The holder portion <NUM> is therefore located at a lower end of the body <NUM> of the device <NUM> to assist in and/or cause clamping of a portion of the body <NUM> to the teeth. In this example the holder portion is located on an outside of a lower portion of the outer <NUM> and inner walls <NUM> and also underneath the base wall <NUM>.

Depending on the material being used for the device <NUM>, in one option, the body <NUM> could be formed to better match the jaw shape but most likely, in another option, the material will have a memory and return to the original shape. The design however allows the device <NUM> to flex and still hold to accommodate a range of jaw shapes and sizes.

The body <NUM> or part of the body <NUM> is designed to be more flexible than the holder portion <NUM> as part of the body when in use contacts the gums. Medicament e.g. an anaesthetic is applied to an inner surface(s) of the body that then contacts the soft tissue or gums.

The body <NUM> walls <NUM>, <NUM> and second wall could be the same material where the wall thickness creates the difference in flexibility.

Alternatively, the body <NUM> and holder portion <NUM> can be formed of the same material where the body <NUM> has an additive such as a foaming chemical to create a more flexible area or the holder portion <NUM> includes a material with an additive to create a more rigid area.

Alternatively the body <NUM> and holder portion <NUM> could be formed of different materials either produced together in a process such as double shot injection moulding, over-moulding and insert moulding or the two walls could be formed of separate parts that are joined together mechanically, or ultrasonic welded or glued.

The shape of the device <NUM> or body <NUM> and holder portion <NUM> can be shaped as a full curve that contacts all the teeth in the upper or lower jaw (maxilla or mandible). Alternatively the device <NUM> could be a part curve e.g. J-shape that contacts only some of the teeth.

A first body <NUM> wall <NUM> or <NUM> could be in direct contact with the teeth and clamp against the teeth or the first wall <NUM> or <NUM> could clamp the second wall <NUM> or <NUM> against the teeth
The positional height <NUM>, <NUM> of the outer wall <NUM> and inner wall <NUM> of body <NUM> is set by the depth of U or channel shape such that the device is held in the correct position with the anaesthetic contacting the gums when the patient closes their jaw and the base of the U is held against the horizontal surface of the tooth.

Yet other variations include having the holder portion <NUM> which can be formed as a separate one piece frame as seen in <FIG> or the holder portion <NUM> can be integrally formed as part of the outer and inner walls <NUM>, <NUM> and base wall <NUM> as raised protuberances or ribs 62B either as separate protuberances or connected continuous protuberances.

The walls <NUM>, <NUM>, <NUM> can be formed as separate components and connected or joined together. Furthermore, the connecting can be a hinge (not shown), the hinge provided between the walls <NUM>, <NUM>, <NUM>.

The optional handle <NUM> may be formed as part of the ribs or be formed as part of the base wall <NUM> and comprising different shapes e.g. a ring, a tab, oval etc..

In yet another variation, a portion of the U-shaped body <NUM> could clamp, touch or abut directly against the gums or it could support another material, such as a soft cotton wad, and clamp the other material against the gums.

Outer wall <NUM> which has a first inner channel surface <NUM> and inner wall <NUM> which has a second inner channel surface <NUM> such that when in use they are configured to contact the soft tissue or gums, could be textured or shaped to hold the anaesthetic.

Other variations include having outer wall <NUM> and inner wall <NUM> but with no base wall <NUM> with the holder portion <NUM> joining, connecting (e.g. clipping in slots) to a lower portion or one end of the outer walls <NUM> and inner walls <NUM> i.e. in effect the holder portion <NUM> could replace the base wall <NUM>.

The holder portion <NUM> is there to cause a clamping or holding action against the teeth while the body <NUM> which includes inner walls <NUM>, outer walls <NUM> and optionally the base walls <NUM> are there to create contact between the medicament e.g. gel and the gums, where the holder portion <NUM> wall is in contact and connected with the body <NUM>.

The handle <NUM> can shaped of any suitable shape that is able to be grabbed or held by a user. For example handle <NUM> it can be shaped as a ring, a tab, be round or square etc.

In this example, a second embodiment of device <NUM> is described with reference to <FIG>.

In this embodiment, the device <NUM> comprises a U-shaped body <NUM> having arms <NUM> and body base end <NUM> in a first plane <NUM> and U shaped cross section in a second plane <NUM> at least one inner wall <NUM>, at least one outer wall <NUM> and base wall <NUM>) with separate or integral holder portion <NUM>.

For the third option, the U shaped body extends around all sides of the jaw which includes an outer wall <NUM> and inner wall <NUM> joined to a base there between, and the holder portion <NUM> is formed of a frame member with U shaped ribs extending laterally therefrom a trunk portion wherein the holder portion is connected or formed to a lower end of the walls <NUM> or <NUM> abuts a low end of the base wall <NUM> to then extend behind the tooth opposite to the side the wall <NUM> or <NUM> is on.

As shown in <FIG>, the thickness of the walls of the outer wall <NUM>, inner wall <NUM> and base wall <NUM> can be varied to affect and control the flexibility of each wall. The inner wall <NUM> can be shaped to be more curved <NUM> (as shown in <FIG>) than the outer wall <NUM> which can also affect how the inner wall <NUM> deflects or bends with respect to the outer wall and/or base wall <NUM> or vice versa, when being fitted to the teeth and gums.

The variation of the thickness can include contours, stepped, angled or recessed portions <NUM> to further assist in the actions of clamping and touching, to any face of the outer surfaces <NUM>, <NUM>, <NUM> or inner surfaces <NUM>, <NUM> and <NUM>, of any of the walls <NUM>, <NUM>, <NUM>.

In this example, having a thicker lower portion of the outer <NUM> and inner <NUM> walls assists in the clamping of the device to the teeth and a thinner upper section having more flexibility than the lower section helps in the need to touch the gums to apply the medicament or topical administration.

Also as shown in <FIG> the protuberances or ribs 62B can be formed as elongate U shaped member of generally rectangular shape with ends formed as fingers <NUM> which extend up the outer surface <NUM>, <NUM> of outer and inner walls <NUM>, <NUM>.

The one piece frame is shaped to be fitted to capture a lower outer portion of the outer wall <NUM>, inner wall <NUM> and base wall <NUM> or optionally the one piece frame is shaped to removably inter-fit or clip into complementary slots along first outer face surface <NUM> of lower part of the outer walls <NUM>, the second outer face <NUM> of the inner walls <NUM> and third outer face surface <NUM> of the base wall.

<FIG> shows a further embodiment, not part of the invention and not covered by the claims. The ribs <NUM>, instead of being discrete U shaped rib branches on a spine, can be formed as a continuous U-shaped member either slotting in underneath wall <NUM> and the lower part of the inner and outer walls <NUM>, <NUM>, or be attached simply to outer surfaces <NUM>, <NUM>, <NUM> of walls <NUM>, <NUM>, <NUM> to protrude therefrom. When the ribs <NUM> are located on slots, the ribs <NUM> can be sized to sit flush with outer surfaces <NUM>, <NUM>, <NUM> or can be sized to be protruding as required.

<FIG> show a further embodiment of the body with wall(s) and holder portion <NUM>, however, as shown in <FIG>, the U-shaped body has arms <NUM> and body base end <NUM> in a first plane <NUM> with single wall (L-shaped) in cross section in a second plane <NUM> i.e. at least one outer wall <NUM> or at least one inner wall <NUM>, separate holder portion <NUM>, with no base wall <NUM>.

The U-shaped body <NUM> in a first plane is a shape covering the outer wall of all sides of the jaw or the inner wall of all sides of the jaw and the holder portion <NUM> includes a separate body comprising a frame member with U shaped ribs extending laterally therefrom a trunk portion. The holder portion <NUM> is a frame member that is connected to or formed to a lower end of the body <NUM> walls <NUM> or <NUM> and abuts a low end of the teeth to then extend behind the tooth opposite to the side that the body <NUM> wall <NUM> or <NUM> is on.

In another variation, the holder portion <NUM> can be formed as separate one piece frame which, as mentioned above, can be separately attached to the outside of the body <NUM> or can be attached directly to the outside of the teeth and then an inner side face of the body <NUM> can be slotted therein whereby the body <NUM> is slotted and clipped into an outside of the frame.

<FIG>, illustrate a further embodiment of the device. In this case, the device <NUM> comprises a U shaped body <NUM> having arms <NUM> and body base end <NUM> in a first plane <NUM> with single wall (L or J-shape) in cross section in a second plane <NUM> i.e. at least one outer wall <NUM> or at least one inner wall <NUM> and base wall <NUM> with integral or separate holder portion <NUM>. A base wall <NUM> may or may not be present.

Assuming a base wall <NUM> is present, the outer wall or inner wall is connected or formed with the base wall <NUM> forming the L or J-shape. The holder portion <NUM> is formed of a frame member with U shaped ribs extending laterally from a trunk or spine portion wherein the holder portion is connected to or formed to a lower end of the walls <NUM> or <NUM> abuts a low end of the base wall <NUM> to then extend behind the tooth opposite to the side the wall <NUM> or <NUM> is on.

<FIG> show a further embodiment of the device <NUM>. In this example, the device <NUM> is designed for use on one side of the jaw (i.e. teeth and gums). The device <NUM> has a substantially straight elongate body <NUM> in a first plane <NUM> and U shaped cross section <NUM> in a second plane i.e. at least one outer wall <NUM>, at least one inner wall <NUM> and base wall <NUM>, with holder portion <NUM>. In another option the elongate body <NUM> can include a curved end portion to abut and hold the device to gums and teeth at the front.

In this embodiment, the body <NUM> is formed as an elongate channel shaped body <NUM> and a cross-section of the body <NUM> comprises an outer wall <NUM> and inner wall <NUM> joined to a base there between. The holder portion <NUM> is formed of a frame member with U shaped ribs extending laterally therefrom a trunk or spine portion wherein the holder portion is connected or formed to a lower end of the walls <NUM> or <NUM> abuts the bottom of the base wall <NUM> to then extend behind the tooth opposite to the side the wall <NUM> or <NUM> is on.

<FIG> illustrate a further embodiment. The device <NUM> in this case is designed for use on one side of the jaw (i.e. teeth and gums). It comprises a substantially straight elongate body in a first plane <NUM> and U shaped cross section in a second plane <NUM> i.e. at least one outer wall <NUM>, at least one inner wall <NUM> and base wall <NUM>, with holder portion <NUM> and no base wall <NUM>. In another option the elongate body can include a curved end portion to abut and hold the device to gums and teeth of a front of the jaw.

The body <NUM> is formed as an elongate channel shaped body and cross section of the body includes an outer wall <NUM> and inner wall <NUM> joined to a base there between, and the holder portion <NUM> is formed of a frame member with U shaped ribs extending laterally therefrom a trunk portion wherein the holder portion is connected or formed to a lower end of the walls <NUM> or <NUM> abuts the bottom of the teeth to then extend behind the tooth opposite to the side the wall <NUM> or <NUM> is on.

<FIG> show a further single sided device <NUM>, this time single sided in terms of mouth side but to potentially treat both sides of the gums. The device <NUM> is similar to earlier embodiments such as those illustrated in <FIG> however is J-shaped in a first plane. The body <NUM> has outer and inner sides <NUM>, <NUM> but these dies only extend along a single body <NUM> arm <NUM> so as to fit to only one side the upper or lower jaw.

<FIG> show the device <NUM> with a base wall <NUM> while <FIG> show the same device <NUM> with no base wall <NUM>.

<FIG> illustrates a further embodiment of the device <NUM>. In this embodiment the holder portion <NUM> can directly contact the teeth. The holder portion <NUM> uses the teeth (clamps over the teeth) to hold the body in place. The holder portion <NUM> comprises a spine 62B and ribs 62A. Attached to the ribs are wall <NUM>, <NUM> of the body <NUM>. No base wall <NUM> is used. The walls <NUM>, <NUM> in this embodiment may be formed using the same material as the holder portion <NUM>, where the portion acting as the body <NUM>,<NUM> is softer and more flexible (using a thinner wall section or foamed portion) and the portion acting as the holder portion <NUM> has a more rigid wall section.

In this example, a method of use of the device <NUM> is shown with reference to <FIG>.

<FIG> shows a device <NUM> similar to that illustrated in <FIG> however, in this embodiment a surface texture area <NUM> is also shown. Medicament (not shown) may be located in or on this textured surface during manufacture or before placing the device <NUM> into the patient's mouth.

Optionally, the shape the body of the device <NUM> may be shaped or moulded to match an outward shape of a jaw of a patient.

As shown in <FIG>, the device <NUM> is slid into the patient's mouth and then, as shown in <FIG>, the device <NUM> is moved upwards against the top teeth <NUM> of the patient's mouth so that the patient's upper teeth <NUM> and gums <NUM> are captured in the body <NUM> inner, outer walls and base wall. As should be appreciated, for a fit to bottom teeth, the device <NUM> would be moved downwards.

Whilst the <FIG> use a holder and body fixed together before use, the body may be inserted first into the patient's mouth and the holder fitted thereafter.

Yet other options include clipping the holder portion <NUM> into slots on a lower portion of inner, outer and base walls.

Optionally, a user could squeeze the holder portion or a part thereof towards the teeth <NUM> to cause the lower portion of the walls <NUM>, <NUM>, <NUM> to clamp the body <NUM> to the teeth <NUM> while keeping the upper portion of an inner surface of the walls <NUM>, <NUM>, <NUM> to abut or touch the gums <NUM> to apply the medicament to the gums <NUM> as required.

<FIG> shows the device <NUM> with parts of the device <NUM> removed to better show the textured region <NUM> located about the patient's gums <NUM>) targeted by the device <NUM> for transfer of medicament. <FIG> shows the patient's mouth post removal of the device <NUM>, the highlighted region <NUM> showing where transfer of medicament has occurred.

Claim 1:
An intraoral applicator device (<NUM>) for delivering a medicament to the soft tissue of a patient's oral cavity, the device (<NUM>) comprising:
a body (<NUM>) with a shape and configuration that generally conforms with at least part of the shape of the teeth and soft tissue of the patient's oral cavity, the body (<NUM>) interior having a wall or walls that align with the sides of the teeth extending from the soft tissue to the teeth top, so that, when fitted to a patient's oral cavity, the body (<NUM>) interior wall or walls are configured to at least partly bear against at least part of the patient's soft tissue adjacent to the teeth; wherein the body (<NUM>) comprises a resilient memory-type material; and
a holder portion (<NUM>), the holder portion (<NUM>) comprising a frame, the frame being configured to clamp over the teeth in the patient's oral cavity such that, when fitted to the patient's oral cavity, at least a part of the holder portion (<NUM>) is configured to be held between an upper and lower set of teeth when brought together in occlusion, the holder portion (<NUM>) also gripping at least part of the body (<NUM>), wherein the holder portion (<NUM>) comprises a resilient material capable of retaining its shape,
wherein the holder portion (<NUM>) applies more clamping to the wall or walls adjacent to the teeth and less pressure as the wall or walls go upward towards the soft tissue;
wherein the frame (<NUM>) comprises a spine (62B) with a first plurality of ribs (62A) extending laterally from a first side of the spine (62B) and a second plurality of ribs (62A) extending laterally from a second side of the spine (62B), wherein the body (<NUM>) is compressed by a force exerted by the first plurality of ribs (62A) and the second plurality of ribs (62A); and,
wherein the holder portion (<NUM>) when fitted to a patient's oral cavity indirectly bears on the body (<NUM>) wall or walls proximal to the holder portion (<NUM>), urging at least part of the body (<NUM>) wall or walls to bear against the side or sides of the patient's teeth proximal to the body (<NUM>);
wherein an upper portion of an inner surface or surfaces of the body (<NUM>) is configured to receive medicament and transfer medicament to soft tissue when fitted and minimize transfer of medicament to the patient's teeth.