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Title:
DENTAL SUPPORT
Document Type and Number:
WIPO Patent Application WO/2015/004066
Kind Code:
A1
Abstract:
A dental support device for inserting between the jaws or teeth of a patient to prevent biting or clamping during treatment comprises a hollow rigid elongate portion for placing between the jaws and a laterally extending flange serving to limit or restrict full insertion of the device into the mouth of the patient and optionally a pliable outer skin formed for cooperative engagement with at least a portion of the outer surface of the elongate portion that provides improved comfort and grip for the patient in use and safety for the user and/or a flexible and/or a pliable inner skin formed for cooperative engagement with at least a portion of the inner surface of the elongate portion that provides an improved grip and thereby improved accuracy and safety for the user.

Inventors:
BEDI RAMAN (GB)
Application Number:
PCT/EP2014/064471
Publication Date:
January 15, 2015
Filing Date:
July 07, 2014
Export Citation:
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Assignee:
BEDI ORALCARE LTD (GB)
International Classes:
A61C5/14; A61B1/24; A61C5/90
Foreign References:
US6517549B12003-02-11
US5590643A1997-01-07
US4944313A1990-07-31
US4041937A1977-08-16
EP1153594A22001-11-14
Other References:
None
Attorney, Agent or Firm:
ELLIS, Michael (Newbyth HouseEast Linton, East Lothian EH40 3DU, GB)
Download PDF:
Claims:
CLAIMS:

1. A dental support device comprising a hollow rigid elongate portion having an outer and inner surface, the elongate portion adapted to be inserted between the jaws or teeth of a human or animal patient and comprising at least one flange extending laterally form the elongate portion at or near the distal (from the patient) end of the elongate portion, the flange serving to limit or restrict full insertion of the device into the mouth of the patient, the device further comprising a flexible and/or pliable and/or resiliently compressible outer cover or outer skin formed in or adapted for cooperative engagement with at least a portion of the outer surface of the elongate portion and/or a flexible and/or pliable and/or resiliently compressible insert or inner skin formed in or adapted for cooperative engagement with at least a portion of the inner surface of the elongate portion. 2. A device as claimed in claim 1 , wherein the flange is rigid.

3. A device as claimed in claim 1 or claim 2, wherein two oppositely directed laterally extending flanges are provided. 4. A device as claimed in any one of the preceding claims, wherein the at least one flange is integrally formed with the elongate portion.

5. A device as claimed in any one of the preceding claims, wherein the elongate portion has a substantially oval cross-sectional profile.

6. A device as claimed in any one of the preceding claims wherein the elongate portion tapers from a relatively broad distal end to a relatively narrow proximal end.

7. A device as claimed in any one of the preceding claims which comprises a flexible or pliable outer cover or outer skin formed in or adapted for cooperative engagement with at least part of the outer surface of the elongate portion. 8. A device as claimed in claim 7, wherein the outer cover or outer skin extends from a proximal end (of the elongate portion, being the patient end) to the distal end and at least partially along the patient facing surface of the flange.

9. A device as claimed in claim 7 or claim 8, wherein the outer cover or outer skin is configured with surface modifications for improved gripping.

10. A device as claimed in claim 9, wherein the surface modifications are selected from one or more of a textured surface, pimples, apertures, ripples, ridges, vanes, and other protrusions, which surface modifications may be configured in an ordered arrangement (e.g. in a substantially longitudinal direction along the length of the elongate portion or substantially laterally, or diagonally spirally between the longitudinal and lateral directions) and/or a disordered arrangement.

11. A device as claimed in any one of the preceding claims wherein the outer cover or outer skin is provided with an agent configured for release to the patient during use.

12. A device as claimed in claim 11, wherein the agent is selected from one or more of a cleansing agent, a disinfecting agent, a breath freshening agent, an antiseptic agent, an antifungal agent and a flavouring agent.

13. A device as claimed in any one of the preceding claims, which comprises a flexible and/or pliable and/or resiliently compressible insert or inner skin for cooperative engagement with inner surface of the elongate portion.

14. A device as claimed in claim 13, wherein the insert or inner skin extends from an inner extremity of the inner surface of the hollow elongate portion to a shoulder portion at a junction between the inner surface and the at least one laterally extending flange and optionally across the shoulder and further optionally along a portion of a user facing surface of the at least one flange.

15. A device as claimed in claim 13 or claim 14, wherein the insert or inner skin is configured with surface modifications for improved comfort and or grip for the user's finger, which the hollow elongate portion and/or insert or inner skin is adapted to receive.

16. A device as claimed in claim 15, wherein the surface modifications are selected from one or more of a textured surface, pimples, apertures, ripples, ridges, vanes, and other protrusions, which surface modifications may be configured in an ordered arrangement (e.g. in a substantially longitudinal direction along the length of the elongate portion or substantially laterally, or diagonally spirally between the longitudinal and lateral directions) and/or a disordered arrangement.

17. A device as claimed in any one of the preceding claims wherein the insert or inner skin is formed of a resiliently compressible foam configured for comfortably and retentively receiving a finger of various sizes.

18. A device as claimed in any one of the preceding claims wherein the insert or inner skin is provided with a component for release to the user's finger during use.

19. A device as claimed in one of the preceding claims, wherein the elongate portion has a longitudinal extent of from 25 to 40 mm.

20. A device as claimed in claim 19 having two oppositely directed laterally extending flanges, wherein a maximum base extent from a peripheral edge of one flange to a peripheral edge of the opposing flange is from 35 to 55 mm.

21. A method of propping open the mouth of a patient, comprising inserting between the jaws of the patient a device as claimed in any preceding claim. 22. A method of delivering an agent to a patient comprising inserting an elongate portion of a device as claimed in any one of the preceding claims, which device is provided with an outer cover or outer skin which outer skin is provided with an agent for release to the patient during use. 23. A kit of parts for a dental support device, which comprises

a rigid support component comprising a hollow, rigid elongate portion having an outer and inner surface and adapted to be inserted between the jaws or teeth of a human or animal patient and at least one rigid flange extending laterally form the elongate portion at or near a distal (from the patient) end of the elongate portion, the flange serving to limit or restrict full insertion of the device into the mouth of the patient; and one or both of

a flexible or pliable outer cover for cooperative engagement with the outer surface of the elongate portion; and

a flexible and/or pliable and/or resiliently compressible insert for cooperative engagement with inner surface of the elongate portion.

24. A dental support device as hereinbefore described with reference to the drawings.

Description:
Dental Support

FIELD OF THE INVENTION

This invention pertains generally to the field of dental supports or dental wedges. More particularly, the invention relates to a dental support device, kit of parts and method of using and manufacturing the same.

BACKGROUND OF THE INVENTION

Oral examination or treatment on uncooperative patients and especially those with special needs is usually effected by wedging open the mouth of the patient with a finger and by restraining head movement.

One known way of achieving this with improved efficiency is using a general dental support or wedge, and such devices have been in use for general dental purposes for a number of years.

However, the devices are often uncomfortable for the user and uncomfortable or irritating for the patient.

The present inventor has conceived of an improved dental support device and method.

PROBLEM TO BE SOLVED BY THE INVENTION

There is a need for improvements in dental support devices for propping the mouth of a patient open during examination or treatment, which provide improved experience for user and patient.

It is an object of this invention to provide a dental support device that overcomes one or more of the problems with the prior art.

SUMMARY OF THE INVENTION

In accordance with a first aspect of the invention, there is provided a dental support device comprising a hollow rigid elongate portion having an outer and inner surface, the elongate portion adapted to be inserted between the jaws or teeth of a human or animal patient and comprising at least one flange extending laterally form the elongate portion at or near the distal (from the patient) end of the elongate portion, the flange serving to limit or restrict full insertion of the device into the mouth of the patient, the device further comprising a flexible and/or pliable and/or resiliency compressible outer cover or outer skin for cooperative engagement with at least a portion of the outer surface of the elongate portion and/or a flexible and/or pliable and/or resiliency compressible insert or inner skin for cooperative engagement with at least a portion of the inner surface of the elongate portion.

In a second aspect of the invention, there is provided a method of propping open the mouth of a patient, comprising inserting between the jaws of the patient a device as defined above.

In a third aspect of the invention, there is provided a method of delivering an agent to a patient comprising inserting an elongate portion of a device as defined above, which device is provided with an outer cover or outer skin which outer skin is provided with an agent for release to the patient during use.

In a fourth aspect of the invention, there is provided a method of delivering an agent to a patient comprising inserting an elongate portion of a device as defined above, which device is provided with an agent delivery conduit or conduits at the distal portion thereof whereby an agent may be delivered to the patient through the device.

In a fifth aspect of the invention, there is provided a kit of parts for a dental support device, which comprises

a rigid support component comprising a hollow, rigid elongate portion having an outer and inner surface and adapted to be inserted between the jaws or teeth of a human or animal patient and at least one rigid flange extending laterally form the elongate portion at or near a distal (from the patient) end of the elongate portion, the flange serving to limit or restrict full insertion of the device into the mouth of the patient; and one or both of

a flexible or pliable outer cover for cooperative engagement with the outer surface of the elongate portion; and a flexible and/or pliable and/or resiliently compressible insert for cooperative engagement with inner surface of the elongate portion.

ADVANTAGES OF THE INVENTION

The dental support device of the invention provides improved fit and comfort for the user and/or the patient and optionally provides functional benefits by way of release of agents or components to the patients or users respectively.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is a perspective exploded view of a device according to one embodiment of the present invention;

Figure 2 is a perspective exploded view of a device according to another embodiment of the present invention;

Figure 3 a is perspective exploded view of a device according to a yet further embodiment of the present invention;

Figure 3b is a perspective unexploded cross sectional view of a device as depicted in Figure 3 a;

Figure 4 is a perspective view of a device according to a further embodiment of the present invention; and

Figure 5 is a view from the underside (distal side) of the device according to the embodiment of Figure 4.

DETAILED DESCRIPTION OF THE INVENTION

A dental support device according to the invention comprises a hollow rigid elongate portion having an outer and inner surface and at least one flange extending laterally form the elongate portion at or near the distal end or base of the elongate portion. The elongate portion is adapted to be inserted between the jaws or teeth of a human or animal patient. Thus, starting with a proximal end (i.e. proximal to the patient) of the device, it may be inserted a distance into the patient's mouth such that the patient may bite on the side or sides of the elongate portion to a maximum distance until the at least one flange abuts the teeth or lips. The flange is configured to limit or restrict full insertion of the device into the mouth of the patient. The device further comprises one or both of a fiexible and/or pliable and/or resiliently compressible outer cover or outer skin and a fiexible and/or pliable and/or resiliently compressible insert or inner skin.

An outer cover or outer skin may be formed in or adapted for cooperative engagement with at least a part of the outer surface of the elongate portion of the device.

An outer cover may be formed, for example, as a sleeve, strap or cap for fitting over the outside of at least part of the elongate portion, the fit ideally being secure. An outer skin may be formed, for example, by a coating or spraying process (e.g. dip-coating or spray coating, painted or printed) onto the outer surface of at least the elongate portion of the device, or may be a sleeve or other cover affixed (e.g. glued) to the outer surface of at least the elongate portion, or, preferably, may be injection moulded onto the outer surface of at least the elongate portion.

An insert or inner skin may be formed on or adapted for cooperative engagement with at least a part of the inner surface of the elongate portion.

An insert may be a fiexible element for slotting into the hollow interior of the elongate portion or may itself be an elongate element having at least a pliable or fiexible inner surface and optionally a more rigid outer surface configured for cooperation with the inner surface of the elongate portion of the device.

An inner skin may be formed, for example, by a coating or spraying process (e.g. dip-coating or spray coating, painted or printed) onto the inner surface of at least the elongate portion of the device, or may be a sleeve or other thin film affixed (e.g. glued) to the inner surface of at least the elongate portion, or by injection moulding onto the inner surface of at least the elongate portion.

Preferably, the flange is rigid. The flange may extend in one or more or all directions. Preferably, two oppositely directed laterally extending flanges are provided, defining a first lateral direction.

Preferably at least one flange is integrally formed with the elongate portion. Preferably the elongate portion and the at least one lateral extending flange make up a support element of the device. Preferably the support element is a one- piece moulded element.

Any suitable material may be used for the elongate portion or support element, but is preferably a rigid set material, such as a plastic (e.g.

polycarbonate, or high density polyethylene) or composite material. Preferably, the material is capable of being thermally moulded (e.g. injection moulded).

The elongate portion may have a circular, quadrangular, pentagonal, hexagonal or any other shaped cross section, but is preferably oval.

The elongate portion may be curved (e.g. domed) or flat ended at the proximal end and is preferably flat ended at the proximal end.

The proximal end should be understood to be that end of the elongate portion that first enters the patient's mouth during normal use, whilst the distal end should be understood to be the other end or that end of the elongate portion that is furthest from the proximal end and closer to the lateral flange or base of the device.

The elongate portion extends in a longitudinal direction being the axis of elongate portion. The elongate portion comprises sides (or in the case of a curved surface, a side) along its length and a proximal end, which may be flat or curved.

The elongate portion may be of constant diameter along its length or may taper part or all of the way from a relatively broad distal end to a relative narrow proximal end, or may demonstrate a reverse taper. Optionally, the elongate portion is relatively narrow at median collar portion part way along the length of the elongate portion between the proximal and distal ends and relatively wide at both of the proximal and distal ends. In a preferred embodiment, the device comprises an elongate portion that is oval in profile. Preferably, the elongate portion is of constant diameter or tapers from distal end to proximal end, preferably at an angle of no more than 30 degrees from the longitudinal axis and preferably no more than 10 degrees.

Preferably the device comprises a pair of flanges projecting outwardly in opposite directions from the distal end of the elongate portion to form 'wings' in a first lateral direction. Preferably the elongate portion may have sides, as mentioned above, comprising first faces (facing along the first lateral direction - that is facing outwardly from the elongate portion in the direction of the flanges) and second faces (facing along a second lateral direction, being a lateral direction substantially perpendicular to the first lateral direction). Preferably the first faces are wider than the second faces. The first faces are the faces that the patient's teeth will most likely make contact with, such that the flanges project upwardly and downwardly relative the bite during use.

Preferably, the device has the following typical dimensions:

A maximum base extent (i.e. a peripheral edge of one flange to a peripheral edge of the opposing flange) of from 25 to 60 mm, more preferably 35 to 55 mm, more preferably 40 to 50 mm and most preferably about 45 mm. A first lateral elongate portion dimension (at base) of from 10 to 20 mm, more preferably 13 to 16 mm, most preferably about 15 mm [i.e. the size of the elongate portion at the base from side to side along the second lateral direction].

A second lateral elongate portion dimension at base of from 15 to 25 mm, more preferably 18 to 22 mm, most preferably about 20 mm [i.e. the size of the elongate portion at the base from first face to second face].

An elongate portion longitudinal extent (i.e. base/distal end to proximal end) of from 15 to 40 mm, preferably at least 20. Optionally in one embodiment from 15 to 30 mm and more preferably from 24 to 28 mm; and optionally in another embodiment from 25 to 40 mm, more preferably 30 to 40 mm (e.g. up to 35 mm), still more preferably 32 to 38 mm. A flange width (not length of a flange along the first direction, but width of a flange orientated in the first direction) of from 0.75 x second lateral elongate portion dimension at base to 1.25 x second lateral elongate portion dimension at base, preferably from lx to l. lx and most preferably greater than lx.

Preferably, the rigid support (i.e. hollow rigid elongate portion and at least one flange) is from 1 to 2 mm thick, more preferably 1.3 to 1.7 mm thick and most preferably about 1.5 mm. Optionally, the rigid support is formed of polycarbonate material.

Preferably, the device comprises a pinch across the second lateral direction about the distal portion of the device, by which it is meant that the lateral dimension at the base is less than the dimension that would be expected if angle of taper from proximal end toward distal end were consistent and/or the lateral dimension at the base is less than the maximum width of any flange extending in a first lateral direction. The pinch enables a medical carer using the device to better grip and control the device by providing a location for the medical carer to hold on the outside second lateral (non-bite) faces of the device as well as in the hollow interior of the device.

Preferably, the device comprises a flexible and/or pliable and/or resiliently compressible outer cover or outer skin formed in or adapted for cooperative engagement with at least part of the outer surface of the elongate portion.

Preferably, the outer cover or outer skin extends from a proximal end (of the elongate portion, being the patient end) to the distal end and, optionally, at least partially along the patient facing surface of the flange.

Optionally, the outer cover or outer skin is configured with surface modifications for improved gripping.

Such surface modifications are preferably selected from one or more of a textured surface, pimples, apertures, ripples, ridges, vanes, and other protrusions, which surface modifications may be configured in an ordered arrangement (e.g. in a substantially longitudinal direction along the length of the elongate portion or substantially laterally, or diagonally spirally between the longitudinal and lateral directions) and/or a disordered arrangement.

Optionally, the outer cover or outer skin is provided with an agent configured for release to the patient during use. Such an agent may be, for example, a cleansing agent, a disinfecting agent, a breath freshening agent, an antiseptic agent, an antifungal agent and/or a flavouring agent. The agent may be configured for sustained release, bolus release, pressure-induced release, or moisture induced release. The agent may be incorporated in any suitable method, such as impregnation, coating or incorporation in bubbles or capsules on or in the surface.

Optionally, the device comprises a flexible and/or pliable and/or resiliently compressible insert or inner skin formed in or adapted for cooperative engagement with inner surface of the elongate portion.

Preferably such insert or inner skin extends from an inner extremity of the inner surface of the hollow elongate portion to a rim at a junction between the inner surface and the at least one laterally extending flange and optionally across the shoulder and further optionally along a portion of a user facing surface of the at least one flange.

Optionally, the insert or inner skin is configured with surface modifications for improved comfort and or grip for the user's finger, which the hollow elongate portion and/or insert or inner skin is adapted to receive.

Such surface modifications are preferably selected from one or more of a textured surface, pimples, apertures, ripples, ridges, vanes, and other protrusions, which surface modifications may be configured in an ordered arrangement (e.g. in a substantially longitudinal direction along the length of the elongate portion or substantially laterally, or diagonally spirally between the longitudinal and lateral directions) and/or a disordered arrangement.

Optionally, the insert or inner skin is formed of a resiliently compressible foam configured for comfortably and retentively receiving a finger of various sizes. Optionally, the insert or inner skin is provided with a component for release to the user's finger during use, such as a cleansing or an antiseptic component. The component may be formed on or in the insert or inner skin in the same optional ways as the agent above in the outer cover or skin.

In a preferred embodiment, an outer skin is provided, which is preferably formed by injection moulding onto an injection moulded rigid support element. The outer skin preferably covers at least a part of the sides of the elongate portion (e.g. the first faces, being the first lateral direction facing sides), preferably the entire surface of the first faces and preferably at least a part of the second faces (being the second lateral direction facing sides). Preferably, the outer skin extends to cover a shoulder of the elongate portion, being the junction of the end and the sides of the elongate portion. Preferably, the outer skin extends from the sides of the elongate portion along a flange junction (i.e. junction of the elongate portion and the flange) and at least the peripheral edges of the flanges (and optionally across the whole proximal surface of the flanges, or just about the periphery of the proximal surface of the flanges, leaving a central portion skin- free).

Preferably, the skin extends as an inner-skin about the rim of the defining the junction of the distal surface of the flanges with the interior surface of the hollow elongate portion and about the peripheral edges of the flanges.

(Optionally, central portions of the distal surfaces of the flanges are skin-free). According to one preferred embodiment, the inner surface is kept substantially skin free, thereby enabling more cost-effective production, and allowing the device to be sized for various sizes. A portion of skin about the rim (bordering the interior surface and the distal surfaces of the flanges) provides a projected portion about the rim which significantly improves user grip and comfort when using the device, without compromising for size.

Preferably, the skin or coating comprises an injection mouldable, pliable or flexible or resiliently compressible material and most preferably a material such as PPE rubber. Preferably, the skin is disposed on the rigid support in a thickness of 0.5 to 1.5 mm, more preferably 0.8 to 1.2 mm, most preferably about 1mm.

According to a further aspect of the invention, there is provided a method of manufacturing a dental support device as defined herein having a rigid hollow support element comprising a rigid hollow support and at least one flange and a pliable and/or flexible and/or resiliently compressible outer skin and/or inner skin, the method comprising a two-stage injection moulding process comprising a first stage in which a first tool assembly enables injection moulding formation of a rigid support and a second stage in which a second tool assembly enables injection moulding formation of the outer and/or inner skin onto the rigid support element.

The invention further relates to a method of propping open the mouth of a patient, comprising inserting between the jaws of the patient a device as claimed in any preceding claim.

The invention further relates to a method of delivering an agent to a patient comprising inserting an elongate portion of a device as claimed in any one of the preceding claims, which device is provided with an outer cover or outer skin which outer skin is provided with an agent for release to the patient during use.

Optionally, the various components may be provided as a kit as described above.

Any suitable material may be used for the outer cover or skin and insert or inner skin. For example, rubber or synthetic rubber may be used.

The invention will now be described in more detail, without limitation, with reference to the accompanying Figures.

As illustrated in Figure 1, a device 101 according to one

embodiment may comprise a rigid support element 103 comprising a tapered elongate portion 105 and pare of lateral flanges 107. A pliable cover 109 may be adapted to fit onto the elongate portion 105.

In Figure 2, a device 201 according to another embodiment comprises a rigid support element 203 comprising a tapered elongate portion 205 and pare of lateral flanges 207. A pliable cover 209 may be adapted to fit onto the elongate portion 205 and a pliable insert 21 1 fits into a hollow interior (not shown) of the elongate portion 205.

In Figures 3a and 3b, a device 301 is shown in which each of the outer cover and insert have lips 313 and 315 that cooperate with the flange 307 to improve stability and retention.

In Figure 4 a device 401 according to another embodiment comprises an elongate portion 403 having flanges 405 extending laterally (in a first lateral direction) from a distal end 407 of the elongate portion 403. The device 401 comprises a rigid support element 409 of translucent or transparent injection moulded polycarbonate visible in the central portions 411 of flanges 405 and at the proximal end 413 of the elongate portion 403. An injection moulded PPE rubber skin 415 is provided in particular on the entirety of the first faces 417 of the side of the elongate portion 403 and about a portion of the second faces 419. The skin 415 extends along the nape 421 (junction between elongate portion 403 and flange 405) and about the peripheral edge 423 of the flange 405. The device 401 is provided with a pinch 425 of lesser width between the two flanges 405 at the base of the elongate portion 403 that improves user grip on the device 401. An uncovered portion 427 of second face 419 extends along the side of the elongate portion 403 from the pinch 425. On the underside (distal side) 503 of the device 501 as illustrated in Figure 5, the skin 515 extends about the peripheral edges 523 of the flanges 505 and about the rim 529 thus improving grip, control and retention of the device on the finger of a user.

The skin 415 provides a pliable material for the patient to bit upon at first faces 417, whilst the distribution of the skin 415 about the device 401 assists in retaining the structure and position of the skin 415, provides comfort about the edges of the device and enables the manufacturability of the device 401 by the two-step injection moulding technique.

The invention has been described with reference to a preferred embodiment. However, it will be appreciated that variations and modifications can be effected by a person of ordinary skill in the art without departing from the scope of the invention.




 
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