CA2986082C

CA2986082C - Mouth care device

Info

Publication number: CA2986082C
Application number: CA2986082A
Authority: CA
Inventors: Rosalyn Anne Harris DAVIES
Original assignee: Individual
Current assignee: Individual
Priority date: 2014-05-28
Filing date: 2015-04-28
Publication date: 2022-06-21
Anticipated expiration: 2035-04-28
Also published as: EP3148368B1; PL3148368T3; AU2015265682A1; CA2986082A1; PT3148368T; GB2526655B; AU2015265682B2; GB201504358D0; WO2015181518A1; JP2017516625A; JP6648380B2; DK3148368T3; ES2892928T3; GB201409492D0; GB2526655A; EP3148368A1

Abstract

The device comprises (a) a unitary integrally moulded elongate shaft forming an elongate handle having a proximal end, and a distal end of circular cross-section; and (b) a head comprising a body portion encircling the distal end of the shaft, and flexible filaments of non-absorbent material and of uniform diameter extending transversely from said body portion. The body portion and the flexible filaments are formed as an integral one-piece moulding that is fused to the distal end of the shaft. The rows of flexible filaments are distributed around the head, and each of the flexible filaments is of non-absorbent material and of uniform diameter, extending transversely relative to the integral one-piece moulding.

Description

MOUTH CARE DEVICE
Field The present invention concerns a mouth care device (also known as an oral hygiene device) and oral hygiene using such a device.
Background Mouth care is an important part of personal hygiene: inadequate mouth care can have an adverse effect on a person's general health and well being.
People who are physically, mentally or medically compromised will often require help from another person to provide their mouth care for them. Evidence suggests this can be very challenging both for the person and the care provider. Many people with dysphagia, poor muscle control, and limited cognitive function often lack the capacity to take care of their own mouth, thus resulting in halitosis ¨ bad breath. For care providers, this offensive smell can be very off-putting, which can result in mouth care not being delivered. There is furthermore clear evidence that people with learning disabilities have poorer oral health than do the general population, and also greater levels of periodontitis. People with challenging neurological behaviours often have a bite reflex which can result in harm both to themselves and to the care provider.
People who are medically compromised often suffer from, for example, extreme sensitivity, xerostomia, excess salivation severe soreness and ulceration due to a side affect of medication. Providing mouth care with a conventional nylon bristle toothbrush is very difficult, and such mouth care is often not carried out for that reason.
Furthermore, conventional nylon bristle toothbrushes are disadvantageous for this purpose for other reasons, as will be explained later.
Failure to manage mouth care for people with complex needs is linked to deteriorations in oral health and to an increase in oral disease_ Oral disease, particularly periodontitis, is linked to systemic diseases such as coronary heart disease, stroke, aspiration pneumonia, certain cancers etc. If mouth care is not provided effectively, people are at risk of increasing health problems of varied nature.
There are disposable devices on the market that have been developed to meet the Date Recue/Date Received 2021-06-16 need of oral care for people with complex needs. For example, known such disposable oral care devices essentially comprise a head comprising a foam mouth sponge, or fabric or tissue, the head being mounted on a hard stiff handle, or "stick", similar to a lollipop ("popsicle") stick.
Problems have been identified with such devices, in that the head can become detached from the handle. An MHRA medical device alert (http://www.mhra.gov.uk) was issued in April 2012 stating 'the foam heads of oral swabs may detach from the stick during use. This may present a choking risk for patients'. In Wales, the Chief Nursing Officer, Chief Dental Officer and Chief Medical Officer withdrew such known foam devices from all NHS establishments.
Furthermore, foam sponges have historically been used to remove plaque bacteria from the tooth surface. However, the typical and distinctive quality of the sponge results in insufficient texture to effectively remove plaque bacteria from the surface of the teeth and to prevent gum disease (gingivitis and periodontitis). The use of a sponge-based oral care device can therefore result in poor oral care and increased oral disease.
A fabric based oral hygiene device is disclosed in US2003/0108846, in which the device comprises an "elongated member" (or handle) and one or more absorbent swabs of non-woven fabric secured to an end thereof. Again problems can arise with detachment of the fabric from the end of the handle. Such a device should, in good clinical practice, be used once and then disposed of.
Although, in general, known conventional toothbrushes are not considered to be suitable for the applications described above in which oral care is provided by a carer for another person (the patient), in a broad sense, conventional toothbrushes can be considered to be encompassed within the term "oral hygiene devices"). The traditional construction of known toothbrushes entails the provision of an elongate shaft having a proximal (grip) end and bristles of nylon or hair secured to the distal end of the shaft.
Some such toothbrushes have the bristles arranged in rows. Examples of disclosures of toothbrushes of this nature are in, for example, CN202014768 (utility model), GB2350783A, GB2406266A, US Patent 5459898, US2001/0044981A and PCT

2 Date Recue/Date Received 2021-06-16 application W097/41754A1. All the toothbrushes disclosed in these documents are of known construction in which separate bristles are secured to the shaft.
Because of the nature of the construction, it is generally recognised that it is possible for the bristles to become detached, thus potentially creating a choking hazard. This feature means that such toothbrushes would be considered to be unsuitable for an application in which oral care is to be provided by a carer for another person (a patient).
Summary The present invention therefore provides a disposable oral hygiene (or mouth care) .. device, the device comprising: (a) a unitary integrally moulded elongate shaft forming an elongate handle having a proximal end (for gripping by the hand of a user), and a distal end (for insertion by the user in a patient's mouth) of circular cross-section; and (b) a head comprising a body portion encircling (surrounding) the distal end of the shaft, and flexible filaments of non-absorbent material and of uniform diameter extending transversely from said body portion. According to the invention, the body portion and the flexible filaments are formed as an integral one-piece moulding that is fused to the distal end of the shaft.
The filaments are generally arranged as a plurality of rows of the integral flexible filaments, each such row extending longitudinally of the shaft and comprising at least five of the filaments, the rows of the filaments being distributed around the head, and the filaments each being of non-absorbent material and of uniform diameter, extending transversely relative to the integrally moulded head.
By "non-absorbent" we mean in the ambient environment of a user's mouth.
Because the flexible filaments are, as indicated, non-absorbent, it is an advantageous feature of the device according to the invention that liquid may be entrained and carried by the flexible filaments, in the interstices between adjacent rows of the flexible filaments.
This contrasts with the prior art arrangements, in which the "head" end is invariably of an absorbent nature.
As indicated, the flexible filaments are all integral with the head which forms the .. integral one-piece moulding, the latter being moulded around and fused to the distal

3 Date Recue/Date Received 2021-06-16 end of the shaft. The shaft itself is preferably a previously formed unitary integrally formed moulding. The two mouldings thus effectively form a single unitary moulding, which thereby acts to prevent the head becoming detached from the handle.
The handle of the device according to the invention is preferably made of a polyolefin .. thermoplastic polymer, which polymer is hygienic (it can be sterile immediately after moulding) and has a history of use for similar products such as toothbrushes.
The material choice should be based on a number of criteria, namely its physiological acceptability and its physical properties. Specifically, the material chosen for the handle should be soft enough to prevent damage to the teeth of patients in the event of involuntary bite reflex during oral health care and carrying out of oral hygiene operations. The handle may have a smooth texture which permits it to be used as a bite pad for patients who may have a bite reflex.
The material of the handle should be malleable or flexible enough to enable it to be bent by the user (that is, formed by the user into a curved or angled shape), in order to aid access to the mouth of the patient; the material should still be robust enough to allow sufficient pressure to be applied during use in oral hygiene. Such flexibility permits angling the device according to the invention for maximum reach inside the mouth of the patient. (Of course, it will be understood that in some circumstances, the "user" and the "patient" may be one and the same person.) .. The proximal end of the handle of the device according to the invention may be shaped to enhance the user's grip, or that end may be provided with grip formations such as grooves or the like.
As indicated, the distal end of the handle of the device according to the invention has a circular cross-section; this cross-section may be constant over at least part of the extent of the head (in which case the relevant part may be cylindrical), or it may vary along the length thereof. When the cross-section of the handle varies, the head may be taper towards the free end; it is particularly preferred that the head is of conical or (more preferably) of frustoconical shape, tapering inwardly towards a distal end face.
It is particularly preferred that the head of the device according to the invention has a distal end face which should be smooth, and the distal end face should furthermore

4 Date Recue/Date Received 2021-06-16 preferably be either flat or slightly convex, in order to further avoid damage to delicate tissue in the user's mouth. It is further preferred that the distal end face of the head should be devoid of (free of) the flexible filaments (such as those described above).
The distal end of the shaft (and also the moulded head as indicated above), are both preferably frustoconical in shape, so as to mirror the general shape of the patient's palate, and to allow for easy access to the sulcus of the cheeks and back of the tongue of the patient.
The moulded head, together with the rows of integral flexible filaments as described, are generally formed around the handle at high temperature, whilst the material forming the moulded head and flexible filaments is in its molten state.
Bonding of the two parts (the head and the handle) may be achieved utilising a mechanical key on the handle portion. Because melted polymer materials shrink on cooling, such shrinkage has the advantageous result that the flexible filament portion pulls down tightly onto the handle and grips onto the mechanical key, so as to prevent the head coming loose in operation.
It is further preferred that the head forms a shroud, such that the resulting shroud circumferentially encircles the distal end of the handle.
The head and the integral flexible filaments are preferably integrally moulded from a thermoplastic elastomer, which (advantageously) is generally a food contact grade .. material. Such thermoplastic elastomers, which are generally inherently non-absorbent, typically exhibit good tensile and tear strength, whilst being soft and flexible, in order to ensure that the head of the device does not create discomfort for the patient during use in a cleaning operation. Such thermoplastic elastomers also give a good bond to the polyolefin constituting the handle, which adds to the mechanical key effect and helps to prevent the head from becoming detached from the handle.
It is further preferred that the head, like the flexible filaments as described above, should be of non-absorbent material.
The integral flexible filaments may be textured; for example, they may include integral

5 Date Recue/Date Received 2021-06-16 minor ridges, which allow for crusty secretions and food debris to stick to each filament for easy removal. Because the filaments are flexible, they are, of course, not suitable for applications, such as plaque removal, which would require hard rubbing.
In some embodiments of the invention, the rows of flexible filaments may be arranged .. in at least part-helical (or part-spiral) manner, in which case each of the respective plurality of rows may comprise a successive notional turn of the relevant helix or spiral.
Such notional turns of the helix or spiral thus extend both around the head and along the length thereof.
Alternatively, each of the rows of flexible filaments may be arranged in a linear fashion.
.. In this case, the number of rows of integral filaments on the head, and their alignment, are preferably both selected so that there is no more than 600 separation between adjacent linear rows. It is particularly preferred that a selected plurality of rows are parallel to one another.
It is further preferred that each flexible filament in a row is parallel to each other flexible filament in that row. In a further preferred embodiment, the free (tissue-contacting) ends of the integrally moulded flexible filaments are either flat or slightly convex, in order to avoid damage to the user's mouth during an oral hygiene operation.
It is particularly preferred that at least some of the integral flexible filaments extend substantially perpendicular to a longitudinal axis of the shaft.
The oral hygiene device according to the invention is preferably disposable;
that is, the device is intended to be used for a period of up to 12 hours and then discarded. It is, however, an advantage of the device according to the invention that it can be used more than once during a 12 hour period; by way of contrast, conventional oral hygiene devices can be used only once and must then be discarded because of the risk of detachment of the head portions thereof.
The oral hygiene device according to the invention is furthermore designed to support patients with complex health needs, and enable them to have their mouths cleaned by respective users each employing a device according to the invention, thereby to achieve a clean and healthy mouth for the relevant patient. The device according to

6 Date Recue/Date Received 2021-06-16 the invention is specifically designed to assist "users" who are carers and care providers, and who carry out mouth care for others (namely for patients).
However, it is also possible for the "user" (that is, the person who manually grips the handle) to be the same as the "patient" (that is the person whose mouth is to be cleaned).
The oral hygiene device according to the invention is generally not intended to remove plaque bacteria from the tooth surface, there being many such products on the market that fulfil that role (such as toothbrushes, as described above).
Specifically, the filaments of the device according to the invention are flexible and therefore unsuitable for applications where significant rubbing of, for example, tooth surfaces is required.
However, the device according to the invention preferably has three main applications, as follows:
a. To cleanse the mouth, so as to enable soft tissues and mucosa to be freed from food debris, oral bacteria and sticky saliva secretions;
b. To assist hydration, so as to be a carrier for aiding hydration of the mouth and soft tissues either by carrying thin liquids such as water, mouth rinses or water based gels etc.; and c. To assist with oral desensitisation for people who have become averse to having their teeth and mouth brushed with a toothbrush.
In order to carry out the function of cleansing the patient's mouth, the head (together with the flexible filaments) is typically rubbed and rotated in a circular motion over the part of the user's oral cavity to be cleansed (namely the tongue, oral mucosa and soft gingivae) to remove food, debris and sticky secretions.
In order to help in carrying out the function of assisting hydration, the flexible filaments of the device according to the invention are preferably strategically placed (in rows, as indicated above) in order to ensure maximum holding of thin liquids such as water, mouth rinses and water based gels. The liquids of this nature are held between adjacent rows of flexible, non-absorbent filaments, and not (as in the case of prior art oral hygiene devices comprising elongate handles and swabs or sponges) by an absorbent head.

7 Date Recue/Date Received 2021-06-16 In order to assist with oral desensitisation for patients who have become averse to having their teeth and mouth brushed with a toothbrush, the device according to the invention can be used to rub and stimulate the patient's lips, mouth and tongue, and the tactile flexible filaments can be massaged around the mouth area to "wake up" the muscles of the mouth for patients with low tone or apraxia.
The present invention therefore further comprises a method of oral hygiene, in which a user inserts the head end of a device according to the invention into the mouth of a patient, and then uses the flexible filaments at the head end to rub internal surfaces of the patient's mouth, such as the tongue, oral mucosa and soft gingivae.
Brief Description of the Drawings Preferred embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which:
Figure 1 is a perspective view an exemplary oral hygiene device according to the invention;
Figure 2 is an enlarged view of the head region of the device of Figure 1 (circled "8"
in Figure 1);
Figure 3 is an end view of the head region of the device of Figure 1; and Figure 4 is a longitudinal sectional view of the device of Figure 1 (along the line A-A
of Figure 3).
Detailed Description Referring to the drawings, in which like parts are denoted throughout by like reference numerals, there is shown an exemplary disposable oral hygiene device 1 comprising a handle portion 2 and a head portion 3.
The handle portion 2 as shown has a unitary, integrally moulded, elongate shaft 4 having a hand grip end 5 and an opposed end 6, longitudinally separated from hand grip end 5, to which is moulded the head portion 3, which is to be inserted into a patient's mouth. Shaft 4 is mainly of circular cross-section, but in the illustrated

8 Date Recue/Date Received 2021-06-16 embodiment, it further includes a cut-out generally flat portion 7 to aid gripping.
The head portion 3 is itself a unitary integral moulding; it comprises a body portion 8 encircling (surrounding), and fused to, the opposed end 6 of handle portion 2, and also (as shown - see especially Fig 2) twelve rows 9a, 9b, 9c, 9d, 9e, 9f, 9g, 9h, 9i, 9j, 9k,91 of integral flexible filaments each of which is generally cylindrical shape. The head portion 3 further has a flat disc shaped end 10, so shaped in order to avoid damage to a patient's mouth during use of the illustrated exemplary device.
Each such row of flexible filaments in the illustrated embodiment extends longitudinally and parallel to the elongate shaft 4; as shown in the illustrated embodiment (again see Figure 2) each row contains twelve such filaments 11,12,13,14,15,16,17,18,19, 20, 21,22 of uniform diameter, extending transversely relative to the head portion 7 and the elongate shaft 4. Some only of the illustrated rows are perpendicular to the longitudinal axis of the elongate shaft 4.
The rows of flexible filaments are distributed around the head portion 7; in the illustrated embodiment (see Figures 2 and 4) there are two opposed sets of three generally parallel rows 9a, 9b, 9c; and 9g, 9h, 9i, respectively; and two opposed sets 9d, 9e, 9f; and 9j, 9k, 91, respectively, which are at successively increased angles (with approximately 600 separation between adjacent such rows).
Each row of flexible filaments is substantially co-planar with a corresponding row of flexible filaments on the opposite side of the head portion 7; thus row 9a is coplanar with row 9i; row 9b is coplanar with row 9h; and row 9c is coplanar with row 9g.
Furthermore, row 9d is coplanar with row 9j; row 9e is coplanar with row 9k;
and row 9e is coplanar with row 91.
The ends 23 of each of the flexible filaments are, as illustrated flat; also as illustrated, some of the flexible filaments are perpendicular to the axis of the elongate shaft 4.

9 Date Recue/Date Received 2021-06-16

Claims

1. An oral hygiene device comprising:
(a) a unitary integrally moulded elongate shaft forming an elongate handle having a proximal end, and a distal end of circular cross-section; and (b) a head comprising a body portion encircling the distal end of the shaft, and flexible filaments of non-absorbent material and of uniform diameter extending transversely from said body portion, the body portion and the flexible filaments being formed as an integral one-piece moulding that is fused to the distal end of the shaft, wherein the integral flexible filaments are in a plurality of rows, each said row extending longitudinally of the shaft and comprising at least five of the filaments, wherein the rows of filaments are distributed around the head such that there is no more than 60 angular separation between adjacent rows and a selected plurality of said rows are parallel to one another, wherein said distal end and head are of frustoconical shape, wherein the head begin of frustoconical shape is tapering inwardly towards a face at the free end that is smooth, devoid of flexible filaments, and either flat or convex.

2. An oral hygiene device according to claim 1, wherein each flexible filament in each row is parallel to each other flexible filament in that row.

3. An oral hygiene device according to claim 1 or claim 2, wherein free ends of the integrally moulded flexible filaments are either flat or slightly convex.

4. An oral hygiene device according to any one of claims 1 to 3, wherein the handle is malleable or flexible enough to enable it to be bent in the mouth of a patient.

5. Art oral hygiene device according to any one of claims 1 to 4, wherein the proximal end of the handle is shaped to enhance grip, or is provided with at least one grip formation.