WO2022038626A1

WO2022038626A1 - A compact electro-mechanical device to curtail residual ridge resorption

Info

Publication number: WO2022038626A1
Application number: PCT/IN2021/050707
Authority: WO
Inventors: Shivsagar Tewary; Abduljabbar Khan; Anand G. Joshi; Pronob Sanyal; Karuna Pawashe; Uzma Belgaumi
Original assignee: Shivsagar Tewary; Abduljabbar Khan
Priority date: 2020-08-21
Filing date: 2021-07-21
Publication date: 2022-02-24
Also published as: ZA202303703B

Abstract

Disclosed is related to the development of a compact and portable Electro-Mechanical device that is incorporated with calibrated electronic circuitry. The said device is capable of providing a calibrated and controllable motion at one of its embodiments and simultaneously dispensing lubricant / medicament from other. The said motion is of the form of vibration but not limited to oscillatory motion, undulated motion, brushing motion. The said vibrations are impelled on the gum overlaying the alveolar bone and produce a massaging action that facilitates the blood flow in those tissues thus curtailing the effect of residual ridge resorption.

Description

REFERENCE:

The instant application is based on the Indian Priority 202021036090 dated August 21, 2020.

FIELD OF INVENTION

The present invention discloses a compact electro -mechanical device to curtail residual ridge resorption. More particularly, the present invention relates to an electro-mechanical gum massager with automated real time lubricant dispenser configured for edentulous condition patients and in addition, as a furtherance incorporates features for brushing and tongue cleaning configured for dentulous patients.

BACKGROUND ART

Residual ridge resorption is a life - long catabolic activity of alveolar bone which follows extraction of tooth. It is an irreversible physiologic procedure of ageing and has both direct and indirect ill-effects on providing tertiary care of old debilitating patients. Continuous stimulation to the edentulous ridges by applying physiological forces retards this resorption phenomenon. One of such home care method is finger massaging which requires manual dexterity. It is a home care method where the patient uses his own index finger to massage the edentulous upper and lower jaws.

Gum massagers have been in use for infants/ kids and dentulous patients but not for completely edentulous ridges. Neither such device is available nor is any treatment regimen followed.

The problem of “finger gingival massaging procedure” which requires manual dexterity was solved by an “Electro-Mechanical device employing a mechanical motion integrated with calibrated Electronic control unit”. The said motion includes vibration and/ or oscillation and/or undulated motion.

Known way, currently, is to use index finger to do finger massaging to increase blood flow in the gums overlying alveolar bone. The finger massaging can be done by the person himself/ herself requiring manual dexterity.

Increase in blood flow maintains osteoblastic activity resulting in minimizing alveolar bone loss and thus curtailing the effects of residual ridge resorption.

It has already been proposed that the embodiment of the earlier Inventions relates to a compact and portable device that in particularly embodies a mechanical rotor system integrated with electronic circuitry that is solely meant for the purpose of brushing and cleaning teeth having many other features included but not limited to charging, timer indicator, connectivity via app. Yet some other inventions relate to use of pointed soft biomaterial spine structure to be used along the gum lines to increase the blood flow and by observation it is confirmed that prior Inventions for teeth growth and gum message for infants the method these inventions relate to is by using a structure having a cushioning material with small embossing on it. The said structure is rubbed gently against the gums to improve the blood flow. It is observed that these methods ostensibly appear to be useful but in fact these aren’t of much use to completely edentulous geriatric patients.

The drawbacks of the known way (finger massaging by self) are - a. Uniform pressure cannot be applied all over gums. b. Patient compliance is required, difficult to achieve specially from geriatric patients. c. Difficult to keep for definitive timing. d. No adjustability in pressure. e. Can’t be done by other than self. f. Requires manual dexterity which is not usually convenient for geriatric patients. g Special Pressure adjustments controls are not provided so as to escalate the process of different types of gum tissue resiliency. h. No provision is provided for simultaneous/ spontaneous automated fluid lubricant application on the gum tissues while massaging. Lubricant reduces friction between the device head and gingival tissues resulting in less abrasion of the same thus ensuring unscathed gum tissues and more patient comfort. Especially it is useful in reducing trauma induced lesions. i. No provision of simultaneous automated medicament topical application with/ without gingival massaging.

In the prior art an Indian application 116/CHE/2006 discloses a "Gum massager is useful to massage gums comprising of a silicone rubber outer cover with cuboid shape and curved edges. Front side is a half circular shape. Inside of these, silicon rubber of same shape sponge with centre hole is there. Both will inserted to the back end side of the tooth brush handle. Then the silicon rubber cover neck is joined to the tooth brush handle and sealed it water proof. By using this instrument our teeth gums, teeth roots, are getting strong, and blood flow increases that prevent bacteria, so that gums and teeth are healthy.

In another prior art an US application US3967617A discloses a mechanical gum massaging device in which the stimulating or massaging element is caused to move (a) in a generally elliptical path, with (b) the plane of said path being substantially perpendicular to the longitudinal axis of the device, and (c) the operative portion of the stimulator element extending outwardly from the device in a direction such that the plane containing said direction and the longitudinal axis of the device is substantially perpendicular to the major axis of said generally elliptical path.

In another prior art a PCT application W02003086141A2 discloses a gum massager, which includes an elongate handle member having a first free end portion and a second end portion (14). The gum massager (22) also includes a massaging head member (22) formed together with the second end portion (14) of the elongate handle member. The massager head member (22) includes a resilient massaging element formed so as to generally adapt to the contours of a gum portion being massaged, when pushed there against.

In yet another prior art an EP application EP0918477A1 discloses an oral brush (10) suitable for massaging the gums, comprising of an elongated handle (12); a head portion (14), sized for insertion into the human mouth, extending from an end of said handle (12); and a brush portion (16) comprising a plurality of bristles extending from said head portion (14), characterized in that said plurality of bristles, comprises of a plurality of first bristles (20) extending from said head portion (14), said first bristles (20) comprising a thermoplastic elastomer which is a styrene-ethylene-butylene-styrene block copolymer, a styrene-butadiene-styrene block copolymer, a styrene-isoprene-styrene block copolymer, a polyolefin elastomer, or a mixture of any two or more of said elastomers, and having a Shore A hardness of 30 or greater and a flexural modulus of at least 5 MPa and a plurality of second bristles (18) extending from said head portion (14) comprising a non-elastomeric material.

In yet another prior art an Indian application 2971 /MUM/2013 discloses a vibration massager configured to provide alterable vibrations of different patterns and varying intensity, frequency and speed. The vibration massager in accordance with the present disclosure comprises a belt, a plurality of vibrators operatively secured to said belt, wherein said vibrators are adapted to generate vibrations, a control system including a driver circuit and said driver circuit adapted to control vibration of said vibrators and a power supply unit adapted to power said plurality of vibrators and said digital control system, wherein at least one of said plurality of vibrators are adapted to generate alterable vibration patterns by varying at least one vibration parameter.

There is limited non -patent literature regarding gingival massaging with any specific device and their outcome for completely edentulous patients n prior art as under: a. Simaan C et al published clinical and histological evaluation of gingival massage in the treatment of chronic gingivitis for a period of 2 and 12 months and concluded that clinically 45 out of 60 cases brought out complete recovery. Histologically, the results showed limited effect on the keratinization of epithelial surface. b. Babu BD et al evaluated the effect of denture soft liner on mandibular ridge resorption in complete denture wearers after 6 and 12 months of denture insertion and concluded that soft denture liner significantly reduces the residual ridge resorption in complete denture wearers as compared to conventional denture wearers (without denture liner) over a period of one year. c. Keremi B et al conducted an investigation to study blood flow of marginal gingival at different teeth and concluded that there is homogeneous marginal blood perfusion both in maxillary and mandibular healthy gingiva. However, difference exists in blood supply between the upper and lower jaws in favour of mandibular marginal gingiva. d. Matsuki M et al used a non - contact laser flowmeter to measure the changing of gingival blood flow and concluded that reproducibility was acceptable through the period of measurement.

SUMMARY OF INVENTION

The principle object of an embodiment of this invention relates in particular to the development to a compact and portable Electro-Mechanical device that is incorporated with calibrated electronic circuitry. The said device is capable of providing a calibrated and controllable motion at one of its embodiments and simultaneously dispensing lubricant / medicament from other. The said motion is of the form of vibration but not limited to oscillatory motion, undulated motion, brushing motion. The said vibrations are impelled on the gum overlaying the alveolar bone and produce a massaging action that facilitates the blood flow in those tissues thus curtailing the effect of residual ridge resorption.

Another object of an embodiment of this invention relates the development of a multi-level multi-purpose compact and portable gum massaging device that is not just capable of gum massaging but also performing other operations. The said operations are not limited to brushing, automated to-fro undulated tongue cleaning, auto fluid dispensing and cleaning of gums, auto-fluid spraying and cleaning in case of edentulous conditions. The said fluid refers to a mouth cleanser and/or mouth flushing and/or mouth sanitizer.

Another object of an embodiment of this invention relates to the development of a gum massaging device. The said massaging device is having an exemplary embodiment that vibrates and referred to as “head structure” in the context on this invention. The said structure employs a soft and cushioned material not limited to latex, Biosynthetic-rubber, natural rubber, composite material intended to ensure the gingival safety and to keep gingiva unscathed during operation of the device. The said head structure has embossing’s on its circumferential surface having a peculiar shape. The shape may have a plurality of varants and the shape of each embossing is not limited to convex cylinder, which is, either convex/ cylindrical and possess a base circumference in a range of 500 to 1000 microns and the height of the said shape either convex/ cylindrical has a base to tip height of 500 to 2000 microns. The said embossing’s are again made of a similar material as described for the overall head but has a smoother, softer and unsharp surface. The said head structure is made easily detachable, replaceable and other features not limited to sterilizable, manually cleavable. The said head structure is made such that it comes in a range of size as per the compatibility and comfort of the end user and the shape is not limited to convex and / or concave and / or concave cum convex. The aforementioned shapes of the head structure along with its embossing in addition are/ or can have additional features for multi-purpose use. Here features not limited to bristles, soft ring structure for tongue cleaning and self- lubricating pores.

Another object of an embodiment of this invention relates to features in particular bristles which are helpful for dentulous patients and the other features mentioned including Fluid lubrication pores is intended to provide lubrication while massaging and/or brushing and/or tongue cleaning. The lubricant system and lubricant pores are a single unit and incorporated with in the said device and will work synchronously and the lubricant fluid is not limited to gum medicaments, oil-based fluids, gel-based fluids. The said tongue cleaning structure is a furtherance and is accomplished with the bristle base to perform tongue cleaning action for both dentulous and edentulous patients. In the aforementioned features the shape, size and mechanism of the features responsible to make these features come into action / utility is also variable in a way not limited to mechanical push, sliding action, smooth scrubbing mechanism for tongue cleaning.

Yet another object of an embodiment of this invention relates in particular to a mechanical vibration system that is precisely controlled by calibrated ECU’s. The said ECU’s are capable of providing control over many aspects of vibration which are not limited to pressure control, amplitude and frequency control, timer control, Intelligent pressure manipulating.

Yet another object of an embodiment of this invention relates to development of a gum massager incorporating various features. The said features not limited to compactness, portability, charging, moderately waterproof, mobile app connectivity for usage alarms, alerts and/ oral hygiene tips, pressure alarms, pressure monitoring and alerts, control over amplitude and frequency of vibration.

Yet another object of an embodiment of this invention relates to development of a gum massager incorporating programmable aforementioned features as mentioned in the previous objectives, In the said features particularly the features like pressure monitoring, frequency of vibration, amplitude of vibration the device has an extra provision and furtherance to store data in a way not limited to storing data in digital format in an application, storing data in a mobile and/or any similar digital GUI based device via Bluetooth or WIFI or any other wireless means. Storing data in a specialised applicated dedicated for the storage purpose in any aforementioned device. The said data is/ can be used in a way not limited to using the data to intelligently redo the performed massaging operations in an efficient way, using the stored data for the user to take sagacious decision on the operational parameters for future usage of the device, using the stored data as a history for dental and medical treatment of the patient. Yet another object of an embodiment of this invention relates to development an electro -mechanical device to help the patient and caregivers to give away inadequate methods such as manual dexterity and / or by the use of brushing device and/or static devices done to restrain the effects of residual ridge resorption also helps to avoid any unwanted gum injury caused due to lack of dexterity in massaging and using non-specific, inadequate and out of purpose devices.

Yet another object of an embodiment of this invention relates to development of a gum massaging device that comes with a compact and portable charger unit. The said charger unit is only compatible to use with the said device.

Yet another object of an embodiment of this invention relates to development of a gum massaging device that is cost effective, economic and efficient in terms of power and durability and affordable by common man.

Therefore such as herein described there is provided an electro-mechanical device for curtailing residual ridge resorption comprising of a concave cum convex shaped (CONVEXO - CONCAVE) head structure; an elongate cylindrical housing body with separate upper and lower casing incorporating plurality of electronic and mechanical circuitry and components, programmed processor, liquid disposing mechanism, display, power supply, switches and configured for use as handle member having a first free end portion and a second end portion; wherein the said head structure is operably attached to the second end portion through connecting limb; wherein the said housing body includes a real time controlled lubricant / medicament dispensing mechanism; wherein said head structure is embodied with electro -mechanical miniature motion generator unit that creates vibrating / oscillating / undulate motion resulting into massaging action; and wherein the said motion is precisely controlled by calibrated ECU’s including controls for amplitude, pressure, frequency, timing with additional features like usage alerts, pressure alarms and intelligent pressure control by programmed processor.

The embodiment of this invention relates to an electro-mechanical device. The embodiment of the said device contemplates a concoction of various electronic and in particular mechanical components whose incorporation is used to create a motion at the concave cum convex (convexo cancave) head shape of the device. The said motion is of an oscillating and/or vibrating and/or an undulate form and further dispensing lubricants / medicaments in a controlled manner in real time. This invention in particular relates to a device which employs a vibrating/ oscillating/ undulate motion generating mechanism at its head which is in addition integrated with programmable timer circuitry, alarming circuitry and amplitude and frequency controlling circuitry, pressure monitoring circuitry. In the context of this invention, the oral use of this device on complete edentulous upper and lower jaw will be done and the results emerging out from the effects of this motion on the bone/jaw will be used to observe the extent to which effects of residual ridge resorption could be curtailed. Use of this device will help in disability limitation to the old aged patients requiring manual dexterity and also their reliance on tertiary care for complete denture rehabilitation.

The embodiment of the invention is characterized by incorporation of electronic and mechanical components together to develop a compact portable contra angled electro-mechanical device, at its tip has an idiosyncratic with concave cum convex designed head structure. The said head structure has an embodied electro-mechanical unit that can create a vibrating and/or oscillating and/or undulate motion. The said head is a soft and cushioned such that the gingiva is unscathed. Below the head there is provided a circular shaped dispensing mechanism for real time controlled supply of lubricants and / or medicaments on demand. The said motion is precisely controlled by a calibrated electronic control unit. The controls provided are in terms of timing, pressure, amplitude, frequency, start/ stop. The said device is used intra orally for gingival massaging. Customarily use of the device will increase the gingival blood flow, thereby curtailing the effects of residual ridge resorption and thus reducing the dwindling alveolar bone especially in completely edentulous geriatric patients.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS

Having described the various embodiments of the invention in general terms. For further understanding of intricate details of one or more embodiment of the invention, reference will now be made to the accompanying drawings & flow diagrams and is not limited by the figures of the accompanying drawings & diagrams, in which like references may indicate similar elements and in which:

Figure 1 illustrates the assembled isometric view of the device contemplating the various parts of the embodiment of the invention in accordance with the invention.

Figure 2 depicts the exploded isometric view illustrating the parts involved in the assembly of the device and / or the assembly of embodiment of the invention in accordance with the invention. It also depicts the head structure briefly.

Figure 3 depicts the isometric both external and internal view of one of the embodiments of the invention and is referred as the upper casing hereafter.

Figure 4 depicts the isometric both external and internal view of yet another embodiment of the invention and is referred as the lower casing hereafter. It also shows the lubricant chamber imbedded in the inside of the said embodiment.

Figure 5 depicts the isometric both external and cross-sectional view of yet another embodiment of the invention, the cross-sectional view showing the internal features of the said embodiment and is referred as the connecting limb hereafter.

Figure 6 depicts the isometric view of yet another embodiment of the invention, It shows the details, features and variants of the said embodiment and is referred as the head structure hereafter. It also with reference to Fig. 4, shows the flow of the lubricant and its outlet trajectory through the head structure.

Figure 7 depicts the exploded isometric view illustrating the intricate details of the parts involved in the function of the device. This figure with conjunction with Fig. 8 describes the interconnection and link between different parts and members of the embodiment of invention.

Figure 8 illustrates a flow/ block diagram contemplating the interconnection of various embodiments of the invention shown in Fig. 1 and exploded view shown in Fig. 7, Figure 8 includes the denomination of corresponding electronic parts that are incorporated with the other embodiments to achieve the said purpose of the invention.

Figure 9 illustrates the isometric view of the embodiment of the device charger. The figure includes both charger and device connected to each other.

Figure 10 illustrates the flow diagram of electronic circuitry of the charger.

DETAILED DESCRIPTION

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items. As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well as the singular forms, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising," when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof.

Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one having ordinary skill in the art to which this invention belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and the present disclosure and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

In describing the invention, it will be understood that a number of techniques and steps are disclosed. Each of these has individual benefit and each can also be used in conjunction with one or more, or in some cases all, of the other disclosed techniques. Accordingly, for the sake of clarity, this description will refrain from repeating every possible combination of the individual steps in an unnecessary fashion. Nevertheless, the specification and claims should be read with the understanding that such combinations are entirely within the scope of the invention and the objectives.

Various embodiments of the invention are described more fully herein after with reference to the accompanying drawings, in which some and/or all embodiments of the invention are illustrated via line diagrams, figure and drawings. Indeed, these inventions may be embodied in many different forms and should not be construed as limited to the embodiment set forth herein; rather, these embodiments are provided so that this disclosure is legitimized. A compact electro -mechanical device to curtail dwindling alveolar bone in complete edentulous geriatric patients is discussed herein. In the following description, specific details are set forth for purpose of explanation and understanding .

The present disclosure is to be considered as an exemplification of the invention, and is not intended to limit the invention to the specific embodiments illustrated by the figures or description below.

Such as herein disclosed is a compact portable concave cum convex head shaped and idiosyncratic designed Electro-Mechanical device characterized by the incorporation of electronic and mechanical units. The said device, at its tip has a uniquely designed head structure. The said structure is soft and cushioned flat surfaced such that the gingiva is unscathed. The said structure is embodied with electro -mechanical miniature motion generator unit that creates vibrating/ oscillating/ undulate motion resulting into massaging action. The body includes a controlled lubricant / medicament, real time dispensing based on manual and / or auto setting mechanism. The body also includes a chamber reservoir for storing the said lubricant / medicament. The said motion is precisely controlled by calibrated ECU’s including controls for amplitude, pressure, frequency, timing with additional features like usage alerts, pressure alarms and intelligent pressure control. The said device is rechargeable and charged by a compatible USB charger. The massaging action achieved by the said device is employed on the gingiva of completely edentulous geriatric patient for gingival massaging thereby, to increase the blood flow in gums overlying alveolar bone and thus, to curtail the effects of residual ridge resorption.

The present invention will now be described by referencing the appended figures representing preferred embodiments. FIG. 1 illustrates the assembled isometric view of all the embodiments of the invention. The specific embodiments highlighted in this figure are “1” which is referred as the casing, “2” which is referred as the connecting limb and “3” which is referred as the head structure. These specific embodiments capsule the electronic and mechanical components which when incorporated together will fulfils the purpose of the invention. Here the embodiment “1” of the device mainly carries the electronic parts and circuitry, the embodiment “2” of the device mainly carries electronic parts such as wire and some portion of mechanical part, embodiment “3” of the device in particularly capsules the mechanical component. The other purposes of each embodiment are as follows, embodiment “1” of the device helps the user to hold and have a grip on the device when in use, embodiment “2” of the device acts as an contra-angled structure and helps the user to get the head structure configured for insertion into any part of his oral space where physical reach through manual handling is otherwise not convenient accompanied by a plurality of dispensing holes / pores disposed at the bottom of the head portion and in the neck collar portion of the body for controlled dispensing of lubricant / medicament, embodiment “3” of the device is the idiosyncratic designed head structure that enables the massaging action to be impelled on the gingival tissues thus to perform gingival massaging.

The FIG. 2 illustrates the isometric exploded view of the embodiments of the invention. This figure mainly features the embodiment “1” of FIG. 1 and indicates the subdivision of embodiment “1” into “la” referred as upper casing and “lb” referred as lower casing. Both these sub embodiments capsules in particularly the electronic components such as timer circuitry, pressure monitoring circuitry, amplitude and frequency controlling circuitry and a leak proof reservoir but not limited to any other electronic module or part or circuitry. It even shows “3” which is the top most head structure responsible for providing and delivering the massaging action on to the gums also the pores on it show the lubrication openings. The overall components la, lb, 2 are the body housing & 3 is the head structure as shown in this figure when assembled together make up the device, the base material used for all these aforementioned components is basically plastic. In plastic the material in specific is not limited to polyolefins (polyethylene, polypropylene, EVA), 3D printing materials (ABS, PETG, PLA) etc. Further the part 2 shown in the figure has an extended scope to be of flexible nature and the same then can be made up of any flexible composite plastic material that is not limited to Linear Low-Density Polyethylene (LLDPE), TPE or TPU etc. In the later stage of this disclosure in Fig 6 the head structure is elaborated and shown wherein the bristle are shown as 28c and embossing are shown as 28e, in which the 28c the bristles are made of nylon material and the embossing’s are of soft plastic material not limited to latex, silicon etc. The said embossing i.e., 28e are peculiar structures protruding out of the base surface of the head structure. These peculiar structures have a shape resembling the hemisphere shape so they have a curved smooth top surface that touches the gums. These embossing’s have a diameter in a range of 0.5 mm to 1 mm and the extent to which they protrude from the base surface is not more than 1.5mm. They are designed and developed in a way that dirt if entrapped can be easily removed by simple cleaning. These embossing’s are produced on the head structure instead of a plane surface because they can act as high impact spots and vibratory pressure distribution through them will be more efficient than a plane surface they act as active pressure points.

The FIG. 3 shows the intricate details of the upper casing “la” of the FIG. 2. This figure clearly shows the extra and intra isometric view of this embodiment. The figure illustrates the feature and compartments of this embodiment in the form of numbers as follows, “4” is the one part of the contour feature inscribed in this member to have an interlock with the connecting limb structure “2” of FIG. 2. “5” is the portion where a part of the electronic circuitry fits along with specific controlling knobs which are then linked with “6” where a part of the power unit rests. “7” is the portion where the knobs and electronic circuitry fits for various other parameter controlling and a part of female USB socket rests in this portion. The said parameter controlling refers to amplitude, frequency, timing, pressure controlling. “8 is the opening of thorough which the said USB socket is exposed out for connecting a male connecter or charger pin. “9” is a hole made that passes through “11” through which any type of fastener not limited to threaded, nut based, rivet based, helps in partly fastening of the upper case with the lower case “lb” of FIG. 2. “10” shows the opening from where the controlling knob is open for the user to adjusted via the use of a mini screw driver and/ or any similar miniature tool.

When the knob is adjusted with the screw the controller unit will sense the change and will manipulate the supply to the vibration unit in a way that the amplitude of vibration can be controlled in a range of 0.1mm to 0.9mm to positive side on a linear scale the same on the negative side which in turn will increase or reduce the pressure on the gums as the impact force gets changed with changing amplitude. Here, we consider the user to hold the device without applying any extra pressure. The knob adjustment is also able to control the frequency of vibration i.e., by controlling the rotational/ movement speed of the vibrating unit i.e., in RPM if the RPM is reduced the frequency of vibratory impacts gets reduced and vice versa. Both the amplitude cum pressure and frequency of the vibration has to be manually set according to the gum sensitivity and comfortability of the user.

The FIG. 4 shows the intricate details of the lower casing “lb” of the FIG. 2. This figure clearly shows the extra and intra isometric view of this embodiment. Here the “12” depicts the other part of the contour feature inscribed in this member “lb” which in conjunction with that on “la” will provide a complete interlock of the connecting limb “2” with the casing “1”. Thus, both “4” in “la” and “12” in “lb” together help fastening and arresting the connecting limb and thus locking its degree of freedom. “13” shows the other part of the compartment where the electronic circuitry rests. “14” is the compartment where the switch and pressure control units are fixed. “15” shows the other part where the power unit rests. “16” shows the compartment for the other part where the USB socket rests. “17” is the hole provided through which fasteners pass and fix to “11” of “la” similarly “20” is hole via “21” through which fasteners pass and fix to “la”. Thus providing complete fastening of “la” and “lb” to create complete embodiment “1” of the device. Here the opening “18” is provided for the switch which is responsible for controlling the electronic functions like turning OFF/ ON. “19” provided is a beads feature on the holding part, it ensures gripping while the user is operating the device. Looking at another embodiment within the intermediate of the lower and the upper casing is the lubricant chamber “27” which is indeed responsible of holding/ storing the lubricant fluid. To the said lubricant chamber is attached a push button 27a at the top of the upper casing “9” which acts as a fastener as well as an intricate push button for pulsing and forcing the lubricant to flow through the channels “27b” and to pass through 27c wherein the secondary storage is provided that is 27d and then follow 27 e come out of the pores 27f and near the vicinity of the head structure “3” and “28” here 27g will hold the vibrating component.

The said pores 27f will act as the orifice or opening for the lubricant fluid to flow out of the secondary chamber 27d, the orifice provided lies in and within a size range of diameter 0.5mm to 1.5mm which makes the orifice to spray out the lubricant in an aerosol fashion in a 360 coverage over the massaging area hence forming a lubricant layer over the gums both on the maxilla and mandible so as to facilitate massaging in a smooth and unscathed manner.

The FIG. 5 depicts the isometric and cross-sectional cut view of connecting limb “2” of FIG. 2. Here “22” is a socket like contour that has a cylindrical cut out/ pocket in which a part of the vibration module rests (a mechanical component), “23” shows the contra-angled shape that helps in getting thorough the difficult regions of the oral space which are otherwise not easy to reach manually through finger massaging. “24” is the positive part of the contour that fixes or sits or rests into the negative contours i.e. “4” in “la” and “12” in “lb” thus arresting or abstaining itself from motion and all the degrees of freedom. The section cut shows inner view of socket “22” which is “25” is this the space whereas said the part of the vibrating module is fixed and 26 shows the sectioned view of “24”.

The FIG. 6 shows the isometric and sectional view of idiosyncratic designed variants of the head structure “28”. This is one of the embodiments of the device and has the main role to play. This embodiment is responsible for providing or delivering the resulting massaging action achieved by the device, on the gingival tissues of completely edentulous geriatric patients. As observed in the figure it shows that the embodiment of this structure on its external surface has minute embossing “29” that act as active pressure site and the said embossing are covered with a film of smooth, soft and cushioned layer so as to have an unscathed gingiva. The said embodiment containing the embossing is an active pressure points and in particular the site of action which helps in efficient delivery of massaging action. This head structure fits over the connecting limb via press-fit on “27g” with “28g” and sits on the portion “22” of connecting limb. Into the head structure is an internal cavity / pocket where the major portion of the electro-mechanical vibrator rests. Thus, the controlled vibrations produced are transformed as massaging action on the outer soft and cushioned surface of the head structure. Also, it is observed in “28” it clearly depicts the different aforementioned features that the head structure can employ. The said features as depicted in one of the drawings “28a” and “28b” clearly show the convex cum concave and or convex/ concave nature of the head structure and to mention these are the variants of the head structure. Also, the other very important variant is “28c” that within itself embodies convex embossing “29” the lubricant pores “28d” from where the lubricant comes out. Also, it clearly shows the bristle structure “28e” which is actuated with the help of “28f” which solely a push button that turns up the bristles so that they can be used even for the tongue cleaning which is in particular helpful to dentulous patients. Thus, the head structure depicted in Fig. 6 when accompanied with that shown in Fig. 4 and Fig. 2 shows the different variants and unique features of the head structure. A person skilled in the art will be able to understand the plurality of configurations of bristles and the different mode of their application in an edentulous case.

FIG. 7 shows the exaggerated exploded view of embodiment of the invention. This FIG. 7 is viewed in conjunction with FIG. 8 which shows the flow/block diagram of the components and their interconnection with the various embodiments/ parts of the device. The description of the components and their incorporation with the embodiments considering both FIG. 7 and FIG. 8 together is as follows, “a” show the compartment of ECU (electronic control unit) that is responsible for controlling the vibration module i.e. in terms of turning on and off, this embodiment feature helps to hold the circuitry performing the said function. This section “a” is interlinked with the compartment “b” this region holds the ECU (electronic control unit) for pressure monitoring and control i.e. this unit based on the pressure impelled by the user on his tissues will control the vibration intensity, this embodiment feature has an opening to the outer surface where fits the switch. The said section “b” is now interlinked with “d” which is a compartment that holds the timer controller circuitry. In the body, there is provided a sealed and leakproof reservoir configured for holding a lubricant and / or medicament with interconnections with the dispensing holes / pores disposed on the neck portion. The chamber is covered with a flexible cover from which the dispensing activity can be initiated on simply pressing. The amount of force applied on the cover is proportion the dispensed lubricant / medicament. In another embodiment, a controlled dispensing of the lubricant / medicament in real time can be obtained through a programmed processor, which releases the said medicament / lubricant through a miniature solenoid operated valve based on the threshold vibration value.

The said ECU fitted in compartment “b” receives power from the battery fitted in compartment “c”. The said battery is of Li-ion rechargeable nature and can be easily replaced after its complete life cycle, just by opening one of the casing “la or lb”. The battery used can have a supply voltage laying in a range of 3.7 Volts to 6 Volts. The supply for the battery goes to the ECU when the power switch sitting in region “h” is turned on. The ECU then supplies the power in a controlled manner to the vibrating unit via the pressure cum amplitude/ frequency controlling knob, these parameters are controlled by the ECU itself by adjusting the power input to the vibrating unit. Via the USB socket sitting at position “e” that open at “f” provides a means to charge the battery. The USB socket is of female USB connector that allows the male socket of the charger to fit in it and engage the connections with correct polarity. This female USB socket is connected to the battery via an overcharge protection circuit cum irreversible current flow circuit that efficiently and safely charges the battery in a way that if it is kept for charging the device cannot be turned on as it sits on the charger unit it can’t be used while charging hence protecting the user from any undesirable electric hazard.

All the said embodiment features “a”, “b”, “d” have outer opening which holds switch’s and/or knobs for adjusting the level of controlling the feature achieved by the corresponding circuitry. All the units “a”, “b” and “d” are interlinked and a common output emerging out of these conjunction drives the vibration module at “k”. The vibration module fits into the socket “k” and emerges out and gets majorly capsulated by the head structure “L”. Now the other embodiment feature of the device is “c” the compartment for holding the power unit such as a battery this unit is interconnected to all the ECU’s at “a”, “b” and “d” and supplies power to drive these ECU’s. This “c” is then connected to “e” where the Female USB socket fits that open out thorough the opening “f”. All the fastening is provided via fasteners at “i”, “j” & “g”. The fasteners may be threaded, screwed, nail, rivet and/or any type not limited to any threaded or non-threaded type of fasteners.

FIG. 9 illustrates the isometric view of the embodiments of custom designed charger and also depicts the final assembled view of the device and charger. The embodiments of the charger include “31” the LCD display that shows the charging required, charging time, amps and voltage of charging battery. And has an integrated charge controlling circuit. The other embodiment is “32” is the indicator of the charge present in the device i.e. glows blue for full charge and red of low charge, this feature of colour coding helps the user to easily distinguish the condition of the battery in his device. Yet another embodiment is “33” which hold the device to be charged. This embodiment has an internal male USB connector that gets connected to the female USB socket of the device to accompany the charging process. Yet another embodiment is “34” where rests the main switch to turn on/ off the charging process. “35” shows the opening form where the main wire is drawn and connected to the mains.

FIG. 10 illustrates the flow/ block diagram contemplating the internal parts of the charger, As depicted in FIG. 10 the flow process is as follows the mains supply is first step-downed and rectified to 6V DC, which then passes through the charging controlling unit that is responsible for ensuring adequate charging, it has an in-built breaker circuit in case of any supply short. Then the supply passes through the current and voltage regulator unit for regulating the voltage to 5V and then the same is shown on the LCD display and a charge display unit shows the charge of the device as full/ low. Then output is provided at the male USB socket that on which the device fits into with the female USB socket of the device.

A prospective interventional split mouth clinical trial study (Clinical Trial 5 Registry No - CTRI/2020/ 10/028517) was conducted on 10 completely edentulous patients between the age of 45 years to 70 years (both age included).

Data was obtained for the patients using Digital OPG radiograph and CBCT.

Distance between the inferior ridge of the body of the mandible and the ridge of 10 the alveolar part adjacent to the mental foramen (IC); and the distance between the lower ridge of the mandible body and the inferior margin of the mental foramen (IM) on both left (L0) and right quadrant (R0) were measured at the time of patient enrolment and after six months (LI, Rl) of intervention. The patients were advised to use the electro-mechanical gum massaging device on 15 the right quadrant and use conventional technique (finger massaging) on the left quadrant.

Radiographic IC/IM index data was derived followed by difference in resorption for the left and right quadrant. Effect of the electro-mechanical device on the hard tissues was assessed by determining the net difference in resorption by 20 the two methods (Df). A positive (Df) indicated that the method of electromechanical device gum massaging would have a greater impact by reducing bone resorption when compared to conventional finger massaging technique and vice versa.

The following results were obtained -

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IC - Distance between the inferior ridge of the body of the mandible and the ridge of the alveolar part adjacent to the mental foramen.

IM - Distance between the lower ridge of the mandible body and the inferior 5 margin of the mental foramen.

IC/IM index -

> 2.34: mild resorption (Class I)

1.67 - 2.33: moderate resorption (Class II)

10 < 1.66 severe resorption (Class III) L0 - Characteristics of left quadrant (pre-intervention) at the start of the study (baseline)

LI - Characteristics of left quadrant (post-intervention) after 6 months of finger massaging done.

RO - Characteristics of right quadrant (pre-intervention) at the start of the study (baseline)

R1 - Characteristics of right quadrant (post-intervention) after 6 months of use of electro -mechanical gum massaging device.

LR - Difference in measurement (L0-L1) after an interval of 6 months in left quadrant (resorption after 6 months of finger massaging) .

RR - Difference in measurement (R0-R1) after an interval of 6 months in right quadrant (resorption after 6 months of device use) .

Df - Difference in resorption amount between use of finger massaging and device use (Effect of device use).

Results revealed that there was decreased mandibular residual ridge resorption on the side where the electro-mechanical gum massaging device was used (right side) when compared to the side where conventional finger massaging was done (left side).

The effectiveness of using electro-mechanical gum massaging device is evident in all patients as the resorption of the right quadrant is less (0.1 - 0.7 mm) over a period of six months as compared to conventional finger massaging.

The particular embodiments and applications were chosen and described to provide the best illustration of the principles of the invention and its practical application to thereby enable one of ordinary skill in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. All such changes, modifications, variations, and alterations should therefore be seen as being within the scope of the present invention as determined by the upcoming description and claims when interpreted in accordance with the breadth to which they are fairly, legally, and equitably entitled.

Claims

Claims:

1. An electro-mechanical device for curtailing residual ridge resorption comprising of : a concave cum convex shaped head structure; an elongate cylindrical housing body with separate upper and lower casing incorporating electronic control unit plurality of electronic and mechanical circuitry and components, programmed processor, liquid dispensing mechanism, display, power supply, switches and configured for use as handle member having a first free end portion and a second end portion; wherein the said head structure is operably attached to the second end portion through connecting limb; wherein the said housing body includes a real time controlled lubricant / medicament dispensing mechanism; wherein said head structure is embodied with electro -mechanical miniature motion generator unit that creates vibrating / oscillating / undulate motion resulting into massaging action; and wherein the said motion is precisely controlled by calibrated ECU’s including controls for amplitude, pressure, frequency, timing with additional features like usage alerts, pressure alarms and intelligent pressure control by programmed processor.

2. The electro-mechanical device as claimed in claim 1, wherein the said device is configured for edentulous condition patient and enables the massaging action to be impelled on the gingival tissues performing gingival massaging.

27 The electro-mechanical device as claimed in claim 1, wherein said head structure is soft and cushioned flat surfaced such that the gingiva is unscathed. The electro -mechanical device as claimed in claim 1, wherein said housing body includes a leakproof chamber reservoir for storing the said lubricant / medicament. The electro -mechanical device as claimed in claim 1, wherein said massaging action achieved by the said device is employed on the gingiva of edentulous patient for gingival massaging thereby, increasing the blood flow in gums overlying alveolar bone in order to curtail the effects of residual ridge resorption. The electro-mechanical device as claimed in claim 1, wherein outside surface of the said housing is configured for holding and have a grip on the said device. The electro-mechanical device as claimed in claim 1, wherein said device acts as an contra-angled structure in order to get the head structure configured for insertion into any part of his oral space where physical reach through manual handling. The electro-mechanical device as claimed in claim 1, wherein said head structure is accompanied by a plurality of dispensing holes / pores disposed at the bottom of the head portion and in the neck collar portion of the body for controlled dispensing of lubricant / medicament. The electro-mechanical device as claimed in claim 1, wherein the said electronic circuitry components includes timer circuitry, pressure monitoring circuitry, amplitude and frequency controlling circuitry and a leak proof reservoir housed inside the upper casing and lower casing respectively. The electro-mechanical device as claimed in claim 1, wherein said top most portion of said head structure is configured for providing massaging action and delivering the lubricant / medicament on to the gums. The electro -mechanical device as claimed in claim 1, wherein said lubricant chamber is attached to a push button at the top of the upper casing which acts as a fastener as well as an intricate push button for pulsing and forcing the lubricant to flow through the channels and to pass through wherein the secondary storage is provided and comes out of the pores and near the vicinity of the head structure and hold the vibrating component. The electro -mechanical device as claimed in claim 1 , wherein the connecting limb is contra-angled shaped and has a socket like contour that has a cylindrical cut out/ pocket in which a part of the vibration module rests (a mechanical component). The electro-mechanical device as claimed in claim 1, wherein the surface of said head surface includes minute embossing configured to act as active pressure site and the said embossing are covered with a film of smooth, soft and cushioned layer so as to have an unscathed gingiva. The electro-mechanical device as claimed in claim 1, wherein the said head structure fits over the connecting limb via press-fit on and sits on the portion of connecting limb; and wherein the said head structure includes an internal cavity/ pocket where the major portion of the electro -mechanical vibrator rests such that the vibrations produced are transformed as massaging action on the outer soft and cushioned surface of the head structure. he electro-mechanical device as claimed in claim 1, wherein the said head structure is a convex cum concave structure which within itself embodies convex embossing, bristles and lubricant pores from where the lubricant comes out. The electro-mechanical device as claimed in claim 1 , wherein the said body, is provided with a sealed and leakproof reservoir configured for holding lubricant and / or medicament with interconnections with the dispensing holes / pores disposed on the head and neck portion. The electro -mechanical device as claimed in claim 4, wherein the said chamber is covered with a flexible cover from which the dispensing activity can be initiated on pressing. The electro -mechanical device as claimed in claim 17, wherein the amount of force applied on the said flexible cover is proportional to the dispensed lubricant / medicament. The electro-mechanical device as claimed in claim 1 , wherein the said dispensing mechanism of the lubricant / medicament in real time is obtained through a programmed processor, which releases the said medicament / lubricant through a miniature solenoid operated valve based on the threshold vibration value. The electro-mechanical device as claimed in claim 1, wherein said housing includes power supply rechargeable battery and a USB port. The electro-mechanical device as claimed in claim 1, wherein said device includes a LCD display. The electro -mechanical device as claimed in claim 1, wherein said ECU includes an overcharge protection circuit cum irreversible current flow circuit configured to supply the power in a controlled manner to the vibrating unit via a pressure cum amplitude/ frequency controlling knob, these parameters are controlled by the ECU itself by adjusting the power input to the vibrating unit. The electro-mechanical device as claimed in claim 22, wherein said controlling knob is adjusted with the screw the controller unit will sense the change and manipulate the supply to the vibration unit in a way that the amplitude of vibration can be controlled in a range of 0.1mm to 0.9mm to positive side on a linear scale the same on the negative side which in turn increase or reduce the pressure on the gums as the impact force gets changed with changing amplitude. The electro-mechanical device as claimed in claim 22, wherein said controlling knob adjustment is configured to control the frequency of vibration by controlling the rotational/ movement speed of the vibrating unit. The electro-mechanical device as claimed in claim 22, wherein said amplitude cum pressure and frequency of the vibration is manually set.

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