ANTIMICROBIAL DENTAL DEVICE FOR TISSUE REGENERATION, METHODS AND USES THEREOF

Abstract

The present disclosure describes an antimicrobial dental device for tissue regeneration comprising: a main body comprising an interior and an exterior surface; electrodes to stimulate the tissue to regenerate and eliminate bacteria, connected by an electrical circuit; wherein the plurality of electrodes is impregnated throughout the interior of the main body for creating micro-electric fields; a plurality of channels oriented from the outer surface towards the interior of the main body to receive a fluid and direct it to the electrical circuit for creating an electric flow; an array of pillars which are hydrophilic, wherein the space between each pillar of the pillar array forms a network of capillary channels to receive and retain the electric flow from the plurality of channels near the tissue; a hydrophobic and insulating zone inside the main body to repel the electric flow in a zone of the tissue to be protected.

Claims

1. An antimicrobial and tissue regenerative dental device comprising: a main body comprising an interior and an exterior surface; a plurality of electrodes to stimulate the tissue to regenerate and eliminate bacteria, connected by an electrical circuit; wherein the plurality of electrodes is impregnated throughout the interior of the main body for creating micro-electric fields; a plurality of channels, oriented from the outer surface towards the interior of the main body to receive a fluid and direct it to the electrical circuit for creating an electric flow; an array of hydrophilic pillars, wherein the space between each pillar of the pillar array forms a network of capillary channels to receive and retain the electric flow from the plurality of channels near the tissue; a hydrophobic and insulating zone inside the main body to repel the electric flow in a zone of the tissue to be protected.

2. The device according to claim 1, wherein the pillar array is arranged along one part of the interior of the main body and the hydrophobic and insulating region is arranged along another part of the interior of the main body.

3. The device according to claim 1, wherein the plurality of channels and the network of capillary channels of the pillar array is a network of interconnected channels.

4. The device according to claim 1, wherein the pillar array comprises a plurality of pillars that protrude towards the tissue.

5. The device according to claim 1, wherein each pillar of the pillar array has a conical, frustoconical, prismatic, cylindrical or pyramidal shape.

6. The device according to claim 1, wherein each of the pillars is at an equidistant distance from the adjacent pillar or pillars.

7. The device according to claim 1, wherein each pillar is spaced apart from the adjacent pillar or adjacent pillars by 0.1 to 2 mm.

8. The device according to claim 1, wherein each channel of the plurality of channels is arranged equidistant from the adjacent channel or channels.

9. The device according to claim 1, wherein each channel is spaced apart from the adjacent channel or channels by 0.5 to 8 mm.

10. The device according to claim 1, wherein the main body is made of polymeric material.

11. (canceled)

12. The device according to claim 1, further comprising an electrical system, wherein the electrical system comprises a battery or piezoelectric component.

13. (canceled)

14. (canceled)

15. (canceled)

16. The device according to claim 1, wherein the electrical system comprises a plurality of electrical wires with positive pole and negative pole, arranged alternately along said device.

17. (canceled)

18. (canceled)

19. (canceled)

20. The device according to claim 1, wherein the fluid is a liquid selected from saliva, gel.

21. The device according to claim 1, wherein the device further comprises an active substance.

22. (canceled)

23. The device according to claim 1, wherein the device is a tray, mouthguard, dressing, or dental bridge.

24. The device according to claim 1, wherein the main body has a U-shape configured to be arranged over a plurality of teeth of a user, for partial or total encapsulation of one or more teeth.

25. (canceled)

26. The device according to claim 1, wherein the plurality of channels are micro-channels.

27. The device according to claim 1, wherein the hydrophilic pillars are micro-pillars.

28. The device according to claim 9, wherein each channel is spaced apart from the adjacent channel or channels by 1 to 3 mm.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0072] For an easier understanding, figures are herein attached, which represent preferred embodiments that are not intended to limit the object of the present description.

[0073] FIG. 1: Schematic representation of an embodiment of a tray-type dental device for antibacterial protection against caries 1, inserted over the teeth, extending to the edge of the gum 2: a) view over the teeth; b) view from above or from the outside 1b; c) view from below or from the inside 1c.

[0074] FIG. 2: Schematic representation of a tray-type dental device wherein: a) exterior view with impregnated electrical system 3 and micro-channels 4 between the electrical system and the interior of the tray 4, with micro-electric fields 3b and micro-electric flows 3c; b) cross-sectional and perspective view of the electrical system 3 and the micro-electric fields and electrical system and micro-channels 4 between the electrical system and the interior of the tray; c) cross-sectional view with detail of the battery 6a and electronic control system 5, or piezoelectric component 6 assisted by patella 6b.

[0075] FIG. 3: Schematic representation of a tray-type dental device: a) view of the interior and top of the surface with micro-pillars 7; b) cross-sectional view of the surface with micro-pillars 7.

[0076] FIG. 4: Schematic representation of an embodiment of the tray-type dental device for gum protection-gingival recession 8: a) view over the teeth and over the gums; b) top view 8b; c) bottom view 8c.

[0077] FIG. 5: Schematic representation of an embodiment of the tray-type dental device for gum protection-gum recession 8: a) cross-sectional and perspective view of the impregnated electrical system 3 and the micro-electric fields and micro-channels 4; b) front view of the impregnated electrical system 3 and detail of the micro-electric fields.

[0078] FIG. 6: Schematic representation of a cross-sectional view of an embodiment of the tray-type dental device for protection of the gums-gingival recession 8 with a hydrophilic surface with micro-pillars 7, where the micro-electric fields are intended to act, and a hydrophobic surface 9, where no electric flow is intended to exist.

[0079] FIG. 7: Schematic representation of an embodiment of the tray-type dental device against biofilm and bone recession 10, around implants: a) exterior view with impregnated electrical system 3, with micro-electric fields 3b, in the implant area; b) cross-sectional and perspective view of the electrical system 3, with negative poles 11 and positive poles 12, and of the micro-electric fields 3b and electrical system 3, including micro-channels 4 between the electrical system and the interior of the tray in the area around the implant; c) cross-sectional view with detail of the hydrophilic surface with micro-pillars 7, in the area where micro-electric flows are desired, and hydrophobic surface 9 in the area where micro-electric flows are not desired.

[0080] FIG. 8: Schematic representation of an embodiment of the tray-type dental device for accelerating orthodontic movement 13, around the teeth to be moved: a) exterior view with impregnated electrical system, with micro-electric fields 3b, with negative poles 11 and positive poles 12, in the area of the teeth to be moved; b) cross-sectional and perspective view of the electrical system 3 and the micro-electric fields 3b and electrical system 3, and the micro-channels 4 between the electrical system and the interior of the tray 4 in the area around the teeth to be moved; c) cross-sectional view with detail of the hydrophilic surface 7 with micro-pillars 7, in the area where micro-electric flows are desired, and hydrophobic surface 9 in the area where micro-electric flows are not desired, around the teeth to be moved.

[0081] FIG. 9: Schematic representation of an embodiment of the bridge-type dental device with antibacterial protection 14: a) top view 14; b) bottom view 14b.

[0082] FIG. 10: Schematic representation of an embodiment of the bridge-type dental device with antibacterial protection: a) bottom view showing the physical texture of the hydrophilic surface with micro-pillars (7); b) vertical cross-sectional view showing the physical texture of the hydrophilic surface with micro-pillars (7).

[0083] FIG. 11: Schematic representation of an embodiment of the bridge-type dental device with antibacterial protection. Cross-sectional and perspective view of the electrical system impregnated in the dental bridge and the micro-electric fields, and the micro-channels 4 connecting the electrical system 3 and the inner surface of the bridge, in contact with soft tissues.

[0084] FIG. 12: Schematic representation of an embodiment of the skin-like dental device of the healing dressing type 15: a) top view (15); b) bottom view (15b) with detail of the hydrophilic surface with micro-pillars 7, in the area where micro-electric flows are desired, and of the hydrophobic surface 9 in the area where micro-electric flows are not desired.

[0085] FIG. 13: Schematic representation of an embodiment of the skin-like dental device of the healing dressing type: a) longitudinal cross-sectional view with impregnated electrical system 3, electronic control system 5 and battery 6a; b) cross-sectional view of the electrical system 3, micro-channels 4 for contact between the electrical system 3 and the inner surface of the dressing, electronic control system 5 and battery 6a.

[0086] FIG. 14: Schematic representation of an embodiment of the skin-like dental device of the healing dressing type: a) cross-sectional view with impregnated electrical system 3, electronic control system 5 and piezoelectric component 6 with patella 6b; b) cross-sectional view of the electrical system 3, micro-channels 4 for contact between the electrical system 3 and the inner surface of the dressing, electronic control system 5 and piezoelectric component 6 with patella 6b.

[0087] FIG. 15: Schematic representation of an embodiment of the skin-like dental device of the healing dressing type: a) Side cross-sectional view showing the impregnated electrical system 3, the micro-channels 4 connecting the electrical system 3 with the liquid or gel, which is accommodated between the micro-pillars 7.

[0088] FIG. 16: Schematic representation of an embodiment of the mouthpiece or skin device: Side cross-sectional view showing the impregnated electrical system 3, the micro-channels 4 connecting the electrical system 3 with the liquid or gel, which is accommodated between the micro-pillars 7 in the hydrophilic zone, the hydrophobic zone 9, and the biological tissues 16, tooth, gum, skin, tongue, or other intraoral tissues.

DETAILED DESCRIPTION

[0089] The present disclosure describes medical devices, more specifically devices for dental use intended for the regeneration of dental, bone, and gingival tissues, and antibacterial action; in particular, an antimicrobial dental device for tissue regeneration comprising: [0090] a main body comprising an interior and an exterior surface; [0091] a plurality of electrodes to stimulate the tissue to regenerate and eliminate bacteria, connected by an electrical circuit; wherein the plurality of electrodes is impregnated throughout the interior of the main body for creating micro-electric fields; [0092] a plurality of channels, preferably micro-channels, oriented from the outer surface towards the interior of the main body to receive a fluid and direct it to the electrical circuit for creating an electric flow; [0093] an array of pillars, preferably micro-pillars, which are hydrophilic, wherein the space between each pillar of the pillar array forms a network of capillary channels to receive and retain the electric flow from the plurality of channels near the tissue; [0094] a hydrophobic and insulating zone inside the main body to repel the electric flow in a zone of the tissue to be protected.

[0095] The present disclosure relates to a device such as a mouthguard, dental bridge, or healing dressing, a tray capable of stimulating hard tissues such as bone, or soft tissues such as gums or skin, or still eliminating bacteria present in the mouth, teeth, or skin. The stimulation of hard tissues serves to prevent bone recession around implants or even promote its growth if recession has already occurred, and to promote bone regeneration or apposition during orthodontic movement on the side subject to traction, accelerating orthodontic movement. Stimulation of soft tissues serves to prevent gum recession and promote its growth if recession has already occurred, and to promote the healing of ulcers or other injuries to tissues 16 inside the mouth, or still to promote skin healing and regeneration. The elimination of bacteria applies in the following situations: bacteria that adhere to teeth, thus preventing the formation of colonies and consequent formation of caries; bacteria that adhere to dental implants, preventing the formation of biofilms; bacteria that adhere to dental bridges and form biofilms; bacteria that are present in wounds or ulcers of the mouth or skin, preventing infections.

[0096] Tissue stimulation 16 and bacteria elimination are caused by the existence of multiple micro-electric fields, distributed uniformly, with the positive 12 and negative 11 poles close enough to be able to create almost constant micro-flows of electric current 3c along the surfaces of action. The intensity, frequency, duration of action, and arrangement of these electric fields depend on the biological entities involved, bone, skin, gums 2, bacteria, and are also customized to the specific needs of each patient, in each specific area of the protector or dressing.

[0097] In an embodiment, each device allows differentiated micro-electric fields to be programmed along the component, which can be purposely altered over time, depending on the stage of treatment, through the electronic control system 5.

[0098] Each device has zones where electrical stimuli are intended to exist and where the electrical poles that promote the micro-electric fields 3b are positioned, which in turn produce micro-electric flows 3c directly in the biological entities, and zones where electrical insulation is intended, where no electric flows are intended to exist. These electrically insulating zones, in addition to defining the zones that do not require electrical stimuli, also serve to delimit the electric flows, preventing them from flowing randomly. In this sense, where the electric poles are located, the surface consists of hydrophilic micro-pillars 7, capable of retaining a certain volume of liquid or gel, thus helping to control the electric flows through this volume of material connecting the electric poles and the biological tissues 16. In addition, the hydrophilic surface, where electrical stimuli are intended to occur, has micro-channels 4, which establish an electrical connection between the electrical system 3 and the liquid or gel retained in the hydrophilic zone between the pillars. This liquid or gel will absorb the electric current flows, ensuring their conduction through the biological entities in contact with the liquid or gel, namely bacteria, gums 2, skin, among others.

[0099] The mouthpiece device has several versions, each one with specific functions, as well as the healing dressing.

[0100] In an embodiment, the present description consists of a mouthguard concept 1, 8, 10, 13, 14, 15 composed of a main body made of polymer, specifically polyetheretherketone-Peek, silicone, polyethylene terephthalate-PET, polyethylene terephthalate glycol-modified-PETG, polycarbonate, acrylic (polymethyl methacrylate-PMMA) or still composites of the above materials, derivatives of both or mixtures thereofor other materials, all of which are biocompatible and non-electrically conductive materials.

[0101] In an embodiment, the polymeric main body, preferably made of biocompatible polymer, comprises an electrical circuit inside it, equivalent to the nervous system of a biological body, with the ability to produce micro-electric fields from the electric field generating region up to the surface of the device and thus electrically stimulate, at multiple points, the tissues adjacent to the device through micro-electric fields 3b, and to promote micro-electric flows 3c in the tissues, consequently causing the regeneration of tissues 16, bone, gum, skin, or the elimination of bacteria in the same tissues, or both simultaneously or alternately.

[0102] In an embodiment, this electrical circuit consists of electrically conductive wires with positive pole 12 and negative pole 11, these wires having diameters of 0.02 mm to 1 mm, which depart from a region generating the electric fields consisting of a battery 6a or a piezoelectric component 6 such as, for example, barium titanate (BaTiO3) or a material with a composition equal or similar to niobate perovskite, composed according to the literature of K, Na and NbO3 and designated KNN. The piezoelectric component 6 has an area of between 4 and 20 mm2 and a thickness of between 0.1 and 3 mm.

[0103] In an embodiment, the electric fields are generated by the battery or, in the case of the piezoelectric component, by the deformation of the piezoelectric component 6 when it is acted upon by a force external to the device, by the deformation caused by the impact of the patella 6b, with dimensions of 0.5 to 3 mm in diameter, preferably 1 to 2 mm in diameter and 0.5 to 3 mm thick, preferably 1 to 2 mm thick, in the case of the patella 6b is made of stainless steel, titanium, CoCr alloy, zirconia, alumina, or other biologically compatible material, which is incorporated inside the piezoelectric component 6 but can move according to the movement of the body, thus generating impacts on the piezoelectric component 6. The electric fields, with values that can vary from 1 mV to 10 V, flow through the electrical circuit and reach the surface of the implant through micro-channels 4 that connect the electrical circuit to the inner surface of the device in multiple areas which are in contact with the tissues 16, skin, teeth, gums 2, tongue, or other intraoral tissues. The electrical system 3 is responsible for transmitting the micro-electric fields 3b from the electric field generating region to the multiple points on the surface of the device.

[0104] In an embodiment, the micro-electric fields 3b may result from the existence of an electrical system 3 inside the body of the device, which is intended to deliver the micro-electric fields 3b generated by a piezoelectric component 6, or by a battery 6a, to multiple points on the internal surface of the device, and whose connection between the electrical circuit and the internal zone of the device is made via micro-channels 4, spaced apart from each other by 1 to 3 mm.

[0105] The location and intensity of the micro-electric fields 3b are defined for each user, taking into account their anatomy and needs, as well as the area and biological entity concerned, but can vary from 1 mV to 10 V, preferably 1 mV to 1 V, and the micro-electric flows 3c created can vary from 500 picoamperes to 500 milliamperes, preferably from 500 picoamperes to 5 milliamperes, for distances between electrical poles ranging from 0.5 to 8 mm, preferably 1 to 3 mm.

[0106] In an embodiment, the biocompatible polymer main body contains different zones with two different types of surfaces, in the inner zone of the devices, or more precisely in the region of contact with the biological tissues 16.

[0107] The surfaces are divided into electrically conductive surfaces and electrically insulating surfaces.

[0108] In an embodiment, the electrically conductive surfaces have micro-pillars with a trapezoidal, polygonal, quadrangular, or circular cross-section, whose dimensions vary from 0.1 mm to 0.5 mm at the top of the pillar and 0.15 to 0.8 mm at the base of the pillar, either side or diameter, the height of the pillars varies between 0.1 mm to 2 mm, and the distance between the pillars varies from 0.1 to 2 mm, thus providing hydrophilic characteristics to the pillar structure.

[0109] In an embodiment, between the pillars of the hydrophilic structure, there should be bodily fluids, such as saliva, or other non-bodily fluids such as water, or even some gel commonly used in the mouth or on the skin, which ensures that the spaces between the pillars and between the devices and the biological tissues 16 are filled, thus ensuring continuity of electric flows in the hydrophilic surface areas.

[0110] In an embodiment, the electrically insulating surfaces are smooth, having no texture, thus preventing the accumulation of any liquid or gel between the devices 1, 8, 10, 13, 14, 15 and the biological tissues 16, teeth, gums, tongue, skin, or other intraoral tissues, thereby preventing or minimizing loss of electric flows to these areas.

[0111] FIG. 1 shows an embodiment of the device, wherein the U-shaped device is configured to be arranged over a plurality of teeth of a user. FIG. 1: Schematic representation of an embodiment of a tray-type mouthpiece device for antibacterial protection against caries 1, inserted over the teeth, extending to the edge of the gums 2: a) view over the teeth; b) view from above or from the outside 1b; c) view from below or from the inside 1c.

[0112] FIG. 2 shows a tray-type dental device. FIG. 2a) shows the impregnated electrical system 3 and micro-channels 4 between the electrical system and the interior of the tray 4, with micro-electric fields 3b and micro-electric flows 3c. FIG. 2b) shows the electrical system 3 and the micro-electric fields and electrical system and micro-channels 4 between the electrical system and the interior of the tray. FIG. 2c) shows a detail of the battery 6a and electronic control system 5, or piezoelectric component 6 assisted by patella 6b, a detail of the piezoelectric component 6b.

[0113] FIG. 3 shows an embodiment of a tray-type dental device, namely the micro-pillars 7.

[0114] FIG. 4 shows an embodiment of the tray-type dental device for gum protection-gingival recession 8.

[0115] FIG. 5 shows an embodiment of the tray-type dental device for gum protection-gingival recession 8, showing the impregnated electrical system 3 and the micro-electric fields and micro-channels 4.

[0116] FIG. 6 shows an embodiment of the tray-type dental device for gum protection-gingival recession 8 with a hydrophilic surface with micro-pillars 7, where the micro-electric fields are intended to act, and a hydrophobic surface 9, where no electric flow is intended to exist.

[0117] FIG. 7 shows an embodiment of the tray-type dental device against biofilm and bone recession 10, around implants, the impregnated electrical system 3, with micro-electric fields 3b, in the implant zone; the electrical system 3, with negative poles 11 and positive poles 12, and the micro-electric fields 3b and electrical system 3, including micro-channels 4 between the electrical system and the interior of the tray in the area around the implant; the hydrophilic surface with micro-pillars 7, in the area where micro-electric flows are desired, and the hydrophobic surface 9 in the area where micro-electric flows are not desired.

[0118] FIG. 8 represents an embodiment of the tray-type dental device for accelerating orthodontic movement 13, around the teeth to be moved, impregnated electrical system, with micro-electric fields 3b, with negative poles 11 and positive poles 12, in the area of the teeth to be moved; electrical system 3, and micro-channels 4 between the electrical system and the interior of the tray 4 in the area around the teeth to be moved; and a hydrophilic surface 7 with micro-pillars 7 in the area where micro-electric flows are desired, and a hydrophobic surface 9 in the area where micro-electric flows are not desired, around the teeth to be moved.

[0119] FIG. 9 shows an embodiment of the bridge-type dental device with antibacterial protection 14.

[0120] FIG. 10 shows an embodiment of the bridge-type dental device with antibacterial protection: a) bottom view showing the physical texture of the hydrophilic surface with micro-pillars (7); b) vertical cross-sectional view showing the physical texture of the hydrophilic surface with micro-pillars (7).

[0121] FIG. 11 shows an embodiment of the bridge-type dental device with antibacterial protection. It shows the electrical system impregnated in the dental bridge and the micro-electric fields 3b, and the micro-channels 4 connecting the electrical system (3) and the inner surface of the bridge, in contact with soft tissues.

[0122] FIG. 12 shows an embodiment of the skin-like dental device of the healing dressing type 15 with detail of the hydrophilic surface with micro-pillars 7, in the area where micro-electric flows are desired, and of the hydrophobic surface 9 in the area where micro-electric flows are not desired.

[0123] FIG. 13 shows an embodiment of the skin-like dental device of the healing dressing type with impregnated electrical system 3, electronic control system 5 and battery 6a; as well as electrical system 3, micro-channels 4 for contact between the electrical system 3 and the inner surface of the dressing, electronic control system 5 and battery 6a.

[0124] FIG. 14 shows an embodiment of the skin-like dental device of the healing dressing type with impregnated electrical system 3, electronic control system 5, and piezoelectric component 6 with patella 6b. FIG. 14 b) shows the electrical system 3, micro-channels 4 connecting the electrical system 3 to the inner surface of the dressing, electronic control system 5 and piezoelectric component 6 with patella 6b.

[0125] FIG. 15 shows an embodiment of the skin-like dental device of the healing dressing type, showing the impregnated electrical system 3, the micro-channels 4 connecting the electrical system 3 with the liquid or gel, which is accommodated between the micro-pillars 7.

[0126] FIG. 16 shows an embodiment of the dental device, showing the impregnated electrical system 3, the micro-channels 4 connecting the electrical system 3 to the liquid or gel, which is accommodated between the micro-pillars 7 in the hydrophilic zone, the hydrophobic zone 9, and the biological tissues 16, tooth, gum, skin, tongue, or other intraoral tissues.

[0127] The term comprises or comprising whenever used in this document is intended to indicate the presence of stated characteristics, elements, integers, steps, and components, but not to preclude the presence or addition of one or more other characteristics, elements, integers, steps, and components, or groups thereof.

[0128] The present invention is, of course, in no way restricted to the embodiments described herein, and a person with average skills in the art will be able to foresee many possibilities for modification thereof and for substitution of technical characteristics with equivalent ones, depending on the requirements of each situation, as defined in the appended claims.

[0129] The following claims define additional embodiments of the present description. Bibliographic references: [0130] [1] Gonalves, I. M. R. ; Carvalho, O. ; Henriques, B. ; Teughels, W. ; Souza, J. C. M. ; Eletrical potential approaches to inhibit biofilm adhesion on titanium implants, Materials Letters, 2019, 255, 126577 [0131] [2] Bins-Ely, L. ; Suzuki, D. ; Magini, R. ; Henriques, B. ; Souza, J. C. M. ; Enhancing the bone healing on electrical stimuli through the dental implant, Computer Methods in Biomechanics and Biomedical Engineering, 2020, 23(14), pp. 1041-1051. [0132] [3] Bins-Ely, L. M. ; Cordero, E. B. ; Souza, J. C. M. ; Benfatti, C. A. M. ; Magini, R. S. ; In vivo electrical application on titanium implants stimulating bone formation, Journal of Periodontal Research, 2017, 52(3), pp.479-484.