WO2016097927A1

WO2016097927A1 - Apparatus and method for delivery of sustained release mechanisms on the teeth

Info

Publication number: WO2016097927A1
Application number: PCT/IB2015/059427
Authority: WO
Inventors: Bart Gottenbos; Amir Hussein RMAILE; Carl Glasse
Original assignee: Koninklijke Philips N.V.
Priority date: 2014-12-18
Filing date: 2015-12-08
Publication date: 2016-06-23

Abstract

A device (50) for delivery of release mechanisms to interproximal areas of teeth comprises ahandle portion (60) having a fluid system (65) that includes at least one reservoir (64) for holding a fluid containing release mechanisms, microburst pump(70) for producing a stream of fluid via a nozzle (52) that connects to the handle portion,having at least one channel (74) and a guidance tip (80) with at least one orifice (82) coupled to the at least one channel. The device further comprises a controller for activating (58) the fluid system (65), wherein responsive to activating, the fluid system isoperable to drive the air cylinder spring mechanism at a rate to expel most fluid at a velocity lower than 15 m/s out the at least one orifice.

Description

APPARATUS AND METHOD FOR DELIVERY OF SUSTAINED RELEASE

MECHANISMS ON THE TEETH

[0001] The present embodiments relate generally to oral healthcare and sustained release mechanisms, and more particularly, to an apparatus and method for delivery of sustained release mechanisms and/or particles to interproximal areas of teeth.

[0002] Active agents from toothpastes and oral rinses quickly reduce in concentration after an application of the same to teeth in a user's mouth. As a result, the active agents from the toothpastes and oral rinses cannot protect the user's teeth for long durations of time (e.g., up to 24 hours). Adhesive particles that can contain, and slowly release, active agents are an attractive solution to maintain effective agent concentrations for longer times. Particle suspensions can flow similarly in the mouth as common mouth rinses. In addition, particle suspensions have an advantage over slow release coatings, since slow release coating generally have to be applied in specialized ways to get them on the teeth.

Moreover, slow release tooth coatings are less user friendly, for example, requiring tooth preparation, painting of coating, drying of coating, etc.

[0003] Particles may be delivered from suspensions simply applied by 30 second rinsing with 20 to 30 ml of formulation, as is the current practice when using common antimicrobial mouth rinses. However, for delivery in the interproximal space of teeth this is far from optimal. A disadvantage of rinsing with antimicrobial mouth rinses is that most of the formulation will be spit out, and most of the particles will adhere to other oral surfaces outside the interproximal space. The interproximal spaces with tight contact areas between two adjacent teeth might not even be treated at all. Since slow release systems are always more expensive than common mouth rinse ingredients, the use of excessive amounts of slow release particles to solve the delivery issues is not commercially viable.

[0004] Accordingly, an improved method and apparatus for overcoming the problems in the art is desired.

[0005] In accordance with one embodiment, a device for delivery of release

mechanisms to interproximal areas of teeth comprises a handle portion having a fluid system that includes a reservoir for holding a fluid containing release mechanisms, an air cylinder driven spring mechanism for producing a stream of fluid via a nozzle that connects to the handle portion having at least one channel and a guidance tip with at least one orifice coupled to the at least one channel. The device further comprises means for activating the fluid system, wherein responsive to activating, the fluid system is operable to drive the air cylinder spring mechanism at a rate to expel most fluid at a velocity lower than 15 m/s out the at least one orifice.

[0006] In one embodiment, the release mechanisms include release particles that comprise at least one or more of suspended particles, gel particles, muco-adhesive particles, slow release particles, sustained release particles, pH triggered release particles, and time-delay release particles. In another embodiment, the air cylinder spring mechanism is driven at a rate less than or equal to 0.35 N/m. In a further embodiment, the fluid containing release mechanisms expelled out the at least one orifice comprises a spray with (i) a main volume of droplet sizes in a range of 0.1 to 0.15 mm diameter and (ii) a full volume of droplet sizes in a range from smaller than 0.01 mm to 1 mm diameter size. In another embodiment, the release mechanisms are expelled at a velocity less than 15 m/s.

[0007] According to yet another embodiment, the reservoir is further for holding at least one of (i) a first fluid and (ii) the fluid containing release mechanisms, wherein the fluid system further comprises at least one air cylinder spring mechanism that couples (a) between the reservoir and a first channel of the at least one channel, the first channel being coupled to the at least one orifice and (b) between the reservoir and a second channel of the at least one channel, the second channel being coupled to the at least one orifice. In addition, the means for activating the fluid system includes activating in at least two operational modes, wherein (i) responsive to activating in a first operational mode, the fluid system is operable to drive the air cylinder spring mechanism at a first rate to expel the first fluid from the reservoir via the first channel to the at least one orifice for thinning a biofilm layer on surfaces of teeth in the interproximal area from an initial thickness to produce at least one or more of a thinned biofilm layer or a completely removed biofilm layer, and (ii) responsive to activating in a second operational mode, the fluid system is operable to drive the air cylinder spring mechanism at a second rate, different from the first rate, to expel the fluid containing release mechanisms from the reservoir via the second channel to the at least one orifice for delivering and depositing release mechanisms onto the surfaces of teeth in the interproximal area.

[0008] In a further embodiment, the first rate (88) comprises an air cylinder driving spring rate to expel the first fluid from the at least one orifice at velocities greater than or equal to 15 m/s and the second rate (90) comprises an air cylinder driving spring rate to expel the fluid containing release mechanisms from the at least one orifice at velocities less than 15 m/s. In another embodiment, the first channel of the at least one channel and second channel of the at least one channel comprise a single channel, and wherein the at least one orifice comprises a single orifice. In a further embodiment, the reservoir comprises a first chamber for holding the first fluid and a second chamber for holding the fluid containing release mechanisms.

[0009] In another embodiment, the device further comprises a nozzle, wherein the at least one orifice comprises one selected from the group consisting of (i) a singular orifice wherein the first channel and the second channel merge into a single channel coupled to the singular orifice, and (ii) separate distinct orifices wherein the first channel is coupled of a first orifice and the second channel is coupled to a second orifice.

[0010] In accordance with another embodiment, a method for delivery of release mechanisms to interproximal areas of teeth comprises providing a handle portion having a fluid system that includes a reservoir for holding a fluid containing release mechanisms, an air cylinder driven spring mechanism for producing a stream of fluid via a nozzle that connects to the handle portion having at least one channel and a guidance tip with at least one orifice coupled to the at least one channel. The method further comprises activating the fluid system operable to drive the air cylinder spring mechanism at a rate to expel most fluid at a velocity lower than 15 m/s out the at least one orifice.

[0011] Still further advantages and benefits will become apparent to those of ordinary skill in the art upon reading and understanding the following detailed description.

[0012] The embodiments of the present disclosure may take form in various components and arrangements of components, and in various steps and arrangements of steps. Accordingly, the drawings are for purposes of illustrating the various embodiments and are not to be construed as limiting the embodiments. In the drawing figures, like reference numerals refer to like elements. In addition, it is to be noted that the figures may not be drawn to scale.

[0013] Figure 1 is a perspective view two adjacent teeth and an interproximal space in an oral cavity;

[0014] Figure 2 is an image view of the surface of the interproximal surface of a tooth subsequent to particle suspensions applied by 30 second rinsing with 20 to 30 ml of formulation, showing very few particles adhering to the tooth surface; [0015] Figure 3 is a table of image views of left and right proximal tooth surfaces subsequent to a targeted delivery of a particle suspension, at different speeds with a spring force of 0.35 N/m, 0.8 N/m, and 1.24 N/m;

[0016] Figure 4 is a perspective view of a device for delivery of release particles to interproximal areas of teeth and for implementing a release particle delivery procedure according to various embodiments of the present disclosure;

[0017] Figure 5 is a schematic view of various components of the device for delivery of release mechanisms to interproximal areas of teeth and for implementing a release particle delivery procedure according to various embodiments of the present disclosure;

[0018] Figure 6 (6(A), 6(B), 6(C) and 6(D)) illustrates side cross-sectional views and sectional views of first and second alternate embodiments of at least one channel and orifice of a nozzle of the device for delivery of release mechanisms to interproximal areas of teeth and for implementing a release mechanism delivery procedure according to additional embodiments of the present disclosure; and

[0019] Figure 7is a flow diagram view of a method for a release mechanism delivery procedure for delivery of release mechanisms to interproximal areas of a user's teeth, according to an embodiment of the present disclosure.

[0020] The embodiments of the present disclosure and the various features and advantageous details thereof are explained more fully with reference to the non-limiting examples that are described and/or illustrated in the drawings and detailed in the following description. It should be noted that the features illustrated in the drawings are not necessarily drawn to scale, and features of one embodiment may be employed with other embodiments as the skilled artisan would recognize, even if not explicitly stated herein. Descriptions of well-known components and processing techniques may be omitted so as to not unnecessarily obscure the embodiments of the present disclosure. The examples used herein are intended merely to facilitate an understanding of ways in which the

embodiments of the present may be practiced and to further enable those of skill in the art to practice the same. Accordingly, the examples herein should not be construed as limiting the scope of the embodiments of the present disclosure, which is defined solely by the appended claims and applicable law. [0021] It is understood that the embodiments of the present disclosure are not limited to the particular methodology, protocols, devices, apparatus, materials, applications, etc., described herein, as these may vary. It is also to be understood that the terminology used herein is used for the purpose of describing particular embodiments only, and is not intended to be limiting in scope of the embodiments as claimed. It must be noted that as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural reference unless the context clearly dictates otherwise.

[0022] Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art to which the embodiments of the present disclosure belong. Preferred methods, devices, and materials are described, although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the embodiments.

[0023] Interproximal spaces generally refer to those areas in the mouth that are most prone to oral disease, since bacteria can easily accumulate in these hard-to-access sites. Common diseases like gingivitis and cavities are most prevalent in the interproximal space. Delivery of slow release anti-plaque agents in the interproximal space may be able to prevent such diseases. As the areas of interproximal space are secluded, slow release systems could be easily retained in the interproximal spaces, while on the alternative tooth surfaces (e.g. buccal/labial and lingual/palatal surfaces) such systems may be easily removed by, for example, eating. In addition, an advantage of slow release systems within the interproximal space is that a user cannot typically feel particles sitting in the

interproximal space, except for large food chunks that are stuck between teeth contact points.

[0024] A typical group of non-selective oral adhesive particles are particles with a positive surface charge. An example is the use of chitosan gel particles, which have amine groups that deliver at a neutral pH a net positive surface charge. As chitosan is a readily available as food grade material, which can create strong hydrogels, it is a very suitable candidate for oral adhesive gel particles.

[0025] With reference now to Figure 1, there is shown a perspective view of an interproximal tooth region. Two adjacent teeth are indicated in Figure 1 by reference numerals 12 and 14, respectively. A 0.5mm gap (i.e., an interproximal space 16 exists between the teeth 12, 14. [0026] Suspensions simply applied by 30 second rinsing with 20 to 30 ml of formulation, as users currently typically deliver mouthwash or other formulas of particle suspensions results in very limited adhesion of particles. Figure 2 is an image view of an interproximal surface of of a tooth 12after application of a 20 to 30 ml suspension by means of a 30 second rinsing, showing very few particles (shown in white) adhering to the interproximal tooth surface.

[0027] As noted herein, sustained release particles can make active oral care agents available for longer times in the mouth, increasing their efficacy. It was envisioned that a device such as Philips Sonicare™ AirFloss™ might possibly be used to deliver particles better, as it is more targeted. For the embodiments of the present invention, different parameter settings for delivery rates were tested to discover an optimal delivery range. When devices with lower air pressures were used, the amount of deposited particles increased dramatically. According to the embodiments of the present disclosure, the inventors discovered a velocity range for delivery of release particles with sprays to obtain effective particle delivery.

[0028] AirFloss-type devices were made with three different air cylinder driving springs to achieve three different velocity delivery rates with a standard 15 ml/shot volume: 0.35 N/m; 0.8 N/m (current AirFloss™ spring and volume rate); and 1.24 N/m. A nozzle was positioned in the interproximal space, and the device was activated to deliver an air pulse and shoot a spray inside the interproximal space.

[0029] With reference now to Figure 3, there is shown a table of image views of left and right interproximal tooth surfaces subsequent to a targeted delivery of an

approximately 15 ml/shot volume suspension white particle suspension using different spring rates: 0.35 N/m, 0.8 N/m, and 1.24 N/m. As evidenced in Figure 3, delivery at 0.35 N/m was capable of depositing substantial amounts of white particles, while delivery using a spring of 0.8 N/m (i.e., as is used in the current AirFloss™ device) or stronger (1.24 N/m) resulted in smaller depositions of white particles.

[0030] Accordingly, the inventors have discovered that spring rates below 0.8N/m are needed in the AirFloss-type device for delivery of particles to the tooth surface. In one embodiment, 0.35 N/m is a good example spring rate, where efficient deposition of particles is possible. The spray resulting from the low spring rate AirFloss-type device was characterized, and the main volume thereof is in droplet sizes ranging from 0.1 to 0.15 mm diameter, although the full range is from smaller than 0.01 to 1 mm in size. The velocities of the 0.1 to 0.15 mm diameter droplets are mainly ranging between 10 and 20 m/s. For the 0.8 N/m spring rate, this main range of velocities is 15 to 25 m/s, which is apparently too fast. Therefore, for optimal particle deposition, the inventors have concluded that speed of the 0.1 to 0.15 mm diameter droplets should be kept below 15 m/s.

[0031] With reference now to Figure 4, a perspective view of a device 50 for delivery of release mechanisms to interproximal areas of teeth, and for implementing a release mechanism delivery procedure is shown. The device 50, includes an activation button 58, a fluid system 65for holding a fluid and release mechanisms, an ergonomic handle 60, control electronics 68, and at least one microburst pump 70 for producing a stream of fluid. A user replaceable nozzle 52 that connects to the handle portion generally includes an elongated body with at least one channel (74, Figure 10) extending from a proximal end of the nozzle to a distal end of the nozzle, with a guidance tip 80 having at least one orifice 82 coupled to the at least one channel.

[0032] In response to operation of the activation button 58, the device is operable to drive the microburst pump 70 at a rate to expel most fluid at a velocity lower than 15 m/s through the at least one channel 74out the at least one orifice (i.e., to expel a main volume of the fluid that comprises droplets having sizes from 0.1 to 0.15 mm diameter within a full range of droplet sizes of a total volume of the fluid from 0.01 to 1 mm diameter, the main volume being greater than 50 %).

[0033] In one embodiment, the fluid system 65 has a fluid reservoir 64, and a second particle reservoir 66, for holding the fluid and release particles, respectively.

[0034] In one embodiment, activation button 58 is operable between an OFF state and at least one activation ON state. The at least one activation ON state can comprise one or more states for causing (b)(i) the microburst pump 70 to be operable to pump fluid from the fluid reservoir 64 via the at least one channel 74 to the at least one orifice 82 and the at least one orifice 82 exhausts the fluid as one selected from the group consisting of a jet, a spray, a burst jet, a burst spray, and any combination thereof, and (b)(ii) the microburst pump 70 to be operable to pump sustained release particles from the release particle reservoir 66 via the at least one channel 74 to the at least one orifice 82 and the at least one orifice 82 exhausts the sustained release particles as one selected from the group consisting of a spray, a burst spray, and any combination thereof, for delivering and depositing the expelled release particles onto surfaces of teeth in the interproximal area, as discussed further herein.

[0035] With to Figures 4 and 5, microburst pump 70 is coupled between the fluid reservoir 64 and a first channel 74a of the at least one channel and between the reservoir 66 for sustained release particles and a second channel 74b.

[0036] Responsive to pressing the activation button 58 to the at least one activation ON state, the at least one microburst pump 70 is controlled via the control electronics 68 for operation in at least one operational mode. Control electronics 68 comprises, for example, any suitable controller or microprocessor and circuitry for carrying out the functions as discussed herein. Responsive to activating the at least one operational mode while directing the guidance tip 80 towards an interproximal area between teeth, the at least one microburst pump 70 is operable (i) at a first setting to pump the fluid from the fluid reservoir 64 via the first channel 74a to the at least one orifice 82. The at least one orifice 82 expels the fluid as one selected from the group consisting of a jet, a spray, a burst jet, a burst spray, and any combination thereof, for thinning a biofilm layer on surfaces of teeth in the interproximal area. The biofilm layer is thereby thinned from an initial thickness to produce at least one or more of a thinned biofilm layer or a completely removed biofilm layer.

[0037] The at least one microburst pump 70 is further operable (ii) at a second setting, different from the first setting, to pump the release particles from the release particles reservoir 66 via the second channel 74b to the at least one orifice 82. The at least one orifice 82 expels the release particles as one selected from the group consisting of a spray, a burst spray, and any combination thereof, for delivering and depositing expelled release particles onto the surfaces of teeth in the interproximal area. In one embodiment, the first channel 74a and second channel 74b comprise a single channel 74, and the at least one orifice 82 comprises a single orifice.

[0038] In view of the above, according to one embodiment, a device 50 for delivery of release particles to interproximal areas of teeth via a nozzle 52 having at least one channel 74 and a guidance tip 80 with at least one orifice 82 coupled to the at least one channel comprises: at least one microburst pump 70; at least one reservoir 64 for holding at least one of (i) a fluid and (ii) release particles for delivery; and an activating button 58 for activating the at least one microburst pump 70 in at least one operational mode. The at least one microburst pump 70 is configured for being coupled to the at least one channel 74 of the nozzle 52. The at least one microburst pump 70 couples (a) between the fluid reservoir 64 and a first channel 74a of the at least one channel 74. The first channel 74a couples to the at least one orifice 82. The at least one microburst pump 70 also couples (b) between the particle reservoir 66 and a second channel 74b of the at least one channel 74. The second channel 74b couples to the at least one orifice 82.

[0039] Responsive to activating the at least one operational mode via the activation button 58, the control electronics 68, operates the at least one microburst pump (i) at a first setting to pump the fluid from the reservoir 64 via the first channel 74a to the at least one orifice 82 and expel the fluid. The at least one orifice 82 expels the fluid as one selected from the group consisting of a jet, a spray, a burst jet, a burst spray, and any combination thereof, for thinning a biofilm layer on surfaces of teeth in the interproximal area. The biofilm layer on surfaces of the teeth in the interproximal area is thereby thinned from an initial thickness to produce at least one or more of a thinned biofilm layer or a completely removed biofilm layer. The at least one microburst pump 70 is further operable (ii) at a second setting, different from the first setting, to pump the release particles from the particle reservoir 66 via the second channel 74b to the at least one orifice 82 and expel the release particles. The at least one orifice 82 expels the release particles as one selected from the group consisting of a spray, a burst spray, and any combination thereof, for delivering and depositing expelled release particles onto the surfaces of teeth in the interproximal area. The deposition of release particles onto the surfaces of teeth in the interproximal area comprises an effective useful deposition of release particles at least sufficient for a given oral healthcare treatment.

[0040] According to one embodiment, the release particles can comprise adhesive release particles. In another embodiment, the release particles can comprise at least one or more of suspended particles, gel particles and muco-adhesive particles. In addition, the release particles can comprise positively charged particles. Furthermore, the release particles can comprise at least one or more of slow release particles, sustained release particles, pH triggered release particles, and time-delay release particles. Moreover, the release particles can also comprise at least one or more of a release mechanism material, anti-plaque agents, drug delivery agents, oral care agents, fluoride delivery agents, and antimicrobial agents. [0041] In accordance with another embodiment, the first setting can comprise a first air cylinder driving spring rate of greater than or equal to 0.35 N/m, preferably greater than or equal to 0.8 N/m, and the second setting can comprise a second air cylinder driving spring rate of less than or equal to 0.35 N/m. In one embodiment, the first air cylinder driving spring rate comprises 0.8 N/m and the second air cylinder driving spring rate comprises 0.35 N/m. In another embodiment, an air cylinder driving spring rate of less than or equal to 0.35 N/m produces an effective useful deposition of release particles onto the surfaces of teeth in the interproximal area. In addition, an air cylinder driving spring rate of greater than or equal to 0.8 N/m produces an effective useful deposition of release particles onto the surfaces of teeth in the interproximal area.

[0042] According to further embodiments, the release particles expelled via the at least one orifice 82 comprises a spray with (i) a main volume of droplet sizes in a range of 0.1 to 0.15 mm diameter and (ii) a full volume of droplet sizes in a range from smaller than 0.01 mm to 1 mm diameter size. In connection with the release particles of the previous sentence and the discussion of the second setting herein above, the second setting can further comprise pumping to expel the main volume of droplet sizes in the range of 0.1 to 0.15 mm diameter of the release particles at a velocity less than 15 m/s. In addition, the second setting of pumping to expel the release particles at a velocity less than 15 m/s produces an effective useful deposition of release particles onto the surfaces of teeth in the interproximal area. Furthermore, a setting for pumping to expel the release particles at a velocity greater than 15 m/s produces an effective useful deposition of release particles onto the surfaces of teeth in the interproximal area.

[0043] In other embodiments, the at least one microburst pump 70 is disposed to provide both liquid sprays and delivery of release particles. In this embodiment, the at least one reservoir 64 provides release particles to the pump 70 for expelling them through orifice 82. Control electronics 68 controls a supply of liquid, air and release particles to the orifice 82 into the expelled output. An advantage of this embodiment is that several elements, including the pump 70 and at least one channel 74, can provide both liquid spray flow and release particle flow in a sequence of liquid and release particle delivery pulses. Thus, expense and complexity is reduced.

[0044] Referring now to Figures 6A-6D, side cross-sectional views and sectional views of first and second alternate embodiments of at least one channel 74 and orifice 82 of an elongated body of a nozzle 52 of the device 50 for delivery of release particles to interproximal areas of teeth and for implementing a release particle delivery procedure are shown. According to one embodiment, the first orifice of the at least one orifice and the second orifice of the at least one orifice 82 comprise one selected from the group consisting of (i) a singular orifice 82 in Figure 6(B), and (ii) separate distinct orifices, as indicated by reference numerals 82a and 82b in Figure 6(D). In other words, the device 50 can further comprise the nozzle 52, wherein the at least one orifice 82 comprises one selected from the group consisting of (i) a singular orifice 81, wherein the first channel 74a and the second channel 74b merge (indicated by reference numeral 77) into a single channel 74 coupled to the singular orifice 82, and (ii) separate distinct orifices, 82a and 82b, wherein the first channel 74a is coupled of a first orifice 82a and the second channel 74b is coupled to a second orifice 82b.

[0045] As illustrated in Figures 6(A) and 6(B), the first channel 74a and the second channel 74b merge (indicated by reference numeral 77) into a single channel 74 coupled to a singular orifice 82. Suitable in-line check valves (i.e., one-way valves), 731 and 741, can be included within the configuration of Figure 6(A) to prevent any undesired reverse flow in either the first channel 74a or the second channel 74b.

[0046] With reference to Figures 6(C) and 6(D), in one embodiment, the first channel 74a and the second channel 74b are coupled to separate distinct orifices 82a and 82b, respectively. As illustrated, orifices 82a and 82b are spaced laterally from one another. In a further embodiment, the orifices can be spaced laterally from one another and arranged in a coaxial configuration (not shown), with one of the first or second orifices being positioned in a central location and the other of the first or second orifices being positioned around the central location.

[0047] Referring now to Figure 7, a flow diagram view of a method 100 for a release particle delivery procedure for delivery of release particles to interproximal areas of a user's teeth, according to an embodiment of the present disclosure, is illustrated. The method 100 begins at step 102, for example, by pressing of an activationbutton on a device for delivery of release particles to interproximal areas. The next step includes a cleaning step for thinning the biofilm at a site to be cleaned (step 104), for example, using one or more of the methods for thinning discussed herein. Cleaning the biofilm layer includes thinning the layer from an initial thickness to produce at least one or more of a thinned biofilm layer or a completely removed biofilm layer.

[0048] Subsequent to thinning the biofilm, within a predetermined time thereafter, the method includes delivering sustained release particles, via a microburst pump, to the cleaned site (step 106). For example, delivering sustained release particles can include using one or more of the methods for delivering sustained release particles discussed herein. The step of delivering sustained release particles for a predetermined interval advantageously deposits sustained release particles onto proximal surfaces within an interproximal area of teeth, as discussed herein.

[0049] In step 108, a query determines whether or not the delivery of sustained release particles is complete. The query can include any suitable query, as determined according to the requirements for a given implementation for release particle delivery. For example, the query may include monitoring a timed duration of the delivery, and indicating non- completion or completion based upon whether or not an expiration of the timed duration of the delivery has occurred. The query could also include whether or not a predetermined number of bursts in a continuous stream of bursts have been delivered. Other query criteria are also possible. In response to release particle delivery not being complete, the method continues with (or repeats) delivering the release particles (step 106). On the other hand, in response to the release particle delivery being complete, the method continues to step 110.

[0050] In step 110, a query determines whether or not an overall release particle delivery for a given oral healthcare procedure for a subject's teeth is complete. In response to the overall biofilm cleaning and release particle delivery procedure not being complete, the method proceeds to a next site to be cleaned in the release particle delivery procedure (step 112). After step 112, the method continues with (or repeats), beginning again at step 104, with thinning of the biofilm at the next site to be cleaned and delivered with release particles. On the other hand, in step 110, in response to the overall biofilm cleaning and release particle delivery procedure being complete, the method terminates at step 114. The step 110 decision to continue or to terminate may be controlled in a variety of ways. The user simply turning the device off is one way. An automatic termination after a set number of cycles is another way.

[0051] According to one embodiment, a method for delivery of release particles to interproximal areas of teeth via a nozzle having at least one channel and a guidance tip with at least one orifice coupled to the at least one channel, comprises: coupling the at least one channel of the nozzle to at least one microburst pump; holding, via a reservoir, at least one of (i) a fluid and (ii) release particles for delivery, wherein the at least one microburst pump couples (a) between the reservoir and a first channel of the at least one channel, the first channel being coupled to the at least one orifice and (b) between the reservoir and a second channel of the at least one channel, the second channel being coupled to the at least one orifice; and activating the at least one microburst pump in at least one operational mode. Responsive to activating the at least one operational mode while directing the guidance tip towards an interproximal area between teeth, the at least one microburst pump operates (i) at a first setting to pump the fluid from the reservoir via the first channel to the at least one orifice and expel the fluid as one selected from the group consisting of a jet, a spray, a burst jet, a burst spray, and any combination thereof, for thinning a biofilm layer on surfaces of teeth in the interproximal area from an initial thickness to produce at least one or more of a thinned biofilm layer or a completely removed biofilm layer. Responsive to activating the at least one operational mode while directing the guidance tip towards an interproximal area between teeth, the at least one microburst pump also operates (ii) at a second setting, different from the first setting, to pump the release particles from the reservoir via the second channel to the at least one orifice and expel the release particles as one selected from the group consisting of a spray, a burst spray, and any combination thereof, for delivering and depositing the expelled release particles onto surfaces of teeth in the interproximal area. Additional aspects of the method are implemented via the device for delivery of release particles to interproximal areas of teeth via a nozzle having at least one channel and a guidance tip with at least one orifice coupled to the at least one channel, as discussed herein.

[0052] Although only a few exemplary embodiments have been described in detail above, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments without materially departing from the novel teachings and advantages of the embodiments of the present disclosure. For example, the embodiments of the present disclosure can be advantageously used in oral delivery of oral adhesive particles, oral hygiene or whitening products, or in any other suitable adhesive particle delivery applications, including coatings. Accordingly, all such modifications are intended to be included within the scope of the embodiments of the present disclosure as defined in the following claims. In the claims, means-plus-function clauses are intended to cover the structures described herein as performing the recited function and not only structural equivalents, but also equivalent structures.

[0053] In addition, any reference signs placed in parentheses in one or more claims shall not be construed as limiting the claims. The word "comprising" and "comprises," and the like, does not exclude the presence of elements or steps other than those listed in any claim or the specification as a whole. The singular reference of an element does not exclude the plural references of such elements and vice- versa. One or more of the embodiments may be implemented by means of hardware comprising several distinct elements, and/or by means of a suitably programmed computer. In a device claim enumerating several means, several of these means may be embodied by one and the same item of hardware. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to an advantage.

Claims

CLAIMS:

1. A device (50) for delivery of release mechanisms to interproximal areas of teeth, comprising:

a handle portion (60) having a fluid system (65) that comprises at least one reservoir (64) for holding a fluid containing release mechanisms, a microburst pump (70) for producing a stream of fluid via a nozzle (52) that connects to the handle portion having at least one channel (74) and a guidance tip (80) with at least one orifice (82) coupled to the at least one channel; and

means for activating (58) the fluid system (65), wherein responsive to activating, the fluid system is operable to drive the microburst pump at a rate to expel most fluid at a velocity lower than 15 m/s out the at least one orifice.

2. The device (50) of claim 1, wherein the release mechanisms comprise release particles that comprise at least one or more of suspended particles, gel particles, muco- adhesive particles, slow release particles, sustained release particles, pH triggered release particles, and time-delay release particles.

3. The device (50) of claim 1, wherein the microburst pump (70) is driven at a rate less than or equal to 0.35 N/m.

4. The device (50) of claim 1, wherein the fluid containing release mechanisms comprises a spray with (i) a main volume of droplet sizes in a range of 0.1 to 0.15 mm diameter and (ii) a full volume of droplet sizes in a range from smaller than 0.01 mm to 1 mm diameter size.

5. The device (50) of claim 1, wherein the fluid system (65) further comprises (a) a first fluid reservoir (64) and a first channel (74a) coupled to the at least one orifice (82) and (b) a second particle reservoir (66) and a second channel (74b) coupled to the at least one orifice (82), and

wherein the means for activating (58) the fluid system (65) includes activating in at least two operational modes, wherein (i) responsive to activating in a first operational mode, the fluid system is operable to drive the microburst pump (70) at a first rate to expel the first fluid from the reservoir (64) via the first channel (74a) to the at least one orifice (82) for thinning a biofilm layer on surfaces of teeth in the interproximal area from an initial thickness to produce at least one or more of a thinned biofilm layer or a completely removed biofilm layer, and (ii) responsive to activating in a second operational mode, the fluid system is operable to drive the microburst pump (70) at a second rate, different from the first rate, to expel the fluid containing release mechanisms from the reservoir (64) via the second channel (74b) to the at least one orifice (82) for delivering and depositing release mechanisms onto the surfaces of teeth in the interproximal area.

6. The device (50) of claim 5, wherein the first rate comprises a microburst pump rate to expel the fluid from the at least one orifice at velocities greater than or equal to 15 m/s and the second rate comprises a microburst pump rate to expel the fluid containing release mechanisms from the at least one orifice at velocities less than 15 m/s.

7. The device (50) of claim 5, wherein the fluid system (50) comprises a first reservoir (64) for holding the first fluid and a second particle reservoir (66) for holding the fluid containing release mechanisms.

8. The device (50) of claim 5, further comprising:

a nozzle (52), wherein the at least one orifice (82) comprises one selected from the group consisting of (i) a singular orifice (82) wherein the first channel (74a) and the second channel (74b) merge into a single channel (74) coupled to the singular orifice, and (ii) separate distinct orifices (82a, 82b) wherein the first channel (74a) is coupled of a first orifice (82a) and the second channel (74b) is coupled to a second orifice (82b).

9. A method for delivery of release mechanisms to interproximal areas of teeth, comprising:

providing a handle portion (60) having a fluid system (65) that comprises at least one reservoir (64) for holding a fluid containing release mechanisms, a microburst pump air cylinder driven spring mechanism (70) for producing a stream of fluid via a nozzle (52) that connects to the handle portion having at least one channel (74) and a guidance tip (80) with at least one orifice (82) coupled to the at least one channel; and activating (58) the fluid system (65) operable to drive the microburst pump air cylinder spring mechanism at a rate to expel most fluid at a velocity lower than 15 m/s out the at least one orifice.

10. The method of claim 9, wherein activating the fluid system further includes driving the microburst pump at a rate less than or equal to 0.35 N/m.

11. The method of claim 9, wherein the fluid containing release mechanisms comprises a spray with (i) a main volume of droplet sizes in a range of 0.1 to 0.15 mm diameter and (ii) a full volume of droplet sizes in a range from smaller than 0.01 mm to 1 mm diameter size.

12. The method of claim 9, wherein the fluid system (65) is further configured for holding at least one of (i) a first fluid and (ii) the fluid containing release mechanisms, wherein the fluid system (65) further comprises a first fluid reservoir (64) and a first channel (74a) of the at least one channel (74), the first channel being coupled to the at least one orifice (82) and (b) a second particle reservoir (66) and a second channel (74b) of the at least one channel (74), the second channel being coupled to the at least one orifice (82), and

wherein activating the fluid system (65) includes activating in at least two operational modes, wherein (i) responsive to activating in a first operational mode, the fluid system is operable to drive the microburst pump (70) at a first rate to expel the first fluid from the reservoir (64) via the first channel (74a) to the at least one orifice (82) for thinning a biofilm layer on surfaces of teeth in the interproximal area from an initial thickness to produce at least one or more of a thinned biofilm layer or a completely removed biofilm layer, and (ii) responsive to activating in a second operational mode, the fluid system is operable to drive the microburst pump (70) at a second rate, different from the first rate, to expel the fluid containing release mechanisms from the reservoir (66) via the second channel (74b) to the at least one orifice (82) for delivering and depositing release mechanisms onto the surfaces of teeth in the interproximal area.

13. The method of claim 12, wherein the first rate comprises expelling the first fluid from the at least one orifice at velocities greater than or equal to 15 m/s and the second rate comprises expelling the fluid containing release mechanisms from the at least one orifice at velocities less than 15 m/s.

14. The method of claim 12, wherein the fluid system comprises holding the first fluid in a first chamber and holding the fluid containing release mechanisms in a second chamber.

15. The method of claim 12, further comprising:

providing a nozzle in which the at least one orifice comprises one selected from the group consisting of (i) a singular orifice wherein the first channel and the second channel merge into a single channel coupled to the singular orifice, and (ii) separate distinct orifices wherein the first channel is coupled of a first orifice and the second channel is coupled to a second orifice.