Toothbrush handle having an inner cavity

(54) Title: TOOTHBRUSH HANDLE HAVING AN INNER CAVITY

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WO2® 1308355 ft (57) Abstract: A personal care article, such as a toothbrush handle having an inner cavity.

WO 2013/078355

PCT/US2012/066316

TOOTHBRUSH HANDLE HAVING AN INNER CAVITY

FIELD OF THE INVENTION

The present invention relates to toothbrush handles having an inner cavity.

BACKGROUND OF THE INVENTION

Toothbrushes are typically manufactured using an injection molding process. Such an injection molding process is characterized by providing a mold in the shape of the toothbrush and injecting molten plastic through a hot channel nozzle into the mold. The toothbrush is then cooled and ejected from the mold. For example, U.S. Pat. No. 5,845,358 shows such a toothbrush made by injection molding. One of the limitations of the conventional injection molding processes is that large diameter handles, and especially large handles with a substantial variation in cross sectional area where cross sectional area both increases and decreases along the length or major axis of the brush, cannot be produced in an efficient manner, due to the cost of increased material and lengthened cooling times, resulting from the increased mass of material used. A second significant limitation of conventional injection molding is that it requires multiple steps, multiple injection nozzles and multiple cavities or cavity sets to make a multiple-component brush.

Toothbrushes with increased handle diameters provide substantial advantages, for instance they can provide increased gripping area for children, increasing the ability of children to handle and use toothbrushes; also people with disabilities such as arthritis sometimes have difficulty in handling toothbrushes due to difficulty in flexing the joints in their hands. Such difficulties are considerably relieved by means of toothbrushes having increased handle diameters. Additionally, the larger cross section handles on the toothbrushes are better for the user from an ergonomic point of view.

Toothbrushes with high-friction and/or low-durometer regions of a second material on the outer surface also provide substantial advantages in gripping. Low-durometer materials, such as those materials whose hardness is measured at less than approximately 90 on the Shore A scale, provide advantages in grip by deforming under the range of comfortable gripping forces. The deformation assists in holding the brush uniformly in position in the hand, and also provides a pleasing tactile feedback. Addition of high-friction grip surfaces directly reduces the squeezing force necessary to maintain a stable orientation of the brush bristles during use. Due to their low strength, however, toothbrushes made entirely from high-friction, low-durometer material are unlikely to exhibit the bend strength necessary to provide adequate force to brush in a

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PCT/US2012/066316 conventional grip style. Thermoplastic Elastomers (TPEs) in the hardness range of Shore A 20 90 are a common second, third or subsequent material used to improve grip on toothbrushes and other personal care articles.

Variations in cross sectional area, including both larger and smaller cross sectional areas, along the length or major axis of the brush assist the user in the grip and handling of the brush during use, when it must be rapidly moved while it may also be wet or slippery. Additionally, materials that maintain a higher coefficient of friction when wet, including TPEs in the abovementioned hardness range can assist in wet-grip situations.

In an attempt to overcome the difficulties associated with the use of injection molding to produce toothbrush handles having increased diameters, it has been suggested to produce toothbrush handles having a hollow body. For example, EP 0 668 140 and EP 0 721 832 disclose the use of air assist or gas assist technology to make toothbrushes having hollow, large cross-sectional handles. In the disclosed process, molten plastic is injected near the base of the toothbrush handle, wherein subsequently a hot needle is inserted into the molten plastic to blow gas into the molten plastic which is then expanded towards the walls of the injection mold. In a similar manner, U.S. Pat. No. 6,818,174 B2 suggests injecting a predetermined amount of molten plastic into the cavity to only partially fill the mold cavity and subsequently inject a gas through a gas injection port formed in the injection mold to force the molten plastic into contact with the walls of the mold cavity. Such injection molding processes using additional air injection have substantial difficulty forming hollow handle bodies with substantially uniform wall thickness, and as such, the potential for optimization of a handle for maximum ergonomic function in minimum material weight and manufacturing efficiency is limited. A further drawback to such injection molding processes is the creation of a vent hole for the gas. EP 0 668 140 provides a possible solution to this problem via use of a moving injection pin to create a sealed part, however the integrity of this seal under the injection molding pressures created in the second shot is highly sensitive to processing conditions and may not result in a reliably-sealed part. The vent hole is formed at the interface of molten plastic and high-pressure gas (and not by mold steel) and thus cannot be made predictably or with high precision. A still further drawback of hollowhandled toothbrushes made using gas-assist injection molding relates to the application or installation of a second, third or subsequent material to the toothbrush by injection molding, or overmolding, where the overmolded material may, in the process of sealing the necessary gas vent, intrude substantially into the hollow void created in the first gas injection step, as there is

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PCT/US2012/066316 nothing to stop it besides friction and the near-atmospheric pressure inside the void. EP 0 721 832 illustrates this effect in detail. While this may still result in a cosmetically-acceptable part, it prevents use of shot-size-limiting devices such as valve gates and can add substantially to the cost of the part. Gas-assist injection molding does not substantially reduce injection pressure or melt energy required to form a plastic article, and most gas-assist injection molding prior art claims a void volume that is only 10-50% of the total part volume, and more often 10-25% of the total part volume

A conventional method to create toothbrush handles having increased cross sections, such as electromechanical toothbrush handles, is to manufacture discrete parts of the handle separately using injection molding, then to assemble these parts in either a separate non-injection molding step, or in a subsequent injection molding step, or most often some combination of the two, whereby the discrete parts from the first step or steps are inserted into an injection mold first and one or more additional materials are injected around them, creating a hollow body from multiple parts. This manufacturing method still has the drawbacks of: requiring the complete melting of plastic, high pressures and associated equipment involved with injection molding, and in addition may have added labor expense associated with both in-mold and out-of-mold assembly of discretely-molded parts for the handle. The use of injection molding to create multiple discrete parts also has the disadvantage that each part must not contain any substantial undercut from which the mold core forming a concave surface of the injection-molded part could not be extracted from the part after molding Further, mold cores must typically contain some mechanism to cool or remove heat, typically embodied as internal channel through which chilled water is forced, and would thus be difficult or impossible to create to make internal geometry for most manual toothbrushes which may have diameters less than 10mm and lengths beyond 150mm. The lack of undercuts in discrete parts combined with the length and diameter of cores required to make non-undercut handle parts combined with the desire for multiple areas of variation in cross sectional area on a toothbrush handle would thus require any discretelyassembled handles to have multiple mating surfaces, which would preferably require seals to maintain barriers to moisture and debris, even under time and repeated use.

Installation of soft-touch or second materials to hollow molded articles can be made by other means such as welding, gluing or use of flexibility of the soft-touch material to itself grip an undercut pre-molded into the main article. These methods all have disadvantages however in long-term adhesion, especially to thermoplastics with less-active surfaces made from materials such as polypropylenes. Durable articles made from multiple components which must be used in

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PCT/US2012/066316 unpredictable circumstances and environments such as consumers' bathrooms must necessarily be constructed more robustly than for example, disposable articles or packages.

Electromechanical toothbrushes in particular are susceptible to problems of assembly, as they are necessarily hollow in order to include batteries, motors and associated electrical linkages and drive components which must be all placed inside with some degree of precision. To avoid the problems and expense of welding plastic parts together and multiple assembly steps of a sealed outer shell, it has been proposed to blow mold the handle for electromechanical toothbrushes. In the assembly of a blow molded electromechanical toothbrush it is necessary to leave the blow molded portion of the handle open in at least one end to accommodate the motor, batteries, and drive system components. In this process, the minimum diameter of at least one opening to the blow molded handle must exceed the smallest linear dimension of every component that will be inserted. Such a large opening would be a drawback in a non-electromechanical handle, which has no need to accommodate internal component entry, and would necessitate an overly-large second part or cap to prevent intrusion and collection of water, paste, saliva and other detritus of conventional use. Such an overly-large opening, if positioned near the head, would interfere substantially with ergonomic use of the brush. Additional constraints to the geometry on the inside surface of the cavity, for example to locate motors, housings, batteries, etc. which must be positioned inside accurately as to be rigidly fixed will also be detrimental to the overall blow molding process, as the majority of the inner cavity surface of a blow molded part cannot be defined directly by steel or other mold material in the mold surfaces, and is instead defined indirectly by steel or other mold material on the outer surface of the handle combined with the wall thickness of the parison, blowing pressure and stretch ratio of the final part to the original parison or preform thickness. Such constraints of these process variables will necessarily limit manufacturing efficiencies.

To accommodate activation of electrical components via a standard button or mechanical switch, at least some portion of a blow molded electromechanical toothbrush handle should be made thin enough to flex substantially under pressure of a finger or hand squeeze. Such a thin-walled structure or film-walled structure necessarily requires some strengthening mechanism to ensure durability and rigidity under use. An internal frame or cap, as described in WO 2004/077996 can be used to provide this necessary strengthening mechanism in an electromechanical toothbrush, but would be a drawback to a manual brush, which does not require additional components to function adequately, in extra expense, complexity and additional load-bearing parts. Further, due

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PCT/US2012/066316 to the linear nature of the motor, power source, and drive shaft of electromechanical toothbrushes there are no or minimal variations to the cross-sectional area of the inner cavity; such that the inner cavity walls provide mechanical support to the internal components to reduce or eliminate unwanted movement or shifting.

An electromechanical toothbrush handle, made by blow molding or injection molding, is typically manufactured with an opening at either end: At a distal end there is typically an opening to accommodate the mechanical translation of power through a drive mechanism to the toothbrush head, and at a proximal end there is typically an opening to accommodate insertion of components during manufacturing and possibly also insertion or removal of the battery by the user. Such a second opening would be unnecessary for a manual toothbrush and would create drawbacks in the need for additional seals and mechanical fasteners. In some blow molding processes, the formation of openings at the distal and proximal ends of the molded part are intrinsic to the process and would benefit the formation of a double-open-end handle, but would not be necessary for a manual toothbrush handle.

There are several advantages to making toothbrush handles lighter in weight overall, regardless of cross section or changes to the size. Lighter handles could provide a more tactile feedback of forces transmitted from the teeth through the bristles to the head to the handle to the hand during brushing. Lighter toothbrush handles would also ship in bulk with greater efficiency from manufacturing centers to retail centers where they are purchased by users. To reduce weight while maintaining stiffness, some toothbrush handles are made from bamboo or balsa wood, however these materials have disadvantages in that they are not easily formable into complex three-dimensional shapes which can be comfortably gripped. Further, these materials are anisotropic, meaning they have elastic moduli and yield strengths or ultimate strengths which vary with the direction of applied load. Carbon-fiber composites and glass-filled injectionmolded plastics are other common examples of anisotropic materials which could be used to make lighter and stronger toothbrushes. Articles made from these materials must therefore be formed with their strongest axis or 'grain' aligned substantially with the major axis of the article in order to resist fracture during the bending forces common to use. Both carbon fiber and glassfilled thermoplastic composites also tend to fail in a brittle manner, with little ductility. This type of failure is undesirable in a device that is placed in the mouth. Further, these materials do not contain intrinsically all of the properties necessary to create light weight, strength in bending and soft-touch, high-friction grip. This creates an extra necessary step in the preparation of the

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PCT/US2012/066316 material prior to forming or machining. This alignment of the grain also can present a specific disadvantage to woods in general in that the presentation of splinters of material is most likely to occur in the direction aligned to typical forces applied by the hand during brushing.

To make toothbrush handles lighter without relying on anisotropic materials such as woods, the articles could be made lighter through the use of non-homogeneous but isotropic materials, such as foamed plastics. Foamed plastics present an advantage in that they can offer a higher strengthto-weight ratio than solid plastics without regard to material orientation. The overall weight savings possible with foamed plastics may be limited however, as the bubbles inside the plastic which create the weight savings also create stress concentrations which will severely reduce strength in tension and will also severely reduce ductility prior to failure. While foamed plastics can provide substantial strength in compression (and are used for exactly this purpose in applications such as packing materials where material weight combined with resistance to compressive crushing is a critical issue) the weakness in tension severely affects bending strength and prevents uniformly-foamed plastics from serving as load-bearing elements in articles which must maintain strength, stiffness and ductility in bending during normal use.

It is familiar to those in the art to use extrusion blow molding to create single-component or single-material lightweight hand-held articles, such as children's toys, such as hollow, plastic bats, golf clubs or any large, plastic article which benefits from being lighter in weight. While these articles can be both stiff and strong in bending, they also generally contain drawbacks which would limit their general use in semi-durable, Class-I medical devices, such as toothbrushes. First, such articles typically contain significant flash along parting lines, or in any locations where the parison is larger in cross sectional area than is the cavity to which it is blown. In these locations the parison folds within the cavity or is pinched off at the cavity party ling, and substantial flash is created. Second, most articles contain some significant vestige of blowing in the form of a hole, which may be accurately or inaccurately formed. Such a vestige would be regarded as a significant defect in a Class-I medical device which must prohibit breach or entry of contaminants to a hollow interior which does not drain effectively. Third, the relative size of these articles is large in comparison to the size of these defects, and the overall function of the articles is not severely affected by these defects. In many cases, the size of the article itself renders the manufacturing process easier, with respect to the minimization of defects. It is not challenging to extrusion blow mold articles, packages or bottles in the size range common to manual toothbrush handles -if the plastic wall thickness can be minimized in proportion to the

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PCT/US2012/066316 overall cross section. Such articles exist in the form of small, typically squeezable, tubes or bottles which in fact benefit from having a very thin, deformable wall which enables dispensing of internal contents, but also makes them unusable or significantly inferior as toothbrushes.

Extrusion- and injection-blow-molded handles for single-component semi-durable consumer goods such as feather dusters and tape dispensers are also known but again these articles would not meet criteria for semi-durable Class I medical devices, specifically with regard to the sealing of the necessary blowing orifice against intrusion of water or other contamination, and in the case of extrusion blow molding, in the appearance of flash on the articles in areas that would directly contact or go into the mouth. These articles can also be brittle, and when too much force is applied, can break or snap suddenly and without ductility, producing sharp edges, making them unusable for use in the oral cavity.

Multi-component blow molded packages, such as water bottles, are known to those familiar in the art. In these embodiments, smooth blow molded bottles are provided with tactile, highfriction surfaces via the use of an in-mold labeling technique, whereby previously injectionmolded, textured labels are placed into mold cavities prior to introduction and blowing of the semi-molten parison of extruded plastic. While these articles do provide the advantage of a large gripping surface which is improved by addition of a high-friction textured surface, they are by nature highly-deformable or squeezable packages designed for liquid storage and dispensing, and would serve poorly as toothbrushes.

It has also been proposed to manufacture manual toothbrushes by blow molding, and in fact it should not prove challenging to extrusion blow mold, injection blow mold, or even injectionstretch blow mold such an article in the general shape and size of a toothbrush or toothbrush handle, however no existing disclosure in the prior art addresses the issues of: Strength in bending, stiffness in bending, overall rigidity, mitigation of flash or other sharp defects, variations in cross-sectional area and undercuts, and obstruction or sealing of the blow hole vestige. Any one of these defects in a blow molded toothbrush or toothbrush handle would severely affect the utility of the article, and as such, improvements are needed to enable a hollow article with material savings maximized by uniform wall thickness which is suitably strong and stiff in bending without breaking in use and does not leak or present uncomfortable defects to the user.

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In view of these drawbacks of the prior art, it is an objective of the present invention to provide an improved toothbrush or toothbrush handle having an inner cavity, which avoids the drawbacks of the prior art.

SUMMARY OF THE INVENTION

A toothbrush handle is provided that comprises a terminal end, connector end, outer surface, inner cavity, and longitudinal axis; the inner cavity having a surface defining a cross-sectional area; wherein the inner cavity has at least one of a greater cross-sectional area, bordered by two lesser cross-sectional areas along the longitudinal axis of the toothbrush or a lesser cross sectional area bordered by two greater cross-sectional areas along the longitudinal axis of the toothbrush; the outer surface defines an outer surface cross-sectional area; a wall formed from the outer cavity surface and inner cavity surface; and the toothbrush handle comprises a single unitary component, wherein the difference between the outer surface cross-sectional area and the inner cavity surface cross-sectional area varies less than 25% over at least 50% of the toothbrush handle length along the longitudinal axis.

A toothbrush handle is provided that comprises a terminal end, connector end, outer surface, inner cavity, and longitudinal axis; the inner cavity having a surface defining a cross-sectional area; wherein the inner cavity has at least one of a greater cross-sectional area, bordered by two lesser cross-sectional areas along the longitudinal axis of the toothbrush or a lesser cross sectional area bordered by two greater cross-sectional areas along the longitudinal axis of the toothbrush; the outer surface defines an outer surface cross-sectional area; a wall formed from the outer cavity surface and inner cavity surface; the toothbrush handle comprises a single unitary component; and wherein the toothbrush handle comprises two or more material layers.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a toothbrush handle according to an embodiment of the present invention.

FIG. 1A is a cross-sectional view of FIG. 1 along section line 1A according to an embodiment of the present invention.

FIG. IB is a cross-sectional view of FIG. 1 along section line IB according to an embodiment of the present invention.

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FIG. 2 is a perspective view of a toothbrush handle according to an embodiment of the present invention.

FIG. 3 is a perspective view of a toothbrush handle according to an embodiment of the present invention.

FIG. 4 is a perspective view of a toothbrush handle according to an embodiment of the present invention.

FIG. 5 is a perspective view of a toothbrush handle according to an embodiment of the present invention.

Fig 6 is a perspective view of a toothbrush handle according to an embodiment of the present invention.

FIG. 6A is a cross-sectional view of FIG. 6 along section line 6A according to an embodiment of the present invention.

Fig 7 is a perspective view of a toothbrush according to an embodiment of the present invention.

FIG. 7A is a cross-sectional view of FIG. 7 along section line 7A according to an embodiment of the present invention.

Fig 8 is a perspective view of a toothbrush handle according to an embodiment of the present invention.

FIG. 8A is a cross-sectional view of FIG. 8 along section line 8A according to an embodiment of the present invention.

Fig 9 is a perspective view of a toothbrush handle according to an embodiment of the present invention.

FIG. 9A is a cross-sectional view of FIG. 9 along section line 9A according to an embodiment of the present invention.

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Fig 10 is a perspective view of a toothbrush handle according to an embodiment of the present invention.

FIG. 10A is a cross-sectional view of FIG. 10 along section line 10A according to an embodiment of the present invention.

Fig 11 is a perspective view of a toothbrush handle according to an embodiment of the present invention.

FIG. 11A is a cross-sectional view of FIG. 11 along section line 11A according to an embodiment of the present invention.

FIG. 12 is diagrammatical representation of a method of analysis.

FIG. 13 is diagrammatical representation of a method of analysis.

FIG. 14 is a chart illustrating deflection in bending vs. specific gravity.

DETAILED DESCRIPTION OF THE INVENTION

The present invention relates to personal care articles having an inner cavity, such as a unitary single-component toothbrush handle that may have different colors, forms, and surface decorations on either or both of the inner cavity or outer surface. The toothbrush handle may be made in a single molding step. The inner cavity varies in cross-sectional area along the length of the toothbrush, wherein the inner cavity is essentially open as compared to an open or closed cell foam material. The toothbrush handle is a unitary piece, but may include separate non-structural elements, such as labels, grip structures, etc. ... In certain embodiments the inner cavity is sealed with no opening to the outer surface of the toothbrush handle. In certain embodiments the unitary toothbrush handle is comprised of distinct regions of different materials, which are intrinsically or chemically bonded to one another as apart of the manufacturing process.

Personal care articles are items used to store, dispense, apply or deliver benefits to a consumer's personal health, beauty, grooming, or other body or human biological system care, maintenance, enhancement or improvement. Examples of personal care articles include, but are not limited to

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PCT/US2012/066316 toothbrushes, toothbrush handles, razors, razor handles, mop handles, vacuum handles, makeup or beauty care applicators, skin care applicators, feminine hygiene applicators, hair care applicators, hair colorant applicators, or hair care articles.

FIG. 1 shows an embodiment of a personal care article, a toothbrush handle 10, having a terminal end 12 and a connector end 14. The toothbrush handle 10 may be unitarily formed as a single piece and comprise an inner cavity 30 and an outer surface 50, wherein the handle outer surface 50 varies in cross-sectional area (OSCA), which is the total area of the cross-section as defined by the outer surface 50, along the handle 10 longitudinal axis L -as shown in FIG. 1A; in this embodiment the handle 10 has a substantially hourglass shape. The inner cavity 30 has an inner cavity surface 32, wherein the inner cavity surface 32 varies in cross-sectional area (ICCA) along the handle longitudinal axis L. As FIG. 1 shows, in certain embodiments the inner cavity 30 of the handle 10 has one or more greater cross-sectional areas ICCAG bordered along the longitudinal axis L of the handle 10 by lesser cross-sectional areas ICCALI, ICCAL2 having a smaller area than the area of the greater cross-sectional area ICCAG- A handle 10 inner cavity 30 may also have a lesser cross-sectional area ICCAL bordered along the longitudinal axis L of the handle 10 by greater cross-sectional areas ICCAGI, ICCAGI having a larger area than the area of the lesser crosssectional area ICCAL- Further, as shown in FIG's 1, 1A and IB, in certain embodiments the square root of the inner cavity surface 32 cross-sectional area varies proportionally to the variations in the square root of the outer surface 50 cross-sectional area along the longitudinal axis L of the handle 10, with the exception of the areas near the terminal 12 and connector end 14 of the toothbrush handle where the inner cavity 30 becomes sealed. In certain embodiments the square root of the inner cavity surface cross-sectional area varies proportionally less than 5 % to the variations in the square root of the outer surface cross-sectional area along the longitudinal axis L of the handle 10 with the exception of the areas near the terminal and connector end of the toothbrush handle. In certain embodiments the thickness of the toothbrush handle wall, the distance between the toothbrush handle outer surface and the inner cavity surface, varies in inverse proportion to the square root of the outer surface cross-sectional area. In certain embodiments the difference between the outer surface cross-sectional area (OSCA) and the inner cavity surface cross-sectional area (ICCA) varies less than about 25%, 20% 15%, 10%, 5% over at least 50%, 70%, 80%, 90% of the toothbrush handle length along the longitudinal axis. For example, in these embodiments areas of a toothbrush handle having a greater outer surface crosssectional area will have a thinner wall (compared to areas having a lesser outer surface crossWO 2013/078355

PCT/US2012/066316 sectional area) as the material has been stretched to a greater degree during the extrusion blow molding process.

In certain embodiments, as shown in FIG's 2 and 3, a handle 110 may be a part of a toothbrush 100 along with a separate neck 150 and head 160. The handle 110 comprises a longitudinal axis (L), a terminal end 112, a connector end 114, an outer surface 116 and an inner cavity 118 as described previously.

In addition the handle 110 can be formed to include a connector 120 to engage a complementary connector 152 in the neck 150 to form a toothbrush 100. The connectors 120, 152 can be formed to allow releasable or permanent connection between the handle 110 and neck 150 in any manner known to one of ordinary skill in the art. For example, the connectors 120, 152 may be provided with connection features, such as a screwing thread so the two connectors 120, 152 can be screwed to each other. Alternately or in addition, one of the connectors 120, 152 may possess a connection feature, such as a bulge, rib, or hook corresponding to a mating undercut in the female portion ofthe opposing connector 120, 152 to attach the portions using a snap fit. Bayonet fittings may also be used, as friction or interference fittings or other common plastic fitments well known to those versed in the art. Further, in addition to or in place of connectors, a connection means can be used to connect a handle and neck, such as adhesive, melting, ultrasonic welding or friction welding.

Connectors in a hollow handle have connection features that provide advantages over connectors made using injection molding, which are typically solid. First, connection features such as a male insertion feature may be physically larger in diameter when made hollow than when made solid, if the connection features are made from common thermoplastics. As connection features are made larger in injection molding, for example, the time for the part to cool in the mold increases roughly in proportion to the square of the diameter, and the ability to maintain consistent geometry becomes more difficult. In addition if the inner cavity extends into the connecter the inner cavity surface may have connector features, such as threading or friction fittings allowing for complementing connectors, such as in the neck, to be inserted into the connector. Injection molded parts that are more than several millimeters thick are also subject to sink marks, which are the manifestation of solidification-based shrinkage of thermoplastic parts. Sink marks are difficult to control and as such are undesirable in any location where precision geometry is required, for example in a snap-fit or screw-fit connection area, or in any area that will rely on

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PCT/US2012/066316 interference fits to create a water-tight seal. Hollow connection features are possible in injection molding, and even in injection molded toothbrush handles, but in general these must be created or cored from the terminal end, and cannot be made hollow and undercut from a single orifice at the connector end. Injection molded parts hollow at the connector end will necessarily have their greatest inner diameter at the point of connection, and are thus severely limited in geometry.

As illustrated in FIG. 2 the head 160 supports a plurality of cleaning elements, such as bristles or tufts of bristles 162. The bristles or tufts of bristles may comprise nylon, PBT, and TPE. In addition to bristles or tufts of bristles a toothbrush head in the present invention may include any suitable cleaning element which can be inserted into the oral cavity. Some suitable cleaning elements include elastomeric massage elements, elastomeric cleaning elements, massage elements, tongue cleaners, soft tissue cleaners, hard surface cleaners, combinations thereof, and the like. The head may comprise a variety of cleaning elements, and is attached to the handle at the connector end via connection features. For example, the head may comprise bristles, abrasive elastomeric elements, elastomeric elements in a particular orientation or arrangement, for example pivoting fins, prophy cups, or the like. Some suitable examples of elastomeric cleaning elements and/or massaging elements are described in U.S. Patent Application Publication Nos. 2007/0251040; 2004/0154112; 2006/0272112; and in U.S. Patent Nos. 6,553,604; 6,151,745. The cleaning elements may be tapered, notched, crimped, dimpled, or the like. Some suitable examples of these cleaning elements and/or massaging elements are described in U.S. Patent Nos. 6,151,745; 6,058,541; 5,268,005; 5,313,909; 4,802,255; 6,018,840; 5,836,769; 5,722,106; 6,475,553; and U.S. Patent Application Publication No. 2006/0080794. Further the cleaning elements can be arranged in any suitable mannaer or pattern on the toothbrush head.

In certain embodiments, as shown in FIG. 4 a toothbrush 200 may comprise a handle 210 and neck 212 connected to a head 214; or in certain other embodiments a toothbrush 230 may comprise a separate handle 232, neck 234, and head 236 -the separate parts may be connected using one or more of the methods of connection listed above.

In certain embodiments of the present invention, a toothbrush handle may be made from multiple layers of material, for example to create different tactile surfaces. Wherein the layers of material may be present on or in the toothbrush handle outer surface. Generally, in a two-layer embodiment, an inner, or substrate, layer is made from a first material which is the main loadWO 2013/078355

PCT/US2012/066316 bearing material and is typically thicker than subsequent outer layers; and an outer layer may be made from a softer material which may have a higher coefficient of friction with wet or dry skin, or other improved tactile features.

In certain embodiments, as shown in FIG. 6 and 6A, of a multi-layer personal toothbrush handle 300, layers of material may be wholly concentric, where all or nearly all of the outer surface 332 of an inner material layer 320 rests integrally adjacent to the entire or nearly entire inner surface 331 of an outer material layer 330. In certain embodiments, as shown in FIG. 7 and 7A, layers of material may vary radially about the perimeter of the outer surface 420 of a toothbrush handle 400, for example creating a stripe or stripes of a second layer material 430 extending along the longitudinal axis of the toothbrush handle, which may be a different color, hardness, durometer or any combination thereof from a first layer material 410. In certain embodiments, as shown in FIG. 8 and 8A, material layers on a handle 500 may vary both radially and axially, where one or more layers of material may appear as a stripe or stripes 530 extending along the longitudinal axis (L) of the handle 500. The stripe or stripes 530 overlay an inner layer of material 520 that contains and forms the inner cavity 510. In certain embodiments, an outer layer of a second material present on or in the outer surface of a toothbrush handle may be small and occupy less than 50%, 40%, 30%, 20%, 20%, or 5% of the circumference of the toothbrush handle outer surface, as compared to a first layer material also present on or in the toothbrush handle outer surface. In another embodiment, a tactile layer made from softer or higher-friction material may occupy 50% or more ofthe toothbrush handle outer surface circumference.

In certain embodiments of multi-layer toothbrush handles, material layer thickness may vary along the toothbrush handle longitudinal axis, the circumference, or both. In the case of extrusion blow molding, this can be accomplished by varying the relative extrusion pressures and/or flow rates of the two or more materials upstream of the extrusion orifice over the course of the extrusion of a single part. As shown in FIG. 9 and 9A the thickness of a first material layer 620 and second material layer 630 may vary along the longitudinal axis (L) of a toothbrush handle 600. In certain embodiments of toothbrush handles 700, as shown in FIG. 10 and 10A a second material layer 730 may be partially or substantially visible through a first material layer 720, which completely or substantially encompasses the second material layer 730. For example the first material layer may be completely or partially transparent or translucent. The first material layer 720 may vary in thickness around the circumference of the toothbrush handle 700, such that the second material layer 730 is closer to the outer surface 710 along portions of the

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PCT/US2012/066316 toothbrush handle 700 as compared to other portions. If the second material layer 730 visibly differs from the first material layer 720, for example different color, material, or texture that difference will be more noticeable in the portions of the toothbrush handle 700 where the second material layer 730 is closer to the outer surface 710. For instance, if the second material layer is colored and the first material layer is translucent the color of the second material layer would be more noticeable or more vibrant in the portion of the toothbrush handle where it is closer to the outer surface.

Extrusion blow molded articles with up to seven layers are known to those familiar in the art, and such layers may serve purposes of vapor barrier, water barrier, gas barrier, perfume barrier, chemical barrier, recycle content, low-cost material content (i.e. filler), or higher-cost material content to include economically color, transparency, translucency, or reaction due to heat or specific or general wavelengths of light, including infrared, visible and ultraviolet.

Multi-layer extrusion blow molded toothbrush handles that include a softer element, for example a ShoreA hardness between 10 and 80, as their outermost layer in the region near the connector end may also have the advantage that the softer material can provide some additional sealing against an attachable head or neck versus a harder material such as polypropylene or most other engineering plastics.

To provide tactile grip, in certain embodiments of a multi-layer toothbrush handle made via inmold labeling, extruded sheets of high-friction or low-durometer flexible material may be first die cut into a pre-determined shape to form labels or coupons; or such labels may be made with three-dimensional textures via injection-molding, thermoforming, or another molding step. The transition between regions of different tactile grip may be distinct, abrupt, and accurate. Very detailed designs and shapes are possible for labels. FIG. 11 and 11A illustrate an embodiment of a toothbrush handle 800 where a label 830 is intrinsically bonded to an inner layer 820.

Labels may be made thin enough to deform so that labels follow closely the three-dimensional shape or contours of the toothbrush handle. Labels made from a polypropylene-based TPE in the Shore A 30-50 range may be under 0.25mm thick when the polypropylene part wall is l-3mm thick to ensure adequate forming outer surface of the handle. In certain embodiments labels may be pre-textured.

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The texture may have a macro structure, micro structure, or both. Macro-structure is defined to comprise texture or features on a length scale greater than 0.1mm such as tactile ribs, bosses, dimples or bumps; and micro-structure is defined to comprise texture or features on a length scale less than 0.05mm such as grit-blasted textures, matte textures, witness lines or parting lines. In certain embodiments a multi-layer toothbrush handle may comprise a primary component forming the majority of the toothbrush handle and a secondary component forming a minority of the toothbrush handle, wherein the second component may be less than 0.4mm thick as measured normal to either the inner or the outer surface of the layer, and greater than 1cm² in area. In certain embodiments, the second component is a material with a higher coefficient of friction and lower durometer than the first component, and has a thickness less than 0.2mm substantially throughout, as measured normal to either the inner or the outer surface of the layer comprising the second material, and has a total exposed surface area greater than 10cm².

The materials from which a hollow toothbrush handle can be made should comprise one or more of the following characteristics: (1) strength or resistance to bending and axial loading, (2) toughness, as the opposite of brittleness, (3) Class I medical device requirements, (4) chemical compatibility with a variety of toothpastes and active chemistries therein, (5) chemical compatibility with other components which are typically attached to toothbrushes such as decals, printed inks, labels, grip elements, head or neck elements and the like, and (6) ability to process to a final geometry by extrusion blow molding, injection blow molding or injection-stretch blow molding. Examples of materials having one or more of the above characterisitics include polypropylenes; nylons (polyamides); polyethyleneterapthalates; low-density and high-density polyethylenes; polyesters; polyvinylchlorides; and engineering plastics such as Acrylonitrile Butadiene Styrene [ABS], polyphenylene ether, polyphenylene oxide. Any sub-types of these materials or other thermoplastics, including blow-molding-grade thermoplastics, with melt flow indices between 0.3 and 3.0g/10min are preferred if a blow molding process is used. Few materials outside of thermoplasts can satisfy all the requirements, however blow molded metal objects are known, and some alloys of zirconium can be formed into hollow shapes using blow molding techniques.

For toothbrushes which are made from multiple materials, in certain embodiments at least one material is from the list named immediately above, and a second material may be composed either from the same list or from any thermoplastic elastomer (TPE) containing materials in the

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PCT/US2012/066316 above list in some fraction, to allow for heat-activated adhesion and improved grip, deflection, and coefficient of friction with skin.

For toothbrush handles having an inner cavity, such as those made from extrusion blow molding it is advantageous to cover the fluid blow hole or hole vestige with the toothbrush head or neck to permit sealing and prevent entry of water or contaminants. Further, for toothbrush handles made from extrusion blow molding it is desirable to cover not only the blow hole, but also remove or reduce any flash, pinch or fold defects that naturally occur during cavity closing, where the extruded parison outer diameter may be larger than the local mold cavity diameter, prior to blowing. These defects may also occur in needle blowing embodiments, or in calibrated-neck embodiments, or in embodiments which use neither a needle nor a metal blowing nozzle to form an inner surface of the blown part.

In certain embodiments a toothbrush handle having an inner cavity may have a center of gravity closer to the head than to the geometric center than is normally possible with a solid brush of conventional shape, which provides for improved dexterity or ergonomics during brushing, or the center of gravity can be placed further from the head than is possible with a solid, homogeneous brush, for example by placement of permanently-mounted weights inside the hollow portion of the handle, which provides for example improved tactile response of the forces transmitted from the teeth to the head to the handle. Such manipulation of center of gravity provides for additional benefits in handling during brushing or storage with no compromise to design elements such as shape, material, or color that appear on the outside of the handle. In addition a toothbrush handle having an inner cavity may have a specific gravity, in certain embodiments below about 0.60g/cm³, or below about 0.20g/cm³ in plastic or about 0.10g/cm³ in metal, while maintaining a modulus or strength sufficient to resist bending during even heavy brushing without concern of alignment or particular arrangement of any raw material or load-bearing element (in contrast to materials having a grain, such as wood or carbon fibers), which is difficult to achieve in a toothbrush handle which is substantially solid and made from common isotropic, homogeneous materials such as plastic or metal.

The toothbrushes of the present invention having an inner cavity can help reduce the amount of excessive force being applied to the toothbrush during brushing, such as when using a typical solid manual toothbrush or electromechanical toothbrush. It is known to those familiar in the art that sustained, repeated brushing with a standard tufted, manual toothbrush with a force of

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PCT/US2012/066316 greater than approximately 5.0 N can lead to a loss of gum tissue over time. For instance there exist electromechanical toothbrushes with integrated feedback systems to warn users when this force is exceeded during use. This suggests that a significant fraction of toothbrush users apply forces up to 5 .ON through the toothbrush head. An example toothbrush of uniform, rectangular cross section made from a solid, homogeneous, isotropic material could be modeled in grip as shown in FIG. 12. The deflection of the head of the toothbrush in this grip during bending in use can be approximated from the equation used to calculate the flexural modulus of a flat bar of material in three point bending as shown in FIG. 13, and as disclosed in ASTM D 790.

Materials used to form toothbrush handles having an inner cavity (hollow toothbrushes) should provide a resistance to bending, or stiffness, when a load is applied normal to the longitudinal axis. Toothbrush handle materials that do not meet this criterion bend severely during normal use, and result in a negative experience or deliver insufficient force to adequately clean teeth. To evaluate candidate materials for construction of a toothbrush handle in as lightweight an embodiment as possible, we define here a ratio for the bending strength of the handle to its overall specific gravity as a measured deflection under specific loading case described in FIG. 13.

The chart in FIG. 14 illustrates this ratio applied to a simple rectangular beam-shaped approximation of solid handles made from isotropic, homogeneous materials; handles made from composite or non-homogeneous, non-isotropic materials; and hollow-handles made from otherwise isotropic, homogeneous materials. Results in the chart are obtained from the analytical equation of bending for the apparatus in FIG. 13 or from the predicted bending in a finiteelement analysis of materials not solvable in analytical form, such as anisotropic materials. It is clear from this chart that solid handles made from isotropic, homogeneous materials cannot achieve a bending strength-to-weight ratio achievable by engineered isotropic, homogeneous hollow handles.

Not all hollow, articles have sufficient bending strength to withstand 5N of force applied in bending normal to the major axis at a distance typical of that applied to a toothbrush between a thumb-fulcrum and the brush head. Certainly not all blow molded articles can withstand such forces in any loading situation: many blow molded packages, such as water bottles, must be filled prior to stacking in pallets as their walls are sufficiently thin that they will significantly deform in compression under even the weight of a few empty bottles on top of them. It is possible to make

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PCT/US2012/066316 toothbrushes and toothbrush handles in a similar fashion, either through use of generally weak materials or through manufacture of extreme thinness of walls, such that they would appear strong, possibly due to use of opaque materials or other decoration. Toothbrushes made from these handles would not collapse under gravity or mild forces, and could appear robust in packaging or in a non-use display but in fact would be displeasing or impossible to use as intended, or to deliver sufficient brushing force to maintain oral health. Generally, toothbrushes or toothbrush handles which deform more than 40mm under a 5 .ON force applied normal to the head on the surface to which bristles are mounted would not be desirable in use. In certain embodiments, the toothbrush handles of the present invention deform less than about 40mm under a 5.CN force applied applied normal to the head on the surface to which bristles are mounted. In certain embodiments the toothbrush handles of the present invention deform less than about 20mm under a 5 .ON force applied normal to the head on the surface to which bristles are mounted. A sample bent under loading as defined by ASTM D 790 should deflect at the point of loading approximately 25% as much as a sample bent and measured for deflection at the load point shown in FIG 12, so a sample bent in ASTM D 790 that deflects more than 10mm under 5 .ON applied load would be considered too weak. In certain embodiments, a sample that deflects more than 5mm under 5 .ON applied load would be considered too weak.

Isotropic, non-homogeneous materials appear from this chart to be candidates also for lightweight handles, however these materials are intrinsically brittle as a result of stress concentrations due to bubbles which are the result of the foaming process. The chart as described above illustrates only predicted or theoretical deflection under load and does not take into account ultimate strength of materials. Toothbrushes made from the foams shown would fracture at the surface under tension while in bending at loads much less than those used during typical brushing.

In general, hollow toothbrush handles with a substantially-uniform wall thickness provide desired resistance to bending with minimal use of material by placement of the material selectively at the outermost diameter, or the furthest location from the bending axis, where it can bear the most bending moment, with the least necessary strength. This selective placement of material naturally reduces the axial forces applied to material elements, caused by bending moments, and results in less strain per material element per unit of applied normal force or bending moment than if the handle is made from solid material or has material placed primarily in the neutral axis. An Ibeam is a common example of selective placement of material as far as possible from a neutral

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PCT/US2012/066316 axis, however an I-beam resists bending quite differently when bent around different. A hollow part which is substantially, or even approximately round in cross section, such as a hollow toothbrush, will provide adequate strength in bending about a variety of axes, which is necessary for a personal care article such as a toothbrush which is hand held and used regularly in many different orientations and must bear loads about nearly any bending axis.

However, not all hollow toothbrush designs would provide sufficient resistance to bending, as defined in the deflection-to-specific-gravity ratio above. Rather, it is easier to manufacture an extrusion blow molded toothbrush with a very thin, flexible wall than it is to manufacture a toothbrush in such a manner whose wall is thick enough to provide adequate resistance to bending. For all extrusion blow molded articles, there is an upper limit on the thickness of the wall which can be created without creation of significant folds or flash lines in the exterior surface of the article. This upper limit is governed by the smallest outer circumference of the portion of the article which is to be rendered hollow, the starting thickness of the extruded material prior to blowing, and the ratio of the initial circumference of the blown section to the final circumference of the blown section. As the wall thickness of the starting material increases, a greater fraction of it may become trapped between mold surfaces intending to mate, thus creating a flat section around all or a portion of the molded article, commonly known as flash. Hollow toothbrush handles with even small amounts of flash would be displeasing to use, especially as flash becomes or feels sharper to the touch the smaller it is.

Elasticity and strength of materials also play a factor in resistance to bending: for example a blow molded toothbrush having sufficient stiffness and made from a relatively strong material, such as PET-G, may be too weak to be considered useful when molded in the same geometry and wall thickness from LDPE or Polypropylene. Even between LDPE and Polypropylene, a Polypropylene toothbrush may be sufficiently stronger than an LDPE toothbrush when molded to the same geometry and wall thickness, such as to be noticeably stiffer by a user.

The wall thickness needed to provide sufficient bend strength will vary with material elastic modulus as well as with the distance of that section of the wall from the toothbrush axial centerline. To a first approximation, a hollow toothbrush with a larger diameter will require less wall thickness to maintain the same bending strength, however as wall thickness decreases, the potential for catastrophic bending by buckling or squeezing becomes possible, so there is as well a lower limit on wall thickness, even at very large cross sections or diameters. We can define an

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PCT/US2012/066316 approximate average wall thickness for the toothbrush as the volume occupied by plastic divided by the average of the inner and outer surface areas of the hollow handle. In certain embodiments average wall thickness may be between is between 0.3 mm and 5.0mm or 1.0mm and 3.0mm. In certain embodiments the thickness of the toothbrush handle wall and the thickness of the individual layers for those embodiments having two or more layers varies less than about 20%, 10% or 5% along the toothbrush handle longitudinal axis.

In certain embodiments of the invention, a polypropylene toothbrush handle whose length is between 60mm and 180mm, and has a weight between 7.0g and 12.0g with material distributed substantially evenly about the wall of the hollow portion, has an overall specific gravity less than 0.5g/cm³.

In addition to the bending strength, rigidity and convenience in manufacturing a hollow toothbrush handle is the advantage to using the un-occupied internal volume to house some useful or decorative element. Such elements can include elements common to assembled hollow brushes such as primarily electronic systems, electromechanical systems, primarily mechanical systems, and decorative elements.

Electronic elements such as batteries, timers, alarms, transducers, accelerometers, lights, speakers, amplifiers, resistors, capacitors, inductors, transistors, circuits, circuit boards, printed electronics, electronic ink and substrates, solder, wires, and similar components can be preassembled into functioning or partially-functioning systems and installed into the void area in a hollow toothbrush handle. Such systems can make particular use of undercuts in the handle, for example by virtue of placement or position against or near an undercut to provide restriction in motion. Such systems may also take advantage of an inner layer of a multi-layer system to provide electrical insulation or conductivity or semi-conductivity between elements integrated to the system, or to elements outside of the toothbrush cavity. An example of this would be an inductive charging system which harvests energy from an external electric field by placement and activation of coils of wire positioned inside of the handle. This is a common method by which power toothbrushes are re-charged when not in use. Specific embodiments of these systems and elements include, but are not limited to: a timer to provide feedback to a user during brushing of the teeth, a force sensor to discourage excessive use of force during brushing, an indicator element informing a user when the expected life of a toothbrush might be reached, lights or sounds to play a song or game during brushing, use of the geometric properties of the

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PCT/US2012/066316 hollow void to resonate or attenuate certain sounds generated inside, an electrostatic generator to charge the system to a high or low potential voltage, creation of an 'electronic pet' or tamagotchi, which will thrive if good brushing habits are maintained and suffer or die if they are not, and the like.

Electromechanical systems such as rotating motors, linear motors, permanent-magnet direct current motors, piezoelectric transducers, buttons, toggle switches, temporary switches, magnets, reed switches can also be used independently, or more likely combined with electrical elements and systems to provide further benefits or feedback to users. Examples include but are not limited to: Use of a motor to create a vibrating tactile feedback, use of piezotransducers or inductive electrical systems to harvest mechanical energy and convert to electrical energy during brushing, use of switches to activate and deactivate electrical or electromechanical systems, use of magnets as elements in inductive systems or to provide detection to an external electrical system, use of strain gauges to measure and feedback or use of vibration-inducing motors or offset-weight motors to create a pleasing tactile sensation at any point in the brush. For the use of mechanical switches, it may also provide an advantage to selectively thin the wall of the toothbrush handle in some areas but not all in order to create a deformable region which can allow deflection through the solid wall of an internally-mounted switch without creating an orifice which must be sealed in an additional step.

Primarily mechanical systems, such as solids, liquids, gasses, colloids, magnets, living or organic elements, phase-change or chemically-transitioning elements, color-change elements, thermochromatic elements, and the like can be installed within a hollow toothbrush handle, either permanently or with the intention of later dispensing, for consumption. Examples of consumable filling elements include but are not limited to: Toothpaste, oral rinse, whitening agents, breath fresheners. Examples of solids include but are not limited to: Articles shaped and designed to add weight or heft to a device, such as iron, zinc, or other metals in solid form; silica, or other granular material, in a single color or multiple colors articles made from liquids could include but are not limited to: water, oils, gels, or combinations thereof, including emulsions, mixtures, solutions and combinations of the above which readily separate, such as oil and water. Magnets placed in a device may add advantages of storage or connection/interaction to ferrous materials or articles, for example cabinetry hardware or refrigerator or household appliance doors. Magnets can also be arranged internally so that they interact with magnets outside the toothbrush to stand the toothbrush on end to prevent the head from touching any bathroom or other storage area

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PCT/US2012/066316 surfaces. Phase-change or color change elements or systems tuned to slightly below human body temperatures may be included into a hollow toothbrush with transparent outer layers for example to create a non-electric timer, which would permit the toothbrush to change color after sufficient time held in the hand.

Separate from installed elements, and an advantage of a hollow toothbrush handle is the ability to decorate a translucent or transparent handle on an inner surface which is isolated from contact by the user via the body of the toothbrush handle. In these embodiments, there would be an advantage in isolating the decorative layer from human contact, for example to create some delay in the temperature elevation of the isolated layer, i.e. for thermochromatic paint which may change color after approximately some set time. Also advantageous would be a reduction in the appearance of wear, in contrast to surfaces which are painted or decaled on the outside surface and subject to mechanical wear and chemical attack.

The dimensions and values disclosed herein are not to be understood as being strictly limited to the exact numerical values recited. Instead, unless otherwise specified, each such dimension is intended to mean both the recited value and a functionally equivalent range surrounding that value. For example, a dimension disclosed as 40 mm is intended to mean about 40 mm.

Every document cited herein, including any cross referenced or related patent or application, is hereby incorporated herein by reference in its entirety unless expressly excluded or otherwise limited. The citation of any document is not an admission that it is prior art with respect to any invention disclosed or claimed herein or that it alone, or in any combination with any other reference or references, teaches, suggests or discloses any such invention. Further, to the extent that any meaning or definition of a term in this document conflicts with any meaning or definition of the same term in a document incorporated by reference, the meaning or definition assigned to that term in this document shall govern.

While particular embodiments of the present invention have been illustrated and described, it would be obvious to those skilled in the art that various other changes and modifications can be made without departing from the spirit and scope of the invention. It is therefore intended to cover in the appended claims all such changes and modifications that are within the scope of this invention.

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