The invention relates to a dispensing device for dental retraction material and in particular to a dispensing device that has a cannula formed of two differently shaped cannula portions, one of which being separable from the cannula to convert the dispensing device for use with the remaining cannula portion.
The restoration of a patient's tooth or teeth often includes the replacement of a natural tooth by a dental restoration or dental prosthesis. Typically a tooth that is to be restored is first prepared by a dentist, for example abraded or ground to an appropriate shape to remove undesired tooth substance, and to provide the tooth with a shape appropriate to receive the dental restoration.
The dental restoration is typically mated precisely with the remaining tooth shape prepared by the dentist on the basis of an impression of the prepared tooth. Therefore the dental impression should be precise, and should represent all tooth structure required to determine the shape of the mating surface of the later dental restoration. In particular the dental impression should represent the transition or the “margin” between the shape prepared in a tooth and the natural tooth shape. For dental restorations that extend below a patient's gingiva (or gums) the dentist also should make the part of the margin accessible for the dental impression that would normally be covered by the gingiva. The procedure of displacing the gingiva from the tooth to make the margin accessible is also known as “gingival retraction” in the field of dentistry. A common gingival retraction procedure includes the insertion of a so called retraction cord in the gingival sulcus.
One known method of gingival retraction includes the use of so-called gingival retraction pastes or dental retraction pastes. Dental retraction pastes are very high viscosity pastes which are typically squeezed directly into a patient's gingival sulcus by means of a dispensing syringe that has a cannula suitable for insertion into the sulcus.
For example WO 2009/151983 A2 discloses a device for use in retracting a gingiva from a human tooth by widening a gingival sulcus with a dental composition. The device comprises a cannula with a free end having an opening for dispensing the dental composition. The free end is shaped to be inserted with its front in the entry of the gingival sulcus, and to laterally displace the gingiva from the tooth as the cannula is moved in the gingival sulcus.
Although existing devices provide for certain advantages there is still a need for a device supporting a convenient and effective gingival retraction procedure. It is further desirable to provide a gingival retraction device and composition that are rather inexpensive and easy to use.
The invention relates to a dispensing device for dental retraction material. The dispensing device comprises a cannula that forms a free front end. The free front end is formed by a first cannula portion of the cannula. The first cannula portion extends from the free front end to a second cannula portion of the cannula. The second cannula portion is arranged directly adjacent the first cannula portion. Further, the first cannula portion has a first elongated section and a first rounded section. The first rounded section extends between the first elongated section and the free front end. A first outer diameter (D1) of the cannula is defined on the first rounded section at the free front end. Furthermore, the second cannula portion has a second elongated section and a second rounded section. The second rounded section extends between the second elongated section and the first cannula portion. A second outer diameter (D2) of the cannula is defined on the second rounded section at the transition between the second rounded section and the first cannula portion. The second outer diameter is greater than the first outer diameter. The first cannula portion further comprises a predetermined separation structure directly adjacent the second cannula portion. The cannula preferably extends along a longitudinal axis.
In one embodiment the dispensing device the first cannula portion is separable from the cannula to convert the dispensing device for use with the second cannula portion.
The invention is advantageous in that it allows the dispensing device to be adapted to a particular clinical situation in a patient's mouth. In particular, the invention allows the diameter of the cannula to be adapted to the size of the patient's sulcus. Accordingly the same dispensing device can be used for a patient having a narrow sulcus as well as for a patient having a wider sulcus. Further the dispensing device can be converted during a dental retraction procedure. For example after the dispensing device was used for beginning the dental retraction procedure the device may be converted by breaking or cutting off the first cannula portion, and the same dispensing device (but just converted) can be used for continuing the dental retraction procedure. Therefore the dispensing device is suitable for a dental retraction procedure on a sulcus having narrower and wider portions. Further, the invention is advantageous in that it minimizes a force (also referred to “extrusion force” in the field of dental dispensing devices) that is needed for extruding (or expelling) the dental retraction material. It has been found that the dental retraction material due to solid contents or poor flowable contents tends to block within the cannula with its typically relatively narrow channel extending therethrough. A stepped configuration of the channel provided by multiple differently sized cylindrical sections provides for a minimized extrusion force.
The predetermined separation structure may form a predetermined breaking line at which the first cannula portion breaks off. For example, in a situation in which a buckling or bending load is exerted between the first and second cannula portion, the first cannula portion typically breaks off at predetermined breaking line. Further, the predetermined separation structure may visually indicate a cutting position at which a cutting tool (for example a knife or scalpel) can be positioned on the cannula for cutting off the first cannula portion. Further, the predetermined separation structure may be shaped for guiding the cutting tool toward a cutting position on the cannula.
In one embodiment, such a predetermined separation structure may be a groove, preferably an annular groove. The groove may be rectangular, U-shaped or V-shaped.
In one embodiment the first elongated section may have a tapered shape. For example the first elongated section may be conical, or composed of at least one conical structure and another structure (for example a cylindrical structure). Further, the second elongated section may have a tapered shape. For example the second elongated section may be conical, or composed of at least one conical structure and another structure (for example a cylindrical structure).
In one embodiment the first outer diameter is within a range of 0.5 mm to 0.8 mm and the second outer diameter is within a range of 0.8 mm to 1.0 mm. Preferably, although the first outer diameter and the second outer diameter may have any dimension within the respective specified ranges, the first and second outer diameter, in combination, are preferably always different.
In one embodiment a third outer diameter (D3) of the cannula is defined on the first elongated section at the transition between the first rounded section and the first elongated section. Further, a fourth outer diameter (D4) of the cannula is defined on the second elongated section at the transition between the second rounded section and the second elongated section. The third outer diameter may be within a range of 1.0 mm to 1.5 mm and the fourth outer diameter may be within a range of 1.5 mm to 2.0 mm. Preferably, although the third outer diameter and the fourth outer diameter may have any dimension within the respective specified ranges, the third and fourth outer diameter, in combination, are preferably always different.
In one embodiment the first rounded section is based on a radius within a range of 0.5 mm to 10 mm (preferably 8 mm or about 8 mm) and the second rounded section is based on a radius within a range of 0.5 to 10 (preferably 8 mm or about 8 mm). Each radius is preferably measured in a plane defined on (congruent with) the longitudinal axis. This means that the longitudinal axis extends on that plane. Preferably, although the radius of the first rounded section and the radius of the second rounded section may have any dimension within the respective specified ranges, the radius of the first rounded section and the radius of the second rounded section, in combination, are preferably always different.
In one embodiment a channel extends through the cannula. Preferably the channel forms a dispensing opening at the free front end. The channel preferably comprises a first channel section that has a first cylindrical channel section and a second channel section that has a second cylindrical channel section. The first channel section preferably extends between the dispensing opening and the second channel section. Further, the first cylindrical channel section has a first channel diameter and the second cylindrical channel section has a second channel diameter. The first channel diameter is preferably smaller than the second channel diameter. Preferably, the first channel diameter is within a range of 0.5 mm to 0.8 mm and the second channel diameter is within a range of 0.8 mm to 1.0 mm.
In one embodiment the second channel section comprises a third cylindrical channel section having a third channel diameter that is greater than the second channel diameter. The third channel diameter is within a range of 1.0 mm to 1.5 mm. Preferably, although the first, second and third channel diameter may have any dimension within the respective specified ranges, the first, second and third channel diameter, in combination, are preferably always different. Generally, the channel may have a stepped configuration formed of a plurality of differently sized channel sections. It has been found that with a stepped configuration the dental retraction material is hindered in blocking within the channel.
In one embodiment the dispensing device further comprises a chamber for storing the dental retraction material. The chamber is in fluid communication with the cannula and in particular with the channel through the cannula. The dispensing device may further have a piston for expelling the dental retraction material from the dispensing device. The chamber may be formed by a container of the dispensing device. The piston may be displaceably received within the container. Further, the piston may seal the chamber at a rear end of the dispensing device. A front end of the dispensing device may be formed by the free front end. A cap may be provided for sealing the front end of the dispensing device. The cap and the piston in combination thus preferably hermetically seal the dental retraction material within the chamber. In one embodiment the dispensing device further comprising the dental retraction material.
The dental retraction material may comprise a liquid and a silicate filler. The group of silicate minerals typically includes, inter alia, silicon dioxides (also named silica), quartz, and phyllosilicates. Alternatively the dental retraction material may comprise a liquid and a combination of at least two different phyllosilicates.
“Phyllosilicates” are silicates forming sheets of silicate tetrahedra with Si2O5. Phyllosilicates can be further divided in sub-groups, e.g. according to the number of sheets or layers arranged with each other. Phyllosilicates are divided for purposes of the present invention into the following subgroups: silicate minerals of the 2:1 layer type group and silicate minerals of the 1:1 layer type group. With respect to this classification a more detailed description can be found in Ullmanns Encyclopedia of Industrial Chemistry (Wiley-VCH), 2005, Silicates; table 4. According to this reference, clay minerals belong to the group of phyllosilicates and can be characterized by the number of layers linked or arranged with each other. This classification is also used with respect to the present invention. For example in kaolinite, having the ideal formula Al2[Si2O5(OH)4]), two single layers are linked or arranged with each other. For example in muscovite, having the ideal formula KAl2(AlSi3O10)(OH)2 and belonging to the Mica type group of minerals, three layers are linked or arranged with each other.
The combination of phyllosilicates may comprise a layer type 1:1 silicate mineral and a layer type 2:1 silicate mineral in a certain ratio relative to each other. Phyllosilicates from the layer type 1:1 silicate mineral which can be used include kaolinite, lizardite and mixtures or combinations thereof, wherein kaolinite is preferred. Phyllosilicates from the layer type 2:1 silicate minerals which can be used include talc-pyrophyllite type minerals, smectite type minerals, vermiculite type minerals, illites type minerals, mica type minerals and mixtures and combinations thereof. Specific examples include talc, willemseite, pyrophyllite, stevensite, saponite (from the talc-pyrophyllite type group of minerals), sponite, sauconite, hectorite, montmorillonite, beidellite, nontronite, volkonskite (from the smectite type group of minerals), phlogopite, biotite, lepidolite, muscovite, illite, glauconite, celadonite (from the mica type group of minerals).
The layer type 1:1 silicate mineral and the layer type 2:1 silicate mineral are typically present in the dental retraction material in a certain weight ratio with respect to each other. This weight ratio includes a range from about 50/50 to about 5/95 or from about 30/70 to about 10/90. That is, the content of the layer type 1:1 silicate mineral and the content of the layer type 2:1 silicate mineral in the dental retraction material can be about equal. It is, however, also within the scope of the invention that the layer type 2:1 silicate mineral is present in excess compared to the layer type 1:1 silicate mineral. If the ratio is within the above mentioned ranges, the resulting dental retraction material is advantageous in that it tends to require a low extrusion force, but may have a relative good storage modulus. Further such a dental retraction material may be removable from a patient's mouth relatively quickly, for example by rinsing with water.
Liquids suitable for preparing the dental retraction material include those which are generally able to form a paste or gel with the other components present. In particular the liquids may include polar and non-polar liquids and mixtures thereof. Specific examples include water, alcohols (e.g. ethanol, n- and iso-propanol, erythritols), ketons (e.g. acetone), glycerine (e.g. ethoxylated glycerin), glycols (e.g. ethyleneglycol, propyleneglycol and/or its oligo or mixed oligomers) and silicon oils.
The dental retraction material may further comprise one or more astringents (sometimes also referred to as haemostatic agent). Astringent(s) that may be useful in assisting haemostasis include, but are not limited to oxides, chloride or sulphate salts of ferrum (e.g. ferric sulfate, ferric sub sulfate, ferric chloride), aluminium (e.g. potassium aluminum sulfate, aluminum ammonium sulfate, aluminum sulfate, aluminum chlorohydrate, aluminum acetate) and zinc, polyphenols, ellag acid, permanganates (e.g. potassium permanganate), potassioum ferrate (IV), silver nitrate and hydrogen peroxide, epinephrine and mixtures thereof. One preferred class of haemostatics include aluminum compounds. The dental retraction material may further comprise one or more additives. Additives, which can be present in the dental retraction material, include colorants, pharmaceutical drugs, anti-microbial agents, anti-evaporation agents, rheology modifiers, flavoring agents, preserving agents, surfactants, pH buffering agent and mixtures and combinations thereof.
A typical dental retraction material may have the following formulation:
Another typical dental retraction material may have the following formulation:
In a further embodiment the dispensing device may be made from a plastic material, for example by injection molding. In particular the container and the cannula are preferably monolithically formed by a plastic material selected from among polyethylene (PE), polypropylene (PP) and (PBT), preferably polybutylene terephthalate (PBT).
The piston may be made of a plastic material selected from among polyethylene (PE), polypropylene (PP) and (PBT), preferably polybutylene terephthalate (PBT), preferably polypropylene (PP). And the cap may be made of a plastic material selected from among polyethylene (PE), polypropylene (PP) and (PBT), preferably polybutylene terephthalate (PBT), preferably polypropylene (PP).
The dispensing device is preferably configured for use with a dental capsule applier. Therefore the container may have an outer annular bulge for retaining the dispensing device in the dental capsule applier.
In a further aspect the invention relates to a method of preparing a dispensing device for dental retraction material for use. The method excludes any steps for treatment of the human or animal body. The dispensing device is configured as disclosed herein and particularly has a first and a second cannula portion. The method comprises the steps of:
Before the breaking or cutting step the first cannula portion preferably forms a first front most diameter that corresponds to the first outer diameter of the dispensing device. By breaking or cutting the first cannula portion off from the cannula, the dispensing device is provided with a different second front most diameter that corresponds to the (greater) second outer diameter. Therefore the dispensing device can be adapted to different clinical situations.
In a further aspect the present specification discloses a dispensing device for dental retraction material. The dispensing device comprises a cannula through which a channel extends. The channel forms a dispensing opening at a free front end of the cannula. The channel comprises a first channel section that has a first cylindrical channel section and a second channel section that has a second cylindrical channel section. The first channel section extends between the dispensing opening and the second channel section. The first cylindrical channel section has a first channel diameter and the second cylindrical channel section has a second channel diameter. The first channel diameter is smaller than the second channel diameter. Further, the first channel diameter is within a range of 0.5 mm to 0.8 mm and the second channel diameter is within a range of 0.8 mm to 1.0 mm.
In one embodiment the second channel section may comprise a third cylindrical channel section having a third channel diameter that is greater than the second channel diameter. The third channel diameter is preferably within a range of 1.0 mm to 1.5 mm.
The dispensing device of this aspect preferably provides for a minimized extrusion force needed for extruding the dental retraction material.
The dispensing device 1 further comprises a cannula 5. The cannula 5 extends along a longitudinal axis A. The cannula 5 has a free front end 6. The cannula 5 particularly is shaped such that it is insertable within the sulcus of a human gums in a patient's mouth. Therefore the free front end 6 of the cannula 5 has a rounded shape without any sharp edges. The free front end 6 is in particular formed by a first cannula portion 7 that extends from the free front 6 end to a second cannula portion 8. The second cannula portion 8 is arranged directly adjacent the first cannula portion 7. Further, the first and second cannula portion 7, 8 are monolithically formed, preferably by injection molding from a plastic material, for example from polybutylene terephthalate (PBT). The first cannula portion 7 has a first elongated section 9 and a first rounded section 10. The first rounded section 10 extends between the first elongated section 9 and the free front end 6. The first rounded section 10 particularly extends over the entire distance between the first elongated section 9 and the free front end 6. The first rounded section 10 in the example is based on a radius of 8 mm. The radius is defined in a plane on the longitudinal axis A. A first outer diameter D1 of the cannula 5 is defined at the free front end 6. The first outer diameter D1 also forms a front most outer diameter. Further, the first outer diameter D1 is defined in a plane that is perpendicular to the longitudinal axis.
The second cannula portion 8 has a second elongated section 11 and a second rounded section 12. The second rounded section 12 extends between the second elongated section 11 and the first cannula portion 7. A second outer diameter D2 of the cannula 5 is defined on the second rounded section 12 at the transition between the second rounded section 12 and the first cannula portion 7. The second outer diameter D2 is defined in a plane that is perpendicular to the longitudinal axis.
Accordingly, the cannula 5 can be broken or cut at the second outer diameter D2 to provide the cannula 5 with a new front most diameter than is increased with respect to the first outer diameter D1. Therefore the cannula 5 is configured for being provided with different front most outer diameters. This helps a dentist to adapt the dispensing device to different clinical situations in a patient's mouth.
A third outer diameter D3 of the cannula 5 is defined on the first elongated section 9 at the transition between the first rounded section 10 and the first elongated section 9. A rear end of the first rounded section 10 therefore also has the third outer diameter D3. The third outer diameter D3 is greater than the first outer diameter D1. And (in the example) the third outer diameter D3 is greater than the second outer diameter D2. Further, a fourth outer diameter D4 of the cannula 5 is defined on the second elongated section 11 at the transition between the second rounded section 12 and the second elongated section 11. The fourth outer diameter D4 is greater than the second outer diameter D2.
The first elongated section 9 in the example comprises a conical section between the third outer diameter D3 and a fifth outer diameter D5. The fifth outer diameter D5 is greater than the third outer diameter D3. Accordingly, the conical section of the first elongated section 9 widens from the third outer diameter D3 toward the fifth outer diameter D5. The first cannula portion 7 comprises a predetermined separation structure 13 directly adjacent the second cannula portion 8. In particular, the first elongated section 9 comprises the conical section and additionally the predetermined separation structure 13. The predetermined separation structure 13 is formed by an annular constriction with respect to the conical section of the first elongated section 9, in particular with respect to the fifth outer diameter D5. Further, the predetermined separation structure 13 is arranged between the second rounded section 12 and the conical section of the first elongated section 9. In the example the predetermined separation structure 13 is a groove that has the second outer diameter D2 at the transition between the first and second cannula portion 7, 8. The predetermined separation structure 13 can weaken the first cannula portion so that it preferably breaks at the predetermined separation structure 13. Or the predetermined separation structure can be used for guiding a cutting tool (for example a scalpel) during cutting off the first cannula portion 7.
The second elongated section 11 in the example also comprises a conical section between the fourth outer diameter D4 and a sixth outer diameter D6. The sixth outer diameter D6 is greater than the fourth outer diameter D4. Accordingly, the conical section of the second elongated section 11 widens from the fourth outer diameter D4 toward the sixth outer diameter D6. In the example the cannula 5 only has two cannula portions (the first and second cannula portion 7, 8). Therefore the second elongated section 11 does not comprise a further predetermined separation structure. However, in another example the cannula may have three (or more) cannula portions with the second (and further) elongated section comprising (a) further predetermined separation structure(s).
The channel 14 has a stepped configuration formed of a plurality of cylindrical channel sections (instead of a conical or non-stepped cylindrical configuration). It has been found that the dental retraction material tends to block if it is urged through a conical channel and that this tendency is minimized if a stepped configuration of a plurality of cylindrical channel sections are used instead.
In particular, the channel 14 comprises a first channel section 16 and a second channel section 17. The first channel section 16 corresponds to a first cylindrical channel section 16a. In the example the second channel section 17 comprises a second cylindrical channel section 17a, a conical channel section 17b and a chamfer 17c. The conical channel section 17b is provided to account for a sufficient wall thickness between an inner surface of the channel 14 and an outer surface of the cannula 5. The skilled person will however recognize that the conical channel section 17b is optional. Further, it has been found that in combination with the second cylindrical channel section 17a the tendency of the dental retraction material to block is still lower than for a channel that is conical only.
The first channel section 16 extends between the dispensing opening 15 (or the free front end 6) and the second channel section 17. The first cylindrical channel section 16a has a first channel diameter C1 and the second cylindrical channel section 17a has a second channel diameter C2. The first channel diameter C1 is smaller than the second channel diameter C2. Further, the dispensing opening 15 corresponds in its diameter to the first channel diameter C1. The second channel section 17 further comprises a third cylindrical channel section 17d having a third channel diameter C3 that is greater than the second channel diameter C2.
The cannula 5 in the example is provided with (optional) reinforcement structures 18 which are shown in more detail in
Filing Document | Filing Date | Country | Kind |
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PCT/IB2019/060073 | 11/22/2019 | WO | 00 |