SYSTEMS AND METHODS

RELATED APPLICATION

[0001] This application claims the filing benefit of U. S. Provisional Application Serial No. 62/218,865, filed September 15, 2015, the disclosure of which is hereby incorporated by reference herein in its entirety.

TECHNICAL FIELD

[0002] The present invention is directed to dental impression trays and, more particularly, to dental impression trays for injection of impression material in situ.

BACKGROUND

[0003] Taking of dental impressions is a critical step in the creation of dental prosthetics and orthodontic appliances tailored to the unique dentition of a particular patient. An analog dental impression is generally formed by creating a negative imprint of dental structure, including one or more teeth, and surrounding soft tissue (i.e., gums) of an upper or lower dental arch of a patient using curable dental impression materials. In some procedures, the analog impression may then be scanned into a computer program, using a scanning device, to generate a corresponding three dimensional electronic model of the analog impression. Alternatively, a digital dental impression may be generated by directly recording three dimensional images of the dental structure and surrounding soft tissues to generate a three dimension, digital dental impression (i.e., an electronic model). A dental impression, analog or digital, may then be used to create a positive replica of the subject dental structure and soft tissue, which in turn is used for creation of dental prosthetics and/or orthodontic appliances. Accordingly, it is important for the dental impression to represent the dental structure of interest as accurately as possible.

[0004] Known devices and methods for creating analog dental impressions generally require use of two or more impression materials, each having a unique viscosity. Generally, such impression materials include a "heavy body" material having a higher viscosity, and a "light body" material having a lower viscosity. The impression materials are loaded into an impression tray, which is shaped to generally conform to the arcuate shape of a dental arch. In some cases, one of the impression materials is also applied to the dental structure. The impression tray is then pressed against the dental arch of the patient in order to force the impression material into the interstices of the dental structure. The dental tray then must be held securely and steadily in position by a dental professional or a patient while the impression material sets. This process is often performed in multiple steps. For example, first the heavy body impression material may be applied to the impression tray to create a low resolution impression of the dental structure. Then, the light body impression material may be applied to the low resolution impression (now set) to create a finalized higher resolution impression of the dental structure. Known injection trays used for taking analog dental impressions include single sided trays, used for taking an impression of a single dental arch, and double-sided trays (known as "triple trays"), used for taking an impression of both dental arches and recording a bite registration simultaneously. Double-sided trays often require the use of rigid impression material, resulting in a less accurate dental impression.

[0005] Inadequacies of known dental impression trays render known procedures for forming analog dental impressions extensive and time consuming, and often require two or more dental professionals to be performed. Moreover, the resulting analog dental impressions formed using known dental impression trays are often lacking in high resolution accuracy for reasons including insufficient control of pressure and containment of the impression material within the impression tray such that the impression material may adequately displace oral fluids (e.g., saliva and blood) and flow fully into dental interstices and gingival sulci; creation of air pockets within the impression material as the material generally conforms to the dental structure; inadequate stabilization of the tray during material setting; and failure to provide an adequate indication to a dental professional of when the impression material has fully set so that the impression may be timely extracted. Accordingly, there is a need for improvement of known dental impression trays and related systems and methods for taking analog dental impressions.

SUMMARY

[0006] A dental impression injection tray according to an embodiment for forming a dental impression of a dental structure includes a tray body defining an impression cavity sized to receive the dental structure. At least one injection port is formed on the tray body and communicates with the impression cavity, and is adapted to direct a supply of impression material into the impression cavity for forming the dental impression. A plurality of gingival sealing elements are coupled to the tray body and are adapted to sealingly engage gum surfaces adjacent to the dental structure and block the impression material from escaping the impression cavity in labial, lingual, mesial, and distal directions during injection of the impression material into the impression cavity. [0007] A dental impression injection system according to an embodiment for forming a dental impression of a dental structure includes a dental impression injection tray having a tray body that includes an injection port and defines an impression cavity sized to receive the dental structure. The system further includes an impression material delivery device operable to inject an impression material into the impression cavity through the injection port for forming the dental impression while the dental impression injection tray is coupled to the dental structure. The system further includes a pressure control mechanism that controls a pressure of the impression material inside of the impression cavity.

[0008] A method according to an embodiment of forming a dental impression of a dental structure with a dental impression injection tray having an impression cavity includes seating the dental impression injection tray on the dental structure so that the dental structure is received within the impression cavity. Impression material is injected into the impression cavity containing the dental structure. The dental impression injection tray is sealed against gum surfaces adjacent to the dental structure to block the impression material from escaping the impression cavity in labial, lingual, mesial, and distal directions during injection. A pressure of the impression material inside the impression cavity is controlled during injection. The impression material is allowed to set to form the dental impression.

[0009] A dental impression injection tray according to another embodiment for forming a dental impression of a dental structure includes a tray body defining an impression cavity sized to receive the dental structure. At least one injection port is formed on the tray body and communicates with the impression cavity, and is adapted to direct a supply of impression material into the impression cavity for forming the dental impression. A plurality of gingival sealing elements are coupled to the tray body and are adapted to sealingly engage gum surfaces adjacent to the dental structure and block the impression material from escaping the impression cavity during injection of the impression material into the impression cavity.

[0010] A method according to another embodiment of forming a dental impression of a dental structure with a dental impression injection tray having an impression cavity includes seating the dental impression injection tray on the dental structure so that the dental structure is received within the impression cavity. Impression material is injected into the impression cavity containing the dental structure. The dental impression injection tray is sealed against gum surfaces adjacent to the dental structure to block the impression material from escaping the impression cavity during injection. A pressure of the impression material inside the impression cavity is controlled during injection. The impression material is allowed to set to form the dental impression. [0011] Various additional features and advantages of the invention will become more apparent to those of ordinary skill in the art upon review of the following detailed description of the illustrative embodiments taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with a general description of the invention given above, and the detailed description given below, serve to explain the invention. Similar reference numerals are used to indicate similar features among various embodiments illustrated in the drawings.

[0013] FIG. 1 is a perspective view of a dental impression injection tray according to an embodiment of the invention, seated on a portion of a lower dental arch.

[0014] FIG. 2 is a perspective view of an end sealing element of the dental impression injection tray of FIG. 1.

[0015] FIG. 3 is a perspective view of a lower sealing structure of the dental impression injection tray of FIG. 1.

[0016] FIG. 4 is a top elevation view showing an underside of the dental impression injection tray of FIG. 1 containing a dental impression of a dental structure, and a

corresponding dental replica formed from the dental impression.

[0017] FIG. 5 is a perspective view of a dental impression injection tray according to another embodiment of the invention for taking a dental impression of a portion of a dental arch.

[0018] FIG. 6 is a bottom perspective view of the dental impression injection tray of FIG. 5.

[0019] FIG. 7A is a bottom perspective view of a dental impression injection tray according to another embodiment of the invention for taking a dental impression of a portion of a dental arch.

[0020] FIG. 7B is a side cross-sectional view of the dental impression injection tray of FIG. 7A, taken along section line 7B-7B.

[0021] FIG. 8 is a top perspective view of a dental impression injection tray according to another embodiment of the invention for taking a dental impression of a portion of a dental arch.

[0022] FIG. 9 is a bottom perspective view of the dental impression injection tray of FIG. 8. [0023] FIG. 10 is a disassembled perspective view of the dental impression injection tray of FIG. 8.

[0024] FIG. 11 is a perspective view of a dental impression injection tray according to another embodiment for taking a dental impression of a portion of a dental arch.

[0025] FIG. 12 is a side view of the dental impression injection tray of FIG. 11.

[0026] FIG. 13 is a side cross-sectional view of the dental impression injection tray of FIG.

11, taken along section line 13-13 in FIG. 12.

[0027] FIG. 14 is a perspective, cross-sectional view of the dental impression injection tray of FIG. 11, taken along line 13-13, showing the injection tray coupled to gum surfaces and dental structure in sealing engagement.

[0028] FIG. 15 is a perspective view of a dental impression injection tray according to another embodiment of the invention for taking a dental impression of a portion of a dental arch.

[0029] FIG. 16 is a bottom perspective view of the dental impression injection tray of FIG. 15.

[0030] FIG. 17 is a perspective view of the dental impression injection tray of FIG. 15, showing the tray mounted to dental structure of a dental arch.

[0031] FIG. 18 is a perspective view of a dental impression injection tray according to another embodiment of the invention for taking an impression of a portion of an upper dental arch and a corresponding portion of a lower dental arch.

[0032] FIG. 19 is a perspective view of a dental impression injection tray according to another embodiment of the invention for taking an impression of a full dental arch.

[0033] FIG. 20 is a cross-sectional view of the dental impression injection tray of FIG. 19, taken along section line 20-20 and showing injection of impression material.

[0034] FIG. 21 is a top elevation view showing the dental impression injection tray of FIG.

19 containing a formed dental impression of a full dental arch.

[0035] FIG. 22 is a diagrammatic view of a dental impression injection system according to an embodiment of the invention.

DETAILED DESCRIPTION

[0036] Referring to the figures, and beginning with FIGS. 1-4, a first embodiment of a dental impression injection tray 10 for forming a dental impression of a portion of a dental arch 1 is shown. For exemplary purposes, the injection tray 10 is shown seated on a right-side portion of a lower dental arch 1, beneath an upper dental arch 2, the dental arches 1, 2 being shown in an open-jaw state and exposing an oral cavity. It will be understood that the injection tray 10, as well as injection trays of other embodiments described herein, may be used on various other portions of the lower and upper dental arches 1, 2. For example, the injection tray 10 may be seated on a left-side portion of the lower arch 1 and still be within the scope of the invention.

[0037] Consequently, as used herein, descriptive terms such as labial, buccal, lingual, mesial, and distal are relative to the chosen reference frame, such as that shown in FIG. 1. The embodiments of the invention, however, are not limited to the chosen reference frame and descriptive terms, as the described injection trays may be used on other portions of the dental arches 1, 2 within the oral cavity. Those of ordinary skill in the art will recognize that the descriptive terms used herein may not directly apply when there is a change in reference frame. For example, when the injection tray 10 is positioned on a left-side of a dental arch 1, 2, as opposed to a right-side, a portion of the injection tray 10 described herein as a "mesial" portion may be positioned distally, while a portion of the injection tray 10 described herein as a "distal" portion may be positioned mesially. As such, the relative terms labial, buccal, lingual, mesial, and distal, used herein, are in no way limiting to a particular location or orientation. Moreover, it will be appreciated that the term "labial" may also mean "buccal" depending on the orientation within the oral cavity of the apparatus being referenced. For example, "labial" may refer to a region adjacent an outer surface of an anterior tooth, or to a region adj acent an outer surface of a posterior tooth.

[0038] The injection tray 10 shown in FIG. 1 includes a tray body 12 defining an impression cavity 14 sized to receive one or more teeth 3, or other dental structure, and adj acent gum surfaces (i.e., gingiva). The tray body 12 further includes a first inj ection port 16, defined by a first fluid fitting 18, for receiving a first flow of dental impression material via a conduit (not shown) coupled to the first fluid fitting 18. The tray body 12 may further include a second injection port 20, defined by a second fluid fitting 22, for receiving a second flow of dental impression material via a conduit (not shown) coupled to the second fluid fitting 22. As shown, the injection ports 16, 20 may be positioned on an upper surface 24 and a side surface 26, respectively, of the tray body 12, for example. Any suitable number of injection ports and corresponding fluid fittings may be provided on the tray body 12. In alternative embodiments, the upper injection port 16 may be omitted from the tray 10 to mitigate interferences with an opposing dental arch, such as the upper dental arch 2, for example. Further, one or more side injection ports 20 may be provided. It will be appreciated that such alternative configurations may be applied to any of the other injection tray embodiments shown and described herein.

[0039] A pressurized flow of impression material may be received through either or both of the injection ports 16, 20, and directed toward the teeth 3 positioned inside of the impression cavity 14. For example, impression material received through the upper injection port 16 is directed apically toward the teeth 3, and impression material received through the side injection port 20 is directed labially (or lingually) toward the teeth 3. The injection ports 16, 20 may be formed with any suitable respective diameters chosen for controlling a flow rate of the impression material inj ected into the impression cavity 14. Additionally, one or both of the injection ports 16, 20 may include a pressure-sensitive inlet valve 28, which may be in the form of a reed valve, or any other suitable flow control mechanism for controlling a flow rate and/or flow direction of the impression material injected into the impression cavity 14 through the injection port 16, 20. For example, a reed valve may be provided having a membrane formed of a silicone or any other suitable material, wherein the membrane is configured to break or actuate (thereby allowing a flow of material through the reed valve) under a predetermined pressure applied by the inj ected impression material. The pressure-sensitive inlet valves 28 may be integrated within or coupled directly to one or both of the injection ports 16, 20, or the inlet valves 28 may be arranged upstream from the injection ports 16, 20 and in-line with conduit coupled to the ports 16, 20.

[0040] The tray body 12 may be formed of any suitable material capable of substantially maintaining a shape of the tray body 12 as the impression cavity 14 is pressurized by injection of impression material. In one embodiment, the tray body 12 may be formed of any substantially rigid polymeric material. In another embodiment, the tray body 12 may be formed of a material, such as thermoplastic material, having a transient plasticity such that the tray body 12 may flex to conform to and enable proper seating of the inj ection tray 10 onto a dental structure, and then harden so as to maintain the conformed shape. In one embodiment, the tray body 12 may be formed of a transparent or translucent material, as generally shown in FIG. 1, to provide a visual indication of the amount of impression material inside of the impression cavity 14 during injection.

[0041] The tray body 12 may include one or more ej ection ports (also referred to as "check points") in addition to the material injection ports 16, 20, through which air and/or impression material inside of the impression cavity 14 may flow outwardly during injection of the impression material. In an exemplary embodiment, the ejection port may be in the form of a pressure-sensitive relief valve 29, shown schematically in FIG. 1, formed in the tray body 12 or in any other suitable portion of the injection tray 10 so as to communicate with the impression cavity 14. The pressure relief valve 29, which may be in the form of a reed valve for example, may be configured to open when acted upon by a predetermined internal pressure within the impression cavity 14 caused by injected impression material and/or air. Accordingly, during injection of impression material into the cavity 14, growing pressure within the cavity 14 may cause the relief valve 29 to open so impression material and/or air to may escape outwardly therethrough. In this manner, a pressure inside of the cavity 14 may be passively controlled during inj ection, as described in greater detail below, and a visual indication may be provided to a dental professional that the cavity 14 is filled and the material injection process is complete. In another embodiment, the ejection ports may be in the form of apertures (not shown) formed in the tray body 12. In yet another embodiment, one of the injection ports 16, 20 may serve as an inj ection port and the other of the ports 16, 20 may serve as an ejection port. Additionally, as described below, a vacuum may be applied to one of the ports 16, 20, or to a separately provided ejection port (e.g., pressure-sensitive relief valve 29), to facilitate withdrawal of air from the impression cavity 14 during material injection, thereby decreasing an injection force required to inj ect material into the cavity 14 and also decreasing the time required to fill the cavity 14 with impression material.

[0042] Referring to FIGS. 1-3, the injection tray 10 further includes a plurality of gingival sealing elements coupled to the tray body 12 and configured to sealingly engage and couple to gum surfaces adjacent to the teeth 3 when the injection tray 10 is seated on the dental arch 1 (i.e., when the tray 10 is positioned "in situ"). In particular, the injection tray 10 includes a labial sealing element 30 adapted to sealingly engage a labial (or "buccal") gum surface 4, a lingual sealing element 32 adapted to sealingly engage a lingual gum surface 5, a mesial sealing element 34 adapted to sealingly engage a mesial gum surface 6, and a distal sealing element 36 adapted to sealingly engage a distal gum surface 7. The mesial and distal sealing elements 34, 36 are also adapted to intimately conform to and sealingly engage teeth 3 or other dental structure disposed at mesial and distal ends of the injection tray 10, as described in greater detail below. To enhance their sealing effect, one or more of the gingival sealing elements 30, 32, 34, 36 may be coated with a layer of sealing fluid, such as a hydrogel, an adhesive, or a high viscosity impression material. Additionally, after seating the inj ection tray 10 onto the dental arch, a small volume of impression material may be injected into the impression cavity 14 to establish a substantially liquid tight seal between the sealing elements 30, 32, 34, 36 and their respective gum surfaces, before inj ecting a more substantial volume of impression material to form the dental impression.

[0043] The gingival sealing elements 30, 32, 34, 36 may be formed of any substantially non-rigid materials suitably flexible for forming a substantially liquid-tight seal with gum surfaces 4, 5, 6, 7 without overly impinging, pressing upon, or otherwise agitating the gum surfaces 4, 5, 6, 7 so as to cause a patient undue discomfort. In one embodiment, one or more of the gingival sealing elements 30, 32, 34, 36 may be formed of a soft spongy polymeric material, a silicon material, or any suitable thermoplastic material, for example. For example, in one embodiment, the labial and lingual sealing elements 30, 32 may be formed of 60 Shore A silicone and the mesial and distal sealing elements 34, 36 may be formed of a soft spongy material. Alternatively, each of the gingival sealing elements 30, 32, 34, 36 may be formed of a soft spongy material. Furthermore, the labial and lingual sealing elements 30, 32 may be formed integrally with the mesial and distal sealing elements 34, 36 so as to define a single unitary sealing structure, which may be formed of a soft spongy material, for example. In another embodiment, one or more of the gingival sealing elements 30, 32, 34, 36 may be inflatable, wherein a seal against an adjacent gum surface is formed when the respective sealing element is in an inflated state. In an embodiment, the materials forming the gingival sealing elements 30, 32, 34, 36 may have a flexibility, or elasticity, greater than that of a material forming the more rigid tray body 12.

[0044] In another embodiment, one or more of the gingival sealing elements 30, 32, 34, 36 may be formed of a plastically-deformable material configured to record a surface contour of an adjacent gum surface when the injection tray 10 is seated onto the dental structure. For example, the gingival sealing elements 30, 32, 34, 36 may be formed of a soft impression foam product known as BIO-FOAM ^® . Advantageously, when formed of such a material, the sealing elements 30, 32, 34, 36 may plastically deform upon engaging gum surfaces adjacent to the dental structure of which an impression is being taken. Thereby, the injection tray 10 may record a surface contour of the gum surfaces in addition to that of the dental structure. As discussed below, in one embodiment the impression cavity 14 of the injection tray 10 may be pre-filled with such impression foam instead of, or in addition to, a liquid impression material for creating a dental impression of the dental structure. Advantageously, use of such impression foam provides for easier cleaning of the injection tray 10 and other related dental tools as compared to use of liquid impression material.

[0045] Referring briefly to FIGS. 5 and 6, a dental impression injection tray 10a according to another exemplary embodiment is shown in which gingival sealing elements 30a, 32a, 34a, and 36a are constructed integrally as a single sealing structure 64a formed of a plastically- deformable impression foam, such as BIO-FOAM ^® . As shown in FIG. 6, the integrally formed sealing elements 30a, 32a, 34a, 36a define a lower opening that opens to the impression cavity 14 and through which dental structure is received into the impression cavity 14.

[0046] Referring back to FIGS. 1-4, in another embodiment one or more portions of the tray body 12 and/or one or more of the gingival sealing elements 30, 32, 34, 36 may be formed of a micro porous material. The microporous material may be formed with an average pore size that is sufficiently large to allow outward flow therethrough of air from the impression cavity 14, and sufficiently small to block outward flow therethrough of impression material from the impression cavity 14. Accordingly, the microporous material allows release of air from the impression cavity 14 during impression material injection while simultaneously retaining injected impression material inside of the cavity 14. Advantageously, this decreases the presence of air pockets within the impression material in the impression cavity 14, and thus in the resulting dental impression, and also reduces the force and pressure required for injecting the impression material into the impression cavity 14. It will be appreciated that the microporous material and the plastically-deformable material described above may be employed in any of the embodiments shown and described herein.

[0047] As shown best in FIG. 1, the gingival sealing elements 30, 32, 34, 36 collectively seal the injection tray 10 against the dental arch 1 to substantially block impression material from escaping the impression cavity 14 in labial, lingual, mesial, and distal directions, for example. Advantageously, the gingival seal created by the sealing elements 30, 32, 34, 36 enables a pressure of the impression material inside of the impression cavity 14 to be controlled during injection of the impression material, as described in greater detail below. Moreover, the sealing elements 30, 32, 34, 36 collectively secure and stabilize the injection tray 10 in a desired orientation relative to the dental arch 1 during injection and setting of the impression material, thereby ensuring a highly accurate dental impression.

[0048] Referring to FIGS. 2 and 3, features of the gingival sealing elements 30, 32, 34, 36 will now be described in greater detail. The mesial and distal sealing elements 34, 36 may be substantially similar or even identical in construction, thus only one mesial/distal sealing element 34, 36 is shown in FIG. 2. The mesial/distal sealing element 34, 36 includes a primary body 40 having a side face 42 defining a substantially arch-like shape in a plane defined by the gingival and occlusal directions, and a thickness in a mesial-distal direction, for example. The primary body 40 includes a first major leg 44 and an opposed second major leg 46 defining a major recess 48 therebetween. The major recess 48 may include a central apex portion extending into the primary body 40. As best shown in FIG. 1, the major recess 48 is sized and shaped to sealingly engage a tooth 3, and adjacent labial and lingual gum surfaces 4, 5 on either side of the tooth 3, at a mesial or distal end of the injection tray 10. In that regard, the mesial/distal sealing element 34, 36 may effectively seal an interproximal space (exemplified at 8) between adjacent teeth 3 at mesial and distal ends of the injection tray 10. Accordingly, the sealing elements 34, 36 function as interproximal gaskets and substantially prevent leakage of impression material from the impression cavity 14 in mesial and distal directions, and moreover stabilize the tray 10 in labial, lingual, mesial, and distal directions.

[0049] The mesial/distal sealing element 34, 36 further includes a secondary body 50 extending outwardly from a face of the primary body 40 and having a side face 52 defining an arch-like shape similar to that of the primary body 40. The secondary body 50 includes a first minor leg 54 and an opposed second minor leg 56 defining a minor recess 58 therebetween. The minor recess 58 is substantially rounded and shaped to receive a corresponding mating feature formed on a lower sealing structure 64 described in greater detail below. The minor recess 58 exposes a conforming portion 60 of the primary body 40. The conforming portion 60 may substantially and elastically deform to conform to a shape of one or more teeth 3 and adj acent gum surfaces at a mesial or distal end of the injection tray 10 to establish a secure seal. As shown in FIG. 1, each of the mesial and distal sealing elements 34, 36 may be coupled to the tray body 12 with one or more connecting elements 62, shown in the form of prong-like structures extending outwardly from the tray body 12.

[0050] Referring to FIG. 3, the labial and lingual sealing elements 30, 32 may be joined together to form an integral, lower sealing structure 64. In particular, the labial and lingual sealing elements 30, 32 may be joined at a first end by a first bridge structure 66 and at a second end by a second bridge structure 68. The bridge structures 66, 68 are formed with archlike shapes to define a channel-shaped dental opening 70 for receiving a portion of a dental arch 1, 2 between the labial and lingual sealing elements 30, 32. Additionally, the bridge structures 66, 68 may bias the labial and lingual sealing elements 30, 32 toward one another to achieve a slight clamping effect that enhances sealing engagement with the respective labial and lingual gum surfaces 4, 5. In another embodiment, the mesial and distal sealing elements 34, 36 may be formed integrally with the labial and lingual sealing elements 30, 32 so as to define unitary sealing structure.

[0051] Each of the labial and lingual sealing elements 30, 32 extends lengthwise in a mesial-distal direction and each may be formed with similar structural features. In particular, in the embodiment shown, each of the labial and lingual sealing elements 30, 32 includes a free inner edge 72 extending between the first and second bridge structures 66, 68 and configured to sealingly engage and elastically deform against a respective gum surface 4, 5. Advantageously, the bridge structures 66, 68 limit, without unduly inhibiting, the ability of the inner edges 72 to flex and expand toward one another during pressurization of the impression cavity 14 via injection of impression material.

[0052] Each of the labial and lingual sealing elements 30, 32 further includes a rounded lower portion 74 and an outer sidewall 76 having an inner lip 84 and an outer lip 86. In one embodiment, the labial sealing element 30 and its outer sidewall 76 may extend longer in an apical direction than the lingual sealing element 32 and its outer sidewall 76. Each of the outer lips 86 may include a plurality of slots 88 for engaging and retaining corresponding mating protrusions 89 formed on the tray body 12, as shown in FIG. 1.. Each of the labial and lingual sealing elements 30, 32 further includes an open channel 90 defined between the respective free inner edge 72 and outer sidewall 76. The open channels 90 allow for flexing of the free inner edges 72 relative to their respective outer sidewalls 76, thereby enabling the labial and lingual sealing elements 30, 32 to more closely conform to their respective gum surfaces 4, 5 to establish an effective seal. Additionally, the labial and lingual sealing elements 30, 32 may be formed with a slight curvature along their lengths to more closely conform to the curvature of a dental arch 1, 2 and thereby enhance the sealing effect.

[0053] During assembly of the injection tray, each of the minor legs 54, 56 of a

mesial/distal sealing element 34, 36 is received within a respective one of the open channels 90 of the labial and lingual sealing elements 30, 32. Additionally, each of the bridge structures 66, 68 is received within the minor recess 58 of the respective mesial or distal sealing element 34, 36. The tray body 12 may then be applied to overlay the side faces 52 of the secondary bodies 50 of the mesial and distal sealing elements 34, 36. Lower edges of the tray body 12 are received between the inner and outer lips 84, 86, and protrusions 89 of the tray body 12 are received within the slots 88 of each of the labial and lingual sealing elements 30, 32. In the assembled form, the mesial sealing element 34 defines a mesial sidewall of the impression cavity 14, and the distal sealing element 36 defines a distal wall of the impression cavity 14.

[0054] Referring to FIG. 4, the injection tray 10 is shown containing a dental impression 92. Shown positioned alongside the injection tray 10 and impression 92 is a dental replica of the original dental structure, formed using the dental impression 92 and known techniques.

[0055] Referring to FIGS. 7A and 7B, a dental impression injection tray 10b according to another exemplary embodiment is shown. As indicated by similar reference numerals, injection tray 10b is similar in structure to injection tray 10 of FIG. 1, except as otherwise described. In particular, injection tray 10b includes a lower sealing structure 64b from which bridge structures 66, 68 (see FIG. 3) are omitted. Additionally, tray 10b includes mesial and distal sealing elements 34b, 36b from which minor recesses 58 (see FIG. 2) are omitted.

Accordingly, the free inner edges 72 of the labial and lingual sealing elements 30b, 32b are provided with an enhanced range of elastic movement.

[0056] Referring to FIGS. 8-10, a dental impression injection tray 100 according to another exemplary embodiment for forming a dental impression of a portion of a dental arch 1, 2 is shown. The injection tray 100 is similar in construction and function to the injection tray 10 described above in connection with FIGS. 1-4, except as generally described otherwise below. In particular, the injection tray 100 includes a tray body 102 and a unitary gingival sealing structure 104 coupled to the tray body 102 to define an impression cavity 103. The tray body 102 may include upper and side injection ports 105 defined by respective fluid fittings 107. The gingival sealing structure 104 includes a labial sealing element 106, a lingual sealing element 108, a mesial sealing element 110, and a distal sealing element 112. The sealing elements 106, 108, 110, 112 may operate in a manner similar to the sealing elements 30, 32, 34, 36 described above in connection with FIGS. 1-4, except that they are integrally formed with one another.

[0057] In particular, each of the labial and lingual sealing elements 106, 108 is formed integrally at mesial and distal ends with the mesial and distal sealing elements 110, 112.

Accordingly, each of the inner edges 114 of the labial and lingual sealing elements 106, 108 is more limited in its ability to flex relative to its corresponding outer sidewall 116 as compared to inner edges 72 relative to their corresponding outer sidewalls 76. However, advantageously, the integral joining of the sealing elements 106, 108, 110, 112 aids in containing pressurized impression material within the impression cavity of the injection tray 100 during injection. The mesial and distal sealing elements 110, 112 may be thinner than the mesial and distal sealing elements 34, 36 of injection tray 10, and sized to slip into the interproximal spaces 8 between teeth 3, thereby sealingly engaging corresponding gum surfaces and functioning as

interproximal gaskets. As best shown in FIGS. 9 and 10, each of the labial and lingual sealing elements 106, 108 may include a flexible, extensible bellow 118 formed at each of the mesial and distal ends thereof. The bellows 118 are expandable when filled with impression material, thereby relieving pressure buildup within the impression cavity of the injection tray 100 during material injection. The sealing structure 104 may be formed of any suitable polymeric material, such as silicone, or a softy spongy material, for example.

[0058] Referring to FIGS. 11-14, a dental impression injection tray 120 according to another exemplary embodiment for forming a dental impression of a portion of a dental arch 1, 2 is shown. The injection tray 120 is similar in construction and function to injection tray 100 described above, except as otherwise described below. The injection tray 120 includes a tray body 122 and a unitary gingival sealing structure 124 coupled to the tray body 122 to define an impression cavity 123. The gingival sealing structure 124 includes a labial sealing element 126, a lingual sealing element 128, a mesial sealing element 130, and a distal sealing element 132. Similar to the embodiment of FIGS. 1-4, and in contrast to the embodiment of FIGS. 8- 10, the labial and lingual sealing elements 126, 128 include respective free inner edges 134 formed independently at their ends from the mesial and distal sealing elements 130, 132, thereby defining open channels 136. Accordingly, the labial and lingual sealing elements 126, 128 have an enhanced ability to flex relative to their respect outer sidewalls to sealingly engage respective labial and lingual gum surfaces 4, 5. Unlike the embodiments of FIGS. 1-4 and FIGS. 8-10, the inner edges 134 of injection tray 120 are not connected to one another at their ends by a connecting structure (e.g., bridge structures 66, 68 or mesial and distal sealing elements 110, 112), as shown in the additional figures provided below. Similar to the embodiments of FIGS. 1-4 and 8-10, the mesial and distal sealing elements 130, 132 of injection tray 120 are shaped and configured to sealingly and interproximally engage one or more teeth 3 positioned mesially and distally of the dental structure of which an impression is being taken, including sealing any corresponding interproximal spaces 8. Such engagement may be with upper and side surfaces of a tooth 3, as shown in FIG. 14, for example.

[0059] Referring to FIGS. 15-17, a dental impression injection tray 140 according to another exemplary embodiment for forming a dental impression of a portion of a dental arch 1, 2 is shown. The injection tray 140 includes a tray body 142 having an upper wall 144 and a pair of opposed side walls 146 and 148 depending downwardly from the upper wall 144 and defining an impression cavity 149. The upper wall 144 includes an injection port 150 for receiving and directing a supply of impression material into the impression cavity. The injection tray 140 further includes a gingival sealing element 152 coupled to the tray body 142 and having a mesial sealing portion 154, an opposed distal sealing portion 155, a labial sealing portion 156, and an opposed lingual sealing portion 158. As shown best in FIG. 17, the labial and lingual sealing portions 156, 158 of the injection tray 140 are adapted to sealingly engage respective labial and lingual gum surfaces 4, 5. Additionally, the mesial and distal sealing portions 154, 155 are adapted to sealingly engage respective mesial and distal gum surfaces 6, 7, as well as sealingly and interproximally engage one or more teeth 3 positioned mesially and distally of the dental structure of which an impression is being taken. Accordingly, the mesial and distal sealing portions 154 may function as interproximal gaskets for sealing interproximal spaces 8. The gingival sealing element 152 may be formed of a soft, flexible material such as a 40 Shore A material, for example.

[0060] Referring to FIG. 18, a dental impression injection tray 160 according to another exemplary embodiment of the invention is shown. The injection tray 160 includes a lower tray portion 162 for taking a dental impression of a partial portion of a lower dental arch 1, and an upper tray portion 164 for taking a dental impression of a partial portion of an upper dental arch 2 that corresponds to the partial portion of the lower dental arch 1. The lower and upper tray portions 162, 164 may include features similar to those of injection tray 100 of FIGS. 8-10, formed about a plane of symmetry corresponding to the upper surface of the tray body 102 of injection tray 100. Alternatively, the lower and upper tray portions 162, 164 may include features corresponding to any of the other partial-arch injection trays 10, 10a, 10b, 120, 140 described herein. In yet another alternative embodiment, the lower and upper tray portions 162, 164 may be sized for taking impressions of full portions of the lower and upper dental arches 1, 2, and may include features similar to those of the full-arch injection tray 180 described below in connection with FIGS. 19-21.

[0061] As shown in FIG. 18, the injection tray 160 includes a tray body 166 spanning between the lower and upper tray portions 162, 164. The tray body 166 defines an impression cavity 168 and includes a plurality of injection ports 170, that open to the impression cavity 168. The injection ports 170 and fluid fittings 172 are shown arranged on a side (e.g., labial or lingual) of the tray body 166, though one or more additional, or substitute, ports 170 may be provided on an end (e.g., mesial or distal) of the tray body 166, as shown in phantom. As is the case for all of the exemplary dental impression injection trays shown and described herein, it will be appreciated that the injection ports 170 may be provided in any suitable quantity and at any suitable locations on the tray body 166.

[0062] The tray body 166 may include features similar to those of tray body 102 of FIGS. 8-10, formed symmetrically about its upper surface. In the illustrated embodiment, the injection tray 160 includes a single impression cavity shared by the upper and lower tray portions 162, 164. As such, the injection tray 160 may be used to form a single dental impression that includes a lower impression portion corresponding to the lower dental arch 1 and an upper impression portion corresponding to the upper dental arch 2. Accordingly, a bite registration of the lower and upper dental arches 1, 2 may be effectively recorded using injection tray 160. In an alternative embodiment, the tray 160 may include separately formed lower and upper impression cavities, separated by an internal wall of the tray body 166, to form separate lower and upper dental impressions.

[0063] The lower and upper tray portions 162, 164 may be substantially similar in construction and function. Furthermore, each of the tray portions 162, 164 may include a sealing structure similar in construction to sealing structure 104 of FIGS. 8-10, for example, as indicated by use of similar reference numerals. Each of the sealing structures 104 defines a dental opening between the respective pair of labial and lingual sealing elements 106, 108 sized to receive a respective portion of the lower and upper dental arches 1, 2 into the impression cavity 168 simultaneously.

[0064] Referring to FIGS. 19-21, a dental impression injection tray 180 according to another exemplary embodiment for forming a dental impression of a full portion of a dental arch 1, 2 is shown. The injection tray 180 includes a tray body 182 having an arcuate shape substantially conforming to the general arcuate shape of a dental arch 1, 2, and having a substantially "U" shaped cross-sectional profile defining an impression cavity in the form of a channel 184 adapted to receive a full dental arch 1, 2. The impression channel 184 includes endcap elements 185 at the ends thereof, which close the impression channel 184 and sealingly engage gum surfaces adjacent to the rear-most molars on a dental arch 1, 2. The endcap elements 185 prevent impression material within the impression channel 184 from escaping in mesial or distal directions from the channel 184. The tray body 182 further includes a plurality of injection ports 186 defined by corresponding fluid fittings 188 that couple to a fluid conduit 190. The injection ports 186 receive and direct a flow of impression material 192 into the impression channel 184 from the fluid conduit 190. In the embodiment shown, the injection tray 180 includes five injection ports 186 spaced along the arcuate shape of the tray body 182 at locations generally corresponding to positions of anterior teeth (e.g., central or lateral incisors) and left and right posterior teeth (e.g., molars or bicuspids). In alternative embodiments, any suitable quantity and placement of injection ports 186 may be provided.

[0065] As best shown in FIGS. 19 and 20, the injection tray 180 further includes a labial sealing element 194 coupled to a labial edge of the tray body 182 and configured to sealingly engage a labial gum surface 4, and a lingual sealing element 196 coupled to a lingual edge of the tray body 182 and configured to sealingly engage a lingual gum surface 5. Each of the sealing elements 194, 196 may be formed with a cross-sectional profile having a substantially "L" or truncated "V" like shape, for example. In particular, each of the sealing elements 194, 196 may include an inner lip 198 and an outer lip 200 extending angularly away from the inner lip 198 and defining a sealing channel 202 adapted to generally receive corresponding curved portions of the labial and lingual gum surfaces 4, 5, respectively, as shown best in FIG. 20. In alternative embodiments, the labial and lingual sealing elements 194, 196 may be formed with different cross-sectional shapes, and each sealing element 194, 196 may be provided with a unique cross-sectional shape.

[0066] In exemplary embodiments, the tray body 182 may be formed of any polymeric material that is suitably rigid to contain the impression material during injection with minimal flexing. The endcaps 185 and the labial and lingual sealing elements 194, 196 may be formed of any polymeric material that is suitably elastic to conform to, and thereby sealingly engage, gum surfaces 4, 5, 6, 7 surrounding the teeth 3 of the dental arch 1, 2, of which an impression is being taken. In alternative embodiments, one or more of the gingival sealing elements 185, 194, 196 may be formed of a plastically-deformable material configured to record a surface contour of the adjacent gum surface when the injection tray 180 is seated onto the dental structure. For example, one or more of the gingival sealing elements 185, 194, 196 may be formed of a soft impression foam such as BIO-FOAM ^® .

[0067] During use, the injection tray 180 is seated on a dental arch 1, 2 so that the teeth 3 are received within the impression channel 184, the labial and lingual sealing elements 194, 196 sealingly engage labial and lingual gum surfaces 4, 5, and the endcaps 195 sealingly engage mesial and distal gum surfaces 6, 7 adj acent to the rear-most molars on the dental arch 1 , 2. Accordingly, the endcaps 185 and the mesial and distal sealing elements 194, 196 function as gingival sealing elements. Impression material 192 is then injected through the conduit 190 and into the impression channel 184 through the injection port 186. A pressure of the impression material 192 may be controlled using any of the exemplary devices and methods described above and below. For example, one or more of the injection ports 186, or one or more portions of the conduit 190, may include a pressure-sensitive valve, such as a reed valve, that passively moderates a flow rate of material 192 entering into the impression channel 184 and thus a pressure within the channel 184. Referring to FIG. 21, the full-arch dental impression injection tray 180 is shown containing a dental impression 204 formed of a full portion of a dental arch 1, 2.

[0068] Any of the dental impression inj ection trays described herein may include one or more bite stopping features (not shown) to substantially prevent undesired impingement between the injection tray and patient teeth. Additionally, the inj ection trays may include one or more gripping features to facilitate gripping and manipulation of the injection tray by a dental professional during seating and removal of the injection tray.

[0069] Referring to FIG. 22, a dental impression injection system 210 according to an embodiment of the invention is shown schematically. The system 210 includes a dental impression injection tray 212, such as one of the injection trays 10, 10a, 10b, 100, 120, 140, 160, or 180 shown and described herein, an impression material delivery device 214, and an impression material supply 216 containing a dental impression material. The material delivery device 214 operates to extrude or otherwise remove impression material from the impression material supply 216 and direct the impression material toward the inj ection tray 212 for inj ection into its impression cavity. The impression material supply 216 may be provided within or remotely from the delivery device 214, for example. In one embodiment, the material supply 216 may be in the form of a refillable or a disposable cartridge receivable within the delivery device 214.

[0070] The impression material delivery device 214 may be a manually operated dispenser, such as a hand actuated gun-like pump device. Alternatively, the delivery device 214may be an automated dispenser having motorized or pneumatically actuated components, for example, capable of providing a high-speed injection flow of impression material to the injection tray 212. In an embodiment in which the delivery device 214 is automated, the system 210 may further include a controller 218 for controlling a flow of impression material inj ected into the inj ection tray 212 by the delivery device 214. Further, the delivery device 214 may be operable to deliver multiple injection shots of the impression material to the injection tray 212 during any one injection cycle. The system 210 may further include a mixing chamber (not shown) into which the impression material is extruded prior to being inj ected into the impression cavity of the injection tray 212. The mixing chamber may be in the form of a mixing tip on a material cartridge, or it may be a chamber formed within the material delivery device 214 or within a separate mixing device, for example.

[0071] In use, prior to injection of impression material into the impression cavity of the inj ection tray 212, air may be inj ected into the impression cavity and onto the dental structure for removal of moisture (e.g., saliva) to achieve a drying effect on the dental structure. For example, as shown in the embodiment of FIG. 1, air may be inj ected through one of the injection ports 16, 20. Additionally, though not shown, an impression material inj ection conduit may be coupled to a first injection port of the injection tray 212 to deliver a flow of impression material into the impression cavity, and a vacuum conduit may be coupled to a second inj ection port (operating as an ejection port, or "check point") of the injection tray 212 for applying a vacuum to the impression cavity to facilitate withdrawal of air from the impression cavity during impression material injection. In this manner, an injection force required for inj ecting the impression material into the impression cavity may be reduced, and presence of air pockets in a formed dental impression may be mitigated or entirely prevented.

[0072] During injection of impression material into an impression cavity (or impression channel) of the injection tray 212, a direction and/or rate of flow of the impression material as it is injected into the impression cavity may be controlled by one or more flow control mechanisms (not shown) formed on the tray body. Such flow control mechanisms may include fins, baffles, channels, reed valves, and similar mechanisms known in the art, for example. In embodiments in which the dental impression inj ection tray 212 includes a plurality of injection ports, inj ection of impression material through the various ports may be performed in a particular sequence. For example, each injection port may be provided with a unique flow control mechanism, such as a reed valve (e.g., as described above), configured to permit flow of impression material therethrough when acted upon by a unique, predetermined pressure exerted by incoming impression material. Alternatively, or in addition, sequence of material injection may be controlled by providing each of the injection ports with a unique diameter. Additionally, a thixotropic impression material having a dynamic viscosity may be used, as described in greater detail below, and a flow rate of the material during injection may be controlled by controlling the viscosity of the material.

[0073] During injection of impression material into an impression cavity, a pressure of the impression material inside of the impression cavity (or impression channel) may also be controlled . In particular, the pressure inside the impression cavity (or "injection pressure") may be controlled so as to achieve a pressure that is high enough to force the impression material to displace oral fluids (e.g., saliva and blood) and fully reach the various dental interstices and interproximal spaces, and to adequately open, expand, and penetrate gingival sulci through gingival tissue retraction. The pressure may be further controlled to maintain adequate gingival tissue retraction throughout impression formation, without causing excessive tissue deformation that might otherwise result in a distorted and inaccurate dental impression. In exemplary embodiments, an injection pressure of approximately 0.1 bar to 4 bar may be provided by the system 210. For example, an injection pressure of approximately 0.4 bar to 2 bar may be provided. Advantageously, such pressure control facilitates optimum precision and accuracy of the dental impression relative to its corresponding dental structure. Such pressure control may be achieved through active and/or passive pressure control mechanisms, for example, as described further below.

[0074] In exemplary embodiments, active pressure control of the injected impression material may be provided by the impression material delivery device 214 and the controller 218, with the assistance of an active pressure control mechanism that includes a pressure sensor 220, which may be electronic or mechanical. The pressure sensor 220 senses a pressure of the impression material inside of the impression cavity of the injection tray 212 and may be mounted directly to the tray body, for example within the impression cavity or otherwise so as to communicate with the impression cavity. The pressure sensor 220 may communicate with the impression material delivery device 214, and/or with the controller 218, to provide an indication of the sensed pressure. In exemplary embodiments, the pressure sensor 220 may be a component of the material delivery device 214.

[0075] In response to receiving the sensed pressure from the pressure sensor 220, the controller 218 may compare the sensed pressure to a predetermined pressure value. The controller 218 may then control the impression material delivery device 214 to increase or decrease, as needed, a flow rate of the impression material being injected in order to increase or decrease the pressure within the impression cavity to match the predetermined pressure value. In this manner, pressure control during impression material inj ection may be automated. In embodiments in which pressure control is not automated, for example when the impression material delivery device 214 is a manually operated device, an indication of a pressure sensed within the impression cavity by a sensing device may be provided directly to the user, for example via any suitable display device (not shown). The user may then manually adjust actuation of the material delivery device 214 as desired, or otherwise adjust one or more adjustable pressure control elements, to vary a flow rate of the impression material as desired, and thereby vary the resulting pressure of the impression material being injected. In exemplary embodiments, the adjustable pressure control elements may be in the form of one or more valves arranged on the material delivery device 214 or between the delivery device 214 and the injection tray 212, for example.

[0076] In other exemplary embodiments, passive pressure control of the injected impression material may be provided by passive pressure control mechanisms in the form of one or more pressure-sensitive relief valves, for example. In one embodiment, the pressure control mechanism may include one or more reed valves (not shown) provided on a wall of the tray body, for example, and configured to release a flow of impression material outwardly from the impression cavity upon a pressure within the impression cavity reaching a predetermined level. In this regard, a passive pressure control mechanism may be tuned, for example by manipulating its physical configuration, to respond (e.g., by opening) to a predetermined pressure, and thereby maintain a desired, predetermined pressure within the impression cavity. Additionally, during inj ection of impression material into the injection tray 212, the channels defined by the labial and lingual sealing elements of the tray 212, such as channels 90 of elements 30, 32 of tray 10 in FIG. 1, may fill with impression material and expand to relieve pressure within the impression cavity. In particular, the inner edges of the labial and lingual sealing elements, such as edges 72 shown in FIG. 3, may flex toward one another to enable channel expansion.

[0077] The dental impression injection system 210 may further include various other sensors (not shown) for monitoring corresponding parameters during impression material injection. For example, the system 210 may include one or more sensors for measuring one or more of the following parameters: a viscosity of the impression material; a force applied for extruding the impression material; a pressure of the impression material inside of the impression cavity of the injection tray; a volume of impression material extruded and/or a volume of impression material inside of the impression cavity; and whether or not, or a particular degree to which, the impression cavity has been filled within impression material. The system 210 may include one or more sensors for measuring various other parameters as well. The sensors may communicate electronic data corresponding to sensed measurements to the controller 218, which may then adjust operation of the impression material delivery device 214, or otherwise provide a visual indication to a user of the sensed measurements, according to pre-scripted electronic instructions, for example.

[0078] The dental impression injection system 210 may further include a curable impression material having a dynamic and controllable viscosity. In one embodiment, the impression material may be thixotropic such that its viscosity may be selectively controlled through agitation (e.g., vibration). For example, the impression material may be formed with a composition similar to that described in U. S. Patent No. 8,822,564, the disclosure of which is incorporated by reference herein in its entirety. Advantageously, the viscosity of the impression material may be selectively tuned to provide desired flow characteristics. For example, the impression material may be initially provided with a low viscosity to achieve a high flow rate and maximum penetration of dental interstices, and then provided with a higher viscosity to achieve a lower flow rate during final stages of material injection when the impression cavity is filled or nearly filled. With passage of time during injection, curing (i.e., setting) of the impression material will also contribute to an increase in material viscosity.

[0079] In another embodiment, the impression material may include a thermally activated component that provides a dynamic viscosity effect that is heat controllable. For example, the impression material may include a component that softens (i. e., becomes less viscous) upon application of heat. Accordingly, a viscosity of the impression material may be controlled by application or removal of heat to the impression material containing the thermally activated component, or to the component itself prior to mixing with the impression material during injection, for example. In another embodiment, the impression material may be a mixture of multiple components, including a particle component, the increasing or decreasing presence of which alters the viscosity of the impression material. Accordingly, the viscosity of the impression material may be tuned by adjusting the proportion of the particle component present within the impression material mixture.

[0080] In embodiments in which the impression material has a dynamic, controllable viscosity, the dental impression inj ection system may further include one or more mechanisms for tuning the viscosity. For example, the system may include an agitating device if the impression material is thixotropic, a heating device if the impression material is thermally activated, or a mixing device if the material viscosity is a function of proportions of mixed components. The viscosity tuning mechanism may be automated and controlled, or it may be manually operated. In another embodiment, the impression material may have a single, fixed viscosity prior to setting, which viscosity is optimized for a desired application.

[0081] The dental impression material may include various additional desirable properties. In one embodiment, the impression material may be fast-setting, such that it is capable of curing from a liquid state to a set, gelled state in less than or equal to approximately 60 seconds, for example in less than or equal to approximately 30 seconds. Additionally, the impression material may include a color changing characteristic that provides a visual indication to the user that the material has fully set, or is otherwise advancing toward a fully set state. For example, the impression material may be formed with a composition similar to that described in U. S. Patent Publication No. 2012/0115978 or U. S. Patent Publication No. 2012/0115109, the disclosures of which are incorporated by reference herein in their entirety. As described above, the tray body of an injection tray in accordance with an embodiment of the invention may be translucent, thereby enabling color change of the impression material to be easily viewed during use. Furthermore, the impression material may have a composition rendering it scannable by an electronic scanning device, for example for creating a three- dimensional electronic model of a dental impression comprised of the impression material.

[0082] In accordance with another aspect of the invention, a dental impression kit may include the dental impression inj ection tray 212 and the material supply 216 in the form of a cartridge containing impression material. The impression material provided in the single-use cartridge may have any one or more of the characteristics described above. Additionally, each of the injection tray 212 and the single-use cartridge may be sufficiently inexpensive for replacement to render them suitable for disposal after a single use. The volume of impression material provided within the cartridge may be tailored to the volume of the impression cavity of the injection tray 212. For example, if the injection tray 212 is configured to form a dental impression of a partial portion of a dental arch, the cartridge may be filled with a small volume of impression material. In contrast, if the injection tray 212 is configured to form a dental impression of a full portion of a dental arch, and/or of multiple dental arches, the cartridge may be filled with a larger volume of impression material. It will be appreciated that the volume of the cartridge itself may be varied depending on the volume of impression material to be contained therein.

[0083] Having described various exemplary embodiments of the invention above in connection with the Figures, embodiments of the invention will now be summarized below, and are denoted " 1 st Embodiment,"2nd Embodiment,"3rd Embodiment," etc. for ease of reference. The claims are presented after this summary of exemplary embodiments.

[0084] In a 1st Embodiment, a dental impression injection tray for forming a dental impression of a dental structure includes a tray body defining an impression cavity sized to receive the dental structure. At least one injection port is formed on the tray body and communicates with the impression cavity, and is adapted to direct a supply of impression material into the impression cavity for forming the dental impression. A plurality of gingival sealing elements are coupled to the tray body and are adapted to sealingly engage gum surfaces adj acent to the dental structure and block the impression material from escaping the impression cavity in labial, lingual, mesial, and distal directions during injection of the impression material into the impression cavity.

[0085] In a 2nd Embodiment, the gingival sealing elements of the 1st Embodiment include a labial sealing element, a lingual sealing element, a mesial sealing element, and a distal sealing element. The labial sealing element is adapted to sealingly engage a labial gum surface and block impression material from escaping the impression cavity labially. The lingual sealing element is adapted to sealingly engage a lingual gum surface and block impression material from escaping the impression cavity lingually. The mesial sealing element is adapted to sealingly engage a mesial gum surface and block impression material from escaping the impression cavity mesially. The distal sealing element is adapted to sealingly engage a distal gum surface and block impression material from escaping the impression cavity distally.

[0086] In a 3rd Embodiment, the dental impression inj ection tray of the 1st or 2nd

Embodiments further includes a pressure mechanism that controls a pressure of the impression material inside of the impression cavity.

[0087] In a 4th Embodiment, the pressure control mechanism of the 3rd Embodiment includes a pressure-sensitive valve.

[0088] In a 5th Embodiment, the dental impression injection tray of any of the preceding Embodiments further includes a flow control mechanism that controls at least one of a rate or direction of flow of the impression material inj ected into the impression cavity.

[0089] In a 6th Embodiment, the tray body of any of the preceding Embodiments is formed with a length such that the impression cavity is sized to receive and form the dental impression of a full portion of a dental arch.

[0090] In a 7th Embodiment, the tray body of any of the 1st through 5th Embodiments is formed with a length such that the impression cavity is sized to receive and form the dental impression of a partial portion of a dental arch.

[0091] In an 8th Embodiment, the mesial sealing element of the 7th Embodiment defines a mesial wall of the impression cavity and is adapted to sealingly engage a mesially located dental structure, and the distal sealing element defines a distal wall of the impression cavity and is adapted to sealingly engage a distally located dental structure.

[0092] In a 9th Embodiment, the mesial sealing element of the 8th Embodiment is adapted to seal a mesially located interproximal space, and the distal sealing element is adapted to seal a distally located interproximal space.

[0093] In a 10th Embodiment, the tray body of any of the 7th through 9th Embodiments is formed with a length such that the impression cavity is sized to receive and form the dental impression of greater than or equal to three teeth and less than or equal to five teeth of the dental arch.

[0094] In an 1 1th Embodiment, the injection tray of any of the 1 st through 5th

Embodiments includes a lower tray portion having a lower dental opening adapted to receive at least a partial portion of a lower dental arch, and the injection tray further includes an upper tray portion having an upper dental opening adapted to receive at least a partial portion of an upper dental arch. Additionally, the plurality of gingival sealing elements includes a plurality of lower gingival sealing elements adapted to engage gum surfaces of the lower dental arch, and a plurality of upper gingival sealing elements adapted to engage gum surfaces of the upper dental arch.

[0095] In a 12th Embodiment, the lower dental opening of the 11th Embodiment is sized to receive a full portion of the lower dental arch and the upper dental opening is sized to receive a full portion of the upper dental arch.

[0096] In a 13th Embodiment, the lower dental opening of the 11th Embodiment is sized to receive only a partial portion of the lower dental arch and the upper dental opening is sized to receive only a partial portion of the upper dental arch

[0097] In a 14th Embodiment, the lower dental opening and the upper dental opening of any of the 11th through 13th Embodiments each open to the impression cavity such that the impression cavity is adapted to form a dental impression of at least a partial portion of the lower dental arch and at least a partial portion of the upper dental arch to thereby record a bite registration corresponding to the lower and upper dental arches

[0098] In a 15th Embodiment, the tray body of any of the preceding Embodiments is comprised of a first material and the gingival sealing elements are comprised of at least one second material.

[0099] In a 16th Embodiment, at least one of the gingival sealing elements of the 15th Embodiment is formed of a plastically-deformable material configured to record a contour of an adjacent one of the gum surfaces.

[00100] In a 17th Embodiment, the injection tray of any of the preceding Embodiments furthers includes at least one ejection port communicating with the impression cavity and adapted to direct at least one of air or impression material outwardly therethrough from the impression cavity during injection of the impression material into the impression cavity.

[00101] In an 18th Embodiment, the at least one ejection port of the 17th Embodiment is adapted to receive a vacuum element for applying a vacuum to the impression cavity to facilitate withdrawal of air from the impression cavity during injection of the impression material.

[00102] In a 19th Embodiment, at least a portion of the tray of any of the preceding Embodiments is formed of a microporous material having a pore size sufficiently large to allow outward flow therethrough of air from the impression cavity, the pore size being sufficiently small to block outward flow therethrough of impression material from the impression cavity. [00103] In a 20th Embodiment, a dental impression kit includes the dental impression injection tray of any of the preceding embodiments, and a single-use cartridge for use with the dental impression inj ection tray, the single-use cartridge containing an impression material for forming the dental impression.

[00104] In a 21 st Embodiment, the impression material of the 20th Embodiment is configured to set in a time of less than or equal to one minute.

[00105] In a 22nd Embodiment, the impression material of the 21 st Embodiment is configured to set in a time of less than or equal to thirty seconds.

[00106] In a 23rd Embodiment, the impression material of any of the 20th through 22nd Embodiments has a controllable viscosity.

[00107] In a 24th Embodiment, the impression material of the 23rd Embodiment has a heat- controllable viscosity.

[00108] In a 25th Embodiment, the impression material of any of the 20th through 22nd Embodiments has a viscosity that is fixed prior to setting.

[00109] In a 26th Embodiment, applied to the dental impression kit of any of the 20th through 25th Embodiments, the impression material is configured to change color when setting, and the tray body is translucent so as to provide a visual indication of the setting.

[00110] In a 27th Embodiment, a dental impression injection system for forming a dental impression of a dental structure includes a dental impression injection tray having a tray body that includes an inj ection port and defines an impression cavity sized to receive the dental structure. The system further includes an impression material delivery device operable to inj ect an impression material into the impression cavity through the injection port for forming the dental impression while the dental impression inj ection tray is coupled to the dental structure. The system further includes a pressure control mechanism that controls a pressure of the impression material inside of the impression cavity.

[00111] In a 28th Embodiment, the dental impression inj ection tray of the 27th Embodiment further includes a plurality of gingival sealing elements coupled to the tray body and adapted to sealingly engage gum surfaces adjacent to the dental structure and block the impression material from escaping the impression cavity in labial, lingual, mesial, and distal directions during inj ection of the impression material into the impression cavity.

[00112] In a 29th Embodiment, the impression material delivery device of the 27th or 28th Embodiments is automated.

[00113] In a 30th Embodiment, the pressure control mechanism of any of the 27th through 29th Embodiments includes a sensor that senses a pressure of the impression material inside of the impression cavity. [00114] In a 31 st Embodiment, the sensor of the 30th Embodiment is mounted to the dental impression injection tray.

[00115] In a 32nd Embodiment, the dental impression inj ection system of the 30th or 31 st Embodiments further includes a controller. The controller receives a signal from the sensor regarding the sensed pressure, compares the sensed pressure to a predetermined pressure, and controls the impression material delivery device to adjust a flow rate of the impression material being injected into the impression cavity.

[00116] In a 33rd Embodiment, the pressure control mechanism of any of the 27th through 32nd Embodiments includes a pressure-sensitive valve.

[00117] In a 34th Embodiment, the pressure-sensitive valve of the 33rd Embodiment includes a reed valve.

[00118] In a 35th Embodiment, the dental impression inj ection tray of any of the 27th through 34th Embodiments further includes a flow control mechanism that controls at least one of a rate or direction of flow of the impression material inj ected into the impression cavity.

[00119] In a 36th Embodiment, the flow control mechanism of the 35th Embodiment includes a pressure-sensitive valve.

[00120] In a 37th Embodiment, the dental impression inj ection tray of any of the 27th through 36th Embodiments further includes at least one ej ection port communicating with the impression cavity and adapted to direct at least one of air or impression material outwardly therethrough from the impression cavity during injection of the impression material into the impression cavity.

[00121] In a 38th Embodiment, the at least one ej ection port of the 37th Embodiment is adapted to receive a vacuum element for applying a vacuum to the impression cavity to facilitate withdrawal of air from the impression cavity during inj ection of the impression material

[00122] In a 39th Embodiment, at least a portion of the tray of any of the 27th through 38th Embodiments is formed of a microporous material having a pore size sufficiently large to allow outward flow therethrough of air from the impression cavity, the pore size being sufficiently small to block outward flow therethrough of impression material from the impression cavity.

[00123] In a 40th Embodiment, the dental impression inj ection system of any of the 27th through 39th Embodiments further includes a supply of impression material for forming the dental impression.

[00124] In a 41 st Embodiment, the impression material of the 40th Embodiment is configured to set in a time of less than or equal to one minute. [00125] In a 42nd Embodiment, the impression material of the 41 st Embodiment is configured to set in a time of less than or equal to thirty seconds.

[00126] In a 43rd Embodiment, the impression material of any of the 40th through 42nd Embodiments has a controllable viscosity.

[00127] In a 44th Embodiment, the impression material of any of the 40th through 42nd Embodiments has a viscosity that is fixed prior to setting.

[00128] In a 45th Embodiment, applied to the dental impression injection system of any of the 40th through 44th Embodiments, the impression material is configured to change color when setting, and the tray body is translucent so as to provide a visual indication of the setting.

[00129] In a 46th Embodiment, a method of forming a dental impression of a dental structure with a dental impression injection tray having an impression cavity includes seating the dental impression injection tray on the dental structure so that the dental structure is received within the impression cavity. Impression material is injected into the impression cavity containing the dental structure. The dental impression injection tray is sealed against gum surfaces adjacent to the dental structure to block the impression material from escaping the impression cavity in labial, lingual, mesial, and distal directions during injection. A pressure of the impression material inside the impression cavity is controlled during inj ection. The impression material is allowed to set to form the dental impression.

[00130] In a 47th Embodiment, the method of the 46th Embodiment further includes sensing a pressure of the impression material within the impression cavity, and controlling the pressure of the impression material includes adjusting a flow rate of the impression material based on the sensed pressure.

[00131] In a 48th Embodiment, the method of the 46th or 47th Embodiments further includes controlling a flow of the impression material injected into the impression cavity.

[00132] In a 49th Embodiment, the method of any of the 46th through 48th Embodiments further includes injecting air into the impression cavity to dry the dental structure before injecting the impression material.

[00133] In a 50th Embodiment, the impression material of any of the 46th through 49th Embodiments has a dynamic viscosity, and the method further includes controlling the viscosity of the impression material.

[00134] In a 51 st Embodiment, the method of any of the 46th through 50th Embodiments further includes applying a vacuum to the impression cavity and withdrawing air therefrom while injecting the impression material into the impression cavity.

[00135] In a 52nd Embodiment, the method of any of the 46th through 51 st Embodiments further includes, while injecting impression material into the impression cavity, allowing air from the impression cavity to flow outwardly through at least one sidewall of the injection tray, and simultaneously blocking impression material from flowing outwardly through the at least one sidewall.

[00136] In a 53rd Embodiment, a dental impression injection tray for forming a dental impression of a dental structure includes a tray body defining an impression cavity sized to receive the dental structure. At least one injection port is formed on the tray body and communicates with the impression cavity, and is adapted to direct a supply of impression material into the impression cavity for forming the dental impression. A plurality of gingival sealing elements are coupled to the tray body and are adapted to sealingly engage gum surfaces adjacent to the dental structure and block the impression material from escaping the impression cavity during injection of the impression material into the impression cavity

[00137] In a 54th Embodiment, a method of forming a dental impression of a dental structure with a dental impression injection tray having an impression cavity includes seating the dental impression injection tray on the dental structure so that the dental structure is received within the impression cavity. Impression material is injected into the impression cavity containing the dental structure. The dental impression injection tray is sealed against gum surfaces adjacent to the dental structure to block the impression material from escaping the impression cavity during injection. A pressure of the impression material inside the impression cavity is controlled during injection. The impression material is allowed to set to form the dental impression.

[00138] While the present invention has been illustrated by the description of specific embodiments thereof, and while the embodiments have been described in considerable detail, it is not intended to restrict or in any way limit the scope of the appended claims to such detail. The various features discussed herein may be used alone or in any combination. Additional advantages and modifications will readily appear to those skilled in the art. The invention in its broader aspects is therefore not limited to the specific details, representative apparatus and methods and illustrative examples shown and described. Accordingly, departures may be made from such details without departing from the scope of the general inventive concept.