Omnidirectional multi-unit abutment system for screw-mounted dental prostheses

Abstract

A multi-unit abutment for mating a dental implant with a screw-mounted prosthesis by means of a coping is disclosed. SOLUTION: The multi-unit abutment has a threaded base post and a ball portion for attachment to the implant. A swivel shell surrounds the ball and may be locked in place by a locking screw. A driving feature in the ball allows a tool passing through the locking screw to drive the base post into the implant with the multi-unit assembly in a linear configuration. The swivel shell is then positioned at the desired inclination and azimuth angle. The swivel shell has an engagement surface for a coping. When a prosthesis is placed on the implant abutment, the locking screw remains accessible through an opening in the coping. Various embodiments are disclosed for gripping the swivel shaft to the ball. A method is described for improving passive alignment of a prosthesis to an implant.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This disclosure claims priority to U.S. Provisional Patent Application No. 63 / 196227, filed June 3, 2021, which is incorporated by reference in its entirety.

[0002] The present invention relates to an omnidirectional multi-unit abutment system for screw-mounted dental prostheses. [Background technology]

[0003] A variety of systems have been introduced to attach dental prostheses to dental implants to replace one or more natural teeth. To simplify future revision or replacement needs, it is desirable to provide a reversible attachment between the implant and prosthesis using a mechanical system, as opposed to direct bonding of the components. These systems may include features that provide proper alignment and retention for acceptable use by the patient. Intermediate components such as titanium bases (also called copings) and separable abutments are often employed to provide proper alignment between the dental prosthesis and one or more implants that are placed in the patient's jawbone, the soft tissues, and the remaining natural teeth. These intermediate elements may be attached to each other by screws, ball-and-socket joints, snap-on mounts, cement, or other mechanical means.

[0004] The simplicity of the screw-mounted system offers several advantages over snap-on systems besides the manufacturing cost. The mounting pressure between the coping and the abutment is easily controlled through the torque applied to the screw to tighten it. This axial tension control and self-aligning nature of the mated screw threads provides greater certainty in mating forces and relative orientation of the components. In the event of screw failure, techniques are known to remove the member without damaging the surrounding components. The screws also have the advantage of independence for removal, since each coping can be loosened individually. Even if the prosthesis is tilted after screw removal to disengage one coping, it is not possible to re-engage another coping.

[0005] In the case of single-tooth crown attachment, the titanium base and abutment surfaces preferably include features that eliminate rotational symmetry about the azimuthal axis in the engagement of the abutment and coping surfaces. These single mount systems may also include a rotation lock feature. This rotational fixation is generally not required when the prosthesis includes multiple copings for attachment to multiple abutments. For example, a 30 degree tapered engagement surface for multiple interface locations is sufficient to provide perfect alignment. This configuration is shown in the figures of this disclosure for convenience and is not meant to be limiting.

[0006] The goal of all implant-mounted prostheses is to provide a passive fit of the prosthetic superstructure to the implant to avoid stresses on the prosthesis or on the osseointegration process of the implant. These stresses can cause problems during initial loading or may become problematic at a later time. Misfit can lead to both mechanical and physiological problems in single and multiple implant treatments. Mechanical problems can include loosening of the prosthetic retention and abutment screws and fracture of components including the screws. Physiological problems can include discomfort, progressive marginal bone loss, bacterial infection, microbial plaque accumulation, and implant loosening.

[0007] Providing a passive fit initially or being able to realign or rework components to accommodate changes later is important for good function and longevity of the prosthesis. Achieving a passive fit remains a challenge due to tolerance build-up and the introduction of misalignments and distortions when manufacturing the prosthesis. The use of direct pick-up impression procedures is beneficial but still requires improvement. An evaluation of passive fit challenges is provided by "Passive Fit Impression Impressions: A Guide to Impression Impressions for Dental Implants," Proc. Nat. Eng. 1999, 144: 1311-1323.

[0008] An increasingly popular treatment option for edentulous patients involves the placement of four to eight implants in the edentulous jaw and attachment of a prosthetic arch. The transmucosal abutments are fastened to the implants and are intended to remain in place indefinitely. Although it is desirable to have all of the axes of the placed implants parallel to one another, the underlying bone structure often results in the implants being loaded at an angle from this ideal mutual orientation. "Multi-unit abutment" is a commonly used descriptor for a particular type of transmucosal abutment used to restore an edentulous jaw with a single prosthetic full-arch prosthesis.

[0009] Multi-unit abutments (commonly referred to as "MUA") are a fairly easy way to improve the divergence angle of implants with options for 0, 17, and 30 degree angulation corrections. Generally, 0 degree MUAs are easier to place as the abutment is placed in line with the linear axis of the implant. 17 and 30 degree MUAs typically include a relatively long "screw access" indicator that makes it difficult to work in tight spaces such as the back of the jaw where these abutments are commonly placed to compensate for the distal angulation of posterior implants popularized by Dr Paolo Maolo in 2004.

[0010] There have been several alternative abutment designs for restoring edentulous arches. Most implant companies have settled on the MUA geometry adopted by Nobel Biocare, but there have been several attempts to improve upon the weaknesses of this geometry. For example, the Dentsply Astra EV system of implants uses a "mulTi base" abutment that improves upon the lack of coverage of the prosthetic screw with multi-unit abutments. Neoss uses a version of the MUA that "reduces the height of the abutment" by using a female connection as opposed to the standard male connection of the MUA. Regardless of the benefits of these improved designs, each design requires the clinician to order a specific stock with a specific angle correction and height. An example of the complexity of inventory management is when an implant system offers different angles or inclination angles (e.g. 0 degrees, 17 degrees, and 30 degrees) with multiple implant / abutment connections (e.g. narrow and regular platforms) and multiple heights to the MUA (e.g. 1.5mm, 2.5mm, 3.5mm, 4.5mm, etc.). Maintaining a sufficient stock ready for immediate loading procedures with full-arch implant fixation requires multiplying the three inclination angle options by the number of platform options and multiplying by the number of tissue heights appropriate for the amount of implants expected to be placed (minimum four according to the Paolo Maoro protocol).

[0011] The resulting inventory equation is: 3 (power options) x 2 (platform connections) x 2 (variable tissue heights) x 4 (implants) = 48 (multi-unit abutments) This inventory problem is magnified when multi-unit abutment systems also require unique implants, titanium bases, and prosthetic fasteners. This inventory management complexity is further exacerbated when practitioners prefer different delivery systems for different patient situations, or when different practitioners in a clinic prefer different delivery offerings.

[0012] In addition to the complexity of inventory management, there are limitations to the discrete nature of the "angle correction" (e.g., limited to three specific angles: 0, 17, and 30) and to the internal connection of the implant at the longitudinal axis, which may be referred to as the azimuth angle. In many cases, the internal hexagon limits the possibilities to six azimuth positions, which includes a 60 degree change from one position to the next. In some cases, 0 degrees is too little for an inclination correction, while 17 degrees is too much. The same is true for 17 to 30. Alternatively, 17 degrees is an adequate inclination correction, but because of the limitation to the six positions of the internal hexagon, the required 17 degree correction cannot be applied in the azimuth direction that is ideal for the required correction. The same is true for a 30 degree correction. For full arch implant treatment, new clinicians have difficulty selecting and placing multi-unit abutments. This can increase procedure time and increase patient morbidity.

[0013] Although there is uncertainty as to whether tilted implants are more prone to osseointegration failure than straight abutments, it is certain that all implants impose higher mechanical stresses and strains on bone structure than natural teeth. Natural teeth can move in their sockets to a greater extent than implants embedded in bone. This natural buffer helps to mitigate the magnitude and range of directions of forces applied from bone to teeth. Screw loosening is associated with bending of the screw joint and a subsidence effect in which the joint parts initially remain separated due to initial surface micro-roughness, but the high points gradually wear away. The microgaps due to the initial mechanical misfit between the elements of the prosthetic superstructure are too small to be detected by a probe, but are large enough to concentrate the mechanical forces that occur in the chewing process from various directions and with various magnitudes. These microgaps are still large compared to the bacteria that can invade and grow in the internal cavities of the entire dental prosthetic superstructure loading.

[0014] Due to the wide range of variables, the specifics of the application, and the difficulty of measuring in the field, there is no acceptable passive fit threshold for long-term success. The quality of the fit is checked in the dental laboratory and when loaded into the patient by analogy, but this is not an exact scientific method. For example, the "one-screw test" for fit involves tightening only one screw at one end of the prosthesis and then looking for lift at the opposite end. A variant of this, the "screw resistance test", involves inserting and seating the screws in sequence and then checking whether more than 180 degrees are needed to achieve, for example, 10 Ncm of torque. Failure of the prescribed go-no-go test criteria means that the prosthesis needs to be reworked or replaced. Since the same process is used to fabricate the replacement, there is no certainty that this replacement will be properly matched.

[0015] Even if all the multi-unit abutments are perfectly aligned and secured to the implant and prosthesis initially, changes may occur over time. For example, the prosthesis may deform, the bone structure may change, or perhaps more likely, the fasteners may loosen or break. In many prior art systems, to adjust the orientation, the prosthesis must be completely removed, the multi-unit abutment fasteners refastened, and the components replaced or perhaps an entirely new prosthesis must be fabricated and fitted. Inefficient trial and error fitting cycles to improve alignment are frustrating for both the patient and the dental practitioner. Replacing a single faulty multi-unit abutment out of several and properly aligning it with the existing prosthesis can be much more difficult than initial loading alignment. A method is needed to make adjustments to the orientation of the multi-unit abutment orientation while the prosthesis is in place.

[0016] Some commercially available systems require on-site sequential assembly of the multi-unit abutment components during loading into the patient's mouth, which increases the likelihood that the patient will accidentally swallow a component. Some systems require the employment of multiple tools, which can also extend the complexity and time of the procedure. [Prior art documents] [Non-patent literature]

[0017] [Non-Patent Document 1] Buzayan, MM and Yunus, NB (2014). "Passive Fit in Screw Retaining Multi-unit Implant Prosthesis Understanding and Achieving: A Review of the Literature." Journal of Indian Prosthodontic Society 14(1), 16-23 (https: / / doi.org / 10.1007 / s13191-013-0343-x). Summary of the Invention [Problem to be solved by the invention]

[0018] To address one or more of the above-mentioned problems and limitations of current multi-unit abutments available on the market, novel multi-unit abutment embodiments are disclosed herein. These units are designed to be omnidirectional, meaning that they can be positioned over a continuous range of orientations sufficient to correct implant angulations commonly found in general practice. While the above considerations were based on structural reasons, tilted implants may also be preferred for purely aesthetic reasons, e.g., to reorient the screw access hole of a single-tooth crown. Omnidirectional multi-unit abutment embodiments are presented that offer advantages in terms of inventory management, placement process, options for angulation and flexibility, improved passive fit, and elimination of angulation limitations or other issues with existing multi-unit abutment systems for single implant crowns and multiple implant prostheses. [Means for solving the problem]

[0019] Some embodiments of the present invention include a multi-unit abutment for screwing onto a dental implant that allows the titanium base to be fitted at a user-selected rotational and inclination angle relative to the implant. This fitting orientation is fixed prior to bonding of the titanium base to the prosthesis, and in some embodiments can be adjusted or fastened by removing the prosthesis retaining screw while the rest of the titanium base is retained by the abutment. In this way, the final relative orientation of the adjustable abutment is directly influenced by the fixed position of the titanium base in the prosthesis. This can correct or mitigate misalignments resulting from the accumulation of placement errors during the fabrication steps of the prosthesis relative to the initial position of the abutment.

[0020] Some embodiments of the invention include a multi-unit abutment that is assembled outside the patient's mouth and attached to a driving tool in a linear configuration for attachment to an implant, reorienting and fixing the orientation of the portion of the abutment that interfaces with the titanium base that is not aligned with the axis of the implant. The titanium base can then be attached to the multi-unit abutment by a prosthetic screw.

[0021] In some embodiments of the invention, a single driving tool can screw the multi-unit abutment into the implant and lock the orientation of the abutment surfaces, while other embodiments use different driving tools for these processes.

[0022] Some embodiments of the invention include a ball portion and a swivel portion that allow relative tilt or rotation but are constrained from being separated from each other. In some embodiments, the relative orientation of the ball and swivel can be fixed by applying pressure to both sides of the ball portion. Some embodiments of the invention include a locking screw that is attached to the swivel portion and applies pressure to both sides of the ball. In some embodiments, a multi-unit abutment can be loaded into the implant by passing a driving tool through an opening in the locking screw. In some embodiments of the invention, the locking screw includes threads for a prosthetic screw. In some embodiments, the locking screw is accessible through a titanium base that is secured to the prosthesis.

[0023] In one embodiment, a system for aligning and mounting a dental prosthesis to an implant by means of a prosthetic screw is described, the prosthetic screw having a head and a threaded shaft, the system comprising: 1. An abutment base having a longitudinal axis, a proximal end having a ball portion and an abutment base drive interface; a distal end having a screw thread for attachment to an implant; and an abutment base comprising: a swivel shell having an inner surface and an outer surface, the swivel shell including a swivel opening proximate a distal end and a threaded opening at a proximal end; A lock screw having a longitudinal axis, a portion having external threads that are compatible with a threaded opening in the swivel shell; a portion having an internal thread sized to mate with the prosthetic screw shaft; a locking screw drive interface, the locking screw being capable of fixing an orientation of a longitudinal axis of the locking screw in an orientation that is not parallel to the longitudinal axis of the abutment base by rotation of the locking screw; A lock screw comprising: Equipped with:

[0024] In one embodiment, attaching the locking screw to the swivel shell about the abutment base with the ball portion loosely captured inside the swivel shell by the abutment base screw thread extending into the swivel opening to form a multi-unit abutment assembly; Inserting an abutment driving tool tip into the locking screw so as to mate with the abutment base driving interface; placing the abutment base driving tool and the multi-unit abutment assembly on the implant; rotating the abutment base driving tool to attach the abutment base to the implant with a first torque; disengaging the abutment base driving tool from the abutment base driving interface; moving the swivel shell to different orientations; Rotating the locking screw driving tool to fix the orientation of the swivel shell axis relative to the implant axis at a second torque; placing a prosthesis having a titanium base on the implant abutment system; Attaching a prosthesis to the implant abutment by a prosthetic screw; It is described how omnidirectional multi-unit abutments can be used in a manner that includes:

[0025] In some embodiments, a system is described for aligning and attaching a dental prosthesis to an implant using a multi-unit implant abutment, the multi-unit implant abutment comprising: 1. A ball-shell assembly comprising: a base having an abutment driving interface for screw attachment to an implant, the base having a first end having a ball and a second end having a threaded post with a longitudinal axis, the threaded post being designed to be screwed into the dental implant with a predetermined torque; a shell portion having an inner surface and an outer surface, the shell portion having a first end with an opening and a second end having a locking screw, the ball being captured inside the shell portion by a threaded portion of the base post that extends into the opening; a ball-shell assembly comprising: a titanium base having an opening at a proximal end and an interface at a distal end designed to be attached at a predetermined location to the exterior of the shell portion; one or more drive tools designed to engage the abutment drive interface with the locking screw, at least one of which can be inserted through an opening in the titanium base to engage the locking screw and apply pressure to the ball to fix the orientation of the shell upon tightening of the locking screw; Equipped with:

[0026] For purposes of this disclosure, a dental prosthesis is broadly defined as incorporating one or more dental copings or titanium bases that can be attached to one or more implant abutments. A variety of titanium base designs are known in the dental industry, and the systems and methods disclosed herein can be adapted for machining with many commercially available types of titanium bases, including pick-up copings, temporary cylinders, inserts, and impression copings. Implant abutments with compatible interfaces to these titanium bases are known in the dental industry. Because the mechanical interfaces are the same, for purposes of this disclosure, implant abutments are considered generic, including abutment analogs. The description of the abutment alignment system and process with a titanium base and implants that are loaded into a patient's jaw should also be considered to describe equivalent inventive concepts that can be used with titanium bases and implant analogs in a dental laboratory. A common geometry includes a conical titanium base that fits onto a conical implant abutment. This system configuration is used in the following figures and discussion, but the inventive concepts may be applied to other types of titanium bases and abutments.

[0027] The inventive concepts disclosed herein may be used in various types of dental prostheses. A dental prosthesis may be any form of impression used in a dental laboratory to aid in the creation and testing of a dental prosthesis. A dental prosthesis may also be fabricated in a dental laboratory using a physical model made from an impression, a newly fabricated dental prosthesis, or an existing prosthesis modified for screw attachment. A dental prosthesis is defined to include a single-tooth appliance such as a crown or a multi-tooth bridge or denture. These prostheses may incorporate a titanium base to provide a separable interface and be oriented with a suitable abutment that is attached to the patient's jaw or gums. Although the name implies an application involving multiple implants, multi-unit abutments may be used separately to attach to implants for single-tooth prostheses. As a result, the term multi-unit abutment is used herein for both single-implant and multiple-implant applications and for any form of dental prosthesis. Multi-unit abutments for use in the inventive concepts disclosed herein include a screw thread for attaching a prosthesis with a titanium base to the abutment and the abutment to an implant. Although the concepts are shown with a general external thread of the multi-unit abutment that engages with an internal thread of the implant, this is for convenience of disclosure. Some inventive concepts may also be applied to systems with an internal thread of the multi-unit abutment that mates with an external thread of the implant, even if not expressly described or limited by functional necessity. These are considered simple variations of the inventive concepts. One advantage of preferring a general internal thread of the implant for abutment attachment is standardization and implementation flexibility. For the same reason, prosthetic screws with external threads and a commercially available titanium base are preferred, but are not necessary to obtain some advantages from the disclosed inventive concepts. These types of variations are considered to be within the scope of this disclosure.

[0028] The systems and methods disclosed herein may be used in prostheses for placement of implants in both the upper and lower jaws. As a result, system portions having a downward orientation for the lower jaw will have an upward orientation for the upper jaw and vice versa. For convenience, disclosure of embodiments of the inventive concepts limited to a single jaw orientation will be considered to disclose embodiments for the opposite jaw orientation. When referring to the clinician's viewpoint, the proximal portion is closer to the clinician than the distal portion. Terms such as top are opposite to the term bottom, and proximal is opposite to distal, and the actual relative orientations will be determined by the context of use. The term tissue side is used interchangeably with concave to refer to the side of the prosthesis that is opposite to the occlusal or convex side.

[0029] The disclosed inventive system is applicable and beneficial to screw-mounted prostheses and abutments. The main advantages of screw mounting are variable tightening torque and reversibility. The terms permanent, semi-permanent, definitive, and final when referring to screw mounting are used interchangeably in this disclosure. A conventional screw that is definitively mounted can still be removed by accessing the screw and rotating it in the opposite direction to that used for mounting. For the purposes of the screw-mounted prostheses of the present disclosure, mounting is semi-permanent, permanent, or definitive in that frequent mounting and removal is not expected in normal use. In contrast, provisional screw mounting is applied for a planned process period or other expected interval. The placement of a titanium base in a dental prosthesis is effectively performed by a lift-off process using provisional screws as disclosed in commonly owned U.S. Pat. No. 11,311,354, which is incorporated herein by reference in its entirety. However, the usefulness of the inventive concepts of the present disclosure does not depend on the use of the systems or methods disclosed in the cited patents.

[0030] Screw attachment of the abutment to the implant is also described in the embodiments. However, some of the concepts disclosed may be easily adapted to other systems that do not utilize screw attachment of the dental component to the implant, such as snap-on or magnetic systems. These modifications are considered obvious variations of the inventive concepts described in this disclosure.

[0031] Removal of the semi-permanent or definitive screw is generally motivated by a problem or opportunity for improvement. Access to the screw to apply a removal tool requires removal of the screw's coating material, which is added for aesthetic reasons. In some embodiments, adjustments to the orientation of the multi-unit abutment are made when the prosthesis is placed on the multi-unit abutment without the semi-permanent or definitive screw in place. This can be to improve the passive fit of the prosthesis to the implant when it is first loaded or after the system has been in use for an extended period of time. Although implant abutments are generally used to initially place the titanium base on the prosthesis, individual alignment errors inevitably accumulate during subsequent processing or over time. The apparatus and method disclosed below, in which the titanium base set of the prosthesis is used to fine-tune the alignment of the multi-unit abutment to the titanium base set, improves the overall passive fit.

[0032] Elements disclosed herein may be characterized as having an axis or longitudinal axis. In the case of a long cylindrical object such as a pencil, it is clear that the longitudinal axis runs through the center of the cylinder from the writing end of the pencil to the eraser end. The longitudinal axis is conventionally considered to be along the length or longest dimension of an object characterized by length, width, and thickness in descending dimensional scale. If instead of a pencil, a screw bolt is considered, the axis or longitudinal axis may also be considered to run through the center from the mating end of the screw to the center of the head of the bolt. The rotation axis and longitudinal axis in this case are the same for a thick and short bolt. In this disclosure, the axis or longitudinal axis of an object with a screw thread is the same as the rotation axis of the screw. The width is measured perpendicular to this rotation axis. Thus, a conventional nut with an internal thread is considered to have a longitudinal axis in the center of the central opening, i.e., where the axis of the matching bolt is located when mated. Thus, a washer without threads that is gripped between a bolt and a nut may also be considered to have a longitudinal axis, or simply an axis that is centered in the opening and perpendicular to the washer plane. For purposes of this disclosure, a linear assembly of components is the result of having the component axes of the assembly in a generally collinear arrangement. Thus, an assembly that includes a bolt with a washer and a nut is a linear assembly even if the washer opening is larger than the width of the threaded section of the bolt, thereby allowing the axis of the washer to move around the shared axis of the bolt and the nut. An external thread is generally characterized as having a minor diameter measured at the root of the threads and a major diameter measured at the apex of the threads. An internal thread is generally characterized as having a minor diameter at the apex and a major diameter at the root. Unless otherwise specified, the width of the external thread of a bolt stem is defined as the major diameter or maximum deviation from the bolt axis, i.e., measured in calipers. The width of the internal thread of a nut is defined as the minor diameter of the internal thread or the smallest deviation from the nut axis, ie, as measured with a pin or plug gauge.

[0033] In this disclosure, some threaded elements that fasten by relative rotation may have some characteristics that may be considered nut-like, such as elements that have both female and male threads, and other characteristics that are screw-like. The term screw is used generically in this disclosure for these threaded elements when discussing the inventive concept. However, the external threads of the screw will be considered to be male and the internal threads will be considered to be female.

[0034] For the purposes of this disclosure, the term ball refers to a mechanical structure that includes some geometric attributes of a sphere. It is a more generic term that allows only some portions of the ball's surface to have an essentially spherical surface while other portions deviate significantly from a spherical surface. A spherical surface is preferred for orientation flexibility and sealing of the interface between the ball and the structure that can be repositioned and locked into position relative to the ball, possibly by pivoting. A shell at least partially surrounds the ball. The interface between the exterior of the ball and the interior of the shell is preferably a spherical surface segment of approximately the same diameter for enhanced frictional grip when initiating the fixation process or to provide a sealing surface that seals the interior of the assembly from biological contamination. Although it is preferred to have the flexibility to position the axes of the prosthetic screw and titanium base at an angle of 30 degrees with respect to the axis of the implant and without any restriction in the rotation angle about either axis, the engaging elements of the implant, ball, shell, or titanium base may be designed to limit this full angular flexibility. Such limiting modifications are well known in the art and may be used with some of the inventive concepts disclosed herein.

[0035] It is common in dental prosthetics to fasten screw elements with a desired torque, or to fasten some elements with a higher or lower torque than some other element combinations. For example, it is common that when three elements are screwed in sequence, it is preferable for the first two to be assembled with a higher torque so that the third element can be installed or removed without affecting the installation of the first two. In some cases, the torque is quantified with a torque wrench, and the practitioner's experience is sometimes used to determine when the torque is sufficient to perform the desired function. For the purposes of this disclosure, it is considered to be specified whether these torques are evaluated quantitatively or qualitatively. If a quantitative minimum torque value or tolerance is specified as essential, measurement with a tool or with a support structure cut into the part is expected. In some embodiments, it is desirable to prevent over-torque that causes structural or biological stresses to the implant fitting or prosthesis through poor control of sacrificial elements. This controlled mechanical failure can result from both intentionally weak structures and characterization of failure characteristics inherent to homogeneous structures.

[0036] Other terms in the specification and claims of this application should be interpreted using their commonly accepted and ordinary meanings as qualified by the contextual language of the place where they are used. "A" or "an," as used herein, is defined as one or more than one. The term "plurality," as used herein, is defined as two or more than two. The term "another," as used herein, is defined as at least a second or more. The terms "including" and / or "having," as used herein, are defined as comprising (i.e., open language). The term "coupled," as used herein, is defined as connected, although not necessarily directly, and not necessarily mechanically. The terms "about" and "essentially" mean ±10 percent. Reference throughout this document to "one embodiment," "certain embodiment," "an embodiment," or similar terms means that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment of the present invention. Thus, the appearances of such phrases in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments without limitation. The term "or," as used herein, is to be construed as inclusive or any one or any combination. Thus, "A, B, or C" means any of the following: "A," "B," "C," "A and B," "A and C," "B and C," "A, B, and C." An exception to this definition is when a combination of elements, functions, steps, or acts is mutually exclusive in some respect by nature.

[0037] The drawings are intended to illustrate certain convenient embodiments of the invention and are not to be considered limiting thereof. The term "means" preceding the present participle of an operation refers to the desired functionality that one skilled in the art may select from among these or equivalents thereof in light of the disclosure herein, provided that one or more embodiments, i.e., one or more methods, devices, or apparatuses for achieving a desired function, and the use of the term "means" is not intended to be limiting. Other objects, features, embodiments, and / or advantages of the invention will become apparent from the following specification taken in conjunction with the following drawings. [Brief description of the drawings]

[0038] [Figure 1] FIG. 1 is an exploded bottom isometric view of a first embodiment of an omnidirectional multi-unit abutment assembly with a titanium base and a prosthetic screw. [Diagram 2] FIG. 1 is an exploded top isometric view of a first embodiment of an omnidirectional multi-unit abutment assembly with a titanium base and a prosthetic screw. [Diagram 3] FIG. 3 is a side view of the assembled system of FIGS. 1 and 2 without the prosthetic screw, with the longitudinal axes of the components aligned. [Figure 4] FIG. 4 is a side cross-sectional view of the assembled system of FIG. 3 taken along the longitudinal axis. [Diagram 5] FIG. 5 is a side view of the assembly of FIG. 4 after reorienting the swivel shell and titanium base. [Figure 6] FIG. 3 is an assembled top isometric view of the omnidirectional multi-unit abutment of FIGS. 1 and 2. [Figure 7] FIG. 5 is a side cross-sectional view of the assembly of FIGS. 3 and 4 during installation onto an implant. [Figure 7A] FIG. 13 is an inset with relative scaling of the implant driving tool. [Figure 8] FIG. 6 is a cross-sectional side view of the assembly of FIGS. 3 and 4 after reorienting the swivel shell and titanium base as in FIG. 5, showing fixation of the orientation by the locking screw. [Figure 8A] FIG. 13 is an inset with relative scaling of the locking screw driving tool. [Figure 9] FIG. 9 is a side cross-sectional view of the assembly of FIG. 8 after fixation of the titanium base by the prosthetic screw. [Figure 10] FIG. 13 is an assembled bottom isometric view of a second embodiment of an omnidirectional multi-unit abutment and titanium base in a linear configuration. [Figure 11] FIG. 11 is a side view of the embodiment of FIG. [Figure 12] 12 is a cross-sectional view of the embodiment of FIG. 11 taken along the longitudinal axis. [Figure 13] FIG. 12 is a cross-sectional view of the embodiment of FIG. 11 after a prosthetic screw has been added. [Figure 14] FIG. 13 is an exploded top isometric view of a third embodiment of an omnidirectional multi-unit abutment with a titanium base and a prosthetic screw. [Figure 15] FIG. 15 is a top isometric view of the embodiment of FIG. 14 in a linear assembled configuration. [Figure 16] 15 is a cross-sectional view of the embodiment of FIG. 14 taken along the longitudinal axis. [Figure 17] FIG. 15 is a schematic top view of a locking screw for the embodiment of FIG. 14 with a hexalobular internal (Torx®) drive feature. [Figure 18] FIG. 15 is a schematic top view of a lockscrew for the embodiment of FIG. 14 with a four-lobe internal drive feature. [Figure 19] FIG. 15 is an exploded top isometric view of a four lobe driver tip with locking screw and abutment base for the embodiment of FIG. [Figure 20] FIG. 13 is an exploded top isometric view of a two-part abutment base stem with a sleeve and swivel mount for a fourth embodiment of an omnidirectional abutment. [Figure 21] FIG. 21 is a top isometric view of an assembled two-part abutment base stem with sleeve and swivel mount of FIG. 20. [Figure 22] 22 is a cross-sectional view of the assembled two-part abutment base stem with sleeve and swivel mount of FIG. 21 , taken along its longitudinal axis. [Figure 23]1 is a cross-sectional view of an application environment of a representative embodiment of an omnidirectional multi-unit abutment including a prosthesis and an implant. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0039] To illustrate the options for providing the advantages of a screw-mounted omnidirectional multi-unit abutment, multiple embodiments are included in the present disclosure. FIGS. 1 and 2 show an exploded view of one embodiment of an omnidirectional multi-unit abutment 100 having four components: an abutment base 1, a swivel mount 2, a swivel base 3, and a locking screw 4. Also shown in the exploded views of FIGS. 1 and 2 is a representative titanium base 5 and a prosthetic screw 6. The omnidirectional multi-unit abutment assembly 100 may be made of titanium or other suitable materials for implant abutment systems, including precious and non-precious metals and alloys, ceramics, and high-strength engineering polymers (e.g., PEEK, PEI), or combinations of the above materials. Treatments, coatings, or gels may be added to the surfaces of the components or spaces between them to prevent unwanted biological growth or pre-union. FIG. 3 shows the elements of FIGS. 1 and 2 in a linear orientation, excluding the prosthetic screw 6. FIG. 4 shows the internal features of the assembly of FIG. 3 along the longitudinal section line A-A of FIG. 3. Please note that in Fig. 4, the presence of a titanium base 5 is shown for illustrative purposes. The titanium base 5 will ultimately be held in a prosthesis (not shown) and attached to the omnidirectional multi-unit abutment using a prosthetic screw 6 shown in Fig. 6. The prosthetic screw 6 may be a permanent screw or a temporary fastener of the type described in commonly owned US Patent No. 11,311,354 and other related applications by continuity. Fig. 6 is a perspective view of the assembly of Figs. 1 and 2 in a linear configuration. Fig. 5 is a side view of the embodiment tilted at about 30 degrees. Figs. 7-9 show various stages of loading and adjustment of this embodiment into an implant.

[0040] The abutment base 1 includes a ball or sphere portion 13 having a diameter of approximately 3.25 mm and an abutment base drive feature 10 at its proximal end. As shown, the drive feature can be a T5 size hexalobular internal (torx) drive feature socket centered on the longitudinal axis at the top of the ball portion 13. Other types of drive tools may be used. The distal end of the abutment base 1 is a threaded portion 14 for attachment to the female threads of an implant 16 secured to the jawbone of a patient. The implant 16 and its attachment to the mandible or maxilla are described generally in this disclosure, since the inventive concept of an omnidirectional multi-unit abutment can be adapted to interface with a variety of abutments. The universal implant 16 shown in FIG. 7 with female threads is a very common design, but the abutment base attachment portion 14 and the mating portion 21 can be adapted to accommodate other implants.

[0041] The swivel base 3 includes an opening 19 and an internal curved portion 15 with a size and shape that essentially matches the curvature of the ball portion 13 of the abutment base 1. The illustrated swivel mount 2 includes internal threads 20 for attachment to the external threads 9 of the locking screw 4. The swivel mount 2 also includes a titanium base mating feature 22 for supporting and orienting the titanium base 5 when attached to the omnidirectional multi-unit abutment 100 by a prosthetic screw. The swivel mount may optionally include a mating feature 11 that may be used to mount a tool such as a wrench to aid in the assembly of the titanium base 5 or to limit its azimuth orientation (not shown). Limiting the orientation of the titanium base by matching mating features between the titanium base and the implant abutment is a common technique useful for single-tooth crowns. The embodiment of the omnidirectional multi-unit abutment 100 herein may be easily adapted to single-tooth prostheses by matching abutment mounting surfaces not described in detail, by fixing the azimuth orientation of the non-cylindrical symmetrical titanium base.

[0042] The ball portion 13 of the abutment base 1 can be captured between the swivel base 3 and the swivel mount 2, which form a swivel shell around the ball portion 13, with the abutment base screw thread portion 14 extending into the swivel base opening 19. For this insertion process, the opening 19 must be larger than the abutment seating projection 21. The swivel base 3 and the swivel mount 2 are preferably joined at the interface joint 12, for example by continuous or spot welding with a laser, after placement around the ball 13 to form the base assembly 101. This joining technique provides a robust assembly of the thin shell over a short distance, although other joining techniques may be used to capture the ball portion 13 within the shell. As shown in the cross-sectional view of FIG. 4, the mechanical design of the internal curvature 15 and opening 19 of the assembled swivel base 3 and swivel mount 2 can be designed to prevent the ball portion 13 of the abutment base from falling out of the swivel shell after joining. The relative size and shape of the opening 19 in the abutment seating protrusion 21 and the size and shape of the abutment base 1 determine the range of tilt possible. Generally, if both the minor diameter or width of the swivel base opening 19 and the swivel mount internal threads 20 are less than the width of the ball 13, the ball 13 will be captured in the shell without the locking screw 4.

[0043] The locking screw 4 as shown has external threads 9 that mate with internal threads 20 of the swivel mount 2. These threads may be, for example, m3×0.35 size. The locking screw 4 also has internal threads 7 for mounting the prosthetic screw 6 and an internal drive feature 8 for a tool mount that fastens the locking screw 4 to the swivel mount 2. Alternative prosthetic screw sizes include m1.4×0.3 threads, m1.6×0.35, UNF1-72, etc. The drive feature 8 may be a socket that accommodates common dental drivers, including Torx T5 or T6, 0.035″ to 0.050″ hex or square drivers, or similarly sized straight or star drivers. As shown, the internal threads 7 and drive feature 8 have a partial overlap along the longitudinal axis of the locking screw. This is a design choice. Complete axial overlap or no axial overlap are other design options.

[0044] The swivel base 3 is configured to mate with a segment of the spherical ball feature 13 when the locking screw 4 is tightened. The views and cross sections shown illustrate an embodiment in which the swivel base and mount are positioned and rotated anywhere within a 30 degree cone as shown in FIGS. 5 and 8. The tilt magnitude and orientation of the allowable adjustment is a design choice, but a 30 degree tilt is generally sufficient for most clinical applications. As shown in this embodiment, the swivel base opening 19 and the opening of the screw 20 of the swivel mount 2 are smaller than the diameter of the ball portion 13. In this case, the ball portion of the abutment base 13 can be loosely gripped by the swivel base 3 and the swivel mount 2 when these two parts are attached to each other. That is, it is not necessary for the locking screw 4 to be attached to the swivel mount 2 in the illustrated embodiment to provide a shell that grips the ball portion 13. This is a design option and not a requirement to benefit from the inventive concepts of the present disclosure.

[0045] The cross-sectional view of FIG. 4 of this omnidirectional multi-unit abutment embodiment including the titanium base 5 can be used to illustrate some of the advantages of the preferred geometric relationships between the elements. As shown, the ball portion 13 is spherical throughout the range of motion of the shell formed by the swivel base 3, swivel mount 2, and locking screw 4. The tilt range limit due to the interference between the swivel base 3 adjacent the opening and the surface 61 of the abutment base 1 near the abutment seating portion 21 is marked as angle b in FIGS. 5 and 9. The internal curvature of the swivel mount 2 is essentially the same as that of the ball portion 13. The locking screw 4 has essentially the same curvature as the ball 13 at the contact area. The internal curvature 15 of the swivel mount 2 is preferably slightly larger than the curvature of the ball 13. As a result, when the locking screw 4 is tightened, the ball portion 13 is in contact with the internal curvature 15 of the swivel base 3 and the corresponding internal curvature of the locking screw 4. Due to the large internal curvature of the swivel mount 2, the locking screw 4 does not contact the ball when fully tightened. Thus, a consistent, continuous circular seal of the swivel base against the ball is provided to help prevent the ingress of biological contamination into the interior of the omnidirectional, multi-unit abutment assembly. In the linear configuration of FIG. 4, the locking screw 4 provides an equivalent circular seal with the ball portion 13. As shown in the maximum tilted state of FIG. 9, a continuous seal of the swivel base 3 against the ball is maintained. However, due to the presence of the abutment drive feature 10, the seal of the locking screw 4 against the ball 13 is not continuous. However, when the titanium base 5 and prosthetic screw 6 are applied to the omnidirectional, multi-unit abutment, the abutment drive feature 10 is effectively sealed.

[0046] The relatively large ring-like contact of the hollow locking screw 4 against the ball 13 distributes the clamping force over a larger area than the concentrated contact of a solid set screw. It has been determined that the enlarged contact and alignment curvature 15 of the swivel base against the ball 13 provides sufficient frictional grip to allow tightening of the locking screw 4 at greater than 25 Ncm without retention of the swivel base 3 or swivel mount 4 when the components are made of titanium. The relatively large contact area also minimizes distortion of the ball 13 due to clamping compared to a concentrated solid set screw, thus facilitating repositioning of the inclination or azimuth angle without interference from distortion of the ball 13 geometry. The relatively large outer diameter of the locking screw 4 also provides sufficient thickness between the internal threads 7 and external threads 9 for mechanical strength to apply torque to the locking screw 4 with a driving tool size comparable to the width of the threads of the prosthetic screw 6.

[0047] A relatively large locking screw 4 allows a sufficient number of locking screw threads 8 to mate with the internal threads 20 of the swivel mount to provide a consistent clamping force on the ball 13. Threads (not shown) may also be used at the joint 12 between the swivel mount 2 and the swivel base 3, but the diameter of the omnidirectional multi-unit abutment would need to be increased to have sufficient wall thickness and mating thread depth to provide strength comparable to the relative sizes shown in FIG. 4. However, if it is desired to prevent over-torque of the locking screw 4, a limited engagement of the screw threads between the swivel mount 2 and the swivel base 3 may be used to cause separation when a threshold torque is reached. Other options for torque limiting include adjusting the preferred weld joint strength as described above, increasing the size of the opening 19 in the swivel mount, and / or incorporating an intentionally thin wall section with low torque resistance in the swivel base adjacent to the opening 19. Although intentional failure by design may result in loss of the omnidirectional multi-unit abutment, this is preferable over-stressing resulting in future failure of the prosthesis or implant retention.

[0048] The hollow locking screw 4 and the drive geometry shown in FIG. 4 provide advantages in loading and maintaining the dental system. After the swivel base 3 is attached to the swivel mount 2 to form the base assembly 101, the shell portion formed by the swivel mount 2 and swivel base 3 grips the ball portion 13 of the implant base. When the locking screw 4 is inserted into the swivel mount 2 and rotated enough to secure it but not to contact the ball portion 13, the omnidirectional multi-unit abutment assembly 100 is formed. A titanium base 5 is optionally placed on top of the omnidirectional multi-unit abutment assembly and the parts aligned on a common axis as shown in FIGS. 3 and 4. The titanium base 5 does not need to be in place during the loading and orientation of the abutment base 1, swivel base 3, swivel mount 2 and locking screw 4. Once aligned in this way, a drive tool 17 is inserted into the titanium base 5 and locking screw 4 to engage the drive feature 10 of the abutment base 1 as shown in FIG. 7. Note that it may be necessary to rotate the drive tool 17 slightly after penetrating the locking screw 4 to mate with the abutment base drive interface 10. Preferably, the mating fit between the drive tool 17 and the abutment base drive feature 10 has enough friction to place the omnidirectional multi-unit abutment assembly on the implant 16, leaving the omnidirectional multi-unit abutment 100 on the drive tool 17, as shown in FIG. 7. Slight torquing of the locking screw 4 in the loosening direction aids in this retention. As the drive tool 17 is rotated, the abutment base threads 14 mate with the implant 16 and the omnidirectional multi-unit abutment assembly is threaded to achieve the desired fit of the abutment fitment 21 to the implant 16. Because the drive tool mates with both the abutment base 1 and the locking screw 4, these parts rotate simultaneously. The position of the locking screw 4 has not changed with respect to the abutment base 1, so the ball portion 13 is not pinched between the swivel base 3 and the locking screw 4.The rotational force from the driving tool 17 drives the abutment base screw 14 deeper into the implant 16 .

[0049] The mating portion 21 of the abutment base that contacts the implant can be modified to match the mating geometry of a fixed angle abutment. The drive feature 10 allows for the fastening of the threaded portion 14 of the abutment base 1 to the implant 16. The fastening of the abutment base 1 to the implant can proceed until the desired mating pressure at the abutment mating portion 21 is obtained. A typical torque value is about 30 Ncm, but this value depends on the implant system employed and can be higher or lower. For immediate loading of the prosthesis, the torque value should be less than the torque value used to load the implant into the jawbone.

[0050] As shown in FIG. 8, once the abutment base 1 is secured to the implant 16, the linear configuration of FIG. 7 is no longer needed. The inclination and azimuth angle of the swivel mount 2 to receive the titanium base 5 desired for prosthetic installation can be selected by movement of the driving tool 18 inserted into the locking screw 4. Rotation of the driving tool 18 causes the locking screw 4 and swivel base 3 to clamp the ball portion 13 and lock the angle of the omnidirectional multi-unit abutment 100. A mating feature 11 can be included to prevent the locking screw and swivel base from rotating while the locking screw 4 is tightened. Other mating features such as eyelets or splines can also be used as anti-rotation or azimuth selection features for this purpose. In the case of a single-tooth prosthesis, the orientation angle of the titanium base is selected and maintained during tightening of the locking screw 4 by the selection feature of the swivel mount 2 mating with the rotational fixation feature of the titanium base. A coaxial two-part tool including a driving tool similar to 18 mated with an anti-rotation feature may be used to orient and tighten the swivel mount 2 and locking screw 4 in place at the ball portion 13 of the abutment base 1. Providing a titanium base 5 included in the arrangement of FIG. 5 may be convenient for azimuth angle selection.

[0051] In both the temporary and final prostheses, the drive feature 7 of the locking screw 4 is preferably accessible from the titanium base 5. Thus, if the locking screw 4 loosens over time, it can be moved and retorqued to the proper orientation, fine-tuning can be done to improve the passive fit, and one of the omnidirectional multi-unit abutments 100 can be replaced and realigned. Comparing the drive tool dimensions d1 shown in the inset of FIG. 7a and d2 shown in the inset of FIG. 8a, the drive tool 18 shown in FIG. 8 is larger than the drive tool 17 of FIG. 7. This is not necessary. The advantage of using two different sizes, for example a T5 driver 17 for driving the abutment base 1 and a T6 driver 18 for fixing the locking screw 4, is that additional clearance is provided for the locking screw 4 while driving the abutment base. The first torque wrench with driving tool 17 and the second torque wrench with driving tool 18 help ensure that the desired torque is obtained, as the torque used to drive the abutment base 1 can be selected to be higher than the torque used for the locking screw 4. Of course, the size and shape of the driving tool 17 must penetrate the locking screw 4 to load the assembled omnidirectional multi-unit abutment 100 into the implant 16 as shown in FIG. 7. The locking screw internal driving interface 8 shown does not extend to the distal side of the locking screw 4, thus preventing the driving tool 18 in FIG. 8 from penetrating the locking screw 4. This is a design choice.

[0052] Some practitioners may prefer to use an experienced physical feel instead of an objective calibrated tool to determine when the desired predetermined torque is applied to the implant base 1 and locking screw 4. If the abutment base driving interface 10 and the locking screw driving interface 8 are the same size and shape, one tool may be used for the driving tools 17 and 18. In this case, after the abutment base 1 is driven into the implant 16 as in FIG. 7, the driving tool 17 only needs to be withdrawn far enough to disengage the abutment base driving interface 10 before repositioning the abutment base by rotating the locking screw 4 to lock the position of the omnidirectional multi-unit abutment 100. If different torques by calibration are desired, two different wrenches would be used for the same driving tool tip size. Some practitioners may choose to leave the driving tip inserted into the omnidirectional multi-unit abutment for both torque application process steps and switch the torque wrench set to a different value. Since the axis of rotation of the drive tool 17 is generally different from the drive tool 18, it is acceptable to use the same torque magnitude for the abutment base 1 and locking screw 4. A torque wrench with a push button or other selector to switch between two different torque settings may be useful. Automatic selection may be based on the difference in the greater drive tool depth required to mate with the abutment base drive interface 10 compared to the locking screw drive interface 8, for example, due to the force required along the axis of the drive tool tip to mate a spring-loaded sheath with a high torque mechanism. In this case, slippage may occur but remain engaged at the lower torque setting, if desired.

[0053] FIG. 9 shows a cross-sectional view of an omnidirectional multi-unit abutment assembly 100 including a prosthetic screw 6 holding a titanium base 5. To facilitate placement of the titanium base 5 in the prosthesis by a lift-off process, the prosthetic screw 6 may be replaced with a breakaway fastener (not shown) as described in the cited U.S. Pat. No. 11,311,354. Note that even after the titanium base 5 is incorporated into the prosthesis, access to the locking screw drive interface 8 is possible by removing the prosthetic screw 6. This essentially changes the configuration from FIG. 9 to FIG. 8. The advantages of this will be described in more detail after other embodiments are presented.

[0054] Variations on the embodiment shown in Figures 1 to 9 are shown in Figures 10 to 13. From a practical design standpoint, given the limitations of conventional abutment diameter and fit height (the distance between the fit surface 22 of the titanium base 5 and the implant fit surface 21 in the first embodiment), as well as other dimensional limitations, the omnidirectional multi-unit abutment design may also include an embodiment in which the abutment base 30 and the ball or spherical feature 31 are initially separate components. In the embodiment of Figures 1 to 9, the ball is approximately 3 mm in diameter. A nominal fit height of approximately 2.5 mm is shown in the figures.

[0055] The second embodiment shown in Figures 10-13 is shown with approximately the same dimensions to work with the same implant 16 and titanium base 5 as the omnidirectional multi-unit abutment assembly 100 shown in Figures 1-9. The fit height between the abutment fit portion 42 and the titanium base seat 41 is also comparable. The main difference is that the swivel 32 is captured between the parts of the two-part abutment base 30. The abutment base 30 of Figure 12 includes a separate ball portion 31 that is attached to the stem portion 34. The separate part 31 may be useful, for example, in cases where the swivel base does not fit the required abutment diameter without interference. Consequently, the embodiment of Figures 10-13 includes a ball 31 with a drive interface 45 that includes a distal mounting hole 46 that is attached to an engagement post feature 35 of the abutment base stem portion 34. After the ball 31 is inserted into the swivel 32, it is assembled to the base stem portion 34 by any form of mechanical fit, such as a press fit, heat shrink, laser welding, adhesive, or a combination thereof. For example, the ball 31 can be lightly press fit onto the post 34 and a small diameter laser weld is made at the interface 35. This method securely joins the ball to the base while minimizing mechanical precision work and providing a fillet at the mating joint 35, sealing the joint from liquid ingress.

[0056] In the illustrated embodiment, the minor diameter of the internal threads 38 of the swivel 32 is large enough for the ball 31 to be inserted into the internal threads 40 of the swivel mount 32. The drive interface 45 can be used to orient the ball for assembly. After gripping the swivel 32 and loading and tightening the locking screw 33, the ball 31 contacts the swivel 32 at the sealing surface 47. An approximately 17.5 degree fit / interference surface is illustrated in FIGS. 12-13. The locking screw 33 also contacts the ball 31 at the interface 48. Various surface finishes and mechanical features can be employed to enhance the locking ability of the engagement surfaces 48, 47 to the ball 31, such as textures, ridges, and ribs. Note that this approach to gripping the swivel 32 to the ball prevents the swivel 32 from falling off the ball 31. The swivel 32 contacts the distal face of the ball in a similar manner to the swivel base 3 of the first embodiment of Figures 1-9, but is also provided with a titanium base fitting 41 which supports the titanium base 5 in a predetermined orientation similar to that provided by the titanium base fitting 22 of the swivel mount 2 described above.

[0057] The locking screw 33 is similar to the locking screw 4 of the first embodiment. It includes a prosthetic screw thread 36, a drive socket feature 37, a mating surface 48, and external threads 39. The proximal end of the ball portion 31 includes a drive socket feature 45 that can be accessed from the locking screw 33 similar to the locking screw 4 described above. When the locking screw 33 is tightened using the drive feature 37, the swivel 32 mates with the mating surface 47 of the ball 31, thus allowing the locking screw 33 to secure the swivel 32 in an ideal omnidirectional orientation up to 30 degrees away from the implant axis and at a desired azimuth angle. Again, the titanium base 5 does not need to be present during loading and orientation of the omnidirectional multi-unit abutment. Through appropriate selection of the size of the prosthetic screw thread 36 and the drive features 45, 37, 44, it is possible to utilize a single drive tool for the three steps of fastening the abutment base 30 to the implant (not shown), locking the orientation of the swivel 32 with the locking screw 33, and fastening the prosthetic screw 44. For example, a single generic T5 drive tool can be used for the M1.6×0.35 prosthetic screw 43 with thread 36 if the drive interfaces 37, 44, 45 have T5 socket characteristics. Of course, in this case, the locking screw drive interface 37 does not need to extend to the locking screw 33 (not shown) to mate with the abutment base drive socket feature 45. It has been determined that the portion of the M1.6 prosthetic screw thread removed for the T5 driver provides adequate thread integrity to adequately hold the prosthetic screw. Other standard and custom combinations of threads and drive geometries may be used to allow the use of a single drive tool.

[0058] By assembling the ball 31 to the abutment base 30, the width of the abutment base 20 at the implant attachment point 42 can be larger than in the first embodiment. In the first embodiment, the threaded end 14 of the abutment base 1 was inserted into the swivel base opening 19 so as to contact the ball portion 13. The ball portion 13 was gripped by joining the swivel mount 2 to the swivel base 3. By combining the characteristics of the swivel base 3 and the swivel mount 2 into a single swivel 32 in this embodiment, the size of the distal end of the abutment base is not limited by the opening at the distal end of the swivel 32 opening. In the embodiment of Figures 10-13, the minor diameter of the locking screw outer thread 39 must be larger than the diameter of the ball 31 so that the ball inserted into the swivel 32 can be joined to the abutment base 30. A comparison of Figures 12 and 4 shows that this results in a shorter depth for thread engagement between the swivel 32 and the locking screw 33.

[0059] Another approach for gripping a swivel shell component to an abutment base with ball feature is shown in Figures 14-16. In this embodiment, an abutment base assembly 101 is fabricated from a swivel 32 and a ball with a tapered stem 50, which has a ball feature 13 with a drive feature 45 at its proximal end and a tapered stem 51 at its distal end. The tapered stem 51 is joined to a base 52 with a tapered socket 53 at its proximal end and an abutment base screw thread 14 at its distal end. The widest part of the ball with tapered stem 50 is the diameter of the ball 13. The swivel 32 is gripped by inserting the tapered stem 51 proximally into the swivel 32 before inserting the tapered stem 51 into the tapered socket 53.

[0060] 15 and 16 show abutment base assembly 101. As noted above, tapered stem 51 and base 52 may be joined by a variety of techniques. However, it is preferred to include welding at interface 63. A comparison of FIG. 16 with FIG. 14 shows that ball portion 13 of ball with tapered stem 50 may have improved structural stability compared to abutment base 31. This may be important considering the small size of the parts and the desirability of a smooth pivoting action and tight seal of the parts when locked in place.

[0061] The locking screw 49 shown in FIG. 14 differs from the locking screws 4 and 33 of the previous embodiments by including a hexagonal driving feature 64 on its outer surface near its proximal end. This hexagonal driving feature 64 is provided to aid in the removal of an incorrect loading. For example, if the prosthetic screw stem 25 breaks off within the locking screw 4, the locking screw driving interface 8 may be blocked to prevent the insertion of the driving tool 18 used to load the omnidirectional multi-unit abutment. As an alternative to removing the broken stem 25, a wrench (not shown) may be applied to the hexagonal feature 64 to remove the locking screw 49. Of course, with the titanium base 5 in place in the omnidirectional multi-unit abutment, these hexagonal features 64 are generally not accessible. As a result, the locking screw driving interface 37 is preferred to use a titanium base embedded in the prosthesis to help align and lock the omnidirectional multi-unit abutment orientation to improve passive fit. If necessary, a wrench may be applied to the side flats 11 of the swivel 32 to aid in removing the trapped lock nut 49 since it is not covered by the titanium base 5 .

[0062] 17 is a top view of the locking screw 49. At the outer edge is the locking screw external thread 39, and at the center is the locking screw internal driving interface 8, shown as a Torx type. The major diameter 66 (dashed line) and minor diameter arc 65 of the screw internal thread 7 are shown. The minor diameter 65 is not a continuous circle, but a series of discontinuous arc segments due to the axial overlap of the locking screw internal driving interface 8 with the locking screw internal thread 7. Note that the locking screw 49 has the locking screw internal driving interface 8 and the internal thread 7 that extends entirely through the locking screw 49. In other words, there is essentially complete axial overlap through the thickness of the locking screw 49, such that both the prosthetic screw thread 25 and the driving tool 18, which are sufficiently long, can penetrate through the thickness of the locking screw 49. The amount of material of the locking screw 49 available for the driving tool 18 to apply torque to lock the orientation of the omnidirectional multi-unit abutment 100 corresponds to the volume enclosed by the major diameter 86 and minor diameter 65 of the screw internal threads 7 minus the material removed to provide a socket of the locking screw driving interface 8 for the driving tool 18 (not shown). The size and shape of the driving tool interface 8 can be modified to vary the strength of the remaining internal threads 7 to hold the prosthetic screw 6 and the maximum torque application to the locking screw 49 to fix the orientation before damaging the internal threads 7.

[0063] 18 is a top view of a locking screw 49 with an alternative locking screw internal drive interface 54. This drive tool interface 49 has four lobes instead of the six lobes of the previously illustrated Torx drive tool interface. A visual comparison with FIG. 17 is sufficient to show that more internal threads are retained as a result of having fewer lobes and a more pronounced lobe transition compared to FIG. 17. As a result, there are material and geometric tradeoff options available to compensate for the loss of mechanical strength resulting from the axial overlap of the internal threads 7 and the locking screw drive interface 54, so that the final alignment and locking of the omnidirectional multi-unit abutment 100 can be achieved with the prosthesis in place.

[0064] 19 shows a four-lobed drive tip 62 for the locking screw 49 of FIG. 18 and an abutment base 59 with a matching four-lobed drive interface 60. For clarity, other components of the omnidirectional multi-unit abutment 100 are not shown. The drive tip 62 is sized to pass through the locking screw 49 so that it can be used to drive the abutment base 59 into the implant 16 (not shown). The drive tip is sized to pass through the titanium base opening 23 (not shown) so that the locking screw 49 can also be rotated to fix the position of the omnidirectional multi-unit abutment in a prosthesis (not shown) in which the titanium base 5 (not shown) is embedded.

[0065] FIG. 20 shows another embodiment of a two-part abutment base 55 that is assembled to grip the swivel 32. In this embodiment, the ball portion 13 and abutment base screw thread 14 are contained in an abutment base stem 56. The distal end of the abutment ball base stem is inserted into the swivel 32 and into a hollow sleeve 57 that matches the interface requirements of the abutment 16 being used. The sleeve 57 has a maximum width that is greater than the diameter of the ball portion 13. As a result, the swivel 32 is gripped when the sleeve 57 is joined to the abutment base stem 56. Any of the various joining operations described above may be used, but preferably includes welding at the interface 58 as shown in FIG. 22. Also shown in FIG. 22 are two critical dimensions for the above assembly process. The minimum diameter "d" of the through opening of the swivel 32 must be greater than the maximum width "c" of the abutment base stem 56 below the ball portion. Due to the similarity of this embodiment to the previous one, other components and features are not described.

[0066] Many other ways of gripping the swivel to the ball with the abutment connection assembly installed are possible, such as various forms of male pins on the ball, female sockets on the abutment base, threaded posts on the ball or abutment, etc. Although an essentially spherical ball is shown embodying the inventive concepts to provide maximum orientation flexibility, other shapes may be used to purposefully limit orientation. Engagement interfaces that also use one or more of the illustrated inventive concepts may be tailored to serve purposes in embodiments not shown.

[0067] 23 shows a cross-section of the application environment of the loaded omnidirectional multi-unit abutment 100 of the first embodiment. An implant 16 is loaded into the patient's bone and soft tissue, shown diagrammatically as 70. The abutment base 1 is screwed into the implant 16 to a desired torque level. In this case, the swivel mount 2 8. The titanium base 5 is embedded in the prosthesis 68. 68 The occlusal surface 72 of the titanium base 5 is shown diagrammatically as 72. 2 The lock screw interface is 8 (Figure 1) The prosthetic screw 6 has been removed so that the prosthetic screw 6 is accessible to the driving tool 71 through the prosthetic screw access hole 69. Although a four lobe driving tool 71 is shown, a smaller driving tool (not shown) would be required to drive the abutment base 1 into the implant 16 as previously described for the first embodiment. As mentioned in the first embodiment, it would be beneficial to be able to make changes to the omnidirectional multi-unit abutment orientation with the prosthesis in place. Figure 23 is used to illustrate this in more detail.

[0068] Although only one implant is shown in FIG. 23, the advantage of on-site adjustment is greater when the prosthesis includes multiple titanium bases that engage multiple implants. During fabrication or modification of a prosthesis for implant attachment, uncertainty in the titanium base position can accumulate. Due to the random nature of these shifts, the orientation and position of the titanium bases can shift from each other and from the abutment set that was originally used to orient the titanium base with the prosthesis. Even if the titanium base was initially perfectly positioned, the shape of the patient's jaw or the prosthesis can change over time. As shown in FIG. 23, removal of the prosthetic screw 6 allows access to the locking screw 4 to be loosened with the driving tool 71. When a refitting force is applied to the prosthesis 68 from the occlusal side 72, the embedded titanium base 5 is pressed against the titanium base fitting 22, thereby correcting the orientation of the omnidirectional multi-unit abutment. Tightening the locking screw 4 with the driving tool 71 while maintaining the refitting force on the prosthesis 68 locks this orientation. The prosthetic screw 6 can then be reinserted and torqued to secure the titanium base 5 and prosthesis 68 in place. If it is desirable to check the torque on the locking screw 4 to see if it has loosened over time, this can be done through the titanium base 5 embedded in the prosthesis 68.

[0069] Similarly, if one omnidirectional multi-unit abutment 100 in the set breaks or needs to be replaced, the prosthesis 68 with the titanium base 5 embedded therein can be removed after removing all of the prosthetic screws 6. Reversing the process of angle setting and implant installation shown in Figs. 8 and 7 removes the broken omnidirectional multi-unit abutment assembly 100. Repeating the process of Fig. 7 to install a new omnidirectional multi-unit abutment 100 to the implant 16 results in the abutment base 1 being secured to the implant 16, but the shell consisting of the swivel base 3, swivel mount 2 and locking screw 4 being loosened. Minimal pressure on the locking screw 4 is sufficient to hold the orientation of the omnidirectional multi-unit abutment against gravity shifting, but only minimal force application is required to change the orientation. Enough swivel mount to fit the titanium base 5 to the prosthesis 68. 2 By roughly placing the abutment 10 and applying manual pressure to the prosthesis from the occlusal side 72, the newly loaded omnidirectional multi-unit abutment is reoriented to align with the titanium base already loaded in the prosthesis. Then, as shown in FIG. 23, the opening 23 in the titanium base 5 is inserted into the prosthesis. (Figure 4) From there, the locking screw 4 can be tightened into place. It is optional whether the prosthetic screw 6 of the original omnidirectional multi-unit abutment 100 is used to maintain alignment pressure on the newly loaded omnidirectional multi-unit abutment 100 prior to tightening the locking screw 6.

[0070] Since the locking screw drive interface 8 is accessible through the titanium base 5 and the prosthesis 68, a variation of the one-screw passive fit test procedure may be used to fine-tune the orientation of the omnidirectional multi-unit abutment to improve the passive fit upon initial loading. A variety of options are seen to take advantage of the ability to reorient the omnidirectional multi-unit abutment 100 through the opening 23 of the titanium base 5 loaded into the prosthesis 68. In one approach, all of the prosthetic screws 6 are removed. While the prosthesis 68 remains in place, all of the omnidirectional multi-unit abutment locking screws 4 are loosened and finger tightened to provide some frictional resistance but prevent pivotal slippage. The actual torque value for proper finger tightening depends on the construction and surface finish of the omnidirectional multi-unit abutment, but is generally less than a few Ncm. All of the prosthetic screws 6 are then reloaded and torqued to the recommended value. In this way, each orientation of the omnidirectional multi-unit abutment fits more closely to the prosthesis 68. A single prosthetic screw 6 is then removed to access the locking screw 4 of the omnidirectional multi-unit abutment at that location. The locking screw 4 is torqued to a predetermined value. The prosthetic screw 6 is reinserted and torqued to a predetermined value. This is repeated until all of the omnidirectional multi-unit abutment locking screws 4 are tightened and all of the prosthetic screws 6 are tightened.

[0071] The fine-tuning process described above may be modified depending on the details of the initial passive fit level. For example, it may be desirable to loosen only some of the omnidirectional multi-unit abutment locking screws 4 while others remain fixed at their anchoring points in the initial prosthesis fitting. This may result from the need to compromise somewhat on the passive fit for good occlusion or other reasons. Alternatively, the results of a routine one-screw or screw resistance test may suggest the orientation adjustment of only a subset of the omnidirectional multi-unit abutments, or a different adjustment sequence. In any case, these passive fit improvements flow directly from the ability to orient and secure the omnidirectional multi-unit abutments while the prosthesis is in place.

[0072] It is preferred that the above embodiment of the omnidirectional multi-unit abutment 100 is adapted to be compatible with the already qualified and commercially successful titanium base 5 and screw implant 16. The threading and fitting of the widely available implant improves the inventory equation, since this implant can be used in the above embodiment with a conventional straight abutment in the same patient. Although less important, compatibility with the widely available screw-mounted titanium base 5 is also considered an advantage. However, the inventive features of the above embodiment can be integrated into or adapted to work with newly designed implants that employ the inventive concepts for passive fit improvement or loading efficiency and repair as described above. These inventive concepts may also be adapted to work with non-screw-mounted prostheses. These adaptations are not excluded and are within the scope of the claims disclosed herein and may be broadly construed to apply thereto. U.S. Pat. No. 11,311,354 includes various approaches to align the titanium base with the abutment for incorporation into the prosthesis using a provisional fastener in a lift-off process. The basic design of the provisional fastener illustrated in the commonly owned patent may be employed with the omnidirectional multi-unit abutments and titanium bases described above.

[0073] The various embodiments are described to illustrate the disclosed inventive concepts, not to limit the invention. Combinations of elements comprising the inventive features of one or more of the embodiments with well-known materials, components, and dental techniques to produce further embodiments that utilize the inventive concepts are considered part of this disclosure. [Explanation of symbols]

[0074] 1 Abutment base 2 Swivel Mount 3 Swivel Base 4 Lock Screw 5 Titanium base 6 Prosthetic Screw 7 Internal Thread 8 Internal Drive Features 9 External Thread 10 Abutment base drive features 11 Mating Features 12 Interface joint 13 Ball part 14 Base mounting part 15 Internal Curvature 16 Implants 17 Power Tools 19 Base opening 20 Internal Thread 21 Abutment fitting projection 22 Titanium base fitting features 23 Titanium base opening 25 Prosthetic screw stem 30 Abutment base 31 Ball 32 Swivel 33 Lock screw 34 Stem part 35 Interface 36 Prosthetic screw 37 Drive Socket Features 39 External thread 40 Internal thread 41 Titanium base attachment part 42 Implant attachment point 43 Prosthetic Screw 44 Driving Interface 45 Driving Interface 46 Distal mounting hole 47 Fitting surface 48 Fitting surface 49 Lock Screw 50 Tapered stem 51 Tapered stem 52 Base 53 Tapered Socket 54 Internal Drive Interface 55 Two-part abutment base 56 Abutment base stem 57 Hollow Sleeve 58 Interface 59 Abutment base 60 4-lobe driven interface 61 Abutment base surface 62 4-lobe drive chip 63 Interface 64 Hexagonal Drive Features 65 Small Path 66 Large diameter 68 Prosthetics 69 Prosthetic screw access hole 70 Bones and Soft Tissues 71 4 Lobe Driven Tool 72 Occlusal surface 100 Omnidirectional Multi-Unit Abutment 101 Base Assembly

Claims

1. A system for aligning and mounting a dental prosthesis on an implant by means of a prosthetic screw, the prosthetic screw having a head and a shaft with a thread, the system comprising:

1. An abutment base having a longitudinal axis, a proximal end having a ball portion and an abutment base drive interface; a distal end having a screw thread for attachment to the implant; and an abutment base comprising: a swivel shell having an inner surface and an outer surface, the swivel shell including a swivel opening proximate a distal end and a threaded opening at a proximal end; A lock screw having a longitudinal axis, a portion having external threads that are compatible with the threaded opening of the swivel shell; a portion having an internal thread sized to fit with the shaft of the prosthetic screw; a lock screw drive interface; A lock screw comprising: Equipped with the locking screw is capable of fixing an orientation of the longitudinal axis of the locking screw in an orientation non-parallel to the longitudinal axis of the abutment base; system.

2. The system of claim 1 , wherein the ball portion of the abutment base is compressed between a portion of the inner surface of the swivel shell and the lock screw.

3. The system of claim 1 , wherein the swivel shell comprises a swivel base and a swivel mount mechanically assembled to grip the ball portion of the abutment base.

4. 2. The system of claim 1, further comprising a titanium base having an opening at the proximal end larger than the shaft of the prosthetic screw and smaller than the head of the prosthetic screw, and a distal end, the distal end being configured to be supported by the outer surface of the distal end of the swivel shell.

5. 2. The system of claim 1, wherein the abutment base driving interface is a socket for receiving an abutment base driving tool, the abutment base driving tool having a longitudinal axis and an abutment base driving tool tip shaped to mate with the abutment base driving interface.

6. The system of claim 1 , wherein the locking screw drive interface is a through socket for receiving a locking screw drive tool.

7. 10. The system of claim 1, further comprising a titanium base and a locking screw drive tool, said locking screw drive tool sized to pass through an opening in said titanium base without interference.

8. The system of claim 5 , wherein the abutment base driving tool tip is sized to pass through the locking screw.

9. 9. The system of claim 8, wherein the abutment base driving tool tip is configured to tighten the abutment base to the implant with a first torque without simultaneously tightening the locking screw to fix an orientation of the swivel shell.

10. 8. The system of claim 7, wherein an orientation of the swivel shell is selected by tilting the locking screw driving tool on the locking screw away from the longitudinal axis of the abutment base and tightening the locking screw with a second torque.

11. The system of claim 5 , wherein the abutment base driving tool tip is used to tighten the lock screw.

12. A method for manufacturing a dental assembly, the method comprising: Providing the system of claim 1; and b. incorporating a titanium base into the dental prosthesis of claim 1 using a temporary fastener. The temporary fastener is a post having an axis and a first post end and a second post end, said first post end being threaded for screw attachment to said locking screw of claim 1; a cap attached to the second post end; Equipped with 2. The temporary fastener is configured to hold the titanium base to the swivel shell of claim 1 by applying a rotational force to the cap to thread the first post end onto the locking screw, and the cap is separable from the post through a release force directed against the first post end. Manufacturing method.

13. 1. A system for fitting and mounting a dental prosthesis to a dental implant, the system comprising:

1. A multi-unit implant abutment, comprising: an abutment base having a first end with a ball and a second end with a threaded post having a longitudinal axis, the ball having an abutment drive interface, the threaded post being configured to be screwed into the dental implant with a predetermined torque for screw attachment to the dental implant; a shell portion having an inner surface and an outer surface, the shell portion having a first end with an opening and a second end with a locking screw, the ball being captured inside the shell portion with the screw post of the abutment base extending into the opening in the shell portion; The multi-unit implant abutment comprises: a titanium base having an opening at a proximal end and an interface at a distal end configured to be attached to an exterior of the shell portion against a mating interface of the shell portion; at least one drive tool sized and configured to engage the abutment drive interface and / or the lock screw; the at least one driving tool is sized and configured to be inserted into the opening in the titanium base to mate with the locking screw, the locking screw being configured to rotatably move to apply pressure to the ball to secure the shell portion in a desired orientation relative to the ball; system.

14. The titanium base is incorporated into the dental prosthesis; 14. The system of claim 13, wherein a force is applied to the dental prosthesis to align the multi-unit implant abutment with the titanium base when the locking screw is tightened while the dental prosthesis is coupled to the titanium base and the titanium base is positioned on the shell portion of the multi-unit implant abutment.

15. The method further includes a prosthetic screw, the prosthetic screw comprising: a head portion having a width greater than the opening in the titanium base; a threaded shaft portion having a width smaller than the opening in the titanium base; Equipped with the locking screw includes threads for receiving the threaded shaft portion of the prosthetic screw; The system of claim 13.

16. an internal thread for mating with the threaded shaft portion of the prosthetic screw; a drive interface for receiving a tool of the at least one drive tool for tightening the lock screw; the lock screw having a longitudinal opening comprising The system of claim 15.

17. The shell portion is provided as a one-piece unit, and the abutment base including the ball and the screw post is provided as a one-piece unit with the ball being gripped in the shell portion. The system of claim 13.

18. 14. The system of claim 13, wherein the locking screw has a longitudinal opening sized to allow an abutment driving tool to extend therethrough to engage an abutment driving interface on the ball.

19. the locking screw driving tool has a longitudinal axis and a maximum width that is less than the maximum width of the threads of the shaft of the prosthetic screw; The system of claim 7.

20. 2. The system of claim 1, wherein the locking screw drive interface is sized and configured to have at least a portion that resides in a common axial position as at least a portion of the threads of the internal threads sized to mate with the shaft of the prosthetic screw.

21. the abutment base driving tool is configured to be inserted into a first location at the abutment base driving interface and configured to be rotated to fasten the abutment base to the implant; 6. The system of claim 5, wherein the abutment base driving tool is configured to be inserted into a second position above the abutment base while inside the locking screw held in the swivel shell, and configured to be rotated to tighten the locking screw with a torque to lock the swivel shell in a selected orientation, the torque to lock being the same as or different from the torque to tighten, and the second position corresponding to the locking screw driving interface.

22. 2. The system of claim 1, wherein the locking screw comprises an annular body and has a maximum outer diameter less than an outer diameter of the ball portion, the swivel shell has a wall having a distal end portion that is hemispherical, and the outer surface comprises a protrusion projecting radially outward at the distal end portion.

23. 2. The system of claim 1, wherein the swivel shell comprises a body with the inner surface and the outer surface, the body of the swivel shell increasing in thickness from the proximal end to the distal end and having a maximum wall thickness below the threaded opening.

24. 2. The system of claim 1, further comprising a titanium base coupled to the swivel shell, the titanium base having an open central channel extending longitudinally therethrough and an inner wall tapering distally outwardly to terminate at a mating surface extending radially outwardly from a distal end portion of the outer surface of the swivel shell, the outer wall of the swivel shell having a taper that matches the inner wall of the titanium base.

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