Dental implant system and additional methods of attachment

Disclosed in this specification is a dental implant assembly with an abutment head integrally joined to an implant body. The top section of the abutment head a shape formed by a linear wall adjacent to an arcuate wall; a ledge is located beneath the top section of the abutment; and the abutment head extends above the ledge a distance of from about 1.5 to about 10 millimeters. The implant body has a base section and a neck section, each of which has a different degree of roughness.

FIELD OF THE INVENTION

A dental implant device comprised of an irregularly-shaped abutment.

BACKGROUND

Dental implants have been known and used since at least the 1930's; see, e.g., U.S. Pat. No. 5,312,254 of Joel L. Rosenlicht. See also U.S. Pat. No. 5,145,371 of Lars Jorneus which discusses the osseointegration method of integrating a dental implant into a patient's jaw. The disclosure of each of these patents is hereby incorporated by reference into this specification.

A wide variety of dental implant styles and systems are currently available. For example, dental implants having cutting means are also known in the art, as disclosed in U.S. Pat. No. 5,338,197, the disclosure of which is hereby incorporated by reference into this specification. Another type of dental implant assembly is one that uses a hexagonal abutment implant system. This assembly is disclosed in U.S. Pat. No. 5,564,924, of which the disclosure is also herein incorporated by reference.

Applicant has described several dental implant devices in U.S. Pat. Nos. 5,338,197; 5,564,924; 5,733,124; and 6,068,479; the entire disclosure of each of these United States patents is hereby incorporated by reference into this specification. Furthermore, reference also may be had to applicant's International Patent Numbers WO0226157A1 and WO9625895A1, the entire disclosure of each of these applications is also hereby incorporated by reference into this specification.

It is an object of this invention to provide an improved dental implant device.

SUMMARY OF THE INVENTION

In accordance with this invention, there is provided a universal dental implant system containing a head portion and a base portion. The base portion includes fastening elements to secure the implant within a jawbone of a patient. The head portion is comprised of a multiplicity of linear walls, at least one of which is disposed angularly in a manner different than the other such walls. The head portion is to receive and support false teeth.

DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT

In general, dental implants are moderately expensive, ranging in cost from approximately two to four hundred dollars (excluding laboratory costs). However, the labor associated with the implant procedure often costs eight to twenty times the amount of the implant itself, ranging from about three to four thousand dollars per tooth. One of the reasons for this substantial cost is the multiplicity of steps required by the implant procedure. An example of these prior art steps will be described below with reference to Nobelpharma catalog PRI 385 94, 2nd edition (published by the Nobelpharma AB, Box 5190, S-402 26 Goteborg, Sweden).

In the first step of the prior art procedure, an implant or “fixture” is purchased; see, e.g., page 7 of the Nobelpharma catalog and the reference to the 3.75 millimeter and 4.0 millimeter titanium fixtures illustrated on such page. The fixture so purchased must then be placed into an “instrument set for fixture placement,” which is shown on page 22 of the Nobelpharma catalog.

Once the fixture is disposed in the “instrument set . . . 2,” a “fixture mount” is then attached to the fixture by means of a wrench and a screwdriver. The “fixture mount” devices are shown on page 22 of the Nobelpharma catalog. The instruments for fixture placement of the fixture are also shown on page 22 of the Nobelpharma catalog (see wrench part17and screwdriver part19).

Next, a “connection to contra-angle handpiece” (see part11on page 22 of the Nobelpharma catalog) is attached to a handpiece (see page 31 of the Nobelpharma catalog) and the implant assembly is then driven into the jawbone of a patient.

Thereafter, the fixture mount is removed from the fixture and a cover screw10(see page 9 of the Nobelpharma catalog) is inserted into the fixture. Next, the surgical site is allowed to heal for about three to about six months. See, e.g., Branemarkaarb/Alberektsson: “Tissue Integrated Prostheses” (Quintessence Books, 1985).

After the healing period, the implant is exposed by surgical procedures and the cover screw is removed. A healing abutment (see page 39 of the Nobelpharma catalog) is then attached to the fixture. In general, the healing abutment is left in place for approximately two to three weeks, depending upon how the patient's tissue has healed.

Thereafter, the healing abutment is removed and an implant abutment is attached to the fixture. The type of implant abutment used will depend on the requirements of the patient. Thus, for example, referring to pages 38 and 39 of the Nobelpharma catalog, one may use a standard abutment, an “EsthetiConee” abutment, a “CeraOneo” abutment, a “Ball Attachment,” an Angulated Abutment,” and other standard and/or proprietary abutments.

Next, the desired prosthesis is formulated by conventional means and adjusted to fit within the patient's mouth. For a single-tooth prosthesis, generally one to two impressions are made to capture the size and shape of the abutment to the tooth.

Multiple mock-ups and adjustments are often made before the final prosthesis is finally secured to the implant.

For a multiple-tooth prosthesis, the course of treatment is not always predictable; multiple impressions and frameworks need to be created involving multiple appointments. Typically, the entire treatment, including initial implant placement and second stage surgery, would span a period of time ranging from two to approximately nine to eighteen months, or longer, before the final prosthesis is secured within the patient's mouth.

In addition to the increased time, labor and costs, various theoretical and practical implications need to be considered for multiple tooth or full-mouth reconstruction. In multiple restorations, “draw,” “common path of insertion,” “parallel,” “passivity” and “stability” are terms that describe the most critical objectives of such a procedure.

Draw is perhaps best described as the effects of friction, but not binding.

Multiple implants and their abutments are rarely, if ever, perfectly aligned within the patient's mouth. Traditional methods of multiple tooth restoration require the heads/abutments and prostheses to be modified or made parallel until a common path of insertion is achieved and until the prosthesis is passive with respect to all of the abutments and soft tissue. In other words, it must be possible to place the prosthesis in position by moving the structure onto the abutments in a straight line (i.e., the common path of insertion), with sufficient friction or draw to ensure a firm fit. Once in place, the prosthesis must be passive, which means it must fit the abutments and the soft tissue profile such that there is no undue tension and no motion can take place.

These prior art procedures require a myriad number of instruments and parts, typically two surgical procedures, many trips by the patient to the dentist, increased treatment times and prolonged healing periods resulting in an overall reduced quality of life for the patient. Further, an expensive, time consuming and labor intensive “trial and error” system is crucial to such procedures because each prosthesis is custom made to the particular shape, design, location and quantity of abutments for each patient. Therefore, not only are the processes tedious and expensive, but, also, each surgical procedure introduces a certain element of risk, pain, and suffering.

In view of the above, there is a need for a dental implant system and associated process of attachment that are simple, predictable and effective. In particular, it is desirable that the dental implant system and attachment process include universal, interchangeable components, reduce post-operative infection, improve device/prosthesis strength and prolong its stability, and reduce the overall time for reconstruction procedures. It is also desirable that the dental implant system and associated process enable a practitioner to form a final prosthesis, including an infinite number of facsimiles of said final prosthesis, based on a single impression.

One embodiment of the present invention contemplates a method of dental reconstruction comprising inserting one or more devices into an edentulous space within a patient's mouth, wherein each of the devices includes a head portion. The method further includes placing a healing ball on each of the heads of the devices and forming a dental impression with impression material, wherein the healing balls transfer with the impression material upon removal from a patient's mouth. In addition, the method includes mounting an analog-abutment within each of the healing balls of the impression, forming a final model of the dental impression including the analog abutments, wherein the final model replicates the patient's edentulous space and creating a final prosthesis using the final model. Lastly, the method includes installing the final prosthesis within the edentulous space of the patient. The present invention also contemplate a universal dental implant system comprising a head portion and a base portion, wherein the base portion includes fastening elements to secure the implant within a jawbone of a patient. The system further includes a healing ball, wherein the healing ball mounts onto the head portion.

In addition, the system further includes a retaining screw or guide pin that secures the healing ball onto the head portion.

In addition, one embodiment of the present invention also contemplates a method of forming a dental prosthetic comprising fixing a stud element in a predetermined site, placing a removable protective element on the stud element and forming a first impression over the protective element at the predetermined site. The method also includes removing the protective element from the stud element with the first impression, mounting an abutment in the protective element contained in the first impression, forming a second impression over the abutment such that the second impression substantially replicates the predetermined site, and creating a prosthesis by relying on information provided by the second impression.

Another embodiment of the present invention contemplates a method of forming a dental prosthetic comprising providing a first impression which replicates a dental site, inserting a fixation element into the first impression, providing a second impression which replicates the dental site and retains the fixation element and modifying the fixation element on the second impression as needed so as to provide sufficient information to create the prosthetic.

Yet another embodiment of the present invention contemplates a model for creating a dental prosthetic comprising a form replicating the region of an edentulous space within a patient's mouth, the form having an analog abutment protruding from the region, and the analog abutment having a modification created to ensure insertability and removability of a prosthetic within a patient's mouth.

FIG. 1Ais a schematic illustration of one implant system. Referring toFIG. 1A, an embodiment of a dental implant system in accordance with the present invention includes a one-piece universal implant abutment device10. In general, the universal implant abutment device10is a single-piece device10including head12, neck14and base16sections. It should be noted that this device10is a single-piece component.

However, it is to be understood that the disclosure of the present invention may also apply to devices including one or more elements. Further, the universal implant system of the present invention may be used to treat both humans and animals alike.

The implant abutment device10shown inFIG. 1Ais preferably made of titanium or titanium alloy. Alternatively, the device10may be made of one or more other materials including, but not limited to, metals and/or metal alloys, such as gold, silver, palladium, vanadium, cobalt alloy, stainless steel and the like, plastics, ceramics. Thus, by way of further illustration, one may use one or more of the materials disclosed in U.S. Pat. No. 5,373,621; U.S. Pat. No. 5,372,660; U.S. Pat. No. 5,358,529; U.S. Pat. No. 5,354,390; U.S. Pat. No. 5,334,264; U.S. Pat. No. 5,326,362; U.S. Pat. No. 5,205,921; and U.S. Pat. No. 5,191,323; the disclosures of which are hereby incorporated by reference into this specification.

The device material should be biocompatible, nontoxic (e.g., medical grade) and provide sufficient strength and structural integrity when implanted within the jawbone of a patient.

Referring again toFIG. 1A, the height HY and diameter HX of the head12of the implant abutment device are approximately within the range of 1.0 millimeter to about 10.0 millimeter, and 1.0 millimeter to 12.0 millimeters, respectively. In one embodiment of the invention, the height HY and diameter HX of the head are approximately 3.0 mm and 3.8 mm, respectively. The associated height NY and diameter NX of the neck14of the implant abutment device10are approximately within the range of 0 millimeters to 8.0 millimeters and 1.0 millimeter to 12.0 millimeters, respectively.

In another embodiment, the walls of the head are extending downwardly and outwardly to intersect with the base. Reference may be had toFIG. 1CandFIG. 1D. In the embodiments depicted, base section16is comprised of threads (not shown). In the embodiments depicted, head12is comprised of a top head section12aand a bottom head section12b. The walls of head12extend downwardly and outwardly from top head section12ato bottom head section12b. In the embodiment depicted, the diameter of bottom head section12bis the same as the diameter of the upper base section of base16. In the embodiment depicted inFIG. 1C, the abutment head12is formed by a linear wall12cand arcuate wall12d. In the embodiment depicted inFIG. 1C, the head12is formed by two linear walls,12c, that are opposite one another, and two arcuate walls12d, that are also opposite one another. In other embodiments, not shown, head12is comprised of more than four walls wherein there is a pattern of alternating linear and arcuate walls. In the embodiments depicted inFIG. 1CandFIG. 1D, the neck section (see neck section12ofFIG. 1A) is absent. In another embodiment, such a neck section is present.

Referring now toFIG. 1E, and to the embodiment depicted therein, device10depicted therein is comprised of head section12, neck section14and base section16. The embodiment depicted inFIG. 1Eis similar to the embodiment depicted inFIG. 1Cexcept in that the device illustrated inFIG. 1Eis includes neck section16. As shown inFIG. 1E, neck section16is comprised of vertical walls16aand16b. In another embodiment (not shown), the walls16aand16bcan be converging or diverging to intersect with the bottom of the head12. In the embodiment depicted, vertical walls16aand16bare substantially parallel.FIG. 1Ealso differs fromFIG. 1Cin thatFIG. 1Eillustrates axial hole17.

In the embodiment depicted inFIG. 1E, axial hole17has a depth17band a width16c. Axial hole17is orientated such that its depth17bis substantially parallel to axis220. Axial hole thus makes the base partially hollow. In one embodiment, a biologically active agent can be embedded in a carrier substance such as collagen sponge, strip, wick and the like; and is disposed within axial hole17. Such an agent may be delivered to the surrounding tissue through holes17a. In the embodiment depicted, holes17aconnect axial hole17to the external environment and permit the transmission of the aforementioned biologically active agent. In the embodiment depicted, the holes are perpendicular to axis220. In another embodiment, not shown, the holes are at a non-perpendicular angle relative to axis220.

In addition, the height BY and diameter BX of the base16of the device10are within the range of approximately 6.0 millimeters to 30.0 millimeters and 1.0 millimeter to 12.0 millimeters, respectively.

Alternative heights and diameters can also be used provided that the overall device dimensions permit proper implantation and functioning of the device10.

As shown inFIGS. 1A and 1B, and in the embodiment depicted therein, the perimeter of the head12is substantially in the shape of a hexagon and includes six, planar, external main-walls18. In one embodiment, the six, planar main-walls18are interconnected by six, substantially planar, external side-walls20. In general, the width MW of each main-wall18is approximately within the range of 1.0 millimeter to 12.0 millimeters and the width SW of each sidewall20is approximately within the range of 0 millimeters to 12.0 millimeters. In another embodiment of the invention, the head configuration includes substantially planar main-walls18and non-planar (e.g., arcuate) side-walls20, thereby producing improved comfort and reduced irritation within the patient's mouth.

Alternatively, the main-walls18may be substantially non-planar and the side walls20planar, or both the main-walls18and side-walls may be substantially non-planar.

In an alternate embodiment, shown inFIG. 2, the main-walls18and side-walls20of the head12are tapered. The main-walls18, side-walls20, or portions thereof, may taper in either radially inward or outward direction. Other configurations of the head12including, but not limited to, cylindrical, triangular, square, and octagonal-shaped are also included within the scope of the claimed invention. Additional shapes, such as those disclosed in U.S. Pat. No. 6,068,479, of which the entire disclosure is incorporated by reference, are also contemplated for use with the present invention. For example, the configuration of the base16and threads32includes, but is not limited to, those configurations as disclosed in U.S. Pat. No. 5,338,197; U.S. Pat. No. 5,435,723; U.S. Pat. No. 5,564,924; U.S. Pat. No. 5,571,017; U.S. Pat. No. 5,601,429; U.S. Pat. No. 5,967,783; and U.S. Pat. No. 6,068,479; the disclosure of each of these patents is hereby incorporated by reference into this specification. The threads32serve to securely attach the base16of the implant abutment device10within the patient's jaw. Other fastening elements including, but not limited to, barbs, retractable barbs, one-way barbs and other textured surfaces may also be used with the present invention.

The cylindrical base16of the device10may be solid or partially hollow. The hollow spaces (i.e. axial hole) can accommodate foreign objects. For example, in one embodiment, the foreign body is an absorbent material (like sponges, collagen tapes, resorbable collagen) impregnated with biologically active agents that are released or come in contact with the surrounding tissue after implantation. Non-integral dental implants that have such axial holes are disclosed in U.S. Pat. No. 6,918,766 to Hall (Method, arrangement and use of an implant for ensuring delivery of bioactive substances to the bone and/or tissue surrounding the implant), the content of which is hereby incorporated by reference into this specification. Such axial holes are contemplated for use with the present invention.

As shown inFIG. 1FandFIG. 1G, the device10is comprised of a generally cylindrical, titanium body19comprises of a head12, neck14and base16, wherein the head12is comprised of smooth walls208and242extending downwardly and outwardly. The cross section of the head12is a substantially flat wall208joined to an arcuate wall242. The neck14has the same diameter as the head12at the intersection, where the surface14aof the neck14is etched such that the surface has an irregular roughness of from about 0.001 micron to about 1000 microns. In another embodiment, the irregular roughness of neck14is from about 0.01 to about 20 microns. In yet another embodiment, the irregular roughness of neck14is from about 3 to about 20 microns. In one embodiment (not shown), such an etching is accomplished by means of parallel grooves created by laser etching one such groove or channel is of 8 microns in size located in the neck section and another groove or channel of different size for example 12 microns located on the base section16.

Means for obtaining such etching are known in the art. For example, reference may be had to U.S. Pat. No. 6,861,364 to Koide (Laser etching method and apparatus therefore) the content of which are hereby incorporated by reference into this specification. The walls14band14cof the neck14are substantially parallel until each wall intersect base16. Base16extends downwardly and inwardly. In the embodiment depicted, neck14has a length of from about 0.1 to about 6 millimeters. Base16is comprised of raised threads32that extend downwardly and inwardly to the bottom part of the base16. The end part of base16has an axial hole17which, in the embodiment depicted, is open at the bottom of base16. Holes17aare in fluid communication with axial hole17such that the biologically active agent disposed in axial hole17may diffuse through holes17a. Holes17aextend radially through base16at right angles to the axis220(seeFIG. 1E) of the device10.

As is indicated inFIG. 1H, a second hole can also be formed in the base section16such that the two holes are at right angles to each other.FIG. 1His a cross sectional view of device10ofFIG. 1Gviewed from the bottom. Hole17ais in fluid communication with axial hole17as is hole17b. There is an angle17cbetween first hole17aand second hole17b. In the embodiment depicted, angle17cis about ninety degrees. In another embodiment, not shown, the angle is other than ninety degrees.

The diameter of hole17aranges from about 0.25 to about 0.75 times of diameter BX (seeFIG. 1A). In general the diameter of axial hole17ais between 1 to 4 millimeters and the depth of the axial hole17is between 0.1 millimeters to the entire length of BY (seeFIG. 1A). In the embodiment depicted inFIG. 1H, the cross section of axial hole17is a circle. In other embodiments, the cross section another shape, such as a circle, triangle, or polygonal shaped. Reference may be had toFIG. 11toFIG. 1N. Such cross sections allow the frictional fitting of a biologically active agent carrier body such as sponges, collagen plugs, tapes etc. In one embodiment of the invention, an absorbent collagen sponge17dhas been used as a carrier. Such a sponge has an elastic, porous mass and absorbs the biologically active agent. In the embodiment shown, the sponge has an uncompressed diameter of about 4 millimeters and, when compressed, has a diameter of about 3.1 millimeters. It can be easily fitted in the axial hole17.

In the embodiment depicted inFIG. 1E, the axial hole17extends partially into base16. In the embodiments show inFIG. 1FandFIG. 1G, the axial hole17extends along the whole length of base16, and at intervals along such base, there are transverse holes17a. In one embodiment, holes17ahave a diameter of from about 0.01 millimeters to about 4 millimeters. In one embodiment, collagen sponge17dalso extends along the entire length of base16.

In another embodiment, shown inFIG. 10andFIG. 1P, the head12is comprised of flat wall208connected with arcuate wall242. Neck14is comprised of parallel walls14band14c. In one embodiment, the parallel walls14band14cof neck14are irregularly roughened. In the embodiment depicted inFIGS. 10 and 1P, base16is comprised of longitudinal channel16a. Such longitudinal channels are known in the art. Reference may be had to U.S. Pat. No. 5,338,197 which is incorporated by reference into this specification.

Longitudinal channel16afluidly connects holes17asuch that any biologically active agent secreted through holes17afrom axial hole17can diffuse vertically along the length of longitudinal channel16aand therefore along the entire length and surrounds the whole implant in the jaw bone.

In another embodimentFIG. 1Q, device10is comprised of an angled ledge formed by the union of reverse curves. In the embodiment depicted inFIG. 1Q, device10is comprised of head section12and neck section14. Neck section14is comprised of ledge26. Ledges such as ledge26may have a variety of configurations. In ledge configuration21a, such a ledge has an acute angle. As is known to those skilled in the art, acute angles are angles measuring between 0 and 90 degrees. Angle23ais such an acute angle. In ledge configuration21b, such a ledge has a right angle. Such a ledge is said to be a horizontally extending ledge. Angle23bis a right angle. In ledge configuration21c, such a ledge has an obtuse angle. An obtuse angle is an angle whose measurement is between 90 and 180 degrees. Angle23cis such an obtuse angle. Configuration21dshows one embodiment of the invention wherein no ledge is present. Instead, the angle23dbetween head12and neck14is 180 degrees. In another embodiment (shown inFIG. 1Q), a sloping, obtuse angle is formed where the ledge joins the bottom part of the head12joining the neck14in the form of a curvature in a downwardly and outwardly sloping configuration, then curving downwardly and inwardly to join with the top part of the base16. In this embodiment, the ledge formed would have no distinct angles, but maintains an overall obtuse angle.

Device10illustrated inFIG. 1Qhas a head section12which is comprised of a plurality of splines (formed by alternating half circles or alternate arcuate walls of different sizes and in alternating reverse arrangements or defined by half circles joined by arcuate tops)258with a substantially circular cross-sectional shape. In the embodiment depicted, four such splines258are illustrated. In another embodiment, more than four such splines are present. See, for example,FIG. 33C. Splines258are configured to have a mating configuration with lower section42of healing ball40. Such a mating configuration only permits the healing ball to be attached to device10in a finite number of orientations. In one embodiment, there is only one such possible orientation.

In another embodiment, illustrated inFIG. 1R, the head12has a mated configured adapted to receive a correspondingly shaped instrument. In the embodiment depicted, head12has a length of from about 1 millimeter to about 8 millimeters and consist of an arcuate wall242extending downward and outward. The bore216can be different configurations. In the embodiment depicted, bore216has a substantially hexagonal cross-sectional shape. Bore216is adapted to engage a correspondingly shaped instrument. The neck14is comprised of parallel14band14cand has a length of from about 0 to about 6 millimeters. In one embodiment, the surface of neck14is irregularly roughened as disclosed elsewhere in this specification. Base16is a cylinder with walls extending downward and inward. In the embodiment depicted, base16is both threaded and etched to produce an irregularly roughened surface. In another embodiment, base16is comprised of axial hole17with fluidly connected holes17aand17b. Both holes17aand17bare at right angles relative to axial hole17. In the embodiment depicted, holes17aand17bare also at right angles relative to one another. Base16is also comprised of longitudinal channel which connects at least two holes17bon the outer surface of base16.

The structural design of the base16depends, in part, on the material or materials used to fabricate the device10. For example, in one embodiment, a base16made of a semi-rigid material may be solid, whereas a base16made of a substantially rigid material may be partially hollow. Alternatively, a base16made of a combination of rigid and semi-rigid materials may include solid and hollow portions. Alternate configurations of the base16not disclosed herein are also included within the scope of the claimed invention.

Referring toFIG. 3, a substantially cylindrical, hollow core34extends through and along the axial length, or portions thereof, of the head12of the device10. The surface of the internal walls36of the head12surrounding the core34may be threaded and slightly tapered. Alternative core34and surrounding wall/wall-surface designs and configurations including smooth, dimpled, grooved, hexagonal, polygonal, tapered, stepped, arcuate and other configurations and combinations thereof, may also be used and are also included within the scope of the claimed invention. In one embodiment, the hollow core34is adapted to receive and securely retain a guide pin, retaining screw and/or healing ball, as described in further detail below.

In alternate embodiments (not shown), the hollow core34extends through and along the axial length, or portions thereof, of the head12and neck14, or head12, neck14and base16. In yet another embodiment, the hollow-core34may be off-axis and/or non-parallel to the axial length of the device10.

The dental implant system of the present invention may also include a healing ball40, shown inFIG. 4, that can be either removably secured or permanently affixed to the universal implant abutment device10. The healing ball40may be made of a variety of materials and combination of materials including, but not limited to, medical grade polyethylene, high-density polyethylene, K-resin, plastics, ceramics, metals and metal-alloys. In general, the healing ball40may be made of any biocompatible, non-toxic (e.g., medical grade) material that permits proper functioning of the healing ball40. In another embodiment of the invention, the healing ball material may also include barium or similar elements that make the healing ball radiopaque.

Referring toFIG. 4, and in the embodiment depicted therein, the healing ball40includes a cylindrical lower portion42and a spherical upper portion44. Other healing ball configurations including, but not limited to, tooth-shaped, cone-shaped, box-shaped, donut-shaped, collar-shaped, cylindrical and spherical, may also be used with the dental implant system. In another embodiment (not shown), the healing ball40may include one or more small holes or recesses. These holes/recesses may function as gripping and/or anti-rotational/anti-torque features that are engaged when tightening, removing or repositioning the healing ball within the patient's mouth.

As shown inFIG. 4, and in the embodiment depicted therein, a hexagonal-shaped opening or bore46extends along the axial length of the lower portion42and partially along the corresponding axial length of the upper portion44. The hexagonal shape of the bore46is used for illustration purposes and not meant to limit the invention. In general, a variety of bore shapes or configurations adapted to engage the head12of the implant abutment device10may be used with the healing ball40of the present invention.

In the embodiment depicted, a cylindrical bore or opening48lies adjacent to and is aligned along the same axis of the hexagonal bore46. The diameter of the cylindrical opening48may be less than, equivalent to or greater than the diameter of the hexagonal bore46. As will be described in further detail below, the cylindrical opening48forms a lumen through the healing ball40, thereby enabling associated components, such as a guide pin, retaining screw, cement, wax and other components included within the scope of the claimed invention, to be inserted therethrough. In yet another embodiment (not shown), the opening48maybe off-axis and/or non-parallel to the axis of the device10.

In an alternate embodiment, shown inFIG. 5, the cylindrical opening48is removed and the hexagonal bore46forms the entire opening or lumen through the healing ball40. In another embodiment (not shown), the hexagonal bore46is removed and the cylindrical bore48forms the entire opening or lumen through the healing ball40. For the sake of simplicity of representation, references to the bore46of the healing ball40in the remainder of this disclosure should be understood to include bore46and/or opening48.

As previously described, the bore46of the healing ball40is configured to match and snugly fit over the hexagonal head12of the implant abutment device10. As such, an octagonal opening in a healing ball40would be used for a device10having an octagonal head12, a triangular bore46in a healing ball40would be used for a device10with a triangular head12, and so on.

In another embodiment (not shown), a reverse configuration of the manner in which the device10and healing ball40engage each other is contemplated. For example, the device10may include a recess, bore or opening into which the healing ball's40mating shaft, post or protrusion is inserted. Other methods of engagement not specifically disclosed herein but known in the art are also comprehended.

In an alternate embodiment (not shown), the bore46is formed of two opposing flat surfaces or walls and two opposing arcuate surfaces or walls. The two flat surfaces of the healing ball40engage two of the main-walls18of the implant/abutment head12and the two arcuate surfaces engage the remaining main-walls18.

Thus, in the embodiment depicted, the healing ball40engages the device head12in a manner similar to a conventional wrench-and-socket configuration. Alternate embodiments of the bore46including, but not limited to, cylindrical, spherical, stepped, cylindrically-tapered, off-axis, non-parallel and other configurations not specifically disclosed herein, are also included within the scope of the claimed invention.

In another embodiment of the healing ball40, the axial length of the bore46is approximately equivalent to the height HY of the head12(shown inFIG. 1).

Alternatively, the length of the bore46may be greater than the height HY of the head12. In one embodiment, the base50of the healing ball40surrounding the bore46rests upon the ledge26(seeFIG. 1A) of the device10, ensuring a proper fit within the patient's mouth. In another embodiment (not shown), the opening of the healing ball40includes an inwardly-extending annular protuberance which is adapted to fit within and is removably secured to a matching annular groove surrounding the device10.

This configuration and other embodiments disclosed in U.S. Pat. No. 6,068,479 (of which the specification is incorporated herein by reference) or not specifically disclosed herein are also included within the scope of the claimed invention.

In one embodiment of the present invention, the healing ball40may be removed from the implant abutment device10prior to attachment of the dental prosthesis. As such, the healing ball40may serve as a temporary cover to protect the patient's tongue, inner-cheek and/or inner-lips from contacting potentially rough or abrasive edges of the device10. In addition, the healing ball40may also function as a tissue spacer, as described in further detail below. Guide pins, retaining screws, wax or other attachment devices or compounds, including various combinations thereof, may be used to temporarily attach the healing ball40to the device10. Once the final prosthesis is available, the attachment device or compound and healing ball are removed and the prosthesis is secured to the implant abutment device10within the patient's mouth.

In another embodiment of the invention, the healing ball40may be permanently affixed to the device10so that the dental prosthesis directly attaches to the healing ball40. For example, prostheses or dentures including metal rings, caps with rubber o-rings, ball attachment replicas and other similar fastening elements may be friction fit over the healing ball40to firmly, securely and removably attach the prosthesis to the implant abutment device10. As shown inFIG. 6A, one or more healing ball40and implant abutment device10assemblies are secured within the patient's mouth. Attachment devices and compounds including, but not limited to, cement, retaining screws, glues, wax, permanent soft-liner materials (such as, for example, silicone or Coesofte) and other attachment devices and compounds, including combinations thereof, may be used to permanently secure the healing ball40onto the implant abutment device10. The fastening elements52of the prosthesis54are then friction fit over the healing balls40to securely attach the prosthesis54within the patient's mouth.

In an alternate embodiment, one or more tooth-shaped healing balls40are permanently affixed to one or more devices10implanted within the patient's jawbone.

As shown inFIGS. 6A and 6B, a prosthesis, denture or partial-denture55including one or more retention clasps, rings or elements57aligned to engage the healing ball(s)40act as retaining elements to secure and stabilize the denture in the patient's mouth.

Alternate configurations of attaching the dental implant system of the present invention either removably or permanently to a prosthesis are well-known to those skilled in the art are also included within the scope of the present invention.

In another embodiment of the invention (not shown), bar-clip overdentures, crowns and/or bridges (such as those disclosed in U.S. Pat. No. 5,174,954, of which the entire disclosure is herein incorporated by reference) may be readily connected to either the healing ball40and implant abutment device assemblies or to the gold-cylinder and implant abutment device10assemblies. As will be apparent to those skilled in the art, the universality of the dental implant system of the present invention enables it to be used in conjunction with many different types of prosthetic applications. Further, it provides the dental practitioner with substantially more flexibility with reduced number of parts/components than the prior art systems.

Referring toFIG. 7, the dental implant system may also include an abutment-analog56. The abutment-analog56is generally a replica of the head12and/or neck14of the implant abutment device10and mainly used in laboratory procedures during construction of patient models and prostheses. The abutment-analog includes a head58and neck60similar in design and configuration to the head12and neck14of the implant abutment device10previously described.

In one embodiment, the head58and neck60of the abutment-analog56are exact replicas of the head12and neck14of the implant abutment device10.

The abutment-analog56may be made from a variety of materials. Examples of such materials include, but are not limited to, brass, gold, titanium, stainless steel, metals, metal-alloys, ceramics, plastics, composites and combinations thereof are also included within the scope of the claimed invention.

As shown inFIG. 7, the abutment-analog56also includes a shaft62. In one embodiment, the shaft62includes cylindrically shaped top64, middle66and bottom67portions. The diameter of each shaft portion64,66,67is variable, ranging in size from approximately 1.0 millimeter to 10.0 millimeters. For example, in one embodiment the top portion64is approximately 3.0 millimeters, the middle portion66is approximately 1.75 millimeters and the bottom portion67is approximately 3.0 millimeters. Alternatively, the top64, middle66and bottom67portions maybe approximately 1.0 millimeter, 3.0 millimeters and 1.0 millimeter, respectively. In general, the shaft62may be configured with various gripping surfaces, projections, indentations, flat/planar portions and non-planar portions to prevent the abutment-analog56from becoming dislodged from or rotating around the rigid stone or plaster material that forms the final model for the prosthesis, as described in further detail below.

Referring toFIGS. 8 and 9, the dental implant system of the present invention may also include a retaining screw68and guide pin70, respectively. Referring toFIG. 8, the retaining screw68is used to secure the healing ball40and/or prosthesis, either permanently or temporarily, onto the implant abutment device10.

As such, the threaded portion72of the retaining screw68is configured to engage the threads on the surface of the internal walls36of the device10. In general, the retaining screw may be approximately 2.0 millimeters to 10.0 millimeters in length. In one embodiment, the diameter of the head74of the retaining screw68may be configured to seat within the lumen of the healing ball40. Alternatively, the head74may be seated on the external surface of the healing ball40. The retaining screw68may be made of a variety of biocompatible, non-toxic materials including, but not limited to, brass, gold, titanium, stainless steel, metals, metal-alloys, ceramics, plastics, composites and combinations thereof.

The guide pin70, shown inFIG. 9, is used to secure the healing ball40to the implant abutment device10for taking final impressions of the position of the head12of the device10. The length of the guide pin70is approximately within the range of 3.0 millimeters to 20.0 millimeters. In general, the guide pin70is configured so that a sufficient portion of the head or shaft76extends outside of the healing ball40, enabling a user or practitioner to firmly and securely grip the guide pin70. The shaft76may be made of a variety of shapes and surface configurations including, but not limited to, cylindrical, conical, polygonal, ribbed, dimpled, smooth and textured.

As with the retaining screw68, the threaded portion78of the guide pin70may also be configured to engage the threads on the surface of the internal walls36of the device10. In addition, a variety of biocompatible, non-toxic materials may be used to fabricate the guide pin70of the present invention. Examples of these materials include, but are not limited to, brass, gold, titanium, stainless steel, metals, metal alloys, ceramics plastics, composites and combinations thereof are also included within the scope of the claimed invention.

Although the retaining screw68and guide pin70are shown inFIGS. 8 and 9, respectively, to include a slotted head, other head configurations known in the art to either manually or mechanically drive the screw68/guide pin70into the device10may also be used and are included within the scope of the claimed invention. One or more of the universal implant abutment device10, healing ball40, abutment-analog56, guide pin70and retaining screw68components of the dental implant system of the present invention may be packaged together to form a kit (not shown). The size, material, shape and configuration of each component compliments the other components, thereby assuring compatibility, interchangeability, durability and perfect fit. In addition, component parameters, such as size, material, shape and configuration of each component for either single or multiple tooth replacement kits, may be the same or variable within each kit.

Each kit may be configured to provide the necessary components for a particular procedure. For example, in one embodiment of the invention, the kit for a single-tooth replacement procedure may include one implant abutment device10, three healing balls40, one abutment-analog56, one retaining screw68and one guide pin70. In another embodiment, a single-tooth replacement kit may include two implant abutment devices10, six healing balls40, two abutment-analogs56, two retaining screws68and two guide pins70. In an alternate embodiment, a multiple-tooth replacement kit may include three implant abutment devices10, nine healing balls40, three abutment-analogs56, three retaining screws68and three guide pins70. Other kit configurations not disclosed herein but known in the art are also included within the scope of the claimed invention.

Many methods of using the universal implant system of the present invention are contemplated herein. Each methodology is related to the particular type of dental reconstruction required by the patient's condition. The following methods are intended as examples and for illustration purposes only and are not meant to limit the claimed invention.

In one embodiment, a mid-crestal and reverse bevel labial incision80is made extending along two teeth and on both sides of the edentulous space, as shown inFIG. 10. A similar incision is made palatally, resulting in a full thickness envelope flap82as shown inFIG. 11.

Referring toFIG. 12, a hole84is then drilled within the jawbone of the patient. The exact point of purchase and approach, either cingulum or labial, within the edentulous space and jaw anatomy are visually determined. In general, the approach should be one that will provide the greatest amount of stability for the device10, and, generally, is parallel to the long axis of adjacent teeth.

One or more drill bits used at variable speeds with sufficient irrigation create the appropriately sized and shaped hole84. The depth of the hole84is sized to receive the base16of the implant abutment device10, and generally ranges from approximately 8 millimeters to 30 millimeters in depth.

Referring toFIG. 13, the implant abutment device10is then manually inserted into the hole84in a sterile manner. In one embodiment, a carrier (not shown) may be used to deliver the implant abutment device10to the hole84and also to begin manually screwing the device10into the hole84. An example of such a carrier is disclosed in U.S. Pat. No. 6,068,479, of which the entire disclosure in incorporated herein by reference. Other carriers and similar tools not specifically disclosed herein but known in the art may also be used and are included within the scope of the claimed invention.

Generally, only a portion of the base16of the implant abutment device10can be manually inserted into the hole84. A power-driven socket-wrench, contra-angle handpiece or similar tool may be used to fully seat the device10within the hole84.

Crestal bone height and clinical parameters such as device stability, tissue thickness as required for prosthesis aesthetics and inter-occlusal distance may also be taken into consideration to determine final position and configuration of the device10.

The gingival tissue and flaps82are inspected, trimmed, coapted and sutured around the head12of the device10. Factors, such as amount of tissue recession after healing, final crown space required and/or other aesthetic and prosthetic considerations, may be taken into account with respect to tissue placement and suturing.

Either immediately after suturing or anytime thereafter, the prosthesis may be attached to the device10. No further surgical procedures are required, unlike prior art processes which often require a second stage surgery to expose and prepare a gingival seat around the device and perform other modifications to ensure proper prosthetic-device engagement. As previously described, with prior art devices and procedures, a space or recess between the device and soft tissue must be created to allow an appropriate interface and ensure proper placement of the prosthesis without trapping soft tissue. In contrast, the prosthesis may be directly attached to the implant abutment device10of the present invention without further surgical intervention.

Referring toFIG. 14, a healing ball40may be attached to the device10to contour the tissue for proper impression registration. In one embodiment of the invention, the healing ball40is attached directly after tissue suturing and prior to hard and soft tissue healing. A retaining screw68or similar component previously described may be used to secure the healing ball40onto the device10. The healing ball40is then left in place for an approximately seven to ten day time period.

Alternate time periods that allow the soft tissue to mature and form a stable recess for the prosthesis may also be used.

After the soft tissue has matured and formed a stable recess, a final impression may be taken from which the prosthesis is created. The original healing ball40is removed, and another, interchangeable healing ball40is secured to the device10with a guide pin70. Alternatively, the original healing ball40is left in place and the retaining screw68is replaced with a guide pin70.

As shown inFIG. 15, an impression tray86with a window or opening88is placed over the healing ball40within the patient's mouth. The opening88of the tray86is aligned with the guide pin70so that the guide pin70protrudes above the impression frame. The guide pin70holds the healing ball40in place during setting of the impression material. After the material is set, the protruding portion of the guide pin70is used to unscrew the guide pin70from the healing ball40and remove the guide pin70through the tray opening88. The healing ball40is then transferred with the impression material when the impression tray86is removed from the patient's mouth, as shown inFIG. 16. The original healing ball40may be re-attached to the device10as a protective covering and tissue spacer.

In an alternate embodiment, anti-rotational grooves, indentations or other types of gripping features may be formed on the healing ball40. These features prevent movement or displacement of the healing ball40within the impression material when the healing balVimpression tray are removed from the patient's mouth.

Referring toFIG. 17, and in the process depicted therein, an abutment-analog56is inserted into the matching cavity of the healing ball40contained within the impression material. As previously described, the abutment-analog56replicates the configuration of the implant abutment device10of the present invention. With the abutment-analog56seated in the healing ball40, an impression is then poured in a rigid stone or plaster material to form the final model90. In general, the entire abutment-analog56, excluding its head58or head58and neck60, may be buried in the final working model90. As such, the remaining exposed portion of the abutment-analog56, together with the impression material, forms an accurate and visible replica of the edentulous space within the patient's mouth prior to restoration, as shown inFIG. 18.

Referring toFIG. 19, a healing ball40, coping (such as a preformed coping in the shape of a healing ball40, tooth or other shapes) or metal framework may be used as part of the final prosthesis92. Some of the materials used to form the final prosthesis include, but are not limited to, metal, metal alloys, ceramics, composites, aluminum oxide, fiber core, zirconium and other materials. The final prosthesis92may be formed using a lost wax technique, laser scan generated images, optical impression, CAD/CAM manufacturing, reverse engineering, rapid prototyping and other conventional techniques or methods. Once complete, the final prosthesis92is then installed within the patient's mouth using cement, retaining screws, or other attachment means known to those skilled in the art.

In an alternate embodiment (not shown), two or more implant abutment devices10may be used for a single tooth (e.g., molar) restoration. The use of multiple implant abutment devices10for a single tooth restoration provides greater support and stability for the final prosthesis. In addition, this configuration provides improved osseointegration and greater device surface area, which also improves the retentive strength of the prosthesis.

A multiple tooth or full-mouth reconstruction method of the present invention is similar to the single tooth reconstruction method. However, as previously described, multiple tooth or full-mouth reconstruction procedures are more involved, requiring common paths of insertion, sufficient friction to ensure a firm fit and no undue soft tissue tension.

In one embodiment, the incision80, hole84and implant abutment device10insertion are made in a manner similar to that previously described for the single tooth reconstruction method. However, the approach is modified to accommodate multiple restorations. For example, the incision80may be larger, multiple holes84are generally created within the jawbone of the patient, and, likewise, multiple implant abutment devices10are inserted within the holes84, as generally shown inFIG. 20. The four-teeth reconstruction shown inFIG. 20is for illustration purposes and not meant to limit the scope of the claimed invention.

After adequate soft tissue healing has occurred and a stable recess for the prosthesis has been formed using healing balls40as previously described, the temporary prosthesis or original healing balls40are removed from each device10.

In one embodiment, a pattern resin or similar material may be used to lute or connect all the healing balls40together as one unit, forming a coping framework. This process may be used for both the original healing balls40and the new healing balls40.

Next, an impression is taken using an appropriately sized impression tray86.

The protruding portions of the guide pins70extend through the opening(s)88in the impression framework, as shown inFIG. 21. Alternatively, a traditional disposable stock tray (not shown) may be used. As such, after all the healing balls40are luted or splinted together thereby forming a “picket-fence” type effect, the guide pins70can be removed from the healing balls40. The healing balls40will remain in position and form in a stable framework due to the “picket-fence” effect and remain in proper alignment with each other. Impression material can then be injected under and around the healing balls40.

After the impression material has set, the guide pins70, tray86and impression material are removed from the patient's mouth. The resulting impression includes the healing balls40incorporated in the impression material. The low height or minimal profile of the head12of each device10and flexibility of the impression media allow an accurate impression to be made, without permanent distortion or damage. In particular, the healing balls40, as integral parts of the impression, may be cleanly withdrawn from the devices10without disturbing the precise relationship of each reference device99. The other devices10are then modified (e.g. portion100, shown in theFIG. 24as encircled by a dashed line, is removed) according to the inclination/alignment of these devices10in relationship to the reference device99to ensure a secure and accurate fit for the final prosthesis.

Healing balls40, copings or metal frameworks are then installed on the modified heads58of the stone model94and may be used as part of the final prosthesis. As previously described, the final prosthesis may be formed using a lost wax technique, laser scan generated images, optical impression, CAD/CAM manufacturing, reverse engineering, rapid prototyping and other conventional techniques or methods.

With the final stone model94as a guide, the corresponding surfaces of the device heads12in the patient's mouth are removed. After a passive placement is achieved, the final prosthesis is then installed using cement, retaining screws or other attachment means to stabilize and secure the prosthesis within the patient's mouth.

In an alternate embodiment of the invention, a template (not shown) together with the final stone model94is used as a guide for removing the necessary portions/surfaces of the device heads12in the patient's mouth. The template may be one or more copings, caps, framework or other types of coverings linked or connected together to maintain alignment of the caps to each other and to their counter-part abutment-analog56in the final stone model94. The template may be made of a variety of materials including, but not limited to, metals, metal alloys, plastics, ceramics, composites and other materials, including combinations of materials.

Further, each cap may be a variety of configurations (such as, for example, cylindrical, spherical, hexagonal, polygonal and other configurations), provided the cap configuration matches to securely engage its corresponding analog-abutment configuration.

The following example and associated figures will reference only a single cap in a template and a single abutment-analog56in a final stone model94, however it is understood that the template and final stone model94include one or more caps and abutment-analog56, respectively.

As previously disclosed, the cap of the template replicates its counterpart head58of the abutment-analog56in the final stone model94. Referring toFIG. 25, a portion100(shown in phantom onFIG. 25) of the analog-abutment head58in the final stone model94is removed or modified as previously described. The corresponding portions of its matching cap102are then also removed, forming a window or some other type of opening104in the cap102that corresponds to the modified area of the head58, shown inFIG. 26.

As shown inFIG. 27, when the cap102is properly positioned or placed over the patient's corresponding implant abutment device10, portions of the device10protruding through the opening104correspond to the removed portions of the analog abutment56. At this point, the user may use an appropriate tool to remove the protruding portions of the device10. Alternatively, the user may simply mark the portions of the device10that need to be modified, remove the cap and then remove/modify the marked portions of the device10. Other methods of modifying the device10, including the cap102, not specifically disclosed but known in the art may also be used.

The quantity of components and associated reconstruction methods of the dental implant system of the present invention are greatly reduced and simplified compared to conventional implant systems and methods of use. Especially in multiple implant situations, the dental implant system of the present invention greatly reduces the number of clinical procedures and total treatment time. In particular, the amount of time between the initial surgery to the tooth/prosthesis mounting is greatly reduced.

Further, the procedures or methods of the present invention are also more predictable with respect to cosmetic and functional effects of the final prosthesis when compared to traditional approaches. As such, the dental implant system of the present invention may reduce post-operative infection, improve device/prosthesis strength and prolong its stability and reduce the overall time for a reconstruction procedure by approximately three months or more. In addition, the dental implant system and associated methods of the present invention enable a practitioner to form a final prosthesis, including an infinite number of facsimiles of said final prosthesis (for example, as spares or replacements if the original prosthesis should become damaged or lost), based on a single impression. In general, the overall procedure using the dental implant system of the present invention is fast, simple and effective.

FIG. 28is a partial exploded view of a dental implant assembly200comprised of a head202which facilitates the use of assembly200in multiple implant restorations.

Referring toFIG. 28, and in the embodiment depicted therein, it will be seen that head202is comprised of sides204,206,208,210, and212. Each of these sides intersects with surface214of neck14. In another embodiment, not shown, no neck section is present and the aforementioned sides meet directly with base16.

In one embodiment, illustrated inFIGS. 34A and 34B, the neck14is omitted and the head202is directly contiguous with base16. In the embodiment depicted inFIGS. 34A and 34B, the head section is substantially smaller than the base section, and thus a ledge is created at the neck section. In the embodiment depicted inFIG. 34CandFIG. 34D, the head section is substantially the same size as the base section, and thus no ledge is created.

Referring again toFIG. 28, and in the embodiment depicted therein, with the exception of side208, each of the other sides forms an angle vis-a-vis surface214that is substantially perpendicular, ranging from about 80 to about 100 degrees and, more preferably, from about 75 to about 95 degrees. However, the side208forms an angle with surface214of less than about 75 degrees.

In the embodiment depicted inFIG. 28, there are at least five sides that intersect surface214at a substantially perpendicular angle. Devices with more of such sides may be used, provided that at least two sides of the head202are substantially perpendicular to the surface214and at least one side forms an angle with such surface of less than about 75 degrees. In one embodiment, at least three such sides of the head202are substantially perpendicular to the surface214. In another embodiment, at least four such sides of the head202are substantially perpendicular to the surface214. In yet another embodiment, at least five such sides of the head202are substantially perpendicular to the surface214.

In another embodiment, depicted inFIG. 28C, at least two of sides of the head202form an angle of from about 45 to about 100 degrees with the surface214and the abutment head is comprised of a linear wall joined to an accurate wall.

Referring again toFIG. 28, a bore216extends from the top surface of the head202to a distance of from about 2 to about 5 millimeters. In one embodiment, the bore216is threaded.

In another embodiment, not shown, the bore216is omitted from the head202. In another embodiment, not shown, the bore216is replaced by an annular groove disposed beneath substantially polygonal portion of head202and surface214. In one embodiment, the bore216is substantially coaxial with the axis220of base16. In another embodiment, illustrated inFIG. 28, the bore216is not coaxial with the axis220but, instead, forms an angle that is less than 45 degrees and, in one embodiment, is substantially identical to the angle formed by side208with surface214.

FIGS. 28A and 29Adisclose a dental implant assembly201which is similar to the assembly200but differs therefrom in that the bore216is substantially perpendicular to the axis220.

FIGS. 28B and 29Bdisclose a dental implant assembly203which is similar to the assembly200but differs therefrom in that the bore216is substantially parallel to the axis220. In the embodiment depicted, bore216is also substantially coincident with the axis220.

Referring again toFIG. 28, it will be seen that a healing ball205is adapted to fit over the head202. A similar healing ball205may be used in the embodiments depicted inFIGS. 28A and 28Bbut has been omitted therefrom for the sake of simplicity of representation.

The shape of the head depicted inFIGS. 29A and 29Bmay be varied. Some other suitable shapes are depicted inFIGS. 30A through 30H.

FIGS. 30A through 30Hpresent a multiplicity of sectional views showing the shapes in which the head202may be. In the embodiments depicted, the shapes are either comprised of straight walls230and/or arcuate sections232.

FIGS. 31A and 31Bare perspective and top views, respectively, of an assembly240in which arcuate section242joins walls244and246(see, for exampleFIG. 31A) of inclined side208. As will be apparent, because arcuate section242theoretically contains an infinite number of walls, the assembly240meets the requirement that at least two such walls are substantially perpendicular to the surface214of base16. In another embodiment, the walls are at an angle of from about 45 to about 95 degrees relative to surface214. In the embodiments depicted, wall242and208extend downwardly and outwardly.

FIG. 32discloses an exploded view of an assembly250that is similar in configuration to the assembly240but differs therefrom in that arcuate section242is comprised of a multiplicity of splines252. In the configuration depicted inFIG. 32, such splines252have a substantially rectangular cross-sectional shape.

Referring again toFIG. 32, and in the embodiment depicted therein, it will be seen that healing ball205preferably is comprised of an orifice256that is adapted to receive the side208and the splines252.

FIG. 32Ais a partial sectional view of an implant assembly207that is similar to the implant assembly201(seeFIG. 28A) but omits that omits the bore216.

FIG. 32Bis a partial sectional view of an implant assembly209that is similar to the implant assembly201(seeFIG. 28A) but differs therefrom in that it does contain a bore216that is substantially aligned with the axis of the assembly209.

As will be apparent fromFIGS. 33A through 33H, different splined arrangements may be used with the assembly250.

Thus, as depicted inFIG. 33A, the splines252may have a substantially rectilinear cross-sectional shape. As depicted inFIG. 33B, the splines256may have a substantially triangular cross-sectional shape. As depicted inFIG. 33C, the splines258may have a substantially circular cross-sectional shape. As depicted inFIG. 33D, the splines260may have a substantially polygonal cross-sectional; in the embodiment, depicted, this shape is formed by alternating rectangles and triangles. As depicted inFIG. 33E, the splines262may have a shape defined by a linear section and an arcuate section; in the embodiment depicted, the splines262are formed by alternating semicircles and flat surfaces. As depicted inFIG. 33F, the splines264may have different shapes which may alternate on the splined surface; thus, e.g., they may contain both triangular, circular, and composite shapes in which flat top intersects two adjacent splines. The splines266depicted inFIG. 33Gare defined by half-circles joined by arcuate tops. By comparison, the splines268depicted inFIG. 33Hare defined by triangular sections joined by arcuate tops. Many other splined shapes, not shown, also may be used. All of the aforementioned walls can be substantial perpendicular or, in other embodiments, form an angle from 45 to 95 degrees relative to the center axis. In one embodiment, such an angle is formed between the walls and the neck. In another embodiment, no neck is present and such an angle is formed between the walls and the base.

FIG. 35is a perspective view of an implant assembly270that is similar to the implant assembly269ofFIGS. 34A and 34Bbut differs therefrom in that the surface272of base16is roughened.

In one embodiment, the surface272is roughened in accordance with the acid-etching procedure disclosed in International patent publication W09616611A2. In the process described in this patent publication, the surfaces of the implant body are exposed to an acidic etching process after the natural titanium oxide layer is removed to attain an essentially uniform roughness over the entire surface (W09616611A2). Reference may also be had to applicant's U.S. Pat. No. 5,733,124, the entire disclosure of which is hereby incorporated by reference into this specification.

In another embodiment, the surface272is roughened in accordance with the procedure disclosed in an article by Cochran et al., “Bone response to unloaded and loaded titanium implants with a sand-blasted and acid-etched surface”, Journal of Biomedical Materials Research, Vol. 40, 1998, p. I. In this process, the surface272is subjected to coarse sand blasting to create macro-roughness in the titanium. This process is followed by acid etching that generates evenly-distributed micro-pits in the sand-blasted surface.

One may roughen such surface272, or other surfaces, by conventional means known to those skilled in the art. Thus, e.g., one may use the roughening processes disclosed in U.S. Pat. No. 5,588,838 of Hannson (micro-roughness having a height between 0.02 millimeters to about 0.2 millimeters); U.S. Pat. No. 5,607,480 of Beaty (individual depressions and dents with transverse dimensions about half of the size of impacting grit particles, on the order of 5-10 microns); U.S. Pat. No. 5,947,735 (additive and subtractive roughening); U.S. Pat. No. 5,897,319 of Wagner et al. (surface roughness of from about 7 t to about 300 microinches); U.S. Pat. No. 6,344,061 of Leitao et al. (surface roughness with an average peak distance between 10 and 1,000 nanometers); U.S. Pat. No. 6,095,817 of Wagner et al., and the like. The entire disclosure of each of these United States patents is hereby incorporated by reference into this specification.

One means for providing the desired degree(s) of roughness to the implant assembly of this invention is described below. The process described below is especially advantageous for use with one-piece implant assemblies.

In this process, all abutment areas are preferably completely covered by soft wax to get a demarcation and to protect the abutment portion of the one piece implant from sandblasting and etching.

Waxing of the implant abutment assembly involves insertion of a guide pin into bore216(seeFIG. 36). The implant assembly is then placed into a pre-drilled Pro-form laminate plate Wax is then heated on a hot plate to a temperature sufficient to melt the wax and liquefy it.

A masking device, such as a plate, is used to separate and isolate the top part of the implant assembly from its bottom part. The plate is preheated to a temperature of about 70 degrees Centigrade for about p10 minutes. Thereafter, wax is poured over the masked implant assembly and allowed to cool for from about 30 to about 45 minutes. Thereafter, the assembly is cooled in a refrigerator for from about 10 to about 15 minutes. The partially masked implant assembly that is partially embedded in wax is then subjected to sandblasting.

Thereafter the exposed portion(s) of the one-piece implant assembly is grit blasted using a Renfert sandblaster with non-recycled aluminum oxide (50 micron size) to remove burrs and metallic contaminants. The sand-blasted assembly is then subjected to acid etching.

In one embodiment, acid etching is accomplished with the use of an acid solution composed of a 10-30 volume percent (150-450 g/1) of 70% nitric acid and 1:3 volume percent (12 to 36 g/1) of 48% hydrofluoric acid (maintaining a ratio of 10 parts nitric acid to 1 part hydrofluoric acid). The surface of the implant assembly to be acid etched is contacted with the acid mixture while being subjected to ultrasonic energy for 3 minutes.

FIGS. 37A and 37Billustrate two devices which may be made by the process of this invention. Referring to these Figures, it will be seen that each of implant assemblies300and302is comprised of base section304, and ledge section320, and head section308.

In each of implant assemblies300and302, the base section304, the ledge section320, and the head section308are integrally joined to each other.

In each of implant assemblies300and302, the head section308has a cross-sectional shape formed by alternating arcuate and linear walls; similar devices are disclosed in U.S. Pat. No. 5,733,124, the entire disclosure of which is hereby incorporated by reference into this specification. Referring to implant assembly300, one of the linear walls is linear wall301, and the arcuate walls are arcuate walls303and305.

Referring to implant assembly302, the linear wall is linear wall307, and the arcuate wall is arcuate wall309.

Each of implant assembles300and302is comprised of a base section304that extends upwardly and outwardly from its bottom310to its top312.

In the embodiments depicted inFIGS. 37A and 37B, the base section304is preferably comprised of two distinct sections. The first section313, extending from point314to point316, has a length318of from about 3 to about 50 millimeters and, preferably, from about 7 to about 17 millimeters. The second section is ledge section320, extending from point314to point322, has a length324of from about 0.0 to about 2 millimeters and, preferably, from about 0.3 to about 0.7 millimeters.

It is advantageous that ledge section320have a length324that is no greater than about 15 percent of the length318of first section313and, more preferably, is less than about 10 percent of the length318of first section313.

In both of the embodiments depicted inFIGS. 37A and 37B, the first section313has a substantially rougher surface than the ledge section320.

FIG. 38is a sectional view of a roughened surface350formed in a substrate352. As will be seen, this roughened surface350is comprised of a multiplicity of peaks354and valleys356. The distances360,362,364,366,368between the peaks354and the valleys356indicate the roughness of surface350. For the purposes of this specification, the roughness of any such surface is the average peak-to-valley distance of the surface. As is known to those skilled in the art, this may be measured by conventional techniques, such as, e.g., scanning electron micrography.

Referring again toFIGS. 37A and 37B, and in the embodiment depicted therein, the first section313will preferably have an average roughness (i.e., an average peak to valley distance of its indentations) of from about 0.3 microns to about 1,000 microns. In another embodiment, the average roughness is from about 10 to about 1,000 microns and, preferably, from about 20 to about 200 microns. In another embodiment, the average roughness is from about 0.3 microns to about 10 microns.

In this embodiment, the ledge section320will preferably have an average roughness (i.e., an average peak to valley distance of its indentations) of from about 0.1 to about 100 microns.

The first section313will preferably have an average roughness that is at least about 10 times as great as the average roughness of the ledge section320. In one embodiment, the first section313has an average roughness that is at least about 50 times as great as the average roughness of ledge section320. In another embodiment, the first section313has an average roughness that is at least about 100 times as great as the average roughness of ledge section320.

One may obtain the differential roughness properties described hereinabove by subjecting the first section313and/or ledge section320to different treatments and/or different lengths of treatment, masking one (with wax, e.g.) while treating another. Thus, for example, the first section313may be treated with both sandblasting and acid etching, whereas the ledge section320may be subjected to micromachining or laser etching.

Thus, e.g., one may use microtexturing to create the roughness in ledge section320. Reference may be had, e.g., to U.S. Pat. Nos. 6,228,434; 5,964,804; 5,782,912; 5,349,503; 5,909,020; and the like. The entire disclosure of each of these United States patents is hereby incorporated by reference into this specification.

Thus, e.g., one may use laser etching to create the roughness in ledge section320. Reference may be had, e.g., to U.S. Pat. Nos. 5,164,324; 6,391,212; 6,277,312; 5,544,775; 5,018,164; and the like. The entire disclosure of each of these United States patents is hereby incorporated by reference into this specification.

In one embodiment, illustrated inFIGS. 37A and 37B, the roughened first section313is coated with a bioactive coating370. The bioactive coating370is comprised of or consists essentially of a biological active material.

As is disclosed in U.S. Pat. No. 6,344,061, the substrate having the desired surface roughness can efficiently be coated in vitro with a layer of one or more biologically active agents; the entire disclosure of this United States patent is hereby incorporated by reference into this specification. The composite coating can be relatively thin, in the order of from, e.g. 50 nanometers to 200 microns, especially from 1 to 50 microns. The biologically active agent in the coating includes, but is not limited to, single or combinations of proteins, lipids, (lipo)polysaccharides, growth-factors, cytostatic agents, hormones, and antibiotics. Examples of such agents are bone morphogenetic proteins (BMP's), basic fibroblast growth factor (bFGF), transforming growth factor (TGF-13), osteogenic growth peptide (OGP), and the like. The molecular weight of said biologically active agents can vary from several tens of Daltons, to thousands of kilo-Daltons. Reference may be had to U.S. Pat. No. 5,935,594 to Ringeisen (Process and Device for treating and healing issue deficiency); U.S. Pat. No. 6,949,251 to Dalal (Porous 13-tricalcium phosphate granules for regeneration of bone tissue); U.S. Pat. No. 6,902,721 to Mundy (Inhibitors of proteasomal Activity for Stimulating Bone Growth); U.S. Pat. No. 6,302,913 to Ripamonti (Biomaterial and Bone Implant for Bone Repair and Replacement); U.S. Pat. No. 6,139,585 to Li (Bioactive Ceramic Coating and Method); U.S. Pat. No. 6,080,799 to Gasper (Compositions and Methods for Stimulating Bone Growth); U.S. Pat. No. 5,944,524 to Hill (Biohybrid Dental Implant); and the like. The term “bone morphogenetic protein” is known to those skilled in the art. For example, reference may be had to the claims of U.S. Pat. No. 5,661,007 to Wozney (Bone morphogenetic protein-11 (BMP-11) compositions); U.S. Pat. No. 5,661,007 to Wozney (Bone morphogenetic protein-9 compositions), and the like. The term “basic fibroblast growth factor” is likewise known in the art. Reference may be made to the claims of U.S. Pat. No. 4,785,079 to Gospodarowicz (Isolation of fibroblast growth factor) and the like. The term “transforming growth factor” is defined in the claims of U.S. Pat. No. 5,278,145 to Keller (Method for protecting bone marrow against chemotherapeutic drugs using transforming growth factor beta 1) and the like. The term “osteogenic growth peptide” is also known in the art. Reference may be had to the claims of U.S. Pat. No. 5,814,610 to Bab (Osteogenic growth oligopeptides and pharmaceutical compositions containing them); U.S. Pat. No. 6,593,394 to Li (Bioactive and osteoporotic bone cement). The content of each of the aforementioned patents is hereby incorporated by reference into, this specification.

In one embodiment, at least a portion of the coated layer has a thickness greater than the average depth of the roughened surface. See, e.g., U.S. Pat. No. 6,344,061. In another embodiment, the biologically active agent is selected from the group consisting of proteins, lipids, (lipo)polysaccharides, growth factors, cytostatic agents, hormones, antibiotics, hydroxyapatite and combinations thereof. See the aforementioned U.S. Pat. No. 6,344,061.

In yet another embodiment, the biologically active agent is selected from the group consisting of bone morphogenetic proteins, basic fibroblast growth factor, transforming growth factor, osteogenic growth peptide, and combinations thereof. See U.S. Pat. No. 6,344,061.

In one embodiment, the coating is comprised of one or more anions selected from the group consisting of hydroxide, chloride, sulphate, nitrate, and combinations thereof. In another embodiment, the coating further comprises one or more cations selected from the group consisting of hydrogen, sodium, potassium, magnesium, and combinations thereof. See, for example, the aforementioned U.S. Pat. No. 6,344,061.

In yet another embodiment, the sandblasting step is replaced by blasting with other abrasive material, such as alumina.

In yet another embodiment, the biologically active material is comprised of organic material comprising a multiplicity of amino acids and/or proteins.

In one embodiment, the organic material is an organic amine containing from about 1 to about 10 carbon atoms and from about 1 to about 4 amino groups. Some suitable materials in this embodiment include gamma-aminopropyletriethyoxysilane, ally! amine, carbodimide, bone morphogenic protein, extracellular matrix proteins, and the like. Reference may be had, e.g., to articles by Wojcik et al. (“Biochemical surface modification . . . for the delivery of protein . . . ,” Biomed Sc Instrum 1997; 33: 166-171), by Puleo et al. (“A technique to immobile bioactive proteins . . . ,” Biomaterials 2002 May; 23(9): 2079-2087), by An et al. (“Prevention of bacterial adherence to implant surfaces . . . ,” J Orthop Res 1996 September; 14(5):846-849), by Bessho et al. (“BMP stimulation of bone response . . . ,” Clin Oral Implants Res 1999 June; 10(3):212-8), by Deligianni et al. (“Effect of surface roughness of the titanium alloy . . . ,” Biomaterials 2002 June; 22(11): 1241-1251), by Dean et al. (“Firbonectin and laminin enhance gingival cell attachment . . . ,” Int J. Oral Maxillofac Implants 1995 November-December; 10(6):721-728), by Keogh et al. (“Albumin binding surfaces for biomaterials,” J Lab Clin Med 1994 October; 124(4):537-545), and the like. The disclosure of each of these publications is hereby incorporated by reference into this specification.

In one embodiment, the biologically active material is coated onto a relatively smooth first section313and/or ledge section320in order to form the roughened surface. As will be apparent, either the roughed surface, and/or the coated surface, will tend to promote adhesion between the implant assembly and the biological tissue surrounding it.

One means of facilitating such adhesion is to impart a charge to one or more of the implant surfaces. Thus, e.g., one may incorporate anions and/or cations into or onto such surface, as is disclosed in such U.S. Pat. No. 6,344,061. Thus, e.g., one may incorporate charged moieties into or onto such surface by the process disclosed in an article by P. S. Chockalinagm et al. entitled “DNA affinity chromatography,” J. Mol Biotechnology 2001 October 19(2): 189-199.

In one embodiment, protein is coupled to silanized titanium with gluaraldehyde. See, e.g., the article by Wojcik et al., “Biochemical surface modification . . . ,” Biomed Sci Instrum 1997; 33: 166-171. Referring again toFIGS. 37A and 37B, and in the embodiments depicted therein, it will be seen that head section308extends a length323above the top surface325of ledge section320of from about 1.5 to about 10 millimeters and, preferably, from about 2 to about 4 millimeters.

The implant assembly of this invention may be used in the process disclosed in U.S. Pat. No. 6,068,479 and, in particular, in theFIG. 18depicted therein; the entire disclosure of such U.S. Pat. No. 6,048,479 is hereby incorporated by reference into this specification.

Thus, e.g., referring to such U.S. Pat. No. 6,048,479 and, in particular, to theFIG. 18thereof, in the first step of this process, step300, device10is connected to an implant fixture.

In this step, it is advantageous to apply a torque no greater than about 20 Newton per centimeter.

Thereafter, in step302of the process, a hole is drilled in the jawbone of the patient sufficiently deep to receive only the length of the implant fixture. In general, this hole is usually from about 8 to about 18 millimeters.

Thereafter, in step304of the process, the hole thus drilled is preferably tapped with a tapping tool such as, e.g., the screw taps illustrated on page 11 of the Nobelpharma catalog.

Thereafter, in step306of the process, the abutment/implant fixture assembly is delivered to the hole by means of the carrier (for example, final model90). The carrier may also be used to start screwing the assembly into the hole, applying downward pressure while turning the assembly. Generally, the carrier will only enable one to drive the abutment/implant fixture assembly a portion of the required distance. The job may be finished by a power-driven socket wrench in step308of the process.

In the next step of this process, step310, the healing ball is preferably snapped onto the device10. In one embodiment, the healing ball is disposed within a compartment of carrier prior to its use.

Thereafter, in step312, the gum tissue where the hole had been drilled is sutured around the healing ball.

In the next step of process, step314, the surgical site is allowed to heal before the device10is directly or indirectly connected to a denture. In general, a healing period of from about 3 to about 6 months is desirable.

After the desired time of healing, no additional surgical procedure is required, unlike the prior art process (which necessitated second stage surgery to remove the cover screw used in the process and to attach the prosthetic abutment). By comparison with prior art processes, applicant's prosthetic abutment is already attached.

At this stage of applicant's process, several options are available.

In one embodiment, illustrated in step316of U.S. Pat. No. 6,068,479, the healing ball is attached directly to a denture into which metal caps with an 0-ring have been cured.

In another embodiment, illustrated in step318, the healing ball is removed from the device10. At this stage, several additional options are available.

One such option is to attach a gold cylinder to the device10in step320.

Once the gold cylinder has been so attached, one may prepare a bar clip overdenture (seeFIG. 12) and attach such denture to the superstructure (see step322). Alternatively, in step324, the gold cylinders can be incorporated into a fixed detachable implant supported bridge and thereafter secured to multiple implants in place in the jawbone.

Alternatively, in step326, after the healing ball has been removed a gold coping may be attached to a tooth where such a gold coping is imbedded in the tooth. Thereafter, in step328, such tooth is attached to the device10.

It is to be understood that the aforementioned description is illustrative only and that changes can be made in the apparatus, in the ingredients and their proportions, and in the sequence of combinations and process steps, as well as in other aspects of the invention discussed herein, without departing from the scope of the invention as defined in the following claims.