US20060078847A1

Movatterモバイル変換

Info

Publication number: US20060078847A1
Application number: US11/288,465
Authority: US
Inventors: Norman Kwan
Original assignee: Individual
Current assignee: Individual
Priority date: 2000-09-29
Filing date: 2005-11-29
Publication date: 2006-04-13
Also published as: US20110129799A1; US8500449B2

Abstract

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.

Description

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

This application is a continuation-in-part of applicant's co-pending patent application U.S. Ser. No. 10/195,007, filed on Jul. 12, 2002, which is a continuation-in-part of U.S. Ser. No. 09/967,556, filed on Sep. 28, 2001, which claimed priority from U.S. Ser. No. 60/237,222, filed on Oct. 2, 2000 and from U.S. Ser. No. 60/236,518, filed on Sep. 29, 2000. The content of each of the aforementioned patent applications is hereby incorporated by reference into this specification.

FIELD OF THE INVENTION

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

BACKGROUND OF THE INVENTION

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.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be described by reference to the following drawings, in which like numerals refer to like elements, and in which:

FIG. 1A is a schematic view of one apparatus of the invention;

FIG. 1B is a top view of the apparatus ofFIG. 1A;

FIG. 1C,FIG. 1D,FIG. 1E,FIG. 1F, andFIG. 1G are side views of another embodiment of the present invention;

FIG. 1H is a bottom view of another embodiment of the present invention;

FIGS. 1I to1N are illustrations of hole configurations for use with the apparatus depicted inFIG. 1H;

FIGS. 1O and 1P are side views of one embodiment of the invention that utilizes holes disposed within longitudinal channels;

FIG. 1Q is a depiction of various ledge configurations;

FIG. 1R is a profile view of one device of the present invention;

FIG. 2 is a partial side view of one one-piece universal implant abutment device;

FIG. 3 is a sectional view of the device ofFIG. 1A;

FIG. 4 is a schematic view of a healing ball of a dental implant system;

FIG. 5 is a schematic of another embodiment of a healing ball of the dental implant system;

FIG. 6A is a perspective view of one embodiment of a dental implant system of the present invention as inserted within the jawbone of a patient;

FIG. 6B is a perspective view of another embodiment of a dental implant system of the present invention as inserted within the jawbone of a patient;

FIG. 7 is a schematic view of an analog-abutment of a dental implant system;

FIG. 8 is a perspective view of a retaining screw of a dental implant system;

FIG. 9 is a perspective view of a guide pin of a dental implant system;

FIG. 10 is a schematic view of an incision formed as part of a process of attachment of the dental implant system in accordance with the present invention;

FIG. 11 is a schematic illustration of a tissue flap formed as part of the methods of attachment of a dental implant system;

FIG. 12 is a schematic illustration of a hole formed as part of the methods of attachment of the dental implant system in accordance with the present invention;

FIG. 13 is a schematic illustration of an implant abutment device inserted within the hole ofFIG. 12;

FIG. 14 is a schematic illustration of a healing ball seated on the device ofFIG. 13;

FIG. 15 is a schematic illustration of an impression tray;

FIG. 16 is a schematic illustration of an impression formed as part of the process of attachment of a dental implant system;

FIG. 17 is a schematic illustration of an analog-abutment inserted within the impression ofFIG. 16;

FIG. 18 is a schematic illustration of a model formed as part of the process of attachment of the dental implant system;

FIG. 19 is a schematic illustration of one embodiment of a prosthesis formed as part of the process of attachment of the dental implant system;

FIG. 20 is a schematic illustration of multiple implant abutment devices inserted within the jawbone of a patient;

FIG. 21 is a schematic illustration of another embodiment of an impression tray;

FIG. 22 is a schematic illustration of one embodiment of an alignment of multiple implant abutment devices of a dental implant system;

FIG. 23 is a schematic illustration of another embodiment of multiple implant abutment devices modified as part of the methods of attachment of the dental implant system;

FIG. 24 is a schematic illustration of yet another embodiment of multiple implant abutment devices modified as part of the methods of attachment of the dental implant system;

FIG. 25 is a schematic illustration of another embodiment of a modified implant abutment device;

FIG. 26 is a schematic illustration of a section of a template of the dental implant system;

FIG. 27 is a schematic illustration of one embodiment of a section of a template positioned on an implant abutment device;

FIG. 28 is an exploded view of an embodiment of an abutment used in the device of this invention;

FIGS. 28A and 28B are perspective views of other abutment assemblies;

FIG. 28C is a side exploded view of another embodiment of the present invention;

FIG. 29 is top view of the abutment ofFIG. 28;

FIGS. 29A and 29B are top views of other abutment assemblies;

FIGS. 30A, 30B,30C,30D,30E,30F,30G,30H,30I,30J, and30K are top views of other abutment assemblies;

FIGS. 31A and 31B are perspective and top views, respectively, of another implant assembly of the invention;

FIG. 32 is an exploded schematic view of an implant assembly of the invention;

FIGS. 32A and 32B are sectional views of abutment assemblies of the invention;

FIGS. 33A, 33B,33C,33D,33E,33F,33G, and33H are top views of other abutment assemblies of the invention;

FIG. 34A is a perspective view of another implant assembly of the invention;

FIG. 34B is a sectional view of another implant assembly of the invention;

FIGS. 34C andFIG. 34D are side views of two additional embodiments of the present invention;

FIG. 35, 36,37A and37B are perspective views of other implant assemblies of the invention; and

FIG. 38 is a sectional view of a roughened surface.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

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 (seewrench part17 and screwdriver part19).

Next, a “connection to contra-angle handpiece” (seepart11 on 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., Branemark/Zarb/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 Nobelphamia 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. 1A is 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 universalimplant abutment device10. In general, the universalimplant abutment device10 is a single-piece device10 includinghead12,neck14 andbase16 sections. It should be noted that thisdevice10 is 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.

Theimplant abutment device10 shown inFIG. 1A is preferably made of titanium or titanium alloy. Alternatively, thedevice10 may 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 thehead12 of 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 theneck14 of theimplant abutment device10 are 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. 1C andFIG. 1D. In the embodiments depicted,base section16 is comprised of threads (not shown). In the embodiments depicted,head12 is comprised of atop head section12aand abottom head section12b. The walls ofhead12 extend downwardly and outwardly fromtop head section12atobottom head section12b.In the embodiment depicted, the diameter ofbottom head section12bis the same as the diameter of the upper base section ofbase16. In the embodiment depicted inFIG. 1C, theabutment head12 is formed by alinear wall12candarcuate wall12d.In the embodiment depicted inFIG. 1C, thehead12 is formed by two linear walls,12c,that are opposite one another, and twoarcuate walls12d,that are also opposite one another. In other embodiments, not shown,head12 is comprised of more than four walls wherein there is a pattern of alternating linear and arcuate walls. In the embodiments depicted inFIG. 1C andFIG. 1D, the neck section (seeneck section12 ofFIG. 1A) is absent. In another embodiment, such a neck section is present.

Referring now toFIG. 1E, and to the embodiment depicted therein,device10 depicted therein is comprised ofhead section12,neck section14 andbase section16. The embodiment depicted inFIG. 1E is similar to the embodiment depicted inFIG. 1C except in that the device illustrated inFIG. 1E is includesneck section16. As shown inFIG. 1E,neck section16 is comprised ofvertical walls16aand16b.In another embodiment (not shown), thewalls16aand16bcan be converging or diverging to intersect with the bottom of thehead12. In the embodiment depicted,vertical walls16aand16bare substantially parallel.FIG. 1E also differs fromFIG. 1C in thatFIG. 1E illustratesaxial hole17.

In the embodiment depicted inFIG. 1E,axial hole17 has adepth17band a width16c.

Axial hole

17 is orientated such that itsdepth17bis substantially parallel toaxis220. 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 withinaxial hole17. Such an agent may be delivered to the surrounding tissue throughholes17a.In the embodiment depicted, holes17aconnectaxial hole17 to the external environment and permit the transmission of the aforementioned biologically active agent. In the embodiment depicted, the holes are perpendicular toaxis220. In another embodiment, not shown, the holes are at a non-perpendicular angle relative toaxis220.

In addition, the height BY and diameter BX of thebase16 of thedevice10 are 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 thedevice10.

As shown inFIGS. 1A and 1B, and in the embodiment depicted therein, the perimeter of thehead12 is substantially in the shape of a hexagon and includes six, planar, external main-walls18. In one embodiment, the six, planar main-walls18 are interconnected by six, substantially planar, external side-walls20. In general, the width MW of each main-wall18 is approximately within the range of 1.0 millimeter to 12.0 millimeters and the width SW of eachsidewall20 is approximately within the range of 0 millimeters to 12.0 millimeters. In another embodiment of the invention, the head configuration includes substantially planar main-walls18 and non-planar (e.g., arcuate) side-walls20, thereby producing improved comfort and reduced irritation within the patient's mouth.

Alternatively, the main-walls18 may be substantially non-planar and theside walls20 planar, or both the main-walls18 and side-walls may be substantially non-planar.

In an alternate embodiment, shown inFIG. 2, the main-walls18 and side-walls20 of thehead12 are tapered. The main-walls18, side-walls20, or portions thereof, may taper in either radially inward or outward direction. Other configurations of thehead12 including, 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 thebase16 andthreads32 includes, 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. Thethreads32 serve to securely attach thebase16 of theimplant abutment device10 within 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.

Thecylindrical base16 of thedevice10 may 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. 1F andFIG. 1G, thedevice10 is comprised of a generally cylindrical,titanium body19 comprises of ahead12,neck14 andbase16, wherein thehead12 is comprised of

smooth walls

208 and242 extending downwardly and outwardly. The cross section of thehead12 is a substantiallyflat wall208 joined to anarcuate wall242. Theneck14 has the same diameter as thehead12 at the intersection, where thesurface14a of theneck14 is 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 ofneck14 is from about 0.01 to about 20 microns. In yet another embodiment, the irregular roughness ofneck14 is 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 thebase 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

walls

14band14cof theneck14 are substantially parallel until each wall intersectbase16.Base16 extends downwardly and inwardly. In the embodiment depicted,neck14 has a length of from about 0.1 to about 6 millimeters.Base16 is comprised of raisedthreads32 that extend downwardly and inwardly to the bottom part of thebase16. The end part ofbase16 has anaxial hole17 which, in the embodiment depicted, is open at the bottom ofbase16.Holes17aare in fluid communication withaxial hole17 such that the biologically active agent disposed inaxial hole17 may diffuse throughholes17a.

Holes

17aextend radially throughbase16 at right angles to the axis220 (seeFIG. 1 E) of thedevice10.

As is indicated inFIG. 1H, a second hole can also be formed in thebase section16 such that the two holes are at right angles to each other.FIG. 1H is a cross sectional view ofdevice10 ofFIG. 1G viewed from the bottom.Hole17ais in fluid communication withaxial hole17 as ishole17b.There is anangle17cbetweenfirst hole17aandsecond hole17b.In the embodiment depicted,angle17cis about ninety degrees. In another embodiment, not shown, the angle is other than ninety degrees.

The diameter ofhole17aranges from about 0.25 to about 0.75 times of diameter BX (seeFIG. 1A). In general the diameter ofaxial hole17ais between 1 to 4 millimeters and the depth of theaxial hole17 is between 0.1 millimeters to the entire length of BY (seeFIG. 1A). In the embodiment depicted inFIG. 1H, the cross section ofaxial hole17 is a circle. In other embodiments, the cross section another shape, such as a circle, triangle, or polygonal shaped. Reference may be had toFIG. 1I toFIG. 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, anabsorbent 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 theaxial hole17.

In the embodiment depicted inFIG. 1E, theaxial hole17 extends partially intobase16. In the embodiments show inFIG. 1F andFIG. 1G, theaxial hole17 extends along the whole length ofbase16, and at intervals along such base, there aretransverse 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 ofbase16.

In another embodiment, shown inFIG. 10 andFIG. 1P, thehead12 is comprised offlat wall208 connected witharcuate wall242.Neck14 is comprised of

parallel walls

14band14c.In one embodiment, the

parallel walls

14band14cofneck14 are irregularly roughened. In the embodiment depicted inFIG. 10 and1P,base16 is comprised oflongitudinal 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 channel

16afluidly connectsholes17asuch that any biologically active agent secreted throughholes17afromaxial hole17 can diffuse vertically along the length oflongitudinal channel16aand therefore along the entire length and surrounds the whole implant in the jaw bone.

In another embodimentFIG. 1Q,device10 is comprised of an angled ledge formed by the union of reverse curves. In the embodiment depicted inFIG. 1Q,device10 is comprised ofhead section12 andneck section14.Neck section14 is comprised ofledge26. Ledges such asledge26 may have a variety of configurations. Inledge 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. Inledge configuration21b,such a ledge has a right angle. Such a ledge is said to be a horizontally extending ledge.Angle23bis a right angle. Inledge 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, theangle23dbetweenhead12 andneck14 is 180 degrees. In another embodiment (shown inFIG. 1Q), a sloping, obtuse angle is formed where the ledge joins the bottom part of thehead12 joining theneck14 in the form of a curvature in a downwardly and outwardly sloping configuration, then curving downwardly and inwardly to join with the top part of thebase16. In this embodiment, the ledge formed would have no distinct angles, but maintains an overall obtuse angle.

Device

10 illustrated inFIG. 1Q has ahead section12 which 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)258 with a substantially circular cross-sectional shape. In the embodiment depicted, foursuch splines258 are illustrated. In another embodiment, more than four such splines are present. See, for example,FIG. 33C.Splines258 are configured to have a mating configuration withlower section42 ofhealing ball40. Such a mating configuration only permits the healing ball to be attached todevice10 in a finite number of orientations. In one embodiment, there is only one such possible orientation.

In another embodiment, illustrated inFIG. 1R, thehead12 has a mated configured adapted to receive a correspondingly shaped instrument. In the embodiment depicted,head12 has a length of from about 1 millimeter to about8 millimeters and consist of anarcuate wall242 extending downward and outward. Thebore216 can be different configurations. In the embodiment depicted, bore216 has a substantially hexagonal cross-sectional shape.Bore216 is adapted to engage a correspondingly shaped instrument. Theneck14 is comprised of parallel14band14cand has a length of from about 0 to about 6 millimeters. In one embodiment, the surface ofneck14 is irregularly roughened as disclosed elsewhere in this specification.Base16 is a cylinder with walls extending downward and inward. In the embodiment depicted,base16 is both threaded and etched to produce an irregularly roughened surface. In another embodiment,base16 is comprised ofaxial hole17 with fluidly

connected holes

17aand17b.Both holes17aand17bare at right angles relative toaxial hole17. In the embodiment depicted, holes17aand17bare also at right angles relative to one another.Base16 is also comprised of longitudinal channel which connects at least two holesl7bon the outer surface ofbase16.

The structural design of thebase16 depends, in part, on the material or materials used to fabricate thedevice10. For example, in one embodiment, abase16 made of a semi-rigid material may be solid, whereas a base16 made of a substantially rigid material may be partially hollow. Alternatively, abase16 made of a combination of rigid and semi-rigid materials may include solid and hollow portions. Alternate configurations of the base16 not disclosed herein are also included within the scope of the claimed invention.

Referring toFIG. 3, a substantially cylindrical,hollow core34 extends through and along the axial length, or portions thereof, of thehead12 of thedevice10. The surface of theinternal walls36 of thehead12 surrounding the core34 may be threaded and slightly tapered.Alternative core34 and 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, thehollow core34 is 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), thehollow core34 extends through and along the axial length, or portions thereof, of thehead12 andneck14, orhead12,neck14 andbase16. In yet another embodiment, the hollow-core34 may be off-axis and/or non-parallel to the axial length of thedevice10.

The dental implant system of the present invention may also include ahealing ball40, shown inFIG. 4, that can be either removably secured or permanently affixed to the universalimplant abutment device10. Thehealing ball40 may 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, thehealing ball40 may be made of any biocompatible, non-toxic (e.g., medical grade) material that permits proper functioning of thehealing 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, thehealing ball40 includes a cylindricallower portion42 and 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), thehealing ball40 may 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 bore46 extends along the axial length of thelower portion42 and partially along the corresponding axial length of the upper portion44. The hexagonal shape of thebore46 is used for illustration purposes and not meant to limit the invention. In general, a variety of bore shapes or configurations adapted to engage thehead12 of the implant abutment devicel 0 may be used with thehealing ball40 of the present invention.

In the embodiment depicted, a cylindrical bore or opening48 lies adjacent to and is aligned along the same axis of thehexagonal bore46. The diameter of thecylindrical opening48 may be less than, equivalent to or greater than the diameter of thehexagonal bore46. As will be described in further detail below, thecylindrical opening48 forms a lumen through thehealing 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), theopening48 maybe off-axis and/or non-parallel to the axis of thedevice10.

In an alternate embodiment, shown inFIG. 5, thecylindrical opening48 is removed and the hexagonal bore46 forms the entire opening or lumen through thehealing ball40. In another embodiment (not shown), the hexagonal bore46 is removed and the cylindrical bore48 forms the entire opening or lumen through thehealing ball40. For the sake of simplicity of representation, references to thebore46 of thehealing ball40 in the remainder of this disclosure should be understood to includebore46 and/oropening48.

As previously described, thebore46 of thehealing ball40 is configured to match and snugly fit over thehexagonal head12 of theimplant abutment device10. As such, an octagonal opening in ahealing ball40 would be used for adevice10 having anoctagonal head12, atriangular bore46 in ahealing ball40 would be used for adevice10 with atriangular head12, and so on.

In another embodiment (not shown), a reverse configuration of the manner in which thedevice10 andhealing ball40 engage each other is contemplated. For example, thedevice10 may include a recess, bore or opening into which the healing ball's40 mating 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), thebore46 is formed of two opposing flat surfaces or walls and two opposing arcuate surfaces or walls. The two flat surfaces of thehealing ball40 engage two of the main-walls18 of the implant/abutment head12 and the two arcuate surfaces engage the remaining main-walls18.

Thus, in the embodiment depicted, thehealing ball40 engages thedevice head12 in a manner similar to a conventional wrench-and-socket configuration. Alternate embodiments of thebore46 including, 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 thehealing ball40, the axial length of thebore46 is approximately equivalent to the height HY of the head12 (shown inFIG. 1).

Alternatively, the length of thebore46 may be greater than the height HY of thehead12. In one embodiment, thebase50 of thehealing ball40 surrounding thebore46 rests upon the ledge26 (seeFIG. 1A) of thedevice10, ensuring a proper fit within the patient's mouth. In another embodiment (not shown), the opening of thehealing ball40 includes an inwardly-extending annular protuberance which is adapted to fit within and is removably secured to a matching annular groove surrounding thedevice10.

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.

Thehealing ball40 is but one of many types of dental copings which may be used with thedevice10 of the present invention. Other types of dental copings and/or gold cylinders including, but not limited to, those disclosed in U.S. Pat. No. 6,068,479; U.S. Pat. No. 5,733,124; U.S. Pat. No. 5,613,854; U.S. Pat. No. 5,571,016; U.S. Pat. No. 5,439,380; U.S. Pat. No. 5,419,702; U.S. Pat. No. 5,213,502; U.S. Pat. No. 5,209,659; U.S. Pat. No. 5,145,371; U.S. Pat. No. 5,108,288; U.S. Pat. No. 5,040,983; U.S. Pat. No. 4,861,267; U.S. Pat. No. 4,797,100; U.S. Pat. No. 4,698,021; U.S. Pat. No. 4,676,751; U.S. Pat. No. 4,492,579; U.S. Pat. No. 4,459,112; U.S. Pat. No. 3,685,115; RE 33,796; RE 33,272; RE 33,099; and the like may also be used with theimplant abutment device10. The entire disclosure of each of these patents is hereby incorporated by reference into this specification.

In one embodiment of the present invention, thehealing ball40 may be removed from theimplant abutment device10 prior to attachment of the dental prosthesis. As such, thehealing ball40 may 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 thedevice10. In addition, thehealing ball40 may 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 thehealing ball40 to thedevice10. Once the final prosthesis is available, the attachment device or compound and healing ball are removed and the prosthesis is secured to theimplant abutment device10 within the patient's mouth.

In another embodiment of the invention, thehealing ball40 may be permanently affixed to thedevice10 so that the dental prosthesis directly attaches to thehealing 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 thehealing ball40 to firmly, securely and removably attach the prosthesis to theimplant abutment device10. As shown inFIG. 6A, one ormore healing ball40 andimplant abutment device10 assemblies 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 thehealing ball40 onto theimplant abutment device10. Thefastening elements52 of theprosthesis54 are then friction fit over thehealing balls40 to securely attach theprosthesis54 within the patient's mouth.

In an alternate embodiment, one or more tooth-shapedhealing balls40 are permanently affixed to one ormore devices10 implanted within the patient's jawbone.

As shown inFIGS. 6A and 6B, a prosthesis, denture or partial-denture55 including one or more retention clasps, rings orelements57 aligned to engage the healing ball(s)40 act 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 thehealing ball40 and implant abutment device assemblies or to the gold-cylinder andimplant abutment device10 assemblies. 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-analog56 is generally a replica of thehead12 and/orneck14 of theimplant abutment device10 and mainly used in laboratory procedures during construction of patient models and prostheses. The abutment-analog includes ahead58 andneck60 similar in design and configuration to thehead12 andneck14 of theimplant abutment device10 previously described.

In one embodiment, thehead58 andneck60 of the abutment-analog56 are exact replicas of thehead12 andneck14 of theimplant abutment device10.

The abutment-analog56 may 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-analog56 also includes ashaft62. In one embodiment, theshaft62 includes cylindrically shaped top64, middle66 and bottom67 portions. The diameter of each

shaft portion

64,66,67 is variable, ranging in size from approximately 1.0 millimeter to 10.0 millimeters. For example, in one embodiment thetop portion64 is approximately 3.0 millimeters, themiddle portion66 is approximately 1.75 millimeters and thebottom portion67 is approximately 3.0 millimeters. Alternatively, the top64, middle66 and bottom67 portions maybe approximately 1.0 millimeter, 3.0 millimeters and 1.0 millimeter, respectively. In general, theshaft62 may be configured with various gripping surfaces, projections, indentations, flat/planar portions and non-planar portions to prevent the abutment-analog56 from 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 retainingscrew68 andguide pin70, respectively. Referring toFIG. 8, the retainingscrew68 is used to secure thehealing ball40 and/or prosthesis, either permanently or temporarily, onto theimplant abutment device10.

As such, the threadedportion72 of the retainingscrew68 is configured to engage the threads on the surface of theinternal walls36 of thedevice10. In general, the retaining screw may be approximately 2.0 millimeters to 10.0 millimeters in length. In one embodiment, the diameter of thehead74 of the retainingscrew68 may be configured to seat within the lumen of thehealing ball40. Alternatively, thehead74 may be seated on the external surface of thehealing ball40. The retainingscrew68 may 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.

Theguide pin70, shown inFIG. 9, is used to secure thehealing ball40 to theimplant abutment device10 for taking final impressions of the position of thehead12 of thedevice10. The length of theguide pin70 is approximately within the range of 3.0 millimeters to 20.0 millimeters. In general, theguide pin70 is configured so that a sufficient portion of the head orshaft76 extends outside of thehealing ball40, enabling a user or practitioner to firmly and securely grip theguide pin70. Theshaft76 may 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 retainingscrew68, the threadedportion78 of theguide pin70 may also be configured to engage the threads on the surface of theinternal walls36 of thedevice10. In addition, a variety of biocompatible, non-toxic materials may be used to fabricate theguide pin70 of 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 retainingscrew68 andguide pin70 are shown inFIGS. 8 and 9, respectively, to include a slotted head, other head configurations known in the art to either manually or mechanically drive thescrew68/guide pin70 into thedevice10 may also be used and are included within the scope of the claimed invention. One or more of the universalimplant abutment device10,healing ball40, abutment-analog56,guide pin70 and retainingscrew68 components 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 oneimplant abutment device10, threehealing balls40, one abutment-analog56, one retainingscrew68 and oneguide pin70. In another embodiment, a single-tooth replacement kit may include twoimplant abutment devices10, sixhealing balls40, two abutment-analogs56, two retainingscrews68 and two guide pins70. In an alternate embodiment, a multiple-tooth replacement kit may include threeimplant abutment devices10, ninehealing balls40, three abutment-analogs56, three retainingscrews68 and 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 reversebevel labial incision80 is 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 fullthickness envelope flap82 as shown inFIG. 11.

Referring toFIG. 12, ahole84 is 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 thedevice10, 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 shapedhole84. The depth of thehole84 is sized to receive thebase16 of theimplant abutment device10, and generally ranges from approximately 8 millimeters to 30 millimeters in depth.

Referring toFIG. 13, theimplant abutment device10 is then manually inserted into thehole84 in a sterile manner. In one embodiment, a carrier (not shown) may be used to deliver theimplant abutment device10 to thehole84 and also to begin manually screwing thedevice10 into thehole84. 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 thebase16 of theimplant abutment device10 can be manually inserted into thehole84. A power-driven socket-wrench, contra-angle handpiece or similar tool may be used to fully seat thedevice10 within thehole84.

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 thedevice10.

The gingival tissue and flaps82 are inspected, trimmed, coapted and sutured around thehead12 of thedevice10. 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 thedevice10. 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 theimplant abutment device10 of the present invention without further surgical intervention.

Referring toFIG. 14, ahealing ball40 may be attached to thedevice10 to contour the tissue for proper impression registration. In one embodiment of the invention, thehealing ball40 is attached directly after tissue suturing and prior to hard and soft tissue healing. A retainingscrew68 or similar component previously described may be used to secure thehealing ball40 onto thedevice10. Thehealing ball40 is 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. Theoriginal healing ball40 is removed, and another,interchangeable healing ball40 is secured to thedevice10 with aguide pin70. Alternatively, theoriginal healing ball40 is left in place and the retainingscrew68 is replaced with aguide pin70.

As shown inFIG. 15, animpression tray86 with a window oropening88 is placed over thehealing ball40 within the patient's mouth. Theopening88 of thetray86 is aligned with theguide pin70 so that theguide pin70 protrudes above the impression frame. Theguide pin70 holds thehealing ball40 in place during setting of the impression material. After the material is set, the protruding portion of theguide pin70 is used to unscrew theguide pin70 from thehealing ball40 and remove theguide pin70 through thetray opening88. Thehealing ball40 is then transferred with the impression material when theimpression tray86 is removed from the patient's mouth, as shown inFIG. 16. Theoriginal healing ball40 may be re-attached to thedevice10 as a protective covering and tissue spacer.

In an alternate embodiment, anti-rotational grooves, indentations or other types of gripping features may be formed on thehealing ball40. These features prevent movement or displacement of thehealing ball40 within 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-analog56 is inserted into the matching cavity of thehealing ball40 contained within the impression material. As previously described, the abutment-analog56 replicates the configuration of theimplant abutment device10 of the present invention. With the abutment-analog56 seated in thehealing ball40, an impression is then poured in a rigid stone or plaster material to form thefinal model90. In general, the entire abutment-analog56, excluding itshead58 orhead58 andneck60, may be buried in thefinal 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, ahealing ball40, coping (such as a preformed coping in the shape of ahealing ball40, tooth or other shapes) or metal framework may be used as part of thefinal 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. Thefinal prosthesis92 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. Once complete, thefinal prosthesis92 is 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 moreimplant abutment devices10 may be used for a single tooth (e.g., molar) restoration. The use of multipleimplant abutment devices10 for 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, theincision80,hole84 andimplant abutment device10 insertion 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, theincision80 may be larger,multiple holes84 are generally created within the jawbone of the patient, and, likewise, multipleimplant abutment devices10 are inserted within theholes84, as generally shown inFIG. 20. The four-teeth reconstruction shown inFIG. 20 is 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 usinghealing balls40 as previously described, the temporary prosthesis ororiginal healing balls40 are removed from eachdevice10.

In one embodiment, a pattem resin or similar material may be used to lute or connect all thehealing balls40 together as one unit, forming a coping framework. This process may be used for both theoriginal healing balls40 and thenew healing balls40.

Next, an impression is taken using an appropriatelysized impression tray86.

The protruding portions of the guide pins70 extend through the opening(s)88 in the impression framework, as shown inFIG. 21. Alternatively, a traditional disposable stock tray (not shown) may be used. As such, after all thehealing balls40 are luted or splinted together thereby forming a “picket-fence” type effect, the guide pins70 can be removed from thehealing balls40. Thehealing balls40 will 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 thehealing balls40.

After the impression material has set, the guide pins70,tray86 and impression material are removed from the patient's mouth. The resulting impression includes thehealing balls40 incorporated in the impression material. The low height or minimal profile of thehead12 of eachdevice10 and flexibility of the impression media allow an accurate impression to be made, without permanent distortion or damage. In particular, thehealing balls40, as integral parts of the impression, may be cleanly withdrawn from thedevices10 without disturbing the precise relationship of eachreference device99. Theother devices10 are then modified (e.g.. portion100, shown in theFIG. 24 as encircled by a dashed line, is removed) according to the inclination/alignment of thesedevices10 in relationship to thereference device99 to ensure a secure and accurate fit for the final prosthesis.

Healingballs40, copings or metal frameworks are then installed on the modified heads58 of thestone model94 and 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 thefinal stone model94 as a guide, the corresponding surfaces of the device heads12 in 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 thefinal stone model94 is used as a guide for removing the necessary portions/surfaces of the device heads12 in 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-analog56 in thefinal 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-analog56 in afinal stone model94, however it is understood that the template andfinal stone model94 include one or more caps and abutment-analog56, respectively.

As previously disclosed, the cap of the template replicates itscounterpart head58 of the abutment-analog56 in thefinal stone model94. Referring toFIG. 25, a portion100 (shown in phantom onFIG. 25) of the analog-abutment head58 in thefinal stone model94 is removed or modified as previously described. The corresponding portions of itsmatching cap102 are then also removed, forming a window or some other type ofopening104 in thecap102 that corresponds to the modified area of thehead58, shown inFIG. 26.

As shown inFIG. 27, when thecap102 is properly positioned or placed over the patient's correspondingimplant abutment device10, portions of thedevice10 protruding through theopening104 correspond to the removed portions of theanalog abutment56. At this point, the user may use an appropriate tool to remove the protruding portions of thedevice10. Alternatively, the user may simply mark the portions of thedevice10 that need to be modified, remove the cap and then remove/modify the marked portions of thedevice10. Other methods of modifying thedevice10, including thecap102, 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. 28 is a partial exploded view of adental implant assembly200 comprised of ahead202 which facilitates the use ofassembly200 in multiple implant restorations.

Referring toFIG. 28, and in the embodiment depicted therein, it will be seen thathead202 is comprised of

sides

204,206,208,210, and212. Each of these sides intersects withsurface214 ofneck14. In another embodiment, not shown, no neck section is present and the aforementioned sides meet directly withbase16.

In one embodiment, illustrated inFIGS. 34A and 34B, theneck14 is omitted and thehead202 is directly contiguous withbase16. 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. 34C andFIG. 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 ofside208, each of the other sides forms an angle vis-a-vis surface214 that is substantially perpendicular, ranging from about 80 to about 100 degrees and, more preferably, from about 75 to about 95 degrees. However, theside208 forms an angle withsurface214 of less than about 75 degrees.

In the embodiment depicted inFIG. 28, there are at least five sides that intersectsurface214 at a substantially perpendicular angle. Devices with more of such sides may be used, provided that at least two sides of thehead202 are substantially perpendicular to thesurface214 and 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 thehead202 are substantially perpendicular to thesurface214. In another embodiment, at least four such sides of thehead202 are substantially perpendicular to thesurface214. In yet another embodiment, at least five such sides of thehead202 are substantially perpendicular to thesurface214.

In another embodiment, depicted inFIG. 28C, at least two of sides of thehead202 form an angle of from about 45 to about 100 degrees with thesurface214 and the abutment head is comprised of a linear wall joined to an acruate wall.

Referring again toFIG. 28, abore216 extends from the top surface of thehead202 to a distance of from about 2 to about 5 millimeters. In one embodiment, thebore216 is threaded.

In another embodiment, not shown, thebore216 is omitted from thehead202. In another embodiment, not shown, thebore216 is replaced by an annular groove disposed beneath substantially polygonal portion ofhead202 andsurface214. In one embodiment, thebore216 is substantially coaxial with theaxis220 ofbase16. In another embodiment, illustrated inFIG. 28, thebore216 is not coaxial with theaxis220 but, instead, forms an angle that is less than 45 degrees and, in one embodiment, is substantially identical to the angle formed byside208 withsurface214.

FIGS. 28A and 29A disclose adental implant assembly201 which is similar to theassembly200 but differs therefrom in that thebore216 is substantially perpendicular to theaxis220.

FIGS. 28B and 29B disclose adental implant assembly203 which is similar to theassembly200 but differs therefrom in that thebore216 is substantially parallel to theaxis220. In the embodiment depicted, bore216 is also substantially coincident with theaxis220.

Referring again toFIG. 28, it will be seen that ahealing ball205 is adapted to fit over thehead202. Asimilar healing ball205 may be used in the embodiments depicted inFIGS. 28A and 28B but has been omitted therefrom for the sake of simplicity of representation.

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

FIGS. 30A through 30H present a multiplicity of sectional views showing the shapes in which thehead202 may be. In the embodiments depicted, the shapes are either comprised ofstraight walls230 and/orarcuate sections232.

FIGS. 31A and 31B are perspective and top views, respectively, of anassembly240 in whicharcuate section242 joinswalls244 and246 (see, for exampleFIG. 31A) ofinclined side208. As will be apparent, becausearcuate section242 theoretically contains an infinite number of walls, theassembly240 meets the requirement that at least two such walls are substantially perpendicular to thesurface214 ofbase16. In another embodiment, the walls are at an angle of from about 45 to about 95 degrees relative tosurface214. In the embodiments depicted,

wall

242 and208 extend downwardly and outwardly.

FIG. 32 discloses an exploded view of anassembly250 that is similar in configuration to theassembly240 but differs therefrom in thatarcuate section242 is comprised of a multiplicity ofsplines252. In the configuration depicted inFIG. 32,such splines252 have a substantially rectangular cross-sectional shape.

Referring again toFIG. 32, and in the embodiment depicted therein, it will be seen thathealing ball205 preferably is comprised of anorifice256 that is adapted to receive theside208 and thesplines252.

FIG. 32A is a partial sectional view of animplant assembly207 that is similar to the implant assembly201 (seeFIG. 28A) but omits that omits thebore216.

FIG. 32B is a partial sectional view of animplant assembly209 that is similar to the implant assembly201 (seeFIG. 28A) but differs therefrom in that it does contain abore216 that is substantially aligned with the axis of theassembly209.

As will be apparent fromFIGS. 33A through 33H, different splined arrangements may be used with theassembly250.

Thus, as depicted inFIG. 33A, thesplines252 may have a substantially rectilinear cross-sectional shape. As depicted inFIG. 33B, thesplines256 may have a substantially triangular cross-sectional shape. As depicted inFIG. 33C, thesplines258 may have a substantially circular cross-sectional shape. As depicted inFIG. 33D, thesplines260 may have a substantially polygonal cross-sectional; in the embodiment, depicted, this shape is formed by alternating rectangles and triangles. As depicted inFIG. 33E, thesplines262 may have a shape defined by a linear section and an arcuate section; in the embodiment depicted, thesplines262 are formed by alternating semicircles and flat surfaces. As depicted inFIG. 33F, thesplines264 may 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. Thesplines266 depicted inFIG. 33G are defined by half-circles joined by arcuate tops. By comparison, thesplines268 depicted inFIG. 33H are 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. 35 is a perspective view of animplant assembly270 that is similar to theimplant assembly269 ofFIGS. 34A and 34B but differs therefrom in that thesurface272 ofbase16 is roughened.

In one embodiment, thesurface272 is roughened in accordance with the acid-etching procedure disclosed in Intemational patent publication WO9616611A2. 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 (WO9616611A2). 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, thesurface272 is 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, thesurface272 is 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 roughensuch 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 10 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 37B illustrate two devices which may be made by the process of this invention. Referring to these Figures, it will be seen that each of

implant assemblies

300 and302 is comprised ofbase section304, andledge section320, andhead section308.

In each of

implant assemblies

300 and302, thebase section304, theledge section320, and thehead section308 are integrally joined to each other.

In each of

implant assemblies

300 and302, thehead section308 has 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 implantassembly300, one of the linear walls islinear wall301, and the arcuate walls are

arcuate walls

303 and305.

Referring to implantassembly302, the linear wall islinear wall307, and the arcuate wall isarcuate wall309.

Each of implant assembles300 and302 is comprised of abase section304 that extends upwardly and outwardly from its bottom310 to its top312.

In the embodiments depicted inFIGS. 37A and 37B, thebase section304 is preferably comprised of two distinct sections. Thefirst section313, extending frompoint314 to point316, has alength318 of from about 3 to about 50 millimeters and, preferably, from about 7 to about 17 millimeters. The second section isledge section320, extending frompoint314 to point322, has alength324 of from about 0.0 to about 2 millimeters and, preferably, from about 0.3 to about 0.7 millimeters.

It is advantageous thatledge section320 have alength324 that is no greater than about 15 percent of thelength318 offirst section313 and, more preferably, is less than about 10 percent of thelength318 offirst section313.

In both of the embodiments depicted inFIGS. 37A and 37B, thefirst section313 has a substantially rougher surface than theledge section320.

FIG. 38 is a sectional view of a roughenedsurface350 formed in asubstrate352. As will be seen, this roughenedsurface350 is comprised of a multiplicity ofpeaks354 andvalleys356. The

distances

360,362,364,366,368 between thepeaks354 and thevalleys356 indicate the roughness ofsurface350. 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, thefirst section313 will 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, theledge section320 will 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.

Thefirst section313 will preferably have an average roughness that is at least about 10 times as great as the average roughness of theledge section320. In one embodiment, thefirst section313 has an average roughness that is at least about 50 times as great as the average roughness ofledge section320. In another embodiment, thefirst section313 has an average roughness that is at least about 100 times as great as the average roughness ofledge section320.

One may obtain the differential roughness properties described hereinabove by subjecting thefirst section313 and/orledge section320 to different treatments and/or different lengths of treatment, masking one (with wax, e.g.) while treating another. Thus, for example, thefirst section313 may be treated with both sandblasting and acid etching, whereas theledge section320 may be subjected to micromachining or laser etching.

Thus, e.g., one may use microtexturing to create the roughness inledge 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 inledge 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 roughenedfirst section313 is coated with abioactive coating370. Thebioactive coating370 is 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 β-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 beta1) 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, allyl 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 Sep; 14(5):846-849), by Bessho et al. (“BMP stimulation of bone response . . . ,” Clin Oral Implants Res 1999 Jun; 10(3):212-8), by Deligianni et al. (“Effect of surface roughness of the titanium alloy . . . ,” Biomaterials 2002 Jun; 22(11): 1241-1251), by Dean et al. (“Firbonectin and laminin enhance gingival cell attachment . . . ,” Int J. Oral Maxillofac Implants 1995 Nov-Dec; 10(6):721-728), by Keogh et al. (“Albumin binding surfaces for biomaterials,” J Lab Clin Med 1994 Oct; 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 smoothfirst section313 and/orledge section320 in 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 Biotechnolgy 2001 Oct 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 thathead section308 extends alength323 above thetop surface325 ofledge section320 of 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. 18 depicted 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. 18 thereof, in the first step of this process, step300,device10 is connected to an implant fixture.

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

Thereafter, instep302 of 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, instep304 of the process, the hole thus drilled is preferably tapped with a tapping tool such as, e.g., the screw taps illustrated onpage 11 of the Nobelpharma catalog.

Thereafter, in step306 of 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 instep308 of the process.

In the next step of this process, step310, the healing ball is preferably snapped onto thedevice10. In one embodiment, the healing ball is disposed within a compartment of carrier prior to its use.

Thereafter, instep312, 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 thedevice10 is 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 instep316 of U.S. Pat. No. 6,068,479, the healing ball is attached directly to a denture into which metal caps with an O-ring have been cured.

In another embodiment, illustrated instep318, the healing ball is removed from thedevice10. At this stage, several additional options are available.

One such option is to attach a gold cylinder to thedevice10 instep320.

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, instep324, 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 thedevice10.

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.

Claims

1. A dental implant assembly comprised of an integral dental implant, wherein said integral dental implant is comprised of a head section and a base section integrally joined to one another, wherein:

(a) said head section has a length of from about 1.5 to about 10 millimeters;

(b) said base section has a length of from about 3 to about 50 millimeters; and

(c) said base section is threaded.

2. The dental implant assembly as recited inclaim 1, wherein said head section is comprised of a top head section and a bottom head section, wherein said head section extends downwardly and outwardly from said top head section to said bottom head section.

3. The dental implant assembly as recited inclaim 1, wherein said base section is comprised of a top base section and a bottom base section, wherein said base section extends upwardly and outwardly from said bottom base section to said top base section.

4. The dental implant assembly as recited inclaim 1, wherein said base section is comprised of a bioactive coating comprised of a biologically active agent.

5. The dental implant assembly as recited inclaim 4, wherein said biologically active agent is selected from the group consisting of a bone morphogenetic protein, a basic fibroblast growth factor, a transforming growth factor, an osteogenic growth peptide, a hydroxyapatite, and combinations thereof.

6. The dental implant assembly as recited inclaim 4, wherein said biologically active agent is a bone morphogenetic protein.

7. The dental implant assembly as recited inclaim 4, wherein said biologically active agent is comprised of a bone morphogenetic protein and a hydroxyapatite.

8. The dental implant assembly as recited inclaim 1, further comprising a neck section disposed between, and integrally joined with, said head section and said base section, wherein said neck section has a length of from about 0.1 to about 6 millimeters.

9. The dental implant assembly as recited inclaim 1, wherein said head section is comprised of a roughened surface that has an average irregular roughness of from about 0.001 to about 1000 microns.

10. The dental implant assembly as recited inclaim 8, wherein said neck section is comprised of parallel walls.

11. The dental implant assembly as recited inclaim 10, wherein said base section is comprised of a roughened section that has a first average irregular roughness of from about 0.001 to about 1,000 microns.

12. The dental implant assembly as recited inclaim 11, wherein said first average irregular roughness is from about 0.01 to about 1000 microns.

13. The dental implant assembly as recited inclaim 11, wherein said first average irregular roughness is from about 3 to about 20 microns.

14. The dental implant assembly as recited inclaim 11, wherein said neck section has a second average irregular roughness such that said first average irregular roughness of said base section is at least about two times as great as said second average roughness of said neck section.

15. A dental implant assembly comprised of an integral dental implant, wherein said integral dental implant is comprised of a head section, a neck section, and a base section integrally joined to one another such that said neck section is disposed between, and integrally joined with, said head section and said base section, wherein:

(a) said head section has a length of from about 1.5 to about 10 millimeters;

(b) said head section has a diameter of from about 1 to about 12 millimeters;

(c) said base section has a length of from about 3 to about 50 millimeters;

(d) said base section has a diameter of from about 1 to about 12 millimeters;

(e) said base section is threaded;

(f) said neck section has a length of from about 0.1 to about 6 millimeters and is comprised of parallel walls;

(g) said neck section has a diameter of from about 1 to about 12 millimeters.

16. The dental implant assembly as recited inclaim 15, wherein said head section is comprised of a multiplicity of walls integrally joined to said head section.

17. The dental implant assembly as recited inclaim 16, wherein said multiplicity of walls is comprised of a first wall that it is substantially perpendicular to said neck section.

18. The dental implant assembly as recited inclaim 17, wherein said multiplicity of walls is comprised of a second wall that is substantially perpendicular to said neck section.

19. The dental implant assembly as recited inclaim 15, wherein said head section is further comprised of a bore that extends into said head section a distance of from about 1.5 to about 10 millimeters.

20. The dental implant assembly as recited inclaim 15, wherein said neck section is further comprised of a ledge with a ledge angle between said head section and said neck section.

21. The dental implant assembly as recited inclaim 15, wherein said neck section is further comprised of a ledge formed by joining the head and the base in reverse curves.

22. The dental implant assembly as recited inclaim 20, wherein said ledge angle is a right angle.

23. The dental implant assembly as recited inclaim 20, wherein said ledge angle is an obtuse angle.

24. The dental implant assembly as recited inclaim 23, wherein said obtuse angle is a sloping obtuse angle.

25. The dental implant assembly as recited inclaim 20, wherein said ledge angle is an acute angle.

26. A dental implant assembly comprised of an integral dental implant, wherein said integral dental implant is comprised of a head section and a base section integrally joined to one another, wherein:

(a) said head section has a length of from about 1.5 to about 10 millimeters;

(b) said base section has a length of from about 3 to about 50 millimeters;

(c) said base section is comprised of a roughened section that has a first average irregular roughness of from about 0.001 to about 1,000 microns;

(d) said base section is threaded;

(e) said base section is comprised of an axial hole that is substantially parallel to the long axis of said implant assembly; and

(f) said base section is comprised of holes that are substantially perpendicular to the long axis of said implant assembly, wherein said holes are in fluid communication with said axial hole.

27. The dental implant assembly as recited inclaim 26, wherein said first average irregular roughness is from about 0.001 to about 10 microns.

28. The dental implant assembly as recited inclaim 26, wherein said first average irregular roughness is from about 3 to about 1000 microns.

29. The dental implant assembly as recited inclaim 27, further comprising a neck section, wherein said neck section is disposed between, and integrally joined with, said head section and said base section, wherein:

(a) said neck section has a length of from about 0.1 to about 6 millimeters;

(b) said neck section is unthreaded; and

(c) said neck section is comprised of parallel walls.

30. The dental implant assembly as recited inclaim 29, wherein said neck section has a second average irregular roughness that is equal to said first average irregular roughness of said base section.

31. The dental implant assembly as recited inclaim 29, wherein

(a) said base section is further comprised of a longitudinal channel disposed on said base section; and

(b) at least one of said holes that are perpendicular to the long axis of said implant assembly is disposed within said longitudinal channel.

32. The dental implant assembly as recited inclaim 27, wherein said dental implant assembly consists essentially of titanium.

33. The dental implant assembly as recited inclaim 29, wherein said neck section is comprised of a ledge, wherein said ledge section is disposed between, and integrally joined with, said head section and said base section wherein:

(a) said head section is comprised of top head section and a bottom head section integrally joined to said top section, wherein:

i. said top head section has a shape formed by a linear wall adjacent to an arcuate wall;

ii. said head section has a length of from about 1.5 to about 10 millimeters;

iii. said bottom head section is integrally joined to said neck section, thus forming said ledge, said ledge having an angle of from about 45 to about 90 degrees;

(b) said base section is comprised of a top base section and a bottom base section, wherein said base section extends upwardly and outwardly from said bottom base section to said top base section wherein said top base section is integrally joined to said neck section;

(c) wherein:

i. said base section has a length of from about 3 to about 20 millimeters, and the surface of said base section has an average irregular roughness of from about 0.001 to about 1,000 microns;

ii. said neck section has a length of from about 0.01 to about 6 millimeters, and the surface of said neck section has an average roughness of from 0.001 to about 1000 microns;

iii. said length of said neck section is less than about 15 percent than said length of said base section; and

iv. said average irregular roughness of said base section is at least about ten times as great as said average roughness of said neck section.

34. The dental implant assembly as recited inclaim 27, wherein said base section is comprised of a bioactive coating comprised of a biologically active agent.

35. The dental implant assembly as recited inclaim 34, wherein said biologically active agent is selected from the group consisting of a bone morphogenetic protein, a basic fibroblast growth factor, a transforming growth factor, an osteogenic growth peptide, a hydroxyapatite, and combinations thereof.

36. The dental implant assembly as recited inclaim 34, wherein said biologically active agent is a bone morphogenetic protein.

37. The dental implant assembly as recited inclaim 34, wherein said biologically active agent is comprised of a bone morphogenetic protein and a hydroxyapatite.

38. The dental implant assembly as recited inclaim 33, wherein said average irregular roughness of said neck is from about 0.1 to about 100 microns.

39. The dental implant assembly as recited inclaim 33, wherein said average irregular roughness of said base is from about 3 to about 1,000 microns.