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`6,095,817
`[11] Patent Number:
`[19]
`United States Patent
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`Wagner et al.
`[45] Date of Patent:
`*Aug. 1, 2000
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`US006095817A
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`[54] DENTAL IMPLANT HAVING MULTIPLE
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`TEXTURED SURFACES
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`[75]
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`Inventors: William R. Wagner, Escondido;
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`Brooks Story, Carlsbad, both of Calif.
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`[
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`[73] Assignee: Sulzer Calcitek Inc., Carlsbad, Calif.
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`*
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`~
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`] Notice.
`This. patent issued on a continued pros
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`ecution application filed under 37 CFR
`1.53(d), and is subject to the twenty year
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`term prov1s10ns of 35 U.S.C.
`patent
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`154(a)(2).
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`[21] Appl NO . 09/256 879
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`’
`”
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`Filed:
`Feb. 24, 1999
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`[22]
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`Related US. Application Data
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`[63]
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`Continuation—in—part of application No. 08/860,657, filed as
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`application No. PCT/US95/16219,Dec.8, 1995.
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`Int. Cl.7 ....................................................... A61C 8/00
`[51]
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`............................................. 433/173; 433/174
`[52] US. Cl.
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`[58] Field Of Search ..................................... 433/172, 173,
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`433/174, 175, 176, 201.1
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`594929470
`5,564,923
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`4,854,872
`8/1989 Detsch.
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`4,854,873
`8/1989 Linden .
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`4,872,840 10/1989 Bori.
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`11/1989 Franek 6t a1~ ~
`478817897
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`6/1990 Edward5~
`479347935
`9/1990 Kawahara et a1.
`4,957,819
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`“1991 56116”
`499869753
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`3/1991 Homsy .
`5,002,488
`9/1991 Otani et a1.
`5,049,074
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`5,104,410
`4/1992 Chowdhary .
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`21 our et a1.
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`5/1992 B If
`5 110 292
`3/1993 Sule .
`5,195,891
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`5/1993 Friedman et a1.
`5,209,659
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`11/1993 Noiles et a1.
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`5,263,986
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`..................... 433/173
`5/1994 Hasegawa et a1.
`5,310,343
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`5,312,256
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`5/1994 Scortecci .............
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`5/1994 Krauser ................................... 433/173
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`5,344,457
`9/1994 Pilliar et a1.
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`5,360,448 11/1994 Thramann.
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`2/1996 Anders ~
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`10/1996 Grassi et a1.
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`5,571,017 11/1996 Niznick ............................... 433/173 X
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`595719617 “/1996 COOPHder 6t a1~~
`6/1997 Somborac et a1.
`..... 433/173
`5,636,989
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`6/1997 Fontenot .................. 433/173
`5,639,237
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`5,863,201
`1/1999 Lazzara et a1.
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`3/1999 lemck~
`578857079
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`OTHER PUBLICATIONS
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`[56]
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`References CitEd
`
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`US PATENT DOCUMENTS
`
`
`3,797,113
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`
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`.
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`12/1987 Branemark et a1.
`.
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`
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`
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`
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`6/1989 Kawahare et a1.
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`
`4,850,870
`7/1989 Lazzara et a1.
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`
`
`
`.
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`
`.
`
`
`
`
`
`
`
`
`
`
`
`M. Block, et al., “Loaded Hydroxylapatite—Coated and
`Grit—Blasted Titanium Implants in Dogs,” The International
`
`
`
`
`
`
`Journal of Oral & Maxillofacial Implants, (1989), vol. 4, pp.
`
`
`
`
`
`
`
`219—225.
`
`D. Buser, et al., Influence of Surface Characteristsics on
`
`
`
`
`
`
`Bone Integration of Titanium Implants.
`
`
`
`
`A Histomorphometric Study in Miniature Pigs, Journal of
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Biomedical Materials Research,
`(1991), vol. 25, pp.
`889—902.
`
`.
`.
`.
`.
`
`
`
`Primary Examiner—Nicholas D. Lucchesi
`
`
`
`
`
`
`Attorney, Agent, or Firm—Philip S. Lyren; Kenneth S.
`Barrow
`
`
`
`
`ABSTRACT
`[57]
`
`
`A dental implant for osseointegration in alveolar bone. The
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`implant includes at least three different and distinct surface
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`reglons‘
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`7 Claims, 6 Drawing Sheets
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`Page 1 0f 11
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`ZIMMER EXHIBIT 1009
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`Page 1 of 11
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`ZIMMER EXHIBIT 1009
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`US. Patent
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`Aug. 1,2000
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`Sheet 1 0f6
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`Aug. 1,2000
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`US. Patent
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`US. Patent
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`US. Patent
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`Aug. 1,2000
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`Sheet 6 0f6
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`1
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`DENTAL IMPLANT HAVING MULTIPLE
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`TEXTURED SURFACES
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`“This is a continuation-in-part of US. application Ser.
`
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`
`
`No. 08/860,657 filed on Oct. 2, 1997 entitled “Dental
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`Implant Having Multiple Textured Surfaces” which claims
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`priority under PCT application Ser. No. PCT/US95/16219
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`filed on Dec. 8, 1995.”
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`TECHNICAL FIELD
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`5
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`10
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`The present invention relates generally to a dental implant
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`for osseointegration in alveolar bone, with the implant
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`configured to receive an abutment for supporting a dental
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`prosthesis.
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`15
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`20
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`25
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`BACKGROUND ART
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`One known arrangement for a dental implant involves an
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`implant portion, or artificial root, that is received in a hole
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`prepared in alveolar bone, and an abutment, or prosthesis
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`support, that is securable to the implant portion and that
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`extends beyond the gingival tissue to support a tooth pros-
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`thesis. The implant portion and the abutment are constructed
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`as separate components that are secured together by means
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`of a screw passed through the abutment and received within
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`a threaded bore in the implant portion.
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`In a first surgical procedure, an incision is made in the
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`gingival tissue to expose the alveolar bone. Following any
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`dressing of the surface of the bone that may be necessary, a
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`30
`hole that is complementary in shape to the implant portion
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`is drilled in the bone and the implant portion is inserted. A
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`healing cap or screw is attached to the implant portion to
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`occlude the threaded bore, and the gingival tissue is stitched
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`closed over the implant portion to await osseointegration.
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`In a subsequent second surgical procedure, following
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`osseointegration of the implant portion, the gingival tissue is
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`again opened to expose the implant portion. The healing cap
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`or screw is removed and replaced with a second healing cap
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`having an outer surface corresponding in shape below the
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`gum-line to that of the abutment, but protruding slightly
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`above the gingival tissue. The gingival tissue surrounding
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`the second healing cap is sutured thereabout to await healing
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`in conformity to the outer surface of the second healing cap.
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`After the gingival tissue has healed, the second healing
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`cap is removed and replaced with a permanent abutment that
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`is secured to the implant. The abutment can be configured to
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`support a single-tooth prosthesis fashioned thereon or to
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`support a bridge structure carrying multiple tooth prosthe-
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`ses.
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`A common clinical problem associated with dental
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`implants is loss of supporting bone at the coronal aspect of
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`the implant. Such loss of bone can be caused by, among
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`other things, infectious etiologies similar to those encoun-
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`tered in periodontal diseases of natural teeth. The association
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`of periodontal pathogenic organisms with the loss of sup-
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`porting alveolar bone highlights the need for scrupulous oral
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`hygiene on the part of the patient and for the ability of a
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`clinician to adequately prevent disease and to treat diseased
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`implant sites. Asmooth surface at the coronal end of a dental
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`implant
`is more easily cleaned of plaque, pathogenic
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`organisms, and endotoxins than is a rough surface that has
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`crevices that cannot be reached readily by mechanical
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`devices such as brushes. Asmooth surface at the coronal end
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`of an implant also facilitates increased accuracy of fit at the
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`interface between the implant and the attached abutment, an
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`important consideration since gaps between these compo-
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`nents can harbor pathogenic accumulations, potentially lead-
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`Page 8 of 11
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`6,095,817
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`2
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`ing to adverse clinical conditions. Consequently, dental
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`implants with a smooth surface in the coronal region are
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`commonly used in clinical practice.
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`Bone tissue reacts differently to metal surfaces with
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`differing surface characteristics. Buser et al. (J Biomed
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`Mater Res 25: 889—902, 1991) implanted cylindrical tita-
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`nium implants having different surface characteristics in
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`miniature pigs. They reported that the percentage of implant
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`surface in direct contact with bone varied directly with
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`increasing roughness of the titanium surface. It has also been
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`observed by others that bone often does not attach to the
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`smooth surface in the coronal region of dental implants.
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`Rather, remodeling of the bone occurs such that the coronal
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`attachment of bone is lowered to the first roughened or
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`textured surface encountered.
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`it has
`To enhance osseointegration of dental implants,
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`been proposed to provide a porous surface on the bone-
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`engaging portion of the implant to permit ingrowth of bone
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`into the surface of the implant. Such a porous surface can be
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`provided on a metal implant by a coating of sintered metal
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`powder, beads, or wire mesh, for example. Concerns have
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`been expressed by some persons, however, that exposure of
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`the porous surface of a dental implant to the oral cavity can
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`result in apical migration of bacteria from the oral cavity
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`through the pores of the porous surface, leading to infection
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`of the bone and consequent loss of bony support for the
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`implant. With that concern in mind, a porous coated dental
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`implant is shown in US. Pat. No. 5,344,457, to Pilliar et al.
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`wherein the implant includes a lower bone-engaging region
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`coated with a porous surface into which bone may grow, and
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`an upper bone-engaging region coated with a non-porous,
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`relatively smooth, bioreactive surface (such as
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`hydroxylapatite) to which bone can bond directly. The
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`presence of bone in apposition to the implant surface above
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`the level of the porous surface is said to afford protection of
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`the porous surface from the migration of pathogens from the
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`oral cavity.
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`that offers
`It would be desirable to have an implant
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`optimum anchoring in bone by ingrowth of bone into a
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`porous surface, a coronal surface designed for optimum
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`hygiene, and protection of the porous surface from the oral
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`cavity not afforded by smooth coronal surfaces. This and
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`other desirable advantages are provided by the present
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`invention.
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`SUMMARY
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`One aspect of the present invention involves a dental
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`implant for osseointegration in alveolar bone of the type
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`including an elongate body having a coronal end for engag-
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`ing an abutment to which a tooth prosthesis can be attached.
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`The elongate body has a bone-engaging surface including a
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`first surface region in which the bone-engaging surface is
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`sufficiently porous to permit ingrowth of bone therein. The
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`bone-engaging surface further includes a second surface
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`region in which the bone-engaging surface is non-porous,
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`biocompatible metal that is sufficiently rough to permit bone
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`to attach thereto. The second surface region is disposed
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`intermediate the first surface region and the coronal end. The
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`bone-engaging surface further
`includes a third surface
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`region in which the bone-engaging surface is non-porous,
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`biocompatible metal and is substantially smooth. The third
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`surface region is disposed intermediate the second surface
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`region and the coronal end.
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`It is an object of the present invention to provide a dental
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`implant of the type having a porous surface to promote
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`osseointegration, wherein the porous surface is protected
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`Page 8 of 11
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`

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`6,095,817
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`3
`from the oral cavity, and wherein good oral hygiene is
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`facilitated at the coronal end of the implant.
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`Other objects and advantages of the present invention will
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`be apparent from the following description of preferred
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`embodiments of the invention made with reference to the
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`drawings.
`BRIEF DESCRIPTION OF DRAWINGS
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`FIG. 1 is a side view, shown partially in cross-section, of
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`a first embodiment of an implant useful for osseointegration
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`within alveolar bone, with the cross-section taken along a
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`plane including the longitudinal axis of the implant, and
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`showing multiple textured surfaces.
`FIG. 2 is an end view of the implant of FIG. 1 showing
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`the abutment-engaging end of the implant.
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`FIG. 3 is a side-view, shown partially in cross-section, of
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`a second embodiment of an implant useful for osseointe-
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`gration within alveolar bone,
`in which structures corre-
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`sponding to the embodiment of FIGS. 1 and 2 are indicated
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`by like primed reference numerals, and showing an alternate
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`porous coating configuration.
`FIG. 4 is a side view of a third embodiment of an implant
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`useful for osseointegration within alveolar bone, in which
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`structures corresponding to the embodiment of FIGS. 1 and
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`2 are indicated by like double-primed reference numerals,
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`and showing an alternate apical end configuration with a
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`machined thread structure.
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`FIG. 5 is a side view of a fourth embodiment of an implant
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`useful for osseointegration within alveolar bone, in which
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`structures corresponding to the embodiment of FIGS. 1 and
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`2 are indicated by like triple-primed reference numerals, and
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`showing an alternate macro-textured porous surface region
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`having a thread-like macrotexture.
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`FIG. 6A is a side view of a fifth embodiment of an implant
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`of the present invention.
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`FIG. 6B is a top view of the implant of FIG. 6A.
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`FIG. 7A is a side view of a sixth embodiment of an
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`implant of the present invention.
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`FIG. 7B is a top view of the implant of FIG. 7A.
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`FIG. 8 is a side view of a seventh embodiment of an
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`implant of the present invention.
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`FIG. 9 is a side view of an eighth embodiment of an
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`implant of the present invention.
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`FIG. 10 is a side view of a ninth embodiment of an
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`implant of the present invention.
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`FIG. 11 is a side view of a tenth embodiment of an implant
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`of the present invention.
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`FIG. 12 is a side view of a eleventh embodiment of an
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`implant of the present invention.
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`FIG. 13 is a side view of a twelfth embodiment of an
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`implant of the present invention.
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`BEST MODE FOR CARRYING OUT THE
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`INVENTION
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`Referring to FIGS. 1 and 2, there is illustrated an implant
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`10 comprising part of a dental implant assembly and con-
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`figured in accordance with the present invention. Implant 10
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`is preferably constructed of a biocompatible material such as
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`titanium, and includes an elongate cylindrical body 12
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`having a proximal, or apical, end 14 and a distal, or coronal,
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`end 16. As used throughout
`this description,
`the terms
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`proximal and apical refer to that end or direction that is
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`toward alveolar bone when the dental implant is implanted,
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`Page 9 of 11
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`4
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`and the terms distal and coronal refer to that end or direction
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`that is away from alveolar bone and toward the oral cavity
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`when the dental implant is implanted. Proximal end 14 is
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`smoothly rounded and approximately hemispherical. Distal
`end 16, which may also be referred to as the abutment-
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`engaging end for reasons that will become apparent from the
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`description below,
`includes an annular shoulder 18 that
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`extends to the periphery of cylindrical body 12 and lies in a
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`plane perpendicular to the longitudinal axis 20 of cylindrical
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`body 12. Cylindrical body 12 has a bone-engaging surface
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`22 with multiple textured surface regions 24, 26 , 28 and 30.
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`Region 28 tapers radially outwardly in the apical direction.
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`Aplurality of splines 32 rise from and extend axially away
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`from shoulder 18 in the distal direction. Splines 32 are
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`interdigitated with similar splines on the proximal end of a
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`mating abutment
`to provide anti-rotational engagement
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`between the implant and abutment, and tactile feedback that
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`signals full engagement between the implant and abutment,
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`as is more fully described in US. Pat. No. 5,449,291, the
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`disclosure of which is hereby incorporated by reference. A
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`central coaxial threaded cylindrical bore 34 in cylindrical
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`body 12 is open at distal end 16 for receiving a threaded
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`screw to retain an abutment on implant 10.
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`A first surface region 24 of bone-engaging surface 22 is
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`sufficiently porous to permit ingrowth of bone therein. By
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`“porous,” it is meant that the material underlying the surface
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`is permeated with interconnected, randomly shaped pores
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`that communicate with the surface. Surface 22 in first
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`surface region 24 is comprised of a porous metal coating
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`formed by sintering titanium or titanium alloy powder
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`within recesses machined into the solid titanium or titanium
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`alloy substrate of which elongate body 12 is constructed.
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`Examples of other processes that are known in the art and
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`that are believed to provide a suitable porous coating in first
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`surface region 24 include sintering of metal beads or metal
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`wire mesh to a titanium or
`titanium alloy substrate.
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`Examples of specific processes for forming porous coatings
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`are provided in US. Pat. Nos. 3,855,638; 4,206,516; 4,542,
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`539; and 5,049,074.
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`A second surface region 26 of bone-engaging surface 22
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`is contiguous with and adjacent surface region 24 and is
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`located intermediate region 24 and region 28. Surface 22 in
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`region 26 is comprised of non-porous, biocompatible metal
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`that is sufficiently rough to permit bone to attach thereto.
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`Preferably, surface region 26 is formed by grit-blasting a
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`previously machined surface of the solid titanium or tita-
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`nium alloy of which elongate body 12 is constructed. Grit
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`blasting at a distance of six to twenty inches with 60 grit
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`alumina particles delivered through a 14 inch nozzle by
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`compressed air at 60 psi results in a rough, but non-porous,
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`metal surface having an average surface roughness of about
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`127 microinches. Preferably, the average surface roughness
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`should be in the range of about 75 to about 300 microinches
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`to be sufficiently rough to promote bone attachment thereto.
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`Growth and attachment of bone to surface 22 in region 26
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`results in a bone-to-implant seal that isolates and protects
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`porous region 24 from exposure to the oral cavity. Region 26
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`is an annular band having a width along the longitudinal axis
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`of elongate body 12 of about 0.25 mm to 2.00 mm, prefer-
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`ably about 0.50 mm to about 1.00 mm and most preferably
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`about 0.75 mm.
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`Bone-engaging surface 22 also includes a third surface
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`region 28, contiguous with and adjacent to surface region 26
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`and located intermediate region 26 and coronal end 16.
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`Surface 22 in region 28 is comprised of non-porous, bio-
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`compatible metal
`that
`is substantially smooth. Surface
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`region 28 is formed by machining the solid titanium or
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`10
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`15
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`20
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`25
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`30
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`6,095,817
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`5
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`titanium alloy of which elongate body 12 is constructed.
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`Surface 22 in region 28 should be sufficiently smooth to
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`allow ready removal of bacterial plaque deposits thereon by
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`conventional oral hygiene techniques,
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`surface 22 in region 28 becomes exposed to the oral cavity.
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`A sufficiently smooth machined surface, having an average
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`surface roughness of about 32 microinches or less, can be
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`provided by conventional machining processes. Region 28 is
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`an annular band having a width along the longitudinal axis
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`of elongate body 12 of about 0.25 mm to about 2.00 mm,
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`preferably about 0.50 mm to about 1.00 mm and most
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`preferably about 0.75 mm. Leaving surface 22 substantially
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`smooth in region 28 also maintains sharp definition of
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`shoulder 18 and permits a close fit to be maintained between
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`implant 10 and the aforementioned abutment of the implant
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`assembly, thereby enhancing the appearance of the prosthe-
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`sis assembly when implanted and alleviating entrapment of
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`bacteria at the implant-to-abutment interface.
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`Surface 22 in region 28 is shown tapered to provide a
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`diametric transition between annular shoulder 18 and the
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`maximum diameter of implant 12 that occurs in regions 24
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`and 26. The radially outward and apical taper of surface 22
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`in region 28 allows an implant of increased nominal diam-
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`eter to be used with an abutment dimensioned to fit annular
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`shoulder 18. Alternatively,
`the nominal diameter of the
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`implant could correspond to that of annular shoulder 18,
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`resulting in an implant of substantially constant diameter
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`throughout regions 24, 26 and 28.
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`Referring again to FIG. 1, there is illustrated the porous
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`metal coating 38 that comprises surface 22 in first surface
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`region 24. Coating 38 is comprised of titanium metallic
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`particles deposited into trough or recess 40 and sintered in
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`place using any suitable sintering process as may be known
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`in the art. Prior to the sintering step, cylindrical body 12,
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`including trough 40 and splines 32, is machined from solid
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`metal stock. Subsequently, coronal splines 32 and surface
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`region 28 are masked. Cylindrical body 12 is then exposed
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`to a grit blasting operation which creates the appropriate
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`surface texture for exposed second surface region 26 and
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`exposed surface region 30 at apical end 14, and creates a
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`roughened surface in trough 40 which can enhance the
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`strength of adhesion of coating 38 thereto during the sin-
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`tering process. Masked surface region 28 and masked
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`splines 32 are shielded from the grit blast, and retain their
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`smooth machined surfaces.
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`FIG. 3 illustrates a further embodiment, in which trough
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`40' is similar to trough 40, but is extended to include the
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`extreme apical hemispherical end 14'. In this embodiment,
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`coating 38' covers the entire surface of elongate cylindrical
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`body 12' apically of second surface region 26'.
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`FIG. 4 illustrates a further embodiment
`in which the
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`hemispherical apical end 14 of FIG. 1 is replaced by helical
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`threads 42, machined into the metal of which implant body
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`12" is constructed, which threads allow the implant to be
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`screwed into and mechanically anchored in bone at the time
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`of surgical placement.
`in which the
`FIG. 5 illustrates a further embodiment
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`porous coating 38'" of first surface region 24'" is fashioned
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`with a macrotexture,
`in the form of a thread 44. Other
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`macrotextures, including concave and convex features such
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`as dimples, grooves, or ridges are also contemplated.
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`FIGS. 6A, 6B, 7A, and 7B show two other alternate
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`embodiments for the present invention. Each implant 50
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`includes a generally cylindrical body extending from a
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`apical end 52 to a coronal end 54. The coronal end includes
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`an engaging interface 56. In FIGS. 6A and 6B, the interface
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`10
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`50
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`55
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`60
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`65
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`Page 10 of 11
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`6
`56 includes a plurality of splines 58 that extend outwardly
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`from a top surface 60. These splines are similar to those
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`described in connection with FIGS. I and 2.
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`In FIGS. 7A and 7B,
`the interface 56 is a hexagonal
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`projection that extends upwardly from a top surface 62. As
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`shown best in FIG. 7B, this hexagonal projection includes
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`six flat surfaces 64.
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`Turning back now to FIGS. 6A and 7A, each implant 50
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`has four different and distinct surface regions, numbered 70,
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`72, 74, and 76.
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`Region 70 is contiguous with and adjacent to the engaging
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`interface 56. This region is similar to region 28 described in
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`connection with FIG. 1: although region 70 does not include
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`a slight taper away from top surfaces 60 and 62.
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`Region 72 is adjacent to region 70. This region 72 is
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`similar to region 26 described in connection with FIG. 1.
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`As shown in FIGS. 6A and 7A, region 74 extends along
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`a substantial portion of the body of the implant 50. This
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`region has a surface that is coated with a biocompatible
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`material 80. This material 80 is a calcium phosphate and
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`preferably is hydroxylapatite (HA). This material may also
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`comprise plasma spray titanium. Alternatively, this region
`74 may be left uncoated and the substrate textured using, for
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`example, a grit blasting technique or other known roughen-
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`ing technique.
`HA may be applied to region 74 in a variety of methods
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`known to those skilled in the art. In a preferred method, the
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`outer surface of