U.S. patent application number 11/288465 was filed with the patent office on 2006-04-13 for dental implant system and additional methods of attachment.
Invention is credited to Norman H. Kwan.
Application Number | 20060078847 11/288465 |
Document ID | / |
Family ID | 46150478 |
Filed Date | 2006-04-13 |
United States Patent
Application |
20060078847 |
Kind Code |
A1 |
Kwan; Norman H. |
April 13, 2006 |
Dental implant system and additional methods of attachment
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.
Inventors: |
Kwan; Norman H.;
(Missisauga, CA) |
Correspondence
Address: |
HOWARD J. GREENWALD P.C.
349 W. COMMERCIAL STREET SUITE 2490
EAST ROCHESTER
NY
14445-2408
US
|
Family ID: |
46150478 |
Appl. No.: |
11/288465 |
Filed: |
November 29, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10195007 |
Jul 12, 2002 |
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11288465 |
Nov 29, 2005 |
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09967556 |
Sep 28, 2001 |
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10195007 |
Jul 12, 2002 |
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60237222 |
Oct 2, 2000 |
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60236518 |
Sep 29, 2000 |
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Current U.S.
Class: |
433/174 ;
433/173 |
Current CPC
Class: |
A61C 8/0001 20130101;
A61C 8/0022 20130101; A61C 8/0075 20130101; A61C 8/008
20130101 |
Class at
Publication: |
433/174 ;
433/173 |
International
Class: |
A61C 8/00 20060101
A61C008/00 |
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 in claim 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 in claim 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 in claim 1, wherein said
base section is comprised of a bioactive coating comprised of a
biologically active agent.
5. The dental implant assembly as recited in claim 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 in claim 4, wherein said
biologically active agent is a bone morphogenetic protein.
7. The dental implant assembly as recited in claim 4, wherein said
biologically active agent is comprised of a bone morphogenetic
protein and a hydroxyapatite.
8. The dental implant assembly as recited in claim 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 in claim 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 in claim 8, wherein said
neck section is comprised of parallel walls.
11. The dental implant assembly as recited in claim 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 in claim 11, wherein
said first average irregular roughness is from about 0.01 to about
1000 microns.
13. The dental implant assembly as recited in claim 11, wherein
said first average irregular roughness is from about 3 to about 20
microns.
14. The dental implant assembly as recited in claim 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 in claim 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 in claim 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 in claim 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 in claim 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 in claim 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 in claim 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 in claim 20, wherein
said ledge angle is a right angle.
23. The dental implant assembly as recited in claim 20, wherein
said ledge angle is an obtuse angle.
24. The dental implant assembly as recited in claim 23, wherein
said obtuse angle is a sloping obtuse angle.
25. The dental implant assembly as recited in claim 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 in claim 26, wherein
said first average irregular roughness is from about 0.001 to about
10 microns.
28. The dental implant assembly as recited in claim 26, wherein
said first average irregular roughness is from about 3 to about
1000 microns.
29. The dental implant assembly as recited in claim 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 in claim 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 in claim 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 in claim 27, wherein
said dental implant assembly consists essentially of titanium.
33. The dental implant assembly as recited in claim 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 in claim 27, wherein
said base section is comprised of a bioactive coating comprised of
a biologically active agent.
35. The dental implant assembly as recited in claim 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 in claim 34, wherein
said biologically active agent is a bone morphogenetic protein.
37. The dental implant assembly as recited in claim 34, wherein
said biologically active agent is comprised of a bone morphogenetic
protein and a hydroxyapatite.
38. The dental implant assembly as recited in claim 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 in claim 33, wherein
said average irregular roughness of said base is from about 3 to
about 1,000 microns.
Description
CROSS-REFERENCE TO RELATED PATENT APPLICATIONS
[0001] 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
[0002] A dental implant device comprised of an irregularly-shaped
abutment.
BACKGROUND OF THE INVENTION
[0003] 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.
[0004] 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.
[0005] 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.
[0006] It is an object of this invention to provide an improved
dental implant device.
SUMMARY OF THE INVENTION
[0007] 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
[0008] The invention will be described by reference to the
following drawings, in which like numerals refer to like elements,
and in which:
[0009] FIG. 1A is a schematic view of one apparatus of the
invention;
[0010] FIG. 1B is a top view of the apparatus of FIG. 1A;
[0011] FIG. 1C, FIG. 1D, FIG. 1E, FIG. 1F, and FIG. 1G are side
views of another embodiment of the present invention;
[0012] FIG. 1H is a bottom view of another embodiment of the
present invention;
[0013] FIGS. 1I to 1N are illustrations of hole configurations for
use with the apparatus depicted in FIG. 1H;
[0014] FIGS. 1O and 1P are side views of one embodiment of the
invention that utilizes holes disposed within longitudinal
channels;
[0015] FIG. 1Q is a depiction of various ledge configurations;
[0016] FIG. 1R is a profile view of one device of the present
invention;
[0017] FIG. 2 is a partial side view of one one-piece universal
implant abutment device;
[0018] FIG. 3 is a sectional view of the device of FIG. 1A;
[0019] FIG. 4 is a schematic view of a healing ball of a dental
implant system;
[0020] FIG. 5 is a schematic of another embodiment of a healing
ball of the dental implant system;
[0021] 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;
[0022] 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;
[0023] FIG. 7 is a schematic view of an analog-abutment of a dental
implant system;
[0024] FIG. 8 is a perspective view of a retaining screw of a
dental implant system;
[0025] FIG. 9 is a perspective view of a guide pin of a dental
implant system;
[0026] 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;
[0027] FIG. 11 is a schematic illustration of a tissue flap formed
as part of the methods of attachment of a dental implant
system;
[0028] 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;
[0029] FIG. 13 is a schematic illustration of an implant abutment
device inserted within the hole of FIG. 12;
[0030] FIG. 14 is a schematic illustration of a healing ball seated
on the device of FIG. 13;
[0031] FIG. 15 is a schematic illustration of an impression
tray;
[0032] FIG. 16 is a schematic illustration of an impression formed
as part of the process of attachment of a dental implant
system;
[0033] FIG. 17 is a schematic illustration of an analog-abutment
inserted within the impression of FIG. 16;
[0034] FIG. 18 is a schematic illustration of a model formed as
part of the process of attachment of the dental implant system;
[0035] 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;
[0036] FIG. 20 is a schematic illustration of multiple implant
abutment devices inserted within the jawbone of a patient;
[0037] FIG. 21 is a schematic illustration of another embodiment of
an impression tray;
[0038] FIG. 22 is a schematic illustration of one embodiment of an
alignment of multiple implant abutment devices of a dental implant
system;
[0039] 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;
[0040] 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;
[0041] FIG. 25 is a schematic illustration of another embodiment of
a modified implant abutment device;
[0042] FIG. 26 is a schematic illustration of a section of a
template of the dental implant system;
[0043] FIG. 27 is a schematic illustration of one embodiment of a
section of a template positioned on an implant abutment device;
[0044] FIG. 28 is an exploded view of an embodiment of an abutment
used in the device of this invention;
[0045] FIGS. 28A and 28B are perspective views of other abutment
assemblies;
[0046] FIG. 28C is a side exploded view of another embodiment of
the present invention;
[0047] FIG. 29 is top view of the abutment of FIG. 28;
[0048] FIGS. 29A and 29B are top views of other abutment
assemblies;
[0049] FIGS. 30A, 30B, 30C, 30D, 30E, 30F, 30G, 30H, 30I, 30J, and
30K are top views of other abutment assemblies;
[0050] FIGS. 31A and 31B are perspective and top views,
respectively, of another implant assembly of the invention;
[0051] FIG. 32 is an exploded schematic view of an implant assembly
of the invention;
[0052] FIGS. 32A and 32B are sectional views of abutment assemblies
of the invention;
[0053] FIGS. 33A, 33B, 33C, 33D, 33E, 33F, 33G, and 33H are top
views of other abutment assemblies of the invention;
[0054] FIG. 34A is a perspective view of another implant assembly
of the invention;
[0055] FIG. 34B is a sectional view of another implant assembly of
the invention;
[0056] FIGS. 34C and FIG. 34D are side views of two additional
embodiments of the present invention;
[0057] FIG. 35, 36, 37A and 37B are perspective views of other
implant assemblies of the invention; and
[0058] FIG. 38 is a sectional view of a roughened surface.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0059] 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).
[0060] 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.
[0061] Once the fixture is disposed in the "instrument set . . .
2," a "fixture mount" is then attached to the fixture by means of a
wrench and a screwdriver. The "fixture mount" devices are shown on
page 22 of the Nobelpharma catalog. The instruments for fixture
placement of the fixture are also shown on page 22 of the
Nobelpharma catalog (see wrench part 17 and screwdriver part
19).
[0062] Next, a "connection to contra-angle handpiece" (see part 11
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.
[0063] Thereafter, the fixture mount is removed from the fixture
and a cover screw 10 (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).
[0064] 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.
[0065] 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.
[0066] 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.
[0067] Multiple mock-ups and adjustments are often made before the
final prosthesis is finally secured to the implant.
[0068] 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.
[0069] 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.
[0070] Draw is perhaps best described as the effects of friction,
but not binding.
[0071] 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.
[0072] 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.
[0073] 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.
[0074] 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.
[0075] In addition, the system further includes a retaining screw
or guide pin that secures the healing ball onto the head
portion.
[0076] 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.
[0077] 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.
[0078] 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.
[0079] FIG. 1A is a schematic illustration of one implant system.
Referring to FIG. 1A, an embodiment of a dental implant system in
accordance with the present invention includes a one-piece
universal implant abutment device 10. In general, the universal
implant abutment device 10 is a single-piece device 10 including
head 12, neck 14 and base 16 sections. It should be noted that this
device 10 is a single-piece component.
[0080] 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.
[0081] The implant abutment device 10 shown in FIG. 1A is
preferably made of titanium or titanium alloy. Alternatively, the
device 10 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.
[0082] 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.
[0083] Referring again to FIG. 1A, the height HY and diameter HX of
the head 12 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 the neck 14 of the implant abutment
device 10 are approximately within the range of 0 millimeters to
8.0 millimeters and 1.0 millimeter to 12.0 millimeters,
respectively.
[0084] In another embodiment, the walls of the head are extending
downwardly and outwardly to intersect with the base. Reference may
be had to FIG. 1C and FIG. 1D. In the embodiments depicted, base
section 16 is comprised of threads (not shown). In the embodiments
depicted, head 12 is comprised of a top head section 12a and a
bottom head section 12b. The walls of head 12 extend downwardly and
outwardly from top head section 12a to bottom head section 12b. In
the embodiment depicted, the diameter of bottom head section 12b is
the same as the diameter of the upper base section of base 16. In
the embodiment depicted in FIG. 1C, the abutment head 12 is formed
by a linear wall 12c and arcuate wall 12d. In the embodiment
depicted in FIG. 1C, the head 12 is formed by two linear walls,
12c, that are opposite one another, and two arcuate walls 12d, that
are also opposite one another. In other embodiments, not shown,
head 12 is comprised of more than four walls wherein there is a
pattern of alternating linear and arcuate walls. In the embodiments
depicted in FIG. 1C and FIG. 1D, the neck section (see neck section
12 of FIG. 1A) is absent. In another embodiment, such a neck
section is present.
[0085] Referring now to FIG. 1E, and to the embodiment depicted
therein, device 10 depicted therein is comprised of head section
12, neck section 14 and base section 16. The embodiment depicted in
FIG. 1E is similar to the embodiment depicted in FIG. 1C except in
that the device illustrated in FIG. 1E is includes neck section 16.
As shown in FIG. 1E, neck section 16 is comprised of vertical walls
16a and 16b. In another embodiment (not shown), the walls 16a and
16b can be converging or diverging to intersect with the bottom of
the head 12. In the embodiment depicted, vertical walls 16a and 16b
are substantially parallel. FIG. 1E also differs from FIG. 1C in
that FIG. 1E illustrates axial hole 17.
[0086] In the embodiment depicted in FIG. 1E, axial hole 17 has a
depth 17b and a width 16c. Axial hole 17 is orientated such that
its depth 17b is substantially parallel to axis 220. Axial hole
thus makes the base partially hollow. In one embodiment, a
biologically active agent can be embedded in a carrier substance
such as collagen sponge, strip, wick and the like; and is disposed
within axial hole 17. Such an agent may be delivered to the
surrounding tissue through holes 17a. In the embodiment depicted,
holes 17a connect axial hole 17 to the external environment and
permit the transmission of the aforementioned biologically active
agent. In the embodiment depicted, the holes are perpendicular to
axis 220. In another embodiment, not shown, the holes are at a
non-perpendicular angle relative to axis 220.
[0087] In addition, the height BY and diameter BX of the base 16 of
the device 10 are within the range of approximately 6.0 millimeters
to 30.0 millimeters and 1.0 millimeter to 12.0 millimeters,
respectively.
[0088] Alternative heights and diameters can also be used provided
that the overall device dimensions permit proper implantation and
functioning of the device 10.
[0089] As shown in FIGS. 1A and 1B, and in the embodiment depicted
therein, the perimeter of the head 12 is substantially in the shape
of a hexagon and includes six, planar, external main-walls 18. In
one embodiment, the six, planar main-walls 18 are interconnected by
six, substantially planar, external side-walls 20. In general, the
width MW of each main-wall 18 is approximately within the range of
1.0 millimeter to 12.0 millimeters and the width SW of each
sidewall 20 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-walls 18 and
non-planar (e.g., arcuate) side-walls 20, thereby producing
improved comfort and reduced irritation within the patient's
mouth.
[0090] Alternatively, the main-walls 18 may be substantially
non-planar and the side walls 20 planar, or both the main-walls 18
and side-walls may be substantially non-planar.
[0091] In an alternate embodiment, shown in FIG. 2, the main-walls
18 and side-walls 20 of the head 12 are tapered. The main-walls 18,
side-walls 20, or portions thereof, may taper in either radially
inward or outward direction. Other configurations of the head 12
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 the base 16 and
threads 32 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. The threads 32 serve to securely
attach the base 16 of the implant abutment device 10 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.
[0092] The cylindrical base 16 of the device 10 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.
[0093] As shown in FIG. 1F and FIG. 1G, the device 10 is comprised
of a generally cylindrical, titanium body 19 comprises of a head
12, neck 14 and base 16, wherein the head 12 is comprised of smooth
walls 208 and 242 extending downwardly and outwardly. The cross
section of the head 12 is a substantially flat wall 208 joined to
an arcuate wall 242. The neck 14 has the same diameter as the head
12 at the intersection, where the surface 14a of the neck 14 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 of neck 14 is from about 0.01 to about 20
microns. In yet another embodiment, the irregular roughness of neck
14 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 the
base section 16.
[0094] 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 14b and 14c of the neck 14 are substantially parallel until
each wall intersect base 16. Base 16 extends downwardly and
inwardly. In the embodiment depicted, neck 14 has a length of from
about 0.1 to about 6 millimeters. Base 16 is comprised of raised
threads 32 that extend downwardly and inwardly to the bottom part
of the base 16. The end part of base 16 has an axial hole 17 which,
in the embodiment depicted, is open at the bottom of base 16. Holes
17a are in fluid communication with axial hole 17 such that the
biologically active agent disposed in axial hole 17 may diffuse
through holes 17a. Holes 17a extend radially through base 16 at
right angles to the axis 220 (see FIG. 1 E) of the device 10.
[0095] As is indicated in FIG. 1H, a second hole can also be formed
in the base section 16 such that the two holes are at right angles
to each other. FIG. 1H is a cross sectional view of device 10 of
FIG. 1G viewed from the bottom. Hole 17a is in fluid communication
with axial hole 17 as is hole 17b. There is an angle 17c between
first hole 17a and second hole 17b. In the embodiment depicted,
angle 17c is about ninety degrees. In another embodiment, not
shown, the angle is other than ninety degrees.
[0096] The diameter of hole 17a ranges from about 0.25 to about
0.75 times of diameter BX (see FIG. 1A). In general the diameter of
axial hole 17a is between 1 to 4 millimeters and the depth of the
axial hole 17 is between 0.1 millimeters to the entire length of BY
(see FIG. 1A). In the embodiment depicted in FIG. 1H, the cross
section of axial hole 17 is a circle. In other embodiments, the
cross section another shape, such as a circle, triangle, or
polygonal shaped. Reference may be had to FIG. 1I to FIG. 1N. Such
cross sections allow the frictional fitting of a biologically
active agent carrier body such as sponges, collagen plugs, tapes
etc. In one embodiment of the invention, an absorbent collagen
sponge 17d has been used as a carrier. Such a sponge has an
elastic, porous mass and absorbs the biologically active agent. In
the embodiment shown, the sponge has an uncompressed diameter of
about 4 millimeters and, when compressed, has a diameter of about
3.1 millimeters. It can be easily fitted in the axial hole 17.
[0097] In the embodiment depicted in FIG. 1E, the axial hole 17
extends partially into base 16. In the embodiments show in FIG. 1F
and FIG. 1G, the axial hole 17 extends along the whole length of
base 16, and at intervals along such base, there are transverse
holes 17a. In one embodiment, holes 17a have a diameter of from
about 0.01 millimeters to about 4 millimeters. In one embodiment,
collagen sponge 17d also extends along the entire length of base
16.
[0098] In another embodiment, shown in FIG. 10 and FIG. 1P, the
head 12 is comprised of flat wall 208 connected with arcuate wall
242. Neck 14 is comprised of parallel walls 14b and 14c. In one
embodiment, the parallel walls 14b and 14c of neck 14 are
irregularly roughened. In the embodiment depicted in FIG. 10 and
1P, base 16 is comprised of longitudinal channel 16a. 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.
[0099] Longitudinal channel 16a fluidly connects holes 17a such
that any biologically active agent secreted through holes 17a from
axial hole 17 can diffuse vertically along the length of
longitudinal channel 16a and therefore along the entire length and
surrounds the whole implant in the jaw bone.
[0100] In another embodiment FIG. 1Q, device 10 is comprised of an
angled ledge formed by the union of reverse curves. In the
embodiment depicted in FIG. 1Q, device 10 is comprised of head
section 12 and neck section 14. Neck section 14 is comprised of
ledge 26. Ledges such as ledge 26 may have a variety of
configurations. In ledge configuration 21a, 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. Angle 23a is such an
acute angle. In ledge configuration 21b, such a ledge has a right
angle. Such a ledge is said to be a horizontally extending ledge.
Angle 23b is a right angle. In ledge configuration 21c, such a
ledge has an obtuse angle. An obtuse angle is an angle whose
measurement is between 90 and 180 degrees. Angle 23c is such an
obtuse angle. Configuration 21d shows one embodiment of the
invention wherein no ledge is present. Instead, the angle 23d
between head 12 and neck 14 is 180 degrees. In another embodiment
(shown in FIG. 1Q), a sloping, obtuse angle is formed where the
ledge joins the bottom part of the head 12 joining the neck 14 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 the base 16. In this embodiment, the ledge formed
would have no distinct angles, but maintains an overall obtuse
angle.
[0101] Device 10 illustrated in FIG. 1Q has a head section 12 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, four such splines 258 are
illustrated. In another embodiment, more than four such splines are
present. See, for example, FIG. 33C. Splines 258 are configured to
have a mating configuration with lower section 42 of healing ball
40. Such a mating configuration only permits the healing ball to be
attached to device 10 in a finite number of orientations. In one
embodiment, there is only one such possible orientation.
[0102] In another embodiment, illustrated in FIG. 1R, the head 12
has a mated configured adapted to receive a correspondingly shaped
instrument. In the embodiment depicted, head 12 has a length of
from about 1 millimeter to about 8 millimeters and consist of an
arcuate wall 242 extending downward and outward. The bore 216 can
be different configurations. In the embodiment depicted, bore 216
has a substantially hexagonal cross-sectional shape. Bore 216 is
adapted to engage a correspondingly shaped instrument. The neck 14
is comprised of parallel 14b and 14c and has a length of from about
0 to about 6 millimeters. In one embodiment, the surface of neck 14
is irregularly roughened as disclosed elsewhere in this
specification. Base 16 is a cylinder with walls extending downward
and inward. In the embodiment depicted, base 16 is both threaded
and etched to produce an irregularly roughened surface. In another
embodiment, base 16 is comprised of axial hole 17 with fluidly
connected holes 17a and 17b. Both holes 17a and 17b are at right
angles relative to axial hole 17. In the embodiment depicted, holes
17a and 17b are also at right angles relative to one another. Base
16 is also comprised of longitudinal channel which connects at
least two holesl 7b on the outer surface of base 16.
[0103] The structural design of the base 16 depends, in part, on
the material or materials used to fabricate the device 10. For
example, in one embodiment, a base 16 made of a semi-rigid material
may be solid, whereas a base 16 made of a substantially rigid
material may be partially hollow. Alternatively, a base 16 made of
a combination of rigid and semi-rigid materials may include solid
and hollow portions. Alternate configurations of the base 16 not
disclosed herein are also included within the scope of the claimed
invention.
[0104] Referring to FIG. 3, a substantially cylindrical, hollow
core 34 extends through and along the axial length, or portions
thereof, of the head 12 of the device 10. The surface of the
internal walls 36 of the head 12 surrounding the core 34 may be
threaded and slightly tapered. Alternative core 34 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, the hollow core 34 is adapted to receive and
securely retain a guide pin, retaining screw and/or healing ball,
as described in further detail below.
[0105] In alternate embodiments (not shown), the hollow core 34
extends through and along the axial length, or portions thereof, of
the head 12 and neck 14, or head 12, neck 14 and base 16. In yet
another embodiment, the hollow-core 34 may be off-axis and/or
non-parallel to the axial length of the device 10.
[0106] The dental implant system of the present invention may also
include a healing ball 40, shown in FIG. 4, that can be either
removably secured or permanently affixed to the universal implant
abutment device 10. The healing ball 40 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, the
healing ball 40 may be made of any biocompatible, non-toxic (e.g.,
medical grade) material that permits proper functioning of the
healing ball 40. In another embodiment of the invention, the
healing ball material may also include barium or similar elements
that make the healing ball radiopaque.
[0107] Referring to FIG. 4, and in the embodiment depicted therein,
the healing ball 40 includes a cylindrical lower portion 42 and a
spherical upper portion 44. Other healing ball configurations
including, but not limited to, tooth-shaped, cone-shaped,
box-shaped, donut-shaped, collar-shaped, cylindrical and spherical,
may also be used with the dental implant system. In another
embodiment (not shown), the healing ball 40 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.
[0108] As shown in FIG. 4, and in the embodiment depicted therein,
a hexagonal-shaped opening or bore 46 extends along the axial
length of the lower portion 42 and partially along the
corresponding axial length of the upper portion 44. The hexagonal
shape of the bore 46 is used for illustration purposes and not
meant to limit the invention. In general, a variety of bore shapes
or configurations adapted to engage the head 12 of the implant
abutment devicel 0 may be used with the healing ball 40 of the
present invention.
[0109] In the embodiment depicted, a cylindrical bore or opening 48
lies adjacent to and is aligned along the same axis of the
hexagonal bore 46. The diameter of the cylindrical opening 48 may
be less than, equivalent to or greater than the diameter of the
hexagonal bore 46. As will be described in further detail below,
the cylindrical opening 48 forms a lumen through the healing ball
40, thereby enabling associated components, such as a guide pin,
retaining screw, cement, wax and other components included within
the scope of the claimed invention, to be inserted therethrough. In
yet another embodiment (not shown), the opening 48 maybe off-axis
and/or non-parallel to the axis of the device 10.
[0110] In an alternate embodiment, shown in FIG. 5, the cylindrical
opening 48 is removed and the hexagonal bore 46 forms the entire
opening or lumen through the healing ball 40. In another embodiment
(not shown), the hexagonal bore 46 is removed and the cylindrical
bore 48 forms the entire opening or lumen through the healing ball
40. For the sake of simplicity of representation, references to the
bore 46 of the healing ball 40 in the remainder of this disclosure
should be understood to include bore 46 and/or opening 48.
[0111] As previously described, the bore 46 of the healing ball 40
is configured to match and snugly fit over the hexagonal head 12 of
the implant abutment device 10. As such, an octagonal opening in a
healing ball 40 would be used for a device 10 having an octagonal
head 12, a triangular bore 46 in a healing ball 40 would be used
for a device 10 with a triangular head 12, and so on.
[0112] In another embodiment (not shown), a reverse configuration
of the manner in which the device 10 and healing ball 40 engage
each other is contemplated. For example, the device 10 may include
a recess, bore or opening into which the healing ball's 40 mating
shaft, post or protrusion is inserted. Other methods of engagement
not specifically disclosed herein but known in the art are also
comprehended.
[0113] In an alternate embodiment (not shown), the bore 46 is
formed of two opposing flat surfaces or walls and two opposing
arcuate surfaces or walls. The two flat surfaces of the healing
ball 40 engage two of the main-walls 18 of the implant/abutment
head 12 and the two arcuate surfaces engage the remaining
main-walls 18.
[0114] Thus, in the embodiment depicted, the healing ball 40
engages the device head 12 in a manner similar to a conventional
wrench-and-socket configuration. Alternate embodiments of the bore
46 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.
[0115] In another embodiment of the healing ball 40, the axial
length of the bore 46 is approximately equivalent to the height HY
of the head 12 (shown in FIG. 1).
[0116] Alternatively, the length of the bore 46 may be greater than
the height HY of the head 12. In one embodiment, the base 50 of the
healing ball 40 surrounding the bore 46 rests upon the ledge 26
(see FIG. 1A) of the device 10, ensuring a proper fit within the
patient's mouth. In another embodiment (not shown), the opening of
the healing ball 40 includes an inwardly-extending annular
protuberance which is adapted to fit within and is removably
secured to a matching annular groove surrounding the device 10.
[0117] 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.
[0118] The healing ball 40 is but one of many types of dental
copings which may be used with the device 10 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
the implant abutment device 10. The entire disclosure of each of
these patents is hereby incorporated by reference into this
specification.
[0119] In one embodiment of the present invention, the healing ball
40 may be removed from the implant abutment device 10 prior to
attachment of the dental prosthesis. As such, the healing ball 40
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 the device 10. In addition, the healing ball 40
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 the healing ball 40 to the device 10.
Once the final prosthesis is available, the attachment device or
compound and healing ball are removed and the prosthesis is secured
to the implant abutment device 10 within the patient's mouth.
[0120] In another embodiment of the invention, the healing ball 40
may be permanently affixed to the device 10 so that the dental
prosthesis directly attaches to the healing ball 40. For example,
prostheses or dentures including metal rings, caps with rubber
o-rings, ball attachment replicas and other similar fastening
elements may be friction fit over the healing ball 40 to firmly,
securely and removably attach the prosthesis to the implant
abutment device 10. As shown in FIG. 6A, one or more healing ball
40 and implant abutment device 10 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 the healing ball 40 onto
the implant abutment device 10. The fastening elements 52 of the
prosthesis 54 are then friction fit over the healing balls 40 to
securely attach the prosthesis 54 within the patient's mouth.
[0121] In an alternate embodiment, one or more tooth-shaped healing
balls 40 are permanently affixed to one or more devices 10
implanted within the patient's jawbone.
[0122] As shown in FIGS. 6A and 6B, a prosthesis, denture or
partial-denture 55 including one or more retention clasps, rings or
elements 57 aligned to engage the healing ball(s) 40 act as
retaining elements to secure and stabilize the denture in the
patient's mouth.
[0123] 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.
[0124] In another embodiment of the invention (not shown), bar-clip
overdentures, crowns and/or bridges (such as those disclosed in
U.S. Pat. No. 5,174,954, of which the entire disclosure is herein
incorporated by reference) may be readily connected to either the
healing ball 40 and implant abutment device assemblies or to the
gold-cylinder and implant abutment device 10 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.
[0125] Referring to FIG. 7, the dental implant system may also
include an abutment-analog 56. The abutment-analog 56 is generally
a replica of the head 12 and/or neck 14 of the implant abutment
device 10 and mainly used in laboratory procedures during
construction of patient models and prostheses. The abutment-analog
includes a head 58 and neck 60 similar in design and configuration
to the head 12 and neck 14 of the implant abutment device 10
previously described.
[0126] In one embodiment, the head 58 and neck 60 of the
abutment-analog 56 are exact replicas of the head 12 and neck 14 of
the implant abutment device 10.
[0127] The abutment-analog 56 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.
[0128] As shown in FIG. 7, the abutment-analog 56 also includes a
shaft 62. In one embodiment, the shaft 62 includes cylindrically
shaped top 64, middle 66 and bottom 67 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 the top portion 64 is approximately 3.0 millimeters,
the middle portion 66 is approximately 1.75 millimeters and the
bottom portion 67 is approximately 3.0 millimeters. Alternatively,
the top 64, middle 66 and bottom 67 portions maybe approximately
1.0 millimeter, 3.0 millimeters and 1.0 millimeter, respectively.
In general, the shaft 62 may be configured with various gripping
surfaces, projections, indentations, flat/planar portions and
non-planar portions to prevent the abutment-analog 56 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.
[0129] Referring to FIGS. 8 and 9, the dental implant system of the
present invention may also include a retaining screw 68 and guide
pin 70, respectively. Referring to FIG. 8, the retaining screw 68
is used to secure the healing ball 40 and/or prosthesis, either
permanently or temporarily, onto the implant abutment device
10.
[0130] As such, the threaded portion 72 of the retaining screw 68
is configured to engage the threads on the surface of the internal
walls 36 of the device 10. In general, the retaining screw may be
approximately 2.0 millimeters to 10.0 millimeters in length. In one
embodiment, the diameter of the head 74 of the retaining screw 68
may be configured to seat within the lumen of the healing ball 40.
Alternatively, the head 74 may be seated on the external surface of
the healing ball 40. The retaining screw 68 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.
[0131] The guide pin 70, shown in FIG. 9, is used to secure the
healing ball 40 to the implant abutment device 10 for taking final
impressions of the position of the head 12 of the device 10. The
length of the guide pin 70 is approximately within the range of 3.0
millimeters to 20.0 millimeters. In general, the guide pin 70 is
configured so that a sufficient portion of the head or shaft 76
extends outside of the healing ball 40, enabling a user or
practitioner to firmly and securely grip the guide pin 70. The
shaft 76 may be made of a variety of shapes and surface
configurations including, but not limited to, cylindrical, conical,
polygonal, ribbed, dimpled, smooth and textured.
[0132] As with the retaining screw 68, the threaded portion 78 of
the guide pin 70 may also be configured to engage the threads on
the surface of the internal walls 36 of the device 10. In addition,
a variety of biocompatible, non-toxic materials may be used to
fabricate the guide pin 70 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.
[0133] Although the retaining screw 68 and guide pin 70 are shown
in FIGS. 8 and 9, respectively, to include a slotted head, other
head configurations known in the art to either manually or
mechanically drive the screw 68/guide pin 70 into the device 10 may
also be used and are included within the scope of the claimed
invention. One or more of the universal implant abutment device 10,
healing ball 40, abutment-analog 56, guide pin 70 and retaining
screw 68 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.
[0134] Each kit may be configured to provide the necessary
components for a particular procedure. For example, in one
embodiment of the invention, the kit for a single-tooth replacement
procedure may include one implant abutment device 10, three healing
balls 40, one abutment-analog 56, one retaining screw 68 and one
guide pin 70. In another embodiment, a single-tooth replacement kit
may include two implant abutment devices 10, six healing balls 40,
two abutment-analogs 56, two retaining screws 68 and two guide pins
70. In an alternate embodiment, a multiple-tooth replacement kit
may include three implant abutment devices 10, nine healing balls
40, three abutment-analogs 56, three retaining screws 68 and three
guide pins 70. Other kit configurations not disclosed herein but
known in the art are also included within the scope of the claimed
invention.
[0135] 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.
[0136] In one embodiment, a mid-crestal and reverse bevel labial
incision 80 is made extending along two teeth and on both sides of
the edentulous space, as shown in FIG. 10. A similar incision is
made palatally, resulting in a full thickness envelope flap 82 as
shown in FIG. 11.
[0137] Referring to FIG. 12, a hole 84 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 the
device 10, and, generally, is parallel to the long axis of adjacent
teeth.
[0138] One or more drill bits used at variable speeds with
sufficient irrigation create the appropriately sized and shaped
hole 84. The depth of the hole 84 is sized to receive the base 16
of the implant abutment device 10, and generally ranges from
approximately 8 millimeters to 30 millimeters in depth.
[0139] Referring to FIG. 13, the implant abutment device 10 is then
manually inserted into the hole 84 in a sterile manner. In one
embodiment, a carrier (not shown) may be used to deliver the
implant abutment device 10 to the hole 84 and also to begin
manually screwing the device 10 into the hole 84. 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.
[0140] Generally, only a portion of the base 16 of the implant
abutment device 10 can be manually inserted into the hole 84. A
power-driven socket-wrench, contra-angle handpiece or similar tool
may be used to fully seat the device 10 within the hole 84.
[0141] Crestal bone height and clinical parameters such as device
stability, tissue thickness as required for prosthesis aesthetics
and inter-occlusal distance may also be taken into consideration to
determine final position and configuration of the device 10.
[0142] The gingival tissue and flaps 82 are inspected, trimmed,
coapted and sutured around the head 12 of the device 10. 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.
[0143] Either immediately after suturing or anytime thereafter, the
prosthesis may be attached to the device 10. No further surgical
procedures are required, unlike prior art processes which often
require a second stage surgery to expose and prepare a gingival
seat around the device and perform other modifications to ensure
proper prosthetic-device engagement. As previously described, with
prior art devices and procedures, a space or recess between the
device and soft tissue must be created to allow an appropriate
interface and ensure proper placement of the prosthesis without
trapping soft tissue. In contrast, the prosthesis may be directly
attached to the implant abutment device 10 of the present invention
without further surgical intervention.
[0144] Referring to FIG. 14, a healing ball 40 may be attached to
the device 10 to contour the tissue for proper impression
registration. In one embodiment of the invention, the healing ball
40 is attached directly after tissue suturing and prior to hard and
soft tissue healing. A retaining screw 68 or similar component
previously described may be used to secure the healing ball 40 onto
the device 10. The healing ball 40 is then left in place for an
approximately seven to ten day time period.
[0145] Alternate time periods that allow the soft tissue to mature
and form a stable recess for the prosthesis may also be used.
[0146] After the soft tissue has matured and formed a stable
recess, a final impression may be taken from which the prosthesis
is created. The original healing ball 40 is removed, and another,
interchangeable healing ball 40 is secured to the device 10 with a
guide pin 70. Alternatively, the original healing ball 40 is left
in place and the retaining screw 68 is replaced with a guide pin
70.
[0147] As shown in FIG. 15, an impression tray 86 with a window or
opening 88 is placed over the healing ball 40 within the patient's
mouth. The opening 88 of the tray 86 is aligned with the guide pin
70 so that the guide pin 70 protrudes above the impression frame.
The guide pin 70 holds the healing ball 40 in place during setting
of the impression material. After the material is set, the
protruding portion of the guide pin 70 is used to unscrew the guide
pin 70 from the healing ball 40 and remove the guide pin 70 through
the tray opening 88. The healing ball 40 is then transferred with
the impression material when the impression tray 86 is removed from
the patient's mouth, as shown in FIG. 16. The original healing ball
40 may be re-attached to the device 10 as a protective covering and
tissue spacer.
[0148] In an alternate embodiment, anti-rotational grooves,
indentations or other types of gripping features may be formed on
the healing ball 40. These features prevent movement or
displacement of the healing ball 40 within the impression material
when the healing balVimpression tray are removed from the patient's
mouth.
[0149] Referring to FIG. 17, and in the process depicted therein,
an abutment-analog 56 is inserted into the matching cavity of the
healing ball 40 contained within the impression material. As
previously described, the abutment-analog 56 replicates the
configuration of the implant abutment device 10 of the present
invention. With the abutment-analog 56 seated in the healing ball
40, an impression is then poured in a rigid stone or plaster
material to form the final model 90. In general, the entire
abutment-analog 56, excluding its head 58 or head 58 and neck 60,
may be buried in the final working model 90. As such, the remaining
exposed portion of the abutment-analog 56, 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 in FIG. 18.
[0150] Referring to FIG. 19, a healing ball 40, coping (such as a
preformed coping in the shape of a healing ball 40, tooth or other
shapes) or metal framework may be used as part of the final
prosthesis 92. Some of the materials used to form the final
prosthesis include, but are not limited to, metal, metal alloys,
ceramics, composites, aluminum oxide, fiber core, zirconium and
other materials. The final prosthesis 92 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, the final
prosthesis 92 is then installed within the patient's mouth using
cement, retaining screws, or other attachment means known to those
skilled in the art.
[0151] In an alternate embodiment (not shown), two or more implant
abutment devices 10 may be used for a single tooth (e.g., molar)
restoration. The use of multiple implant abutment devices 10 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.
[0152] 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.
[0153] In one embodiment, the incision 80, hole 84 and implant
abutment device 10 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, the incision 80 may be larger, multiple
holes 84 are generally created within the jawbone of the patient,
and, likewise, multiple implant abutment devices 10 are inserted
within the holes 84, as generally shown in FIG. 20. The four-teeth
reconstruction shown in FIG. 20 is for illustration purposes and
not meant to limit the scope of the claimed invention.
[0154] After adequate soft tissue healing has occurred and a stable
recess for the prosthesis has been formed using healing balls 40 as
previously described, the temporary prosthesis or original healing
balls 40 are removed from each device 10.
[0155] In one embodiment, a pattem resin or similar material may be
used to lute or connect all the healing balls 40 together as one
unit, forming a coping framework. This process may be used for both
the original healing balls 40 and the new healing balls 40.
[0156] Next, an impression is taken using an appropriately sized
impression tray 86.
[0157] The protruding portions of the guide pins 70 extend through
the opening(s) 88 in the impression framework, as shown in FIG. 21.
Alternatively, a traditional disposable stock tray (not shown) may
be used. As such, after all the healing balls 40 are luted or
splinted together thereby forming a "picket-fence" type effect, the
guide pins 70 can be removed from the healing balls 40. The healing
balls 40 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 the healing balls 40.
[0158] After the impression material has set, the guide pins 70,
tray 86 and impression material are removed from the patient's
mouth. The resulting impression includes the healing balls 40
incorporated in the impression material. The low height or minimal
profile of the head 12 of each device 10 and flexibility of the
impression media allow an accurate impression to be made, without
permanent distortion or damage. In particular, the healing balls
40, as integral parts of the impression, may be cleanly withdrawn
from the devices 10 without disturbing the precise relationship of
each reference device 99. The other devices 10 are then modified
(e.g.. portion 100, shown in the FIG. 24 as encircled by a dashed
line, is removed) according to the inclination/alignment of these
devices 10 in relationship to the reference device 99 to ensure a
secure and accurate fit for the final prosthesis.
[0159] Healing balls 40, copings or metal frameworks are then
installed on the modified heads 58 of the stone model 94 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.
[0160] With the final stone model 94 as a guide, the corresponding
surfaces of the device heads 12 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.
[0161] In an alternate embodiment of the invention, a template (not
shown) together with the final stone model 94 is used as a guide
for removing the necessary portions/surfaces of the device heads 12
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-analog 56 in the final stone model 94.
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.
[0162] 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.
[0163] The following example and associated figures will reference
only a single cap in a template and a single abutment-analog 56 in
a final stone model 94, however it is understood that the template
and final stone model 94 include one or more caps and
abutment-analog 56, respectively.
[0164] As previously disclosed, the cap of the template replicates
its counterpart head 58 of the abutment-analog 56 in the final
stone model 94. Referring to FIG. 25, a portion 100 (shown in
phantom on FIG. 25) of the analog-abutment head 58 in the final
stone model 94 is removed or modified as previously described. The
corresponding portions of its matching cap 102 are then also
removed, forming a window or some other type of opening 104 in the
cap 102 that corresponds to the modified area of the head 58, shown
in FIG. 26.
[0165] As shown in FIG. 27, when the cap 102 is properly positioned
or placed over the patient's corresponding implant abutment device
10, portions of the device 10 protruding through the opening 104
correspond to the removed portions of the analog abutment 56. At
this point, the user may use an appropriate tool to remove the
protruding portions of the device 10. Alternatively, the user may
simply mark the portions of the device 10 that need to be modified,
remove the cap and then remove/modify the marked portions of the
device 10. Other methods of modifying the device 10, including the
cap 102, not specifically disclosed but known in the art may also
be used.
[0166] 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.
[0167] 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.
[0168] FIG. 28 is a partial exploded view of a dental implant
assembly 200 comprised of a head 202 which facilitates the use of
assembly 200 in multiple implant restorations.
[0169] Referring to FIG. 28, and in the embodiment depicted
therein, it will be seen that head 202 is comprised of sides 204,
206, 208, 210, and 212. Each of these sides intersects with surface
214 of neck 14. In another embodiment, not shown, no neck section
is present and the aforementioned sides meet directly with base
16.
[0170] In one embodiment, illustrated in FIGS. 34A and 34B, the
neck 14 is omitted and the head 202 is directly contiguous with
base 16. In the embodiment depicted in FIGS. 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 in
FIG. 34C and FIG. 34D, the head section is substantially the same
size as the base section, and thus no ledge is created.
[0171] Referring again to FIG. 28, and in the embodiment depicted
therein, with the exception of side 208, each of the other sides
forms an angle vis-a-vis surface 214 that is substantially
perpendicular, ranging from about 80 to about 100 degrees and, more
preferably, from about 75 to about 95 degrees. However, the side
208 forms an angle with surface 214 of less than about 75
degrees.
[0172] In the embodiment depicted in FIG. 28, there are at least
five sides that intersect surface 214 at a substantially
perpendicular angle. Devices with more of such sides may be used,
provided that at least two sides of the head 202 are substantially
perpendicular to the surface 214 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 the head 202 are
substantially perpendicular to the surface 214. In another
embodiment, at least four such sides of the head 202 are
substantially perpendicular to the surface 214. In yet another
embodiment, at least five such sides of the head 202 are
substantially perpendicular to the surface 214.
[0173] In another embodiment, depicted in FIG. 28C, at least two of
sides of the head 202 form an angle of from about 45 to about 100
degrees with the surface 214 and the abutment head is comprised of
a linear wall joined to an acruate wall.
[0174] Referring again to FIG. 28, a bore 216 extends from the top
surface of the head 202 to a distance of from about 2 to about 5
millimeters. In one embodiment, the bore 216 is threaded.
[0175] In another embodiment, not shown, the bore 216 is omitted
from the head 202. In another embodiment, not shown, the bore 216
is replaced by an annular groove disposed beneath substantially
polygonal portion of head 202 and surface 214. In one embodiment,
the bore 216 is substantially coaxial with the axis 220 of base 16.
In another embodiment, illustrated in FIG. 28, the bore 216 is not
coaxial with the axis 220 but, instead, forms an angle that is less
than 45 degrees and, in one embodiment, is substantially identical
to the angle formed by side 208 with surface 214.
[0176] FIGS. 28A and 29A disclose a dental implant assembly 201
which is similar to the assembly 200 but differs therefrom in that
the bore 216 is substantially perpendicular to the axis 220.
[0177] FIGS. 28B and 29B disclose a dental implant assembly 203
which is similar to the assembly 200 but differs therefrom in that
the bore 216 is substantially parallel to the axis 220. In the
embodiment depicted, bore 216 is also substantially coincident with
the axis 220.
[0178] Referring again to FIG. 28, it will be seen that a healing
ball 205 is adapted to fit over the head 202. A similar healing
ball 205 may be used in the embodiments depicted in FIGS. 28A and
28B but has been omitted therefrom for the sake of simplicity of
representation.
[0179] The shape of the head depicted in FIGS. 29A and 29B may be
varied. Some other suitable shapes are depicted in FIGS. 30A
through 30H.
[0180] FIGS. 30A through 30H present a multiplicity of sectional
views showing the shapes in which the head 202 may be. In the
embodiments depicted, the shapes are either comprised of straight
walls 230 and/or arcuate sections 232.
[0181] FIGS. 31A and 31B are perspective and top views,
respectively, of an assembly 240 in which arcuate section 242 joins
walls 244 and 246 (see, for example FIG. 31A) of inclined side 208.
As will be apparent, because arcuate section 242 theoretically
contains an infinite number of walls, the assembly 240 meets the
requirement that at least two such walls are substantially
perpendicular to the surface 214 of base 16. In another embodiment,
the walls are at an angle of from about 45 to about 95 degrees
relative to surface 214. In the embodiments depicted, wall 242 and
208 extend downwardly and outwardly.
[0182] FIG. 32 discloses an exploded view of an assembly 250 that
is similar in configuration to the assembly 240 but differs
therefrom in that arcuate section 242 is comprised of a
multiplicity of splines 252. In the configuration depicted in FIG.
32, such splines 252 have a substantially rectangular
cross-sectional shape.
[0183] Referring again to FIG. 32, and in the embodiment depicted
therein, it will be seen that healing ball 205 preferably is
comprised of an orifice 256 that is adapted to receive the side 208
and the splines 252.
[0184] FIG. 32A is a partial sectional view of an implant assembly
207 that is similar to the implant assembly 201 (see FIG. 28A) but
omits that omits the bore 216.
[0185] FIG. 32B is a partial sectional view of an implant assembly
209 that is similar to the implant assembly 201 (see FIG. 28A) but
differs therefrom in that it does contain a bore 216 that is
substantially aligned with the axis of the assembly 209.
[0186] As will be apparent from FIGS. 33A through 33H, different
splined arrangements may be used with the assembly 250.
[0187] Thus, as depicted in FIG. 33A, the splines 252 may have a
substantially rectilinear cross-sectional shape. As depicted in
FIG. 33B, the splines 256 may have a substantially triangular
cross-sectional shape. As depicted in FIG. 33C, the splines 258 may
have a substantially circular cross-sectional shape. As depicted in
FIG. 33D, the splines 260 may have a substantially polygonal
cross-sectional; in the embodiment, depicted, this shape is formed
by alternating rectangles and triangles. As depicted in FIG. 33E,
the splines 262 may have a shape defined by a linear section and an
arcuate section; in the embodiment depicted, the splines 262 are
formed by alternating semicircles and flat surfaces. As depicted in
FIG. 33F, the splines 264 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. The splines 266 depicted in FIG.
33G are defined by half-circles joined by arcuate tops. By
comparison, the splines 268 depicted in FIG. 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.
[0188] FIG. 35 is a perspective view of an implant assembly 270
that is similar to the implant assembly 269 of FIGS. 34A and 34B
but differs therefrom in that the surface 272 of base 16 is
roughened.
[0189] In one embodiment, the surface 272 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.
[0190] In another embodiment, the surface 272 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, the
surface 272 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.
[0191] One may roughen such surface 272, 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.
[0192] 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.
[0193] 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.
[0194] Waxing of the implant abutment assembly involves insertion
of a guide pin into bore 216 (see FIG. 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.
[0195] 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.
[0196] 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.
[0197] 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.
[0198] 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 and 302 is
comprised of base section 304, and ledge section 320, and head
section 308.
[0199] In each of implant assemblies 300 and 302, the base section
304, the ledge section 320, and the head section 308 are integrally
joined to each other.
[0200] In each of implant assemblies 300 and 302, the head section
308 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 implant assembly
300, one of the linear walls is linear wall 301, and the arcuate
walls are arcuate walls 303 and 305.
[0201] Referring to implant assembly 302, the linear wall is linear
wall 307, and the arcuate wall is arcuate wall 309.
[0202] Each of implant assembles 300 and 302 is comprised of a base
section 304 that extends upwardly and outwardly from its bottom 310
to its top 312.
[0203] In the embodiments depicted in FIGS. 37A and 37B, the base
section 304 is preferably comprised of two distinct sections. The
first section 313, extending from point 314 to point 316, has a
length 318 of from about 3 to about 50 millimeters and, preferably,
from about 7 to about 17 millimeters. The second section is ledge
section 320, extending from point 314 to point 322, has a length
324 of from about 0.0 to about 2 millimeters and, preferably, from
about 0.3 to about 0.7 millimeters.
[0204] It is advantageous that ledge section 320 have a length 324
that is no greater than about 15 percent of the length 318 of first
section 313 and, more preferably, is less than about 10 percent of
the length 318 of first section 313.
[0205] In both of the embodiments depicted in FIGS. 37A and 37B,
the first section 313 has a substantially rougher surface than the
ledge section 320.
[0206] FIG. 38 is a sectional view of a roughened surface 350
formed in a substrate 352. As will be seen, this roughened surface
350 is comprised of a multiplicity of peaks 354 and valleys 356.
The distances 360, 362, 364, 366, 368 between the peaks 354 and the
valleys 356 indicate the roughness of surface 350. 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.
[0207] Referring again to FIGS. 37A and 37B, and in the embodiment
depicted therein, the first section 313 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.
[0208] In this embodiment, the ledge section 320 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.
[0209] The first section 313 will preferably have an average
roughness that is at least about 10 times as great as the average
roughness of the ledge section 320. In one embodiment, the first
section 313 has an average roughness that is at least about 50
times as great as the average roughness of ledge section 320. In
another embodiment, the first section 313 has an average roughness
that is at least about 100 times as great as the average roughness
of ledge section 320.
[0210] One may obtain the differential roughness properties
described hereinabove by subjecting the first section 313 and/or
ledge section 320 to different treatments and/or different lengths
of treatment, masking one (with wax, e.g.) while treating another.
Thus, for example, the first section 313 may be treated with both
sandblasting and acid etching, whereas the ledge section 320 may be
subjected to micromachining or laser etching.
[0211] Thus, e.g., one may use microtexturing to create the
roughness in ledge section 320. 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.
[0212] Thus, e.g., one may use laser etching to create the
roughness in ledge section 320. 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.
[0213] In one embodiment, illustrated in FIGS. 37A and 37B, the
roughened first section 313 is coated with a bioactive coating 370.
The bioactive coating 370 is comprised of or consists essentially
of a biological active material.
[0214] 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
.beta.-tricalcium phosphate granules for regeneration of bone
tissue); U.S. Pat. No. 6,902,721 to Mundy (Inhibitors of
proteasomal Activity for Stimulating Bone Growth); U.S. Pat. No.
6,302,913 to Ripamonti (Biomaterial and Bone Implant for Bone
Repair and Replacement); U.S. Pat. No. 6,139,585 to Li (Bioactive
Ceramic Coating and Method); U.S. Pat. No. 6,080,799 to Gasper
(Compositions and Methods for Stimulating Bone Growth); U.S. Pat.
No. 5,944,524 to Hill (Biohybrid Dental Implant); and the like. The
term "bone morphogenetic protein" is known to those skilled in the
art. For example, reference may be had to the claims of U.S. Pat.
No. 5,661,007 to Wozney (Bone morphogenetic protein-11 (BMP-11)
compositions); U.S. Pat. No. 5,661,007 to Wozney (Bone
morphogenetic protein-9 compositions), and the like. The term
"basic fibroblast growth factor" is likewise known in the art.
Reference may be made to the claims of U.S. Pat. No. 4,785,079 to
Gospodarowicz (Isolation of fibroblast growth factor) and the like.
The term "transforming growth factor" is defined in the claims of
U.S. Pat. No. 5,278,145 to Keller (Method for protecting bone
marrow against chemotherapeutic drugs using transforming growth
factor beta 1) and the like. The term "osteogenic growth peptide"
is also known in the art. Reference may be had to the claims of
U.S. Pat. No. 5,814,610 to Bab (Osteogenic growth oligopeptides and
pharmaceutical compositions containing them); U.S. Pat. No.
6,593,394 to Li (Bioactive and osteoporotic bone cement). The
content of each of the aforementioned patents is hereby
incorporated by reference into. this specification.
[0215] 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.
[0216] 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.
[0217] 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.
[0218] In yet another embodiment, the sandblasting step is replaced
by blasting with other abrasive material, such as alumina.
[0219] In yet another embodiment, the biologically active material
is comprised of organic material comprising a multiplicity of amino
acids and/or proteins.
[0220] 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.
[0221] In one embodiment, the biologically active material is
coated onto a relatively smooth first section 313 and/or ledge
section 320 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.
[0222] 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.
[0223] 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 to FIGS. 37A and 37B, and in the
embodiments depicted therein, it will be seen that head section 308
extends a length 323 above the top surface 325 of ledge section 320
of from about 1.5 to about 10 millimeters and, preferably, from
about 2 to about 4 millimeters.
[0224] 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
the FIG. 18 depicted therein; the entire disclosure of such U.S.
Pat. No. 6,048,479 is hereby incorporated by reference into this
specification.
[0225] Thus, e.g., referring to such U.S. Pat. No. 6,048,479 and,
in particular, to the FIG. 18 thereof, in the first step of this
process, step 300, device 10 is connected to an implant
fixture.
[0226] In this step, it is advantageous to apply a torque no
greater than about 20 Newton per centimeter.
[0227] Thereafter, in step 302 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.
[0228] Thereafter, in step 304 of the process, the hole thus
drilled is preferably tapped with a tapping tool such as, e.g., the
screw taps illustrated on page 11 of the Nobelpharma catalog.
[0229] Thereafter, in step 306 of the process, the abutment/implant
fixture assembly is delivered to the hole by means of the carrier
(for example, final model 90). The carrier may also be used to
start screwing the assembly into the hole, applying downward
pressure while turning the assembly. Generally, the carrier will
only enable one to drive the abutment/implant fixture assembly a
portion of the required distance. The job may be finished by a
power-driven socket wrench in step 308 of the process.
[0230] In the next step of this process, step 310, the healing ball
is preferably snapped onto the device 10. In one embodiment, the
healing ball is disposed within a compartment of carrier prior to
its use.
[0231] Thereafter, in step 312, the gum tissue where the hole had
been drilled is sutured around the healing ball.
[0232] In the next step of process, step 314, the surgical site is
allowed to heal before the device 10 is directly or indirectly
connected to a denture. In general, a healing period of from about
3 to about 6 months is desirable.
[0233] 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.
[0234] At this stage of applicant's process, several options are
available.
[0235] In one embodiment, illustrated in step 316 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.
[0236] In another embodiment, illustrated in step 318, the healing
ball is removed from the device 10. At this stage, several
additional options are available.
[0237] One such option is to attach a gold cylinder to the device
10 in step 320.
[0238] Once the gold cylinder has been so attached, one may prepare
a bar clip overdenture (see FIG. 12) and attach such denture to the
superstructure (see step 322). Alternatively, in step 324, the gold
cylinders can be incorporated into a fixed detachable implant
supported bridge and thereafter secured to multiple implants in
place in the jawbone.
[0239] Alternatively, in step 326, 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 step 328, such
tooth is attached to the device 10.
[0240] 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.
* * * * *