U.S. patent number 3,707,006 [Application Number 05/067,148] was granted by the patent office on 1972-12-26 for orthopedic device for repair or replacement of bone.
This patent grant is currently assigned to Gulf Oil Corporation. Invention is credited to Jack C. Bokros, Willard H. Ellis.
United States Patent |
3,707,006 |
Bokros , et al. |
December 26, 1972 |
ORTHOPEDIC DEVICE FOR REPAIR OR REPLACEMENT OF BONE
Abstract
Prosthetic devices for repair of replacement of bone structure
in a living body, and methods of orthopedic repair which employ
such devices. The orthopedic devices comprise a substrate and a
pyrolytic carbon coating on the substrate, which pyrolytic carbon
coating is compatible with living tissue and which has a density of
at least about 1.5 grams per cubic centimeter. Examples of suitable
substrates are those which have a modulus of elasticity
approximating that of natural bone such as polycrystalline carbon,
and fiber aggregates such as carbon fiber aggregates and refractory
wire metal screens. The pyrolytic carbon coating of the orthopedic
devices may be polished to provide an effective wear surface, while
the surface roughness of the as-deposited coating may be employed
to achieve a bond with natural bone tissue. The pyrolytic carbon
coating is preferably isotropic and may be doped with a suitable
carbide-forming element, such as silicon, to provide additional
structural strength and wear resistance.
Inventors: |
Bokros; Jack C. (San Diego,
CA), Ellis; Willard H. (Leucadia, CA) |
Assignee: |
Gulf Oil Corporation (San
Diego, CA)
|
Family
ID: |
22074017 |
Appl.
No.: |
05/067,148 |
Filed: |
August 26, 1970 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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649811 |
Jun 29, 1967 |
3526005 |
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Current U.S.
Class: |
424/422;
433/201.1; 427/223 |
Current CPC
Class: |
A61F
2/30965 (20130101); A61L 27/08 (20130101); A61F
2/3609 (20130101); A61F 2/28 (20130101); A61C
8/0013 (20130101); A61C 8/0012 (20130101); A61F
2/30767 (20130101); A61F 2/36 (20130101); A61F
2/38 (20130101); A61F 2002/365 (20130101); A61F
2310/00173 (20130101); A61F 2310/00574 (20130101); A61F
2002/30828 (20130101); A61F 2/3662 (20130101); A61F
2002/3241 (20130101); A61F 2002/30589 (20130101); A61F
2230/0019 (20130101); A61F 2002/30831 (20130101); A61F
2002/3631 (20130101); A61F 2/3676 (20130101); A61F
2002/30563 (20130101); A61F 2002/3611 (20130101); A61F
2230/0091 (20130101); A61F 2220/005 (20130101); A61F
2310/00161 (20130101); A61F 2002/30153 (20130101); A61F
2002/30474 (20130101); A61F 2220/0025 (20130101); A61F
2002/30084 (20130101); A61F 2002/30892 (20130101); A61F
2002/30293 (20130101); A61F 2002/3674 (20130101); A61F
2002/30448 (20130101); A61F 2002/30934 (20130101); A61F
2/367 (20130101); A61F 2002/3007 (20130101) |
Current International
Class: |
A61C
8/00 (20060101); A61F 2/28 (20060101); A61F
2/30 (20060101); A61F 2/38 (20060101); A61F
2/36 (20060101); A61L 27/00 (20060101); A61K
6/02 (20060101); A61L 27/08 (20060101); A61K
6/027 (20060101); A61F 2/00 (20060101); A61F
2/32 (20060101); A61f 001/24 () |
Field of
Search: |
;3/1
;128/1,92C,92CA,92R,92BC ;32/1R,1A ;117/46CG,46CB,46CC
;23/209.1,209.2,209.4 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Other References
"Ethicon Tantalum Gauze" advertisement page 4 by Ethicon Suture
Laboratories, Inc., New Brunswick, N.J., Surgery, Gynecology &
Obstetrics, Sept. 1951. .
Vitallium Surgical Appliances Catalog, by Howmet Corp. Austenal
Medical Division, N.Y., N.Y., 1964, MacIntosh Tibial Plateaus (No.
6958-5) on page 61 relied upon..
|
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Frinks; Ronald L.
Parent Case Text
This application is a continuation-in-part of copending application
Ser. No. 649,811, filed June 29, 1967, now U.S. Pat. No. 3,526,005.
Claims
What is claimed is:
1. A composite orthopedic prosthetic device for repair or
replacement of bone structure in a living body, comprising a
refractory substrate of suitable predetermined shape and a
vapor-deposited pyrolytic carbon coating on said substrate, said
pyrolytic carbon coating being compatible with living tissue and
having a bulk density of at least about 1.5 grams per cubic
centimeter, a crystallite size no greater than about 200 A, a
thickness of at least about 25 microns, and a Bacon Anisotrophy
Factor of not more than about 2.0, and said pyrolytic carbon
coating having an as-deposited surface porosity on at least a
portion of its surface intended to be placed adjacent living bone
tissue upon implantation.
2. A prosthetic device according to claim 1 wherein the prosthesis
is a framework prosthesis adapted to provide sufficient access to
nutrients for the growth of living bone tissue therethrough, and
wherein said substrate is a fiber aggregate form.
3. A prosthetic device according to claim 2 wherein said substrate
is made of refractory metal selected from the group consisting of
tungsten, tantalum, molybdenum, and alloys thereof.
4. A prosthetic device according to claim 2 wherein said substrate
is made of carbon fiber.
5. A prosthetic device according to claim 1 wherein said substrate
has a thermal coefficient of expansion of from about 3 .times.
10.sup.-.sup.6 /.degree.C. to about 8 .times. 10.sup.-.sup.6
/.degree.C.
6. A prosthetic device according to claim 5 wherein the substrate
has a modulus of elasticity of between about 1 .times. 10.sup.6
psi. to about 5 .times. 10.sup.6 psi.
7. A prosthetic device according to claim 6 wherein the substrate
is artificial graphite having a modulus of elasticity between about
1.7 .times. 10.sup.6 psi. and about 4 .times. 10.sup.6 psi. such
that the pyrolytic carbon coated substrate has a modulus of
elasticity approximating that of natural bone.
8. A prosthetic device according to claim 7 wherein said substrate
is isotropic polycrystalline graphite having an average crystallite
size of about 300 A, a density of about 1.9 grams per cubic
centimeter, and a modulus of elasticity of about 1.7 .times.
10.sup.6 psi.
9. A prosthesis according to claim 7 wherein said density of said
pyrolytic carbon coating is between about 1.9 and about 2.2 grams
per cm.sup.3.
10. A prosthetic device according to claim 7 wherein said device is
a joint prosthesis having a bone-joining surface and an
articulating wear surface, and wherein the pyrolytic carbon coating
on the wear surface is polished to reduce friction and improve wear
characteristics
11. A prosthetic device according to claim 10 wherein the
bone-joining surface has at least one projection adapted to fit in
interlocking relationship with a mating, natural bone surface.
12. A prosthetic device according to claim 7 wherein the prosthetic
device is a dental prosthesis having a base portion adapted to be
inserted into a jawbone, an abutment for attaching a tooth or other
denture, and an intermediate portion between the abutment and base
portion of sufficient length such that upon insertion the abutment
protrudes the proper distance from the jawbone for attachment of
the tooth or other denture.
13. A dental prosthesis according to claim 12 wherein the base
portion of the prosthesis is formed with indentations penetrating
through the pyrolytic carbon coating into the substrate.
14. A prosthetic device according to claim 1 wherein the surface of
said pyrolytic carbon coating is provided with oxygen-bearing polar
groups to enhance the attachment of bone or other tissue thereto.
Description
The present invention relates to prosthetic devices designed for
use in orthopedics. More particularly, the present invention
relates to repairing orthopedic defects by using prosthetic devices
designed for such purposes.
The use of prosthetic devices for repair or replacement of bone
structure in a living body is well known. Conventional prosthetic
devices have been constructed from metals, ceramic, and plastics,
depending upon their intended application. Their development has
been spurred by the intense human need peculiar to an adverse
medical situation; such devices, however, are only partially or
temporarily adequate and have various serious defects which limit
their use to situations of such seriousness that their substantial
disadvantages are outweighed.
One requirement for a satisfactory prosthetic device which is to be
permanently implanted is that it be physiologically inert for
indefinite periods of time, and one difficulty with conventional
devices is that the materials from which they are constructed may
be physiologically rejected, may cause inflammation of bodily
tissue or may be degraded by bodily processes. For example, metals
may corrode to cause structural weakness and pathology from the
corrosion products. Plastics, even those extremely chemically
inert, such as polytetrafluoroethylene may be degraded in the body
over long periods of time, or cause inflammation or abnormal cell
growth.
Furthermore, the stresses developed within the skeletal framework
of a living body, which is naturally designed to serve a
load-bearing function, provide considerable difficulties of a
mechanical and structural nature. In addition, the functional
interrelationship between the skeleton and the rest of the body is
of such a biologically intricate nature that even more complex
difficulties confront the development of suitable prosthesis. For
example, joint prostheses are conventionally constructed from
metals or plastics. Not only do plastics tend to be degraded in the
body, but they also exhibit poor wear characteristics under the
severe mechanical performance requirements for a joint prosthesis.
Metal-metal joint prostheses tend to gall and wear, and the
metallic dust created thereby may require re-operation. Metallic
prostheses which replace only part of a functional joint may be so
rigid that they cause damage to the remaining, natural portions of
the joint.
These problems are particularly acute for skeletal regions which
are normally subjected to considerable stress. For example,
conventional hip joint ball prosthesis may appear to operate
satisfactorily for up to several years; however, such prostheses
generally tend to eventually cause thickening, inflammation, and
pain in the synovial lining and capsule of the joint.
Replacement of one articulating portion of a joint with a rigid,
metallic prosthesis may have a deleterious effect upon the tough,
elastic cartilage which covers the remaining, articulating end of
the natural portion of the joint. Contact and wearing, particularly
under conditions of load-bearing or stress, of a hard metallic
prosthesis against a portion of natural bone will usually result in
damage to the living bone tissue. Furthermore, under the conditions
of stress associated with skeletal functionality, conventional
metallic, rigid prostheses exhibit considerable difficulty in
remaining permanently implanted in a supportive function in living
bone. Such metallic prostheses have so high a modulus of elasticity
that they do not flex in harmony with the bone in which they are
implanted, but rather, because they are more rigid than the bone,
concentrate stress in portions of the remaining, lower modulus
bone, particularly at the metal-bone interface. Thus, not only do
conventional metallic prosthesis exhibit the undesirable
characteristic of subjecting remaining portions of natural bone to
unnatural, concentrated stress, but they also have the additional
disability of being difficult to anchor in the natural bone because
stress concentration at the interfaces between the bone and the
prosthesis will cause the prosthesis to toggle or otherwise work
loose from its fastening to the bone.
When a segment of bone is missing due to accident or surgery, there
is at present no satisfactory method other than bone homograft to
replace the missing bone segment and join the remaining portion of
the bone. Attempts have been made to use porous ceramics to act as
a skeleton or framework into which new bone might grow, so that the
missing segment of bone would be replaced partially by natural
processes. Such approaches employing porous ceramic prostheses have
been generally unsuccessful, not only because such materials are
often not accepted by the body but also because the very objective
of fostering natural bone growth within the ceramic has not been
successfully attained.
Metallic dental prostheses which abut or penetrate the jaw bones
also suffer the disabilities and shortcomings associated with metal
prostheses in general, and dental repair is still conventionally
accomplished by extracorporeal support from remaining natural teeth
or gums.
Prosthetic and orthopedic devices have been used for a number of
years, and it is expected that usage of such devices will increase
in the future as medical expertise continues to improve. The
provision of improved prosthesis for repair or replacement of bone
structure in a living body would greatly facilitate the development
of that medical expertise and alleviate considerable human
suffering.
It is an object of the present invention to provide improved
prosthetic devices. Another object is to provide prosthetic devices
which are physiologically compatible with body tissues although
implanted in the body for long periods of time. A further object of
the invention is to provide prosthetic devices which perform
exceptionally well in the demanding mechanical environment of the
skeletal structure of a living body, and which are capable of
establishing a firm bond thereto. Still another object of this
invention is to provide prosthetic devices which are eminently
suited for extended functional performance as, for example, joint
prostheses, dental prostheses, whole or partial bone replacement
prostheses, and framework-like prosthesis into and throughout which
natural, living bone tissue may grow so that repair or replacement
of bone structure may be partially accomplished by natural
processes. An additional object is to provide improved prostheses
which have a modulus of elasticity approximating that of natural,
living bone, and which do not concentrate substantial stress at the
prosthesis-bone interface, but rather flex in harmony with the
natural bone under applied stress. A still further object of this
invention is to provide a method of repairing an orthopedic defect
by using prosthetic devices through which the qualities of natural
living bone may be closely approximated.
These and other objects of the invention are more particularly set
forth in the following detailed description and in the accompanying
drawings of which
FIG. 1 is a perspective view partially broken away, of a knee joint
prosthesis;
FIG. 2 is a bottom view of the knee joint prosthesis of FIG. 1;
FIGS. 3 and 4 are perspective views of dental prostheses adapted to
be implanted into a jaw bone of a living body;
FIG. 5 is a perspective view, partially broken away, of a hip joint
prosthesis, and
FIG. 6 is a bone framework prosthesis into and throughout which
living bone tissue may grow so that replacement of bone structure
in a living body may occur partially through natural bone
growth,
FIG. 7 is a side elevation, partially broken away, of the bone
framework prosthesis of FIG. 6 in position between two segments of
natural bone.
It has been found that prosthetic devices having improved
characteristics can be made by coating suitable substrates of the
desired shape and size with pyrolytic carbon. Pyrolytic carbon is
capable not only of significantly increasing the strength of the
substrate upon which it is coated, but it is also able to resist
wear and deterioration even when implanted within a living body for
long periods of time. While reference is hereinafter generally made
to the use of prosthetic devices for repair or replacement of bone
structure in a living human body, it should also be recognized that
the improved prosthetic devices and orthopedic processes may also
have veterinary applications in other living animals which have an
internal skeletal structure. For example, it may be desirable to
use prosthetic devices having the indicated pyrolytic carbon
coatings for use in orthopedic repair or replacement of bone in
horses, dogs, or other domestic animals.
In general, the pyrolytic carbon coating is applied to a suitable
substrate material so that it covers at least a major portion of
the surface thereof. The thickness of the pyrolytic carbon coating
should be sufficient to provide the necessary strength for its
intended use, and often it is desirable to employ the coating to
impart additional strength to the particular substrate being
coated. The coating will be at least 25 microns thick and usually
at least about 50 microns thick. If a fairly weak substrate is
being employed, for instance, one made of artificial graphite, it
may be desirable to provide a thicker coating of pyrolytic carbon
to strengthen the composite prosthetic device.
Moreover, although an outer coating which is substantially entirely
fairly dense pyrolytic carbon has adequate structural strength, the
codeposition of silicon or some other carbide-forming additive may
be employed to improve the strength and wear resistance of the
carbon coating. As described in more detail hereinafter, silicon in
an amount up to about 20 weight percent can be dispersed as SiC
throughout the pyrolytic carbon without detracting from the
biologically compatible properties of the pyrolytic carbon.
For use on complex shapes and in order to obtain maximum structural
strength, it is desirable that a pyrolytic carbon coating on the
substrate be nearly isotropic. Anisotropic carbons tend to
delaminate when complex shapes are cooled after depositing the
pyrolytic coating at high temperatures. Thus, for coating complex
shapes (i.e., those having a radius or radii of curvature less than
1/4 inch), the pyrolytic carbon should have a BAF (Bacon
Anisotrophy Factor) of not more than about 1.3. For non-complex
shapes, higher values of BAF up to about 2.0 may be used, and for
flat shapes, pyrolytic carbon having a BAF as high as about 20 may
be used. The BAF is an accepted measure of preferred orientation in
the layer planes in the carbon crystalline structure. The technique
of measurement and a complete explanation of the scale of
measurement is set forth in an article by G.E. Bacon entitled "A
Method for Determining the Degree of Orientation of Graphite" which
appeared in the Journal of Applied Chemistry, Vol 6, p. 477,
(1956). For purposes of explanation, it is noted that 1.0 (the
lowest point on the Bacon scale) signifies perfectly isotropic
carbon, while higher values indicate increasing degrees of
anisotrophy.
The density of the pyrolytic carbon is considered to be an
important feature in determining the additional strength which the
pyrolytic carbon coating will provide the substrate. The density is
further important in assuring tissue compatibility, and sufficient
wear resistance of the prosthetic device where appropriate. It is
considered that the pyrolytic carbon should at least have a density
of about 1.5 grams per cubic centimeter, and preferably the
pyrolytic carbon has a density between about 1.9 grams/cm.sup.3 and
about 2.2 grams/cm.sup.3.
A further characteristic of the carbon which also affects its
structural strength contribution is the crystallite height or
apparent crystallite size. The apparent crystallite size is herein
termed L.sub.c and can be obtained directly using an X-ray
diffractometer. In this respect
L.sub.c = (0.89 .lambda.)/(.beta. cos .theta.)
wherein:
.lambda. is the wavelength in Angstroms
.beta. is the half-height (002) line width, and
.theta. is the Bragg angle.
Pyrolytic carbon coatings for use in prosthetic devices should have
a crystallite size no greater than about 200 A. In general, the
desirable characteristics for pyrolytic carbon for use in
prosthetic devices are greater when the apparent crystallite size
is small, and preferably the apparent crystallite size is between
about 20 and about 50 A.
Since the substrate material for the prosthetic device will
preferably be completely encased in pyrolytic carbon, choice of the
material from which to form the substrate is not of utmost
importance per se. However, the substrate material should have the
requisite mechanical strength and structural properties for the
particular prosthetic application for which it is going to be
employed. However, if the prosthetic device in use will have
portions of the substrate exposed to bodily tissues, for example,
as might occur from machining the prosthetic device into final form
after the basic shape has been coated with pyrolytic carbon, the
substrate should be selected from materials which are relatively
biologically inert, preferably artificial graphite.
It is very important that the substrate material be compatible with
pyrolytic carbon, and more particularly that it be suitable for use
in the process conditions for coating with pyrolytic carbon.
Although it is desirable that the substrate material have
sufficient structural strength to resist possible failure during
its end use, materials which do not have sufficiently high
structural strengths (by themselves) may be employed by using the
pyrolytic carbon deposited thereupon to supply additional
structural strength for the prosthetic device.
Because pyrolytic carbon is, by definition, deposited by the
pyrolysis of a carbon-containing substance, the substrate will be
subjected to the fairly high temperatures necessary for pyrolysis.
Generally, hydrocarbons are employed as the carbon-containing
substance to be pyrolyzed, and temperatures of at least about
1000.degree.C. are used. Some examples of the deposition of
pyrolytic carbon to produce coated articles having increased
stability under high temperature and neutron radiation conditions
are set forth in U.S. Pat. No. 3,298,921. Processes illustrated and
described in this U.S. patent employ methane as the source of
carbon and utilize temperatures generally in the range from about
1500.degree. to 2300.degree.C. Although it is possible to deposit
pyrolytic carbon having the desired properties with regard to the
instant invention at somewhat lower temperatures by using other
hydrocarbons, for example, propane or butane, generally it is
considered that the substrate materials should remain substantially
unaffected by temperatures of at least about 1000.degree.C., and
preferably by even higher temperatures. The pyrolytic carbons
deposited either with or without silicon at temperatures below
about 1500.degree.C. are particularly suited for use in prosthetic
devices because such pyrolytic carbons have exceptional tissue and
bone compatibility, wear resistance, mechanical strength, and in
combination with a suitable substrate will provide a prosthesis
with a modulus of elasticity which is close to that of bone.
Because the substrate is coated at relatively high temperatures and
the prosthetic device will be employed at temperatures usually very
close to ambient, the coefficients of thermal expansion of the
substrate and of the pyrolytic carbon deposited thereon should be
relatively close to each other if the pyrolytic carbon is to be
deposited directly upon the substrate and a firm bond between them
is to be established. While the above-identified U.S. patent
contains a description of the deposition of an intermediate, low
density, pyrolytic carbon layer, the employment of which might
provide greater leeway in matching the coefficients of thermal
expansion, it is preferable to deposit the pyrolytic carbon
directly upon the substrate and thereby avoid such an additional
intermediate layer. Pyrolytic carbon having the desired
characteristics can be deposited having a thermal coefficient of
expansion in the range of between about 3 and about 6 .times.
10.sup.-.sup.6 /.degree.C. measured at 20.degree.C. Accordingly,
substrate materials are chosen which have the aforementioned
stability at high temperatures and which have thermal coefficients
of expansion within or slightly above this general range, for
example up to about 8 .times. 10.sup.-.sup.6 /.degree.C. Examples
of suitable substrate materials include artificial graphite, boron
carbide, silicon carbide, tantalum, molybdenum, tungsten, and
various ceramics, such as mullite.
Prosthetic devices which are intended to replace a significant
amount of bone tissue without partial replacement by means of
natural bone growth, preferably employ artificial graphite as the
substrate material because these materials have a modulus of
elasticity of from about 2 to about 4 .times. 10.sup.6 psi., which
is ordinarily in the range of that of natural living bone. For
example, a particularly preferred form of graphite for use as a
substrate material is polycrystalline graphite. An example of such
a graphite is the polycrystalline graphite sold under the trade
name POCO AXF Graphite, which has a density of about 1.9 grams per
cubic centimeter, an average crystallite size (L.sub.c) of about
300 A, an isotropy of nearly 1.0 on the Bacon scale, and a modulus
of elasticity of about 1.7 .times. 10.sup.6 psi.
When it is desired to provide a framework into and through which
new bone tissue may grow, for example, in order to firmly attach a
prosthetic device to a bone, or in order to replace or repair bone
structure partially through replacement by new, natural bone
tissue, as hereinafter described, substrates such as suitable
metallic or carbon screens, wires or fibers may be employed as the
substrate material. For example, a screen formed from an alloy of
50 percent molybdenum and 50 percent rhenium may be used. Screens
of tantalum, tungsten, molybdenum or alloys thereof, which are
preferably coated with tungsten to prevent embrittlement during the
coating with pyrolytic carbon, may also be used. Fiber aggregates
in addition to screens such as non-woven felted structures and
filament-wound structures may also be used as substrate
materials.
The pyrolytic carbon coating is applied to the substrate using a
suitable apparatus for this purpose. Preferably, an apparatus is
utilized which maintains a substrate in motion while the coating
process is carried out to assure that the coating is uniformly
distributed on the desired surfaces of the substrate. A rotating
drum coater or a vibrating table coater may be employed. When the
substrates to be coated are small enough to be levitated in an
upwardly flowing gas stream, a fluidized bed coater is preferably
used. When larger substrates are employed, or where it is desired
to vary the thickness or other characteristics of the pyrolytic
carbon coating over different portions of the substrate, different
coating methods may be employed, such as supporting the substrate
on a rotating or stationary mandrel within a large fluidized
bed.
As discussed in detail in the above-identified United States
patent, the characteristics of the carbon which is deposited may be
varied by varying the conditions under which pyrolysis is carried
out. For example, in a fluidized bed coating process wherein a
mixture of a hydrocarbon gas, such as methane, and an inert gas,
such as helium or argon, is used, variance in the volume percent of
the hydrocarbon gas, the total flow rate of the fluidizing gas
stream, and the temperature at which pyrolysis is carried out, all
affect the characteristics of the pyrolytic carbon which is
deposited. Control of these various operational parameters not only
allows deposition of pyrolytic carbon having the desired density,
apparent crystallite size, and isotropy, but it also permits
regulation of the desired thermal coefficient of expansion of the
deposited pyrolytic carbon. This control may also be used to
"grade" a coating in order to provide a variety of exterior
surfaces. One can deposit a strong base isotropic pyrocarbon
coating, having a BAF of 1.3 or less, and near the end of the
coating operation, the coating conditions can be gradually changed
to obtain a highly oriented outer layer. Using this technique,
suitable coatings having outer surfaces which are highly
anisotropic and, for example, are about 25 microns thick, can be
conveniently deposited.
Generally, when pyrolytic carbon is deposited directly upon the
surface of the substrate material, the pyrolysis conditions are
controlled so that the pyrolytic carbon which is deposited has a
coefficient of expansion matched to within plus or minus 25 percent
of the coefficient of expansion of the substrate material, and
preferably to within about plus or minus 20 percent. Because
pyrolytic carbon has greater strength when placed in compression
than when placed in tension, the thermal coefficient of expansion
of the pyrolytic carbon is most preferably about equal to or less
than that of the substrate. Under these conditions, good adherence
to the substrate is established and maintained during the life of
the prosthetic devices, and upon cooling of the pyrolytic
coating-substrate composite, the pyrolytic carbon coating is placed
in compression under conditions of its intended use at about
ambient temperature.
As previously indicated, the coating may be substantially entirely
pyrolytic carbon, or it may contain a carbide-forming additive,
such as silicon, which has been found to enhance the overall
mechanical properties of the coating. Silicon in an amount of up to
about 20 weight percent, based on the total weight of silicon plus
pyrolytic carbon, may be included without detracting from the
desirable physiological properties of the pyrolytic carbon, and
when silicon is used as an additive, it is generally employed in an
amount between about 10 and about 20 weight percent. Examples of
other carbide-forming elements which might be used as additives in
equivalent weight percents include boron, tungsten, tantalum,
niobium, vanadium, molybdenum, aluminum, zirconium, titanium, and
hafnium. Generally, such an element would not be used in an amount
greater than 10 atom percent, based on the total atoms of pyrolytic
carbon plus the element.
The carbide-forming additive is co-deposited with the pyrolytic
carbon by selecting a volatile compound of the element in question
and supplying this compound to the deposition region. Usually, the
pyrolytic carbon is deposited from a mixture of an inert gas and a
hydrocarbon or the like, and in such an instance, the inert gas is
conveniently employed to carry the volatile compound to the
deposition region. For example, in a fluidized bed coating process,
all or a percentage of the fluidizing gas may be bubbled through a
bath of methyltrichlorosilane or some other suitable volatile
liquid compound. Under the temperature at which the pyrolysis and
co-deposition occurs, the particular element employed is converted
to the carbide form and appears dispersed as a carbide throughout
the resultant product. As previously indicated, the presence of
such a carbide-forming additive does not significantly change the
crystalline structure of the pyrolytic carbon deposited from that
which would be deposited under the same conditions in the absence
of such an additive.
Pyrolytic carbon having the physical properties mentioned
hereinbefore, is considered to be particularly advantageous for
constituting the surface for a prosthetic device because it is
inert to the metabolic processes, enzymes and other juices
(physiological fluids) found within living bodies. In addition,
such pyrolytic carbon is not injurious to natural bone growth.
Particularly preferred is pyrolytic carbon which has a density
between about 1.9 and about 2.2 grams per cubic centimeter, wherein
the superficial porosity of such carbon facilitates the growth of
bone thereto, which is particularly conducive to natural bone
growth so that the creation of a good bond between natural bone and
the prosthetic device may be established. In order to enhance
attachment of either bone or tissue, the surface may be oxidized.
This can be done to 1) enhance the superficial roughness and/or to
2) provide oxygen-bearing polar groups on the surface which may
react with tissue or bone molecules.
The pyrolytic carbon surface of the prosthetic device may be
fabricated with different physical properties at different surface
locations, for example a dense, polished wear surface may be
employed at the articulating end of a joint prosthesis while a
surface having a rough, more porous surface may be employed at the
surfaces at which the prosthesis is joined with natural bone to
facilitate bone growth thereto.
In addition to mechanical modification of the pyrolytic carbon
surface such as polishing, it may be desirable to utilize other
physical or chemical modifications of the pyrolytic carbon surface.
For example, chemisorbed gases, such as oxygen, may be removed to
provide a more hydrophobic surface, or conversely, a surface having
an adsorbed gas, such as oxygen, or which is chemically modified
such as by forming surface hydroxyl groups, may be employed to
provide a more hydrophilic surface. It is believed that pyrolytic
carbon surfaces which are more hydrophilic, such as those having
surface hydroxyl groups, are more conducive to the establishment of
a firm bond with natural bone tissue.
In addition, the prosthetic device should be sterile before
implantation in a living body. The device may be sterilized and
chemisorbed oxygen removed by heating in a vacuum at an elevated
temperature. For example, the pyrolytic carbon-coated prosthesis
may be ultrasonically cleaned in benzene, and then again in
distilled water, and then out-gassed at 900.degree.C. for two hours
to effect complete sterilization and to remove absorbed gases and
provide a hydrophobic surface. The device may be sterilized also by
heating in a suitable vacuum for about 6 hours at 130.degree.C. or
by steam autoclaving. The prosthetic device can also be sterilized
chemically, as by treating with benzalkonium chloride, and
optionally with a suitable anticoagulant which safeguards against
the occurrence of thrombosis, such as heparin, for cases in which
the application involves the intra-vascular system.
When the prosthetic device is ready for its intended use, for
example, as a joint prosthesis or an internal replacement for
another bone segment, or as a dental prosthesis, known surgical and
dental procedures are employed. It is recognized that provision of
the improved prosthesis of this invention will likely result in
development of improved medical techniques of orthopedic repair.
The prosthetic devices may be secured in the proper location within
the body by suitable means and procedures, including those which
are hereafter described for specific embodiments of the present
invention.
Illustrated in FIG. 1 of the drawings is a knee joint prosthesis 10
for replacing damaged knee joints. The knee joint prosthesis 10 is
formed from a substrate 12 upon which is deposited a pyrolytic
carbon exterior coating 14. The prosthesis 10 has a pivotal wear
surface 16 which is arcuate in one direction between a front
surface 26 and a rear surface 28 and which is designed for pivoting
against another such arcuate wear surface in the functioning of a
knee joint. The wear surface 16 is only slightly curved in the
direction between lateral edges 30, in order to restrict pivoting
in that direction and thus stabilize the knee joint against
sideward movement. The pivotal wear surface 16 is buff-polished
with a diamond dust abrasive in order to reduce friction and
wear.
As shown more clearly in FIG. 2, the face 18 which is opposite the
wear surface 16 is provided with a series of projections or lugs 20
and indentations or grooves 22 to assure a strong, stable
mechanical connection of the prosthesis 10 with the natural bone of
the femur or tibia. The pyrolytic carbon coating on the
bone-joining face 18 having the lugs 20 and grooves 22 is not
polished, but rather is permitted to retain the degree of roughness
associated with its deposition. In addition, it may be oxidized to
enhance attachment. This roughness fosters the development of a
strong mechanical joint between the prosthesis 10 and the natural
bone through the growth of natural bone tissue thereto. The
pyrolytic carbon deposited on the front and rear surfaces 26 and 28
and on the side surfaces 24 of the prosthesis 10 may also be
polished in order to reduce the possibility of irritation of
tissues which may come into sliding contact with these surfaces
during movement of the joint.
The substrate 12 is preferably formed from a polycrystalline
graphite, sold under the trade name POCO AXF graphite, which has a
density of about 1.9 grams per cubic centimeter, and average
crystallite size (L.sub.c) of about 300A, and an isotropy on the
Bacon scale of nearly 1.0. The graphite has a Youngs modulus of
elasticity of 1.7 .times. 10.sup. 6 psi. The substrate is formed in
the shape of the prosthesis 10 and is coated with a layer of
pyrolytic carbon about 500 microns thick which has a density of
about 1.9 gm/cm.sup.3 and a modulus of elasticity of 4 .times.
10.sup.6 psi. The composite prosthesis 10 has an effective modulus
of elasticity which is in the range of that of natural living bone,
which has a modulus between about 2 .times. 10.sup. 6 and 4 .times.
10.sup. 6 psi.
For replacement of a damaged knee joint, the natural bone joint
portion corresponding to the prosthesis 10 is surgically removed,
and the remaining end is shaped to provide a mating face that will
fit in interlocking relationship with the lug and groove containing
face 18. The unpolished pyrolytic carbon coating 14 on the face 18
is conducive to natural bone tissue growth and adherence thereto,
and its presence induces acceptance of the replacement prosthesis
as a functionally permanent section of the natural bone. Because
the prosthesis has a rigidity closely approximating that of the
natural bone, an excellent anchor is provided, and the prosthesis
will remain permanently and perform like natural bone. Thus, since
the modulus of elasticity of the prosthesis 10 is very close to
that of natural bone, the bone and the prosthesis which is attached
to it deform elastically in harmony so that the tendency for the
device to work loose is greatly reduced.
It is contemplated that the prosthesis 10 would be employed with a
mating prosthesis; thus, for the design shown in FIGS. 1 and 2, the
entire knee joint would be replaced by prostheses at the
articulating ends of both the femur and the tibia. In use against a
mating carbon piece as described above, the polished arcuate
surface 16 of the pyrolytic carbon coating has extremely good wear
resistance so that re-operation because of inflammation caused by
dust resulting from wear is not necessitated. It is understood that
if it is desired or necessary to only replace one portion of the
knee joint, (i.e., only that of either the femur or tibia), that
the pivotal wear surface 16 may be fabricated in a different shape
to more beneficially function against the articulating end of the
natural bone portion of the joint. In such a case, it is understood
that the matching of physical properties of natural bone achieved
through the use of the pyrolytic carbon-coated graphite substrate
is superior to the mating of a natural bone end (or cartilage) into
contact with, for example, a metal which has a modulus of
elasticity which may be 10 times higher than that of the natural
bone end. Where necessary to repair or replace a knee joint which
requires additional replacement of other portions of natural bone,
the illustrated prosthetic device may readily be increased in size
as necessary.
Shown in FIG. 3 is a prosthesis 40 for implant dentistry. The
dental prosthesis 40 is fabricated in the desired shape from a
substrate 42 of polycrystalline POCO AXF graphite, such as
described hereinabove, which has deposited thereon a pyrolytic
carbon coating 44. The substrate 42 is fabricated so that it has a
rectangular upper abutment 46 and a lower base section 54 having
exterior spiral projections or threads 48 thereon so that the
prosthesis may be screwed into a suitable hole drilled into the
jawbone in order to provide an immediate anchoring for the
prosthesis. The substrate is fabricated with an intermediate
cylindrical portion 50 separating the upper abutment 46 and the
base section 54 with threads 48, so that when the prosthesis is
screwed into a hole drilled in the jawbone until the end 52 of base
section 54 contacts the bottom of the hole, the upper abutment 46
will protrude the proper distance through the gum line.
The upper abutment 46 provides a stud-like surface to which a
denture such as a porcelain tooth, can be readily mounted, for
example, by standard cements. Subsequent growth of natural bone
tissue will more firmly anchor the prosthesis into the jawbone. The
porcelain tooth is preferably affixed only after sufficient bone
tissue growth has occurred to functionally anchor the
prosthesis.
FIG. 4 illustrates another dental prosthesis 60 which may also be
fabricated from a polycrystalline carbon substrate 62 and a
pyrolytic carbon exterior coating 64. The prosthesis 60 has an
upper abutment 66 which is reinforced by a 10 percent tungsten-90
percent tantalum alloy wire 68 penetrating through the abutment 66
from a position slightly above the upper surface of the abutment,
to a position extending into the intermediate portion 72 of the
prosthesis. The wire 68 is inserted into and suitably bonded to the
substrate 62 prior to deposition of pyrolytic carbon coating 64
thereon. After deposition of the pyrolytic carbon coating,
longitudinal indentations or grooves 70 are machined into a base
portion 74 of the prosthesis of sufficient depth to penetrate
through the pyrolytic carbon coating 64 and expose the substrate
62. The prosthesis 60 has an intermediate portion 72 of sufficient
length such that when the grooved base portion 74 is inserted into
a suitably drilled hole in the jawbone, the pyrolytic carbon-coated
upper abutment 66 and the wire 68 will protrude a sufficient
distance so that a porcelain tooth may be adequately adhered
thereto. The after-machined grooves 70 provide localized exposed
regions of the porous substrate into which bone tissue may grow,
which may be used in combination with the as-deposited surface
roughness of the prosthesis to provide attachment to the jawbone
through natural bone tissue growth.
The prosthesis has approximately the same modulus of elasticity as
the natural bone into which it is inserted so that it performs in
harmony with the natural bone without concentrating stress at the
natural bone-prosthesis interface, which might cause the prosthesis
to work loose. The wire 68, having pyrolytic carbon deposited
thereon, provides structural reinforcement in the upper portion of
the prosthesis without affecting the modulus of the base portion
which is inserted into the natural bone, and is particularly
adapted for longer, narrower artificial teeth which may be more
difficult to anchor to the prosthesis, such as cuspids and
incisors.
The pyrolytic carbon-coated dental prostheses have the outstanding
strength which is required for satisfactory performance under the
demanding conditions required of dental insert prostheses. While
two possible configurations of prostheses have been illustrated, it
is apparent that others may be used as well. For example, the root
may have a multitude of grooves, holes or crevices that were
originally machined into the substrate (a special case of this is
the helical spiral threads illustrated in FIG. 3). A smooth-walled
substrate might also possibly be used, in which case one might rely
completely on the as-deposited surface roughness of the pyrolytic
coating and the adherence of natural bone tissue growth thereto to
provide attachment. The porosity of the pyrolytic carbon may be
varied depending upon the degree of natural bone adhesion to the
pyrolytic carbon which is desired in each case.
Alternately, the dental implant may be machined with the same
profile as the extracted tooth and is implanted in the cavity left
after the extraction. In practice, a tooth may be extracted and an
impression made of the resulting cavity. The tooth may be replaced
to retain the shape of the cavity until the carbon prosthesis is
fabricated. Then the tooth is removed and the prosthesis implanted.
The prosthesis is compatible with the natural tissue of the
cavity.
Illustrated in FIG. 5 is a shock-absorbing hip joint prosthesis 80
which has a ball section 82 fabricated from a polycrystalline
carbon substrate 84 having a coating 86 of pyrolytic carbon thereon
and which is shaped so as to be an effective replacement for the
natural bone portion of the joint. The exterior portion of the
pyrolytic carbon coating 88 is polished to a high gloss by buffing
with a diamond dust abrasive to provide an exceptional wear surface
and to reduce friction. The ball 82 is fastened to a metal shank or
strut 90 by means of a suitable elastomer interlayer 92 which is
adhesively bonded to each.
One common problem with the metal-hip joint prostheses has been
their lack of the shock-absorbing characteristics of natural bone;
the use of the ball 82 which is a carbon substrate coated with
pyrolytic carbon reduces this deficiency, but additional cushioning
of the joint may be desirable. In this regard, the elastomer
interlayer 92 not only provides bonding between the ball and the
metal strut 90 but also serves a shock-absorbing function. The
shock-absorbing layer 92 may be fabricated from polyethylene or
other suitable rubbery material, and it may be protected from body
juices by a suitable seal 98 which is held in slight compression
against both the ball and the metal strut by biasing tension
produced by the elastomer fastening.
At its end opposite the ball 82, the strut 90 angles to form a rod
100 which is inserted into and bonded to a tapered sleeve 102
fabricated from polycrystalline carbon, which may have an outer
coating of pyrolytic carbon 104. A fastener 106 may be used on the
end of the rod 100 to secure the sleeve thereto. The tapered sleeve
102 with the pyrolytic carbon coating 104 thereon is eminently
suited for insertion into the femur to provide an excellent bond by
means of adhesion with natural bone tissue.
Alternatively, the entire prosthesis 80 may be fabricated from a
carbon substrate having deposited thereon a coating of pyrolytic
carbon, either with or without the shock-absorbing feature of the
illustrated embodiment.
In certain instances where a segment of bone is missing due to
accident or surgery, there is at present no satisfactory method
other than bone homograft which is available to join the remaining
portions of the bone or replace the missing bone segment. The
structure of natural bone is fibrous with channels running
longitudinally therethrough. Illustrated in FIG. 6 is a tubular
bone segment replacement framework 120. The framework 120 is formed
by rolling a strip of woven metallic screen (such as 10 percent
tungsten-90 percent tantalum alloy screen) into tubular form,
followed by deposition thereon of a pyrolytic carbon coating 124.
Thus, bone cells which are formed within the framework 120 have
sufficient access to nutrients to become calcified (i.e., strong
and supportive) via the longitudinal channels provided between and
through the coils of the roller screen 120.
In the illustrated embodiment, the center of the framework is
hollow, and the tightness of the roll, the mesh size of the screen
122 and the thickness of the pyrolytic coating 124 deposited
thereon are variables that are determined by the particular
application. The deposition of the pyrolytic carbon coating 124
upon the screen 122 is accomplished in such a manner that the
physical characteristics of the screen are largely preserved, i.e.,
the regular geometry and porosity of the screen remains.
In use, the framework 120 abuts the bone segments to be joined (or
the bone segment) and is fastened thereto by suitable means. For
example, the framework 120 may be provided with a central elongated
core portion 126 for insertion into the marrow portion of natural
bone, as illustrated in FIG. 6. FIG. 7 illustrates the framework
prosthesis 120 in position between two segments of natural bone
130.
Since the pyrolytic carbon coating 124 is conducive to natural bone
growth, and since the regular geometry of the framework 120 is such
that bone cells may grow throughout the framework while being
provided with sufficient nutrients, the framework 120 provides a
means of permitting natural bone tissue growth to replace or repair
missing or diseased bone segments, partially through natural
processes. Other more complicated shapes may be formed by laying up
formed sheets of screening so that many layers are used, and
fastening these together for coating. Filament winding procedures
which employ the winding of single or multiple strands, or other
suitable processes for forming structural networks of fibers may be
used. The resulting shapes, when coated with pyrolytic carbon,
should have sufficient porosity and oriented channels so that
proper healthy bone can form within and around it. Suitable
surgical procedures, such as "seeding" the framework with small
portions of natural bone segments from the patient may be developed
through the use of such devices to greatly speed up the natural
replacement process.
Screening or fiber segments having pyrolytic carbon coatings
deposited thereon may also be employed with other prosthetic
devices such as those formed from a carbon substrate to aid in the
formation of a strong bond between the prosthetic device and
natural bone.
Pyrolytic carbon coated on a metal wire substrate may also have
other prosthetic applications. For example, a prosthesis for insert
dentistry may be provided which comprises a bridge constructed of a
suitable refractory wire having an abutment thereon. The whole
device is coated with pyrolytic carbon and placement is made, not
into the jawbone, but rather so that the prosthesis straddles the
jawbone. It is implanted under the skin so that only the small
abutment protrudes through the skin; in this case also, the carbon
coated framework grows to the bone to provide a strong support for
the abutment. Subsequently, a denture such as a porcelain tooth or
other dental prosthesis is fastened to the abutment, which provides
firm support. Such implants are useful for supporting
extracorporeal dental bridgework so that additional mechanical
strain need not be placed on remaining teeth by fastening the
bridgework to them.
Although the foregoing examples disclose the best modes presently
contemplated by the inventors for carrying out their invention, it
should be understood that these examples are only illustrative and
do not constitute limitations upon the invention which is defined
by the claims appearing at the end of the specification. The
following Examples further illustrate the fabrication and use of
specific embodiments of this invention.
EXAMPLE I
A knee-joint prosthesis such as illustrated in FIGS. 1 and 2 is
machined from polycrystalline graphite (POCO AXF graphite). The
machined substrate is designed to be of sufficient size for repair
of the knee joint of an average, adult human male. The substrate is
placed in a rotating wire cage within a reaction chamber that
contains in addition a bed of particles. The substrate fits loosely
in the wire cage so that, when it is rotated, the point or points
of contact of the substrate with the wire cage will change as they
rotate, so that the pyrolytic carbon coating will be evenly
deposited.
The reaction chamber is heated to a temperature of about
1350.degree.C. When the temperature of the substrate reaches about
1350.degree.C., a flow of helium gas and propane, such that there
is a partial pressure of propane of 0.4 (total pressure one
atmosphere), is introduced into the reaction vessel so that it is
directed against the surfaces of the substrate, which is being
rotated in the wire cage. The propane decomposes under these
conditions to deposit a dense isotropic pyrolytic carbon coating
upon all of the surfaces of the polycrystalline graphite substrate.
Under these coating conditions, the carbon deposition rate is about
5 microns per minute, and the propane gas flow is continued until
an isotropic pyrolytic carbon coating about 500 microns thick is
deposited on the substrate. After the desired thickness of
pyrolytic carbon is deposited on the outside of the prosthesis
substrate, the propane gas flow is terminated. The coated substrate
is cooled fairly slowly in the helium gas stream, and it is then
removed from the reaction chamber.
The wear surface and the front, rear, and side surfaces of the
prosthesis are buffed to a high gloss by using a diamond dust
abrasive. The as-deposited surface roughness of the pyrolytic
coating is allowed to remain on the bone-joining face containing
the lugs and grooves, and this facilitates the establishment of a
strong bond between the prosthesis and the natural bone.
Measurement shows that the pyrolytic carbon has a density of about
1.9 gm/cm.sup.3, an L.sub.c of about 30 A. and a BAF of about
1.1.
EXAMPLE II
Dental prosthesis substrates like those illustrated in FIG. 3 are
machined from artificial polycrystalline graphite (POCO graphite).
The prostheses have squared abutments about 4 mm. high and 2 mm.
wide, an intermediate portion about 6 mm. long and 3 mm. in
diameter, and a threaded base portion about 8 mm. long and 4 mm. in
diameter at the outside of the threads.
The artificial graphite employed as a substrate has a coefficient
of thermal expansion of about 8 .times. 10.sup.-.sup.6 /.degree.C.
when measured at 50.degree.C. The dental prosthesis substrates are
coated with pyrolytic carbon using a fluidized bed coating
apparatus which includes a reaction tube having a diameter of about
3.8 centimeters that is heated to a temperature of about
1350.degree.C. A flow of helium gas sufficient to levitate a number
of the relatively small prostheses along with the bed is maintained
upwardly through the apparatus.
A number of prostheses are coated together with a charge of about
50 grams of zirconium dioxide particles which have diameters in the
range of about 150 to 250 microns. The particles are added along
with the prostheses to provide a deposition surface area of the
desired amount, relative to the size of the region of the reaction
tube wherein the pyrolysis occurs, inasmuch as the relative amount
of available surface area is another factor which influences the
physical characteristics of the resultant pyrolytic carbon. When
the temperature of the particles which are levitated within the
reaction tube reaches about 1350.degree.C., propane is admixed with
the helium to provide an upwardly flowing gas stream having a total
flow rate of about 10 l. per minute and having a partial pressure
of propane of about 0.4 (total pressure 1 atmosphere). The propane
decomposes under these conditions and deposits a dense isotropic
pyrolytic carbon coating upon all of the articles in the fluidized
bed. Under these coating conditions, the carbon deposition rate is
about 5 microns per minute. The propane gas flow is continued until
an isotropic pyrolytic carbon coating about 300 microns thick is
deposited on the outside of the prostheses substrates. At this
time, the propane gas flow is terminated and the coated articles
are cooled fairly slowly in the helium gas and then removed from
the reaction tube coating apparatus.
Photomicrographs taken of the pyrolytic carbon coating of the
prostheses using an electron-scanning microscope show the
as-deposited surfaces to have a coral-like appearance. The dental
prosthesis may be screwed into suitably drilled holes in a living
jawbone to provide an abutment to which an artificial tooth or a
denture may be affixed. The pyrolytic carbon coating is conducive
to bone growth, and the natural formation of bony tissue around and
attached to the prosthesis in time will provide a very firm anchor
for the prosthesis. In addition, the prosthesis matches the modulus
of elasticity of natural bone, and there is little or no tendency
for the prosthesis to work loose under severe loads after the
prosthesis has been heated in place.
EXAMPLE III
A sheet of metal screen is selected which is composed of an alloy
of 10 percent tungsten-90 percent tantalum, which is woven from
wire having a diameter of 0.005 and a mesh of 20 such wires per
inch. A single, T-shaped piece is cut from the screen having a
cross piece dimension of 21/2 inches by 6 inches, and a base piece
dimension of 11/2 inches wide, which is equal to the length of the
missing bone segment. The wire screen is rolled up from the cross
piece toward the base so that a tube such as that illustrated in
FIGS. 6 and 7 is formed, which has an outside diameter equivalent
to that of the bone to be replaced. The rolled tube has an outer
layer of screen about 11/2 inches long, and a centrally located
internal tubular portion of the rolled screen which is 21/2 inches
long. The rolled screen is fastened in this position and
structurally interlaced by means of fine wires of the same
tungsten-tantalum alloy, and any sharp ends of wire from the screen
or the fastening wires are bent inwardly and crimped. The rolled
tube is placed loosely on a rotating mandrel in a reaction tube
having a diameter of 4 inches through which a flow of helium is
maintained and which is heated to a temperature of about
1300.degree.C.
In addition to the wire tube, a charge of about 100 grams of
zirconium dioxide particles which have diameters in the range of
about 150 to 250 microns is introduced to modify the relative
amount of available surface area for deposition. When the screen
reaches the temperature of the reaction tube, propane is added to
the upward flow of helium past the screen on the rotating mandrel.
The gas stream has a partial pressure of propane of 0.4 (total
pressure one atmosphere). The propane decomposes under these
conditions to deposit a dense isotropic pyrolytic carbon coating
upon the screen. The propane gas flow is continued until an
isotropic pyrolytic carbon coating about 200 microns thick is
deposited on the outside of the wire screen substrate. This degree
of deposition leaves intact the mesh nature of the screen, while
strengthening it, and providing the physiologically beneficial
pyrolytic carbon coating thereon.
The prosthesis may be used to replace a 11/2 inch section of
damaged or diseased bone in a manner such as illustrated in FIG. 7.
Thus, 1/2 inch lengths of the bone segment to be joined are bored
out so that the inner tube portions may be slipped into the bone
ends. The framework prosthesis may be affixed, for example by small
pins or small pyrolytic carbon-coated screws.
EXAMPLE IV
A knee joint prosthesis is prepared exactly as Example I, except
that different structure is provided for achieving a firm bond
between the prosthesis and the natural bone to which it is
attached. Instead of a series of lugs and grooves as in the
prosthesis illustrated in FIGS. 1 and 2, the substrate is provided
with only one lug located centrally in the bone joining face;
however, a strip of metal screen (90 percent-tungsten-10 percent
tantalum alloy is wrapped around and bonded to the periphery of the
substrate so that one side of the screen does not extend quite up
to the wear surface, but on the other side overlaps beyond the bone
joining face a distance of about 1/2 inch. Deposition of the
pyrolytic carbon coating as in Example I serves to further bond the
screen to the substrate and to weld the entire prosthesis together
as a unit. Following deposition of the pyrolytic carbon coating as
in Example I, the wear surface is highly polished by buffing with a
diamond dust abrasive.
The prosthesis may be implanted by machining the bone face it is to
abut so that it receives the lug, and by slipping the pyrolytic
carbon-coated screen over the outside of the bone end. The screen
may be fastened by means of screws or pins if desired; subsequent
growth of bone tissue to the prosthesis, including the bone joining
face and the overlapping screen, provides a stable bond. The
technique illustrated in this Example may also be employed in the
joining of other types of prostheses to natural bone segments.
Although the figures and examples illustrate only certain specific
embodiments of this invention, such as the specific types of
prosthetic devices, specific pyrolytic carbon coating methods,
fastening methods and substrate materials, it is contemplated that
other embodiments may be employed also. Thus, in addition to knee
and hip joints, other joints, such as finger, elbow and shoulder
joints, may be repaired or replaced by pyrolytic carbon coated
prostheses. In addition, long bones, others such as phlanges,
vertebrae, etc., may be repaired or replaced in whole or in
part.
Although the examples particularly describe the deposition of
pyrolytic carbon through the use of propane, it is understood that
other hydrocarbons, or mixtures of hydrocarbons, may be employed to
deposit the pyrolytic carbon coating on the substrate. The
variables of the deposition process itself may be employed to vary
the properties of the pyrolytic carbon coating, or to accommodate
the size, temperature-stable range, or structure of the substrate
material.
A number of specific methods of fastening the prosthetic device to
natural bone tissue have been demonstrated. The pyrolytic carbon
coating is believed to have a particular degree of as-deposited
surface roughness or surface porosity which aids in the adherence
of growing bone tissue thereto. In support of this theory by which,
however, it is not intended that the invention be limited,
photomicrographs made through the use of an electron scanning
microscope reveal that preferred pyrolytic carbon deposits have a
surface which looks similar, under high magnification, to coral.
The porosity is only superficial; the bulk of the coating is dense
with a preferred range of density from about 1.9 g./cm.sup.3 to
about 2.2 g./cm.sup.3.
Although a wide range of substrate materials may be employed, those
which have a modulus of elasticity near that of natural bone are
particularly preferred for use in prostheses for bulk replacement
of bone. Artificial graphites are particularly preferred. For
framework prostheses, various refractory fibers and wires which
have been formed in woven, wound and nonwoven structure may be
employed as substrates. Prostheses made from such substrates are
also useful for providing support for mending shattered or diseased
bones, which support does not corrode, weaken or inflame, as can
prior art devices, and which may remain permanently as a structural
part of the healed bone segment. Where it is desired that high
modulus metallic fibers or screens not be used, lower modulus
fibers, such as carbon fibers, cloth or screen, may be coated with
pyrolytic carbon to provide a lower modulus framework which has
high strength and the biological compatibility and other properties
of pyrolytic carbon.
Various features of the invention are set forth in the following
claims.
* * * * *