U.S. patent number 3,906,550 [Application Number 05/428,763] was granted by the patent office on 1975-09-23 for prosthetic device having a porous fiber metal structure.
Invention is credited to Jorge Galante, William Rostoker.
United States Patent |
3,906,550 |
Rostoker , et al. |
September 23, 1975 |
Prosthetic device having a porous fiber metal structure
Abstract
Prosthetic devices for replacement, attachment and
reconstruction of bone structure in the skeletal systems of humans
and animals. The prosthetic devices may be a fiber metal structure
of sufficient section to support loads adequately or may include a
solid load carrying member having a fiber metal structure secured
to the surface thereof. The fiber metal structure is sintered and
open-pored so that the bone and tissue into which the prosthetic
device is implanted will grow into such fiber metal structure. To
provide the proper interlock between fibers, the individual fiber
strands are prekinked prior to cutting into the desired length. The
kink pattern should be substantially sinusoidal. Preferably such
kink pattern should have an amplitude (H) to period (W)
relationship, H/W of 0.24 or greater.
Inventors: |
Rostoker; William (Chicago,
IL), Galante; Jorge (Oakbrook, IL) |
Family
ID: |
23700309 |
Appl.
No.: |
05/428,763 |
Filed: |
December 27, 1973 |
Current U.S.
Class: |
623/23.55;
419/24; 428/613; 606/76; 29/419.1; 428/605; 433/201.1 |
Current CPC
Class: |
A61C
8/0012 (20130101); A61B 17/72 (20130101); A61F
2/32 (20130101); A61F 2/30907 (20130101); A61L
27/04 (20130101); A61F 2/3607 (20130101); Y10T
428/12479 (20150115); A61F 2/3662 (20130101); Y10T
428/12424 (20150115); A61F 2002/30968 (20130101); A61F
2250/0063 (20130101); A61F 2002/30599 (20130101); Y10T
29/49801 (20150115) |
Current International
Class: |
A61B
17/68 (20060101); A61B 17/72 (20060101); A61C
8/00 (20060101); A61F 2/32 (20060101); A61F
2/30 (20060101); A61L 27/04 (20060101); A61F
2/36 (20060101); A61L 27/00 (20060101); A61F
2/00 (20060101); A61F 001/24 (); A61C 013/30 () |
Field of
Search: |
;3/1,1.9-1.913
;128/92C,92CA,92BC,92R ;32/1A |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Other References
"Sintered Fiber Metal Composites as a Basis for Attachment of
Implants to Bone," by J. Galante et al., The Journal of Bone and
Joint Surgery, Vol. 53-A, No. 1, January 1971, pp. 101-114, Mar.
1..
|
Primary Examiner: Frinks; Ronald L.
Attorney, Agent or Firm: Siegel; Albert
Government Interests
There is reserved to the government of the United States of America
a non-exclusive, irrevocable and royalty-free license to make and
use, and to sell as provided by law, embodiments of the invention
as hereinafter described and claims, with the power to sublicense
for all governmental purposes.
Claims
We claim:
1. A prosthetic device for incorporation into the skeletal
structure of a human or animal including:
a porous fiber metal structure formed from a plurality of
substantially, sinusoidally shaped fiber strands, each of said
fibers having a ratio of amplitude to period of substantially 0.24
or greater, said strands being metallurgically bonded to each other
at their points of contact, said fiber metal structure providing at
least a portion of the surface of said prosthetic device adjacent
said skeletal structure to enable bone and soft tissue growth into
said metal structure, said period being substantially the length of
a cycle of said sinusoidal fiber strand and said amplitude being
substantially the height/2 between a positive peak and a negative
peak of said sinusoidal fiber strand.
2. The prosthetic device of claim 1, wherein said fiber metal
structure is between 10% and 70% porous.
3. The prosthetic device of claim 1, wherein the diameter of said
fiber strands is between about 0.013 centimeters and 0.030
centimeters.
4. The prosthetic device of claim 1, wherein the length of said
fiber strands is between about 1.3 centimeter and 3.8
centimeters.
5. The prosthetic device of claim 1 includes a noncompressible rod,
said fiber metal structure being secured to the outside of said
rod.
6. The prosthetic device of claim 1, wherein said fiber metal
structure is selected from the group consisting of titanium,
Co-Cr-W alloy, stainless steel, tantalum and zirconium.
7. The prosthetic device of claim 1, includes:
a wear resistant member, said fiber metal structure being mounted
on said wear member, said fiber metal structure adapted to be in
contact with said skeletal structure when implanted therein.
8. The prosthetic device of claim 5, wherein said fiber metal
structure comprises a plurality of cylindrical segments mounted on
and surrounding said rod.
9. The prosthetic device of claim 8 further includes:
a second porous fiber metal structure having a bore therein, said
bore being dimensioned to receive said rod with said segments
thereon.
10. The prosthetic device of claim 1 wherein said device is a
dental prosthesis, including an upstanding mounting member mounted
in said fiber metal structure and extending outward therefrom, said
fiber metal structure extending around said upstanding member for
operatively contacting the jaw bone to receive the growth of said
jaw bone and gingival soft tissue.
Description
BACKGROUND OF THE INVENTION
This invention relates to prosthetic devices for replacement,
reconstruction and attachment in the skeletal system of humans and
animals; and more particularly is directed to a prosthetic device
including a porous fiber metal structure.
Prosthetic devices are used to partially or completely replace
joints or bone segments in the skeletal structure of humans or
animals. One of the major problems involved in the use of
prosthetic devices is the attachment of the prosthetic implant to
the adjacent bone. There are four principal methods by which the
device can be attached to the bone. These methods include: (1).
Impaction of the prosthetic stem into the medullary cavity of the
bone; (2). Mechanical internal fixation, e.g., screws; (3). Methyl
methacrylate polymerizing "in situ" used as a cement or filler
between the prosthesis and the bone; and (4). Porous materials into
which the bone can grow. Each of these methods presents problems
that can cause failure of the prosthetic implant.
The devices which are impacted into the medullary cavity are held
in place by a compressive residual stress interaction which may be
more commonly referred to as a force fit. If this stress
interaction is relaxed in the surrounding bone, due to physical or
biological processes, the attachment is lost and the device becomes
loose, thereby requiring surgical removal and refitting of the
prosthesis.
Mechanical internal fixation produces acceptable limited term
attachments. However, in long term use the device may become loose
and thereby require replacement.
Polymethyl methacrylate has also produced acceptable limited term
attachments. However, doubts still exist as to the overall safety
of its use from a biological point of view partly from damage to
surrounding tissue from monomer and heat interaction, and partly
that the plastics may age in the body fluid thereby becoming
brittle and tending to crack or crumble.
An open-pore material into which bone could grow should provide
ideal skeletal fixation. Numerous materials and processes for
producing porous aggregates have been disclosed which serve this
purpose. For example, see U.S. Pat. No. 3,314,420. Typically these
aggregates are powder metals or powder ceramics which are
compressed and sintered to produce a porous but relatively strong
body. In order to obtain the high level of porosity and acceptable
green strength, rather fine powders are required, the use of which
substantially limits the size of the pores. During sintering much
of the porosity ceases to become interconnecting and thus a high
proportion of the pores at the surface become isolated from the
interior of the body. This isolation limits bone ingrowth and
results in a situation similar to the roughened surface of a solid.
Furthermore, the mechanical properties of sintered powders are not
ideal; for example, porous consolidated ceramics are very weak and
brittle, and cracks propagate quickly throughout the whole body of
the porous aggregate at low stresses or with small impact energies.
Consolidated metal powders with porosities in the range of 40-60%
void, are stronger than the consolidated ceramics but still are
very brittle and have poor toughness. Moreover, sintered metal
powders are susceptible to fatigue failure. Both sintered ceramics
and metal powders have compliances which more closely approximate
the pore free material. Compliance is defined as the change in
elastic strain per unit change in stress.
The subject invention provides a prosthetic device which is
non-toxic, compatible and not subject to loosening or movement
after implantation, and further includes the provision of an
open-pore attachment for bone ingrowth which attachment is highly
compliant, not brittle, resistant to crack propagation and has a
broad range of readily controllable pore sizes.
SUMMARY OF THE INVENTION
There is provided by this invention a prosthetic device including a
porous aggregate produced by molding and sintering short metal
fibers. The sintering process creates metallurgical bonds at the
points of contact of the fibers. Thus, the fiber metal aggregate
has considerable mechanical strength due to mechanical interlock of
the fibers and the sintered bonds.
The degree of mechanical interlock and mechanical strength of the
porous aggregate is appreciably improved if the wire is kinked
prior to being cut into the short metal fibers. The kinking pattern
should be sinusoidal. Preferably, the ratio of amplitude and period
of the sine wave should be 0.24 or greater. After the kinking is
formed, the wire is cut into the desired lengths.
By using fiber metals the range of pore sizes can be readily
controlled and the attachment is not subject to the crack
propagation and low strength problems associated with ceramics or
powdered metal attachments and provides a highly compliant
non-brittle connection. Moreover, in view of the use of fiber
metals, the pores are interconnecting and remain so after
sintering. Thus bone growth can penetrate for a substantial
distance into the fiber metal structure and thereby provide a very
secure connection. By the appropriate selection of the fiber metal
composition, an essentially inert attachment can be achieved;
hence, the fiber metal attachment is not subject to the aging
problems or reaction problems of the plastics of the prior art.
Since the pore size can be readily controlled by the pressing and
forming parameters, the density of the sintered composite can
approximate the density of the bone to which the prosthetic device
is implanted.
BRIEF DESCRIPTION OF THE DRAWINGS
Referring to the drawings in which the same characters of reference
are employed to indicate corresponding similar parts throughout the
several figures of the drawings:
FIG. 1 is a vertical sectional view illustrating an exemplary hip
joint prosthesis;
FIG. 2 is a stress-strain diagram for a molded and sintered Co-Cr-W
alloy fiber aggregate;
FIG. 3 illustrates a sinusoidal kinking pattern of a wire length
prior to being cut into the fiber strands used in the fiber metal
structure of FIG. 1;
FIG. 4 illustrates an enlargement of a portion of a molded fiber
metal structure;
FIG. 5 is a vertical sectional view depicting a femur having a bone
segment reconstruction prosthesis; and
FIG. 6 is a vertical view of a mounting for a dental
prosthesis.
DESCRIPTION OF THE PREFERRED EMBODIMENT
Referring now to FIG. 1 of the drawings, the reference numeral 10
indicates generally a hip joint prosthesis which is exemplary of
the prosthetic devices embodying the principles of the subject
invention. The joint prosthesis 10 comprises two individual
prosthesis, a femur prosthesis 12 and a acetabulum prosthesis 14.
The femur prosthesis 12 comprises a load carrying means 16 of solid
construction and a sintered fiber metal attachment structure
indicated generally by the reference numeral 18.
The solid load carrying means 16 includes a ball 20 carried on a
flange 22, which in turn is mounted to a rod 24 having a cup-shaped
bottom end member 26. The fiber metal attachment structure 18
includes a plurality of tubular fiber metal segments 28a, 28b, 28c,
28d, and 28e.
The rod 24 and segments 28a through 28e are inserted into the
medullary cavity of the femur 30 which is appropriately reamed and
is thus fixed in place so that the ball 20 is properly orientated
with respect to the hip socket 32. As the healing process takes
place, the bone which is adjacent the fiber metal segments 28a
through 28e grows into the attachment 18. It has been observed that
after the bone ingrowth has proceeded to a substantial degree, a
secure fixation is produced between the ingrown bone and the fiber
metal implant.
The attachment segments 28a through 28e can be secured to the rod
24 in a number of ways. The most effective way is to
metallurgically bond the fibers contacting the surface of the rod
thereto; however, it will be appreciated that the flange 22 and end
member 26 when tightened also act to hold the attachment segments
28 in place. Other methods by which the segments 28 are mounted to
the rod 24, include cementing or the like or mechnical fixation;
however, as indicated above metallurgical attachment is
preferred.
The solid load carrying rod 24 or a similar member is normally used
when tension and bending loads may be anticipated. However, where
only compressive loads are experienced, the fiber metal structure
18 may be used without such rod 24. However, in some situations
where stresses and strains are realized, a fiber metal structure of
substantial area may be used without the rod 24.
The acetabulum prosthesis 14 includes fiber metal attachment
component 34 and a solid wear insert 36. The fiber metal attachment
is molded into the proper shape and then fitted into a cavity
formed in the acetabulum during surgery. Bone ingrowth will hold
the fiber component 34 rigidly in place. Since a fiber metal
surface is probably not particularly wear resistant, the wear
insert 36 is molded integral with the fiber component 34.
Furthermore, the insert 36 not subject to bone ingrowth can be held
in place mechanically so that it can be subsequently removed and
replaced if necessary.
In another prosthetic system, a union may be accomplished between
the upper and lower portions 38 and 40 of a severed femur 30
generally as shown in FIG. 5. As is seen, the severance space 41 is
filled with a cylindrical sintered fiber metal member 42 having a
center core hole 44 through which a sintered fiber-sleeved shaft 46
is passed, to provide fixation to the extremities of the femur 30.
The shaft 46 includes a solid center member 48, sintered fiber
metal sleeves 50a, 50b, 50c, 50d and 50e, and end members 52 and
54. Shaft 46 is fitted into the medullary cavity 56 of the femur 30
which is appropriately reamed.
In still another prosthetic application, a device 58, as shown in
FIG. 6, may be implanted in the jawbones 60 of humans or animals as
a basis for mounting artificial teeth or dentures. The dental
prosthesis 58 comprises a monolithic sintered fiber metal member
62, and a solid center shaft 64 passing centrally through the fiber
member 62. Shaft 64 includes a flanged bottom 65. When bone or
tissue grows into the fiber member 62, the upper end of the shaft
40 is securely held in place and an artificial tooth 66 can then be
mounted thereon. The ingrowth of gingival tissue provides a
bacterial seal.
The fiber metal segments 28, and the fiber metal attachment
component 34 shown in FIG. 1, and the fiber metal member 42 and
sleeves 50 shown in FIG. 5, and the fiber metal member 62 shown in
FIG. 6 are all porous aggregates produced by molding and sintering
short metal fibers. The points of contact between fibers become
metallurgical bonded during sintering. Thus, the fiber metal
aggregate has considerable mechanical strength due to the sintered
bonds and the mechanical interlocks.
Short lengths of fine wire such as stainless steel, unalloyed
titanium or Co-Cr-W alloy, are mechanically molded into the desired
precise shapes using constraining dies and moving punches. When
loading the wire charge of short metal fibers in the die during
molding, the long axes thereof, should be on the most part coaxial
with the punch motion. Upon applying the proper pressure with the
dies and punches, a three-dimensional mechanically interlocked
network of fibers is formed.
The degree of interlock and unsintered or "green" strength of a
pressing with the dies, is substantially increased if the original
wire is prekinked prior to cutting the wire into the short fibers.
The desired kinking can be accomplished by passing the wire through
a set of meshing gears.
It has been found that the wire should be prekinked into a
sinusoidal pattern to provide the greatest mechanical interlock, as
shown in FIG. 3. Thereafter, the kinked sinusoidal wire is cut into
the desired short fiber lengths.
To provide the optimum interlock the kink pattern should have an
amplitude (H) to period relationship (W), H/W of 0.24 or
greater.
The kinked short fiber strands of 316 L stainless steel; unalloyed
titanium and Co-Cr-W alloy wire, are molded into the precise shape
for the fiber metal aggregate as aforestated, using constraining
dies and moving punches. The choice of the wire size and the
density of the fiber strands loaded in the dies will govern the
final parameter dimensions of the fiber metal aggregate.
The molding operation is followed by a sintering stage in which
points of contact become actual metallurgical bonds. Adequate
bonding has been obtained with oven temperatures within the range
of 1070.degree. - 1240.degree. C for approximately 2 hours.
Repressing, using the same die and punch tooling, of the sintered
metal fiber aggregate must be done to enable the aggregate to be
formed into precise and reproducible dimensions which are necessary
for good clinical responses.
The sintered fiber metal aggregates shown in FIGS. 1, 5 and 6 may
be molded having void or a porosity of 40 to 50 percent per unit
area. A porosity of 60% could also be achieved, but the green
strength is generally too fragile, and therefore, could effect the
dimensional control because of elastic recovery. Also fiber metal
aggregate having such greater porosities are not sufficiently firm
at the edges and tend to crumble.
Wire sizes as fine as 0.013 centimeters in diameter and as coarse
as 0.030 centimeters in diameter have been satisfactorily molded.
In the molded and sintered fiber metal aggregate, the metal fibers
are completely interconnected. The pore shapes as may be seen from
FIG. 4, which is a magnification of a portion of a sintered-molded
fiber metal aggregate, cannot be described in any simple geometric
shape. The largest principal dimension of the pores is
approximately equal to the wire diameter when the void content is
about 50 percent. However, pressing or molding to higher densities
would lead to more constricted pore sizes.
Wire is cut to lengths ranging from 1.3 to 3.8 centimeters. The
longer the wire, the more difficult it is to feed into dies. On the
other hand, long wire lengths give more interlock and better molded
strengths.
Turning now to FIG. 2, a graphical representation of a reversible
(elastic) stress strain cycle is shown for Co-Cr-W alloy wire of
0.023 centimeters in diameter, molded to 50 percent porosity and
sintered at 1240.degree. C for 3 hours. Before testing and
obtaining the data for FIG. 2, the sintered specimen was
recompressed to a 7% reduction in height.
The elastic properties of Co-Cr-W alloy and other metal of the same
class, such as stainless steel and titanium have elastic properties
more like an elastomer than a metal. A sintered specimen shows a
purely plastic strain range of about 3-10 percent on the
application of very small loads. Thereafter, there is an elastic
strain range of about 3 percent in which the modulus is a
continuous function of strain (FIG. 2). For the strain range of
about 1 percent, the modulus is about 10.sup.4 kg/cm2 for the
sintered fiber metal structure.
The sintered porous fiber metal structure disclosed herein has an
elastic modulus substantially less than the elastic modulus for
porous metals produced by sintered powders. This enables the
sintered porous fiber metal structure to be an effective interface
between bone tissue and a load-bearing prosthesis; and it further
provides a very high compliance (large strains per unit applied
stress), which is a safeguard against high localized stresses at
the prothesis-tissue interface.
By repressing procedures the external dimensions of prostheses may
be precisely regulated to the excavation so that a zero clearance
fit exists. The zero clearance fit is vital to the clinical success
of fixation by bone and soft tissue. In the absence of a zero
clearance fit, the prothesis is isolated by fibrous or
non-functional tissue. For a tooth root prosthesis this leads to
loosening. Other porous materials cannot easily be sized to precise
dimensions.
The foregoing specification and description are intended as
illustrative of the invention, the scope of which is defined in the
following claims.
* * * * *