U.S. patent number 3,855,638 [Application Number 05/360,954] was granted by the patent office on 1974-12-24 for surgical prosthetic device with porous metal coating.
This patent grant is currently assigned to Ontario Research Foundation. Invention is credited to Robert M. Pilliar.
United States Patent |
3,855,638 |
Pilliar |
December 24, 1974 |
SURGICAL PROSTHETIC DEVICE WITH POROUS METAL COATING
Abstract
A novel surgical prosthetic device having many useful surgical
applications comprises a composite structure. The composite
consists of a solid metallic material substrate and a porous
coating adhered to and extending at least partially over the
surface of the substrate. The porous coating has certain critical
characteristics, and the individual values depend on the end use to
which the device is put. There are described a number of surgical
and dental applications.
Inventors: |
Pilliar; Robert M. (Toronto,
Ontario, CA) |
Assignee: |
Ontario Research Foundation
(Sheridan Park, Ontario, CA)
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Family
ID: |
26238722 |
Appl.
No.: |
05/360,954 |
Filed: |
May 16, 1973 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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148316 |
Jun 1, 1971 |
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Foreign Application Priority Data
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Jun 4, 1970 [GB] |
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27110/70 |
Feb 4, 1971 [GB] |
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3964/71 |
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Current U.S.
Class: |
623/23.55;
433/173 |
Current CPC
Class: |
A61F
2/30 (20130101); A61F 2/30767 (20130101); B22F
7/002 (20130101); C23C 24/087 (20130101); A61F
2/36 (20130101); A61L 27/306 (20130101); A61F
2002/30769 (20130101); A61F 2310/00023 (20130101); A61F
2310/00407 (20130101); A61F 2310/00401 (20130101); A61F
2/0811 (20130101); A61F 2310/00029 (20130101); A61F
2002/30968 (20130101); A61F 2002/30011 (20130101); A61F
2/2875 (20130101); A61F 2250/0023 (20130101); A61F
2/32 (20130101); A61F 2310/00017 (20130101); A61F
2310/00413 (20130101) |
Current International
Class: |
A61F
2/30 (20060101); A61F 2/36 (20060101); A61L
27/00 (20060101); A61K 6/02 (20060101); A61L
27/30 (20060101); C23C 24/00 (20060101); A61K
6/04 (20060101); C23C 24/08 (20060101); B22F
7/00 (20060101); A61F 2/00 (20060101); A61F
2/32 (20060101); A61F 2/28 (20060101); A61F
2/08 (20060101); A61f 001/24 () |
Field of
Search: |
;3/1
;128/92C,92BC,92CA,334R,92R,92D ;32/1A ;117/71M |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
"Sintered Fiber Metal Composites as a Basis for Attachment of
Implants to Bone" by V. Galante et al., The Journal of Bone &
Joint Surgery, Vol. 53-A, No. 1, January 1971, pages
101-114..
|
Primary Examiner: Frinks; Ronald L.
Attorney, Agent or Firm: Sim & McBurney
Parent Case Text
REFERENCE TO RELATED APPLICATION
This application is a continuation-in-part of application Ser. No.
148,316 filed June 1, 1971, now abandoned.
Claims
What I claim is:
1. A surgical prosthetic device comprising a composite structure
consisting of a solid metallic material substrate and a porous
coating of said metallic material adhered to and extending at least
partially over the surface of said substrate to a thickness of
about 100 microns to about 1,000 microns, said metallic material
being substantially non-corrodable and non-degradable by body
fluids,
said porous coating consisting of a plurality of small discrete
generally ball-shaped particles of said metallic material bonded
together at their points of contact with each other and said
substrate to define a plurality of connected, interstitial pores
uniformly distributed throughout said coating,
said particles being of a size and being spaced from each other to
establish an average interstitial pore size of from about 20
microns to about 200 microns substantially uniformly distributed
throughout said coating and a coating porosity of between about 10
and about 40 percent.
2. The device of claim 1 wherein said average interstitial pore
size is from about 50 to about 200 microns.
3. The device of claim 1 wherein said average interstitial pore
size is from about 50 to about 100 microns.
4. The device of claim 1 wherein said metallic material is selected
from austenitic stainless steel, titanium, titanium alloys and
cobalt alloys.
5. The device of claim 1 wherein said metallic material is
VITALLIUM.
6. The device of claim 1 wherein said metallic material is
VITALLIUM and said particles are of +325 mesh size.
7. The device of claim 6 wherein said particle sizes are from +325
mesh to -100 mesh.
8. The device of claim 2 wherein said coating is impregnated with
bone-binding cement.
9. The device of claim 7 wherein said coating is provided to a
depth of about 500 microns.
10. The device of claim 1 wherein said solid substrate has two of
said porous coatings of said metallic material adhered to and each
extending partially over the surface of said substrate to said
thickness, one of said porous coatings having an average
interstitial pore size below about 50 microns for the ingrowth of
soft tissue and the other of said porous coatings having an average
interstitial pore size above about 50 microns for the ingrowth of
hard tissue.
Description
FIELD OF INVENTION
This invention relates to surgical prosthetic devices.
BACKGROUND TO THE INVENTION
The use of surgical prosthetic devices, otherwise known as
implants, is well known in various surgical applications, such as
reconstructive surgery, for example, in the replacement of hip
joints or the like. These applications generally involve the use of
an implant constructed of metal or alloy which substantially is not
corroded or otherwise degraded by body fluids. These prior art
implants, however, suffer from a number of defects.
Typically, in the setting of broken bones metal plates have been
used which are secured to either side of the bone fracture. The
plates are commonly secured to the bone by screws. While the plate
in time becomes encapsulated in bone and body tissue, no bond is
formed between the implant and the tissue. If one of the screws
comes loose, the patient may have to undergo additional corrective
surgery.
Suggestions have been made in the prior art to provide surgical
prosthetic devices which are capable of permanent incorporation
into the body, usually the bone with bonding between the implant
and the tissues.
In one prior art suggestion, there is described a prosthetic device
consisting of a metal substrate or base having a thin porous
coating of metal overlying and bonded to the surface. The presence
of the pores allows the soft or hard tissue to grow into the porous
coating of the device and hence achieve incorporation into the
body.
The only method of forming the coating which is described in this
prior art suggestion is the technique of plasma or flame spraying
onto the metal substrate. The result of this process is a densely
adherent layer of the sprayed metal on the substrate metal with no
porosity or practically no porosity at the interface between the
coating and the substrate and with gradually increasing porosity,
including increasing pore size and decreasing density, from the
interface to the surface of the coating.
While this technique may be effective in providing a porous coating
on a metal substrate, nevertheless the technique results in a very
serious defect in the finished prosthetic device. In tests designed
to show the in-growth of tissue into the coated surface of the
device a pin, having the coating thereon, after embedding in a bone
for a period of time was subjected to a pull-out test. This
pull-out test resulted in shearing at the interface between the
coating and the base metal. This result indicates that the overall
strength of the device is less than the bone. Quite clearly, the
provision of a device weaker than the bone to which it is attached
could result in failure of the device due to shearing at the
interface with harmful and painful consequences for a patient who
is treated using such a device.
This defect of this device is a direct result of its method of
manufacture. Plasma spraying is a well known technique and
generally is employed where it is desired to achieve a low porosity
coating, often entirely pore free. Very thin plasma coatings
therefore tend to be very dense and a progressive increase in pore
size and decrease in density is a commonly-known result. If plasma
spraying is continued eventually a uniform pore size of the coating
is achieved, but the thickness of the coating required is at least
ten thousands of an inch.
Another result of plasma or flame spraying is that a very hot
molten mass impinges onto a relatively cold substrate surface
causing the setting up of considerable interfacial thermal stresses
which result in an inherent weakness which manifests itself in the
interfacial shearing action observed in tests.
Another prior art suggestion involves the provision of a prosthetic
device constructed of porous ceramic material. This material is
structurally weak and attempts to overcome this defect involve
filling the bulk of the device with resin material, leaving a
porous surface area. Although the presence of the resin may
increase the strength of the central portion of the device, the
surface region remains weak. Further, the presence of resin
material degradable by body fluids would lead to unsatisfactory use
in the human body. In addition, the maximum pore size for the
ceramic is indicated to be 50 microns, and much smaller sizes are
preferred. If the pore size were greater than 50 microns, then the
structure would become too weak for effective use. A consequence of
this pore size limitation will become apparent hereinafter in the
discussion of the present invention
SUMMARY OF INVENTION
The surgical prosthetic device of the present invention has a
unique construction which overcomes the weakness problems
associated with the prior art devices, as disscused above. The
surgical prosthetic device of the invention comprises a composite
structure consisting of a solid metallic material substrate and a
porous coating adhered to and extending at least partially over the
surface of the substrate. The porous coating on the surface of the
substrate has several parameters, described in detail below, which
are essential to the provision of a satisfactory device free from
the defects of the prior art devices.
The porous coating consists of a plurality of small discrete
particles of metallic material bonded together at their points of
contact with each other to define a plurality of connected
interstitial pores in the coating. The particles are of the same
metallic material as the metallic material from which the substrate
is formed. It is essential that this be the case otherwise
corrosion at the substrate-coating interface may occur due to a
cell action with body fluids.
The metallic material from which the substrate and coating are
formed is one which is not corroded or otherwise degraded by the
body fluids of the patient. Examples of suitable materials include
austenitic stainless steel, titanium, titanium alloys and cobalt
alloys. The cobalt alloy VITALLIUM (Trademark) has been found to be
especially useful.
BRIEF DESCRIPTION OF DRAWING
The accompanying drawing is a photomicrograph of the surface
structure of an implant in accordance with one embodiment of the
invention after four months implantation in a dog femur.
DETAILED DESCRIPTION OF INVENTION
In the surgical prosthetic device of the invention, the metal
particles are bonded to one another and to the substrate in such a
manner that particle-to-particle separation and
particle-to-substrate separation would require a shear stress
greater than the transverse shear stress required for bone
fracture. Thus, in the present invention, the composite structure
is stronger than bone and hence is free from the interfacial
shearing encountered by the prior art and discussed in detail above
and also is free from intracoating failure.
In the present invention, therefore, when tissue ingrowth and
tissue ossification is complete, break away of the coated part of
the prosthetic device will occur by a bone fracture rather than a
fracture within the coating itself or at the coating-substrate
interface.
Another essential parameter of the coating which assists in the
provision of a superior product is the pore and pore size
distribution through the depth of the coating. In the present
invention, both the pore and pore size distribution are
substantially uniform from the coating-substrate interface to the
surface of the coating. This uniformity of pore and pore size
distribution through the coating results in a substantial
uniformity of strength through the thickness of the coating and
ensures ingrowth of tissue and its calcification through the entire
thickness of the layer to the interface with the substrate.
These latter conditions are in contrast to the structure of the
prior art where there is a progressive increase in pore size and
porosity from the coating-substrate interface to the surface. The
prior art therefore lacks uniformity of strength throughout the
thickness of the layer and further does not allow the ingrowth of
tissue through the whole depth of the layer, resulting in a
less-satisfactory incorporation into the body.
It also is essential to control the interstitial pore size and the
coating porosity within critical limits, although variations
between the limits may be made depending on the individual
requirements. The critical limits depend on the application to
which the implant is to be put.
In order for the porous adherent coating to be able to sustain
bone, or other hard tissue growth, it is essential that the
interstitial pore size exceed about 50 microns. Generally, the
interstitial pore size is between about 50 and 100 microns,
although larger pore sizes up to about 200 microns may be employed.
Since the particles in the powder from which the coating is formed
are not usually of uniform size, the pore sizes vary somewhat
throughout the coating, although their distribution is
substantially uniform.
Where the ingrowth of soft tissue only is to be sustained, the
interstitial pore size may be less than 50 microns, down to about
20 microns.
This finding of essential pore sizes for ingrowth of tissue
contrasts markedly with one of the prior art suggestions mentioned
above wherein the maximum pore size indicated is 50 microns, with
the preferred range being considerably less. This prior art device
therefore is capable only of sustaining ingrowth of soft tissue and
in its preferred aspects is incapable of sustaining even soft
tissue ingrowth.
Further, it is essential that the porosity of the surface coating
not exceed about 40 percent and be at least about 10 percent. It is
only be controlling the porosity within this range at the pore
sizes recited above that it is possible to provide a surgical
prosthetic device that has an overall strength greater than the
shear strength of bone and at the same allow for ingrowth of
tissue. At porosities below about 10 percent, there are
insufficient pores in the surface to provide sufficient ingrowth
whereby upon later calcification a strong mechanical fixation is
achieved. At porosities above about 40 percent the overall
mechanical strength falls below the required level. The pore size
and porosity values are achieved by controlling the manner of
formation of the coating and the particle size of the material used
in the coating formation.
The depth of the porous coating on the surface of the substrate and
the ratio of depth of coating to depth of substrate may vary over a
wide range between essential limits. The lower limit of thickness
is about 100 microns, which is the thickness of surface coating
required to sustain bone tissue ingrowth with good mechanical
interlocking in the pores, generally equivalent to about 2 to 3
monolayers of particles, while the upper limit of thickness is
about 1,000 microns which is dictated by the strength
considerations discussed above. Typically, a depth of about 500
microns is used on about a 1/4 inch round substrate, using from
+325 to -100 mesh particle coatings.
Referring now to the accompanying photomicrograph there is shown a
250 times magnification of an elongated substrate 10 of circular
cross-section and a porous adherent coating 12. The substrate 10
and the coating 12 each are formed of VITALLIUM. The coating 12 is
formed of from +325 to -100 mesh powder and a plurality of
interconnected interstitial pores filled with bone tissue is
provided. The pores and pore size distribution are substantially
uniform through the depth of the coating 12.
A dog's femur 14 is situation adjacent the coating 12 and the
ingrowth of bone tissue 16 can be seen. The growth of bone tissue
is throughout the depth of the coating to the substrate surface.
The ingrowth of the bone tissue was woven and lamullar together and
had the architectural configuration of adult compact bone with
osteone formation. Since the appearance of tissue elements may be
deceptive by reflection under the optical microscope, further
testing by way of electron microprobe scan analyses of the porous
coating 12 was carried out. Probing from the bone 14 across the
coating 12 to the substrate 10 showed the calcium and phosphorus
contents of the tissue ingrowth 16 to be the same as that of the
femur 14. These observations confirm that the coating 12 was not
only penetrated by living tissue but it was sufficiently porous to
allow the infiltration of bone growth.
The micrograph shows no untoward reaction of the bone tissue 16 to
the metal of the coating 12. This observation is significant in
view of the large surface area of metal exposed to possible
reaction in an open pored structure.
The surgical prosthetic device of the invention has a number of
uses. For example, the implant may be used to bridge the gap
between bone ends caused by removal of a portion of the bone. The
removal of the portion may be due to irreparable shattering, a
cancerous growth or the like.
The implant, generally in the form of a cylindrical rod, is
positioned within the bone ends. At least those areas of the
implant in contact with and adjacent the bone ends are provided
with the porous adherent coating. The presence of the porous
adherent coating allows bone or hard tissue to grow into the
surface of the implant, so that the implant is incorporated into
the bone and the implant thereby is secured to the bone ends.
The implant of the invention by the presence of the porous adherent
coating allows bone or hard tissue to grow into the surface of the
implant, so that the implant is incorporated into the bone and a
much stronger joint is provided.
When the implant is used in this bridging role, in those areas
between the bone ends, a porous adherent coating also may be
provided on the surface of the implant, so that body (or soft)
tissue may grow into the surface. Therefore, the implant is not
only encapsulated in the body, but is incorporated into the bone
and soft tissue of the patient. In this way, a very rigid structure
is obtained.
The process of growth of bone tissue into the porous adherent
coating takes some time and it is necessary to provide an initial
affixing of the bone ends and the plate to position the implant for
ingrowth of the bone tissue. In the case of bone setting, the
implant, in the form of a plate, may be secured by screws, either
side of the break. In the case where the implant is used as a
bridge between bone ends, the implant, in the form of an elongated
cylindrical rod, may be secured within the bone ends.
A further use of the surgical prosthetic device of the invention
lies in artifical joints, for example, a hip prosthesis. When
artifical joints are included in the body, it is necessary that
they be affixed in the joint socket and this has been achieved
using cements. In some joints, such as the hip joint, the stresses
at certain positions are greater than at others and it may be
desired to utilize adhesion achieved other than by the use of
cements.
The artifical joints may be constructed in accordance with the
present invention. The coating may be provided on the substrates,
if desired, only at those positions where the joint will be
subjected to high stress. As in the case of the bridging of bone,
the bone tissue of the socket grows into the surface coating and
thereby more tightly binds the prosthesis. Cement is used to
position the prosthesis in the socket and cement may be employed
additionally at the areas of the porous coating. The entire
prosthesis may be formed as a composite and it has been found that
the use of a cement, such as methyl methacrylate, together with the
porous surface gives rise to a much enhanced adhesion of the
prosthesis to the socket as compared to use of a cement in the
absence of a porous surface.
In this case, the increased surface area and morphology of the
implant occasioned by the presence of the porous coating provides
the enhanced adhesion. A further application of the implant of the
invention is in a McIntosh arthroplasty of the knee.
An additional use of the implant of the invention is in the
affixing of artificial limbs, etc. to amputees. In this embodiment,
the implant, usually as an elongated rod, is secured in the bone of
the stump. In the area of the implant adjacent the bone, an
adherent porous coating is provided in accordance with this
invention. The presence of the coating allows bone tissue to grow
into the surface of the implant and rigidly secure the implant
therein. The rod projects from the stump and after the implant is
securely affixed to the bone, the artificial limb then may be
secured to the projecting portion.
At least at the portion of the rod adjacent the body surface, the
implant is provided with a porous surface. The soft body tissue at
the surface of the stump, therefore, may grow into the surface of
the implant at the point where it projects from the stump and
thereby the surface of the skin is sealed to the implant. In the
absence of the porous coating of the invention, such a seal does
not form and infection of the stump may occur.
In common with the embodiments discussed above, certain parameters
are necessary for the coating in the area of the fixture to the
bone in order to sustain bone tissue growth into the coating and
the discussion above with reference to the implant used in the
setting of bone applies equally here. In particular, the pore size
of the porous coating in at least the area of the implant adjacent
the bone stump should exceed 50 microns.
The implant of the invention may be used in brain surgery, to
replace bone removed from the cranium during a brain operation. The
surgical prosthetic device of the invention in this embodiment
assumes the form of a circular disc, or other shape, conforming in
size to the hole formed in the skull, with a porous adherent
coating formed around the peripheral areas where the device engages
the skull bone. Bone tissue grows from the skull into the porous
surface, and the disc thereby is incorporated into the skull.
The implant of the invention in the form of a staple may be used in
the rejoining of tendon, muscle or other soft tissue to bone, for
example, in a shoulder. The staple consists of a substrate and a
coating, the coating being formed to sustain the growth of bone and
soft tissue therein. The implant may be formed with different forms
of coating, one area sustaining bone tissue growth and the other
soft tissue growth. It is possible to employ a smaller interstitial
pore size for soft tissue growth, as discussed above, down to about
20 microns, as compared to the pore size for bone tissue growth
where an interstitial pore size exceeding about 50 microns is
required.
Another area of use of the present invention is in dentistry. The
implant may be anchored to the mandible and at the point of
projection of the implant through the gingival, a porous coating is
provided.
Gum tissue grows into the coating and thereby seals the gum
surface. In this way, the collection of foreign substances, causing
infection, at the implant-gingival interface is prevented.
The area of the implant adjacent the mandible may be provided with
a coating, in accordance with the present invention, in order to
more securely anchor the implant to the jaw bone by bone tissue
ingrowth.
The implant of the present invention also may be employed to
provide a quick-release valve secured to the body surface of a
patient for connecting internal parts of the body to external
treatment devices. The implant generally consists of a ring of
metal having a peripheral porous coating adjacent the areas of
attachment to the patient's body surface. Since the growth of body
tissue into the surface takes time, temporary securement of the
implant may be achieved in any desired manner, such as by the use
of sutures.
The ring is formed so that efficient connection between internal
parts of the body and devices external of the body may be provided,
the particular form depending on the end use.
It will be seen that a novel surgical prosthetic device is provided
which has many useful surgical applications and which has many
advantages over prior art methods. The enhanced strength of implant
to bone or soft tissue provided by the porous adherent surface
represents a significant advance in surgery.
The surgical prosthetic device of the invention may be formed in
any convenient manner. For example, the porous coating may be
formed by diffusion bonding of the particles and the surface.
Typically, it is possible to provide a porous adherent coating
having the desired characteristics by using metallic particles,
such as VITALLIUM, having particle sizes from +325 to -100 mesh in
this technique. It is not possible to use -325 mesh powder when
bone tissue ingrowth and calcification is to be sustained since the
interstitial pore sizes of coatings formed from such powder drop
below 50 microns. Implants including coatings formed from such -325
mesh powder are useful, however, where soft tissue ingrowth is to
be sustained, provided that the interstitial pore size does not
fall below 20 microns.
One convenient powder metallurgy technique for forming the coating
in the device of the present invention utilizes a slurry of
metallic powder suspended in aqueous solution with organic binders.
The slurry may be held in a mold around the area of the substrate
to which it is desired to impart the porous coating. Alternatively,
the slurry may be of a consistency to be self-supporting on the
surface.
The slurry is heated to remove the water and finally sintered in an
inert or reducing atmosphere, such as hydrogen, to burn off the
organic binder and fuse the particles together and to the
substrate.
The particle size of the metallic powder and the conditions of
formation of the porous coating are controlled to provide the
desired interstitial pore size, porosity, strength and depth of
coating. For a typical implant of the invention, employing a
VITALLIUM substrate, VITALLIUM powder of from +325 to -100 mesh
particle size requires to be heated at about 2,200.degree.F for at
least 2 hours in a dry hydrogen atmosphere to provide a
satisfactory product. Longer sintering times produces a stronger
product.
A study of the effect of firing time on the properties of VITALLIUM
powder coating (+325 mesh) at a firing temperature of about
2,200.degree.F has indicated a relationship between the density of
the coating and the sintering time. The density is related to the
porosity and the shear strength of the final coating, and the shear
strength therefore varies with sintering time. The results are
indicated in the following Table I:
TABLE I ______________________________________ Sintering Density
Shear Porosity Time g/cc Strength % (hrs.) (psi)
______________________________________ 2 4.8 2,500 40 5 5.2 4,000
35 ______________________________________
(Average values for samples formed by coating and slurry
methods.)
Under certain circumstances, it may be desired to machine the
coating to a particular shape and this may be achieved by firing
the coating to a strength at which the coating is machinable,
machining the coating to the desired shape and then firing the
machined coating to the final forms.
The coating may be formed in any other desired manner, for example,
from the metallic powder. A depression may be formed in the surface
of the substrate, free-flowing metallic powder, in the absence of
organic binder, may be poured into the depression and the powder
fired to produce the coating.
In a typical two-stage operation, a VITALLIUM coating may be fired
at 2,100.degree. to 2,150.degree.F for about one hour to give the
strength. The coating then is machined and fired again at about
2,200.degree.F for at least 2 hours, sometimes for as long as 8
hours, depending on the strength requirements of the final
coating.
Where a slurry is used, the mold may be subjected to pressure
during whole or part of the firing operation.
It is possible to provide the same pore size at two different
positions of tissue ingrowth but in certain circumstances it may be
desirable to provide two different types of coating on the same
implant.
After formation of the composite structure, if desired, the porous
surface may be treated with a variety of materials prior to implant
in the body. These materials may include materials to promote the
growth of hard or soft tissues or with antibiotics.
In the present invention, both the substrate and the powder are
sintered to achieve diffusion bonding between the metal particles
and between the metal particles and the substrate, and hence the
thermal stresses encountered by the prior art by the use of flame
spraying are avoided.
The product of the invention is superior to the prior art in terms
of overall strength and ability to sustain satisfactory
interlocking ingrowth of both bone and soft tissues.
EXAMPLES
The invention is illustrated by the following Examples:
EXAMPLE 1
This example illustrates the formation of a surgical prosthetic
device of the invention.
A VITALLIUM rod of 1/4 inch diameter was degreased and cleaned. An
aqueous VITALLIUM powder slurry consisting of 74 parts by weight of
+325 mesh atomized VITALLIUM powder, 25 parts by weight of an
aqueous solution of 1 percent methylcellulose, 1 part by weight of
a 21/2 percent aqueous solution of dioctyl sodium sulfosuccinate
and 0.25 parts by weight of ammonium hydroxide was made up. This
slurry was applied to the degreased and cleaned VITALLIUM rod to a
depth of 1/32 inch.
After drying, the coated rod was sintered at 2,200.degree.F in a
dry hydrogen atmosphere of 99.99 percent purity for approximately
two hours. The product was cooled in the hydrogen atmosphere.
Examination of the product indicated that the spherical powder
particles had fused at each contact point between themselves and
the rod and an interior communicating substantially uniform pore
structure with pore sizes ranging from 50 to 100 micron was
evident.
EXAMPLE II
Cylindrical rods cut from the product of Example 1 were implanted
into the tibia of adult mongrel dogs. Drill holes were made at
right angles to the longitudinal axes of the tibial shafts and the
implants were introduced so as to penetrate only the medial cortex,
the inner portion of the implant being free in the medullary
cavity. The effective area of contact between the VITALLIUM coating
and the bone was relatively small, being equal to the cortical
surface exposed by the drillhole.
A push-out test designed to measure the force required to dislodge
the implant from the cortical bone was carried out in the following
way. An Instron tester with a compression cell and specially
designed adaptor was used to apply compressive loading directly to
the implant. The specimen of bone was held rigidly in a vice with
care being taken to ensure that the line of action of the loading
force was directly perpendicular to that of the implanted rods. In
each case, a compression load was applied at a rate of 0.2 inches
per minute and the force recorded graphically. The force required
to dislodge the implant was taken as that required to produce the
first movement of the rod. The force per unit area in p.s.i. then
was calculated, affording an expression of the shear strength of
the interface between the bone and the implant material.
The push-out force was tested on various samples after first
inserting into the bone and then after four months' implantation.
Parallel studies were carried out using the rods having porous
coatings formed from -325 mesh VITALLIUM powder. By way of
comparison, test results on smooth VITALLIUM rods also were
obtained. The results are reproduced in the following Table II:
TABLE II
__________________________________________________________________________
+325 mesh VITALLIUM -325 mesh VITALLIUM No coating - psi psi
VITALLIUM rod psi 0 time 4 months 0 time 4 months 0 time 4 months
__________________________________________________________________________
148 1520 49 850 210 220 164 1670 66 930 240 220 180 1690 74 1060
270 300 230 1740 90 1060 300 330 278 1780 98 1140 315 340
__________________________________________________________________________
It will be seen from the results of this Table II that implants of
the +325 mesh VITALLIUM coated specimens showed a markedly enhanced
bonding characteristic, with the force required to dislodge those
being in the range of 1,500 to 1,800 pounds per square inch. The
-325 mesh VITALLIUM coated specimens also bonded well, but the
degree of enhancement of fixation (850 to 1,150 psi) obtained was
less. In complete contrast to these results obtained with products
of the invention, the implants formed only of VITALLIUM rod
exhibited little or no change in bonding characteristics over a
four-month period.
EXAMPLE III
Rods of metal were embedded in polymethylmethacrylate cement. The
metals involved were VITALLIUM having a coating of +325 mesh
VITALLIUM powder, formed as outlined in Example 1, buffed VITALLIUM
and stainless steel.
After 24 hours' immersion, the specimens were trimmed so that there
was no cement adherent to the inferior pole of the rods and the
samples were mounted in the Instron machine of Example II for
compression testing. The flat undersurface of the acrylic provided
an ideal base for conducting the push-out test, care having been
taken in embedding the metal to ensure that the compressive forces
would be applied directly along the long axis of the rod.
The results are reproduced in the following Table III:
TABLE III ______________________________________ VITALLIUM coating
Buffed VITALLIUM Stainless Steel +325 mesh psi psi psi
______________________________________ 1740 530 580 2180 545 595
2470 580 610 2470 610 633 2700 610 660
______________________________________
It will be seen from these results that the implants formed in
accordance with prior art methods may be dislodged from the acrylic
with a force of 500 to 600 psi. In contrast, with the implant of
the present invention, the implant could not be dislodged at all;
instead the acrylic cement shattered, breaking through the line of
the implant without movement of the metal rod. It is apparent,
therefore, that the porous surface provides a greatly increased
surface area for fixation and mechanical interlocking, with
consequentially increased adhesive power. The cement adheres much
more strongly to the porous surface and this fact has considerable
practical application in providing greater stability for the
components of a total hip prosthesis or McIntosh arthroplasty of
the knee.
Modifications are possible within the scope of the invention.
* * * * *