U.S. patent number 3,816,854 [Application Number 05/376,220] was granted by the patent office on 1974-06-18 for prosthesis for total arthroplasty of the elbow joint.
Invention is credited to Allen P. Schlein.
United States Patent |
3,816,854 |
Schlein |
June 18, 1974 |
PROSTHESIS FOR TOTAL ARTHROPLASTY OF THE ELBOW JOINT
Abstract
A prosthesis for total replacement arthroplasty of the elbow
joint consists of a hinge joint having two intramedullary stems
adapted for insertion into the medullary canals of the humerus and
the ulna respectively, and which is articulated at the time of
operation. The free end of one of the stems is formed with an
integral partial cylinder within which is secured a cylindrical
bearing member formed of ultra high density polyethylene having an
axial bore for receiving a pivot pin carried on the free end of the
other stem. A radial slot in the bearing member, of a width
slightly less than the diameter of the pivot pin, allows the pin to
be snapped into the bore of the bearing member to form the hinge
joint.
Inventors: |
Schlein; Allen P. (Stratford,
CT) |
Family
ID: |
23484144 |
Appl.
No.: |
05/376,220 |
Filed: |
July 3, 1973 |
Current U.S.
Class: |
623/20.12 |
Current CPC
Class: |
A61F
2/3804 (20130101); A61F 2002/3813 (20130101); A61F
2310/00029 (20130101); A61F 2220/0025 (20130101); A61F
2002/3082 (20130101); A61F 2002/305 (20130101); A61F
2002/3831 (20130101); A61F 2230/0021 (20130101); A61F
2002/30131 (20130101); A61F 2002/4631 (20130101); A61F
2002/3822 (20130101); A61F 2002/30624 (20130101); A61F
2002/30878 (20130101); A61F 2002/30154 (20130101); A61F
2230/0013 (20130101) |
Current International
Class: |
A61F
2/38 (20060101); A61F 2/00 (20060101); A61F
2/30 (20060101); A61F 2/46 (20060101); A61f
001/24 () |
Field of
Search: |
;3/1
;128/92C,92CA,92R |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Kamm; William E.
Assistant Examiner: Frinks; Ronald L.
Attorney, Agent or Firm: Olson; Spencer E.
Claims
I claim:
1. Prosthesis for total replacement of the elbow joint of humans
comprising,
first and second elongated stems formed of a metal alloy which is
essentially nonreactive with body tissue,
said first stem having a U-shaped member integrally joined to and
extending from one end thereof,
a pivot pin secured to and extending between the arms of said
U-shaped member,
said second stem having a bearing member integrally joined to one
end thereof, said bearing member including a cylindrical
non-metallic member having an axial bore of substantially the same
diameter as said pivot pin for supporting said pivot pin to form a
hinge joint, said non-metallic member having a slot extending
radially from the bore to the outer surface thereof and having a
width sufficiently smaller than the diameter of said pivot pin that
said pin is normally retained in the bore yet allows the pivot pin
to be forced through the slot to permit articulation of the hinge
joint after insertion of said items in their respective
intramedullary canals.
2. Prosthesis in accordance with claim 1, wherein said bearing
member comprises a hollow partial cylinder formed of the same
material and integrally joined to said second stem with its
longitudinal axis perpendicular to the longitudinal axis of the
stem, and
wherein said cylindrical member is formed of high density
polyethylene and is secured within said partial cylinder with the
bore coaxial with the axis of the cylinder and with said slot lying
in a plane which includes the axis of the cylinder and is
substantially perpendicular to the longitudinal axis of said second
stem.
3. Prosthesis in accordance with claim 2, wherein the longitudinal
axis of said first stem is offset approximately 7.degree. from an
imaginary plane including the longitudinal axis of said second stem
and perpendicularly bisecting said pivot pin.
4. Prosthesis in accordance with claim 3, wherein the bore in said
cylindrical member is truncated so as to have a slightly larger
diameter at its extremities than at its midpoint for allowing
lateral toggle action of the hinge joint.
5. Prosthesis in accordance with claim 3, wherein said first stem
is shorter than said second stem.
6. Prosthesis in accordance with claim 3, wherein said stems are of
square cross-section.
7. Prosthesis in accordance with claim 2, wherein said hollow
partial cylinder has an inner diameter to receive said cylindrical
member with a press fit and encompasses an arc of at least
180.degree. and has a plurality of bosses protruding from the inner
wall thereof each engaging a respective one of a corresponding
number of depressions formed in the outer surface of said
cylindrical member for securing said cylindrical member within said
partial cylinder.
8. Prosthesis in accordance with claim 2, wherein said partial
cylinder is formed with stops for engaging the arms of said
U-shaped member to limit the included angle between the two stems
to approximately 180.degree..
9. In a prosthesis consisting of a hinge joint having a pivot pin
and a bearing member pivotally engaging the pivot pin, an improved
bearing member comprising,
a hollow partial cylinder formed of a metal alloy which is
essentially nonreactive with body tissue, and which encompasses an
arc of at least 180.degree., and
a cylindrical member formed of high density polyethylene and having
an axial bore and an outer diameter substantially equal to the
inner diameter of said partial cylinder secured within said partial
cylinder,
said partial cylinder having a plurality of bosses protruding from
the inner wall thereof and distributed over its arcuate length each
engaging a respective one of a corresponding number of similarly
distributed depressions formed in the outer surface of said
cylindrical member for preventing axial movement of the cylindrical
member relative to the partial cylinder.
Description
BACKGROUND OF THE INVENTION
Research workers all over the world for many years have attempted a
variety of methods of arthroplasty to lessen the disability for the
patient suffering from rheumatoid arthritis of the elbow joint, or
to replace elbow joints which are relatively immobile due to other
causes such as shattering of the joint as by gunshot. The
development of relatively nonreactive metallic implants has made it
possible to successfully replace the elbow joint. To be successful,
the arthroplasty must not only restore movement and abolish pain,
but must also provide a stable fulcrum for the forearm.
Devices of various types have been developed in an attempt to
satisfy these objectives, two of which are described in the
following articles:
"Arthroplasty of the Elbow Joint Using A Vitallium Prosthesis,"
Constantin Chatzidakis, M.D., International Surgery, Vol. 53, No.
2, February, 1970.
"Total Replacement Arthroplasty of the Elbow Joint for Rheumatoid
Arthritus," Roger Dee, The Journal of Bone and Joint Surgery, Vol.
54B, No. 1, February, 1972.
The prosthesis described in these articles consists essentially of
a hinged joint cast in two sections from a chrome-nickel-cobalt
alloy known as Vitallium (trademark of Howmedica, Inc., New York,
N.Y.) which is articulated at operation by means of an axis pin.
The prosthesis described by Roger Dee, which has enjoyed some
acceptance in Europe, has a bifurcated member at the free end at
one of the stems for receiving the free end of the other stem, the
two members being pivotally joined and held together by a soft
metal pin. One end of the pin is flared at manufacture and after
the stems have been inserted in the medullary canals, the pin is
inserted and retained by flaring the other end with a special
G-clamp. Both stems are curved with their convexity posteriorly,
and the stem of the ulnar component also has a curve which is
convex laterally and follows the corresponding curve of the
olecranon and proximal part of the ulnar shaft. Because of this,
separate prostheses have to be made for the left and right elbows.
Moreover, because of the large size of the hinge joint of the Dee
prosthesis, it is necessary to completely resect the muscle
attachments at the distal humerus, thus seriously weakening the
muscles that extend the arm.
Insofar as applicant is aware, all prostheses of the kind here
under consideration, including the just-described Dee device,
employ a metal-to-metal hinge joint of dissimilar metals which has
undesirably high friction which limits its action and, more
significantly, results in abrasion of the contacting parts and
release of metallic particles which are dispersed to the tissue
surrounding the implant which often cause "giant cell" reaction.
The abrasion also causes pitting of the mating parts which is
aggravated by cathodic action that takes place due to the pin and
stems being formed of different metals. Indeed, the bearing pin
frequently deteriorates to a degree to require replacement which,
of course, subjects the patient to another operation.
SUMMARY OF THE INVENTION
The primary object of the present invention is to provide an
improved prosthesis for total replacement arthroplasty of the elbow
joint which eliminates the above-outlined shortcomings of currently
available prostheses of this type. A more specific object is to
provide a total elbow prosthesis which is smaller than those
currently available, is relatively simple and inexpensive to
fabricate, and which is more easily articulated at operation than
the prostheses now available.
These and other objects are accomplished in a prosthesis consisting
of a hinge joint having two stems which are inserted into the
medullary canals of the humerus and the ulna, respectively, and
which, like the prior art devices, is articulated at the time of
operation. The stems are formed of relatively nonreactive metal,
preferably Vitallium, one end of one of which is formed with an
integral partial hollow cylinder within which is secured a
cylindrical bearing member formed of ultra high density
polyethylene. The bearing member is retained within the partial
cylinder by a plurality of protuberances or bosses formed on the
inside wall of the cylinder which engage corresponding depressions
in the outer surface of the polyethylene cylinder. The bearing
member has an axial bore and a slot which extends radially from the
bore to its outer surface, the slot having a width slightly smaller
than the diameter of the bore. The other stem has a generally
U-shaped member integrally joined to the free end thereof, the
spacing between the legs of which being slightly greater than the
length of the bearing and in which is supported a bearing pin
having a diameter substantially equal to the diameter of the bore
in the bearing member. The polyethylene is sufficiently resilient
that the bearing pin can be readily forced through the slot in the
bearing member to thereby articulate the joint, yet safely and
reliably join the two stems together. Thus, the joint has a
low-friction metal-to-polyethylene bearing which substantially
eliminates the possibility of foreign particles being dispersed
into the surrouding tissue and which is not subject to cathodic
action. There are no protruding fastening means for the bearing
member, and the bearing pin is also flush with the outer surfaces
of the U-shaped member so as not to cause irritation of surrounding
tissue.
Another important feature of the prosthesis is that the
longitudinal axis of the ulnar stem (the one carrying the pivot
pin) is at an angle of approximately 7.degree. relative to a line
perpendicular to the axis of the pin so as to correspond to the
natural carrying angle of the arm. The stem and the integral
U-shaped member being otherwise symmetrical it is thus possible to
use the same ulnar stem for both the left and right arms simply by
flipping the stem through 180 degrees prior to insertion in the
bearing member. Thus, it is unnecessary to provide a different
prosthesis for the left arm than for the right.
DESCRIPTION OF THE DRAWINGS
Other objects, features, and advantages of the invention, and a
better understanding of its construction and operation will be had
from the following detailed description, taken in conjunction with
the accompanying drawings, in which:
FIG. 1 is an exploded isometric view of the prosthesis according to
the invention;
FIG. 2 is an isometric view of the assembled prosthesis;
FIG. 3 is an elevation view of the prosthesis illustrating the
angular relationship between the two stems;
FIG. 4 is an enlarged fragmentary cross-sectional view of one of
the stems illustrating the construction of the bearing member;
and
FIG. 5 is a lateral cutaway view of the human elbow showing the
prosthesis in place.
DESCRIPTION OF THE PREFERRED EMBODIMENT
The prosthesis according to the invention, which is shown
substantially full size in the drawings, consists of two
intramedullary stems, a humeral stem 10 for insertion into the
medullary canal of the humerus, and a somewhat shorter ulnar stem
12 to be inserted in the ulna. Typically, the humeral stem is four
inches long and the ulnar stem has an overall length of 23/4
inches. Both stems are preferably of square cross-section,
typically one-quarter inch square, and slightly pointed at one end
and are formed, as by casting, of a chrome-nickel-cobalt alloy
known as Vitallium. At least two sides of both stems, preferably
opposite sides as shown, are fluted with one or more grooves 14 to
improve their bond with the acrylic cement employed to secure the
stems in the intramedullary canals.
Integrally joined to one end of the humeral stem 10 is a partial
cylinder 16, also formed of Vitallium, the longitudinal axis of
which is perpendicular to the longitudinal axis of stem 10. The
cylindrical member 16 is typically 1/2 inch long and 3/4 inch in
diameter, encompasses slightly more than a 180.degree. arc, with
the open side of the cylinder essentially straddling a plane
containing the longidutinal axis of the cylinder and lying
perpendicular to the longitudinal axis of the stem 10.
As best seen in FIGS. 1 and 4, a plurality of protuberances or
bosses 16a are formed on the inner wall of partial cylinder 16
which, in cooperation with the arcuate shape of the cylinder, serve
to retain a cylindrical bearing member 18 within the cylinder. The
bearing member 18 is preferably formed of ultra high density
polyethylene and has a like plurality of depressions 18a formed in
the outer surface thereof at locations to be engaged by the bosses
16a when it is inserted in the partial cylinder. The bearing member
is dimensioned to be received in the partial cylinder 16 with a
press fit and is sufficiently elastic as to be pressed into either
end of cylinder 16, over the bosses 16a, until it is centered
within the cylinder with the bosses engaging the depressions in the
plastic member. The bearing member has an axial bore 18b and is
formed with a slot 18c which extends radially from the bore to the
outer surface. As best seen in FIG. 4, the width of the slot 18c is
slightly smaller, typically 11/2 mm., than the diameter of the bore
18b. The bore 18b is slightly truncated, being of slightly larger
diameter at its ends than at the midpoint, for reasons to be
discussed below.
The stem 12 has integrally joined to end thereof, as by casting, a
U-shaped member 20 the arms 20a and 20b of which are spaced apart a
distance slightly greater than the length of bearing member 18 and
have a height dimension somewhat less than the diameter of the
bearing member, typically 7/16 inch. The length of the arms is
approximately equal to the diameter of the bearing member and there
is supported therebetween, at a point essentially midway of the
height dimension of the arms and approximately 1/4 inch in from
their free ends, a bearing pin 22 having a diameter approximately
11/2 mm larger than the width of slot 18c and approximately equal
to the midpoint diameter of the trancated bore 18b to allow it to
be "snapped" through the slot. The slight truncation of bore 18b
allows a slight amount of "toggle" between the pin and bore in the
lateral plane, and is designed to allow movement of pin 22 through
an angle of approximately .+-.3.degree. relative to bearing member
18 to compensate for deviation in individual patients from the
average carrying angle of 7.degree. incorporated in the design of
the prosthesis. Moreover, the non-rigid joint minimizes the chance
of breakage of the bearing member or pin in the event the patient
should fall on the elbow. The pin 22, also formed of Vitallium, is
secured in openings in the arms 20a and 20b, preferably be
electrowelding, and the ends ground smooth and flush with the outer
walls of the arms, as by centerless grinding, to remove any source
of irritation to surrounding tissue.
As shown in FIGS. 1 and 2, cylinder 16 is slightly longer than
bearing member 18 and has cutouts 16b at the lower front edge
thereof which serve as stops for the arms 20a and 20b when the stem
12 is at an angle of about 180.degree. relative to stem 10, thereby
to prevent motion of the forearm beyond its normal fully extended
position. Because in the average human the center line of the
humerus makes an angle of about 7.degree. with the center line of
the ulna (the one of two bones of the forearm that articulate), the
stem 12 is formed such that its longitudinal axis makes an angle of
approximately 7.degree. with the longitudinal axis of stem 10 when
the joint is articulated. Although evident in FIGS. 1 and 2, this
feature is best seen in the elevation view of FIG. 3 where it is
seen that the axis of stem 12 is at an angle of 7.degree. relative
to the longitudinal axis of stem 10. This angle is outward from the
body with the consequence that stem 12 must be on one side or the
other of stem 10 depending upon whether the implant is in the left
or the right arm. By virtue of the symmetrical location of pin 22
in the U-shaped member 20, it is possible to accomodate either the
left or right arm with the same device by inserting stem 12 in the
orientation shown in FIG. 1 and in solid line in FIG. 3 for one arm
and simply flipping the stem 12 through an angle of 180.degree.
from the position shown in FIG. 1 when the implant is to be made in
the other arm. In the latter case, shown in dot-dash lines in FIG.
3, the 7.degree. angle is at the opposite side of the center line
of stem 10.
Without going into the full details of the operation procedure, the
manner in which the prosthesis is inserted will now be generally
described with reference to FIG. 5. Good access to the medial and
lateral aspects of the elbow is provided by a curved postero-radial
incision and by raising full thickness flaps. Depending on the
nature of the damage to the osseous structures, the proximal ulna
is cut away and a slot is cut in the distal humerus having a width
sufficient to accomodate the pivot joint of the prosthesis. By
virtue of the ability to accomodate the present relatively small
prosthesis in the slot in the humerus, the amount of bone that need
be removed from the ulna is such that the triceps insertion is
never completely destroyed, that is, the muscle that extends the
arm is not appreciably weakened by the operation. The medullary
cavities are reamed out to the necessary depth to receive the stems
12 and 14 and the proximal portions shaped as needed using a rasp.
The ulnar stem is then cemented into position with acrylic cement,
for example, and after a trial reduction, the humeral stem is also
cemented into place. Alternatively, in cases where the ligamentous
structure is so tight as to preclude pulling apart of the
components of the elbow, the cement is initially put into both
cavities and both stems introduced simultaneously, with the pin 22
engaging the outer extremity of the slot 18c. The joint is
articulated by snapping the pin 22 through slot 18c into the bore
18b of the bearing member. Articulation can be accomplished with
relatively little force, and thus minimul trauma to the patient,
and requires no special tools. Similarly, in the unlikely event
that the prosthesis need ever be repaired or removed, special tools
are not required to disengage the pin from the bearing member.
It will be apparent from the forgoing that applicant has provided a
total elbow prosthesis which by reason of its small size permits
improvement in the surgical procedure, is free of external
protuberances that could cause irritation of surrounding tissue,
has low friction, does not have metal-to-metal contacts which can
cause dispersion of reactive metal particles or result in
deleterious cathodic action, and which can be readily articulated
without the need for special tools. While there is disclosed what
is now considered to be a preferred embodiment, many modifications
and variations therein will be readily apparent to those skilled in
the art. Accordingly, all such variations and modifications are
included within the intended scope of invention as defined by the
following claims.
* * * * *