U.S. patent number 3,866,248 [Application Number 05/458,692] was granted by the patent office on 1975-02-18 for cement restrictor for total hip operations.
This patent grant is currently assigned to Abcor, Inc.. Invention is credited to Frederick J. Kummer.
United States Patent |
3,866,248 |
Kummer |
February 18, 1975 |
CEMENT RESTRICTOR FOR TOTAL HIP OPERATIONS
Abstract
A cement restrictor device adapted for use in a hip replacement
operation, which device comprises: a raised cap-like upper element
defining a cavity therein, the upper element having a continuous
solid upper surface, the lower edge of the element adjoined to a
peripheral lid element extending outwardly from the lower edge
thereof, the lower crown portion of the cap-like element generally
adjacent to the adjoinment to the lid element characterized by a
plurality of peripheral passages therein to permit the passage of a
cement material therethrough, whereby the upper element may be
inserted into a hole in a bone of about the size of the upper
element and cement applied to the interior cavity and forced
through the passageway so as to lock the device between the lid
element and the cement into the hole in the bone.
Inventors: |
Kummer; Frederick J. (Boston,
MA) |
Assignee: |
Abcor, Inc. (Cambridge,
MA)
|
Family
ID: |
23821735 |
Appl.
No.: |
05/458,692 |
Filed: |
April 8, 1974 |
Current U.S.
Class: |
606/92;
623/23.48 |
Current CPC
Class: |
A61F
2/30723 (20130101); A61F 2/34 (20130101); A61F
2002/30065 (20130101); A61F 2002/30309 (20130101); A61F
2002/30574 (20130101); A61F 2230/0063 (20130101); A61F
2002/4631 (20130101); A61F 2002/3082 (20130101); A61F
2/32 (20130101); A61F 2002/30777 (20130101); A61F
2210/0071 (20130101); A61F 2002/30787 (20130101); A61B
17/8808 (20130101) |
Current International
Class: |
A61F
2/30 (20060101); A61F 2/00 (20060101); A61F
2/32 (20060101); A61F 2/34 (20060101); A61F
2/46 (20060101); A61f 001/24 () |
Field of
Search: |
;3/1
;128/92C,92CA,92R,83 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
Muller Total Hip Prosthesis, (Advertisement Page XXV), The Journal
of Bone & Joint Surgery, British Vol. 53-B, No. 3, August,
1971. .
The Journal of Bone & Joint Surgery, British Vol. 54-B, No. 1,
February, 1972, Advertisement page by Thackray Charnley, P.O. Box
171, Park Street, Leeds LS1, 1RQ, England..
|
Primary Examiner: Frinks; Ronald L.
Attorney, Agent or Firm: Crowley; Richard P.
Claims
What is claimed is:
1. A cement restrictor device adapted for use in a hip replacement
operation, which device comprises:
a raised cap-like upper element defining a cavity therein, the
upper element having a continuous solid upper surface, the lower
edge of the element adjoined to a peripheral lid element extending
outwardly from the lower edge thereof, the lower crown portion of
the cap-like element generally adjacent to the adjoinment to the
lid element characterized by a plurality of peripheral passages
therein to permit the passage of a cement material therethrough,
whereby the upper element may be inserted into a hole in a bone of
about the size of the upper element and cement applied to the
interior cavity and forced through the passageway so as to lock the
device between the lid element and the cement into the hole in the
bone.
2. The device of claim 1 wherein the upper cap-like element is a
hemispherical dome-like element.
3. The device of claim 1 wherein the device comprises a polymeric
material of olefinic resin or nylon.
4. The device of claim 1 wherein the passageways are generally
equally spaced about the periphery and the number of passageways
ranges from about 5 to 15.
5. The device of claim 1 wherein the diameter of the cavity is
about one-half the diameter of the lid element.
6. The device of claim 1 wherein the passageways comprise a
plurality of slots about the periphery.
7. A cement restrictor device adapted for use in an operation to
lock the device into a hole in a bone, which device comprises:
a hemispherical dome-like raised upper element defining a cavity
therein, the upper element having a continuous solid upper surface,
the lower edge of the upper element adjoined to a peripheral flat
lid element extending outwardly from the lower edge thereof, the
lower crown portion of the upper element generally adjacent to the
lid element characterized by a plurality of equally spaced slot
passageways therein to permit the passage of cement therethrough,
the device composed entirely of a medically acceptable polymeric
material, whereby the dome-like element may be inserted into a hole
in a pelvic bone, cement applied to the cavity and forced through
the slot passageways and hardened to lock the device into the hole
between the hardened beads of cement and the lid element.
8. In a method of replacing a diseased or damaged hip which
comprises:
a. reaming a cavity into the pelvic bone of a patient;
b. drilling a plurality of holes into the bone to provide a means
to anchor a socket element therein by the use of a hardenable
cement;
c. inserting in the holes a cement restrictor device which
comprises a raised cap-like upper element defining a cavity
therein, the upper element having a continuous solid upper surface,
the lower edge of the element adjoined to a peripheral lid element
extending outwardly from the lower edge thereof, the lower crown
portion of the cap-like element generally adjacent to the
adjoinment to the lid element characterized by a plurality of
peripheral passages therein to permit the passage of a cement
material therethrough;
d. applying a cement material to the interior of the reamed cavity
and forcing some of the cement through the passageways of the
cement restrictor device;
e. inserting a prosthetic socket element into the cement-coated
cavity; and
f. hardening the cement to secure the cement restrictor to the
holes and the socket element within the cavity.
9. The method of claim 8 wherein the cement restrictor device and
the socket element are composed of the same or similar polymeric
material.
10. The method of claim 8 wherein the cement restrictor device is
composed of high-density polyethylene.
11. The method of claim 8 wherein the cement material is a
dough-like composition of polymethylmethacrylate.
12. The method of claim 8 wherein the passageways in the cement
restrictor device are slot passageways equally distributed about
the periphery, the device is composed of a polymeric material, and
the upper element comprises a hemispherical dome-like element.
Description
BACKGROUND OF THE INVENTION
The employment of prosthetic devices in a total hip operation for
the replacement of diseased or damaged hips is becoming a rather
common operation. A number of prosthetic devices used in such hip
operations are available. One such device referred to as a Charnley
device comprises a metal femoral (ball or shank) component which
articulates in an acetabular polymer socket component. In use, the
surgeon reams a hemispherical shaped cavity into the pelvic bone
and then drills typically three or four holes into the bone at the
bottom of the cavity to aid in anchoring the socket therein. A
device known as a Charnley cement restrictor is then inserted into
each of the drilled holes. The Charnley cement restrictor comprises
a fine wire mesh screen in the general shape of a top hat, with the
wire formed of stainless steel or a cobalt-chromium alloy known as
Vitallium (a trademark of Howmedica, Inc.) A dough-like polymeric
cement material is then spread onto the inner surface of the reamed
pelvic hole. The purpose of the Charnley cement restrictor is to
prevent the cement from entering the abdominal cavity of the
patient, and to aid in mechanically locking the socket in the
pelvic cavity with the hardened cement. Typically, the cement
penetrates the screen of the Charnley cement restrictor and forms
small beads thereon. The polymeric socket is then inserted into the
cement-lined cavity and the cement hardened to hold the socket
therein.
Recent work (Corrosion Behavior of a Metallic Implant: A Scanning
Electron Microscope Study, by J. W. Pugh, W. Jaffe, F. J. Kummer
and J. C. Runkle, 2nd Annual Bioengineering Conference of New
England Proceedings, April 1974) indicates that such implanted
metallic components corrode with crevice corrosion particularly
rapidly, which corrosion may necessitate a major operation to
remove the corroded metallic components.
Further, a disadvantage of the Charnley cement restrictor employed
in such total hip operations is the penetration of the cement into
and through the fine wire screen and the formation of small hard
cement beads on the abdominal side of the screen. Such beads are
subject to breaking off in use and migrating into the abdominal
cavity and effecting a loosening of the prosthesis socket component
in the cavity.
SUMMARY OF THE INVENTION
My invention concerns an improved cement restrictor, the method of
manufacturing and the method of employing such restrictor. In
particular, my invention relates to an all-polymeric cement
restrictor and the method of employing such restrictor in place of
the Charnley cement restrictor in total hip operations.
My cement restrictor comprises a polymeric device formed into a
general top-hat or derby-hat-like shape having dome and lid
sections, with a plurality of holes about the periphery of the
crown where the dome section joins the flat lid section. My cement
restrictor device provides an effective and efficient means through
the position of the holes to distribute the cement material to
insure excellent locking and mechanical stability of the device
within the pelvic holes. Further, the holes employed in my device
distribute and direct the cement in a manner to lock the prosthesis
into the holes within the pelvic cavity. The employment of a solid
dome section and holes about the crown prevents small beads of
cement from forming on the abdominal side of the dome section,
while permitting the larger beads of cement forced through the
crown holes to hold the device in place.
My device is formed of a medically acceptable polymer and
preferably of the same or similar type of polymer as the type of
socket component used, such as, but not limited to, olefinic resins
like polyethylene and polypropylene, polyamides like nylon, and
other polymeric materials capable of being employed within the
human body. My polymeric cement restrictor is nonreactive with the
cement material, noncorrosive, and particularly avoids crevice
corrosion problems of the prior art, is noncarcinogenic in nature
and exhibits sufficient strength and stiffness to prevent the
cement from pushing the restrictor out of place. My cement
restrictor has many distinct and important advantages over the
presently employed Charnley or other cement restrictor devices.
My cement restrictor may be manufactured by forming the polymeric
material into the desired shape, such as by forming a thermoplastic
polymer as a sheet material under heat and pressure on a mandrel or
in a mold or by other techniques of forming such polymers, such as
by casting, extruding, blow-molding and the like, either as one
component or in separate components, and then formed or assembled
into the desired form.
My cement restrictor is characterized by a continuous solid,
raised, central component, such as a dome or other shape. The
number, type, arrangement, size and shape of the holes about the
periphery of the crown or the area just above the lid section may
vary, depending on the particular needs and use of the device. It
is essential that the holes be positioned in the crown area near
the lid and about the periphery in a single or multiple lines. It
is preferred also that the holes be sufficient in size to permit
the cement to be forced therethrough to form a large bead, such as
a mushroom shape when arcuate-like slits are used to hold the
restriction in the holes and to prevent the formation of very small
beads which might break off; e.g., average hole sizes or diameters
of 1/16 to 1/4 inch, with from about 5 to 15 holes equally spaced.
Holes of such size in the form of circles, slots, stars, crosses,
etc. may be usefully employed.
Holes should not be placed in the upper dome section, since the
cement forced therethrough does not contribute to the locking
action and may break off if small beads are formed. Thus, it is
essential that the upper top section be a solid section. With a
continuous solid dome section, the cement is forced by the
hemispherical dome shape back toward the holes in the crown
section, and is used more effectively.
Any cement material medically acceptable for use in the operation
may be employed; however and typically, a polymeric cement which is
noncarcinogenic, nonreactive with the polymer used for the socket
component, and in a dough-like form or a composition of similar
consistency is employed. A common cement material is a curable
acrylic polymer, such as polymethylmethacrylate known as Simplex (a
Trademark of Howmedical, Inc.).
My invention will be described for the purposes of illustration
only in reference to a cement restrictor device in a total hip
operation with a Charnley prosthetic device; however, my device may
be usefully employed in other prosthetic operations and with other
prosthetic devices as a cement restrictor.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a schematic illustration of a Charnley prosthetic
device.
FIGS. 2A and 2B are representative illustrations of the side and
front views respectively of a pelvic bone section showing my cement
restrictor used therein.
FIG. 3 is an illustrative view of a polymeric sheet prior to being
formed into my device.
FIG. 4 is a side view of my cement restrictor device.
FIG. 5 is a perspective view of my cement restrictor device.
FIG. 6 is a representative enlarged cross-sectional view of my
cement restrictor device in use along lines 6--6 of FIG. 2.
DESCRIPTION OF THE EMBODIMENTS
FIG. 1 shows a Charnley prosthetic device 10 used in total hip
operations comprising a femoral ball and shank element 12 of
stainless steel or Vitallium, and a high-density polyethylene
socket element 14, with the external surface to be placed into the
reamed pelvic cavity grooved or otherwise formed or treated to be
held by the hardened cement. The polyethylene socket 14 has a
diameter of about 3 inches and a depth of slightly less than 11/2
inches.
FIGS. 2A and 2B show views of a pelvic bone section 16 with a
hemispherical cavity 18 therein reamed out by the surgeon during
the hip operation and typically to a diameter of about 4 inches and
a depth of 1 and 1/2 inches. Four holes 20 are drilled into the
bone element 16 and inserted in each hole is my cement restrictor
22. The holes 20 are usually about 1/2 inch in diameter.
FIG. 3 shows a generally circular polymeric sheet material 24
composed of high-density polyethylene preferably of the same or
similar type as used in the socket 14, the sheet about 40 to 60
mils. in thickness to provide sufficient strength to the restrictor
22 to prevent it from being forced out of the holes 20 on the
application of the cement by the surgeon. The sheet 24 has a
plurality of arcuate-shaped holes or slots 26 distributed in a
circular ring about the center of the sheet, with the area in the
middle to form the dome element 28 and the area outside the slots
26 to form the lid element 30. The sheet 24 is then hat-formed,
such as, for example, over a mandrel or in a vacuum mold, to form
the cement restrictor as shown in FIGS. 4 and 5.
FIGS. 4 and 5 show one embodiment of the cement restrictor 22 of my
invention comprising a rounded, continuous solid, dome-like top
element 28, a plurality of slots 26 equally spaced and formed about
the lower crown area of the top element 28 just above the lid
element 30. The restrictor 22 has a hemispherical internal cavity
therein. It is essential to position the slots 26 only in the crown
area and not in the middle or top of the dome area 28, since,
otherwise, cement may be permitted to enter the abdominal cavity.
The slots 26 illustrated are about 1/8 of an inch in depth, and the
ten slots are equally spaced about the crown periphery. The
restrictor is about 1 inch in overall diameter, with the cavity
diameter of about 1/2 inch to fit into the holes 20, and a depth of
about 1/2 inch. Arcuate-type slots of from 7 to 10 in number are
preferred for the holes, since such slots provide for a large
mushroom-like bead of cement adjacent the pelvic bone which insures
a good locking action.
FIG. 6 is an enlarged cross-sectional view along lines 6--6 of FIG.
2 showing the restrictor device 22 in use, with a hardened cement
material 34 forming mushroom-like beads 36 by being forced through
slots 26 to secure the device 22 to the bone wall 16, while the lid
30 is on the other side of the bone wall. The cement material is
polymethylmethacrylate or other acceptable hardenable cement.
In use, the surgeon smears and packs the dough-like cement material
34 into the internal walls of the cavity 18 to a depth of about 1/4
to 1/2 an inch, and then inserts the socket 14 into the cavity.
My cement restrictor may be formed of a metal or metal alloy where
corrosion is not a problem. My device may be used in any
application where it is desired to provide a cement-locking means
with restricted cement on the opposite side of the device.
* * * * *