U.S. patent application number 10/215660 was filed with the patent office on 2003-07-10 for joint prosthesis assembly and method for installing same.
Invention is credited to Mansour, Paul G., Snelson, Jamie, Stocks, Gregory W..
Application Number | 20030130740 10/215660 |
Document ID | / |
Family ID | 22428802 |
Filed Date | 2003-07-10 |
United States Patent
Application |
20030130740 |
Kind Code |
A1 |
Stocks, Gregory W. ; et
al. |
July 10, 2003 |
Joint prosthesis assembly and method for installing same
Abstract
A joint prosthesis assembly includes a stem for disposition in a
canal of a first bone constituting a first portion of the joint, a
neck fixed to the stem, a collar fixed on the neck and having a
peripheral groove, and an articulating head fixed on the neck. The
assembly further includes a cup for disposition in a second bone
constituting a second portion of the joint, an insert disposed in
the cup to provide an interior lining for the cup, the insert being
configured to receive the articulating head for movement therein,
and the insert having a peripheral groove therein. A sleeve-shaped
membrane is provided with a first O-ring fixed thereto at a first
end thereof for disposition in the insert groove, and a second
O-ring fixed thereto at a second end thereof for disposition in the
collar groove. The membrane is thereby disposed to capture
particulate debris generated by the articulating head in the
insert. There is further contemplated a method for installing the
assembly.
Inventors: |
Stocks, Gregory W.;
(Bellaire, TX) ; Mansour, Paul G.; (Midland,
TX) ; Snelson, Jamie; (Round Rock, TX) |
Correspondence
Address: |
Mark J. Pandiscio
Pandiscio & Pandiscio
470 Totten Pond Road
Waltham
MA
02154
US
|
Family ID: |
22428802 |
Appl. No.: |
10/215660 |
Filed: |
August 9, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10215660 |
Aug 9, 2002 |
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09540446 |
Mar 31, 2000 |
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6432141 |
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60127197 |
Mar 31, 1999 |
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Current U.S.
Class: |
623/22.17 ;
623/23.21; 623/23.39 |
Current CPC
Class: |
A61F 2002/30028
20130101; A61F 2002/302 20130101; A61F 2002/365 20130101; A61F
2230/0065 20130101; A61F 2310/0097 20130101; A61F 2002/30827
20130101; A61F 2002/009 20130101; A61F 2002/30009 20130101; A61F
2002/30932 20130101; A61F 2230/0067 20130101; A61F 2230/0008
20130101; A61F 2220/0033 20130101; A61F 2/32 20130101; A61F
2002/30682 20130101; A61F 2002/30003 20130101; A61F 2002/30677
20130101; A61F 2002/3021 20130101; A61F 2/34 20130101; A61F
2002/30125 20130101; A61F 2/3662 20130101; A61F 2250/0051 20130101;
A61F 2250/0024 20130101; A61F 2002/30327 20130101; A61F 2002/30822
20130101; A61F 2/30742 20130101; A61F 2002/30828 20130101; A61F
2002/3611 20130101; A61F 2002/3631 20130101; A61F 2220/0075
20130101; A61F 2002/30332 20130101; A61F 2/02 20130101; A61F
2002/30108 20130101; A61F 2002/30217 20130101; A61F 2250/0028
20130101; A61F 2002/30589 20130101; A61F 2002/30011 20130101; A61F
2/36 20130101; A61F 2250/0039 20130101; A61F 2002/30461
20130101 |
Class at
Publication: |
623/22.17 ;
623/23.21; 623/23.39 |
International
Class: |
A61F 002/32; A61F
002/30 |
Claims
What is claimed is:
1. A joint prosthesis assembly comprising: a stem for disposition
in a canal of a first bone constituting a first portion of the
joint; a neck fixed to said stem; a collar fixed on said neck, said
collar having a peripheral annular groove therein; an articulating
head fixed on said neck; a cup for disposition in a second bone
constituting a second portion of the joint; an insert disposed in
said cup to provide an interior lining for said cup, said insert
being adapted to receive said articulating head for movement
therein, said insert having a peripheral annular groove therein;
and a sleeve-shaped membrane having a first O-ring fixed thereto at
a first end thereof for disposition in the insert groove, and a
second O-ring fixed thereto at a second end thereof for disposition
in the collar groove, said membrane being thereby disposed to
capture particulate debris generated by said articulating head in
said insert.
2. A joint prosthesis assembly in accordance with claim 1 wherein
said membrane includes a first end portion at the first end
thereof, a second end portion at the second end thereof, and a
middle portion therebetween, the end portions having apertures
therein permitting ingrowth of tissue to anchor the ends at an
operative site, and the middle portion being devoid of apertures
permitting ingrowth of tissue.
3. A joint prosthesis assembly in accordance with claim 1 wherein
the first and second ends are circularly displaced from each other
around a central axis therethrough by an angle of about
35.degree.-55.degree..
4. A joint prosthesis assembly in accordance with claim 1 wherein
the membrane further includes a middle portion between the first
and second ends thereof, the middle portion being formed so as to
be pre-stressed in a circular direction, around a central axis
thereof, at an angle of about 35.degree.-55.degree..
5. A joint prosthesis assembly in accordance with claim 1 wherein
said insert is further provided with an annular suture groove
proximate said insert peripheral annular groove, said membrane is
provided with a flexible flap extending from the membrane first end
and having a strand of suture fixed thereto, and the insert suture
groove is adapted to receive the strand of suture, to place the
first O-ring in a position proximate the insert peripheral annular
groove.
6. A joint prosthesis assembly in accordance with claim 1 and
further comprising tabs fixed to each of the O-rings for manual
manipulating of the O-rings.
7. A joint prosthesis assembly in accordance with claim 5 and
further comprising tabs fixed to the first O-ring to facilitate
pulling the first O-ring from the position proximate the insert
peripheral annular groove to a second position at which the first
O-ring snaps into the insert peripheral annular groove.
8. A joint prosthesis assembly in accordance with claim 1, wherein
said membrane is generally frusto-conically shaped.
9. A joint prosthesis assembly in accordance with claim 8 wherein
the joint comprises a hip joint, and the membrane is provided with
a larger acetabular end and a smaller femoral end.
10. A joint prosthesis assembly comprising: a stem for disposition
in a canal of a first bone constituting a first portion of the
joint; a neck fixed to said stem; a collar fixed on said neck; an
articulating head fixed on said neck; a cup for disposition in a
second bone constituting a second portion of the joint; an insert
disposed in said cup to provide an interior lining for said cup,
said insert being adapted to receive said articulating head for
movement therein; a sleeve-shaped membrane having a first connector
structure fixed thereto at a first end thereof for connection to
said insert, and a second connector structure fixed thereto at a
second end thereof for connection to said collar, said membrane
being thereby disposed to capture particulate debris generated by
said articulating head in said insert; a first end portion of said
membrane proximate the first end of said membrane and a second end
portion of said membrane proximate the second end of said membrane
having apertures therein permitting ingrowth of tissue to further
secure said membrane in an operative position; and a middle portion
of said membrane being devoid of apertures therein permitting
ingrowth of tissue.
11. A joint prosthesis assembly in accordance with claim 10 wherein
the first connector structure comprises a first O-ring fixed to the
first end portion of said membrane and engageable with said insert,
and a second O-ring fixed to the second end portion of said
membrane and engageable with said collar.
12. A joint prosthesis assembly in accordance with claim 10 wherein
the first and second end portions are circularly displaced from
each other around a central axis therethrough by an angle of about
35.degree.-55.degree..
13. A joint prosthesis assembly in accordance with claim 10 wherein
said middle portion is formed so as to be pre-stressed in a
circular direction around a central axis thereof, at an angle of
about 35.degree.-55.degree..
14. A joint prosthesis assembly in accordance with claim 10 wherein
said end portions are sufficiently porous to permit the tissue
ingrowth, and said middle portion is a selected one of
substantially non-porous and insufficiently porous to permit tissue
ingrowth.
15. A joint prosthesis assembly in accordance with claim 14 wherein
the middle portion is substantially frusto-conically shaped.
16. A joint prosthesis assembly comprising: a stem for disposition
in a canal of a first bone constituting a first portion of the
joint; a neck fixed to said stem; a collar fixed on said neck; an
articulating head fixed on said neck; a cup for disposition in a
second bone constituting a second portion of the joint; an insert
disposed in said cup to provide an interior lining for said cup,
said insert being adapted to receive said articulating head for
movement therein; and a sleeve-shaped membrane having a first
connector structure fixed thereto at a first end thereof for
connection to said insert, and a second connector structure fixed
thereto at a second end thereof for connection to said collar, said
membrane being thereby disposed to capture particulate debris
generated by said articulating head in said insert; wherein the
first and second ends are circularly displaced from each other
around a central axis therethrough by an angle of about
35.degree.-55.degree..
17. A joint prosthesis assembly in accordance with claim 16 wherein
the first connector structure comprises a first O-ring fixed to the
first end portion of said membrane and engageable with said insert,
and a second O-ring fixed to the second end portion of said
membrane and engageable with said collar.
18. A joint prosthesis assembly in accordance with claim 16 wherein
the first and second end portions of said membrane are provided
with apertures therein permitting ingrowth of tissue to further
secure said membrane in an operative position, and the middle
portion of said membrane is devoid of apertures permitting ingrowth
of tissue.
19. A joint prosthesis assembly comprising: a stem for disposition
in a canal of a first bone constituting a first portion of the
joint; a neck fixed to said stem; a collar fixed on said neck; an
articulating head fixed on said neck; a cup for disposition in a
second bone constituting a second portion of the joint; an insert
disposed in said cup to provide an interior lining for said cup,
said insert being adapted to receive said articulating head for
movement therein; and a sleeve-shaped membrane having a first
connector structure fixed thereto at a first end thereof for
connection to said insert, and a second connector structure fixed
thereto at a second end thereof for connection to said collar, said
membrane being thereby disposed to capture particulate debris
generated by said articulating head in said insert; wherein a
middle portion of said membrane is formed so as to be pre-stressed
in a circular direction around a central axis therethrough, by an
angle of about 35.degree.-55.degree..
20. A joint prosthesis assembly in accordance with claim 19 wherein
the first connector structure comprises a first O-ring fixed to the
first end portion of said membrane and engageable with said insert,
and a second O-ring fixed to the second end portion of said
membrane and engageable with said collar.
21. A joint prosthesis assembly in accordance with claim 19 wherein
the first and second end portions of said membrane are provided
with apertures therein permitting ingrowth of tissue to further
secure said membrane in an operative position, and the middle
portion of said membrane is devoid of apertures permitting ingrowth
of tissue.
22. A method for installing a joint prosthesis assembly, the method
comprising the steps of: providing a joint prosthesis assembly
comprising: a stem for disposition in a canal of a first bone
constituting a first portion of the joint; a neck fixed to said
stem; a collar fixed on said neck, said collar having a peripheral
annular groove therein; an articulating head fixed on said neck; a
cup for disposition in a second bone constituting a second portion
of the joint; an insert disposed in said cup to provide an interior
lining for said cup, said insert being adapted to receive said
articulating head for movement therein, said insert having a
peripheral annular groove therein; and a sleeve-shaped membrane
having a first O-ring fixed thereto at a first end thereof for
disposition in the insert groove, and a second O-ring fixed thereto
at a second end thereof for disposition in the collar groove;
mounting a first sub-assembly of said stem, neck, collar and
articulating head on the first bone, and mounting a second
sub-assembly of said cup and insert on the second bone; mounting
the membrane around said articulating head; fitting said
articulating head in said insert; and placing the first O-ring in
the insert groove to fix the membrane first end to said insert, and
placing the second O-ring in the collar groove to fix the membrane
second end to said collar; said membrane being thereby disposed to
capture particulate debris generated by said articulating head in
said insert.
23. A method in accordance with claim 22 and including the further
step of twisting said membrane circularly about its central axis
about 35.degree.-55.degree. before securing the last of (1) the
first O-ring to said insert and (2) the second O-ring to said
collar, with said membrane in a twisted state.
24. A method in accordance with claim 22 wherein said insert is
provided with an annular suture groove proximate but spaced from
the insert peripheral annular groove, said membrane is provided
with a flexible flap extending from the membrane first end and
having a strand of suture connected thereto, and the insert suture
groove is adapted to receive the strand of suture, and wherein the
first O-ring is provided with tabs extending therefrom, and wherein
the steps of placing the first O-ring in the insert groove
comprises the steps of: placing the strand of suture in the insert
suture groove; tightening and tying the strand of suture in the
insert suture groove; and manipulating the tabs to pull the first
O-ring toward the insert peripheral circular groove until the first
O-ring snaps into the insert peripheral annular groove, to fix the
membrane first end to the insert.
25. A joint prosthesis assembly in accordance with claim 1 wherein
the joint comprises one of the group consisting of a knee joint, a
shoulder joint and an elbow joint.
26. A joint prosthesis assembly in accordance with claim 10 wherein
said membrane is formed out of PTFE.
27. A joint prosthesis assembly in accordance with claim 26 wherein
said first end portion of said membrane and said second end portion
of said membrane are formed out of expanded PTFE, and further
wherein said middle portion of said membrane is formed out of
non-expanded PTFE.
28. A joint prosthesis assembly in accordance with claim 1 wherein
said membrane includes an antibiotic.
29. A joint prosthesis assembly in accordance with claim 28 wherein
said antibiotic is applied to the surface of said membrane as a
coating.
30. A joint prosthesis assembly in accordance with claim 28 wherein
said antibiotic is impregnated into the material of said membrane.
Description
REFERENCE TO PENDING PRIOR PATENT APPLICATION
[0001] This application claims the benefit of pending prior U.S.
Provisional Patent Application Serial No. 60/127,197, filed Mar.
31, 1999 by Gregory W. Stocks for ENCAPSULATED HIP REPLACEMENT
PROSTHESIS.
FIELD OF THE INVENTION
[0002] This invention relates to the field of orthopedic surgery in
general, and more specifically to a joint prosthesis assembly and
method for installing same.
BACKGROUND OF THE INVENTION
[0003] A natural hip joint is a ball and socket joint in which a
hemispherical head moves freely within a concave socket.
[0004] Artificial hip joints are an approximation of natural hip
joints. More particularly, artificial hip joints consist of a metal
(or metal alloy) head which articulates inside a metal (or metal
alloy) cup. Often the metal socket is lined with very dense
plastic, typically Ultra High Molecular Weight Polyethylene
(UHMWPE), so as to reduce friction in the artificial bearing.
[0005] In 1994, 165,000 total hip replacements (THR's) were
performed in the United States. Due to the success of the THR
operation, the improved quality of life it provides, and the
increasing elderly population, this number is expected to increase
in the future.
[0006] The expected life of an artificial hip is less than 10 years
in active adults and about 10-20+ years in less active adults. When
the artificial hip wears out, it must be replaced with a new
artificial hip. This procedure is typically referred to as a
"revision". In 1994, THR revision surgery accounted for
approximately 20% of all THR surgery, and is expected to increase
inasmuch as many patients are receiving THR's at an earlier age.
According to The National Center For Health Statistics, the annual
number of total hip revisions will increase to 157,000 by the year
2010 and 219,000 by the year 2030.
[0007] THR revision surgery is typically more complex,
time-consuming and complication-prone than standard THR
surgery.
[0008] Accordingly, it is desirable to find a way to extend the
life of the artificial hip.
[0009] According to the National Institutes of Health, "the
principle cause of prosthesis failure appears to be the generation
of particles, which, in turn, cause inflammation and bone
resorption around the prosthesis (osteolysis)" (NIH Consensus
Statement: Total Hip Replacement. 1994; 12:1-31). The problem of
osteolysis in THR involves three aspects: (a) the creation of
debris particles within the artificial joints; (b) the migration of
the debris particles to the bone around the prosthesis; and (c) a
cellular reaction to the debris particles.
[0010] Extensive research has been published regarding the
aforementioned first and third aspects of the problem.
[0011] More particularly, some current work is aimed at reducing
the production of wear particles at the bearing surface of the
artificial joint by using new metal-on-metal bearing designs, or
modifying existing metal-polyethylene hips; however, it is unlikely
that these modifications will eliminate wear particles completely,
some of which have been found in the liver, spleen, and lymph
nodes, and have been implicated as a cause of cancer.
[0012] Research aimed at reducing osteolysis by better
understanding and controlling the biological cellular response, the
third aspect described above, is widespread. Currently, a
clinically useful approach has not been elucidated, although
anti-inflammatory medications and anti-osteoclast medications show
promise. Many investigators, however, have reservations about
treating a localized problem with a systemic agent.
[0013] The present invention addresses the problem of osteolysis by
focusing on the second aspect identified above, i.e., the migration
of the debris particles to the bone around the prosthesis. More
particularly, the present invention provides an improved
"Sealed-Bearing" total hip replacement (SB-THR) which incorporates
the use of a limiting membrane that encapsulates the bearing and
prevents debris particles from migrating from the prosthesis to the
surrounding bone. The SB-THR could potentially eliminate osteolysis
in the primary THR, thereby sparing thousands of patients from the
ordeal of revision surgery and effecting significant savings in
health care costs to society.
[0014] In addition, the SB-THR has the additional advantage that it
can prevent so-called "third bodies" from entering the space
between the femoral head and the pelvic socket, where they can
accelerate wear on the head and the socket. Such "third bodies"
typically comprise small pieces of bone which are created during
the milling process when the femoral canal is prepared or the
socket seat is prepared; and/or small pieces of the prosthesis
which may flake off the outer surface of the prosthesis, e.g.,
hydroxyapetite or porous metal for encouraging bone ingrowth.
[0015] There has been some prior work in the area of the
sealed-bearing concept. See, for example, U.S. Pat. Nos. 4,731,088
(Collier), 5,514,182 (Shea), and 5,755,807 (Anstaett et al.).
[0016] Accepting that the sealed bearing membrane is advantageous
in eliminating or discouraging migration of debris particles, it
becomes critical that the sealing membrane itself not present a
problem, as by disconnection from a member of the joint.
[0017] A further complication lies in the fact that a sealing
membrane in the hip joint flexes, when a leg is moved, not only in
a bending direction, but also in a twisting or rotating direction,
in which the sleeve-like membrane twists around its central
axis.
[0018] There is, therefore, a need for a membrane adapted to
encapsulate a bodily joint, such as a hip joint, so as to prevent
migration of debris particles. There is further a need for securely
attaching the membrane to the members of the joint. A related
further need exists for effecting long term attachment of the
membrane to the members of the joint, such that upon gradual
elimination of holding power of the initial attachment means, other
attachment means grow stronger and increase the holding security of
the membrane. A still further need exists for compensating for the
bend-and-twist movement of the membrane in hip assemblies, such
that undue strain from repetitive movement does not weaken the
structure of the membrane. And a still further need is to provide
an improved total joint replacement assembly which may be used in
joints other than the hip, e.g., the knee, the shoulder, the elbow,
etc.
OBJECTS OF THE INVENTION
[0019] It is, therefore, an object of the invention to provide a
sealed-bearing type of total hip replacement assembly and/or other
total joint replacement assembly.
[0020] A further object of the invention is to provide such an
assembly which includes an encapsulating membrane which captures
and prevents migration of debris particles.
[0021] A further object of the invention is to provide such a
membrane having thereon means for accurately and securely attaching
the membrane to supporting structures at either end thereof.
[0022] A still further object of the invention is to provide such a
membrane as permits localized ingrowth of tissue to further secure
the membrane to the supporting structures.
[0023] A still further object of the invention is to provide such a
membrane configured to reduce stress fatigue of the membrane
resulting from long term use of the membrane.
[0024] A still further object of the invention is to provide a
method for installing such an assembly.
SUMMARY OF THE INVENTION
[0025] With the above and other objects in view, as will
hereinafter appear, a feature of the present invention is the
provision of a joint prosthesis assembly, the assembly comprising a
stem for disposition in a canal of a first bone constituting a
first portion of the joint, a neck fixed to the stem, a collar
fixed on the neck, the collar having a peripheral annular groove
therein, and an articulating head fixed on the neck, the assembly
further comprises a cup for disposition in a second bone
constituting a second portion of the joint, and an insert disposed
in the cup to provide an interior lining for the cup, the insert
being adapted to receive the articulating head for movement
therein, the insert having a peripheral annular groove therein. A
sleeve-shaped membrane is provided with a first O-ring fixed
thereto at a first end thereof for disposition in the insert
groove, and a second O-ring fixed thereto at a second end thereof
for disposition in the collar groove. The membrane is thereby
disposed to capture particulate debris generated by the
articulating head in the insert.
[0026] In accordance with a further feature of the invention, there
is provided a joint prosthesis assembly comprising a stem for
disposition in a canal of a first bone constituting a first portion
of the joint, a neck fixed to the stem, a collar fixed on the neck,
and an articulating head fixed on the neck. The assembly further
comprises a cup for disposition in a second bone constituting a
second portion of the joint, and an insert disposed in the cup to
provide an interior lining for the cup, the insert being adapted to
receive the articulating head for movement therein. A sleeve-shaped
membrane is provided with a first connector structure fixed thereto
at a first end thereof for connection to the insert, and a second
connector structure fixed thereto at a second end thereof for
connection to the collar. The membrane is thereby disposed to
capture particulate debris generated by the articulating head in
the insert. A first end portion of the membrane proximate the first
end of the membrane and a second end portion of the membrane
proximate the second end of the membrane have apertures therein
permitting ingrowth of tissue to further secure the membrane in an
operative position, and a middle portion of the membrane is devoid
of apertures therein permitting ingrowth of tissue.
[0027] In accordance with a still further feature of the invention,
there is provided a joint prosthesis assembly comprising a stem for
disposition in a canal of a first bone constituting a first portion
of the joint, a neck fixed to the stem, a collar fixed on the neck,
and an articulating head fixed on the neck. The assembly further
comprises a cup for disposition in a second bone constituting a
second portion of the joint, and an insert disposed in the cup to
provide an interior lining for the cup, the insert being adapted to
receive the articulating head for movement therein. The assembly
further includes a sleeve-shaped membrane having a first connector
structure fixed thereto at a first end thereof for connection to
the insert, and a second connector structure fixed thereto at a
second end thereof for connection to the collar, the membrane being
thereby disposed to capture particulate debris generated by the
articulating head in the insert. The first and second ends are
circularly displaced from each other around a central axis
therethrough by an angle of about 35.degree.-55.degree..
[0028] In accordance with still another feature of the invention,
there is provided a joint prosthesis assembly comprising a stem for
disposition in a canal of a first bone constituting a first portion
of the joint, a neck fixed to the stem, a collar fixed on the neck,
and an articulating head fixed on the neck. The assembly further
includes a cup for disposition in a second bone constituting a
second portion of the joint, and an insert disposed in the cup to
provide an interior lining for the cup, the insert being adapted to
receive the articulating head for movement therein. The assembly
further comprises a sleeve-shaped membrane having a first connector
structure fixed thereto at a first end thereof for connection to
the insert, and a second connector structure fixed thereto at a
second end thereof for connection to the collar. The membrane is
thereby disposed to capture particulate debris generated by the
articulating head in the insert. A middle portion of the membrane
is formed so as to be pre-stressed in a circular direction around a
central axis therethrough, by an angle of about
35.degree.-55.degree..
[0029] In accordance with a still further feature of the invention,
there is provided a method for installing a joint prosthesis
assembly. The method comprises the steps of providing a joint
prosthesis assembly comprising a stem for disposition in a canal of
a first bone constituting a first portion of the joint, a neck
fixed to the stem, a collar fixed on the neck, the collar having a
peripheral annular groove therein, an articulating head fixed on
the neck, a cup for disposition in a second bone constituting a
second portion of the joint, an insert disposed in the cup to
provide an interior lining for the cup, the insert being adapted to
receive the articulating head for movement therein, the insert
having a peripheral annular groove therein, and a sleeve-shaped
membrane having a first O-ring fixed thereto at a first end thereof
for disposition in the insert groove, and a second O-ring fixed
thereto at a second end thereof for disposition in the collar
groove. The method includes the further steps of mounting a first
sub-assembly of the stem, neck, collar and articulating head on the
first bone, mounting a second sub-assembly of the cup and insert on
the second bone, mounting the membrane around the articulating
head, fitting the articulating head in the insert, placing the
first O-ring in the insert groove to fix the membrane first end to
the insert, and placing the second O-ring in the collar groove to
fix the membrane second end to the collar. The membrane is thereby
disposed to capture particulate debris generated by the
articulating head in the insert.
[0030] The above and other features of the invention, including
various novel details of construction and combinations of parts,
will now be more particularly described with reference to the
accompanying drawings and pointed out in the claims. It will be
understood that the particular assembly and method embodying the
invention are shown by way of illustration only and not as
limitations of the invention. The principles and features of this
invention may be employed in various and numerous embodiments
without departing from the scope of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0031] The above and other objects and features of the present
invention will be more fully disclosed in the following detailed
description of the preferred embodiments of the invention, which is
to be considered together with the accompanying drawings wherein
like numbers refer to like parts, and further wherein:
[0032] FIG. 1 is a diagrammatic illustration of a natural hip
joint;
[0033] FIG. 2 is a diagrammatic exploded view, partly in section,
of a prior art total hip replacement assembly;
[0034] FIG. 3 is a diagrammatic, partly sectional, view of the
prior art assembly of FIG. 2 installed;
[0035] FIG. 4 is an elevational exploded view of one form of total
hip replacement assembly, less an encapsulating membrane portion,
illustrative of an embodiment of the invention;
[0036] FIG. 5 is a diagrammatic elevational illustration of an
encapsulating membrane portion for use with the assembly of FIG.
4;
[0037] FIG. 6 is a side elevational view of an insert portion of
the assembly of FIG. 4;
[0038] FIG. 7 is an enlarged illustration of a boxed portion of the
insert portion of FIG. 6;
[0039] FIG. 8 is a diagrammatic, partly sectional, view of the
assembly of FIGS. 4 and 5 combined and in operative position;
[0040] FIG. 9 is a diagrammatic perspective view of the
encapsulating membrane portion wherein, for clarity of
illustration, selected structures have been omitted from view;
[0041] FIGS. 10 and 11 are diagrammatic views of an encapsulating
membrane, illustrating an operational feature of prior art
membranes; and
[0042] FIGS. 12 and 13 are similar to FIGS. 10 and 11, but
illustrative of a feature of the inventive encapsulating
membrane.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0043] Referring to FIG. 1, it will be seen that a natural hip
joint 20 comprises a femoral head portion 22, which is generally
hemispherical in shape, and which articulates freely in an
acetabulum 24, forming a natural bearing. A natural semi-permeable
sack or bursa (not shown), generally referred to as the capsule of
the hip joint, surrounds the bearing, enclosing synovial fluid,
which serves to lubricate the bearing. The femoral head portion 22
extends to a femoral neck portion 26, which is sufficiently narrow
to allow full range of motion.
[0044] A prior art artificial hip (FIG. 2) approximates the major
components of the natural joint 20. The artificial hip is typically
made of metal or metal alloy. Traditionally, a hip prosthesis
consists of a femoral sub-assembly 30 and an acetabular
sub-assembly 32. The artificial femoral subassembly 30 includes a
stem 34, which is inserted into a canal 36 in the patient's femur
38 for support and load distribution. During hip replacement
surgery, an incision is made and the patient's hip is dislocated,
revealing the patient's femoral head 22 (FIG. 1) and acetabulum 24
(FIG. 1). The patient's femoral head 22 (FIG. 1) is removed and the
canal 36 (FIG. 2) is drilled into the patient's femur 38. The
artificial stem 34 is fitted into the canal 36, often using bone
cement for anchorage. When bone cement is not used, part of the
stem 34 may be textured or covered with Titanium mesh (or similar
network) to promote bone in-growth. Often, there is a lip 40 for
the distribution of load across the femur 38. An end of the femoral
sub-assembly 30 is an articulating head 42 which may be permanently
attached or press fit onto a femoral neck 44, in which case the
femoral neck 44 is generally in the shape of a Morris taper to
ensure a tight, slip-resistant fit.
[0045] The acetabular sub-assembly 32 comprises a cup 46 in which
the articulating head 42 articulates. The acetabular cup 46 may be
screwed and/or glued into the patient's acetabulum 24 (FIG. 3).
Often, the outer surface of the cup 46 is covered in Titanium mesh,
or similar network, to promote bone in-growth. An insert 48,
typically of plastic material, is usually placed between the
articulating head 42 and the acetabular cup 46 to reduce load and
friction in the bearing. The insert 48 may be made of high density
plastic such as Ultra High Molecular Weight Polyethylene (UHMWPE).
Once installed, the patient's hip is relocated and the incision is
closed.
[0046] The assembly of the present invention is adapted to
encapsulate the bearing of the prosthesis, to prevent migration of
wear particles that are generated by the articulation of the
femoral head portion 42 and the acetabular cup 46, or insert 48. In
addition, the assembly of the present invention can prevent
so-called "third bodies" from migrating into the bearing area of
the prosthesis. Improvements which are made to the current
artificial hip prosthesis, and described herein, include an
increased offset dual-groove UHMWPE insert 50 (FIG. 4), a femoral
collar 52, and a sleeve-shaped encapsulating membrane 54 (FIG.
5).
[0047] The encapsulating membrane 54 is made of biocompatible
material, such as Cytoplast SB.TM., and can easily be extruded into
any desired thickness. The sleeve shape of the membrane 54
preferably is generally frusto-conical, having a larger circular
acetabular end 56, a smaller circular femoral end 58, and a middle
portion 60 extending therebetween. Both ends 56, 58 of the membrane
54 have a connector structure, preferably an attached O-ring 62,
64, respectively, made of the same or similar material as the
membrane 54 for fastening the membrane 54 to the insert 50 and
femoral collar 52. Each O-ring 62, 64 is provided with tabs 66,
preferably set equidistant from each other along its circumference,
to provide a surgeon with a place to hold for pulling the membrane
54 into place and adjusting its location. The tabs 66 may be made
of the same material as the membrane 54 and may be textured to
provide additional "growth points" for the natural bursa to attach
when it regenerates after surgery. The end 56 of the membrane 54
with the larger diameter is, preferably, provided with a flexible
flap 68 that extends along at least a portion of the membrane's
circumference. A suture 70 is contained in the flap 68 to aid in
the installation of the membrane 54, as will be discussed
below.
[0048] Referring to FIGS. 6 and 7, it will be seen that the insert
50 is provided with two grooves 72, 74. The groove 72 is located
close to the open end of the insert 50 and is used to seat and
secure the O-ring 62 on the larger end 56 of the membrane 54. The
groove 74 is disposed approximately 1.5 mm behind groove 72 and is
used to seat the suture 70, which acts as a guide to direct the
placement of the O-ring.
[0049] During installation, visibility in the area of the membrane
end 56 can be limited. To attach the end 56 of the membrane to the
insert 50, the surgeon grasps both ends of the suture 70 and fits
the suture 70 in the groove 74, substantially by "feel" in some
cases. The suture 70 is secured, as by tying, in the groove 74. The
tabs 66 are then pulled until the O-ring 62 pops into place in the
groove 72 (FIG. 7). In effect, suture 70 acts as something of a
pursestring to secure (sometime substantially by feel alone)
flexible flap 68 to groove 74 in insert 50; thereafter, tabs 66 can
be used to manipulate O-ring 62 into groove 72 in insert 50.
[0050] The femoral sub-assembly 30 is provided with the elliptical
femoral collar 52 (FIGS. 4 and 8) around the femoral neck portion
44, with a groove 76 formed along its perimeter. The O-ring 64 from
the smaller end 58 of the membrane 54 is seated in the groove
76.
[0051] As shown in FIGS. 5, 8 and 9, the encapsulating membrane 54
includes the first (acetabular) end portion 56, the middle portion
60, and the second (femoral) end portion 58. The end portions 56,
58 are the portions which are anchored to the joint members, while
the middle portion 60 is not directly anchored to joint members or
tissue. The ends 56, 58 are fabricated so as to be porous, or
otherwise are provided with apertures or recesses or texture or
surface treatment or the like, all of which constructions are
intended to be encompassed by the general term "apertures", so as
to encourage tissue ingrowth. The middle portion 60 is fabricated
so as to discourage tissue ingrowth, as by being made substantially
non-porous, or otherwise without apertures or recesses or texture
or surface treatment or the like of sufficient size to permit
ingrowths, all of which constructions are intended to be
encompassed by the general term "devoid of apertures".
[0052] Thus, if after a period of years the O-rings 62, 64 suffer
from fatigue and their holding power is diminished, the ingrowth of
tissue through the membrane end portions 56, 58 serves to maintain
the membrane securely affixed at either end.
[0053] By way of example but not limitation, encapsulating membrane
54 may be formed out of PTFE, with end portions 56, 58 being formed
out of expanded PTFE so as to encourage tissue ingrowth, and with
middle portion 60 being formed out of non-expanded PTFE so as to
prevent tissue ingrowth.
[0054] If desired, membrane 54 may include an antibiotic to
minimize the risk of infection associated with hip replacement
surgery. The antibiotic may be applied to the surface of the
membrane as a coating, or it may be impregnated into the material
of the membrane.
[0055] In FIGS. 10 and 11, there is illustrated the known fact that
in hip joints, when a proximate leg is flexed, the membrane 54
covering the joint twists, as for example, in the direction
indicated by arrow 80 in FIG. 11. It is known that the twist around
the central axis c-c is about 45.degree..+-.10.degree.. Thus, the
membrane 54 is continually moved from a substantially relaxed
position, as indicated in FIG. 10 wherein hypothetical straight
lines 82 illustrate the relaxed, unstressed state of the membrane
middle portion 60, to a stressed condition, indicated in FIG. 11
wherein hypothetical curved lines 82' illustrate the stressed state
of the membrane middle portion 60. It will be apparent that
continually stressing and relaxing the membrane 54 in this manner
eventually introduces fatigue into the membrane structure, which
may lead to the rupture or tearing of the membrane and the escape
of debris.
[0056] It has been found to be beneficial to provide the membrane
with a pre-set twist of about 45.degree. in the direction opposite
to arrow 80, that is, in the direction of arrow 84 in FIG. 12. The
pre-setting of the twist may be built into the membrane middle
portion 60, as by alignment of fibers in the material of the middle
portion, or may be introduced by the surgeon at the time of the THR
operation. In the latter case, the surgeon manually shifts one end
of the membrane through angle a, preferably an estimated
45.degree., before securing that end in place. Thereafter, upon
flexing of the proximate leg, the "stressed" state, indicated by
hypothetical lines 86 in FIG. 12, is relieved, indicated by
hypothetical lines 86' in FIG. 13, by movement of the middle
portion 60 of the membrane 54 in the direction of arrow 88 around
the central axis c-c.
[0057] Installation of the above-described assembly requires the
steps of mounting the femoral sub-assembly 30, including the stem
34, neck 44, collar 52 and articulating head 42 on the first bone
38, mounting the acetabular sub-assembly 32, including the cup 46
and insert 50 on the second bone 24, mounting the membrane 54
around the articulating head 42, fitting the articulating head 42
in the insert 50, placing the first O-ring 62 in the insert groove
72 to fix the membrane first end 56 to insert 50, and placing the
second O-ring 64 in the collar groove 76 to fix the membrane second
end 58 to the collar 52, the membrane being thereby disposed to
capture particulate debris generated by the articulating head 42 in
the insert 50. In addition, membrane 54 can also prevent so-called
"third bodies" from migrating into the bearing area of the
prosthesis.
[0058] Alternatively, if desired, the membrane's second O-ring 64
can be seated in collar groove 76 before its first O-ring 62 is
seated in insert groove 72.
[0059] In cases in which the aforesaid twist is desired, and is not
formed or pre-set in the membrane 54, the above-described method is
modified to include the further step of twisting the membrane 54
circularly about its central axis c-c, about 35.degree.-55.degree.,
before securing the last of the first O-ring 62 to insert 50 and
the second O-ring 64 to the collar 52 with the membrane 54 in a
twisted state.
[0060] The method described herein, and particularly the step of
placing the first O-ring 62 in the insert groove 72 preferably
further includes the steps of placing the strand of suture 70 in
the insert suture groove 74, tightening and tying the strand of
suture 70 in the insert suture groove 74, and manipulating the tabs
66 to pull the first O-ring 62 toward the insert peripheral annular
groove 72 until the first O-ring 62 snaps into the insert
peripheral annular groove 72, to fix the membrane first end 56 to
the insert 50.
[0061] There is thus provided an improved sealed-bearing total hip
prosthesis including an encapsulating membrane having (1) improved
means for securely mounting at the site, (2) means for further
securing at the site over time, and (3) means for relieving stress
fatigue therein. In addition, there is provided an improved total
joint replacement assembly which may be used in joints other than
the hip, e.g., the knee, the shoulder, the elbow, etc.
[0062] There is further provided a method for installing the
above-described prosthesis assembly.
[0063] It is to be understood that the present invention is by no
means limited to the particular construction and method steps
herein disclosed and/or shown in the drawings, but also comprises
any modifications or equivalents within the scope of the
claims.
* * * * *