WO2001080772A1

WO2001080772A1 - Wear-resistant artificial joint

Info

Publication number: WO2001080772A1
Application number: PCT/US2001/012870
Authority: WO
Inventors: Behrooz Tohidi
Original assignee: Behrooz Tohidi
Priority date: 2000-04-21
Filing date: 2001-04-20
Publication date: 2001-11-01
Also published as: AU2001257137A1; US20030208280A1

Abstract

Artificial joints (100) wherein the mating surfaces (104 and 102) are both non-metallic, preferably plastic, even more preferably polyethylene and even more preferably ultra-high molecular weight polyethylene. Because neither of the bearing surfaces (108 and 110) of the artificial joint are made of metal, there is a potential for greatly reduced wear, and consequently, a potential for reducing the number of joint replacement surgeries.

Description

WEAR-RESISTANT ARTIFICIAL JOINT

The present invention relates to orthopedic prostheses utilized in joint replacements, and more particularly to prosthetic joint replacements wherein there is moving contact

between mating (or bearing) prosthetic surfaces.

BACKGROUND OF THE INVENTION

The bones of a human (or animal) skeleton provide rigid, structural reinforcement for the body. Despite this rigidity, movement of the body (walking, chewing, etc.) is still

permitted by the fact that bones are attached to each other at movable joints, where two or

more separate bones move relative to each other.

One common joint geometry is the hinge joint, such as the hinge joint of the human

elbow or knee. A pure hinge joint allows relative rotation, such that both bones maintain a constant, mutual planar orientation. Another common joint geometry is the ball-and-socket

joint, such as the human shoulder joint. A ball-and-socket joint allows rotation in more than

one plane. Then there are more complex joint geometries, which can facilitate complex

combinations of relative translational and rotational movement between adjacent bones.

Examples of these more complex geometries can be found in the human jaw and the human hip.

In all of these types of joints, bones come into direct, physical contact with each other.

At the joint, the bones move relative to each other, exhibiting rotational contact, rolling

contact, translational contact, or some combination of these. Of course, this moving contact

causes wear on the joints themselves. However, the portions of bones that come into mutual contact at joints are generally

coated with cartilaginous material (or cartilage) The natural cartilage has a combination of

material properties, such as hardness, coefficients of friction, elasticity and compressive strength, so that the cartilage wear due to moving contact at the joint is relatively slow, and

the cartilage at the joint typically outlasts the life of the human or animal to whom the joint

belongs In this case, the wear at the joint is not considered very problematic

Nevertheless, some people live long enough that their joint cartilage deteriorates

and/or wears out More particularly, the cartilage can wear or deteriorate down to the bone material portion of the joint When this happens, catastrophic or semi-catastrophic failure of

the bone can occur due to the lack of capacity that bone matter has with respect to moving

contact and wear This wear problem is especially likely to occur if the joint (1) had less

cartilage than normal to begin with, (2) is subject to a disease that affects cartilage, (3) is

subject to an accident or other trauma affecting the cartilage, (4) is exercised more often than

average, and/or (5) is routinely placed under greater-than-average stress The problem of

cartilage wear is especially prevalent at the knee joint and hip joint, in part because the weight

of the human body bears on this joint as it moves during walking, running and even standing, thereby exacerbating wear

In an effort to restore functions of a deteriorated or damaged joint, surgeons have

devised numerous methods of partial and total joint replacements In these joint replacements,

portions of the bone at the existing joint are either removed or supplemented with prosthetic

components designed to restore some or all of the original functionality of the joint Today,

hip and knee joint replacements are common Increasingly, shoulder joints and other joints in

the body are being replaced as well Existing joint prostheses generally have a protruding, or male, member (sometimes

called a "ball") and a recessed, or female, member (sometimes called a "socket") Initially,

both the male and female members were made of metal However, experience indicated that this metal-on-metal construction resulted in a high degree of wear in the earlier designs at

locations where there was moving contact between the male member and the female member

(The locations where mating joint surfaces contact are herein called "bearing surfaces ") This wear on bearing surfaces caused early artificial joint failures, and usually mandated additional

surgery to go back into the body and replace the worn artificial joint with a fresh, new artificial

joint

In order to reduce wear on the joint components, the female component was modified

to include a non-metallic (usually plastic) insert, which covered the bearing surface of the female component This has resulted in artificial joints that have metal-on-plastic contact,

which has been the prevalent artificial joint design for some time now One example of an

artificial joint that utilizes dissimilar materials at the bearing surfaces is presented in U S

patent 5,879,407 to Waggener In Waggener an artificial joint includes a ball and a socket

The surface of the ball is ceramic and the surface of the socket is made of a noble metal or

alloy, such as platinum An example of a more common plastic-on-metal artificial joint is

shown in U S patent 4,055,862 to Farling

In metal-on-plastic joints, considerable research has been directed toward improving

the characteristics of the plastic insert so that its moving contact with the metal surface of the

mating artificial joint component would undergo minimal wear in normal use

Notwithstanding some advances in the area of metal finishes, as well as in the area of polishes

for the plastic insert, the metal-on-plastic design still has significant wear and tends to fail over time due primarily to wear. More particularly, there are two distinct concerns about wear.

One concern is that the bearing surface will wear out completely, such as when a plastic insert

bearing surface wears out and exposes an underlying stem. Another concern is that particles

that wear off of the joint may remain in the vicinity of the joint and cause problems such as

increased wear and loosening of the insert or prosthesis.

SUMMARY OF THE INVENTION

The inventor of the present invention has recognized a problem inherent in the above-

described artificial joint research. Specifically, the research appears to be fixated on metal-on-

plastic artificial joints. The possibility of plastic-on-plastic artificial joints appears to have been neglected or rejected as unfeasible.

According to the present invention, and ignoring the conventional wisdom that

artificial joints should be metal-on-metal or plastic-on-metal, it has been determined that

plastic-on-plastic artificial joints are feasible, and are sometimes superior to conventional

plastic-on-metal designs. This is especially true for plastic-on-plastic joints where the plastic material(s) are chosen to have superior wear characteristics. Generally speaking, less wear

means fewer artificial joint failures and associated artificial joint replacement surgeries.

More subtly, wear resistant artificial joints made according to the present invention

may facilitate the manufacture of artificial joints that precisely emulate the complex bearing

surface geometry of a healthy joint. This is good because it allows the body to move in a

natural fashion and will limit range of movement less. Also, if more precise emulation of

healthy joint geometry is achieved, the reduced wear of the present invention can help the joint

maintain this geometry over time. For example, if a normal joint bearing surface has a narrow ridge, the plastic-on-plastic artificial joint of the present invention may be made to more easily

form the narrow ridge in the first place, and to also allow the narrow ridge to hold out against wear over time

According to a preferred aspect of the present invention, ultra high molecular weight

polyethylene ("UHMWPE") is used on both mating, bearing surfaces of an artificial joint This

UHMWPE-on-UHMWPE joint experiences very little wear and represents a tremendous

advance over conventional metal-on-plastic joints The decrease in artificial joint wear on

artificial joints made according to the present invention may mean fewer replacement surgeries and diminished surgery-related health risks

At least some embodiments of the present invention have one or more of the following

advantages, objects and/or benefits

(1) to provide an artificial joint that exhibits less wear in normal use,

(2) to provide an artificial joint that less frequently experiences catastrophic or

semi-catastrophic failure in normal use,

(3) to provide an artificial joint that generates less debris at its bearing surface,

(4) to provide an artificial joint that requires less frequent (surgical) replacement,

(5) to provide an artificial joint that is easier to move,

(6) to provide a less expensive artificial joint,

(7) to provide an artificial joint that can be more easily manufactured and sculpted

to better match the shape of the cartilaginous surface of a healthy joint, and

(8) to provide an artificial joint that can better maintain the (sometimes intricate)

shape of the cartilaginous surface of a healthy joint, notwithstanding wear caused by normal

use of the artificial joint According to the present invention, an artificial joint includes a first joint member and a second joint member. The first joint member includes a first bearing surface made of artificial,

non-metallic material. The second joint member includes a second bearing surface made of

artificial, non-metallic material. The first bearing surface and the second bearing surfaces are

shaped to mate to guide relative movement of the artificial joint.

According to another aspect of the present invention, an artificial human knee joint

includes a first joint member and a second joint member. The first joint member includes a

first bearing surface made of artificial material. The second joint member includes a second

bearing surface made of artificial material. The first bearing surface and the second bearing

surfaces are shaped to mate to guide relative movement of the artificial joint. The first and

second bearing surfaces have a coefficient of friction of less than 0.1 when the joint is placed under normal use in a human body.

According to another aspect of the present invention, an artificial joint includes a first

joint member, which includes a first bearing surface and a first anchor member. The first

anchor member has a generally tubular shape, and includes an inner anchor surface and an

outer anchor surface. The inner anchor surface is disposed around an interior surface of the

first anchor member. The outer anchor surface is disposed around an exterior surface of the first anchor member.

Other advantages, objects and benefits will become apparent through a review of the rest of this document. BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will become more fully understood from the detailed description

given below, together with the accompanying drawings, which are given by way of illustration

only, and thus are not to be construed as limiting the scope of the present invention In the

drawings

Fig 1 is a perspective view of a first embodiment of an artificial joint according to the present invention,

Fig 2 is a cross-sectional view of the first embodiment of an artificial joint according

to the present invention,

Fig 3 is a cross-sectional view of a second embodiment of an artificial joint according to the present invention,

Fig 4 is a perspective view of a third embodiment of an artificial joint according to the present invention,

Fig 5 is a cross-sectional view of the femoral component of the third embodiment artificial joint, and

Fig 6 is another cross-sectional view of the femoral component of the third embodiment artificial joint

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Before starting a description of the Figures, some terms will now be defined

DEFINITIONS the present invention: at least some embodiments of the present invention; references

to various feature(s) of the "present invention" throughout this document do not mean that all

claimed embodiments or methods include the referenced feature(s). ultra high molecular weight polyethylene ("UHMWPE"): any polyethylene resin with a

molecular weight greater than 1,000,000.

"at least double melt": material that has undergone double melting, triple melting or

any greater number of melts.

"at least triple melt": material that has undergone triple melting or any greater number

of melts. bone: can include calcic matter, as well as cartilaginous matter, marrow and any other

type of matter included in a bone structure.

coefficient of friction: refers to the specific coeffecient of friction value as normally measured in the context of artificial joints.

open-ended interior space of an artificial joint component: refers to interior space that

is open ended at the time the artificial joint is inserted in a bone.

Artificial: means material not made by a body at the location where the material is

present in the body; for example, plastic is an artificial material because it is not manufactured by a body at all; as a further example, if material is taken out of a person's left knee and

inserted into their right knee, that material would be artificial, for purposes of this document,

because the material, while manufactured by the body, is not located at the location where the

body manufactured it.

To the extent that the definitions provided above are consistent with ordinary, plain

and accustomed meanings (as generally evidenced, inter alia, by dictionaries and/or technical lexicons), the above definitions shall be considered supplemental in nature To the extent that

the definitions provided above are inconsistent with ordinary, plain and accustomed meanings

(as generally evidenced, inter alia, by dictionaries and/or technical lexicons), the above

definitions shall control If the definitions provided above are broader than the ordinary, plain

and accustomed meanings in some aspect, then the above definitions will control at least in

relation to their broader aspects

To the extent that a patentee may act as its own lexicographer under applicable law, it

is hereby further directed that all words appearing in the claims section, except for the above-

defined words, shall take on their ordinary, plain and accustomed meanings (as generally

evidenced, inter alia, by dictionaries and/or technical lexicons), and shall not be considered to be specially defined in this specification Notwithstanding this limitation on the inference of

"special definitions," the specification may be used to evidence the appropriate ordinary, plain

and accustomed meanings (as generally evidenced, inter alia, by dictionaries and/or technical lexicons), in the situation where a word or term used in the claims has more than one pre-

established meaning and the specification is helpful in choosing between the alternatives

Referring to Figs 1 (perspective view) and 2 (cross-sectional view), an artificial joint

100 is shown Artificial joint 100 is a ball and socket joint that allows rotation in more than

one plane Artificial joint 100 includes a ball component 102 and a socket component 104

Ball component 102 includes base plate 106 and ball insert 108 Base plate 106 includes base

portion 106a and stem portion 106b When artificial joint 100 is inserted in a body, at least a

portion of stem 106b is driven into the subconjural portion of one of the bones of the joint in

the conventional manner Base plate 106 is preferably made of metal and is preferably made of titanium or

stainless steel Alternatively, base plate 106 could be made of other metals and alloys to achieve the desired characteristics and functionality For example, the same metals which are

used to make the stem portion of conventional plastic-on-metal joints can be similarly used to make base plate 106 Ball insert 108 is preferably made of UHMWPE and is adhered to base

plate 106 in the manner conventionally used to adhere polyethylene and metal parts in conventional plastic-on-metal artificial joints The preferred construction of ball insert 108

will be more fully described below

Socket component 104 comprises a base plate 112 and a socket insert 110 Base plate 112 includes base portion 112a and stem portion 112b When artificial joint 100 is

inserted in a body, at least a portion of stem 112b is driven into the subconjural portion of one

of the bones of the joint in the conventional manner Base plate 108, like base plate 106, is

preferably made of titanium or stainless steel

When both of stem 106b and stem 112b are properly driven into adjacent bones, ball

insert 108 and socket insert 110 contact to become bearing surfaces, whose shapes guide permitted motion of the artificial joint Socket insert 110 is preferably made of UHMWPE and

is adhered to base plate 112 in any manner conventionally used to adhere polyethylene and

metal parts in conventional plastic-on-metal artificial joints, such as by gluing, bonding, screwing, or press-fitting

An important difference between at least some embodiments of the present invention

and conventional artificial joints is that neither of the bearing surfaces 108, 110 are made of

metal Rather, the bearing surfaces are both non-metallic This is because metal bearing

surfaces wear (as in a metal-on-metal joint) or cause wear (as in a plastic-on-metal joint) This use of a metal bearing surface is generally inconsistent with the extremely low characteristics

of friction, which are believed to be achievable with the present invention

More preferably, the bearing surfaces are both plastic, and even more preferably, both

bearing surfaces are polyethylene Polyethylene' s combination of strength, toughness,

smoothness, compressibility, elasticity, stiffness, pore density and other material properties is well-known, and polyethylene is conventionally preferred in plastic-on-metal artificial joints However, when polyethylene constitutes both bearing surfaces, as in the present invention, the

relevant coefficient of friction and associated wear is believed to decrease dramatically It is

believed that certain other plastics could also lead to similar advantageous results

The preferred polyethylene bearing insert surfaces of the present invention is UHMWPE It is believed that the use of UHMWPE can lead to a relevant coefficient of

friction of 0 1, 0 05 or even as low as 0 01 With coefficients of friction this low, there is

drastically reduced wear of the bearing surface Reduced wear of the bearing surface means

that the bearing surface will maintain its shape and integrity, and that there will be less debris

and associated particle wear It is believed that the low friction artificial joints of the present

invention may substantially outlast a human or animal lifetime so that surgeries to replace worn or particle-damaged artificial joints will no longer be necessary

Another preferred type of polyethylene according to the present invention is

polyethylene that has been melted down two or more times Multiple melt polyethylene

generally exhibits increased purity, cross-linking, elasticity, and strength, and a decreased

tendency to delaminate Accordingly, multiple melt polyethylene has been shown to be

capable of high repetition translational contact with an equivalent polyethylene product to

produce a virtually wearless system Double melt polyethylene is therefore preferred according to the present invention Triple (or more) melt polyethylene is even more preferred

One brand of this multiple-melt polyethylene is known as Dursul (It is noted that the word

Dursul may be subject to trademark rights )

All artificial joint components are preferably sterilized in any conventional manner The inserts are preferably sterilized by gamma radiation

Referring now to Fig 3, an alternative embodiment of an artificial joint 300 is shown

Artificial joint 300 includes ball component 302 and socket component 304 Ball component 302 includes base plate 306 and ball insert 308 Socket component 304 includes base plate

312 and socket insert 310 Both ball insert 308 and socket insert 310 are made of triple melt

UHMWPE As shown in Fig 3, ball insert 308 completely surrounds base plate 306, in the

vicinity of reference numeral 309, for improved wear characteristics at both ball component

302 and socket component 304

Referring now to Fig 4, artificial knee joint 400 is shown Knee joint 400 includes

femoral component 402 and a tibial component 404 Femoral component 402 includes metal

base plate 406 and triple melt UHMWPE insert 408 Similarly, tibial component 404 includes metal base plate 412 and triple melt UHMWPE insert 410 Metal base plate 406 includes

anchor (or stem) members 405 for insertion into the subconjural bone of the femur Metal

base plate 412 includes anchor members 414 for insertion into the subconjural bone of the

tibia The mating, bearing surfaces of inserts 408 and 410 are preferably shaped to match the

natural geometry of a healthy knee as closely as possible

In order to form this geometry, the inserts may be formed by any conventional

UHMWPE forming technique, such as by molding and/or machining When choosing the

forming technique, the ability of the forming technique to accurately achieve the desired shape should be considered The effect that the forming technique may have on surface wear should

also be considered For example, it is believed by some that molded polyethylene bearing surfaces have better wear characteristics than machined bearing surfaces, at least in the context

of conventional plastic-on-metal joints

It is further noted that the complex geometry shown in Fig 4, which attempts to

accurately emulate the shape of cartilage in a healthy knee, includes ridges and depressions It

is believed that the plastic-on-plastic joints of the present invention may be especially advantageous in the context of knee joint replacements because the complex geometry of the

artificial knee joint will hold its shape better under decreased friction and wear For example,

the anatomy of a natural knee can be duplicated all the way to the periphery of the cortical

rim, such that the artificial joint feels and performs more naturally Also, artificial knee joints

are subjected to a high degree of stress and associated wear because they carry most of the

body's weight and are subjected to both intermittent and repetitive motions Therefore, it is

especially advantageous to decrease wear in joints like the knees and hips, which tend to wear faster than lower stress joints

Anchor members 405 will now be discussed in more detail with reference to Figs 5 and 6 Fig 5 shows femoral component 402 just after it has been driven into a femur bone

500 As is conventional, material may be removed from the end of the femur bone prior to

insertion of femoral component 402 It is the anchor members 405 that secure femoral component 402 to femur 500

While conventional anchor members are cylindrically solid in construction, anchor

members 405 are tubular in construction so that they include an open-ended interior space 450 As shown in Fig 5 , bone matter begins to flow into this interior space when it is first

driven into femur 500

As shown in Fig 6, as time passes, the bone grows to fill this interior space 450, and bonds to the interior wall of interior space 450 By filling interior space 450 and bonding to it,

the bond between femur 500 and femoral component 402 is greatly strengthened as the bone

heals This is advantageous because the more secure attachment allows the artificial joint to

perform better, and can ward off repair work that is conventionally necessitated when a

prosthetic component becomes loose Preferably, the inside of the interior space is

constructed and treated to promote bonding with the regrowing bone

While anchor members 405 are cylindrically tubular in shape, other tube profiles are possible Also, non-tubular constructions with other types of interior spaces are also possible,

such as open ended or hollowed out spheroid anchors (although these may be more difficult to

drive into the bone) Furthermore, ridges or other surface discontinuities can be provided on

the interior anchor member surface to further promote tight bonding between bone and

prosthesis

Although the artificial joints of the present invention have been explained in terms of a

generic ball and socket joint geometry of Figs 1 to 3 and a knee joint of Fig 4, those skilled in

the art will appreciate that the range of joints for which the present invention can be utilized is

significant For example, the present invention could be utilized in not only a replacement

knee, but could equally be utilized to replace the joints in ankles, feet, hips, elbows, wrists,

hands, shoulders or mouth, as well as other joints in a human or animal Also, while joints

according to the present invention are preferably applied to joints that emulate natural joint

geometry, the non-metallic bearing surfaces and tubular stems of the present invention could also be applied in the context of joints that do not precisely emulate a natural joint. For

example, U.S. patent 3,945,053 (incorporated by reference) discloses an artificial, rolling

contact knee joint which has bearing surfaces that are not particularly similar to the natural

bearing surfaces of a knee.

Another preferred embodiment of the present invention includes use of all poly male

and female components with roughened and similar anchoring parts that are bonded to bone

by bone cement (e.g., polymethyl-methacrylate based bone cement).

Many other variations on the above-described artificial joints are possible. Such

variations are not to be regarded as a departure from the spirit and scope of the invention, but rather as modifications intended to be encompassed within the scope of the following claims,

to the fullest extent allowed by applicable law.

Claims

What is claimed is:

1 An artificial joint comprising a first joint member comprising a first bearing surface made of artificial, non-metallic material, a second joint member comprising a second bearing surface made of artificial, non-metallic material, with the first bearing surface and the second bearing surfaces being shaped to mate to guide relative movement of the artificial joint

2 The artificial joint of claim 1 wherein the first bearing surface is made of plastic, and the second bearing surface is made of plastic

3 The artificial joint of claim 2 wherein the first bearing surface is made of polyethylene, and the second bearing surface is made of polyethylene

4 The artificial joint of claim 3 wherein the first bearing surface is made of ultra high molecular weight polyethylene, and the second bearing surface is made of ultra high molecular weight polyethylene 5 The artificial joint of claim 3 wherein the polyethylene of the first bearing surface is at least double melt polyethylene, and the polyethylene of the second bearing surface is at least double melt polyethylene

6 The artificial joint of claim 5 wherein the polyethylene of the first bearing surface is at least triple melt polyethylene, and the polyethylene of the second bearing surface is at least triple melt polyethylene

7 The artificial joint according to claim 2 further comprising a first bone, with the first joint member being constrained to the first bone, and a second bone, with the second joint member being constrained to the second bone

8 The artificial joint of claim 2 wherein the first joint member further comprises a first anchor portion made of artificial material, the first anchor portion being structured to constrain the first joint member to a bone, and the second joint member further comprises a second anchor portion made of artificial material, the second anchor portion being structured to constrain to second joint member to a bone

9 The artificial joint of claim 8 wherein the first and second joint members are all poly, and the first and second anchor portions are roughened

10 The artificial joint of claim 4 wherein

the first anchor portion is made of metal, and

the second anchor portion is made of metal

11 An artificial human knee joint comprising a first joint member comprising a first bearing surface made of artificial material, a second joint member comprising a second bearing surface made of artificial material,

with the first bearing surface and the second bearing surfaces being shaped to mate to guide

relative movement of the artificial joint, and with the first and second bearing surfaces having a

coefficient of friction of less than 0 1 when the joint is placed under normal use in a human body

12 The joint of claim 1 1 wherein the coefficient of friction is less than 0 01

13 The joint of claim 1 1 wherein the first and second bearing surfaces are both made

of triple melt ultra high molecular weight polyethylene

14 An artificial joint comprising a first joint member comprising

a first bearing surface, and

a first anchor member defining an open-ended interior space, the first anchor member comprising an inner anchor surface disposed around an interior surface of the interior space, and an outer anchor surface disposed around an exterior surface of the first anchor member

15 The artificial joint of claim 14 further comprising a bone, with the first anchor member being disposed within the bone so that at least a portion of the inner anchor surface is in contact with the bone

16 The artificial joint of claim 15 wherein the first anchor member is disposed so that at least a portion of the outer anchor surface is in contact with the bone

17 The artificial joint of claim 14 wherein the first anchor portion is made of metal

18 The artificial joint of claim 17 wherein the first anchor portion is made of titanium

19 The artificial joint of claim 14 wherein the inner anchor surface comprises surface discontinuities structured to promote bonding of the inner anchor surface to growing bone

20 The artificial joint of claim 14 further comprising a second joint member comprising a second bearing surface shaped to mate with the first bearing surface, with the first and second bearing surfaces both being made of ultra high molecular weight polyethylene; and a second anchor member defining an open-ended interior space, the second anchor member comprising: an inner anchor surface disposed around an interior surface of the interior space; and an outer anchor surface disposed around an exterior surface of the first anchor member.