The present application claims priority from Australian Provisional Patent Application No 2006900086, Australian Provisional Patent Application No 2006900406, Australian Provisional Patent Application No 2006901324, Australian Provisional Patent Application No 2006904349 filed on 9 Jan. 2006, 27 Jan. 2006, 15 Mar. 2006, 19 Aug. 2006, the contents of which are incorporated herein by reference.
The present invention relates to a joint replacement prosthesis for implantation into the body of an individual, in particular to a joint replacement prosthesis which can function to replace at least a part of the joint of an individual and which can operate in a substantially quiet mode.
Joints, such as the hip, knee, ankle, elbow and shoulder, are formed by the ends of two or more bones connected by cartilage tissue, which in healthy joints, acts as a protective cushion for the joint, allowing smooth, low friction movement of the joint. Through disease, injury or old age, the cartilage may become damaged causing the tissue around the joint to become inflamed and hence cause pain to the individual, which over time, can cause the cartilage to erode, thereby resulting in the rough edges of the bone contacting and rubbing against each other causing further damage to the joint and significant pain to the individual.
If only some of the joint is damaged, it may be possible for a surgeon to repair or replace the damaged portions of the joint through a variety of surgical procedures and treatments. However, if the entire joint becomes damaged or deteriorates significantly through such conditions as osteoarthritis, rheumatoid arthritis, or avascular necrosis, reparative treatment may not be possible and a more radical treatment may be necessary.
Such conditions have been successfully treated by total replacement joints to replace the diseased or damaged joint. To replace the knee or hip joint, a surgeon typically removes the diseased or damaged parts and inserts artificial parts, commonly referred to as prostheses or implants. As artificial joints and the surgical techniques to implant them have evolved over time, such joint replacements are becoming more accessible to a number of individuals and function more like a healthy natural joint.
In this regard, in recent times hip replacements have been among the most commonly performed orthopedic procedures and have been shown to be a successful means for relieving pain and restoring mobility to the individual. In a total hip replacement procedure, the ball part of the joint is removed and replaced with a ball attached to a stem which is wedged into a hollowed out space formed in the femur of the individual. Damaged bone and cartilage are removed from the socket and a cup-like component is inserted into the socket to receive the ball of the stem.
An alternative to total hip replacement is a procedure referred to as hip resurfacing, which has also been successful in treating damaged hip joints. In such a procedure, rather than replacing the femoral head, the head of femur is preserved and reshaped and the reshaped bone is then capped with a metal ball that is fixedly attached to the neck of the femur. The socket/acetabulum is prepared in a similar manner to a total hip replacement to receive the metal ball of the femur. As is appreciated, such a procedure requires less bone removal than a total hip replacement, however relies upon the same principles to replicate the action of a healthy hip joint.
Due to the success of hip replacement surgery, the procedure is being performed in patients of various ages and as such, it is important that the implants last the lifetime of the recipient, which can be as long as 70-80 years for some recipients. For this reason, various types of hip replacement implants have been proposed using a variety of different materials. There are implants whereby the ball is made from a hard material (such as metal or ceramic) and the cup is made from a plastic (typically polyethylene) which may or may not have a metal backing of titanium, stainless steel or cobalt chrome. Such implants tend to wear over time as the plastic material wears out. This can be at a rate of 0.1 mm per year or more. To avoid this, alternative bearing surfaces to the hard material-on-plastic have been proposed, which are referred to as hard-on-hard. These systems typically employ metal-on-metal or ceramic-on-ceramic bearing surfaces, whereby substantially all parts of the prosthesis are made from a metal or ceramic material. Such hard-on-hard systems have been shown to significantly reduce the amount of wear and have the potential to increase the life of the implant.
Whilst hip replacement surgery has been proven relatively successful in restoring movement to individuals and relieving pain previously experienced in the joint, in some instances an undesirable outcome has been the presence of an audible squeak associated with the implant in some individuals. Such a squeak may be experienced by the individual when bending or during walking and can be a source of embarrassment and distress to the individual. Implant squeaking is more prevalent in implants with hard-on-hard bearing surfaces (metal-on-metal implants or ceramic-on-ceramic implants).
In the case of modular acetabular components where there is a ceramic insert and a titanium shell the two components are joined by a locking mechanism in the form of a taper. This locking mechanism is designed for generally axial loading. While such a locking mechanism may perform adequately under generally axial loads they do not perform well under other loadings and in particular edge loading. Edge loading produces loads that are nearly perpendicular to the axis of the component. Under these conditions the prior art inserts can tilt out of the shell, uncoupling the two components. Such uncoupling may lead to undesirable squeaking of the prosthesis.
Therefore, there is a need to provide a joint replacement method and prosthesis that can be employed to relieve pain associated with the damaged joint and to restore mobility to the joint, whilst reducing the occurrence of audible squeaking associated with the prosthesis.
Any discussion of documents, acts, materials, devices, articles or the like which has been included in the present specification is solely for the purpose of providing a context for the present invention. It is not to be taken as an admission that any or all of these matters form part of the prior art base or were common general knowledge in the field relevant to the present invention as it existed before the priority date of each claim of this application.
Throughout this specification the word “comprise”, or variations such as “comprises” or “comprising”, will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps.
In a first aspect, the present invention is an implantable joint prosthesis comprising:
a first component attachable to a first bone of a recipient; and
a second component attachable to a second bone of a recipient,
wherein said first and second components are arranged to facilitate relative movement between said first and second bone of the recipient, and at least one of said first and/or second components comprises at least one modifying means, said modifying means modifying the first and/or second component such that a dynamic response of at least a part of the first and/or second component to a stimulus is modified.
In a second aspect, the present invention is an acetabular component of an implantable hip prosthesis, said acetabular component having a main axis and comprising a cup member shaped to receive an insert member substantially therein, wherein the insert member and the cup member are coupled together by a primary locking mechanism, said primary locking mechanism retaining the insert member and the cup member in coupling engagement when said acetabular component is subjected to a load substantially along said main axis;
the prosthesis characterised in that the acetabular component comprises a secondary locking mechanism to couple together the insert member and the cup member.
Typically, said secondary locking mechanism retains the insert member and the cup member in coupling engagement when said acetabular component is subjected to a load that deviates from along said main axis.
In the second aspect, the secondary locking mechanism may retain the locking member and the cup member in locking engagement when the load applied to the acetabular component is at an angle to the main axis. The angle of the load may be from 1° to 90° relative to the main axis. The angle may be between 10° and 70° relative to the main axis. Furthermore, the angle of load may be between 20° and 50° relative to the main axis.
The dynamic response may comprise the resonant frequency of at least a part of the first and/or second components.
In one embodiment, the magnitude of the dynamic response may be modified such that any noise resulting from a resonance of said at least a part of the first and/or second component is reduced and preferably to a level that is not audible to a human.
Alternatively, the frequency of the dynamic response may be modified. The frequency of the dynamic response may be modified to a frequency greater than 7 KHz. Preferably, the frequency of the dynamic response is modified to a frequency greater than 10 KHz. Still further, the frequency of the dynamic response may be modified to a frequency in the range of 10 KHz to 20 KHz. Yet further, the dynamic response frequency may be modified to a frequency greater than 20 KHz. The frequency of the dynamic response may also be modified to a frequency less than 1 KHz and preferably less than 500 Hz; more preferably less than 20 Hz.
In a further embodiment, both the magnitude and the particular frequency of the dynamic response may be modified.
The implantable joint prosthesis may comprise an implantable hip prosthesis. The implantable hip prosthesis may be a total hip prosthesis or a partial hip prosthesis.
The first component may comprise a femoral component for attachment to the femur of the recipient. The femoral component may be in the form of a stem which is insertable into a cavity formed in the femoral bone. The stem may include a neck region which projects from the femur. The femoral component may also comprise a head element arranged to be received by the neck region of the stem. The head element may be in the form of a ball or part thereof. The surface of the ball may be substantially spherical in configuration and may be made from a hard material, such as a ceramic or a metal.
The second component may be an acetabular component for attachment to the acetabulum of the pelvis. The acetabular component may comprise a cup which is configured to be anchored into the acetabulum. The cup may receive the head element of the femoral component and is shaped to substantially conform to the head element. In one form, the cup may comprise an insert which is configured to be received within the cup. The insert may be made from a hard material such as a ceramic or a metal. In this arrangement, the insert may receive the head element of the femoral component to facilitate articular movement between the femoral component and the acetabular component.
The insert may include a main body having an upper face comprising a rim and a recessed inner surface. The recessed inner surface may receive the femoral component. An outer surface of the insert may comprise a tapered region that extends from the rim towards a base of the insert.
Similarly, the cup may comprise an upper face having a rim and a recessed inner surface. The recessed inner surface may receive the insert. A region of the inner surface of the cup may be tapered. The tapered region of the insert and the tapered region of the cup may be wholly or partially engageable with each other. The region of engagement between the tapered surfaces provides an interface between the cup and the insert.
The modifying means of the present invention may comprise a number of means with the common feature being that it alters the dynamic response of at least a part of the prosthesis by either modifying the magnitude of the response or modifying the actual frequency of the response.
The modifying means may modify the physical properties of the first and/or second component or parts thereof. Modifications of various physical properties may change the dynamic response of the first or the second component or parts thereof such that the response is not audible to humans. Examples of modifying means that modify the physical properties of the components or parts thereof are discussed in further detail below and include but are not limited to shape modifying members, stiffness modifying members and mass modifying members of the first and/or second component or parts thereof.
In a further embodiment, the first and/or second component may be configured such that the frequency of the dynamic response is damped. In this embodiment, the first and/or second component may comprise a damping member to dampen certain frequencies such that the dynamic response is shifted out of an audible range.
The acetabular cup of the acetabular component may comprise at least one shape modifying member. Preferably, the cup includes a plurality of shape modifying members. The shape modifying members are typically ribs or struts that extend outwardly from an outer surface of the cup. The ribs or struts may extend substantially around the circumference of the cup, either longitudinally or laterally relative to the main axis of the cup. The ribs or struts may be evenly spaced. Preferably, the ribs or struts may be asymmetrically spaced.
In a further embodiment, the acetabular component comprises at least one stiffness modifying member. Preferably, the stiffness modifying member increases the stiffness of the acetabular cup such that it is less likely to distort. Typically, the stiffness modifying member increases either or both the hoop stiffness and the bending stiffness of the acetabular cup.
In many hip prostheses, the acetabular cup is relatively flexible. An insert is fitted within the cup and a femoral head received in the insert. When subjected to various loads, the relatively flexible cup may undergo a distortion. The relationship between the insert and the cup, therefore, changes. For example, the insert may become uncoupled from the cup as will be discussed in further detail below This uncoupling may allow the cup to resonate at a particularly frequency that is audible to a human being.
The stiffness modifying member may comprise one or more ribs or struts positioned on the outer surface of the cup to increase the stiffness of the cup. The ribs or struts may be the same as the shape modifying members discussed above and it should be appreciated that the effects of the modifying means may overlap; a member that alters the shape of a component may also modify the stiffness and vice versa.
The stiffness modifying member may further comprise a ring member that is stiffer than the cup. The ring member may be made from the same material as the material of the cup. In this embodiment, the ring member may include stiffening features to increase the stiffness of the ring member. For example, the stiffening features may include ribs or struts that extend outwardly from the ring member. Alternatively, the ring member may include a flange member that extends outwardly therefrom.
The cup may be made from titanium and the ring member may be made from a different material selected from cobalt chrome alloy and stainless steel.
The ring member may extend substantially circumferentially around the outer surface of the cup. The ring member may extend around the entire circumference of the acetabular cup. The ring member may be substantially flush with the rim of the cup. Alternatively, the ring member may extend beyond the rim of the cup or may be recessed relative to the rim of the cup. The ring member may be bonded to the cup. For example, the ring member may be press fitted to the outer surface of the cup. Alternatively, the ring member may be bonded to the acetabular cup by hot isostatic pressing (HIPing).
The stiffness of the cup may also be modified by altering the thickness of the cup. Particularly, the diameter of at least a portion of the tapered region of the cup may be varied in the range of approximately between 2 mm to 10 mm
Resonance of the cup in an audible range may also be prevented by locking the insert and the cup together under all loading conditions (particularly under loading of the femoral head on the edge of the insert) such that the cup is not free to resonate at its audible natural frequency ie the insert and the cup act as a composite structure with a different resonant frequency to that of the cup alone. The modifying means of the first aspect or the secondary locking mechanism of the second aspect may cause the insert and the cup to remain in locking engagement under all loading conditions.
The complementary tapers of the insert and the cup may allow for a press fit between the two components to friction fit them together. While the taper provides a sufficient lock under generally axial loads, it may not sufficiently lock the two components together under other loads that deviate from the main axis of the acetabular component, including during edge loading and impingement (wherein the neck of the femoral component hits the edge of the acetabular component).
Preferably, the insert and the cup are locked together using either mechanical details or by altering other variables including friction, taper angle of the insert and the stiffness of the cup as will be discussed in more detail below.
In one embodiment of the second aspect of the invention, the secondary locking mechanism comprises at least one mechanical locking mechanism to secure the insert within the cup such that the two components act as a composite structure under clinically relevant loads and particularly during edge loading and impingement. The secondary locking mechanism of this embodiment may comprise a mechanical detail on the insert and a complementary receiving member on the cup. Further, the insert may include an intermediate member positioned substantially around the circumference of the insert. In this embodiment, the mechanical detail may be positioned on the intermediate member rather than on the insert.
In a further embodiment of the second aspect, the secondary locking mechanism may comprise the stiffness of the cup. In this embodiment, the cup may include a ring member as described above. Alternatively, or in addition to the ring member, the stiffness of the acetabular cup may be altered by altering the thickness of at least a portion of the tapered region of the cup. Particularly, the thickness of the entire region of the cup that forms an interface with the insert may be varied. The thickness may be varied in the range from 2 mm to approximately 10 mm. Preferably, the range of thickness variation is between 2 mm and 5 mm. Still further, the thickness variation may be in the range of 2 mm to 2.85 mm.
Further, the stiffening features may comprise ribs, struts or flanges as discussed above.
The secondary locking mechanism may comprise a combination of two or more of said ring member, the thickness of the cup and stiffening features. The locking mechanism of this embodiment is achieved by providing an optimal stiffness of the cup such that the cup will not be distorted under load such that the insert is uncoupled from the cup.
The secondary locking mechanism may further comprise a combination of cup stiffness and the friction coefficient between the insert and the cup. If the friction coefficient is low, the stiffness of the cup may be increased to allow the insert and the cup to act as a composite structure.
Additionally, the secondary locking mechanism may comprise a combination of optimal stiffness and taper angle of the insert and the cup. As the taper angle decreases relative to the main axis of the acetabular component, the axial capacity (ability for the insert and the cup to remain as a composite under axial load) of the acetabular component may decrease but the edge loading capacity (ability of the insert and the cup to remain as a composite when the load deviates from the main axis) may increase. The decrease in axial capacity in this embodiment may be countered by the stiffness of the cup, and particularly by an increase in stiffness in accordance with the various embodiments described herein. Alternatively, a base region of the insert and a base region of the cup may be engageable with each other to provide an additional load path to counter the decrease in axial capacity.
Preferably, the taper angle is in the range of between 4 degrees and 10 degrees relative to the main axis of the cup.
Still further, the secondary locking mechanism may comprise a combination of stiffness of the cup, friction coefficient between cup and insert and taper angles of the insert and the cup.
The secondary locking mechanism preferably minimises the motion of the insert and the cup relative to each other. Preferably, the relative motion between the insert and the cup is less than 40 microns when the acetabular component is subjected to a load that deviates from the main axis of the component.
The femoral component of the prosthesis may also comprise the modifying means. The modifying means may modify the geometric shape of the femoral component. Still further, the modifying means may modify the stiffness of the femoral component. The modifying means may also modify the mass distribution of the femoral component. The shape and/or stiffness and/or mass distribution of either or both of the femoral stem and the bead element of the femoral component may be modified by the modifying means.
In another embodiment, the geometric structure of the first and/or second components are modified such that the resonant frequency of the first component is mismatched with the resonant frequency of the second component to reduce the tendency for mode coupling between the two components.
By way of example only, the invention is now described with reference to the accompanying drawings:
a to 39e depict embodiments of locking mechanisms of the present invention;
a is a cross-sectional view of an acetabular component of the invention showing a locking mechanism;
b is a top plan view of the acetabular component of
a and 46b show a further embodiment of a component of the prosthesis of the present invention.
The present invention will be described in relation to a hip joint prosthesis, however it will be appreciated by a person skilled in the art that the present invention could be equally be applied to a prosthesis suitable for use with any joint, whether the prosthesis be a partial or full replacement of the natural joint.
With regard to
Cartilage 5, 7 lines the acetabulum 4 and head 8 of the femur respectively to provide a cushioning function to the joint 10 and to prevent the bones from rubbing together. To ensure that the head 8 of the femur is maintained in a close and stable position within the acetabulum 4, ligaments 3 are provided around and inside the joint 10. Muscles (not shown) which surround the hip joint 10 provide further stability to the hip joint 10.
Conditions such as osteoarthritis may cause a deterioration and/or disintegration of the smooth cartilage surfaces 5 and 7 which in turn can lead to pain and restricted motion of the joint 10. This typically occurs as a gradual onset of worsening hip pain and decreased mobility in the joint 10 which makes normal walking and ascending and descending of stairs a progressively harder task. Should the condition worsen considerably, a total hip prosthesis 20 may be necessary, as is shown in
The prosthesis 20 generally comprises two portions, a femoral portion 12 and an acetabular portion 14. The femoral portion 12 comprises a metal step 11 which is configured to be placed into a marrow cavity formed in the femoral bone 6. The size and shape of the cavity being such that the stem 11 is tightly received therein and maintained in position. In this regard, bone cement may be applied to, assist in securing the stern 11 in position, or the stem 11 may have a surface texture which, over time, will allow the stem 11 to become secured in position through osseointegration with the femur.
A head element 13 is secured to the neck 11a of the stem 11 to function as the damaged femoral head 8 of
The acetabular portion 14 generally comprises an insert 15 and a cup 17. The insert 15 is configured to be received within the cup 17 such that it is retained in position therein. The insert 15 is made from a ceramic or metal material and is shaped to receive the head 13 of the femoral portion when in position. The cup 17 is implanted into the acetabulum 4 of the pelvis 2. To facilitate implantation, the acetabulum 4 is drilled and prepared to create a recess whereby the cup 17 is securely fitted into the acetabulum 4. The cup 17 may be cemented in position within the acetabulum 4, or may be positioned through tightness of fit and/or screws, whereafter osseointegration may occur.
As is shown in
As discussed previously, an alternative to total hip replacement is a procedure known as hip resurfacing, which unlike the procedure discussed above in relation to
As will be appreciated, during use, such as during walking/running and various bending actions, the components of the prosthesis 20 experience a wide variety of forces in order to perform their function. Due to the wide variety of physical characteristics of individuals as well as the wide variety of surgical techniques employed to implant the prosthesis in the hip joint, forces exerted on the components may vary on an individual basis.
The present applicant conducted a review of 17 recipients of ceramic-on-ceramic hip prosthesis who had reported instances of an audible squeak resulting from their prosthesis. In order to investigate this occurrence further, orientation of the acetabular portion 14 of the prostheses was compared for each of the 17 squeaking prosthesis as well as for 17 matched recipients having prostheses with no reported instances of squeaking. Tests found that 94% of the non-squeaking implanted prosthesis were orientated in an ideal range of 25°+/−10° anteversion and 45°+/−10° inclination but only 35% of the squeaking implanted prostheses were in this range (p=0.0003). These results demonstrate the importance of acetabular portion orientation as one factor in the phenomenon of squeaking.
Of the 17 cases reporting squeaking prosthesis, eight of these exhibited squeaking during a bending movement, four exhibited squeaking during walking, whilst the remaining five exhibited squeaking of the prosthesis after prolonged periods of walking. Generally, it was found that prostheses that squeaked with walking had acetabular components that were more anteverted (40°) than prostheses that squeaked with bending (19°) (p=0.001) or following prolonged walking (18°) (p=0.020).
Generally, the prostheses started squeaking after an average of 14 months following implantation. The individuals were found to be younger, heavier and taller than patients with silent prostheses. Several of the individuals that reporting prosthesis squeaking underwent revision surgery to correct the phenomenon, thereby allowing the components of the squeaking prostheses to be retrieved and further analysed.
The analysis identified that common to all of the prostheses that exhibited squeaking was the evidence of edge loading and stripe wear between the insert 15 and the head 13 of the stem 11. Similarly, several of the prostheses that exhibited squeaking also showed evidence of impingement of the neck 11a of the prosthesis against the rim of the cup 17 of the acetabular portion.
Stripe wear is the term used to describe a long and narrow region of damage that is found on the head 13 of the stem as well as the inside of the insert 15 of a prosthesis. Stripe wear is the result of line contact between the head 13 and the edge of the insert 15. An example of what contributes to edge loading and stripe wear can be appreciated in considering a prosthesis recipient rising from a seated position. In such a physical action the recipient must firstly forcefully stretch the thigh that has been bent up, to an angle of at least 90°. When the thigh is bent in such a manner, the head 13 of the stem 11 is typically in contact with the back edge (rim) of the insert 15 of the cup 17. Upon stretching the thigh, the head 13 is initially against the back edge of the insert 15 before it begins to rotate with the individual's leg, thereby creating edge loading in the prosthesis.
To further investigate the audible squeak, sound recordings were further collected from over 30 patients with squeaking ceramic on ceramic hip prostheses and the sounds analysed by Fourier transformation to allow the major frequency components of the squeak to be determined.
The typical pattern was a harmonic series with a fundamental frequency between 400 Hz and 7500 Hz. Each patient has one or more characteristic fundamental frequencies that recurred with each squeak. Three patients recorded on two separate occasions had identical frequency signatures on both occasions.
In vitro studies were also carried out to determine the natural frequency of hip replacement components using an impulsive stimulus and an acoustic emission analysis. Titanium femoral stems and ceramic femoral heads both assembled and unassembled and modular ceramic/titanium acetabular components, which included testing the titanium shell and the respective ceramic inserts both assembled according to the manufacturers instructions and unassembled were tested.
No resonance was detected in the audible range in any of the modular ceramic/titanium acetabular components when they were correctly assembled and no resonance was detected in the audible range in any of the ceramic inserts or ceramic heads when tested unassembled.
Audible resonance was detected in all of the titanium shells when tested unassembled. The fundamental frequency of the titanium shell ranged from 4300 Hz to 9800 Hz with higher modes extending into higher frequencies. The thinner and larger shells tested had the lower frequency.
Of the ceramic inserts, when tested unassembled all were outside or at the limit of the audible range and only the thinnest of the larger diameter inserts had a fundamental frequency that was low enough to be detected by the equipment used (see
The titanium femoral components had a minimum frequency around 1500 Hz and multiple natural frequencies in the human audible range between 2 kHz and 20 kHz.
Based upon the experimental data, it is considered that the audible squeak is a result of vibration between the components of the prosthesis during specific body movements causing the components to vibrate at the natural or harmonic frequencies, which happen to fall within an audible range.
In particular, it is considered that such vibrations are generated by the edge loading occurring between the head 13 of the stem 11 and the insert 15 of the cup 17 and/or impingement of the neck 11a against the rim 18 of the cup 17. The vibrations generated by the movement of the components of the prosthesis 20, namely the driving force, causes at least one of the components to resonate at its natural or resonant frequency. The frequency of this generated vibration will depend on the physical characteristics of the component(s) (including its mass, tension and stiffness) as well as the load between the surfaces and the magnitude of the forces present in the movement. The load and forces will change throughout the activity, such as bending to pick something up or walking up a flight of stairs, hence it is considered that the frequency of the vibrations being generated may change throughout the activity. Further, different components of the prosthesis 20 will have a different frequency response to the generated vibration.
Squeaking can be considered to be due to a dynamic response to an applied movement during gait. This is a case where there is a response to a stimulus and the head 13 bears against the acetabular cup insert 15. The stimulus is in the form of a rate of movement, friction, geometry and other factors. These lead to a load as a function of time. The response may vary due to variations in the stiffness, mass distribution and fixation of the acetabular cup 17 and liner 15 in addition to said variations in the femoral component.
Based upon the above described experimental analysis of the phenomena of squeaking reported in hip replacement prostheses, it is proposed that by altering the physical characteristics of components of the prosthesis, the natural or resonant frequencies of the components can be altered to occur outside the audible range of hearing of the human ear.
In
Referring to
In
Referring to
As shown in
In
As shown in
As shown in
In
When positioned within the acetabular cup 17, the device 51 may be in a naturally expanded state as shown in
An alternative damping device 53 to that shown in
The above examples look at altering properties of the prosthesis to modify the resonance of individual components of the assembly. A further embodiment of the invention considers the interaction between components and in particular the cup 17 and the insert 15.
In particular, resonance of the cup 17 in an audible range may be prevented by locking the insert 15 and the cup 17 together under all loading pressures and particularly under loading of the femoral head on the edge of the insert such that the cup is not free to resonate at its audible natural frequency ie the insert and the cup act as a composite structure with a different resonant frequency to that of the cup alone.
The insert 15 and the cup 17 may be locked together using mechanical details or by altering other variables including friction, taper angle of the insert 15 and the stiffness of the cup 17. By providing a good locking mechanism between the cup 17 and the insert 15, the likelihood of the insert 15 disengaging from the cup during normal or abnormal gait activities is prevented or at least substantially reduced. Such disengagement between the cup 17 and insert 15 can change the load characteristics of the prosthesis thereby producing vibrations within the prosthesis 20 which contribute to the emission of an audible squeak from the prosthesis.
In
As shown in
An alternative embodiment of the stabilising ring 70a is shown in
Another embodiment of the stabilising ring 70b is shown in
The embodiments of the invention depicted in
The plan views depicted in
The angle of the complementary tapers of the insert 15 and the cup 17 and the stiffness of the cup 17 can increase the risk of squeaking of the prosthesis during use. As shown in
To increase the stiffness of the cup 17 and thus improve the locking of the insert 15 and the cup 17, the cup 17 may include a stiffening ring 100. The stiffening ring 100 is made of a stiffer material than the material of the cup 17, that is, it has a higher Young's modulus than the cup 17. The stiffening ring increases both the hoop and the bending stiffness of the cup thereby reducing the propensity of the insert to disengage from the cup.
Another important variable in providing a non-squeaking prosthesis is the friction between the insert 15 and the cup 17.
Item A denotes a friction coefficient of 1.5 and a cup stiffness for a 2 mm thick Titanium alloy. Item B denotes a function coefficient of 0.2 mm and a cup stiffness for a 2 mm thick Cobalt Chrome alloy. Item C denotes a friction coefficient of 0.1 and a cup stiffness for a 3 mm Titanium alloy. The area of the graph marked D is the region wherein the insert and the cup will act as a composite member under all clinically relevant loads. Region E is a lower risk region for squeaking and region F is a high risk region for squeaking.
The particular examples provided at items A, B and C demonstrate the relationship between stiffness and friction coefficient. However, there are many possible combinations and distributions of material that can result in similar ring stiffness. The following equations allow the relative stiffness of these combinations to be compared and encompass all combinations of variables as outlined herein.
For a homogenous material the ring stiffness is given by the formula:
The ring stiffness is given by the formula:
Where y is the mobilised length of the ring.
An optimal combination of ring stiffness and friction coefficient and/or taper angle will provide a composite structure wherein movement of the insert 15 and the cup 17 is minimised, and preferably to less than 40 microns.
a and 46b depict an insert member 15 that includes surface details 15b to modify the friction properties of the insert 15. Other examples include roughening the outer surface of the insert 15.
It will be appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the invention as shown in the specific embodiments without departing from the spirit or scope of the invention as broadly described. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive.
Number | Date | Country | Kind |
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2006900086 | Jan 2006 | AU | national |
2006900406 | Jan 2006 | AU | national |
2006901324 | Mar 2006 | AU | national |
2006904349 | Aug 2006 | AU | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
---|---|---|---|---|
PCT/AU2006/001968 | 12/22/2006 | WO | 00 | 12/19/2008 |