Pain from degenerative joint disease is a major health problem in the industrialized world and replacement of the degenerating joint is emerging as the preferred treatment strategy in these patients. Removal of the painful joint and replacement with a mobile prosthesis is an intuitive and highly successful treatment option. Because of the aging population, these operations are being performed in an increasing number of patients. Despite the success of joint replacement surgery, implant failure remains a significant problem. Wear of the implant components and device loosening from the underlying bone have emerged as the most common reasons for device failure. Implant replacement with a second operation is more technically difficult, more costly, has a higher complication rate and a lower probability of success than the initial joint replacement procedure. Thus, it is highly advantageous that implant longevity be maximized.
Overall, the encouraging experience with the mobile hip prosthesis has lead to development of prosthetic joints for use in the knee, shoulder, ankle, digits and other joints of the extremities. The vast experience with these devices has again shown that the wear debris produced by the bearing surfaces and the loosening that occur at the bone-device interface are major causes of implant failure. The latter is at least partially caused by the former, since it's been shown that the particulate debris from the bearing surfaces promote bone re-absorption at the bone-device interface and significantly accelerates device loosening. In the long term, the degradation products of the implant materials may also produce negative biological effects at distant tissues within the implant recipient.
While ceramic and polymer implant components produce wear debris, these degradation products are usually deposited as insoluble particles around the implant thereby limiting the extent of potential toxicity. In contrast, metallic degradation products may be present as particulate and corrosion debris as well as free metals ions, composite complexes, inorganic metal salts/oxides, colloidal organo-metallic complexes and other molecules that may be transported to distant body sites. In fact, studies have revealed chronic elevations in serum and urine cobalt and chromium level after prosthetic joint replacement. Given the known toxicity of titanium, cobalt, chromium, nickel, vanadium, molybdenum and other metals used in the manufacture of orthopedic implants, the tissue distribution and biologic activity of their degradation products is of considerable concern. Host toxicity may be produced directly by the reactive metallic moieties as well as by their alterations of the immune system, metabolic function, and their potential ability to cause cancer. These issues are thoroughly discussed in the text “Implant Wear in Total Joint replacement” edited by Thomas Wright and Stuart Goodman and published by the American Academy of Orthopedic Surgeons in 2000. The text is hereby incorporated by reference in its entirety.
More recently, joint replacement has been attempted in the spine. Because each of the twenty three motion segments between the second cervical vertebra and the sacrum contains three joints, there is a vast potential for the use of joint replacement technology in the spine. Unlike joints in the extremities, proper function of the spinal joints (e.g., inter-vertebral disc and facet joints) returns the attached bones to the neutral position after the force producing the motion has dissipated. That is, a force applied to the hip, knee or other joints of the extremities produces movement in the joint and a change in the position of the attached bones. After the force has dissipated, the bones remain in the new position until a second force is applied to them. In contrast, the visco-elastic properties of the spinal disc and facet joint capsule dampen the force of movement and return the vertebral bones to a neutral position after the force acting upon them has dissipated.
Prosthetic joint implants that attempt to imitate native spinal motion have usually employed springs, memory shape materials, polyurethane, rubber and the like to recreate the visco-elastic properties of the spinal joints. U.S. Pat. Nos. 4,759,769; 5,674,296; 5,976,186; 6,022,376; 6,093,205; 6,348,071; 6,761,719; 6,966,910 (all of which are herein incorporated by reference in their entirety) and others disclose some of these spinal implants. When subjected to the millions of cycles of repetitive loading that is required of a spinal joint prosthesis, all implants to date have been plagued by excessive wear and degeneration secondary to the fairly modest wear characteristics of these elastic elements. Thus, in addition to the wear debris generated by the bearing surface(s), the elastic materials used to recreate spinal motion will produce a second source of degradation products. Given the number of joints in the spine and the extensive potential application of replacement technology in these joints, it is critical that the wear debris from the implanted prosthesis be minimized.
The preceding discussion illustrates a continued need in the art for the development of mobile orthopedic prosthesis' with a reduced wear profile. This development would maximize the functional life of the prosthesis and minimize the production of degradation products and their potential toxicity.
Various orthopedic implants are disclosed herein. The wear characteristics of the implant are at least partially determined by the material of composition, the coefficient of friction and the load borne by the bearing surface. The first two variables have been extensively studied and manipulated. In the disclosed devices, magnetic fields are used to alter the bearing surface load within the device. One or more elements of the mobile prosthesis produce a magnetic field and the prosthesis is constructed in such a way so as to produce attraction/repulsion forces between the prosthesis sub-segments. The magnetic fields are used to partially or completely separate and unload the articulating surfaces of the prosthetic joint. This feature minimizes the contact between the articulating surfaces, thereby increasing device longevity and producing a lesser quantity of toxic wear debris.
In another application, a neutral configuration of the orthopedic implant exists in which the various forces acting upon the mobile prosthesis are in relative balance. Movement of the prosthesis away from the neutral position produces an imbalance in the sum of forces and causes the prosthesis to oppose any movement away from that neutral position. After the force acting upon the prosthesis has dissipated, the implant returns the attached bones to the neutral position. Unlike prior art, use of magnetic fields can recreate the visco-elastic motion characteristics of the native spine without the use of elastomers or mechanical means that produce degradation products.
In another application, magnetic fields are used to increase the holding power of an internal locking mechanism within an orthopedic implant. In another application, the magnetic fields themselves are used to treat the painful surrounding tissues. U.S. Pat. No. 6,524,233; 6,447,440; 6,119,631; 6,048,302; 5,842,966; 5,669,868; 5,665,049; 5,453,073; 5,387,176; 5,131,904; and other illustrate the therapeutic use of magnetic fields. The fields generated by the magnetic members of the implant may be used to reduce the pain within the neighboring tissues. Since variable magnetic fields have been shown to provide a greater therapeutic effect on surrounding tissues than magnetic fields of constant value, the static fields produced by the fixed implant magnets may be varied. While this can be done by using electro-magnets with pulsatile variation in field strength, it can also be done using a mobile magnetic shield on a fixed magnet. For example, a member of the prosthesis that is mobile relative to the magnetic field source can be fitted with magnetically shielding material and positioned between the field source and the target tissue. With normal prosthesis movement, the shielding member will move between the magnetic member and the surrounding tissues and the tissues will experience a variation in the magnetic field.
In one aspect, there is disclosed an orthopedic device adapted to be implanted between a first bone and a second bone of a skeletal structure, comprising: a first member having an abutment surface adapted to contact a surface of the first bone, wherein the first member emits a first magnetic field of a first polarity; a second member having an abutment surface adapted to contact a surface of the second bone, wherein the second member emits a second magnetic field of the same polarity as the first polarity; and at least one bearing member between the first and second members that permits relative movement between the first and second members and that bears a load between the first and second members, wherein the load on the bearing surface is reduced as a result of an interaction of the magnetic fields.
In another aspect, there is disclosed an orthopedic device adapted to be implanted between a first bone and a second bone of a skeletal structure, comprising: a first abutment member having an abutment surface adapted to contact a surface of the first bone; a first magnetic member at least partially contained within the first abutment member, wherein the first magnetic member emits a first magnetic field of a first polarity; a second abutment member having an abutment surface adapted to contact a surface of the second bone; and a second magnetic member at least partially contained within the second abutment member, wherein the second magnetic member emits a second magnetic field of the same polarity as the first polarity; wherein the first and second abutment members have a spatial relationship that is at least partially determined by an interaction of the first and second magnetic fields.
In another aspect, there is disclosed an orthopedic device adapted to be implanted between a first bone and a second bone of a skeletal structure, comprising: a first abutment member having an abutment surface adapted to contact a surface of the first bone; a first magnetic member at least partially contained within the first abutment member, wherein the first magnetic member emits a first magnetic field; a second abutment member having an abutment surface adapted to contact a surface of the second bone; and a second magnetic member at least partially contained within the second abutment member, wherein the second magnetic member emits a second magnetic field; wherein the first and second abutment members have a default spatial relationship and wherein movement of the first and second members away from the default spatial relationship is opposed by interaction of the first and second magnetic fields.
In another aspect, there is disclosed an orthopedic device adapted to be implanted between a first bone and a second bone of a skeletal structure, comprising: a first abutment member having an abutment surface adapted to contact a surface of the first bone; a first magnetic member at least partially contained within the first abutment member, wherein the first magnetic member emits a first magnetic field; and a second abutment member having an abutment surface adapted to contact a surface of the second bone; a second magnetic member at least partially contained within the second abutment member, wherein the second magnetic member emits a second magnetic field; wherein the first and second members can move relative to one another and wherein relative movement between the first and second members is at least partially hindered by interaction of the magnetic fields.
In another aspect, there is disclosed an orthopedic device adapted to be implanted in a patient, comprising: a first member having an abutment surface adapted to attach to a surface of a bone so as to aid in segmental stabilization of the patient's skeletal system; and a first magnetic member at least partially contained within the first abutment member, wherein the first magnetic member emits a first magnetic field such that the magnetic field reaches a tissue of the patient.
Other features and advantages will be apparent from the following description of various embodiments, which illustrate, by way of example, the principles of the disclosed devices and methods.
Disclosed are devices and methods for the use of magnets in orthopedic prosthesis. While these device principles are illustrated in use within spinal implants, it should be appreciated that they can be used with any orthopedic device.
The implant 105 includes an upper component 110 and a lower component 115. A bearing component 120 is interposed between the upper and lower components and interacts with a complimentary spherical cut-out on component 110. A first magnet 122 is mounted within a seat in bearing component 120 and a second magnet 124 is mounted in the lower component 115. As shown in the cross-sectional views of
The upper and lower components 110 and 115 each have an abutment surface 125 that is adapted to abut against a vertebra when the implant 105 is positioned in a disc space. The abutment surfaces 125 of the upper and lower components are preferably configured to promote interaction with the adjacent bone and affix the implant to the bone.
With reference to
In use, an intervertebral disc is removed from the disc space between first and second (or upper and lower) vertebrae. After the inter-vertebral disc is removed, the implant 105 is placed into the evacuated disc space. The abutment surface 125 of the component 110 of the implant 105 abuts the lower surface of the upper vertebra while the abutment surface 125 of the lower component 115 abuts the upper surface of the lower vertebra. As mentioned, the abutment surface of each upper and lower component is preferably configured to promote interaction with the adjacent bone and affix the implant to it. For that purpose, the abutment surfaces may be textured, corrugated or serrated. They may be also coated with substances that promote osteo-integration such as titanium wire mesh, plasma-sprayed titanium, tantalum, and porous CoCr. The surfaces may be further coated/made with osteo-conductive (such as deminerized bone matrix, hydroxyapatite, and the like) and/or osteo-inductive (such as Transforming Growth Factor “TGF-B,” Platelet-Derived Growth Factor “PDGF,” Bone-Morphogenic Protein “BMP,” and the like) bio-active materials that promote bone formation. Further, helical rosette carbon nanotubes or other carbon nanotube-based coating may be applied to the surfaces to promote implant-bone interaction.
With reference to the embodiment of
The implant 105 can exist in a neutral state. When in the neutral state, the various magnetic forces are in balance such that the upper and lower components are in a predetermined position relative to one another. The implant is preferably configured so that the neutral position provides an adequate distance between the upper and lower components and contact between the upper and lower components does not interfere with movement of the bearing component.
Movement of the implant away from the neutral position produces an imbalance in the sum of the magnetic forces. The implant resists movement away from the neutral position and returns the attached vertebral bones to the neutral position after the forces acting upon it have dissipated. In an alternative embodiment, the implant has an internal latch that prevents separation of the two members even when the weight borne is less than the repulsive force of the magnetic fields.
With reference to the cross-sectional view of
In another embodiment, the function of the facet joints of the first and second vertebrae of the spine may be modified or replaced using a dynamic screw assembly.
The assembly of
With reference to
It should be appreciated that the size and shape of the spaces 1505 can be varied. Moreover, the saddle member 510 can be sized and shaped relative to the outer housing 505 such that other spaces are formed. At least one purpose of the spaces is to permit relative movement between the saddle member 510 and the outer housing 505 and this can be accomplished in various manners. Thus, the screw can be moved from a first orientation (such as the neutral position) to a second orientation while the rod is immobilized relative to the inner member 510.
The inner saddle member 510 can slidably move within the outer housing 505 along a direction aligned with axis S wherein the amount movement is limited by the interplay between the inner saddle member and outer housing. This type of movement is represented in
In one embodiment, protrusions 920 of saddle member 510 as well as central post 5055 outer housing 505 can be fitted with (or made out of) members capable of producing a magnetic field. The magnetic members are positioned with like polarity facing one another so that the components repel each other. While the device permits movement of the inner saddle member 510 relative to the housing 505, the repulsive magnetic fields of the saddle member and the housing resist any movement away from the neutral position and return the assembly to neutral after the force producing the movement has dissipated. The interaction of the magnetic fields influences the extent of rotation and translation of members of the assembly.
Although a Morse taper locking mechanism provides a powerful immobilization, it may be loosened with only a modest backout of the locking members 2120 relative to the housing 2105. This may be prevented by the addition of a magnetic locking mechanism. One or more magnet components M and M1 can be positioned within the locking member(s) 2120 and/or housing 2105, as shown in
Finally, the fields generated by the magnetic members of the implant may have pain reducing effects on neighboring tissues. These fields will bath neighboring tissues and may provide an additional benefit and advantage over orthopedic implants that do not contain magnets. Since magnetic fields of varying strength are believed to have greater tissue effect than fields with constant strength, the devices may be configured so that the neighboring tissues are exposed to a variable magnetic filed. In an embodiment, a member of the prosthesis that is mobile relative to the magnetic field source can be fitted with magnetically shielding material and positioned between the field source and the target tissue. With normal prosthesis movement, the shielding member will move between the magnetic member and the surrounding tissues and the tissues will experience a variation in the magnetic field.
The disclosed devices or any of their components can be made of any biologically adaptable or compatible materials. Materials considered acceptable for biological implantation are well known and include, but are not limited to, stainless steel, titanium, tantalum, combination metallic alloys, various plastics, resins, ceramics, biologically absorbable materials and the like. Any components may be also coated/made with osteo-conductive (such as deminerized bone matrix, hydroxyapatite, and the like) and/or osteo-inductive (such as Transforming Growth Factor “TGF-B,” Platelet-Derived Growth Factor “PDGF,” Bone-Morphogenic Protein “BMP,” and the like) bio-active materials that promote bone formation. Further, any surface may be made with a porous ingrowth surface (such as titanium wire mesh, plasma-sprayed titanium, tantalum, porous CoCr, and the like), provided with a bioactive coating, made using tantalum, and/or helical rosette carbon nanotubes (or other carbon nanotube-based coating) in order to promote bone in-growth or establish a mineralized connection between the bone and the implant, and reduce the likelihood of implant loosening.
Although embodiments of various methods and devices are described herein in detail with reference to certain versions, it should be appreciated that other versions, embodiments, methods of use, and combinations thereof are also possible. Therefore the spirit and scope of the appended claims should not be limited to the description of the embodiments contained herein.
This application claims priority of co-pending U.S. Provisional Patent Application Ser. No. 60/774,519 filed Feb. 18, 2006. Priority of the aforementioned filing date is hereby claimed and the disclosure of the Provisional Patent Application is hereby incorporated by reference in its entirety.
Number | Date | Country | |
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60774519 | Feb 2006 | US |