The invention relates to joint replacement devices and methods.
Degenerative joint disease of the small joints of the hands and feet affects millions of Americans. Currently available technologies are available which replace severely damaged joints with prosthetic joints; however, these techniques require open excision of the diseased joint and open placement of the prosthetic joint.
Many current designs for small joint prosthesis are based upon articulating designs that are similar to designs used for large joints. These large joint technologies are more than thirty years old. While bearing surface articulating joints are certainly expected to be highly durable, cost of manufacture is relatively high and requires open procedure type techniques to place. The articulating surface type joints closely mimic the structure of a native joint; with articulating surfaces that are formed along a radius of motion much like a native joint. In this sense, the articulating prosthetic joints are the closest thing to a natural joint allowing for natural motion between proximal and distal bones with the prosthetic joint between. This has the benefit of preserving the spatial relationships of the native ligaments through normal range of motion. Surgeries for placement of an articulating type joint in the hand are very similar to a total knee replacement procedure, while these surgeries do not typically take as long as a total knee surgery, they are lengthy.
Some prosthetic joint devices are based upon resilient polymer insertions that allow movement across a joint through plastic deformation. Resilient polymer type prosthetic joints have been available for more than twenty years; these joints permit motion with a hinge type structure that typically moves the center of motion to a volar geometry, affecting normal ligamentous relationship across the joint. Placement requires an open technique with careful dissection to preserve native collateral ligament structures to attain a good post surgical result. Of necessity these surgeries have been lengthy and are typically limited to replacement of two or three joints at a time. Longevity of soft joint replacements are dependent upon loads that they are subjected to, this technology may not be suitable for patients who use their hands even for relatively light manual labor.
There is a need for a small joint replacement device that can be placed utilizing a percutaneous technique.
There is a need for a small joint replacement device that can be manufactured for low cost.
There is a need for small joint replacement technologies that may be affected in a short operative time with multiple joints replaced at a single surgery.
There is a need for small joint replacement technologies that are composed of materials of a highly durable nature.
The invention exploits shape memory material to effect construction of an artificial joint. Placement is effected through a minimally invasive surgical technique, wherein the device transforms from a collapsed indeterminate form to a determinate form as heat is introduced. The device self deploys to a determinate geometric shape having super elastic properties.
In one embodiment, the device comprises first and second shape memory component. Each component may be separately placed into a surgically formed osteotomy/arthrotomy 102 utilizing a thermal transition method of deployment across a native joint space.
The first placed component in this embodiment may be an anchor 202 which is introduced into the preformed osteotomy/arthrotomy utilizing the thermal method of deployment. The anchor may form an outer sheath that is coiled, or helical. The anchor holds the device in the osteotomy in the associated bone. A second placed component, which may continuously formed with the anchor, is a flexible section 206, which acts as a hinge. The anchor is sized at deployment to allow tolerance so that the device may be rotated within the osteotomy/arthrotomy post deployment. Radial positioning of the component allows bending at the flexible section in a biased manner, which allows for bending preferentially in a single plane or multiple planes with greater resistance to bending in other planes. Positioning movement allows the device to be positioned along the long axis of the osteotomy/arthrotomy, such that the portion of the component with greatest diameter, section 206, shown as having a flower petal configuration, may be placed between the bones to coincide with the portion of the arthrotomy 104 having the greatest diameter.
The flexible section in this embodiment is in an outer sheath, with helical wires expanded outwardly in what may be a “flower petal” like arrangement. This section may be formed of one or more windings, and has a diameter that is greater than the diameter of the osteotomy. This enlarged diameter accommodates bending at this portion that is positioned between the bones, thereby forming a flexible joint between anchor 202 and anchor 204. The enlarged winding or “flower petal” geometry creates a section with attenuated structural properties, such that the distal cylindrical portion may move through a predetermined radius relative to the proximal cylindrical portion.
A second or inner component may be placed utilizing the thermal method of deployment. The inner component may be placed concentrically within the outer component or outer sheath.
Geometrically, the inner component may be comprised of three separate sections from distal to proximal: an inner or distal portion 302, which may be cylindrical, that expands within the distal anchor 202, a flexible section, which may be a middle “bending arm” section having attenuated structure 306 that favors bending in a specific plane or planes, and functions to separate under stress at placement the distal and proximal portions of the outer component, thus opening the joint space 106, and the proximal portion 304 that expands at deployment, locking the proximal anchor 204 of the outer component into the formed osteotomy/arthrotomy 502.
The inner component of this embodiment may by designed at the flexible middle section to favor motion in a specified plane or planes, which may be accomplished through selective attenuation 308 of flexible middle section 306. Further, this selective attenuation allows the structure to resist bending in a plane or planes that would be unfavorable. In one embodiment, the flexible “bending arm” section has three round wire members that are so arranged that there is a single member at the most volar aspect and two wires that are at the most dorsal aspect.
Mechanical relationships may be maintained between the geometrically distinct areas of the device through flexion and extension motions. The “bending arm” portion of the inner component serves to maintain a specified distance between distal and proximal cylindrical portions of the device while favoring bending in a specified plane or planes. The “bending arm” portion of the inner component may be configured to allow for a controlled degree of compression or axial expansion along its length by having short segments of helix that are of less diameter than required to engage the anchor. See 318 of
It is anticipated that the device may be secured within the osteotomy/arthrotomy though expansive force applied to the device as the inner component is deployed. However, there are alternate means through which it is anticipated that the device may be secured in place. The device may be secured utilizing small diameter screws 500 placed axially or through a side wall. The device may be secured utilizing bone staples 504 placed axially or through a side wall. The device may be coated with bone growth or stimulation factors to promote fusion at points of contact. The device may be filled with native bone graft or artificial bone graft 506 to promote fusion. The device may be secured utilizing artificial or naturally derived adhesives capable of bonding to bone.
Functional relationships of the device to native bone and joint structures are designed to closely mimic natural function of the joint while alleviating common pathologic conditions that affect the joints of the human body. Placement technique utilizes an arthrotomy procedure in addition to an osteotomy; this component of the procedure serves to remove pathologic joint tissue and place the articulating joint surfaces at a distance from each other thus reducing chronic change processes that result from “bone on bone” conditions of osteoarthritis and rheumatoid disease processes. The joint is designed to provide a radius of rotation with the distal cylindrical portion moving along an arc of predetermined distance from the proximal cylindrical portion; the structural relationship forming this linkage may be rigid in nature with an absolute fixed distance between the two cylindrical portions or the relationship may be semi-rigid allowing for some extension and/or compression along the length of the “bending arm”. The joint will separate with tension applied along its axis 107 as compared with its neutral position 108. Compressive force applied along the axis of the joint will cause the joint space to diminish 110. Compressive and extensile motion is accommodated by providing a short segment of free helix at the proximal and/or distal most part of the flexible “bending arm” section, said free helix having a controlled resistance to force applied along the axis of the flexible “bending arm” section 306.
In another embodiment, the outer component or outer sheath is omitted. The inner component of the device as described herein serves forms the prosthetic joint.
The device as positioned for use in the spine is preferred to be a coiled structure, and may be helical in structure. Exemplary coiled structures are shown in
The device is constructed to maintain a super-elastic form at body temperature, and may assume this shape at slightly below body temperature. This final deployed form of the device has a shape and size that may be a coiled or helical structure at opposite ends, with the anchoring ends joined by flexible section or arm. The structural properties of the device, when maintained at temperatures at or above the transition temperature, which is preferred to be at, or slightly below, body temperature is able to correct or assist in correcting joint dysfunction between adjoining bones.
Currently available materials meeting desirable specifications for formation of the shape memory joint are various alloys of nitinol or nitinol like alloys. Alloy composition may be adjusted, creating shape memory materials having super-elastic and shape set characteristics (austenite state) near body temperature, while retaining those shape characteristics at body temperature and higher temperatures. These alloys exist at lower temperatures in martensite state wherein the material is relatively malleable and has no shape set or super-elastic properties, the shape may be expressed as “indeterminate” at these temperatures. When the shape of the device is indeterminate, if a dynamic force is placed upon the device and the dynamic force changes the shape, the shape into which the device is changed is retained when the dynamic force is removed. This martensite state corresponds to the pre-deployment malleable form, or indeterminate form, of the device. In this state, the device may be linear, like a wire, and may be bent or shaped like a wire. In a preferred embodiment, the wire 210 may be shaped manually by a physician installing the device.
When heat is applied to the device, the device assumes its predetermined super-elastic austenite “shape memory” form with high strength and predicable shape and structural capabilities. The device will retain this shape as long as the temperature is maintained above the predetermined temperature, which is preferred to be just below body temperature of the human or other vertebrate into which the device is to be positioned. When a dynamic force is not being actively applied to the device at this higher temperature, the device assumes and retains a predetermined shape, which may be summarily referred to as a determinate shape. The device is shown in various embodiments of determinate shape in the drawing Figures.
In one embodiment, the device is a wire 210 having a substantially round cross section. The determinate form of the device is shape set to a coiled or helical form for anchors 202 and 204 and ends 302 and 304.
The device may be repositioned during the placement process by terminating heat introduction, and pulling the device in the opposite direction and into the catheter, where the temperature environment is less than Mf. Stated otherwise, the transition process is reversed.
The device is placed into an osteotomy formed by a tool 402 in the adjoining bones. A tool 404 may also be used to form an arthrotomy.
This Application is a continuation in part of application Ser. No. 11/196,891 filed Aug. 4, 2005. Applicant claims the benefit of provisional application Ser. No. 60/982,210 filed Oct. 24, 2007.
Number | Date | Country | |
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60982210 | Oct 2007 | US |
Number | Date | Country | |
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Parent | 11196891 | Aug 2005 | US |
Child | 12256730 | US |