Orthopedic replacement of damaged or degenerated natural wrist joints is well known in the orthopedic arts. Prior to the introduction of a prosthetic joint replacement for the wrist, individuals suffering from a joint disease in the wrist such as radio-carpal arthritis are often surgically treated by a fusion procedure. Fusion involves repairing the injured wrist joint structures with a fixed plate or rod that stiffens the wrist. That is, the joint is fixed in position by a device that allows no movement of the wrist. While this is an improvement over a diseased or injured wrist joint, it is clearly unsatisfactory.
Existing orthopedic prostheses for wrist joint implantation have a number of limitations. Currently, most prosthetic wrist implants provide the patient with only limited functionality of the wrist, as otherwise the implant becomes unstable. A major function of the wrist is to transfer pronosupination torques from the forearm to the hand, in all positions without losing stability. This critical functional aspect of the wrist joint is overlooked in current arthroplasty designs.
It has been found that implants that allow metal to metal contact between the radial and carpal components tend to cause shedding of metal particles that may migrate into surrounding tissues and may cause tissue necrosis and consequent implant failure. Furthermore, typical metal and high molecular weight polyethylene implants succumb to wear phenomena and subsequent osteolysis and other complications.
It would be valuable for a prosthetic wrist implant to provide a secure, strong, and stable attachment to the surrounding bones in order to lower complications related to implant loosening. Further, it would be beneficial to avoid or limit metal-to-metal and metal on high molecular weight polyethylene contact between the radial and carpal components to limit wear phenomena of typical prosthetic joints with bearing surfaces. The prosthetic wrist implant of the present invention addresses the needs and limitations of current designs.
In one aspect, the present invention relates to a prosthetic wrist implant comprising: a radial component positioned proximal to a carpal component, the radial component having an elongated radial stem extending in a proximal direction configured to attach to a radius bone, and the carpal component having a distal surface configured to attach to one or more carpal bones; and an interposed component positioned between the radial component and the carpal component, the interposed component attached to the carpal component by a mobile connection rotatable about a first axis, and to the radial component by a mobile connection rotatable about a second axis, the first axis and the second axis being orthogonal to each other.
In one embodiment, the implant has a center of rotation positioned at an intersection of the first axis and the second axis. In one embodiment, the mobile connections between the interposed component, the carpal component, and the radial component are configured to rigidly support a pronosupination torque.
In one embodiment, the interposed component comprises two orthogonally intersecting axle arms. In one embodiment, the mobile connection between the interposed component and the radial and carpal components is a hinged connection. In one embodiment, the hinged connection comprises a low friction bearing. In one embodiment, the bearing is sealed.
In one embodiment, the interposed component comprises a spherical component having a first groove and a second groove embedded on an outer surface of the spherical component, the first groove being aligned along a curve of a first great-circle of the spherical component, the second groove being aligned along a curve of a second great-circle of the spherical component, and wherein a plane of the first great-circle and a plane of the second great-circle are orthogonal to each other. In one embodiment, the carpal component and the radial component each comprise a runner sized and arced to fit within and slide along the first and second grooves of the spherical component, respectively. In one embodiment, the runner of the radial component is attached to a distal plate connected to the radial component such that the runner is positioned offset from a central long axis of the radial component. In one embodiment, the offset is between about 5 mm and 25 mm.
In one embodiment, the interposed component comprises a substantially spherical component having a first groove and a second groove embedded on an outer surface of the spherical component, the first groove being aligned along a curve of a first great-circle of the spherical component, the second groove being aligned along a curve of a second great-circle of the spherical component, a plane of the first great-circle and a plane of the second great-circle are orthogonal to each other, and the first great-circle having a radius that is smaller than a radius of the second great-circle.
In another aspect, the present invention relates to a prosthetic wrist implant comprising: a radial component positioned proximal to a carpal component, the radial component having an elongated radial stem extending in a proximal direction configured to attach to a radius bone, and the carpal component having a distal surface configured to attach to one or more carpal bones; and a non-articulating interposed component comprising a first curved piece and a second curved piece, each curved piece comprising a curved length having two ends and a vertex; wherein the first curved piece is attached to the carpal component at each end, the second curved piece is attached to the radial component at each end, and the first curved piece and the second curved piece are attached to each other at their vertices.
In one embodiment, the first and second curved pieces and the attachment between the first and second curved pieces are flexible about two orthogonal axes to form a flexible interposed component configured to support flexion, extension, radial deviation, ulnar deviation, and combinations thereof. In one embodiment, the flexible interposed component is configured to support the transfer of a pronosupination torque.
In another aspect, the present invention relates to a method of implanting a prosthetic wrist implant, comprising the steps of: providing the prosthetic wrist implant of the present invention; aligning the center axis of rotation with the long axis of a patient's forearm; and positioning the center of axis of the prosthetic wrist implant near the patient's capitate bone.
In one embodiment, the prosthetic wrist implant is positioned such that an intersection of the first axis and the second axis is aligned between the proximal extent of the capitate bone and ¼ of the height of the capitate bone measured from its proximal extent. In one embodiment, the first axis is aligned orthogonally with the radial extension to volar flexion movement of the dart thrower's motion, and the second axis is aligned in parallel with the radial extension to volar flexion movement of the dart thrower's motion. In one embodiment, the first axis is aligned 45°±15° oblique from the sagittal plane of a patient's hand. In one embodiment, the first axis is aligned with the plane defined by the insertion of the flexor carpi ulnaris and the extensor carpi radialis longus/extensor carpi radialis brevis of a patient's arm.
The following detailed description of embodiments of the invention will be better understood when read in conjunction with the appended drawings. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities of the embodiments shown in the drawings.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, exemplary methods and materials are described.
As used herein, each of the following terms has the meaning associated with it in this section.
The articles “a” and “an” are used herein to refer to one or to more than one (i.e., to at least one) of the grammatical object of the article. By way of example, “an element” means one element or more than one element.
“About” as used herein when referring to a measurable value such as an amount, a temporal duration, and the like, is meant to encompass variations of ±20%, ±10%, ±5%, ±1%, or ±0.1% from the specified value, as such variations are appropriate to perform the disclosed methods.
Ranges: throughout this disclosure, various aspects of the invention can be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 2.7, 3, 4, 5, 5.3, and 6. This applies regardless of the breadth of the range.
The present invention provides prosthetic wrist implants that solve the problems and limitations associated with current wrist prostheses. The implants minimize wear phenomena associated with current materials at articulating surfaces and allow for transfer of pronosupination torque across the wrist. The implants consist of an intersegment component between the radius portion and the carpal portion of a wrist.
Referring now to
Interposed component 110 is a cross-shaped piece formed from two axle arms aligned along axis 112 and axis 114. Interposed component 110 is connected to carpal component 106 by a first arm aligned along axis 112 and to radial component 108 by a second arm aligned along axis 114. Axis 112 and axis 114 are orthogonal to each other, and correspond to the wrist's extension to flexion range of motion and ulnar deviation to radial deviation range of motion, respectively. However, it should be understood that implant 100 can be implanted in any suitable orientation, such that the alignment of axis 112 and axis 114 with respect to the wrist's ranges of motion are interchangeable. In some embodiments, the connection is a hinged connection, such as by way of hinge connectors (
Referring now to
In various embodiments, the connection between the interposed components with the carpal components and radial components includes a low wear or low friction bearing, such as a polymer bearing or a polyethylene bearing, to minimize or prevent metal-on-metal contact. The bearing can be sealed to prevent any worn down metal or plastic particles from being exposed to the body. In other embodiments, the entire articulating space of the wrist implants can include an enclosure or casing to prevent any worn down metal or plastic particles from being exposed to the body.
Referring now to
Referring now to
Interposed component 414 comprises a solid spherical shape having a first groove 416a and a second groove 416b. Grooves 416a and 416b are each open at their top and embedded into the outer surface of the spherical shape of interposed component 414. Groove 416a is aligned along the curve of a first great-circle, and groove 416b is aligned along the curve of a second great-circle, wherein a plane of the first great-circle and a plane of the second great-circle are aligned orthogonal to each other (dashed lines,
Referring now to
Interposed component 516 comprises a solid spherical shape having a first groove 518a and a second groove 518b. Grooves 518a and 518b are each open at their top and embedded into the outer surface of the spherical shape of interposed component 516. Groove 518a is aligned along the curve of a first great-circle, and groove 518b is aligned along the curve of a second great-circle, wherein a plane of the first great-circle and a plane of the second great-circle are aligned orthogonal to each other (dashed lines,
In certain embodiments, implant 500 can be tuned for enhanced fit and mobility. Referring now to
The various prosthetic wrist implants of the present invention can be implanted into a user's wrist space in any suitable configuration. In some embodiments, an implant of the present invention is implanted such that an interposed component has a center of rotation (that is, the point where the axes corresponding to the wrist's extension to flexion range of motion and ulnar deviation to radial deviation range of motion intersect) aligned with the long axis of a patient's forearm. In some embodiments, an implant is positioned such that the center of rotation is placed at approximately the proximal aspect of a patient's capitate bone. In some embodiments, an implant is positioned such that the center of rotation is placed between the proximal extent of the capitate to ¼ the height of the capitate from its proximal extent. In some embodiments, the axes corresponding to the wrist's extension to flexion range of motion and ulnar deviation to radial deviation range of motion are aligned with the wrist's dart thrower's motion. The dart thrower's motion is a movement in the wrist from radial extension to ulnar flexion and combines flexion/extension with radial/ulnar deviation. Aligning an implant of the present invention with the dart thrower's motion thereby aligns the implant a first axis orthogonally with the radial extension to ulnar flexion direction and aligns a second axis in parallel with the radial extension to ulnar flexion direction. In some embodiments, the first axis is set at approximately 45 degrees +/−15 degrees oblique from the sagittal plane of a patient's hand. In some embodiments, the first axis is aligned with the plane defined by the insertion of the flexor carpi ulnaris and the extensor carpi radialis longus/extensor carpi radialis brevis of a patient's arm.
The various components of the present invention described above can be constructed using any suitable method known in the art. The method of making may vary depending on the materials used. For example, components substantially comprising a metal may be milled from a larger block of metal or may be cast from molten metal. Likewise, components substantially comprising a plastic or polymer may be milled from a larger block, cast, or injection molded. In some embodiments, the devices may be made using 3D printing or other additive manufacturing techniques commonly used in the art. In various embodiments, the components can be constructed using a porous or semi-porous structure to encourage osseointegration.
The invention is further described in detail by reference to the following experimental examples. These examples are provided for purposes of illustration only, and are not intended to be limiting unless otherwise specified. Thus, the invention should in no way be construed as being limited to the following examples, but rather, should be construed to encompass any and all variations which become evident as a result of the teaching provided herein.
Without further description, it is believed that one of ordinary skill in the art can, using the preceding description and the following illustrative examples, make and utilize the compounds of the present invention and practice the claimed methods. The following working examples therefore, specifically point out exemplary embodiments of the present invention, and are not to be construed as limiting in any way the remainder of the disclosure.
The disclosures of each and every patent, patent application, and publication cited herein are hereby incorporated by reference in their entirety. While this invention has been disclosed with reference to specific embodiments, it is apparent that other embodiments and variations of this invention may be devised by others skilled in the art without departing from the true spirit and scope of the invention. The appended claims are intended to be construed to include all such embodiments and equivalent variations.
This application claims priority to U.S. Provisional Patent Application No. 62/650,413, filed Mar. 30, 2018, the contents of which are incorporated by reference herein in their entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/US2019/024769 | 3/29/2019 | WO | 00 |
Number | Date | Country | |
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62650413 | Mar 2018 | US |