FIELD OF THE INVENTIONThe invention generally relates to devices, systems, and methods for realignment of bone, e.g. during bony osteotomy.
BACKGROUND OF THE INVENTIONThere are many occasions in orthopedic surgery when a bone is angled improperly due to congenital deformity, trauma, failed surgeries, and uneven arthritic wear in joints. A surgical operation called an osteotomy is done to correct this misalignment. In an osteotomy the bone is cut and then realigned to correct the improper angle.
In an osteotomy procedure, the surgeon removes a wedge of bone near a damaged joint. The procedure shifts weight from an area where there is damaged cartilage to an area where there either more cartilage or healthier cartilage. In this manner, weight is spread more evenly across the joint cartilage.
Osteotomy is commonly performed on the knee or hip joint. Osteotomy may help correct knee deformities such as bowleg or knock-knee deformities. Osteotomy may also be used to correct damage due to arthritis. For example, osteotomy may be performed in patients too young for a total joint replacement.
It is desirable to provide a new device which both simplifies the re-angling operations and enables correction to be more precise.
SUMMARY OF THE INVENTIONThe invention provides devices, systems, and methods for re-aligning or re-angling a bone.
One aspect of the invention provides a system comprising a body sized and shaped to re-align a bone region toward a desired anatomic position and at least one fixation member for securing the body to the bone region.
In one embodiment, the fixation member includes at least one fixation plate sized and configured for association with the body to secure the body to the bone region.
In one embodiment, the fixation member comprises at least one screw and/or at least one staple and/or at least one stem.
In one embodiment, the body includes at least one aperture formed through it sized and configured for engagement with a fixation member. In this arrangement, the aperture can include internal threads for receiving a screw.
In one embodiment, the body is generally wedge-shaped.
In one embodiment, the fixation member includes a fixation plate formed with a first surface geometry. In this arrangement, the body includes a second surface geometry that mates with the first surface geometry.
In one embodiment, the system further comprises a total joint replacement including a stem. In this arrangement, the body includes an aperture formed through it sized and configured for engaging the stem.
Another aspect of the invention provides an osteotomy device comprising a generally wedge-shaped body and at least one intramedullary post extending from the wedge-shaped body.
Another aspect of the invention provides a method comprising providing a body sized and shaped to re-align a bone region toward a desired anatomic position and at least one fixation member for securing the body to the bone region. The method includes selecting an bone region, forming a cavity in the bone region sized and configured to receive the body, and inserting the body in the bone region to re-aligned the bone region toward a desired anatomic position. The method includes fixing the body to the bone region with the fixation member.
Another aspect of the invention provides a method comprising providing a body sized and shaped to re-align a bone region toward a desired anatomic position and at least one fixation plate sized and configured for association with the body to secure the body to the bone region. The method includes selecting an bone region, forming a cavity in the bone region sized and configured to receive the body, and inserting the body in the bone region to re-aligned the bone region toward a desired anatomic position. The method includes fixing the body to the bone region with the fixation plate.
Another aspect of the invention provides a method comprising providing a body sized and shaped to re-align a bone region toward a desired anatomic position, the body including at least one aperture formed through it sized, and a fixation member sized and configured for engagement with aperture. The method includes selecting a bone region, forming a cavity in the bone region sized and configured to receive the body, and inserting the body in the bone region to re-align the bone region toward a desired anatomic position. The method includes fixing the body to the bone region by engaging the fixation member through the aperture.
Other objects, advantages, and embodiments of the invention are set forth in part in the description which follows, and in part, will be obvious from this description, or may be learned from the practice of the invention.
BRIEF DESCRIPTION OF THE DRAWINGSFIG. 1 is a top view of a foot.
FIG. 2 is a front view of a leg.
FIG. 3 is a perspective view of a re-angling device according to the present invention.
FIG. 4A is a plan view of a bone with a wedge shaped gap cut therein.
FIG. 4B shows a re-angling device of the type shown inFIG. 3 being inserted into the bone of the type shown inFIG. 4A.
FIGS. 4C to 4F show a re-angling device of the type shown inFIG. 3 being secured to a bone of the type shown inFIG. 4A using alternative fixation plate and fixation member.
FIGS. 5A and 5B show an alternative embodiment of a re-angling device being inserted into a bone.
FIG. 6A is an exploded perspective view of an alternative re-angling device and fixation plate wherein the re-angling device is formed with a protrusion and the fixation plate is formed with a mating aperture.
FIG. 6B shows the alternative re-angling device and fixation plate ofFIG. 6A secured in a bone of the type shown inFIG. 4A.
FIGS. 6C to 6F show additional alternative embodiments of the re-angling device and fixation plate ofFIG. 6A.
FIG. 6G is an exploded perspective view of an alternative re-angling device and fixation plate wherein the re-angling device is formed with a aperture and the fixation plate is formed with a mating protrusion.
FIG. 7A is an exploded perspective view of a alternative re-angling device and fixation plate being inserted into a bone of the same type shown inFIG. 4A.
FIG. 7B shows the alternative re-angling device and fixation plate ofFIG. 7A secured in a bone of the same type as shown inFIG. 4A.
FIG. 8 shows an alternative re-angling device with a integrally formed fixation plate secured in a bone of the same type as shown inFIG. 4A.
FIG. 9A is a perspective view of an alternative embodiment of a re-angling device.
FIG. 9B shows the alternative re-angling device ofFIG. 9A secured to a bone of the same type as shown inFIG. 4A by a fixation plate and fixation members.
FIGS. 10A and 10B show an alternative re-angling device inserted into a bone of the type shown inFIG. 4A.
FIGS. 10C to 10G show various alternative embodiments of the re-angling device ofFIG. 10A.
FIG. 10H shows the re-angling device ofFIG. 10B secured in the bone with a fixation plate and fixation members.
FIG. 11A is a perspective view of an alternative embodiment of the re-angling device ofFIG. 3 with a hole therethrough for a total joint replacement stem.
FIG. 11B shows the re-angling device ofFIG. 11A inserted into a bone.
FIG. 11C is a perspective view of an alternative embodiment of the re-angling device like that shown inFIG. 11A, inserted into a bone with the hole receiving a fixation pin.
FIG. 11D is a perspective view of an alternative embodiment of the re-angling device like that shown inFIG. 11A, the hole being internally threaded for receiving a screw.
FIG. 11E shows the re-angling device ofFIG. 11E inserted into a bone and fixated with a screw through the hole.
DESCRIPTION OF THE PREFERRED EMBODIMENTAlthough the disclosure hereof is detailed and exact to enable those skilled in the art to practice the invention, the physical embodiments herein disclosed merely exemplify the invention which may be embodied in other specific structures. While the preferred embodiment has been described, the details may be changed without departing from the invention, which is defined by the claims.
FIGS. 1 and 2 show the anatomy of the human foot and leg, respectively. While it is contemplated that osteotomy may be in any part of the human anatomy, osteotomy is commonly performed on the metatarsal and the femur.
I. Re-Angling Device with Separate Fixation Plate
FIG. 3 shows adevice10 for re-angling or realigning a bone region according to the present invention. Thisdevice10 is sized and configured to be inserted into a gap formed in the bone region to accommodate placement of thedevice10. Thedevice10 is sized and configured to re-angle or realign the bone region toward a desired anatomic position, e.g., during an osteotomy procedure.
In a first illustrated embodiment, there-angling device12 is generally wedge shaped, and is sized and configured to fit into a wedge-shaped gap cut into the bone region. The size and configuration of there-angling device12 can vary, as long as it functionally serves to re-angle or realign the bone region in a desired manner.
In the embodiment shown inFIG. 3, there-angling device12 includes a generallyrectangular base16, a pair of wedge surfaces14 which extend from laterally opposed edges of thebase16 and meet at a point opposite thebase16, and a pair of end surfaces18 which extend from laterally opposed edges of thebase16 and engage one edge of eachwedge surface14.
In order to insert thedevice12 into thebone6, an appropriately sized wedge of bone is removed from the application site, creating a wedge-shapedgap8, as shown inFIG. 4A. The application site is chosen by the physician based on the anatomy of the patient. Thegap8 is created using any appropriate surgical device, such as an appropriately sized and configured surgical saw. Thedevice12 is then inserted into thegap8 in thebone6 as shown inFIG. 4B. Thedevice12 may then be secured to thebone6. Thedevice12 may be secured to the bone by any known method used in the art, for example, and not limited to bone cement, a temporary plate, and a permanent plate.
In one method of fixation, as shown inFIG. 4C, thedevice12 is secured in the gap by placing afixation plate20 over there-angling device12. Thefixation plate20 is then attached to thebone6 using afixation member24. In some circumstances, it may be desirable to drill pilot holes in either thefixation plate20 or thebone6 prior to inserting thefixation member24. Thefixation member24 preferably extends through thefixation plate20 and into thebone6 to secure there-angling device12 to thebone6.
In the embodiment shown inFIG. 4C, thefixation plate20 takes the form of asingle fixation plate22 that extends across the entire length of there-angling device12.
It is also contemplated that thefixation plate20 could take the form ofmultiple fixation plates122, each of which extends across only a portion of the re-angling device, as shown inFIG. 4D.
In the representative embodiments shown inFIGS. 4C and 4D thefixation members24 comprisesscrews26, such as surgical screws. However, it should be understood that the fixation members may be chosen from a variety of fixation members known in the art. For example, thefixation member24 could also be abone staple126, as shown inFIG. 4E or abarbed bone staple226 as shown inFIG. 4F.
As shown inFIG. 4E, it may be desirable to provide thefixation plate20 with at least one preformedaperture34 through which afixation member24 may extend to secure thefixation plate20 to thebone6. Theaperture34 may be threaded or not threaded depending on the type offixation member24 to be used.
The size and shape of thedevice10,fixation plate20, andfixation members24 are chosen by the physician based on each individual patient's anatomy and the type of bone in which the device is to be used.
Thedevice10, thefixation plate20, and thefixation members24 may be made of various materials commonly used in the prosthetic arts including, but not limited to, metals, ceramics, tantalum, polyethylene, biologic type polymers, hydroxyapetite, rubber, titanium, titanium alloys, tantalum, chrome cobalt, surgical steel, or any other total joint replacement metal and/or ceramic, bony in-growth surface, sintered glass, artificial bone, any porous metal coat, metal meshes and trabeculations, metal screens, uncemented metal or ceramic surface, other bio-compatible materials, or any combination thereof.
It may be desirable to provide thedevice10, thefixation plate20, and thefixation members24 with surfaces, or a portion of a surface, that allow for bony ingrowth. The surfaces of thedevice10,fixation plate20, andfixation members24 could be covered with biological bone substitute or biological stimulators for example, but not limited to hydroxygretite, calcium phosphate, calcium sulfate, or one of the bone morphogenic stimulators. Alternatively, the surfaces ofdevice10, thefixation plate20, and thefixation members24 could be covered with surface texturing to induce bony in-growth. The surface texturing can comprise, e.g., through holes, and/or various surface patterns, and/or various surface textures, and/or pores, or combinations thereof. Thedevice10 can be coated or wrapped or surfaced treated to provide the surface texturing, or it can be formed from a material that itself inherently possesses a surface conducing to bony in-growth, such as a porous mesh, hydroxyapetite, or other porous surface.
It may further be desirably for thedevice10 to be covered with various coatings such as antimicrobial, antithrombogenic, and osteoinductive agents, or a combination thereof.
II. Re-Angling Device Fixed with One or More Crossing Screws
It is further contemplated that there-angling device10 described above may be fixed by one or more fixation members inserted through the alternativere-angling device112 as shown inFIGS. 5A and 5B. There-angling device112 may take generally the same form as described above. However, in such an embodiment the need for afixation plate20 is eliminated.
In order to insert the alternativere-angling device112 into thebone6, an appropriately sized wedge of bone is removed from the application site, creating a wedge-shapedgap8, as shown inFIG. 4A. The wedge-shapedgap8 is formed using any appropriate surgical device, such as an appropriately sized and configured surgical saw. As discussed in reference to the embodiments above, the application site is chosen by the physician based on the anatomy of the patient. The size and particular configuration of the alternativere-angling device112 is also selected by the physician based on the anatomy of the patient. The alternativere-angling device112 may then be inserted into thegap8 in thebone6 and secured to thebone8 by afixation member24 as shown inFIG. 5A. In the illustrated embodiment thefixation member24 comprises a threadedscrew26. Thefixation member24 is secured using any appropriate surgical devices, such as an appropriately sized and configured surgical screwdriver. As shown inFIG. 5A, thescrew26 is screwed though there-angling device112 and into thebone6. It is further contemplated thatmultiple fixation members24 could be utilized to fasten a singlere-angling device112, as shown inFIG. 5B. It may be desirable, but not necessary, to have a pilot hole in there-angling device112 to aid in insertion of the at least onefixation member24. The re-angling device could be preformed with an aperture, such as apilot hole28, as shown inFIG. 5A. Alternatively, thepilot hole28 could be drilled in thedevice112 by the surgeon either before or after inserting there-angling device112 in thebone6. There-angling device112 andfixation members24 may be formed of any appropriate prosthetic material as describe above, and if desirable may include surfaces adapted to promote bony-in-growth as also described above.
III. Re-Angling Device with Slot for Attachment to a Fixation Plate
In an additional representative embodiment, are-angling device10 may be removably coupled to afixation plate20. As shown inFIG. 6A, there-angling device112 andfixation plate322 may take generally the same form as described above. However, there-angling device112 includes afirst surface geometry30 and thefixation plate20 includes asecond surface geometry32 that nests or mates with thefirst surface geometry30. In the illustrated embodiment, the first surface geometry comprises afemale aperture30 and the second surface geometry comprises a matingmale protrusion32. Theprotrusion32 is sized and configured to be received in theaperture30 formed in there-angling device112. The mating male and female configurations may be reversed. That is, the first surface geometry on the device can comprise a male projection and the second surface geometry on the device comprises a mating female aperture.
In the first representative embodiment, theprotrusion32 and theaperture30 each take a tapered rectangular shape. Theprotrusion32 andaperture30 may take any shape including, but not limited to square (seeFIG. 6C), morse taper, triangular (seeFIG. 6D), star-shaped (seeFIG. 6E), or round (seeFIG. 6F).
There-angling device112 and thefixation plate322 may be coupled prior to inserting there-angling device112 into thebone6. Alternatively, there-angling device112 may first be inserted into thebone6, then thefixation plate322 may be coupled to there-angling device112.
Thefixation plate322 is then fixed to thebone6 by at least onefixation member24, as shown inFIG. 6B and described in further detail above. In the illustrated embodiment, thefixation member24 takes the form of ascrew26, however it should be understood that thefixation member24 may take any form.
Alternatively the re-angling device212 may be formed with aprotrusion38 and thefixation plate422 may be formed with amating aperture36, as shown inFIG. 6H. The illustrated embodiment includes a rectangular taperedprotrusion38 and a generallyrectangular aperture36, however as described above, theaperture36 andprotrusion38 may take any mating shape.
In order to insert thedevice112 into the bone, an appropriately sized wedge of bone is removed from the application site, creating a wedge-shapedgap8, as shown inFIG. 4A. The application site is chosen by the physician based on the anatomy of the patient.
There-angling device112,212,fixation plate322,422 andfixation members24 may be formed of any appropriate prosthetic material as describe above, and if desirable may include surfaces adapted to promote bony-in-growth as also described above.
IV. Re-Angling Device with Hole for Screw Attachment to a Fixation Plate
In an additional representative embodiment both there-angling device10 and thefixation plate20 may be preformed with an aperture. As shown inFIG. 7A, anaperture530 is formed in there-angling device112 and anaperture136 is formed in thefixation plate422. In this manner, thefixation plate422 may be fixed to there-angling device112 via afixation member24 such as ascrew26, as shown inFIG. 7B.
It is contemplated that theaperture136 in thefixation plate422 and theaperture530 in there-angling device112 could be threaded as shown inFIG. 7A, or unthreaded. It is also contemplated that theaperture136 in thefixation plate422 could be threaded while theaperture530 in there-angling device112 is not threaded, or vice versa.
It may be desirable, although not necessary, to provide thefixation plate422 with at least oneaperture34 through which thefixation members24 may extend as shown inFIG. 7A. It may be desirable, but not necessary, to provide the at least oneaperture34 with internal threads as shown inFIG. 7A.
There-angling device112 is generally wedge-shaped, as described above. The size and specific configuration of there-angling device112,fixation plate422, andfixation members24 are chosen by the physician based on each individual patient's anatomy and the type of bone in which thedevice112 is to be used. There-angling device112 and thefixation plate422 may be attached prior to inserting there-angling device112 into thebone6, or after there-angling device112 has been inserted into thebone6.
As described above with respect to the previous embodiments, in order to insert there-angling device112 into thebone6, an appropriately sized wedge of bone is removed from the application site, creating a wedge-shapedgap8, as shown inFIG. 4A. The wedge-shapedgap8 is formed using any appropriate surgical device, such as an appropriately sized and configured surgical saw. As discussed in reference to the embodiments above, the application site is chosen by the physician based on the anatomy of the patient. The size and particular configuration of the re-angling device is also selected by the physician based on the anatomy of the patient. There-angling device112 is then inserted into thegap8 in thebone6 and secured to thebone6 by afixation member24 as shown inFIG. 7B. In the illustrated embodiment thefixation member24 comprises a threadedscrew26, however it should be understood that any appropriate fastener may be utilized. Thefixation member24 is secured using any appropriate surgical devices, such as an appropriately sized and configured surgical screwdriver. As shown inFIG. 7B, thescrew26 is screwed though thefixation member422 and into thebone6.
There-angling device112,fixation plate422 andfixation members24 may be formed of any appropriate prosthetic material as describe above, and if desirable may include surfaces adapted to promote bony-in-growth as also described above.
V. Re-Angling Device with Integral Fixation Plate
In an additional representative embodiment, there-angling device10 and thefixation plate20 are integrally formed as asingle device312, as shown inFIG. 8. The alternativere-angling device312 may take generally the same wedge-shaped configuration as described above.
To insert thedevice312 into thebone6, an appropriately sized wedge ofbone6 is removed from the application site, creating a wedge-shapedgap8, as shown above inFIG. 4A. The application site is chosen by the physician based on the anatomy of the patient. Thedevice312 is then inserted into thegap8 in the bone as shown inFIG. 8 and secured to thebone6. In one embodiment, there-angling device312 may be fixed to the bone through at least onefixation member20. In the illustrated embodiment, thefixation member20 takes the form of ascrew26. However, thefixation member20 may comprise any suitable fixation member, including, by means of example a surgical screw or a surgical staple. As described above, and shown inFIG. 7A, it may be desirable, although not necessary to includeapertures34 in thefixation plate portion22 of thedevice312 through which thefixation members24 may extend. It is further contemplated that in some situations it may be desirable, although not necessary, to provide theapertures34 in thefixation plate portion22 with pre-formed threads, as described in detail above.
The size and the particular configuration of there-angling device312 are preferably chosen by the physical based on the anatomy of the patient being treated.
There-angling device312 andfixation members24 may be formed of any appropriate prosthetic material as describe above, and if desirable may include surfaces adapted to promote bony-in-growth as also described above.
VI. Wedge with Angle in Two Planes
In an additional representative embodiment shown inFIGS. 9A and 9B, there-angling device412 may be formed such that thebone6 may be angled in two planes. The configuration of the re-angling device is similar to that shown inFIG. 3 and described above, however thebase416 is generally trapezoidal, rather than rectangular.
To insert thedevice412 into thebone6, an appropriately sized wedge ofbone6 is removed from the application site, creating a wedge-shapedgap8, as shown above inFIG. 4A. The application site is chosen by the physician based on the anatomy of the patient. Thedevice412 is then inserted into thegap8 in the bone as shown inFIG. 9B and secured to thebone6. In one embodiment, there-angling device412 may be fixed to the bone through at least onefixation member20. In the illustrated embodiment, thefixation member20 takes the form of ascrew26. However, thefixation member20 may comprise any suitable fixation member, including, by means of example a surgical screw or a surgical staple. As described above, and shown inFIG. 7A, it may be desirable, although not necessary to includeapertures34 in thefixation plate portion22 of thedevice312 through which thefixation members24 may extend. It is further contemplated that in some situations it may be desirable, although not necessary, to provide theapertures34 in thefixation plate portion22 with pre-formed threads, as described in detail above.
The size and the particular configuration of there-angling device412 are preferably chosen by the physical based on the anatomy of the patient being treated.
The re-angling device and fixation members may be formed of any appropriate prosthetic material as describe above, and if desirable may include surfaces adapted to promote bony-in-growth as also described above.
VII. Re-Angling Device with Intramedullary Post
In an additional representative embodiment, there-angling device512 may include at least oneintramedullary post40, as shown inFIG. 10A. Theintramedullary post40 may extend into thebone6 to further secure there-angling device512 within thebone6.
To insert thedevice512 into thebone6, an appropriately sized wedge ofbone6 is removed from the application site, creating a wedge-shapedgap8, as shown above inFIG. 4A. At least one aperture may be formed in thebone6, the aperture being adapted to accept the at least oneintramedullary post40. The application site is chosen by the physician based on the anatomy of the patient. Thedevice512 is then inserted into thegap8 in the bone as shown inFIG. 8 and secured to thebone6. The size and the particular configuration of there-angling device512 are preferably chosen by the physical based on the anatomy of the patient being treated.
It is further contemplated that there-angling device512 could be formed with a pair ofposts40, as shown inFIG. 10B.
It is further contemplated that thepost40 on there-angling device512 could take any shape. For example, the post could be square (seeFIG. 10C), star-shaped (seeFIG. 10D), triangular (seeFIG. 10E), rounded (seeFIG. 10F) or pointed (seeFIG. 10G).
There-angling device512 may be formed of any appropriate prosthetic material as describe above, and if desirable may include surfaces adapted to promote bony-in-growth as also described above.
VIII. Re-Angling Device for Use with Stem of Total Joint Replacement or Internal Fixation
It is also contemplated that any of the re-angling devices described above may be formed with ahole44 therethrough as shown inFIG. 11A.
Thehole44 may be sized and configured for the particular application. For example, thehole44 may be sized and configured such that when there-angling device612 is inserted into thebone6, the stem46 of a total joint replacement may be inserted through thehole44, as shown inFIG. 11B. Alternatively, thehole44 may be sized and configured for receiving apin48, as shown inFIG. 11C. Alternatively, thehole44 may be internally threaded, as shown inFIG. 11D, and be sized and configured for receiving ascrew50, as shown inFIGS. 11D and 11E. In any embodiment, the basic configuration of there-angling device612 is the same as described above. The particular size and configuration of thedevice612 is determined by the physician based on the bone being treated and the anatomy of the patent.
In order to insert thedevice612 into the bone, an application site is chosen by the physician based on the anatomy of the patient. An appropriately sized wedge of bone is removed from the application site, creating a wedge-shapedgap8, as shown inFIG. 4A. Thedevice612 may then be inserted into the gap in the bone as shown inFIG. 11B. Thedevice612 may then be secured to thebone6 by any known method used in the art. For example, thedevice612 may be secured in thegap8 by placing afixation plate20 over there-angling device612, asFIG. 11B shows. Thefixation plate20 can be attached to thebone6 using at least onefixation member24. Thefixation member24 preferably extends through thefixation plate20 and into thebone6 to secure there-angling device612 to thebone6. In the illustrative embodiment, thefixation member24 comprises at least one screw, however anyappropriate fixation member24 may be utilized without departing from the invention. In FIG.11B, there-angling device612 is oriented so that thehole44 receives the stem46 of a total joint replacement. In other embodiments, thedevice612 may be oriented so that the hole receives a pin48 (FIG. 11C) or a screw50 (FIG. 11E), which can be installed using standard surgical procedures known in the art. Thepin48 orscrew50 secures there-angling device612 to the bone through thehole44. In these arrangements, a fixation plate20 (as shown inFIG. 11B) need not be provided, but optionally, it can be, if additional fixation is desired.
It may be desirable to provide thefixation plate20 or plates with at least one preformedaperture34 through which afixation member24 may extend to secure thefixation plate20 to thebone6, as shown inFIGS. 6A and 6B. Theaperture34 may be threaded or not threaded.
There-angling device612 andfixation members20,24,46,48, and50 may be formed of any appropriate prosthetic material as describe above, and if desirable may include surfaces adapted to promote bony-in-growth as also described above.
The foregoing is considered as illustrative only of the principles of the invention. Furthermore, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described. While the preferred embodiment has been described, the details may be changed without departing from the invention, which is defined by the claims.