EP1983911A1

EP1983911A1 - A fracture fixation device and implantation jig therefor

Info

Publication number: EP1983911A1
Application number: EP06733966A
Authority: EP
Inventors: Jorge L. Orbay; Javier E. Castaneda; Edward Mebarak
Original assignee: DePuy Products Inc
Current assignee: DePuy Products Inc
Priority date: 2006-01-27
Filing date: 2006-01-27
Publication date: 2008-10-29
Also published as: IL193043A; NO20083686L; EP1983911A4; IL193043A0; CA2640225A1; AU2006336444A1; JP2009524473A; WO2007086854A1

Abstract

A fracture fixation device includes a plate portion and an intramedullary nail portion which is offset relative to the plate portion by a neck portion. The plate portion includes longitudinally displaced peg holes which orient pegs along an imaginary surface parallel to subchondral bone of an articular surface. The upper surface of the plate portion includes a dimple to reference a jig. The nail portion includes threaded screw holes oriented normal to an endosteal surface, and a smaller K- wire alignment hole parallel to the screw holes. The jig has a first portion which references with the dimple and a second portion in alignment over the screw holes of the nail portion. The back of the first portion of the jig is curved upward to facilitate maneuvering of the jig. The first and second portions of the jig includes K-wire guide holes which direct K-wires relative to holes in the device.

Description

A FRACTURE FIXATION DEVICE AND IMPLANTATION JIG THEREFOR

BACKGROUND OF THE INVENTION 1.. Field of the Invention

This invention relates broadly to surgical devices. More particularly, this invention relates to surgical devices and tools for implanting fracture fixation devices.

2. State of the Art

Severe long bone fractures are often treated with plating. In plating, a relatively large incision is made at the location of the fracture, musculature and tendons are displaced from the bone to expose the bone surface, and a bone plate is fixedly attached to one or more pieces of the fractured bone in a manner which, ideally, supports and stabilizes the fracture for healing. Due to the relatively invasive nature of the procedure required to implant the plate, plating is generally reserved for fractures which cannot be treated with a less invasive method of immobilization.

Less complicated fractures are often treated with casting or wires. However, such conservative treatment may not provide the stabilization and support necessary for desirable recovery. Yet, the operative procedure of plating is often too invasive for the relative non- severity of the fracture. Moreover, conventional plating can result in tendon irritation and skin necrosis, and may require extensive periosteal stripping in order to apply the plate on the bone surface. As such, many of the less displaced fractures, and particularly metaphyseal fractures (fractures at the end of the long bones), remain under-treated.

By way of example, a Colles' fracture, which results from compressive forces being placed on the distal radius bone, and which causes backward displacement of the distal fragment and radial deviation of the hand at the wrist, is treated with a dorsal plate when there is a significant degree of displacement. However, a less-displaced Colles' fracture is commonly under-treated due to the hesitancy of physicians to prescribe operative and invasive treatment. If not properly treated, such a fracture results in permanent wrist deformity. It is therefore important to align the fracture and fixate the bones relative to each other so that proper healing may occur. More recently, relatively minimally invasive fixation devices have become available for treatment of wrist fractures. For example, U.S. Pat. No. 6,379,359 to Dahners teaches an intrafocal fixation device including an intramedullary portion and a plate portion which seats at the metaphysis. However, devices like that described in Dahners are not likely to obtain acceptance by surgeons or be effective without addressing several critical issues. First, the subchondral bone must be properly supported. Second, the support must be properly aligned on the bone. Third, the support for the subchondral bone needs to be applied in a manner which is not counter to the minimally invasive design of the implant. Fourth, the implant should not necessitate undue removal of bone, which may further weaken the fracture location. It is therefore necessary to provide to the surgeon with a fracture fixation implant and a jig facilitating the implant thereof.

SUMMARY OF THE INVENTION

It is therefore an object of the invention to provide a fixation device and a jig for assistance in implantation of the fixation device relative to a fractured bone.

It is another object of the invention to provide a fixation device designed to treat metaphyseal fractures.

It is a further object of the invention to provide a jig assembly which provides proper alignment between longitudinally displaced holes drilled in bone and corresponding openings in an intramedullary portion of the fixation device such that fasteners can be inserted through the holes and openings.

It is an additional object of the invention to provide a jig assembly which facilitates drilling of axially aligned holes through peg holes in a plate of a fixation device and through metaphyseal bone.

In accord with these objects, which will be discussed in detail below, a fracture fixation device and a jig therefor are provided. A fracture fixation device according to the invention a supra-metaphyseal plate portion and an intramedullary nail portion which is horizontally and vertically offset relative to the plate portion by a neck portion. The plate portion includes longitudinally displaced fixed angle holes, each of which is adapted to orient a peg (or locking screw, collectively referred to as 'peg') in a different angular orientation such that pegs therethrough generally corresponds to the articular surface of the subchondral bone. The nail portion includes threaded screw holes oriented normal to an endosteal surface, and a smaller K- wire alignment hole parallel to the screw holes.

An implantation jig for the fixation device has a first portion with a concave surface seatable on the plate portion of the fixation device, and a relatively elevated second portion in alignment over the screw holes of the intramedullary nail portion of the fixation device.

The first portion includes openings in alignment with the fixed angle holes. A cannulated locking drill guide locks the jig relative to the implant and is used to guide a drill in alignment with one of the fixed angle holes. The back of the first portion of the jig is curved upward to facilitate maneuvering the nail portion of the fixation device within the intrafocal space and to allow the first portion to rest on the diaphyseal-side of the fracture during the implantation process. The first portion of the jig includes two K- wire guide holes which extend on either side of the front end of plate portion when the jig is coupled to the plate portion. The K-wire guide holes are designed to closely hold an appropriately sized K-wire and direct it at a fixed angle parallel to the endmost screw hole of the plate portion. Two such guide holes are provided, as the endmost holes for left and right fixation devices (for left and right hands) each have opposite respective angles, and the jig may be used with each of the left and right devices. For a particular application, the K-wire guide hole located on the side of the operative limb (left or right hand) is used. The respective K-wire guide hole defines an axis which is substantially parallel to and closely spaced to the axis of the endmost screw hole, thus anticipating the path of a peg through the endmost screw hole. In use, prior to drilling any holes into bone for the pegs for the screw holes, a K-wire is drilled into bone through the appropriate K-wire guide hole and its placement within the bone is viewed under fluoroscopy to ensure its placement, and the subsequent placement of the peg through the endmost screw hole, relative to the articular surface of the subchondral bone is appropriate.

The second portion of the jig includes longitudinally displaced holes or slots for drill guides. The second portion also includes a K- wire guide hole configured to direct a K- wire at a fixed angle into the K- wire alignment hole of the nail portion of the fixation device. Similar to above, prior to drilling any holes into the diaphysis for the screws for the nail portion, a K- wire is drilled through the K- wire guide hole in the second portion and its placement can be viewed under fluoroscopy to ensure its placement relative to the diaphysis is appropriate.

Additional objects and advantages of the invention will become apparent to those skilled in the art upon reference to the detailed description taken in conjunction with the provided figures.

BRIEF DESCRIPTION OF THE DRAWINGS

Fig. 1 is a side elevation of a fixation device according to the invention;

Fig. 2 is a plan view of a fixation device according to the invention;

Fig. 3 is a bottom view of the plate-portion end of the fixation device of the invention;

Fig. 4 is a plate-portion end view of the fixation device of the invention; and

Fig. 5 is a perspective view of an implantation jig according to the invention coupled to the fixation device of the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Turning now to Figs. 1 through 4, a fracture fixation device 10 according to the invention includes a supra-metaphyseal plate portion 12 and an intramedullary nail portion 14 which is horizontally and vertically offset relative to the plate portion by a neck portion 16. The plate portion 12 has a narrow profile and is slightly rounded about its upper surface 20. The plate portion 12 includes four longitudinally displaced fixed angle holes 22, 24, 26, 28, each preferably threaded, and each of which is adapted to lock a fastener, such as a smooth or threaded shaft peg 30, in a different orientation from the others (i.e., the axes are oblique relative to each other). When viewed from the plate end of the device, the pegs 30 are laterally displaced defining an imaginary surface (generally transverse to the longitudinal axis A of the plate portion) which generally corresponds to (i.e., extends parallel to) the articular surface of the subchondral bone. The plate portion 12 includes a dimple 32 for referencing an implantation jig, as described below. The nail portion 14 includes three threaded screw holes 34, 36, 38 oriented normal to a preferably flattened endosteal surface 40, and a smaller K-wire alignment hole 42 parallel to the screw holes and sized to closely receive a K-wire at a fixed angle. The tail end 44 of the nail portion 14 is provided with a portion 46 having downward and then upward curve which facilitates maneuvering the tail end of the nail portion through the intrafocal space and into the medullary canal.

' With the fixation device 10 in mind, turning now to Fig.5, an implantation jig 100 for the fixation device has a first portion 102 seatable on the plate portion 12 of the fixation device, and a relatively elevated second portion 104 in alignment over the screw holes 34, 36, 38 of the intramedullary nail portion 14 of the fixation device 10.

The first portion 102 includes a lower nub (not shown) which seats in the dimple 32 (Fig. 2) on the plate portion 12 of the fixation device. In addition, the first portion includes access openings 106 (at the front), 110 (at the left side, and at right the side, not shown), 108 (at the rear) in axial alignment with the fixed angle screw holes 22, 24, 26, 28. Such openings are preferably initially positioned over drill guide tips (not shown) which are inserted in all of the fixed angle holes of the plate portion but the hole beneath access opening 110. The drill guide tips which functions as miniature drill guides, are described in detail in co-owned U.S. Serial No. 11/011,917, filed December 14, 2004, which is hereby incorporated by reference herein in its entirety. As another option, the drill guides tips are not necessitated, and individual drill guides can be inserted into the fixed angle holes just prior to drilling holes into bone in alignment with the holes. In accord with one aspect of the invention, a cannulated locking drill guide 116 having a threaded end 118 is provided through opening 110 and thread into hole 26 in the plate portion 12, such that a portion of the guide 116 applies a force against said jig 100. The locking drill guide 116 in conjunction with the engagement of the nub within the dimple 32 immobilizes the jig 100 relative to the fixation device 10 so that the two are fixed relative to each other.

In accord with another aspect of the invention, the back 120 of the first portion 102 of the jig 100 is curved upward to facilitate maneuvering the nail portion 14 of the fixation device within the intrafocal space and to allow the first portion to rest on the diaphyseal-side of the fracture (e.g., the proximal cortex of the distal radius) during the implantation process.

The plate portion 12 of the fixation device 10 is too narrow to support the inclusion of K- wire guide holes. Thus, in accord with a further aspect of the invention, the first portion 102 of the jig 100 includes two K-wire guide holes 122, 124 which extend on either side of the front of the plate portion when the jig 100 is fixed relative to the fixation deice 10 to guide a K-wire offset relative to the plate portion. The K-wire guide holes 122, 124 are designed to closely hold an appropriately sized K-wire 126 and direct it at a fixed angle parallel to the endmost screw hole 22 (e.g., distalmost where the fixation device is used at the distal radius). Two such guide holes are provided, as the endmost holes for left and right fixation devices (for left and right hands) each have opposite respective angles, and the same jig may be used with each of the left and right devices. For a particular application, the K-wire guide hole located opposite the side on which the locking drill guide is positioned is used. That is, as shown in Fig. 5, with the locking drill guide on the left side of the plate, the right side K-wire guide hole 122 is used. The respective K-wire guide hole 122 defines an axis which is laterally offset, substantially parallel to, and closely spaced to the axis of the endmost screw hole 22 (preferably within approximately 5 mm), thus anticipating the path of a peg through the endmost screw hole 22. In use, prior to drilling any holes into bone for the pegs 30 for the screw holes, a K-wire 126 is drilled into bone through the appropriate K-wire guide hole 122 and its placement within the bone is viewed under fluoroscopy to ensure its placement relative to the articular surface of the subchondral bone is appropriate. If correct, the screw holes can be drilled with assurance that the screws will not enter the articular space. If not correctly located as indicated by K-wire fluoroscopic visualization, the plate can be repositioned, the K- wire re-drilled and re-examined until placement is correct.

The second portion 104 of the jig includes longitudinally displaced holes or slots 130, 132, 134, as described in detail in U.S. Pat. No. 6,926,720, to longitudinally align drill guides with the screw holes 34, 36, 38 of the intramedullary portion 14 of the fixation device 10. In accord with yet another aspect of the invention, the second portion 104 also includes a K-wire guide hole 136 configured to direct a K-wire 138 at a fixed angle into the K-wire alignment hole 142 of the nail portion of the fixation device. Similar to above, prior to drilling any holes into the diaphysis for the screws for the nail portion, a K-wire is drilled through the K-wire guide hole in the second portion and its placement can be viewed under fluoroscopy to ensure its placement relative to the diaphysis is appropriate. If correct, the screw holes can be drilled with assurance that the screws will be properly aligned relative to the axis of the diaphysis. If not correctly aligned as indicated by fluoroscopic visualization, the nail portion can be repositioned, the K-wire re-drilled and re-examined until placement is correct.

The jig is usable in combination with drill guides, bits and gauges as described in previously incorporated U.S. Patent No. 6,926,720.

There have been described and illustrated herein embodiments of a fixation device and implantation jig therefor. While particular embodiments of the invention have been described, it is not intended that the invention be limited thereto, as it is intended that the invention be as broad in scope as the art will allow and that the specification be read likewise. For example, while pegs have been described for use within the fixation device, other fixed angle bone fixators can be used as well. It will therefore be appreciated by those skilled in the art that modifications could be made to the provided invention without deviating from its spirit and scope as claimed.

Claims

What is claimed is:

1. A fracture fixation device, comprising: a supra-metaphyseal plate portion having an upper surface with a dimple for referencing an implantation jig and a plurality of fixed angle holes for receiving bone fixators; and an intramedullary nail portion which is horizontally and vertically offset relative to the plate portion by a neck portion.

2. A fracture fixation device according to claim 1, wherein: said plate portion has a length longer than a width, with a longitudinal axis substantially parallel to said nail portion.

3. A fracture fixation device according to claim 1, wherein: said plate portion has a substantially rounded upper surface.

4. A fracture fixation device according to claim 1, wherein: said fixed angle holes are threaded.

5. A fracture fixation device according to claim 1, wherein: at least two of said fixed angle holes have axes which are oblique relative to each other.

6. A fracture fixation device according to claim 1, comprising: said nail portion includes a plurality of screw holes.

7. A fracture fixation device according to claim 6, wherein: said screw holes are parallel to each other and threaded.

8. A fracture fixation device, comprising: a supra-metaphyseal plate portion with a plurality of fixed angle holes for receiving bone fixators; and an intramedullary nail portion which is horizontally and vertically offset relative to the plate portion by a neck portion, said nail portion including a plurality of screw holes, and a K- wire alignment hole smaller than said screw holes parallel to said screw holes and sized to closely receive a K- wire at a fixed angle.

9. A fracture fixation device according to claim 8, wherein: said screw holes are threaded.

10. A fracture fixation device according to claim 8, wherein: said nail portion includes a substantially fiat endosteal surface which is on a same side of said device as said plate portion.

11. A fracture fixation device according to claim 8, wherein: said nail portion includes a the tail end having a curved portion.

12. A fracture fixation device according to claim 8, wherein: said plate portion has a length longer than a width, with a longitudinal axis substantially parallel to said nail portion.

13. A fracture fixation device according to claim 8, wherein: said fixed angle holes are threaded.

14. A fracture fixation device according to claim 8, wherein: at least two of said fixed angle holes have axes which are oblique relative to each other.

15. A fracture fixation device, comprising: a supra-metaphyseal plate portion including an upper surface with a plurality of fixed angle holes for receiving bone fixators, said plate portion defining a longitudinal axis substantially parallel to an intramedullary portion of said device, said intramedullary nail portion being horizontally and vertically offset relative to said plate portion by a neck portion, wherein said fixed angle holes being each have an axis extending in a distinct orientation from the other fixed angle holes, with said axes defining an imaginary surface which extends transverse to the longitudinal axis.

16. A fracture fixation device according to claim 15, wherein: said imaginary surface generally corresponds to the articular surface of the subchondral bone of the distal radius.

17. A fracture fixation device according to claim 15, wherein: said fixed angle holes are threaded.

18. A fracture fixation device according to claim 15, wherein: said nail portion includes a plurality of screw holes.

19. A fracture fixation device according to claim 18, wherein: said screw holes are threaded.

20. A fracture fixation device according to claim 18, wherein: said nail portion includes a K-wire alignment hole parallel to said screw holes and sized to closely receive a K-wire at a fixed angle.

21. An implantation jig for use with a fracture fixation device, comprising: a) a first portion having front and rear portions, and a lower surface including structure for referencing the jig relative to the fracture fixation device, and provided with a plurality of access openings through which holes may be drilled, the rear portion including an upward curve relative to the lower surface and the front portion including a first K-wire guide hole to guide a K-wire at a fixed angle; and b) a second portion provided with a plurality of parallel longitudinally displaced openings to receive a drill guide, and a second K-wire guide hole oriented parallel to the displaced openings, said second portion being vertically displaced relative to said first portion.

22. An implantation jig according to claim 21, wherein: said front portion includes another K-wire guide hole oriented at substantially an opposite angle from said first K-wire guide hole.

23. In an implantation jig for use with a fracture fixation device having a fixed angle hole for a fastener, the implantation jig including a device contacting surface at which it is removably couplable to the fixation device, the improvement comprising: the implantation jig including at least one K- wire guide hole sized to closely receive a K-wire such that the K- wire is guided at substantially a fixed angle substantially parallel to the fixed angle hole of the fixation device, but offset from said device contacting surface.

24. The improvement of claim 23, wherein: the K-wire guide hole positions a K-wire within approximately 5 mm of the axis of the fixed angle hole.

25. The improvement of claim 23, wherein: the jig includes two K-wire guide holes, directed at laterally opposite angles.

26. The improvement of claim 23, wherein: the jig includes at least two K-wire guide holes, at least one of which is oriented normal to an endosteal surface of the fixation device.

27. The improvement of claim 23, wherein: the implant contacting surface leads into an upwardly curved surface.

28. An assembly of a fixation device and an implantation jig, comprising: a) an orthopedic implant including a plate portion and an intramedullary portion longitudinally and vertically offset relative to said plate portion, said plate portion including a fixed angle hole for receiving a bone fixators, the fixed angle hole having an axis; b) an implantation jig including a first portion with a first K-wire guide hole to guide a K-wire at a fixed angle and offset from said plate portion of said implant, but substantially parallel to and closely spaced relative to the axis of the fixed angle hole; and c) means for coupling said jig to said implant.

29. The assembly of claim 28, wherein: said intramedullary portion includes an endosteal surface and at least one fixed angle hole having an axis oriented parallel to said endosteal surface, and a K- wire alignment hole to orient a K- wire at a fixed angle relative to said at least one fixed angle hole, said K- wire alignment hole substantially parallel to and closely spaced relative to the axis of the fixed angle hole in said nail portion, and said implantation jig including a second portion which offset and parallel to said intramedullary portion, said second portion including a second K-wire guide hole oriented parallel to the second K-wire hole, said second portion being vertically displaced relative to said first portion.

30. An assembly according to claim 28, wherein: said first portion of said implantation jig includes front and rear portions, said K-wire guide hole provided at said front portion, and said rear portion including an upward curve relative to a lower surface of said first portion.

31. An assembly according to claim 28, wherein: said first portion of said implantation jig includes front and rear portions, and said K- wire guide hole provided at said front portion, and said rear portion curves upward relative to an implant contacting surface of said first portion.

32. An assembly according to claim 31, wherein: said front portion includes first and second K-wire guide holes.

33. An assembly according to claim 28, wherein: said means for coupling includes a cannulated drill guide which engages the implant and applies a force against said jig.

34. An assembly according to claim 28, wherein: said means for coupling includes one of a dimple and a nub on an implant contacting surface of said jig, and the other of a dimple and a nub on a jig contacting surface of said implant.