Modification of percutaneous intrafocal plate system

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 60/415,662 filed Oct. 3, 2002, the disclosure of which is incorporated herein by reference in its entirety.

[0002] The present invention relates generally to surgical apparatuses and methods, and more particularly, to a percutaneous intrafocal plate surgical apparatus and method.

[0003] There are a variety of apparatuses and methods presently being used to address metaphyseal fractures. As is well known to those skilled in the art, metaphyseal fractures consist of fractures near the end of a bone in the area of the junction between the tubular shaft of the bone and the spongy, blocky, end portions of the bone known as the metaphysis and epiphysis. Bone fractures in this metaphyseal area, especially fractures that are oblique, tend to cause the fragment to be pulled off to one side of the shaft by the forces applied by the muscles which are, in effect, continually attempting to shorten the bone. A variety of apparatuses and methods for surgically addressing metaphyseal fractures have been developed and are well known in the medical arts. Examples of such apparatuses and methods include, for example, casts, external fixators, pins and plates. Each of these will be discussed hereinafter for a better understanding of the state of the art in apparatuses and methods for addressing metaphyseal bone fractures.

[0004] Casts are used to align metaphyseal fractures that are transverse and to prevent the bone sections from falling off to the side. However, when a fracture is not transverse but oblique, the fracture tends to shorten within the cast and thereby allow displacement and an unsatisfactory outcome. Although casts are often attempted with fractures which might otherwise be treated with the apparatus and method of the invention described and claimed hereinafter, they are frequently unsuccessful and subsequently require that the patient be treated surgically to effect a satisfactory outcome.

[0005] External fixators are devices which consist of pins implanted in the bone on opposing sides of the fracture and connected with a metal frame which is external to the patient's limb. The pin insertion site where the pin penetrates the skin and underlying fat, muscle and the like on its way to insertion into the bone becomes a source of pain for a patient as well as a site of infection due to the chronically open wound about the pin during the time that the fracture is healing. Furthermore, in one of the most common locations for this kind of fracture, the distal radius, the pins often irritate the tendons which pass over and about the bone and thus induce stiffness of the fingers because of the patient's reluctance to move his fingers and thereby induce pain from the tendons.

[0006] Percutaneous pins are often used to treat metaphyseal fractures and, in fact, some of the percutaneous pins are inserted intrafocally. These are called Kapandji pins. These pins are usually left sticking out through the skin and thus, similarly to the external fixators discussed above, serve as a source of infection and as a source of pain and irritation to neighboring tendons. Pins can, however, be inserted through a small incision and provide an excellent reduction for some metaphyseal fractures.

[0007] Metaphyseal fractures can be addressed quite well with conventional plates. However, a large incision is required to implant a plate and this is known to result in a large scar. Moreover, the plate is known to be a large, broad and lumpy device which can be prominent underneath the underlying tendons and skin and soft tissue, and thus it can many times be painful. In addition, tendons which traverse over plates are often irritated by the plates and this can lead to stiffness.

[0008] Thus, despite the existence of a wide variety of conventional apparatuses and methods for surgically addressing a metaphyseal fracture, there remains much room for improvement in the art, particularly for a percutaneous intrafocal plate apparatus and method which is simple, safe and effective for addressing a metaphyseal fracture and which is inserted percutaneously or through a very small incision, that does not protrude through the skin, and which presents a low profile so as not to irritate overlying tissue.

[0009] In accordance with the present invention, an intrafocal plate apparatus and method are provided for addressing metaphyseal and similar bone fractures. The apparatus comprises an elongated plate element having a flat plate surface at one end thereof defining a top surface and a bottom surface and a leading end and a trailing end. A longitudinally extending resilient body element depends from the trailing end of the flat surface and defines a shoulder at one end which joins the flat plate surface and an arcuate pin at the other end. The intrafocal plate is formed so that a force applied at the arcuate pin end causes a force to be applied in the opposite direction at the flat plate surface.

[0010] Also, in accordance with the present invention, a method for addressing a metaphyseal or similar type of bone fracture is provided utilizing the intrafocal plate described hereinabove. In a preferred embodiment, the method according to this invention comprises the initial step of providing an intrafocal plate as described hereinbefore. The pin end of the elongated plate element is inserted through a skin incision formed proximate to the metaphyseal bone fracture site and the pin end is intrafocally inserted into the fracture site. Next, the elongated plate element is manipulated as necessary in order to lever the metaphyseal fracture into a reduced position. Finally, the body element of the elongated plate element is pushed into the tubular hollow of the fractured bone such that the pin will resiliently contact the inside wall surface of the tubular hollow at a site opposing the fracture site and thereby cause the shoulder of the elongated plate element to seat in the fracture site and urge the flat plate surface of the elongated plate element against the outside surface of the bone.

[0011] It is therefore an object of the present invention to provide a novel intrafocal plate for addressing metaphyseal and similar type fractures and a method for using the same.

[0012] It is another object of the present invention to provide an intrafocal plate apparatus and method for using same which can safely and effectively be utilized to address metaphyseal and similar type fractures.

[0013] It is another object of the present invention to provide an intrafocal plate apparatus and method for using same which is inserted percutaneously or through a small incision so as not to protrude through the skin and which is stable in use and low profile in construction so as not to irritate overlying tissue.

[0014] Some of the objects of the invention having been stated hereinabove, and which are addressed in whole or in part by the present invention, other objects will become evident as the description proceeds when taken in connection with the accompanying drawings as best described hereinbelow.

[0015] FIGS. 1A, 1B of the drawings are a front elevation view and side elevation view, respectively, of the intrafocal plate according to the present invention;

[0016] FIGS. 2A, 2B of the drawings are a front elevation view and a side elevation view, respectively, of a second embodiment of the intrafocal plate according to the present invention;

[0017] FIG. 3 of the drawings is a side elevation view of a break-away screw which can optionally be used with the intrafocal plates shown in FIGS. 1A, 1B and FIGS. 2A, 2B;

[0018] FIGS. 4A, 4B of the drawings show the intrafocal plate of FIGS. 1A, 1B used with screw(s) to secure a Colles fracture and a radial styloid fracture, respectively;

[0019] FIGS. 5A-5D of the drawings are schematic views of the method of the present invention utilizing the intrafocal plate of FIGS. 1A, 1 B to secure a radial styloid fracture;

[0020] FIG. 6A of the drawings shows a schematic drawing of the intrafocal plate of FIGS. 1A, 1B inserted without a screw for a Colles fracture wherein the arrow shows the direction which the bone fragment would attempt to displace and which the intrafocal plate has been positioned to prevent;

[0021] FIG. 6B of the drawings is a schematic view showing the use of two intrafocal plates of FIGS. 1A, 1B to address a transverse fracture of the proximal tibia which could tend to displace in either direction but which has been stabilized by the two intrafocal plates positioned on opposing sides of the bone;

[0022] FIGS. 7A, 7B of the drawings show a modification to the intrafocal plate shown in FIGS. 1-6 wherein an overhang is provided at the heel or trailing end of the plate element and the modified plate in use to secure a Colles fracture, respectively;

[0023] FIGS. 8A, 8B of the drawings are a top elevation and side elevation view, respectively, of a second embodiment of the modified intrafocal plate shown in FIGS. 7A, 7B; and

[0024] FIGS. 9A, 9B of the drawings show a top elevation and side elevation view, respectively, of a third embodiment of the modified intrafocal plate shown in FIGS. 7A, 7B in use to secure a Colles fracture.

[0025] A novel intrafocal plate apparatus and method for using the same to address a metaphyseal bone fracture or the like are provided in accordance with the present invention. Referring now to FIGS. 1A, 1B through FIGS. 6A, 6B of the drawings, the percutaneous intrafocal plate apparatus 10 and the method of use of apparatus 10 will now be described in detail.

[0026] Intrafocal plate 10 is intended to solve many of the problems of prior art devices for addressing metaphyseal bone fractures (and other similar fractures) by being inserted percutaneously, or through a very small incision, so as not to be left protruding through the skin. Apparatus 10 is particularly advantageous since it is a low profile device that will not tend to irritate overlying tissue.

[0027] Apparatus 10 comprises a plate element 10A top portion, a downwardly and inwardly extending body element 10B. Body element 10B of apparatus 10 forms a shoulder 10C at one end at its juncture with plate element 10A and an arcuate pin 10D at the other end thereof. Referring particularly to FIGS. 1A, 1B, it will be appreciated that plate element 10A defines one or more apertures 10A therein (applicant contemplates from 1 to 4 apertures) to facilitate affixation of intrafocal plate 10 to a bone in a manner to be described hereinafter. Although one or more apertures 10A may be provided in plate element 10A of intrafocal plate 10, applicant contemplates that the intrafocal plate could be affixed to a metaphyseal fracture using the methodology described hereinafter without the necessity for one or more screws, or in other words that the use of screws in combination with intrafocal plate 10 is optional. Further, applicant contemplates that apparatus 10 can be formed without shoulder 10C at the juncture of body element 10B and plate element 10A as a matter of design choice; however, applicant believes it preferable to incorporate shoulder 10C into apparatus 10.

[0028] Referring now to FIGS. 2A, 2B, wherein like numbers represent like parts, intrafocal plate 10 will be understood to be formed from plate element 10A and body element 10B wherein the top portion of body element 10B forms shoulder 10C at its juncture with plate element 10A and an arcuate pin 10D at its other end. Additionally, in this alternative embodiment of the invention, applicant contemplates that plate element 10A may be provided with one or more spikes 10E depending outwardly from the bottom surface of plate element 10A to facilitate affixation of intrafocal plate 10 to a metaphyseal fracture. Although applicant does not believe the invention requires providing one or more apertures in plate element 10A, it is preferable that this embodiment of the invention incorporate both one or more apertures 10A in plate element 10A in addition to one or more spikes 10E. Shoulder 10C is also optional in this embodiment of apparatus 10, but applicant believes it preferable to incorporate shoulder 10C into the apparatus to enhance seating of apparatus 10 in the fracture site as described hereinafter.

[0029] FIG. 3 depicts a screw, generally designated 20, which can be used in combination with intrafocal plate 10 if so desired by a surgeon. As noted hereinbefore, the insertion of one or more screws 20 through apertures 10A of intrafocal plate 10 is optional and is not required by the apparatus of the invention. Referring again to FIG. 3, it will be appreciated that screws 20 are provided with a threaded portion 20A and a stem portion 20B which define a neck N at the juncture thereof. Thus, the neck at the juncture of the threaded portion 20A and the stem portion 20B will allow the stem or pin to be broken off the screw after insertion by the physician. This facilitates easy insertion of screw 20 through intrafocal plate 10 and the bone thereunder, and then removal of the stem or pin 20B so that no portion of screw 20 will be left protruding through the skin.

[0030] Referring now to FIG. 4A, intrafocal plate 10 can be seen implanted in a typical Colles fracture of the distal radius, and FIG. 4B shows intrafocal plate 10 planted in a radial styloid fracture. In both FIGS. 4A and 4B, it can be seen that the fracture is somewhat oblique and thus, muscle will attempt to shorten the bone and tend to force the bone fragments to slide laterally to the right. Intrafocal plate 10 when affixed to the fracture site will prevent this sliding from taking place. Screws 20 may optionally be used with intrafocal plate 10 as necessary, and their use may keep intrafocal plate 10 from sliding in or out of the bone and may hold the bone fragment in a more secure position in certain situations. It will be appreciated that in the second embodiment of the invention, intrafocal plate 10 shown in FIGS. 2A, 2B may be used to address the fracture shown in FIGS. 4A, 4B and the spikes 10E thereof would also serve to keep the plate in a secure position affixed to the bone of the fracture site.

[0031] Also in accordance with present invention, the method for securing a metaphyseal bone fracture or the like is provided utilizing intrafocal plate 10 as described hereinabove. In a preferred embodiment, the method according to this invention can be appreciated with reference to FIGS. 5A-5D which demonstrate the insertion of pin end 10D into a radial styloid fracture similar to that shown in FIG. 4B. The method of insertion of intrafocal plate 10 is similar regardless of the type of fracture that is being addressed, although applicant contemplates that intrafocal plate 10 will normally be used to address metaphyseal bone fractures.

[0032] Referring to FIG. 5A, a skin incision I is made more proximate to the end of the bone than the actual fracture site F. In FIG. 5B, pin end 10D of intrafocal plate 10 is inserted through incision I, tugging the incision somewhat proximal on the radius so that pin end 10D can be inserted into the fracture site F. This can be done by palpation and with fluoroscopic guidance without actually seeing fracture site F and therefore using a very small incision. As shown in FIG. 5B, arcuate pin end 10D is inserted 180 degrees rotated relative to the position in which it will eventually lie so that it is easier to slip into fracture site F. In FIG. 5C, once pin 10D is inserted into fracture site F, intrafocal plate 10 is rotated 180 degrees to put the curve of pin end 10D back proximally along the shaft of the radius. As plate element 10A of intrafocal plate 10 is pushed distally, fracture site F is itself reduced by the leverage force applied by pin end 10D. This also takes tension off of skin incision I so that it is not pulled as far proximately as was done initially. Pin end 10D is then pushed down into the tubular hollow of the more proximal portion of the bone as shown in FIG. 5D.

[0033] FIG. 5D shows pin end 10D of intrafocal plate 10 completely inserted and held with an insertion tool (similar to a small angled pliers). Pin end 10D of intrafocal plate 10 is resiliently urged against the remote back wall of the tubular hollow from the fracture site as also shown in FIG. 5D. Shoulder 10C of intrafocal plate 10 between plate element 10A and pin end 10D is now seated in fracture site F so as to keep intrafocal plate 10 from sliding further into the bone or from sliding out of the bone, and also the shoulder helps to avoid a tendency to over-reduce the fracture site. Once intrafocal plate 10 is fully inserted into the fracture site and bone, the insertion tool can be removed so as to allow plate element 10A of intrafocal plate 10 to snap back against the bone and skin incision I to fall back into place. At this point, intrafocal plate 10 may be stable without a screw 20 being used to affix intrafocal plate 10 to the bone. However, one or more screws 20 may be inserted to ensure that intrafocal plate 10 does not slide in or out of the fracture site and to further stabilize the fracture fragment against shortening or lateral displacement. The alternative embodiment of intrafocal plate 10 shown in FIGS. 2A, 2B is used in the same manner as the first embodiment of the invention, but one or more spikes 10E depending from the bottom surface of plate element 10A will serve to secure the intrafocal plate to the bone when intrafocal plate 10 is fully inserted and the insertion tool removed so as to allow plate element 10A of intrafocal plate 10 to snap against the bone. The use of screws 20 for either of the two intrafocal plates is optional and the decision of the physician performing the procedure.

[0034] FIG. 6A of the drawings shows intrafocal plate 10 inserted without a screw for a Colles fracture. The arrow depicted therein shows the direction which the upper bone fragment will tryto displace and which intrafocal plate 10 is used in order to prevent. Intrafocal plate 10 can also be used in fractures where the direction of displacement is not preordained by the obliquity of the fracture as best shown in FIG. 6B. This transverse fracture of the proximal tibia may tend to displace in either direction, but can be stabilized with two intrafocal plates 10 as shown on opposing sides of the fractured bone. Further, if the dotted line shown in FIG. 6B represents yet another fracture splitting the end of the bone into two fragments, two intrafocal plates 10 from either side can be used to squeeze the two fragments together. Normally, another screw would be used to hold the two bone fragments together in addition to two intrafocal plates 10 and two screws 20, but intrafocal plates 10 may be used in order to get the reduction so that another screw can be inserted later.

[0035] Applicant believes that intrafocal plate 10 lends itself to use most commonly in the distal radius, like intrafocal pins are currently being used, but that intrafocal plates 10 can also be used in many other long bone locations in the body, such as the tibia and fibula, femur, ulna, humerus, metacarpal, metatarsal, and phalanges. Applicant further believes that most uses of intrafocal plate 10 would be for metaphyseal bone fractures (e.g., fractures near the end of the bone in the area of the junction between the tubular shaft and the spongy, blocky, ending of the bone known as the metaphysis or epiphysis). However, applicant does not intend to limit the use of the novel intrafocal plate to metaphyseal bone fractures since other uses may be found for the novel apparatus and method described hereinbefore, and all such apparatuses and uses are intended to fall within the scope of the invention as set forth in the appended claims.

[0036] As previously observed, although screws 20 shown in FIG. 3 of the drawings may optionally be used with intrafocal plates 10 of the invention shown in FIGS. 1A, 1B and 2A, 2B, applicant does not believe that screws 20 are necessary to be used with intrafocal plates 10.

[0037] A modification of the intrafocal plate apparatus described above is shown in FIGS. 7A, 7B; 8A, 8B; and 9A, 9B which provides for a heel or overhang at the tail of the plate element in order to prevent the intrafocal plate from producing over reduction and thereby forcing the bone fragment beneath the plate too far to the other side of the bone when the intrafocal plate has been fully inserted through the fracture into the bone. Further, the heel or overhang at the trailing end of the plate can further serve to stabilize the fracture against the inner cortex of the bone.

[0038] More specifically, the primary embodiment of the intrafocal plate described hereinabove (see FIGS. 1-6) may allow for the possibility of over reduction of a bone fracture. This occurs in fractures that are very unstable. Whereas with most fractures the bones tend only to displace in one direction because intact soft tissues prevent the fracture from displacing in the opposite direction, in some unstable fractures (e.g., all of the soft tissue are disrupted) the bone fragments can displace in either direction. In this type of case, the primary embodiment of the intrafocal plate described hereinabove (see FIGS. 1-6) may possibly over reduce the fracture such that it is displaced in the opposite direction from its original displacement. In some circumstances this can be controlled by inserting another plate on the opposite side of the bone, but with some bones the anatomy is such as to make insertion of a plate on the opposite side dangerous. The modification or alternative embodiment of the intrafocal plate described hereinbelow provides a heel or overhang of the plate element which serves to prevent excessive displacement of the fracture by the intrafocal plate as well as to generally stabilize the fracture.

[0039] Three different types of the intrafocal plate possessing the heel or overhang at the trailing end of the plate element will be described hereinafter (see FIGS. 7-9), but it should be understood and appreciated that the applicant contemplates that many other embodiments of the intrafocal plate with an overhang at the trailing end of the plate element could be made without departing from the scope of the invention which is defined by the claims appended hereto. In all embodiments of the modified intrafocal plate, applicant contemplates that the body element may extend either generally parallel to or at an acute angle to the plate element thereof.

[0040] FIG. 7A depicts a first type of the intrafocal plate with a stabilizing heel and comprises plate element 30A top portion and a downwardly extending body element 30B. Body element 30B comprises an arcuate proximal end which is joined to plate element 30A and a pin at the other end thereof. The pin at the end of body element 30B may be arcuate, straight or define a curved tip. As with the previous embodiment of the invention described hereinabove and shown in FIGS. 1-6, applicant contemplates that body element 30B will be formed of a resilient material so as to urge plate element 30A against the bone fracture (see FIG. 7B) when inserted into the bone in the manner also described hereinabove. Plate element 30A defines one or more apertures 30A therein to facilitate the optional affixation of intrafocal plate 30 to a bone with screws. Although one or more apertures 30A may optionally be provided in plate element 30A of intrafocal plate 30, applicant contemplates that the intrafocal plate may be affixed to a metaphyseal or other fracture using the methodology described hereinbefore with reference to FIGS. 1-6 but without the necessity for one or more screws, or in other words that the use of screws in combination with intrafocal plate 30 is optional. Further, applicant contemplates that body element 30B depending outwardly and downwardly from plate element 30A may be formed as a separate element and affixed to plate element 30A or may be formed as an integral part and extension of plate element 30A.

[0041] Referring again to FIG. 7B, intrafocal plate 30 can be seen implanted in a typical Colles fracture of the distal radius, and it can be seen that the fracture is somewhat oblique and thus muscle will attempt to shorten the bone and tend to force the bone fragments to slide laterally to the right. Intrafocal plate 30 when affixed to the fracture site will reduce any fracture overhang and prevent this sliding from taking place. The heel or overhang 30AA of plate element 30A will serve to prevent over reduction of the fracture such that it is displaced in the opposite direction from its original displacement. This can be easily understood with reference to FIG. 7B of the drawings wherein heel or overhang 30AA can be seen to prevent plate element 30A from moving too far to the left and thus over reducing the fracture when intrafocal plate 30 is fully inserted into the bone.

[0042] FIGS. 8A and 8B depict another type of the invention comprising intrafocal plate 40 having plate element 40A and body element 40B extending outwardly and downwardly therefrom. Plate element 40A includes optional apertures 40A therein and heel or overhang 40AA defined between where body element 40B connects to plate element 40A and the trailing end of plate element 40A.

[0043] Finally, FIGS. 9A and 9B depict yet another type of the invention generally designated 50 and comprising plate element 50A having body element 50B extending outwardly and downwardly therefrom in a sinuous pathway so as to contact the front portion of the bone in order to secure plate element 50A against the fracture site of the bone. Plate element 50A optionally includes a plurality of apertures therein through which screws S have been inserted in order to secure intrafocal plate 50 against the Colles fracture of the bone shown in FIGS. 9A and 9B. The heel or overhang 50AA of plate element 50A shown in the drawings extends significantly downwardly from the juncture of body element 50B with plate element 50A. Applicant contemplates that the heel or overhang defined between the connection of the body element with the plate element and the trailing edge of the plate element can be of a relatively short, medium or of a relatively long length for each of the three configurations shown in FIGS. 7A, 7B; 8A, 8B; and 9A, 9B as well as all other configurations contemplated to be within the scope of the present invention. As noted hereinbefore, the heel or overhang 30AA, 40AA and 50AA in intrafocal plates 30, 40 and 50, respectively, serves to prevent over reduction of a fracture as well as to generally stabilize the intrafocal plate against the fracture site. It can also stabilize the plate to the bone by pinching the cortex of the bone between the overhang 50AA and the body element 50B as in FIGS. 9A and 9B.

[0044] It will be understood that various details of the invention may be changed without departing from the scope of the invention. Furthermore, the foregoing description is for the purpose of illustration only, and not for the purpose of limitation, as the invention is defined by the claims as set forth hereinafter.