专利摘要:
expandable trochanteric femoral stem. the present invention relates to a bone fixation device comprising a bone fixation rod extending from a proximal end to a distal end, the distal end having a helical structure configured to engage a bone, the end proximal having an opening extending into it and a first glove configured for insertion over a proximal portion of the bone fixation rod and through an orifice of the intramedullary nail, the first glove allowing the bone fixation nail to move axially inside it within a predetermined range of movement together with a locking screw configured to limit the movement of the bone fixation rod in relation to the first sleeve, the locking screw configured to lock the opening in the fixation rod in a locked way. bone and having a head and threaded shaft extending distally from it.
公开号:BR112013018525B1
申请号:R112013018525-2
申请日:2012-01-18
公开日:2021-03-23
发明作者:Markus Buettler;Simon Stucki;Stefan Wolf;Martin Felder;Stan KMIEC;Kyle HENNING;Dana Pappalardo;This Aebi
申请人:Synthes Gmbh;
IPC主号:
专利说明:

[0001] [0001] This application claims priority for US provisional application serial number 61 / 435,036 filed on January 21, 2011 and entitled "Trochanteric Femoral Nail Augmentable", and US provisional application serial number 61 / 477,857 filed on April 21, 2011 and entitled "Trochanteric Femoral Nail Augmentable", the complete descriptions of which are incorporated herein by reference. FIELD OF THE INVENTION
[0002] [0002] The present invention relates to devices and methods for fixing and stabilizing intertrochanteric fractures. Specifically, the present invention relates to a multi-component, telescopic bone fixation system, with telescopic action, which has an external sleeve configured to receive a bone fixation rod through it, the bone fixation rod being configured to engage way locked with the bone. One or more locking screws and / or plugs are provided to lock a bone clamp rod position after the rod is positioned as desired in relation to the outer sleeve. BACKGROUND
[0003] [0003] Fractures are often treated with screws or other fixation devices inserted in or through a bone to stabilize fractured portions of the same after the portions are placed in corrective alignment. Trochanteric bone fixation treatments include the insertion of an intramedullary nail into a medullary cavity of a bone and a subsequent insertion of a bone fixation nail into a condylar portion of the bone at an angle to the intramedullary nail (i.e., along an axis of the trochanter). Once implanted, conventional trochanteric bone fixation devices allow central and lateral migration of the bone fixation nail inside, and sometimes outside, an external periphery of the bone. In addition, conventional bone fixation devices comprise multiple elements that increase the complexity of bone fixation procedures and also minimize the degree of adjustability of the components in relation to each other. Consequently, this prevents the adaptation of these bone fixation devices to the individual needs of several patients. Such systems therefore reduce the anchoring intensity of bone fixation devices, increasing the likelihood of additional fractures or other complications. SUMMARY OF THE INVENTION
[0004] [0004] The present invention relates to a bone fixation device comprising a bone fixation rod extending from a proximal end to a distal end, the distal end having a helical structure configured to engage a bone , the proximal end having an opening extending into it and a first glove configured for insertion over a proximal portion of the bone fixation rod and through an orifice of the intramedullary nail, the first glove allowing the bone fixation nail move axially within it within a predetermined range of motion along with a locking screw configured to limit the movement of the bone clamping rod relative to the first sleeve, the locking screw configured to lock the opening in the rod in a locked manner of bone fixation and having a head and threaded shaft extending distally therefrom. BRIEF DESCRIPTION OF THE DRAWINGS
[0005] [0005] Fig. 1 shows a perspective view of a bone fixation system according to a first exemplary embodiment of the present invention;
[0006] [0006] Fig. 2 shows a first partial cross-sectional view of the device of Fig. 1;
[0007] [0007] Fig. 3 shows a second partial cross-sectional view of the device of Fig. 1;
[0008] [0008] Fig. 4 shows an enlarged partial cross-sectional view of the device of Fig. 1;
[0009] [0009] Fig. 5 shows a perspective view of a bone fixation system according to a second exemplary embodiment of the present invention;
[0010] [00010] Fig. 6 shows a first perspective view of the system of Fig. 5;
[0011] [00011] Fig. 7 shows a first partial cross-sectional view of the device of Fig. 5;
[0012] [00012] Fig. 8 shows a second partial cross-sectional view of the device of Fig. 5;
[0013] [00013] Fig. 9 shows a perspective view of a bone fixation system according to a third exemplary embodiment of the present invention;
[0014] [00014] Fig. 10 shows a first partial cross-sectional view of the system of Fig. 9;
[0015] [00015] Fig. 11 shows a second partial cross-sectional view of the system of Fig. 9;
[0016] [00016] Fig. 12 shows a perspective view of the system of Fig. 9 in a first insertion configuration;
[0017] [00017] Fig. 13 shows a perspective view of the system of Fig. 9 in a second insertion configuration;
[0018] [00018] Fig. 14 shows a perspective view of the system of Fig. 9 in a third insertion configuration;
[0019] [00019] Fig. 15 shows a perspective view of the system of Fig. 9 in a fourth insertion configuration;
[0020] [00020] Fig. 16 shows a first partial cross-sectional view of a bone fixation system according to a fourth exemplary embodiment of the present invention;
[0021] [00021] Fig. 17 shows a second partial cross-sectional view of the bone fixation system of Fig. 16;
[0022] [00022] Fig. 18 shows a perspective view of a locking device for use with the bone fixation system of Fig. 16;
[0023] [00023] Fig. 19 shows a perspective view of an internal and external glove according to the bone fixation system of Fig. 16.
[0024] [00024] Fig. 20 shows a perspective view of a bone fixation system according to a fifth exemplary embodiment of the present invention;
[0025] [00025] Fig. 21 shows a first partial cross-sectional view of the system of Fig. 20;
[0026] [00026] Fig. 22 shows a second partial cross-sectional view of the system of Fig. 20;
[0027] [00027] Fig. 23 shows a third partial cross-sectional view of the system of Fig. 20;
[0028] [00028] Fig. 24 shows a fourth partial cross-sectional view of the system of Fig. 20;
[0029] [00029] Fig. 25 shows a perspective view of an insertion tool according to a sixth exemplary embodiment of the present invention, which can be used to insert the bone fixation system of Fig. 20;
[0030] [00030] Fig. 26 shows a first partial cross-sectional view of the tool in Fig. 25 with the system in Fig. 19;
[0031] [00031] Fig. 27 shows a second partial cross-sectional view of the tool in Fig. 25 with the system in Fig. 19;
[0032] [00032] Fig. 28 shows a third partial cross-sectional view of the tool in Fig. 25 with the system in Fig. 19;
[0033] [00033] Fig. 29 shows a perspective view of a bone fixation system according to a seventh exemplary embodiment of the present invention;
[0034] [00034] Fig. 30 shows a first partial cross-sectional view of the system of Fig. 29;
[0035] [00035] Fig. 31 shows a second partial cross-sectional view of the system of Fig. 29;
[0036] [00036] Fig. 32 shows a third partial cross-sectional view of the system of Fig. 29;
[0037] [00037] Fig. 33 shows a perspective view of an insertion tool according to an eighth exemplifying embodiment of the present invention, which can be used for insertion of the bone fixation system of Fig. 29;
[0038] [00038] Fig. 34 shows a first partial cross-sectional view of the tool of Fig. 33 with the system of Fig. 28;
[0039] [00039] Fig. 35 shows a second partial cross-sectional view of the tool of Fig. 33 with the system of Fig. 28;
[0040] [00040] Fig. 36 shows a third partial cross-sectional view of the tool of Fig. 33 with the system of Fig. 28;
[0041] [00041] Fig. 37 shows a fourth partial cross-sectional view of the tool of Fig. 33 with the system of Fig. 28;
[0042] [00042] Fig. 38 shows a perspective view of a bone fixation system according to a ninth exemplary embodiment of the present invention;
[0043] [00043] Fig. 39 shows a first partial cross-sectional view of the system of Fig. 38;
[0044] [00044] Fig. 40 shows a second partial cross-sectional view of the system of Fig. 38;
[0045] [00045] Fig. 41 shows a third partial cross-sectional view of the system of Fig. 38;
[0046] [00046] Fig. 42 shows a first perspective view of a bone fixation device according to a tenth exemplary embodiment of the present invention;
[0047] [00047] Fig. 43 shows a second perspective view of the element of Fig. 42;
[0048] [00048] Fig. 44 shows a third perspective view of the element of Fig. 42;
[0049] [00049] Fig. 45 shows a longitudinal cross-sectional view of an intramedullary nail to be used with the bone fixation element of Fig. 42
[0050] [00050] Fig. 46 shows a first perspective view of a bone fixation device according to an eleventh exemplary embodiment of the present invention;
[0051] [00051] Fig. 47 shows a partial cross-sectional view of the element of Fig. 46;
[0052] [00052] Fig. 48 shows a third perspective view of the element of Fig. 46; and
[0053] [00053] Fig. 49 shows a fourth perspective view of the element in Fig. 46. DETAILED DESCRIPTION
[0054] [00054] The present invention can be further understood with reference to the description below and the accompanying drawings. The present invention relates, in general, to devices and methods for fixing and stabilizing intertrochanteric fractures. It should be noted that, although the modalities of the present invention have been described with respect to specific bones, the present invention can also be used in any other bone fixation procedures including, but not limited to, fixation of femoral fractures and fractures other long bones. The present invention relates to a multi-component telescopic bone fixation system that has an external sleeve configured to receive a bone fixation rod through it, the bone fixation rod being configured to engage in a locked way with the bone. One or more locking screws and / or plugs are provided to lock a bone clamp rod position after the rod is positioned as desired in relation to the outer sleeve. Specifically, an exemplary external glove according to the invention comprises a locking element configured to engage an intramedullary nail in a locked manner through which the nail is inserted to limit its lateral migration within a desired range when implanted in the bone. The exemplary bone fixation rod according to the invention is configured for pivoting insertion through the outer sleeve and into the bone. The bone fixation rod and the external sleeve of the invention are configured so that a lateral and central movement of the same after implantation remains within a predetermined desired range. The term "proximal", as used here, refers to a direction close to a doctor or another user, while the term "distal" refers to a direction close to a target portion of a fractured or otherwise damaged bone. .
[0055] [00055] As shown in Figures 1 to 4, a bone fixation system 100 according to the invention comprises an external sleeve 102, a bone fixation element 104 configured for insertion through external sleeve 102 and a locking screw 106 configured for insertion into the bone fixation element 104. The outer sleeve 102 comprises a longitudinal channel 108 extending through it along a longitudinal axis 138 from a proximal end 110 to a distal end 112 and can be shaped as, for example, for example, an elliptical cylinder (e.g., oblong) to prevent the outer sleeve 102 from rotating with respect to an intramedullary nail 10 through which the outer sleeve 102 can be inserted. The person skilled in the art will understand, however, that the outer sleeve 102 can have any of a variety of shapes as long as the outer sleeve 102 is prevented from rotating in relation to the intramedullary nail 10. The outer sleeve 102 can be configured so that a the first longitudinal side wall 114 has a first length and a second longitudinal side wall 116 has a second length greater than the first length so that the proximal end 110 is substantially oblique. This reduces possible damage to the patient's soft tissue and prevents the proximal end 110 of the outer sleeve 102 from moving away excessively from a lateral cortex of a bone through which it is inserted. In an exemplary embodiment, a difference in length between the first and second opposite side walls 114, 116 can be approximately equivalent to a length of a head 107 of the locking screw 106 so that the locking screw 106 can be seated at least partially inside the outer sleeve 102 in an operational configuration to reduce a degree of external stress applied to it after implantation. The second side wall 116 additionally comprises a first burr 118 adjacent to the distal end 112 of the outer sleeve 102. The first burr 118 protrudes from the outer sleeve 102 in a sufficient length to allow it to engage with a peripheral wall of a orifice of the intramedullary nail 12, as will be described in more detail later in this document. A distal face of the first burr 118 has an angled wall 120 tapering in the direction of a distal direction so that a radially compressive force applied to the angled wall 120 (for example, during distal advancement on an intramedullary nail 10) compresses the first burr 118 radially inward until it is substantially flush with the outer wall of the outer sleeve 102. A proximal face of the first burr 118 comprises a proximal wall 122 extending substantially perpendicularly from the outer sleeve 102. Consequently , after the first burr 118 is advanced through the intramedullary nail 10, the burr 118 protrudes radially outward under its natural inclination to engage the proximal wall 122 with the peripheral wall of the orifice of the intramedullary nail 12 thus preventing proximal retraction of the external glove 102 from the intramedullary nail 10. Thus, the bone fixation element 104 is also prevented from migrating air proximally after being inserted through sleeve 102, thus avoiding a loss of fixation. The outer sleeve 102 further comprises a second burr 124 adjacent the proximal end 110 of the outer sleeve 102 and aligned with the second side wall 116. The second burr 124 extends from the outer sleeve 102 substantially perpendicular thereto and is configured to limit a depth of insertion of the outer sleeve 102 into the orifice of the intramedullary nail 12.
[0056] [00056] The bone fixation system 100 additionally comprises the bone fixation element 104 configured and dimensioned for insertion through the channel 108 of the outer sleeve 102. The bone fixation element 104 extends from a proximal end 126 to a distal end 128 and comprises a proximal threaded portion 130, a substantially cylindrical central portion 132 and a distal blade 134 (in this exemplary embodiment, blade 134 is helical). A proximal portion of the blade 134 has an enlarged outer diameter 135 greater than an inner diameter of the outer sleeve 102 to prevent proximal retraction of the blade 134 into the outer sleeve 102 beyond the extent defined by the contact between the proximal end of the blade 134 and the outer sleeve 102. It should also be noted that, although the blade 134 of Figures 1 to 3 is shown with notches 136 extending helically along the bone fixation element 104, any other types of blades and / or threads can be used without departing from the scope of the invention. For example, blade 134 may comprise threads or indentations that extend substantially helically over the distal portion of element 104 at any angle to longitudinal axis 138, as shown, for example, in Figures 9 to 15.
[0057] [00057] The proximal threaded portion 130 has a first diameter smaller than a second diameter of the cylindrical portion 132 and is configured to be, at least partially, inserted into an opening 140 extending into the cylindrical portion 132. Specifically, a distal end of the threaded portion 130 comprises a flange 142 configured and dimensioned to engage a groove 141 in the opening 140 of the cylindrical portion 132. The threaded portion 130 can be rotatable with respect to the cylindrical portion 132. In an exemplary embodiment, the proximal threaded portion 130 it can be fitted into the opening 140 during manufacture so that a central longitudinal channel 144 extending through the proximal threaded portion 130 is open and aligned with a central longitudinal channel 146 extending through the cylindrical portion 132 and the blade 134. In an exemplary modality, channels 144, 146 are opened at the proximal and distal ends al 126, 128 to allow the insertion of a medical tool or injectable material (for example, a bone reinforcing material) through them. Alternatively, the channels 144, 146 can receive a guide wire through them so that the bone fixing element 104 can be slid over the guide wire and into the bone. A predetermined length of a proximal portion of the channel 144 can be provided with thread 148 configured to allow the threaded engagement with the locking screw 106, as will be described in more detail below. Thread 148 may also allow compression of a bone fracture and / or removal of bone fixation element 104.
[0058] [00058] The proximal threaded portion 130 is configured to receive in a threaded manner a connector 150 on it. The connector 150 has an outer diameter substantially equivalent to an outer diameter of the cylindrical portion 132 and an inner diameter of the outer sleeve 102. In an exemplary embodiment, the connector 150 is threadedly attached to the bone fixation element 104 prior to insertion through the outer sleeve 102. The connector 150 is substantially cylindrical and extends from a proximal end 152 to a distal end 154. For example, the connector 150 may include a flat surface that extends along a length of the same and corresponding to a flat surface of the channel 108. As shown in Fig. 4, a distal portion of the connector 150 comprises at least one flap 156 defined by a first and a second groove 158 extending proximally from the distal end 154. A distal end of flap 156 comprises a notch 160 that extends radially outwardly from connector 150 at a predetermined distance. The notch 160 can engage a portion of an insertion instrument to prevent the system 100 from being disassembled therefrom. It should be noted that, although the present embodiment is described with a tab 156, any number of tabs 156 can be provided on the connector 150, in any arrangement, without departing from the scope of the invention. The distal end 154 of the connector 150 can also be provided with a serrated, notched, or otherwise treated surface 162, configured and dimensioned to engage a respectively formed surface 164 over a proximal end of the cylindrical portion 132. As those skilled in the art will understand , engaging the treated surfaces 162, 164 prevents the connector 150 from rotating with respect to the cylindrical portion 132 which, in turn, prevents the proximal threaded portion 130 from rotating with the cylindrical portion 132. The connector 150 can also be keyed in an inner surface of the channel 108 of the outer sleeve 102 so that when combined with the engagement of the treated surfaces 162, 164, the bone fixation element 104 is prevented from rotating in relation to the opening 12 of the intramedullary nail 10.
[0059] [00059] The exemplary locking screw 106 of the invention is provided with a head 107 that has an outer diameter greater than an inner diameter of the outer sleeve 102 and a threaded shaft portion 109 extending distally therefrom, wherein one of a predetermined portion and an entire length of axis 109 is threaded. The locking screw 106 is configured to control a depth of lateral movement of the bone fixation element 104 within the bone after implantation. Specifically, a depth of insertion of the locking screw 106 into the proximal threaded portion 130, together with an axially sliding movement of the bone fixing screw 106 into the outer sleeve 102, allows a physician or other user to control a range of motion of the bone. bone fixing element 104 within the bone. Such an embodiment is shown in Figures 2 and 3, in which the locking screw 106 is inserted to a first target depth to allow lateral movement of the bone fixation element 104 within the outer sleeve 102 by ± 10 mm. Specifically, in Fig. 2, axis 109 is threaded on the proximal threaded portion 130 at a first depth, selected so that when the head 107 comes into contact with the proximal end 110 of the outer sleeve 102, the increased diameter portion 135 is separated from the distal end 112 of the outer sleeve 102 by approximately 10 mm. It should be noted, however, that this range can be increased or decreased as desired by the surgeon by changing the depth of insertion of the axis 109 into the proximal threaded portion 130. Fig. 3 shows the system in Fig. 2 after the fixation element 104 has been proximally retracted into the outer sleeve 102 (for example, under normal force application during / after implantation). The proximal movement of the bone fixation element 104 within the outer sleeve 102 is limited by engaging the increased diameter portion 135 with the distal end 112 of the outer sleeve 102.
[0060] [00060] According to an exemplary method of the bone fixation system 100, a fractured or otherwise damaged bone (not shown) is placed in corrective alignment and the intramedullary nail 10 is inserted into a medullary cavity of the same to a position target and guidance in any known way. The bone fixation element 104 is then inserted through the hole of the intramedullary nail 12 at a target depth until the enlarged diameter portion 135 has moved distally out of the intramedullary nail 12. The outer sleeve 102, the fixation element bone 104 and connector 150 can be pre-assembled and inserted through the hole of the intramedullary nail 12 at a target depth until the first burr 118 has at least passed through the hole in the nail 12. After the outer sleeve 102, the bone fixing element 104 and the connector 106 are positioned inside the orifice 12, as desired, the locking screw 106 can be inserted into it. As described in more detail earlier, during insertion through the nail hole 12, engaging the angled wall 120 with an inner wall of the intramedullary nail hole 12 causes the first burr 118 to be compressed radially until it is substantially aligned against the outer sleeve 102 as it moves distally out of the orifice of the intramedullary nail 12. Once the radially compressive force has been removed (that is, when the first burr 118 moves distally out of the nail orifice 12), the first burr 118 returns to an inclined configuration that extends radially outwardly from outer sleeve 102 at a predetermined distance. In this configuration, the first burr 118 is prevented from being proximally retracted out of the intramedullary nail hole 12 due to the engagement of the proximal wall 122 with the outer periphery of the intramedullary nail hole 12. When the bone fixation system 100 meets If properly seated within the bone, an intramedullary nail locking screw (not shown) is inserted into a locking screw hole 14 of the intramedullary nail 10 until the distal end of the nail contacts the outer sleeve 102 to apply it still has a compressive holding force, as those skilled in the art will understand.
[0061] [00061] Figures 5 to 8 show a bone fixation system 200 according to another embodiment of the invention. The bone fixation system 200 is formed substantially similar to the bone fixation system 100 of Fig. 1, in which similar elements are referred to with similar reference numbers. Specifically, the system 200 comprises an outer sleeve 202 formed substantially similar to the outer sleeve 102 and extending from a proximal end 210 to a distal end 212. Similar to the outer sleeve 102, the outer sleeve 202 may be a cylinder elliptic. However, unlike outer sleeve 102, outer sleeve 202 has a uniform longitudinal length. The bone clamping system 200 additionally comprises the protective cap 206 in place of the locking screw 106. The protective cap 206 allows compression, as shown in Fig. 7, and comprises a head 207 that has an outside diameter greater than one inner diameter of the outer sleeve 202, and a threaded shaft 209 extending distally from the head 207. The bone fixation system 200 functions substantially similar to the bone fixation system 100 of Figures 1 to 4, with the element of bone fixation 104 being moved axially in relation to the outer sleeve 202 by approximately ± 10 mm. The bone fixation element 104 of Figures 5 to 8 is prevented from moving distally with respect to the outer sleeve 202 beyond a limit defined by the engagement of the head 207 with the proximal end 210 of the outer sleeve 202, and is prevented from moving proximally to the outer sleeve 202 due to engagement of the increased diameter portion 135 with the distal end 212 of the outer sleeve 202.
[0062] [00062] As shown in Figures 9 to 15, a bone fixation system 300 according to an additional embodiment of the invention is substantially similar to the bone fixation system 100 of Figures 1 to 4, in which similar elements are referred to with numbers similar reference points. The bone clamping device 100 comprises an outer sleeve 302 extending from a proximal end 310 to a distal end 312 and having a channel 308 extending longitudinally therethrough. A predetermined length of a proximal portion of the outer sleeve 302 is provided with an internal thread 311 for engaging an insertion tool that inserts the outer sleeve 302 through the stem 10 over the head element 304. The outer sleeve 302 is configured and sized to receive a bone fixation element 304 therethrough, the bone fixation element 304 having a threaded portion 334, a cylindrical body portion 332 and an opening 340 extending into a proximal end of the cylindrical body portion 322 However, although the opening 140 of the bone fixing system 100 is configured to lock the proximal threaded portion 130 in lock, the exemplary opening 340 of Figures 9 to 15 extends distally into a proximal end 339 of the cylindrical body 322 in deep enough to allow threaded engagement directly with a 306 locking screw. Opening 340 can be opened to the groove central longitudinal 146 extending through the cylindrical portion 332 and the threaded portion 304, as described in more detail earlier.
[0063] [00063] The exemplary locking screw 306 comprises an elongated threaded shaft portion 309 and a head 307. The axis portion 309 is configured and dimensioned to thread the hooks of aperture 340 in a threaded manner. An outer diameter of the head 307 is configured to allow its insertion in opening 304 and also to allow the complete insertion of the locking screw 306 in the channel 308 of the external sleeve 302. In an exemplary embodiment, the locking screw 306 additionally comprises a central longitudinal channel 305 extending through it from the head 307 to a distal end of the axis 309. The channel 305 has substantially the same diameter as the central longitudinal channel 146 which extends through the cylindrical portion 332 and the threaded portion 304. Consequently, when the locking screw 306 is inserted in the cylindrical portion 332, the central longitudinal channel 305 is longitudinally aligned with and open to the canalet the central longitudinal 146. The locking screw 306 allows compression and prevents the central migration of the bone fixation element 304 through the femoral head.
[0064] [00064] As shown in Fig. 12, in a first exemplary step according to the invention, the bone fixation element 304 is inserted on a guide wire into a bone and through a lateral transverse hole of the intramedullary nail 10 until reaching a target depth within the bone (not shown). The bone fixation element 304 is dimensioned so that when positioned at the target depth, at least a part of the cylindrical body portion 332 is received within the intramedullary nail 10. As shown in Fig. 13, the outer sleeve 302 is then inserted into the bone and through the transverse orifice of the intramedullary nail 10 at least until the first burr 118 is moved out of the transverse orifice, as described in more detail in previous embodiments. As shown in Fig. 14, the locking screw 306 is then inserted into opening 340 to a target depth within it. The locking screw 306 is configured to limit a range of lateral movement of the bone fixation element 304 relative to the outer sleeve 302 after insertion into the bone. In addition, the locking screw 306 allows compression and prevents central migration of the bone fixation element 304 through the femoral head. As shown in Fig. 15, a longitudinal alignment of the channel 305 with the central longitudinal channel 146 allows for the insertion of instruments through the bone fixation system 300 after its implantation in the bone.
[0065] [00065] Figures 16 to 18 show a bone fixing device 400 insertion system according to another embodiment of the invention. Specifically, as shown in Figures 16 to 18, the bone fixation system 400 is substantially similar to the bone fixation system 100 of Figures 1 to 4, with similar elements referred to with similar reference numbers. The bone fixation device 400 comprises an outer sleeve 402 that extends from a proximal end 410 to a distal end 412 and that has a channel 408 extending longitudinally through it that is received over an inner sleeve 404 that extends from a proximal end 426 to a distal end 428 which can include any desired bone engaging structure 434 (e.g., a thread, a helical blade, etc.). The outer sleeve 402 also includes a stem engaging structure such as a hemispherical projection 424 that engages a correspondingly shaped recess in the stem to lock the outer sleeve 402 in a desired rotational position and orientation with respect to stem 401. For example, the stem it may include a bayonet groove (not shown) configured to lock the hemispherical projection 420 after the outer sleeve 402 is rotated by a desired amount (e.g., 180 °) inside it. An inner surface next to the proximal end 410 of outer sleeve 402 includes a frame 411 (for example, grooved teeth), which can be engaged by an insertion tool so that outer sleeve 402 can be rotated distally through the stem into the bone over the inner sleeve 404. The inner sleeve 404 includes a proximal portion 430, a central cylindrical body portion 432, the bone engaging structure 434 near the distal end 428 with a groove 446 extending through the same. The proximal portion 430 of the inner sleeve 404 has an outer surface including a plurality of longitudinally extending flat surfaces. For example, the proximal portion 430 can be hexagonal. The person skilled in the art will understand, however, that the proximal portion 430 can have any of a variety of shapes as long as the outer surface includes at least two flat surfaces, preferably opposite each other.
[0066] [00066] As shown in Fig. 18, a locking device 450 for rotationally stabilizing the inner sleeve 406 relative to the outer sleeve 402 includes a pair of finger-like inserts 452 extending distally from a rotating collar 454 surrounding a head portion 407 of a screw 406 so that the screw can rotate with respect to the collar. The collar 454 includes an engagement structure 456 on an outer surface of the same which corresponds to the structure 411 of the proximal end 410 of the outer sleeve 402. For example, the collar 454 may include grooved teeth along its outer surface, which correspond to the teeth grooves arranged along the inner surface of the proximal end 410 of the outer sleeve 402. In use, as shown in Fig. 19, the locking device 450 is inserted into the groove 446 of the inner sleeve 404 so that the finger-like inserts 452 extend over the flat surfaces of the proximal portion 430 of the inner sleeve 404 within a space between these flat surfaces and the inner surface of the channel 408 of the outer sleeve 402 to prevent the inner sleeve 404 from rotating with respect to the finger-like inserts 452 The engagement structure 456 of the collar 454 engages the structure 411 of the inner sleeve 404 so that the collar 454 is prevented from rotating with respect to the outer sleeve 402, but that p bone moves axially in relation to it. Screw 406, however, can rotate with respect to collar 454 and finger-like inserts 452 to engage a threaded portion 448 of groove 446. In this way, screw 406 secures locking device 450 to inner sleeve 404 so that the internal and external gloves 404, 402 are prevented from rotating in relation to each other, but that can move longitudinally in relation to each other.
[0067] [00067] Inner sleeve 404 can be introduced through stem 401 first with outer sleeve 402 being slid over it, or both sleeves 402 and 406 can be introduced together. After the outer sleeve 402 is locked in a desired position by engaging the hemispheric projection 424 with the bayonet groove, the locking device can be engaged by inserting the finger-like inserts 452 in the space between the flat surfaces of the sleeve inner 404 and the inner surface of channel 408. The user then advances screw 406 into channel 446 by screwing it into thread 448 via an installation tool engagement frame (for example, hexagonal opening 458) at the end proximal to it.
[0068] [00068] As shown in Figures 20 to 24, a bone fixation system 500 according to another embodiment of the invention comprises an inner sleeve 502, an outer sleeve 503, a bone fixation element 504, a compression screw 505 and a stop screw 506 which also acts as a plug. The bone fastening element 504 extends from a proximal end 526 to a distal end 528 and comprises a substantially cylindrical portion 532 and a bone engaging structure 534 (e.g., thread, blade, etc.). A length of the bone engaging structure 534 has an increased outer diameter 535 that is greater than an outer diameter of the inner sleeve 502. The bone engaging structure 534 extends over a predetermined length of the distal portion of the bone fixation nail. 504, configured to extend outside the outer sleeve 502 and in direct contact with the bone in an operational configuration. A partially threaded opening 540 extends into the cylindrical portion 532 at a distance configured to allow the threaded engagement with the compression screw 505. Specifically, the threaded opening 540 extends distally from the proximal end 526 and comprises a first non-threaded section 541 configured and dimensioned to receive an increased diameter head 507 from the first locking screw 505, a central threaded portion 542 configured and dimensioned to engage threads on an axis 626 of a connection screw 620 and an un-threaded portion distal 543 opening into the central longitudinal groove 146 which extends through the bone fixing element 504. The central threaded portion 542 and the distal non-threaded portion 543 can have substantially the same diameter that corresponds to an outer diameter axis 509. The compression screw 505 additionally comprises a central longitudinal channel 546 configured adapted to be longitudinally aligned with and opened to the central longitudinal groove 146 of the bone fixing element 504 in an operational configuration to allow the insertion of tools and other materials through it, as described in more detail earlier.
[0069] [00069] The substantially cylindrical portion 532 of the bone fixation element 504 is configured to be received, at least partially, within a channel 508 that extends through the inner sleeve 502. Specifically, the inner sleeve 502 extends from a proximal end 510 to a distal end 512 and comprises a proximal threaded portion 514 next to the proximal end and a smooth outer axis portion 516 extending distally therefrom. The inner sleeve 502 is substantially tapered so that a distal portion of it has a larger diameter than a proximal portion, as will be described in more detail with respect to the exemplary method of the invention. An outer diameter of the shaft portion 516 is less than a diameter of the enlarged outer diameter portion 535 of the element 504 to prevent proximal removal of the helical blade 534 into it. An internal diameter of the shaft portion 516 receives the substantially cylindrical portion 532 with a substantial friction fit to prevent lateral movement of the element 504 within it. The proximal threaded portion 514 has a smaller internal and external diameter than the shaft portion 516 to prevent retraction of the element 504 into it. The proximal threaded portion 514 is also provided with internal threads 515 configured to engage a head 557 of stop screw 506 and external threads 517 configured to engage external sleeve 503, as will be described in more detail later in this document.
[0070] [00070] The outer sleeve 503 extends from a proximal end 550 to a distal end 552 close to the distal end 512 of the inner sleeve 502. The outer sleeve 503 also comprises a proximal threaded portion 554 and an axis portion 556 that extends distally from it. Shaft portion 556 is configured to engage inner sleeve 502 with a substantial friction fit. The proximal threaded portion 554 comprises an inner thread 558 configured to threadably engage the outer threads 517 of the inner sleeve 502. The proximal threaded portion 554 and the shaft portion 556 can be formed as separate elements attached to each other by a snap coupling. edge and groove. In this way, the inner and outer sleeves 502, 503 and the fastening element 504 are fixed in relation to each other without the need for a proximal locking element.
[0071] [00071] According to an exemplary method of the invention, as shown in Figures 25 to 28, an insertion tool 600 is used to guide the bone fixation system 500 into the bone. The insertion instrument 600 comprises a first elongated tool 602 having an elongated cylindrical axis 604 and a handle 606 at a proximal end thereof. The first elongated tool 602 is configured so that a distal end 608 of the shaft 604 comes into contact with the proximal end 550 of the proximal threaded portion 554. The tool 602 engages the proximal threaded portion 554 so that the turning of the tool, for example clockwise, the threaded portion 554 is also rotated over the threaded portion 514 of the inner sleeve 502, causing the outer sleeve 503 to move distally from the inner sleeve 502, locking the system on the stem 10, as will be described in more detail bellow. A second elongated tool 610 is configured and dimensioned to be received, at least partially, within the first elongated tool 602 and comprises a substantially elongated cylindrical shaft portion 612 and a handle 614 adjacent to a proximal end thereof. A predetermined length of the shaft portion 612 is provided with an external thread 616 configured to allow threaded engagement with a compression nut 618 provided thereon. A distal end of the second elongated tool 610 can be configured to engage the proximal end 526 of the fastener 504 where, for example, the fastener 504 includes a threaded bone engaging structure 534. The insertion instrument 600 also comprises a elongated connecting screw 620 which can be inserted through the second elongated tool 610, connecting screw 620 having an elongated cylindrical shaft 622 and a head 624 next to a proximal end thereof. A distal end of the connecting screw 620 comprises a threaded portion 626 configured to threadably engage the threaded portion 542 of the opening 540 of the bone fixing element 504.
[0072] [00072] In a first step, the insertion instrument 600 is connected to the bone clamping system 500 as shown in Fig. 25. A distally directed force is then applied to the connection screw 620 to cause the clamping element to move forward. bone 504 and the inner and outer gloves 502, 503 through the orifice of the intramedullary nail 12 and into the bone (not shown). In case the bone engaging structure 534 of the fastener 504 is a blade, the fastener 504 can be inserted through the bone by applying a distal force to the connecting screw 620 by means of an impact force on the head 624 of the same. In case the bone engagement structure 534 is a thread, the user can rotate the handle 614 to rotate the tool 610, for example, clockwise to rotate the bone fastener 504 into the bone. In the insertion configuration of Fig. 25, the inner sleeve 502 can be positioned so that its distal end 512 is positioned distally with respect to the distal end 552 of the outer sleeve 503. Tool 602 is rotated to move the outer sleeve 502 distally in in relation to the inner sleeve 502. The relative longitudinal movement of the inner sleeve 502 in relation to the outer sleeve 503 causes a distal conical portion of the inner sleeve 502 to apply a radially expanding force to the outer sleeve 503, locking the system 500 into the stem 10. Compression nut 618 can then be rotated a distance necessary to add compression to the bone. The turning of the compression nut 618 causes the enlarged outer diameter portion 535 of the bone engaging structure 534 and the distal ends of the inner and outer sleeves 502, 503 to move closer to each other as shown in Fig. 28. After the bone fastener 504 is moved to a target position, the insertion tool 600 is removed and the first locking screw 505 is inserted into opening 540 to a first target depth that can correspond to a depth of the fastener of bone 504 within the bone (not shown). The second locking screw 506 is then inserted into the inner sleeve 502 until the outer threads of the head 557 engage the inner threads 558 of the inner sleeve 502. The second locking screw 506 is threaded distally into the inner sleeve 502 until a distal end of it contacts the head 507 of the first locking screw 505. The first and second locking screws 505, 507 thus lock a position of the bone fixation element 504 within the bone and also allow lateral movement of the even within a desired range, as described in more detail earlier.
[0073] [00073] As shown in Figures 29 to 32, a bone fixation system 700 according to yet another embodiment of the invention comprises a bone fixation rod 704 formed substantially similar to the bone fixation rods of previous modalities. The bone fixation rod 704 comprises a substantially elongated cylindrical portion 732 which has a helical blade 734 at a distal end thereof. An opening 740 extends into a proximal end 726 of the bone clamping rod 704 to a predetermined depth and comprises a proximal threaded portion 742 and a distal non-threaded portion 744. Opening 740 is configured and sized to engage a locking screw 706 is threaded. System 700 also comprises a substantially cylindrical outer sleeve 702 which extends from a proximal end 710 to a distal end 712 and which has a central longitudinal groove 708 extending therethrough. The distal end 712 comprises a support 703 extending into the channel 708 at a selected distance to prevent the head 707 of the locking screw 706 from moving distally beyond it. An internal threaded portion 705 extends into the proximal end 710 at a selected distance to allow threaded engagement with a plug 750, as will be described in more detail later in this document.
[0074] [00074] The exemplary bone fixation system 700 can be inserted into a bone (not shown) using the insertion instrument 600 'formed in a substantially similar manner to the insertion instrument 600 previously described in this document, and similar elements are referred to with similar reference numbers. Specifically, the insertion instrument 600 'comprises a first elongated tool 602' having an elongated cylindrical axis 604 and a handle 606 'at a proximal end thereof. The handle 606 ', according to this modality, is circumferential and extends around the entire circumference of the proximal end of the first elongated tool 602'. Alternatively, the handle 606 'may be a multi-component handle having multiple gripping portions distributed around the circumference of the first elongated tool 602'. The distal end 608 of the shaft 604 is configured to contact the proximal end 710 of the outer sleeve 702. The distal end 608 can be dimensioned and shaped to engage a proximal end 710 of corresponding shape (for example, hexagonal) of the outer sleeve 702. A second elongated tool 610 'is configured and dimensioned to be received, at least partially, within the first elongated tool 602' and comprises the substantially elongated cylindrical shaft portion 612 and a handle 614 adjacent to a proximal end thereof. A predetermined distal length of the shaft portion 612 includes an external thread 616 'configured to allow threaded engagement with the internal threaded portion 705 of the outer sleeve 702. The elongated compression instrument 620 can be inserted through the second elongated tool 610' and comprises the elongated cylindrical axis 622 and a head 624 at a proximal end thereof. A distal end of the elongated compression instrument 620 is configured to engage a head portion of the locking screw 706.
[0075] [00075] According to an exemplary method of the invention, the insertion tool 600 'is positioned with the bone fixation system 700 as shown in Fig. 33. As shown in Fig. 34, the second elongated tool 610' is then used to advance the bone fixation rod 704 into the bone. Specifically, if the bone clamping rod 704 comprises the blade 734, a distal axial force is applied to the second elongated tool 610 '. If the bone clamping rod is a threaded screw, the cable 606 'can be rotated to cause the threaded screw to rotate distally into the bone. A transverse locking cap 16 is then inserted into the locking screw hole 14 of the intramedullary nail 10 to apply a transverse locking force to the outer sleeve 702 to lock a position thereon. As shown in Fig. 36, the elongated compression element 620 can then be inserted through the second elongated tool 610 'to add compression. Specifically, the elongated pressing element 620 can be rotated with respect to the second elongated tool 610 'to rotate the screw 706, which pulls the fastener 704, which is engaged proximally to it in a threaded manner. Once the desired compression is achieved, the insertion instrument 600 'can be removed from the bone fixation device 700, as shown in Fig. 37. The plug 750 can then be inserted into the outer sleeve 702, as shown in Fig. 29. As described in more detail in previous embodiments, the bone fixation rod 704 may be allowed to move laterally within the outer sleeve 702 by approximately 10 mm from the configuration in Fig. 30 to the configuration in Fig. 31. If desired restrict this movement to a smaller range of movement, a plug 750 'with a longer length can be inserted into the outer sleeve 702. Additionally, also as described in previous embodiments, the plugs 750, 750', the locking screws 706 and the stem bone anchoring devices 704 can all comprise central longitudinal channels extending through them and configured to align with each other in an operational configuration deployed to allow for insertion of medical tools or other materials through them.
[0076] [00076] As shown in Figures 38 to 41, a bone fixation system 800, according to another embodiment of the invention, comprises a bone fixation rod 804 having a substantially cylindrical portion 832 and a distal helical blade 834. An aperture 840 is provided on a proximal end thereof and comprises a proximal threaded portion 842 and a distal unstroked portion 844 open to the central longitudinal groove 146. Aperture 840 is configured and sized to receive a compression screw 806 therein. The compression screw 806, according to this modality, has an increased diameter head 807 and a threaded shaft 809 configured to threadly engage the proximal threaded portion 842.
[0077] [00077] The bone fixation system 800 also comprises a substantially cylindrical outer sleeve 802 that extends from a proximal end 810 to a distal end 812, the distal end 812 comprising the increased thickness portion 703 to prevent the compression screw 806 moves distally beyond it. A proximal portion of the outer sleeve 802 comprises a plurality of grooves 811 that define a respective number of arms 813 that can deflect radially outwardly by applying a radially expanding force to them. An exemplary insertion method of the bone fixation system 800 is substantially similar to the methods presented above, in which the bone fixation nail 804 and the outer sleeve 802 are inserted through an orifice of the intramedullary nail 12 to a target depth so that the arms 813 are located proximal to the orifice of the intramedullary nail 12. The locking screw 806 is at least partially threaded into the opening 840 during insertion. After the stem 804 and the outer sleeve 802 are inserted to a target depth, a plug 850 is threaded at the proximal end 810 to threadably engage the inner threads 852 of the outer sleeve 802 to partially expand the outer sleeve 802 radially and thereby , assist in locking it inside the bone, as those skilled in the art will understand. In this configuration, the bone fixation rod 804 can be moved axially within the outer sleeve by approximately 10 mm, as described in more detail earlier. As would be understood by those skilled in the art, this movement can be eliminated or limited by inserting a locking cap 854 through the plug 850 so that the distal end 856 of it is contiguous with the head 807 of the locking screw 806, as shown in Fig. 40. The locking cap 854 can also comprise a central longitudinal groove 858 extending longitudinally through it to allow insertion of tools or other materials through it, as described in more detail earlier.
[0078] [00078] A bone fixation system 900, according to another exemplary embodiment of the invention, comprises a bone fixation element 904, as shown in Figures 42 to 44, sized and shaped for insertion through a 12 'hole. an intramedullary nail 10 ', as shown in Fig. 45. Similar to the nail 10 previously described, the intramedullary nail 10' extends along a longitudinal axis, and the orifice 12 'extends through the nail 10' at an angle to the longitudinal axis. The intramedullary nail 10 ', however, further comprises a locking pin 14' disposed within a groove 18 'of the nail 10' proximally to the orifice 12 'and a plunger 16' disposed within the groove 18 'of the nail 10' distally to the 12 'hole. The locking pin 14 'includes a pair of arms 22', each of which is positioned on opposite sides of the hole 12 '. The locking pin 14 'can be moved distally within the stem 10' so that the arms 22 'extend into the hole 12' to engage cut-out areas 938 of the bone fixation element 904, as will be described in more detail. bellow. The lock pin 14 'is moved longitudinally within the channel 18' through a lock actuation 20 'coupled to a proximal end of the lock pin 14'. The locking drive 20 'is threadedly engaged with an internal surface of the channel 18' and pivotally engaged with the proximal end of the locking pin 14 'so that the rotation of the locking drive 20' in a first direction relative to the rod 10 'moves the locking pin 14' distally into the channel 18 'so that the arms 22' extend into the hole 12 '. Rotating the locking drive 20 'in a second direction moves the locking pin 14' proximally to the rod 10 '.
[0079] [00079] The plunger 16 'includes a protrusion 24' which extends proximally thereafter. The plunger 16 'is movable between a first and a second position by means of a spring 24', which tilts the plunger 16 'in the first position. In the first position, the protrusion 26 'extends into the orifice 12' while in the second position the plunger 16 'is moved distally from the rod 10' so that the protuberance 16 'does not extend into the orifice 12' . The plunger 16 'is prevented from moving beyond a predetermined longitudinal strip by means of a pin 28' that fixes the plunger 16 'to the rod 10'. The protrusion 16 'is dimensioned and shaped to engage a serrated portion 936 of the bone fixation element 904, as will be described in more detail below.
[0080] [00080] The bone fastening element 904 includes an elongated cylindrical portion 932 and a distal bone engaging portion 934. The distal portion 934 may include bone engaging structures such as threads or blades. The element 904 extends from a proximal end 910 to a distal end 912. The elongated portion 932 comprises a serrated edge portion 936 extending along a predetermined length thereof at an angle substantially parallel to a longitudinal axis of the stem 904 In another embodiment, two serrated portions 936 separated from each other approximately 180 ° apart, as shown in Fig. 44. The serrated portion 936 is cut to engage the protrusion 26 'of the plunger 16' so that the element bone anchor 904 can be inserted through hole 12 'and into a head portion of a bone, but prevented from migrating to a central position through it.
[0081] [00081] The element 904 may also comprise a pair of longitudinal indented areas 938, also separated from each other by approximately 180 ° and separated from the respective areas of the serrated portions at approximately 90 °. The cut-out areas 938 are engaged by the arms 22 'of the lock pin 14' when the lock pin 14 'is moved so that the arms 22' extend into the hole 12 '. The engagement between the arms 22 'and the longitudinal indented areas 938 prevents the bone fixation element 904 from rotating in relation to the rod 10' and allows a central / lateral sliding movement within a predefined range of movement defined by the proximal and distal ends of the cropped area 938.
[0082] [00082] The distal portion 934 can be threaded or include blades to engage a bone into which the bone fixation element is inserted. The distal portion 934 can also include openings 940 that extend into it and open to the channel 908. The openings 942 can be arranged over the distal portion 934 in any configuration without departing from the scope of the invention (for example, misaligned, longitudinally aligned, etc.) and can be used to allow the injection of a material (for example, a bone reinforcing material) into the bone after implant. An opening 940 can extend to the proximal end 910 of the stem 904 at a predetermined distance to allow engagement with a locking screw (not shown), as described in more detail in previous embodiments.
[0083] [00083] Figures 46 to 49 show a bone fixation system 1000 according to another exemplary embodiment of the invention. The bone fixation system comprises a bone fixation rod 1004 formed substantially similar to the bone fixation rods of previous modalities. The bone clamping system 1000 also comprises an outer sleeve 1002 configured to receive the bone clamping rod 1004 through it and a locking screw 1006 configured to be, at least partially, inserted into the outer sleeve 1002. The outer sleeve 1002 comprises a longitudinal channel 1008 extending through it along a longitudinal axis 1038 from a proximal end 1010 to a distal end 1012. The longitudinal channel 1008 can be shaped like a substantially elliptical or circular cylinder without departing from the scope of the invention . The outer sleeve 1002 can also be provided with flat areas 1015 along the first and second longitudinal side walls 1014, 1016 to provide additional rotational stability of the outer sleeve 1002 with respect to the intramedullary nail 10, as also described in previous embodiments. The first longitudinal side wall 1014 has a first length and the second longitudinal side wall 1016 has a second length greater than the first length so that the proximal end 1010 is substantially oblique. In an exemplary embodiment, a difference in length between the first and second opposite side walls 1014, 1016 is approximately equal to a difference in length between a first and second side walls 1014 ', 1016' of the locking screw 1006 to allow the level flush with them when in an operational configuration. The second side wall 1016 additionally comprises a burr 1018 adjacent to the proximal end 1010 of the outer sleeve 1002. The burr 1018 protrudes from the outer sleeve 1002 in a length sufficient to permit engagement with a peripheral wall of the stem bore. intramedullary 12, as described in more detail in previous modalities.
[0084] [00084] The bone fixation element 1004 extends from a proximal end 1026 to a distal end (not shown). The proximal end 1026 of the bone fixation element 1004 is formed with a tab 1028 that has a shape complementary to that of a recess 1009 formed on a head 1007 protruding from the locking screw 1006. Specifically, as shown in Fig. 49, the tab 1028 extends proximally in the opposite direction of the bone fixing element 1004 along a side wall 1029 at a predetermined distance. The locking screw 1006 is provided with a recess 1009 positioned to receive the tab 1028 inside it in an operational configuration. The bone fixation element 1004 also comprises a longitudinal groove 1030 extending longitudinally through it from the proximal end 1026 to the distal end (not shown). A proximal portion 1032 of the longitudinal channel 1030 is formed with a diameter substantially similar to the diameter of a channel 1005 extending through the locking screw 1006 to allow a transfer of a desired medical tool or injectable material from the locking screw 1006 to the bone fixation element 1004 and subsequently into a target region of a bone without interference. The diameter of the groove 1030 of the bone fixation element 1030 decreases incrementally in a distal direction by means of an intermediate groove portion 1032 and a distal groove portion 1034, as shown in Fig. 49. The flange 1028 of the bone fixation element Bone 1004 further comprises a notch 1038 formed substantially similar to burr 1018, notch 1038 being configured to engage the ratchets 1040 provided over a proximal portion of channel 1008 of outer sleeve 1002. The exemplary embodiment of Figures 46 to 49 provides an integrated ratchet mechanism to allow the telescopic movement of the bone fixation element 1004 in relation to the outer sleeve 1002, preventing and / or minimizing the central migration of the bone fixation element 1004, while reducing wear by friction of the same. As discussed in more detail in previous embodiments, a distal portion (not shown) of bone fixation element 1004 can be provided with a helical blade, thread, notches, or any other shape to facilitate bone fixation when implanted in a position target trochanteric.
[0085] [00085] The locking screw 1006 also comprises a notch (not shown) adjacent to the groove 1009, the notch also being configured to engage the grooves 1040 of the outer sleeve 1002 as a ratchet, as will be described in more detail below.
[0086] [00086] According to an exemplary method of the bone fixation system 1000, a fractured or otherwise damaged bone (not shown) is placed in corrective alignment and the intramedullary nail 10 is inserted into a medullary cavity of it to a position target and guidance in any known way. The bone fixation element 1004 is then inserted through the hole of the intramedullary nail 12 at a target depth until a distal portion of increased diameter is moved distally out of the intramedullary nail 12. The outer sleeve 1002 is then inserted through the hole of the intramedullary nail until the notch 1038 of the bone fixation element 1004 engages the threads 1040 of the outer sleeve 1002, as shown in Fig. 48. An intramedullary nail locking screw 16 'can then be inserted into the screw hole lock 14 of the intramedullary nail 10 to lock a position of the outer sleeve 1002 and prevent lateral migration of the same (for example, during temporary extraction). After the outer sleeve 1002 and the bone fixation element 1004 are positioned as desired within orifice 12, locking screw 1006 is inserted into it so that recess 1009 is flush against flap 1028 and notch (not shown) ) it securely engages the grooves 1040. The locking screw 1006 can be provided with marks to assist its insertion into the outer sleeve 1002 at a desired angle to ensure proper positioning against this bone fixation element 1004. In this configuration, the locking screw 1006 is prevented from being retracted proximally out of the hole of the intramedullary nail 12 due to the engagement of the notch (not shown) with the grooves 1040. As with the previous modalities, the bone fixation system 1000 allows the lateral movement of the bone fixation element 1004 within the outer sleeve 1002 by approximately ± 10 mm.
[0087] [00087] It will be apparent to those skilled in the art that various modifications and variations may be made to the structure and methodology of the present invention, without departing from the spirit or scope of the invention. Thus, it is intended that the present invention encompasses modifications and variations of the same as long as they are within the scope of the appended claims and their equivalents.
权利要求:
Claims (13)
[0001]
Bone fixation device (100, 200, 300, 400, 500, 700), comprising: a bone fixation rod (504, 704, 804, 1004) extending from a proximal end (110, 210, 310, 410, 510, 710, 810, 910, 1010) to a distal end (112, 212, 312, 412, 512, 712, 812, 912, 1012), the distal end (112, 212, 312, 412, 512, 712, 812, 912, 1012) having a helical structure (134, 434, 534, 734, 834) configured to engage a bone, and the proximal end (110, 210, 310, 410, 510, 710, 810, 910, 1010) having an opening (140, 340, 540, 740, 840, 940) that extends to its interior; a first glove (102, 202, 402, 503, 1002, 404, 406, 502) configured for insertion over a proximal portion (430) of the bone fixation rod (504, 704, 804, 1004) and through a hole of the intramedullary nail (12), the first glove (102, 202, 402, 503, 1002, 404, 406, 502) allowing the bone fixation nail (504, 704, 804, 1004) to move axially within it in a predetermined range of motion; and a locking screw (106, 306, 505, 506, 706, 806, 1006) configured to limit the movement of the bone fixation rod (504, 704, 804, 1004) in relation to the first sleeve (102, 202, 402 , 503, 1002, 404, 406, 502), the locking screw (106, 306, 505, 506, 706, 806, 1006) configured to lock the opening (140, 340, 540, 740, 840, in a locked manner), 940) on the bone fixation rod (504, 704, 804, 1004) and having a head (107, 307, 507, 707, 807, 1007) and a threaded shaft (109, 209, 309, 809) that extends distally from it. wherein the sleeve (102, 202, 402, 503, 1002, 404, 406, 502) still comprises a first radial support (703) located adjacent to a distal end (112, 212, 312, 412, 512, 712, 812 , 912, 1012) of the first glove (102, 202, 402, 503, 1002, 404, 406, 502) configured to prevent proximal retraction of the first glove (102, 202, 402, 503, 1002, 404, 406, 502 ) out of the orifice of the intramedullary nail (12) beyond it, characterized by the fact that the first radial support (703) is radially compressible inwards, until it is flush against an external wall of the first sleeve (102, 202, 402, 503, 1002, 404, 406, 502) during the distal advance through the orifice of the intramedullary nail (12).
[0002]
Device (100, 200, 300, 400, 500, 700) according to claim 1, characterized by the fact that it also comprises a second radial support (703) located adjacent to a proximal end (110, 210, 310, 410 , 510, 710, 810, 910, 1010) of the first glove (102, 202, 402, 503, 1002, 404, 406, 502) configured to prevent distal movement of the first glove (102, 202, 402, 503, 1002 , 404, 406, 502) in the orifice of the intramedullary nail (12) in addition to it.
[0003]
Device (100, 200, 300, 400, 500, 700) according to claim 1, characterized by the fact that it still comprises a second glove (102, 202, 402, 503, 1002, 404, 406, 502) provided on the first glove (102, 202, 402, 503, 1002, 404, 406, 502) and axially movable with respect to it.
[0004]
Device (100, 200, 300, 400, 500, 700), according to claim 3, characterized by the fact that the first glove (102, 202, 402, 503, 1002, 404, 406, 502) is tapered in shape so that a distal end (112, 212, 312, 412, 512, 712, 812, 912, 1012) of it has a larger diameter than a proximal end (110, 210, 310, 410, 510, 710, 810 , 910, 1010) thereof, wherein a proximal end (110, 210, 310, 410, 510, 710, 810, 910, 1010) of the first glove (102, 202, 402, 503, 1002, 404, 406, 502) threadedly engages a proximal end (110, 210, 310, 410, 510, 710, 810, 910, 1010) of the second sleeve (102, 202, 402, 503, 1002, 404, 406, 502).
[0005]
Device (100, 200, 300, 400, 500, 700) according to claim 1, characterized in that a proximal portion (430) of the first glove (102, 202, 402, 503, 1002, 404, 406 , 502) comprises a plurality of longitudinal grooves (811) defining a respective number of radially deflectable arms (813).
[0006]
Device (100, 200, 300, 400, 500, 700) according to claim 1, characterized in that a proximal portion (430) of the bone fixation rod (504, 704, 804, 1004) comprises a first threaded connector (130, 554) having the opening, the first threaded connector (130, 554) having a flange (142) on a distal end (112, 212, 312, 412, 512, 712, 812, 912, 1012 ) of the same to engage a groove (104, 1040) provided on the bone fixation rod (504, 704, 804, 1004), and a second threaded connector (130, 554) configured to threadably engage the first connector (130 , 554) threaded and having an outside diameter substantially equivalent to an outside diameter of the proximal portion (430) of the bone fixation rod (504, 704, 804, 1004), wherein the second threaded connector (130, 554) comprises a pair of slots (158) defining a flap (156, 1028) that protrudes radially extending outwardly for engaging an insertion instrument (600, 600 ’).
[0007]
Device (100, 200, 300, 400, 500, 700) according to claim 6, characterized in that a distal face of the second threaded connector (130, 554) comprises a treated surface (162) configured to engage a respectively treated surface (162) over the proximal portion (430) of the bone fixation rod (504, 704, 804, 1004), where the treated surface (162) is a serrated or notched surface.
[0008]
Device (100, 200, 300, 400, 500, 700) according to claim 1, characterized by the fact that a diameter of the head (107, 307, 507, 707, 807, 1007) of the locking screw (106 , 306, 505, 506, 706, 806, 1006) is greater than or equal to an internal diameter of the first glove (102, 202, 402, 503, 1002, 404, 406, 502).
[0009]
Device (100, 200, 300, 400, 500, 700) according to claim 1, characterized by the fact that the bone fixation rod (504, 704, 804, 1004) comprises a central longitudinal groove (144, 146, 546, 305, 708, 858) extending through it and it is opened close to its proximal and distal ends to allow the insertion of a tool through it, in which the helical structure (134, 434, 534, 734, 834) comprises a first opening (942) extending inwards and open to the central longitudinal channel (144, 146, 546, 305, 708, 858) to allow an infusion or removal of a material through it .
[0010]
Device (100, 200, 300, 400, 500, 700) according to claim 1, characterized by the fact that a proximal end (110, 210, 310, 410, 510, 710, 810, 910, 1010) of the helical structure (134, 434, 534, 734, 834) comprises a portion of increased diameter (135) to prevent proximal retraction of the bone fixation rod (504, 704, 804, 1004) inside a first glove (102 , 202, 402, 503, 1002, 404, 406, 502) in addition to the same.
[0011]
Device (100, 200, 300, 400, 500, 700) according to claim 1, characterized by the fact that the helical structure (134, 434, 534, 734, 834) is a helical blade (134, 434, 534, 734, 834) or a threaded portion.
[0012]
Device (100, 200, 300, 400, 500, 700) according to claim 1, characterized in that a proximal portion (430) of the bone fixation rod (504, 704, 804, 1004) comprises a first serrated portion extending along a first longitudinal side wall (114, 116, 1014, 1016) thereof.
[0013]
Device (100, 200, 300, 400, 500, 700), according to claim 1, characterized by the fact that it still comprises a first notch (1038) located on the proximal end (110, 210, 310, 410, 510 , 710, 810, 910, 1010) of the bone fixation rod (504, 704, 804, 1004), the notch (1038) being configured to engage a grooved portion of the first sleeve (102, 202, 402, 503, 1002, 404, 406, 502) to lock a position of the bone fixation rod (504, 704, 804, 1004) in relation to the outer sleeve (102, 202, 302, 402, 502, 503, 702, 802 , 1002), and a second notch (1038) located on the distal end (112, 212, 312, 412, 512, 712, 812, 912, 1012) of the locking screw (106, 306, 505, 506, 706, 806, 1006), the second notch (1038) configured to engage the grooved portion of the first sleeve (102, 202, 402, 503, 1002, 404, 406, 502) as a ratchet to lock a position of the locking screw (106 , 306, 505, 506, 706, 806, 1006) in relation to the outer sleeve rna (102, 202, 302, 402, 502, 503, 702, 802, 1002).
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IES85130Y1|2009-02-18|A bolt apparatus
同族专利:
公开号 | 公开日
JP5931924B2|2016-06-08|
EP2665432B1|2016-04-13|
TWI536954B|2016-06-11|
WO2012099944A1|2012-07-26|
CA2825276C|2019-04-30|
KR20140010382A|2014-01-24|
BR112013018525A2|2016-10-18|
CO6910169A2|2014-03-31|
RU2601982C2|2016-11-10|
HUE027609T2|2016-10-28|
US20120191092A1|2012-07-26|
TW201242567A|2012-11-01|
RU2013132740A|2015-02-27|
CA2825276A1|2012-07-24|
CN103327918A|2013-09-25|
CN103327918B|2016-12-14|
JP2014508578A|2014-04-10|
US8808293B2|2014-08-19|
EP2665432A1|2013-11-27|
KR101926352B1|2018-12-07|
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法律状态:
2018-12-18| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
2020-09-15| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application [chapter 6.1 patent gazette]|
2021-01-19| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
2021-03-23| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 18/01/2012, OBSERVADAS AS CONDICOES LEGAIS. |
优先权:
申请号 | 申请日 | 专利标题
US201161435036P| true| 2011-01-21|2011-01-21|
US61/435,036|2011-01-21|
US201161477857P| true| 2011-04-21|2011-04-21|
US61/477,857|2011-04-21|
PCT/US2012/021695|WO2012099944A1|2011-01-21|2012-01-18|Trochanteric femoral nail augmentable|
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