DEVICE TO DEPLOY A BONE FIXATION SYSTEM AND SIGHTING INSTRUMENT TO GUIDE THE INSERTION OF A BONE FIX

专利摘要:
femoral neck fracture implant. The present invention relates to a device for implanting a bone fixation system comprising an insertion tool extending from a proximal end to a distal end, the distal end having an engaging portion for engaging with detachably a proximal end of a bone plate, wherein the insertion tool has an elongated groove extending therethrough to allow insertion of a first protective sleeve therethrough, wherein a longitudinal axis of the elongated groove is coaxial with a longitudinal axis of a first opening that extends through the bone plate and a first protective sleeve that can be inserted into the elongated groove, and which guides the insertion of an anti-rotation screw therethrough and through the bone plate. bone, a longitudinal axis of the first protective sleeve being at an angle to the longitudinal axis of the groove elongated.
公开号:BR112014012012B1
申请号:R112014012012-9
申请日:2012-11-19
公开日:2021-06-01
发明作者:Tom Overes；David Mueller；Martin Oswald
申请人:Synthes Gmbh；
IPC主号:

专利说明:

PRIORITY CLAIM
[001] This application claims priority from US Provisional Application Serial No. 61/561,439, filed November 18, 2011 and entitled "fastener", and US Provisional Application Serial No. 61/692,053, filed on November 22, August 2012 and entitled "Femoral Neck Fracture Implant", the entire descriptions of which are incorporated herein by reference. FIELD OF THE INVENTION
[002] The present invention relates to fasteners, fastener assemblies, kits for fastener assemblies, methods of mounting fastener assemblies and methods of implanting fastener assemblies into a bone. BACKGROUND
[003] Femoral neck fractures are often treated with a pin or other implant inserted into the femoral head along a geometric axis of the femoral neck. One product is the Stryker® Hansson® Pin System which are first and second shaft ends separated from each other by a sidewall without threading on their outer surface. The Hansson® Pin has a hook capable of positioning a first end region to secure the Hansson® Pin to the femoral head. The hook is installed by pushing a rod on the second end, which in turn installs the hook through a hole in the side wall. Generally, two or three Hansson® pins are inserted into the femoral head to secure the femoral head and to facilitate healing of the femoral neck fracture.
[004] Other known products for treating femoral neck fractures include the Stryker® Gamma3® Hip Fracture System and the Smith + Nephew® Trigen® Intertan® Trochanteric Pin System. Both of these systems include an intramedullary pin insertable into the femur and have shaft-like fasteners insertable through the intramedullary pin into the femoral head to stabilize the femoral neck fracture. Additionally, each of these systems includes a feature to minimize unwanted rotation of the femoral head relative to the shaft-like fastener that is secured to the pin. After the fastener is attached, central migration of the femoral head relative to the neck fracture can cause an axis-like fastener end to pierce the femoral head and injure the hip joint. Another well-known product is Synthes® DHS® which includes a bone plate attachable to the femur near the femoral head. The bone plate is prevented from rotating as it is positioned by a plurality of bone screws that extend through the plate into the femur. The bone plate includes a groove that extends over a portion positioned to allow a shaft-like fastener to be passed through a groove in the femoral head to stabilize the femoral head and allow for healing of a femoral neck fracture. The shaft-like fastener is pressed to drive it into the femoral head.
[005] It is an objective of the present invention to provide an improved system for fixation of femoral neck fracture. SUMMARY OF THE INVENTION
[006] The present invention relates to a device for implanting a bone fixation system comprising an insertion instrument extending from a proximal end to a distal end, the distal end having an engaging portion for releasably engaging a proximal end of a bone plate, the insertion tool having an elongated channel extending therethrough to allow insertion of a first protective sleeve therethrough where a longitudinal axis of the elongated trough is coaxial with a longitudinal geometric axis of a first opening extending through the bone plate and a first protective sleeve insertable into the elongated trough and guiding the insertion of an anti-rotation screw through it and through the bone plate, a longitudinal axis of the first protective sleeve being angled with respect to the longitudinal axis of the elongated channel.
[007] In a first aspect, the present invention provides a sighting instrument to guide the insertion of a bone fixation device into a bone comprising a sighting arm including a first portion and a second portion, the first portion being extends from a proximal end to a distal end and having an elongated channel extending therethrough, the distal end having an engaging portion that releasably engages a proximal end of the bone fixation device, a sidewall of the sighting arm including an elongated slit open to the elongated channel; and an elongate member removably insertable into the elongated channel, the elongate member having a first stem portion and a second stem portion, wherein the first stem portion is inserted into the elongated channel and lockably engages the arm. sight, the second shank portion extending through the elongated slit and having an opening extending therethrough to guide an anti-rotation screw insert therethrough and into the bone fixation device.
[008] In a second aspect, the present invention includes a method of implanting a bone fixation device into a bone comprising: engaging a distal end of a guide assembly to a proximal end of a bone fixation device in a manner that a first portion of the guide assembly has an elongated channel extending therethrough that is coaxial with a longitudinal axis of the bone fixation device, the first portion extending from a proximal end to a distal end; inserting an elongated rod portion through the elongated channel, the elongated rod portion including a first protective sleeve; inserting the bone fixation device into a bone rod such that a first portion of the bone plate is positioned on an outer surface of the bone and a second portion of the bone plate is received within the bone; and inserting an anti-rotation screw through the first protective sleeve until a rod of the anti-rotation screw extends outward from the bone fixation device at an angle offset from the longitudinal axis of the bone fixation device. BRIEF DESCRIPTION OF THE DRAWINGS
[009] Various embodiments of the invention will be described below by way of example and with reference to the attached drawings in which:
[0010] Fig. 1 shows a first perspective view of a bone clamp assembly according to a first exemplary embodiment of the invention;
[0011] Fig. 2 shows a second perspective view of the bone clamp assembly of Fig. 1;
[0012] Fig. 3 shows a first perspective view of a bone plate of the bone clamp assembly of Fig. 1;
[0013] Fig. 4 shows a second perspective view of the bone plate of Fig. 3;
[0014] Fig. 5 shows a third perspective view of the bone plate of Fig. 3;
[0015] Fig. 6 shows a cross-sectional view of the bone plate of Fig. 3;
[0016] Fig. 7 shows a first perspective view of an implant stem of the bone clamp assembly of Fig. 1;
[0017] Fig. 8 shows a second perspective view of the implant stem of Fig. 7;
[0018] Fig. 9 shows a cross-sectional view of the implant stem of Fig. 7;
[0019] Fig. 10 shows a partial cross-sectional view of the bone clamp assembly of Fig.;
[0020] Fig. 11 shows a first surgical step for using the bone clamp assembly of Fig. 1;
[0021] Fig. 12 shows a second surgical step for using the bone clamp assembly of Fig. 1;
[0022] Fig. 13 shows a third surgical step for using the bone clamp assembly of Fig. 1;
[0023] Fig. 14 shows a fourth surgical step for using the bone clamp assembly of Fig. 1;
[0024] Fig. 15 shows a fifth surgical step for using the bone clamp assembly of Fig. 1;
[0025] Fig. 16 shows a sixth surgical step for use of the bone clamp assembly of Fig. 1;
[0026] Fig. 17 shows a seventh surgical step for using the bone clamp assembly of Fig. 1;
[0027] Fig. 18 shows an eighth surgical step for using the bone clamp assembly of Fig. 1;
[0028] Fig. 19 shows a ninth surgical step for using the bone clamp assembly of Fig. 1;
[0029] Fig. 20 shows a tenth surgical step for using the bone clamp assembly of Fig. 1;
[0030] Fig. 21 shows a side view of the bone clamp assembly of Fig. 1 in a first post-operational configuration;
[0031] Fig. 22 shows a cross-sectional view of the bone clamp assembly of Fig. 21;
[0032] Fig. 23 shows a side view of the bone clamp assembly of Fig. 1 in a second post-operational configuration;
[0033] Fig. 24 shows a cross-sectional view of the bone clamp assembly of Fig. 23;
[0034] Fig. 25 shows a side view of a bone clamp assembly according to a first alternative embodiment of the invention;
[0035] Fig. 26 shows a cross-sectional view of the bone clamp assembly of Fig. 25;
[0036] Fig. 27 shows a side view of a bone clamp assembly according to a second alternative embodiment of the invention;
[0037] Fig. 28 shows a cross-sectional view of the bone clamp assembly of Fig. 27;
[0038] Fig. 29 shows a perspective view of a bone clamp assembly according to a third alternative embodiment of the invention;
[0039] Fig. 30 shows a perspective view of a bone clamp assembly according to a fourth alternative embodiment of the invention;
[0040] Fig. 31 shows a perspective view of a bone clamp assembly according to a fifth embodiment of the invention;
[0041] Fig. 32 shows a first surgical step for using the bone clamp assembly of Fig. 31;
[0042] Fig. 33 shows a second surgical step for using the bone clamp assembly of Fig. 31;
[0043] Fig. 34 shows a first embodiment of a kit for packaging any of the bone fastener assemblies according to the invention;
[0044] Fig. 35 shows a second embodiment of a kit for inserters for use with the anchor bone in accordance with the invention;
[0045] Fig. 36 shows a perspective view of a bone clamp assembly according to another embodiment of the invention;
[0046] Fig. 37 shows a first perspective view of a bone plate of the bone clamp assembly of Fig. 36;
[0047] Fig. 38 shows a second perspective view of the bone plate of Fig. 36;
[0048] Fig. 39 shows a cross-sectional view of the bone plate of Fig. 36;
[0049] Fig. 40 shows a first perspective view of an implant stem of the bone clamp assembly of Fig. 36;
[0050] Fig. 41 shows a second perspective view of the implant stem of Fig. 40;
[0051] Fig. 42 shows a third perspective view of the implant stem of Fig. 40;
[0052] Fig. 43 shows a cross-sectional view of the implant stem of Fig. 40;
[0053] Fig. 44 shows a side view of the implant stem of Fig. 40;
[0054] Fig. 45 shows a perspective view of an anti-rotation screw of the bone clamp assembly of Fig. 37;
[0055] Fig. 46 shows a first surgical step for using the bone clamp assembly of Fig. 36;
[0056] Fig. 47 shows a second surgical step for using the bone clamp assembly of Fig. 36;
[0057] Fig. 48 shows a third surgical step for using the bone clamp assembly of Fig. 36;
[0058] Fig. 49 shows a fourth surgical step for using the bone clamp assembly of Fig. 36;
[0059] Fig. 50 shows a fifth surgical step for using the bone clamp assembly of Fig. 36;
[0060] Fig. 51 shows a perspective view of a bone clamp assembly according to another embodiment of the invention;
[0061] Fig. 52 shows a side view of the bone clamp assembly of Fig. 51;
[0062] Fig. 53 shows a perspective view of a bone clamp assembly according to another embodiment of the invention;
[0063] Fig. 54 shows a first perspective view of an implant stem according to another embodiment of the invention;
[0064] Fig. 55 shows a second perspective view of the implant stem of Fig. 54;
[0065] Fig. 56 shows a cross-sectional view of the implant stem of Fig. 54;
[0066] Fig. 57 shows a perspective view of an inserter for the implant according to the invention in a first operational configuration;
[0067] Fig. 58 shows a perspective view of the device of Fig. 57 in a second operational configuration;
[0068] Fig. 59 shows a perspective view of the device of Fig. 57 in a third operational configuration;
[0069] Fig. 60 shows a perspective view of the device of Fig. 57 in a fourth operational configuration;
[0070] Fig. 61 shows a perspective view of the device of Fig. 57 in a fifth operational configuration;
[0071] Fig. 62 shows a first perspective view of the device of Fig. 57 in a sixth operational configuration; and
[0072] Fig. 63 shows a second perspective view of the device of Fig. 57 in the sixth operational configuration. DETAILED DESCRIPTION
[0073] The present invention can be further understood with reference to the following description and the accompanying drawings, in which like elements are referred to with like reference numerals. The present invention relates to the treatment of fractures and, in particular, to devices for fixing femoral neck fractures. Exemplary embodiments of the present invention describe a bone plate having a first portion positionable against an outer surface of a fractured or otherwise injured bone and a second portion partially inserted into the bone. A first bone screw hole extends through the first portion and a second bone screw hole extends through the second portion. The second portion additionally receives a bone fixation rod sized to extend through a fractured portion of the femoral neck into the femoral head. The bone fixation rod includes a transverse opening that extends through a sidewall thereof along a transverse opening axis angled with respect to a bone fixation rod axis such that a bone fixation element Bone (eg, a bone screw) inserted through the transverse opening extends outward from the nail into the bone to aid in fracture fixation and compression while also preventing rotation of the femoral head relative to the bone as will be described in more detail. follow. It should be noted that the terms "proximal" and "distal" as used herein refer to a direction towards (proximal) and away from (distal) a user of the device. In an exemplary embodiment, the system and method disclosed herein can be used for fractures of the femoral neck. It is noted that while the exemplary system and method are directed towards a fixation of a femoral head fracture, the exemplary bone fixation system can be used on any other bone in the body without departing from the scope of the invention.
[0074] The exemplary system and method, according to the invention, provides a minimally invasive surgical technique to treat femoral neck fractures with the use of one or two incisions, depending on the thickness of soft tissue, as those skilled in the art will understand . Furthermore, since the bone plate and stem implant of the invention are inserted into the body simultaneously, the exemplary system and method according to the invention can be positioned more quickly and accurately compared to the present systems. As will be described in more detail below, the exemplary method according to the invention eliminates the need to press the bone fixation device to insert it into the bone. It should also be noted that the terms "central" and "lateral" as used herein indicate a direction toward (central) and away from (lateral) a midline of a patient's body within which the device is bone fixation must be implanted. Furthermore, the terms "cranial" and "caudal" as used herein are intended to indicate a direction towards a head (cranial) and towards the feet (caudal) of the patient within which the bone fixation device should be deployed.
[0075] As shown in Figures 1 to 10, a bone fixation system 100 according to the first embodiment of the present invention comprises a bone plate 102 sized and shaped for placement on a target portion of the femoral stem opposite the femoral head. (ie, over a location through which a geometric axis of the femoral neck passes). The bone plate 102 comprises a first portion 104 shaped to engage an outer surface of the target portion of the femur along a first portion axis parallel to an axis of the shaft of the femur and a second portion 106 that extends away of the first portion along a second geometric axis of portion 120 angled relative to the first plane at an angle selected such that, when the first portion 104 is positioned over the target portion of the femur, a geometric axis of the second portion 120 becomes extends along the geometric axis of the femoral neck. In an exemplary embodiment, the first and second portions 104, 106 are angled so that a bone-contacting surface 107 of the first portion 104 surrounds an angle α of approximately 130° with respect to the second geometric axis of portion 120 as shown in Fig. 10. At this angle, the second geometry axis of portion 120 involves an angle β of approximately 40° with respect to a locking hole geometry axis 110 of a locking hole 108 extending through plate 102. It is noted, however, that any other angle may be used as needed to accommodate a patient's anatomy without departing from the scope of the invention. For example, the angle β can be 45°. Lock hole geometry axis 110 in this embodiment extends substantially perpendicular to the first portion axis. However, those skilled in the art will understand that the orientation of the lock hole geometry axis 110 can be varied as desired. The locking hole 108 includes a multifaceted surface, like the thread 112, for threadably engaging a corresponding thread in a shank 12 of a bone fixation element 10 (e.g., a bone screw) inserted therethrough. The bone fixation element 10 may be a standard locking screw known in the art. A proximal portion of the locking hole 108 may include an unthreaded recess 114 to seat a head 14 of the bone anchor 10, as would be understood by those skilled in the art. An outer surface of first portion 104 may be substantially rounded so that first portion 104 has a smooth outer profile that prevents soft tissue irritation.
[0076] The second portion 106 is substantially cylindrical and extends from the first portion 104 to a distal end 116 over a selected length such that when the first portion 104 is positioned over the target portion of the femur, the second portion 106 extends through the femoral neck to a desired position within the femoral head. A central elongated channel 118 extends through the second portion along the second geometric axis of portion 120. An outer surface of the channel is substantially smooth with the exception of a strut 122 adjacent the distal end 116. The strut 122 extends proximally. in the channel 118 a predetermined distance and includes a proximal seat 124 and an elongated face 126. As will be described in more detail below, the proximal seat 124 provides a lock for an implant stem 130 while the face 126 prevents and/or minimizes a rotation of rod 130 relative to bone plate 102.
[0077] The bone fixation system 100 further comprises an implant stem 130 for insertion through the plate 102 along the geometric axis of the femoral neck and the second axis of portion 120 in the femoral head. Stem 130 is formed as a substantially elongated cylindrical member extending from a proximal end 132 to a distal end 134 along a central longitudinal axis 136. A diameter of the implant stem in this embodiment is approximately 10 mm. However, other dimensions can be used to accommodate differences in patient anatomy without departing from the scope of the invention. In an exemplary embodiment, distal end 134 may be blunt to prevent implant stem 130 from cutting through bone 1. An outer surface of implant stem 130 comprises an elongated cutout 138 extending from proximal end 132 towards the distal end 134 and forming a flat surface configured to engage face 126 of strut 122 which prevents rotation of rod 130 relative to plate 102. As those skilled in the art will understand, a shape of cutout 138 is selected so that when implanted, forces tending to rotate the fractured femoral head relative to the femoral stem are reacted, resulting in the femoral head being held in a desired stable alignment with the femoral stem. That is, cutout 138 eliminates the need for a friction fit between the implant stem 130 and the second portion 106 to prevent rotation of the implant stem 130. Any rotational force applied thereto is converted to an angled moment arm applied to the implant stem. Cutout 138 is a portion of an outer surface of implant stem 130 milled, or otherwise formed, to define a substantially flat face that engages face 126 in an operative configuration, as will be described in more detail below. A proximal end of cutout 138 comprises a tab 140 extending radially therefrom a selected distance to allow tab 140 to engage seat 124, which prevents implant stem 130 from being inserted distally beyond seat 124 , defining a maximum length by which rod 130 can be inserted into bone. In an operational configuration, implant stem 130 engages bone plate 102 via a form fit. As will be described in more detail below with regard to the method of use, the engagement of the form fitting allows for lateral and central telescopic migration of the implant stem 130 relative to the bone plate 102 after implantation. This migration allows the Implant Stem 130 to move laterally as the bone head moves into a corrected position during healing.
[0078] The implant stem 130 comprises a first channel 142 extending longitudinally therethrough from the proximal end 132 to the distal end 134 in alignment with the central longitudinal axis 136. In an exemplary embodiment, the first channel 142 is dimensioned to receive a guide wire (eg, a Kirschner wire) therethrough to guide an insertion of the implant stem 130 into the bone. The implant stem 130 further comprises a second substantially cylindrical channel 144 extending therethrough along a axis 148 from the proximal end 132 to a distal opening 146 in a side wall of the implant stem 130. The axis 148 therein One embodiment is angled approximately 7.5° with respect to the central longitudinal axis 136. In another embodiment, the angle may be 5°, 6°, 8°, or any other angle greater than 5°. In yet another embodiment, the angle can be in the range between 0° and 5°. As shown in Fig. 8, the distal opening 146 of the second channel 144 is circumferentially separated from the cutout. Due to the angular orientation of the second channel 144 relative to the implant stem 130, an opening of the second channel 144 in the distal opening 146 is substantially oval to allow a stem 22 of an anti-rotation screw 20 to be inserted through the same skirt thereof. Specifically, the second channel 144 has a substantially circular cross section. However, because the second channel 144 exits the implant stem 130 at an oblique angle as shown in Figures 7 to 9, the distal opening 146 is oval in shape. The proximal end of the second channel 144 is formed with a threaded portion 150 to threadably engage the thread formed on the shank 22 of the anti-rotation screw 20. The threaded portion 150 may have a tapered diameter to engage a tapered diameter of a screw head 24 anti-rotation 20, the diameter of the threaded portion 150 being selected to prevent the head 24 from being inserted beyond it.
[0079] Figures 11 to 20 represent an exemplary method of using the bone fixation system 100. In a first step, a patient is placed in a supine position on an operating table and the fractured bone 30 is provisionally brought to an alignment corrected by one or more of traction, abduction, and internal rotation as would be understood by those skilled in the art. A direct lateral incision approximately 3 to 4 cm in length is made proximal to a tip of a greater trochanter. The iliotibial tract is then divided longitudinally and the vastus lateralis muscle is dorsally separated from the intramuscular membrane. The proximal femoral stem of a bone 1 is then exposed without retracting the periosteum. A guidewire is inserted through a center of the femoral head at a desired angle until a distal end of the guidewire extends into the subchondral bone, as those skilled in the art will understand. If desired, one or more additional guidewires can be inserted into the femoral head, as would be understood by those skilled in the art. A known flaring device (not shown) is then guided over the guidewire to guide a bore for insertion of an implant in accordance with the invention. The stent is then removed from the bone 30 and the physician measures the appropriate implant length and selects an appropriately sized implant stem 130. The implant stem 130 is then inserted through the channel 118 of the second portion 106 of the implant plate. bone 102 until engagement of tab 140 with seat 126 prevents further distal movement of implant stem 130. Mounted bone plate 102 and implant stem 130 are then secured to an insertion tool 40 including an arm portion 42 and an elongated rod portion 44, a distal end 46 of which releasably secures the bone plate 102, as shown in Figures 11 to 13. It is noted that although the arm portion 42 is shown with a curvature, any other format can be used without departing from the scope of the invention. Arm portion 42 includes a first opening 48 extending through a first portion at a first end thereof and a second opening 50 extending through a second portion at a second end thereof. As will be described in more detail below, the first opening 48, in accordance with this embodiment, has a substantially circular cross-section to allow insertion of a first substantially cylindrical protective sleeve 60 therethrough. The second opening 50 has a substantially oblong cross-sectional shape (e.g. oval, rectangular, etc.) to allow insertion of a second protective sleeve 70 therethrough, as will also be described in more detail below. In an exemplary embodiment, bone plate 102 is slidably inserted into engagement with distal end 46, although other attachment mechanisms may be employed without departing from the scope of the invention. Exemplary system 100 eliminates the need for an impactor to guide bone plate 102 and implant stem 130 into bone. However, in an alternative embodiment, an impactor (not shown) can be used to first press implant stem 130 into the femoral neck of a bone 1 and into the femoral head and subsequently press bone plate 102 into a lateral portion of the bone 1 until plate 102 sits flush with bone. Specifically, once bone plate 102 has been secured to insertion tool 40, an impactor can be inserted through bone plate 102 against implant stem 130 to press system 100 into bone. The impactor (not shown) and guidewire (not shown) can then be removed from the bone, leaving the insertion tool 40 and system 100 positioned in the bone, as shown in Fig. 14.
[0080] A first protective sleeve 60 is then inserted through the first opening 48 in the insertion tool 40. The first protective sleeve 60 may extend through the first opening 48 and the distal end 46 of the insertion tool 40 at a predetermined angle with respect to the angle of the elongated rod portion 44. In an exemplary embodiment, the first protective sleeve 60 and the elongated rod 44 confine an angle of approximately 40, although other angles may be used without departing from the scope of the invention . The first protective sleeve 60 guides the drilling of a hole in the bone 1 to allow insertion of the bone fixation element 10 (i.e., a bicortical nail screw) therein. Specifically, a drilling mechanism known in the art can be inserted through the first protective sleeve 60 to drill an opening through the locking hole 108 of the bone plate 102 and into the bone 1. The drilling mechanism can then be removed and bone fixation element 10 can be inserted through first protective sleeve 60 and bone plate 102 and into bone 1. The dimensions of bone fixation element 10 are selected to allow bicortical insertion of the same through bone 1 , as those skilled in the art will understand. The first protective sleeve 60 can then be removed from the insertion tool, which leaves the bone fixation element 10 in place within the bone 1.
[0081] As shown in Figures 17 to 18, the second protective sleeve 70 may comprise a first portion of elongated rod 72 that has a first channel 74 extending therethrough, with the first portion of elongated rod 72 being insertable through the insertion tool. In an operational configuration, a longitudinal axis 75 of first channel 74 is substantially aligned with longitudinal axis 136 of implant stem 130. Second protective sleeve 70 further comprises a second elongated stem portion 76 having a second channel 78 that extends therethrough, a longitudinal axis 77 of the second elongated stem portion 76 being displaced from the longitudinal axis 75 by approximately 5° to align with the axis 148 of the implant stem 130, as described in greater detail above and shown in Fig. 9. The elongated rod 44 may comprise an elongated slot (not shown) in a side wall thereof to allow insertion of the second protective sleeve 70 in the position shown in Fig. 18.
[0082] Once the second protective sleeve 70 has been seated against the proximal end 132 of the implant stem 130, a piercing mechanism (not shown) can be inserted through the second channels 78 and 144 to prepare the bone 1 for the anti-rotation bone screw 20. As those skilled in the art will understand, in softer bone, pre-drilling may not be necessary. As would be understood by those skilled in the art, a drive mechanism (not shown) can then be used to insert the anti-rotation screw 20 through the second protective sleeve 70 and the implant stem 130 and into the bone 1. shield 70 and insertion tool 40 can then be removed from the body, leaving system 100 implanted in bone 1. Once implanted, the femoral head is prevented from rotating relative to bone 1 by means of the anti-rotation screw. 20 and bone plate 102. Stem 130 may migrate within a desired range relative to bone plate 102. Specifically, implant stem 130 and combined bone fixation element anti-rotation screw 20 inserted therethrough , are capable of migrating a distance x from the configuration of Figures 21 to 22 to the configuration of Figures 23 to 24. Those skilled in the art will understand that such migration of the implant stem 130 relative to the bone plate 102 minimizes the risk of central drilling of the implant stem 130 through the femoral head after implantation and as the bone heals.
[0083] It is observed that, although the exemplary method portrays the insertion of the bicortical screw 10 first, followed by the insertion of the anti-rotation screw 20, the order of insertion can be changed without deviating from the scope of the invention to suit, for example, a surgeon preference. For example, the insertion method for the 800 system, as described below, is directed at inserting an anti-rotation screw first, followed by a bicortical screw.
[0084] Figures 25 to 26 represent a system 200 according to a first alternative embodiment according to the invention. System 200 is formed substantially similarly to system 100, in that similar elements have been referenced with similar reference numerals. System 200 comprises a bone plate 102 and an implant stem 230. The implant stem 230 is formed substantially similar to the implant stem 130 with the exception of a reduced diameter distal portion 240. The implant stem 230 is extends from the proximal end 132 to the distal end 234. The reduced diameter distal portion 240 extends proximally from the distal end 134 a predetermined distance. As those skilled in the art will understand, the reduced diameter portion 240 reduces the amount of bone removal required to insert the implant stem 230 into the bone and has a wider spread between the distal end 234 of the implant stem 230 and the end Distal of Anti-Rotation Screw 20.
[0085] Figures 27 to 28 represent a system 300 according to a second alternative embodiment according to the invention. System 300 is formed substantially similarly to system 100 in that similar elements have been referenced with similar reference numerals. System 300 comprises a bone plate 102 and an implant stem 330 formed substantially similar to the implant stem 130, with the exception of a threaded distal portion 340. The implant stem 330 extends from a proximal end 132 to an end distal end 234 with the threaded distal portion 340 extending proximally from the distal end 134 a predetermined distance. As those skilled in the art will understand, the threaded distal portion 340 assists in retaining the implant stem 330 within bone 1.
[0086] Fig. 29 represents a system 400 according to a third alternative embodiment according to the invention. System 400 is formed substantially similarly to system 100 in that similar elements have been referenced with similar reference numerals. System 400 comprises a bone plate 102 and an implant stem 430. The implant stem 430 is formed substantially similar to the implant stem 130 with the exception of a position and angle of a channel 444 extending therethrough. . Specifically, channel 144 of system 100 extends from proximal end 132 to a distal opening 146 positioned in a cranial surface of the implant stem in an operative configuration. In contrast, channel 444 extends from proximal end 132 to a distal end 446 positioned on a caudal surface of implant stem 430 in an operative configuration. A groove geometry axis 448 of groove 444 is angled approximately -5° with respect to the central longitudinal axis 136. However, those skilled in the art will understand that such angle may vary as desired without departing from the scope of the invention.
[0087] Fig. 30 represents a system 500 according to a fourth alternative embodiment according to the invention. System 500 is formed substantially similarly to system 100 in that similar elements have been referenced with similar reference numerals. System 500 comprises a bone plate 102 and an implant stem 530 formed substantially similar to implant stem 130 with the exception of a position and angle of a groove 544 extending therethrough. Specifically, the channel 544 extends from the proximal end 132 to a distal end 546 positioned on a surface of the implant stem 530 which, in an operative configuration, faces one of an anterior and a posterior direction. A physician can determine which of the 100, 400 and 500 systems to use according to, for example, a size and location of a fracture in the bone, as those skilled in the art will understand.
[0088] Figures 31 to 33 represent a system 600 according to a fifth alternative embodiment according to the invention. System 600 is formed substantially similarly to system 100 in that similar elements have been referenced with similar reference numerals. System 600 comprises a bone plate 602 and implant stem 130, bone plate 602 being formed substantially similar to implant stem 130 with the exception of an additional locking hole extending therethrough. Specifically, bone plate 602 comprises a central longitudinal groove 118. A first locking hole 608 is positioned caudally of the central longitudinal groove 118 and is substantially similar to locking hole 108. A second locking hole 609 extends through the bone plate 602 cranially with respect to the central longitudinal channel 118. A hole axis 610 of the second locking hole is substantially parallel to the channel axis 120 of the central longitudinal channel 118 so that a bone fixation element 10' is inserted. through it does not cut any other portion of system 600.
[0089] An exemplary insertion method for system 600 is substantially similar to the method presented above with respect to system 100. However, once the first and second bone fixation elements 10, 20 have been inserted, a third sleeve drill bit 80 is inserted through insertion tool 40 to align with the second locking hole. A drilling mechanism (not shown) is inserted through the drill sleeve 80 and into the bone to define the trajectory of the bone fixation element 10'. A drive mechanism (not shown) is then inserted through drill sleeve 80 to screw bone fastener 10' into bone 1. Exemplary system 600 provides added structural support to bone 1 and may be particularly advantageous in bone with multiple fractures or otherwise weaker bones.
[0090] As shown in Fig. 34, systems 100, 200, 300, 400, 500 and 600 can be produced and packaged as a 700 kit, including bone plate 102, 602, implant stem 130, 230, 330 , 430, 530, and anti-rotation screw 20 along with instructions for implantation as described above. Implant stem 130, 230, 330, 430, 530 and anti-rotation screw 20 can be supplied in dimensions corresponding to each other. The kit can be sold in a variety of implant stem lengths to meet the requirements of a particular procedure. The bone fixation element 10 can be offered separately. Kit 700 may include a molded package 702 formed from plastic or other suitable material that has a removable seal 704 provided thereon, wherein the seal 704 maintains the sterility of the system.
[0091] Fig. 35 represents a single-use kit for the instruments required to complete a bone fixation procedure in accordance with the invention, as described above in relation to the exemplary method of use for system 100. A kit 750 of according to the invention may include the insertion tool 40, the corresponding removable rod portion 44 and the first and second protective sleeves 60, 70. In an operational configuration, the removable rod portion 44 is secured to an elongated rod 46 , which is additionally secured to the second protective sleeve 70 by means of a Y-connector. One side wall of the inserter 40 includes a slit (not shown) which allows insertion of the Y-connector beyond it. The removable rod portion 44 further comprises a tab 48 including a protruding distal end 49 which extends radially away from it. In an operational configuration, tab 48 is received through second opening 50 with a snap-in engagement. Specifically, tab 48 is deformed radially inward when it is inserted through the second opening 50. Once moved into it, tab 48 moves radially outward to assume its initial configuration, so that the protruding distal end 49 is received within a corresponding portion of the second opening 50, thus locking the stem portion 44 into the instrument 40. The insertion instrument 40 can be produced from a low cost plastic injection molding, while the protective sleeves 60, 70 and the stem portion 44 can be formed from an inexpensive metal injection molding. In another embodiment, the insertion tool 40 can be produced from standard parts (eg, standard tubing, etc.) connected to form the structure shown. Kit 750 may be sold as a single unit for use with any of the exemplary systems 100, 200, 300, 400, 500, 600, 800 shown herein.
[0092] Figures 36 to 50 represent a system 800 according to another alternative embodiment according to the invention. System 800 is formed substantially similar to system 100, in that similar elements have been referenced with similar reference numerals. System 800 comprises a bone plate 802 and an implant stem 830. The implant stem 830 is formed substantially similar to the implant stem 130, with the exception of the structural differences noted below.
[0093] The bone plate 802 comprises a first portion 804 shaped to engage an outer surface of the target portion of the femur along a first portion axis parallel to an axis of the femoral shaft and a second portion 806 that engages extends away from the first portion along a second portion geometric axis inclined relative to the first plane at an angle selected such that when the first portion is positioned over the target portion of the femur, a second portion geometric axis becomes extends along the geometric axis of the femoral neck. First portion 804 comprises a locking hole 808 that extends through plate 802 along a locking hole 810 axis that extends substantially perpendicular to a first portion axis. Lock hole 808 is formed substantially similar to locking hole 108 of system 100 and may include a multifaceted surface, such as thread 812, to threadably engage a corresponding thread in shank 12 of bone anchor 10 ( for example, a bone screw) inserted through it. An outer surface of the first portion 804 is substantially rounded so that the first portion 804 has a smooth outer profile substantially corresponding to that of the target portion of the femur. The outer surface of first portion 804 further comprises one or more recesses 805 configured and sized to allow gripping of bone plate 802 by insertion tool 40, as will be described in more detail below in connection with the exemplary method. Recess 805 may extend substantially parallel to a geometric axis of first portion 804. In an exemplary embodiment, first and second recesses 805 may be provided on opposing walls of first portion 804 to allow gripping of bone plate 802 The dimensions of each of the recesses can be selected to fit the dimensions of a gripping portion of the implant retainer
[0094] The second portion 806 is substantially cylindrical and extends from the first portion 804 to a distal end 816. An elongated central channel 818 extends through the second portion along a second geometric axis of portion 820. An outer surface of the channel 818 is substantially smooth, with the exception of a strut 822 adjacent the distal end 816. The strut 822 extends radially into the channel 818 for a predetermined distance and is delimited on both sides by grooves 824. extends proximally from the distal end 816 of the second portion. In an exemplary embodiment, cutout 826 is substantially rectangular with rounded corners and is open at distal end 816. Cutout 826 is positioned so that, in an operative configuration, the cutout faces a cranial direction. The dimensions of cutout 826 can be selected to allow the anti-rotation screw 80 to extend therefrom, as shown in Figures 35 and 45 to 46. That is, cutout 826 avoids the need to advance the implant stem 830 outward of bone plate 102 beyond a threshold distance. Instead, in smaller bones, the implant stem 830 may extend outward from the bone plate 802 only the minimum distance required, whereby a distal end 846 of the second channel 844 is housed within the second portion 806. In the operational configuration, anti-rotation screw 80 can be inserted through implant stem 830 to extend out of cutout 826. As those skilled in the art will understand, cutout 826 can be formed in any length to allow use of system 800 in bone which has varied dimensions. Additionally, for use on longer bones, cutout 826 may optionally be omitted. Additionally, cutout 826 allows the implant stem 830 to telescopically move relative to bone plate 802.
[0095] The second portion 806 further comprises the first and second recesses 828 provided in the opposite walls adjacent to a proximal end of the channel 818. The first and second recesses are configured and sized to allow the insertion of a corresponding portion of a locking core therethrough to guide the insertion of the bone plate 802 over the bone, as will be described in more detail below.
[0096] The implant stem 830 is formed as a substantially elongated cylindrical member extending from a proximal end 832 to a substantially blunt distal end 834 along a central longitudinal axis 836. An outer surface of the stem of implant 830 comprises an elongated cutout 838 extending from a proximal end 839 to a distal end 834, wherein the cutout 838 is shaped to match the shape of strut 822 and grooves 824 to allow engagement therebetween. As described in greater detail in connection with system 100, this engagement prevents rotation of rod 830 relative to plate 802. As those skilled in the art will understand, engagement of strut 822 with proximal end 839 of cutout 838 prevents rod 130 from extends distally away from plate 802, defining a maximum extent through which rod 830 can be inserted into bone. Additionally, due to the hemispherical shape of the cutout 838, a rotational force applied to the implant stem 830 after implantation is converted to a substantially perpendicular moment arm, which prevents the implant stem 830 from behaving like a wedge against the walls of the second portion 806. Preventing the wedge behavior of the implant stem 830 also prevents high frictional forces that can influence the ability of the implant stem 830 to move telescopically relative to the plate 802.
[0097] The implant stem 830 comprises a first channel 842 extending longitudinally therethrough from the proximal end 832 to the distal end 834 in alignment with a central longitudinal axis 836. The first channel 842 is sized to receive a wire. guide (eg, a Kirschner wire) through it to guide the insertion of the 830 Implant Stem into the bone. The implant stem 830 further comprises a second channel 844 extending therethrough along a geometric axis 848 from the proximal end 132 to a distal opening 846 in a side wall of the implant stem 830, the distal opening being the 846 is circumferentially separate from cutout 838. Distal opening 846 is substantially oval to allow a shank 82 of an anti-rotation screw 80 to be inserted therethrough to exit it. Similar to distal opening 146, distal opening 846 is oval due to an oblique position of the second substantially circular groove 844 relative to the implant stem 830. The proximal end of the second groove 844 includes threads 850 to threadably engage the thread formed in the rod 82 of anti-rotation screw 80, as described in more detail below. While thread 150 of implant stem 130 is substantially tapered, thread 850 is substantially cylindrical.
[0098] The anti-rotation screw 80 extends from a head 84 at a proximal end and along the shank 82 to a distal end 86. The shank 82 includes a first portion 88 that has a first outside diameter selected to allow engagement with the thread 850 of implant stem 830. Specifically, first portion 88 includes a first threaded region 89, including a two-threaded thread to assist in engaging the same with thread 850. First portion 88 also includes a non-tapered region. threaded 90 shaped to allow telescopic movement of the anti-rotation screw 80 when inserted in a target orientation in the bone. First portion 88 preferably has a substantially tapered shape that corresponds to a tapered shape of second channel 844. A second unthreaded portion 92 extends distally from first portion 88. A diameter of second portion 92 is greater than a diameter of tapered portion 90, forming a telescoping lock 94 at a junction thereof. In an operative configuration, the second portion 92 extends outward from the implant stem 830 and into the bone. A third threaded portion 96 extends distally from the second unthreaded portion 94 and includes the single threaded sponge threading configured to engage the bone in an operative configuration, as will be described in more detail in connection with the exemplary method below. As those skilled in the art will understand, the two-thread thread of the first threaded region 89 corresponds to a gap of the single-thread thread of the third portion 96. In another embodiment, a larger gap of the thread in the third threaded portion 96 can be used to facilitate the compression of the femoral head on the stem 82.
[0099] An exemplary method of using the bone fixation system 800 is substantially similar to the method of using system 100 described in detail above in relation to Figures 11 to 20. Specifically, once the fractured bone 30 has been provisionally placed on a corrected alignment and an incision has been made, one or more guidewires are inserted into a center of the femoral head at a desired angle until a distal end of the guidewire extends into the subchondral bone, as those skilled in the art will understand. A known reamer device (not shown) is then guided over the guidewire to widen a hole hole for insertion of an implant in accordance with the invention. Implant stem 830 is then inserted through channel 818 of second portion 806 of bone plate 802 until engagement of strut 822 with proximal end 839 of cutout 838 prevents further distal movement of implant stem 830. 802 and implant stem 830 are then secured to insertion tool 40, including an arm portion 42 and an elongated stem portion 44, a distal end 46 from which releasably secures recesses 805 of bone plate 802 Once bone plate 802 has been secured to insertion tool 40, an impactor can be inserted through bone plate 802 and implant stem 830 to impact system 800 into bone. The impactor (not shown) and guidewire (not shown) can then be removed from the bone, leaving insertion tool 40 and system 800 positioned in the bone.
[00100] As shown in Figures 48 to 49, the second protective sleeve 70 is then inserted through the second opening 50 and through the elongated shaft 44 until a distal end thereof is seated against the implant shaft 830. A piercing mechanism (not shown) can be inserted through second channels 78 and 844 to prepare bone 1 for anti-rotation bone screw 80. As those skilled in the art will appreciate, in softer bone, pre-drilling may not be necessary. As will be understood by those skilled in the art, a drive mechanism (not shown) can then be used to insert the anti-rotation screw 80 through the second protective sleeve 70 and implant stem 830 and into bone 1. The second protective sleeve 70 and insertion tool 40 can then be removed from the frame, leaving system 800 implanted in bone 1. Once implanted, the femoral head is prevented from rotating relative to bone 1 by means of the anti-rotation screw 80 and the end plate. bone 802.
[00101] As shown in Fig. 50, the first protective sleeve 60 is then inserted through the first opening 48 in the insertion tool 40 to guide the drilling of a hole in the bone 1 to allow the insertion of the bone fixation element 10 (ie a bicortical shank screw) there. Specifically, a drilling mechanism known in the art can be inserted through the first protective sleeve 60 to drill an opening through the locking hole 808 of the bone plate 802 and into the bone 1. The drilling mechanism can then be removed and the Bone fixation element 10 can be inserted through the first protective sleeve 60 and bone plate 802 and into bone 1.
[00102] Figures 51 to 52 show a system 900 according to yet another embodiment of the invention. System 900 is formed substantially similar to system 800 and includes a bone plate 902 having first and second portions 904, 906 and an implant stem 930 with one or more elastic deflection structures at a distal end thereof. . Implant stem 930 includes an elongated channel 942 that extends therethrough from a proximal end (not shown) to a distal end 934. A second channel 944 extends therethrough at an angle relative to a central longitudinal axis of the implant. even to house the anti-rotation screw 80, as described in greater detail in relation to previous modalities. Implant stem 930 further comprises a plurality of elongated slots 950 extending proximally from distal end 934 and terminating in a substantially circular cutout at proximal ends 952. In an exemplary embodiment, implant stem 930 may include two slots 950 provided in opposing walls of implant stem 930 to define two malleable arms 954. Note, however, that any number of slots 950 may be provided without departing from the scope of the invention. As those skilled in the art will understand, the malleable arms 954 increase an overall elasticity of the implant stem 930 by distributing a maximum load applied to the distal end 934, allowing the stem 930 to deform rather than fracture when subjected to excessive loads. By allowing deformation of the Implant Stem 930, the pliable arms 954 prevent inadvertent penetration of the Implant Stem 930 through bone, as those skilled in the art will understand.
[00103] Fig. 53 represents a system 1000, according to another embodiment of the invention. System 1000 represents an implant stem 1030 formed substantially similar to the implant stems 130, 830 described above. However, rather than being inserted through a bone plate, the implant stem 1030 is insertable through an intramedullary nail 1002. The intramedullary pin 1002 includes a transverse opening 1004 that extends therethrough, with the transverse opening 1004 it has a shape formed by the first and second overlapping circular channels 1006, 1008. The first circular channel 1006 is configured to allow insertion of the implant stem 1030 therethrough and extends through the intramedullary nail 1002 at a first angle. The second circular channel 1008 is open to the first circular channel and extends through the intramedullary nail 1002 at a second angle different than the first angle. Specifically, an angle of the second circular groove 1008 substantially corresponds to an angle of the second groove 144 relative to the first groove 142 of the implant stem 1030. In this way, the anti-rotation screw 80 inserted through the second groove 144 is guided through the second groove 1008 and outward from an opposite wall of intramedullary nail 1002.
[00104] An outer wall of the implant stem 1030 may include a cutout 1038 configured to engage a respectively shaped strut (not shown) provided in the first channel 1006. The engagement of the strut (not shown) with the cutout 1038 prevents rotation of the stem of implant 1030 with respect to transverse opening 1004. Additionally, engagement of the strut (not shown) with a proximal end 1039 of cutout 1038 limits an insertion depth of implant stem 1030 into bone, as described in greater detail in prior embodiments. .
[00105] Figures 54 to 56 represent an implant stem 1130 according to yet another embodiment according to the invention. Implant stem 1130 is formed substantially similar to implant stems 130, 830 except as noted hereinafter. Implant Stem 1130 can be used with any of the bone plates 102, 602, 802, 902 and intramedullary nails 1002 discussed above. Implant stem 1130 is formed as a substantially elongated cylindrical member extending from a proximal end 1132 to a substantially blunt distal end 1134 along a central longitudinal axis 1136. An outer surface of implant stem 1130 comprises an elongated cutout 1138 extending from a proximal end 1139 to a distal end 1134, with cutout 1138 being formed substantially similar to cutout 838. However, unlike previous embodiments, implant stem 1130 does not comprise a central longitudinal channel that extends through it. Instead, implant stem 1130 comprises only a channel 1144 extending therethrough along a geometric axis 1148 from proximal end 1132 to a distal opening 1146 in a side wall of implant stem 1130 for receiving, for example , an anti-rotation screw (not shown) through it. Consequently, unlike previous embodiments, which can optionally be guided into bone over a pre-positioned guidewire, the exemplary implant stem 1130 can be inserted into bone after removing the guidewire therefrom. That is, the implant stem 1130 can be guided into the bone through a pre-drilled hole therein.
[00106] Although the invention and its advantages have been described in detail, it should be understood that various changes, substitutions and alterations can be made in this document without departing from the spirit and scope of the invention as defined by the appended claims. For example, any of the implant stems and bone plates presented herein may be optionally coated with Diamond-Like Carbon (DLC) to prevent osseointegration thereof, as those skilled in the art will understand, and/ or to reduce friction and therefore improve telescoping between the bone plate and the implant stem. In addition, the scope of this application is not intended to be limited to the specific modalities of the process, machine, fabrication and substance composition, means, methods and steps described in the descriptive report. As will be readily understood by the person skilled in the art from the description of the present invention, processes, machines, fabrication, composition of substance, means, methods or steps presently existing or to be developed later and which substantially perform the same function or which substantially achieve the same result as the corresponding embodiments described herein can be used in accordance with the present invention.
[00107] Figures 57 to 62 represent a kit 1200 according to another embodiment of the invention, as required to complete a bone fixation procedure. Kit 1200 is formed substantially similar to kit 750 described above, with like elements being referenced with like reference numerals. However, while the 750 kit is configured for single use, the 1200 kit can be used any number of times to perform multiple procedures. Note that kit 1200 can also be configured for single use without departing from the scope of the invention. Additionally, while the removable rod portion 44 of the kit 750 engages instrument 40 with a click/push-in engagement, a removable rod portion 1250 of the kit 1200 engages an instrument 1240 with a threaded engagement, as will be described in greater detail hereinafter in this document. Note, however, that kit 1200 may also employ the snap-fit engagement of kit 750 without departing from the scope of the invention. Kit 1200 in accordance with the invention includes an insertion tool 1240 which extends from a proximal end 1242, including a curved arm 1244, to a distal end 1246. A first opening 1247 extends through the arm 1244 to guide the first sleeve protection 60 through it, as will be described in more detail in relation to the exemplary method below. A second opening 1248 extends to the proximal end 1242, allowing insertion of the removable rod portion 1250 therein. The instrument 1240 also comprises an elongated slot 1249 in a side wall thereof to accommodate the width of the shank portion 1250 when inserted therein.
Removable rod portion 1250 includes a first elongated rod portion 1252 extending from a first proximal end 1254 to a distal end 1256 and including a first channel 1258 extending therethrough. In an operational configuration, a longitudinal axis 1260 of first channel 1258 is substantially aligned with longitudinal axis 136 of implant stem 130. Removable stem portion 1250 further comprises a substantially substantially shaped second elongate stem portion 1262 similar to the second protective sleeve 70 and extending from a second proximal end 1264 to the distal end 1256. A second channel 1268 extends through the second stem portion 1262 along a longitudinal axis 1270 offset from the longitudinal axis 1260 at approximately 7.5° to align with the geometric axis 148 of the implant stem 130, as described in greater detail with respect to previous embodiments. The first and second elongated rod portions 1252, 1262 extend to a common distal end 1256 by means of a connecting element 1280. Connecting element 1280 in accordance with this embodiment comprises an elongated slit 1282 extending through a side wall thereof to allow insertion of the anti-rotation screw 20 therethrough and through the implant 130 to extend into the bone, as will be described in greater detail in relation to the exemplary method below.
[00109] The first elongated rod portion 1252 includes a locking element 1284 at the first proximal end 1254. The locking element 1284 includes a threaded portion 1286 and a screw 1288 that can be rotated (e.g., manually by a user) to screw threaded portion 1286 into a corresponding threaded region (not shown) provided within opening 1248 of instrument 1240. Specifically, rotation of screw 1288 rotates the entire first elongated rod portion 1252 with respect to connecting element 1280. of the invention, the first elongated rod portion 1252 is removably secured to the connecting element 1280. In another embodiment, the first elongated rod portion 1252 is permanently secured to the connecting element 1280 and axially movable with respect to the even within a predetermined range of motion that corresponds to an axial length of the threaded portion 1286 to allow for threading and unthreading. using it in the instrument 1240, as those skilled in the art will understand. The second elongated rod portion 1262 may also be permanently or removably attached to the connecting element 1280, as those skilled in the art will appreciate.
[00110] According to an exemplary method according to the invention, a patient is placed in a supine position on an operating table and a fractured femur is provisionally placed in a corrected alignment by means of one or more of traction, abduction and internal rotation, as will be understood by those skilled in the art. An incision is formed in the skin and the bone is pulled apart to create a hole hole for insertion of an implant in accordance with the invention. Assembled bone plate 102 and implant stem 130 are then secured to insertion tool 1240 by sliding engagement between distal end 1246 and a proximal end of bone plate 102, as described in greater detail in earlier embodiments. Removable rod portion 1250 is then inserted into opening 1248 so that distal end 1256 extends adjacent distal end 1246 of instrument 1240, as shown in Fig. 58. Screw 1288 is then rotated to actuate, by threading, the first elongated rod portion 1252 on instrument 1240 and in threaded engagement with a threaded portion (not shown) of opening 1248. Locking element 1284 is configured so that when screw 1288 contacts an outer surface of instrument 1240 , the first elongated rod portion 1252 is locked against rotation or axial movement relative to the instrument 1240.
[00111] Once the shank portion 1250 has been locked into the instrument 1240, and the bone fixation system 100 is inserted into the bone, a piercing mechanism (not shown) can be inserted through the channel 1270 to prepare the bone for anti-rotation bone screw 20. As those skilled in the art will understand, in softer bone, pre-drilling may not be necessary. A drive mechanism (not shown) can then be used to insert the anti-rotation screw 20 through the second elongated shank portion 1262 and the implant shank 130 and into the bone, as shown in Figures 59 and 60. In the implanted configuration, one end The distal end of the anti-rotation screw 20 is separated from a distal end of the implant stem 130 by approximately 5 mm. As shown in Figures 61 to 63, the first protective sleeve 60 is then inserted through the first opening 1247 in the insertion tool 1240. As described in greater detail in the previous embodiments, the first protective sleeve 60 extends through the first opening 1247 and into the distal end 46 of the insertion instrument 40 at a predetermined angle relative to the angle of the first elongated rod portion 1252 (e.g., 45°, etc.) until a distal end thereof is in contact with the orifice. locking 108, as shown in the partial cutaway view of Fig. 62. An optional piercing mechanism known in the art can be inserted through the first protective sleeve 60 to pierce an opening through the locking hole 108 of the bone plate 102 and into of the bone. The piercing mechanism can then be removed and the bone fixation element 10 can be inserted through the first protective sleeve 60 and bone plate 102 and into bone 1. The first protective sleeve 60 and instrument 1240 can be then removed, leaving the system 100 implanted in the bone. Note that although the exemplary method depicts the insertion of the anti-rotation screw 20 followed by the bicortical screw 10 first, the order of insertion can be changed without departing from the scope of the invention to follow, for example, the surgeon's preference. Additionally, although kit 1200 is described in relation to system 100, kit 1200 can be employed with any of the systems 200, 300, 400, 500, 600, 800 disclosed herein.
[00112] A method for implanting a bone fixation device into a bone according to the invention comprises the steps of: engaging a distal end of a guide assembly to a proximal end of a bone fixation device such that a the first portion of the guide assembly having an elongate channel extending therethrough is coaxial with a longitudinal axis of the bone fixation device, the first portion extending from a proximal end to a distal end; inserting an elongated rod portion through the elongated channel, wherein the elongated rod portion includes a first protective sleeve; inserting the bone fixation device into a bone rod such that a first portion of the bone plate is positioned on an outer surface of the bone and a second portion of the bone plate is received within the bone; and inserting an anti-rotation screw through the first protective sleeve until a shank of the anti-rotation screw extends out of the bone fixation device at an angle offset from the longitudinal axis of the bone fixation device. The implanted anti-rotation screw is displaced in relation to the longitudinal geometric axis of the bone fixation device by approximately 5°. The method may further comprise the step of inserting a second protective sleeve through an opening formed in a second portion of the guide assembly and inserting a locking thread through the second protective sleeve and the bone fixation device and into of the bone.
[00113] It will be understood by those skilled in the art that various modifications and alterations of the invention can be made without departing from the broad scope of the appended claims. Some of these have been discussed above and others will be evident to those skilled in the art.

权利要求:
Claims (16)
[0001]
1. Device for implanting a bone fixation system, characterized in that it comprises: an insertion instrument (40) including an arm (42) and a rod (44) coupled to the arm (42), the rod ( 44) extending from a proximal end to a distal end (46), the distal end (46) having an engaging portion for releasably engaging a proximal end of a bone plate (102); that the arm (42) has an elongated channel extending therethrough along a longitudinal axis of the channel to allow insertion of a first protective sleeve (60) therethrough, wherein the longitudinal axis of the channel is coaxial. with a longitudinal axis of a first opening extending through the bone plate (102) and wherein the longitudinal axis of the channel is angled relative to a longitudinal axis of the shank (44); a first protective sleeve (60) insertable through the elongated channel and into a distal portion of the insertion tool (40); and a second protective sleeve (70) insertable through the insertion tool (40) along the stem (44), the second protective sleeve (70) including a first channel (74) and a second channel (78) configured to guide the insertion of an anti-rotation screw (20) therethrough and through the bone plate (102), with a longitudinal axis of the first groove of the second protective sleeve (70) being at an angle to a longitudinal axis (77 ) of the second channel (78) of the second protective sleeve (70).
[0002]
2. Device according to claim 1, characterized in that the first channel (74) of the second protection sleeve (70) and the second channel (78) of the second protection sleeve (70) cover an angle of one among 5th, 6th, 7.5° and 8th.
[0003]
3. Device according to claim 1, characterized in that the first and second channels (74, 78) of the second protective sleeve (70) cover an angle greater than 5°.
[0004]
4. Device according to claim 1, characterized in that the second channel (78) of the second protective sleeve (70) is configured to guide the insertion of a locking screw through it and into a second opening in the bone plate (102).
[0005]
5. Device according to claim 4, characterized in that the second protective sleeve (70) and the elongated channel cover an angle of approximately 45°.
[0006]
6. Device according to claim 4, characterized in that the arm (42) includes an opening (50) extending therethrough to guide the insertion of the second protective sleeve (70).
[0007]
7. Device according to claim 1, characterized in that the second protective sleeve (70) is insertable through the rod (44).
[0008]
8. Device according to claim 7, characterized in that a proximal end of the rod (44) includes a locking mechanism for lockingly engaging the insertion tool (40).
[0009]
9. Device according to claim 8, characterized in that the locking mechanism includes a flap (48) that can be flexed configured to engage a corresponding opening formed in the insertion tool (40) with a snap fit.
[0010]
10. Device according to claim 7, characterized in that the rod (44) is connected to the second protective sleeve (70) through a Y-connector.
[0011]
11. Device according to claim 1, characterized in that a side wall of the inserter (40) includes an elongated slit open to the elongated channel, the slit allowing insertion of the Y-connector beyond it. .
[0012]
12. Device according to claim 1, characterized in that the device is a set of single use.
[0013]
13. Device according to claim 1, characterized in that the device can be used to perform a plurality of procedures.
[0014]
14. Sighting instrument (1240) for guiding the insertion of a bone fixation device (102) into a bone, characterized in that it comprises: a sighting arm (1244), including a first portion and a second portion, the first portion extending from a proximal end to a distal end (1246) and having an elongated channel extending therethrough, the distal end (1246) having an engaging portion that engages so removable a proximal end of the bone fixation device (102), wherein a sidewall of the sight arm (1244) includes an elongated slit open to the elongated channel; and an elongate element (1250) removably insertable into the elongated channel, the elongate element (1250) having a first stem portion (1252) and a second stem portion (1262), wherein the the first rod portion (1252) is inserted into the elongated channel and lockingly engages the sight arm (1244), wherein the second rod portion (1262) extends through the elongated slot and has an opening extending therethrough. them to guide the insertion of an anti-rotation screw (20) therethrough and into the bone fixation device (102).
[0015]
15. Sighting instrument (1240) according to claim 14, characterized in that the second portion includes an opening (1247) extending therethrough, an opening opening geometric axis being angled at relation to a geometric axis of the elongated channel.
[0016]
16. Sighting instrument (1240) according to claim 15, characterized in that it further comprises a protective sleeve (60) that can be inserted through the opening (1247) towards the distal end (1246) of the second portion, such that a distal end of the protective sleeve (60) is positioned adjacent a proximal end of the bone fixation device (102).

类似技术:

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公开号 | 公开日 | 专利标题

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BR112014012012B1|2021-06-01|DEVICE TO DEPLOY A BONE FIXATION SYSTEM AND SIGHTING INSTRUMENT TO GUIDE THE INSERTION OF A BONE FIXATION DEVICE INTO A BONE

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法律状态:
2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

---

2019-11-05| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2020-10-20| B06A| Patent application procedure suspended [chapter 6.1 patent gazette]|

---

2021-03-23| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

---

2021-06-01| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 19/11/2012, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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US201161561439P| true| 2011-11-18|2011-11-18|

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US61/561,439|2011-11-18|

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US201261692053P| true| 2012-08-22|2012-08-22|

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US61/692,053|2012-08-22|

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PCT/CN2012/001563|WO2013071701A1|2011-11-18|2012-11-19|Femoral neck fracture implant|

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