One way sliding device for intramedullary intertrochanteric fixation implants

<u>Field of the Invention</u>

0001The present invention relates to devices for treating fractures of long bones and, in particular, to internal fixation devices.

<u>Background</u>

0002Fractures commonly occur in the femur, for example in the femoral neck, intertrochanteric and peritrochanteric regions. Such fractures may be fixed with an intramedullary device and an implant. As is understood by those skilled in the art, the intramedullary device (e.g., an intramedullary nail) is positioned in the medullary canal of a long bone such as the femur. An implant, which may be formed as a helical blade or a lag screw, may then be inserted laterally through bone to pass through an opening of the intramedullary device until a free end of the implant enters the head of the bone. For example, where the bone is a femur, the implant passes through the shaft of the femur, through the intramedullary device and into the femoral head via the neck of the femur to secure the femoral head to a remaining portion of the femur. After implantation, such an implant may move laterally relative to the intramedullary nail along the path over which it was inserted. Some lateral movement of the implant is expected. However, in some cases, the implant may migrate medially through the intramedullary device, resulting in a protrusion through the femoral head and into the acetebulum causing complications.

0003<patcit id="pcit0001" dnum="EP1547534A2"><text>EP 1 547 534 A2</text></patcit> discloses an intramedullary nail to be inserted into a medullary canal of a femur. The nail comprises an oblique opening for slidably receiving a bone fastener. The bone fastener is secured in the opening in order to prevent medial movement of the bone fastener by means of an engaging member which is axially inserted into the intramedullary nail and tightened by an adjusting member.

0004<patcit id="pcit0002" dnum="WO03032852A2"><text>WO 03/032852 A2</text></patcit> discloses an intramedullary nail system comprising an intramedullary nail and a compression screw. The compression screw is inserted into an opening through the nail. In order to prevent medial movement of the screw, a sleeve is provided over the screw in the opening which is secured by means of a sleeve lock engaging the sleeve via locking tabs.

0005The intramedullary nail disclosed in <patcit id="pcit0003" dnum="WO2007038560A1"><text>WO 2007/038560 A1</text></patcit> also includes an oblique opening to receive an implant. In order to prevent the implant from moving medially, serrations on the shank of the implant may be provided which engage a pin received in a cavity in the intramedullary nail.

0006Equally, <patcit id="pcit0004" dnum="WO2008064059A2"><text>WO 2008/064059 A2</text></patcit> discloses an intramedullary nail for insertion into the canal of the femur. A bone fastener and a sliding sleeve are inserted into an opening extending through the intramedullary nail. In order to prevent movement of the sleeve, a set screw is axially inserted into the intramedullary nail to engage the sleeve.

<u>Summary of the Invention</u>

0007The present invention is directed to a device for treating fractures as defined in claim 1.

<u>Brief Description of the Drawings</u>

0008<ul id="ul0001" list-style="none" compact="compact"><li><figref idref="f0001">Fig. 1</figref> shows a side view of a device according to a first exemplary embodiment of the invention;</li><li><figref idref="f0002">Fig. 2</figref> shows a side view of a distal facing surface of an implant of the device of <figref idref="f0001">Fig. 1</figref>;</li><li><figref idref="f0002">Fig. 3a</figref> shows a perspective view of a locking mechanism of the device of <figref idref="f0001">Fig. 1</figref>;</li><li><figref idref="f0003">Fig. 3b</figref> shows a perspective view of a locking mechanism and an intramedullary device according to an alternate embodiment of the present invention;</li><li><figref idref="f0003">Fig, 3c</figref> shows a perspective view of the locking mechanism of <figref idref="f0003">Fig. 3b</figref>;</li><li><figref idref="f0004">Fig. 4</figref> shows a side view of an intramedullary nail and the locking mechanism the device of <figref idref="f0001">Fig. 1</figref>, in a first configuration;</li><li><figref idref="f0004">Fig. 5</figref> shows a perspective view of the intramedullary nail and the locking mechanism of <figref idref="f0004">Fig. 4</figref>;</li><li><figref idref="f0005">Fig. 6</figref> shows a side view of the intramedullary nail and the locking mechanism of the device of <figref idref="f0001">Fig 1</figref>, in a second configuration;</li><li><figref idref="f0005">Fig. 7</figref> shows a perspective view of the intramedullary nail and the locking mechanism of <figref idref="f0005">Fig. 6</figref>;</li><li><figref idref="f0006">Fig. 8</figref> shows a perspective view of the device of <figref idref="f0001">Fig. 1</figref>;</li><li><figref idref="f0006">Fig. 9</figref> shows a side view of the device of <figref idref="f0001">Fig. 1</figref>;</li><li><figref idref="f0007">Fig. 10</figref> shows an opposite side view of <figref idref="f0006">Fig. 9</figref>;</li><li><figref idref="f0007">Fig. 11</figref> shows a lateral cross-section of the device of <figref idref="f0001">Fig. 1</figref>;</li></ul>

<u>Detailed Description</u>

0009The present invention may be further understood with reference to the following description and the appended drawings, wherein like elements are referred to with the same reference numerals. The present invention relates to devices for treating fractures of long bones and, in particular, to internal fixation devices. It is noted that although exemplary embodiments of the present invention are described below with respect to the treatment of fractures of the femur, the invention is not intended to limit the application of the invention to such fractures, as the invention may also be employed in the treatment of other fractures such as, for example, the humerus, tibia, etc. It should also be noted that the terms distal and proximal, used herein, refer to a direction toward (proximal) and away from (distal) a user of the device. As indicated above, fractures of long bones, particularly fractures in which a break is formed between a trochanteric head and a shaft of the bone, may be treated by implanting an intramedullary device along an axis of the shaft of the bone (i.e., in the medullary canal). An implant may then be inserted laterally through the bone to pass through the intramedullary device into the trochanteric head. Devices according to the present invention are designed to permit a desired degree of migration of the implant back toward the point through which it was inserted into the bone (i.e., lateral migration) while minimizing migration of the implant further into the trochanteric head toward the acetebulum (i.e., medial migration).

0010As shown in <figref idref="f0001 f0002 f0003 f0004 f0005 f0006 f0007">Figs. 1 - 11</figref>, a device 100 according to an exemplary embodiment of the present invention comprises an implant 102 and an intramedullary nail 104 including a locking mechanism 106 (e.g., a ratchet mechanism) permitting limited migration of the implant 102 through the nail 104 laterally while preventing medial migration. As shown in <figref idref="f0001">Fig. 1</figref>, an oblique opening 108 extending through the nail 104 in a plane substantially perpendicular to a longitudinal axis of the nail 104. The opening 108 is sized to receive the implant 102 therethrough. A channel 110 extending through a portion of the nail 104 along the longitudinal axis opens to the opening 108 houses the locking mechanism 106. In the embodiment shown, the channel 110 and the locking mechanism 106 extend distally of the opening 108 so that the locking mechanism 106 engages a distal side of the implant 102 when the implant 102 is inserted through the oblique opening 108. Those skilled in the art will understand that the channel 110 and the locking mechanism 106 may alternatively be located on the proximal side of the implant 102. The locking mechanism 106 includes a biasing member 140 (e.g., a spring) engaging a pawl member 105 to urge the pawl member 105 into contact with the implant 102.

0011As shown in <figref idref="f0002">Fig. 2</figref>, a distal facing surface of a locking engaging portion of the implant 102 which, when assembled in a desired configuration, overlaps with the channel 110 includes features for engaging corresponding structures of the pawl member 105. Specifically, the implant 102 comprises a shaft 112 extending from a proximal end 114 to a distal end (not shown) coupled to the proximal end of a blade or other bone engaging structure (not shown). As would be understood by those skilled in the art, the bone engaging structure may be formed as a helical blade extending distally from the distal end of the shaft 112. It will be understood by those of skill in the art however, that the bone engaging structure may be any other fixation means such as, for example, a lag screw.

0012The locking engaging portion of the shaft 112 includes a plurality of abutting structures 116 spaced from one another along a portion of a length of the shaft 112. Each of the abutting structures 116 includes a ramped surface 117 extending from a position adjacent to a radially inner end of the abutting structure 116 immediately distal thereto and angling gradually outward to an abutting surface 119. As would be understood by those of skill in the art, the abutting surfaces 119 of the abutting structures 116 may extend substantially perpendicular to a longitudinal axis of the implant 102.

0013As shown in <figref idref="f0002">Fig. 3a</figref>, the pawl member 105 includes an implant engaging surface 130 angled to substantially align with an angle of the opening 108. A pawl 126 including a proximally facing abutting surface 127 extends out from the surface 130 so that, when in an operational position, the abutting surface 127 of the pawl 126 engages an abutting surface 119 of one of the abutting structures 116 of the implant 102. Thus, engagement between the pawl 126 and the abutting structure 116 of the shaft 112 prevents movement of the implant 102 medially relative to the nail 104. However, the implant 102 may slide laterally as the angled distal surface of the pawl 126 and the angled surfaces 117 of the abutting structures 116 allow the shaft 112 to slide laterally over the pawl member 105. A protrusion 128 including a ramped surface 134 extends outward from the implant engaging surface 130 by a distance greater than the pawl 126 so that, during insertion of the implant 102 through the opening 108, contact between the shaft 112 and the protrusion 128 moves the locking engaging portion of the shaft 112 out of contact with the pawl 126 until the implant 102 has been advanced to a desired position in the bone. When in the desired position, the implant 102 is rotated about its longitudinal axis to a locking orientation in which the protrusion 128 aligns with and enters a groove 118 formed in the shaft 112. At this point, the abutting structures 116 of the shaft 112 and the pawl 126 are aligned with one another so that, as the implant 102 moves toward the pawl member 105 due to the insertion of the protrusion 128 into the groove 118, the pawl 126 engages one of the abutting structures 116 corresponding to the desired medial-most position of the implant 102. As described above, engagement between the abutting surface 127 of the pawl 126 and the abutting surface 119 of the abutting structure 116 prevents further medial migration of the implant 102. This contact between the pawl member 126 and the corresponding abutting structure 116 is maintained by the biasing member 140 which urges the pawl member 105 toward the shaft 112 at all times.

0014To ensure that the locking mechanism 106 does not move beyond the first and the second configuration, the locking mechanism 106 may also include an elongated hole 124 extending laterally through the locking mechanism 106, distally of the shoulder 122, for receiving a pin (not shown) which fixes the locking mechanism 106 to the intramedullary nail 104. Thus, the intramedullary nail 104 also includes a hole 136 extending laterally therethrough, distally of the oblique opening 108 such that the position of the hole 136 corresponds to a position of the elongated hole 124. The hole 136 may be substantially circular such that the intramedullary nail 104 remains stationary while the locking mechanism 106 moves relative to the intramedullary nail 104 along the longitudinal axis. It will be understood by those of skill in the art that the pin inserted through the holes 124, 136 fixes the locking mechanism 106 to the intramedullary nail 104 such that the locking mechanism 106 and the intramedullary nail 104 may not rotate relative to one another, but may move between the first configuration and the second configuration along the longitudinal axis of the intramedullary nail 104.

0015In an alternative embodiment, as shown in <figref idref="f0003">Figs. 3b - 3c</figref>, a locking mechanism 106' may include a pawl member 105' formed with a recess 124' rather than an elongate hole for fixing the locking mechanism 106' within an intramedullary nail 104'. The recess 124' may be fixed within the intramedullary nail 104' via a pin 137' that is inserted into the intramedullary nail 104' and the recess 124'. The locking mechanism 106' is substantially similar to the locking mechanism 106 and may be used in the device 100 in substantially the same manner. The recess 124' may be formed on an outer surface 125' of the pawl member 105' and may include a first portion 142', a second portion 144' and a third portion 146'. The first portion 142' extends longitudinally along a portion of the outer surface 125' from an edge 156' of the pawl member 105' to a proximal end 148' of the first portion 142'. The second portion 144' extends substantially horizontally along a portion of the outer surface 125' from the proximal end 148' of the first portion 142' to an opposite end 150'. The third portion 146' extends from the end 150' longitudinally along the outer surface 140' in a distal direction. The first portion 142', the second portion 144' and the 146' are connected such that they form a single continuous recess 124'.

0016The intramedullary nail 104' includes a hole 136' extending laterally through one side of the intramedullary nail 104', distally of an oblique opening 108' such that a positioning of the hole 136' corresponds to position of the recess 124'. The hole 136' is adapted and configured to receive the pin 137' therethrough. A length of the pin 137' may be slightly longer than a thickness of the intramedullary nail 104'. The thickness is determined by a distance from an outer surface 109' of the intramedullary nail 104' to a channel 110' of the intramedullary nail 104', which extends longitudinally therethrough. Thus, when the pin 137' is inserted through the hole 136' such that a proximal end 152' of the pin 137' is flush with the outer surface 109', a distal end 154' of the pin 137' extends into the channel 110' for engaging the recess 124'. The hole 136' may be substantially circular such that the intramedullary nail 104 remains substantially stationary while the locking mechanism 106' moves relative to the intramedullary mail 104' along the longitudinal axis.

0017To fix the locking mechanism 106' within the intramedullary nail 104', a biasing member 140' of the locking mechanism 106' may be inserted into the channel 110' along with the pawl member 105' such that the biasing member 140' urges the pawl member 105' into a position of contact with an implant (not shown) that is inserted into the opening 108'. The pawl member 105' is inserted distally into the channel 110' until the distal end 154' of the pin 137' that is inserted into the hole 136' engages the first portion 142' of the recess 124' via the edge 156' of the first portion 142'. The pawl member 105' is pressed further distally against the urging of the biasing member 140' such that the first portion 142' slides along the pin 137' until the proximal end 148' of the first portion 142' is in contact with the pin 137. The pawl member 105' may then be rotated about a longitudinal axis thereof such that the second portion 144' slides along the pin 137' until the pin 137' is contacting the opposite end 150' of the second portion 144'. Upon reaching the opposite end 150', the pawl member 105' may be released, the biasing member 140' urging the pawl member 105' in a proximal direction such that the third portion 146' slides along the pin 137' until the pin 137' engages a distal end 158' of the third portion 146'. Thus, it will be understood by those of skill in the art that once the locking mechanism 106' is fixed within the intramedullary nail 104', the locking mechanism 106' is movable along the longitudinal axis to engage the implant, as described in regard to the device 100: Longitudinal movement of the locking mechanism 106' results in sliding of the third portion 146' longitudinally along the distal end 154' of the pin 137'.

0018In a first configuration, shown in <figref idref="f0004">Figs. 4 - 5</figref>, when no implant 102 is present in the opening 108, the implant engaging surface 130 substantially aligns with a wall of the oblique opening 108 while the pawl 126 and the protrusion 128 extend into the oblique opening 108. Then, as an implant 102 is inserted into the opening 108, contact between the implant 102 and the ramped surface 134 forces the pawl member 105 into the channel 110 to a second configuration in which the protrusion 128 is moved into the channel 110 to a second configuration shown in <figref idref="f0005">Figs. 6 and 7</figref> to allow the implant 102 to be advanced medially through the opening 108. The pawl member 105 is constrained so that it does not move further into the opening 108 than desired (i.e., beyond a desired first configuration), by a pin 135 passing through an opening 136 in the intramedullary nail 104, and through an elongated opening 124 in the pawl member 105. As described above, when the implant 102 has been inserted to a desired position in the bone, the implant 102 is rotated about its axis until the groove 118 aligns with the protrusion 128. At this point the biasing member 140 moves the pawl member 105 back to the first configuration with the protrusion 128 received within the slot 118 and the pawl 126 engaging one of the abutting structures 116 of the implant 102 corresponding to the desired maximum insertion of the implant 102 into the bone. Thereafter, as forces are applied to the implant 102 (e.g., as weight is placed on the bone), the implant 102 may move laterally as ramped surfaces 117 slide over the pawl 126. The abutting surface 119 engages the pawl 126 preventing any further movement medially. In addition, as each abutting surface 119 moves laterally past the pawl 126, a new medial-most position of the implant 102 is defined.

0019The intramedullary nail 104 may further include a shoulder 138 within the channel 110 positioned below the oblique opening 108. A reduced diameter shaft 120 extends from an end of the pawl member 105 to a shoulder 122 at an end of an upper portion of the pawl member 105. The biasing member 140 is received between the shoulder 122 and the shoulder 138 of the channel 110 to urge the pawl member 105 toward the opening 108. A diameter of a portion of the channel 110 closer to the opening 108 than the shoulder 138 is larger than a diameter of the portion of the channel 110 extending past the shoulder 138 away from the opening 108. It will be understood by those of skill in the art that the diameters of these portions the channel 110 correspond to the diameters of the proximal end 118 of the pawl member 105 and the shaft 120, respectively.

0020In use, the intramedullary nail 104 is inserted into an intramedullary canal (e.g., of a femur) with a central axis of the oblique opening 108 substantially aligned with a central axis of the femoral neck. It will be understood by those of skill in the art that the intramedullary nail 104 may be inserted into the bone using any accepted insertion method. For example, a guidewire may be inserted into the medullary canal of the longitudinal shaft and the intramedullary nail 104 slid therealong. Thus, it will also be understood by those of skill in the art that the intramedullary nail 104 and the locking mechanism 106 housed therewithin may also include a guide wire lumen along the longitudinal axis thereof. Once the intramedullary nail 104 has been appropriately positioned, the implant 102 is inserted through the bone into the oblique opening 108 to a desired position and the implant 102 is rotated to return the locking mechanism 106 to the first configuration preventing further medial movement as described above.

0021If it becomes necessary to remove the implant 102 for any reason, however, the implant 102 may be rotated about the central axis of the oblique opening 108, as shown in <figref idref="f0007">Fig. 11</figref> to move the protrusion 128 out of the groove 118 and force the pawl member 105 back to the first configuration. At this point the locking mechanism 106 is disengaged from the abutting structures 116 of the implant 102 and the implant 102 may be slid entirely out of the opening 108 even after the protrusion 128 is located distally beyond the distal end of the groove 118. If the bone engaging structure of the implant 102 is formed as a helical blade, those skilled in the art will understand that this structure may be rotatably coupled to the shaft 112 of the implant 102 so that the engagement between the locking mechanism 106 and the abutting structures 116 of the implant 102 is maintained. Thus, any rotation of the helical blade during insertion would not require a corresponding rotation of the shaft 112. However, it will be understood by those of skill in the art that the bone engaging structure of the implant 102 may be any known capable of securing the femoral head and neck to the shaft through engagement of an intramedullary nail 104.