Driver and system for threaded intramedullary nail retaining end cap - Patents.com

Abstract

A driver for engaging an end cap of an intramedullary nail. The driver includes a handle extending from a proximal end to a distal end along a longitudinal axis of the driver. The handle has a handle channel extending longitudinally therethrough. The driver also includes a shaft extending through the handle channel from the proximal end to the distal end along the longitudinal axis. The shaft has a shaft channel extending longitudinally therethrough. A distal end of the shaft extends distally from the handle. The distal end of the shaft forms a drive element that is inserted into a head portion of the end cap. The driver further includes a retaining pin slidably received in the shaft channel. The retaining pin also extends along the longitudinal axis. The distal end of the retaining pin is configured to reversibly lock the shaft to the head portion of the end cap.

Description

[Technical field]

[0001] The present invention relates generally to a driver and system for fixating two or more portions of a fractured bone, and more particularly to a driver and system that engages an end cap for insertion into a channel of an intramedullary nail for internal fixation of a long bone, such as a femur. [Background technology]

[0002] Fractures of the femur often occur at the femoral neck and intertrochanteric region. Such fractures can be treated with screws or other fixation devices inserted into or through the bone to stabilize and fix the position of the different portions of the bone relative to one another after they have been correctly aligned. Trochanteric bone fixation treatment typically involves inserting an intramedullary nail into the medullary cavity of the bone, followed by inserting a bone fixation nail into the condylar portion of the bone at an angle to the intramedullary nail (i.e., along the axis of the trochanter). Summary of the Invention [Means for solving the problem]

[0003] One exemplary embodiment of the present application is a driver for engaging an end cap of an intramedullary nail. The driver includes a handle extending from a proximal end to a distal end along a longitudinal axis of the driver and having a handle channel extending longitudinally therethrough. The driver includes a shaft extending from a proximal end to a distal end through the handle channel along the longitudinal axis and having a shaft channel extending longitudinally therethrough. A distal end of the shaft extends distally from the handle. The distal end of the shaft forms a drive element configured to be inserted into a head portion of the end cap. The driver further includes a retaining pin slidably received in the shaft channel and extending from the proximal end to the distal end along the longitudinal axis. The distal end of the retaining pin is configured to reversibly lock the shaft to the head portion of the end cap.

[0004] In another aspect of the application, a system for engaging a proximal end of an intramedullary nail is provided. The system includes a driver including a handle extending from a proximal end to a distal end along a longitudinal axis of the driver and having a handle channel extending longitudinally therethrough. The driver also includes a shaft extending from a proximal end to a distal end along the longitudinal axis through the handle channel and having a shaft channel extending longitudinally therethrough. A distal end of the shaft extends distally from the handle. The distal end of the shaft forms a drive element. The driver further includes a retaining pin slidably received in the shaft channel and extending from the proximal end to the distal end along the longitudinal axis. The distal end of the retaining pin includes a thread. The retaining pin also includes a lumen extending longitudinally therethrough. The system also includes an end cap having a lumen extending therethrough. The end cap includes a body configured to engage the channel of the intramedullary nail and a shaft channel extending longitudinally therethrough. and a head portion configured to receive the drive element and reversibly lock the head portion to the shaft. The head portion of the end cap includes threads configured to threadingly engage corresponding threads on the retaining pin. The system further includes a guidewire slidably inserted through the lumen of the retaining pin and the lumen of the end cap to align the drive element with the head portion of the end cap. These and other aspects of the present invention will become apparent to those of ordinary skill in the art upon reading the following detailed description of the invention, including the drawings and appended claims. [Brief description of the drawings]

[0005] [Figure 1a] 1 illustrates a driver according to one embodiment of the present invention for engaging an end cap for insertion into a channel of an intramedullary nail. [Figure 1b] FIG. 1b shows a side view of the handle of the driver of FIG. 1a. [Figure 1c] 1b shows another side view of the driver's handle of FIG. 1a. [Figure 1d] FIG. 1B shows a cross-sectional view of the handle shown in FIG. 1B and FIG. [Figure 1e]1b shows a portion of the shaft of the driver of FIG. 1a and a clamp in an open configuration for transmitting torque applied through the handle to the shaft, according to one embodiment of the present invention. [Figure 1f] 1c shows the shaft and part of the clamp in the locked configuration of FIG. 1e. [Diagram 2] FIG. 1b shows a detailed view of the distal most portion of the driver of FIG. 1a engaging an end cap for insertion into a channel of an intramedullary nail. [Diagram 3] FIG. 1b shows a proximal view from the distal end of the driver of FIG. 1a. [Figure 4] FIG. 2 illustrates a side view of an end cap according to one embodiment of the present invention. [Diagram 5] 5 shows a perspective view of a femoral system according to one embodiment of the present invention including the driver of FIG. 1 a engaging the end cap of FIG. 4 and guiding the end cap over a guide wire for insertion into the proximal opening of the channel of the intramedullary nail. [Figure 6] 5 shows a perspective view of a femoral system according to an alternative embodiment of a driver engaging the end cap of FIG. 4 for insertion into a proximal opening of a channel of an intramedullary nail in the femur. [Figure 7] 7 shows a perspective view of the system of FIG. 6 with the driver in an elastically deformed configuration extending along a curved path away from the longitudinal axis of the driver. [Figure 8a] 5 illustrates a perspective view of one embodiment of a flexible driver engaging the end cap of FIG. 4. [Figure 8b] FIG. 8b shows a side view of the flexible driver shaft of FIG. 8a having a number of grooves extending along the length of the shaft to impart increased flexibility to the shaft. [Figure 8c] 8c shows a detailed view of a portion of the shaft of FIG. 8b having multiple grooves. [Figure 8d] 8c shows another detailed view of a portion of the shaft of FIG. 8b having multiple grooves. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0006] The present disclosure may be further understood with reference to the following description and the accompanying drawings, in which like elements are referred to with the same reference numerals. It should be noted that as used herein, the terms "proximal" and "distal" are intended to refer to directions toward (proximal) and away from (distal) the user of the device.

[0007] 1a-1c and 3 show a driver 100 for engaging an end cap 200 that can be coupled to the proximal end 12 of an intramedullary nail 10. The driver 100 includes a handle 102 that extends from a proximal end 104 to a distal end 106 along a longitudinal axis L1. The handle 102 has a handle channel 108 that extends longitudinally through the handle 102 from the proximal end 104 to the distal end 106 along the longitudinal axis L1. The handle 102 can have any suitable size and shape for a user to hold in the palm of their hand and manually manipulate the handle 102. Preferably, the handle 102 is sized and shaped to provide an ergonomic shape for a user to hold in the palm of their hand and manually rotate the driver 100.

[0008] In the exemplary embodiment, the handle 102 has an elongated shape. As shown in FIG. 1a, the handle 102 has a tapered elongated shape such that the diameter of the handle 102 decreases from the enlarged portion 110 (located proximal to the distal end 106) toward the distal end 106. In particular, the handle 102 is spherical. Specifically, the handle 102 includes a tapered portion 112 that increases from a first diameter at the proximal end 104 to a maximum diameter at the enlarged portion 110 and adjacent the distal end 106, the tapered portion 112 being shaped to aid in ergonomic use of the handle 102 in a user's hand.

[0009] The driver 100 also includes a shaft 120 extending through the handle channel 108 from a proximal end 122 to a distal end 124 along a longitudinal axis L1. The shaft 120 is coaxial with the handle 102 along the longitudinal axis L1. In some embodiments, the shaft 120 has a cross-sectional diameter of about 7.5 mm to about 14 mm in a plane perpendicular to the longitudinal axis L1 between the proximal end 122 and a portion proximal to the drive element 128 located at the distal end 124 (e.g., along the plane A-A' as shown in FIG. 1a). The shaft 120 has a shaft channel 126 extending longitudinally through the shaft 120 from the proximal end 122 to the distal end 124 along the longitudinal axis L1. The shaft channel 126 is coaxial with the shaft 120 and defines an inner diameter of an inner surface of the shaft channel 126. In some embodiments, the inner diameter of the shaft 120 is about 4.15 mm to about 4.5 mm. As shown in FIG. 1a, the shaft 120 is longer than the handle 102 such that the distal end 124 of the shaft 120 extends distally beyond the distal end 106 of the handle 102. For example, the shaft 120 extends from about 166 cm to about 328 cm distally beyond the distal end 106 of the handle. The proximal end 122 of the shaft 120 can be fixed anywhere along the length of the handle channel 108. For example, as shown in FIG. 1a, the proximal end 122 of the shaft 120 is disposed at the proximal end 104 of the handle 102. In another example, the proximal end 122 of the shaft 120 is disposed within the handle channel 108 between the proximal end 104 and the distal end 106 of the handle 102.

[0010] In one embodiment, the handle 102a can be formed as an elastomeric (e.g., silicone) molding on the shaft 120, for example, as shown in Figures 1b-1d. The elastomeric molding is formed on the shaft 120 such that the handle channel 108 is defined in the elastomeric molding around the shaft 120. The elastomeric molding provides a soft material that reversibly deforms to provide an ergonomic shape for a user to hold in the palm of their hand. Additionally, the elastomeric molding increases friction between the surface of the handle 102a and the palm of the user's hand to provide the handle 102a that is easy and comfortable to hold in the user's hand. Figure 1b shows a side view of the elastomeric molded handle 102a over a portion of the shaft 120, and Figure 1c shows a side view of the elastomeric molded handle 102a from the side opposite the side shown in Figure 1b. As seen in Figures 1b and 1c, the handle 102a includes a tapered section 112a formed on the shaft 120 in a tapered shape where the width of the handle 102 increases from a first diameter at the proximal end 104 to a maximum width at the enlarged section 110a of the handle 102a, and has a narrower width adjacent the distal end 106. Figure 1d shows a cross-sectional view of the embodiment of Figures 1b and 1c along a plane along the longitudinal axis L1 (e.g., along the plane B-B' as shown in Figure 1b). As seen in Figure 1d, the height of the handle 102a between the opposing sides shown in Figures 1b and 1c in this exemplary embodiment is constant along the length of the handle 102a.

[0011] The shaft 120 includes one or more clamps 114 disposed at or near the enlarged portion 110 of the handle 102, which extend along a plane transverse to the longitudinal axis L1. The clamps 114 may include any suitable structure that clamps onto the shaft 120 and extends transverse to the longitudinal axis L1, such that when a user rotates the silicone molded handle 102, torque is transferred to the shaft 120. As shown in the embodiment of Figures 1e and 1f, the clamps 114 are disposed on the shaft 120 and then molded with an elastomeric molding over both the shaft 120 and the clamps 114 to form the handle 120. The clamps 114 are movable between an open configuration, shown in Figure 1e, and a locked configuration, shown in Figure 1f. The clamps 114 include a first portion 115 and a second portion 116 that slidably engage with each other and define a slot 117 therebetween. In the open configuration shown in Figure 1e, the slot 117 is suitably sized and shaped to slidably receive the shaft 120 therein. The first and second portions 115, 116 are configured to move toward one another (as indicated by the arrows in Figure 1e) to a locked configuration shown in Figure 1f to reduce the size of the slot 117, such that by forcing the first and second portions 115, 116 toward one another, the slot 117 lockingly engages the shaft 120 and is clamped firmly against the exterior of the shaft 120. The handle 102 may further include additional surface features (not shown) configured to enhance a user's grip of the handle 102.

[0012] The distal end 124 of the shaft 120 forms a drive element 128 that is suitably sized and shaped to be inserted into the head portion 208 of the end cap 200. In particular, the drive element 128 is suitably sized and shaped to non-rotatably engage the recess 216 of the head portion 208 of the end cap 200. In one embodiment, the drive element 128 is suitably sized and shaped to non-rotatably engage the recess 216 such that manipulation of the handle 120 while the drive element 128 is engaged with the recess 216 drives the body portion 206 of the end cap 200 into the channel 16 of the intramedullary nail 10. The drive element 128 is configured to non-rotatably engage the head portion 208 of the end cap 200 such that rotation of the handle 102 transmits torque to the drive element 128 via the shaft 120. Torque applied to the handle 102 rotatably drives the end cap 200 into the channel 16 of the intramedullary nail 10.

[0013] The drive element 128 shown in FIG. 1a is in the shape of an elongated cylinder with a series of circumferentially spaced projections 132. As shown in FIG. 1a, the projections 132 are equally spaced around the circumference of the cylinder. The projections 132 in this embodiment are rounded or curvilinear and extend along a portion or the entire length of the drive element 128, defining a longitudinal groove 130 therebetween that extends along a portion or the entire length of the drive element 128. The projections 132 form protruding surface features for non-rotatably engaging with the head portion 208 of the end cap 200. Alternatively, the drive element can have an elongated shape with a polygonal or substantially polygonal cross-section, for example a substantially hexagonal (e.g., hex key) cross-section in a plane perpendicular to the longitudinal axis L1 of the shaft 120.

[0014] The driver 100 further includes a retaining pin 140 extending through the shaft channel 126 from a proximal end 142 to a distal end 144 along the longitudinal axis L1. The retaining pin 140 is coaxial with the shaft 120 along the longitudinal axis L1. The retaining pin 140 is sized and shaped to be slidable and / or rotatable within the shaft channel 126. In some embodiments, the retaining pin 140 is sized and shaped to correspond to the size and shape of the shaft channel 126, e.g., cylindrical. The cylindrical shape of the retaining pin 140 can have a cross-sectional outer diameter of about 3 mm to about 4 mm and an inner diameter of about 1.7 mm to about 2.1 mm in a plane perpendicular to the longitudinal axis L1. The retaining pin 140 defines a lumen 146 extending longitudinally from the proximal end 142 to the distal end 144 along the longitudinal axis L1. Lumen 146 in this embodiment is coaxial with retaining pin 140 and defines a thickness d (shown, for example, in Figures 2 and 3) from the outer surface of retaining pin 140 to the inner surface of lumen 146. In some embodiments, the thickness d of the retaining pin is from about 0.45 mm to about 1.15 mm.

[0015] As shown in FIG. 1a, the proximal end 142 of the retaining pin 140 extends proximally beyond the proximal end 122 of the shaft 120. The retaining pin 140 can be slidably movable or longitudinally fixed within the shaft channel 126. In some embodiments, the distal end 144 of the retaining pin 140 extends distally beyond the distal end 124 of the shaft 120. In other embodiments, the distal end 144 of the retaining pin 140 is slidably movable between a retracted configuration in which the distal end 144 is disposed within the shaft channel 126 and an expanded configuration in which the retaining pin 140 extends distally beyond the distal end 124 of the shaft 120 such that the retaining pin 140 can engage the head portion 208 of the end cap 200. The distal end 144 of the retaining pin 140 includes surface features configured to reversibly lock the shaft 120 to the head portion 208 of the end cap 200. In particular, the surface features are suitably sized and shaped to reversibly engage corresponding features in the head portion 208 of the end cap 200. When the surface features engage the head portion 208, the end cap 200 is lockingly coupled to the distal end 144 of the retaining pin 140. For example, the surface features in this embodiment include threads 146 for engaging corresponding threads 220 in the head portion 208 of the end cap 200.

[0016] The driver 100 further includes a knob 160 rotatably connected to the proximal end 122 of the shaft 120. Rotation of the knob 160 about the longitudinal axis L1 rotates the retaining pin 140 to lock and unlock the retaining pin 140 from the head portion 208 of the end cap 200. In this embodiment, the knob 160 is rotatably connected to the shaft 120 via an axle mechanism 162 fixedly attached to the proximal portion of the shaft 120. As shown in FIG. 1a, the axle mechanism 162 is inserted into the proximal portion of the shaft channel 126 and rotatably secured therein. The axle mechanism 162 includes an axle channel 164 extending longitudinally therethrough for receiving the retaining pin 140. The axle mechanism 162 is rotatably connected to the knob 160. Knob 160 is also non-rotatably connected to proximal end 142 of retaining pin 140 such that rotation of knob 160 about longitudinal axis L1 in a desired direction rotates retaining pin 140 in the same direction.

[0017] For example, FIG. 1a shows that the proximal end 142 of the retaining pin 140 is embedded within the knob 160. The knob 160 further includes a knob channel 166 aligned with the lumen 146 of the retaining pin 140 to allow the guidewire 300 to extend through the knob channel 162 and into the lumen 146 of the retaining pin 140. The knob 160 can have any size and shape suitable for holding between the fingertips of a user's hand to facilitate manual manipulation of the knob 160. Preferably, the knob 160 is suitably sized and shaped to provide an ergonomic shape for a user to pinch between the index finger and thumb to manually manipulate or rotate the knob 160. The knob 160 can include additional surface features (not shown) configured to enhance grip of the knob 160 by the user's fingertips, as will be appreciated by those skilled in the art.

[0018] 4 illustrates an end cap 200 configured to be inserted into the proximal opening 14 of the channel 16 in the intramedullary nail 10 to close the proximal opening 14 of the channel 16 to prevent bone ingrowth into the channel 16. The end cap 200 is configured to reversibly engage and disengage the inner surface of the channel 16 in the intramedullary nail 10 via any suitable engagement structure, such as, for example, threads 212 configured to engage corresponding threads in the inner surface of the channel 16. The end cap 200 extends from a proximal end 202 to a distal end 204 and includes a body portion 206 and a head portion 208 proximal to the body portion 206. The body portion 206 extends from its proximal end 210 to the distal end 204 of the end cap 100. The head portion 208 extends proximally from the proximal end 210 of the body portion 206. End cap 200 further includes a lumen 214 that extends along its longitudinal axis L2 from proximal end 202 to distal end 204. Lumen 214 is configured to receive a guidewire 300 therethrough.

[0019] The body portion 206 of the end cap 200 is configured to be inserted into and engage the channel 16 of the intramedullary nail 10. In particular, the distal end 204 is suitably sized and shaped to be inserted into the proximal opening 14 of the channel 16 in the intramedullary nail 10 and to fixedly engage the interior of the channel 16 of the intramedullary nail 10. The body portion 106 may include any suitable engagement structure, such as threads 212, snap fasteners, adhesive, or screws, for attaching the end cap 200 to the channel 16 of the intramedullary nail 10. In some embodiments, the body portion 206 includes at least a portion having threads 212 configured to threadingly engage the interior of the channel 16 of the intramedullary nail 10. The threads 212 may extend along a portion or the entirety of the longitudinal length of the body portion 206. The threads 212 are configured to mate with corresponding threads within the channel 16 of the intramedullary nail 10 when the end cap 200 is driven into the channel 16 of the intramedullary nail 10 to secure the end cap 200 to the proximal end 12 of the intramedullary nail 10.

[0020] The head portion 208 of the end cap 200 includes a recess 216 for engaging the driver 100, and in particular the drive element 128 of the shaft 120. For example, the recess 216 has a size and shape corresponding to the size and shape of the drive element 128 for receiving and engaging the drive element 128. The recess 216 is suitably sized and shaped to engage the drive element 128 such that manipulation of the handle 100 while the drive element 128 is engaged with the recess 216 drives the end cap 200 into or out of the channel 16 of the intramedullary nail 10. More specifically, the recess 216 is configured to non-rotatably engage the drive element 128 such that rotation of the shaft 120 transfers torque from the shaft 120 through the head portion 208 to drive the body portion 206 of the end cap 200 into the channel 16.

[0021] The recess 216 also includes corresponding surface features suitably sized and shaped to reversibly engage surface features at the distal end 144 of the retaining pin 140 such that the head portion 208 of the end cap 200 is reversibly locked to the shaft 120. For example, the recess 216 includes a recess 218 extending distally from the recess 216 along the longitudinal axis L2. In some embodiments, the recess 218 is a cylindrical channel having corresponding threads 220 configured to mate with the threads 146 at the distal end 144 of the retaining pin 140 to secure the end cap 200 to the distal end 144 of the retaining pin 140 when the retaining pin 140 extends distally beyond the distal end 124 of the shaft 120 and is driven into the recess 218. The recess 218 is suitably sized and shaped to engage the distal end 144 of the retaining pin 140 such that rotation of the knob 160 rotates the retaining pin 140 and drives the threads 146 located on the distal end 144 of the retaining pin 140 into locking engagement with corresponding threads 220.

[0022] Once the threads 146 of the retaining pin 140 are locked into the corresponding threads 220 of the head portion 208, the end cap 200 is lockingly coupled to the distal end 144 of the retaining pin 140 such that manipulation of the shaft 120 does not inadvertently disengage the head portion 208 from the driver 100. This minimizes the risk of the end cap 200 being accidentally dropped during implantation. After the end cap 200 has been driven into a desired position within the channel 16 of the intramedullary nail 10, the threads 146 of the retaining pin 140 are suitably sized and shaped to disengage from the corresponding threads 220 by rotating the knob 160 in a counter direction to rotatably withdraw the distal end 144 of the retaining pin 140 from the recess 218 to unlock the retaining pin 140 from the head portion 208.

[0023] The driver 100 and end cap 200 described above may be provided with a guide wire 300 as part of a system 400 for engaging the proximal end of the intramedullary nail 16. As seen in the exemplary embodiment shown in FIG. 5, the end cap 200 may be installed on the proximal end 12 of the intramedullary nail 10 by inserting the guide wire 300 into the channel 16 of the intramedullary nail 10 and sliding the end cap 200 over the guide wire 300 via the lumen 214 towards a desired location on the proximal end 12 of the intramedullary nail 10. The driver 100 is also configured to receive the guide wire 300 therethrough and slide into position to engage the head portion 208 of the end cap 200. Specifically, when the system is in use, the guide wire 300 is slidably inserted from the proximal end of the driver 100 through the knob channel 162 and lumen 146 to the distal end 144 of the retaining pin 140 and through the recess 216 and lumen 214 of the end cap 200. The driver 100 and end cap 200 are slid into position along the guidewire 300 to engage the driver 100 and end cap 200 such that the longitudinal axis L1 of the driver 100 and the longitudinal axis L2 of the end cap 200 are substantially aligned or are aligned within a predetermined acceptable angle range.

[0024] When the driver 100 is inserted into the recess 216 of the end cap 200 for engagement with the head portion 208, the knob 160 is rotated to drive the threads 146 of the retaining pin 140 into the corresponding threads 220 of the head portion 208 to lock and engage the distal end 144 of the retaining pin 140 to the end cap 200. Once the end cap 200 is securely locked to the driver 100, manipulation (e.g., rotation) of the handle 102 transfers applied force and / or torque to the end cap 200. In particular, the driver 100 can be manipulated to drive the body portion 206 of the end cap 200 into the channel 16 of the intramedullary nail 10. The end cap 200 can be driven into the channel 16 of the intramedullary nail 10 such that a portion or the entire longitudinal length of the body portion 206 of the end cap 200 is located within the channel 16 when the end cap is fully inserted. In some embodiments, only a portion of the length of the body portion 206 is inserted and engages the channel 16 such that the end cap 200 provides a proximal extension to the intramedullary nail 10 .

[0025] In certain embodiments, the shaft 102 and / or the retaining pin 140 are formed of a material having sufficient rigidity to resist deformation of the shaft during use. For example, the shaft 102 has sufficient rigidity to resist twisting and / or bending when an expected amount of force and / or torque is applied via the handle 102 to drive the body portion 206 of the end cap 200 into the channel 16 of the intramedullary nail 10. Additionally or alternatively, the retaining pin 140 has sufficient rigidity to resist twisting and / or bending when the knob 160 is rotated to drive the threads 146 of the retaining pin 140 into the corresponding threads 220 of the head portion 206. The stiffness of the shaft 102 and / or retaining pin 140 is such that it does not rebound against an applied force and / or torque such that the distal end 124 of the shaft 102 and / or the distal end 144 of the retaining pin 140 are easily substantially aligned to engage the head portion 208 of the end cap 200, and in particular to engage the threads 146 of the retaining pin 140 with corresponding threads 220 of the head portion 208, during use of the device. The shaft 102 and / or retaining pin 140 can be formed from any suitable material that provides the desired stiffness, such as, for example, stainless steel (e.g., 1.4301 stainless steel, 1.4542 stainless steel, custom 465 stainless steel, 1.4123 stainless steel, or 1.4109 stainless steel).

[0026] In another embodiment, the driver 500 can include a shaft 520 and a retaining pin 540 that are flexible and reversibly movable between a relaxed configuration and a deformed configuration. The driver 500 shown in Figures 6 and 7 is substantially similar to the driver 100 of Figures 1a-c and 3, and like elements are referenced with like reference numerals. In this alternative embodiment, the shaft 520 and the retaining pin 540 are movable between a relaxed configuration (shown in Figure 6) in which the shaft 520 and the retaining pin 540 lie along the longitudinal axis L3, and a deformed configuration (shown in Figure 7) in which the shaft 520 and the retaining pin 540 elastically deform to extend along a curved path from the longitudinal axis L3 to the end cap 200. This allows the user to manipulate the end cap 200 in the same manner described above, even if the patient's particular anatomy or the geometry of the surgical approach makes it difficult or impossible to obtain a straight line approach of the driver 500 to the end cap 200.

[0027] The shaft 520 and retaining pin 540 of this embodiment may be deformed when the end cap 200 is inserted into the intramedullary nail 10 to secure the femur 2 using the device 500. The shaft 520 and retaining pin 540 may be deformed when a force is applied to push the shaft 520 and retaining pin 540 to bend along a curved path, for example to avoid the iliac crest 4 during use. When the force is removed from the shaft 520 and retaining pin 540, the shaft 520 and retaining pin 540 return to a relaxed configuration. In one example, the flexibility of the shaft 102 and / or retaining pin 140 varies along its length. For example, the shaft 102 and / or retaining pin 140 may include multiple regions, each region having a different degree of flexibility.

[0028] In one exemplary embodiment, the driver 600 can include a shaft 620 including surface features that increase the flexibility of the shaft 620 such that the shaft 620 is movable between a relaxed configuration and a deformed configuration. The driver 600 shown in FIG. 8a is substantially similar to the driver 100 of FIGS. 1a-c and 3, and like elements are referenced with like reference numerals. In this exemplary embodiment, the shaft 620 includes aligned grooves 622 that surround an outer surface of the shaft 620 and extend along at least a portion of the shaft 620 to impart increased flexibility to the shaft 620. For example, the grooves 622 can extend along the length of the shaft 620 (e.g., 200 mm of the shaft 620), such that the shaft 620 is flexible enough to bend up to 45° away from the longitudinal axis L1, as shown in FIG. 8b and FIG. 8c. The grooves 622 can include laser cut windings that surround an outer surface of the shaft 620. The laser cut windings may be angled relative to a plane along the longitudinal axis L1 and may be substantially parallel to each other.

[0029] In one exemplary embodiment shown in FIG. 8c, the groove 622 extends at an angle of 72° from a plane along the longitudinal axis L1. The groove 622 can have any suitable shape and pattern. As shown in FIGS. 8b-8d, the groove 622 is cut into an interlocking pattern having wings 624 extending transversely to the angle of the windings, the wings 624 including a wide portion 626 and a narrow neck portion 628. The narrow neck portion 628 is configured to interlock with the wide portion 626 of the next wing 624 in the interlocking pattern. The wide portion 626 has a width x1 and the narrow neck portion 628 has a width x2, where x1>x2. For example, the wide portion 626 has a width x1 of about 5.1 mm to 5.5 mm and the narrow neck portion 628 has a width x2 of about 2.6 mm to 3.0 mm. The windings can be spaced apart by a distance y between each winding, as shown in FIG. 8d. Distance y may be, for example, from about 2.6 mm to about 5.2 mm. In one particular embodiment (not shown), shaft 620 may have multiple regions, each region having a different degree of flexibility provided by a different distance y between the windings, with smaller distances y resulting in increased flexibility of shaft 620.

[0030] The shafts 520, 620 and / or the retaining pins 540 can be formed from any material that deforms when a predetermined level of force is applied to the material and returns to its original shape when the external force is removed. In one embodiment, the shaft 620 is formed from a metal, particularly a biocompatible stainless steel (e.g., 1.4542 stainless steel), and includes aligned grooves 622 extending along at least a portion of the shaft 620 to impart increased flexibility to the shaft 620 as described above. In another embodiment, the shafts 520, 620 can be formed from an elastic material. The elastic material can be a shape memory metal alloy, such as nitinol. In particular, the elastic material can consist of a nickel-titanium alloy with 45% < Ni < 55%, 45% Ti < 55% and x + y = 100%. Such materials have particularly good biocompatibility and high elasticity. The shape memory metal alloy can have a transition temperature above about 50°C, more preferably above about 80°C. In another embodiment, the transition temperature can be higher than about 100°C, preferably higher than about 120°C.

[0031] The specific embodiments disclosed herein are intended to illustrate some aspects of the present invention, and the invention described and claimed herein is not limited in scope by these embodiments. Any equivalent embodiments are intended to be within the scope of the present invention. Indeed, various modifications of the present invention will become apparent to those skilled in the art from the foregoing description. Such modifications are also intended to fall within the scope of the appended claims. All publications cited herein are incorporated by reference in their entirety.

[0032] 〔Embodiments〕 (1) A driver for engaging an end cap of an intramedullary nail, a handle having a handle channel that extends along the longitudinal axis of the driver from a proximal end to a distal end and longitudinally through the interior, a shaft extending through the handle channel from a proximal end to a distal end along the longitudinal axis and having a shaft channel extending longitudinally therethrough, the distal end of the shaft extending distally from the handle, the distal end of the shaft forming a drive element configured to be inserted into a head portion of the end cap; a retaining pin slidably received in the shaft channel and extending from a proximal end to a distal end along the longitudinal axis, the distal end of the retaining pin configured to reversibly lock the shaft to the head portion of the end cap. (2) A driver as described in embodiment 1, wherein the handle is formed from an elastomeric material. (3) A driver as described in embodiment 2, further comprising a clamp, the clamp extending along a plane intersecting the longitudinal axis of the handle and fixedly fastened to the shaft to transmit torque applied to the handle through the clamp to the shaft. (4) The driver of embodiment 1, further comprising a knob rotatably connected to the proximal end of the shaft, wherein rotation of the knob about the longitudinal axis rotates the retaining pin to lock and unlock the head portion of the end cap. (5) A driver as described in embodiment 1, wherein the retaining pin includes a lumen extending longitudinally therethrough, the lumen being sized and shaped to slidably receive a guidewire therethrough.

[0033] (6) The driver of embodiment 4, wherein the distal end of the retaining pin is provided with threads configured to threadingly engage corresponding threads in the head portion of the end cap. (7) A driver as described in embodiment 1, wherein the distal end of the retaining pin extends distally beyond the distal end of the shaft. (8) The driver of embodiment 1, wherein the shaft is rotatably fixed within the handle channel such that rotation of the handle transmits torque via the shaft to the drive element, and the drive element is configured to non-rotatably engage the end cap such that torque applied to the handle rotatably drives the end cap to couple the end cap to the intramedullary nail. (9) A driver as described in embodiment 8, wherein the shaft is formed of a material having sufficient rigidity to resist deformation of the shaft during use. (10) The driver of embodiment 1, wherein the shaft and retaining pin are flexible and reversibly movable between a relaxed configuration in which the shaft and retaining pin lie along the longitudinal axis and a deformed configuration in which the shaft and retaining pin elastically deform and extend along a curved path to the end cap.

[0034] (11) A driver as described in embodiment 10, wherein the flexibility of the shaft varies along the length of the shaft. (12) A driver as described in embodiment 10, wherein the shaft has a plurality of aligned grooves circumferentially around an exterior surface of the shaft to impart flexibility to the shaft. (13) The driver of claim 1, wherein the wall of the retaining pin has a thickness of about 0.45 mm to about 1.15 mm. (14) The driver of claim 1, wherein the retaining pin has an outer diameter of about 3 mm to about 4 mm. (15) The driver of embodiment 14, wherein the guidewire has a diameter of about 1.6 mm to about 2.0 mm.

[0035] (16) A system for engaging a proximal end of an intramedullary nail, comprising: (i) a driver, a handle extending along a longitudinal axis of the driver from a proximal end to a distal end and having a handle channel extending longitudinally therethrough; a shaft extending through the handle channel from a proximal end to a distal end along the longitudinal axis and having a shaft channel extending longitudinally therethrough, the distal end of the shaft extending distally from the handle, the distal end of the shaft forming a drive element; a retaining pin slidably received in the shaft channel and extending from a proximal end to a distal end along the longitudinal axis, the distal end of the retaining pin comprising a thread and the retaining pin including a lumen extending longitudinally therethrough; (ii) an end cap having a lumen extending therethrough; a body configured to engage a channel of the nail; an end cap comprising a head portion configured to receive the drive element and to reversibly lock the head portion to the shaft, the head portion comprising threads configured for threaded engagement with corresponding threads on the retaining pin; (iii) a guidewire slidably inserted through the lumen of the retaining pin and the lumen of the end cap to align the drive element with the head portion of the end cap. (17) The system of claim 16, wherein the distal end of the retaining pin extends distally beyond the distal end of the shaft. (18) The system of embodiment 16, wherein the shaft is rotatably fixed within the handle channel such that rotation of the handle transmits torque via the shaft to the drive element, and the drive element is configured to non-rotatably engage the end cap such that torque applied to the handle rotatably drives the end cap to couple the end cap to the intramedullary nail. (19) The system of embodiment 18, wherein the shaft is formed of a material having sufficient rigidity to resist deformation of the shaft during use. (20) The system of embodiment 18, wherein the shaft and retaining pin are flexible and reversibly movable between a relaxed configuration in which the shaft and retaining pin lie along the longitudinal axis and a deformed configuration in which the shaft and retaining pin elastically deform and extend along a curved path to the end cap.

Claims

1. 1. A driver for engaging an end cap of an intramedullary nail, comprising: a handle extending along a longitudinal axis of the driver from a proximal end to a distal end and having a handle channel extending longitudinally therethrough; a shaft extending through the handle channel from a proximal end to a distal end along the longitudinal axis and having a shaft channel extending longitudinally therethrough, the distal end of the shaft extending distally from the handle, the distal end of the shaft forming a drive element configured to be inserted into a head portion of the end cap; a retaining pin slidably received in the shaft channel and extending from a proximal end to a distal end along the longitudinal axis, the distal end of the retaining pin configured to reversibly lock the shaft to the head portion of the end cap; the shaft and the retaining pin are flexible and reversibly movable between a relaxed configuration in which the shaft and the retaining pin lie along the longitudinal axis and a deformed configuration in which the shaft and the retaining pin elastically deform to extend along a curvilinear path to the end cap; the shaft includes a plurality of aligned grooves circumferentially about an exterior surface of the shaft to provide flexibility to the shaft; The driver, wherein the plurality of aligned grooves are angled relative to a plane along the longitudinal axis.

2. The driver of claim 1 , wherein the handle is formed from an elastomeric material.

3. 3. The driver of claim 2, further comprising a clamp, the clamp extending along a plane transverse to the longitudinal axis of the handle and fixedly fastened to the shaft to transmit torque applied to the handle through the clamp to the shaft.

4. 2. The driver of claim 1, further comprising a knob rotatably connected to the proximal end of the shaft, wherein rotation of the knob about the longitudinal axis rotates the retaining pin to lock and unlock the head portion of the end cap.

5. The driver of claim 1 , wherein the retaining pin includes a lumen extending longitudinally therethrough, the lumen being sized and shaped to slidably receive a guidewire therethrough.

6. The driver of claim 4 , wherein the distal end of the retaining pin includes threads configured to threadingly engage corresponding threads in the head portion of the end cap.

7. The driver of claim 1 , wherein the distal end of the retaining pin extends distally beyond the distal end of the shaft.

8. 2. The driver of claim 1, wherein the shaft is rotatably secured within the handle channel such that rotation of the handle transmits torque through the shaft to the drive element, and the drive element is configured to non-rotatably engage the end cap such that torque applied to the handle rotatably drives the end cap to couple the end cap to the intramedullary nail.

9. The driver of claim 1 , wherein the flexibility of the shaft varies along the length of the shaft.

10. The driver of claim 1 , wherein the walls of the retaining pin have a thickness between 0.45 mm and 1.15 mm.

11. The driver of claim 1 , wherein the retaining pin has an outer diameter of between 3 mm and 4 mm.

12. The driver of claim 5, wherein the guidewire has a diameter of between 1.6 mm and 2.0 mm.

13. 1. A system for engaging a proximal end of an intramedullary nail, comprising: (i) a driver, a handle extending along a longitudinal axis of the driver from a proximal end to a distal end and having a handle channel extending longitudinally therethrough; a shaft extending through the handle channel from a proximal end to a distal end along the longitudinal axis and having a shaft channel extending longitudinally therethrough, the distal end of the shaft extending distally from the handle, the distal end of the shaft forming a drive element; a retaining pin slidably received in the shaft channel and extending from a proximal end to a distal end along the longitudinal axis, the distal end of the retaining pin comprising a thread and the retaining pin including a lumen extending longitudinally therethrough; (ii) an end cap having a lumen extending therethrough; a body configured to engage a channel of the nail; an end cap comprising a head portion configured to receive the drive element and to reversibly lock the head portion to the shaft, the head portion comprising threads configured for threaded engagement with corresponding threads on the retaining pin; (iii) a guidewire slidably inserted through the lumen of the retaining pin and the lumen of the end cap to align the drive element with the head portion of the end cap; the shaft and the retaining pin are flexible and reversibly movable between a relaxed configuration in which the shaft and the retaining pin lie along the longitudinal axis and a deformed configuration in which the shaft and the retaining pin elastically deform to extend along a curvilinear path to the end cap; the shaft includes a plurality of aligned grooves circumferentially about an exterior surface of the shaft to provide flexibility to the shaft; The plurality of aligned grooves are angled relative to a plane along the longitudinal axis.

14. The system of claim 13 , wherein the distal end of the retaining pin extends distally beyond the distal end of the shaft.

15. 14. The system of claim 13, wherein the shaft is rotatably secured within the handle channel such that rotation of the handle transmits torque through the shaft to the drive element, and the drive element is configured to non-rotatably engage the end cap such that torque applied to the handle rotatably drives the end cap to couple the end cap to the nail.

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