Systems and methods relating to surgical staples and surgical staple inserters

Abstract

To provide devices, systems and methods thereof for treating fractures of a foot using staples and staple inserters.SOLUTION: A staple 100 has a plurality of legs 102, and a bridge 104 connecting the plurality of legs. The staple is composed of nitinol, which may be bent upon application of a force and returned to the initial state after the force has been lifted. An inserter engages the staple and bends the staple at the bridge to splay the legs further apart for implantation at the fracture site. After implantation, the inserter is removed and the staple compresses the fracture.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present disclosure relates to surgical implants for treating fractures of the foot, and more particularly, the present disclosure relates to surgical nitinol staples for implantation in the foot to treat fractures, and inserters for implanting the surgical nitinol staples in the foot. [Background technology]

[0002] During surgical procedures to treat fractures on the foot region, surgeons may use screws or plates to stabilize the fracture. The use of screws and plates for fractures, arthrodesis or osteotomies can result in loss of compression over time. After surgery, slight movement of bone fragments during patient ambulation can lead to migration or loosening of the implant. If compression is lost too much, malunion or nonunion can occur and revision surgery may be required to properly compress the bone fragments together. Therefore, there is a need for alternative fixation systems and methods, such as staples and staple inserters, to overcome the above-mentioned shortcomings. Summary of the Invention

[0003] To meet this and other needs, according to one embodiment, an implantable surgical staple for treating a fracture in a patient's foot includes a first leg configured to be placed on a first side of the fracture, the first leg having a first tip, a second leg configured to be placed on a second side of the fracture different from the first side, the second leg having a second tip, and a bridge disposed between the first and second legs. The bridge includes an angled cut such that an upper portion of the bridge is a first width that is less than a second width of a lower portion of the bridge. In an initial state, the first tip and the second tip are spaced apart a first distance and move to a second distance greater than the first distance when a force is applied to the bridge.

[0004] According to one embodiment, an implantable system for treating a fractured leg of a patient includes a staple configured for implantation at a surgical site. The staple includes a first leg configured for placement on a first side of the fracture, the first leg having a first tip, a second leg configured for placement on a second side of the fracture different from the first side, the second leg having a second tip, and a bridge disposed between the first and second legs. The bridge includes an angled cut such that an upper portion of the bridge is a first width that is less than a second width of a lower portion of the bridge. In an initial state, the first tip and the second tip are spaced apart a first distance and move to a second distance greater than the first distance when a force is applied to the bridge. The implantable system also includes an inserter configured to engage the staple and apply a force to the bridge to move the first tip and the second tip from a first distance to a second distance. [Brief description of the drawings]

[0005] A more complete understanding of the present invention, together with its attendant advantages and features, will be more readily appreciated by reference to the following detailed description when considered in conjunction with the accompanying drawings, in which: [Figure 1] 1 illustrates a surgical staple for implantation into bone, according to an exemplary embodiment of the present disclosure; [Diagram 2] 1 illustrates a surgical staple inserter according to an exemplary embodiment of the present disclosure; [Diagram 3] 1 illustrates a surgical staple attached to an inserter for implantation into bone, according to an exemplary embodiment of the present disclosure; [Figure 4] 1 illustrates a surgical staple attached to an inserter for implantation into bone, according to an exemplary embodiment of the present disclosure; [Diagram 5] 1 illustrates a surgical staple attached to an inserter for implantation into bone, according to an exemplary embodiment of the present disclosure; [Figure 6A] 1 illustrates a surgical staple for implantation into bone, according to an exemplary embodiment of the present disclosure; [Figure 6B] 1 illustrates a surgical staple for implantation into bone, according to an exemplary embodiment of the present disclosure; [Figure 7A] 1 illustrates a surgical staple for implantation into bone, according to an exemplary embodiment of the present disclosure; [Figure 7B] 1 illustrates a surgical staple for implantation into bone, according to an exemplary embodiment of the present disclosure; [Figure 8A] 1 illustrates a surgical staple for implantation into bone, according to an exemplary embodiment of the present disclosure; [Figure 8B] 1 illustrates a surgical staple for implantation into bone, according to an exemplary embodiment of the present disclosure; [Figure 9A] 1 illustrates a surgical staple for implantation into bone, according to an exemplary embodiment of the present disclosure; [Figure 9B] 1 illustrates a surgical staple for implantation into bone, according to an exemplary embodiment of the present disclosure; [Figure 9C] 1 illustrates a surgical staple for implantation into bone, according to an exemplary embodiment of the present disclosure; [Figure 10A] 1 illustrates a surgical staple for implantation into bone, according to an exemplary embodiment of the present disclosure; [Figure 10B] 1 illustrates a surgical staple for implantation into bone, according to an exemplary embodiment of the present disclosure; [Figure 10C] 1 illustrates a surgical staple for implantation into bone, according to an exemplary embodiment of the present disclosure; [Figure 11A] 1 illustrates a surgical staple for implantation into bone, according to an exemplary embodiment of the present disclosure; [Figure 11B] 1 illustrates a surgical staple for implantation into bone, according to an exemplary embodiment of the present disclosure; [Figure 11C] 1 illustrates a surgical staple for implantation into bone, according to an exemplary embodiment of the present disclosure; [Figure 12A] 1 illustrates a surgical staple for implantation into bone, according to an exemplary embodiment of the present disclosure; [Figure 12B]1 illustrates a surgical staple for implantation into bone, according to an exemplary embodiment of the present disclosure; [Figure 12C] 1 illustrates a surgical staple for implantation into bone, according to an exemplary embodiment of the present disclosure; [Figure 13A] 1 illustrates a surgical staple inserter according to an exemplary embodiment of the present disclosure; [Figure 13B] 1 illustrates a surgical staple inserter according to an exemplary embodiment of the present disclosure; [Figure 14] 1 illustrates an exploded view of a surgical staple inserter according to an exemplary embodiment of the present disclosure; [Figure 15A] 1 illustrates a surgical staple inserter according to an exemplary embodiment of the present disclosure; [Figure 15B] 1 illustrates a surgical staple inserter according to an exemplary embodiment of the present disclosure; [Figure 16A] 1 illustrates a portion of a surgical staple inserter according to an exemplary embodiment of the present disclosure. [Figure 16B] 1 illustrates a portion of a surgical staple inserter according to an exemplary embodiment of the present disclosure. [Figure 17] 1 illustrates a portion of a surgical staple inserter according to an exemplary embodiment of the present disclosure. [Figure 18] 1 illustrates a portion of a surgical staple inserter according to an exemplary embodiment of the present disclosure. [Figure 19A] 1 illustrates a surgical staple inserter according to an exemplary embodiment of the present disclosure; [Figure 19B] 1 illustrates a surgical staple inserter according to an exemplary embodiment of the present disclosure; [Figure 20] 1 illustrates an exploded view of a surgical staple inserter according to an exemplary embodiment of the present disclosure; [Figure 21] 1 illustrates a surgical staple inserter according to an exemplary embodiment of the present disclosure; [Figure 22] 1 illustrates a surgical staple inserter according to an exemplary embodiment of the present disclosure; [Diagram 23]1 illustrates a surgical staple inserter according to an exemplary embodiment of the present disclosure; DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0006] The embodiments of the present disclosure are generally directed to devices, systems, and methods for fixation of bone fractures, including the foot. Nitinol staples are an alternative or complementary fixation device to screw or plate fixation of fractures, arthrodesis, or osteotomies. The shape memory or superelastic properties of Nitinol allow the staples to provide continuous compression across the bone gap. Nitinol staples are designed with legs that bend inward in a free state. Prior to insertion during surgery, the staple legs are distracted outward using an inserter so that the legs are parallel or close to parallel. The staple is embedded, and removal of the inserter allows the legs to return to a free state, resulting in continuous compression of the bone gap. The compression provided by the staples is less likely to loosen than compression provided by screws and / or plates due to the superelastic properties of Nitinol. The following disclosure includes staple designs, including staples designed for the forefoot, midfoot, and hindfoot, as well as staples that provide greater rotational stability for applications requiring more compression. The various sizes of each style provide the surgeon with a complete set to cover all applications for use on the foot.

[0007] Referring to FIG. 1, an exemplary staple consistent with the principles of the present disclosure is shown. Staple 100 includes legs 102 and bridge 104. Nitinol staples are designed such that the legs are free to bend inward. The conventional method of inserting these staples involves using a drill guide based on the selected size to determine the bridge length and leg length of the staple by drilling parallel holes on either side of the bone gap that are perpendicular to the bone surface. The staple is then loaded into an inserter by distracting the staple legs outward so that the legs are parallel, embedding the staple into the bone. The inserter is then removed from the staple, thereby allowing the legs to return to their free state, thereby continuously compressing the bone gap. These multiple instruments can be either reusable or single use, but add a small amount of time to the procedure of inserting Nitinol staples.

[0008] Procedures involving the implantation of nitinol staples can be cumbersome due to the number of instruments used and the challenges in maintaining visibility of pre-drilled holes for the staple legs prior to implantation. Consistent with the principles of the present disclosure, systems and methods for implanting staples using ultrasonic technology are described in more detail below that allow a surgeon to implant nitinol staples without the need to pre-drill pilot holes for the staple legs.

[0009] The present disclosure enables a variety of methods of embedding Nitinol staples using ultrasonic technology by allowing the staple to create a pathway for itself to embed into the bone without the need for pre-drilling. By using ultrasonic technology, the sharp tips of the staple legs can cut into the bone during insertion.

[0010] 1 shows an exemplary staple 100 having two legs 102. Between the legs 102 is a bridge 104. The bridge 104 and legs 102 may have different lengths depending on the size of the staple selected. The legs 102 may have teeth 106 that are used to prevent the staple 100 from backing out of the bone after it has been implanted. The legs 102 may have a sharp tip 108 that is used to help facilitate insertion of the staple into the bone.

[0011] 2 illustrates an exemplary embodiment of an ultrasound device 200 consistent with the principles of the present disclosure. The ultrasound device 200 includes a handle 202 connected to a cord 204 that provides electrical current from a power source to the ultrasound device 200. The power source provides motion to components within the handle 202.

[0012] As shown in Figures 3-5, the handle 202 has a protrusion 206 that is either fixed therein or removable. The protrusion 206 may be located, for example, under the bridge 104 of the staple 100. The handle 202 has a mechanism 208, which may be in the form of a dial 208 that, when actuated or rotated, causes the protrusion 206 to either stretch open or compress closed. When stretched open, the protrusion 206 compresses the legs 102 of the staple 100, stretching the legs 102 open so that the legs 102 are parallel to one another.

[0013] Once the legs 102 of the staple 100 are distracted, the ultrasonic device 200 can be turned on to convert electrical current into high frequency mechanical vibrations. These vibrations are transmitted from the internal components of the handle 202 to the prongs 206 and from the prongs 206 to the staple 100. The vibrations can be either a linear stroke pattern in an up-down or side-to-side motion, or an elliptical stroke pattern.

[0014] The high frequency vibrations may be sustained at 20 kHz or higher. Due to the speed of the vibrations, the sharp tips 108 of the staples 100 act as cutting tools, cutting a path through the bone as they are pressed against the bone. Once the legs 102 are at the proper depth into the bone, the ultrasonic device 200 is stopped, the prongs 206 are squeezed closed, and the handles 202 are removed from the staples 100, forcing the bottom of the bridges 104 flat against the bone.

[0015] This procedure simplifies the insertion of the staple into the bone. Because the tip of the staple leg can cut its own path by using ultrasonic technology, the drilling step is eliminated and there is no longer a need for a drill guide or drill bit, thus simplifying the procedure and reducing the surgical time.

[0016] 6A and 6B show a staple 600 consistent with the principles of the present disclosure. The staple 600 may be configured for use in the forefoot of a patient needing treatment for a fracture. The staple 600 may include legs 602 and a bridge 604. The legs 602 and bridge 604 may have different lengths depending on the size of the staple selected. The bridge 604 may be configured to have a slight curvature and the legs 602 may be angled inwardly in their resting state. The legs 602 may include teeth or serrations 606. The teeth 606 may be located on the inside of the legs 602 and angled upwardly. This helps prevent the staple 600 from backing out of the bone after it has been implanted. The number of teeth or serrations 606 may vary based on the length of the legs 602. The legs 602 may have a tapered tip 608 that is used to help facilitate insertion of the staple 600 into the bone. In FIG. 6B, a side view of staple 600 shows that the bridge 604 and legs 602 are of uniform thickness, resulting in a flat staple shape.

[0017] 7A and 7B show a staple 700 consistent with the principles of the present disclosure. The staple 700 may be configured for use in the hindfoot of a patient needing treatment for a fracture. The staple 700 may include legs 702 and a bridge 704. Teeth or serrations 706 and a tapered tip 708 may also be present on the staple 700. As shown in FIG. 7B, a side view of the staple 700 shows that the staple 700 may be thicker than the staple 600 used in the forefoot. Because the majority of compression comes from the bridge 704 of the staple 700, the thickness of the bridge 704 is tapered to be thicker than the legs 702 to provide the greater compressive force required to hold against forces on the hindfoot.

[0018] 8A and 8B show a staple 800 consistent with the principles of the present disclosure. The staple 800 may be configured for use in the hindfoot of a patient requiring treatment of a fracture. The staple 800 may have legs 802 and a bridge 804. The staple 800 may also have teeth 806 and a tapered tip 808. The staple 800 may differ from the previously described staples by having four legs 802 instead of two legs to provide more fixation points and provide greater rotational stability. The staple 800 may have a thicker bridge 804 compared to the legs 802 to account for forces in the hindfoot where this staple is primarily used. The four legs of this staple remain in line to maintain the narrow profile of these staples for locations that do not have a wide bone surface.

[0019] 9A, 9B, and 9C show a staple 900 consistent with the principles of the present disclosure. The staple 900 may be configured for use in the hindfoot of a patient requiring treatment of a fracture. The staple 900 may have legs 902 and a bridge 904. The staple 900 may also have teeth 906 and a tapered tip 908. The staple 900 may be X-shaped when viewed from the top of the bridge 904. The staple 900 provides a larger contact area around the joint while still providing a greater amount of rotational stability. The staple 900 may have two rows of legs 902. The staple 900 may be used in areas with sufficient bone surface to accommodate the full width.

[0020] 10A, 10B, and 10C show a staple 1000 consistent with the principles of the present disclosure. The staple 1000 may be configured for use in the hindfoot of a patient requiring treatment of a fracture. The staple 1000 includes legs 1002 and a bridge 1004. The staple 1000 may also have teeth 1006 and a tapered tip 1008.

[0021] As shown in FIG. 10B, a side view of staple 1000 shows that it is thicker than a forefoot style staple, such as staple 600. Since most of the compression comes from the bridge of the staple, the thickness of bridge 1004 is angled to be thicker than legs 1002 to provide the greater compression force required to hold against the forces on the rearfoot. At the top of bridge 1004 is an angled cut 1010. As shown in FIG. 10C, a top view of staple 1000 shows that the angled cut 1010 of bridge 1004 allows bridge 1004 to thin slightly toward the center, facilitating bending at this location when the staple is engaged with an inserter to embed into the bone. Bridge 1004 includes angled cut 1010 such that the width of the top of the bridge is less than the width of the bottom of bridge 1004. During implantation into bone, a force is applied to the bridge 1004, causing the legs 1002 to spread apart such that the tapered tips 1008 are a greater distance apart than in their original position. After the staple 1000 is implanted, the legs 1002 move towards each other to provide a compressive force at the fracture site.

[0022] 11A, 11B, and 11C show a staple 1100 consistent with the principles of the present disclosure. The staple 1100 may be configured for use in the hindfoot of a patient needing treatment for a fracture. The staple 1100 may have legs 1102 and a bridge 1104. The staple 1100 may also have teeth 1106 and a tapered tip 1108. The staple 1100 may have four legs 1102 instead of two legs to provide more fixation points and provide greater rotational stability. The staple 1100 may have a thicker bridge 1104 compared to the legs 802 to account for forces in the hindfoot where this staple is primarily used. The four legs of this staple remain in line to maintain the narrow profile of these staples for locations that do not have a wide bone surface. The staple 1100 may also have an angled cut 1110 at the top of the bridge 1104, as shown in the side and top views of Figures 11B and 11C, respectively.

[0023] 12A, 12B, and 12C show a staple 1200 consistent with the principles of the present disclosure. The staple 1200 may be configured for use in the hindfoot of a patient requiring treatment of a fracture. The staple 1200 may have legs 1202 and a bridge 1204. The staple 1200 may also have teeth 1206 and a tapered tip 1208. The staple 1200 may be I-shaped when viewed from the top of the bridge 1204. The staple 1200 provides a larger contact area around the joint while still providing a greater amount of rotational stability. The staple 1200 may have two rows of legs 1202. The staple 1200 may be used in areas with sufficient bone surface to accommodate the full width.

[0024] 13A-18 show an inserter 1300 consistent with the principles of the present disclosure. The inserter 1300 includes a housing 1302, a cam lever 1304, a post 1306, a tip 1308, a central pin 1310, and a spring 1312. In operation, a staple is held by the tip 1308 with the cam lever 1304 in a first position as shown in FIGS. 13A and 13B. When the cam lever 1304 is in a second position as shown in FIGS. 15A and 15B, the post 1306 is moved by the cam lever 1304 to provide a force on the bridge of the staple, causing the legs to spread wider than their original position and the staple to be embedded in bone. The components of the inserter 1300 are described in further detail below.

[0025] The housing 1302 houses the other components of the inserter 1300 and provides the surgeon with a flat outer surface 1314 to grip when embedding the Nitinol staples into bone. The distal end 1316 of the inserter 1300 reduces in width to limit the extent to which the housing 1302 obstructs the view of the staples being inserted into the surgical site. The housing 1302 includes multiple holes for pins and posts to hold or interact with the components together and to deploy the staples. The housing 1302 also includes a pocket 1318 from one side that allows the deployment mechanism to be assembled.

[0026] The cam lever 1304 has an arm 1320 that is offset from the cam 1322 and extends beyond the contour of the housing 1302 when assembled. The cam lever 1304 has a pin hole 1324 located at the center of the cam 1322 around which the cam 1322 rotates when assembled. The cam 1322 itself is designed to have a varying radius along its circumference depending on where it contacts the mating part.

[0027] The post 1306 has a distal end 1326 that extends out from the distal end 1316 of the housing 1302 when assembled. The post 1306 has a shaft 1328 and a proximal end 1330 that contacts the cam lever 1304 during use. The shaft 1328 may have a constant diameter. The distal end 1326 is tapered to avoid interference with the tip 1308 during assembly and use. The distal end 1326 of the post 1306 presses down on the staple bridge. The proximal end 1330 of the post 1306 has a larger diameter than the shaft 1328. This provides a larger surface area for the cam lever 1304 to slide against. This also allows the spring 1312 to press against the post 1306 and helps hold it in the housing 1302.

[0028] The tips 1308 are press-fit into the housing 1302 during assembly. Each of the tips 1308 may have two bosses 1332 and 1334, one on each end of the piece. The boss 1332 on the proximal end is what is press-fit into the housing 1302 and the boss 1334 on the distal end is used to load a staple onto the staple inserter. The staple rests on the boss 1334 on the distal end of the tip 1308. The tip 1308 is press-fit into the staple inserter such that the staple rests on the two bosses 1334.

[0029] The center pin 1310 may be press fit into one side of the housing 1302, pass through a pin hole 1324 in the cam lever 1304, and then press fit again through the other side of the housing 1302. The center pin 1310 holds the cam lever 1304 in place while allowing it to rotate about it.

[0030] The spring 1312 may be disposed around the shaft 1328 of the post 1306 and fits within a pocket 1318 in the housing 1302. The spring 1312 presses the post 1306 into the housing 1302 and keeps the tip of the post 1306 out of the way of the staples for easy assembly.

[0031] To load a staple onto the inserter 1300, the cam lever 1304 is pulled down to its unlocked position, as shown in Figures 13A and 13B. The cam 1322 on the cam lever 1304 is positioned so that its smallest radius faces distally and rests against the post 1306. This allows more room for the post 1306 to embed within the housing 1302. This creates space for the bridge of the staple to seat on the distal boss 1334 of the tip 1308.

[0032] Once the staple is in place, the cam lever 1304 is actuated to its locked position, as shown in FIGS. 15A and 15B. This rotates the cam 1322 on the cam lever 1304 so that the maximum radius faces distally, which slides against the post 1306 and depresses it. The post 1306 continues to be pushed out of the housing 1302 until it contacts the bridge of the staple, forcing it to bend. While the staple bridge is bending, the legs of the staple are parallel. This is the locked, deployed position that allows the staple to be embedded into bone.

[0033] Once the staple is embedded in the bone, the surgeon pulls down on the cam lever 1304 to release the post 1306 from pushing down on the staple and then slides the tip 1308 out from under the staple bridge. One of the surfaces of the inserter 1300 may be used to compress the staple flush with the bone or an additional tool may be used to compress it. The groove in the housing 1302 into which the tip 1308 is embedded determines the distance and angle between the distal bosses 1334 of the tip 1308. The angle of the groove can be changed depending on the bridge length of the staple being installed. Each staple bridge length has a separate staple inserter with a set tip angle. Figures 16A and 16B show inserters with different tip angles.

[0034] 17, the tip 1308 can be assembled to the opposite side of the housing 1302. This requires the surgeon to twist counterclockwise to remove the tip 1308 from under the bridge of the staple, as opposed to sliding it.

[0035] As shown in Figure 18, the tip 1308 can be implemented as a single component bridged together with more material, reducing the overall components required and facilitating the assembly method.

[0036] The inserter 1300 allows for quick movement of the cam lever 1304 to release the staple after it has been implanted. The inserter 1300 also has the ability to reload onto the staple if the surgeon determines it needs to be moved or removed entirely after implantation. Some existing staple inserters do not allow for reinsertion of the staple inserter once the staple has been removed.

[0037] 19A-21, an inserter 1900 consistent with the principles of the present disclosure is shown. The inserter 1900 includes a housing 1902, an arm 1904, and a threaded post 1906. In operation, a staple is loaded onto the arm 1904, and as the threaded post 1906 rotates, the arm 1904 retracts toward the proximal end of the housing 1902, causing a bridge of the staple to engage a portion of the housing 1902, bending the bridge and spreading the legs of the staple further apart. Each of the component inserter 1900 is described in further detail below.

[0038] The housing 1902 can include other components of the inserter 1900 and can provide the surgeon with a flat outer surface to grip when embedding the nitinol staples into bone. The distal end 1908 of the housing 1902 narrows in width, thereby limiting how much the housing 1902 blocks the view of the staples being embedded in the surgical site. The housing 1902 includes a hole 1910 on the proximal end 1912 for placement of the threaded post 1906 during assembly. The housing 1902 also includes a pocket 1914 on the rear side in which the arm 1904 is positioned during assembly and allows for translation during use. The housing 1902 includes a tip or pin 1916 that projects downwardly from the distal end 1908 and interacts with the bridge of the staple during use.

[0039] The arm 1904 has a threaded hole 1918 on a proximal end 1920 of the arm 1904 that mates with the threaded post 1906. The arm 1904 has two bosses 1922 on a distal end 1924 of the arm 1904 that are used to load a staple onto the inserter 1900. The staple rests on both bosses 1922 while being loaded.

[0040] The threaded post 1906 has a distal end 1926 that is threaded to interact with the arms 1904. A proximal end 1928 of the threaded post 1906 has a wing nut shape that protrudes beyond the proximal end 1912 of the housing 1902 for a surgeon to rotate clockwise to load staples and counterclockwise to remove staples.

[0041] The inserter 1900 is designed to push down on the top of the middle bridge of the staple while simultaneously holding the underside of the bridge near the corner. This causes the bridge of the staple to bend downward, which causes the legs of the staple to flex outward so that they are parallel to each other for embedding in the bone. To assemble, the arm 1904 is placed into the housing 1902 from the rear side and the threaded post 1906 is embedded from the proximal end 1912 into the hole 1910 in the housing 1902 and screwed into the threaded hole 1918 on the arm 1904.

[0042] To load a staple onto the inserter 1900, the threaded post 1906 is rotated counterclockwise, which causes the arm 1904 to translate distally, creating sufficient space between the boss 1922 on the arm 1904 and the tip 1916 of the housing 1902, as shown in FIG. 19A. With the space created, a staple can be seated on the distal boss 1922 of the arm 1904.

[0043] Once the staple is in place, the threaded post 1906 is rotated clockwise. This causes the arms 1904 to translate proximally back into the housing 1902. The tips 1916 on the housing 1902 contact the bridge of the staple as the threaded post 1906 is rotated, forcing the bridge of the staple to bend. While the staple bridge is bending, the legs are parallel. This is the locked, deployed position that allows the staple to be embedded into bone, as shown in FIG. 19B.

[0044] Once the staple is embedded in the bone, the surgeon rotates the threaded post 1906 counterclockwise, releasing the tension created on the staple and allowing the legs to bend inward, then sliding the bosses 1922 of the arms 1904 out from under the staple bridge. One of the surfaces of the inserter 1900 may be used to compress the staple flush with the bone, or an additional tool may be used to compress it. The distance between the bosses 1922 of the arms 1904 can be varied depending on the bridge length of the staple being attached. Each staple bridge length has a separate staple inserter with a set distance between the bosses.

[0045] The arms 1904 may be recessed within the housing 1902 to prevent disassembly. Figure 20 is an exploded view of the inserter 1900, showing how the arms 1904 fit within pockets 1914 in the housing 1902, yet still allow translation for deployment and removal of the staples.

[0046] The inserter 1900 allows for a screw mechanism to release the staple after it has been implanted. The inserter 1900 also has the ability to reload onto the staple if the surgeon determines it needs to be moved or removed entirely after implantation. Some existing staple inserters do not allow for reinsertion of the staple inserter once the staple has been removed.

[0047] 22 and 23 show an inserter 2200 consistent with the principles of the present disclosure. The inserter 2200 includes a housing 2202 and a threaded post 2204. These components are described in further detail below.

[0048] The housing 2202 can contain the other components of the inserter 2200 and can provide the surgeon with a flat outer surface to grip when embedding the Nitinol staples into bone. The distal end 2206 of the inserter 2200 includes a protrusion 2208 that acts as a resting surface for the staple. The housing 2200 includes a threaded through hole 2210 on the proximal end 2212 for placement of the threaded post 2204 during assembly.

[0049] The threaded post 2204 has a smooth, rounded distal end 2214 to interface with the bridge of a staple. The threaded post 2204 includes a shaft 2216. A mid-section 2218 of the shaft 2216 is threaded to interface with the housing 2202. The proximal end 2220 of the post 2204 may have a wing nut shape that protrudes beyond the proximal end 2212 of the housing 2202 for the surgeon to rotate clockwise to load the staple and counterclockwise to remove the staple.

[0050] The inserter 2200 is designed to press down on the top of the middle bridge of the staple while simultaneously holding the underside of the bridge near the corner. This causes the bridge of the staple to bend downward, which causes the legs to flex outward and become parallel to each other for embedding in the bone. To assemble, the threaded post 2204 is threaded into the housing 2202 from the proximal end 2212 of the housing 2202.

[0051] To load a staple onto the inserter 2200, the threaded post 2204 is rotated counterclockwise, which causes the tip of the threaded post 2204 to translate distally. This creates sufficient space between the protrusion 2208 on the housing 2202 and the tip of the threaded post 2204. With the space created, the staple can be seated on the protrusion 2208 of the housing 2202.

[0052] Once the staple is in place, the threaded post 2204 is rotated clockwise. This translates the threaded post 2204 distally. The tip of the threaded post 2204 contacts the bridge of the staple as the threaded post 2204 is rotating, forcing the staple bridge to bend. While the staple bridge is bending, the legs are parallel. This is the open, deployed position that allows the staple to be embedded into the bone.

[0053] Once the staple is embedded in the bone, the surgeon rotates the threaded post 2204 counterclockwise, releasing the tension created on the staple and allowing the legs to bend inward, then sliding the prongs 2208 of the housing 2202 out from under the staple bridge. One of the surfaces of the inserter 2200 may be used to compress the staple flush with the bone, or an additional tool may be used to compress it. The distance between the prongs 2208 of the housing 2202 may vary depending on the bridge length of the staple being installed. Each staple bridge length has a separate staple inserter with a set distance between the prongs.

[0054] The inserter 2200 allows for a screw mechanism to release the staple after it has been implanted. The inserter 2200 has the ability to reload onto the staple if the surgeon determines it needs to be moved or removed entirely after implantation. Some existing staple inserters do not allow for reinsertion of the staple inserter once the staple has been removed. The inserter 2200 is low profile and allows for visualization of the surgical site where the staple is being implanted.

[0055] It is further understood that various changes in the details, materials, and arrangements of parts described and illustrated to explain the nature of the invention may be made by those skilled in the art without departing from the scope of the invention as expressed in the claims. Those skilled in the art will appreciate that the above-described embodiments are non-limiting. It will also be understood that one or more features of one embodiment may be partially or fully incorporated in one or more other embodiments described herein.

Claims

1. 1. An implantable surgical staple for treating a leg fracture in a patient, comprising: a first leg configured to be positioned on a first side of the fracture, the first leg having a first tip; a second leg configured to be placed on a second side of the fracture different from the first side, the second leg having a second tip; a bridge disposed between the first leg and the second leg, the bridge including an angled cut such that an upper portion of the bridge has a first width that is less than a second width at a lower portion of the bridge; 1. An implantable surgical staple, wherein in an initial state, the first tip and the second tip are spaced apart a first distance and, when a force is applied to the bridge, the bridge moves to a second distance that is greater than the first distance.

2. The implantable surgical staple of claim 1 , wherein the first leg, the second leg, and the bridge are comprised of Nitinol.

3. The implantable surgical staple of claim 1 , wherein the first leg and the second leg are configured to provide compression to the fracture after implantation.

4. The implantable surgical staple of claim 1 , wherein the first leg and the second leg include teeth configured to prevent backout of the staple after implantation in the patient.

5. The implantable surgical staple of claim 1 , wherein said first tip and said second tip are tapered.

6. The implantable surgical staple of claim 1 , wherein the angled cut narrows the bridge toward a center of the bridge.

7. The implantable surgical staple of claim 1 , further comprising a third leg and a fourth leg.

8. The implantable surgical staple of claim 7 , wherein the third leg has a third tip and the fourth leg has a fourth tip.

9. The implantable surgical staple of claim 8 , wherein the third leg and the fourth leg include teeth to prevent backout of the surgical staple after implantation.

10. The implantable surgical staple of claim 9, wherein the third tip is tapered and the fourth tip is tapered.

11. 1. An implantable system for treating a leg fracture in a patient, comprising:

1. A staple configured for implantation at a surgical site, said staple comprising: a first leg configured to be positioned on a first side of the fracture, the first leg having a first tip; a second leg configured to be placed on a second side of the fracture different from the first side, the second leg having a second tip; a bridge disposed between the first leg and the second leg, the bridge including an angled cut such that an upper portion of the bridge has a first width that is less than a second width at a lower portion of the bridge; a bridge, in an initial state, wherein the first end and the second end are spaced apart a first distance, and when a force is applied to the bridge, the bridge moves to a second distance greater than the first distance; an inserter configured to engage the staple to apply the force to a bridge to move the first tip and the second tip from the first distance to the second distance.

12. 12. The implantable system of claim 11, wherein the first leg, the second leg, and the bridge are constructed from Nitinol.

13. 12. The implantable system of claim 11, wherein after implantation, the first leg and the second leg are configured to provide compression to the fracture.

14. 12. The implantable system of claim 11, wherein the first leg and the second leg include teeth configured to prevent backout of the staple after implantation in the patient.

15. 12. The implantable system of claim 11, wherein the first end and the second end are tapered.

16. 12. The implant system of claim 11, wherein the angled cut narrows the bridge toward a center of the bridge.

17. The implantable surgical staple of claim 11, further comprising a third leg and a fourth leg.

18. The implantable surgical staple of claim 17, wherein the third leg has a third tip and the fourth leg has a fourth tip.

19. 20. The implantable surgical staple of claim 18, wherein the third leg and the fourth leg include teeth to prevent backout of the surgical staple after implantation.

20. The implantable surgical staple of claim 19, wherein the third tip is tapered and the fourth tip is tapered.

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