Trauma staples and associated tools and methods

Abstract

A system for an orthopedic procedure, includes a staple and a surgical tool. The tool includes a cylindrical shaft defining a lumen, and a head at an end of the shaft including a fork portion and first and second hooks extending from the fork portion. Each of the first and second hooks include a shelf having a notch configured to receive a bridge of a staple. A plunger is receivable within the lumen, and the head includes an opening to allow the plunger to extend therethrough to engage the bridge.

Description

2024-115. DEX-PCT; 67145-932 PCTTitle:TRAUMA STAPLES AND ASSOCIATED TOOLS AND METHODSInventors:Manish ThapaCory ShultzDr. Erik KubiakDr. Anish KadakiaDr. Thomas HarrisAlex SzypaCarlson, Gaskey & Olds400 W. Maple Road, Suite 350 Birmingham, MI 48009(248) 988-83602024-115. DEX-PCT; 67145-932 PCTTRAUMA STAPLES AND ASSOCIATED TOOLS AND METHODS CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims priority from United States Provisional Patent Application Number 63 / 753,070 filed on February 3, 2025, the entire contents of which are incorporated by reference.BACKGROUND

[0002] In the field of orthopedic surgery it is common to rejoin broken bones, which can be rejoined using staples. Staples are formed from a plurality of legs connected together by a bridge. The legs of the staples may be inserted into pre-drilled holes on either side of the fracture line, with the bridge of the staple spanning the fracture line.SUMMARY

[0003] In some aspects, the techniques described herein relate to a surgical tool, including a cylindrical shaft defining a lumen, and a head at an end of the shaft including a fork portion and first and second hooks extending from the fork portion. Each of the first and second hooks include a shelf having a notch configured to receive a bridge of a staple. A plunger is receivable within the lumen, and the head includes an opening to allow the plunger to extend therethrough to engage the bridge.

[0004] In some aspects, the techniques described herein relate to a system for an orthopedic procedure, including: a staple, and a surgical tool including a cylindrical shaft defining a lumen, and a head at an end of the shaft including a fork portion and first and second hooks extending from the fork portion. Each of the first and second hooks include a shelf having a notch configured to receive a bridge of a staple. A plunger is receivable within the lumen, and the head includes an opening to allow the plunger to extend therethrough to engage the bridge.

[0005] In some aspects, the techniques described herein relate to a method, including one or more of the following steps: drilling pilot holes into a bone; advancing a plunger onto a bridge of a staple, the advancing causing legs of the staple to move toward parallel; inserting the legs into the pilot holes; retracting the plunger from the bridge; and rotating a tool to disengage the staple from first and second hooks.

[0006] These and other features may be best understood from the following specification and drawings, the following of which is a brief description.2024-115. DEX-PCT; 67145-932 PCTBRIEF DESCRIPTION OF THE DRAWINGS

[0007] Figure 1 discloses an example system for an orthopedic procedure.

[0008] Figure 2 discloses another view of the system of Figure 1.

[0009] Figure 3 discloses another view of the system of Figures 1-2.

[0010] Figure 4 discloses another view of the system of Figures 1-3.

[0011] Figure 5 discloses another view of the system of Figures 1-4.

[0012] Figure 6 discloses an exploded view of the system of Figures 1-5.

[0013] Figure 7 discloses a cross-sectional view of an example surgical tool relative to the system of Figures 1-6.

[0014] Figure 8 discloses an exploded view of the system of Figures 1-7.

[0015] Figure 9 discloses another view of the system of Figures 1-8.

[0016] Figure 10 discloses another view of the system of Figures 1-9.

[0017] Figure 11 A discloses an example staple.

[0018] Figure 1 IB discloses another view of the example staple of Figure 11 A.

[0019] Figure 11C discloses another view of the example staple of Figures 11A- IIB.

[0020] Figure 11D discloses another view of the example staple of Figures 11A- IIC.

[0021] Figure 12A discloses another example staple.

[0022] Figure 12B discloses another view of the example staple of Figure 12A.

[0023] Figure 13 A discloses another example staple.

[0024] Figure 13B discloses another view of the example staple of Figure 13A.

[0025] Figure 14A discloses another example staple.

[0026] Figure 14B discloses another view of the example staple of Figure 14A.

[0027] Figure 14C discloses a cross-sectional view of a leg of the example staple of Figures 14A-14B.

[0028] Figure 15 discloses an example staple leg within an example bone hole configuration.

[0029] Figure 16 discloses a method of inserting an implant.2024-115. DEX-PCT; 67145-932 PCT

[0030] Figure 17A discloses an example drill guide, which may be included in the example system.

[0031] Figure 17B discloses another view of the example drill guide of Figure 17A.

[0032] Figure 17C discloses another view of the example drill guide of Figures 17A-17B.

[0033] Figure 18 discloses an example head of another drill guide.

[0034] Figure 19 discloses an example head of another drill guide.

[0035] Figure 20 discloses an example head of another drill guide.

[0036] Figure 21 discloses example additional components of the example system.

[0037] Figure 22A illustrates the example system inserting a staple into a bone.

[0038] Figure 22B illustrates another view of the example system inserting a staple into a bone.

[0039] Figure 22C illustrates another view of the example system inserting a staple into a bone.

[0040] Like reference numbers and designations in the various drawings indicate like elements.DETAILED DESCRIPTION

[0041] This disclosure relates to implants, such as staples or other similar implants, and associated tools and surgical methods. The implants and tools disclosed may be utilized for fixating fractures in implementations.

[0042] In implementations, the systems and methods disclosed may be utilized in deep working areas, such as for the femur, hip, pelvis, tibia or other similarly situated areas.

[0043] An exemplary surgical tool may include a cylindrical shaft defining a lumen, and a head at an end of the shaft including a fork portion and first and second hooks extending from the fork portion. One or both of the first and second hooks may include a shelf having a notch configured to receive a bridge of a staple. A plunger may be receivable within the lumen, with the head including an opening to allow the plunger to extend therethrough to engage the bridge.

[0044] An exemplary system for an orthopedic procedure may include a staple. A surgical tool for insertion of the staple may include a cylindrical shaft defining a lumen, and a head2024-115. DEX-PCT; 67145-932 PCTat an end of the shaft including a fork portion and first and second hooks extending from the fork portion. One or both of the first and second hooks may include a shelf having a notch configured to receive a bridge of a staple. A plunger may be receivable within the lumen, with the head including an opening to allow the plunger to extend therethrough to engage the bridge. The system may include one or more other components, such as a drill guide, drill guide extender, drill bits, a tamp, and a staple removal tool, including those examples disclosed herein.

[0045] Exemplary staples may be utilized with the systems and methods disclosed herein and may be movable between an undeformed position in which the legs converge toward one another, and a deformed position in which the legs are parallel or about parallel. The exemplary staples may be utilized to apply compressive force across a fracture site.

[0046] An exemplary method may include drilling pilot holes into a bone, advancing a plunger onto a bridge of a staple to cause legs of the staple to move toward parallel, inserting the legs into the pilot holes, retracting the plunger from the bridge, and rotating a tool to disengage the staple from first and second hooks. Each of the first and second hooks may include a shelf having a notch to receive a bridge of the staple, and the tool may include a cylindrical shaft defining a lumen, with the plunger received within the lumen.

[0047] As illustrated in Figure 1, a system 20 for an orthopedic procedure may include a surgical tool 22 for insertion of a staple 24. In implementations, the staple 24 is a trauma staple. In implementations, the staple 24 is made of nitinol. The surgical tool 22 may include a shaft 26, which may be cylindrical in implementations, defining a lumen 28. A head 30 at an end of the shaft 26 includes a fork portion 32 and first and second hooks 34A, 34B extending from the fork portion 32. The example fork portion 32 defines a transitional fork from the shaft 26 to the two hooks 34A, 34B. The shaft 26 and the head 30 may form a Y-shape. The tool 22 may be reusable.

[0048] A plunger 37 is received within, and movable proximally and / or distally within, the lumen 28. The head 30 includes an opening 39 to allow the plunger 37 to extend therethrough to engage a bridge 40 of the staple 24 received on the first and second hooks 34A, 34B.

[0049] In implementations, one or more of the shaft 26, the fork portion 32, and the hooks 34A, 34B may be monolithic. In implementations, one or more of the shaft 26, the fork portion 32, and the hooks 34A, 34B may be continuous and made of the same material. In2024-115. DEX-PCT; 67145-932 PCTimplementations, one or more of the shaft 26, the fork portion 32, and the hooks 34A, 34B is made of steel. In implementations, the shaft 26, the fork portion 32, and the hooks 34A, 34B can be fabricated as a unified component using steel or other similar materials, manufactured as a continuous piece. In implementations, the shaft 26, the fork portion 32, and the hooks 34A, 34B may be formed by subtractive manufacturing, i.e., removing by material from a solid block or sheet to create a desired shape and dimensions.

[0050] As shown in Figures 2 and 3, one or both of the first and second hooks 34A, 34B include a shelf 38A, 38B. In implementations, one or both shelves 38A, 38B may include a notch 42 for receiving the bridge 40 therein. As shown, the staple 24, when loaded, is received against the shelves 38A, 38B such that a distal surface of the bridge 40 contacts a proximal surface of the shelves 38A, 38B. The proximal surface may include the notches 42 in implementations.

[0051] The shelves 38 A, 38B may be stepped as shown, with the notches included in an upper stepped portion 38SU laterally outwardly spaced from a lower stepped portion 38SL. The stepped arrangement may allow the staple to be secured within the notches while the bridge 40 is pressed downward by the plunger 37, which is described further below, without interference by the lower stepped portion 38SL with the bridge 40.

[0052] The staple 24 includes legs 43 that extend distally from the bridge 40 and are positioned outward of the shelves 38 A, 38B. In implementations, in an undeformed position, the legs 43 may converge toward one another as they extend distally from the bridge 40. A gap G may be included between the hooks 34A, 34B as shown. In implementations, the legs 43 may be inserted into pre-drilled holes in bone (e.g., holes on either side of the fracture line) to fixate a fracture.

[0053] As shown in Figures 4-7, a plunger handle 44 may be included at the proximal end of the plunger 37. A handle 48 may be included at the proximal end of the shaft 26. The plunger handle 44 may be proximal to the handle 48 as shown. The plunger 37 may include a threaded portion 50 for engaging with internal threads 52 within the lumen 28, which may be in the shaft 26 or the handle 48, such that rotation of the plunger handle 44 in a first direction advances the plunger 37 distally and rotation of the plunger handle 44 in a second, different direction retracts the plunger 37 proximally. The notches 42 (see Figure 2) may prevent the staple 24 from rotating in response to the frictional force applied by the rotating plunger 37 to the bridge 40.2024-115. DEX-PCT; 67145-932 PCT

[0054] The tool 22 may be of sufficient length to be utilized within deep working areas. With reference to Figure 6, in implementations, the length LI of the shaft 26 including the handle 48 and the head 30 may be between about 5-8 inches. In implementations, the length L2 from the distal end of the handle 48 to the distal end of the tool may be between about 3-7 inches. In implementations, the length L2 from the distal end of the handle 48 to the distal end of the tool may be about 5 inches. In implementations, the length L3 of the plunger handle 44 may be between 1-4 inches. In implementations, the length L3 of the plunger handle 44 may be about 2.25 inches. The length and dimensions of the tool 22 may allow for proper working length in deeper anatomies, such as those found in a trauma surgical setting. The systems disclosed herein may provide a comprehensive reusable solution to anatomical reduction and provisional fixation of fractures without the hassle of applying and navigating around reduction clamps or drilling and measuring for screws.

[0055] As the plunger 37 is advanced distally, it will press downward on a proximal surface of the bridge 40, causing the legs 43 to move toward parallel with one another, as is shown in Figure 8. That is, the plunger 37 and shelves 38A, 38B allow for 3-point bending of the staple bridge 40 to open the legs 43 to parallel.

[0056] In implementations, the staple 24 may be inserted into pre-drilled holes in a bone with the legs 43 in a parallel or about parallel position, such as is shown in Figures 22A-22C. The legs 43 may be inserted into a position in which the legs 43 are opposite one another from a fracture line F. Once inserted, the plunger 37 may be released, causing the legs 43 to move toward a more converged position again when inside the holes. In implementations, this convergence results in compression of the bone, such as for healing of a fracture. In implementations, the head 30 may then be rotated to release the staple 24 from the tool 22. The staple 24 may be further seated into the bone, such as with a tamp or other similar tool.

[0057] As shown in Figure 9, with reference to Figure 3, when the staple 24 is loaded onto the surgical tool 22 and received in the notches 42, a plane Pl may bisect the staple 24. The first hook 34A may include a first post 46A extending from the fork portion 32, the second hook 34B includes a second post 46B extending from the fork portion 32. The first post 46A and the second post 46B may be opposite the plane Pl from one another. The shelf 38A of the first hook 34A and the shelf 38B (behind the shelf 38A in the view of Figure 9; see Figure 3) of the second hook 34B extend through the plane Pl. The plane Pl may also bisect the shaft 26 and the2024-115. DEX-PCT; 67145-932 PCTplunger 37 (see Figure 3). In implementations, the shelf 38A of the first hook extends in a first direction XI from the first post 46A, and the shelf 38B extends in a second direction X2 from the second post. The direction XI is opposite the direction X2. The directions XI and X2 may be parallel or about parallel to one another.

[0058] In implementations, the fork portion 32 and the first post 46A include a continuous flat surface 56A parallel with the plane Pl. The fork portion 32 and the second post 46B may also include a continuous flat surface 56B parallel with the plane Pl and opposite the surface 56A. Such flat surfaces 56A, 56B may allow for improved maneuvering within deep working areas in implementations. Other configurations may be utilized in implementations. The surface 56A and the surface 56B may be substantially identical. The surface 56A and the surface 56B may be mirror symmetrical. The example surfaces 56A, 56B span a portion of the fork portion 32 and their respective hooks 34A, 34B. One or both of the example surfaces 56A, 56B may be J-shaped as shown (see Figure 8). In implementations, the end surface of the shelf 38A may be planar or parallel with the surface 56B. The end surface of the shelf 38B may be planar or parallel with the surface 56 A.

[0059] As shown in Figure 10, in implementations, the shelf 38A has a maximum width W1 measured in a third direction X3 perpendicular or about perpendicular to the first direction XI, and the shelf 38B has a maximum width W2 measured in the third direction X3. The staple 24 has a maximum inner length LSI between legs 43 in its undeformed position. Applicant has found that maximizing the widths W 1 and W2 relative to the length LSI may increase stability in some implementations. The width W 1 and the width W2 may lie in the plane PL

[0060] In implementations, the fork portion 32 has a width W4 greater than an outer diameter DI of the shaft 26. Applicant has found that this diameter and width relationship and / or having a cylindrical shaft 26 allows a surgeon to operate in deep working areas in a minimally invasive manner. In implementations, the diameter DI may be between 0.25-1 inch. In implementations, the diameter DI may be about 0.4 inches.

[0061] In deep working area implementations, the systems and methods disclosed address the challenges that traumatologists encounter in fixating fractures in deep working areas. The instruments may provide a longer working length, and the inserter may allow for release of the staple without changing the position of the inserter relative to the bone and surrounding soft tissue, as to not impinge or be impinged upon by those anatomies. The shape and design of the2024-115. DEX-PCT; 67145-932 PCTinserter may allow for a greater potential for visualization and control compared to prior art designs.

[0062] Various types and configurations of staples may be utilized with systems disclosed herein, including one or more of the examples disclosed herein.

[0063] Figures 11A-11D illustrate one example staple 24 in an undeformed position that may be utilized with the systems and methods disclosed herein. The bridge 40 may be curved to arch upward, with two legs 43 extending from the bridge 40. The legs 43 converge toward one another as they extend away from the bridge 40. The bridge 40 connects the legs 43. The inner faces 60 of the legs 43 face one another and may include serrations 62. The serrations 62 may be included near the distal end of the leg 43.

[0064] A horizontal baseline B extending horizontally from leg to leg may be defined, and the example bridge 40 may be curved to arch upward relative to a horizontal baseline B as shown. One or both of the legs 43 may be angled less than 90 degrees with the baseline B when the staple 24 is in the undeformed position. In some implementations, the outer lateral surface 66 of one or both of the legs 43 is angled at an angle a degrees from the baseline B. In implementations, the angle a is less than 90 degrees. In implementations, the angle a is between 70-80 degrees, which Applicant has found may provide optimal contact with the cortical layer of the bone and mimic the functionality of a traditional bone clamp in some applications. In implementations, the angle a is about 75 degrees. A beveled edge 70 may extend from the outer lateral surface 66 to a distal tip edge 72 as shown, providing a taper of the leg 43 from the outer lateral surface 66 to the tip edge 72.

[0065] As shown in Figure 11C, the staple 24 may have an outer maximum length LS2. In implementations, the width LS2 is between 0.47 inches and 1 inches.

[0066] As shown in Figure 11D, the staple 24 may have a total height Hl. In implementations, the height Hl is between 0.4 and 0.5 inches. In implementations, the width WS1 is between 0.05 and 0.1 inches. The staple 24 may have a uniform width WS1.

[0067] The staple 24 may be made of nitinol, a shape memory alloy (SMA) including nickel and titanium, in implementations. Other materials, including stainless steel alloys or titanium alloys, may be utilized for the staples disclosed herein.

[0068] Figures 12A and 12B illustrate another example staple 124 in an undeformed position that may be utilized with the systems and methods disclosed herein, and being2024-115. DEX-PCT; 67145-932 PCTsubstantially similar to the staple 24. The bridge 140 has a greater width WS2 than the width WS3 of the legs 143, which may provide greater compression and rotational stability in some applications. In implementations, the width WS2 is between 0.15 and 0.2 inches. In implementations, the width WS3 is between 0.05 and 0.1 inches. Other dimensions and relationships of the example staple 124 may be the same as those described for the example staple 24. The widths WS2, WS3 may be maximum widths of the bridge 140 and legs 143, respectively. A curved transition portion 168 may be included as the staple 124 transitions and tapers in width from the bridge 140 to the legs 143.

[0069] In implementations, the staples 24 and 124 may be utilized for fracture fixation in deep working areas. In implementations, as described, the staples 24, 124 provide cortical compression of a fracture by using a specific angle for the legs of the staples. The shape of the tips of the legs and serrations may aid with the specific fixation of said cortices. The disclosed processes may provide precise control over staple placement and ensures robust fixation at the surgical site, such as by promoting bone stability and facilitating healing. The leg length of the staples 24, 124 may allow for compression and reduction at the cortical layer of bone, while keeping the intermedullary canal of long bones such as the tibia, femur, and humerus, clear for the passing of intermedullary nails and / or screws, or to accommodate for screw-plate constructs.

[0070] Figures 13 A and 13B show another example staple 224 substantially similar to the staples 24, 124, except that the legs 243 have a greater width WS3 than the width WS2 of the bridge 240. In implementations, the width WS3 is 1.25 to 2 times greater than the width WS2. In implementations, the wider legs 243 may provide a greater surface area for compression against bone in certain applications. Furthermore, in some applications, the wider profile may provide improved rotational stability when spanning multiple bones, without the need of additional legs. In implementations, the wider profile may be better suited for revision surgeries and / or for patients with compromised bone quality (osteoporotic) or in general for applications where there is a need for enhanced rotational stability. In implementations, having a narrower bridge may minimize soft tissue prominence and / or periosteal damage. A smooth transition (e g., curved) from the bridge 240 to the legs 243 may be included at a transition portion 268 between the bridge 240 and each leg 243, which may preserve the compressive strength of the staple 224 in some applications. The wider legs 243 may further increase stability and uniform compressive force distribution in some applications.2024-115. DEX-PCT; 67145-932 PCT

[0071] Figures 14A-14C show another example staple 324 substantially similar to the staple 224 except that the legs 343 are beveled such that the legs 343 are hexagonal in cross section. In implementations, as shown, the cross-section is an irregular hexagon. In implementations, the beveled legs 343 provide for ease of insertion and / or and improve contact of staple leg 343 to bone in some applications.

[0072] In implementations, beveled edges of legs 343 may allow for easier insertion of the staple legs due to a sharper and thinner contact edge along the legs compared to other configurations. Any of the staples disclosed herein may include the disclosed beveled edges and / or hexagonal cross section.

[0073] As shown in Figure 14C, a staple leg 343 may include surfaces 374A-374F that form the hexagonal cross section. The surfaces 374B and 374E may be parallel or about parallel to one another. The surfaces 374A and 374F may meet at a end edge 376A, and the surfaes 374C and 374D may meet at an end edge 376B opposite the end edge 376A. The surface 374A may be larger than the surface 374F. The surface 374C may be larger than the surface 374D. the surfaces 374A and 374C may be congruent. The surfaces 374D and 374F may be congruent. The surface 374B extends from the surface 374A to the surface 374C. the surface 374E extends from the surface 374D to the surface 374F.

[0074] As shown in Figures 15, in implementations, one or more legs 343 of the staple 324 may be inserted into overlapping drill holes 378A, 378B in bone. The overlapping holes 378A, 378B may form a “snowman” shape as shown. Although two overlapping holes 378A, 378B are shown, other numbers of overlapping holes may be utilized.

[0075] As shown, the end edge 376A is received against the inner surface of the hole 378A, and the end edge 376B is received against the inner surface of the hole 378B. One or both of the surfaces 374B and 374E may span across both holes 378A, 378B. The surfaces 374A and 374F may be included within the hole 378A, and the surfaces 374C and 374D may be included within the hole 378B.

[0076] In implementations, by using a smaller drill and drilling multiple holes for the leg 343 in an overlapping fashion, one can create a drill tunnel in the bone that more closely matches the outer dimensions of the staple leg 343, ultimately minimizing the amount of bone loss and thus maximizing contact area of the staple 324 to bone within the drill tunnel. In some applications, this may lead to greater stability of the legs within the drilled tunnels. In some2024-115. DEX-PCT; 67145-932 PCTapplications, this may lead to efficient transfer of compressive force within the bone due to minimized gap between the staple and the cortical layer of the bone. Although the staple 324 is shown in the illustrative example, other disclosed staples, including the staples 24 and 124, may be modified to have hexagonal legs and may be utilized in the manner illustrated in implementations.

[0077] In implementations, additionally or alternatively, one hole per leg for any of the staples disclosed herein may be drilled for receiving the leg.

[0078] In implementations, the staples 224, 324 may be applicable for fractures (e.g., trauma / deep working areas etc.). Additionally, the staples 224, 324 may provide unique benefits for revision surgeries and / or for patients with compromised bone quality (osteoporotic) or in general for applications where there is a need for enhanced rotational stability, greater compression over a larger surface area.

[0079] As illustrated in Figure 16, a surgical method 500 utilizing one or more of the disclosed examples may include one or more of the following steps. In implementations, the method 500 may be utilized to insert and secure an implant (e.g., any of the staples disclosed herein) to a surgical site (e.g., a fractured bone site). Fewer or additional steps than are recited below could be performed within the scope of this disclosure, and the recited order of steps is not intended to limit this disclosure. With reference to the examples disclosed herein, one or more of the following steps may be performed.

[0080] At 502, the method 500 may include drilling pilot holes into a bone, such as at a fracture site. In implementations, the holes may be spaced according to the dimensions of the staple to ensure proper alignment and fit. In implementations, before drilling, the fracture may be reduced, such as by clamping the bone fragments together. In implementations, one or more of the example drill guides disclosed herein may be utilized for drilling the holes into the bone. In implementations, the holes may be opposite a fracture from one another.

[0081] At 504, the method 500 may include loading a staple 24, 124, 224, 324 onto the surgical tool 22.

[0082] At 506, the method 500 may include placing the plunger 37 inside the lumen 28. The plunger handle may be rotated (e.g., clockwise) to push the plunger 37 against the bridge 40 of the staple 24, 124, 224, 324, causing the legs 43, 143, 243, 343 of the staple 24, 124, 224,2024-115. DEX-PCT; 67145-932 PCT324 to expand from their closed position into a parallel configuration. The staple 24, 124, 224, 324 may then be ready for insertion.

[0083] At 508, the method 500 may include aligning the legs 43, 143, 243, 343 of the staple with the pre-drilled holes in the bone.

[0084] At 510, the method 500 may include inserting the legs 43, 143, 243, 343 into the holes (e.g., Figures 22A-22C). The method 500 may include tapping the tool 22 with a mallet or other similar device to push the legs 43, 143, 243, 343 into the bone.

[0085] At 512, to disengage the tool 22 from the staple 24, 124, 224, 324, the method 500 may include rotating the plunger handle (e.g., counterclockwise) to retract the plunger 37. The method 500 may include rotating the entire body of the surgical tool 22 to fully detach it from the staple 24, 124, 224, 324. In implementations, the tool 22 may be rotated about 90 degrees to release the staple. The step 512 may be performed after the step 510.

[0086] At 514, the method may include removing the tool 22 from the surgical site.

[0087] At 516, with the surgical tool removed, the method 500 may include further driving the staple into the bone (e.g., using a tamp 92 and a mallet or other similar tools) until it sits completely flush with the surface. In implementations, this step may ensure stability and minimize protrusion, which could interfere with healing or surrounding tissues.

[0088] Various drill guides may be included in the system 20 and / or may be utilized for drilling holes in bone as described herein. Figures 17A-17C illustrate one example drill guide 80 including a head 82 and a shaft 84 extending therefrom. The head 82 may include two guide sleeves 86 defining channels 87 therein for passing a drill bit (e.g., drill bits 91A, 91B in Figure 20) through. The sleeves 86 may be configured to ensure appropriate angle, position, and / or spacing of the drilled holes. A handle 88 may be included at the proximal end of the shaft 84. In implementations, the length L4 of the shaft 84 from the head 82 to the handle 88 may be between 2-5 inches in implementations. The length L4 of the shaft 84 from the head 82 to the handle 88 may be about 2.6 inches in implementations. The length L5 of the sleeves 86 may be about 1.2 inches in some implementations. In implementations, the overall length L6 measured parallel to the sleeves 86 may be between 3-6 inches. In implementations, the overall length L6 measured parallel to the sleeves 86 may be about 4.14 inches. A bar 89 may connect the sleeves 86, with the shaft 84 extending from the bar 89. In implementations, a drill guide extension (e.g., drill guide extension 90) may be affixed to the handle 88 if additional length is desired.2024-115. DEX-PCT; 67145-932 PCT

[0089] A central longitudinal axis Al may be defined through the shaft 84 and a central longitudinal axis A2 may be defined through the sleeve 86. The axis Al and the axis A2 may be angled an angle 0 from one another. In implementations, the angle 0 is between 0-30 degrees for visibility in deeper placements and clearance of soft tissue and surrounding anatomy. In implementations, the angle 0 is about 25 degrees. In implementations, the disclosed length and angular relationships may allow the drill guide to be used in depth without obstruction from the surrounding tissue. One or more of the shaft 84, sleeves 86, and handle 88 may be cylindrical. Applicant has found that the various configurations and dimensions for the drill guide 80 may be beneficial for fracture fixation in deep working areas.

[0090] Figure 18 illustrates a head 682 for another example drill guide having overlapping hole openings 687, such as for use in the configuration shown in Figure 15.

[0091] Figure 19 illustrates another example head 782 having openings 787 for three overlapping holes.

[0092] Figure 20 illustrates another example head 882 with openings 887 that do not overlap.

[0093] As illustrated in Figure 21, various other components may be included in the system 20, including one or more of a drill guide extension 90, drill bits 91A, 91B, tamp 92, and removal tool 93. The drill guide extension 90 may be affixed to the handle of a drill guide (e g., drill guide 80) to lengthen the drill guide in some applications. In implementations, the tamp 92 may have a length between 10 and 11 inches and may be utilized for any of the tamping techniques disclosed herein. In implementations, the removal tool 93 may have an overall length between 10-11 inches and may have a hook 94 at its distal end.

[0094] In some aspects, the techniques described herein relate to a surgical tool for insertion of a staple, including: a cylindrical shaft defining a lumen; a head at an end of the shaft including a fork portion and first and second hooks extending from the fork portion, each of the first and second hooks including a shelf having a notch configured to receive a bridge of the staple; and a plunger receivable within the lumen, the head including an opening to allow the plunger to extend therethrough to engage the bridge.

[0095] In some aspects, the techniques described herein relate to a system for an orthopedic procedure, including: a staple; and a surgical tool for insertion of the staple, including: a cylindrical shaft defining a lumen; a head at an end of the shaft including a fork portion and first2024-115. DEX-PCT; 67145-932 PCTand second hooks extending from the fork portion, each of the first and second hooks including a shelf having a notch configured to receive a bridge of the staple; and a plunger receivable within the lumen, the head including an opening to allow the plunger to extend therethrough to engage the bridge.

[0096] In this disclosure, the term “about” means that the expressed qualities, quantities, ranges etc. need not be exact but may be approximated and / or larger or smaller, reflecting acceptable tolerances, conversion factors, measurement error, etc.

[0097] Although the different non-limiting embodiments are illustrated as having specific components or steps, the embodiments of this disclosure are not limited to those particular combinations. It is possible to use some of the components or features from any of the non-limiting embodiments in combination with features or components from any of the other non-limiting embodiments.

[0098] It should be understood that like reference numerals identify corresponding or similar elements throughout the several drawings. It should further be understood that although a particular component arrangement is disclosed and illustrated in these exemplary embodiments, other arrangements could also benefit from the teachings of this disclosure.

[0099] The foregoing description shall be interpreted as illustrative and not in any limiting sense. A worker of ordinary skill in the art would understand that certain modifications could come within the scope of this disclosure. For these reasons, the following claims should be studied to determine the true scope and content of this disclosure.

Claims

2024-115. DEX-PCT; 67145-932 PCTCLAIMSWhat is claimed is:

1. A surgical tool, comprising:a cylindrical shaft defining a lumen;a head at an end of the shaft including a fork portion and first and second hooks extending from the fork portion, each of the first and second hooks including a shelf having a notch configured to receive a bridge of a staple; anda plunger receivable within the lumen, the head including an opening to allow the plunger to extend therethrough to engage the bridge.

2. The surgical tool of claim 1, wherein the head is configured for a plane to bisect the staple when the staple is received in the notches, the first hook includes a first post, the second hook includes a second post, the first post and the second post are opposite the plane from one another.

3. The surgical tool of claim 2, wherein the shelf of the first hook extends in a first direction from a first post, the shelf of the second hook extends in a second direction from a second post, wherein the first direction is opposite the second direction.

4. The surgical tool of claim 3, wherein the shaft, the fork portion, and the hooks are monolithic.

5. The surgical tool of claim 3, wherein the shelf of the first hook and the shelf of the second hook extend through the plane.

6. The surgical tool of claim 5, wherein the fork portion and the first post define a continuous flat surface parallel with the plane.

7. The surgical tool of claim 3, wherein the plane bisects the shaft and the plunger.2024-115. DEX-PCT; 67145-932 PCT8. The surgical tool of claim 4, wherein the shelf of the first hook has a first width measured in a third direction about perpendicular to the first direction, the shelf of the second hook has a second width measured in the third direction, and the first width and the second width lie in the plane.

9. The surgical tool of claim 1, wherein the fork portion has a width greater than an outer diameter of the shaft.

10. The surgical tool of claim 1, wherein the lumen includes a first threaded portion, and the plunger includes a second threaded portion engageable with the first threaded portion.

11. The surgical tool of claim 10, wherein, when the first threaded portion is threadedly engaged with the second threaded portion, rotation of the plunger advances the plunger toward the bridge.

12. The surgical tool of claim 1, wherein the shaft, the fork portion, and the hooks are monolithic.

13. The surgical tool of claim 6, wherein the shaft, the fork portion, and the hooks comprise steel.

14. The surgical tool of claim 1, wherein the shaft and the head form a Y-shape.

15. The surgical tool of claim 1, including a gap between the first and second hooks to accommodate the plunger.

16. The surgical tool of claim 1, wherein the hooks are formed by subtractive manufacturing.

17. A system for an orthopedic procedure, comprising:a staple; anda surgical tool for insertion of the staple, comprising:a cylindrical shaft defining a lumen;2024-115. DEX-PCT; 67145-932 PCTa head at an end of the shaft including a fork portion and first and second hooks extending from the fork portion, each of the first and second hooks including a shelf having a notch configured to receive a bridge of the staple; anda plunger receivable within the lumen, the head including an opening to allow the plunger to extend therethrough to engage the bridge.

18. The system of claim 17, wherein first and second legs extend from the bridge.

19. The system of claim 18, wherein each of the first and second legs has beveled corner edges.

20. The system of claim 19, wherein the first and second legs are hexagonal in cross section.

21. The system of claim 17, comprising:a drill guide including a head extending from a shaft, the head including two sleeves, wherein the shaft has a first central longitudinal axis, and one of the sleeves has a second central longitudinal axis, and the first central longitudinal axis and the second central longitudinal axis are angled between 0 and 30 degrees from one another.

22. The system of claim 21, wherein the first central longitudinal axis and the second central longitudinal axis are angled 25 degrees from one another.

23. The system of claim 21, comprising:one or more drill bits receivable within the sleeves.

24. The system of claim 21, comprising:a drill guide extender attachable to a drill guide handle of the drill guide.

25. The system of claim 17, comprising:a tamp for tamping the bridge.2024-115. DEX-PCT; 67145-932 PCT26. A method, comprising:drilling pilot holes into a bone;advancing a plunger onto a bridge of a staple, wherein the advancing causes legs of the staple to move toward parallel;inserting the legs into the pilot holes;retracting the plunger from the bridge; androtating a tool to disengage the staple from first and second hooks, each of the first and second hooks including a shelf having a notch configured to receive a bridge of the staple, wherein the tool includes a cylindrical shaft defining a lumen, and the plunger is received within the lumen.

27. The method of claim 26, wherein the advancing of the plunger includes rotating the plunger in a first direction, and the retracting of the plunger includes rotating the plunger in a second direction opposite the first direction.

28. The method of claim 27, wherein the lumen includes a first threaded portion, and the plunger includes a second threaded portion engageable with the first threaded portion.

29. The method of claim 26, wherein the bone is one of a femur, hip, pelvis, and tibia.

30. The method of claim 26, wherein retracting the plunger causes the staple legs to converge.

31. The method of claim 26, wherein the retracting the plunger is performed after inserting the legs into the pilot holes.

32. The method of claim 26, wherein the tool includes a head at an end of the shaft including a fork portion and the first and second hooks extending from the fork portion.2024-115. DEX-PCT; 67145-932 PCT33. The method of claim 32, wherein the head is configured for a plane to bisect the staple when the staple is received in the notches, the first hook includes a first post, the second hook includes a second post, the first post and the second post are opposite the plane from one another.

34. The method of claim 33, wherein the shelf of the first hook extends in a first direction from a first post, the shelf of the second hook extends in a second direction from a second post, wherein the first direction is opposite the second direction.

35. The method of claim 26, comprising:tamping the staple farther into the holes after disengaging the staple from first and second hooks.

36. The method of claim 26, comprising drilling the pilot holes through a drill guide including a head extending from a shaft, the head including two sleeves, wherein the shaft has a first central longitudinal axis, and one of the sleeves has a second central longitudinal axis, and the first central longitudinal axis and the second central longitudinal axis are angled between 0 and 30 degrees from one another.

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