A tool assembly for implanting an implant

Abstract

A tool assembly for implanting a rod implant into a bone, comprising a rod-shaped preparation tool (1) and a plurality of rod-shaped broaches (2, 3, 4, 5, 6) of different sizes, the rod-shaped preparation tool (1) having a distal tip (32) and a plurality of cutting teeth (31) along its length. Each broach has a distal tip and a plurality of cutting teeth (31) along its length. The preparation tool (1) is shorter than the smallest broach, has more cutting teeth (31) per unit length, and has a sharper distal tip (32).

Description

Technical Field

[0001] The present invention relates to tools used by a surgeon during an implantation procedure. Background Art

[0002] All orthopedic implants require a tool assembly to be able to install the implant components. The assembly will include several trial fittings for determining the size of the implant components required for the patient, as well as some specific tools to assist in fixing the implant in the patient's joint. Implant tool assemblies are usually augmented in the operating room with general-purpose tools that are readily available in an orthopedic setting, such as impactors of various weights, osteotomes of various sizes, retractors of various types, K-wires (Kirschner wires), and oscillating saws.

[0003] The present invention aims to achieve an improvement in the efficiency of implantation procedures. Summary of the Invention

[0004] We describe a tool assembly for installing a rod implant into bone. The features of the tool assembly are also described. We also describe a kit that includes the tool assembly described in any example, as well as a rod implant. Aspects of the kit are described. We also describe a device for installing an implant, which includes the tool assembly of any example and a tray for holding these tools. Aspects of the device are described. We also describe broaches of various examples. We also describe dual-purpose tools of various examples. We also describe component fixing devices in various examples.

[0005] According to one aspect, we describe a tool assembly for installing a rod implant into bone, comprising:

[0006] a rod-shaped preparation tool having a distal tip and a plurality of cutting teeth along its length; and

[0007] a plurality of rod-shaped broaches of different sizes, each broach having a distal tip and a plurality of cutting teeth along its length,

[0008] wherein the preparation tool is shorter than the smallest broach, has more cutting teeth per unit length, and has a sharper distal tip.

[0009] In one case, the preparation tool and the broaches include a flat proximal handle end having a groove to assist in gripping.

[0010] The preparation tool and the broaches may include a flange at the distal end of the proximal handle of the tool. The flange may be truncated on one side of the handle.

[0011] In some cases, the distal head of the preparation tool and the broaches are curved in the palmar direction and substantially straight in the dorsal direction.

[0012] The tool assembly may further include a rod insertion tool having engagement features for engaging corresponding engagement features of the implant rod to directly transfer a force applied to the rod insertion tool to the rod implant.

[0013] The tool assembly may also include at least one additional tool that is a dual-purpose tool. In one case, the dual-purpose tool has a head that can provide a file and a broach. In another case, the dual-purpose tool includes a lever for elevating bone. The lever may include a distal engagement slot.

[0014] The tool assembly as claimed may further include a rod replacement tool.

[0015] The tool assembly may also include at least one trial head for temporarily placing in the bone during preparation of the bone to receive the implant head. In one case, some dimensions of the trial head are smaller than the dimensions of the implant head. There may be multiple trial heads of different sizes.

[0016] A kit is also provided that includes the tool assembly of the present invention and a rod implant. The rod implant may be configured for intramedullary engagement with the end of the first metacarpal. In one case, the implant includes a plug for the proximal end of the rod.

[0017] In one case, the implant is for the first carpometacarpal joint for separating the trapezium from the first metacarpal. The implant includes a proximal implant portion having a saddle-shaped surface for translational movement on the trapezium, and the rod may be mounted in the proximal portion by a hinged coupling device (such as a ball and socket joint). The proximal portion may include a head for mounting to the rod.

[0018] We also describe a device for mounting an implant that includes the tool assembly of the present invention and a tray for holding the tools. The tray may include a base, side walls upright from the base, and tool support strips mounted to the base. In one case, the tray includes two support strips extending across the tray, each support strip including spaced grooves for receiving a portion of the tool. The tools may be mounted to the strips in the order in which they are used in surgery. A cover for the tray may have a single strip projecting inwardly therefrom to engage the tools and hold them in position in the tray.

[0019] A broach for preparing bone to receive an implant is also provided, which includes a proximal handle, a shaft extending from the handle, and a flange between the handle and the shaft. In one case, the flange is truncated on one side of the handle. The handle may include multiple generally flat sides having grooves to enhance gripping. The distal head may be curved in the palmar direction and substantially flat in the dorsal direction.

[0020] We also describe a dual-purpose tool for reshaping bone to receive an implant, which includes a handle, a shaft extending from the handle, and a distal cutting head having a first side and a second side opposite the first side. The first side of the cutting head has a file feature and the second side of the head has a broach feature. In one case, the first side is concave and the second side is convex. The distal end of the tool can be round, square, flat, or annular. In some cases, the handle includes a plurality of generally flat sides and includes grooves to assist in gripping.

[0021] We also describe a dual-purpose tool that includes a handle, a shaft extending from the handle, and a distal tip. The shaft is angled relative to the handle to facilitate the manipulation of small bones, and the distal tip has a slot to engage an element to facilitate the leverage of the element. The shaft can be generally flat. The handle can include a plurality of generally flat sides and includes grooves to assist in gripping.

[0022] The tool assembly includes specific tools and tool features. These tools are designed for specific implants, but their novel features can also be applied to other areas of orthopedic surgery. Description of the Drawings

[0023] The present invention will be more clearly understood from the following description given by way of example only, in which:

[0024] Figure 1 is a perspective view showing an implant including proximal and distal portions;

[0025] Figure 2(a) is a cross-sectional view through the distal portion of the implant, and Figure 2(b) is a perspective view of the rod of the distal portion, Figure 2(c) is a perspective view of the complete distal portion, and Figure 2(d) is a perspective view of the proximal portion;

[0026] Figure 3 is a set of views showing a part of the distal portion of the implant, including a top plan view, an end view, a perspective view, and a cross-sectional view;

[0027] Figure 4 shows a tool assembly according to the present invention in one example;

[0028] Figure 5 is a view of the preparation device tool of the present invention, and Figure 6 is an enlarged view of the distal end of the preparation device tool;

[0029] Figure 7 is a pair of side views of the broach and different rotational positions;

[0030] Figure 8 is a side view of the first dual-purpose tool, and Figure 9is a side view and a plan view of the head of a first dual-purpose tool;

[0031] Figure 10 is a pair of side views of a second dual-purpose tool at different orientation angles about its axis, Figure 11 is an enlarged side view of the head of the tool, and Figure 12 is a perspective view of the tool holding the head and the rod structure in use;

[0032] Figures 13(a) to 13(c) is a complete side view of a rod insertion tool, an enlarged side view of its head, and an on-axis end view;

[0033] Figure 13(b) is a cross-sectional side view, and Figure 13(c) is a schematic enlarged cross-sectional view showing the rod insertion tool in use;

[0034] Figure 14(a) is a side view of a rod replacement tool, Figure 14(b) is a plan view of the tool, and Figure 14(c) is an enlarged side view of the head of the rod replacement tool;

[0035] Figure 15 is a photograph of a prior art tool;

[0036] Figure 16 is an enlarged view of the handle end of some tools;

[0037] Figure 17 is an enlarged view of the flange of some tools;

[0038] Figure 18 is a set of detail views of the flange of some tools;

[0039] Figure 19(a) 、 19(b) and 19(c) show an alternative rod insertion tool in use;

[0040] Figure 20(a) is a side view of a bushing replacement tool, and Figure 20(b) shows the head of the tool engaged with the bushing; and

[0041] Figure 21 is a view of a trial head used during implant installation;

[0042] Figure 22 is a view of an instrument tray, and Figure 23 is for Figure 22 a view of the lid of the instrument tray; and

[0043] Figure 24(a) is a perspective view of an intraoperative assembly, and Figure 24(b) is an end view of a component of the assembly. Detailed Description

[0044] An example of an implant that can be installed using the tool assembly of the present invention is shown in Figures 1 to 3 . Referring to Figures 1 to 3 , the implant 1 has a distal portion with a plug 100 in the rod 110 and a proximal portion 120. In this case, the implant 1 is for the first carpometacarpal joint of a mammal and is used to space the trapezium bone of the joint from the first metacarpal bone of the joint while allowing translational and rotational movement of the first metacarpal bone relative to the trapezium bone. The distal portion 110 is configured for intramedullary engagement with the end of the first metacarpal bone. The proximal portion 120 has a curved saddle-shaped pedestal 122 that has a proximal-facing surface 124 for sliding on or traversing the trapezium bone. As is known, the articulated coupling device includes a neck 123 that bridges the saddle 122 to the ball 121. This allows for controlled articulation of the trapezium bone and the first metacarpal bone.

[0045] The plug 100 may have a cushioned interface feature, in this case a flange 105 with a profiled proximal-facing surface 101. Distally on this surface, there is a shoulder 102 that serves as a key for engaging the plug 100 in the rod 111 and preventing rotation of the plug in the rod, and an edge 106 surrounds the socket 103 to receive the articulated coupling ball 121. The ball 121 (especially see Fig. 2(d)) has a snap-fit engagement in the socket 103, behind the edge 106 of the socket, to enable intraoperative assembly of the articulated hemiarthroplasty and also prevent disassembly of the device in the body. As needed, the socket can be centered or offset in any direction or angle.

[0046] Even more distally, the plug 100 includes an annular locking edge 104 for snap-fitting into a corresponding groove in the notch 115 of the rod 111 that houses the plug 100. The engagement of the plug 100 into the rod 111 is effective due to the elasticity of the plug material and the fact that there is full surface-to-surface contact in a snap-fit manner between the edge 104 and its corresponding engagement surface within the rod 111. The plug is keyed by the shoulder 102 to prevent rotation and potential posterior wear.

[0047] Referring to Figure 4 , a tool assembly for installing an implant (such as the implant of Figures 1 to 3 ) is shown. The tool assembly in this example includes:

[0048] A preparation device 1 ( Figure 5 and 6 );

[0049] A set of five broaches 2, 3, 4, 5, 6 of different sizes ( Figure 7 );

[0050] A first dual-purpose tool 7 ( Figure 8 and 9 );

[0051] The second dual-purpose tool 8( Figure 10 、 11 and 12);

[0052] The rod insertion tool 9( Figure 13(a) 、 13(b) 、13(c)); and

[0053] The rod replacement tool 10( Figure 14(a) 、 14(b) 、14(c)).

[0054] The preparation device 1( Figure 5 and 6 )[[ID=2⑧]]

[0055] Refer to Figure 5 and Figure 6 , the preparation device 1 has a cutting head 30 and facilitates the first cut into the metacarpal bone and eliminates the need for a drill or the like by the surgeon before deploying the first broach 2. In addition, the geometry of the cutting head 30 of the preparation device 1 is modeled after the geometry of the smallest broach (broach 2) in the tool assembly. The preparation device 1 is smaller, shorter, has more cutting teeth 31 per unit length, and has a sharper tip 32, but has the necessary curved palmar and flat dorsal geometry of the broach and implant. The distal tip of the preparation device does not have a toothless bone marrow compressing distal end, which is a feature of the broach. In this case, the head 30 has 17 cutting teeth 31 and generally preferably has teeth in the range of 12 to 22, and more preferably in the range of 14 to 20.

[0056] The end result is that the preparation device 1 penetrates further than a drill or the like, can be used to more precisely locate the initial incision, and most importantly, reduces the effort required for the first broach 2. This is a particularly important benefit for surgeons with low or weak hand strength.

[0057] The broach( Figure 7 )

[0058] The broaches 2, 3, 4, 5, 6 (referred to as broaches A to E) match the geometry of the implant rod 111. Therefore, the end user can use the broach as a trial rod. When the surgeon has completed broaching the metacarpal cavity, there is no need to place a separate trial rod in position to evaluate the fit of the rod because the broach itself will provide this clinical information.

[0059] In addition to the tools described, a trial implant head 70( Figure 22 ) can be used during the surgery, as described in more detail below.

[0060] To install the implant, a first incision is made in the metacarpal bone using the preparation device 1. Due to its cutting tooth density and the fact that the geometry of the preparation device is very similar to that of the smallest broach (dimension A, 2), the preparation device also helps the surgeon to create the accurate position and orientation of the broach, thereby creating a rod implant within the metacarpal bone. Then one or more broaches 2, 3, 4, 5, 6 are used to broach the metacarpal cavity. The broaches are used in ascending order of size. Thus, after using the preparation device, dimension A (2) follows. For any given metacarpal bone, based on the surgeon's sense during broaching and / or using X-ray images, the surgeon decides whether successive broach sizes are required. After broaching, the rod insertion tool 9 is used to insert the rod portion 110 of the implant into the metacarpal cavity until the metacarpal rod implant 110 is positioned flush or just protruding with respect to the resected metacarpal bone. The close relationship between the broach and the rod implant facilitates this, and the surgeon can estimate the final position of the base of the rod relative to the resected metacarpal bone based on the position of the final broach used by him or her.

[0061] The first dual-purpose tool 7 ( Figure 8 and Figure 9 )

[0062] Referring Figure 8 and 9 , the first dual-purpose tool 7 has two features, a file 52 and a broach 53. The file 52 on the concave side can be used to carve the trapezium bone into the exact radius of the implant head 120. The convex side of the tool 7 is provided with broach-like teeth 53, which can be used to remove incidental bone spurs or other protrusions encountered during the carving of the trapezium bone.

[0063] As described above, the head 50 of the tool has a dual-purpose performance. It has a shaft 51, which is tapered or otherwise diameter-reduced to facilitate access to small joints.

[0064] The concave side 52 of the head 50 has a file structure and is designed to carve the trapezium bone into the shape of the implant head. The convex side 53 has a broach structure for removing bone spurs and is designed to cut during the pulling stroke rather than the pushing stroke.

[0065] Other uses include maxillofacial surgery in cases where bone reconstruction is required but the surgeon does not wish to have to continuously remove and replace tools. For example, the first dual-purpose tool 7 can be inserted into a body cavity and used for filing functions, left in place but rotated 180 degrees, and then used for broaching or bone reshaping functions.

[0066] The tool 7 can be used to modify the geometry of the outer or inner surface of any bone according to the geometry of the bone, the cutting surface, and the distal end of the tool, and the novel dual-functional head facilitates easy use.

[0067] The shape of the distal end of the tool 7 can be round, square, flat, or annular, depending on the desired anatomical geometry to be created for its use.

[0068] The distal cross-sections above and below the centerline can have one geometry on one side and another geometry on the other side, i.e., annular on one side and flat on the other side.

[0069] The second dual-purpose tool 8 ( Figure 10 、 11 and 12)

[0070] Referring Figure 10 、 11 and 12, the second dual-purpose tool 8 is used as a metacarpal elevator to move tissue to one side and present the metacarpal to the surgeon for resection. It includes a shaft 60 and a head 6 for resection. It includes a shaft 60 and a head 64 having a keyhole feature 63. The keyhole feature 63 is located at the distal end of the head 64 of the second dual-purpose tool 8 and can be used to separate the trial head (70) from the implant shaft, as Figure 12 shown.

[0071] The tool 8 can be used, for example, as a metacarpal elevator and for presenting the metacarpal to the surgeon for resection. The shaft 60 is flat and angled with respect to the handle 61 and provides optimal access to both the metacarpal and the fulcrum position. The head 64 is curved to match the curvature of the metacarpal.

[0072] In addition, the keyhole slot 63 at the distal end of the head 64 matches the radius of the neck of the implant shaft 111 and can be used to pry the trial head 70 out of the bushing 100 when the surgeon is ready to install the implant head 120, as Figure 12 shown. Generally, the head of the tool 8 is a multi-purpose claw that serves as a holder or gripping lever for remote objects.

[0073] Other uses of the second dual-purpose tool 8 include: a) manipulating any small bones during surgery, such as the second to fifth metacarpals; b) removing a plate from a bone by using the tool to lever the plate away from the bone during small joint surgery; c) removing a plate with screws in situ, where the keyhole can be positioned around the nail or screw while the plate is levered away from the bone; d) removing a screw from a bone, where the slot / keyhole 63 is used to lever the screw out of the bone, which may be of poor quality but the screw is in a situation with a certain degree of fixation.

[0074] The rod insertion tool 9 ( Figure 13(a) 、 13(b) and 13(c))

[0075] The internal features of the head 40 of the rod insertion tool 9 capture the profile and depth of the bushing flange 100, and these features allow the distal portion of the tool head to bottom out on the base of the metacarpal rod implant 111. The distal head 40 of the tool 9 is positioned on the base of the rod 111. When the surgeon manipulates the rod 111 into the bone, the bushing 100 will not be damaged because if an impactor is used in combination with the rod insertion tool 9, the force is transferred from the metal head of the rod insertion tool 9 to the metal base of the rod 111.

[0076] The profile of the distal portion of the tool head 40 extends beyond the profile of the base of the metacarpal rod implant 111. These design features ensure that the bushing 100 cannot be inserted flush or below into the bone when the metacarpal rod implant 111 is already in a position flush with or only protruding from the resected metacarpal.

[0077] The outer fillet at the distal end of the rod insertion tool 9 is smaller than the inner diameter of the bushing 100 at the snap-fit location, and since the rod insertion tool 9 closely envelops the outside of the bushing 110, no damage is caused to the snap fit of the bushing 110 with the ball of the head 121.

[0078] The rod replacement tool 10 ( Figure 14(a) 、 14(b) 、14(c))

[0079] If necessary, the rod replacement tool 10 can be used to remove the rod 110 from the metacarpal cavity. If the bushing 100 is removed from the rod 110, the fine metric threads 45 of the tool can engage the fine metric threads 47 in the rod 111 (see FIG. 13(b)), and if desired, the rod 111 can be removed. The rod replacement tool 10 has a full circular flange 46 for the impactor to assist in rod withdrawal, regardless of how deeply the threads engage each other.

[0080] If the implant rod 111 is implanted without the polymer bushing 100, the rod replacement tool 10 can be used to position the rod 111 and facilitate impacting the rod 111 into place. This also applies to rods without polymer bushings, instead having a metal socket with mating threads for the rod replacement tool 10 at the distal end of the socket.

[0081] The grooved and flanged handle ( Figures 16 to 18 )

[0082] FIG. 15 shows a circular serrated handwheel that is located at the proximal end of many prior art orthopedic rasps. The prior art circular proximal end (used with an impactor for tool removal) is grasped by the surgeon and can facilitate twisting of the tool, which can result in a larger hole in the bone than expected. The hole created by the cutting head of the rasp should correspond to the geometry of the implant. The prior art rasp with a circular type handle is twisted to effect a grip in the bone.

[0083] In the tool assembly, the tool has a flat elongated proximal handle 20 with a groove 21 to aid gripping, such as Figure 16 and 17 Thus, the tool promotes axial movement, and this results in a hole being created in the bone that more accurately conforms to the geometry of the broach cutting head and, thus, the geometry of the implant.

[0084] The preparation device 1, the broaches 2, 3, 4, 5, 6 and the rod changing tool 10 all have flanges 25, 46 at the distal end of the handle 20, such as Figures 16 to 18 As shown. If desired, flanges 25 (and 46 on tool 10) enable the driver to be used for tool extraction purposes. They also serve as a stop for the surgeon's hand and, in conjunction with the flat surface on the handle that carries the tool markings 26 and serves as a thumb grip, facilitate stable axial forward movement of the preparation device 1 and broaches 2, 3, 4, 5, 6.

[0085] This means that the tool of the present invention requires little or no impact compared to other tools. This reduces potential fracture injuries to bones during surgery, which are observed in clinical practice using conventional tools.

[0086] like Figure 18 As shown, the flange 25 of the preparation device 1 and all broaches 2 , 3 , 4 , 5 , 6 are truncated to provide a 270° non-circumferential side edge 27 in the palmar aspect.

[0087] This facilitates the surgeon by enabling the tool to be used at an angle closely aligned with the axis of the metacarpal bone during surgery. This feature further reduces any tendency of the surgeon to twist the tool and allows sufficient space on the distal side of the flange for an impactor to aid in tool withdrawal if necessary.

[0088] Rod Insertion Tool 90( Figure 19(a) 、 19(b) and 19(c))

[0089] The alternative stem insertion tool 90 includes a ball 91 having a diameter smaller than that of the implant head ball, but just large enough to provide a light snap-fit. This light snap-fit provides attachment between the tool 90 and the implant stem-sleeve assembly 110 so that the surgeon can use the tool to transport the implant directly from the preparation area to the implantation site.

[0090] Bushing replacement tool 95( Figure 20(a) and 20(b) )

[0091] The tool assembly may additionally include a tool 95 for withdrawing a bushing 100 from a rod 111 that has been assembled and implanted in a metacarpal bone. The bushing may need to be removed when access to the threaded portion 47 of the rod is required to remove or replace the rod. The threaded head 96 of the tool 95 is configured for a double-threaded tapered thread, where the helix of the thread engages the snap-fit diameter of the socket within the bushing 100. The tool 95 is screwed into the bushing 100 until resistance is felt at the point where the bushing 100 can be easily pried out of the rod housing 112 (as shown in FIG. 20(a)).

[0092] The test head 70 ( Figure 21 )

[0093] The test head 70 conforms to the geometry of the associated implant head 120 and, in addition, has two through-holes 71 passing through the saddle and has two letter identifications suitable for each of the four test head types laser-etched onto the base. The through-holes 71 help to distinguish the test head 70 from the component 120 of the implant.

[0094] The ball diameter of the test head 70 is also slightly smaller than the ball diameter of the implant head 120 such that the snap fit of the bushing 100 is not stressed. Although the ball diameter is slightly reduced, the dispersion distance from the metacarpal bone to the trapezium bone is maintained the same as that of the implant head 120 by increasing the neck length of the test head 70.

[0095] Using the test head 70 in combination with the implant rod 111 reduces the number of surgical steps successfully completed by the end user. By first using the test head 70 to check the dimensions before selecting the implant to be used, the need for the surgeon to open and use implants on a trial-and-error basis is avoided.

[0096] The instrument tray 80 ( Figure 22 and 23 )

[0097] The advantage of the instrument tray is that instead of including multiple brackets to accommodate the individual tools 85, all the tools are positioned by two strips 81, 82, which may be the polymer PPSU (polyphenylsulfone), mounted (e.g., screwed) to the base 83 or integrally formed with the base. The tools (only the tool 85 is shown) are further secured by a single strip 86 attached to the underside of the cover 87, which acts on the thumb grip plane of the handle of the tool. The correct orientation of the cover 87 (and thus the securing strip 86) is ensured by positioning two latches closer together on one side of the cover than on the other side (not shown).

[0098] The intraoperative component fixing device 140 (FIGS. 24(a) and (b))

[0099] The component fixture 140 can be used in a surgical environment to assemble the bushing 100 into the rod 111. The base 141 of the fixture 140 has separate retainers 142 for each implant rod size. Each retainer 142 has a socket 143 for cradling the distal (narrow) end of the rod 111 to hold it in an upright position. The retainer 141 also has aligned upper through-holes for holding the wider (proximal) end of the rod 111. For a particular rod size, the dimensions of each retainer increase from left to right and are referred to as rods A, B, C, D, and E, respectively.

[0100] The assembly further includes a pusher 148 having a knurled finger wheel 149 for rotating a screw 150 having a lower pushing face 151. The screw 150 extends through the pusher body and has a pair of parallel dovetails 152 for engaging in corresponding dovetail slots 145.

[0101] The rod 111 is vertically placed in the appropriate retainer 141, and the bushing 100 is aligned with the universal cap formed by the body 152 of the pusher 148, which incorporates a light snap fit when it is assembled to the bushing. When the pusher 148 is fully pushed into place in any set of slots 145, it is positioned such that the center of the screw 150 is centered above the rod. The screw 150 is then rotated to fully push the bushing 100 into the rod 111, thereby seating the bushing 100 in the rod 111.

[0102] List of all tools for a preferred example

[0103] The following is a list of all the components of the entire tool assembly device in one example.

[0104]

[0105]

[0106] It should be understood that the described device provides a major assistance to the surgeon in performing the operation in terms of accuracy and reduced time.

[0107] The present invention is not limited to the embodiments described above, and it can vary in structure and details.

Claims

1. A tool assembly for implanting a rod implant into a bone, comprising: A plurality of bar broaches (2 - 6) of different sizes, each broach having a distal head and a plurality of cutting teeth along its length, a bar preparation tool (1) having a distal head (30) and a plurality of cutting teeth (31) along its length; characterized in that the preparation tool is shorter than the smallest broach, has more cutting teeth per unit length, and has a sharper distal tip; and the tool assembly further includes a rod insertion tool (9) having an implant rod engagement feature for engaging a corresponding engagement feature of an implant rod (111) to transmit a force applied to the rod insertion tool to the rod implant, and wherein the engagement feature includes: an external rounded corner feature (40), or a ball (91), the ball (91) being configured to snap - fit into the implant.

2. The tool assembly according to claim 1, wherein, The ball (91) is configured to snap - fit into a bushing (100) of the implant rod (111).

3. The tool assembly according to claim 1, wherein, Each of the preparation tool and the broach includes a proximal handle (20) having a groove (21) to assist in gripping and a flange (25) at the distal end of the proximal handle.

4. The tool assembly according to claim 3, wherein The flange (25) is truncated (27) on one side of the handle.

5. The tool assembly according to any one of claims 1 to 4, characterized in that The distal head (30) of the preparation tool (1) and the distal head (30) of the broach (2 - 6) are each bent in the palmar direction and straight in the dorsal direction.

6. The tool assembly according to any one of claims 1 to 4, characterized in that Also included is a dual - purpose tool, the dual - purpose tool including a head providing both a file (52) and a broach (53), the head providing both the file (52) and the broach (53) having a first side and a second side opposite the first side, the first side having a concave shape and including file features, and the second side having a convex shape and including broach features.

7. The tool assembly according to any one of claims 1 to 4, characterized in that Also included is a dual - purpose tool, the dual - purpose tool including a rod (60) and a claw - shaped head (64) for lifting bone, and the claw - shaped head (64) for lifting bone further includes a distal engagement slot (63).

8. The tool assembly according to any one of claims 1 to 4, characterized in that Also included is a rod replacement tool (10), the rod replacement tool (10) including a thread (45) for engaging a threaded socket (47) of the implant rod.

9. The tool assembly according to any one of claims 1 to 4, characterized in that, Included is a bushing removal tool (95) for removing a bushing (100) assembled in the implant rod (111), the implant rod having been implanted in a metacarpal bone, the bushing removal tool including a threaded head (96) configured to engage the bushing by tool rotation.

10. The tool assembly according to any one of claims 1 to 4, characterized in that, Also included is at least one trial head (70) for being temporarily placed in or on a bone or an implant component during preparation of the bone to receive an implant head, wherein some of the dimensions of the trial head (70) are smaller than the corresponding dimensions of the implant head.

11. The tool assembly according to claim 10, wherein, The tool assembly further includes a dual - purpose tool, the dual - purpose tool including a rod (60) and a claw - shaped head (64) for lifting bone, and the claw - shaped head for lifting bone has a slot (63) configured to separate the trial head from the implant rod.

12. The tool assembly according to claim 10, wherein Including a plurality of trial heads of different sizes.

13. The tool assembly according to claim 10, characterized in that, The test head includes a ball for insertion into the implant socket, and the ball is smaller than the implant ball for the socket.

14. The tool assembly according to claim 10, characterized in that, The test head includes at least one hole (71) that is not functional but serves to identify the test head.

15. A kit comprising the tool assembly according to any one of claims 1 to 14, and further comprising an implant having an implant stem (111).

16. The kit according to claim 15, wherein The implant stem (111) is configured for intramedullary engagement with the end of the first metacarpal bone.

17. The kit according to claim 16, wherein The implant includes a bushing (100) for the proximal end of the implant stem.

18. The kit according to any one of claims 15 to 17, characterized in that, The implant is for the first carpometacarpal joint and is for spacing the trapezium bone from the first metacarpal bone. The implant includes a proximal implant portion (120) having a saddle-shaped surface (122) for translational movement on the trapezium bone, and the implant stem (111) can be mounted to the proximal implant portion by a hinged coupling device.

19. The kit according to claim 18, characterized in that, The hinged coupling device is a ball and socket joint.

20. The kit according to claim 18, characterized in that The proximal implant portion (120) includes a head for mounting to the implant stem.

21. A device for installing an implant, characterized in that, The device includes the tool assembly according to any one of claims 1 to 14 and a tray (80) for receiving the tool assembly. The tray includes a base, side walls standing upright from the base, and tool support strips mounted to the base, where the tools are mounted to the strips in the order of use in surgery.

22. The device according to claim 21, characterized in that, Including a cover (87) for the tray, the cover having a strip (86) projecting inwardly therefrom to engage the tools and hold them in position in the tray.

23. The device according to claim 22, characterized in that, The strip (86) of the cover is configured to engage the plane of the tool handle for proper closing of the cover and the tools.

24. The device according to any one of claims 21 to 23, characterized in that, Also included is an assembly fixing device (140) for assembling the bushing (100) into the implant stem (111). The fixing device includes a plurality of stem holders (142) for each of a plurality of implant stem sizes and a pusher device (148) arranged to push the bushing (100) into the stem (111) when the handle (147) is rotated.

25. The device according to claim 24, wherein Each holder (142) has a socket (143) for cradling the distal end of the stem (111) and an aligned through hole (144) for holding it in the bushing (100) insertion position.

26. The device according to claim 24, characterized in that, The pusher device (148) includes a screw (150) having a pusher face (151) extending through the pusher body.

27. The device according to claim 26, wherein, The pusher body includes a pair of parallel dovetails (152) for engaging corresponding dovetail grooves (145) to position the pusher screw in alignment with the stem in the holder.

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