Orthopedic broach

Abstract

To provide an improved orthopedic broach better adapted to a shape and design of a hip joint stem implant transplanted later.SOLUTION: An improved orthopedic broach is used to prepare an intramedullary canal of a patient's bone such as, for example, a patient's femur, to receive an orthopedic implant such as, for example, a hip stem implant. The broach has differential teeth or tooth patterns. In one preferred example, the broach includes three different types of teeth including diamond teeth, compaction teeth, and extraction teeth. The different teeth patterns are specifically arranged on the sides of the broach to optimize bone removal and bone compaction for a subsequently implanted hip stem implant. In addition, the different teeth patterns and locations enhance rotational stability. As such, the broach is configured to compact bone in certain areas while removing bones in other areas, all while maintaining broach rotation.SELECTED DRAWING: Figure 1A

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is a nonprovisional application of pending U.S. Provisional Patent Application No. 63 / 530,154, entitled "Orthopedic Broach," filed on August 1, 2023, and claims the benefit of the filing date thereof, the entirety of which is incorporated herein by reference.

[0002] The present disclosure relates generally to orthopaedic devices and instruments, and more particularly to an orthopaedic broach for preparing a patient's intramedullary canal to receive an implant, such as a femoral hip stem implant. [Background technology]

[0003] Orthopedic implants are well known and common in today's society. Orthopedic implants can be used, for example, to stabilize injuries, support fractures, fix joints, and / or correct deformities. Orthopedic implants may be permanently or temporarily attached to bones in various locations, such as implanted within a bone canal or other cavity, implanted under soft tissue and attached to the outer surface of the bone, or placed externally and attached by fasteners such as screws, pins, and / or wires. Some orthopedic implants allow the position and / or orientation of two or more bone fragments or two or more bones to be adjusted relative to one another.

[0004] One type of orthopedic implant is a hip stem implant used to repair the hip joint. The hip joint is a frequent site of joint damage and / or injury. The hip stem implant may be implanted into or otherwise associated with a bony anatomical structure to treat traumatic injuries, reconstruct joint function, or for other purposes. The hip stem implant may include an elongated insertion region (e.g., a stem) that may be at least partially inserted into the intramedullary canal of the patient's proximal femur.

[0005] In some cases, the success of a hip stem implant depends on how well the elongated insertion region or stem fits into the patient's bone anatomy (e.g., the intramedullary canal of the patient's femur). For example, it is important that the proximal portion of the elongated insertion region or stem of the hip stem implant fits tightly into the intramedullary canal (e.g., creates a press fit between the proximal region of the implant and the inner surface of the intramedullary canal of the patient's femur) so that the stem loads the proximal portion of the patient's femur and prevents bone loss (and potentially subsequent implant failure) due to stress shielding and / or resorption. It is also important that the distal portion is properly positioned within the intramedullary canal, but the fit should not be so tight as to prevent proximal loading.

[0006] A good fit between the hip stem implant and its associated bony anatomy can also help prevent or reduce micromotion between the implant and the bone. Excessive micromotion can also lead to implant failure.

[0007] Furthermore, when implanting a hip stem implant, proper preparation of the patient's intramedullary canal to receive the hip stem implant is important. As a result, orthopedic surgical instruments, such as broaches, have been developed. Broaches are used, for example, during hip arthroplasty surgery. The surgeon uses the broaches to prepare the inner surface of the patient's intramedullary canal to receive the hip stem implant. The surgeon's preparation of the intramedullary canal is designed to ensure a proper fit between the patient's femur and the hip stem implant.

[0008] Implantation of a hip stem implant requires precise preparation of the bone or intramedullary canal to ensure good contact between the hip stem implant and the patient's bone. Generally speaking, reducing the gap or space between the hip stem implant and the patient's bone (e.g., between the outer surface of the implant and the inner surface of the intramedullary canal) while ensuring adequate stem contact in critical areas of the intramedullary canal in the anterior / posterior and medial / lateral directions improves initial stability and long-term bone ingrowth / fixation.

[0009] The intramedullary canal of a patient's bone (e.g., femur) may be prepared for implantation of a hip stem implant by broaching and reaming the resected end of the proximal femur. The intramedullary canal of the patient's femur may be prepared using a broach to provide a seat for the hip stem implant. Generally speaking, a broach is a cutting tool that can be moved or manipulated axially to create, enlarge, prepare, etc., a cavity or intramedullary canal of a patient's bone. Broaches can be used to create cavities having non-circular cross sections. They are particularly suited to preparing a portion of the intramedullary canal to receive a hip stem implant to ensure that the tapered shape of the hip stem implant, which may be of a complex irregular shape, properly matches the shape of the inner surface of the patient's intramedullary canal. As will be appreciated by those skilled in the art, with the head of the patient's femur removed, a broach can be inserted into the intramedullary canal of the femur. The softer, somewhat spongy cancellous bone surrounds the intramedullary canal. Surrounding the cancellous bone is cortical bone, which is stronger. The broach can be used to cut the bone.

[0010] Improper bone cavity preparation can result in loosening of the hip stem implant over time (e.g., a proximally fixed hip stem implant can loosen over time if bone fixation with the implant occurs away from the intended fixation area on the hip stem implant).To further complicate things, recent developments in hip stem implants have resulted in hip stem implants that include coated and uncoated sections of the hip stem implant. Summary of the Invention [Problem to be solved by the invention]

[0011] It would therefore be beneficial to provide an improved orthopaedic broach that better matches the shape and design of the hip stem implant that is subsequently implanted. Additionally, a need remains for an improved broach that avoids, or at least minimizes, distal fixation of proximally coated hip stem implants. The present invention fulfills these needs and provides other benefits and advantages in a novel and unobvious manner.

[0012] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to aid in determining the scope of the claimed subject matter. [Means for solving the problem]

[0013] In accordance with one or more aspects of the present disclosure, an improved orthopaedic broach is disclosed. The orthopaedic broach is positioned and configured to prepare an intramedullary canal of a patient's bone to receive an implant, such as a hip stem implant. The broach is positioned and configured to avoid, or at least minimize, distal fixation of the hip stem implant within the patient's intramedullary canal. Additionally, the broach is positioned and configured to optimize preparation of the intramedullary canal such that a desired press fit is achieved between a proximal region of the hip stem implant and an inner surface of the patient's intramedullary canal.

[0014] In some examples, the broach includes a differential tooth pattern. That is, the broach includes a plurality of separate tooth patterns. In one example, the broach includes a first, second, and third tooth pattern, each of the tooth patterns being different or unique from the other tooth patterns. Exemplary tooth patterns include diamond teeth, compression teeth, extraction teeth, or any combination thereof, all of which are described in more detail below. The various tooth patterns are positioned and configured at specific locations on the broach to achieve specific purposes. In some examples, the teeth are positioned and configured to optimize the remaining bone in the patient's intramedullary canal to facilitate improved engagement with a subsequently implanted hip stem implant. In certain examples, the teeth are positioned and configured to optimize and prepare the bone for optimal fixation of the implant. The broach can help improve engagement against proximally formed porous coating surfaces and / or anterior and / or posterior grooves that may be formed on the anterior and posterior sides of the proximal region of the hip stem implant.

[0015] For example, the broach may include a first tooth pattern on its inside, the first tooth pattern arranged and configured as cutting teeth optimized for bone removal. Particular examples of cutting teeth are diamond teeth or pyramidal shaped teeth (these terms are used interchangeably herein without any intent to be limiting or distinguishing). The diamond teeth are provided to cut or remove bone of the patient to avoid, or at least minimize, distal fixation of a subsequently implanted hip stem implant. The diamond teeth are arranged and configured to penetrate and remove any bone that they contact. This can create an envelope that facilitates proper positioning of the distal region along the inside of the broach and therefore the final implant. This can also avoid bone fixation of the inner distal region of the subsequently implanted hip stem implant in the intramedullary canal. The overall desire is to create an envelope that minimizes or avoids press fit of the inner distal region of the hip stem implant in the intramedullary canal. A further desire is to create a preferential press fit on the proximal portion of the hip stem implant, for example in areas corresponding to anterior and posterior grooves and / or porous coating areas formed on the hip stem implant. The diamond teeth facilitate improved contact between the diamond teeth along the inner arc and the patient's cancellous bone to prevent or at least resist rotational movement (e.g., providing diamond teeth on the inside of a broach increases the rotational stability of a subsequently implanted hip stem implant by preventing or at least minimizing rotation of the subsequently implanted hip stem implant within the intramedullary canal of the patient's bone).

[0016] In addition, the anterior and posterior sides of the broach include a second tooth pattern. In addition, the outer portion of the broach may also include a second tooth pattern. The second tooth pattern may be arranged as compression teeth. The compression teeth are shaped and optimized to compress, as opposed to cut or remove, the patient's bone on the inner surface of the intramedullary canal. The compression teeth are configured to leave larger particles of bone at the bone interface with greater penetration and densification of the local bone tissue. In various examples, the compression teeth may extend horizontally (e.g., the compression teeth may extend perpendicular to the longitudinal axis of the broach). When so arranged, the broach is arranged and configured to form horizontal and parallel ridges on the inner surface of the patient's intramedullary canal. The ridges may be angled relative to anterior and posterior grooves that may be formed on the anterior and posterior sides of a subsequently implanted hip stem implant.

[0017] In addition, the broach may include a third tooth pattern. The third tooth pattern may be arranged as extraction teeth. In some examples, an outer portion of the broach may include extraction teeth. In some examples, an outer transition surface or chamfer having an anterior side and a posterior side may include extraction teeth (e.g., an inclined transition surface or chamfer formed at the intersection of the lateral side with the anterior side and the posterior side). In some examples, a proximal region of the broach may include extraction teeth formed in or on an anterior-lateral and posterolateral aspect (e.g., extraction teeth formed on the lateral side along a transition surface or chamfer having an anterior side and a posterior side of the broach). The extraction teeth are configured to remove bone residue. The extraction teeth may be configured to preferentially achieve a press fit away from adjacent bone at the "corners" of the broach where the surface density of bone is higher on the anterior, posterior, and lateral sides. The extraction teeth may help achieve an optimized or preferential press fit in a corresponding region of a hip stem implant.

[0018] In some instances, the remaining exterior portion of the broach includes compression teeth.

[0019] In various examples, the orthopedic broach may be provided as part of or operatively associated with a system or kit, such as, for example, a hip stem implant that is subsequently implanted, or the orthopedic broach may be provided separately.

[0020] The hip stem implant may include a proximal region, a distal region, an anterior side, a posterior side, a medial side, and a lateral side. In various examples, the proximal region includes a porous coated and / or roughened surface or region. Additionally or alternatively, the proximal region may include a plurality of grooves formed on the anterior and posterior sides of the hip stem implant.

[0021] The broach is generally of a similar size and shape as the hip stem implant. The broach includes a proximal region, a distal region, an anterior, a posterior, a medial, and a lateral. In one preferred example, the broach includes three different types of teeth including diamond teeth, compression teeth, and extraction teeth.

[0022] An orthopedic broach is disclosed, the orthopedic broach being positioned and configured to prepare an intramedullary canal of a bone, the broach comprising a body having proximal and distal portions, an anterior side, a posterior side opposite the anterior side, a medial side, and a lateral side opposite the medial side, the medial and lateral side extending between the anterior and posterior sides, the lateral side comprising an anterior lateral side at an intersection of the lateral side and the anterior side and a posterior lateral side at an intersection of the lateral side and the posterior side, the medial side comprising a plurality of diamond teeth, the anterior lateral side and the posterior lateral side comprising a plurality of extraction teeth having a different shape compared to the plurality of diamond teeth.

[0023] In any preceding or subsequent example, the anterior and posterior sides include a plurality of compacted teeth having a different shape as compared to both the plurality of diamond teeth and the plurality of extracted teeth.

[0024] In any preceding or following example, at least a portion of the exterior side includes a plurality of compression teeth.

[0025] In any preceding or following example, the plurality of extraction teeth extend the entire length of the body along the anterior and posterior lateral corners of the body.

[0026] In any preceding or following example, the anterior lateral surface and the posterior lateral surface are defined by only the proximal portion.

[0027] In any preceding or following example, the plurality of compression teeth extends substantially the entire exterior length from the proximal portion to the distal portion of the body.

[0028] In any preceding or following example, each of the plurality of compression teeth is configured as parallel ledges extending horizontally from the outside to the inside of the front and rear sides of the broach.

[0029] In any preceding or following, the plurality of compression teeth extends substantially the entire length of the front and rear sides from the proximal portion to the distal portion of the body.

[0030] In any preceding or following example, each of the plurality of extracted teeth is configured as a horizontal tooth including an angled cut groove relief therethrough.

[0031] In any preceding or following example, each of the plurality of diamond teeth includes a pointed or spiky tip.

[0032] In any preceding or following example, the plurality of diamond teeth extends substantially the entire length of the interior of the body from the proximal end to the distal end.

[0033] In any preceding or following example, the body includes a connection mechanism arranged and configured to couple the broach to one of the handle and the orthopaedic impactor.

[0034] In any preceding or following example, the body includes a distal tip that is free of teeth.

[0035] In some examples, an orthopedic broach comprises a body including a plurality of diamond teeth on an interior side thereof, a plurality of compression teeth on an anterior and posterior side thereof, a plurality of extraction teeth on an anterior lateral side thereof and a plurality of compression teeth on at least a portion of an exterior side, each of the diamond teeth, the extraction teeth, and the compression teeth having a different shape compared to the other teeth.

[0036] Examples of the present disclosure provide many advantages. For example, by providing a broach that includes a differential tooth pattern, the broach is positioned and configured to optimize the remaining bone within the patient's intramedullary canal. This facilitates improved engagement with a subsequently implanted hip stem implant, particularly with respect to the proximally formed porous coated surface and / or anterior and / or posterior grooves. For example, the broach is optimized to ensure the creation of any envelope, such as a 360 degree envelope around the distal region, to provide distal clearance to avoid distal fixation (e.g., the distal portion of the broach is configured to abut (i.e., slightly contact but not to the level of press fit) to avoid distal press fit). Meanwhile, the broach facilitates press fit along the proximal region of the implant (e.g., transition may occur under the porous region of the subsequently implanted hip stem implant).

[0037] Additionally, the broach is positioned and configured to provide the surgeon with improved rotational stability. For example, the positioning of the diamond teeth and extraction teeth allows the surgeon to assess rotational stability. That is, during broaching, the surgeon can rotate the inserted broach. If properly sized, the broach will provide rotational resistance, thereby indicating that the broach is properly sized. This can also inform the surgeon that the patient's intramedullary canal has been properly prepared. Thus, the surgeon has more confidence that the corresponding subsequently implanted hip stem implant will be properly sized and properly seated within the prepared intramedullary canal. This preparation allows the surgeon more confidence that proper sizing of the implant has been achieved, allowing the surgeon to assess that the subsequently implanted hip stem implant will be properly seated within the patient's intramedullary canal.

[0038] At least some further features and advantages of embodiments of the present invention, as well as the structure and operation of various embodiments of the present invention, are described in detail below with reference to the accompanying drawings.

[0039] By way of example, embodiments of the disclosed apparatus will now be described with reference to the accompanying drawings, in which: [Brief description of the drawings]

[0040] [Figure 1A] FIG. 2 is a side or front view of one example of an orthopedic broach that may be used in accordance with one or more aspects of the present disclosure, the front side including compression teeth. [Figure 1B] FIG. 1B is a side or rear view of the orthopedic broach shown in FIG. 1A, the rear including compression teeth. [Figure 1C] FIG. 1B is a side or inner view of the orthopedic broach shown in FIG. 1A, the inner side including diamond teeth. [Figure 1D] FIG. 1B is a side or exterior view of the orthopedic broach shown in FIG. 1A, the exterior including compression teeth and extraction teeth. [Figure 1E] FIG. 2 is another view of the orthopedic broach, showing anterior and posterior views from an orthopedic perspective. [Figure 1F] FIG. 2 is another view of the orthopedic broach, showing an exterior view of the orthopedic view. [Figure 1G] FIG. 2 is another view of the orthopedic broach, a medial view from an orthopedic perspective. [Figure 2A] FIG. 2 is a diagram of an example of a hip stem implant that may be used with the orthopedic broach shown in FIGS. 1A-1G. [Figure 2B] FIG. 2 is another view of an example of a hip stem implant that may be used with the orthopedic broach shown in FIGS. 1A-1G. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0041] The drawings are not necessarily to scale. The drawings are merely representational and are not intended to illustrate specific parameters of the present disclosure. The drawings are intended to illustrate various examples of the present disclosure and therefore should not be considered limiting in scope. In the drawings, like numbers represent like elements.

[0042] Various features of the orthopedic broach are described below with reference to the accompanying drawings. It should be understood that the various features of the orthopedic broach may be used independently of one another or in combination with one another. The disclosed examples may take different forms and may optionally include one or more of the features, geometries, and / or dimensions described herein. Thus, the broach should not be construed as being limited to the specific examples described herein. Rather, these examples are provided so that this disclosure will convey the particular features, geometries, and / or dimensions to one of ordinary skill in the art.

[0043] The disclosed orthopaedic broaches are configured to optimize bone removal and / or preparation in a patient to facilitate improved engagement with a subsequently implanted orthopaedic implant, such as, for example, a hip stem implant. The disclosed broaches are positioned and configured to provide rotational stability, which allows for compression of bone in certain areas while removing bone in other areas, while maintaining the rotational stability of the broach.

[0044] In some examples, an orthopedic broach includes a body having differential tooth patterns. The different tooth patterns can be arranged and configured to prepare a patient's bone. For example, the broach includes first, second, and third different tooth patterns.

[0045] 1A-1G, a broach 100 may be utilized to prepare an intramedullary canal of a patient's bone, such as, for example, the patient's femur, to receive an orthopedic implant, such as, for example, a hip stem implant. A non-limiting example of the disclosed broach is manufactured and sold by Smith & Nephew, Inc. under the name ACCUBROACH®. A non-limiting example of a hip stem implant 300 is shown in FIGS. 2A and 2B. However, although the disclosed broach 100 will be described in conjunction with this exemplary hip stem implant 300 (described in more detail in U.S. patent application Ser. No. 18 / 685,093, which is incorporated herein by reference, and manufactured and sold by Smith & Nephew, Inc. under the name CATALYSTEM® Primary Hip System), the disclosed broach 100 is not so limited and may be used with any suitable implant now known or later developed. Accordingly, the broach should not be limited to use with a particular type or configuration of implant unless expressly claimed.

[0046] In a particular example, the broach 100 may include three different types of teeth including diamond teeth 132, compression teeth 112, and extraction teeth 114. In a preferred example, the broach 100 includes diamond teeth 132 formed on the inner surface or medial side 106 of the broach 100 for sequentially removing bone (the terms surface and side are used interchangeably herein without any limiting or distinguishing intent). The broach 100 includes extraction teeth 114 along its anterior-lateral and postero-lateral surfaces, aspects or regions 108B (the terms are used interchangeably herein without any limiting or distinguishing intent). The positioning of the diamond teeth 132 along the inner surface 106 of the broach 100 and the extraction teeth 114 along the anterior-lateral and postero-lateral regions 108B and 108B of the broach 100 allows the surgeon to assess the rotational stability of the broach 100 within the patient's intramedullary canal and / or provides the surgeon with improved feedback / assessment of the final implant fitting and / or sizing.

[0047] 2A and 2B, as described in U.S. Patent Application Serial No. 18 / 685,093, the subsequently implanted hip stem implant 300 may include a proximal region 310 and a distal region 330. The hip stem implant 300 also includes an anterior side 302, a posterior side 304, a medial side 306, and a lateral side 308. In various examples, the proximal region 310 includes and is defined by a porous coated and / or roughened surface or region 320 (terms used interchangeably herein without any intent to limit or distinguish). The anterior side 302 and the posterior side 304 may also include grooves 325 formed therein. The grooves 325 have been shown to facilitate improved engagement with the remaining patient's bone following the broaching process. The grooves 325 may be sloped (e.g., sloped downward) along the anterior side 302 and the posterior side 304 of the hip stem implant 300 from the lateral side 308 to the medial side 306. In some examples, the groove 325 may extend to and along at least a portion of the medial side 306 of the hip stem implant 300 .

[0048] The disclosed broach 100 includes a body 101 having a proximal region 110 and a distal region 130. The body 101 includes an anterior side 102, a posterior side 104, a medial side 106, and a lateral side 108, with the anterior side 102 and the posterior side 104 extending between the medial side 106 and the lateral side 108. The body 101 includes an exterior surface having a size and shape substantially similar to a hip stem implant designed to prepare a bone cavity to receive it.

[0049] The broach 100 includes differential teeth or tooth patterns. In one preferred example, the broach 100 includes a plurality of different types of teeth, such as three different types of teeth including, for example, diamond teeth 132, compression teeth 112, and extraction teeth 114.

[0050] The diamond teeth 132 are arranged and configured to cut and remove bone. The diamond teeth 132 are optimized to cut and remove bone while providing more localized compression than the extraction teeth 114 and less than the compression teeth 112. The diamond teeth 132 may be characterized as having a pointed or spiked tip. For example, the diamond teeth 132 may include a trough and a protrusion with an end in the form of a tip. Each tip may be abutted by multiple surfaces that protrude from the surrounding trough. In the diamond teeth 132, each of these sides converge to a point in the form of a sharp tip. The diamond teeth 132 are arranged and configured to facilitate cutting of bone.

[0051] The extraction teeth 114 may be characterized as having ridges, which have sharp edges. The geometry of the extraction teeth 114 provides a chip break feature that improves bone removal to create a bone surface that mimics the geometry of the hip implant that will be placed after use of the broach. The chip break feature allows debris generated during the broaching process to escape the broach-bone interface. This prevents debris buildup between the teeth and subsequent forcing (compaction) of the debris into the intermedullary wall. The chip break feature allows for improved bone removal to create a bone surface that mimics the geometry of the hip implant that will be placed after use of the broach. The extraction teeth 114 may be configured as horizontal teeth with angled "cut groove" reliefs passing through for effective removal of bone residue intended to preferentially achieve a press fit from adjacent bone, for example, at the "corners" of the broach on the anterior, posterior, and lateral bone with greater surface density to achieve an optimized or preferential press fit with the corresponding areas of the hip stem implant. For example, the extraction tooth 114 may include repeating troughs and protrusions with ends in the form of ridges, which may have sharp or blunt edges extending along their length. Each ridge may be abutted by multiple surfaces that protrude from the troughs of the tooth.

[0052] The compression teeth 112 may be characterized as having flat ends or surfaces, or as ridges, ledges, or steps. The compression teeth 112 include or form parallel ridges, ledges, or steps (these terms are used interchangeably herein without any intent to limit or distinguish). The compression teeth 112 are optimized to improve bone compaction while minimizing bone raking. The compression teeth 112 do not include a pressure relief mechanism (unlike an extraction tooth / chip breaker). This arrangement means that as bone debris accumulates during the broaching process, it is forced into the intermedullary wall of the patient's bone. The generally tapered geometry of the body of the broach and the back angle of the teeth minimize debris removal during broach removal. For example, the compression teeth 112 may include a repeating pattern of troughs and protrusions with ends in the form of flat ridges. The flat ridges may have a length that extends uninterrupted across the width of the surface area that includes the compression teeth. In contrast to the extraction teeth 114, the compression teeth 112 do not include a chip breaking feature. The compression teeth 112 operate to reduce the tendency to strip bone and improve bone compaction for greater stability.

[0053] As shown, the body 101 includes a connection mechanism 175 arranged and configured to couple the broach 100 to a handle, an orthopedic impactor, or the like. In some examples, the connection mechanism 175 may be provided in the form of a post. Alternatively, the connection mechanism 175 may be provided in the form of a cavity, a pocket, or the like. Alternatively, any suitable connection mechanism now known or later developed may be used.

[0054] The distal region 130 may terminate in a distal tip 140. The distal tip 140 may be devoid of teeth. This shape may minimize perforation of the patient's cortex by the distal tip 140 during the broaching process.

[0055] Each of the diamond teeth 132, compression teeth 122, and extraction teeth 114 are specifically positioned and configured to optimize improved engagement of the prepared bone with the hip stem implant depending on their location. In the particular example shown, the broach 100 includes diamond teeth 132 on its inner side 106. In the particular example shown, the broach 100 includes extraction teeth 114 along a posterior and anterior transition or chamfer region or surface 108B with the outer side 108 (e.g., the extraction teeth 114 are positioned on an angled transition or chamfer surface 108B formed at the intersection of the outer side 108 with the anterior side 102 and posterior side 104). So positioned, the broach 100 is optimized to ensure distal clearance to avoid distal fixation (e.g., optimized to create an envelope (e.g., a 360 degree envelope)). This can facilitate a press fit along the proximal region of the implant.

[0056] Additionally and / or alternatively, the broach 100 is positioned and configured to ensure rotational stability of the broach 100 within the intramedullary canal of the patient's bone during use. The positioning of the diamond teeth 132 and the extraction teeth 114 allows the surgeon to determine rotational stability; that is, during broaching, the surgeon can rotate the inserted broach 100. If properly sized, the broach 100 will provide resistance to rotation, thereby indicating that the broach 100 is properly sized and that the patient's intramedullary canal has been properly prepared. Thus, the surgeon can assess that a subsequently implanted hip stem implant will be properly seated within the patient's intramedullary canal.

[0057] It has been found that the particular combination of tooth patterns described herein provides a particularly reliable, secure, and stable implantation. The particular broach shown and described includes a combination of the three described types of teeth positioned along various particular portions of the broach body. While these positions and tooth patterns can be varied, a specific embodiment of the broach will now be described. As shown in Figures 1C and 1G, the medial side 106 of the broach 100 includes diamond teeth 132 having a first tooth pattern. As best shown in Figures 1A, 1B, and 1E, the anterior side 102 and posterior side 104 include compacted teeth 112 having a second tooth pattern. Figures 1D and 1F show that the lateral side 108 includes a region 108A having compacted teeth 112 and a region 108B having extracted teeth 114 having a third tooth pattern. The extraction teeth 114 having the third tooth pattern are positioned at or adjacent to a corner, edge, or intersection between the anterior and posterior sides 102, 104 and the lateral side 108 (e.g., a transition or chamfer surface or region 108B between the anterior and posterior sides 102, 104 and the lateral side 108). In some examples, the proximal region 110 may include extraction teeth 114 formed in its anterior and posterior lateral regions 108B. So arranged, the lateral side 108 of the broach 100 includes the compression teeth 112 and the extraction teeth 114 in at least its proximal region 110.

[0058] 1C and 1G show that the inner side 106 of the broach 100 includes diamond teeth 132 having a first tooth pattern that is different from the second and third tooth patterns. In a preferred example, the diamond teeth 132 may extend the entire length or substantially the entire length of the inner side 106 from the proximal end to the distal end of the broach 100.

[0059] The diamond teeth 132 formed on the inner side 106 of the broach 100 optimize the broach 100 to facilitate removal of any bone portions that protrude onto the inner surface of the intramedullary canal of the patient's bone during insertion of the broach 100. The diamond teeth 132 have been found to provide superior performance in scraping (for clearance) and gripping the bone, and rotational stability when the broach 100 is fully seated within the canal of the patient's bone. Additionally, the provision of the diamond teeth 132 on the inner side 106 of the broach 100 improves rotational stability, preventing, or at least assisting in preventing, the subsequently implanted hip stem implant 300 from rotating within the intramedullary canal of the patient's bone. Additionally, the diamond teeth 132 may provide a lower coefficient of friction with the patient's bone, which provides an advantage to the portion of the broach intended to penetrate the patient's tissue.

[0060] As previously discussed, the broach 100 is positioned and configured to create a 360 degree envelope that minimizes or avoids press fit of the distal region 330 of the hip stem implant 300 within the intramedullary canal. The disclosed broach 100 is configured to create a preferential press fit in the proximal region 310 of the hip stem implant 300, avoiding a distal press fit in favor of an abutting contact that does not rise to the level of a press fit. For example, the disclosed broach 100 is configured to create a preferential press fit in the porous coating region 320. Additionally or alternatively, the disclosed broach 100 is configured to create a preferential press fit in the region including the anterior and posterior grooves 325. In one example, the geometry of the distal region 130 of the broach 100 may be sized and configured to be larger than the distal region 330 of the hip stem implant 300 to create an envelope or clearance. The distal region 130 of the broach 100 may be configured to remove bone leaving an envelope or contact between the distal region 330 of the hip stem implant 300 that extends from the distal tip 340 of the hip stem implant 300 to the end of the porous coating region 320 formed on the proximal region 310 of the hip stem implant 300. This transition is intended to avoid any kind of press fit with the distal region 330 of the hip stem implant 300 by providing distal clearance between the inner surface of the patient's intramedullary canal and the distal region 330 of the hip stem implant 300 (e.g., a loosely fitting distal region). This in turn helps to achieve and / or promote a proximal press fit hip stem implant 300. As a result, excessive fit over time with growth, which may lead to distal femoral pain and distal stem loosening due to stress shielding of the proximal stem, is avoided. Additionally, diamond teeth 132 may be extended onto the distal region 130 of the broach 100 to remove cortical bone proximal to the isthmus and distal to the lesser trochanter in the central body of the hip stem implant.

[0061] 1A, 1B, and 1E, the compression teeth 112 may extend the entire length, or substantially the entire length, of the anterior 102 and posterior 104 sides of the broach 100 from the proximal end to the distal end. The compression teeth 112 are configured to compress bone on the inner surface of the intramedullary canal as opposed to cutting or removing bone. The greater number and size of bone residue particles from the compression teeth 112 provide a greater degree of broach residue, such as, for example, the inclined geometry of the anterior and posterior grooves 325 formed in the hip stem implant 300 creates a nearly positive rake angle. This allows the residue to be more effectively "peeled" into the anterior and posterior grooves 325. This process is intended to provide an opportunity for osseo-induction into the anterior and posterior grooves 325 to provide long-term implant stability. The greater densification depth from the compression teeth 112 is also intended to provide a stronger bone canal for the initial femoral stem press fit fixation.

[0062] As shown in Figures 1A, 1B, and 1E, the compression teeth 112 may extend horizontally across the anterior 102 and posterior 104 sides of the broach 100. The compression teeth 112 may extend horizontally across the anterior 102 and posterior 104 sides between the medial 106 and lateral 108, including the anterior-lateral and posterolateral regions 108B. The compression teeth 112 are configured to allow for bone preservation and stability. During insertion of the broach 100 into the patient's intramedullary canal, the compression teeth 112 push or compress the patient's bone. This creates an improved envelope for subsequent implantation of the hip stem implant.

[0063] During insertion of the broach 100, the compression teeth 112 leave behind pockets in the patient's bone positioned and configured to interact with, for example, the porous coating region 320 and / or the anterior and / or posterior grooves 325 formed in the hip stem implant 300. The compression teeth 112 compress and displace bone that they contact while also leaving cancellous bone that engages, for example, the porous coating region 320 and / or the anterior and posterior grooves 325 of the implant 300.

[0064] As shown, the compression teeth 112 may form parallel ridges that extend horizontally in the patient's bone (e.g., the anterior and posterior tooth patterns may be disposed approximately perpendicular to the longitudinal axis of the subsequently implanted hip stem implant 300) and may be angled relative to the anterior and posterior grooves 325 formed in the subsequently implanted hip stem implant 300. The vertically disposed compression teeth 112 compact and / or densify the cancellous bone, leaving behind a slight step pattern. The corresponding opposing anterior 302 and posterior 304 sides of the implant 300 may include grooves 325 that are angled relative to the arrangement of the vertically disposed compression teeth 112 on the broach 100, thereby creating a cross-hatched pattern. The compression teeth 112 press against the patient's bone anterior and posterior to the patient's intramedullary canal, scraping the patient's bone during implantation of the hip stem implant 300 to create an improved envelope for receiving the stem of the hip stem implant 300, while at the same time leaving a pocket for the groove 325 formed in the hip stem implant 300 to fill with bone ingrowth (e.g., the groove 325 formed in the hip stem implant 300 leaves a ridge in the patient's bone that can be scraped off, eliminating or at least minimizing any gaps that the bone needs to bridge).

[0065] After broaching with the hip stem implant 300 positioned within the intramedullary canal of the patient's bone, the compression teeth 112 formed on the anterior 102 and posterior 104 sides of the broach 100 are configured to cross-hatch with the grooves 325 formed on the anterior 302 and posterior 304 sides of the hip stem implant 300. During implantation, the hip stem implant 300 scrapes or scrapes off the stepped cavity apexes (e.g., parallel ridges) left by the broaching process into the recesses of the grooves 325 formed on the anterior 302 and posterior 304 sides of the hip stem implant 300. This can promote bone ingrowth and increase resistance to subsidence and rotational micromotion.

[0066] The parallel ridges created in the patient's intramedullary canal by the broaching process can then be scraped away during implantation of the hip stem implant 300. It has been found that providing a broach with teeth shaped as described above minimizes any gaps that may remain between the scraped bone and the anterior and posterior grooves 325 of the hip stem implant 300, thereby facilitating improved long term stability.

[0067] By providing the compression teeth 112 on the anterior 102 and posterior 104 sides of the broach 100, the inner bone surface of the patient's intramedullary canal is compressed to more fully and precisely interact with the final implant. It addresses the interface between the implant 300 and the patient's bone (cortical / cancellous). As a result, the diaphysis of the intramedullary canal of the patient's bone is removed to compress and densify the bone attachment to the porous coating region 320 formed on the implant 300 while contacting / supporting the distal region 330 of the hip stem implant 300 without a press fit. This allows a differential press fit to the proximal ingrowth surface on the hip stem implant 300. This avoids a distal "pedastool" or press fit that may result in long term stress shielding of the proximal femur and loosening of the implant.

[0068] 1D and 1F, the lateral side 108 of the broach 100 may include a region 108A having compressed teeth 112. Thus, the lateral side 108 includes a region 108A having compressed teeth 112 similar to the anterior side 102 and the posterior side 104. The lateral side 108 of the broach 100 may also include a region 108B including extracted teeth 114 having a third tooth pattern. As shown, the lateral side 108 may include chamfers or transition surfaces or regions 108B between the lateral side 108 and the anterior side 102 and the posterior side 104. In some instances, these chamfers or transition surfaces or regions 108B are positioned along and extend from the proximal region 110 of the broach 100. As shown, the chamfers or transition surfaces or regions 108B between the lateral side 108 and the anterior side 102 and the posterior side 104 define the region 108B including extracted teeth 114 having a third tooth pattern. Along at least the proximal region 110 of the broach 100, the lateral side 108 includes a region 108B (e.g., a chamfered surface or a transition surface) that includes extraction teeth 114 positioned along corners, edges, or intersections between the anterior and posterior sides 102, 104 and the lateral side 108. More specifically, the lateral side 108 includes extraction teeth 114 formed on its anterior-lateral and postero-lateral aspects. The locations of the extraction teeth 114 are positioned and configured to correspond to proximal press-fit sections of a femoral stem of the same size in the anterior-lateral and postero-lateral aspects or regions.

[0069] In this example, the extraction teeth 114 are arranged and configured as corner teeth. They function to cut, extract, and / or remove the patient's bone that contacts the extraction teeth 114 during broaching. In this manner, the extraction teeth 114 may be referred to as chip breakers arranged and configured to cut the patient's bone (e.g., optimized to remove cancellous bone). The extraction teeth 114 may provide interrupted cuts in the anterior-lateral and postero-lateral aspects of the proximal region of the broach 100 to create a press fit in the corresponding proximal, anterior-lateral and postero-lateral regions where the implant will seat. This may also reduce bone densification. The interrupted cuts facilitate a more aggressive pattern that allows a path for bone extrusion during broaching and relief of the proximal cortical bone in the patient's femur. The extraction teeth 114 may be configured to provide annular grinding while incorporating relief for bleeding material during the broaching process.

[0070] The extraction tooth 114 extracts the patient's bone outside of the intramedullary canal of the patient's bone. The extraction tooth 114 removes any bone outside of the intramedullary canal on the patient's bone with minimal compression to facilitate clearance (e.g., prevent lateralization that may cause the broach to be inserted crookedly (e.g., at an angle)). The extraction tooth 114 facilitates clearance during implantation of the hip stem implant 300 by preventing or at least minimizing lateralization. The extraction tooth 114 assists in the removal of bone in the anterior-lateral and postero-lateral regions of the intramedullary canal of the patient's bone. So positioned, soft tissue may be spared.

[0071] As best shown in FIGS. 1E and 1F , the compression teeth 112 on the lateral side 108 may extend the entire length or substantially the entire length of the lateral side 108 from the proximal end to the distal end of the broach 100. The extraction teeth 114 may extend from the proximal end toward the distal end. The extraction teeth 114 may extend the entire length or substantially the entire length of the lateral side 108 from the proximal end to the distal end. The extraction teeth 114 may be located at corners between the anterior side 102 and the lateral side 108 (e.g., anterior lateral corners) and corners between the posterior side 104 and the lateral side 108 (e.g., posterior lateral corners) along the entire length of the broach 100. Alternatively, the extraction teeth 114 may extend 25% to 75% or more of the length of the lateral side 108. In some particular examples, the extraction teeth 114 extend 50% to 75% of the length of the lateral side 108. In a further specific example, the extracted tooth 114 extends about 65% to 70% of the length of the lateral side 108. Additionally and / or alternatively, in some examples, each of the chamfered surfaces or regions 108B including the extracted tooth 114 may extend 10% to 40% of the width of the lateral side 108 at the proximal end. In some examples, each of the chamfered surfaces or regions 108B including the extracted tooth 114 may extend 20% to 35% of the width of the lateral side 108 at the proximal end. In a further specific example, the extracted tooth 114 extends about 30% to 35% of the width of the lateral side 108 at the proximal end. In a further specific example, the extracted tooth 114 covers about 33% of the lateral side 108.

[0072] The broach may be manufactured from any suitable material now known or later developed. For example, the broach may be manufactured entirely from stainless steel. Alternatively, other metals may be used. Additionally, in some instances, the broach may be made from a hard plastic such as PEEK.

[0073] The broach may be formed using any desired or suitable methodology or technique, now known or later developed. For example, the broach may be manufactured using any now known or later developed additive manufacturing technique. By some non-limiting known techniques, the broach can be manufactured from selective laser sintering (SLS), direct metal laser sintering (DMLS), electron beam melting (EBM), selective laser melting (SLM), three-dimensional printing, and the like. For example, the broach may be formed as a monolithic or one-piece component. In other examples, additive manufacturing techniques, such as, for example, electron beam melting methods, or methods that use a laser to subtract or remove select portions of material from an initially solid material, may be used. In other examples, some or all of the broach may be formed using casting or other techniques or methods.

[0074] Although the present disclosure refers to specific examples, numerous modifications, substitutions, and alterations to the described examples are possible without departing from the spirit and scope of the present disclosure, as defined in the appended claims. Therefore, the present disclosure is not intended to be limited to the described examples, but to have a full scope defined by the language of the following claims and their equivalents. The description of any examples is for illustrative purposes only and is not intended to suggest that the scope of the present disclosure, including the claims, is limited to these examples. In other words, although exemplary examples of the present disclosure have been described in detail herein, it should be understood that the concept of the present invention may be variously embodied and used in other manners, and the appended claims are intended to be construed to include such variations, except as limited by the prior art.

[0075] The foregoing description has been presented for purposes of illustration and description and is not intended to limit the disclosure to one or more forms disclosed herein. For example, various features of the disclosure are grouped together in one or more examples or configurations for the purpose of simplifying the disclosure. However, it should be understood that various features of a particular example or configuration of the disclosure may be combined in alternative examples or configurations. Any example or feature of any section, part, or any other component illustrated or specifically described in connection with various examples of similar sections, parts, or components herein may be applied interchangeably to any other similar examples or features illustrated or described herein. Furthermore, components having the same name may be the same or different, and one skilled in the art will understand that each component may be modified in a similar manner or substituted to perform the same function.

[0076] Moreover, the following claims are hereby incorporated into the Detailed Description by reference, with each claim standing on its own as a separate example of this disclosure.

[0077] As used herein, elements or steps recited in the singular and preceded by the word "a" or "an" should be understood as not excluding a plurality of elements or steps, unless such exclusion is expressly recited. Moreover, references to "one example" in this disclosure are not intended to be interpreted as excluding the existence of additional examples that also incorporate the recited features.

[0078] The phrases "at least one," "one or more," and "and / or" as used herein are open-ended expressions that are both conjunctive and disjunctive in operation. The terms "a" (or "an"), "one or more," and "at least one" may be used interchangeably herein. All directional references (e.g., proximal, distal, top, bottom, upward, downward, left, right, lateral, longitudinal, front, rear, top, bottom, upper, lower, vertical, horizontal, radial, axial, clockwise, and counterclockwise) are used for identification purposes only to aid the reader's understanding of this disclosure and are not intended to limit the position, orientation, or use of the disclosure in particular. References to connections (e.g., engaged, attached, coupled, connected, joined) should be interpreted broadly and may include intermediate members for movement between and among collections of elements, unless otherwise indicated. Thus, references to connections do not necessarily imply that two elements are directly connected and in a fixed relationship to one another. All rotational references represent relative motion between the various elements. Identifying references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to imply importance or priority, but are used to distinguish one feature from another. The drawings are for illustrative purposes only, and the dimensions, positions, order, and relative relationships to size reflected in the accompanying drawings may vary. [Explanation of symbols]

[0079] 100 broach, 101 body, 102 anterior, 104 posterior, 106 medial, 108 lateral, 108A region, 108B region, 110 proximal region, 112 compression teeth, 114 extraction teeth, 130 distal region, 132 diamond teeth, 140 distal tip, 175 connection mechanism, 300 hip stem implant, 302 anterior, 304 posterior, 306 medial, 308 lateral, 310 proximal region, 320 porous coating region, 325 groove, 330 distal region, 340 distal tip

Claims

1. 1. An orthopaedic broach arranged and configured to prepare an intramedullary canal of a bone, said orthopaedic broach comprising: a body having proximal and distal portions, a front side, a rear side opposite the front side, a medial side, and an lateral side opposite the medial side, the medial side and the lateral side extending between the front side and the lateral side, the lateral side comprising an anterior lateral side at an intersection of the lateral side with the front side and a posterior lateral side at an intersection of the lateral side with the lateral side; Equipped with The inner portion includes a plurality of diamond teeth; an anterior lateral surface and a posterior lateral surface comprising a plurality of extraction teeth having a different shape compared to a plurality of diamond teeth.

2. The orthopedic broach of claim 1 , wherein the anterior side and the posterior side include a plurality of compaction teeth having a different shape as compared to both the plurality of diamond teeth and the plurality of extraction teeth.

3. The orthopaedic broach of claim 2 , wherein at least a portion of the outer side includes a plurality of compression teeth.

4. The orthopedic broach of claim 3 , wherein a plurality of said extraction teeth extend the entire length of said body along anterior and posterior lateral corners of said body.

5. The orthopedic broach of claim 3 , wherein the anterior lateral surface and the posterior lateral surface are defined only by the proximal portion.

6. The orthopaedic broach of claim 3 , wherein a plurality of said compression teeth extend substantially the entire length of said exterior from said proximal portion to said distal portion of said body.

7. The orthopaedic broach of claim 2 , wherein each of said plurality of compression teeth is configured as parallel ledges extending horizontally from the outer side to the inner side of said anterior and posterior sides of said orthopaedic broach.

8. The orthopedic broach of claim 2 , wherein a plurality of said compression teeth extend substantially the entire length of said anterior and posterior sides from said proximal portion to said distal portion of said body.

9. The orthopaedic broach of claim 1 , wherein each of the plurality of extraction teeth is configured as a horizontal tooth including an angled cut groove relief therethrough.

10. The orthopedic broach of claim 1 , wherein each of said plurality of diamond teeth includes a pointed or spiked tip.

11. The orthopedic broach of claim 10 , wherein the plurality of diamond teeth extend substantially the entire length of the inner side from the proximal end to the distal end of the body.

12. The orthopaedic broach of claim 1 , wherein the body includes a connection mechanism positioned and configured to couple the orthopaedic broach to one of a handle and an orthopaedic impactor.

13. The orthopedic broach of claim 1 , wherein the body includes a distal tip that is free of teeth.

14. 1. An orthopaedic broach arranged and configured to prepare an intramedullary canal of a bone, said orthopaedic broach comprising: a body having proximal and distal portions, a front side, a rear side opposite the front side, a medial side, and an lateral side opposite the medial side, the medial side and the lateral side extending between the front side and the lateral side, the lateral side comprising an anterior lateral side at an intersection of the lateral side with the front side and a posterior lateral side at an intersection of the lateral side with the lateral side; Equipped with The inner portion includes a plurality of diamond teeth; the front side and the rear side include a plurality of compression teeth; the anterior lateral surface and the posterior lateral surface include a plurality of extracted teeth; The outer side includes a plurality of compression teeth; An orthopedic broach, wherein each of the diamond teeth, the extraction teeth, and the compression teeth has a different shape compared to the other teeth.

15. The orthopedic broach of claim 14 , wherein a plurality of said extraction teeth extend substantially the entire length of said body along anterior and posterior lateral corners of said body.

16. The orthopedic broach of claim 14 , wherein the anterior lateral surface and the posterior lateral surface are defined only by the proximal portion.

17. The orthopedic broach of claim 14 , wherein a plurality of the compression teeth extend substantially the entire length of the exterior from the proximal portion to the distal portion of the body.

18. The orthopaedic broach of claim 14 , wherein each of the plurality of compression teeth is configured as parallel ledges extending horizontally from the outer side to the inner side of the anterior and posterior sides of the orthopaedic broach.

19. The orthopaedic broach of claim 14 , wherein a plurality of the compression teeth extend substantially the entire length of the anterior and posterior sides from the proximal portion to the distal portion of the body.

20. The orthopaedic broach of claim 14 , wherein each of the plurality of extraction teeth is configured as a horizontal tooth including an angled cut groove relief therethrough.

21. The orthopedic broach of claim 14 , wherein each of the plurality of diamond teeth includes a pointed or spiked tip.

22. 22. The orthopaedic broach of claim 21, wherein a plurality of said diamond teeth extend substantially the entire length of said interior from said proximal portion to said distal portion of said body.

23. The orthopedic broach of claim 14 , wherein the body includes a distal tip that is free of teeth.

Images