Humeral implant and systems and methods for implanting the same
The convertible prosthesis system addresses the challenge of converting shoulder arthroplasty by providing a modular system with interchangeable components, ensuring minimal bone loss and improved surgical outcomes.
Patent Information
- Application Number
- JP2025066881
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2021-03-17
- Filing Date
- 2025-04-15
- Publication Date
- 2025-07-23
AI Technical Summary
Existing shoulder arthroplasty techniques face challenges in converting from anatomical to reverse prostheses, leading to bone loss and unpredictable functional outcomes, especially in cases of severe arthritis or humeral fractures, due to difficulties in removing and repositioning components.
A convertible prosthesis system with interchangeable components, including stemless and stemmed humeral anchors, allows for conversion between anatomical and reverse reconstructions without extensive bone removal, utilizing shared implant tools and joint components for flexibility and stability.
Facilitates seamless conversion between anatomical and reverse shoulder reconstructions, minimizing bone loss and improving surgical outcomes by using a modular system with interchangeable components.
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Figure 2025108587000001_ABST
Abstract
Description
Technical Field
[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 200,608, filed Mar. 17, 2021, the disclosure of which is hereby incorporated by reference in its entirety.
Background Art
[0002] Field This application relates to a reverse - type anatomical shoulder prosthesis for fracture repair.
[0003] Description of Related Art Arthroplasty is the standard treatment for the treatment of shoulder arthritis. A typical anatomical shoulder replacement attempts to mimic the anatomical state. For example, a metallic humeral stem and a humeral head replacement are attached to the humerus of the arm to replace the humeral side of the arthritic shoulder joint. Such a humeral head replacement can articulate with the original glenoid fossa or an opposing glenoid resurfacing device.
[0004] The standard treatment for more severe cases of shoulder arthritis is reverse - type reconstruction, which involves reversing the kinematics of the shoulder joint. A reverse - type shoulder prosthesis can be provided by fixing a hemispherical device (also called a glenoid ball) to the glenoid fossa and implanting a humeral stem with a cavity capable of receiving the glenoid ball.
[0005] Since the patient's disease may progress after anatomical treatment, reoperation may be necessary to perform reverse shoulder reconstruction. In known techniques, changes in prosthesis type are addressed either below or above the resection surface. In prostheses that are converted from an anatomical structure to a reverse structure by modularity below the resection surface, it has been found that removing the anatomical device incorporated into the patient's bone anatomy is difficult for the surgeon and may potentially cause excessive bone loss in the patient. One advantage of such a conversion is that the reverse insert can be partially placed below the resection surface, thus shortening the distance between the cavity and the transverse contour of the humerus. Such a position has been proven beneficial for inverse kinematics. Conversely, in prostheses that are converted from anatomical to reverse on the resection surface using an adapter, the position of the cavity is further pushed out from the humerus by adding the adapter on the resection surface, thus changing the inverse kinematics. Such a structure usually consists of three components and has extra modularity compared to a two-component structure, potentially causing structural disassembly or damage. One possibility to limit kinematic changes and modularity is to reverse the material of the seating surface by providing a harder cavity within the humerus and a softer hemispherical device fixed to the glenoid fossa. However, in proven clinical designs and preferred embodiments, the cavity is usually softer than the hemispherical device.
[0006] In the case of three-part and four-part displacement or dislocation of the proximal humerus fracture, the proximal humerus also needs to be reconstructed. Hemiarthroplasty may be used in the treatment of such displaced fractures, but it has been frequently reported that the functional outcomes of these surgeries are poor and unpredictable. SUMMARY OF THE INVENTION
[0007] A convertible prosthesis that can be converted from an anatomical replacement to a reverse reconstruction without removing components incorporated into the anatomical structure of the patient's bone is highly desirable. To improve patient outcomes, such a convertible prosthesis should also function well when converted to a reverse reconstruction while respecting the biomechanics of a true anatomical replacement. In some cases, it may be desirable to configure the convertible prosthesis for use in humeral fracture repair surgery.
[0008] Improved humeral anchors, components, assemblies, and methods are needed to provide more flexibility when manipulating the soft tissues around the shoulder joint. Such an anchor may benefit from a plurality of openings each capable of receiving a plug or screw for securing the humeral anchor to the patient. Such an anchor may benefit from having a V-shaped profile to reduce the amount of bone that a clinician must remove from the patient in order to implant the humeral anchor.
[0009] In some aspects of the present disclosure, a stem for a shoulder prosthesis is disclosed. The stem can include an inner side, an outer side opposite the inner side, and a plurality of openings. Each opening of the plurality of openings can be adapted to receive a screw or one or more plugs. The plurality of openings can include a first opening and a second opening. The first opening can be disposed proximal to the second opening. Each of the first and second openings can include a length measured along a longitudinal centerline between an inner first opening, an outer second opening, and them. The longitudinal centerline of at least one of the first and second openings can be angled with respect to a longitudinal plane extending in the inner-outer direction of the stem. Alternatively, the longitudinal centerline of at least one of the first and second openings can be angled with respect to a longitudinal plane extending in the anterior-proximal direction of the stem, or with respect to any plane of the stem.
[0010] The stem of the foregoing paragraph, or as further described herein, can also include one or more of the following features. Each of the first and second openings can be angled in the anterior-posterior direction with respect to the inner and outer longitudinal planes. Alternatively, each of the first and second openings can be angled in the inner-outer direction with respect to the anterior-posterior longitudinal planes. The first and second openings can be angled in opposite directions with respect to the longitudinal plane. Alternatively, the first and second openings can be angled in the same direction with respect to the longitudinal plane. The stem can further include a distal shaft portion, a proximal portion, and a metaphyseal portion. The distal shaft portion can be adapted to be fixed within the medullary canal of the humerus. The proximal portion can have a stem surface. The metaphyseal portion can extend between and connect the distal shaft portion and the proximal portion. The metaphyseal portion can include an inner portion and first and second outer arms. Alternatively, the metaphyseal portion can include only one outer arm, or three or more outer arms. The distal shaft portion can include a plurality of openings. The distal shaft portion can include a plurality of grooves. The plurality of grooves can extend longitudinally. The plurality of grooves can be circumferentially spaced. Each of the plurality of grooves can taper towards the distal tip of the stem. The first opening can be disposed proximal to the plurality of grooves. The second opening can extend through at least one of the plurality of grooves. Alternatively, both the first and second openings can be disposed proximal to the plurality of grooves or can extend through at least one of the plurality of grooves. The plurality of openings can further include a third opening disposed distal to the second opening. The longitudinal centerline of each of the first and second openings can be angled at about 30° with respect to the longitudinal plane of the stem. Alternatively, the longitudinal centerline of each of the first and second openings can be angled at less than about 30° or greater than about 30° with respect to the longitudinal plane of the stem. For example, the angle can be about 15° or about 45°. The longitudinal centerlines of each of the first and second openings can be angled at different angles.For example, the longitudinal centerline of the first opening can be angled at approximately 15°, and the longitudinal centerline of the second opening can be angled at approximately 45°.
[0011] Including any stem of any of the preceding paragraphs and / or any stem described herein A system is disclosed. Each opening of the plurality of openings can include a length measured along the longitudinal centerline between the first opening, the second opening, and them. This system can include at least one plug adapted to be received by one or more of the plurality of openings of the stem.
[0012] The system of the preceding paragraph, or what is further described herein, can also include one or more of the following features. At least one plug can include at least one elongated plug. The width of at least one elongated plug may be less than its length. The length of one or more of the plurality of openings may be shorter than the length of at least one elongated plug. Alternatively, the length of one or more of the plurality of openings may be greater than or equal to the length of at least one elongated plug. One or more of the plurality of openings can be adapted to receive at least one elongated plug along the entire length of the one or more openings. The width of at least one plug may be greater than its length. The length of one or more of the plurality of openings may be greater than the length of at least one plug. Two or more of the plugs can be adapted to be inserted into one or more of the openings along the longitudinal centerline.
[0013] A kit is disclosed that includes the stem of any of the foregoing paragraphs and / or any of the stems described herein. The kit can include a reverse insert, an anatomical joint component, and / or a spacer. The reverse insert can have a proximal portion and a distal portion. The proximal portion of the reverse insert can include a concave surface configured to receive a glenoid sphere. The distal portion can include a projection. The reverse insert can be adapted to couple directly to the stem. The anatomical joint component can have a proximal portion and a distal portion. The proximal portion of the anatomical joint component can include a convex surface. The distal portion of the anatomical joint component can include a projection. The anatomical joint component can be adapted to couple directly to the stem. The spacer can include a proximal portion and a distal portion. The spacer can be adapted to couple a reverse insert or an anatomical joint component to the stem. The proximal portion of the spacer can be symmetric or asymmetric.
[0014] In some aspects of the present disclosure, a kit for a shoulder prosthesis is disclosed. The kit can include a stem, a reverse insert, an anatomical joint component, and / or a spacer. The stem can include a distal shaft portion, a proximal portion, and a metaphyseal portion. The distal shaft portion can be adapted to be fixed within the medullary canal of the humerus. The proximal portion can have a stem face. The metaphyseal portion can include an inner portion and first and second outer arms. Alternatively, the metaphyseal portion can include only one outer arm or three or more outer arms. The first and second outer arms can extend between and connect the distal shaft portion and the proximal portion. The reverse insert can have a proximal portion and a distal portion. The proximal portion of the reverse insert can include a concave surface adapted to receive a glenoid sphere. The distal portion of the reverse insert can include a projection. The reverse insert can be adapted to couple directly to the stem face. The anatomical joint component can have a proximal portion and a distal portion. The proximal portion of the anatomical joint component can include a convex surface. The distal portion of the anatomical joint component can include a projection. The anatomical joint component can be adapted to couple directly to the stem face. The spacer can include a proximal portion, a distal portion, and a projection. The projection of the spacer can extend from the distal surface of the spacer. The spacer can be adapted to couple a reverse insert or an anatomical joint component to the stem. The proximal portion of the spacer can be asymmetric. The projection can be adapted to provide rotational alignment between the spacer and the stem.
[0015] The kits of the preceding paragraphs, or the subject matter further described herein, can also include one or more of the following features. The proximal portion of the spacer can be symmetric. The stem surface can include a central cavity. The central cavity of the stem surface can be adapted to receive a reverse insert or an anatomical joint component. The distal shaft portion of the stem can include a plurality of apertures. The plurality of apertures of the distal shaft portion can be adapted to receive a screw or a plug. The spacer can include an engagement mechanism. The engagement mechanism can project from the distal side surface of the spacer. The engagement mechanism can extend distally to the protrusion. The distal portion of the spacer can include first and second outer notches. The first notch can be disposed opposite the second notch. Alternatively, the spacer can include a single outer notch or three or more outer notches. The proximal portion of the spacer can include a proximal edge and a distal edge. The proximal edge can be angled with respect to the distal edge. The proximal edge can be angled at about 5° with respect to the distal edge of the proximal portion of the spacer. Alternatively, the proximal edge can be angled at less than about 5° or greater than about 5° with respect to the distal edge of the proximal portion of the spacer. For example, the proximal edge can be angled at about 3° or about 10°. Alternatively, the distal edge can be angled with respect to the proximal edge. The kit can further include a second stem. The distal shaft portion of the second stem can be longer than the distal shaft portion of the first stem. The kit can further include one or more plugs. The plug can be adapted to be received by one of the plurality of apertures. The plug can include a polyethylene material or any suitable material. For example, the plug can include a bone graft.
[0016] The kits of the foregoing paragraphs, or the subject matter further described herein, can also include one or more of the following features. The kit can further include a second spacer. The second spacer can include a proximal portion and a distal portion. The second spacer can be adapted to couple a reverse insert or an anatomical joint component to the stem.
[0017] In some aspects of the present disclosure, a stem for a shoulder prosthesis is disclosed. The stem can include a distal shaft portion, a proximal portion, a metaphysis portion, and a suture groove. The distal shaft portion can be adapted to be fixed within the medullary canal of the humerus. The proximal portion can have a stem face. The stem face can be surrounded by a proximal rim. The metaphysis portion can include an inner portion and first and second outer arms. Alternatively, the metaphysis portion can include only one outer arm or three or more outer arms. The first and second outer arms can extend between the distal shaft portion and a base portion of the proximal portion and connect them. The suture groove can be adapted to engage a suture. The suture groove can extend between the proximal rim and the metaphysis portion along the inside of the proximal portion. The suture groove can also extend around at least a portion of the perimeter of the proximal portion. The suture groove can include a first concave curvature, a second concave curvature, and a convex portion. The second concave curvature can be distal to the first curvature. The convex portion can be disposed between the first concave curvature and the second concave curvature.
[0018] The stem of the foregoing paragraphs, or the subject matter further described herein, can also include one or more of the following features. The height of the suture groove can be between about 0.5 cm and about 1.0 cm. The stem can further include a plurality of grooves. The plurality of grooves can be disposed on the outside of the proximal portion. The plurality of grooves can extend in the anterior-posterior direction. The stem can further include a plurality of grooves on the outer surfaces of the first and second outer arms of the metaphysis portion.
[0019] In some aspects of the present disclosure, a stem for a shoulder prosthesis is disclosed. The stem can include a distal shaft portion, a proximal portion, a metaphyseal portion, and one or more apertures. The distal shaft portion can be adapted to be fixed within the medullary canal of the humerus. The proximal portion can have a stem face. The stem face can include a central recess, a peripheral wall, and a base portion. The peripheral wall can be disposed along the periphery of the central recess. The base portion can be disposed distally relative to the peripheral wall. The metaphyseal portion can include an inner portion and first and second outer arms. Alternatively, the metaphyseal portion can include one outer arm, or three or more outer arms. The first and second outer arms can extend between the distal shaft portion and the base portion of the proximal portion and connect them. The inner portion can include one or more arms. The arms can have an outer edge. The first and second outer arms can have an inner edge. One or more windows can be defined between the outer edge of the inner arm and the inner edge of the first and second outer arms. The apertures can be adapted to receive screws or plugs. The apertures can be disposed on the distal side of the window of the metaphyseal portion and can extend in the anteroposterior direction.
[0020] The stem of the foregoing paragraph, or as further described herein, can also include one or more of the following features. The longitudinal centerline of the aperture can be less than about 1.0 cm from the distal edge of the window. The aperture can include a circular cross-section. The stem can further include additional apertures. The additional apertures can be disposed on the distal side of the aperture. Each of the additional apertures can be adapted to receive screws or plugs.
[0021] In some aspects of the present disclosure, a kit for a shoulder prosthesis is disclosed. The kit can include a stem, a stem holder, and a jig. The stem can be adapted to be implanted in a patient's shoulder. The stem can include a proximal portion and a plurality of openings. The proximal portion can have a stem face. Each of the plurality of openings can be adapted to receive cement or screws to secure the stem within the patient's shoulder. The stem holder can be adapted to implant the stem in the patient's shoulder when the stem is secured with cement. The jig can be adapted to implant the stem in the patient's shoulder when the stem is secured with one or more screws.
[0022] The kits of the foregoing paragraphs, or the subject matter further described herein, can also include one or more of the following features. The kit can further include a second stem. The second stem can include a second length and a plurality of openings. The stem can include a first length that is shorter than the second length. The jig can be adapted to implant the second stem into a patient's shoulder when the second stem is secured with one or more screws. The jig can include a distal arm extension adapted to guide one or more screws into one or more of the plurality of openings of the second stem. The distal arm extension of the jig can be adapted to be movable between a first side and a second side of the jig. The distal arm extension can be positioned on the first side of the jig to implant the second stem into the patient's left shoulder. The distal arm extension can be positioned on the second side of the jig to implant the second stem into the patient's right shoulder. The jig can include an interface portion. The interface portion can be adapted to removably couple to a stem face of the second stem. The jig can include an insertion head. The insertion head of the jig can be adapted to receive an insertion force from a tool for implanting the second stem into a patient's shoulder. The insertion head of the jig can be positioned proximal to the interface portion. The jig can include a height gauge. The height gauge of the jig can be adapted to determine a height position of the second stem when implanting the second stem into a patient's shoulder. The stem holder can include an insertion head. The insertion head of the stem holder can be adapted to receive an insertion force from a tool for implanting the stem into a patient 's shoulder. The stem holder can include a height gauge. The height gauge of the stem holder can be adapted to determine a height position of the stem when implanting the stem into a patient's shoulder.
[0023] In some aspects of the present disclosure, a system for implanting a shoulder prosthesis is disclosed. The system can include a stem and a jig. The stem can be adapted to be implanted into a patient's shoulder. The stem can include a plurality of apertures. The plurality of apertures can be adapted to receive one or more screws for fixing the stem within the patient's shoulder. The jig can be adapted to introduce the stem into the patient's shoulder. The jig can include a distal arm extension. The distal arm extension can be adapted to guide one or more screws into one or more of the plurality of apertures of the stem. The distal arm extension of the jig can be adapted to be movable between a first side of the jig and a second side of the jig. The distal arm extension can be positioned on the first side of the jig to implant the stem into the patient's left shoulder. The distal arm extension can be positioned on the second side of the jig to implant the stem into the patient's right shoulder. The distal arm extension can include a screw guide. The screw guide can be adapted to align one or more screws with one or more of the apertures of the stem. The screw guide can include a first aperture, a second aperture, and a slide plate. Alternatively, the screw guide can include only a single aperture or can include three or more apertures. The slide plate can be adapted to cover the first or second aperture of the screw guide. The first aperture of the screw guide can be adapted to align the threads of one or more screws with the first aperture of one or more of the apertures of the stem when the distal arm extension is on the first side of the jig. The second aperture of the screw guide can be adapted to align the threads of one or more screws with the second aperture of one or more of the apertures of the stem when the distal arm extension is on the second side of the jig. The slide plate can cover the first aperture of the screw guide when the distal arm extension is on the second side of the jig. The slide plate can cover the second aperture of the screw guide when the distal arm extension is on the first side of the jig.
[0024] The system of the foregoing paragraph, or what is further described herein, can also include one or more of the following features. The jig can further include an inserter portion. The inserter portion can include an insertion head. The insertion head can be adapted to receive an insertion force from a tool. The inserter portion can further include an interface portion. The interface portion can be adapted to removably couple to a proximal portion of the stem. The jig can further include a height gauge. The height gauge can be adapted to determine the height position of the stem when implanting the stem into the patient's shoulder. The jig can further include a vertical support structure. The vertical support structure can extend between the height gauge and the distal arm extension. The vertical support structure can include a proximal end and a distal end. The distal arm extension can be adapted to rotate about the distal end of the vertical support structure and move between a first side and a second side of the jig. The distal arm extension can include a first portion and a second portion. The first portion of the distal arm extension can be coupled to the distal end of the vertical support structure and can extend radially outward from the longitudinal axis of the jig. The second portion of the distal arm extension can include a screw guide and a second screw guide. The second screw guide can include an opening. The opening can be adapted to align a second screw of one or more screws with a third opening of one or more openings of the stem. The second screw guide can include an opening adapted to align a second screw of one or more screws with a third opening of one or more openings of the stem. The first opening of one or more openings of the stem can be adjacent to the distal tip of the stem. The second opening of one or more openings of the stem can be proximal to the first opening of one or more openings of the stem. One or more of the one or more openings of the stem Of the openings of the [device], a third opening may be proximal to a second opening of one or more of the openings of the stem. The distal arm extension can include a curvature or a bend. The curvature or bend can extend between a first portion and a second portion to align the screw guide and the second screw guide with one or more of the openings of the stem. The slide plate can move between a first position and a second position along the longitudinal axis of the screw guide. The slide plate can be in the first position when the distal arm extension is on a first side of the jig. The slide plate can be in the second position when the distal arm extension is on a second side of the jig. The slide plate can be adapted to move between the first position and the second position by gravity. Alternatively, the slide plate can be adapted to move between the first position and the second position by other forces. For example, a user can manually move the slide plate between the first position and the second position.
[0025] In some aspects of the present disclosure, a method for positioning a stem of a shoulder prosthesis within the medullary canal of a patient's humerus is disclosed. The method can include attaching a stem surface of the stem to an interface portion of a stem holder, inserting the stem into the medullary canal of the humerus, and fixing the stem within the medullary canal of the humerus. The stem can include a proximal portion and a distal shaft portion. The proximal portion can have a stem surface. The distal shaft portion can have a plurality of openings.
[0026] The method of the preceding paragraph, or the content further described herein, can also include one or more of the following features. This method can further include inserting a plug into an opening among a plurality of openings of the stem and cutting the length of the plug. The opening can include a first opening, a second opening, and a length measured along the longitudinal centerline therebetween. The plug can include a length and a width. The width may be smaller than the length of the plug. The length of the plug may be longer than the length of the opening. This method can further include inserting a first plug into one of the plurality of openings of the stem and inserting a second plug into one of the plurality of openings of the stem. The opening can include a first opening, a second opening, and a length measured along the longitudinal centerline therebetween. Each of the first and second plugs can include a length and a width. The width may be larger than the length of each of the first and second plugs. The length of the opening may be longer than the length of each of the first and second plugs. Fixing the stem can include providing bone cement within the medullary canal of the humerus. This method can further include applying an insertion force to the insertion head of the stem holder. Fixing the stem within the medullary canal can include inserting a screw into one of the plurality of openings of the stem. This method can further include aligning the screw guide of the stem holder with the plurality of openings. The screw guide can be carried by the distal arm extension of the stem holder. This method can further include disposing the distal arm extension of the stem holder on the first side of the stem holder when the stem is inserted into the humerus of the left shoulder and disposing the distal arm extension of the stem holder on the second side of the stem holder when the stem is inserted into the humerus of the right shoulder. When the distal arm extension is on the second side of the stem holder, the distal arm extension can be inverted compared to when the distal arm extension is on the first side of the stem holder. When the distal arm extension is on the first side of the stem holder, the screw guide can cover the first opening among the plurality of openings. When the distal arm extension is on the second side of the stem holder, the screw guide can cover the second opening among the plurality of openings.This method can further include sliding a plate on the screw guide to a first position covering the first opening or a second position covering a second one of the plurality of openings. The plate can slide by gravity. Alternatively, the user can manually move the sliding plate between the first position and the second position.
[0027] Any feature, structure, or step disclosed herein can be replaced, combined with, or omitted in relation to any other feature, structure, or step disclosed herein. Further, for the purpose of summarizing the present disclosure, certain aspects, advantages, and features of the invention are described herein. It will be understood that not all such advantages necessarily are achieved in accordance with any particular embodiment of the invention disclosed herein. No aspect of this disclosure is essential or absolutely necessary. These and other features, aspects, and advantages are described below with reference to the drawings, which are intended to illustrate, but not limit, the invention. In the drawings, like reference numerals consistently indicate corresponding features throughout the similar embodiments. The following are brief descriptions of each of the drawings.
[0028]
Brief Description of the Drawings
Brief Description of the Drawings
[0029]
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DETAILED DESCRIPTION OF THE INVENTION
[0030] This description sets forth specific details of various embodiments, but it should be understood that this description is illustrative only and should in no way be construed as limiting. Further, various applications of such embodiments and their modifications that may occur to those skilled in the art are also encompassed by the general concepts described herein. All features described herein, and any combination of two or more of such features, are included within the scope of the invention as long as the features included in such combination do not conflict with each other.
[0031] Figures 1A and 1B show two conventional approaches to total shoulder arthroplasty. Figure 1A shows an implant system 10 of an anatomical approach, in which the native humeral head of the native human humerus H is replaced with an anatomical insert or joint component 16 that includes a joint body 12 with a convex joint surface 14. In some configurations, the glenoid fossa of the scapula can be modified with an implant that provides a concave surface for the articulation of the humeral joint body 12. The humeral joint body 12 is fixed to the humerus H using a humeral stem 30. The humeral joint body 12 can be fixed to the humeral stem 30 using an adapter.
[0032] Figure 1B shows an implant system 20 of a reverse approach, in which a reverse insert or joint component 40 that includes a joint body 44 with a concave joint surface 48 is attached to the humerus H. A spherical joint body, generally called a glenoid ball 46, is attached to the glenoid fossa region of the scapula. In this case, the concave joint surface 48 disposed on the humerus H articulates with the glenoid ball 46 fixed to the scapula. The reverse joint body 44 is attached to a spacer 42 disposed between the reverse humeral joint body 44 and a humeral stem 30 surgically implanted in the humerus H. The humerus H is prepared by providing access to the medullary canal of the humeral canal H.
[0033] It can be seen that the anatomical approach and the reverse approach generally use different hardware to fix the joint components. For example, the presence of the spacer 42 may require more joint space. Therefore, the reverse configuration may only be suitable for some patients with a large joint space or some patients after more invasive preparation of the humerus and / or scapula.
[0034] In the case of a standard shoulder prosthesis, if a surgeon wishes to convert a primary anatomical shoulder prosthesis to a reverse shoulder prosthesis, the surgeon typically has to remove the entire prosthesis, thereby risking further weakening of the bone. However, when using a modular system such as the implant systems 10 and 20 shown in FIGS. 1A and 1B, the surgeon may leave the stem 30 implanted in the bone and simply replace the anatomical insert 16 with a reverse insert 40. For example, the anatomical insert 16 can be removed using a wedge or similar instrument. The reverse insert 40 can be inserted to directly engage the stem surface of the humeral stem 30 and can be driven into place, for example, using an impactor or similar tool.
[0035] I. Systems and Kits with Shared Implant Components FIG. 2 is a schematic view of a total arthroplasty system including an arthroplasty kit 100 that can be used to perform an anatomical arthroplasty or a reverse arthroplasty, or to convert from an anatomical arthroplasty to a reverse arthroplasty or from a reverse arthroplasty to an anatomical arthroplasty, according to various embodiments. The kit 100 can include one or more stemless humeral anchors 103, one or more stemmed humeral anchors 113, one or more joint components 161, and / or one or more spacers and adapters 150 configured to couple the stemless humeral anchor 103 or the stemmed humeral anchor 113 to an anatomical insert or a reverse insert. The stemless humeral anchor 103 can have a distal portion 105 and a proximal portion 107. The distal portion 105 of the anchor 103 shown in FIG. 2 can have one or more fins 109 that extend distally. The fins 109 can be configured to fix the anchor 103 within the humerus. The stemless anchor 103 can have a tapered profile in which the anchor 103 narrows from the proximal portion 107 towards the distal portion 105.
[0036] As shown in FIG. 2, the stemless anchor 103 can be provided in a plurality of sizes to accommodate patients of different sizes, different degrees of humeral bone damage, and the like. In some embodiments, the outer size of the stemless anchor 103 may vary to fit within different sized resected portions of the humerus. For example, the kit 100 can include a plurality of stemless anchors 103A, 103B, 103C, 103D, ··· 103n, where n is the number of different sizes. Although four sizes are shown in FIG. 2 (e.g., with anchors 103A to 103D and n = 4), in other embodiments, the kit can include any suitable number of anchors. In some embodiments, the lengths l1 of the stemless anchors 103A to 103D can also vary by a depth selected by the clinician based on the particular patient being treated such that they extend into the humerus. Further, the anchors 103A to 103D can have different fin lengths l f of the fins 109 to accommodate different sized humeri.
[0037] In various embodiments, the fin lengths l f of the anchors 103A to 103D can be substantially different to beneficially provide a wide range of anchor strengths in the humerus and accommodate patients with different levels of bone damage. In the configuration of FIG. 2, for example, the first anchor 103A can have the shortest overall length l1 and the shortest overall fin length l f . The fourth anchor 103D can have the longest overall length l1 and the longest overall fin length l f . In various embodiments, the ratio of the overall length l1 of one anchor 103 (e.g., the largest anchor 103) to the overall length l1 of another anchor 103 (e.g., the smallest anchor 103) in the kit 100 can be in the range of 1.15 to 2.5, in the range of 1.18 to 2.5, in the range of 1.2 to 2.5, in the range of 1.2 to 2, in the range of 1.2 to 1.8, in the range of 1.2 to 1.6, in the range of 1.3 to 1.6, or in the range of 1.25 to 1.4.
[0038] Kit 100 can also include one or more humeral anchors 113 with stems. Kit 100 can include one or more humeral stem anchors 112, each of which can include a proximal metaphyseal portion 120 and an elongated diaphyseal portion 116 extending therefrom. The diaphyseal portion 116 may also be referred to herein as a stem or stem portion. The humeral anchor 113 with a stem may be used for patients in whom the stemless anchor 103 cannot be properly fixed to the humerus, such as patients who have experienced severe bone loss. Similar to the stemless anchor 103, Kit 100 can include humeral stem anchors 113 (which may also be referred to herein as anchors with stems) having a plurality of different sizes, such as different outer sizes and / or different lengths l2. For example, as shown in FIG. 2 , the humeral anchor 113 with a stem can have a length l2 that is longer than the length l1 of the stemless anchor 103 . Each can have its own length l2. Advantageously, by including anchors 113 with stems of different sizes in Kit 100, the clinician can select an appropriate size for a particular patient, taking into account the size and health of the patient's bone, and securely implant the anchor 113 into the patient. In various embodiments, the length l2 of the humeral anchor with a stem can range from about 55 mm to about 175 mm. In contrast, the shorter length l1 of the stemless humeral anchor 103 can be in the range of about 16 mm to about 28 mm. In various embodiments, the humeral anchor 113 with a stem can be configured to reach the intramedullary canal of the humerus H for additional fixation.
[0039] In some embodiments, the humeral anchor 113 with a stem can include a trauma or fracture stem anchor or humeral stem 30, 230 that can be used for patients who have experienced a fracture of the humerus H. The trauma or fracture stems 30, 230 may be used when the humerus is fractured into one or more parts. Further, the shaft portions of the fracture stems 30, 230 each have a length l 3、It may have l4, and as a result, the length l4 of the shaft portion of the longer fracture stem 230 can be longer than the length l3 of the shaft portion of the shorter fracture stem 30. In various embodiments, the length l4 of the shaft portion of the longer fracture stem 230 can be in the range of about 125 mm to about 175 mm, in the range of about 150 mm to about 175 mm, or about 168 mm. In contrast, the shorter length l3 of the shaft portion of the shorter fracture stem 30 can be in the range of about 50 mm to about 100 mm, in the range of about 75 mm to about 100 mm, or about 88 mm.
[0040] Advantageously, the kit 100 can include one or more shared humeral components for use with either the stemless humeral implant 103 or the stemmed humeral implant 113, depending on which implant 103 or 113 is more suitable for the anatomical structure of the humerus of a particular patient. For example, the shared humeral components of the kit 100 can include a plurality of articular components or assemblies 161 that can be used in combination with either the stemless implant 103 or the stemmed implant 113. As described herein, both the stemless humeral anchor 103 and the stemmed humeral anchor 113 can include a shared engagement mechanism that can be used with the same set of tools and / or articular components. For example, as described herein, the stemless anchor 103 and the stemmed anchor 113 can include convex and concave locking mechanisms configured to engage with the same set of articular components.
[0041] For example, the kit 100 can include an anatomical joint component 160 configured to mechanically couple to both the stainless humeral implant 103 and the stemmed humeral implant 113. A clinician may select the anatomical joint component 160 for an appropriate surgical anatomical reconstruction. The anatomical joint component 160 can include a coupler 168 and an articular body 164 (anatomical) configured to mechanically engage the coupler 168. As shown in FIG. 2, the articular body 164 of the anatomical joint component 160 can include a rounded convex surface configured to engage the articular fossa surface of the patient. The coupler 168 can function to mechanically connect the anatomical articular body 164 (e.g., rounded or substantially spherical) to either the stainless humeral implant 103 or the stemmed humeral implant 113, depending on the humeral structure of the patient. The articular body 164 and the coupler 168 can include a metal such as cobalt, chromium, or titanium. In some embodiments, the articular body includes a pyrolytic carbon layer at least on the articular surface. In various embodiments, the kit 100 can include anatomical joint components 160 having multiple sizes.
[0042] The kit 100 includes a stainless humeral implant 103 and a stemmed humeral implant It can include a reverse joint component 180 configured to be mechanically coupled to both the humerus 103 and the stemmed humerus implant 113. A clinician may select the reverse joint component 180 for a surgery where reverse anatomical reconstruction is appropriate. The reverse joint component 180 can include a reverse joint body 184 and a locking device 188 configured to secure the reverse joint component 180 to the stemless humerus implant 103 or the stemmed humerus implant 113 according to the recommendation of the clinician during the surgery. As shown, the reverse joint body 184 can include a rounded concave surface (e.g., substantially spherical) configured to engage a glenoid sphere (not shown, but may be combined with the kit to form a larger surgical kit in some cases) connected to the patient's glenoid fossa. Further, in some embodiments, the kit 100 can include a wear-resistant reverse joint component 180A, which may be substantially similar to the reverse joint component 180, but may be further formed to include vitamin E to promote long-term compatibility with the patient's bone structure. The reverse components 180, 180A can include a polymer including, for example, ultra-high molecular weight polyethylene. In various embodiments, the kit 100 can include reverse joint components 180, 180A having multiple sizes.
[0043] Kit 100 can also include one or more spacers 150 that can mechanically couple a reverse type joint component 180 or an anatomical joint component 160 to a stemless humeral implant 103 or a stemmed humeral implant 113. As shown in FIG. 2, one or more spacers 150 can be provided in multiple sizes to accommodate patients of different sizes, different degrees of humeral bone damage, etc. For example, kit 100 can include multiple spacers 150A, 150B, 150C, ··· 150n, where n is the number of different sizes. Although four sizes are shown in FIG. 2 (for example, equipped with spacers 150A to 150D, n = 4), in other embodiments, the kit can include any suitable number of spacers. In addition, one or more spacers 150 can be symmetric or asymmetric. One or more spacers and adapters 150 will be further described below in connection with FIGS. 9A - 12C.
[0044] During the arthroplasty surgery, the clinician may examine the bone structure of the humerus and / or scapula to determine whether the anatomical structure is suitable for a stemless or stemmed humeral anchor and whether the anatomical structure is suitable for an anatomical reconstruction or a reverse type anatomical reconstruction. Advantageously, kit 100 shown in FIG. 2 can provide the clinician with a total arthroplasty system that includes a stemless or stemmed anchor and components that are compatible with anatomical or reverse type anatomical structures. For example, during the surgery, the clinician may observe that the patient has sufficient humeral structure so that a stemless anchor 103 can be used to reduce damage to the patient's anatomical structure. The clinician may also choose to proceed with an anatomical reconstruction or a reverse type construction and accordingly can select either an anatomical joint component 160 or a reverse type joint component 180, 180A.
[0045] Similarly, during shoulder joint formation surgery, if the clinician determines that the patient's bone structure is damaged or that a stemmed anchor 113 is otherwise more suitable, the clinician can select an appropriately sized stemmed anchor 113. The clinician can further choose whether to proceed with an anatomical reconstruction or a reverse type construction and, accordingly, can select either an anatomical joint component 160 or a reverse type joint component 180, 180A. Advantageously, the kit 100 of FIG. 2 includes interchangeable or interoperable components that can be used with either a stemmed anchor or a stemless anchor and with either an anatomical or reverse type anatomical reconstruction. The common humeral joint component 161 (e.g., an anatomical or reverse type anatomical joint body) can be used with either a stemless or a stemmed anchor 103, 113, so that the clinician can make or change a reconstruction decision during the surgery. Thus, the kit 100 enables the clinician to quickly determine the reconstruction surgery that is most suitable for the patient and provides the clinician with the components to be used in that reconstruction surgery. As described above, in the case of a humeral fracture, the kit 100 can also include one or more trauma stems 30, 230. Advantageously, the trauma stems 30, 230 can include an engagement mechanism that is substantially similar or identical to the engagement mechanism of the stemless anchor 103 and the humeral stem anchor 113, such that the trauma stem(s) 30, 230 can be used with the common joint component 161 and a common set of tools. Thus, advantageously, the kit 100 can be used with either a stemless or a stemmed humeral anchor 103, 113 and can be used for anatomical or reverse type anatomical reconstructions and can provide a common set of implant tools and a common set of joint components 161.
[0046]
[0047] In some embodiments, the coupler 168 can include a proximal extension 163A configured to connect to the articulating body 164 and a distal extension 163B. The distal extension 163B can be received within the first recesses 52, 252 of the stem surfaces 50, 250 of the fracture stems 30, 230 for anatomical reconstruction. In some embodiments, the recesses 52, 252 can be recessed (e.g., extend distally) from the distal ends of the second recesses 54, 254. In these embodiments, the disk or intermediate portion 162 can provide a spacer function when used with the trauma stems 30, 230. In some configurations, the recesses 52, 252 can be lifted toward the resection surface to remove the disk or intermediate portion 162 disposed between the proximal extension 163A and the distal extension 163B. Further details of the trauma stem are described in International Application No. PCT / US2015 / 065126, entitled "CONVERTIBLE STEM / FRACTURE STEM", filed Dec. 10, 2015, the entire content of which is incorporated by reference.
[0048] The final implant can take any suitable configuration, such as those described in International Application No. PCT / US2019 / 054007, entitled "SHOULDER PROSTHESIS COMPONENTS AND ASSEMBLIES", and International Application No. PCT / US2019 / 054023, entitled "MODULAR HUMERAL HEAD", both filed Apr. 9, 2020. The final implant can take any suitable configuration as disclosed in International Application No. PCT / US2020 / 053629, entitled "SHOULDER PROSTHESIS COMPONENTS AND ASSEMBLIES", filed Sep. 30, 2020. The articulation component can take any suitable configuration as disclosed in International Application No. PCT / US2020 / 053625, entitled "REVERSE SHOULDER SYSTEMS", filed Sep. 30, 2020. The entire content of each application listed in this paragraph is incorporated by reference.
[0049] II. Examples of Fracture Stems FIG. 3 shows a shoulder arthroplasty system for treating a humerus fracture patient. The arthroplasty system may include a fracture stem 30, an anatomical joint component 160, a reverse-type joint component 180, a plurality of screws 170 configured to fix the fracture stem 30 within the patient's humerus, and / or a plurality of plugs 700A, 700B configured to be received by a plurality of openings of the stems 30, 230. As discussed above, when anatomical reconstruction is appropriate, the clinician may couple the anatomical joint component 160 to the stem 30. The coupler 168 may mechanically couple the joint body 164 to the stem surface 50 of the fracture stem 30.
[0050] When reverse-type reconstruction is appropriate, the clinician may couple the reverse-type joint component 180 to the fracture stem 30. The clinician may directly couple the reverse-type joint component 180 to the stem surface 50 of the fracture stem 30, or may use a spacer 150 to couple the reverse-type joint component 180 to the stem surface 50 of the fracture stem 30. For example, FIG. 4 shows an assembled reverse-type shoulder prosthesis 20 with a spacer 150 for coupling the reverse-type joint component 180 to the fracture stem 30.
[0051] Figures 5A-7B illustrate embodiments of the fracture stem 30. The stem 30 of FIGS. 1A and 2A is a fracture stem configured to be used in the humerus fracture repair surgery described herein. The stem 30 is configured to be fixed within the medullary canal of the patient's humerus. As shown in FIG. 5A, the stem 30 includes a distal portion 32, a proximal portion 34, a medial side 93, and a lateral side 91. In some embodiments, the stem 30 is a one-piece body. Thus, the stem 30 can have a one-piece structure and the distal portion 32 and the proximal portion 34 can be integrally formed. In some embodiments, the stem 30 and / or other humerus anchors herein can have a distal portion that includes a taper. For example, the distal portion 32 can have an overall shape that tapers gradually so that it better conforms to the humerus into which it is implanted. The length of the distal portion 32 of the stem 30 can be varied as will be further described below in connection with FIGS. 8A-8F.
[0052] In some embodiments, the proximal portion 34 includes a spherical portion. For example, as shown in FIG. 5C, the outer surface 35 of the proximal portion 34 can have a generally hemispherical shape. The proximal end of the proximal portion 34 can include a stem surface 50, which will be further described below in connection with FIG. 7. The stem 30 can further include a metaphyseal portion 90 between the distal portion 32 and the proximal portion 34, as shown in FIGS. 5A and 5C. The metaphyseal portion 90 can include three or more arms that extend between and connect the distal portion 32 and the proximal portion 34. In the illustrated embodiment, the metaphyseal portion 90 includes three arms, namely, an inner arm 92, a first outer arm 94, and a second outer arm 96. The inner arm 92 can be disposed near the calcaneus. The inner arm 92 can be angled inwardly. Thus, the proximal end 110 of the inner arm 92 can be disposed inwardly relative to the distal end 112 of the inner arm 92, as shown in FIG. 5C. For example, the proximal end 110 can be angled inwardly relative to the distal end 112 by about 10° to about 15°, or about 12°. The first outer arm 94 and the second outer arm 96 can be configured and arranged to support the tubercle. The first outer arm 94 and the second outer arm 96 can be angled outwardly or laterally. Thus, as shown in FIG. 5C, the proximal end 114 of the first outer arm 94 can be disposed outwardly relative to the distal end 116 of the first outer arm 94, and the proximal end 118 of the second outer arm 96 can be disposed outwardly relative to the distal end 120 of the second outer arm 96. The angle and shape of each arm 94, 96 can be selected to conform to the anatomical structure of a particular patient's bone based on virtual surgery and / or numerical simulation of bone distortion by the prosthesis. For example, the proximal ends 114, 118 of the first and second outer arms 94, 96 can be angled outwardly relative to the distal ends 116, 120 of the first and second outer arms 94, 96 by between about 5° and about 10°, or about 8°. Use of the fracture stem 30 of the present disclosure in fracture repair surgery advantageously serves to promote healing of the tubercle and inhibit or reduce resorption of the tubercle.
[0053] As shown in FIGS. 5B and 5C, the stem 30 can include a notch 108. The notch 108 may be at or near the position where the inner 93 of the epiphyseal portion 90 intersects the proximal portion 34. For example, the notch 108 may be at or near the position where the inner 93 of the inner arm 92 intersects the proximal portion 34. The notch 108 can extend from this position along the inner 93 of the proximal portion 34 to the peripheral rim 38 of the proximal portion 34. For example, the height H1 of the notch 1 08 can be about 5 mm to about 10 mm, about 7 mm to about 8 mm, or about 8.6 mm. In some configurations, the height H1 of the notch 108 can be between about 20% and about 50%, or about 30% and about 40% of the height of the epiphyseal portion 90. The notch 108 can also extend in the anteroposterior direction along the outer surface 35 of the inner 93 of the proximal portion 34. For example, the notch 108 can extend along at least a portion of the circumference of the proximal portion 34. In some configurations, the notch 108 extends only along the inner side of the proximal portion 34. In some configurations, the notch 108 can include a convex portion 108b between two concave portions 108a, 108c. The notch 108 can be configured to engage a suture in a fracture repair surgery and can help prevent the suture from slipping or shifting out of position.
[0054] The stem 30 can also include fins 102 that project from the outer 91 of the distal portion 32. In the illustrated embodiment, the fins 102 extend distally from the proximal portion of the distal portion 32 along a portion of the length of the distal portion 32. The fins 102 can help facilitate proper positioning of the stem 30 during placement of the stem. In some configurations, the length of the fins 102 can be about 20 mm to about 40 mm, about 25 mm to about 35 mm, or about 30.8 mm. In some configurations, the length of the fins 102 is about 10% to about 40%, or about 20% to about 30% of the total length L of the stem 30 T1 (shown in FIG. 5F).
[0055] In some configurations, a window or opening 104 can be defined between the outer edge 113 of the inner arm 92 and the inner edges 115, 119 of the first outer arm 94 and the second outer arm 96, respectively. In some embodiments of the fracture repair surgery, a bone graft can be placed within the opening 104 to facilitate the fixation of the bone and the stem 30. The space or gap 106 shown in FIG. 5E can be defined or formed between the inner edge 117 of the first outer arm 94 and the inner edge 121 of the second outer arm 96. In the illustrated embodiment, the gap 106 has an elongated rounded rectangular shape, although other shapes or configurations are possible. As shown, the gap 106 can extend from the proximal portion of the distal portion 32 to the proximal portion 34. The space 106 can allow for increased bone growth and fixation and can, for example, allow for the placement of bone graft material within the opening 104, within the space 106, and / or on the outside of the outer arms 94, 96. For example, in some surgeries, the stem 30 can be used in a tuberosity fixation surgery using a horseshoe graft. An example of such a surgery is Levy, Jonathan C. and Badman, Brian, Reverse Shoulder Prosthesis for Acute Four-Part Fracture: Tuberosity Fixation U sing a Horseshoe Graft, J Orthop Trauma, It is described in Volume 25, Number 5, May 2011. In such an operation, a horseshoe graft can be placed on the outer surface of the metaphysis portion 90. The design of the metaphysis portion 90 can help provide stability to the horseshoe graft. The space 106 allows the horseshoe graft to form or grow within or through the window 106, improving fixation and tubercle repair. In particular, more paths for the formation or growth of bone that bridges between the fracture parts are provided, so that absorption of the tubercle can be reduced or prevented. The peripheral rim 38 of the stem surface 50 can also help support and stabilize the tubercle. The shape and size of the horseshoe graft can be selected based on numerical simulations, and virtual surgery can be used to accurately restore the position of the tubercle.
[0056] The metaphysis portion 90 can include one or more through-holes 98. For example, one or more through-holes 98 may be disposed under the fenestration 104. The through-holes 98 can be configured to receive one or more screws 170 or plugs 700A, 700B, which will be further described below in relation to FIGS. 13 - 16. In the illustrated configuration, only one through-hole 98 extending in the anteroposterior direction is shown. Advantageously, when the stem 30 is implanted into the patient, inserting a screw into the through-hole 98 can improve the stability and mechanical strength of the stem 30. For example, using this additional screw can reduce the stress on the weak point of the stem 30. The weak point may be located near or along the through-hole 98, and the additional screw can reduce the stress on this point by about 30% to about 50%, or about 40% compared to the stress on this point without the additional screw inserted into the through-hole 98.
[0057] In some configurations, the distal portion 32 can include a plurality of grooves 130 that extend longitudinally and are spaced circumferentially. For example, the distal portion 32 can have only four grooves 130. Each of the four grooves 130 can have a narrow distal end and a wider proximal end. In some configurations, the distal portion 32 of the stem 30 can include one or more openings 62, 64 configured to receive one or more screws 170 or plugs 700A, 700B, which will be further described below in connection with FIGS. 13 - 16. In the illustrated configuration, the distal portion 32 of the stem 30 includes only two openings, a proximal opening 62 and a distal opening 64. In some configurations, at least one of the openings 62, 64 can extend through at least one of the longitudinal grooves 130. In some configurations, each opening 62, 64 can have a diameter of about 2 mm to about 10 mm, about 4 mm to about 8 mm, or about 4.4 mm. In some configurations, each opening 62, 64 can have a length of about 2 mm to about 10 mm, about 4 mm to about 8 mm, or about 5.4 mm.
[0058] In some configurations, the openings 62, 64 may be spaced apart from each other. For example, the distance between the two openings 62, 64 can be about 10 mm to about 30 mm, or about 15 mm to about 25 mm. In some configurations, the distance between the two openings 62, 64 can be about 10% to about 40% of the length of the distal shaft portion 32, or about 20% to about 30% of the length of the distal shaft portion 32. In some configurations, the distal opening 64 can be disposed at a position about 25 mm to about 45 mm, or about 30 mm to about 40 mm from the distal tip 33 of the stem 30. In some configurations, the distance between the distal opening 64 and the distal tip 33 can be about 20% to about 50% of the length of the distal shaft portion 32, or about 30% to about 40% of the length of the distal shaft portion 32. In some configurations, the proximal opening 62 can be disposed at a position about 45 mm to about 65 mm, or about 50 mm to about 60 mm from the distal tip 33 of the stem 30. In some configurations, the distance between the proximal opening 62 and the distal tip 33 can be about 40% to about 70% of the length of the distal shaft portion 32, or about 50% to about 60% of the length of the distal shaft portion 32.
[0059] As shown in FIG. 5E, the openings 62, 64 may be angled with respect to the longitudinal plane 31 of the stem 30 such that the longitudinal centerlines extending along the lengths of the respective openings 62, 64 are angled from the longitudinal plane 31. The longitudinal plane 31 can extend in the inner-outer direction of the stem 30. In some configurations, the angle between the longitudinal centerline of the proximal opening 62 and the longitudinal plane 31 can be about 15° to about 75°, about 30° to about 60°, or about 30°. In some configurations, the angle between the longitudinal centerline of the distal opening 64 and the longitudinal plane 31 can be about 15° to about 75°, about 30° to about 60°, or about 30°. In some configurations, the proximal opening 62 can be angled in a direction opposite to that of the distal opening 64.
[0060] As shown in FIG. 5E, in some configurations, the outer side 91 of the outer surface 35 of the proximal portion 34 may include a plurality of horizontal grooves 111. The plurality of horizontal grooves 111 can be configured to enhance the stability of the nodules. In some configurations, each of the outer arms 94, 98 can include one or more horizontal grooves 111. In some configurations, the horizontal grooves 111 can be displaced from the proximal ends 114, 118 of the outer arms 94, 98. For example, the region between the horizontal grooves 111 and the outer arms 95, 98 may include a smooth surface. The maximum length of the plurality of horizontal grooves 111 can be about 10 mm to about 20 mm, about 12 mm to about 18 mm, or about 1 4 mm to about 16 mm. The minimum length of the horizontal grooves 111 can be about 1 mm to about 10 mm, about 3 mm to about 8 mm, or about 5 mm to about 6 mm.
[0061] FIGS. 5F and 5G show different dimensions of the stem 30. For example, the stem 30 can have an overall length L of about 100 mm to about 150 mm, about 110 mm to about 140 mm, about 120 mm to about 130 mm, or about 136 mm T1 . As shown in the illustrated configuration, the stem 30 may have various widths. For example, the stem 30 has a maximum width W T , a first width W1 measured in the inner-outer direction at a first length L1 from the distal tip 33 of the stem 30, a second width W2 measured in the inner-outer direction at a second length L2 from the distal tip 33, and a third width W3 measured in the inner-outer direction and a third length L3 from the distal tip 33. In addition, the stem 30 can have a fourth width W4 measured in the front-rear direction at a first length L1 from the distal tip 33, a fifth width W5 measured in the front-rear direction at a third length L3 from the distal tip 33, and a sixth width W6 measured in the front-rear direction at a fourth length L4 from the distal tip 33.
[0062] In some configurations, the first length L1 can be about 30 mm to about 70 mm, about 40 mm to about 60 mm, or about 59 mm. In some configurations, the first length L1 is about 30% to about 60% of the overall length L T1 , about 40% to about 50% of the overall length L T1 , or the overall length LT1 can be about 43% of. In some configurations, the second length L2 can be about 60 mm to about 100 mm, about 70 mm to about 90 mm, or about 80 mm. In some configurations, the second length L2 is the total length L T1 from about 40% to about 70% of the total length L T1 from about 50% to about 60% of the total length L T1 or can be about 59% of the total length L. In some configurations, the third length L3 can be about 80 mm to about 120 mm, about 90 mm to about 110 mm, or about 96 mm. In some configurations, the third length L3 is the total length L T1 from about 50% to about 80% of the total length L T1 from about 60% to about 70% of the total length L T1 or can be about 71% of the total length L. In some configurations, the fourth length L4 can be about 90 mm to about 130 mm, about 100 mm to about 120 mm, or about 107 mm. In some configurations, the fourth length L4 is the total length L T1 from about 60% to about 90% of the total length L T1 from about 70% to about 80% of the total length L T1 or can be about 79% of the total length L.
[0063] In some configurations, the maximum width W T can be smaller than the total length L T1 . For example, the maximum width W T can be about 20 mm to about 50 mm, about 30 mm to about 40 mm, or about 38 mm. In some configurations, the maximum width W T is from about 10% to about 40% of the total length L T1 from about 20% to about 30% of the total length L T1 or can be about 28% of the total length L T1 . In some configurations, the first width W1 can be about 5 mm to about 20 mm, or about 10 mm to about 15 mm. In some configurations, the first width W1 is from about 10% to about 60% of the maximum width W T from about 20% to about 50% of the maximum width W T or the maximum width W TIt can be about 30% to about 40%. In some configurations, the second width W2 can be about 7 mm to about 25 mm, or about 10 mm to about 20 mm. In some configurations, the second width W2 is about 10% to about 70% of the maximum width W T of, about 20% to about 60% of the maximum width W T or about 30% to about 50% of the maximum width W T It can be. In some configurations, the third width W3 can be about 10 mm to about 25 mm, or about 15 mm to about 20 mm. In some configurations, the third width W3 is about 20% to about 70% of the maximum width W T of, about 30% to about 60% of the maximum width W T or about 40% to about 50% of the maximum width W T It can be. In some configurations, the fourth width W4 can be about 5 mm to about 20 mm, or about 10 mm to about 15 mm. In some configurations, the fourth width W4 is about 10% to about 60% of the maximum width W T of, about 20% to about 50% of the maximum width W T or about 30% to about 40% of the maximum width W T It can be. In some configurations, the fifth width W5 can be about 8 mm to about 20 mm, or about 10 mm to about 15 mm. In some configurations, the fifth width W5 is about 10% to about 60% of the maximum width W T of, about 20% to about 50% of the maximum width W T or about 30% to about 40% of the maximum width W T It can be. In some configurations, the sixth width W6 can be about 10 mm to about 20 mm, or about 10 mm to about 15 mm. In some configurations, the first width W1 is about 20% to about 70% of the maximum width W T of, about 30% to about 60% of the maximum width W T or about 40% to about 50% of the maximum width W T and can be obtained. The following table shows examples of the widths of various sizes of the stem 30.
[0064]
Table 1
[0065] Figures 7A and 7B show the stem surface 50 of the stem 30. As described above, the stem surface 50 can include a first recess 52 that is recessed from the distal end of the second recess 54. For example, as shown in FIGS. 7A-7B, the second recess 54 can be wider and larger than the first recess 52. In some embodiments, the second recess 54 can be defined by a generally cylindrical wall or a slightly tapered wall. Similarly, the first recess 52 can be defined by a generally cylindrical wall or a slightly tapered wall. In some embodiments, the second recess 54 can be sized and shaped to receive the insert 161. For example, the first recess 52 can be sized and shaped to receive a portion of the coupler 168 to convert the reverse type anatomical reconstruction device of FIG. 4 to the anatomical reconstruction device of FIG. 1A. Further, the first recess 52 can be sized and shaped to receive the engagement mechanisms 156A, 156B, 156C of one or more spacers and adapters 150.
[0066] As shown in FIGS. 7A and 7B, the stem surface 50 can include one or more interface components such as one or more openings 51a, 51b, 53, grooves 56, and one or more slots 55a, 55b, 55c, 55d, 57a, 57b. The one or more openings 51a, 51b, 53 can include first and second openings 51a, 51b, and an anti-rotation opening 53. In some configurations, the one or more openings 51a, 51b, 53 can be configured to engage a particular portion of a tool configured to insert the anatomical joint component 160, reverse type joint component 180, one or more spacers 150, and / or the stem 30 into a patient's bone (e.g., stem holder 900 or jig 1000). For example, the anti-rotation opening 53 can be configured to engage the protrusions 155A, 155B of the one or more spacers and adapters 150. When assembled, the protrusions 155A, 155B can extend into the anti-rotation opening 53 to minimize or eliminate rotation of the spacer or adapter 150 relative to the stem surface 50 of the stem 30. In some configurations, the one or more openings 51a, 51b, 53 can be configured to engage tools such as the stem holder 900 or jig 1000, which will be further described below in connection with FIGS. 18A-21E.
[0067] In some configurations, one or more of the slots 55a, 55b, 55c, 55d, 57a, 57b can be sized and configured to engage an insert 161 (such as the articulation components 160, 180). For example, the slots 55a, 55b, 55c, 55d, 57a, 57b can engage or receive corresponding ridges of the insert 161. As described herein, the slots 55a, 55b, 55c, 55d, 57a, 57b can limit rotation of the insert 161 relative to the anchor 30. The slots 55a, 55b, 55c, 55d, 57a, 57b can also guide the forward movement of the insert 161 into the upper portion of the second recess 54. The slots 55a, 55b, 55c, 55d, 57a, 57b can be disposed perpendicular to the stem surface 50 and circumferentially spaced from each other. For example, the first and second slots 55a, 55b can be adjacent to each other and disposed on opposite sides of the third and fourth slots 55c, 55d. Further, the fifth and sixth slots 57a, 57b can be disposed on opposite sides of each other. In some configurations, the fifth and sixth slots 57a, 57b can have a wider width than the first, second, third, and fourth slots 55a, 55b, 55c, 55d. In the embodiments of FIGS. 7A and 7B, the slots 55a, 55b, 55c, 55d, 57a, 57b can extend from a position proximate the peripheral rim 38 toward the bottom of the second recess 54. In some configurations, the stem surface 50 can include one or more protrusions 58a, 58b between adjacent slots 55a, 55b, 55c, 55d. For example, the one or more protrusions 58a, 58b can include a first protrusion 58a between adjacent slots 55a, 55b and a second protrusion 58b between adjacent slots 55c, 55d. The first and second protrusions 58a, 58b can be configured to engage a portion of the insert 161 (such as the distal portions 152A, 152B, 152C of one or more spacers and adapters 150). Further, the stem surface 50 can include a groove 56 extending circumferentially around the second recess 54. The groove 56 can be sized and configured to receive a locking ring of an articulation body assembly (such as any of the inserts 161 described herein).
[0068] Figures 8A - 8F show another embodiment of the stem 230 similar to the embodiments of the stem 20 illustrated and described in connection with FIGS. 3 - 7B. Reference numerals for the same or substantially the same features may share the same last two digits. As shown in FIG. 8B, the stem 230 has an overall length L T1 longer than the overall length L T2 of the stem 30. For example, the overall length L T2 of the stem 230 can be about 150 mm to about 250 mm, about 160 mm to about 240 mm, about 170 mm to about 230 mm, or about 215 mm. In some configurations, the overall length L T2 of the longer stem 230 is about 130% to about 180%, about 140% to about 170%, about 150% to about 160%, or about 158% of the overall length L T1 of the shorter stem 30.
[0069] As shown in FIGS. 8C - 8F, the distal portion 232 of the stem 230 can include one or more openings 262, 264, 265, 267, 269 configured to receive one or more screws 170 or plugs 700A, 700B, which will be further described below in connection with FIGS. 13 - 16. In the illustrated configuration, the distal portion 232 of the stem 230 can include only five openings: a first opening 262, a second opening 264, a third opening 265, a fourth opening 267, and a fifth opening 269. The first and second openings 262, 264 can be the same as or similar to the proximal and distal openings 62, 64 of the stem 30. For example, as shown in FIG. 8E, the first and second openings 262, 264 can be angled with respect to the longitudinal plane 231 of the stem 230 such that the longitudinal centerlines extending along the lengths of the respective openings 262, 264 are angled from the longitudinal plane 231. The longitudinal plane 231 can extend in the inner - outer direction of the stem 230. In some configurations, the angle between the longitudinal centerline of the first opening 262 and the longitudinal plane 231 can be about 15° to about 75°, about 30° to about 60°, or about 30°. In some configurations The angle between the longitudinal centerline of the second opening 264 and the longitudinal plane 231 may be about 15° to about 75°, about 30° to about 60°, or about 30°. In some configurations, the first opening 262 can be angled in a direction opposite to the second opening 264.
[0070] As shown in FIG. 8E, the third, fourth, and fifth openings 265, 267, 269 may be angled with respect to a second longitudinal plane (not shown) that is substantially perpendicular to the longitudinal plane 231. For example, the longitudinal centerline of the third opening 265 may extend in the same direction as the second longitudinal plane such that the third opening 265 extends in the front-rear direction. In some configurations, the angle between the longitudinal centerline of the fourth opening 267 and the second longitudinal plane may be about 10° to about 30°, about 15° to about 25°, or about 20°. In some configurations, the angle between the longitudinal centerline of the fifth opening 269 and the second longitudinal plane may be about 10° to about 30°, about 15° to about 25°, or about 20°. In some configurations, the fourth opening 267 can be angled in a direction opposite to the fifth opening 269.
[0071] In some configurations, the first and second openings 262, 264 may be spaced apart from each other. For example, the distance between the two openings 62, 64 can be about 4% to about 20% of the total length L T2 of the stem 230, or about 10% to about 15% of the total length L T2 of the stem 230. In some configurations, the first opening 262 can be disposed at a position about 130 mm to about 160 mm, or about 140 mm to about 150 mm, from the distal tip 233 of the stem 230. In some configurations, the distance between the first opening 262 and the distal tip 233 is about 45% to about 75% of the total length L T2 of the stem 230, or about 45% to about 75% of the total length L T2can be about 55% to about 65%. In some configurations, the second opening 262 can be disposed at a position about 105 mm to about 135 mm, or about 115 mm to about 125 mm, from the distal tip 233 of the stem 230. In some configurations, the distance between the second opening 264 and the distal tip 233 is about 40% to about 80% of the total length L of the longer stem 230, or about 50% to about 70% of the total length L of the longer stem 230. T2 T2 can be about 50% to about 70%.
[0072] In some configurations, the first and second openings 262, 264 may be spaced from the third, fourth, and fifth openings 265, 267, 269. For example, the distance between the second opening 264 and the third opening 265 can be about 60 mm to about 100 mm, or about 70 mm to about 90 mm. In some configurations, the distance between the second opening 264 and the third opening 265 is about 20% to about 60% of the total length L of the stem 230, or about 30% to about 50% of the total length L of the stem 230. T2 T2 can be about 30% to about 50%.
[0073] In some configurations, the third opening 265 can be disposed at a position about 20 mm to about 60 mm, or about 30 mm to about 50 mm, from the distal tip 233 of the stem 230. In some configurations, the distance between the third opening 265 and the distal tip 233 is about 5% to about 40% of the total length L of the stem 230, or about 10% to about 30% of the total length L of the stem 230. In some configurations, the fourth opening 267 can be disposed at a position about 10 mm to about 50 mm, or about 20 mm to about 40 mm, from the distal tip 233 of the stem 230. In some configurations, the distance between the fourth opening 267 and the distal tip 233 is about 5% to about 30% of the total length L of the longer stem 230, or about 5% to about 30% of the total length L of the longer stem 230. T2 T2 T2 T2 can be from about 10% to about 20%. In some configurations, the fifth aperture 269 can be positioned at a location from about 5 mm to about 40 mm, or from about 10 mm to about 30 mm, from the distal tip 233 of the stem 230. In some configurations, the distance between the fifth aperture 269 and the distal tip 233 is about 5% to about 30% of the total length L of the longer stem 230, or about 10% to about 20% of the total length L of the longer stem 230. T2 can be from about 5% to about 30% of the total length L of the longer stem 230, or about 10% to about 20% of the total length L of the longer stem 230. T2 can be from about 10% to about 20%.
[0074] In some configurations, the third aperture 265 can be configured to receive the screw 170 when fixing the stem 230 to the patient's left or right shoulder. In some configurations, the fourth aperture 257 can be configured to receive the screw 170 when fixing the stem 230 to the patient's right shoulder. In some configurations, the fifth aperture 259 can be configured to receive the screw 170 when fixing the stem 230 to the patient's left shoulder. In other configurations, the fourth aperture 257 can be configured to receive the screw 170 when fixing the stem 230 to the patient's left shoulder, and the fifth aperture 259 can be configured to receive the screw 170 when fixing the stem 230 to the patient's left shoulder.
[0075] III. Examples of Components of the Humeral Assembly As described above in connection with FIG. 3, the shoulder arthroplasty system or humeral assembly can include a number of components such as the adapter 168, the spacer 150, the plurality of screws 170, and / or the plurality of plugs 700A, 700B.
[0076] Figures 9A - 11C show different embodiments of the spacer 150. Figures 9A - 9C show an embodiment of the spacer 150A. The spacer 150A can include a proximal portion 151A and a distal portion 152A. The proximal portion 151A can have a diameter larger than the diameter of the distal portion 152A such that the proximal portion 151A extends radially outward from the distal portion 152A. In some configurations, the distal portion 152A extends from the distal surface 153A of the proximal portion 151A.
[0077] As shown in FIGS. 9A and 9B, the distal portion 152A can include a distal surface 154A. The distal surface 154A can include a protrusion 155A and an engagement mechanism 156A. In some configurations, the protrusion 155A and the engagement mechanism 156A can extend distally from the distal surface 154A. As described above, the protrusion 155A can be configured to engage with the anti-rotation openings 53, 253 of the stems 30, 230. When the spacer 150A is coupled to the stems 30, 230, the protrusion 155A can extend into the anti-rotation openings 53, 253 to minimize or eliminate rotation of the spacer 150A relative to the stem surfaces 50, 250 of the stems 30, 230. The engagement mechanism 156A can be configured to engage with the first recesses 52, 252 of the stem surfaces 50, 250 of the stems 30, 230. When the spacer 150A is coupled to the stems 30, 230, the engagement mechanism 156A can extend into the first recesses 52, 252. In some configurations, the engagement mechanism 156A can have a substantially cylindrical shape or any other suitable shape. In some configurations, the engagement mechanism 156A can be disposed at or near the center of the distal surface 154A. In some configurations, the protrusion 155A can be disposed inside or outside the engagement mechanism 156A.
[0078] As shown in FIGS. 9A and 9B, the distal portion 152A can include a curved outer surface with one or more notches 157A. The one or more notches 157A can be disposed on the opposite side of the distal portion 152A. The one or more notches 157A can be configured to align with one or more slots 55a, 55b, 55c, 55d, 255a, 255b, 255c, 255d and the first and second protrusions 58a, 58b, 258a, 258b. For example, the one or more notches 157A can engage with one or more slots 55a, 55b, 55c, 55d, 255a, 255b, 255c, 255d and the first and second protrusions 58a, 58b, 258a, 258b to minimize or eliminate rotation of the spacer 150A relative to the stem surfaces 50, 250 of the stems 30, 230.
[0079] As shown in FIG. 9B, the proximal portion 151A may be asymmetric with respect to the longitudinal axis. For example, the distal edge 158A of the proximal portion 151A on the inner side 93A of the spacer 150A may extend further inward than the proximal edge 159A of the proximal portion 151A on the inner side 93A of the spacer 150A. Further, the distal edge 158A of the proximal portion 151A on the outer side 91A of the spacer 150A may extend further outward than the proximal edge 159A of the proximal portion 151A on the outer side 91A of the spacer 150A. In some configurations, the distal edge 158A on the outer side 91A of the spacer 150A may extend inward with respect to the proximal edge 159A on the outer side 91A of the spacer 150A. In some configurations, the distal edge 158A on the inner side 93A of the spacer 150A may extend outward with respect to the proximal edge 159A on the inner side 93A of the spacer 150A. The distal edge 158A on the outer side 91A of the spacer 150A may extend further outward than the proximal edge 159A of the proximal portion 151A on the outer side 91A of the spacer 150A. In some configurations, the distal edge 158A on the inner side 93A of the spacer 150A may extend outward with respect to the proximal edge 159A on the inner side 93A of the spacer 150A.
[0080] As shown in FIG. 9C, the proximal portion 151A can include a proximal surface 400. The proximal surface 400 can be the same as or substantially similar to the stem surface 50 of the stem 30 illustrated and described in connection with FIGS. 7A and 7B. Reference numerals with the same or substantially the same features may share the same last two digits. For example, the proximal surface 400 can be configured to couple to the stem surfaces 30, 230 of the reverse articulation component 180, the adapter or coupler 168, or the articulating body 164. The proximal surface 400 can include a first recess 452, a second recess 454, a peripheral rim 438, a groove 456, one or more slots 455a, 455b, 455c, 455d, 457a, 457b, and first and second protrusions 457a, 457b. As shown in the illustrated configuration, the proximal surface 400 may include only the aforementioned features. In other configurations, the proximal surface 400 can also include one or more openings that are the same as or similar to one or more of the openings 51a, 51b, 53 of the stem 30.
[0081] Figures 10A - 10B show another embodiment of spacer 150B that is similar to the embodiment of spacer 150A illustrated and described in relation to Figures 9A - 9B. Reference numerals for the same or substantially the same features may share the same first three digits. As shown in Figure 10B, the proximal portion 151B may be angled. For example, the proximal edge 159B of the proximal portion 151B may be angled with respect to the distal edge 158B of the proximal portion 151B such that the proximal edge 159B on the inner side 93B of the spacer 150B extends more proximally than the proximal edge 159B on the outer side 91B of the spacer 150B. For example, the proximal edge 159B can be angled at about 1° to about 20°, or about 5° to about 15°, or 5° with respect to the distal edge 158B. In some configurations, the proximal edge 159B on the inner side 93B of the spacer 150B can extend more distally than the proximal edge 159B on the outer side 91B of the spacer 150B.
[0082] Figure 10C shows the proximal surface 500 of the spacer 150B, which may be similar to the proximal surface 400 of the spacer 150A of the stem 30 illustrated and described in relation to Figures 7A - 7B and 9C and the stem surface 50. Reference numerals for the same or substantially the same features may share the same last three digits.
[0083] Figures 11A - 11B show another embodiment of the spacer 150C similar to the embodiment of the spacer 150A illustrated and described in connection with FIGS. 9A - 9B. Reference numerals for the same or substantially the same features may share the same first three digits. As shown in FIGS. 11A and 11B, the distal portion 152C can include only the engagement mechanisms 156C and one or more notches 157C on the curved outer surface of the distal portion 152C. In some configurations, the distal portion 152C can include projections similar or identical to the projections 155A of the spacer 150C. As shown in FIG. 11B, the spacer 150C may be symmetric about the longitudinal axis and / or may not be angled. For example, the distal edges 158C of the proximal portion 151C on both sides 91C, 93C of the spacer 150C are aligned with the proximal edges 159C of the proximal portion 151C on both sides 91C, 93C of the spacer 150C.
[0084] FIG. 11C shows the proximal face 600 of the spacer 150B, which may be similar to the proximal face 400 of the spacer 150A of the stem 30 and the stem face 50 illustrated and described in connection with FIGS. 7A - 7B and 9C. Reference numerals for the same or substantially the same features may share the same last three digits.
[0085] Figures 12A - 12C illustrate embodiments of the adapter or coupler 168. As described above, the coupler 168 can include a proximal extension 163A configured to connect to the articulating body 164 and a distal extension 163B. In some configurations, the distal extension 163B can include a first distal portion 163C and a second distal portion 163D. The second distal portion 163D can extend distally from the first distal portion 163C. In some configurations, the first distal portion 163C can have a larger diameter than the second distal portion 163D. The first distal portion 163C can be configured to engage within the second recesses 54, 254, 454, 554, 564 of the fracture stems 30, 230 or the spacers 150A, 150B, 150C. The second distal portion 163D can be configured to engage within the first recesses 52, 252, 452, 552, 562 of the fracture stems 30, 230 or the spacers 150A, 150B, 150C. A disk or intermediate portion 162 can be disposed between the proximal extension 163A and the distal extension 163B. The disk or intermediate portion 162 can contact the peripheral rims 38, 238, 438, 538, 638 of the fracture stems 30, 230 or the spacers 150A, 150B, 150C. In some configurations, the disk or intermediate portion 162 can provide a spacer function during use when the adapter or coupler 168 is coupled to the stems 30, 230. In some configurations, the disk or intermediate portion 162 can include a window 165. The window 165 can reveal corresponding indicators on the stem that indicate the orientation or configuration of the articulating body 164 relative to other members of the joint prosthesis (e.g., the anchors 103, 113 or the articular socket component) or, in the case of hemiarthroplasty, the native articular socket. The adapter or coupler 168 may also include a channel 165 that extends between a proximal end 165A and a distal end 165B.
[0086] Figures 13A and 13B show an embodiment of a screw 170 that can be received by a plurality of openings 62, 64, 98, 262, 264, 265, 267, 269, 298 in the stems 30, 230. The screw 170 may have a length that is longer than the width of the screw 170. The length of the screw 170 may be longer than the length of the plurality of openings 62, 64, 98, 262, 264, 265, 267, 269, 298. For example, when the screw 170 is inserted into an opening among the plurality of openings 62, 64, 98, 262, 264, 265, 267, 269, 298, a portion of the screw 170 may be inserted into the patient's bone. The screw 170 can be configured to fix the stems 30, 230 to the patient's bone. In some configurations, the screw 170 can have a continuous thread 176 between the proximal head 172 of the screw 170 and the distal end 174 of the screw 170. In some configurations, the screw 170 can include one or more notches 178 at the distal end of the screw 170. The one or more notches 178 can extend from the distal end 174 of the screw 170 to at least a portion of the thread 176. Advantageously, the screw 170 can be configured to be screwed into, for example, the patient's bone faster with the one or more notches 178 compared to a screw 170 without the one or more notches 178.
[0087] Figures 14 - 16 show various embodiments of plugs 700A, 700B. Figure 14 shows the stem 30 with one or more plugs 700 in each of the openings 62, 64, 98. The one or more plugs 700 can each include an elongate plug 700A and / or a plug 700B shown in Figures 15 and 16. When the stem 30 is used for cement fixation applications, the one or more plugs 700 can prevent cement from bridging across the openings among the plurality of openings 62, 64, 98. The one or more plugs 700 can include a polyethylene material, a bone graft, or a combination thereof. For example, a clinician can create the one or more plugs 700 using a graft tool 800 that is further described below in connection with Figures 17A - 17C.
[0088] As shown in FIG. 15, the elongated plug 700A can include a length that is longer than the width of the elongated plug 700A. For example, the length and width of the elongated plug 700A may be similar to or the same as the length and width of the openings among the plurality of openings 62, 64, 98, such that a single elongated plug 700A can be received by the plug 700A. In some configurations, the length of the elongated plug 700A can be from about 10 mm to about 40 mm, from about 20 mm to about 30 mm, or about 25 mm. In some configurations, the width of the elongated plug 700A can be from about 2 mm to about 10 mm, or about 4.4 mm. In some configurations, the width of the elongated plug 700A can be about 5% to about 30%, about 10% to about 20%, or about 18% of the length of the elongated plug 700A. The elongated plug 700A can also include a plurality of slots 702A that extend along the length of the elongated plug 700A and are circumferentially spaced apart. The length of each of the plurality of slots 702A may be less than or equal to the length of the elongated plug 700A. The width of each of the plurality of slots 702A can be from about 0.1 mm to about 1.0 mm, or about 0.5 mm.
[0089] As shown in FIG. 16, the plug 700B can include a width greater than the length of the plug 700B. For example, the length of the plug 700B may be shorter than the length of the openings among the plurality of openings 62, 64, 98, and the width of the plug 700B may be the same as the width of the openings 62, 64, 98 among the plurality of openings so that a plurality of plugs 700B (e.g., two, three, four or more) can be received by the openings, or may be the width of the openings among the plurality of openings 62, 64, 98. In some configurations, the length of the plug 700B can be about 1.0 mm to about 4.0 mm, about 2.0 mm to about 3.0 mm, or about 2.5 mm. In some configurations, the width of the plug 700B can be about 2 mm to about 10 mm, or about 4.4 mm. In some configurations, the length of the plug 700B can be about 30% to about 70%, about 40% to about 60%, or about 56% of the width of the plug 700B. The plug 700B can include a plurality of slots 702B that extend along the length of the plug 700B and are spaced circumferentially. The length of each of the plurality of slots 702B may be less than or equal to the length of the plug 700B. The width of each of the plurality of slots 702B can be about 0.1 mm to about 1.0 mm, or about 0.5 mm.
[0090] For example, it may be desirable to use the elongated plug 700A to facilitate handling and insertion into one or more of the plurality of openings 62, 64, 98. On the other hand, it may be desirable to use one or more of the plugs 700B (e.g., two, three, four, five or more plugs 700B) to fill the opening(s) 62, 64, 98 without the need to cut the length of the plug 700B. The use of the plugs 700A, 700B will be further described below in connection with FIGS. 18E - 18H, 19F, 20E, and 21E.
[0091] Figures 17A - 17F illustrate a graft tool 800 that can be used to create one or more plugs 700 from bone. The graft tool 800 can include an impactor 810 and a tip 850. The impactor 810 can include a distal end 820, a proximal end 830, and an intermediate portion 840 extending between the two ends 820, 830. The distal end 820 can include an insertion head 822 having a diameter larger than the intermediate portion 840 and / or the proximal end 830. The insertion head 822 can be configured to receive an insertion force from a tool (e.g., a mallet). The proximal end 830 can include a first portion 832 and a second portion 834 proximal to the first portion 832. The circumferential length of the first portion 832 can extend beyond the circumferential length of the intermediate portion 840. The diameter or circumferential length of the second portion 834 can be about the same as or larger than the diameter or circumferential length of the intermediate portion 840. The impactor 810 can also include a channel 842 extending from the distal end 820 to the proximal end 830.
[0092] Figures 17C - 17F illustrate different views of the tip 850. As shown in FIG. 17C, the tip 850 can include a distal portion 852 having a distal end 854 and a proximal portion 856 having a proximal end 858. The distal portion 852 can have a diameter larger than the proximal portion 856. In some configurations, the distal portion 852 can have a varying diameter. For example, the diameter of the distal end 854 of the distal portion 852 can be larger than the diameter of the proximal end of the distal portion 852. As shown in FIG. 17D, in some configurations, the maximum diameter D of the distal portion 852 max1can be from about 5 mm to about 30 mm, from about 10 mm to about 20 mm, or about 15.9 mm, or about 16.9 mm. In some configurations, the distal portion 852 can have a funnel-shaped configuration. The distal portion 852 of the tip 850 can be configured to couple to the proximal end 830 of the impactor 810. For example, as shown in FIG. 17B, the distal portion 852 of the tip 850 can include a recess 851 that can be threaded, and a second portion 834 of the proximal end 830 of the impactor 810 can have a corresponding thread for engaging the threaded opening of the tip 850. The recess 851 can extend from the distal end 854 of the tip portion 850 toward the proximal end 858 of the tip portion 850. In some configurations, the length of the recess 851 can be less than or equal to the length of the distal portion 852. In some configurations, when the impactor 810 is coupled to the tip 850, the proximal side surface of the first portion 832 of the proximal end 830 of the impactor 810 can abut the distal side surface of the distal end 854 of the tip 850.
[0093] FIG. 17F shows a cross-sectional view of the tip 850 taken along line 17F-17F of FIG. 17D. FIG. 17F shows an example of the dimensions of the tip 850. The proximal portion 856 of the tip 850 can have a diameter smaller than the diameter of the distal portion 852. In some configurations, the proximal portion 856 can have a varying diameter. For example, the diameter of the distal end of the proximal portion 856 can be larger than the diameter of the proximal end 858 of the proximal portion 856. In some configurations, the maximum diameter D max2 of the proximal portion can be from about 2 mm to about 20 mm, from about 5 mm to about 10 mm, or about 6.4 mm. In some configurations, the minimum diameter D min of the proximal portion can be from about 2 mm to about 20 mm, from about 5 mm to about 10 mm, or about 4.4 mm. The diameter of the distal end of the proximal portion 856 can be the same as or similar to the diameter of the proximal end of the distal portion 852. The proximal portion 856 can have a channel 853 that extends from the proximal end 858 toward the distal end 854. The length of the channel 853 can be greater than or equal to the length of the proximal portion 850. In some configurations, the channel 853 can extend at least partially into the distal portion 852.
[0094] In use, the clinician can screw the impactor 810 into the tip 850. The clinician can position the proximal end 858 of the tip 850 against the patient's bone. The clinician can apply an insertion force to the insertion head 822 using a mallet, whereby a portion of the bone fills the channel 853 of the tip 850. When a sufficient amount of bone has entered the channel 853, the clinician can remove the bone graft from the tip 850. As shown in FIG. 17G, the clinician removes the tip 850 from the impactor 810 and uses a tool 860 such as a driver or a rod with a flat end to push the tool 860 against one end of the bone graft until the bone graft exits the proximal end 858 of the tip 850, thereby removing the bone graft from the tip 850. The clinician can insert a tool such as a pin or rod with a flat end into the channel 842 of the impactor 810 to remove the bone graft from the tip 850 and push the bone graft until it exits the proximal end 858 of the tip 850. Advantageously, using a rod with a flat end can reduce or prevent damage to the bone graft. Once the bone graft has been removed, the clinician can insert the bone graft into one or more of the openings 62, 64, 98, 262, 264, 265, 267, 269 of the stems 30, 230.
[0095] IV. Methods and Instruments for Shoulder Arthroplasty The humeral anchors described above can be implanted using the specific tools and instruments described below in connection with FIGS. 18A-21E.
[0096] A. Dual Surgical Instruments One advantage of the various kits and systems disclosed herein is that multiple different types of humeral anchors can be implanted using shared instruments. Examples of shared instruments are described below.
[0097] 1. Stem Holder As discussed above, the stems 30, 230 may include one or more interface mechanisms, such as one or more openings 51a, 51b, 53, 251a, 251b, 253, etc., configured to engage with a tool and enable insertion of the stems 30, 230 into bone. FIGS. 18A - 18I show a stem holder 900 configured to dispose the stems 30, 230 within bone (e.g., the humerus H). As will be described in more detail below, the stem holder 900 can be configured to receive, for example, an insertion force from a mallet to properly insert the stems 30, 230 into bone. For example, the proximal surfaces of the stems 30, 230 (e.g., the stem surfaces 50, 250) can receive a majority of the insertion force through direct contact with the distal surface 903 of the stem holder 900.
[0098] The stem holder 900 may include an elongated body 905. The elongated body 905 may generally extend from a first or proximal end 902 of the stem holder 900 to a second or distal end 904 of the stem holder 900. As shown in FIG. 18B, the elongated body 905 may include a stem interface portion 910 at the second end 904 of the stem holder 900. The stem interface portion 910 may be configured to engage the stem surfaces 50, 250 of the stems 30, 230. For example, the stem interface portion 910 can include one or more interface mechanisms 911, 912, 913, 914. The plurality of interface mechanisms can include a first interface mechanism 911, a second interface mechanism 913, a third interface mechanism 912, and / or a fourth interface mechanism 914, which will be further described below in connection with FIG. 18C. The third interface mechanism 912 can extend distally from the distal surface 903 of the stem holder 900 and be configured to engage the second recesses 54, 254 of the stems 30, 230. For example, the second recesses 54, 254 can receive the third interface mechanism 912. In some configurations, the third interface mechanism 912 can be spaced apart from the periphery of the distal surface 903 such that a portion of the distal surface 903 can contact the peripheral rim 38, 238 of the stem surfaces 50, 250 when the stems 30, 230 are coupled to the stem holder 900. In some configurations, the third interface mechanism 912 can include two portions that are connected at one end and otherwise spaced apart. The gap between the two portions of the third interface mechanism 912 can have a width corresponding to the width of the fourth interface mechanism 914 such that the fourth interface mechanism 914 can be received by the gap between the two portions. The first and second interface mechanisms 911, 913 can extend distally from the distal surface of the third interface mechanism 912. For example, the first interface mechanism 911 can extend from the distal surface of one of the two portions of the third interface mechanism 912, and the second interface mechanism 913 can extend from the distal surface of the other of the two portions of the third interface mechanism 912.The first and second interface mechanisms 911, 913 may be configured to engage with one or more of the openings 51a, 51b, 53, 251a, 251b, 253 of the stem 30, 230. For example, the first interface mechanism 911 may be received by the second opening 51b of the stem surfaces 50, 250, and the second interface mechanism 913 may be received by the first opening 51a of the stem surfaces 50, 250.
[0099] The stem holder 900 may also include a movable assembly 906 (see FIGS. 18C and 18D) coupled to the elongated body 905. FIG. 18D shows a stem holder 900 with an elongated body 905 that is partially transparent so that internal components (such as the movable assembly 906) can be seen. The movable assembly 906 may include a handle 908 disposed between the first end 902 and the second end 904 of the stem holder 900. The handle 908 may be coupled to the elongated body 905 at a pivot position 918, for example, pivotably coupled.
[0100] As shown in FIGS. 18C and 18D, the movable assembly 906 may also include a fourth interface mechanism 914 disposed at the second end 904 of the stem holder 900. The fourth interface mechanism 914 may be coupled to the elongated body 905 at a pivot position 919, for example, pivotably coupled. In some configurations, the fourth interface mechanism 914 may be a fixed peg that is fixed relative to the remainder of the stem holder 900 and does not move. The fourth interface mechanism 914 may be configured to engage with one of the one or more openings 51a, 51b, 53, 251a, 251b, 253 of the stem 30, 230. For example, the fourth interface mechanism 914 may be a peg configured to interface with the anti-rotation openings 53, 253.
[0101] The handle 908 can be directly or indirectly coupled to the fourth interface mechanism 914. For example, the handle 908 can be indirectly coupled to the fourth interface mechanism 914 by a spring link mechanism 916. The spring link mechanism 916 may have an arcuate portion and a spring gap 920. The spring link mechanism 916 can be indirectly coupled to the elongated body 905 by the handle 908 and / or the fourth interface mechanism 914 without a direct connection between the spring link mechanism 916 and the elongated body 905.
[0102] The handle 908 can be configured to move the fourth interface mechanism 914 between a first configuration and a second configuration. The proximal end of the handle 908 can move freely relative to the elongated body 905. The transition between the first configuration and the second configuration can include rotation and / or translation of the fourth interface mechanism 914 relative to the elongated body 905. For example, by actuating (e.g., pivoting) the handle 908 away from the elongated body 905, the fourth interface mechanism 914 can be moved from the first configuration to the second configuration, while by releasing the handle 908, the fourth interface mechanism 914 can be returned to the first configuration. In the second configuration, the fourth interface mechanism 914 can be rotated to be at least partially retracted relative to the distal surface 903 of the stem holder 900. In this position, the surgeon may engage the stem surfaces 50, 250 of the stems 30, 230. While the fourth interface mechanism 914 is engaged with the stem surfaces 50, 250 of the stems 30, 230, the handle 908 may be released to apply a gripping force to the stems 30, 230 (e.g., toward the elongated body 905). In the first configuration, the spring link mechanism 916 is compressed (e.g., the spring gap 920 is slightly closed) and can provide a spring force that helps to hold the fourth interface mechanism 914 in a closed state relative to the stems 30, 230.
[0103] In some configurations, the fourth interface mechanism 914 may be angled with respect to the first and second interface mechanisms 911, 913. For example, the longitudinal axes of the first and second interface mechanisms 911, 913 may extend substantially perpendicular from the distal face of the third interface mechanism 912. Thus, the longitudinal axis of the fourth interface mechanism 914 may be angled with respect to the longitudinal axes of the first and second interface mechanisms 911, 913. As the fourth interface mechanism 914 moves from the first configuration to the second configuration, the angle between the fourth interface mechanism 914 and the first and second interface mechanisms 911, 913 may decrease. In some configurations, the angle between the fourth interface mechanism 914 and the first and second mechanisms 911, 913 may increase when moving the fourth interface mechanism 914 from the first configuration to the second configuration.
[0104] The stem holder 900 may include at least one insertion head 924 configured to receive an insertion force from a tool (e.g., a mallet). For example, the stem holder 900 may include a single insertion head 924 that may be disposed at the first end 902 of the stem holder 900. In some configurations, the at least one insertion head can include two insertion heads including the insertion head 924 and a second insertion head disposed near the second end 904 of the stem holder 900. The insertion head 924 may be coupled to the elongated body 905. In some configurations, the insertion head 924 may be aligned with the longitudinal axis of the elongated body 905. In some configurations, the insertion head 924 may be disposed at an angle with respect to the longitudinal axis of the elongated body 905. When a force is applied to the insertion head 924, the insertion force is directed toward the stems 30, 230 in a direction aligned with the longitudinal axes of the stems 30, 230, and the stems 30, 230 can be implanted into the bone.
[0105] The stem holder 900 can be configured to receive the posterior tilt rod. For example, the posterior tilt rod can be inserted into one of the openings 926. Each opening may be configured to position the posterior tilt rod at a different angle corresponding to a desired resection angle, allowing the surgeon to evaluate the version. If the resection of the proximal bone is not accurate, or for other reasons at the discretion of the surgeon, the surgeon can change the resection surface.
[0106] The stem holder 900 may also include a height gauge 930 configured to determine the height of the stems 30, 230 relative to the humerus bone or the depth of the stems 30, 230 within the humerus bone. For example, prior to implanting the stems 30, 230 into the humerus bone, a clinician can determine the appropriate stem height of the stems 30, 230 relative to the humerus bone based on an X-ray of the humerus bone, a trial stem, or other suitable method. The height gauge 930 can include a ruler 932, a connecting rod 934, a connecting hub 940, and a marker 950. The ruler 932 can include a plurality of marks (not shown) associated with measurement values (e.g., millimeters (mm), centimeters (cm)). In some configurations, the ruler 932 can have an elongated shape (e.g., cylindrical). In some configurations, the longitudinal axis of the ruler 932 can be substantially parallel to the longitudinal axis of the elongated body 905. The connecting rod 934 can be configured to couple the height gauge 930 to the elongated body 905. In some configurations, the elongated body 905 can include a connector portion 928 configured to receive the connecting rod 934. The elongated body 905 can include the connector portion 928 on one or both sides of the elongated body 905. When the elongated body 905 has connector portions 928 on both sides, the clinician can position the connecting rod 934 in either of the connector portions 928. The connecting rod 934 can have an elongated shape (e.g., cylindrical shape). In some configurations, the longitudinal axis of the connecting rod 934 can be substantially perpendicular to the longitudinal axis of the ruler 932 and / or the elongated body 905.
[0107] Marker 950 can extend perpendicularly from the distal end of ruler 932. The distal surface of marker 950 can be configured to be disposed on the humerus after the humeral head has been removed. Connector hub 940 can be configured to couple ruler 932 and connector rod 934. Connector hub 940 can include an adjustment portion 942 and a connector portion 944. Adjustment portion 942 can be configured to move ruler 932 relative to connector rod 934. In some configurations, adjustment portion 942 can have a funnel-like shape. In use, after a clinician determines the appropriate stem height and connects stems 30, 230 to stem holder 900, the clinician can rotate wheel 942 to move ruler 932 until ruler 932 reaches the appropriate stem height. The clinician can apply an insertion force to insertion head 924 to insert stems 30, 230 into the humerus until marker 950 contacts the resected portion of the humerus.
[0108] Stem holder 900 may form part of a kit that includes a stemless bone anchor and / or a stemmed bone anchor. The stemless bone anchor and / or the stemmed bone anchor can include any of the features of the implant described above. Stem interface portion 910 can be configured to engage the stem holder interface of the stemless bone anchor and / or the stem surface of the stemmed bone anchor.
[0109] In use, the same stem holder 900 can engage the stem holder interface of a first stemless bone anchor or the stem surface of a second stemmed bone anchor. The stemless bone anchor and / or the stemmed bone anchor can include any of the features of the implant described above. For example, stem holder 900 can engage the stem holder interface of the stemless bone anchor and advance the stemless bone anchor into the bone substance exposed during bone resection. When advancing the stemless bone anchor, a force can be applied to insertion head 924 of stem holder 900 to apply a force perpendicular to the bone resection surface.
[0110] The same stem holder 900 can engage the stem surface of the stemmed bone anchor and advance the stemmed bone anchor to position the stem of the bone anchor within the medullary canal of the bone. When advancing the stemmed bone anchor, a force can be applied to the insertion head 924 of the stem holder to apply a force aligned with the longitudinal axis of the stemmed bone anchor to embed the stem into the bone.
[0111] 2. Jig Figures 19A - 21E show different configurations of jigs 1000, 1100, 1200 configured to position stems 30, 230 within a bone (e.g., the humerus H). As will be described in more detail below, the jigs 1000, 1100, 1200 can be configured to receive an insertion force, for example, from a mallet, to appropriately insert the stems 30, 230 into the bone. For example, the proximal surfaces of the stems 30, 230 (e.g., the stem surfaces 50, 250) can receive a majority of the insertion force through direct contact with the distal surfaces 1003, 1103, 1203 of the jigs 1000, 1100, 1200.
[0112] Figures 19A - 19F show an embodiment of the jig 1000. The jig 1000 can extend between a first end or proximal end 1002 and a second end or distal end 1004. Near the proximal end 1002 or adjacent thereto, the jig can include a proximal portion 1006. The proximal portion 1006 can include an inserter portion 1008 and a connecting bridge 1010. The inserter portion 1008 can include at least one insertion head 1012 and an elongated body 1016.
[0113] The elongated body 1016 may generally extend from the insertion head 1012 towards the second end 1004 of the jig 1000. The longitudinal axis of the elongated body 1016 may be substantially perpendicular to the longitudinal axis of the connection bridge 1010. The elongated body 1016 may include an interface portion 1014 at the distal end of the elongated body 1016. The interface portion 1014 may be configured to engage the stem surfaces 50, 250 of the stems 30, 230. The interface portion 1014 can be the same as or similar to the stem interface mechanism 910 described in connection with FIG. 18B. For example, as shown in FIG. 19C, the interface portion 1014 can include a plurality of interface mechanisms 1020, 1022, 1024, 1026 extending from the distal side surface 1018 of the interface portion 1014. The plurality of interface mechanisms can include a first interface mechanism 1022, a second interface mechanism 1024, a third interface mechanism 1020, and a fourth interface mechanism 1026.
[0114] The jig 1000 may also include a movable assembly 1030 (see FIGS. 1 19D and 19E) coupled to the elongated body 1016. FIG. 19E shows the jig 1000 with a connection bridge 1010 that is partially transparent so that the elongated body 1016 and internal components (e.g., the movable assembly 1030) can be seen. The movable assembly 1030 may include a handle 1032 disposed along the connection bridge 1010. The handle 1032 may be coupled to the elongated body 1016 at a pivot position 1034, for example, pivotally coupled.
[0115] As shown in FIGS. 19D and 19E, the movable assembly 1030 may also include a fourth interface mechanism 1026 disposed at the distal end of the elongated body 1026. The fourth interface mechanism 1026 may be coupled, e.g., pivotably coupled, to the elongated body 1026 at the pivot position 1036. In some configurations, the fourth interface mechanism 1026 may be a stationary peg that is fixed relative to the remainder of the stem holder 1000. The fourth interface mechanism 1026 may be configured to engage one of the one or more openings 51a, 51b, 53, 251a, 251b, 253 of the stem 30, 230. For example, the fourth interface mechanism 1026 may be a peg configured to interface with the anti-rotation openings 53, 253.
[0116] The handle 1032 may be directly or indirectly coupled to the fourth interface mechanism 1026. For example, the handle 1032 may be indirectly coupled to the fourth interface mechanism 1026 by a spring link mechanism 1038. The spring link mechanism 1038 may have an arcuate portion and a spring gap 1040. The spring link mechanism 1038 may be indirectly coupled to the elongated body 1016 by the handle 1032 and / or the fourth interface mechanism 1026 without a direct connection between the spring link mechanism 1038 and the elongated body 1016.
[0117] The handle 1032 can be configured to move the fourth interface mechanism 1026 between a first configuration and a second configuration. The free end 1033 of the handle 1032 can move freely with respect to the elongated body 1016. The transition between the first configuration and the second configuration can include rotation and / or translation of the fourth interface mechanism 1026 with respect to the elongated body 1016. For example, by actuating (e.g., pivoting) the free end 1033 of the handle 1032 away from the connection bridge 1010, the fourth interface mechanism 1026 can be moved from the first configuration to the second configuration, while by releasing the free end 1033 of the handle 1032, the fourth interface mechanism 1026 can be returned to the first configuration. In the second configuration, the fourth interface mechanism 1026 can be rotated to at least partially retract it with respect to the distal surface 1018 of the interface portion 1014. In this position, the surgeon may engage the stem surfaces 50, 250 of the stems 30, 230. While the fourth interface mechanism 1026 is engaged with the stem surfaces 50, 250 of the stems 30, 230, the free end 1033 of the handle 1032 can be released to apply a gripping force to the stems 30, 230 (e.g., toward the connection bridge 1010). In the first configuration, the spring link mechanism 1038 is compressed (e.g., the spring gap 1040 is slightly closed) and can provide a spring force that helps to hold the fourth interface mechanism 1026 in a closed state with respect to the stems 30, 230.
[0118] As shown in FIGS. 19A and 19B, the handle 1032 can also include an elongated gap 1031. The elongated gap 1031 can be configured to receive the distal portion of the insertion head 1012 such that the distal portion of the insertion head 1012 can be coupled to the elongated body 1016 and / or the connection bridge 1010.
[0119] At least one insertion head 1012 can be configured to receive an insertion force from a tool (e.g., a mallet). For example, the jig 1000 can include a single insertion head 1012 that can be disposed at a first end 1002 of the jig 1000. In some configurations, at least one insertion head can include two insertion heads including the insertion head 1012 and a second insertion head disposed near a second end 1004 of the jig 1000. The insertion head 1012 can be coupled to an elongated body 1016. In some configurations, the insertion head 1012 may be parallel or aligned with the longitudinal axis of the elongated body 1016. In some configurations, the insertion head 1012 can be disposed at an angle with respect to the longitudinal axis of the elongated body 1016. When a force is applied to the insertion head 1012, the insertion force is directed toward the stems 30, 230 in a direction aligned with the longitudinal axes of the stems 30, 230, and the stems 30, 230 can be implanted into the bone.
[0120] The stem holder 1000 can be configured to receive a posterior tilt rod. For example, the posterior tilt rod can be inserted into one of the openings 1042. Each opening may dispose the posterior rod at a different angle corresponding to a desired resection angle, allowing the surgeon to evaluate the version. If the resection of the proximal bone is not accurate, or for other reasons at the discretion of the surgeon, the surgeon can change the resection surface.
[0121] As shown in FIGS. 19A to 19C, the jig 1000 may include a height gauge 1050 configured to measure the height of the stems 30, 230 with respect to the humerus or the depth of the stems 30, 230 within the humerus. The height gauge 1050 may be similar or identical to the height gauge 930 of the stem holder 900. For example, the height gauge 1050 can include a ruler 1052 and a marker 1054. The ruler 1052 can include a plurality of marks (not shown) associated with measurement values (e.g., millimeters (mm), centimeters (cm)). In some configurations, the ruler 1052 can have an elongated shape. The ruler 1052 can have a substantially square cross-sectional shape. In some configurations, the longitudinal axis of the ruler 1052 can be substantially parallel to the longitudinal axis of the elongated body 1016. In some configurations, the longitudinal axis of the ruler 1052 can be substantially perpendicular to the longitudinal axis of the connection bridge 1010. The proximal end of the ruler 1052 can be directly or indirectly coupled to the connection bridge 1010.
[0122] Marker 1054 can extend perpendicularly from the ruler 1052. The distal surface of the marker 1054 can be configured to be disposed on the humerus after the humeral head has been removed. In some configurations, the height gauge 1050 can include a marker connector 1056. The marker connector 1056 can include an opening configured to receive the ruler 1052. The marker connector 1056 can be configured to couple the marker 1054 to the ruler 1052. The marker connector 1056 can include an adjustment portion 1058 configured to allow the marker 1054 and the marker connector 1056 to move relative to the ruler 1052. In some configurations, the adjustment portion can be a release button 1058. In use, after the clinician determines the appropriate stem height and connects the stem 30, 230 to the jig 1000, the clinician can press the release button 1058 to move the marker connector 1056 until the marker connector 1056 and the marker 1054 reach the appropriate stem height. The clinician can release the release button 1058 to fix the position of the marker connector 1058 and the marker 1054 relative to the ruler 1052. The clinician can apply an insertion force to the insertion head 1012 to insert the stem 30, 230 into the humerus until the marker 1054 contacts the resected portion of the humerus.
[0123] The jig 1000 can further include a vertical support structure 1060 and one or more screw guides 1064. The vertical support structure 1060 can extend from the height gauge 1050 to the distal end 1004 of the jig 1000. The vertical support structure 1060 can be coupled to the height gauge 1050 at the proximal end of the vertical support structure 1060. For example, the vertical support structure 1060 can be coupled to the height gauge 1050 by one or more fastening screws 1062. The vertical support structure 1060 can be configured to couple the jig 1000 to the distal arm extension 1102, which will be further described with reference to FIGS. 20A - 21E.
[0124] One or more screw guides 1064 may be configured to align one or more screws 170 with one or more openings 62, 64 within the distal shaft portion 32 of the stem 30. For example, as shown in FIGS. 19A - 19C, each of the one or more screw guides 1064 may be configured to receive a drill sleeve 1070. The drill sleeve 1070 can include a channel 1072 that extends from the distal end of the drill sleeve 1070 (i.e., the end of the drill sleeve 1070 opposite the screw 30) to the proximal end (i.e., the end of the drill sleeve 1070 facing the stem 30). The channel 1072 can be sized and shaped to receive the screw 170. For example, a surgeon can insert the screw 170 through the channel 1072 and drill the screw 170 through one or more openings 62, 64 of the distal shaft portion 32 of the stem 30 to fix the stem 30 to the patient's humerus. In some configurations, the drill sleeve 1070 can include a plurality of drill sleeves. The plurality of drill sleeves can be configured to be nested within one another.
[0125] Figures 20A - 21E show a first configuration (Figs. 20A - 20E) and a second configuration (Figs. 21A - 21E) of another embodiment of the jig 1100. The jig 1100 can include the above-described jig 1000 in addition to the distal arm extension 1102. The distal arm extension 1102 can be configured to align one or more screws 170 with one or more openings 265, 267, 269 in the distal shaft 232 of the stem 230. The distal arm extension 1102 can include a first portion 1104 including a first end of the distal arm extension 1102 and a second portion 1106 including a second end of the distal arm extension 1102. The distal arm extension 1102 can include a curvature between the first end and the second end. The first portion 1104 of the distal arm extension 1102 can be coupled to the distal end of the vertical support structure 1060. For example, the first end of the first portion 1104 can be fixed to the distal end of the vertical support structure 1060 by a fastening screw 1062. In some configurations, the distal arm extension 1102 extends radially outward from the first end of the first portion 1104 to the second end of the second portion 1106.
[0126] The distal arm extension 1102 can be configured to be movable between a first side (Figs. 20A - 20E) and a second side (Figs. 21A - 21E) of the jig 1100. For example, the clinician can loosen the fastening screw 1062 connecting the distal arm extension 1102 to the vertical support structure 1060 and rotate the distal arm extension 1102 around the distal end of the vertical support structure 1060. When the distal arm extension 1102 is on the appropriate side of the jig 1100, the clinician can tighten the fastening screw 1062 to fix the distal arm extension 1102 to the appropriate side of the jig 1100. The jig 1100 can be configured to implant the stem 230 into the patient's left arm when the jig 1100 is on the first side of the jig 1110. The jig 1100 can be configured to implant the stem 230 into the patient's right arm when the jig 1100 is on the second side of the jig 1110.
[0127] The distal arm extension 1102 can include one or more screw guides 1108, 1110. For example, one or more guides 1108, 1110 can include a first screw guide 1108 and a second screw guide 1112. The first and second screw guides 1108, 1110 can be disposed on a second portion 1106 of the distal arm extension 1102. The first screw guide 1108 can be disposed at a second end of the second portion 1106. The second screw guide 1110 can be disposed between a second end of a second portion 1104 of the distal arm extension 1102 and a first portion 1104 of the distal arm extension 1102. For example, the second screw guide 1110 can be adjacent to the first screw guide 1108 The first and second screw guides 1108, 1110 can be configured to align the screw 170 with one or more of the openings 265, 267, 269 of the stem 240. For example, the first screw guide 1108 can align the screw 170 with the fourth or fifth opening 267, 259, and the second screw guide 1110 can be configured to align the screw 170 with the third opening 265. In some configurations, as shown in FIGS. 20A-21E, each of the first and second screw guides 1108, 1110 can be configured to receive a drill sleeve 1070.
[0128] The first screw guide 1108 can include one or more openings 1112, 1114 configured to align the screw 170 with one or more of the openings 265, 267, 269 of the stem 230. For example, one or more openings can include a first opening 1112 and a second opening 1114. The first opening 1112 can align the screw 170 and / or the drill sleeve 1070 with the fifth opening 269. The second opening 1114 can align the screw 170 and / or the drill sleeve 1070 with the fourth opening 269.
[0129] The first screw guide 1108 can include a slide plate 1116 that is movable between a first position and a second position. The slide plate 1116 can be configured to cover the first or second opening 1112, 1114 of the first screw guide 1108. For example, the slide plate 1116 can include corresponding first and second openings that are aligned with the first and second openings 1112, 1114 of the first screw guide 1108, respectively. As shown in FIGS. 20A-20E, when the distal arm extension 1102 is on the first side of the jig 1100, the slide plate 1116 can be in the first position. When the slide plate 1116 is in the first position, the slide plate 1116 can cover the second opening 1114, and the first opening of the slide plate 1116 can be aligned with the first opening 1112 of the first screw guide 1108, such that the first screw guide 1108 can align the screw 170 and / or the drill sleeve 1070 with the fifth opening 269. As shown in FIGS. 21A-21E, when the distal arm extension 1102 is on the second side of the jig 1100, the slide plate 1116 can be in the second position. When the slide plate 1116 is in the second position, the slide plate 1116 can cover the first opening 1112, and the second opening of the slide plate 1116 can be aligned with the second opening 1114 of the first screw guide 1108, such that the first screw guide 1108 can align the screw 170 and / or the drill sleeve 1070 with the fourth opening 267.
[0130] The slide plate 1116 can be configured to move along the longitudinal axis of the first screw guide 1108 and move between a first position and a second position. The slide plate 1116 can be configured to move between the first position and the second position by gravity and / or by the user manually moving the slide plate 1116. In some configurations, the slide plate 1116 can include a slide mechanism that can move the slide plate 1116 between the first position and the second position. For example, when the distal arm extension 1102 is moved to the first side of the jig 1100, gravity, the user, and / or the slide mechanism can move the slide plate 1116 distally to the first position relative to the body of the first screw guide 1108, such that the upper opening (e.g., the second opening 1114) is covered and the lower opening (e.g., the first opening 1112) is not covered. As a further example, when the distal arm extension 1102 is moved to the second side of the jig 1100, gravity, the user, and / or the slide mechanism can move the slide plate 1116 distally to the second position relative to the body of the first screw guide 1108, such that the upper opening (e.g., the first opening 1112) is covered and the lower opening (e.g., the second opening 1114) is not covered. Advantageously, even when the surgeon implants the stem 230 into the patient's left arm or right arm, the slide plate 1116 can prevent the surgeon from inserting the screw 170 and / or the drill sleeve 1070 into the wrong opening of the first and second openings 1112, 1116 for the surgery.
[0131] The jigs 1000, 1100 may form part of a kit that includes a stemless bone anchor and / or a stemmed bone anchor. The stemless bone anchor and / or the stemmed bone anchor can include any of the features of the implants described above. The interface portion 1014 can be configured to engage a jig interface of a stemless bone anchor that is the same or similar to the stem holder interface described above, and / or the stem surface of a stemmed bone anchor.
[0132] In use, the same jigs 1000, 1100 can engage with the jig interface of the first stainless bone anchor or the stem surface of the second stemmed bone anchor. The stainless bone anchor and / or the stemmed bone anchor can include any of the features of the implant described above. For example, the jigs 1000, 1100 can engage with the jig interface of the stainless bone anchor and advance the stainless bone anchor into the bone substance exposed during bone resection. When advancing the stainless bone anchor, a force can be applied to the insertion head 1012 of the jigs 1000, 1100 to apply a force perpendicular to the resection surface of the bone.
[0133] The same jigs 1000, 1100 can engage with the stem surface of the stemmed bone anchor and advance the stemmed bone anchor to position the stem of the bone anchor within the medullary canal of the bone. When advancing the stemmed bone anchor, a force can be applied to the insertion head 1012 of the jigs 1000, 1100 to apply a force aligned with the longitudinal axis of the stemmed bone anchor to embed the stem into the bone.
[0134] B. Method of implanting the humeral anchor The above-described humeral anchors can be implanted according to the methods described below in connection with FIGS. 18A-21E. These methods can advantageously use certain tools and instruments such as those described above that can be shared between the stainless anchor 103 and the stemmed anchors 30, 230. This provides the advantage of reducing the training required to complete the surgery.
[0135] 1. Method of using the stem holder FIGS. 18E-18H show a stem holder 900 coupled to the stem 30, and FIG. 18I shows the stem holder 900 coupled to the stem 30 with the stem 30 implanted in the humerus H.
[0136] Before implanting the stem 30 into the humerus H, the surgeon can prepare the humerus H. The surgeon can excise the humerus H at the anatomic neck to separate the articular surface of the humerus H from the remainder of the humerus H. When the articular surface is separated from the remainder of the humerus H, an excision surface is created. Optionally, the surgeon can apply a protective tool, such as a plate, to the excision surface to cover the newly exposed cancellous bone. It is important to protect the newly exposed cancellous bone. This is because this bone will be formed in a later part of the method such that it has a recess having an internal contour that coincides with the outer surface or the outer and distal surfaces of any anchor (e.g., the metaphyseal portion of a stainless anchor or a stemmed anchor). Optionally, the surgeon can remove the protective tool, size the excised humerus H, and determine which size of the stem 30, 230 (or other anchors disclosed herein) should be used for a particular patient. Following the excision step, or the optional protection and / or sizing steps, the surgeon can ream the humerus H to create a recess or cavity in the exposed cancellous bone. The reaming step can create a stepped internal recess or cavity in the metaphyseal end of the humerus H shaped to receive the humeral anchor portion, e.g., the metaphyseal portion of the stainless anchor 103 or the stemmed anchors 30, 230.
[0137] After the humerus H is prepared, the surgeon can use a trial anchor with the stem holder 900, and the connection to the trial head assembly or the trial insert assembly can be removed more easily than in the case of the final implant. The trial step allows the surgeon to select or confirm the size to be used for the final implant. During this step, the surgeon may use the height gauge 930 to determine the appropriate stem height for a particular patient. The surgeon can couple the stem holder 900 to the trial anchor and move the wheel 942 until the marker 950 contacts the exposed cancellous bone. Also, the surgeon may use the graft tool 800 to create any plug 700 from the excised humeral head.
[0138] Figures 18E - 18H show a stem holder 900 coupled to the stem 30. The stem holder 900 can be coupled to either another stem 230 or a stemless anchor 103. By using a common instrument, the surgeon can determine during the operation that the stemless anchor 103 is not appropriate, and then, after additional preparation of the humerus H to complete the preparation of the humerus H for the humeral stems 30, 230, can quickly switch to the humeral stems 30, 230.
[0139] In the case of the stem 30, the stem holder 900 can grip the stem 30 within its recess by engaging a tool interface, for example, one or more openings 51a, 51b, 53. Optionally, the surgeon can insert one or more plugs 700 into one or more openings 62, 64, 98 of the humeral stem 30. In the case of the elongate plug 700A, the surgeon may cut the elongate plug 700A so that the elongate plug 700A is the same length as the openings 52, 54, 98. In the case of the plug 700B, the surgeon may insert a first plug 700B into one end of the openings 52, 54, 98 and a second plug 700B into the other end of the openings 52, 54, 98.
[0140] Thereafter, the distal shaft portion 32 of the humeral stem 30 can be inserted through a recess formed in the resection surface and further into the intramedullary canal. When the distal shaft portion 32 is disposed in the diaphysis of the humerus H and the diaphyseal end portion 90 is disposed in the diaphysis of the humerus H, an interference fit load can be applied to the stem holder 900. In particular, an impactor, for example a mallet, can strike an interference head 924 disposed at the proximal end 902 of the stem holder 900 to drive the humeral stem 30 to firmly engage with the humerus H generally along the axis of the distal shaft portion 32 of the humeral stem 30. For example, the surgeon can apply an interference force to the stem holder 900 until the marker 950 contacts the humerus H.
[0141] In the case of the stemless anchor 103, the stem holder 900 can grip the anchor within its recess by engaging the tool interface. The anchor 103 can then be moved into the recess formed in the humerus H and pressed against the prepared surface. Thereafter, an impactor, such as a mallet, can be used to apply a load to the interference head 924 along its longitudinal axis at the proximal end 904 of the stem holder 900. Thus, the load can be directed laterally, for example, substantially perpendicular to the plane of the resection surface formed in the resection step. Thus, the insertion step can be achieved using the same impactor instrument, such as the stem holder 900, for stemless implants 103 and stemmed implants such as the humeral stem 30, 230.
[0142] The interference step can be performed following the aforementioned insertion step. The interference step includes inserting the anatomical assembly 160, the reverse type articular body 180, and / or the spacer 150 into the stemmed anchor 30 (or another stemmed anchor 230). As discussed above, the kit 100 includes shared implant components. Thus, the interference step can be the same for the humeral stems 30, 230 as for the stemless anchor 103. 2. Method of Using the Jig Figures 19F, 20E, and 21E show jigs 1000, 1100 coupled to the stem 30 or the stem 230, where the stems 30, 230 are implanted in the humerus H. Prior to implanting the stems 30, 230, the surgeon can prepare the humerus H in the same or a similar manner as described above in connection with the method(s) of using the stem holder 900.
[0143] FIG. 19F shows a jig 1000 coupled to the stem 30. The jig 1000 can be coupled to either another stem 230 or a stemless anchor 103. By using a common instrument, the surgeon can determine during the surgery that the humeral stem 30 is not appropriate, and then, after additional preparation of the humerus H to complete the preparation of the humerus H for the humeral stem 230, quickly switch to another humeral stem 230.
[0144] In the case of the stem 30, the jig 1000 can grip the stem 30 within the stem surface 50 by engaging a tool interface, such as one or more openings 51a, 51b, 53. Optionally, the surgeon can insert one or more plugs 700 into one or more openings 62, 64, 98 of the humeral stem 30. In the case of the elongate plug 700A, the surgeon may cut the elongate plug 700A so that the elongate plug 700A is the same length as the openings 52, 54, 98. In the case of the plug 700B, the surgeon may insert a first plug 700B into one end of the openings 52, 54, 98 and a second plug 700B into the other end of the openings 52, 54, 98.
[0145] Thereafter, the distal shaft portion 32 of the humeral stem 30 can be inserted through a recess formed in the resection surface and further into the intramedullary canal. When the distal shaft portion 32 is disposed in the diaphysis of the humerus H and the diaphyseal end portion 90 is disposed in the diaphysis of the humerus H, an interference fit load can be applied to the jig 1000. In particular, an impactor, such as a mallet, can strike an interference head 1012 disposed at the proximal end 1002 of the jig 1000 to drive the humeral stem 30 to firmly engage with the humerus H generally along the axis of the distal shaft portion 32 of the humeral stem 30. For example, the surgeon can apply an interference force to the jig 1000 until the marker 1053 contacts the humerus H.
[0146] The embedding step can be performed following the aforementioned insertion step. The embedding step includes embedding the anatomical assembly 160, the reverse joint body 180, and / or the spacer 150 into the stemmed anchor 30 (or another stemmed anchor 230). As discussed above, the kit 100 includes shared implant components. Thus, the embedding step can be the same for the humeral stems 30, 230 as well as for the stemless anchor 103.
[0147] In the case of the stem 30, after the embedding step, a fixation step can be performed. The minimal skin incision can be made at the planned entry point of the screw 170. The drill sleeve 1070 can be inserted into one of the screw guides 1064. The drill sleeve 1070 can be advanced through the incised entry point to the humerus H. The tool can be inserted through the channel 1072 of the drill sleeve 1070 to form a hole in the humerus H and pass through one of the openings 62, 64. For example, a drill can be used to create the hole. The same or another tool can be used to insert the screw 170 into the channel 1072 of the drill sleeve 1070 and the pre-formed hole. These steps can be repeated to insert the screw 170 into the other of the openings 6 2, 64.
[0148] Figures 20E and 21E show the jig 1100 coupled to the stem 230. The jig 1100 can be coupled to either another stem 30 or the stemless anchor 103. In the case of the stem 230, the jig 1100 can grip the stem 230 within the stem surface 250 by engaging a tool interface, such as one or more openings 251a, 251b, 253. Optionally, one or more plugs 700 can be inserted into one or more of the openings 262, 264, 265, 267, 269, 298 of the humeral stem 230. For example, one or more plugs 700 can be inserted into the fourth opening 267 of the stem 230 when implanting the stem 230 into the patient's left arm (Figure 20E). Alternatively, one or more plugs 700 can be inserted into the fifth opening 269 of the stem 230 when implanting the stem 230 into the patient's right arm (Figure 21E). In the case of the elongate plug 700A, the surgeon may cut the elongate plug 700A such that the elongate plug 700A is the same length as the openings 267, 269. In the case of the plug 700B, the surgeon may insert the first plug 700B into one end of the openings 267, 269 and the second plug 700B into the other end of the openings 267, 269.
[0149] Thereafter, the distal arm extension 1102 can be moved to the first side of the jig 1100 (Figure 20E) or the second side of the jig 1100 (Figure 21E) depending on which arm of the patient is being operated on. The distal arm extension 1102 can be fixed in this position by tightening the most distal fastening screw 1062. The distal shaft 232 of the humeral stem 230 is cut It can be inserted through the recess formed on the surface and further inserted into the intramedullary canal. When the distal shaft 232 is disposed on the diaphysis of the humerus H and the metaphyseal portion 290 is disposed on the diaphysis of the humerus H, an insertion load can be applied to the jig 1100. In particular, an impactor, such as a mallet, strikes the insertion head 1012 disposed at the proximal end 1002 of the jig 1100 to drive the humeral stem 230 and firmly engage with the humerus H generally along the axis of the distal shaft 232 of the humeral stem 230. For example, the surgeon can apply an insertion force to the jig 1100 until the marker 1053 contacts the humerus H.
[0150] The insertion step can be performed following the above-described insertion step. The insertion step includes driving the anatomical assembly 160, the reverse joint body 180, and / or the spacer 150 into the stemmed anchor 230 (or another stemmed anchor 30). As discussed above, the kit 100 includes shared implant components. Thus, the insertion step can be the same for the humeral stems 30, 230 as well as for the stemless anchor 103.
[0151] In the case of the stem 230, after the insertion step, a fixation step can be performed. A minimal skin incision can be made at the planned entry point of the screw 170. The drill sleeve 1070 can be inserted into one of the screw guides 1064, 1108, 1110. The drill sleeve 1070 can advance through the incised entry point to the humerus H. The tool can be inserted through the channel 1072 of the drill sleeve 1070 to form a hole in the humerus H and pass through one of the openings 262, 264, 265, 267, 269. For example, a drill can be used to create the hole. The same or another tool can be used to insert the screw 170 into the channel 1072 of the drill sleeve 1070 and the pre-formed hole. These steps can be repeated to insert the screw 170 into other openings of the openings 262, 264, 265, 267, 269 as needed.
[0152] Other variations and terms Although specific embodiments have been described herein, the implants and methods described herein can interchangeably use any articulating components as appropriate to the situation. .
[0153] As used herein, the relative terms "proximal" and "distal" are to be defined from the perspective of the implant. Thus, proximal refers to the direction of the articulating component, and distal refers to the direction of the stem of the humeral anchor, or the threads or porous surface or other anchor structure of the stemless anchor, etc., when the implant is assembled.
[0154] Unless otherwise specifically stated or understood otherwise within the context in which it is used, conditional language such as "can", "could", "might", or "may" generally intends to convey that a certain feature, element, and / or step is included in one embodiment but not in other embodiments. Thus, such conditional language is generally not intended to imply that a feature, element, and / or step is required in one or more embodiments in any way.
[0155] The terms "comprising", "including", "having", etc. are synonymous and are used inclusively in an open-ended manner, not excluding additional elements, features, acts, operations, etc. Also, the term "or" is used in its inclusive sense (not in its exclusive sense), and when used, for example, to connect a list of elements, the term "or" means one, some, or all of the elements in the list. Further, the articles "a", "an", and "the" used in this application and the appended claims should be construed to mean "one or more" or "at least one" unless otherwise specified. having
[0156] The ranges disclosed herein include any and all overlapping, sub-ranges, and combinations thereof. Language such as "up to", "at least", "greater than", "less than", and "between" includes the recited numbers. Numerical values preceded by terms such as "about" or "substantially" include the recited numerical value and need to be interpreted based on the context (e.g., as accurate as reasonably possible under the circumstances, e.g., ±5%, ±10%, ±15%, etc.). For example, "about 1" includes "1". Clauses preceded by terms such as "substantially" or "generally" include the recited clause and should be interpreted based on the context (e.g., as reasonably possible under the circumstances). For example, "substantially spherical" includes "spherical". Unless otherwise specified, all measurements are made under standard conditions including temperature and pressure.
[0157] As used herein, the phrase referring to "at least one" of a list of items refers to any combination of those items including a single member. By way of example, "at least one of A, B, or C" is intended to cover A, B, C, A and B, A and C, B and C, and A, B, and C. Conjunctions such as the phrase "at least one of X, Y, and Z" are understood in the context generally used to convey that an item, term, etc. can be at least one of X, Y, or Z, unless otherwise specified. Thus, such conjunctions are generally not intended to suggest that in a particular embodiment, at least one of X, at least one of Y, and at least one of Z must each be present.
[0158] Although specific embodiments and examples have been described herein, it should be emphasized that many variations and modifications may be made to the humeral head assembly shown and described in this disclosure, and those elements may be different to form further embodiments or acceptable examples. It should be understood that they may be combined and / or modified. All such modifications and variations are intended to be included within the scope of the present disclosure herein. A wide variety of designs and approaches are possible. The mechanisms, structures, or steps disclosed herein are not essential or indispensable.
[0159] Some embodiments have been described in relation to the accompanying drawings. However, it should be understood that the figures are not drawn to scale. Distances, angles, etc. are merely illustrative and do not necessarily have an exact relationship to the actual dimensions and layout of the devices shown. Components can be added, removed, and / or rearranged. Further, any particular feature, aspect, method, characteristic, quality, trait, element, etc. of the disclosure herein associated with various embodiments can be used in all other embodiments shown herein. Additionally, it will be recognized that any method described herein can be implemented using any device suitable for performing the recited steps.
[0160] For the purposes of the present disclosure, certain aspects, advantages, and novel features are described herein. It will be understood that not all such advantages may necessarily be achieved in accordance with any particular embodiment. Thus, for example, one skilled in the art will recognize that the disclosure may be embodied or implemented in a manner that achieves one advantage or group of advantages taught herein without necessarily achieving other advantages that may be taught or suggested herein.
[0161] These inventions have been disclosed in connection with certain preferred embodiments and examples, but it will be understood by those skilled in the art that the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses of the present invention and obvious modifications and equivalents thereof. In addition, while some variations of the present invention have been shown and described in detail, other modifications within the scope of the present invention will be readily apparent to those skilled in the art based on this disclosure. It is also contemplated that various combinations or sub - combinations of the specific features and aspects of the embodiments may be made within the scope of the present invention. It should be understood that the various features and aspects of the disclosed embodiments may be combined with or replaced by each other to form various modes of the disclosed invention. Further, the actions of the disclosed processes and methods may be changed in any way, including by changing the order of the actions, and / or inserting additional actions, and / or deleting actions. For this reason, it is intended that at least some of the scope of the present invention disclosed herein should not be limited by the specific disclosed embodiments described above. The limitations are to be construed broadly based on the language employed and are not to be limited to the examples described herein or the examples described during the examination of the application, which are to be construed as non - exclusive.
[0162] None of the methods disclosed herein need to be performed in the order described. The methods disclosed herein include specific actions taken by a practitioner. However, those methods may also include, either explicitly or implicitly, instructions from a third party to those actions. For example, an action such as "coupling the glenoid guide to the glenoid rim" includes "instructing the coupling of the glenoid guide and the glenoid rim".
Claims
1. A stem for a shoulder prosthesis, comprising: an inner side; an outer side opposite to the inner side; a plurality of openings, each opening of the plurality of openings being configured to receive a screw or one or more plugs, the plurality of openings including a first opening and a second opening, the first opening being disposed proximal to the second opening, each of the first and second openings including a length measured along a longitudinal center line therebetween, the longitudinal center line of at least one of the first and second openings being angled with respect to a longitudinal plane extending in the inner-outer direction of the stem; and the plurality of openings; The stem for a shoulder prosthesis, comprising the above.
2. The stem according to claim 1, wherein each of the first and second openings is angled in the front-rear direction with respect to the longitudinal plane.
3. The stem according to claim 1, wherein the first and second openings are angled in opposite directions with respect to the longitudinal plane.
4. A distal shaft portion adapted to be fixed within the medullary canal of the humerus; a proximal portion having a stem surface; a metaphysis portion extending between and connecting the distal shaft portion and the proximal portion; The stem according to claim 1, further comprising the above.
5. The stem according to claim 4, wherein the metaphysis portion includes an inner portion and first and second outer arms.
6. The stem according to claim 4, wherein the distal shaft portion includes the plurality of openings.
7. The stem according to claim 4, wherein the distal shaft portion includes a plurality of longitudinally extending grooves, the plurality of grooves being circumferentially spaced apart.
8. The stem according to claim 7, wherein each of the plurality of grooves tapers towards the distal tip of the stem.
9. The stem according to claim 7, wherein the first opening is disposed proximal to the plurality of grooves.
10. The stem according to claim 7, wherein the second opening extends through at least one of the plurality of grooves.
11. The stem according to claim 1, wherein the plurality of openings further includes a third opening disposed distal to the second opening.
12. The stem according to claim 1, wherein the longitudinal centerlines of each of the first and second openings are angled 30° with respect to the longitudinal plane of the stem.
13. A system comprising: the stem according to claim 1, wherein each of the plurality of openings includes a first opening, a second opening, and a length measured along a longitudinal center line therebetween; at least one plug configured to be received by one or more of the plurality of openings of the stem; the system comprising.
14. The system according to claim 13, wherein the at least one plug includes at least one elongate plug, and a width of the at least one elongate plug is less than its length.
15. The system according to claim 14, wherein the length of the one or more of the plurality of openings is shorter than the length of the at least one elongate plug.
16. The system according to claim 14, wherein the one or more of the plurality of openings are configured to receive the at least one elongate plug along an entire length of the one or more openings.
17. The system according to claim 13, wherein a width of the at least one plug is greater than its length, and the length of the one or more of the plurality of openings is greater than the length of the at least one plug.
18. The system according to claim 17, wherein two or more of the plugs are configured to be inserted into the one or more openings along the longitudinal centerline.
19. A kit comprising: the stem according to claim 1; a reverse insert having a proximal portion and a distal portion, the proximal portion of the reverse insert including a concave surface configured to receive a glenoid sphere, the distal portion including a protrusion, the reverse insert being configured to be directly coupled to the stem; the reverse insert; an anatomical joint component having a proximal portion including a convex surface and a distal portion including a protrusion, the anatomical joint component being configured to be directly coupled to the stem; A spacer including a proximal portion and a distal portion, configured to couple the reverse insert or the anatomical joint component to the stem, wherein the proximal portion of the spacer is symmetric, the spacer, and The kit including
20. A kit for a shoulder prosthesis, A stem, A distal shaft portion adapted to be fixed within the medullary canal of the humerus, A proximal portion having a stem surface, A metaphyseal portion including a medial portion and first and second outer arms extending between and connecting the distal shaft portion and the proximal portion, The stem including A reverse insert having a proximal portion and a distal portion, the proximal portion of the reverse insert including a concave surface configured to receive a glenoid sphere, the distal portion including a projection, the reverse insert being configured to couple directly to the stem surface, the reverse insert, and An anatomical joint component having a proximal portion including a convex surface and a distal portion including a projection, the anatomical joint component being configured to couple directly to the stem surface, the anatomical joint component, and A spacer including a proximal portion, a distal portion, and a projection extending from a distal surface of the spacer, the spacer being configured to couple the reverse insert or the anatomical joint component to the stem, the proximal portion of the spacer being asymmetric, the projection being configured to provide rotational alignment between the spacer and the stem, the spacer, and The kit including
21. The kit according to claim 20, further comprising a second spacer including a proximal portion and a distal portion, the second spacer being configured to couple the reverse insert or the anatomical joint component to the stem, wherein the proximal portion of the spacer is symmetric.
22. The kit according to claim 20, wherein the stem surface includes a central cavity configured to receive the reverse insert or the anatomical joint component.
23. The kit according to claim 20, wherein the distal shaft portion of the stem includes a plurality of openings configured to receive screws or plugs.
24. The kit according to claim 20, wherein the spacer includes an engagement mechanism protruding from the distal surface of the spacer, and the engagement mechanism extends distally to the protrusion.
25. The kit according to claim 20, wherein the distal portion of the spacer includes first and second outer notches, and the first notch is disposed on the opposite side of the second notch.
26. The kit according to claim 20, wherein the proximal portion of the spacer includes a proximal edge and a distal edge, and the proximal edge is angled with respect to the distal edge.
27. The kit according to claim 26, wherein the proximal edge is angled 5° with respect to the distal edge of the proximal portion of the spacer.
28. The kit according to claim 20, further comprising a second stem, wherein the distal shaft portion of the second stem is longer than the distal shaft portion of the first stem.
29. The kit according to claim 20, further comprising a plug configured to be received by one of the plurality of openings.
30. The kit according to claim 29, wherein the plug comprises a polyethylene material.
31. A stem for a shoulder prosthesis, A distal shaft portion adapted to be fixed within the medullary canal of the humerus, A proximal portion having a stem surface surrounded by a proximal rim, A medial portion, and first and second outer arms extending between and connecting the distal shaft portion and the base portion of the proximal portion, including a metaphyseal portion, A suture groove configured to engage a suture, the suture groove extending between the proximal rim and the metaphyseal portion along the inside of the proximal portion, the suture groove including a first concave curve, a second concave curve distal to the first curve, and a convex portion between the first concave curve and the second concave curve, the suture groove, Including, the stem.
32. The stem according to claim 31, wherein the height of the suture groove is 0.5 cm to 1.0 cm.
33. The stem according to claim 31, further comprising a plurality of grooves on the outside of the proximal portion.
34. The stem according to claim 31, wherein the plurality of grooves extend in the anteroposterior direction.
35. The stem according to claim 31, further comprising a plurality of grooves on the outer surfaces of the first and second outer arms of the metaphyseal portion.
36. A stem for a shoulder prosthesis, A distal shaft portion adapted to be fixed within the medullary canal of the humerus, A proximal portion having a stem surface, the stem surface including a central recess, a peripheral wall along the periphery of the central recess, and a base portion distal to the peripheral wall, the proximal portion, A metaphyseal portion including an inner portion and first and second outer arms extending between the distal shaft portion and the base portion of the proximal portion and connecting them, the inner portion including an arm having an outer edge, the first and second outer arms having inner edges, and a window being defined between the outer edge of the inner arm and the inner edges of the first and second outer arms, the metaphyseal portion, An opening configured to receive a screw or a plug, the opening being disposed distal to the window of the metaphyseal portion and extending in the anteroposterior direction, the opening, including the stem.
37. The stem according to claim 36, wherein a longitudinal centerline of the opening is less than 1.0 cm from a distal edge of the window.
38. The stem according to claim 36, wherein the opening includes a circular cross-section.
39. The stem according to claim 36, further including additional openings disposed distal to the opening, each of the additional openings being configured to receive a screw or a plug.
40. A kit for a shoulder prosthesis, A stem configured to be implanted in a patient's shoulder, A proximal portion having a stem surface, A plurality of openings, each of the plurality of openings being configured to receive cement or screws for fixing the stem within the patient's shoulder, the plurality of openings, including the stem, A stem holder configured to implant the stem in the patient's shoulder when the stem is fixed with the cement, A jig configured to implant the stem in the patient's shoulder when the stem is fixed with one or more screws, including the kit.
41. The kit according to claim 40, further including a second stem, the second stem including a second length and a plurality of openings, the stem including a first length shorter than the second length.
42. The kit according to claim 41, wherein the jig is configured to implant the second stem into the shoulder of the patient when the second stem is fixed by the one or more screws.
43. The jig includes a distal arm extension configured to guide the one or more screws into one or more of the plurality of openings of the second stem. The kit according to claim 42.
44. The distal arm extension of the jig is configured to be movable between a first side and a second side of the jig. The distal arm extension is disposed on the first side of the jig for implanting the second stem into the left shoulder of the patient, and the distal arm extension is disposed on the second side of the jig for implanting the second stem into the right shoulder of the patient. The kit according to claim 43.
45. The kit according to claim 41, wherein the jig includes an interface portion configured to removably couple to the stem surface of the second stem.
46. The kit according to claim 45, wherein the jig includes an insertion head configured to receive an insertion force from a tool for implanting the second stem into the shoulder of the patient, and the insertion head is located proximal to the interface portion.
47. The kit according to claim 41, wherein the jig includes a height gauge configured to determine the height position of the second stem when implanting the second stem into the shoulder of the patient.
48. The kit according to claim 40, wherein the stem holder includes an insertion head configured to receive an insertion force from a tool for implanting the stem into the shoulder of the patient.
49. The kit according to claim 40, wherein the stem holder includes a height gauge configured to determine the height position of the stem when implanting the stem into the shoulder of the patient.
50. A system for implanting a shoulder prosthesis into a patient's shoulder, comprising: A stem configured to be implanted into the patient's shoulder, the stem including a plurality of openings configured to receive one or more screws for fixing the stem within the patient's shoulder; and A jig configured to introduce the stem into the patient's shoulder. A distal arm extension configured to guide the one or more screws into one or more of the plurality of openings of the stem, wherein the distal arm extension of the jig is configured to be movable between a first side of the jig and a second side of the jig, and the distal arm extension is disposed on the first side of the jig for implanting the stem into the patient's left shoulder, and the distal arm extension is disposed on the second side of the jig for implanting the stem into the patient's right shoulder, the distal arm extension being included, The distal arm extension includes a screw guide configured to align the one or more screws with the one or more openings of the stem, the screw guide including a first opening, a second opening, and a slide plate configured to cover the first or the second opening of the screw guide, the first opening of the screw guide being configured to align the screw of the one or more screws with a first opening of the one or more openings of the stem when the distal arm extension is on the first side of the jig, and the second opening of the jig being configured to align the screw of the one or more screws with a second opening of the one or more openings of the stem when the distal arm extension is on the second side of the jig, The slide plate covers the first opening of the screw guide when the distal arm extension is on the second side of the jig, and the slide plate covers the second opening of the screw guide when the distal arm extension is on the first side of the jig, The jig, The system including.
51. The system according to claim 50, wherein the jig further includes an inserter portion including an insertion head configured to receive an insertion force from a tool.
52. The system according to claim 51, wherein the inserter portion further includes an interface portion configured to removably couple to a proximal portion of the stem.
53. The system according to claim 50, wherein the jig further includes a height gauge configured to determine a height position of the stem when implanting the stem into the patient's shoulder.
54. The jig of claim 53, further comprising a vertical support structure extending between the height gauge and the distal arm extension, the vertical support structure including a proximal end and a distal end. **Claim 55** The system of claim 54, wherein the distal arm extension is configured to rotate about the distal end of the vertical support structure and move between the first side and the second side of the jig. **Claim 56** The system of claim 55, wherein the distal arm extension includes a first portion and a second portion. **Claim 57** The system of claim 56, wherein the first portion of the distal arm extension is coupled to the distal end of the vertical support structure and extends radially outward from the longitudinal axis of the jig. **Claim 58** The system of claim 56, wherein the second portion of the distal arm extension includes the screw guide and a second screw guide. **Claim 59** The system of claim 58, wherein the second screw guide includes an opening configured to align a second screw of the one or more screws with a third opening of the one or more openings of the stem. **Claim 60** The system of claim 59, wherein the first opening of the one or more openings of the stem is adjacent to the distal tip of the stem. **Claim 61** The system of claim 59, wherein the second opening of the one or more openings of the stem is proximal to the first opening of the one or more openings of the stem. **Claim 62** The system of claim 59, wherein the third opening of the one or more openings of the stem is proximal to the second opening of the one or more openings of the stem. **Claim 63** The system of claim 58, wherein the distal arm extension includes a curvature extending between the first portion and the second portion to align the screw guide and the second screw guide with the one or more openings of the stem. **Claim 64** The system of claim 50, wherein the slide plate is configured to be movable between a first position and a second position along the longitudinal axis of the screw guide. **Claim 65** The slide plate is in the first position when the distal arm extension is on the first side of the jig The system of claim 64. **Claim 66** The system of claim 64, wherein the slide plate is in the second position when the distal arm extension is on the second side of the jig. **Claim 67** The system of claim 64, wherein the slide plate is configured to move between the first position and the second position by gravity. **Claim 68** A method of placing a stem of a shoulder prosthesis within the medullary canal of a patient's humerus, attaching a stem face of the stem to an interface portion of a stem holder, the stem including a proximal portion having the stem face and a distal shaft portion having a plurality of openings, the attaching, inserting the stem into the medullary canal of the humerus, fixing the stem within the medullary canal of the humerus, the method comprising. **Claim 69** inserting a plug into an opening of the plurality of openings of the stem, the opening including a first opening, a second opening, and a length measured along a longitudinal centerline therebetween, the plug including a length and a width smaller than the length of the plug, the length of the plug being longer than the length of the opening, the inserting, cutting the length of the plug, the method of claim 68, further comprising. **Claim 70** inserting a first plug into one of the plurality of openings of the stem, inserting a second plug into the one of the plurality of openings of the stem, the opening including a first opening, a second opening, and a length measured along a longitudinal centerline therebetween, each of the first and second plugs including a length and a width larger than the length of each of the first and second plugs, the length of the opening being larger than the length of each of the first and second plugs, the inserting, the method of claim 68, further comprising. **Claim 71** The method of claim 68, wherein fixing the stem includes providing bone cement within the medullary canal of the humerus. **Claim 72** The method of claim 71, further comprising applying an insertion force to a fitting head of the stem holder. **Claim 73** The method of claim 68, wherein fixing the stem within the medullary canal includes inserting a screw into one of the plurality of openings of the stem. **Claim 74** The method according to claim 68, further comprising aligning a screw guide of the stem holder carried by a distal arm extension of the stem holder with the plurality of openings.
75. The method according to claim 74, further comprising arranging the distal arm extension of the stem holder on a first side of the stem holder when the stem is inserted into the humerus of the left shoulder, and arranging the distal arm extension of the stem holder on a second side of the stem holder when the stem is inserted into the humerus of the right shoulder.
76. When the distal arm extension is on the second side of the stem holder, the distal arm The method according to claim 75, wherein the distal arm extension is inverted compared to when the distal arm extension is on the first side of the stem holder.
77. The method according to claim 76, wherein when the distal arm extension is on the first side of the stem holder, the screw guide covers a first opening of the plurality of openings, and when the distal arm extension is on the second side of the stem holder, the screw guide covers a second opening of the plurality of openings.
78. The method according to claim 79, further comprising sliding a plate on the screw guide to a first position covering the first opening or a second position covering the second opening of the plurality of openings.
79. The method according to claim 78, wherein the plate slides by gravity.
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