Patent Application
20240008994
The present application relates to reverse and anatomic shoulder prostheses for fracture repair.
Arthroplasty is the standard of care for the treatment of shoulder joint arthritis. A typical anatomical shoulder joint replacement attempts to mimic anatomic conditions. For example, a metallic humeral stem and a humeral head replacement are attached to the humerus of the arm and replace the humeral side of the arthritic shoulder joint. Such humeral head replacement can articulate with the native glenoid socket or with an opposing glenoid resurfacing device.
For more severe cases of shoulder arthritis, the standard treatment is a reverse reconstruction, which includes reversing the kinematics of the shoulder joint. A reverse shoulder prosthesis can be provided by securing a semi-spherical device (sometimes called a glenoid sphere) to the glenoid and implanting a humeral stem with a cavity capable of receiving the glenoid sphere.
As patient disease may progress after anatomic treatment, revision surgery may be necessary to perform a reverse reconstruction of the shoulder. In the known art, the change in the type of prosthesis is addressed either below the plane of resection or above the plane of resection. In prostheses that are converted from anatomic to reverse by a modularity below the plane of resection, removal of anatomic devices that have integrated into the patient's bony anatomy proves to be difficult for the surgeon, and could potentially cause excessive patient bone loss. One advantage of such conversion is that the reverse insert could partially reside below the resection plane and therefore reduce the distance between the cavity and the lateral contour of the humerus. Such position has proven to be beneficial to a reversed kinematics. In the contrary, in prostheses that are converted from anatomic to reversed above the plane of resection, using an adaptor, reverse kinematics are altered as the position of the cavity is further pushed out of the humerus by the addition of the adaptor above the resection plane. Such constructs are typically made of three components that present an extra modularity in comparison to two component constructs and could potentially cause disassembly or breakage of the construct. One possibility to limit the alteration of the kinematics and limit the modularity is to inverse the bearing surface material by having a harder cavity within the humerus and a softer semi-spherical device secured to the glenoid. But the proven clinical design and preferred embodiment is usually that the cavity is softer than the semi-spherical device.
In cases of displaced or dislocated 3- and 4-part proximal humeral fractures, the proximal humerus also needs to be reconstructed. Although hemi-arthroplasty procedures may be used for the treatment of such displaced fractures, the functional outcomes of these procedures are often reported as poor and unpredictable.
A convertible prosthesis that can be converted from an anatomic replacement to a reverse reconstruction without removal of parts integrated into the patient's bony anatomy is highly desirable. For improved patient outcomes, such a convertible prosthesis should respect the biomechanics of a true anatomic replacement while also performing well when converted into a reverse reconstruction. In some cases, it may also be desirable for the convertible prosthesis to be configured for use in a humeral fracture repair procedure.
Improved humeral anchors, components, assemblies, and methods are needed to provide more flexibility in working with soft tissue around the shoulder joint. Such anchors may benefit from multiple apertures that can each receive a plug or a screw for securing the humeral anchor in the patient. Such anchors may benefit from having a V-shaped profile to reduce the amount of bone the clinician has to remove from the patient to implant the humeral anchor.
In some aspects of the disclosure, a stem for a shoulder prosthesis is disclosed. The stem can include a medial side, a lateral side opposite the medial side, and a plurality of apertures. Each aperture of the plurality of apertures can be adapted to receive a screw or one or more plugs. The plurality of apertures can include a first aperture and a second aperture. The first aperture can be positioned proximal to the second aperture. Each of the first and second apertures can include a first opening on the medial side, a second opening on the lateral side, and a length measured along a longitudinal centerline therebetween. The longitudinal centerline of at least one of the first and second apertures can be angled relative to a longitudinal plane extending in a medial-lateral direction of the stem. Alternatively, the longitudinal centerline of each of at least one of the first and second apertures can be angled relative to a longitudinal plane extending in an anterior-proximal direction of the stem or relative to any plane of the stem.
The stem of the preceding paragraphs or as described further herein can also include one or more of the following features. Each of the first and second apertures can be angled in an anterior-posterior direction relative to the medial-lateral longitudinal plane. Alternatively, each of the first and second apertures can be angled in medial-lateral direction relative to the anterior-posterior longitudinal plane. The first and second apertures can be angled in opposite directions relative to the longitudinal plane. Alternatively, the first and second apertures can be angled in the same direction relative 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 anchored in a medullary canal of a humerus. The proximal portion can having a stem face. The metaphyseal portion can extend between and connect the distal shaft portion and the proximal portion. The metaphyseal portion can include a medial portion and first and second lateral arms. Alternatively, the metaphyseal portion can include only one lateral arm or more than two lateral arms. The distal shaft portion can include the plurality of apertures. The distal shaft portion can include a plurality of grooves. The plurality of grooves can extend in a longitudinal direction. The plurality of grooves can be circumferentially spaced apart. Each of the plurality of grooves can narrow toward a distal tip of the stem. The first aperture can be positioned proximal to the plurality of grooves. The second aperture can extend through at least one of the plurality of grooves. Alternatively, the first and second apertures can both be positioned proximal to the plurality of grooves or extend through at least one of the plurality of grooves. The plurality of apertures can further include a third aperture positioned distal to the second aperture. The longitudinal centerline of each of the first and second apertures can be angled about 30° relative to the longitudinal plane of the stem. Alternatively, the longitudinal centerline of each of the first and second apertures can be angled at less than or more than about 30° relative to the longitudinal plane of the stem. For example, the angle can be about 15° or about 45°. The longitudinal centerline of each of the first and second apertures can be angled at different angles. For example, the longitudinal centerline of the first aperture can be angled at about 15° and the longitudinal centerline of the second aperture can be angled at about 45°.
A system including the stem of any of the preceding paragraphs and/or any of the stem described herein is disclosed. Each aperture of the plurality of apertures can include a first opening, a second opening, and a length measured along a longitudinal centerline therebetween. The system can include at least one plug adapted to be received by one or more apertures of the plurality of apertures of the stem.
The system of the preceding paragraphs or as described further herein can also include one or more of the following features. The at least one plug can include at least one elongate plug. A width of the at least one elongate plug can be less than a length thereof. The length of the one or more apertures of the plurality of apertures can be less than the length of the at least one elongate plug. Alternatively, the length of the one or more apertures of the plurality of apertures can be equal to or greater than the length of the at least one elongate plug. The one or more apertures of the plurality of apertures can be adapted to receive the at least one elongate plug along the entire length of the one or more apertures. A width of the at least one plug can be greater than a length thereof. The length of the one or more apertures of the plurality of apertures can be greater than the length of the at least one plug. Two or more of the plugs can be adapted to be inserted into an aperture of the one or more apertures along the longitudinal centerline.
A kit including the stem of any of the preceding paragraphs and/or any of the stem described herein is disclosed. The kit can include a reverse insert, an anatomical articular 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 glenosphere. The distal portion can include a protrusion. The reverse insert can be adapted to directly couple to the stem. The anatomical articular component can have a proximal portion and a distal portion. The proximal portion of the anatomical articular component can include a convex surface. The distal portion of the anatomical articular component can include a protrusion. The anatomical articular component can be adapted to directly couple to the stem. The spacer can include a proximal portion and a distal portion. The spacer can be adapted to couple the reverse insert or the anatomical articular component to the stem. The proximal portion of the spacer can be symmetric or asymmetric.
In some aspects of the disclosure, a kit for a shoulder prosthesis is disclosed. The kit can include a stem, a reverse insert, an anatomical articular 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 anchored in a medullary canal of a humerus. The proximal portion can have a stem face. The metaphyseal portion can include a medial portion and first and second lateral arms. Alternatively, the metaphyseal portion can include only one lateral arm or more than two lateral arms. The first and second lateral 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 glenosphere. The distal portion of the reverse insert can include a protrusion. The reverse insert can be adapted to directly couple to the stem face. The anatomical articular component can have a proximal portion and a distal portion. The proximal portion of the anatomical articular component can include a convex surface. The distal portion of the anatomical articular component can include a protrusion. The anatomical articular component can be adapted to directly couple to the stem face. The spacer can include a proximal portion, a distal portion, and a protrusion. The protrusion of the spacer can extend from a distal facing surface of the spacer. The spacer can be adapted to couple the reverse insert or the anatomical articular component to the stem. The proximal portion of the spacer can be asymmetric. The protrusion can be adapted to provide rotational alignment between the spacer and the stem.
The kit of the preceding paragraphs or as described further herein can also include one or more of the following features. The proximal portion of the spacer can be symmetric. The stem face can include a central cavity. The central cavity of the stem face can be adapted to receive the reverse insert or the anatomical articular 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 feature. The engagement feature can project from the distal facing surface of the spacer. The engagement feature can extend distally of the protrusion. The distal portion of the spacer can include first and second lateral cutouts. The first cutout can be positioned opposite the second cutout. Alternatively, the spacer can include a single lateral cutout or more than two lateral cutouts. The proximal portion of the spacer can include a proximal edge and a distal edge. The proximal edge can be angled relative to the distal edge. The proximal edge can be angled about 5° relative to the distal edge of the proximal portion of the spacer. Alternatively, the proximal edge can be angled less than or more than about 5° relative to the distal edge of the proximal portion of the spacer. For example, the proximal edge can be angled about 3° or about 10°. Alternatively, the distal edge can be angled relative to the proximal edge. The kit can further include a second stem. A distal shaft portion of the second stem can be longer than the distal shaft portion of the first stem. The kit can further include a plug or a plurality of 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.
The kit of the preceding paragraphs or as described further 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 the reverse insert or the anatomical articular component to the stem.
In some aspects of the disclosure, a stem for a shoulder prosthesis is disclosed. The stem can include a distal shaft portion, a proximal portion, a metaphyseal portion, and a suture groove. The distal shaft portion can be adapted to be anchored in a medullary canal of a humerus. The proximal portion can have a stem face. The stem face can be surrounded by a proximal rim. The metaphyseal portion can include a medial portion and first and second lateral arms. Alternatively, the metaphyseal portion can include only one lateral arm or more than two lateral arms. The first and second lateral arms can extend between and connect the distal shaft portion and the base portion of the proximal portion. The suture groove can be adapted to engage a suture. The suture groove can extend between the proximal rim and the metaphyseal portion along a medial side of the proximal portion. The suture groove can also extend around at least a portion of a circumference 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 positioned between the first concave curvature and the second concave curvature.
The stem of the preceding paragraphs or as described further herein can also include one or more of the following features. A 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 positioned on a lateral side of the proximal portion. The plurality of grooves can extend in an anterior-posterior direction. The stem can further include a plurality of grooves on lateral surfaces of the first and second lateral arms of the metaphyseal portion.
In some aspects of the disclosure, a stem for a shoulder prosthesis is disclosed. The stem can include a distal shaft portion, a proximal portion, a metaphyseal portion, and an aperture or a plurality of apertures. The distal shaft portion can be adapted to be anchored in a medullary canal of a 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 positioned along a periphery of the central recess. The base portion can be positioned distal to the peripheral wall. The metaphyseal portion can include a medial portion and first and second lateral arms. Alternatively, the metaphyseal portion can include one lateral arm or more than two lateral arms. The first and second lateral arms can extend between and connect the distal shaft portion and the base portion of the proximal portion. The medial portion can include an arm or a plurality of arms. The arm can have a lateral edge. The first and second lateral arms can have medial edges. A fenestration or a plurality of fenestrations can be defined between the lateral edge of the medial arm and the medial edges of the first and second lateral arms. The aperture can be adapted to receive a screw or a plug. The aperture can be positioned distal to the fenestration of the metaphyseal portion and extend in an anterior-posterior direction.
The stem of the preceding paragraphs or as described further herein can also include one or more of the following features. A longitudinal centerline of the aperture can be less than about 1.0 cm from a distal edge of the fenestration. The aperture can include a circular cross-section. The stem can further include additional apertures. The additional apertures can be positioned distal to the aperture. Each of the additional apertures can be adapted to receive a screw or a plug.
In some aspects of the 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 into a shoulder of a patient. The stem can include a proximal portion and a plurality of apertures. The proximal portion can have a stem face. Each of the plurality of apertures can be adapted to receive cement or a screw to secure the stem within the shoulder of the patient. The stem holder can be adapted to implant the stem into the shoulder of the patient when the stem is being secured with the cement. The jig can be adapted to implant the stem into the shoulder of the patient when the stem is being secured with one or more screws.
The kit of the preceding paragraphs or as described further 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 apertures. The stem can include a first length less than the second length. The jig can be adapted to implant the second stem into the shoulder of the patient when the second stem is being secured with the one or more screws. The jig can include a distal arm extension adapted to guide the one or more screws into one or more apertures of a plurality of apertures of the second stem. The distal arm extension of the jig can be adapted to be moveable 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 second stem into a left shoulder of the patient. The distal arm extension can be positioned on the second side of the jig to implant the second stem into a right shoulder of the patient. The jig can include an interfacing portion. The interfacing portion can be adapted to be removably coupled to the stem face of the second stem. The jig can include an impaction head. The impaction head of the jig can be adapted to receive impaction forces from a tool to implant the second stem into the shoulder of the patient. The impaction head of the jig can be located proximal to the interfacing portion. The jig can include a height gauge. The height gauge of the jig can be adapted to determine a height positioning of the second stem when implanting the second stem into the shoulder of the patient. The stem holder can include an impaction head. The impaction head of the stem holder can be adapted to receive impaction forces from a tool to implant the stem into the shoulder of the patient. The stem holder can include a height gauge. The height gauge of the stem holder can be adapted to determine a height positioning of the stem when implanting the stem into the shoulder of the patient.
In some aspects of the 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 shoulder of a patient. The stem can include a plurality of apertures. The plurality of apertures can be adapted to receive one or more screws to secure the stem within the shoulder of the patient. The jig can be adapted to introduce the stem into the shoulder of the patient. The jig can include a distal arm extension. The distal arm extension can be adapted to guide the one or more screws into one or more apertures of the plurality of apertures of the stem. The distal arm extension of the jig can be adapted to be moveable 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 a left shoulder of the patient. The distal arm extension can be positioned on the second side of the jig to implant the stem into a right shoulder of the patient. The distal arm extension can include a screw guide. The screw guide can be adapted to align the one or more screws with the one or more apertures of the stem. The screw guide can include a first aperture, a second aperture, and a sliding plate. Alternatively, the screw guide can include only a single aperture or more than two apertures. The sliding 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 a screw of the one or more screws with a first aperture of the one or more 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 screw of the one or more screws with a second aperture of the one or more apertures of the stem when the distal arm extension is on the second side of the jig. The sliding plate can cover the first aperture of the screw guide when the distal arm extension is on the second side of the jig. The sliding plate can cover the second aperture of the screw guide when the distal arm extension is on the first side of the jig.
The system of the preceding paragraphs or as described further 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 impaction head. The impaction head can be adapted to receive impaction forces from a tool. The inserter portion can further include an interfacing portion. The interfacing 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 a height positioning of the stem when implanting the stem into the shoulder of the patient. 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 to move between the first and second sides 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 extend radially outward from a longitudinal axis of the jig. The second portion of the distal arm extension can include the screw guide and a second screw guide. The second screw guide can include an aperture. The aperture can be adapted to align a second screw of the one or more screws with a third aperture of the one or more apertures of the stem. The second screw guide can include an aperture adapted to align a second screw of the one or more screws with a third aperture of the one or more apertures of the stem. The first aperture of the one or more apertures of the stem can be adjacent a distal tip of the stem. The second aperture of the one or more apertures of the stem can be proximal to the first aperture of the one or more apertures of the stem. The third aperture of the one or more apertures of the stem can be proximal to the second aperture of the one or more apertures of the stem. The distal arm extension can include a curvature or a bend. The curvature or bend can extend between the first portion and the second portion to align the screw guide and the second screw guide with the one or more apertures of the stem. The sliding plate can move between a first position and a second position along a longitudinal axis of the screw guide. The sliding plate can be in the first position when the distal arm extension is on the first side of the jig. The sliding plate can be in the second position when the distal arm extension is on the second side of the jig. The sliding plate can be adapted to move between the first and second positions by gravitational forces. Alternatively, the sliding plate can be adapted to move between the first and second positions by other forces. For example, a user can manually move the sliding plate between the first and second positions.
In some aspects of the disclosure, a method for positioning a stem for a shoulder prosthesis into a medullary canal of a humerus of a patient is disclosed. The method can include: attaching a stem face of a stem to an interfacing portion of a stem holder; inserting the stem into the medullary canal of the humerus; and securing the stem in the medullary canal of the humerus. The stem can include a proximal portion and a distal shaft portion. The proximal portion can have the stem face. The distal shaft portion can have a plurality of apertures.
The method of the preceding paragraphs or as described further herein can also include one or more of the following features. The method can further include: inserting a plug into an aperture of the plurality of apertures of the stem and cutting the length of the plug. The aperture can include a first opening, a second opening, and a length measured along a longitudinal centerline therebetween. The plug can include a length and a width. The width can be less than the length of the plug. The length of the plug can be greater than the length of the aperture. The method can further include: inserting a first plug into one of the plurality of apertures of the stem; and inserting a second plug into said one of the plurality of apertures of the stem. The aperture can include a first opening, a second opening, and a length measured along a longitudinal centerline therebetween. Each of the first and second plugs can include a length and a width. The width can be greater than the length of each of the first and second plugs. The length of the aperture can be greater than the length of each of the first and second plugs. Securing the stem can include providing bone cement in the medullary canal of the humerus. The method can further include applying impaction forces to an impaction head of the stem holder. Securing the stem in the medullary canal can include inserting a screw into one of the plurality of apertures of the stem. The method can further include aligning a screw guide of the stem holder with the plurality of apertures. The screw guide can be carried by a distal arm extension of the stem holder. The method can further include: positioning 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 a left shoulder and positioning 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 a 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 a first aperture of the plurality of apertures. When the distal arm extension is on the second side of the stem holder, the screw guide can cover a second aperture of the plurality of apertures. The method can further include sliding a plate on the screw guide to a first position to cover the first aperture or a second position to cover the second aperture of the plurality of apertures. The plate can slide by gravitational forces. Alternatively, a user can manually move the sliding plate between the first and second positions.
Any feature, structure, or step disclosed herein can be replaced with or combined with any other feature, structure, or step disclosed herein, or omitted. Further, for purposes of summarizing the disclosure, certain aspects, advantages, and features of the inventions have been described herein. It is to be understood that not necessarily any or all such advantages are achieved in accordance with any particular embodiment of the inventions disclosed herein. No aspects of this disclosure are essential or indispensable.
These and other features, aspects and advantages are described below with reference to the drawings, which are intended to illustrate but not to limit the inventions. In the drawings, like reference characters denote corresponding features consistently throughout similar embodiments. The following is a brief description of each of the drawings.
While the present description sets forth specific details of various embodiments, it will be appreciated that the description is illustrative only and should not be construed in any way as limiting. Furthermore, various applications of such embodiments and modifications thereto, which may occur to those who are skilled in the art, are also encompassed by the general concepts described herein. Each and every feature described herein, and each and every combination of two or more of such features, is included within the scope of the present invention provided that the features included in such a combination are not mutually inconsistent.
One can see that the anatomic and reverse approaches generally use different hardware to secure the articular components. For example, the presence of the spacer 42 may require more joint space. Thus, the reverse configuration may only be suitable for some patients with large joint space or following more invasive preparation of the humerus and/or the scapula.
With a standard shoulder prosthesis, when a surgeon desires to convert a primary anatomic shoulder prosthesis into a reverse shoulder prosthesis, the surgeon must typically remove the entire prosthesis, thereby risking further weakening the bone. However, using a modular system such as implant systems 10 and 20 illustrated in
As shown in
In various embodiments, the fin lengths lf of the anchors 103A-103D can differ substantially so as to beneficially provide a wide range of anchor strengths to the humerus and accommodate patients with different levels of bone damage. In the arrangement of
The kit 100 can also include one or a plurality of stemmed humeral anchors 113. The kit 100 can include one or more humeral stem anchors 112, each of which includes a proximal metaphysis portion 120 and an elongate diaphysis portion 116 extending therefrom. The diaphysis portion 116 is sometimes referred to herein as a stem or stem portion. The stemmed humeral anchors 113 may be used in patients in which stemless anchors 103 may not be adequately secured to the humerus, for example, in patients that have experienced severe bone loss. As with the stemless anchors 103, the kit 100 can include humeral stem anchors 113 (sometimes referred to herein as a stemmed anchor) having a plurality of different sizes, e.g., different lateral sizes and/or different lengths l2. For example, as shown in
In some embodiments, the stemmed humeral anchors 113 can include trauma or fracture stem anchors or humeral stems 30, 230, which can be used in patients that have experienced a fracture of the humerus H. The trauma or fracture stems 30, 230 may be used where the humerus has fractured into one or more pieces. Moreover, the shaft portions of the fracture stems 30, 230 may also have respective length l3, l4 such that 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 lengths l4 of the shaft portion of the longer fracture stem 230 can be in a range of about 125 mm and about 175 mm, in a range of about 150 mm and about 175 mm, or about 168 mm. By contrast, the shorter lengths l3 of the shaft portion of the shorter fracture stem 30 can be in a range of about 50 mm and about 100 mm, a range of about 75 mm and about 100 mm, or about 88 mm.
Beneficially, the kit 100 can comprise one or a plurality of shared humeral components that be used with either the stemless humeral implants 103 or the stemmed humeral implants 113, depending on which implant 103 or 113 would be more appropriate for a particular patient's humeral anatomy. For example, the shared humeral components of the kit 100 can comprise a plurality of articular components or assemblies 161 that can be used in conjunction with either the stemless implants 103 or the stemmed implants 113. As explained herein, both the stemless humeral anchors 103 and the stemmed humeral anchors 113 can include shared engagement features that can be used with the same set of tools and/or articular components. For example, as described herein, the stemless anchors 103 and stemmed anchors 113 can include convex and concave locking features configured to engage with the same set of articular components.
For example, the kit 100 can include an anatomic articular component 160 configured to mechanically couple to both the stemless humeral implants 103 and the stemmed humeral implants 113. The clinician may select the anatomic articular component 160 for procedures in which an anatomic reconstruction is suitable. The anatomic articular component 160 can comprise a coupler 168 and an articular body 164 (anatomical) configured to mechanically engage the coupler 168. As shown in
The kit 100 can also include a reverse articular component 180 configured to mechanically couple to both the stemless humeral implants 103 and the stemmed humeral implants 113. The clinician may select the reverse articular component 180 for procedures in which a reverse anatomic reconstruction is suitable. The reverse articular component 180 can comprise a reverse articular body 184 and a locking device 188 configured to secure the reverse articular component 180 to a stemless humeral implant 103 or a stemmed humeral implant 113, depending on the clinician's recommendation during the procedure. As shown, the reverse articular body 184 can comprise a rounded concave surface (e.g., essentially spherical) configured to engage with a glenosphere connected to the glenoid of the patient (not shown but in some cases combined with the kit into a larger surgical kit). In addition, in some embodiments, the kit 100 can include a wear resistant reverse articular component 180A, which may be generally similar to the reverse articular component 180 but may further be formed to include vitamin E to promote long-term compatibility with the patient's bone structure. The reverse components 180, 180A can comprise a polymer, including, for example, ultra-high molecular weight polyethylene. In various embodiments, the kit 100 can include reverse articular components 180, 180A having a plurality of sizes.
The kit 100 can also include one or more spacers 150 that can mechanically couple the reverse articular component 180 or the anatomical articular component 160 to the stemless humeral implants 103 or the stemmed humeral implants 113. As shown in
During an arthroplasty procedure, the clinician may inspect the bone structure of the humerus and/or the scapula to determine whether the anatomy is suitable for a stemless or stemmed humeral anchor, and whether the anatomy is suitable for an anatomical or reverse anatomical reconstruction. Beneficially, the kit 100 shown in
Similarly, if during a shoulder arthroplasty procedure, the clinician determines that the patient's bone structure is damaged or otherwise more suited to a stemmed anchor 113, then the clinician can select an appropriately sized stemmed anchor 113. The clinician can further select whether to proceed with an anatomical reconstruction or a reverse construction, and can accordingly select either the anatomical articular component 160 or the reverse articular component 180, 180A. Beneficially, the kit 100 of
As explained above, for humeral fractures, the kit 100 can also include one or more trauma stems 30, 230. Beneficially, the trauma stem(s) 30, 230 can include engagement features generally similar to or the same as the engagement features in the stemless anchors 103 and humeral stem anchors 113, such that the trauma stem(s) 30, 230 can be used with a common set of shared articular components 161 and tools. Beneficially, therefore, the kit 100 can provide a shared set of implantation tools and a shared set of articular components 161 that can be used with either stemless or stemmed humeral anchors 103, 113, and that can be used for anatomical or reverse anatomical reconstructions.
In some embodiments, the coupler 168 can comprise a proximal extension 163A configured to connect to the articular body 164 and a distal extension 163B. The distal extension 163B for can be received within a first recess 52, 252 of a stem face 50, 250 of the fracture stem 30, 230 for anatomical reconstructions. In some embodiments, the recess 52, 252 is can be recessed from (e.g., extends distally from) a distal end of a second recess 54, 254. In these embodiments, the disc or middle portion 162 can provide a spacer function in use in the trauma stem 30, 230. In some configurations, the recess 52. 252 can be elevated toward the resection plane, and the disc or middle portion 162 disposed between the proximal extension 163A and the distal extension 163B can be eliminated. Additional details of trauma stems may be found throughout International Application No. PCT/US2015/065126, titled “CONVERTIBLE STEM/FRACTURE STEM,” filed Dec. 10, 2015, the entire contents of which are included in the Appendix.
The final implant can take any suitable configuration, such as any that are described in International Application No. PCT/US2019/054007, titled “SHOULDER PROSTHESIS COMPONENTS AND ASSEMBLIES,” and International Application No. PCT/US2019/054023, titled “MODULAR HUMERAL HEAD,” which were filed on Apr. 9, 2020. The final implant can take any configuration as disclosed in International Application No. PCT/US2020/053629, titled “SHOULDER PROSTHESIS COMPONENTS AND ASSEMBLIES,” filed on Sep. 30, 2020. The articular components can take any configuration as disclosed in International Application No. PCT/US2020/053625, titled “REVERSE SHOULDER SYSTEMS,” filed Sep. 30, 2020. The entire contents of each of the applications listed in this paragraph are included in the Appendix.
When a reverse reconstruction is suitable, the clinician may couple the reverse articular component 180 to the fracture stem 30. The clinician may directly couple the reverse articular component 180 to the stem face 50 of the fracture stem 30 or the clinician may use a spacer 150 to couple the reverse articular component 180 to the stem face 50 of the fracture stem 30. For example,
In some embodiments, the proximal portion 34 includes a spherical portion. For example, as shown in
As shown in
The stem 30 can also include a fin 102 protruding from the lateral side 91 of the distal portion 32. In the illustrated embodiment, the fin 102 extends from a proximal portion of the distal portion 32 distally along a portion of a length of the distal portion 32. The fin 102 can help promote correct positioning of the stem 30 during stem placement. In some configurations, a length of the fin 102 can be between about 20 mm and about 40 mm, between about 25 mm and about 35 mm, or about 30.8 mm. In some configurations, the length of the fin 102 can be between about 10% and about 40% or about 20% and about 30% of a total length LT1 (shown in
In some configurations, a fenestration or window 104 can be defined between a lateral edge 113 of the medial arm 92 and medial edges 115, 119 of the first 94 and second 96 lateral arms, respectively. In some embodiments of a fracture repair procedure, a bone graft can be placed in the fenestration 104 to help promote bone-to-stem fixation. A space or gap 106, shown in
The metaphyseal portion 90 can include one or more through holes 98. For example, the one or more through holes 98 may be positioned below the fenestration 104. The through holes 98 can be configured to receive one or more screws 170 or plugs 700A, 700B, which are further described below in relation to
In some configurations, the distal portion 32 can include a plurality of grooves 130 extending in a longitudinal direction and are circumferentially spaced apart. 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 apertures 62, 64 configured to receive one or more screws 170 or plugs 700A, 700B, which are further described below in relation to
In some configurations, the apertures 62, 64 may be spaced apart from one another. For example, a distance between the two apertures 62, 64 can be between about 10 mm and about 30 mm, or about 15 mm and about 25 mm. In some configurations, the distance between the two apertures 62, 64 can be between about 10% and about 40% of a length of the distal shaft portion 32 or between about 20% and about 30% of the length of the distal shaft portion 32. In some configurations, the distal aperture 64 can be positioned between about 25 mm and about 45 mm or about 30 mm and about 40 mm from a distal tip 33 of the stem 30. In some configurations, the distance between the distal aperture 64 and the distal tip 33 can be between about 20% and about 50% of the length of the distal shaft portion 32, or about 30% and about 40% of the length of the distal shaft portion 32. In some configurations, the proximal aperture 62 can be positioned between about 45 mm and about 65 mm or about 50 mm and about 60 mm from the distal tip 33 of the stem 30. In some configurations, the distance between the proximal aperture 62 and the distal tip 33 can be between about 40% and about 70% of the length of the distal shaft portion 32, or about 50% and about 60% of the length of the distal shaft portion 32.
As shown in
As shown in
In some configurations, the first length L1 can be between about 30 mm and about 70 mm, about 40 mm and about 60 mm, or about 59 mm. In some configurations, the first length L1 can be between about 30% and about 60% of the total length LT1, about 40% and about 50% of the total length LT1, or about 43% of the total length LT1. In some configurations, the second length L2 can be between about 60 mm and about 100 mm, about mm and about 90 mm, or about 80 mm. In some configurations, the second length L2 can be between about 40% and about 70% of the total length LT1, about 50% and about 60% of the total length LT1, or about 59% of the total length LT1. In some configurations, the third length L3 can be between about 80 mm and about 120 mm, about 90 mm and about 110 mm, or about 96 mm. In some configurations, the third length L3 can be between about 50% and about 80% of the total length LT1, about 60% and about 70% of the total length LT1, or about 71% of the total length LT1. In some configurations, the fourth length L4 can be between about 90 mm and about 130 mm, about 100 mm and about 120 mm, or about 107 mm. In some configurations, the fourth length L4 can be between about 60% and about 90% of the total length LT1, about 70% and about 80% of the total length LT1, or about 79% of the total length LT1.
In some configurations, the maximum width WT can be less than the total length LT1. For example, the maximum width WT can be between about 20 mm and about mm, about 30 mm and about 40 mm, or about 38 mm. In some configurations, the maximum width WT can be between about 10% and about 40% of the total length LT1, about 20% and about 30% of the total length LT1, or about 28% of the total length LT1. In some configurations, the first width W1 can be between about 5 mm and about 20 mm, or about 10 mm and about 15 mm. In some configurations, the first width W1 can be between about 10% and about 60% of the maximum width WT, about 20% and about 50% of the maximum width WT, or about 30% and about 40% of the maximum width WT. In some configurations, the second width W2 can be between about 7 mm and about 25 mm, or about 10 mm and about 20 mm. In some configurations, the second width W2 can be between about 10% and about 70% of the maximum width WT, about 20% and about 60% of the maximum width WT, or about 30% and about 50% of the maximum width WT. In some configurations, the third width W3 can be between about 10 mm and about 25 mm, or about 15 mm and about 20 mm. In some configurations, the third width W3 can be between about 20% and about 70% of the maximum width WT, about 30% and about 60% of the maximum width WT, or about 40% and about 50% of the maximum width WT. In some configurations, the fourth width W4 can be between about 5 mm and about 20 mm, or about 10 mm and about 15 mm. In some configurations, the fourth width W4 can be between about 10% and about 60% of the maximum width WT, about 20% and about 50% of the maximum width WT, or about 30% and about 40% of the maximum width WT. In some configurations, the fifth width W5 can be between about 8 mm and about 20 mm, or about 10 mm and about 15 mm. In some configurations, the fifth width W5 can be between about 10% and about 60% of the maximum width WT, about 20% and about 50% of the maximum width WT, or about 30% and about 40% of the maximum width WT. In some configurations, the sixth width W6 can be between about 10 mm and about 20 mm, or about mm and about 15 mm. In some configurations, the first width W1 can be between about 20% and about 70% of the maximum width WT, about 30% and about 60% of the maximum width WT, or about 40% and about 50% of the maximum width WT. The table below provides example widths for different sizes of the stem 30.
As shown in
In some configurations, the one or more slots 55a, 55b, 55c, 55d, 57a, 57b can be sized and configured to engage an insert 161 (such as the articular components 160, 180). For example, the slots 55a, 55b, 55c, 55d, 57a, 57b can engage or receive corresponding ridges of an insert 161. As explained 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, 55d, 57a, 57b can also guide the advancement of the insert 161 into an upper portion of the second recess 54. The slots 55a, 55b, 55c, 55d, 57a, 57b can be disposed vertically along the stem face 50 and can be circumferentially spaced from one another. For example, first and second slots 55a, 55b may be positioned adjacent each other and opposite third and fourth slots 55c, 55d. Further, fifth and sixth slots 57a, 57b may be positioned opposite one another. In some configurations, the fifth and sixth slots 57a, 57b may have a greater width than the first, second, third, and fourth slots 55a, 55b, 55c, 55d. In the embodiment of
As shown in
As shown in
In some configurations, the first and second apertures 262, 264 may be spaced apart from one another. For example, the distance between the two apertures 62, 64 can be between about 4% and about 20% of the total length LT2 of the stem 230 or about 10% and about 15% of the total length LT2 of the stem 230. In some configurations, the first aperture 262 can be positioned between about 130 mm and about 160 mm or about 140 mm and about 150 mm from a distal tip 233 of the stem 230. In some configurations, the distance between the first aperture 262 and the distal tip 233 can be between about 45% and about 75% of the total length LT2 of the stem 230, or about 55% and about 65% of the total length LT2 of the stem 230. In some configurations, the second aperture 262 can be positioned between about 105 mm and about 135 mm or about 115 mm and about 125 mm from the distal tip 233 of the stem 230. In some configurations, the distance between the second aperture 264 and the distal tip 233 can be between about 40% and about 80% of the total length LT2 of the longer stem 230, or about 50% and about 70% of the total length LT2 of the longer stem 230.
In some configurations, the first and second apertures 262, 264 may be spaced apart from the third, fourth, and fifth apertures 265, 267, 269. For example, a distance between the second aperture 264 and the third aperture 265 can be between about mm and about 100 mm, or about 70 mm and about 90 mm. In some configurations, the distance between the second aperture 264 and the third aperture 265 can be between about 20% and about 60% of the total length LT2 of the stem 230 or about 30% and about 50% of the total length LT2 of the stem 230.
In some configurations, the third aperture 265 can be positioned between about 20 mm and about 60 mm or about 30 mm and about 50 mm from a distal tip 233 of the stem 230. In some configurations, the distance between the third aperture 265 and the distal tip 233 can be between about 5% and about 40% of the total length LT2 of the stem 230, or about 10% and about 30% of the total length LT2 of the stem 230. In some configurations, the fourth aperture 267 can be positioned between about 10 mm and about mm or about 20 mm and about 40 mm from the distal tip 233 of the stem 230. In some configurations, the distance between the fourth aperture 267 and the distal tip 233 can be between about 5% and about 30% of the total length LT2 of the longer stem 230, or about 10% and about 20% of the total length LT2 of the longer stem 230. In some configurations, the fifth aperture 269 can be positioned between about 5 mm and about 40 mm or about 10 mm and 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 can be between about 5% and about 30% of the total length LT2 of the longer stem 230, or about 10% and about 20% of the total length LT2 of the longer stem 230.
In some configurations, the third aperture 265 can be configured to receive a screw 170 when securing the stem 230 in a left or right shoulder of a patient. In some configurations, the fourth aperture 257 can be configured to receive the screw 170 when securing the stem 230 in the right shoulder of the patient. In some configurations, the fifth aperture 259 can be configured to receive the screw 170 when securing the stem 230 in the left shoulder of the patient. In other configurations the fourth aperture 257 can be configured to receive the screw 170 when securing the stem 230 in the left shoulder of the patient and the fifth aperture 259 can be configured to receive the screw 170 when securing the stem 230 in the left shoulder of the patient.
As explained above in relation to
As shown in
As shown in
As shown in
The asymmetry of the asymmetric spacer 150A is defined as follows. As shown in
Compared to the symmetric cylindrical spacer 150C shown in
This beneficial effect of the asymmetric spacer 150A is now described with reference to
The stem implants 30 and 230 are examples of fracture stem implants. However, the asymmetric spacer 150A can also be used with standard humeral stem implants to achieve the similar beneficial effect of selectively distalizing the humerus while iminizing lateralization of the humerus.
As shown in
With the asymmetric spacer 150A in the arthroplasty kit 100, a surgeon can use the asymmetric spacer 150A to adjust the position of the reverse shoulder prosthetic joint. In the case of an initial arthroplasty procedure assembling a reverse prosthetic shoulder joint, after a stemless humeral anchor 103 or a stemmed humeral anchor 113 is positioned in the proximal end of the prepared humerus, the reverse articular component 180 or 180A can be attached to the anchor 103, 113 with an asymmetric spacer 150A in between to position the articulating assembly (comprising the reverse articular component 180 or 180A and a glenosphere 164) to selectively distalize the humerus while minimizing any lateralization of the humerus. An asymmetric spacer 150A having the appropriate thickness and appropriate amount of asymmetry would be selected for a given patient. In the case of a revision arthroplasty, if the position of the originally placed stemless humeral anchor 103 or the originally placed stemmed humeral anchor 113 is too low in the humerus, an appropriately dimensioned asymmetric spacer 150A can be positioned between the humeral anchor 103 or 113 and the reverse articular component 180, 180A.
In some embodiments, a protrusion similar to the protrusion 155A can be placed at a different location on the distal facing surface 154A to function as a locating key for keying the asymmetric spacer to a different rotational position. This can be used to vary the direction of the distalization. In some embodiments, the protrusion 155A on the distal facing surface 154A of the spacer can be omitted to allow arbitrary rotation of the asymmetric spacer. Either way, some examples of benefits from having the ability to dial in the direction of the asymmetry are (but now limited to these): a) pure distalization would allow to tension more deltoid and get additional construct stability of the shoulder without adding tension on fractured tuberosity (in a fracture cases, surgeons generally do not want to tighten too much on the tuberosity to enhance healing without tuberosity migration); b) anterior or posterior offset to accommodate internal rotation/external rotation balance; c) anterior or posterior offset to accommodate bone distortion (Fracture sequalae for instance); d) anterior or posterior offset to accommodate joint subluxation in a tight shoulder. and e) optimizing impingement free range of motion by the ability to place the tray offset in any direction.
As shown in
As shown in
It may be desirable, for example, to use the elongate plug 700A for ease of handling and inserting into one or more of the plurality of apertures 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 aperture(s) 62, 64, 98 without needing to cut the length of the plug 700B. Methods of using the plugs 700A, 700B are further described below in relation to
In use, the clinician can thread the impactor 810 into the tip 850. The clinician can position the proximal end 858 of the tip 850 against the bone of a patient. The clinician can use a mallet to apply impacting forces to the impaction head 822, which causes portions of the bone to fill the channel 853 of the tip 850. Once a sufficient amount of bone is in the channel 853, the clinician can remove the bone graft from the tip 850. As shown in
The humeral anchors described above can be implanted using certain tools and instruments that are described below in connection with
One advantage of various kits and systems disclosed herein is that multiple different types of humeral anchors can be implanted using shared instrumentation. Examples of shared instrumentation are discussed below.
1. Stem Holder
As discussed above, a stem 30, 230 may include one or more interfacing features, such as the one or more apertures 51a, 51b, 53, 251a, 251b, 253, configured to engage a tool and enable insertion of the stem 30, 230 into the bone.
The stem holder 900 may include an elongate body 905. The elongate 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
The stem holder 900 may also include a moveable assembly 906 (see
As shown in
The handle 908 may be directly or indirectly coupled to the fourth interfacing feature 914. For example, the handle 908 may be indirectly coupled to the fourth interfacing feature 914 by a spring linkage 916. The spring linkage 916 may have an arcuate portion and a spring gap 920. The spring linkage 916 may be indirectly coupled to the elongate body 905 by the handle 908 and/or the fourth interfacing feature 914 without a direct connection between the spring linkage 916 and the elongate body 905.
The handle 908 can be configured to move the fourth interfacing feature 914 between a first configuration and a second configuration. A proximal end of the handle 908 can be free to move relative to the elongate body 905. The transition between the first configuration and the second configuration may include rotation and/or translation of the fourth interfacing feature 914 with respect to elongate body 905. For example, actuating (e.g., pivoting) the handle 908 away from the elongate body 905 may move the fourth interfacing feature 914 from the first configuration to the second configuration, while releasing the handle 908 may move the fourth interfacing feature 914 back to the first configuration. In the second configuration, the fourth interfacing feature 914 can be rotated and at least partially retracted with respect to a distal surface 903 of the stem holder 900. In this position, the surgeon may engage the stem face 50, 250 of the stem 30, 230. While the fourth interfacing feature 914 engages the stem face 50, 250 of the stem 30, 230, the handle 908 may be released (e.g., toward the elongate body 905) so as to apply a gripping force to the stem 30, 230. In the first configuration, the spring linkage 916 can be compressed (e.g. the spring gap 920 has been slightly closed), and provide a spring force which can help to hold the fourth interfacing feature 914 closed against the stem 30, 230.
In some configurations, the fourth interfacing feature 914 may be angled relative to the first and second interfacing features 911, 913. For example, longitudinal axes of the first and second interfacing features 911, 913 may extend substantially perpendicularly from the distal surfaces of the third interfacing feature 912. Accordingly, a longitudinal axis of the fourth interfacing feature 914 may be angled relative to the longitudinal axes of the first and second interfacing features 911, 913. When the fourth interfacing feature 914 is moved from the first configuration to the second configuration, the angle between the fourth interfacing feature 914 and the first and second interfacing features 911, 913 can decrease. In some configuration, the angle between the fourth interfacing feature 914 and the first and second features 911, 913 may increase when moving the fourth interfacing feature 914 from the first configuration to the second configuration.
Stem holder 900 may include at least one impaction head 924 configured to receive impaction forces from a tool (e.g., a mallet). For example, the stem holder 900 may include a single impaction head 924 that may be disposed at the first end 902 of the stem holder 900. In some configurations, the at least one impaction head can include two impaction heads with the impaction head 924 and a second impaction head being positioned closer to the second end 904 of the stem holder 900. The impaction head 924 may be coupled with the elongate body 905. In some configurations, the impaction head 924 may be aligned with the longitudinal axis of the elongate body 905. In some configurations, the impaction head 924 may be disposed at an angle relative to the longitudinal axis of the elongate body 905. When a force is applied to the impaction head 924, the impacting force can be directed to the stem 30, 230 in a direction aligned with a longitudinal axis of the stem 30, 230 to embed the stem 30, 230 in the bone.
The stem holder 900 may also be configured to receive a retroversion rod. For example, the retroversion rod may be inserted into one of the openings 926. Each opening may position the retroversion rod at a different angle, corresponding to the desired angle of resection, and allow the surgeon to evaluate the version. If the proximal bone resection was not accurate or for other reasons dictated by surgeon judgment, the surgeon can modify the resection plane.
The stem holder 900 may also include a height gauge 930 configured to determine a height of the stem 30, 230 relative to the humerus or a depth of the stem 30, 230 within the humerus. For example, prior to implanting the stem 30, 230 into the humerus, a clinician can determine the appropriate stem height of the stem 30, 230 relative to the humerus based on x-rays of the humerus, a trial stem, or other suitable methods. The height gauge 930 can include a ruler 932, a connector rod 934, a connector hub 940, and a marker 950. The ruler 932 can include a plurality of markings (not shown) associated with a measurement (e.g., millimeters (mm), centimeters (cm)). In some configurations, the ruler 932 can have an elongate shape (e.g., a cylinder). In some configurations, a longitudinal axis of the ruler 932 can be substantially parallel to the longitudinal axis of the elongate body 905. The connector rod 934 can be configured to couple the height gauge 930 to the elongate body 905. In some configurations, the elongate body 905 can include a connector portion 928 configured to receive the connector rod 934. The elongate body 905 can include the connector portion 928 on one or both sides of the elongate body 905. When the elongate body 905 has connector portion 928 on both sides, the clinician can position the connector rod 934 in either of the connector portions 928. The connector rod 934 can have an elongate shape (e.g., a cylindrical shape). In some configurations, a longitudinal axis of the connector rod 934 can be substantially perpendicular to the longitudinal axis of the ruler 932 and/or the elongate body 905.
The marker 950 can extend perpendicularly from a distal end of the ruler 932. A distal facing surface of the marker 950 can be configured to be positioned on the humerus after the humeral head is removed. The connector hub 940 may be configured to couple the ruler 932 and the connector rod 934. The connector hub 940 can include an adjustment portion 942 and a connector portion 944. The adjustment portion 942 can be configured to move the ruler 932 relative to the connector rod 934. In some configurations, the adjustment portion 942 can be a wheel 942. In use, after the clinician has determined the appropriate stem height and connected the stem 30, 230 to the stem holder 900, the clinician can turn the wheel 942 to move the ruler 932 until the ruler 932 reaches the appropriate stem height. The clinician can apply impaction forces to the impaction head 924 to insert the stem 30, 230 into the humerus until the marker 950 contacts the resected portion of the humerus.
The stem holder 900 may form part of a kit including a stemless bone anchor and/or a stemmed bone anchor. The stemless and/or stemmed bone anchor may include any of the features of the implants described above. The stem interfacing portion 910 may be configured to engage the stem holder interface of the stemless bone anchor and/or the stem face of the stemmed bone anchor.
In use, the same stem holder 900 may engage the stem holder interface of a first, stemless bone anchor or the stem face of a second, stemmed bone anchor. The stemless and/or stemmed bone anchor may include any of the features of the implants described above. For example, the stem holder 900 may engage the stem holder interface of the stemless bone anchor and advance the stemless bone anchor into bone matter exposed at a resection of a bone. When advancing the stemless bone anchor, a force may be applied to the impaction head 924 of the stem holder 900 to apply a force perpendicular to the resection plane of the bone.
The same stem holder 900 may engage the stem face of the stemmed bone anchor and advance the stemmed bone anchor to position the stem of the bone anchor in a medullary canal of the bone. When advancing the stemmed bone anchor, a force may be applied to the impaction head 924 of the stem holder 900 to apply a force aligned with a longitudinal axis of the stemmed bone anchor to embed the stem in the bone.
2. Jig
The elongate body 1016 may generally extend from the impaction head 1012 toward the second end 1004 of the jig 1000. A longitudinal axis of the elongate body 1016 can be substantially perpendicular to a longitudinal axis of the connecting bridge 1010. The elongate body 1016 may include an interfacing portion 1014 at a distal end of the elongate body 1016. The interfacing portion 1014 may be configured engage the stem face 50, 250 of a stem 30, 230. The interfacing portion 1014 can be the same as or similar to the stem interfacing feature 910 described in relation to
The jig 1000 may also include a moveable assembly 1030 (see
As shown in
The handle 1032 may be directly or indirectly coupled to the fourth interfacing feature 1026. For example, the handle 1032 may be indirectly coupled to the fourth interfacing feature 1026 by a spring linkage 1038. The spring linkage 1038 may have an arcuate portion and a spring gap 1040. The spring linkage 1038 may be indirectly coupled to the elongate body 1016 by the handle 1032 and/or the fourth interfacing feature 1026 without a direct connection between the spring linkage 1038 and the elongate body 1016.
The handle 1032 can be configured to move the fourth interfacing feature 1026 between a first configuration and a second configuration. A free end 1033 of the handle 1032 can be free to move relative to the elongate body 1016. The transition between the first configuration and the second configuration may include rotation and/or translation of the fourth interfacing feature 1026 with respect to elongate body 1016. For example, actuating (e.g., pivoting) the free end 1033 of the handle 1032 away from connecting bridge 1010 may move the fourth interfacing feature 1026 from the first configuration to the second configuration, while releasing the free end 1033 of the handle 1032 may move the fourth interfacing feature 1026 back to the first configuration. In the second configuration, the fourth interfacing feature 1026 can be rotated and at least partially retracted with respect to the distal surface 1018 of the interfacing portion 1014. In this position, the surgeon may engage the stem face 50, 250 of the stem 30, 230. While the fourth interfacing feature 1026 engages the stem face 50, 250 of the stem 30, 230, the free end 1033 of the handle 1032 may be released (e.g., toward the connecting bridge 1010) so as to apply a gripping force to the stem 30, 230. In the first configuration, the spring linkage 1038 can be compressed (e.g. the spring gap 1040 has been slightly closed), and provide a spring force which can help to hold the fourth interfacing feature 1026 closed against the stem 30, 230.
As show in
The at least one impaction head 1012 can be configured to receive impaction forces from a tool (e.g., a mallet). For example, the jig 1000 may include a single impaction head 1012 that may be disposed at the first end 1002 of the jig 1000. In some configurations, the at least one impaction head can include two impaction heads with the impaction head 1012 and a second impaction head being positioned closer to the second end 1004 of the jig 1000. The impaction head 1012 may be coupled with the elongate body 1016. In some configurations, the impaction head 1012 may be parallel to or aligned with a longitudinal axis of the elongate body 1016. In some configurations, the impaction head 1012 may be disposed at an angle relative to the longitudinal axis of the elongate body 1016. When a force is applied to the impaction head 1012, the impacting force can be directed to the stem 30, 230 in a direction aligned with a longitudinal axis of the stem 30, 230 to embed the stem 30, 230 in the bone.
The jig 1000 may also be configured to receive a retroversion rod. For example, the retroversion rod may be inserted into one of the openings 1042. Each opening may position the retroversion rod at a different angle, corresponding to the desired angle of resection, and allow the surgeon to evaluate the version. If the proximal bone resection was not accurate or for other reasons dictated by surgeon judgment, the surgeon can modify the resection plane.
As shown in
The marker 1054 can extend perpendicularly from the ruler 1052. A distal facing surface of the marker 1054 can be configured to be positioned on the humerus after the humeral head is removed. In some configurations, the height gauge 1050 can include a marker connector 1056. The marker connector 1056 can include an aperture 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 marker connector 1056 relative to the ruler 1052. In some configurations, the adjustment portion can be a release button 1058. In use, after the clinician has determined the appropriate stem height and connected the stem 30, 230 to the jig 1000, the clinician can turn the push the release button 1058 and move the marker connector 1056 until the marker connector 1056 and the marker 1054 reaches the appropriate stem height. The clinician can release the release button 1058 to secure a positon of the marker connector 1058 and marker 1054 relative to the ruler 1052. The clinician can apply impaction forces to the impaction head 1012 to insert the stem 30, 230 into the humerus until the marker 1054 contacts the resected portion of the humerus.
The jig 1000 may 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 couple to the height gauge 1050 at a 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 with a distal arm extension 1102, which is further described below
The one or more screw guides 1064 can be configured to align one or more screws 170 with the one or more apertures 62, 64 in the distal shaft portion 32 of the stem 30. For example, as shown in
The distal arm extension 1102 can be configured to be moveable between a first side of the jig 1100 (
The distal arm extension 1102 can include one or more screw guides 1108, 1110. For example, the 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 positioned on the second portion 1106 of the distal arm extension 1102. The first screw guide 1108 can be positioned at the second end of the second portion 1106. The second screw guide 1110 can be positioned between the second end of the second portion 1104 of the distal arm extension 1102 and the first portion 1104 of the distal arm extension 1102. For example, the second screw guide 1110 can be adjacent the first screw guide 1108. The first and second screw guides 1108, 1110 can be configured to align a screw 170 with one or more of the apertures 265, 267, 269 of the stem 240. For example, the first screw guide 1108 can align a screw 170 with the fourth or fifth aperture 267, 259 and the second screw guide 1110 can be configured to align the screw 170 with the third aperture 265. In some configurations, as shown in
The first screw guide 1108 can include one or more apertures 1112, 1114 configured to align a screw 170 with one or more apertures 265, 267, 269 of the stem 230. For example, the one or more apertures can include a first aperture 1112 and a second aperture 1114. The first aperture 1112 can align the screw 170 and/or the drill sleeve 1070 with the fifth aperture 269. The second aperture 1114 can align the screw 170 and/or the drill sleeve 1070 with the fourth aperture 269.
The first screw guide 1108 can include a sliding plate 1116 that can move between a first position and a second position. The sliding plate 1116 can be configured to cover the first or second aperture 1112, 1114 of the first screw guide 1108. For example, the sliding plate 1116 can include corresponding first and second apertures that align with the first and second apertures 1112, 1114 of the first screw guide 1108, respectively. When the distal arm extension 1102 is on the first side of the jig 1100, as shown in
The sliding plate 1116 can be configured to move along a longitudinal axis of the first screw guide 1108 to move between the first and second positions. The sliding plate 1116 can be configured to move between the first and second positions by gravitational forces and/or the user manually moving the sliding plate 1116. In some configurations, the sliding plate 1116 can include a sliding mechanism that can move the sliding plate 1116 between the first and second positions. For example, when the distal arm extension 1102 is moved to the first side of the jig 1100, gravitational forces, the user, and/or the sliding mechanism can move the sliding plate 1116 distally relative to the body of the first screw guide 1108 to the first position such that the top aperture (e.g., the second aperture 1114) is covered and the bottom aperture (e.g., the first aperture 1112) is uncovered. As a further example, when the distal arm extension 1102 is moved to the second side of the jig 1100, gravitational forces. the user, and/or the sliding mechanism can move the sliding plate 1116 distally relative to the body of the first screw guide 1108 to the second position such that the top aperture (e.g., the first aperture 1112) is covered and the bottom aperture (e.g., the second aperture 1114) is uncovered. Advantageously, whether the surgeon is implanting the stem 230 in the left or right arm of the patient, the sliding plate 1116 can prevent the surgeon from inserting the screw 170 and/or the drill sleeve 1070 into the incorrect aperture of the first and second apertures 1112, 1116 for the procedure.
The jig 1000, 1100 may form part of a kit including a stemless bone anchor and/or a stemmed bone anchor. The stemless and/or stemmed bone anchor may include any of the features of the implants described above. The interfacing portion 1014 may be configured to engage the jig interface of the stemless bone anchor, which is the same as or similar to the stem holder interface described above, and/or the stem face of the stemmed bone anchor.
In use, the same jig 1000, 1100 may engage the jig interface of a first, stemless bone anchor or the stem face of a second, stemmed bone anchor. The stemless and/or stemmed bone anchor may include any of the features of the implants described above. For example, the jig 1000, 1100 may engage the jig interface of the stemless bone anchor and advance the stemless bone anchor into bone matter exposed at a resection of a bone. When advancing the stemless bone anchor, a force may be applied to the impaction head 1012 of the jig 1000, 1100 to apply a force perpendicular to the resection plane of the bone.
The same jig 1000, 1100 may engage the stem face of the stemmed bone anchor and advance the stemmed bone anchor to position the stem of the bone anchor in a medullary canal of the bone. When advancing the stemmed bone anchor, a force may be applied to the impaction head 1012 of the jig 1000, 1100 to apply a force aligned with a longitudinal axis of the stemmed bone anchor to embed the stem in the bone.
The humeral anchors described above can be implanted following methods discussed below in connection with
1. Methods of Using the Stem Holder
Before implanting the stem 30 into the humerus H, the surgeon can prepare the humerus H. The surgeon can resect the humerus H at the anatomic neck to separate the articular surface of the humerus H from the rest of the humerus H. The separation of the articular surface from the rest of the humerus H creates a resection surface. Optionally, the surgeon can apply a protect tool, such as a plate, to the resected surface to cover the newly exposed cancellous bone. It is important to protect the newly exposed cancellous bone because this bone is to be formed in later parts of the method to have a recess having an inner profile that matches the outer or exterior and distal surface of any of the anchors (e.g., the stemless anchor or the metaphysis portion of the stemmed anchors). The surgeon can optionally remove the protect tool and size the resected humerus H to determine which size of the stem 30, 230 (or other anchors as disclosed herein) should be used for the particular patient. Following the resection step, or the optional protection and/or sizing steps, the surgeon can ream the humerus H to form a recess or cavity in the exposed cancellous bone. The reaming step can produce a stepped internal recess or cavity in the metaphysis of the humerus H shaped to receive a humeral anchor portion, e.g., the stemless anchor 103 or a metaphysis potion of a stemmed anchor 30, 230.
After the humerus H has been prepared, the surgeon can use the stem holder 900 to employ trial anchors, which can have more easily disengaged connections with a trial head assembly or trial insert assembly than would be the case in a final implant. The trial step can enable the surgeon to choose or confirm a size to be used in the final implant. During this step, the surgeon may also use the height gauge 930 to determine an appropriate stem height for the particular patient. The surgeon may couple the stem holder 900 to the trail anchor and move the wheel 942 until the marker is 950 contacts the exposed cancellous bone. Also, the surgeon may use the graft tool 800 to create any plugs 700 from the removed humeral head.
In the case of the stem 30, the stem holder 900 can grip the stem 30 in the recess thereof by engaging the tooling interfaces, e.g., the one or more apertures 51a, 51b, 53. Optionally, the surgeon can insert one or more plugs 700 into the one or more apertures 62, 64, 98 of the humeral stem 30. In the case of an elongate plug 700A, the surgeon may cut the elongate plug 700A so that the elongate plug 700A is the same length as the aperture 52, 54, 98. In the case of a plug 700B, the surgeon may insert a first plug 700B in one end of the aperture 52, 54, 98 and a second plug 700B in the other end of the aperture 52, 54, 98.
Thereafter, the distal shaft portion 32 of humeral stem 30 can be inserted through the formed recess in the resection surface and further inserted into the intramedullary canal. Once the distal shaft portion 32 is in the diaphysis of the humerus H and the metaphyseal portion 90 is in the metaphysis of the humerus H, an impaction load can be applied to the stem holder 900. In particular, an impactor, e.g., a mallet, can strike the impaction head 924 that is disposed at the proximal end 902 of the stem holder 900 driving the humeral stem 30 into firm engagement 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 impaction forces to the stem holder 900 until the marker 950 contacts the humerus H.
In the case of a stemless anchor 103, the stem holder 900 can grip the anchor in the recess thereof by engaging the tooling interfaces. Thereafter, the anchor 103 can be moved into the recess formed in the humerus H and pressed against the prepared surface. Thereafter, an impactor, e.g., a mallet, can be used to apply a load to the impaction head 924 at the proximal end 904 of the stem holder 900 and along the longitudinal axis thereof. The load can thus be directed transverse to, e.g., generally perpendicular to the plane of the resection surface that is formed in the resection step. Thus the inserting step can be achieved for a stemless implant 103 and for a stemmed implant such as the humeral stem 30, 230 using the same impactor instrument, e.g., the stem holder 900.
An impacting step can follow the previously described inserting step. The impacting step involves impacting an anatomic assembly 160, reverse articular body 180, and/or a spacer 150 into the stemmed anchor 30 (or another stemmed anchor 230). As discussed above, the kit 100 includes shared implant components. As such, the impacting step can be the same for the humeral stem 30, 230 as for the stemless anchors 103.
2. Methods of Using the Jig
In the case of the stem 30, the jig 1000 can grip the stem 30 in the stem face by engaging the tooling interfaces, e.g., the one or more apertures 51a, 51b, 53. Optionally, the surgeon can insert one or more plugs 700 into the one or more apertures 62, 64, 98 of the humeral stem 30. In the case of an elongate plug 700A, the surgeon may cut the elongate plug 700A so that the elongate plug 700A is the same length as the aperture 52, 54, 98. In the case of a plug 700B, the surgeon may insert a first plug 700B in one end of the aperture 52, 54, 98 and a second plug 700B in the other end of the aperture 52, 54, 98.
Thereafter, the distal shaft portion 32 of humeral stem 30 can be inserted through the formed recess in the resection surface and further inserted into the intramedullary canal. Once the distal shaft portion 32 is in the diaphysis of the humerus H and the metaphyseal portion 90 is in the metaphysis of the humerus H, an impaction load can be applied to the jig 1000. In particular, an impactor, e.g., a mallet, can strike the impaction head 1012 that is disposed at the proximal end 1002 of the jig 1000 driving the humeral stem 30 into firm engagement 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 impaction forces to the jig 1000 until the marker 1053 contacts the humerus H.
An impacting step can follow the previously described inserting step. The impacting step involves impacting an anatomic assembly 160, reverse articular body 180, and/or a spacer 150 into the stemmed anchor 30 (or another stemmed anchor 230). As discussed above, the kit 100 includes shared implant components. As such, the impacting step can be the same for the humeral stem 30, 230 as for the stemless anchors 103.
After the impacting step, in the case of the stem 30, a securing step can be performed. A minimal skin incision may be performed at a 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. A tool can be inserted through the channel 1072 of the drill sleeve 1070 to create a hole in the humerus H and through one of the apertures 62, 64. For example, a drill can be used to create the hole. The same or another tool can be sued to insert a screw 170 into the channel 1072 of the drill sleeve 1070 and into the previously created hole. These steps can be repeated to insert a screw 170 into the other one of the apertures 62, 64.
Thereafter, the distal arm extension 1102 can be moved to the first side of the jig 1100 (
An impacting step can follow the previously described inserting step. The impacting step involves impacting an anatomic assembly 160, reverse articular body 180, and/or a spacer 150 into the stemmed anchor 230 (or another stemmed anchor 30). As discussed above, the kit 100 includes shared implant components. As such, the impacting step can be the same for the humeral stem 30, 230 as for the stemless anchors 103.
After the impacting step, in the case of the stem 230, a securing step can be performed. A minimal skin incision may be performed at a 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 be advanced through the incised entry point to the humerus H. A tool can be inserted through the channel 1072 of the drill sleeve 1070 to create a hole in the humerus H and through one of the apertures 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 a screw 170 into the channel 1072 of the drill sleeve 1070 and into the previously created hole. These steps can be repeated to insert a screw 170 into the other ones of the apertures 262, 264, 265, 267, 269, as needed.
Although certain embodiments have been described herein, the implants and methods described herein can interchangeably use any articular component, as the context may dictate.
As used herein, the relative terms “proximal” and “distal” shall be defined from the perspective of the implant. Thus, proximal refers to the direction of the articular component and distal refers to the direction of an anchor component, such as a stem of a humeral anchor or a thread or porous surface or other anchoring structure of a stemless anchor when the implant is assembled.
Conditional language, such as “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements, and/or steps. Thus, such conditional language is not generally intended to imply that features, elements, and/or steps are in any way required for one or more embodiments.
The terms “comprising,” “including,” “having,” and the like are synonymous and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list. In addition, the articles “a,” “an,” and “the” as used in this application and the appended claims are to be construed to mean “one or more” or “at least one” unless specified otherwise.
The ranges disclosed herein also encompass any and all overlap, sub-ranges, and combinations thereof. Language such as “up to,” “at least,” “greater than,” “less than,” “between,” and the like includes the number recited. Numbers preceded by a term such as “about” or “approximately” include the recited numbers and should be interpreted based on the circumstances (e.g., as accurate as reasonably possible under the circumstances, for example ±5%, ±10%, ±15%, etc.). For example, “about 1” includes “1.” Phrases preceded by a term such as “substantially,” “generally,” and the like include the recited phrase and should be interpreted based on the circumstances (e.g., as much as reasonably possible under the circumstances). For example, “substantially spherical” includes “spherical.” Unless stated otherwise, all measurements are at standard conditions including temperature and pressure.
As used herein, a phrase referring to “at least one of” a list of items refers to any combination of those items, including single members. As an 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. Conjunctive language such as the phrase “at least one of X, Y and Z,” unless specifically stated otherwise, is otherwise understood with the context as used in general to convey that an item, term, etc. may be at least one of X, Y or Z. Thus, such conjunctive language is not generally intended to imply that certain embodiments require at least one of X, at least one of Y and at least one of Z to each be present.
Although certain 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 the present disclosure, the elements of which are to be understood as being differently combined and/or modified to form still further embodiments or acceptable examples. All such modifications and variations are intended to be included herein within the scope of this disclosure. A wide variety of designs and approaches are possible. No feature, structure, or step disclosed herein is essential or indispensable.
Some embodiments have been described in connection with 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 bear an exact relationship to actual dimensions and layout of the devices illustrated. Components can be added, removed, and/or rearranged. Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like in connection with various embodiments can be used in all other embodiments set forth herein. Additionally, it will be recognized that any methods described herein may be practiced using any device suitable for performing the recited steps.
For purposes of this disclosure, certain aspects, advantages, and novel features are described herein. It is to be understood that not necessarily all such advantages may be achieved in accordance with any particular embodiment. Thus, for example, those skilled in the art will recognize that the disclosure may be embodied or carried out in a manner that achieves one advantage or a group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.
Although these inventions have been disclosed in the context of certain preferred embodiments and examples, it will be understood by those skilled in the art that the present inventions extend beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the inventions and obvious modifications and equivalents thereof. In addition, while several variations of the inventions have been shown and described in detail, other modifications, which are within the scope of these inventions, will be readily apparent to those of skill in the art based upon this disclosure. It is also contemplated that various combination or sub-combinations of the specific features and aspects of the embodiments may be made and still fall within the scope of the inventions. It should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the disclosed inventions. Further, the actions of the disclosed processes and methods may be modified in any manner, including by reordering actions and/or inserting additional actions and/or deleting actions. Thus, it is intended that the scope of at least some of the present inventions herein disclosed should not be limited by the particular disclosed embodiments described above. The limitations are to be interpreted broadly based on the language employed and not limited to the examples described in the present specification or during the prosecution of the application, which examples are to be construed as non-exclusive.
Any methods disclosed herein need not be performed in the order recited. The methods disclosed herein include certain actions taken by a practitioner; however, they can also include any third-party instruction of those actions, either expressly or by implication. For example, actions such as “coupling a glenoid guide with the glenoid rim” include “instructing coupling of a glenoid guide with a glenoid rim.”
This application is a continuation-in-part of International Application No. PCT/US2022/070304, filed on Jan. 24, 2022, which claims benefit to U.S. Provisional Application No. 63/200,608, filed Mar. 17, 2021, the disclosures of which are incorporated herein by reference in their entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63200608 | Mar 2021 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US22/70304 | Jan 2022 | US |
| Child | 18369138 | US |
